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 .
The amendments and remarks filed 11/10/25 are acknowledged. Claims 1, 4, 5, 8, 10, 22, and 29 have been amended. Claims 2-3, 6-7, 9, 11-21, 23-28, and 30-72 have been canceled. Claims 73-81 have been added. Claims 1, 4, 5, 8, 10, 22, 29, and 73-81 are pending.
Newly submitted claims 75-76 and 78-81 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of newly submitted claims 75-76 and 78-79 and the invention of the previously examined claims are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed the invention of newly added claims 75-76 have a materially different design and effect. For instance, the product of the newly added claims is directed to a nucleic acid, whereas the product of the previously examined claims is directed to a protein. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
The invention of newly submitted claims 80-81 and the invention of the previously examined claims are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, product of the previously examined claims can be used in a materially different process, such as a binding assay.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 75-76 and 78-81 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1, 4, 5, 8, 10, 22, 29, 73, 74, and 77 are under examination.
Terminal Disclaimer
The terminal disclaimer filed on 11/10/15 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application 17/028,643 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Rejections
The rejection of claims 1, 2, 4-8, 10-12, 15-18, 22, 24-27, and 29 under 35 U.S.C. 112(a) or 4. 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in light of Applicant’s amendment thereto. See paragraph 4, page 2 of the previous Office action.
The rejection of claims 2, 4, and 15-16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second 6. 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, is withdrawn in light of Applicant’s amendment thereto. The cancelation of claims 2 and 15-16 renders the rejection moot. See paragraph 6, page 12 of the previous Office action.
The rejection of 5 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as 9. 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, is withdrawn in light of Applicant’s amendment thereto. See paragraph 9, page 14 of the previous Office action.
The rejection of claims 1, 2, 4, 5, 7, 10, 11, 17, and 24 under 35 U.S.C. 102(a)(1) and 12. 102(a)(2) as being anticipated by Frelinger et al. (WO 2011/123683 A2, published October 6, 2011), is withdrawn in light of Applicant’s amendment thereto. See paragraph 12, page 15 of the previous Office action.
The rejection of claims 1, 2, 4, 5, 7, 10-12, 15-17, 24, and 29 under 35 U.S.C. 103 as 17. being unpatentable over Frelinger et al. (US Patent No 8734774, published May 27, 2014) in view of Gillies (WO/03048334 A2, published June 12, 2003), is withdrawn in light of Applicant’s amendment thereto. See paragraph 17, page 17 of the previous Office action.
The rejection of claims 1, 2, 4-8, 10-12, 15-18, 24, and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,696,724, is withdrawn in light of Applicant’s amendment thereto. See paragraph 19, page 21 of the previous Office action.
The rejection of claims 1, 2, 4-8, 10-12, 15-18, 24, and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,696,723, is withdrawn in light of Applicant’s amendment thereto. See paragraph 20, page 22 of the previous Office action.
The rejection of claims 1, 2, 4-8, 10-12, 15-18, 24, and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,352,403, is withdrawn in light of Applicant’s amendment thereto. See paragraph 21, page 23 of the previous Office action.
The rejection of claims 1, 2, 4, 6-8, 10-12, 15-18, 24, 25 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,453,710 is withdrawn in light of Applicant’s amendment thereto. See paragraph 22, page 24 of the previous Office action.
The rejection of claims 1, 2, 6-8, 10-12, 15-18, 24, 25 and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,535,658 is withdrawn in light of Applicant’s amendment thereto. See paragraph 23, page 26 of the previous Office action.
The rejection of claims 1, 2, 6-8, 10-12, 15-18, and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,981,716 (reference application) is withdrawn in light of Applicant’s amendment thereto. See paragraph 24, page 27 of the previous Office action.
The rejection of claims 1, 2, 4-8, 10-12, 15-18, 24-27, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16-19 of U.S. Patent No. 12,275,769 (reference application) is withdrawn in light of Applicant’s amendment thereto. See paragraph 25, page 28 of the previous Office action.
The provisional rejection of claims 1, 2, 4, 6-8, 10-12, 15-17, and 24 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 6, 9-11, 13-14, and 16-20 of copending Application No. 17/741,275 (reference application) is withdrawn in light of Applicant’s amendment thereto. See paragraph 26, page 30 of the previous Office action.
