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 1-18 are under consideration in the instant Office Action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that SEQ ID NO: 12 has no amino acid listing in the CRF since it is only a 3 amino acid sequence. This specific sequence is disclosed in the parent application 17/222,370 as SEQ ID NO: 12 being VAS. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
The disclosure of SEQ ID NO:12 needs to be spelled out in the instant specification and in the instant claim 1.
Specification
The disclosure is objected to because of the following informalities: SEQ ID NO: 12 has no amino acid listing in the CRF since it is only a 3 amino acid sequence. This specific sequence is disclosed in the parent application 17/222,370 as SEQ ID NO: 12 being VAS but fails to be disclosed in the instant specification. The instant specification needs to be amended to disclose and properly identify the amino acid sequence. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 calls out “…SEQ ID NO 15…” but it should be “…SEQ ID NO: 15…”. Further, claim 1 calls for SEQ ID NO: 12 but requires the deletion of the sequence identifier and spell out the amino acid sequence of VAS. Appropriate corrections are required.
Claim 12 is objected to because of the following informalities: There is a typo in claim 12 since claim 12 calls out “the heavy chain variable region of SEQ ID NO: 2” but it should be “…“the heavy chain variable region is SEQ ID NO: 2”. Appropriate corrections are 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 1, 2, 4-5, 7, 9-10 and 17-18 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.
Independent claim 1 calls for one or more amino acid modifications wherein the one or more amino acid modifications to enhance a clearance rate of the modified anti-PD-L 1 antibody is located at H315 and/or H440. Further dependent claims call for one or more amino acid modifications to abolish Fc-related effector function are located at L239, L240, and/or K327. Due to the specific claim language of one or more amino acid modifications it is unclear how many and what specific modifications are required to achieve the required function. While dependent claims do call out possible sites like the ones disclosed as H315 and/or H440 and L239, L240, and/or K327, it is unclear which modifications or their combinations are required to achieve the stated effect. Certain dependent claims do call out specific sequences that that address these issued and amending the claims to incorporate these limitations would overcome these indefinite issues.
MPEP § 2173.02 (II) states that one of the purposes of examination under 35 USC § 112, second paragraph is to determine whether the claim apprises one of ordinary skill in the art of its scope and, therefore, serves the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent. See, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). See also In re Larsen, No. 01-1092 (Fed. Cir. May 9, 2001) (unpublished). If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). In this case, others are not fairly apprised of the scope of the claimed amino acid modification in the heavy chain constant domains of the claimed antibodies and thus not fairly warned as to what constitutes infringement.
Claim Rejections - 35 USC § 103
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al., US9,567,399 (instant PTO-891) in view of Campbell et al., WO2017220569 (instant PTO-892) and Kuenkele et al., US2018179287 (instant PTO-892).
Campbell ’399 teaches antibodies and antigen binding fragments thereof that specifically bind to programmed cell death 1 ligand (PD-L1) and include the 84G09 antibody that has all of the instantly claimed CDR sequences (see column 27, starting at line 40) as instant claims 1 and 17-18. Campbell ’399 teaches SEQ ID NOs: 23 and 25 (see columns 151-152) that encompasses instantly claimed CDR sequences SEQ ID NOs: 10-15 as required in instant claims 1 and 17-18. Campbell ’399 teaches SEQ ID NO: 23 which is the same sequence as instantly claimed light chain sequence SEQ ID NO: 9 as required in instant claim 13. Campbell ’399 teaches SEQ ID NO: 25 which is the same as instantly claimed light chain sequence SEQ ID NO: 21 of instant claim 16. Campbell ’399 teaches SEQ ID NOs: 13 and 15 (see columns 147-148) that encompasses instantly claimed CDR sequences SEQ ID NOs: 3-8 as required in instant claims 1 and 17-18. Campbell ’399 teaches SEQ ID NO: 13 which is the same sequence as instantly claimed sequence SEQ ID NO: 2 of instant claim 12. Campbell ’399 teaches kappa light chain constant regions and light chain constant regions in SEQ ID NOs: 207 and 209 (see column 63, lines 28-35) which is the same sequence as instantly claimed SEQ ID NO: 16 as in instant claim 15. Campbell ‘399 teaches antibodies in pharmaceutical compositions and providing them in kits (see column 4, lines 40-50) as required in instant claims 17-18. Campbell ’399 teaches creating Fab antibodies which are modified antibodies. While Campbell ’399 teaches heavy chain sequences, such as SEQ ID NO: 299 with 95% match, Campbell ’399 does not specifically teach SEQ ID NOs: 42-44.
