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Re: Joseph_K post# 413321

Tuesday, 05/02/2023 3:18:36 AM

Tuesday, May 02, 2023 3:18:36 AM

Post# of 461419
I read the patent available here:
Sigma-1 receptor agonist systolic blood pressure therapy

This patent uses "Working examples", rather than "Prophetic examples", also called paper
examples, that originates from the P2a AD trial describing actual findings and was filed Nov. 28, 2018. The priority date is well before the 2020 peer reviewed paper and any disclosure of the hypertension properties of A2-73.

I believe this is first and only Anavex patent I have seen so far based on Working examples.

The way to tell if a patent is based on Working or Prophetic examples is the tense they are written in.

Prophetic Versus Working Examples Prophetic examples, also called paper examples, are typically used in a patent application to describe reasonably expected future or anticipated results. Prophetic examples describe experiments that have not in fact been
performed. Rather, they are presented in a manner that forecasts simulated or predicted results. In contrast, working examples correspond to work performed or experiments conducted that yielded actual results. The Manual of Patent Examining Procedure (MPEP) states that prophetic examples should not be described using the past tense. MPEP 608.01(p), subsection II. Prophetic examples may be written in future or present tense. This drafting technique assists readers in differentiating between actual working examples and
prophetic examples.


A Prophetic example will be written in the present or future tense and if using past tense would be rejected, whereas a Working example is described in the past tense just as we see e.g. in Example of the hypertension patent:

Example 1

Effect of 5 mg and 30 mg Once Daily dosage A2-73.
A 70 year old male that has been taking 5 mg A2-73 orally once a day exhibits a 24-hour ambulatory systolic blood pressure of 150 mg Hg. The dose of A2-73 is then increased so that the subject is administered A2-73 daily, at a dosage of 30 mg/day for a period of 25 days. His 24-hour ambulatory systolic blood pressure is then measured at 135 mg Hg and maintained indefinitely with the daily oral dose of 30 mg of A2-73.


See: The USPTO’s New Guidelines on Prophetic and Working Examples in Patent Applications and Corresponding Practices in India and China and the reference: Properly Presenting Prophetic and Working Examples in a Patent Publication.

Taking an Anavex composition of matter patent, which tends to be filed before any clinical trial data is available, uses Prophetic examples. For example: WO2018231216A1 - Anavex2-73 for the treatment of alzheimer's disease

EXAMPLE 1
[0053] A 63 year-old male presents with early signs of Alzheimer's disease. He is orally administered a pharmaceutical composition containing 30 mg ANAVEX2-73 according to an intermittent dosing regimen where each cycle includes daily administration for 10 days (dosing period) followed by 10 days of no administration (resting period). The patient is administered 30 mg ANAVEX2-73 according to the intermittent dosing regimen for 6 months. His loss of cognitive function stabilizes during that period.
EXAMPLE 2
A 58 year-old male presents with signs of early onset Alzheimer's disease. He is orally administered a pharmaceutical composition containing 50 mg ANAVEX2-73 according to an intermittent dosing regimen where each cycle includes daily administration for 10 days (dosing period) followed by 20 days of no administration (resting period). His loss of cognitive function stabilizes during that period.
EXAMPLE 3
[0054] A 60 year-old female presents with signs of early onset Alzheimer's disease. She is administered 3 mg of ANAVEX2-73 intravenously according to an intermittent dosing regimen where each cycle includes daily administration for 5 days (dosing period) followed by 20 days of no administration (resting period) for one year. Her loss of cognitive function stabilizes during that period.

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