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 .
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.
Election/Restrictions
Applicant’s election without traverse in the reply filed on 20 March 2026, is acknowledged.
Examiner requested Applicant elect a species of salt from claims 42-43 (see page 4 of previous Office Action). However, Applicants provided a non-responsive election: Applicants elected Form P.
Therefore, the Examiner has withdrawn the Election of Species Requirement of 29 December 2025.
All claims have been examined on the merits.
Current Status of 18/553,317
This Office Action is responsive to the amended claims of 20 March 2026.
Claims 1-2, 5-7, 35-40, 42-44, and 81-87 have been examined on the merits. Clams 1 and 42-43 are original. Claims 2, 5-7, 35-40, 44, and 81-87 are previously presented.
Priority
The effective filing date is 2 April 2021.
Specification
The one-page amendment of 29 September 2023 is formally entered into the record.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 20 March 2026; and 28 July 2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 40, 84, and 87 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 term “substantially” in claim 40 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
As drafted, the “substantially pure” of claim 40 renders the metes and bounds of claim 40 undefined (hence rendering claim 40 indefinite under 35 USC 112(b)). The artisan has no way of knowing the standard by which to ascertain whether the drug substance of claim 40 comprises a crystalline form of claim 1 that is “substantially pure”. There is no definition or disclosed standard by which to judge “substantially pure” either in the Specification or in the claims.
This same issue is present with “substantially pure” within claims 84 and 87 thereby causing claims 84 and 87 to be rejected as indefinite under 35 USC 112(b).
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 2 and 5-6 are 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.
Dependent claims 2 and 5-6 are not further limiting and are rejected under 35 USC 112(d). As drafted, parent/independent claim 1 recites Form P, which inherently contains all the elements found in the dependent claims 2 and 5-6, such as DSC and XRPD data. If claim 1 did not contain the inherent limitations of claims 2 and 5-6, the claim 1 would technically not be reciting “Form P”. Thus, claims 2 and 5-6 do not truly further limit what is already (inherently) disclosed within claim 1.
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.
Claim Rejections - 35 USC § 103
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.
Claims 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over:
EFREMOV (WO 2020/190754 A1, provided by Applicants and referenced in IDS of 28 July 2025),
in view of:
SALTS (Berge, Stephen, et al. “Pharmaceutical Salts.” J. of Pharm Sciences. (January 1977), Vol. 66, No. 1, pp. 1-19).
Instant claims 42-43 are drawn to the underlying compound:
PNG
media_image1.png
136
312
media_image1.png
Greyscale
described as:
PNG
media_image2.png
64
506
media_image2.png
Greyscale
paired to a Markush list of alternative embodiments of pharmaceutically acceptable salts, wherein “salts” are understood to be “crystalline”.
Determining the scope and contents of the prior art:
The prior art reference EFREMOV teaches the active pharmaceutical ingredient / compound:
PNG
media_image1.png
136
312
media_image1.png
Greyscale
, described as
PNG
media_image2.png
64
506
media_image2.png
Greyscale
(see page 387; see page 385; and see page 139). EFREMOV teaches that the compound, above, is a Polycomb Repressive Complex 2 (PRC2) active pharmaceutical ingredient (API) (see “Abstract”), which is the same function as that of the instant application. Moreover, EFREMOV teaches that pharmaceutically acceptable salts are envisioned and thus can be paired with the API (see “Abstract”).
The reference SALTS teaches that benzenesulfonic acid salt, citric acid salt, fumaric acid salt, maleic acid salt, L-malic acid salt, hydrochloric acid salt, methanesulfonic acid salt, and phosphoric acid salts are well-known and commonly utilized pharmaceutically acceptable salts approved by the FDA (see Table 1 page 2; see Table 3 page 5). Use of any of these pharmaceutically acceptable salts permits the medicinal chemist to manipulate/influence the underlying active pharmaceutical ingredient’s chemical, biological, physical, and economic characteristics and hence permit optimization thereof (see page 1).
Ascertaining the differences between the prior art and the claims at issue:
While EFREMOV teaches the instant claims’ 42-43 underlying compound (the “API”) and generic “pharmaceutically acceptable salts thereof” (see citations, above), it does not teach the pairing of API with any one of the instant claims’ 42-43 salts.
