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ok thanks at least i know who i'm dealing with.
How can Bristol-Myers Squibb NOT be in on it,its one of their main revenue producing drugs.They are into everything they dont miss a trick they must be in on it.The US patent office has nothing on Ovarian or a {SINGLE NUCLEOTIDE POLYMORPHISMS AND COMBINATIONS THEREOF PREDICTIVE FOR PACLITAXEL RESPONSIVENESS}well it did.The patent # was 60/334,310 and 60/410,363 now its gone and no follow up,ya thats right.With a international Patent App.# pct/us02/38345 I'm sorry but there's something more here than what meets the eye. Its all hanging on "Once funding sufficient to screen 250 patients at $1,000 per patient is received" a very small thread indeed.
bag8ger, Thanks for the info.My best to you
Nice work Worktoplay
where's Ovarian and PACLITAXEL RESPONSIVENESS classifier
A bigger bunch of bull i never heard. Something is up.
Oh ya i get it Dnap has so much revenue comming in they dont need the PACLITAXEL classifier
There's even a international App. for the Patent on PACLITAXEL RESPONSIVENESS and now nothing. Can it be Tony has something coming up like real soon on it.
Tony has said more than once that there are patents that he wants no one to know about.How he can take a patent like the one for PACLITAXEL RESPONSIVENESS as far as he did and just have it drop out of sight - no where to be found is beyond me.Here's a comp. who for years put a lot into the making this happen,Time,money,trials etc. and like magic its gone.Can it be that the patent for paclitaxel Responce is closer than most of us think ???? Why did Tony in the beginning say it would be out before Statnome than later change his mind. There is nothing anywhere on this stuff. Before it was on the Dnap web site, the US patent office had it. There was info. out at hand, Now there's nothing, WHY.
INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
(11) WO 03/045227
REVISED VERSION
(13) A3
(21) PCT/US02/38345
(22) 26 November 2002 (26.11.2002)
(25) English
(26) English
(30) 60/334,310 28 November 2001
(28.11.2001) US
(30) 60/410,363 11 September 2002
(11.09.2002) US
(43) 05 June 2003 (05.06.2003)
(51)7 C12Q 1/68, C12P 19/34, C12M 1/34, C07H 21/04
(54) SINGLE NUCLEOTIDE POLYMORPHISMS AND COMBINATIONS THEREOF PREDICTIVE FOR PACLITAXEL RESPONSIVENESS
(71) DNAPRINT GENOMICS, INC. [US/US]; 900 Cocoanut Avenue, Sarasota, FL 34236 (US).
(72)
(75) FRUDAKIS, Tony, N. [US/US]; 3707 Plumosa Terrace, Bradenton, FL 34210 (US).
(74) HAILE, Lisa, A.; Gary Cary Ware & Friedenrich LLP, Suite 1100, 4365 Executive Drive, San Diego, CA 92121-2133 (US).
(81) AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, OM, PH, PL, PT, RO, RU, SC, SD, SE, SG, SI, SK, SL, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, YU, ZA, ZM, ZW
(84) ARIPO patent (GH, GM, KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian patent (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European patent (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, SK, TR), OAPI patent (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
For information on time limits for entry into the national phase please click here
Published
-- with international search report
-- before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments
(88) 21 August 2003 (21.08.2003)
(57) Single nucleotide polymorphisms (SNPs) and combinations of SNPs that allow an inference as to whether a cancer patient is likely to respond or not respond to paclitaxel (Taxol®) are provided. Also provided are methods of determining a whether a cancer patient should be treated with paclitaxel.
eye color for Aug.; Hair color for Dec.;skin color or shade in Nov.; Me Rich in Jan.2005
Is it Retinome tm or Ancestryby DNA 3.0 ??
Eye color out my guess in Aug. 2004
Eye,hair and skin for 2004 = 2005 $$$$$$$$$$$
If you know Dnap has in its hand ready to market, A Patent approved, FDA approved Statnome Classifier but wants a shareholder approval vote for a 7 to 1 RS before its released, would you vote - Yes
Do you really think with a 500 million Float in one hand and a Patent approval for Statnome Classifier with FDA approval in the other hand,and Dnap wanting to get on Nasdx will not first do a RS ????? I dont know But I would !!
500 Million Float - NO PROBLEM - with Statnome
My guess for statnome approval time frame = In 2002 there were 15 Steps completed. In 2003 there were 3 more up to July.Now From Aug.2003 to Dec. add 7 more {because thats the way it went in 2002} that puts us at 18+7=26 in Dec.2003.Add say 3 more for Jan & Feb. thats 29 steps going into March 2004. Ave Steps to a Ave. approval time ---Somewhere between 45 and 55 steps.So Far with 29 steps over a 2 year time frame thats 15 steps a year ave. Sothat leaves us with for 2004 {15-3=12 more to the end of this year thats 29+12=41 steps completed by end of 2004 That puts us some where around mid 2005 for a Statnome Patent approval is my guess, say between July 2005 and July 2007.
Plant Patents
The law also provides for the granting of a patent to anyone who has invented or discovered and asexually reproduced any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber-propagated plant or a plant found in an uncultivated state.
Asexually propagated plants are those that are reproduced by means other than from seeds, such as by the rooting of cuttings, by layering, budding, grafting, inarching, etc.
With reference to tuber-propagated plants, for which a plant patent cannot be obtained, the term “tuber” is used in its narrow horticultural sense as meaning a short, thickened portion of an underground branch. Such plants covered by the term “tuber-propagated” are the Irish potato and the Jerusalem artichoke.
An application for a plant patent consists of the same parts as other applications. The term of a plant patent shall be 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application under 35 U.S.C. 120, 121 or 365(c), from the date of the earliest such application was filed.
The specification should include a complete detailed description of the plant and the characteristics thereof that distinguish the same over related known varieties, and its antecedents, expressed in botanical terms in the general form followed in standard botanical text books or publications dealing with the varieties of the kind of plant involved (evergreen tree, dahlia plant, rose plant, apple tree, etc.), rather than a mere broad non-botanical characterization such as commonly found in nursery or seed catalogs. The specification should also include the origin or parentage of the plant variety sought to be patented and must particularly point out where and in what manner the variety of plant has been asexually reproduced. The Latin name of the genus and species of the plant should be stated. Where color is a distinctive feature of the plant, the color should be positively identified in the specification by reference to a designated color as given by a recognized color dictionary. Where the plant variety originated as a newly found seedling, the specification must fully describe the conditions (cultivation, environment, etc.) under which the seedling was found growing to establish that it was not found in an uncultivated state.
A plant patent is granted on the entire plant. It therefore follows that only one claim is necessary and only one is permitted.
