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 .
Status of Claims
Claims 1, 4, 8-10 and 12-24 are pending in the instant application. Claims 1, 4, 12-14 are amended, claims 2-3, 5-7 and 11 are cancelled and claims 15-24 are new via the amendment filed October 28th, 2025.
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/US20/62400 filed November 25th, 2020, which claims priority to 62/941,542, filed November 27th, 2019.
Response to Restriction/Election Requirement
Search and examination has been limited as previously discussed in the Office action dated. Examination is limited to the extent that claims are readable on elected group I, with compound I and disorder eating disorder. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration. As such, claims 10 and 14 remain withdrawn.
New claims 16-18 and 20-22 are drawn to a nonelected disorder and as such, are also withdrawn.
Maintained Objections
Applicant’s arguments and amendments, filed October 28th, 2025, with respect to the objection of claims 8 and 12 have been fully considered and are not persuasive. Claims 8 and 12 stand objected.
Applicant argues that claims 8 and 12 have been cancelled, however, in the amendment filed October 28th, 2025, the claims are still pending. Further, Applicant has not amended the claims to recite “wherein the PDE1 inhibitor is selected from the group consisting of…” and insert “and” before the last compound.
Withdrawn Rejections
Claim Rejections - 35 USC § 112(a)
Applicant’s arguments and amendments, filed October 28th, 2025, with respect to rejection of claims 1-3, 7-9 and 12-13 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The 112(a) rejection of claims 1-3, 7-9 and 12-13 has been withdrawn.
Applicant has overcome this rejection by amending claim 1 to delete “prophylaxis”.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments and amendments, filed October 28th, 2025, with respect to rejection of claims 2-9 and 11-13 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The 112(b) rejection of claims 2-9 and 11-13 has been withdrawn.
Applicant has overcome the rejections under 35 U.S.C. 112(b) by either cancelling the claims or amending the claims to delete optional limitations that contain the terms “e.g.,”, “pref.”, “i.e.”, “such as”, and “for example”. Applicant has also overcome the rejection by amending claims 1 and 4 to remove the previous reference to the specification. Further, Applicant has clarified the position of
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sufficiently. However, note that applicant has not overcome the 112(b) rejection of claims 1 and 4 as the claims still recite the optional limitations “e.g.,” and “for example”.
Claim Rejections - 35 USC § 102
Applicant’s arguments and amendments, filed October 28th, 2025, with respect to rejection of claims 1-9 and 11-13 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. The 102(a)(1) rejection of claims 1-9 and 11-13 has been withdrawn.
Applicant has overcome the rejection by amending claim 1 to remove “prophylaxis”.
Double Patenting
Applicant’s arguments and amendments, filed October 28th, 2025, with respect to the double patenting rejection of claims 1-9 and 11-13 have been fully considered and are persuasive. The double patenting rejection of claims 1-9 and 11-13 has been withdrawn.
Applicant has overcome the rejection by deleting ADHD from the list of conditions, diseases and disorder, deleting “prophylaxis” in claim 1 and the removal of the optional limitations that followed “e.g.,” in claims 1 and 4. However, Applicant’s amendments have necessitated a new grounds double patenting rejection presented below.
Response to Arguments
Applicant’s arguments, regarding the rejection under 35 U.S.C. 102 are moot in view of the withdrawn rejection and the newly applied claim rejections below.
Applicant’s arguments, regarding the double patenting rejections over copending Application Nos. 18/967,095 and 17/757,572 are moot in view of the withdrawn rejections.
Applicant’s arguments, regarding the double patenting rejections over copending U.S. Patent No. 11,291,666 are moot in view of the newly applied claim rejection below.
Maintained Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 4, 9, 13, 15, 19 and 23-24 are 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. The following reasons apply:
Regarding claims 1 and 4, the phrase "e.g.” renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The applies to, for instance, the recitation in formula IV “C1-4 alkyl (e.g., methyl)”. See MPEP § 2173.05(d). The phrase "e.g.," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. These rejections apply to each and every occurrence of “e.g.”, in the claims.