The rejection of claims 1, 2, 4, 6-8, 10-12, 15-17, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 16-18 of copending Application No. 18/045,160 (reference application) is withdrawn in light of Applicant’s amendment thereto. See paragraph 28, page 33 of the previous Office action.
The provisional rejection of claims 1, 2, 4, 6-8, 10-12, 15, 16, 24, and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 9, 11-15, 18, 20-21, 35 37, 38, 40, and 57 of copending Application No. 18/054,601 (reference application) is withdrawn in light of Applicant’s amendment thereto. See paragraph 29, page 35 of the previous Office action.
The rejection of claims 1, 2, 4, 6-8, 10-12, 15, 16, 24, and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 and 26-29 of copending U.S. Patent No. 18/166,700 (reference application) is withdrawn in light of Applicant’s amendment thereto. See paragraph 30, page 36 of the previous Office action.
The provisional rejection of claims 1, 2, 4, 7, 10-12, 15-17, 24, and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 89-96, 98-100, 102, 104-119, and 121 of copending Application No. 17/028,643 (reference application), is withdrawn in light of the terminal disclaimer filed 11/10/25. See paragraph 31, page 37 of the previous Office action.
The provisional rejection of claims 1, 2, 4, 7, 10-12, 15-17, 24, and 29 on the ground of nonstatutory double patenting as being unpatentable over claims 73, 75, 76, and 78-83 of copending Application No. 18/601,474 (reference application) is withdrawn in light of Applicant’s amendment thereto. See paragraph 32, page 39 of the previous Office action.
New Rejections Necessitated by Applicant’s Amendment
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 1, 8, 10, 29, and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,036,266 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a fusion polypeptide comprising an IL-21 cytokine polypeptide, a IL-21 blocking moiety, and a protease cleavable polypeptide linker. The ‘266 claims teach an inducible cytokine polypeptide comprising a) a cytokine polypeptide; b) a cytokine blocking moiety that inhibits cytokine receptor activating activity of the cytokine polypeptide; and c) a half-life extension domain; wherein the cytokine polypeptide is operably linked to the cytokine blocking moiety through a first linker comprising a cleavable peptide and the cytokine blocking moiety is operably linked to the half-life extension domain through a second linker. The ‘266 claims teach wherein the inducible cytokine polypeptide comprises a substrate for a protease and has at least about 10X less cytokine receptor activating activity relative to the polypeptide that contains the cytokine that is produced by protease cleavage of the inducible cytokine polypeptide. The ‘266 claims teach wherein cytokine polypeptide comprises IL-2, IL-7, IL-12, IL-15, IL-18, IL-21, IL-23, TGF, interferon alpha, interferon beta, interferon gamma, TNF, TGFbeta, CXCL10, CCL19, CCL20, CCL21, or a mutein, a variant, an active fragment, or a subunit of any of the foregoing. The ‘266 claims teach wherein the cytokine blocking moiety is a ligand-domain of fragment of a cognate receptor for the cytokine polypeptide or an antibody or antigen-binding fragment of an antibody that binds the cytokine polypeptide. The ‘266 claims teach wherein half-life extension domain is an immunoglobulin Fc, human serum albumin or a fragment thereof that binds neonatal Fc receptor, or an antigen-binding portion of an antibody that binds to FcRn or to human serum albumin.
Regarding the limitations set forth in claims 10 and 29, the limitations recite functions that naturally flow from the fusion. Given that the patent claims teach the same structure (i.e., fusion polypeptide), the functional limitations recited in the instant claims would inherently be present in the fusion protein of the ‘266 claims. The difference between the instant claims and the ‘266 claims is that the ‘266 claims are drawn to a method of using the cytokine polypeptide. However, the cytokine polypeptide used in the method of the ‘266 claims is the same cytokine polypeptide recited in the instant claims. Thus, the ‘266 claims are an obvious variation of the instant claims, and the ‘266 claims and the instant claims are not patentably distinct.
Applicant Arguments
Applicant did not address the rejection.
Response to Arguments
Given that Applicant did not address the rejection, the rejection is maintained for the reasons set forth above.
Claim Status
Claims 4, 5, 22, and 73 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No claims are allowed.
Conclusion
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 SANDRA CARTER whose telephone number is (571)272-2932. The examiner can normally be reached 8:00-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa L. Ford can be reached at (571)272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANDRA CARTER/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674