The oath or declaration required of the applicant in addition to the statements required for other applications must include the statement that the applicant has asexually reproduced the new plant variety. If the plant is a newly found plant, the oath or declaration must also state that the plant was found in a cultivated area.
Plant patent drawings are not mechanical drawings and should be artistically and competently executed. The drawing must disclose all the distinctive characteristics of the plant capable of visual representation. When color is a distinguishing characteristic of the new variety, the drawing must be in color. Two duplicate copies of color drawings must be submitted. All color drawings should include a one-inch margin at the top for Office markings when the patent is printed.
Specimens of the plant variety, its flower or fruit, should not be submitted unless specifically called for by the examiner.
The filing fee on each plant application and the issue fee can be found in the fee schedule. For a qualifying small entity filing and issue fees are reduced by half. Plant patent applications may be published pursuant to Title 35, United States Code, Section 122(b), but the publication is not reduced for small entities.
All inquiries relating to plant patents and pending plant patent applications should be directed to the United States Patent and Trademark Office and not to the Department of Agriculture.
The Plant Variety Protection Act (Public Law 91577), approved December 24, 1970, provides for a system of protection for sexually reproduced varieties, for which protection was not previously provided, under the administration of a Plant Variety Protection Office within the Department of Agriculture. Requests for information regarding the protection of sexually reproduced varieties should be addressed to Commissioner, Plant Variety Protection Office, Agricultural Marketing Service, National Agricultural Library Bldg., Room 0, 10301 Baltimore Blvd., Beltsville, Md. 20705-2351.
Maintenance Fees
All utility patents that issue from applications filed on and after December 12, 1980 are subject to the payment of maintenance fees which must be paid to maintain the patent in force. These fees are due at 3 1/2, 7 1/2 and 11 1/2 years from the date the patent is granted and can be paid without a surcharge during the “window-period” which is the six-month period preceding each due date, e.g., three years to three years and six months. (See fee schedule for a list of maintenance fees.) In submitting maintenance fees and any necessary surcharges, identification of the patents for which maintenance fees are being paid must include the patent number, and the application number of the U.S. application for the patent on which the maintenance fee is being paid. If the payment includes identification of only the patent number, the Office may apply payment to the to the patent identified by patent number in the payment or the Office may return the payment. (See 37, Code of Federal Regulations, section 1.366(c).)
Failure to pay the current maintenance fee on time may result in expiration of the patent. A six-month grace period is provided when the maintenance fee may be paid with a surcharge. The grace period is the six-month period immediately following the due date. The USPTO does not mail notices to patent owners that maintenance fees are due. If, however, the maintenance fee is not paid on time, efforts are made to remind the responsible party that the maintenance fee may be paid during the grace period with a surcharge.
Patent Office Action
The applicant is notified in writing of the examiner’s decision by an Office “action” which is normally mailed to the attorney or agent of record. The reasons for any adverse action or any objection or requirement are stated in the Office action and such information or references are given as may be useful in aiding the applicant to judge the propriety of continuing the prosecution of his/her application.
If the claimed invention is not directed to patentable subject matter, the claims will be rejected. If the examiner finds that the claimed invention lacks novelty or differs only in an obvious manner from what is found in the prior art, the claims may also be rejected. It is not uncommon for some or all of the claims to be rejected on the first Office action by the examiner, relatively few applications are allowed as filed.
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Applicant’s Reply
The applicant must request reconsideration in writing, and must distinctly and specifically point out the supposed errors in the examiner’s Office action. The applicant must reply to every ground of objection and rejection in the prior Office action. The applicant’s reply must appear throughout to be a bona fide attempt to advance the case to final action or allowance. The mere allegation that the examiner has erred will not be received as a proper reason for such reconsideration.
In amending an application in reply to a rejection, the applicant must clearly point out why he/she thinks the amended claims are patentable in view of the state of the art disclosed by the prior references cited or the objections made. He/she must also show how the claims as amended avoid such references or objections. After reply by the applicant, the application will be reconsidered, and the applicant will be notified as to the status of the claims, that is, whether the claims are rejected, or objected to, or whether the claims are allowed, in the same manner as after the first examination. The second Office action usually will be made final.
Interviews with examiners may be arranged, but an interview does not remove the necessity of replying to Office actions within the required time.
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Final Rejection
On the second or later consideration, the rejection or other action may be made final. The applicant’s reply is then limited to appeal in the case of rejection of any claim and further amendment is restricted. Petition may be taken to the Director in the case of objections or requirements not involved in the rejection of any claim. Reply to a final rejection or action must include cancellation of, or appeal from the rejection of, each claim so rejected and, if any claim stands allowed, compliance with any requirement or objection as to form. In making such final rejection, the examiner repeats or states all grounds of rejection then considered applicable to the claims in the application.
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Amendments to Application
Following are some details concerning amendments to the application: The applicant may amend before or after the first examination and action as specified in the rules, or when and as specifically required by the examiner.
After final rejection or action, amendments may be made canceling claims or complying with any requirement of form which has been made in an Office action. The admission of any such amendment or its refusal, and any proceedings relative thereto, shall not operate to relieve the application from its condition as subject to appeal or to save it from abandonment. If amendments touching the merits of the application are presented after final rejection, or after appeal has been taken, or when such amendment might not otherwise be proper, they may be admitted upon a showing of good and sufficient reasons why they are necessary and were not earlier presented.
No amendment can be made as a matter of right in appealed cases. After decision on appeal, amendments can only be made as provided in the rules.
The specifications, claims, and drawing must be amended and revised when required, to correct inaccuracies of description and definition or unnecessary words, and to provide substantial correspondence between the claims, the description, and the drawing. All amendments of the drawings or specifications, and all additions thereto must not include new matter beyond the original disclosure. Matter not found in either, involving a departure from or an addition to the original disclosure, cannot be added to the application even though supported by a supplemental oath or declaration, and can be shown or claimed only in a separate application.
Amendments to the specification must be made by the submission of clean new or replacement paragraph(s), section(s), specification, or claim(s). This practice will provide a specification (including claims) in clean, or substantially clean, form that can be effectively captured and converted by optical character recognition (OCR) scanning during the patent printing process. This practice requires applicant to provide, in addition to the clean version of a replacement paragraph/section/claim, a marked-up version using applicant’s choice of a conventional marking system to indicate the changes, which will aid the examiner in identifying the changes that have been made. The marked-up version must be based on the previous version and indicate (by markings) how the previous version has been modified to produce the clean version submitted in the current amendment. The term “previous version” means the version of record in the application as originally filed or from a previously entered amendment. In addition, when presenting new or amended claims, the applicant must point out how they avoid any reference or ground rejection of record, which may be pertinent, in a remarks/arguments section.
