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 .
Priority
The instant application is a 371 National Stage Entry of PCT/CN2022/142594 filed on December 28, 2022 which claims priority to foreign application No. CN202210000887.9 filed on January 4, 2022.
Status of Claims
Acknowledgement is made of original (3-4, 6-8) and amended (1-2, 5, 9-12) claims filed on July 1, 2024. Claims 1-12 are pending in instant application.
Information Disclosure Statement
The information disclosure statement filed on December 19, 2024 has been considered except where lined through.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title should reflect the structure and utility of the claimed compound. This may result in slightly longer titles, but the loss in brevity of title will be more than offset by the gain in its informative value in indexing, classifying, searching, etc (see MPEP § 606.01).
The following title is suggested: CRYSTAL FORM OF URAT1 INHIBITOR PULIGINURAD AND PREPERATION THEREOF.
Claim Interpretation
The phrase which appears in claims 9-10 “An application of the crystal form I of the compound as represented by formula A of claim 1 in the preparation of a drug for the prevention and/or treatment of...” is ambiguous, describing a compound, a use, and possibly a method. For the purpose of compact prosecution, claims 9-10 are interpreted to describe solely a composition of matter. Claims 9-10 are herein interpreted as a “use claim” for failing to recite distinct steps, preventing its interpretation as a method claim. See MPEP § 2173.05(q).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the phrase “An application of the crystal form I of the compound as represented by formula A of claim 1 in the preparation of a drug for the prevention and/or treatment of...” is unclear if a product or process is being claimed. See also 35 USC 112(b) rejection below.
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 6-10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 6-8, claim 6 recites “the compound as represented by formula A is prepared referring to CN106008340 A”. An incorporation by reference of essential material to an unpublished U.S. patent application, a foreign application or patent, or to a publication is improper under 37 CFR 1.57(d). See MPEP § 608.01(p)(I)(A)(2). Claims 7-8 depend from claim 6, and do not remedy this issue.
Regarding claims 9-10, the claims recite the phrase “An application of the crystal form I of the compound as represented by formula A of claim 1 in the preparation of a drug for the prevention and/or treatment of...” which is ambiguous, describing a product with intended use or possibly a method of making with intended use and no active steps. Applicant is requested to clearly distinguish a category of invention under 35 USC 101 for each claim. See also 35 USC 101 rejection above.
Further regarding claim 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim 10, the phrases “may be used”, “alternatively,” and “primarily” render the claim indefinite because they appear to be stand-ins for phrases like “for example” or “preferably”. It is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(d)
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 2-4 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.
Claim 1 describes crystal form I of a compound of Formula A, which is described in the specification as being a distinct polymorph with a corresponding XRPD spectra (see instant spec. at pp. 3-4 Table 3) and other properties shown in Figures 2-7. The cited claims describing specific peaks do not serve to further limit claim 1 because claim 1 describes Form I which inherently possesses the properties belonging to the polymorph.
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.
Allowable Subject Matter
Claims 1, 5, 11-12 are allowed.
The closest prior art appears to be US 20180072678 A1 Xu et. al.1
Xu teaches a compound of Formula A (see Xu at p. 86 claim 8 compound 48), a pharmaceutical composition comprising a disclosed compound (Xu claims 16-17), and treating hyperuricemia and diseases related to hyperuricemia like gout (Xu claim 15). Xu does not discuss crystallization. While an artisan might be motivated to purify Xu’s Compound 48 via crystallization, they would have no assurance of success of obtaining the instantly claim form I given multiple crystalline forms exist (see instant spec. at p. 7 “form III”, p. 9 “form VI”, p. 10 “form IV”). Despite sharing the same structure, each polymorph of a compound has a distinct set of properties; the prior art does not contemplate or put into practice isolating polymorphs of a compound of instant Formula A. Accordingly, claims 1, 5, 11-12 are free of prior art.
Conclusion
The title is objected to.
Claims 1, 5, 11-12 are allowed.
Claims 2-4, 6-10 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Published March 15, 2018. Hereinafter Xu.
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