DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's preliminary amendment filed on 01/26/2024 is acknowledged.
Claims 81-97 are pending.
3. 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.
4. Claims 83, 86, 88, 91 and 93-97 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claims 83, 88 and 93 are indefinite, because the recitation of “B7-H1” lacks proper antecedent basis in the respective base claims. While a person of skill in the art would be aware that “B7-H1” is generally used in the art as a synonym of “PD-L1,” the use of a different term within the same set of claims appears to indicate that it refers to different subject matter.
(ii) Claims 86, 91 and 96 are indefinite, because the recitation of “the chemotherapeutic agent” lacks proper antecedent basis in the respective base claims. It appears that claim 86 was intended to depend on claim 85, claim 91 on claim 90, and claim 96 on claim 95, which dependence is provisionally assumed for examination purposes.
(iii) Claims 94-97 are indefinite, because they encompass the indefinite limitations of the claim on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 81-97 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11827706.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘706, which are directed to the same method as instantly claimed.
The present application is a continuation of USSN 17072756 which issued as US ‘706 patent. Instantly recited MEDI4736 is an anti-PD-L1 antibody comprising SEQ ID NOS: 1-8 recited in US ‘706 claims, as disclosed in present specification (e.g. [0069] of US 20240150469).
Specifically US ‘706 claims are directed to a method of treating squamous cell carcinoma of the head and neck (SCCHN) comprising administering to the patient 15 mg/kg or 1500 mg of MEDI4736 every 14 to 21 days, wherein at least 25% of the tumor cells are PD-L1 positive by immunohistochemistry (claims 1, 3-4, 8-9, 11, 15, 17), wherein the SCCHN is refractory to at least one chemotherapeutic agent such as Vemurafenib, Afatinib, Cetuximab, Carboplatin, Bevacizumab, Erlotinib, or Pemetrexed (claims 5-6, 12-13, 18-19).
7. Claims 81-97 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 10336823 (cited on IDS) and 10829557.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of US ‘823 and US ‘557, optionally as evidenced by, or in view of, Chen et al. (US 7794710) and/or Cogswell et al. (US 20130309250).
The present application is a continuation (via USSN 17072756) of applications issued as US ‘823 and US ‘557. The claims of each of US ‘823 and US ‘557 are directed to methods of treating non-small cell lung carcinoma (NSCLC) comprising administering MEDI4736 at 15 mg/kg (US ‘823), or at 1500 mg (US ‘557) every 14 to 21 days, wherein at least 25% of the tumor cells are PD-L1 positive, and wherein the tumor is refractory to at least one chemotherapeutic agent.
It was known to those skilled in the art before the effective filing date of the claimed invention that a broad variety of cancers could be treated by anti-PD-L1 antibodies, including lung cancer and head and neck cancer (e.g. claims 1-12 of Chen et al.), and in particular NSCLC and SCCHN (e.g. claims 1, 3, and 7 of Cogswell et al.).
Therefore, a person of skill in the art would have at once envisaged the instantly claimed method in view of the methods claimed in US ‘823 and US ‘557. Alternatively, a person of skill in the art would have deemed the instantly claimed method to be obvious in view of the methods claimed in US ‘823 and US ‘557.
8. The following US Patents share a coinventor and/or an assignee with the present application, and disclose and/or claim subject matter similar to that of the present claims, but do not contain patented claims which would anticipate or make obvious the presently claimed invention:
Claim 13 of US Patent No. 10232040 (cited on IDS) is directed to a method of treating NSCLC comprising administering 10 mg/kg of MEDI4736 and 1 mg/kg tremelimumab. This claim is deemed to neither anticipate the instant claims nor make them obvious because, given the knowledge in the art before the effective filing date of the claimed invention, there was insufficient expectation that 10 mg/kg or 15 mg/kg of MEDI4736 would be therapeutically effective in the absence of tremelimumab.
Claims 1, 2 and 13 of US Patent No. 10092645 are directed to a method of treating head and neck cancer comprising administering MEDI4736 and fractionated radiation therapy. These claims are deemed to neither anticipate the instant claims nor make them obvious because, given the knowledge in the art before the effective filing date of the claimed invention, there was insufficient expectation that 10 mg/kg or 15 mg/kg of MEDI4736 would be therapeutically effective in the absence of radiation therapy.
9. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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