The following format is suggested in an amendment paper: (1) a clean version of each replacement paragraph/section/claim with clear instructions for entry, (2) starting on a separate page, any remarks/arguments (37 CFR 1.111 and MPEP 714), and (3) starting on a separate page, a marked-up version entitled “Version with markings to show changes made.”
No change in the drawing may be made except by permission of the Office. Changes in the construction shown in any drawing may be made only by submitting new drawings. A sketch in permanent ink showing proposed changes, to become part of the record, must be filed for approval by the Office before the new drawings are filed. The paper requesting amendments to the drawing should be separate from other papers.
The original numbering of the claims must be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When claims are added by amendment or substituted for canceled claims, they must be numbered by the applicant consecutively beginning with the number next following the highest numbered claim previously presented. When the application is ready for allowance, the examiner, if necessary, will renumber the claims consecutively in the order in which they appear or in such order as may have been requested by applicant.
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Time for Reply and Abandonment
The reply of an applicant to an action by the Office must be made within a prescribed time limit. The maximum period for reply is set at six months by the statute which also provides that the Director may shorten the time for reply to not less than 30 days. The usual period for reply to an Office action is three months. A shortened time for reply may be extended up to the maximum six-month period. An extension of time fee is normally required to be paid if the reply period is extended. The amount of the fee is dependent upon the length of the extension. Extensions of time are generally not available after an application has been allowed. If no reply is received within the time period, the application is considered as abandoned and no longer pending. However, if it can be shown that the failure to prosecute was unavoidable or unintentional, the application may be revived by the Director. The revival requires a petition to the Director, and a fee for the petition, which must be filed without delay. The proper reply must also accompany the petition if it has not yet been filed.
Publication of Patent Applications
Publication of patent applications is required by the American Inventors Protection Act of 1999 for most plant and utility patent applications filed on or after November 29, 2000. On filing of a plant or utility application on or after November 29, 2000, an applicant may request that the application not be published, but only if the invention has not been and will not be the subject of an application filed in a foreign country that requires publication 18 months after filing (or earlier claimed priority date) or under the Patent Cooperation Treaty. Publication occurs after expiration of an 18-month period following the earliest effective filing date or priority date claimed by an application. Following publication, the application for patent is no longer held in confidence by the Office and any member of the public may request access to the entire file history of the application.
As a result of publication, an applicant may assert provisional rights. These rights provide a patentee with the opportunity to obtain a reasonable royalty from a third party that infringes a published application claim provided actual notice is given to the third party by applicant, and a patent issues from the application with a substantially identical claim. Thus, damages for pre-patent grant infringement by another are now available.
Provisional Application for a Patent
Since June 8, 1995, the USPTO has offered inventors the option of filing a provisional application for patent which was designed to provide a lower cost first patent filing in the United States and to give U.S. applicants parity with foreign applicants. Claims and oath or declaration are NOT required for a provisional application. Provisional application provides the means to establish an early effective filing date in a patent application and permits the term “Patent Pending” to be applied in connection with the invention. Provisional applications may not be filed for design inventions.
The filing date of a provisional application is the date on which a written description of the invention, drawings if necessary, and the name of the inventor(s) are received in the USPTO. To be complete, a provisional application must also include the filing fee, and a cover sheet specifying that the application is a provisional application for patent. The applicant would then have up to 12 months to file a non-provisional application for patent as described above. The claimed subject matter in the later filed non-provisional application is entitled to the benefit of the filing date of the provisional application if it has support in the provisional application. If a provisional application is not filed in English, then any non-provisional application claiming priority to the provisional application must have a translation of the provisional application filed therein. See title 37, Code of Federal Regulations, Section 1.78(a)(5).
Provisional applications are NOT examined on their merits. A provisional application will become abandoned by the operation of law 12 months from its filing date. The 12-month pendency for a provisional application is not counted toward the 20-year term of a patent granted on a subsequently filed non-provisional application which relies on the filing date of the provisional application.
A surcharge is required for filing the basic filing fee or the cover sheet on a date later than the filing of the provisional application.
A brochure on Provisional Application for Patent is available by calling the USPTO General Information Services at 1-800-786-9199 or 703-308-4357 or by accessing USPTO’s Web site at http://www.uspto.gov/.
What Is a Patent?
A patent for an invention is the grant of a property right to the inventor, issued by the United States Patent and Trademark Office. Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States or, in special cases, from the date an earlier related application was filed, subject to the payment of maintenance fees. U.S. patent grants are effective only within the United States, U.S. territories, and U.S. possessions. Under certain circumstances, patent term extensions or adjustments may be available.
The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. What is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. Once a patent is issued, the patentee must enforce the patent without aid of the USPTO.
There are three types of patents:
Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or compositions of matters, or any new useful improvement thereof;
Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture; and
Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plants.
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What Is a Trademark or Servicemark?
A trademark is a word, name, symbol, or device that is used in trade with goods to indicate the source of the goods and to distinguish them from the goods of others. A servicemark is the same as a trademark except that it identifies and distinguishes the source of a service rather than a product. The terms “trademark” and “mark” are commonly used to refer to both trademarks and servicemarks.
Trademark rights may be used to prevent others from using a confusingly similar mark, but not to prevent others from making the same goods or from selling the same goods or services under a clearly different mark. Trademarks which are used in interstate or foreign commerce may be registered with the USPTO. The registration procedure for trademarks and general information concerning trademarks is described in a separate pamphlet entitled “Basic Facts about Trademarks.”
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What Is a Copyright?
Copyright is a form of protection provided to the authors of “original works of authorship” including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished. The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the copyrighted work, to prepare derivative works, to distribute copies or phonorecords of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.
The copyright protects the form of expression rather than the subject matter of the writing. For example, a description of a machine could be copyrighted, but this would only prevent others from copying the description; it would not prevent others from writing a description of their own or from making and using the machine. Copyrights are registered by the Copyright Office of the Library of Congress.
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Patent Laws
The Constitution of the United States gives Congress the power to enact laws relating to patents, in Article I, section 8, which reads “Congress shall have power . . . to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” Under this power Congress has from time to time enacted various laws relating to patents. The first patent law was enacted in 1790. The patent laws underwent a general revision which was enacted July 19, 1952, and which came into effect January 1, 1953. It is codified in Title 35, United States Code. Additionally, on November 29, 1999, Congress enacted the American Inventors Protection Act of 1999 (AIPA), which further revised the patent laws. See Public Law 106-113, 113 Stat. 1501 (1999).
The patent law specifies the subject matter for which a patent may be obtained and the conditions for patentability. The law establishes the United States Patent and Trademark Office to administer the law relating to the granting of patents and contains various other provisions relating to patents.
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What Can Be Patented
The patent law specifies the general field of subject matter that can be patented and the conditions under which a patent may be obtained.