Claims 9, 13, 15, 19 and 23-24 do not resolve the issue of indefiniteness as are also rejection under 112(b).
New 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) 1, 4, 8-9, 12-13, 15, 19 and 23-24 are newly rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al (WO 2018/049417 A1) in view of Haleem et al (Life Sciences 178 (2017) 87–93) and Thornton et al (J Anxiety Disord. 2011 June ; 25(5): 727–730).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Snyder teaches a method of treating a condition characterized by abnormal neurotransmitter production and/or response, including depression and anxiety, comprising administration of a PDE1 inhibitor to a patient in need thereof (claim 3). Snyder teaches that the PDE1 inhibitor is (claim 7):
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This compound is embraced by instant Formula II, wherein R4 is H, R5 is phenyl, X is C1 alkylene, Y is arylene and Z is heteroaryl.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Snyder does not explicitly that the condition is an eating disorder.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Haleem teaches that food restriction can decrease serotonin, a neurotransmitter, production in anorexia nervosa patients to precipitate depression, psychosis and hyperactivity (abstract)
Further, Thornton teaches that anorexia nervosa and anxiety disorders are commonly comorbid, with upper estimates suggesting that 83% of individuals with anorexia nervosa have a lifetime history of one or more anxiety disorders (introduction, paragraph 1).
As such, regarding claims 1 and 4, as Snyder teaches a method of treating a condition characterized by abnormal neurotransmitter production and/or response, including depression and anxiety, with a compound of instant formula (II), one of ordinary skill in the art could recognize that a patient struggling with anorexia nervosa would also struggle with anxiety as Thornton teaches that 83% of anorexia patients struggle with anxiety and also would be further motivated to administer the compound to a patient with anorexia nervosa as Haleem teaches that those with anorexia nervosa have an abnormal production level of the neurotransmitter serotonin.
Regarding claims 8 and 12, as seen above, the PDE1 inhibitor is compound 1,
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Regarding claims 9, 13 and 23-24, Snyder teaches that the PDE1 inhibitor is administered in combination with selective serotonin reuptake inhibitors (claim 10).
Regarding claims 15 and 19, as seen above, the eating disorder is anorexia nervosa.
New Double Patenting Rejections necessitated by Amendment
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.
Claim 1, 4, 8-9, 12-13, 15, 19 and 23-24 are newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,291,666 B2 in view of Snyder et al (WO 2018/049417 A1), Haleem et al (Life Sciences 178 (2017) 87–93) and Thornton et al (J Anxiety Disord. 2011 June ; 25(5): 727–730).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent claims a method for the treatment of treating a condition characterized by abnormal neurotransmitter production and/or response, including depression and anxiety, comprising administration of a PDE1 inhibitor to a patient in need thereof (claim 3) The patent also claims that the PDE1 inhibitor is the following compound (claim 4):
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The patent also claims that the PDE1 inhibitor is administered in combination with serotonin reuptake inhibitors (claim 10).
The teachings of Snyder, Thornton and Haleem relative to claims 1, 4, 8-9, 12-13, 15, 19 and 23-24 are incorporated herein by reference. The instant claims are deemed to be obvious variants of the subject matter of patent No. 11,291,666 B2 for the same reasons as under 35 USC 103.
Claims 1, 4, 8-9, 12-13, 15, 19 and 23-24 are newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No.9,849,132 B2 in view of Snyder et al (WO 2018/049417 A1), Haleem et al (Life Sciences 178 (2017) 87–93) and Thornton et al (J Anxiety Disord. 2011 June ; 25(5): 727–730).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent claims a method of treating anxiety comprising administering an effective amount of the following compound (claim 9):
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The teachings of Snyder, Thornton and Haleem relative to claims 1, 4, 8-9, 12-13, 15, 19 and 23-24 are incorporated herein by reference. The instant claims are deemed to be obvious variants of the subject matter of patent No. 11,291,666 B2 for the same reasons as under 35 USC 103.
Correspondence
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699