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 .
Status of Claims
Claims 1-6, 9-14, 16-17, 20 and 22-26 are pending in the application. Claims 1-6, 9-14, 16-17, 20 and 22-26 are examined herein.
Priority
This application is a 371 of PCT/CN2022/072933 filed 01/20/2022 and claims foreign priority to CHINA 202110088776.3 filed 01/22/2021.
It is noted that Applicants have not provided an English translation of the certified copy of the foreign priority application as required by 35 U.S.C. 119(b). Without the English translation, one cannot ascertain if the instant invention is supported in the Chinese application. Therefore, art prior to the PCT date, but not before the date of the Chinese application may be cited against the claims. Accordingly, claims 1-6, 9-14, 16-17, 20 and 22-26 have been afforded an effective filing date of 01/20/2022, the filing date of the PCT application.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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 2-5 and 10-13 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.
Regarding claims 2-5, the claims depend directly or indirectly from claim 1 and recite the crystal form I of a compound of formula (A) characterized by additional X-ray powder diffraction peaks. “Form I of a compound of formula (A)” is the most specific recitation of a solid form and will inherently exhibit the recited X-ray powder diffraction peaks of the dependent claims 2-5. This is not considered as further limiting the scope of claim 1, which is improper.
Regarding claims 10-13, the claims depend directly or indirectly from claim 9 and recite the crystal form II of a compound of formula (A) characterized by additional X-ray powder diffraction peaks. “Form II of a compound of formula (A)” is the most specific recitation of a solid form and will inherently exhibit the recited X-ray powder diffraction peaks of the dependent claims 10-13. This is not considered as further limiting the scope of claim 1, which is improper.
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.
It is suggested that Applicants amend to remove the specific recitation of form I and form II in the claims, to overcome this rejection.
Allowable Subject Matter
The crystalline forms I and II of a compound of formula (A) as in claim 1 and claim 9 have been found to be free of prior art. Except for the 35 U.S.C. 112(d) rejection drafted above, all claims would be allowable.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Van Dongen et al. (WO 2018/141854 A1, publication date 09 August 2018, hereinafter Van Dongen in the IDS). Van Dongen teaches piperazine derivatives for influenza virus inhibition (Title; Abstract; Pg. 5, Lns. 10-25). Van Dongen teaches compounds having formula (I) or a stereo-isomeric, a pharmaceutically acceptable salt, a solvate or a polymorph thereof (Pg. 5, Ln. 30 – Pg. 6, Ln. 27).
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Van Dongen teaches an exemplary compound, compound 3 shown below (Pg. 17, first compound; Pg. 43, Table 2).
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191
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Compound 3 of Van Dongen differs from the instant compound in the point of attachment of the tetrazole ring, location of the methyl substituent on the tetrazole ring, a piperazine versus piperidine ring and the alkyl substituent attached to the amide functionality, as highlighted above.
There is no teaching or suggestion in the prior art to arrive at the crystalline forms of the instant compound of formula (A). Therefore, the instant claims are novel and non-obvious over the compounds taught in the prior art for use in a method of treating/preventing influenza.
Conclusion
Claims 2-5 and 10-13 are rejected.
Claims 1, 6, 9, 14, 16-17, 20 and 22-26 are allowed.
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/P.S.R./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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