In the language of the statute, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act or method, and primarily includes industrial or technical processes. The term “machine” used in the statute needs no explanation. The term “manufacture” refers to articles that are made, and includes all manufactured articles. The term “composition of matter” relates to chemical compositions and may include mixtures of ingredients as well as new chemical compounds. These classes of subject matter taken together include practically everything that is made by man and the processes for making the products.
The Atomic Energy Act of 1954 excludes the patenting of inventions useful solely in the utilization of special nuclear material or atomic energy for atomic weapons.
The patent law specifies that the subject matter must be “useful.” The term “useful” in this connection refers to the condition that the subject matter has a useful purpose and also includes operativeness, that is, a machine which will not operate to perform the intended purpose would not be called useful, and therefore would not be granted a patent.
Interpretations of the statute by the courts have defined the limits of the field of subject matter that can be patented, thus it has been held that the laws of nature, physical phenomena, and abstract ideas are not patentable subject matter.
A patent cannot be obtained upon a mere idea or suggestion. The patent is granted upon the new machine, manufacture, etc., as has been said, and not upon the idea or suggestion of the new machine. A complete description of the actual machine or other subject matter for which a patent is sought is required.
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Novelty And Non-Obviousness, Conditions For Obtaining A Patent
In order for an invention to be patentable it must be new as defined in the patent law, which provides that an invention cannot be patented if: “(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent,” or “(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country more than one year prior to the application for patent in the United States . . .”
If the invention has been described in a printed publication anywhere in the world, or if it has been in public use or on sale in this country before the date that the applicant made his/her invention, a patent cannot be obtained. If the invention has been described in a printed publication anywhere, or has been in public use or on sale in this country more than one year before the date on which an application for patent is filed in this country, a patent cannot be obtained. In this connection it is immaterial when the invention was made, or whether the printed publication or public use was by the inventor himself/herself or by someone else. If the inventor describes the invention in a printed publication or uses the invention publicly, or places it on sale, he/she must apply for a patent before one year has gone by, otherwise any right to a patent will be lost. The inventor must file on the date of public use or disclosure, however, in order to preserve patent rights in many foreign countries.
Even if the subject matter sought to be patented is not exactly shown by the prior art, and involves one or more differences over the most nearly similar thing already known, a patent may still be refused if the differences would be obvious. The subject matter sought to be patented must be sufficiently different from what has been used or described before that it may be said to be nonobvious to a person having ordinary skill in the area of technology related to the invention. For example, the substitution of one color for another, or changes in size, are ordinarily not patentable.
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The United States Patent And Trademark Office
Congress established the United States Patent and Trademark Office (USPTO or Office) to issue patents on behalf of the government. The Patent Office as a distinct bureau dates from the year 1802 when a separate official in the Department of State who became known as “Superintendent of Patents” was placed in charge of patents. The revision of the patent laws enacted in 1836 reorganized the Patent Office and designated the official in charge as Commissioner of Patents. The Patent Office remained in the Department of State until 1849 when it was transferred to the Department of Interior. In 1925 it was transferred to the Department of Commerce where it is today. In 1975, the name of the Patent Office was changed to the Patent and Trademark Office.
The United States Patent and Trademark Office administers the patent laws as they relate to the granting of patents for inventions, and performs other duties relating to patents. It examines applications for patents to determine if the applicants are entitled to patents under the law and grants the patents when they are so entitled; it publishes issued patents, most patent applications filed on or after November 29, 2000, at 18 months from the earliest filing date, and various publications concerning patents; records assignments of patents; maintains a search room for the use of the public to examine issued patents and records; and supplies copies of records and other papers, and the like. Similar functions are performed with respect to the registration of trademarks. The USPTO has no jurisdiction over questions of infringement and the enforcement of patents, nor over matters relating to the promotion or utilization of patents or inventions.
The head of the Office is the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (Director). The Director’s staff includes the Deputy Under Secretary of Commerce and Deputy Director of the USPTO, the Commissioner for Patents, the Commissioner for Trademarks, and other officials. As head of the Office, the Director superintends or performs all duties respecting the granting and issuing of patents and the registration of trademarks; exercises general supervision over the entire work of the USPTO; prescribes the rules, subject to the approval of the Secretary of Commerce, for the conduct of proceedings in the USPTO, and for recognition of attorneys and agents; decides various questions brought before the Office by petition as prescribed by the rules; and performs other duties necessary and required for the administration of the United States Patent and Trademark Office.
The work of examining applications for patents is divided among a number of examining technology centers (TC), each TC having jurisdiction over certain assigned fields of technology. Each TC is headed by group directors and staffed by examiners and support staff. The examiners review applications for patents and determine whether patents can be granted. An appeal can be taken to the Board of Patent Appeals and Interferences from their decisions refusing to grant a patent, and a review by the Director of the USPTO may be had on other matters by petition. The examiners also identify applications that claim the same invention and may initiate proceedings, known as interferences, to determine who was the first inventor.
In addition to the examining TCs, other offices perform various services, such as receiving and distributing mail, receiving new applications, handling sales of printed copies of patents, making copies of records, inspecting drawings, and recording assignments. At present, the USPTO has over 6,000 employees, of whom about half are examiners and others with technical and legal training. Patent applications are received at the rate of over 300,000 per year. The Office receives over five million pieces of mail each year.
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General Information and Correspondence
All business with the United States Patent and Trademark Office (USPTO or Office) should be transacted in writing and all correspondence relating to patent matters should be addressed to “ COMMISSIONER FOR PATENTS, P.O. Box 1450; Alexandria, VA 22313-1450.” If a special mail box is appropriate, the special mailbox should also be used. Mail properly addressed to different mail boxes should be mailed separately to ensure proper routing. For example, after final correspondence should be mailed to “Mail Stop AF, Commissioner for Patents; P.O. Box 1450; Alexandria, VA 22313-1450,” and assignments should be mailed to “Mail Stop Assignment Services, Director of the U.S. Patent and Trademark Office; P.O. Box 1450; Alexandria, VA 22313-1450.” Correspondents should be sure to include their full return addresses, including zip codes. The principal location of the USPTO is Crystal Plaza 3, 2021 Jefferson Davis Highway, Arlington, Virginia. The personal presence of applicants at the USPTO is unnecessary.
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Library, Search Room Searches and Patent and Trademark Depository Libraries
The Scientific and Technical Information Center of the United States Patent and Trademark Office located at Crystal Plaza 3, 2C01, 2021 Jefferson Davis Highway, Arlington, VA, has available for public use over 120,000 volumes of scientific and technical books in various languages, about 90,000 bound volumes of periodicals devoted to science and technology, the official journals of 77 foreign patent organizations, and over 40 million foreign patents on paper, microfilm, microfiche, and CD-ROM. The Scientific and Technical Information Center is open to the public from 8:30 a.m. to 5:00 p.m., Monday through Friday except federal holidays.