Campbell ‘569 teaches the same 84G09 antibody and also teaches the heavy chain SEQ ID NO: 114 (see page 103) which is the same as instantly claimed SEQ ID NO: 42 as in instant claims 7-11.
Kuenkele teaches that antibodies may have no effector function by modifying the constant regions by lacking an Fc part or having a blocked, masked Fc part, which is not recognized by the immune cells or immune system (see paragraphs 125 and 127) as required in instant claims 1-2, 4-5, 7, 9-10. Kuenkele teaches that the choice of the type and length of the constant regions depends on whether the effector functions are desired (see paragraph 158). Kuenkele teaches modified constant regions including SEQ ID NO: 271 with modifications that match the ones instant SEQ ID NO: 57 as required in instant claims 1-3, 5-6. Kuenkele does not teach the instantly claimed antibody with the specifically claimed CDR sequences.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Campbell ‘399, Campbell ’569 and Kuenkele. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because Campbell ‘399 and Campbell ’569 both teach the same 84G09 antibody that has the same CDRS as the instant claims and Kuenkele teaches that one would be capable of modifying the Fc portion of the antibody to match the required action of the Fc response with the immune system. It would be obvious to substitute equivalent components for the antibody to keep the specific antibody binding and reduce any of the possible side effects of the Fc portion of the antibody with the immune system. Further, modifications to Fc region also control the clearance of the antibodies from a subject’s system. Therefore, as in stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an “express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)." Moreover, this section of the MPEP teaches "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Accordingly, the cumulative reference teachings render obvious the claimed antibody. Finally any point mutations within the Fc portion of the antibody to reduce its immune system effect would be accomplished through routine optimization (see MPEP § 2144.05) to achieve the best possible antibody Fc function based on the knowledge of the antibody prior art. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,995,141. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘141 claims a modified anti-Programmed Death Ligand 1 (PD-L1) antibody, comprising a heavy chain comprising a heavy chain variable region including a CDR1 of SEQ ID NO: 3 or SEQ ID NO: 4, a CDR2 of SEQ ID NO: 5 or SEQ ID NO: 6, and a CDR3 of SEQ ID NO: 7 or SEQ ID NO: 8, and a heavy chain constant region of SEQ ID NO: 55; SEQ ID NO: 56 or SEQ ID NO: 57 and wherein the heavy chain is SEQ ID NO: 42, SEQ ID NO: 43 or SEQ ID NO: 44 and a light chain comprising a light chain variable region including CDR1 of SEQ ID NO: 10 or SEQ ID NO: 11, a CDR2 of SEQ ID NO: 12 or SEQ ID NO: 13 and a CDR3 of SEQ ID NO: 14 or SEQ ID NO 15. Therefore, ‘141 anticipates the instant claimed invention since ‘141 discloses the same instant sequences for the modified PD-L1 antibody.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,732,046. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘046 claims a modified anti-Programmed Death Ligand 1 (PD-L1) antibody, comprising a heavy chain comprising a heavy chain variable region including a CDR1 of SEQ ID NO: 3 or SEQ ID NO: 4, a CDR2 of SEQ ID NO: 5 or SEQ ID NO: 6, and a CDR3 of SEQ ID NO: 7 or SEQ ID NO: 8, and a heavy chain constant region of SEQ ID NO: 55 and wherein the heavy chain is SEQ ID NO: 42 and a light chain comprising a light chain variable region including CDR1 of SEQ ID NO: 10 or SEQ ID NO: 11, a CDR2 of SEQ ID NO: 12 or SEQ ID NO: 13 and a CDR3 of SEQ ID NO: 14 or SEQ ID NO 15. Therefore, ‘046 anticipates the instant claimed invention since ‘141 discloses the same instant sequences for the modified PD-L1 antibody.
Conclusion
No claims are allowed.
Advisory Information
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675