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 .
Claim of Foreign Priority
Applicant’s claim of foreign priority to CN202110696953.6 and Certified Copy of Foreign propriety documents are acknowledged. To perfect such priority, Applicant is required to provide an English language translation of the foreign priority documents.
Objections to the Drawings
The Drawings are objected to for being illegible/blurry. Clear versions are requested.
Status of the Claims
Claims 1-4, 21, and 22 are pending and examined.
Allowable Subject Matter
Claims 1 is allowed.
Requirement for Information
The examiner makes Request for Information pursuant to M.P.E.P. § 704.11(b). The examiner notes that the Specification and claim 4 provide 5 separate methods for arriving at a single polymorph.
The examiner requests confirmation that each of the processes described in claim 4 when performed independently will yield a claimed polymorph of crystal form A; and
The examiner requests confirmation that the methods and products described in the following U.S. Pat. Nos. assigned to Applicant do not include and/or yield a polymorph of crystal form A. Those patent nos. are: 10,654,836; 11,001,572; 11,827625; and 12,358,898. The examiner makes this same request with respect to WO/2017/198221 referred to in the instant Specification at paragraphs 6 and 7 as yielding only amorphous solid forms.
The examiner did not identify prior art relevant to be applied to the claimed polymorph with the exception of the list documents set forth above.
The examiner will weigh allowability based upon the factual statements provided by Applicant in response to this Request. The status of the claims may change depending upon the response to this Request.
Claim Rejections - 35 USC § 112
Claims 3, 4, and 22 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. Claims 4 and 22 recite the word preferably and it is not clear is the preference is intended to be a requirement of the claims. Correction is requested.
With regard to claim 3, the M.P.E.P. explains the following: 2173.05(s) Reference to Figures or Tables [R-10.2019]:
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Here, it appears that the XRPD peak data can be provided to practically define the invention without exceptional need to reference Figure 1.
Further, the term “substantially” in the context of the claim and Specification is not clear. For example, while the Specification defines this term to include a deviation of 0.1 to 0.2, the claim already includes a limitation of +/-0.2 as it dependent from claim 1. As such, it is not clear if the claim is already inclusive of a substantial deviation or if such is in addition to the margin of error set forth in independent claim 1.
With further regard to claim 22, if the preferred embodiments are merely a range it remains improper for being a narrow range within a broader range.
Claim Rejections - 35 USC § 112
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, 3, and 21 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. In particular claims 2 and 3 are limited to a specific polymorph, which is the same polymorph claimed in instant claim 1. It is not clear how the identical polymorph of claims 2 and 3 further limit the same polymorph of claim 1. The examiner acknowledges that the identical polymorph is described differently, but it would appear that it is not possible to infringe claim 1 without also infringing claims 2 and 3.
Further, claim 21 does not appear to be further limiting of claim 1 because it broadens claim 1. Claim 1 is directed to a single compound with nothing else. Conversely, dependent claim 21 is an open-ended composition comprising the compound of claim 1 and anything else. As such, claim 21 does not further limit claim 1.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628