The Patent Search Room located at Crystal Plaza 3, 1A01, 2021 Jefferson Davis Highway, Arlington, VA, is where the public may search and examine U.S. patents granted since 1790. Patents are arranged according to the U.S. Patent Classification System of over 400 classes and over 136,000 subclasses. By searching in these classified groupings of patents, it is possible to determine, before actually filing an application, whether an invention has been anticipated by a U.S. patent, and it is also possible to obtain the information contained in patents relating to any field of endeavor. The Patent Search Room contains a set of U.S. patents arranged in numerical order and a complete set of the Official Gazette.
A Files Information Room also is maintained where the public may inspect the records and files of issued patents and other open records. Applicants, their attorneys or agents, and the general public are not entitled to use the records and files in the examiners’ rooms. The Patent Search Room is open from 8 a.m. to 8 p.m. Monday through Friday except on federal holidays.
Many inventors attempt to make their own search of the prior patents and publications before applying for a patent. This may be done in the Patent Search Room of the USPTO, and in libraries, located throughout the United States, which have been designated as Patent and Trademark Depository Libraries (PTDLs). An inventor may make a preliminary search through the U.S. patents and publications to discover if the particular invention or one similar to it has been shown in the prior patent. An inventor may also employ patent attorneys or agents to perform the preliminary search. This search may not be as complete as that made by the USPTO during the examination of an application, but only serves, as its name indicates, a preliminary purpose. For this reason, the patent examiner may, and often does, reject claims in an application on the basis of prior patents or publications not found in the preliminary search.
Those who cannot come to the Patent Search Room may order from the USPTO copies of lists of original patents or of cross-referenced patents contained in the subclasses comprising the field of search, or may inspect and obtain copies of the patents at a Patent and Trademark Depository Library. The PTDLs receive current issues of U.S. patents and maintain collections of earlier issued patent and trademark information. The scope of these collections varies from library to library, ranging from patents of only recent years to all or most of the patents issued since 1790.
These patent collections are open to public use. Each of the PTDLs, in addition, offers the publications of the U.S. Patent Classification System (e.g., Manual of Classification, Index to the U.S. Patent Classification System, Classification Definitions, etc.) and other patent documents and forms, and provides technical staff assistance in their use to aid the public in gaining effective access to information contained in patents. The collections are organized in patent number sequence.
Available in all PTDLs is the Cassis CD-ROM system. With various files, it permits the effective identification of appropriate classifications to search, provides numbers of patents assigned to a classification to facilitate finding the patents in a numerical file of patents, provides the current classification(s) of all patents, permits word searching on classification titles, and on abstracts, and provides certain bibliographic information on more recently issued patents.
Facilities for making paper copies from microfilm, the paper bound volumes or CD-ROM are generally provided for a fee.
Due to variations in the scope of patent collections among the PTDLs and in their hours of service to the public, anyone contemplating the use of the patents at a particular library is advised to contact that library, in advance, about its collection, services, and hours, so as to avert possible inconvenience. For a complete list of PTDLs, refer to the USPTO Web site at www.uspto.gov.
A provisional application for patent (provisional application) has a pendency lasting 12 months from the date the provisional application is filed. The 12-month pendency period cannot be extended. Therefore, an applicant who files a provisional application must file a corresponding non-provisional application for patent (non-provisional application) during the 12-month pendency period of the provisional application in order to benefit from the earlier filing of the provisional application. In accordance with 35 U.S.C. §119(e), the corresponding non-provisional application must contain or be amended to contain a specific reference to the provisional application.
Once a provisional application is filed, an alternative to filing a corresponding non-provisional application is to convert the provisional application to a non-provisional application by filing a grantable petition under 37 CFR §1.53(c)(3) requesting such a conversion within 12 months of the provisional application filing date.
However, converting a provisional application to a non-provisional application (versus filing a non-provisional application claiming the benefit of the provisional application) will have a negative impact on patent term. The term of a patent issuing from a non-provisional application resulting from the conversion of a provisional application will be measured from the original filing date of the provisional application.
By filing a provisional application first, and then filing a corresponding non-provisional application that references the provisional application within the 12-month provisional application pendency period, a patent term endpoint may be extended by as much as 12 months.
The later-filed nonprovisional application claiming the benefit of the provisional application must include at least one claim particularly pointing out and distinctly claiming the subject matter which the applicant regards as the invention. See 35 U.S.C. 112, 2nd paragraph. Although a claim is not required in a provisional application, the written description and any drawing(s) of the provisional application must adequately support the subject matter claimed in the later filed nonprovisional application in order to benefit from the provisional application filing date. Therefore, care should be taken to ensure that the disclosure filed as the provisional application adequately provides a written description of the full scope of the subject matter regarded as the invention and desired to be claimed in the later filed nonprovisional application. Additionally the specification shall disclose the manner and process of making and using the invention, in such full, clear, concise and exact terms as to enable any person skilled in the art to which the invention pertains to make and use the invention and set forth the best mode contemplated for carrying out the invention. See 35 U.S.C. 112, 1st paragraph. Back to Top
Provisional Application for Patent Filing Date Requirements
The provisional application must be made in the name(s) of all of the inventor(s). It can be filed up to one year following the date of first sale, offer for sale, public use, or publication of the invention. (These pre-filing disclosures, although protected in the United States, may preclude patenting in foreign countries.)
A filing date will be accorded to a provisional application only when it contains:
a written description of the invention, complying with all requirements of 35 U.S.C. §112 ¶ 1 and
any drawings necessary to understand the invention, complying with 35 U.S.C. §113.
If either of these items are missing or incomplete, no filing date will be accorded to the provisional application.
To be complete, a provisional application must also include the filing fee as set forth in 37 C. F. R. 1.16(k) and a cover sheet identifying:
the application as a provisional application for patent;
the name(s) of all inventors;
inventor residence(s);
title of the invention;
name and registration number of attorney or agent and docket number (if applicable);
correspondence address; and
any US Government agency that has a property interest in the application.
Cover Sheet: Form PTO/SB/16, available on the printable forms page of the USPTO website at http://www.uspto.gov/web/forms/sb0016.pdf, may be used as the cover sheet for a provisional application.
This information is general in nature and is not meant to substitute for advice provided by a patent practitioner. Applicants unfamiliar with the requirements of US patent law and procedures should consult an attorney or agent registered to practice before the USPTO.
A list of attorneys and agents can be searched at the USPTO Web site at http://www.uspto.gov and examined without charge at Patent and Trademark Depository Libraries (PTDLs). A printed list is available from the US Government Printing Office at:
Superintendent of Documents (SuDocs)
P. O. Box 371954
Pittsburgh, PA 15250-7954
For information or to order by telephone call 202-512-1800. The SuDocs Web site is at http://www.access.gpo.gov/su_docs/. Back to Top
Cautions
Provisional applications are not examined on their merits.
