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 .
Claims 60-72 are presented for examination.
Applicants’ drawings, information disclosure statement, and preliminary amendment filed September 20, 2024 have been received and entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 60-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,208,096 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference between the present application’s claims and the patented application’s claims lies in that the present application’s claims have additional agents, such as a second antidepressant medication and/or an antipsychotic combined with presently claimed active agent, (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone or a pharmaceutically acceptable salt thereof.
The present application’s claims would anticipate the patented application’s claims because the patented application’s claim recite “comprising” and thus opens the claim to the inclusion of additional agents.
Claims 60-72 are not allowed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 60-72 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/528,485 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the present application teaches a method for selecting a treatment for major depressive disorder in a human patient having impaired verbal memory comprising administering to the patient about 80 mg of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-ylmethanone or a. pharmaceutically acceptable salt thereof daily, and the copending application teaches a method for selecting a treatment for major depressive disorder, post-traumatic stress disorders, or one or more symptoms thereof in a human patient and treating the patient comprising: (a) objectively assessing whether the patient has impaired learning and/or memory and (b) upon an assessment from step (a) initiating oral administration of from about 40 to about 240 mg of (4- benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone or a pharmaceutically acceptable salt thereof daily.
Note in the copending application in claim 2, the patient has objectively determined impaired verbal learning and/or memory.
Note in the copending application, claim 8, the active agent’s dose of about 80 mg.
Note in the copending application, clam 10, the human patient suffers from impaired learning and/or memory by VM-REACT (Verbal Memory REcAll Computerized Test).
Note in the copending application, claims 11 and 12, the human patient is not concurrently treated with a second antidepressant medication, or the human patient is concurrently treated with a second antidepressant medication.
Note in the copending application, claims 17 and 18, the human patient is concurrently treated with an antipsychotic.
Claims 60-72 are not allowed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 65, 66, 68 and 71 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad terms: second antidepressant medication and a selective serotonin reuptake inhibitor. The mere fact that Applicant may have discovered one type of second antidepressant medication in combination with 80 mg of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone or a pharmaceutically acceptable salt thereof to treat major depressive disorder is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of selective serotonin reuptake inhibitor in combination with 80 mg of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone or a pharmaceutically acceptable salt thereof to treat major depressive disorder is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claims 65, 66, 68 and 71 are not allowed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 64 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 64 is rendered indefinite and vague by the phrase “task”, should the phrase be –test—since the phrase refers back to.
Claim 64 is not allowed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 60-62, 66-68, 71 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Johe (9,572,807 B2) in view of WO 2019/222629 A1, hereby known as Johe and/or WO 2019/094032 A1, hereby known as Johe and further in view of Sennfelt et al., “Bupropion in the Treatment of Major Depressive Disorder in Real-life Practice”, Clinical Drug Investigation, Vol. 31, Supp. 1, pages 19-24 (2011), Clevenger et al., “The role of selective serotonin reuptake inhibitors in preventing relapse of major depressive disorder”, Therapeutic Advances in Psychopharmacology, Vol. 8, No. 1, pages 49-58 (2018), and Tran et al., Quetiapine for Major Depressive Disorder: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines, Canadian Agency for Drugs and Technologies in Health (January 30, 2020).
Johe teaches a method to treating major depressive disorder (MDD) in a human subject with the administration of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3- yl|methanone or a pharmaceutically acceptable salt thereof daily (see column 8, compound 1). Note column 2, lines 28-42 teach the active agent can administer orally and various dosage range of 10 mg/day and 130 mg/day, once or twice daily, including 80 mg.
The instant invention differs from the cited reference in that the cited reference does not teach the active agent is effective in treating impaired learning and/or memory. However, the secondary reference(s), Johe '629 and/or Johe '032. Johe '629 teaches on page 6, section [0032] that NSI-189 improves memory. Also note on the same page 6, section [0033] that NSI-189 ameliorated the learning disability. Johe '032 teaches NSI-198 is effective to ameliorate cognitive deficiencies, wherein cognitive deficiencies are decreases in attention and memory.
Clearly, one skilled in the art would have assumed the administration of NSI-189 to teach to treat major depressive disorder in a human patient would obviously teach or improve the human patient's impaired learning and/or memory in the absence of evidence to the contrary.
The instant invention differs from the cited references in that the cited references do not teach the additional of a second antidepressant medication or an antipsychotic. However, the tertiary, quaternary and quinary references, Sennfelt et al., Clevenger et al., and Tran et al. teach the second antidepressant medication, and an antipsychotic are effective in the treatment of major depressive disorder. Sennfelt et al. teach the bupropion (an antidepressant medication) is effective in the treatment of major depressive disorder. Clevenger et al. teach selective serotonin reuptake inhibitors are effective in the treatment and prevention of major depressive disorder. Finally, Tran et al. teach an antipsychotic, quetiapine, is effective in the treatment of major depressive disorder.
Clearly, one skilled in the art would have assumed the addition of a second antidepressant medication with the primary active agent, (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3- yl|methanone or a pharmaceutically acceptable salt thereof, into a single composition would give an additive effect in the absence of evidence to the contrary.
Claims 60-62, 66-68, 71 and 72 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/ Primary Examiner, Art Unit 1629
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