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 Status
Applicant’s preliminary amendments received 25MAY2023 are acknowledged.
Claims 1-15 have been canceled.
Claims 16-26 are new.
Claims 16-26 are pending in the instant application (i.e., Claim(s) 16 is/are independent).
Priority
The present application is a CON of US Patent No. 11690911 which was a 371 National Stage of PCT International Application No. PCT/EP2018/070729, filed 31JAN2018, which claims foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of EPO Patent Application No: 17184950.8 filed on 04AUG2017 has been received in the previous filing and is acknowledged.
Information Disclosure Statement
No information disclosure statement(s) (IDS) have been filed.
Specification
The disclosure is objected to because of the following informalities:
Unless noted on PTO-892, Examiner has not considered any references in the specification.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see p 47 of the originally filed specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 contains a typographical and formatting error:
“A combination of at least two components, component A and component B, comprising a component A being an inhibitor of ATR kinase and component B being a PD-1 inhibitor or a PD-L1 inhibitor…
salt
thereof…….. component B is pembrolizumab as PD-1 inhibitor, or atezolizumab as PDL1
inhibitor…”
should be corrected to:
“A combination of at least two components, comprising component A and component B, wherein component A comprises an inhibitor of ATR kinase and component B comprises a PD-1 inhibitor or a PD-L1 inhibitor…
salt thereof…component B is pembrolizumab as the PD-1 inhibitor, or atezolizumab as the PD-L1 inhibitor….” or something of similar nature.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 19-21 and 23 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.
Claim 19, recites the phrase "optionally," which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(h)(II). Claims 20-21 are also rejected since they depend from claim 20, but do not remedy this deficiency.
Claim 23 recites the limitation "joint formulation.” Because claim 16 recites that component B is administered prior to component A, the pharmaceutical composition comprising component A, component B, and a pharmaceutically acceptable excipient must be in separate formulations, as exemplified on p 56 of the originally filed specification. Therefore, there is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-22 and 24-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,690,911, herein referred to as “’911.” Although the claims at issue are not identical, they are not patentably distinct from each other because method of treating a hyper-proliferative disease comprising administering an effective amount of a combination comprising known component A (i.e., ATR kinase inhibitor) and known component B (i.e., PD1 or PDL1 inhibitor), wherein component B is administered to the patient prior to the first administration of component A of the ‘911 patent is an obvious variant of the product comprising known component A (i.e., ATR kinase inhibitor) and known component B (i.e., PD1 or PDL1 inhibitor) for the use of treatment of a hyper-proliferative disease, wherein component B is administered to the patient prior to the first administration of component A of the instant application.
‘911 patent claims
Instant Application patent claims, underline corresponds to direct mapping to claim 1 of the ‘911 patent and italics corresponds to additional claim limitations.
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16. A combination of at least two components, component A and component B, comprising a component A being an inhibitor of ATR kinase and component B being a PD-1 inhibitor or a PD-L1 inhibitor, in which said component A has the formula:
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or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a pharmaceutically acceptable salt thereof, and in which said component B is pembrolizumab as PD-1 inhibitor, or atezolizumab as PDL1 inhibitor, said combination being for use in the treatment of a hyperproliferative disease, said hyperproliferative disease being lymphoma, lung carcinoma, or colon carcinoma, wherein said component B is to be administered prior to the first administration of component A.
17. The combination of claim 16, wherein component B is pembrolizumab.
18. The combination of claim 16, wherein component B is atezolizumab.
22. A pharmaceutical composition comprising a combination as defined in claim 16 together with one or more pharmaceutically acceptable excipients.
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19. A kit comprising, component A as defined in claim 16; Component B as defined in claim 16; and optionally Component C, wherein component C is one or more further pharmaceutical agents.
In this instance, because the method of treating a hyper-proliferative disease comprising administering an effective amount of a combination comprising known component A (i.e., ATR kinase inhibitor) and known component B (i.e., PD1 or PDL1 inhibitor), wherein component B is administered to the patient prior to the first administration of component A of claim 1 of the ‘911 patent, is silent on the specific PD-1 or PD-L1 inhibitor, the specification was consulted to determine the scope of the generic term of PD-1 or PD-L1 inhibitor. Per the specification of the ‘911 patent, component B is selected from nivolumab, pembrolizumab,…atezolizumab…and LY3300054 (col 34, lines 42-49). Therefore, there is no clear difference between the scope of the combinations of claims 16-18 of the instant application and the methods of use of the combination of claim 1 of the ‘911 patent.
