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 .
DETAILED ACTION
Filing Receipt and Priority
The filing receipt mailed 03/20/2025 states that the instant application is a 371 of PCT/CN2022/136194, filed 12/02/2022.
The filing receipt also states that the instant application claims foreign benefit of CHINA PCT/CN/2021/134939, filed 12/02/2021.
The certified copy submitted 05/28/2024 supports the instant claims. Therefore, the effective filing date is 12/02/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted 07/15/2024, 10/04/2024, 10/29/2024, 12/18/2024, 04/23/2024, and 02/03/2026 have been considered.
Claim Objection
Claim 9 is objected to for the use of “ethanol/water”. The backslash is typically used to denote a ratio of one component to another. Here applicant is claiming crystalline form obtained from a solvent system comprised of ethanol and water. The claim would be in better form if amended to state the specific ethanol to water mixture, as found in para. [00250].
Rejections
Claim Rejections - 35 USC § 112(a)
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, 6, 9, 11, 16, 38, 43, 48, 50, 61-64 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.
Claims 1, 11, and 38 are drawn to crystalline compounds of Patterns C, G, and H. Claim 1 specifically is drawn to Pattern C which is characterized by at least the property of having a thermos-gravimetric analysis (TGA) similar to instant figure 2, a DSC thermogram similar to instant figure 3, a DSC thermogram with an endotherm having an onset at about 137oC, and/or non-hygroscopicity, along with characterization data based on XRPD data.
The language of claim 1 requires only that one of the properties a-f exist in the crystalline form of Pattern C (property g is drawn to a combination of properties a-f). In a sense, applicant is claiming a crystalline form that is characterized only by a TGA, a DSC thermogram, or hygroscopicity. None of these properties by themselves sufficiently characterize a crystalline form so that it is distinct from other crystalline forms. Characterization requires at least XRPD pattern characterization.
Similar issues are present in claims 11 and 38. As claims 6, 9, 16, 43, 48, 50, and 61-64 are dependent on claims 1, 11, and 38, they are also rejected.
Claim Rejections - 35 USC § 112(b)
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 1, 6, 8-9, 11, 16, 17, 38, 43-44, 48, 50, 61-64 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.
Relative Term
The term “substantially” in claims 1, 11, and 38 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.
The term “substantially” is used the above claims to specify that the claimed crystalline form has specific properties. See below.
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However, “substantially” is not defined within the specification. There is nothing within the figures or specification that would indicate to one of ordinary skill how an XRPD pattern or thermos-gravimetric analysis that is “substantially similar” to the claimed characterization would appear. Therefore, the claims are indefinite.
As claims 6, 8-9, 16, 17, 43-44, 48, 50, 61-64 are dependent on claims 1, 11, and 38, they are also rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Yan (WO2020118113, of the record).
As stated in the 112(a) written description above, claim 1 is drawn to a crystalline form having at least one property a-f of those listed in claim 1 or a combination of properties a-f. Therefore, the scope of claim 1 encompasses a crystalline form that is simply hygroscopic. Yan on p. 51, Example 6 discloses a crystalline form 2 of compound I that is non-hygroscopic (para. [00213]).
Examiner’s Comments
The closest art is found in Yan (US12,145,917, published 11-19-2024, priority to 12/05/2019). Yan discloses crystalline forms which are characterized as having XRPD patterns different than those instant claimed.
Claims 3, 13, and 40 would be allowable if written in independent form.
Additionally, the critical characteristics, which are the XRPD peaks of patterns C, G, and H, should be required (See 112(a) written description rejection above).
Conclusion
No claims allowed.
Allowable subject matter indicated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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