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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/12/2026 has been entered.
Claims 1-2, 6, 13, 17-24 and 26-34 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements filed on 3/23/2026 and 6/12/2026 are acknowledged and have been considered except where lined through.
Rejections Maintained:
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 19-20, 23-24, and 27-32 remain 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.
Regarding claims 19-20, 23-24, and 27-32, each of the claims are drawn to a crystal, wherein the crystal comprises 50% or 99% of the crystal of a different claim. A crystal comprising a certain percentage of a crystal of a different claim 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. For example, the specification and claims do not appear to teach which portion of the crystal of the previous claim is supposed to be “maintained” and which is to be excluded.
In response to this rejection, Applicants contend, referring to claim 19 as an example, the phrase “A crystal of… comprising at least 50% of the crystal of claim 17” means that the crystal of claim 19 includes a portion of at least 50% of the crystal of claim 19 that satisfies the features recited in claim 17. By way of analogy, Applicants assert that this wording is analogous to a hypothetical claim 19 that recites a composition comprising at least 50% by weight of the compound of claim 17.
These arguments have been carefully considered, but are not found persuasive.
First, as noted above, the specification, as originally filed, does not appear to define what is encompassed by a crystal comprising a portion of a least 50% or 99% of another crystal. In particular, the specification and claims do not appear to teach which portion of the crystal of the previous claim is supposed to be “maintained” and which is to be excluded. Regarding Applicants analogy, the Examiner disagrees that a comprising 50% by weight of the compound of claim 17 is analogous to what is being claimed in the instant application. In the analogous example, the composition has to comprise the compound. This is not the case in the instant claims. Only 50% of the crystal is present and the specification and claims do not appear to teach which portion of the crystal of the previous claim is supposed to be “maintained” and which is to be excluded.
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 19-20, 23-24, and 27-32 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 NEW MATTER REJECTION.
Claims 19-20, 23-24, and 27-32 are drawn to a crystal, wherein the crystal comprises 50% or 99% of the crystal of a different claim. In the response to the Non-Final rejection of 10/02/2025, Applicants asserted that support for the claims can be found at least in paragraph 0080 of the specification. However, a careful review of the specification, as originally filed, does not lend support for a crystal, wherein the crystal comprises 50% or 99% of the crystal of a different claim. The only support for %’s appears to be paragraph 0097 which states:
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78
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Accordingly, this does not appear to explicitly or implicitly provide support for a crystal comprising 50% or 99% of a crystal of a different claim. In particular, paragraph 0097 appears to be directed to the crystalline form.
Note: While the Examiner did not previously apply this rejection, the rejection has been applied upon reconsideration of the 112 (b) above and Applicants not providing a definition supported in the specification.
Conclusion
Claims 1-2, 6, 13, 17-18, 21-22, 26 and 33-34 are free of the prior art. As noted in the prior office action, the closest prior art is Miyazaki et al. (US10,155,768B2, 2018-12-18, IDS) whom teaches the claimed compound (example 85) and also contemplates crystalline forms (column 87, lines 34-46). While the prior art contemplates crystalline forms, the prior art does not explicitly teach the synthesis of these crystalline forms.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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