DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 8, 10-17, 19, 20, 22, 24-29 and 36-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of anxiety, does not reasonably provide enablement for treatment of depression. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (a) the nature of the invention; (b) the breadth of the claims; (c) the state of the prior art; (d) the amount of direction provided by the inventor; (e) the existence of working examples; (f) the relative skill of those in the art; (g) whether the quantity of experimentation needed to make or use the invention based on the content of the disclosure is "undue"; and (h) the level of predictability in the art (MPEP 2164.01 (a)).
Nature of the invention and Breadth of the claims:
The claims are directed to treatment of depression comprising a step of administering to a subject an effective amount of a pridopidine and one or more compounds 1-8 as recited in claim 1. The claims are limited in scope with regards to therapeutic agent but encompass a multitude of different depressive disorders some of which are recited in claim 10.
State of the prior art and level of predictability in the art:
US 2020/0030308 teaches compounds 1-8 as impurities present in a batch of pridopidine and suggests administration of pridopidine with small amounts of impurities for treatment of Huntington’s disease and anxiety. US 2020/0030308 is silent with regards to treatment of depression.
Asia et al (Movement Disorders Clinical Practice, 2022, 9(1) 20-30) teaches pridopidine as a therapeutic agent that helps stabilize psychomotor function in patients with HD and examines adverse effects (AE) associated with pridopidine administration. In Discussion on page 27, Asia teaches:
“The rate of overall AEs, AEs that led to withdrawal and most other AEs decreased in the of pridopidine more than in the placebo, except for some adverse effects such as depression…” (sentence bridging columns 1 and 2).
Amount of direction provided by the inventor and existence of working examples:
Examples in the specification show an anti-depressive effect of pridopidine in a forced swim test and demonstrate synergistic effect on BDNF secretion when combined with compound 1 or compound 4. The other 6 claimed compounds were not tested and their effect is therefore unknown.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention:
Although the skill of those skilled in the art is high in the area of medicine and neuroscience, a person would not be able to predictably practice the claimed invention commensurate with the scope of the claims. Asia et al teach that pridopidine increased depression when compared to a placebo group. This result is contradictory to claimed subject matter and a person of ordinary skill would in fact question the efficacy of the claimed clinical intervention. The examples in the specification indicate synergistic effect of pridopidine with compounds 1 and 4, both of which have a hydroxyl group. The other compounds have not been tested and do not have a hydroxyl group. It’s unclear if the other compounds would also synergistically combine with pridopidine.
Thus, given these considerations, one of ordinary skill in the art clearly would not be able to practice the claimed method such that it can be used as contemplated in the specification without first engaging in substantial and undue experimentation. Therefore, the claims are rejected under 35 U.S.C. §112, first paragraph, as lacking and enabling disclosure.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 7, 8, 11, 12, 13, 14, 15, 16, 17, 19, 22, 25, 26, 27, 28, 29, 36-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al (US 2020/0030308).
Scope of prior art
Art teaches pharmaceutical compositions comprising pridopidine and a pridopidine analogue selected from compounds 1-7 including currently claimed compounds 1 and 4 (paragraphs [0169]- [0204]). Art teaches the composition in the form of a tablet or a capsule (paragraph [0207]) and HCl salt of pridopidine). Art also teaches once daily or mare than once daily administration of the composition to a subject for treatment of anxiety disorders (page 43, claims 21, 22) and Huntington’s disease (page 43, claims 11, 12). With regards to amount of pridopidine in the dosage unit, art teaches 22.5-315mg, which is entirely within the scope of the current claim 29.
Ascertaining the difference
Claims 7-8 – Schmidt teaches treatment of anxiety disorder, but does not list the specific anxiety disorders recited in claims 7-8.
Claims 13-17 and 19 – Schmidt teaches treatment of anxiety and Huntington’s disease, but does not identify the stage of Huntington’s disease, the number of GAG repeats in the huntingtin gene.
Claim 22 – Schmidt teaches treatment of anxiety but does not recite the symptoms associated with anxiety.
Claims 2-3 is directed to art recognized techniques for measuring anxiety. Schmidt teaches treatment of anxiety, but not how to measure the anxiety in a subject.
Obviousness
A person of ordinary skill in the art would have found it obvious to treat an anxiety disorder in a subject in need thereof by administering to said subject an effective amount of a composition comprising Pridopidine and a pridopidine analogue selected from compounds 1-8 as recited in claim 1 of Schmidt.
While Schmidt does not recite the currently claimed anxiety disorders, they are within the scope of the generic recitation of “anxiety disorder”. A skilled artisan would have found it obvious to try treating an any anxiety disorder including generalized anxiety disorder and anxiety related to PTSD. A skilled artisan would have also found it obvious to treat subjects with Huntington’s disease who experience anxiety. Treatment of both, Huntington’s disease and anxiety, is suggested by Schmidt. A skilled artisan would have found it obvious to treat anxiety in a subject with Huntington’s disease at any stage of the disease. One would expect reduction in anxiety in the subject irrespective of the stage of the Huntington’s disease. Applicants can overcome this by a showing that anxiety is reduced at claimed stages of the disease but not reduced at other stages.
Schmidt teaches treatment of an anxiety disorder, but does not recite symptoms associated with anxiety. A skilled artisan would have found it obvious to treat a subject with an anxiety disorder who is experiencing symptoms of said disorder as recited in current claim 22. One would expect that treatment of anxiety would result in relief of symptoms associated with it.
A skilled artisan would have found it obvious to utilize anxiety rating scale that is known in the art. The current specification discloses that the scales recited in claims 2-3 are known to those skilled in the art (paragraph [00105], page 18).
Conclusion
Claims 1-5, 7, 8, 10-17, 19, 20, 22, 24-29 and 36-40 are pending
Claims 1-5, 7, 8, 10-17, 19, 20, 22, 24-29 and 36-40 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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