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
Claims 18-31 are pending in the instant application.
Claims 26-31 are withdrawn from consideration.
Claims 18-25 are examined herein.
Priority
The instant application claims benefit of foreign priority to CN202010612905.X, filed on 30 June 2020, and the benefit of priority to PCT/CN2021/102949, filed on 29 June 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 30 June 2020.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 09 February 2023, is acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Election/Restrictions
Applicant’s election of Group I, with traverse, claims 18-25, in the reply filed on 18 August 2025 is acknowledged. Applicant further elects the phosphate salt of Formula (I). The traversal is on the grounds that because Groups I-III are related as product and process of use of said product that there is unity of invention and no analysis of a special technical feature was required.
Applicant’s arguments have been considered but are not persuasive. The inventions lack unity of invention because they do not share a special technical feature. The technical relationship among inventions is only fulfilled when those inventions involve one or more of the same or corresponding special technical features. See 37 CFR.475(a). Since Jin et al. (WO2019062662A1) teach pharmaceutically acceptable salts of the reference compound 8, which is the instant compound, there is not a special technical feature and therefore no unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
If the elected species is not identified in the art, the search will be expanded to additional species per MPEP 802.03.
Claim Interpretation
Claims 22 and 24 recite the relative term “substantially,” this term is defined in paragraph [00105] of the specification and therefore is not subject to a 112(b) rejection.
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 19-24 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 recites the phosphate crystalline Form A, this form encompasses all properties of said Form, i.e. the x-ray powder diffraction pattern values and differential scanning calorimetry peaks. Recitation of these values in dependent claims does not further limit claim 1 since the Form includes all peaks.
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 18 and 25 are allowed.
The closest prior art is Jin et al. (WO2019062662A1) and Zhang et al. (WO2015014256A1).
Jin teaches pharmaceutically acceptable salts of compounds of Formula (I) (claim 1), (pictured below), and the preferred embodiment, compound 8 (claim 11), pictured below which is the instant Formula (I). Jin discloses salts of inorganic acids, including phosphoric acid, for ion exchange (paragraph [00101]).
PNG
media_image1.png
202
472
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Greyscale
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128
270
media_image2.png
Greyscale
Jin does not disclose an embodiment of a phosphate salt of compound 8 nor a crystalline form of a phosphate salt of compound 8. Additionally, the process of making the reference compound 8 is different than the instant compound synthetic steps. Therefore, the instant crystalline forms are not obvious over reference compound 8 as the synthetic steps required to obtain these forms are not the same as those used to prepare compound 8 and are not suggested by the work of Jin.
Zhang teaches pharmaceutically acceptable salts of compounds of Formula (I)(claim 1), (pictured below), and the preferred embodiment, compound 42 (claim 20), pictured below which is the instant Formula (I). Zhang discloses salts of inorganic acids, including phosphoric acid, for ion exchange (paragraph [00142]).
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media_image3.png
200
608
media_image3.png
Greyscale
PNG
media_image4.png
144
298
media_image4.png
Greyscale
Zhang does not disclose an embodiment of a phosphate salt of compound 42 nor a crystalline form of a phosphate salt of compound 42. Additionally, the process of making the reference compound 8 is different than the instant compound synthetic steps. Therefore, the instant crystalline forms are not obvious over reference compound 42 as the synthetic steps required to obtain these forms are not the same as those used to prepare compound 42 and are not suggested by the work of Zhang.
Conclusion
Claims 19-24 are rejected.
Claims 18 and 25 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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