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
The amendments to the claims filed January 14, 2026 are acknowledged and entered. Claims 3-6 are pending.
Priority
This application is a 371 of PCT/EP2021/076406, filed September 24, 2021, which claims priority of EP21155774.9, filed February 8, 2021, and EP20198482.0 filed, September 25, 2020.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on June 14, 2023. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Election/Restriction
The restriction requirement as set forth in the Office action mailed on November 6, 2025 is hereby withdrawn due to Applicant amendments.
Claim Rejections - 35 USC § 102 / 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 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)(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.
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.
Claims 3-6 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 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 instant claims are drawn to a solid form of a cocrystal of Siponimod with adipic acid regarded as Form 11, characterized by XRPD pattern having 2ɵ values of 6.7⁰, 12.7⁰ and 13.5⁰ (±0.2 degrees 2ɵ). The specification teaches Form 11 is further characterized by XRPD 2ɵ values of 17.0⁰ and 21.7⁰ (see pages 6-7). A person of ordinary skill in the art would recognize that the peaks corresponding to Form 11 disclosed at pages 6-7 of the specification are properties of Form 11 which are inherently included in the scope of claim 3 which is drawn to Form 11.
Prior art reference, 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], the present invention provides novel solid state forms). Pathi teaches wherein the cocrystal is the hemi adipic acid cocrystal which corresponds to a molar ratio of Siponimod to adipic acid of 2:1, which the specification teaches is the molar ratio of Form 11 (see page 6 of the instant specification, lines 10-15, Siponimod with adipic acid (2:1), Form 11). The prior art XRPD peaks at 6.5⁰, 16.79⁰ and 21.85⁰ overlap the XRPD peaks corresponding to Form 11 when considering the ±0.2 error of the claims (e.g. peaks 6.5⁰, 16.79⁰ and 21.85⁰ (±0.2 degrees 2ɵ) of the prior art overlap peaks 6.7⁰, 17.0⁰ and 21.7⁰ (±0.2 degrees 2ɵ) which the specification teaches correspond to Form 11, see pages 6-7). Pathi further teaches the cocrystal can be prepared by dissolving Siponimod and adipic acid in ethyl acetate and isolating the solid form (see claim 70, steps c-d; see [0293] organic solvents are selected from ethyl acetate).
Pathi does not specifically recite all of the XRPD peaks claimed (e.g. peaks 7.5⁰, 12.7⁰, 13.5⁰); however, the additionally claimed XRPD peaks are no more than characteristics or properties which are inherent to Form 11. Because the prior art reference is silent about the claimed XRPD peaks 7.5⁰, 12.7⁰, 13.5⁰, 16.4⁰ and 18.3⁰, there is no way to compare the prior art with the current application other than to confirm the prior art cocrystal teaches three XRPD peaks that characterize claimed Form 11. However, based on the similarity of crystallization conditions 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.
MPEP 2112 states:
"SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
The claiming of a new use, new function or unknown property, which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)."
In this case, the "unknown property" is the physical data of the XRPD. This is unknown because the prior art reference is silent on this property. MPEP 2112 goes on to state:
"A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103”
Again, the "characteristic" which the prior art is silent on is the additionally claimed XRPD data corresponding to peaks at 7.5⁰, 12.7⁰, 13.5⁰, 16.4⁰ and 18.3⁰ (±0.2 degrees 2ɵ).
This is not an ordinary inherency situation where it is not explicitly stated what the product actually is. In the reference applied, the reference explicitly teaches exactly what the compound is. In fact, it is the opposite. In a normal inherency situation, the claim is of known structure, and the reference is of unknown structure. Here, the reverse is true, and hence the legal circumstances of inherency-in-the-prior-art do not apply. The only difference is the property of the compound about which the reference happens to be silent.
See for example Ex parte Anderson, 21 USPQ 2d 1241 at 1251, discussion of Rejection E. The claims had “numerical or functional values for certain properties which [the authors of the references] did not measure.” The PTO presented no reasoning as to why the prior art material would have been expected to have those properties. Instead, the decision states, "There is ample precedent for shifting the burden to an applicant to reproduce a prior art product whose final structure or properties are, at least, in part determined by the precise process used in its manufacture." (page 1253).
In another example, certain claims of Ex parte Raychem Corp. 25 USPQ2d 1265 required a linearity ratio of less than 1.2. The decision notes that neither reference discloses any values of the linearity ratio. The PTO presented no reasoning as to what the ratio would be expected to be in the references. The Decision states: "However, this does not end the inquiry since, where the Patent and Trademark Office is not equipped to perform the needed testing, it is reasonable to shift the burden of proof to Raychem to establish that (1) the argued difference exists…."
And indeed, there have been a number of cases in which applicants have pointed to silence of the prior art with regard to this or that property: In re Pearson, 181 USPQ 641; In re Zierden 162 USPQ 102; In re Lemin, 140 USPQ 273; Titanium Metals Corporation of America v. Banner, 227 USPQ 773; In re Benner, 82 USPQ 49. Going further, if silence about properties of prior art compounds could be relied on, then one could not reject over references with no utility (see In re Schoenwald, 22 USPQ2d 1671), since applicants could always insert the utility into the claim as a property.
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. No new matter permitted.
Claim Rejections - 35 USC § 112d
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
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.
Claim 4 depends upon claim 3, which is directed toward a cocrystal Form 11 of Siponimod with adipic acid, and recites wherein said cocrystal is characterized by XRPD pattern having 2ɵ values 6.7⁰, 7.5⁰, 12.7⁰, 13.5⁰, 16.4⁰ and 18.3⁰. Claim 4 does not further limit the cocrystal Form 11 of claim 3 as it does no more than recite additional XRPD peaks which are properties that are inherent to and within the definition of cocrystal Form 11. In looking to the specification, the claimed cocrystal Form 11 is defined by the XRPD peaks listed in the table at pates 6-7 and includes all peaks that are recited in both claims 3 and 4. The additional peaks recited in claim 4 are therefore already within the scope of claim 3 based on the definition of “Form 11" as set forth in the specification and are not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claim is allowed.
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February 18, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624