DETAILED ACTION
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 amendment, filed 07/14/2026, has been entered.
Claims 1-15, 19, 48, 51-69, 86-99 have been canceled.
Claims 100-111 have been added.
Claims 16-18, 20-47, 49-50, 70-85, 100-111 are pending.
Claims 17, 18, 21-25 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions/species, there being no allowable generic or linking claim.
Claims 16, 20, 26-47, 49-50, 70-85, 100-111 are currently under examination as they read on a DPP3 monoclonal antibody that binds to a DPP3 peptide of SEQ ID NO: 2.
Claim Rejections - 35 USC § 112
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 16, 20, 26-27, 29-38, 41, 43-47, 49-50, 70-73, 75-80, 83-85, 100-108, 110-111 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. 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.
The previous rejection can be found in the previous Office Action, mailed 01/13/2026.
Applicant’s arguments have been fully considered but are not persuasive as to the claims that continue to encompass a genus of DPP3 antibodies defined primarily by the antigen/epitope bound, the method by which the antibodies are generated, and/or their functional activity, without sufficient structural limitations.
Applicant argues that amended claim 16 satisfies the written description requirement because the recited process of immunizing an animal with the peptide consisting essentially of SEQ ID NO: 2, generating hybridomas, and selecting cells expressing an antibody that binds SEQ ID NO: 2 allegedly imparts distinctive structural characteristics to the resulting antibodies. Applicant further relies on MPEP § 2113 and contends that the resulting antibodies constitute a relatively small and structurally related subgenus.
The argument is not persuasive. Although a process limitation in a product-by-process claim may be considered to the extent that the process necessarily imparts structural characteristics to the resulting product, Applicant has not established that immunization with SEQ ID NO: 2 and subsequent selection for binding to SEQ ID NO: 2 necessarily results in antibodies possessing a common or predictable antibody structure sufficient to identify the members of the claimed genus. The recited process selects antibodies according to their ability to bind the peptide and inhibit DPP3 enzyme activity; it does not specify the amino acid sequences or other structural characteristics of the antibody variable regions responsible for those functions.
Applicant’s reliance on Rudikoff does not establish otherwise. As discussed in the rejection, antibody-antigen recognition depends upon the sequences and conformations of the antigen-binding regions, and even relatively small sequence changes may substantially affect antigen-binding activity. The fact that antibodies are positively selected for binding to the same antigen establishes a common functional property, but does not establish that all antibodies surviving that selection necessarily possess a common structural characteristic by which a skilled artisan could visualize or recognize the members of the claimed genus.
Applicant’s reliance on Hazarika is similarly unpersuasive. Hazarika may demonstrate that immunization with different peptides can generate populations of antibodies having particular binding specificities. However, evidence that a particular peptide elicits antibodies capable of recognizing a corresponding antigen does not establish that those antibodies constitute a structurally predictable genus or that antibodies generated against the same peptide necessarily share identifying antibody sequences or structures. Rather, the evidence establishes selection according to antigen-binding function.
Applicant additionally points to clones 1963–1969 in Table 3 of the Specification as antibodies generated using SEQ ID NO: 2 that bind full-length DPP3 and inhibit DPP3 enzyme activity. These examples provide support for the particular antibodies actually disclosed, but they do not, without more, establish possession of the full scope of antibodies encompassed by claims that permit substantial variation in the antigen-binding regions. The disclosed functional activity of these antibodies does not provide a structure-function correlation sufficient to permit one of ordinary skill in the art to identify, from structure, other antibodies throughout the claimed genus that would possess the required binding and inhibitory functions.
Applicant’s argument has been considered in full but has not been found convincing. Therefore, the rejection is maintained as it applies to amended and newly added claims.
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.
Claims 16, 20, 43-47, 49-50, 70-71, 83-85, 100-108, 111 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (Cancer Res; 77(11) June 1, 2017) in view of Campbell (Monoclonal Antibody Technology, 1984, Chapter 1, pages 1-32).
The previous rejection can be found in the previous Office Action, mailed 01/13/2026.
Applicant’s arguments have been fully considered but are not persuasive.
Applicant argues that Lu would not have motivated one of ordinary skill in the art to arrive at the claimed DPP3 monoclonal antibody because Lu teaches that the interaction between DPP3 and KEAP1 is independent of DPP3 enzymatic activity. Applicant further argues that one of ordinary skill would therefore have expected an antibody directed to the ETGE-containing region to disrupt the DPP3-KEAP1 interaction rather than inhibit DPP3 enzymatic activity.
In response, it is noted that Lu’s teaching that the DPP3-KEAP1 interaction is independent of DPP3 enzymatic activity merely establishes that DPP3 enzymatic activity is not required for its interaction with KEAP1. Such teaching does not establish that an antibody binding to the ETGE-containing region of DPP3 would be incapable of affecting or inhibiting DPP3 enzymatic activity. Nor does Lu teach away from generating antibodies against this region. Rather, Lu identifies the ETGE-containing region as a known, functionally relevant region of DPP3 and further demonstrates the use of an anti-DPP3 monoclonal antibody in investigating DPP3. Campbell further teaches that generation of monoclonal antibodies against macromolecules was conventional and that it was customary for those working with a macromolecule to generate monoclonal antibodies thereto. Accordingly, one of ordinary skill in the art, having knowledge of the functionally relevant ETGE-containing region disclosed by Lu, would have had reason to generate monoclonal antibodies against an antigenic DPP3 peptide encompassing that region using the conventional antibody-generation techniques taught by Campbell and to select antibodies having the desired binding and functional properties.
Applicant’s argument that Campbell does not specifically disclose DPP3 is likewise not persuasive. The rejection is based on the combined teachings of Lu and Campbell. Lu is relied upon for teaching DPP3 and its ETGE-containing region, whereas Campbell is relied upon for establishing the conventional generation and selection of monoclonal antibodies against macromolecular targets. It is not necessary that Campbell independently disclose DPP3 or the claimed antibody.
Applicant further characterizes inhibition of DPP3 enzymatic activity as a surprising result. However, the mere fact that Lu does not expressly predict that an antibody against the ETGE-containing region would inhibit DPP3 enzymatic activity does not, by itself, establish nonobviousness of the claimed antibody where the prior art provides reason to generate antibodies against the identified DPP3 region and evaluate the resulting antibodies for their properties. Obviousness does not require that the prior art predict the precise properties ultimately possessed by every antibody generated.
Accordingly, Applicant’s arguments do not overcome the rationale for combining the teachings of Lu and Campbell, and the rejection is maintained.
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 16, 20, 26-47, 49-50, 70-85, 100-111 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,530,276. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclosed the same or nearly the same DPP3 binder as the present claims. Therefore, the claims anticipate each other.
Applicant argues that the patent claims are distinct from the present claims. In response, it is noted that the patent claims are directed to a DPP3 binder that reads on an antibody comprising the same CDRs (SEQ ID NOs: 7-9 and 10-KVS-11); same VH and VL (SEQ ID NO: 5, 6) and same heavy and light chains (SEQ ID NO: 12,13). Therefore, the two set of the claims are directed to overlapping subject matter. The rejection is therefore maintained as it applies to amended/newly added claims. Applicant’s request to hold the rejection in abeyance has been noted.
Conclusion
No claim is allowed.
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 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 SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHARON X WEN/Primary Examiner, Art Unit 1641
Prosecution Insights