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 response filed on 09/04/2025 is acknowledged.
3. Claims 1-9 are pending and under consideration.
4. The following rejections are maintained in view of Applicant’s amendment filed on 09/04/2025.
5. The instant application is not properly a divisional application of 17/315,547. The isolated nucleic acid of claims 6-8 reads directly on the subject matter of claims 1-15 of U.S. Patent 11,891,444 as was detailed in the office action mailed on 05/08/2025 and again set forth below. In the same way, the polypeptide of claim 2 of reads directly on the polypeptide of claims 1-6 of U.S. Patent 11,001,629. The instant claims are directed to the same invention as the patented claims.
6. 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.
7. Claim 1-2 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,001,629 (IDS filed on 02/05/2024; Reference 1) in view of WO 2004/056392 (PTO-892; Reference N). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-6 of U.S. Patent No. 11,001,629 are directed to a protein or polypeptide comprising an antigen binding domain that binds a human NKp46 polypeptide, wherein the domain comprises a heavy chain variable region (VH) and a light chain variable region (VL) combination selected from the group consisting of:(a) a VH comprising an amino acid sequence of SEQ ID NOS: 199 or 200 (NKp46-1H1 or H3 variable domain), and a VL comprising an amino acid sequence of the amino acid sequence of SEQ ID NO: 201 (NKp46-1L1 variable domain); (b) a VH comprising an amino acid sequence of SEQ ID NOS: 202, 203 or 204 (NKp46-2 H1, H2 or H3 variable domain), and a VL comprising an amino acid sequence of SEQ ID NO: 205 (NKp46-2 L1 variable domain); (c) a VH comprising an amino acid sequence of SEQ ID NOS: 206, 207 or 208 (NKp46-3 H1, H3 or H4 variable domain), and a VL comprising an amino acid sequence of SEQ ID NO: 209 (NKp46-3 L1 variable domain); (d) a VH comprising an amino acid sequence of SEQ ID NOS: 210, 211 or 212 (NKp46-4 H1 variable domain), and a VL comprising an amino acid sequence of SEQ ID NO: 213 (NKp46-4 L2 variable domain); (e) a VH comprising an amino acid sequence of SEQ ID NO: 215 (NKp46-9 H2 variable domain), and a VL comprising an amino acid sequence of SEQ ID NOS: 217 or 218 (NKp46-9 L1 or L2 variable domain); or (f) a VH comprising an amino acid sequence of SEQ ID NO: 216 (NKp46-9 H3 variable domain), and a VL comprising an amino acid sequence of SEQ ID NOS: 217 or 218 (NKp46-9 L1 or L2 variable domain) of claim 1; wherein the protein is an antibody of claim 2; wherein the VH and the VL are placed on a single polypeptide chain and fused to one another via a peptide linker of claim 3; wherein the VH is positioned on a first polypeptide chain within the protein and the VL is positioned on a second polypeptide chain within the protein of claim 4; the protein is a full length IgG antibody, or a fragment thereof that retains binding to the NKp46 polypeptides of claim 5; and wherein the protein binds a macaca fascicularis (cynomolgus) NKp46 polypeptide of claim 6.
The instant claims are directed to a polypeptide comprising the exact same sequences.
The reference teachings anticipate the claimed invention of claim 2.
The claimed invention differs from the prior art in the recitation of a method of cancer in a subject comprising administering the polypeptide of claims 1 and 9.
WO 2004/056392 teaches the used of anti-NKp46 antibodies to treat cancer, including melanoma, Chronic Myeloid Leukemia, Acute Myeloid Leukemia, Lymphomas, Multiple Myeloma, hepatocarcinoma, lung adenocarcinoma and Neuroblastoma. (In particular, abstract, Page 5, claims, whole document).
It would have been obvious to one of ordinary skill in the art at the time of invention to have administered the antigen binding domain that binds a human NKp46 protein of U.S. Patent No. 11,001,629 to a patient to treat cancer.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s arguments filed on 09/04/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“Claims 1-2 and 9 are rejected under the judicially created doctrine of "obviousness-type" double patenting over claims 1-6 of U.S. Patent No. 11,001,629. Applicant respectfully traverses.
