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 .
Claims 2, 4, 5, 7, 9, 11, 14-18, 21-27, 30-32, 34, 35, 37 and 38 are pending in the application.
This action is in response to applicants' amendment dated January 20, 2026. Claims 37 and 38 have been amended.
Response to Amendment
Applicant's arguments filed January 20, 2026 have been fully considered with the following effect:
The applicant's amendments are sufficient to overcome the 35 U.S.C. 102(a)(1), anticipation rejection, labeled paragraph 1) in the last office action, which is hereby withdrawn.
The applicant's amendments are sufficient to overcome the nonstatutory double patenting rejection, labeled paragraph 2) in the last office action, which is hereby withdrawn.
In view of the amendment dated January 20, 2026, the following new grounds of rejection apply:
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 2, 4, 5, 7, 37 and 38 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 pre-AIA the applicant regards as the invention. The following reason(s) apply:
Claims 2 and 5 and claims dependent thereon are vague and indefinite in that they are substantial duplicates of each other in that the X-ray powder diffraction pattern of Claim 2 is not patentably distinct from the X-ray powder diffraction pattern of Claim 5.
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, 7, 37 and 38 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.
Claims 4, 37 and 38 depend upon claim 2, which is directed toward a crystalline form of the compound of Formula (I) and Claim 7 depends upon claim 5. Claims 4 and 7 recite XRPD peaks associated with the crystalline form of the compound of Formula (I). These claims recite details that are inherent to the scope of the crystalline form of a compound of Formula (I) as set forth in the instant specification (see paragraphs [0337] and [0344] and are therefore necessarily within the scope of claims 2 and 5, respectively. Claims 37 and 38 additionally do not further limit the crystalline form of the compound of Formula (I) of claim 2 where the statement of intended use is not given any patentable weight.
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 Objections
Claims 9, 11, 14, 15, 34 and 35 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.
Allowable Subject Matter
Claims 16-18, 21-27 and 30-2 are allowed. None of the prior art of record nor a search in the pertinent art area teaches the process of preparing the compounds of Formula (I) and (VII) and the compounds of Formula (VII) or the compositions of Formula (I) where impurities of Formula C, D or E (Claim 31) or Formula A, B, C, D or E (Claim 34) are present in the composition.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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 H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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