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 and Response to Amendments
The amendments filed May 20, 2026 have been acknowledged and entered. Claims 3-6 and 16 are pending.
Maintained Rejections
Claim Rejections - 35 USC § 102 / 103
Claims 3-6 and 16 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by Pathi et al. (US 2023/0212115 A1, Application No. 18/000,121; effectively filed before the effective filing date of the instant application; see e.g. priority document IN202021038947 filed September 9, 2020 at pages 21, 23 and 26 which teaches a solid form of a cocrystal of Siponimod with adipic acid ) or, in the alternative, claims 3-6 and 16 are rejected under 35 U.S.C. 103 as obvious over by Pathi et al. (US 2023/0212115 A1, Application No. 18/000,121).
The reasons for this rejection were set forth in the previous Office Action mailed February 20, 2026 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed May 20, 2026 have been fully considered but they are not persuasive.
Applicant argues Pathi teaches the XRPD pattern for its cocrystal has characteristic peaks at 4.97,
6.5, 9.58, 13.03, 16.79, 19.58, and 21.85 at page 19, paragraph [0267]. The Form 11 cocrystal as disclosed in the peak table on pages 6-7 of the present specification ( and to which the Examiner refers) does not include peaks at 4.87, 9.58, 13.03, or 19.58. Because these peaks are absent, the cocrystal of Pathi, which is characterized by these peaks, is not the same as the cocrystal Form 11 as alleged by the Examiner (page 1 of remarks). Applicant also argues other evidence that shows the Examiner is mistaken in asserting that the Pathi cocrystal (Figure 13, Form C1) is prima facie the same as applicant's Form 11 includes the DSC data. The DSC curve for the Pathi cocrystal (FIG. 13) shows an endotherm at 128°C. Accordingly, Pathi neither teaches nor renders obvious the claimed cocrystal Form 11. Contrary to the Examiner's assertion, no basis for inherency exists. The claimed XRPD peaks that are missing from Pathi are not inherent but are truly absent as Pathi has disclosed a different form.
These arguments are not found persuasive because Pathi teaches a solid form of a cocrystal of Siponimod with adipic acid comprising an XRPD pattern having 2ɵ values of 6.5⁰, 16.79⁰ and 21.85⁰ (±0.2 degrees 2ɵ) (see claim 67-68 and [019]). Applicant points to an embodiment disclosed in Pathi which was not discussed in the previous Office Action and argues Pathi does not anticipate the instant claims; however, the invention of Pathi is a cocrystal comprising an XRPD pattern having 2ɵ values of 6.5⁰, 16.79⁰ and 21.85⁰ (±0.2 degrees 2ɵ) which overlap the presently claimed Form 11. The invention of Pathi is not a single embodiment as alleged by Applicant. Based on the similarity of crystallization conditions (see page 4 of previous Office Action, Pathi teaches the cocrystal can be prepared by dissolving Siponimod and adipic acid in ethyl acetate and isolating the solid form) and overlapping XPRD peaks, a person of ordinary skill in the art would reasonably conclude that the cocrystal of the reference corresponds to instantly claimed Form 11.
The rejection is still deemed proper and thus maintained.
As noted in the rejection :
It is well settled that the PTO can require an applicant to establish that a prior art product does not necessarily possess the characteristics of the claimed product when the prior art and claimed products are identical or substantially identical. An applicant's burden under these circumstances was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product...Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, or 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products (footnote omitted).
“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102. on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)). See MPEP 2112.
Overcoming the rejection is very straightforward. One simply replicates the prior art procedure. If the XRPD data are different at all in that product, compared to the instant invention, then the rejection is overcome.
Claim Rejections - 35 USC § 112d
Claims 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The reasons for this rejection were set forth in the previous Office Action mailed February 20, 2026 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed May 20, 2026 have been fully considered but they are not persuasive.
Applicant argues claim 4 includes all the limitations of parent claim 1. Claim 4 also recites
additional characteristic peaks and thus further limits the scope of claim 3 (page 5 of remarks)
This argument is not found persuasive because claim 4 does no more than recite additional properties (i.e. XRPD peaks) which are inherent to the crystal form of claim 3. The recitation of a property is not regarded as a further limitation because the property is inherent and thus always present. In the instant case, Applicant has specifically identified the crystalline form (Form 11) in claim 3 and the dependent claim 4 only recites additional properties which are inherent to this crystal form. Examiner thus respectfully disagrees with Applicant’s argument that claim 4 is narrower than parent claim 3 and is in full compliance with § 112( d).
Applicant further states the Examiner's view that the additional peaks are necessarily inherent is not believed to be a recognized or proper basis for rejection under § 112( d). The reciting of an inherent property may fail to create novelty over prior art, but the additional recitation of properties, inherent or not, is a further limitation. The Examiner's rejection seems to unfairly conflate the two separate concepts (pages 5-6 of remarks).
Examiner has searched the MPEP and is unable to find support for Applicant’s argument that the above § 112( d) rejection is improper. Applicant is encouraged to support their argument with the appropriate citation.
The rejection is still deemed proper and thus maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
June 8, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
Prosecution Insights