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 .
Priority
This application filed on 08/30/2023, is a U.S. national stage of PCT/IB2022/051832 filed on 03/02/2022, which claims priority to and the benefit of Italian patent application no. 102021000004964, filed 03/03/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 08/30/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
DETAILED ACTION
Applicant’s amendment and argument filed on 03/16/2026 have been received and have been carefully Considered. Claims 1, 9 and 11 were amended. Claims 2, 4, 6 and 8 were cancelled. Claims 1, 3, 5, 7 and 9-11 are pending.
Withdrawn Claim Objection
Objection to claim 11 for the typographical error, is withdrawn in view of Applicant’s amendment filed on 03/16/2026 that amended claim 11 by replacing “por” activation with “poor” activation.
Withdrawn Claim Rejections - 35 U.S.C. 112(b)
Rejection of claims 9-11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reciting “or a compound”, is withdrawn in view of Applicant’s amendment filed on 03/16/2026 that amended claim 9 by deleting “or a compound”.
Withdrawn Claim Rejections - 35 USC § 112(a) (New matter Rejection)
Rejection of claim 9 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the written description requirement for reciting “or a compound”, that may not be described in the specification, is withdrawn in view of Applicant’s amendment filed on 03/16/2026 that amended claim 9 by deleting “or a compound”.
Rejection Maintained/Modified in view of the Amendment
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by M. Stama et al. European Journal of Medicinal Chemistry, 2017, Volume 141, pages 703-720, “Stama” cited in the PTO-892 dated 12/17/2025).
Stama discloses N-formyl peptide receptor 2 (FPR2) agonists for treating central nervous system (CNS) disorders, [Title]. Stama discloses FPR2 agonist, compound 17, [Abstract, and page 706, Table 1]:
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458
614
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Stama’s FPR2 agonist, compound 17, above anticipates claim 1 formula (I), wherein:
R is
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122
258
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.
Claim 5 is anticipated because Stama discloses that the above compound is FPR2 receptor agonists.
Regarding claim 3, a medicament is interpreted as a substance use as medicine/therapeutic agent. Stama’s whole paper is directed to the use of FPR2 agonist i.e., comp. 17 for treating CNS disorders. For example, Stama discloses that compound 17 is tested for anti-neuroinflammatory effect, wherein compound 17 effectively blocked LPS-induced cell death. [page 708, col. 2, 3rd para.].
Claim 9 is interpreted as "A pharmaceutical composition comprising a compound of formula (I) according to claim 1, at least one pharmaceutically acceptable vehicle and at least another active compound." See 112(b) Rejection above. The vehicle is interpreted as a carrier, a solvent or an inert medium where the active ingredient is dissolved or suspended. Stama discloses that the FPR2 agonists, compound 17 are dissolved in potassium phosphate buffer, [page 717, col. 2, 2nd para.]. The buffer medium meets the term vehicle. Stama discloses that FPR2 agonist i.e., compound 17 the cells were treated with WRW4 alone or in combination with compound 17. [page 708, col. 2, last para.]. Thus, Stama discloses FPR2 agonist, compound 17 in a vehicle with an active compound (WRW4).
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 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.
Claims 1, 3, 5, 7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over M. Stama et al. European Journal of Medicinal Chemistry, 2017, Volume 141, pages 703-720, “Stama” cited in the PTO-892 dated 12/17/2025) in view of Yan, C., et al. Neuroreport. 26.6 (2015): 341-345, “Yan” cited in the IDS dated 08/30/2023), as evidenced by Z. Guo et al. Stroke, 2016; 47(2): 490-7, “Guo” cited in the PTO-892 dated 12/17/2025).
Stama is applied to claims 1, 3, 5 and 9 as discussed in the 102 Rejection above, and incorporated herein.
The disclosure set forth above in the 102 Rejection over the same Stama et al. reference is herein incorporated by reference.
