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 .
Application Status
The Response to the Election of Species Requirement, filed December 11, 2025, is acknowledged. Applicant elects without traverse the species of anti-TREM-1 antibody comprising a heavy chain CDR1, CDR2, and CDR3 comprising the amino acid sequences set forth as SEQ ID NO: 136, 137, and 138, respectively, with a corresponding heavy chain variable region (VH) amino acid sequence of SEQ ID NO: 130, and a light chain CDR1, CDR2, and CDR3 comprising the amino acid sequences set forth as SEQ ID NO: 35, 36, 139, respectively, with a corresponding light chain variable region (VL) amino acid sequence of SEQ ID NO: 131. This election appears to correspond to antibody clone “P1-047323” (e.g., Tables 1 and 5 at pages 65 and 76 of the instant specification). With respect to the epitope bound by the elected antibody, Applicant provisionally elects, with traverse, “a different epitope than mAb 0170” as recited in original claim 1. Applicant requests that the species election of a specific epitope be reconsidered and withdrawn in view of the fact that the pending claims recite antibodies comprising a combination of three VH CDRs amino acid sequences and three VL CDR amino acid sequences. However, Applicant has not distinctly or specifically pointed out any supposed errors with the original restriction requirement. Accordingly, the requirement is maintained for the reasons of record.
Applicant submits that claims 8-21 read on the elected species.
The amended claims filed December 11, 2025 are entered. Claims 1-7 are canceled. Claims 8-13 and 16-20 are amended. Claims 8-21 are pending and under examination herein.
Information Disclosure Statement (IDS)
A complete copy of the foreign patent reference corresponding to WO 2017/152102 A2, cited in the IDS filed January 13, 2022, does not appear to have been supplied to the Office. The full reference is attached herein. See PTO-892.
Claim Rejections - 35 USC § 112(b)
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.
Claim 21 is 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.
Regarding claim 21, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examples and preferences in a claim may lead to confusion over the intended scope of the claim. The description of examples or preferences is properly set forth in the specification rather than the claims.
It is noted for Applicant that “preferred” limitations will not be treated as required for the purpose of applying prior art.
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.
(1)
Claims 8-11, 17, and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of co-pending Application No. 17/627,070 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims anticipate the instantly claimed invention.
Regarding claims 8 and 19-20, co-pending claims 1, 14, and 18-19 recite a treatment method (e.g., for inflammatory bowel disease or rheumatoid arthritis) that comprises administering an antagonistic anti-TREM-1 antibody comprising three heavy chain CDRs comprising the amino acid sequences of SEQ ID NO: 159, 160, and 161, respectively (which share 100% sequence identity to instant SEQ ID NO: 136, 137, and 138, respectively) and three light chain CDRs comprising the amino acid sequences of SEQ ID NO: 70, 71, and 162, respectively (which share 100% sequence identity to instant SEQ ID NO: 35, 36, and 139, respectively). Regarding claims 9-10, co-pending claim 19 recites that the anti-TREM-1 antibody comprises a VH comprising the amino acid sequence of SEQ ID NO: 153 and a VL comprising the amino acid sequence of SEQ ID NO: 154 (which share 100% sequence identity to instant SEQ ID NO: 130 and 131, respectively). Regarding claim 11, co-pending claim 20 recites that the antibody comprises a heavy chain constant region comprising the amino acid sequence set forth as SEQ ID NO: 48, 47, 11, or 12 (which share 100% sequence identity to instant SEQ ID NO: 123, 122, 124, and 125, respectively) and a light chain constant region comprising the amino acid sequence set forth as SEQ ID NO: 35 (which shares 100% sequence identity to instant SEQ ID NO: 126).
A method of treatment that comprises administering said antibody necessarily confers possession of a pharmaceutical composition (i.e., a composition comprising the antibody and a pharmaceutically acceptable carrier), anticipating claim 17.
Regarding claim 21, co-pending claim 2 recites the method of co-pending claim 1 wherein the subject was previously treated with (i.e., further administered) a standard of care treatment, preferably wherein the standard of care treatment comprises an anti-TNF-α antibody.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(2)
Claims 8 and 12-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of co-pending Application No. 17/627,070 as applied to claims 8-11, 17, and 19-21 above, further in view of Pincetic (WO 2017/152102 A2; cited in IDS and PTO-892).
The teachings of the co-pending reference application are recited in the provisional non-statutory double patenting rejection above.
However, the co-pending claims do not recite a nucleic acid, vector, or cell encoding the claimed antagonistic anti-TREM-1 antibody; an immunoconjugate comprising the antibody; or a kit comprising the antibody.
Pincetic discloses compositions comprising antagonistic anti-TREM-1 antibodies (e.g., T1-34, T1-22, T1-40, and T1-39) and methods of use thereof in treating inflammatory disorders such as Crohn’s disease or inflammatory bowel disease, alone or in combination with another therapeutic agent (e.g., Abstract; ¶ 0016-0022, 0037-0040, 0055; Figure 9D). As illustrated in Table 7 (page 174), the antagonistic anti-TREM-1 antibodies T1-34 and T1-39 bind to human TREM-1 epitopes corresponding to 83-GRIILEDY-90 and 191-NLTNVTDIIRV-201 (i.e., epitopes other than D38-L45, E46-Q56, and/or Y90-L96 of human TREM-1, similarly to the epitope-steered antibody of the instantly claimed invention).
