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 .
Applicant’s amendments, filed on 04/01/2026 are acknowledged. Claim 38 is cancelled. Claims 28, 30-31, 33-34, 36-37 and 180-191 are pending. Claims 33, 36-37 remain withdrawn from consideration for the reason of record.
Claims 28, 30-31, 34, and 180-191 are currently under consideration.
The previous rejections not repeated in this office action is withdrawn because of either amendment to the claims or persuasive arguments.
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 28, 31, 180 and 183-189 remain 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.
Applicants argue that claim 180 is amended and further limits claim 28 by requiring the light chain region comprise a kappa light chain, whereas claim 28 only requires the light chain region comprise a constant region comprising the substitutions/deletions recited in the claim.
These arguments are fully considered but found unpersuasive because SEQ ID NO:1 in claim 28 is a kappa light chain. Note paragraph [0005] of the specification. Since both are a kappa light chain, it is not clear what is the difference between the property boundary of claim 28 and 180.
As for claim 31, applicant argues that claim 31 is amended as suggested by Examiner. This argument is fully considered but found unpersuasive because of the nature of SEQ ID NO:2, mostly undefined amino acid Xs. The scope of the amended claim 31 as related to the protein G Fab binding protein domain is broader than the scope in the base claim. The scope in the independent claim is limited to a G Fab binding protein domain with the three modified isotype recognition regions, i.e. SEQ ID Nos 9-11. However, at least 70% sequence identity to SEQ ID NO:2 do not have the modified recognition regions.
Claim 30 remain rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant argues that claim 28 is drawn to a mutated polypeptide at the position 16-20 residues of SEQ ID NO: 1 and claim 30 further limits claim 28. Applicant also argues with withdrawn claim 33 and it is not clear how this argument is not relevant for claim 30 not being further limit.
These arguments are fully considered but found unpersuasive because the previously provided sequence alignment shows SEQ ID NO: 1 comprises SEQ ID NO: 17, which is within the mutated range of the base claim, i.e. residues 16-20 of SEQ ID NO:1. However, it is same sequence as SEQ ID NO: 1, not mutated sequence.
Claims 34 is newly 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.
The previously provided sequence alignment shows that SEQ ID NO: 3 in claim 187, which depends on claim 34. SEQ ID NO: 3 in claim 187 comprises SEQ ID NO: 9, which is deleted in the latest amendment. Thus, the scope of claim 34 is not clear since SEQ ID NO: 3 in claim 187 has the deleted sequence.
Claim 187 newly rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
SEQ ID NO: 3 in claim 187 comprises SEQ ID NO: 9, which is deleted in claim 34. Therefore, claim 187 does not further limit the base claim.
Claim 191 recites the limitation "the polypeptide" in 1. There is insufficient antecedent basis for this limitation in the claim. It is not clear whether the antigen binding fragment of claim 191 is attached to a polypeptide comprising a Fab, or a polypeptide comprising a protein G Gab binding domain.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28, 30-31, 34, and 180-191 remain rejected for the reason of record set forth in the office action mailed 1/2/2026 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant argues the rejection overlooks that the present claims are constrained by multiple concrete, sequence-defined structural identifiers. The specification provides detailed identifying structural characteristics (including explicit sequences) for both (a) the modified Fab light-chain constant region used in the claimed constructs and (b) the claimed modified protein G Fab-binding domains and their isotype- recognition modifications. For example, the application as filed provides specific Fab light-chain sequences incorporating SEQ ID NO:17 into the constant region of the Fab. See, e.g., sequences provided in application as filed at [0115]. Likewise, the specification expressly discloses examples of modified protein G Fab-binding domain sequences having a YAYVHE sequence (SEQ ID NO:9). These disclosures provide exactly the type of structure-based "identifying characteristics" contemplated by MPEP §2163 and in Ariad for genus support and, further, provide representative species by actual sequence disclosure. the specification explains that the disclosure is directed, in part, to a modular, scaffold-based system that provides a useful engineered Fab scaffold/protein G Fab-binding- domain interface irrespective of the antigen-binding Fab structure. In Example 1, the specification states that the inventors developed "a platform that can introduce multiple functionalities into a class of Fab-based affinity reagents in a 'plug and play' fashion" and further explains that the platform "exploits the ultra-tight binding interaction between affinity matured variants of a Fab scaffold (FabS) and a domain of an immunoglobulin binding protein, protein G (GA1)." Application as filed at [0357]; see also [0080]. These disclosures confirm that the inventors had possession of an interchangeable platform in which different antigen-binding domains may be swapped into the same engineered framework.