The benefits of the provisional application cannot be claimed if the one-year deadline for filing a non-provisional application has expired.
Provisional applications cannot claim the benefit of a previously-filed application, either foreign or domestic.
It is recommended that the disclosure of the invention in the provisional application be as complete as possible. In order to obtain the benefit of the filing date of a provisional application the claimed subject matter in the later filed non-provisional application must have support in the provisional application.
If there are multiple inventors, each inventor must be named in the application.
The inventor(s) named in the provisional application must have made a contribution to the invention as described. If multiple inventors are named, each inventor named must have made a contribution individually or jointly to the subject matter disclosed in the application.
The non-provisional application must have one inventor in common with the inventor(s) named in the provisional application to claim benefit of the provisional application filing date.
A provisional application must be entitled to a filing date and include the basic filing fee in order for a non-provisional application to claim benefit of that provisional application.
There is a surcharge for filing the basic filing fee or the cover sheet on a date later than filing the provisional application.
Provisional applications for patent may not be filed for design inventions.
Amendments are not permitted in provisional applications after filing, other than those to make the provisional application comply with applicable regulations.
No information disclosure statement may be filed in a provisional application.
A provisional application cannot result in a U. S. patent unless one of the following two events occur within 12 months of the provisional application filing date:
a corresponding non-provisional application for patent entitled to a filing date is filed that claims the benefit of the earlier filed provisional application; or
a grantable petition under 37 CFR 1.53(c)(3) to convert the provisional application into a non-provisional application is filed. Back to Top
Fee
Fees are subject to change annually. The current fee for a provisional application for patent can be found on the fee page (see 37 CFR 1.16(k)). General Information Services Division (GISD) customer service representatives are available Monday through Friday (except Federal holidays) at 800-786-9199 to provide fee information. Payment by check or money order must be made payable to "Commissioner for Patents". Mail the provisional application and filing fee to:
Mail Stop Provisional Patent Application
Commissioner for Patents
Box 1450
Alexandria, VA 22313-1450
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Features
provides simplified filing with a lower initial investment with one full year to assess the invention’s commercial potential before committing to the higher cost of filing and prosecuting a non-provisional application for patent;
establishes an official United States patent application filing date for the invention;
permits one year’s authorization to use "Patent Pending" notice in connection with the invention;
begins the Paris Convention priority year;
enables immediate commercial promotion of the invention with greater security against having the invention stolen;
preserves application in confidence without publication in accordance with 35 U.S.C. 122(b), effective November 29, 2000;
permits applicant to obtain USPTO certified copies;
allows for the filing of multiple provisional applications for patent and for consolidating them in a single §111(a) non-provisional application for patent;
provides for submission of additional inventor names by petition if omission occurred without deceptive intent (deletions are also possible by petition).
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Warnings
A provisional application automatically becomes abandoned when its pendency expires 12 months after the provisional application filing date by operation of law. Applicants must file a non-provisional application claiming benefit of the earlier provisional application filing date in the USPTO before the provisional application pendency period expires in order to preserve any benefit from the provisional-application filing.
Beware that an applicant whose invention is "in use" or "on sale" (see 35 U.S.C. §102(b)) in the United States during the one-year provisional-application pendency period may lose more than the benefit of the provisional application filing date if the one-year provisional-application pendency period expires before a corresponding non-provisional application is filed. Such an applicant may also lose the right to ever patent the invention (see 35 U.S.C. §102(b)).
Effective November 29, 2000, a claim under 35 U.S.C. 119(e) for the benefit of a prior provisional application must be filed during the pendency of the non-provisional application, and within four months of the non-provisional application filing date or within sixteen months of the provisional application filing date (whichever is later). See 37 CFR 1.78 as amended effective November 29, 2000.
Independent inventors should fully understand that a provisional application will not mature into a granted patent without further submissions by the inventor. Some invention promotion firms misuse the provisional application process leaving the inventor with no patent.
My guess for statnome approval time frame = In 2002 there were 15 Steps completed. In 2003 there were 3 more up to July.Now From Aug.2003 to Dec. add 7 more {because thats the way it went in 2002} that puts us at 18+7=26 in Dec.2003.Add say 3 more for Jan & Feb. thats 29 steps going into March 2004. Ave Steps to a Ave. approval time ---Somewhere between 45 and 55 steps.So Far with 29 steps over a 2 year time frame thats 15 steps a year ave. Sothat leaves us with for 2004 {15-3=12 more to the end of this year thats 29+12=41 steps completed by end of 2004 That puts us some where around mid 2005 for a Statnome Patent approval is my guess, say July 2005
Compositions and methods for inferring a response to statin
Search results for application number:10/188,359
Application Number: 10/188,359 Customer Number: -
Filing or 371(c) Date: 07-01-2002 Status: Docketed New Case - Ready for Examination
Application Type: Utility Status Date: 06-17-2003
Examiner Name: JOHANNSEN, DIANA B Location: ELECTRONIC
Group Art Unit: 1634 Location Date: 06-18-2003
Confirmation Number: 6205 Earliest Publication No: US 2003-0215819 A1
Attorney Docket Number: DNA1150-3 Earliest Publication Date: 11-20-2003
Class/ Sub-Class: 435/006 Patent Number: -
First Named Inventor: Tony Frudakis, Bradenton, FL (US) Issue Date of Patent: -
Title Of Invention: Compositions and methods for inferring a response to statin
Select Search Option
Continuity Data Published Documents
File History
Number Date Contents Description
18 07-09-2003 IFW TSS Processing by Tech Center Complete
17 07-02-2003 IFW TSS Processing by Tech Center Complete
16 06-17-2003 Case Docketed to Examiner in GAU
15 11-19-2002 Application Dispatched from OIPE
14 11-19-2002 Application Is Now Complete
13 11-04-2002 Payment of additional filing fee/Preexam
8 11-04-2002 CRF Disk Has Been Received by Preexam / Group / PCT
7 11-04-2002 A statement by one or more inventors satisfying the requirement under 35 USC 115, Oath of the Applic
6 09-05-2002 Notice Mailed--Application Incomplete--Filing Date Assigned
5 09-04-2002 IFW Scan & PACR Auto Security Review
4 07-25-2002 CRF Is Good Technically / Entered into Database
3 07-01-2002 Initial Exam Team nn
2 07-01-2002 CRF Disk Has Been Received by Preexam / Group / PCT
1 07-01-2002 Initial Exam Team nn
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Compositions and methods for inferring a response to statin--- http://pair.uspto.gov/cgi-bin/final/pairsearch.pl
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Compositions and methods for inferring a response to statin
---- http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsea....
bag8ger,your kindness and thoughtfulness is well received, thankyou.
terry hallinan,Your welcome. I do have an optimistic assessment of the scientific value of DNAP's technology despite numerous internal contradictions.Still I think they will do very well, there are many things still being worked on at Dnap that few people know about and were always the last to know.