Relevant to claim 12, Pincetic describes bispecific antibodies comprising an anti-TREM-1 antibody of the disclosure which further bind to a second antigen (e.g., ¶ 0206, 0238-0239). Relevant to claims 13-15, Pincetic discloses isolated nucleic acids, vectors, and host cells encoding an antibody of the invention (e.g., ¶ 0036). Relevant to claim 16, Pincetic teaches antibodies of the invention which are conjugated to another agent (e.g., ¶ 0035, 0321-0322, 0354-0355). Relevant to claim 18, Pincetic describes kits containing an isolated antibody of the invention and instructions for use (e.g., ¶ 0432-0438).
In view of the further teachings of Pincetic, it would have been obvious to one of ordinary skill in the art, before the filing date of the instantly claimed invention, to possess a nucleic acid, vector, or host cell encoding the anti-TREM-1 antibody of the co-pending reference application or an immunoconjugate or kit comprising said antibody. The skilled artisan would have been motivated to do so because the antagonistic anti-TREM-1 antibody recited in the co-pending claims, like those of Pincetic, has utility in treating inflammatory diseases in which TREM-1 is implicated. The nucleic acid, vector, and host cell would be useful for generating the antibody, while the immunoconjugate or kit would be useful for carrying out a method of treatment. There would have been a reasonable expectation of success because the antagonistic anti-TREM-1 antibodies described in the co-pending claims and by Pincetic are functional equivalents, and one of ordinary skill in the art would recognize that one could be substituted for the other to achieve the same desired purpose of treating an inflammatory disease.
This is a provisional nonstatutory double patenting rejection.
(3)
Claims 8-11, 17, and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of co-pending Application No. 19/376,434 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims anticipate the instantly claimed invention.
Regarding claims 8 and 19-20, co-pending claims 1, 14, and 18-19 recite a treatment method (e.g., for inflammatory bowel disease or rheumatoid arthritis) that comprises administering an antagonistic anti-TREM-1 antibody comprising three heavy chain CDRs comprising the amino acid sequences of SEQ ID NO: 159, 160, and 161, respectively (which share 100% sequence identity to instant SEQ ID NO: 136, 137, and 138, respectively) and three light chain CDRs comprising the amino acid sequences of SEQ ID NO: 70, 71, and 162, respectively (which share 100% sequence identity to instant SEQ ID NO: 35, 36, and 139, respectively). Regarding claims 9-10, co-pending claim 19 recites that the anti-TREM-1 antibody comprises a VH comprising the amino acid sequence of SEQ ID NO: 153 and a VL comprising the amino acid sequence of SEQ ID NO: 154 (which share 100% sequence identity to instant SEQ ID NO: 130 and 131, respectively). Regarding claim 11, co-pending claim 20 recites that the antibody comprises a heavy chain constant region comprising the amino acid sequence set forth as SEQ ID NO: 48, 47, 11, or 12 (which share 100% sequence identity to instant SEQ ID NO: 123, 122, 124, and 125, respectively) and a light chain constant region comprising the amino acid sequence set forth as SEQ ID NO: 35 (which shares 100% sequence identity to instant SEQ ID NO: 126).
A method of treatment that comprises administering said antibody necessarily confers possession of a pharmaceutical composition (i.e., a composition comprising the antibody and a pharmaceutically acceptable carrier), anticipating claim 17.
Regarding claim 21, co-pending claim 2 recites the method of co-pending claim 1 wherein the subject was previously treated with (i.e., further administered) a standard of care treatment, preferably wherein the standard of care treatment comprises an anti-TNF-α antibody.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(4)
Claims 8 and 12-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of co-pending Application No. 19/376,434 as applied to claims 8-11, 17, and 19-21 above, further in view of Pincetic (WO 2017/152102 A2; supra).
The teachings of the co-pending reference application are recited in the provisional non-statutory double patenting rejection above.
However, the co-pending claims do not recite a nucleic acid, vector, or cell encoding the claimed antagonistic anti-TREM-1 antibody; an immunoconjugate comprising the antibody; or a kit comprising the antibody.
The teachings of Pincetic are recited in the provisional non-statutory double patenting rejection above.
In view of the further teachings of Pincetic, it would have been obvious to one of ordinary skill in the art, before the filing date of the instantly claimed invention, to possess a nucleic acid, vector, or host cell encoding the anti-TREM-1 antibody of the co-pending reference application or an immunoconjugate or kit comprising said antibody. The skilled artisan would have been motivated to do so because the antagonistic anti-TREM-1 antibody recited in the co-pending claims, like those of Pincetic, has utility in treating inflammatory diseases in which TREM-1 is implicated. The nucleic acid, vector, and host cell would be useful for generating the antibody, while the immunoconjugate or kit would be useful for carrying out a method of treatment. There would have been a reasonable expectation of success because the antagonistic anti-TREM-1 antibodies described in the co-pending claims and by Pincetic are functional equivalents, and one of ordinary skill in the art would recognize that one could be substituted for the other to achieve the same desired purpose of treating an inflammatory disease.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Elizabeth A Shupe whose telephone number is (703) 756-1420. The examiner can normally be reached Monday to Friday, 9:30am - 6:00pm EST.
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, Julie Wu can be reached at (571) 272-5205. 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.
/ELIZABETH A SHUPE/Examiner, Art Unit 1643
/Brad Duffy/Primary Examiner, Art Unit 1643