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 .
DETAILED ACTION
Response to Amendment
1. Claims 32 and 39-41 have been amended and claims 43-45 added as requested in the amendment filed on March 26, 2026. Following the amendment, claims 32-45 are pending in the instant application.
2. Claims 32-45 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. Applicant’s arguments filed on March 26, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
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.
5. Claims 32-44, as amended, and new claim 45 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.
6. Claim 32, as currently presented, recites “wherein the effects of treatment with initial dose are observed by the patient starting within 24 hours after administration of the initial dose.” This limitation describes a subjective opinion of the patient under treatment, which renders the claim indefinite. See MPEP 2173.05(b) II, IV Relative terminology, Subjective terms, which states,
When a subjective term is used in the claim, the examiner should determine whether the specification supplies some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014) (holding the claim phrase "unobtrusive manner" indefinite because the specification did not "provide a reasonably clear and exclusive definition, leaving the facially subjective claim language without an objective boundary").
In the instant case, to meet the limitations of the method, one must include the “observation” obtained from the patient under treatment, and it is not obvious what objective, tangible and repeatable steps support the limitation, as currently claimed.
7. The same applies to claims 39-41, which explicitly require participation of the patients under treatment as part of the inventive concept, thus violating objectivity requirement of claim interpretation.
8. Similarly, claim 45 recites a limitation, which describes the patient’s experience after the treatment with a single dose of NPY, and is therefore, as explained earlier, interpreted as a relative terminology because it depends solely on the opinion or feelings of the subject. While one skilled in the art can readily practice objective and repeatable steps of administering NPY at certain doses, one does not know what stands for the same administration of the same dose and meeting requirement from the patient to “experience a reduction in at least one symptom of MDD.”
9. Claims 33-38 and 42-44 are indefinite for being dependent from indefinite claims.
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.
10. Claim(s) 32-38 and 42 stand rejected under 35 U.S.C. 103 as being unpatentable over Serova et al., further in view of Wu et al.; Heilig; Eaton et al.; Brothers et al.; Widerlöv et al. and Chaturvedi et al., J Adv Pharm Technol Res, 2011, 2(4):215-22. See reasons of record in section 3 of Paper mailed on June 26, 2024, section 8 of Paper mailed on January 27, 2025 and in section 9 of Paper mailed on October 03, 2025.
At pp. 7-10 of the Response, Applicant explains the difficulties in the field of drug development for treatment of psychiatric disorders. Applicant’s statement is not disputed.
At p. 10, Applicant submits that, “[S]ubsequent to filing this application the inventors (together with others) conducted a proof- of- concept study at the Karolinska Institutet, Stockholm, Sweden. In the study thirty MDD patients on a stable dose of a conventional antidepressant insufflated 6.8 mg NPY (n = 12) or placebo (n = 18) in a double -blind randomized fashion. Effects were assessed at baseline, +1 hour, +5 hours, +24 hours, and +48 hours. The primary outcome was change in depression severity measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). The results indicate that a single dose of intra-nasal NPY provided an antidepressant effect. […] the reported study shows that a single dose of NPY decreases symptoms of MDD. There is no hint of this property of NPY in the cited prior art. This is a surprising and unexpected property of NPY and is evidence that the present claims are not obvious over the cited prior art.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
Claims 32-38 and 42 encompass treatment of MDD by administration of NPY, 1 to 100 mg, intranasally, broadest reasonable interpretation consistent with the specification as originally filed. The specification contemplates administering “a single dose of the composition [comprising NPY] or multiple doses of the composition,” p. 4, without pointing out any significance of the effect of a single dose administration. The working examples at pp. 69-70, Example 4, and p. 71, Example 7, describe prophetic protocols of the treatment of MDD, without pointing out any significance of the effect of a single dose administration. Thus, at the time of filing of the instant patent application, the specification was limited to the disclosure of treatment of MDD by intranasal administration of NPY in general. The Examiner maintains that the cited prior art of record provided an ordinary practitioner with enough information and motivation to practice the instant invention as currently claimed, see full reasoning explained earlier. Administering the same drug using the same method of delivery and to the population suffering from the same disorder is reasonably expected to produce the same result, even if the result is not immediately articulated or appreciated by the patient under treatment.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
11. No claim is allowed.
12. 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 OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
April 22, 2026
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