While SALTS teaches benzenesulfonic acid salt, citric acid salt, fumaric acid salt, maleic acid salt, L-malic acid salt, hydrochloric acid salts, methanesulfonic acid salt, and phosphoric acid salts are well-known and commonly utilized pharmaceutically acceptable salts approved by the FDA (see citations, above) and teaches the motivation to pair the API with a salt, it does not teach the pairing of the API with any of the instant claims’ 42-43 salts.
Resolving the level of ordinary skill in the pertinent art:
The artisan is knowledgeable in procedures to pair an API with a “pharmaceutically acceptable salt”. The artisan is also knowledgeable in the benefits to pairing API with “pharmaceutically acceptable salt”.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
Instant claims 42-43 are prima facie obvious in light of the combination of references EFREMOV and SALTS.
The prior art reference EFREMOV teaches that the compound
PNG
media_image2.png
64
506
media_image2.png
Greyscale
illustrated as
PNG
media_image1.png
136
312
media_image1.png
Greyscale
(see page 387; see page 385; see page 139) to be a Polycomb Repressive Complex 2 (PRC2) active pharmaceutical ingredient (API) (see “Abstract”), which is the same function as that of the instant application.
The artisan would be expected to pair any of the well-known FDA-approved commercially marketed “pharmaceutically acceptable salts”: benzenesulfonic acid salt, citric acid salt, fumaric acid salt, maleic acid salt, L-malic acid salt, hydrochloric acid salt, methanesulfonic acid salt, and phosphoric acid salts (listed in Table 1 page 2; and Table 3 page 5 of SALTS prior art reference) to the API of EFREMOV because (1) EFREMOV envisions pairing its API with “pharmaceutically acceptable salts” (see “Abstract”) and (2) it is well-known in the medicinal arts that pairing APIs with “pharmaceutically acceptable salts” permits optimization of the API (see page 1 of SALTS reference).
The artisan would be motivated to pair the EFREMOV API
PNG
media_image1.png
136
312
media_image1.png
Greyscale
(citation, above) with any of the well-known FDA-approved commercially marketed “pharmaceutically acceptable salts”: benzenesulfonic acid salt, citric acid salt, fumaric acid salt, maleic acid salt, L-malic acid salt, hydrochloric acid salt, methanesulfonic acid salt, and phosphoric acid salts (listed in Table 1 page 2; and Table 3 page 5 of SALTS prior art reference) to manipulate/influence the underlying active pharmaceutical ingredient’s chemical, biological, physical, and economic characteristics and hence permit optimization thereof (see page 1 of SALTS prior art reference). In addition, “salt forms” are considered “crystalline forms”, absent evidence that the salt “crystal” is instead a polymorph. This teaches instant claims 42-43.
Conclusion
Claims 44 and 81-83 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 2, 5-6, 40, 42-43, 84, and 87 are not presently allowable as written.
Claims 1, 7, 35-39, and 85-86 are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a specific polymorph form of the underlying compound:
PNG
media_image1.png
136
312
media_image1.png
Greyscale
of instant claims 1 and 7, which is disclosed as:
PNG
media_image2.png
64
506
media_image2.png
Greyscale
.
The reference EFREMOV (WO 2020/190754 A1, provided by Applicants and referenced in IDS of 28 July 2025), discloses the instant claimed compound:
PNG
media_image1.png
136
312
media_image1.png
Greyscale
(see page 387). This compound underlies all the polymorphs of instant claims 1 and 7.
However, EFREMOV is a close art but not a prior art reference as it is silent as to “crystalline”, “polymorph”, “X-ray”, or “powder”. Thus EFREMOV does not anticipate or render obvious the instant claims 1 and 7.
Furthermore, there is no known rationale (and no known prior art reference providing said rationale) that would permit modifying the EFREMOV reference to arrive at the polymorphs of instant claims 1 and 7.
The specific polymorph forms A-W of instant claims 1 and 7 are made via specific processes not seen in the prior art. Also, polymorphs can differ one from another in respects to solubility, dissolution rate, and/or bioavailability. It is generally difficult to predict whether a given compound will form any crystalline solid-state forms and very difficult to predict the physical properties of these crystalline solid-state forms (pages 1-2 of instant Specification).
Therefore, the alternative polymorph forms of instant claims 1 and 7 are novel and non-obvious over the underlying compound in the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. 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.
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights