DETAILED ACTION
This constitutes a Non-Final Office Action given two new rejections under 35 USC 112(a), below.
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.
Current Status of 18/558,351
This Office Action is responsive to the amended claims of 8 June 2026.
Claims 1-24 have been examined on the merits. Claims 1-3, 5-6, 8, and 12-14 are previously presented. Claims 4 and 7 are original. Claims 9-11 are currently amended. Claims 15-24 are new.
Priority
The effective filing date is 6 May 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8 June 2026, was filed after the mailing date of the Non Final Office Action on 7 January 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
The Examiner acknowledges receipt of and has reviewed Applicants’ claim amendments and Reply of 8 June 2026.
Applicants removed “include” from the claims thereby rendering moot the indefiniteness rejection of record (made within paragraph 8-10 of the previous Office Action).
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-24 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a Written Description lack of possession rejection.
Applicants claim “an organic acid salt” as a limitation of the polymorph of claim 1. Under the broadest reasonable interpretation (BRI), this is interpreted as “any organic acid salt”. An “organic acid” is a broad/huge genus that is defined as any acid that has carbon atoms. Moreover, Applicants’ dependent claim 4 provides examples of organic acid salts: lactate, benzene sulfonate, and toluene sulfonate. Consider, too, Applicants’ Specification provides more examples of organic acid salts which include salts formed from inorganic acids (see pages 7-8 of Specification). Thus, the definition and examples (of the claims and Specification) of “organic acid salt” leads to the conclusion that the genus “organic acid salt” is very broad and quite large/huge.
In contrast, and against this backdrop, Applicants disclose actual possession of the following four (4) species of organic acid salts: 3-carboxylic acid (see Preparation Example 2 within paragraph [151] of page 23 of the Specification); lactic acid (“lactate”) of paragraph [169] (page 26); benzene sulfonate (see paragraph [171] of page 26 of Specification); and toluene sulfonate (paragraph [178] of page 27).
However, the four (4) species of organic acid salts, previous paragraph, are not a representative number of species of the broad/huge genus “organic acid salts” of instant claim 1.
The 35 USC 112(a) written description requirement requires that Applicants disclose a representative number of species of broad genus groups, such as “organic acid salts”. See, for example, MPEP 2163.
Thus, claim 1 is rejected as Applicants lack possession of the broad “organic acid salts” under written description requirement of 35 USC 112(a). Applicants have disclosed only four species they were actually in possession of at the time of filing this application, see, above. Said species are not a representative number of species of the broad “organic acid salts” genus. Furthermore, claims 2-24 are similarly rejected as lacking written description possession under 35 USC 112(a) since these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
To render this rejection moot: Applicants can move the species of “organic acid salts” from claim 4 into claim 1 (and cancel claim 4) if they define the claim 4 limitations as Markush alternative limitations of “organic acid salts” within amended claim 1. So, for example, claim 1 can be revised to: -- A crystalline form IV of an organic acid salt of a compound of the following formula 1, wherein the organic acid salt is selected from the group consisting of: lactate, benzene sulfonate, and toluene sulfonate, …. -- . Dependent claims would also need to be amended accordingly.
Claims 1-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for making the following organic acid salts: lactate, benzene sulfonate, and toluene sulfonate, does not reasonably provide enablement for making any “organic acid salt” as per the broadest reasonable interpretation (BRI) of the instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In order to determine compliance with the enablement requirement, the Federal Circuit developed the following framework of factors under In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). See also MPEP 2164.01(a).
(A) The breadth of the claims:
The BRI of the claims drawn to making “an organic acid salt” of formula I of claim 1 includes any organic acid salt. For reasons previously described, the genus “organic acid salt” is very broad/huge.
(B) The nature of the invention:
The invention concerns a crystal polymorph of any organic acid salt of formula I of claim 1. Claim 1 and the claim 6 method of making it do not further limit/define species of “organic acid salts”.
(C) The state of the prior art:
Polymorphs are very unique due to the method of making them and therefore usually do not have any anticipatory or obvious prior art. The instant claims are no exception, as the specific physico-chemical (XRPD peaks) of instant claim 1 act to distinguish claim 1 from the prior art.