The vice's of men will never stop and our divisions are by our own hand, how distasteful and sad.
Worktoplay,ok thanks but i dont think we will see anything by then and i'm sure we will continue to chat as time passes, info. being as old as it is and progress being as slow as it is,not much can be said.LOL
Worktoplay - From Post # 12744 {"The utility patents for Ovanome and Statnome are still under review at the Patent Office".} Can you please post here where you got this info. On the Ovarian patent still active at the US Patent office.Please post it.I have searched everywhere and found none on Ovarian.
Worktoplay thanks for the responce but where did you get the info on Ovarian patent ? Can you please post the site that shows the App. for ovarian is still active. Thanks for your time.I do understand what Ming was trying to do and i have no problems with it. I have a high respect for Ming. I was just giving a little feedback.
Like it or not the only thing we have for this year is Forensics products and even that will be limited to eye color comming out at best,next year hair and skin.Oh Ya maybe a Merg. for this year ?????? That it. Its a great comp. but its going to take time.My point, Patience based on a real view of things.Patience,Patience,Patience.
The only status on Statnome at the FDA is,see below.Thats it.From Dnap's WEB SITE --- {Once perfected, we believe STATINOMETM will be able to dramatically improve the rewards associated with taking statins by obviating the risks associated with adverse response. STATINOMETM is projected to enter clinical studies for FDA approval by late 2004 or early 2005.}So For Statnome to be submitted to the FDA your looking at around 2006.GoodNight
Docket Management
Docket: 02D-0018 - Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Prodcuts; Draft Guid
Comment Number: EC -2
Accepted - Volume 1
Comment Record
Commentor Dr. Tony Frudakis Date/Time 2003-02-04 10:16:39
Organization DNAPrint genomics, Inc.
Category Company
Comments for FDA General
Questions
1. General Comments It certainly is encouraging that the FDA mandates respect for quality issues related to measuring population structure and demographics, but as a geneticist, the current practice of collecting sociocultural (i.e. non-anthropological) data as described in lines 69-71 is somewhat disconcerting. For the sake of the science, and the health of all, we think it is time to incorporate molecular anthropological data metrics as well. We have three issues we would like to point out: 1. Socioeconomic or Geographical measures of “race” are not as tightly linked to drug response as Biogeographical Ancestry (BGA), which is the heritable component of “race”. 2. Because it is subjective, imprecise and sometimes inaccurate, the self-reporting of race as is currently practiced obscures how and why “race” or BGA is related to drug response. 3. The rigid binning of patients into prefabricated racial groups is a practice of generalization, which again does little for our ability to learn how BGA relates to drug response. Many US residents trace their origins to multiple populations through the process of admixture. Proportional BGA can and should be measured using molecular anthropological methods in a scientifically reproducible manner. 4. Thanks to recent advances in genome data resources and testing methods, BGA proportions can now be easily measured for less than it costs to extract DNA from a sample. Pharmacogenetics attempts to identify those specific sequences linked to variable drug response, but we already know from decades of observations that the heritable component of “race” - the biogeographical ancestry (BGA) - is an important factor in the equation (Burroughs et al., 2002, Kalow 1992). The reason for this is that genetic drift, geographical and/or reproductive isolation, and regional selective pressures have molded the allele frequencies of our ancestors for compatibility with alkaloids, tannins (self-defense chemicals) and other xenobiotics found in their indigenous diets. Most drugs are derived from these chemicals, and so it is no coincidence that the family of enzymes that that allow us to detoxify these chemicals is the same family that we use to metabolize drugs (called xenobiotic metabolism genes, of which the cytochrome P450s are the most commonly studied). However, in addition to pharmacokinetics and drug metabolism, pharmacodynamics, or how a drug mechanistically interacts with the patient is also important for understanding variable drug response. We believe pharmacodynamics to be significantly more complex to unravel, requiring whole genomes be screened not just certain gene families, and we have found that the most economical and efficacious method for screening genomes relies on the measurement of SNPs across the genome that carry information about BGA and other levels of population structure. Specifically, we use a method called Mapping by Admixture Linkage Disequilibrium (MALD), first introduced by Chakraborty and Weiss back in 1988. The method requires the ability to measure individual BGA proportions and in an effort to enable ourselves access to perform MALD, as well as to help expand the influence of this method, we developed an 80-marker test for determining BGA proportions and their confidence intervals. The basic methodology for doing this was first described by Hanis et al., 1986, but our method involves a number of important improvements. Since determining individual or group BGA proportions is also useful for reducing bias interjected during the formulation of many case-controlled study designs (Terwilliger et al., 2002), we also offer the method as a separate service to the academic genomics market (as well as to a general recreational genealogical market - see www.ancestrybydna.com for a more detailed description of the test). The test enables us to determine the relative proportionality of BGA within individuals – for example while one person may register with 80%African, 20% Native American ancestry, another may register 90% Indo European and 10% East Asian ancestry. If the primary objective of FDA approved research is to “Collect…data using standard categories to enhance patient safety” (lines 75-78), it would seem the way that population affiliation is measured today leaves a great deal to be desired. As currently measured with biographical questionnaires, little knowledge of population structure other than the obvious is obtained, and only basic connections between population structure and drug response would be apparent to the trial sponsor or the FDA. Consistency of reporting is a significant problem the FDA would like to address (line 111), but with a subjective and imprecise method of data collection, consistency would seem difficult to achieve. Rather than reformulating how questions are asked, it seems to us that consistency is better addressed by replacing the subjective nature of the exercise with objective, reproducible science. In fact, it would seem that standardization is of paramount importance for the collection of “race” data, because its measure is perhaps as subjective as for any other attribute. Specifically, the self-reporting of race is not as trivial an exercise as the self-reporting of gender. First, many people do not know what their “race” is, or are of sufficient admixture that they have trouble classifying themselves (lines 151-155). This is not uncommon here in the US, which we all know to be a melting pot. For example, a woman of European descent raised in Puerto Rico may describe herself as Hispanic and though she socio-culturally identifies with Hispanics, her xenobiotic metabolism and drug target polymorphisms would align most closely with Europeans and/or West Africans. The current guidelines potentiate this type of problem by using “nonanthropologic designations that describe the sociocultural