Stama discloses that FPR2 plays critical roles in inflammatory reactions and FPR2-specific pathological inflammatory responses. Stama discloses that compound (S)-17) is an effective FPR2 agonist in the central nervous system (CNS) being able to reduce interleukin and TNF-a levels. Stama discloses that these results lead to the use of compound (S)-17 in the treatment of CNS disorders characterized by neuroinflammation, chronic inflammatory diseases, and CNS diseases. [Abstract, and page 713, col. 2, 2nd para.]. Stama also discuss in vivo studies to support the contribution of FPR2 in inflammation [page 704, col. 1, 3rd para.].
While Stama discloses the effectiveness of compound 17 in treating CNS disorders characterized by neuroinflammation, Stama does not teach that the disorder is an autism spectrum disorder.
Yan teaches the role of lipoxin A4 (LXA4), a mediator involved in the resolution of inflammation, in autism spectrum disorders (ASD) patient. [Title]. As evidenced by Guo, FPR2 receptor is known as LXA receptor, and LXA4 is the endogenous agonist for FPR2 receptor.
Yan teaches the connection between the plasma levels plasma levels of LXA4 and the severity of ASD, wherein the mean plasma levels of LXA4 were significantly lower in autistic children compared with the normal children (P<0.0001). [Abstract]. Yan teaches that there was a significant negative relationship between circulating LXA4 levels and severity of autism evaluated by Childhood Autism Rating Scale scores (P=0.006). [Abstract]. Yan also draws the connection between plasma levels of high-sensitivity C-reactive protein (Hs-CRP), interleukin-6 (IL-6), and leukocyte count as a measure of inflammatory markers and LXA4 as a marker of anti-inflammatory bioactive lipid in Chinese children with ASD. [page 341, col. 2, 1st para.]. plasma interleukin levels were reduced in LXA4-treated rats compared with those administered saline vehicle. [page 334, col. 2, 2nd para.].
In view of the foregoing discussion, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to use Stama’s FPR2 agonist, compound 17 for the treatment of ASD. One of ordinary skill in the art would have been motivated to administer FPR2 agonist to ASD patients for treating ASD with reasonable expectation of success because Yan teaches that decreased plasma levels of LXA4 is connected with the severity of ASD; the mean plasma levels of LXA4 were significantly lower in autistic children compared with the normal children; there was a significant negative relationship between circulating LXA4 levels and severity of autism; the Levels of LXA4 decreased with increasing severity of ASD [page 343, col. 1], the inflammatory markers measure by high level of interleukin and leukocyte in children with ASD, and plasma interleukin levels were reduced in LXA4-treated rats compared with those administered saline vehicle; and Stama discloses that compound (S)-17) is an effective FPR2 agonist for the treatment of the CNS disorders characterized by neuroinflammation, being able to reduce interleukin and TNF-a levels. Therefore, one of ordinary skill in the art have access to Yan would be motivated to utilize an effective FPR2 agonist to treat ASD, and therefore, meet each and every limitation of claims 7, 10, and 11.
Response to Arguments
Applicant argues:
As Stama does not describe each and every element as disclosed in the claim, and all the additional references fail to correct Stama's deficiencies. It is respectfully submitted that Stama is not an anticipatory reference for the claimed invention. It is respectfully requested that this rejections be reconsidered and withdraw.
Examiner response:
Applicant’s arguments have been fully considered but found not persuasive. Claim 1 recites:
“A compound of formula (I) … and the chiral carbon, denoted by the asterisk, is in the S and/or R configuration, or compounds (S)-4, (S)-7, (S)-8, (S)-9 and (S)-16 of formula: …”. The claim 1 as written claimed compound of formula (I) OR compounds (S)-4, (S)-7, (S)-8, (S)-9 and (S)-16. Amended claim 1 deleted claim (S)-16, however, Stama’s compound 17 still anticipates the claim 1 compound of formula (I), see the above modified 102 Rejection. Thus, the anticipatory rejection over Stama is maintained.
Conclusion
Claims 1, 3, 5, 7, 9-11 are rejected. No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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