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 .
Claims 2-4, 6-14, 16-22, 30-31, 33, 35-37, 40, 42, 45, 48-55, and 57-64 have been cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 15, 23-29, 32, 34, 38-39, 43-44, 46-47, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over any of U.S. Patent No. 11,939,382; U.S. Patent No. 12,570,744, U.S. Patent Application Publication 2022/0411509 (of record), and WO 2022/229919 (of record) in view of Grogan et al. (U.S. Patent Application Publication 2017/0086131).
U.S. Patent No. 11,939,382; U.S. Patent No. 12,570,744, U.S. Patent Application Publication 2022/0411509, and WO 2022/229919 are equivalent documents. These documents have the same applicant as the instant application but no common inventors with the instant application. Each of these documents disclose the bispecific binding protein having the anti-PD-1 antibody and anti-TIGIT antibody sequences recited in instant claim 1, 15, and 44. See at least claims of U.S. Patent No. 11,939,382 and U.S. Patent No. 12,570,744. See at least paragraph [0062, 0064-0065, 0067, 0069, 0071, 0081, 0136] for the limitations of instant claims 23-29, 34, 38-39. The light chains would implicitly have either a kappa or lambda constant region. See instant claim 32. Treatment of cancer with the bispecific antibodies is disclosed. The documents do not disclose the amounts of about 70 mg to about 1500 mg.
Grogan et al. discloses administering anti-TIGIT antibodies. The antibodies can be bispecific with PD-1 antibodies. Pharmaceutical compositions and kits including instructions are disclosed. Treating cancers such as non-small cell lung cancer (NSCLC) are disclosed. The NSCLC cancer can be late state (i.e. advanced). (See instant claim 39.) The amount administered can be about 100 mg to about 1400 mg. About 700 mg and about 800 mg are disclosed. (See instant claims 1 and 44.) They can be administered every week (i.e. every 7 days) and the patient can receive from about two to about twenty doses (i.e. up to 35 cycles. (See instant claim 5.) See at least claims 1, 81-84, 87, 179, and 181-182 and paragraphs [0259, 0334, and 0388].
It would have been obvious to administer the bispecific antibodies of any of U.S. Patent No. 11,939,382; U.S. Patent No. 12,570,744, U.S. Patent Application Publication 2022/0411509, and WO 2022/229919 in the amount of about 70 mg to about 1500 mg as suggested by Grogan et al. to treat cancer The pharmaceutical compositions of instant claims 44, 46-47, and 56 would have been obvious. One would have been motivated to do so to provide additional methods of treatment using the bispecific antibodies. The disclosure of about 700 mg or 800 mg suggests the claimed “about 750 mg” in instant claim 46. The disclosure of about 1400 mg suggests the claimed “about 1500 mg” in instant claim 47. With respect to instant claim 43, none of the references indicate that the subject or patient was previously treated with a checkpoint inhibitor. This fairly suggests checkpoint inhibitor naïve subjects.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over any of U.S. Patent No. 11,939,382; U.S. Patent No. 12,570,744, U.S. Patent Application Publication 2022/0411509, and WO 2022/229919 in view of Grogan et al. (U.S. Patent Application Publication 2017/0086131) as applied to claims 1, 5, 15, 23-29, 32, 34, 38-39, 43-44, 46-47, and 56, above, and further in view of Goodenow et al. (U.S. Patent Application Publication 2018/0078639).
None of U.S. Patent No. 11,939,382; U.S. Patent No. 12,570,744, U.S. Patent Application Publication 2022/0411509, WO 2022/229919 or Grogan et al. (U.S. Patent Application Publication 2017/0086131) discloses that the subject has a PD-L1 tumor proportion score of greater than or equal to 1% as in instant claim 41.
Goodenow et al. discloses anti-PD-1 antibodies can be administered to treat NSCLC in subjects having a PD-L1 tumor proportion score (PD-L1 TPS) between 1% and 50% or 50% or greater. See at least paragraph [0045].
It would have been obvious to administer the bispecific antibodies of any of U.S. Patent No. 11,939,382; U.S. Patent No. 12,570,744, U.S. Patent Application Publication 2022/0411509, and WO 2022/229919 in the amount of about 70 mg to about 1500 mg as suggested by Grogan et al. to treat cancer where the subjects have a PD-L1 tumor proportion score (PD-L1 TPS) between 1% and 50% or 50% or greater as taught by Goodenow et al. One would have been motivated to do so to provide additional methods of treatment using the bispecific antibodies.
