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 06/30/2023 is acknowledged.
Claims 1, 5, 12-14, 16-19, 21, 24-25, 28-29, 31-32, 36, 40 and 56-57 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. Claim 57 is 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.
Dependent claim 57 is indefinite, because the recitation of “the sequence shown in SEQ ID NO: 24,” lacks proper antecedent basis in the base claim(s).
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. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
6. Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 11548948 (cited on IDS). This is a statutory double patenting rejection.
7. 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.
8. Claims 5, 12, 16-18, 31-32, 36, 40 and 56 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11548948 (cited on IDS).
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 ‘948.
In particular, the subject matter of instant claim 5, subclause (iv) is anticipated by the subject matter of US ‘948 claim 2, subclause (vi), as well as by US ‘948 claim 7, for the following reasons:
Claim 2 of US ‘948 depends on claim 1, and recites in subclause (vi):
The antibody molecule, or fragment thereof according to claim 1, wherein:
(vi) the first sequence has the sequence set forth in SEQ ID NO: 23, the second sequence has the sequence set forth in SEQ ID NO: 11, and the third sequence has the sequence set forth in SEQ ID NO: 31.
Instant claim 5 depends on claim 1, which, as noted in section 6 above, is identical to claim 1 of US ‘948. Subclause (iv) of claim instant 5 is reproduced herein:
The antibody molecule, or fragment thereof, according to claim 1, wherein:
(iv) the first sequence has the sequence set forth in SEQ ID NO: 23, the second sequence has the sequence set forth in SEQ ID NO: 11, and the third sequence has the sequence set forth in SEQ ID NO: 31,
and the residue at position 38 of the CH3 domain of the antibody molecule, or fragment thereof, is valine (V) or alanine (A).
Thus, instant claim 5(iv) differs from US ‘948 claim 2(vi) in stipulating that the residue at position 38 of CH3 domain is either valine or alanine. Since US ‘948 claim 2(vi) does not specify the residue at position 38, the residue is the same as in the reference wild-type CH3 sequence.
As specified in claim 1, the claims utilize the amino acid residue numbering according to the ImMunoGeneTics (IMGT) numbering scheme. Figure 1B-1C of the present disclosure shows the wild-type IgG1 CH3 domain amino acid sequence with the corresponding IMGT amino acid residue numbers. In particular, Figure 1B shows that the amino acid residue at position 38 of the wild-type CH3 sequence is alanine. Accordingly, the amino acid residue at position 38 of the antibody recited in US ‘948 claim 2(vi) is alanine, and so the antibody of US ‘948 claim 2(vi) is within the scope instant claim 5(iv). The same antibody is also recited in claim 7 of US ‘948.
Instant claim 12 is anticipated by US ‘948 claim 1, which recites the same amino acid sequences.
Instant claim 16 is anticipated by US ‘948 claim 8, which recites human IgG1 CH3 domain amino acid sequences.
Instant claims 17-18 and 56 are anticipated by US ‘948 claim 2(vi) for the same reason as presented herein above.
Instant claims 31-32 and 36 are anticipated by US ‘948 claims 13-14, which recite the same limitations.
Claim 40 is included in the rejection, because antibody conjugates were routinely used in the art before the effective filing date of the claimed invention, and as such would be at once envisaged by those skilled in the art.
9. US Patent No. 11629189 and copending application USSN 18/174925 (published as US 20230348601) share a coinventor and/or an assignee with the present application, and claim subject matter similar to that of the present claims, but do not contain patented or currently pending claims which would anticipate or make obvious the presently claimed invention.
Specifically, each of US ‘189 and USSN ‘925 recites a multispecific antibody comprising a Fab and an Fc region, wherein the Fab comprises an ICOS binding site and wherein the Fc region comprises a PD-L1 binding site which is provided by a CH3 domain in which residues 14 to 18 are substituted by SGYW (SEQ ID NO: 617), residues 45.1 to 78 are substituted by EPQYWA (SEQ ID NO: 618), and residues 92 to 101 are substituted by SNWRWQLDD (SEQ ID NO: 619). The above sequences are identical to instant SEQ ID NOS: 23, 11 and 31, respectively (see SCORE), recited e.g. in instant claim 5, subclause (iv). US ‘189 also recites the Fc region of the antibody comprising SEQ ID NO: 620, which is identical to SEQ ID NO: 41 (see SCORE) recited in instant claim 29.
Instant claims 5 and 21 depend on claim 1, which specifically excludes antibodies with a CH3-derived PD-L1 binding site comprising SEQ ID NOS: 23, 11 and 31, which also comprise a CDR-based ICOS binding site, i.e. the antibody recited in US ‘189 and USSN ‘925. Accordingly, instant claims are not anticipated by the patented claims of US ‘189 or by the presently pending claims of USSN ‘925.
Neither US ‘189 nor USSN ‘925 recites any variant sequences at positions 92-100 of the CH3 domain, and it was unknown prior to the present invention which substitutions at these positions would be compatible with PD-L1 binding. Therefore, instant claims would not have been obvious over the patented claims of US ‘189 or over the presently pending claims of USSN ‘925.
10. Claims 13-14, 19, 21, 24-25 and 28-29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all relevant limitations of the base claim and any intervening claims.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 8:30 AM – 5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644