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
This application claims the benefit of and priority to PCT/CN2022/109030, filed July 29, 2022, and is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/13/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 7, 8, 14, 15, 17, 21, 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 is directed to the Form B polymorph of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione.
Claims 2, 7, 8, 14, 15, 17, 21, and 24 recites the polymorph of claim 1, and characterized by XRPD patters with increasing multiples of peaks, characteristics of DSC thermogram and a triclinic crystal system with a P1 Space Group. Where as the crystalline Form B has been identified in claim 1, the incorporation of additional characteristics in subsequent claims do not further limit claim subject matter and the where the subsequent claims are still drawn to Form B.
Claim 31 is 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 30 is directed to Form C of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione.
Claim 31 is rejected as being improper dependent for failing to further limit claim 30. In the instant application, claim 30 identifies Form C polymorph of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione. Whereas the crystalline form has been defined, the incorporation of additional peaks to the same form in subsequent claims does not further limit the claim and since the subsequent claims are still drawn to the same crystalline form.
Claim 50 is 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 49 is directed to Form D of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione.
Claim 50 is rejected as being improper dependent for failing to further limit claim 49. In the instant application, claim 49 identifies Form D polymorph of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione. Whereas the crystalline form has been defined, the incorporation of additional peaks to the same form in subsequent claims does not further limit the claim and since the subsequent claims are still drawn to the same crystalline form.
Claim 66 is 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 65 is directed to Form E of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione.
Claim 66 is rejected as being improper dependent for failing to further limit claim 65. In the instant application, claim 65 identifies Form E polymorph of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione. Whereas the crystalline form has been defined, the incorporation of additional peaks to the same form in subsequent claims does not further limit the claim and since the subsequent claims are still drawn to the same crystalline form.
Claim 93 is 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 92 is directed to Form F of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione.
Claim 93 is rejected as being improper dependent for failing to further limit claim 92. In the instant application, claim 92 identifies Form C polymorph of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione. Whereas the crystalline form has been defined, the incorporation of additional peaks to the same form in subsequent claims does not further limit the claim and since the subsequent claims are still drawn to the same crystalline form.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing where the dependent claims comply with statutory requirements.
REASONS FOR ALLOWABLE SUBJECT MATTER
The following is an examiner’s statement of reasons for allowance: Claims 1, 30, 49, 65, 92, 109, 111, and 117 would be allowable based on Grillo et al, WO 2020092208A1, where the reference art teaches the parent compound of (6S,7S)-6-fluoro-7-(2-fluoro-5-methylphenyl)-3- (tetrahydro-2H-pyran-4-yl)-5,6,7,8-tetrahydropyrido [2,3-d]pyrimidine-2,4(1 H,3H)-dione but does not teach the specific crystalline forms.
Summary of the Claims
Claims 1, 2, 7, 8, 14, 15, 17, 21, 24, 30, 31, 49, 50, 65, 66, 92, 93, 109, 111, and 117 are pending.
Claims 2, 7, 8, 14, 15, 17, 21, 24, 31, 50, 66, and 93 are rejected.
Claims 1, 30, 49, 65, 92, 109, 111, and 117 are in condition for allowance.
Conclusion
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/S.H.D./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627