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 1, 5, 15, 23-24, 28, 32, 34, 38-39, 43-44, 46-47, and 56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,939,382 in view of Grogan et al. (U.S. Patent Application Publication 2017/0086131).
Claims 1-3 of U.S. Patent No. 11,939,382 disclose bispecific antibodies meeting the sequence limitations of instant claims 1, 15, and 44. Issued claim 4 meets the limitations of instant claims 23-24 and 28 as well as claim 34. Issued claim 8 is a pharmaceutical composition as is instant claim 44. Issued claims 16-17 are directed to a method of treating cancer as in claim 38. The claims of the ‘382 patent do not disclose the amounts of about 70 mg to about 1500 mg.
Grogan et al. discloses administering anti-TIGIT antibodies. The antibodies can be bispecific with PD-1 antibodies. Pharmaceutical compositions and kits including instructions are disclosed. (See instant claims 44, 46-47, and 56.) Treating cancers such as non-small cell lung cancer (NSCLC) are disclosed. The NSCLC cancer can be late state (i.e. advanced). (See instant claim 39.) The amount administered can be about 100 mg to about 1400 mg. About 700 mg and about 800 mg are disclosed. (See instant claims 1 and 44.) They can be administered every week (i.e. every 7 days) and the patient can receive from about two to about twenty doses (i.e. up to 35 cycles. (See instant claim 5.) See at least claims 1, 81-84, 87, 179, and 181-182 and paragraphs [0259, 0334, and 0388].
It would have been obvious to administer the bispecific antibodies claimed in U.S. Patent No. 11,939,382 in the amount of about 70 mg to about 1500 mg as suggested by Grogan et al. to treat cancer. The pharmaceutical compositions of instant claims 44, 46-47, and 56 would have been obvious. One would have been motivated to do so to provide additional methods of treatment using the bispecific antibodies. The light chains would implicitly have either a kappa or lambda constant region. See instant claim 32. The disclosure of about 700 mg or 800 mg suggests the claimed “about 750 mg” in instant claim 46. The disclosure of about 1400 mg suggests the claimed “about 1500 mg” in instant claim 47. With respect to instant claim 43, none of the references indicate that the subject or patient was previously treated with a checkpoint inhibitor. This fairly suggests checkpoint inhibitor naïve subjects.
The instant claims are not patentably distinct from the issued claims in view of Grogan et al.
Claims 1, 5, 15, 23-29, 32, 34, 43-44, 46-47, and 56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,570,744 in view of Grogan et al. (U.S. Patent Application Publication 2017/0086131).
Grogan et al. is applied as above.
Claims 1-3 of U.S. Patent No. 12,570,744 disclose bispecific antibodies meeting the sequence limitations of instant claims 1, 15, and 44. Issued claims 4 and 6-9 meet the limitations of instant claims 23-28. Issued claim 4 meets the limitations of instant claim 34. Issued claim 10 meets the limitations of instant claim 29. Issued claim 11 is a pharmaceutical composition as is instant claim 44. Issued claims 17-178 are directed to a method of treating cancer as in claim 38. The claims of the ‘744 patent do not disclose the amounts of about 70 mg to about 1500 mg.
It would have been obvious to administer the bispecific antibodies claimed in U.S. Patent No. 12,570,744 in the amount of about 70 mg to about 1500 mg as suggested by Grogan et al. to treat cancer. The pharmaceutical compositions of instant claims 44, 46-47, and 56 would have been obvious. One would have been motivated to do so to provide additional methods of treatment using the bispecific antibodies. The light chains would implicitly have either a kappa or lambda constant region. See instant claim 32. The disclosure of about 700 mg or 800 mg suggests the claimed “about 750 mg” in instant claim 46. The disclosure of about 1400 mg suggests the claimed “about 1500 mg” in instant claim 47. With respect to instant claim 43, none of the references indicate that the subject or patient was previously treated with a checkpoint inhibitor. This fairly suggests checkpoint inhibitor naïve subjects.
The instant claims are not patentably distinct from the issued claims in view of Grogan et al.
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.
Claim 24 is 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 24 is confusing in reciting “at least one substitution selected from” and naming multiple substitutions at the same position. See for example 221K and 221Y. Both of these substitutions cannot occur simultaneously. Clarification is requested.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
Mpa20170088613
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