The specification discloses both covalent conjugation and non-covalent complexation of the Fab and protein G Fab binding domain, which is expressly included in the currently amended claim. As acknowledged in the Action, the specification describes protein G binding domain binds non-covalently to the epitope on the Fab, forming a high affinity complex. Further, the specification describes covalent conjugation of the Fab and protein G Fab binding domain via peptide linkers/fusions, including linker placement and linker-length guidance. The specification provides a dedicated linker disclosure explaining that linkers may be used "to separate any of the domain/regions described herein," including placement "between ... the Fab heavy or light chain region [and] the protein G Fab binding domain." Application as filed at [0244]. Linker sequences are also provided in the specification.
These arguments are fully considered but found unpersuasive. As for applicant’s argument with the specification providing structural feature of the claimed modified Fab light-chain constant region, the base claim 28 is drawn to a modified SEQ ID NO: 1 (a kappa constant light chain), where the modification occurs at residues 16-20 with a substitution/deletion. However, the species in claim 30 has the same LRT, note SEQ ID NO: 17. The claims 28 and 30 do not provide any guidance of identifying characteristics to a substitution/deletion at residues 16-20 of SEQ ID NO: 1. Since claim 30 is a dependent claim of the base claim and drawn to a Fab of the polypeptide, claim 30 should be a modified a Fab. However, based on both claim 28, 30 and 34, it is not clear what the core structural feature of the claimed a modified a Fab is.
As for applicant’s argument with protein G Fab binding domain structural features, claim 28 indicates that the claimed protein G Fab binding domain would have SEQ ID NO: 9. 10, or 11. However, claim 31 indicates the claimed the domain structural features is not limited to what those examples/feature in the specification applicants argues. Claim 31 as written, the scope is much broader than the examples in the specification, because 70% identity to an unknown sequence, (note SEQ ID NO: 2, 31 amino acids residues in length, undefined Xs, 29 out of 31 are mostly unstructured sequences.
As for linkers, the rejection is not about linkers linking the claimed modified Fab light-chain constant regions and protein G Fab binding domains. The rejection is about the claims do not recite the core structures necessary for the claimed modified Fab light-chain constant regions and protein G Fab binding domain.
Claim Rejections – 35a F USC § 102
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.
Claim 187 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by KOSSIAKOFF et al (WO 2016061427 A1; published 04/21/2016).
KOSSIAKOFF teaches a protein G Fab binding domain has 100% sequence identity to SEQ ID NO: 3 (see alignment below; Qy is SEQ ID NO: 3 and Db is KOSSIAKOFF sequence reported in ¶0144).
Query Match 100.0%; Score 147; DB 1; Length 29;
Best Local Similarity 100.0%;
Matches 29; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RTLSGYTTTTAVDAATAEKVFKQYAYVHE 29
|||||||||||||||||||||||||||||
Db 1 RTLSGYTTTTAVDAATAEKVFKQYAYVHE 29
Applicant argues that SEQ ID NO: 9 is deleted from claim 34. This argument is fully considered but found unpersuasive because SEQ ID NO: 3 comprises now deleted SEQ ID NO: 9 in claim 34.
Double Patenting
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).
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.
Claim 187 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim1 and 4-12 of U.S. Patent No. 10759834 B2 (reference) in view of KOSSIAKOFF et al (WO 2016061427 A1; published 04/21/2016).
SEQ ID NO: 3 in claim 187 and SEQ ID NO: 3 in the reference claim 1 is identical as the previously provided sequence alignment shows.
Applicant argues that SEQ ID NO: 9 is deleted from claim 34. This argument is fully considered but found unpersuasive because SEQ ID NO: 3 comprises now deleted SEQ ID NO: 9 in claim 34.
Conclusion
THIS ACTION IS MADE FINAL. 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 fial 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 Misook Yu whose telephone number is (571)272-0839. The examiner can normally be reached M-Th, 7-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, YVONNE (BONNIE) EYLER can be reached at (571)272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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