construct of our society” (lines 69-71). Where a person was raised and lives may indeed have an impact on how they respond to a drug, so nonannthropologic metrics should still be used, but so too may BGA have an impact and this too needs to be measured accurately. Nonetheless, we (unpublished results) and others (Risch et al., 2002; Rosenberg et al., 2002) have shown that when tested against methods of reporting that rely on genome markers, majority population affiliation is quite accurately reported on questionnaires. We have amassed BGA data on over 1,700 individuals and have yet to observe a single discordant result in terms of majority ancestry (in terms of minor ancestry, family pedigrees also show concordant results). Therefore, our results suggest that the mis-reporting of majority race is not a very significant event, and that authors such as Risch and Rosenberg are correct to attach value to self-reported racial classifications, and that determination of majority ancestry affiliation is not the main problem with current self-reporting methods. The problem is that even if a patient knows their majority affiliation, classifying a patient in a single group sacrifices more subtle information related to population structure and sub-structure. Not only is this exercise inaccurate and misleading if the patient is of admixed ancestry, and many patients are, but it is also equally problematic for those who not even know that they are of admixed ancestry. We also observed considerable admixture within a significant percentage of individuals we have tested to date, and considerable structure within most majority BGA groups as well, and it is not unreasonable to suspect that this admixture may have some bearing on drug response. For example, our unpublished results using the ancestrybydna test, and those of Rosenberg et al., 2002 show there to be significant structure within the “Caucasian” or “European” population; Russians and Scandanavians commonly exhibit minor East Asian heritage (possibly through the Lapps) and numerous other examples similar to this can be found. Is this component of ancestry linked to the response of any currently FDA approved drug? Nobody knows and the way “race” is reported today, nobody will ever know. The recommended recruitment of trial participants mandated in 1993 by the NIH Revitalization Act and described in lines 288 – 300 does not allow for such information to be learned, though using tests such as that we have developed would. This problem is relevant for the FDAMA 1997 act (lines 337-346), the Demographic rule of the 21 CFR amendments of 1998 (lines 348-353), the 1999 Population Pharmacokinetics guidance (lines 355-359), in addition to others. In lines of 169-175, a separate problem is also apparent in the non-anthropological method of determining population affiliation. Individuals of the South Asian sub-continent of India are more closely linked culturally, socially and in terms of molecular genetic distance to Europeans than East Asians. The OMB Directive 15 groups them with Asians, which has meaning in a geographical but not a biogeographical context, and since the latter is more relevant for a clinical trial or any other medical practice, it is what should be measured. We suggest that the FDA should pay more attention to molecular characterization of population structure when evaluating and assisting with the construction of clinical trials. Thanks to the human genome project, we now have the means by which to determine not just majority BGA for an individual or group, but BGA proportions if the patient or group is of admixed ancestry. In fact, DNAPrint genomics performs this type of testing for less per sample than most companies pay to extract DNA from blood, and we would be happy to send a validation pack to the FDA or any other group that desires to learn more about the test. We have validated the test on parental and admixed populations, in family pedigrees, with blind challenge, repeated testing and sampling, performance on sample mixtures, and on large numbers of patients of known admixture. To be sure, collecting a buccal swab and sending it to a testing center is less convenient and more expensive than asking for self-reported race on a questionnaire (the average test costs about $160 in bulk), but given the importance of BGA to drug response which is indirectly acknowledged in recent FDA guidelines such as this, it would seem that this inconvenience would be well worth the benefits. We now have the power to get the science right, but the FDA needs to learn about and evaluate such tests so that we can utilize this power to improve our development of safe and efficacious drugs. Burroughs V.J., Maxey R.W., Levy R.A.. (2002) Racial and ethnic differences in response to medicines: towards individualized pharmaceutical treatment. J. Natl. Med. Assoc. (2002) 94:1-26. Chakraborty, R. and Weiss, K. (1988) Admixture as a tool for finding linked genes and detecting that difference from allelic association between loci. (1988) Proc. Natl. Acad. Sci. 85:9119-9123. Risch, N., Burchard, E., Ziv, E., and Tang, H..(2002) Categorization of humans in biomedical research: genes, race and disease. Genome Biology. 3:1-12. Rosenberg, N.A., Pritchard, J.K., Weber, J.L., Cann, H.M., Kidd, K.K., Zhivotovsky, L.A., and Feldman, M.W. (2002) Genetic Structure of Human Populations. Science. 298:2381-2385.
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http://www.fda.gov/ohrms/dockets/dailys/03/Feb03/020603/8004e14c.html
The Statnome patent process is not even half way completed. We would be lucky,LUCKY to have it completed by the end of next year,based on the Rate of progress in its history file.
Also there is no patent or patent app. for Ovanome.
MING THERE EXPIRED PLEASE GIVE ME A BREAK
The only Patent on Statnome is this -
Search results for publication number:US 2003-0215819 A1
Application Number: 10/188,359
Customer Number: -
Filing or 371(c) Date: 07-01-2002 Status: Docketed New Case - Ready for Examination
Application Type: Utility Status Date: 06-17-2003
Examiner Name: JOHANNSEN, DIANA B Location: ELECTRONIC
Group Art Unit: 1634 Location Date: 06-18-2003
Confirmation Number: 6205 Earliest Publication No: US 2003-0215819 A1
Attorney Docket Number: DNA1150-3 Earliest Publication Date: 11-20-2003
Class/ Sub-Class: 435/006 Patent Number: -
First Named Inventor: Tony Frudakis, Bradenton, FL (US) Issue Date of Patent: -
Title Of Invention: Compositions and methods for inferring a response to statin
Select Search Option
Continuity Data Published Documents
File History
Number Date Contents Description
18 07-09-2003 IFW TSS Processing by Tech Center Complete
17 07-02-2003 IFW TSS Processing by Tech Center Complete
16 06-17-2003 Case Docketed to Examiner in GAU
15 11-19-2002 Application Dispatched from OIPE
14 11-19-2002 Application Is Now Complete
13 11-04-2002 Payment of additional filing fee/Preexam
8 11-04-2002 CRF Disk Has Been Received by Preexam / Group / PCT
7 11-04-2002 A statement by one or more inventors satisfying the requirement under 35 USC 115, Oath of the Applic
6 09-05-2002 Notice Mailed--Application Incomplete--Filing Date Assigned
5 09-04-2002 IFW Scan & PACR Auto Security Review
4 07-25-2002 CRF Is Good Technically / Entered into Database
3 07-01-2002 Initial Exam Team nn
2 07-01-2002 CRF Disk Has Been Received by Preexam / Group / PCT
1 07-01-2002 Initial Exam Team nn
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Compositions and methods for inferring a response to statin
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History of Patent # 60/322,478 =
File History
Number Date Contents Description
5 08-31-2003 EXPIRED PROVISIONAL
4 10-19-2001 Application Dispatched from OIPE
3 10-18-2001 Correspondence Address Change
2 09-21-2001 IFW Scan & PACR Auto Security Review
1 09-13-2001 Initial Exam Team