As discussed above, the pending application is a proper divisional application of the '547 application, which is a divisional application of the grandparent 16/066,688 application (the '688 application) that issued as U.S. Patent No. 11,001,629.
Under 35 U.S.C. § 121, a patent issuing on an application with respect to which a requirement for restriction has been made or on an application filed as a result of such a requirement, shall not be used as a reference . . . against a divisional application . .., if the divisional application is filed before issuance of the patent on the other application.
The CAFC in Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc. 592 F.3d 1340, 1352 (Fed. Cir. 2010) stated: We have recognized the reach of § 121 in situations where the patent subject to a double patenting challenge and the application in which the restriction requirement was entered share a common lineage. See Geneva Pharms., 349 F.3d at 1378 ("[I]f the [patent subject to the double-patenting challenge] and the [patent that is the basis of the challenge] trace their lineage back to a common parent which was subject to a restriction requirement, then § 121 intervenes to prevent [an obviousness-type] double patenting rejection."). We have also held that § 121 applies specifically to continuing applications deriving from a divisional application filed as a result of a restriction requirement. See, e.g., Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1580 (Fed. Cir. 1991) (extending the protection of § 121 to a patent issuing from a continuation application that descended from a divisional application filed as a result of a restriction requirement); Amgen Inc. v. F. Hoffmann-La Roche Ltd, 580 F.3d 1340, 1354 (Fed.
Cir. 2009)("[I]ntervening continuation applications do not render a patent ineligible for § 121 protection so long as they descended from a divisional application filed as a result of a restriction requirement."). We see no reason why §
121 would not likewise extend to a divisional of a divisional.
In G.D. Searle LLC v. Lupin Pharms., Inc., the CAFC confirmed that § 121 applies to a divisional of a divisional of the grandparent application, so long as (1) the claims prosecuted in two or more applications share a common lineage in the divisional chain; and (2) the lines of demarcation drawn by the examiner are preserved as between application." G.D. Searle LLC v. Lupin Pharmaceuticals, Inc., 790 F.3d 1349 (Fed. Cir. 2015).
Here, the current application and the first divisional application '547 share a common lineage in the divisional chain; they both share a common specification with the grandparent application '688 (now U.S. Patent No. 11,001,629). Both, the '688 application and its divisional '547 were subject to restriction requirements and the claims pending in the current application were presented and non-elected in both applications. Thus, the lines of demarcation drawn by the examiner between the '688, '547 and the pending claims are preserved. The claims of the current application enjoy the protection of 35 U.S.C. § 121 because the current application is a proper divisional application of '547, which is a divisional application of '688; the claims prosecuted in the current application, the '547 application, and the '688 application share a common lineage in the divisional chain; and the current claims preserve the lines of demarcation drawn by the Examiner. Accordingly, Applicant respectfully requests withdrawal of the obviousness-type double patenting rejection over claims 1-6 of U.S. Patent No. 11,001,629.”
It is the Examiner’s position that Applicant has not addressed the fact that claims 1-6 of U.S. Patent 11,001,629 and instant claim 2 have the same scope, making this application not a proper divisional application.
The rejection stands for reasons of record.
