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 .
Application Status
The amendment filed on 2/02/2026 in response to the Non-Final rejection of 10/02/2025 is acknowledged. Claims 1-2, 6, 13 and 17-32 are currently pending and under consideration.
Rejections Withdrawn:
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.
The rejection of Claims 5, 10-12 and 16 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicants amendments.
The rejection of Claims 3-4, 7-9 and 14-15 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of Applicants amendments.
New Objections/Rejections necessitated by Applicants Amendments:
Claim Objections
Claim 25 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 18-20, 22-24 and 26-32 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 phrase “at least one characteristic” in claims 18, 22 and 26 is a relative phrase which renders the claim indefinite. The phrase “at least one characteristic ” 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. In the instant case, the claims recite “The crystal of claim …, having at least one characteristic chosen from a DSC thermogram the same as Figure 3C and a TGA profile the same as Figure 3B.” Thus, it is unclear what the context of at least one characteristic refers to. For example, is the at least one characteristic is a TGA profile having a peak or mound at between 40 and 50 or is the one characteristic the entire TGA profile of Figure 3B? If the latter is Applicants intent, it is suggested to amend the claim to remove “at least one characteristic chosen from” and replacing “and” with “and/or” between the DSC thermogram and the TGA profile.
Regarding claims 19-20, 23-24 and 27-30, 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.
Conclusion
Claims 1-2, 6, 13, 21 and 25 are free of the prior art. Claim 25 is objected to. 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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 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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