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 .
Response to Amendment
The amendment filed 12/03/2025 is acknowledged. Claims 3-8, 11-16, 19-24, 27, 30, 32, 40, 42-44, and 46-48 are canceled. Claims 1-2, 26, and 37 have been amended.
Election/Restrictions
As noted in the non-final office action dated 8/7/2025, the response to the restriction/election requirement filed 2 July 2025 is acknowledged. Applicant elects Group I, claims 1, 2, 25, 26, 28, 29, 31, 33-38 drawn to variant polypeptides comprising a human IgG1 Fc domain including an amino acid substitution at one or more positions in the human IgG1 domain from positions 217, 228, 229, 243, 262, 273, 274, 288, 290, 298, 305, 309, 310, 321, 326, 344, 353, 356, 363, 364, 368, 375, 388, 389, 390, 397, 398, 399, 401, 405, 407, 409, 410, 413 424, 438, and 442 by numbering of the EU index as in Kabat; nucleic acids encoding the polypeptides, host cells, or vectors comprising the nucleic acids, compositions comprising the polypeptides and a pharmaceutical carrier, and kits comprising the polypeptides. Additionally, Applicant provisionally elects P228K as a species of specific mutation. Both elections are made without traverse.
Claims 9, 10, 17, 18, 39, 41, and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2 July 2025.
However, Applicant has canceled the elected species P228K. Therefore, for search purposes, the Examiner has rejoined the species P217R.
Claim Status
Claims 1-2, 9, 10, 17, 18, 25, 26, 28, 29, 31, 33-39, 41, and 45 are pending. Claims 9, 10, 17, 18, 39, 41, and 45 are withdrawn as described in the Election/restriction section above. Claims 1-2, 25, 26, 28-29, 31, and 33-38 are under examination in the instant office action.
Withdrawal of Rejections
The rejection of claims 1, 2, 25, 26, 28, 29, 31, 33-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of the amendment to the claims.
The rejection of claim 26 on the basis that it contains an improper Markush grouping of alternatives is withdrawn in view of the amendment to the claims.
The rejection of claims 1, 25, 26, 28, 29, 31, 33-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amendment to the claims.
The rejection of claims 1, 2, 25, 28, 29, 33-37 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 20180044711 A1 to Spidel et. al. published 15 February 2018 is withdrawn in view of the amendment to the claims.
The rejection of claims 26, 31, and 38 under 35 U.S.C. 103 as being unpatentable over US 20180044711 A1 to Spidel et. al. published 15 February 2018 as applied to claims 1 and 25 above, and further in view of WO2009006520 A1 to Dall'Acqua et. al. published 8 January 2009 is withdrawn in view of the amendment to the claims.
Claim Rejections - 35 USC § 102- New, necessitated by amendment
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 25, 26, 28-29, 31, and 33-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 10106624 B2 to Moore et. al published 23 October 2018 (Of record, cited in IDS 2/24/2022).
As noted above, due to the cancellation of elected species P228K, the examiner has rejoined species P217R.
Regarding claims 1 and 25, Moore et. al. teaches “novel immunoglobulin compositions that co-engage at least two antigens” (Abstract, reads on antibody comprising the variant polypeptide) comprising protein variants of the human Fc region of IgG1 wherein the constant domain comprises the mutation P217R ([14], [127], Claim 1)numbering according to the EU index as in Kabat [64]. Moore et. al. teaches that the immunoglobulin compositions may be antibodies ([35-40], [84-97]) or fusion proteins ([50], [104-[106]).
Regarding claim 2, Moore et. al. teaches that the IgG1 Fc may comprise additional Fc substitutions including 252Y/254T/256E and 428L/434S in order to increase FcRn binding or serum half-life ([18], Fig. 34, [34], [182]).
Regarding claim 26, the polypeptide is a bispecific binding to two target antigens [4], [183-186] (reads on binding a target polypeptide). Moore et. al. recites exemplary polypeptide target antigens CD20, CD19, and Her2 among others.
Regarding claim 28, the antibody is a bispecific antibody ([35-40], [84-97]).
Regarding the functional limitations of claims 29 and 31 of exhibiting increased affinity to FcRn at pH 6.0 relative to a control antibody or Fc fusion protein, respectively, comprising SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3 or reduced affinity to FcRn at pH 7.4 relative to the same control protein, this claim recites an inherent property that does not further limit the structure of human IgG1 constant domain. An artisan would expect any fusion protein comprising the mutation would exhibit this property because it is a function of the Fc domain which an artisan would expect would not be influenced by the antigen-binding or fusion partner domain. Applicant is reminded that products of identical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Regarding claims 33-36, Moore et. al. teaches nucleic acids encoding the novel immunoglobulin compositions ([9], Claim 2) and vectors and host cells comprising the nucleic acids ([9], claim 3).
Regarding claim 37, Moore et. al. teaches that embodiments of the multispecific antibodies are conjugated with drugs to form antibody drug conjugates [208-247], particularly those drugs that are used for cancer therapy [212] and compositions comprising the polypeptides of the inventions and a pharmaceutically acceptable carrier or diluent [10], [282-290].
Claim Rejections - 35 USC § 103- New, necessitated by amendment
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over US 10106624 B2 to Moore et. al published 23 October 2018 (Of record, cited in IDS 2/24/2022).
The teachings of Moore et. al. in regards to claims 1 and 25 are in the 102 rejection above.
Regarding claim 38, Moore et. al. does not explicitly teach a kit comprising the antibody or Fc fusion protein and instructions for use. Moore et. al. teaches pharmaceutical compositions comprising the polypeptides and a carrier suitable for the desired delivery method (reads on a kit comprising the antibody or Fc fusion protein). In regards to the instructions for use, MPEP 2112.01.III teaches “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)”.
It would have been prima facie obvious for a person of ordinary skill in the art, before the effective filing date, to include instructions for use with the pharmaceutical composition of Moore et. al. in order to benefit from disclosing the proper use (e.g. method of administration, dose) to a medical professional, resulting in the claimed kit.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 25, 26, 28-29, 31, and 33-38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kathleen CunningChen whose telephone number is (703)756-1359. The examiner can normally be reached Monday - Friday 11-8:30 ET.
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/KATHLEEN CUNNINGCHEN/Examiner, Art Unit 1646
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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