8. Claims 6-8 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,891,444 (IDS filed on 02/05/2024; Reference 3). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-15 of U.S. Patent No. 11,891,444 are directed to an isolated nucleic acid encoding and/or a light chain variable region (VL) selected from the group consisting of:(a) a VH comprising an amino acid sequence of SEQ ID NOS: 199 or 200 (NKp46-1 Hi or H3 variable domain), and a VL comprising an amino acid sequence of the amino acid sequence of SEQ ID NO: 201 (NKp46-1 Li variable domain); (b) a VH comprising an amino acid sequence of SEQ ID NOS: 202, 203 or 204 (NKp46-2 H1, H2 or H3 variable domain), and a VL comprising an amino acid sequence of SEQ ID NO: 205 (NKp46-2 L1 variable domain); (c) a VH comprising an amino acid sequence of SEQ ID NOS: 206, 207 or 208 (NKp46-3 H1, H3 or H4 variable domain), and a VL comprising an amino acid sequence of SEQ ID NO: 209 (NKp46-3 L1 variable domain); (d) a VH comprising an amino acid sequence of SEQ ID NOS: 210, 211 or 212 (NKp46-4 Hi variable domain), and a VL comprising an amino acid sequence of SEQ ID NO: 213 (NKp46-4 L2 variable domain); (e) a VH comprising an amino acid sequence of SEQ ID NO: 215 (NKp46-9 H2 variable domain), and a VL comprising an amino acid sequence of SEQ ID NOS: 217 or 218 (NKp46-9 L1 or L2 variable domain); or (f) a VH comprising an amino acid sequence of SEQ ID NO: 216 (NKp46-9 H3 variable domain), and a VL comprising an amino acid sequence of SEQ ID NOS: 217 or 218 (NKp46-9 L1 or L2 variable domain) of claim 1; a recombinant host cell comprising a nucleic acid according to claim 1 of claim 2; a method of producing a protein comprising culturing a cell of claim 2 under conditions suitable for expression of the protein and recovering the protein of claim 3; wherein said nucleic acid encodes a VH comprising SEQ ID NOS: 199 or 200 of claim 4; wherein said nucleic acid encodes a VL comprising SEQ ID NO: 201 of claim 5; wherein said nucleic acid encodes a VH comprising SEQ ID NOS: 202, 203 or 204 of claim 6; wherein said nucleic acid encodes a VL comprising SEQ ID NO: 205 of claim 7; wherein said nucleic acid encodes a VH comprising SEQ ID NOS: 206, 207 or 208; of claim 8; wherein said nucleic acid encodes a VL comprising SEQ ID NO: 209 of claim 9; wherein said nucleic acid encodes a VH comprising SEQ ID NOS: 210, 211 or 212 of claim 10; wherein said nucleic acid encodes a VL comprising SEQ ID NO: 213 of claim 11; wherein said nucleic acid encodes a VH comprising SEQ ID NO: 215 of claim 12; wherein said nucleic acid encodes a VL SEQ ID NOS: 217 or 218 of claim 13; wherein said nucleic acid encodes a VH comprising SEQ ID NO: 216 of claim 14; and wherein said nucleic acid encodes a VL SEQ ID NOS: 217 or 218.
The reference teachings anticipate the claimed invention.
Applicant’s arguments filed on 09/04/2025 have been fully considered, but are not found persuasive.
Applicant argues:
“Claims 6-8 are rejected under the judicially created doctrine of "obviousness-type" double patenting over claims 1-15 of U.S. Patent No. 11,891,444. Applicant respectfully traverses.
As discussed above, the pending application is a proper divisional application of the '547 application that issued as U.S. Patent No. 11,891,444. As also discussed, the current claims enjoy the protection of 35 U.S.C. § 121 because the current application is a proper divisional application of '547, which is a divisional application of '688; the claims prosecuted in the current application, the '547 application, and the '688 application share a common lineage in the divisional chain; and the current claims preserve the lines of demarcation drawn by the Examiner. Accordingly,
Applicant respectfully requests withdrawal of the obviousness-type double patenting rejection over claims 6-8 of U.S. Patent No. 11,891,444.”
It is the Examiner’s position that Applicant has not addressed the fact that claims 1-15 of U.S. Patent No. 11,891,444 and instant claims 6-8 have the same scope, making this application not a proper divisional application.
The rejection stands for reasons of record.
9. No claim is allowed.
10. Claims 3-5 are objected to for dependence upon rejected base claim 2.
11. 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 extension fee 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 date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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May 3, 2025
/Nora M Rooney/
Primary Examiner, Art Unit 1641