As such, the prior art cannot provide enablement/guidance. Thus, we look to the Specification for that guidance/enablement.
(D) The level of one of ordinary skill:
The artisan is knowledgeable in making formula I (claim 1) and the specific crystalline forms of organic acid salts of formula I that are detailed within the Examples of the Specification.
(E) The level of predictability in the art:
Methods of making species of compounds of formula I which differ between 2-5 carbon atoms at the “alkyl” of variable R1 of instant claim 1 involve a high level of predictability in the organic chemistry arts. However, the methods of making a crystal form IV with the specific physical-chemical XRPD peaks disclosed in instant claim 1 in which the polymorph can be “any organic acid salt” (as per the limitations/wording of instant claim 1) involve lower predictability and undue experimentation. This is because each organic acid salt will introduce different XRPD peaks into the resultant crystalline polymorph and because the genus “organic acid salts” is huge (see, above). It would be undue experimentation and high unpredictability to sample each “organic acid salt” known to an artisan to make the specific polymorphs and resultant XRPD peaks of instant claim 1, absent specific guidance (not seen in the Specification*).
(F) *The amount of direction provided by the inventor:
While the Specification does provide guidance as to making the crystalline form IV of the following organic acid salts of formula I: lactic acid (“lactate”) of paragraph [169] (page 26); benzene sulfonate (see paragraph [171] of page 26 of Specification); and toluene sulfonate (paragraph [178] of page 27), the Specification does not provide guidance that would enable the artisan to make any other crystalline forms of other organic acid salts with the specific XRPD peaks disclosed within instant claim 1.
(G) *The existence of working examples: and
While the Specification does provide guidance as to making the crystalline form IV of the following organic acid salts of formula I: lactic acid (“lactate”) of paragraph [169] (page 26); benzene sulfonate (see paragraph [171] of page 26 of Specification); and toluene sulfonate (paragraph [178] of page 27), the Specification does not provide guidance that would enable the artisan to make any other crystalline forms of other organic acid salts with the specific XRPD peaks disclosed within instant claim 1.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Methods of making species of compounds of formula I which differ between 2-5 carbon atoms at the “alkyl” of variable R1 of instant claim 1 involve a high level of predictability in the organic chemistry arts, and therefore need lower levels of experimentation to make and/or use the compound (non-polymorph) of formula I.
However, the methods of making a crystal form IV thereof with the specific physical-chemical XRPD peaks disclosed in instant claim 1 in which the polymorph can be “any organic acid salt” (as per the limitations/wording of instant claim 1) involve lower predictability and higher levels of / undue experimentation to make and/or use the invention as instantly claimed. This is because each organic acid salt will introduce different XRPD peaks into the resultant crystalline polymorph and because the genus “organic acid salts” is huge (see, above). It would be undue experimentation and high unpredictability to sample each “organic acid salt” known to an artisan to make the specific polymorphs of instant claim 1, absent specific guidance (not seen in the Specification) and therefore, the broad “organic acid salts” of the instant claim 1 rises to undue experimentation.
Given the above, claim 1 is rejected under scope of enablement (35 USC 112(a)). Moreover, claims 2-24 are similarly rejected under scope of enablement under 35 USC 112(a) since these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
To render this rejection moot: Applicants can move the species of “organic acid salts” from claim 4 into claim 1 (and cancel claim 4) if they define the claim 4 limitations as Markush alternative limitations of “organic acid salts” within amended claim 1. So, for example, claim 1 can be revised to: -- A crystalline form IV of an organic acid salt of a compound of the following formula 1, wherein the organic acid salt is selected from the group consisting of: lactate, benzene sulfonate, and toluene sulfonate, …. -- . Dependent claims would also need to be amended accordingly.
Conclusion
No claims are presently allowable as written.
Claim 1 is free of the prior art for the rationale stated within paragraphs 12-15 of the Non-Final Office Action mailed 7 January 2026. Moreover, the instant claim 1 is distinguished from the prior art by a combination of the specific XRPD peaks that any invention of instant claim 1 is required to possess and the fact that claim 1 is drawn to a crystalline polymorph.
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.
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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.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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