Furthermore, because the method of claim 15 of the ‘911 patent, comprises a combination comprising components A, B, and C, wherein component B comprises a PD-1 or PD-L1 inhibitor, wherein component C is one or more further pharmaceutical agents, is silent on the specific PD-1 or PD-L1 inhibitor and the combination comprising components A, B, and C being a part of a kit the specification was consulted to determine the scope of the generic term PD-1 or PD-L1 inhibitor and the term combination. Per the specification of the ‘911 patent, component B is selected from nivolumab, pembrolizumab,…atezolizumab…and LY3300054 (col 34, lines 42-49) and a combination covers a kit comprising components A, B, and optionally component C (col 36, lines 60-61). Thus, there is no clear difference between the scope of the kits comprising a combination of components A, B, and optionally C of claims 19-21 of the instant application and the methods of use of the combinations comprising a kit of components A, B, and optionally C of claim 15 of the ‘911 patent.
Additionally, because the method of claim 13 of the ‘911 patent comprises a pharmaceutical composition comprising a combination comprising component A and B, wherein component B is administered prior to component A; it is clear that component A and component B must be present in separate formulations as recited in claim 24 of the instant application and because the method of claim 13 of the ‘911 patent comprises a pharmaceutical composition, comprising a combination, comprising component A and B, wherein component B comprises a PD-1 or PD-L1 inhibitor, is silent on the specific PD-1 or PD-L1 inhibitor, the specification was consulted to determine the scope of the generic term of PD-1 or PD-L1 inhibitor. Per the specification of the ‘911 patent, component B is selected from nivolumab, pembrolizumab,…atezolizumab…and LY3300054 (col 34, lines 42-49). Therefore, there is no clear difference between the scope of the pharmaceutical compositions of claims 22 and 24-25 of the instant application and the methods of use of the pharmaceutical compositions of claim 13 of the ‘911 patent.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In this instance, prior art, WO 2016/020320 (Bayer Pharma Aktiengesellschaft, et al., 11FEB2016) was considered in the Office Action filed 31MAY2022 pertaining to Application No. 16/635812, now issued as claims 1-15 of U.S. Patent No. 11,690,911 (i.e., NSDP rejection).
The position of the Office in the Office Action filed 31MAY2022 was that prior art, WO 2016/020320, was an obvious variant of the products claimed in Application No. 16/635812 filed 06MAY2022, which recited a combination comprising at least two components, component A and component B, wherein component A is an inhibitor of ATR kinase and component B is a PD-1/PD-L1 inhibitor, wherein component A has the formula:
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and component B is selected from the group consisting of nivolumab, pembrolizumab,…atezolizumab…and LY3300054 (i.e., claims 1 and 5-6 of the 16/635812 application). The prior art, WO 2016/020320 (Bayer Pharma Aktiengesellschaft, et al., 11FEB2016) taught that a kit-of-parts or non-fixed combination, the components comprising the active ingredients comprising 2-[(3R)-3-methylmorpholin-4-yl]-4-(l-methyl-lH-pyrazol-5-yl)-8-(lH-pyrazol-5-yl)-l,7- naphthyridine and one or more anti-hyperproliferative, cytostatic, cytotoxic substances for treatment of cancers, inclusive of 1311-chTNT,…cisplatin,…ipilimumab (i.e., anti-CTLA-4 antibody),…nivolumab (i.e., anti-PD-1 antibody),…pembrolizumab (anti-PD-1 antibody), etc. for the treatment of hyperproliferative disease (such as lymphomas, lung carcinomas, colorectal carcinomas) are in separate units (i.e., separate formulations) and may be administered separately, sequentially, simultaneously, concurrently, or chronologically staggered (p 50-51, Example 111, p 55-56 of the specification of WO 2016/020320).
Per Applicant’s arguments, p 6-11, Rejections under 35 USC §103 section, filed on 30NOV2022 for Application No. 16/635812, the WO 2016/020320 art did not teach that upon administration of component B prior to component A (i.e., steps of a method rather than the combination product itself) resulted in unexpected synergistic effects. Therefore because of the amendment to the claims of the 16/635812 application, filed 30NOV2022, which included the cancellation of claims 1-5, etc., and amendments to claims 6-9, etc., which included limitations relating to the order of administration of a composition, for example:
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(i.e., now issued claim 1 of the ‘911 patent), the rejections were withdrawn in the Examiners Amendment filed 17FEB2023.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM EST.
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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641