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 .
Applicant’s amendment, filed on 11/11/2025, is acknowledged.
Claims 1-70, 84, and 85 are cancelled.
Claims 71-83 and 86-90 are currently pending.
Claims 87-90 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
Claims 71-83 and 86 are under examination.
In view of the amendments and remarks filed 11/11/2025, the following rejections remain.
In view of Applicant’s amendments and remarks, filed 11/11/2025, The 35 U.S.C. § 112 enablement rejection is hereby withdrawn.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 71-83 and 86 stand rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (Angew Chem Int Ed Engl. 2016 Aug 16;55(34):9894-7. doi: 10.1002/anie.201603488. Epub 2016 Jun 15, on IDS submitted 12/20/2022, in Office Action mailed 8/11/2025) in view of Sagiv-Barfi et al. (Sci Transl Med. 2018 Jan 31;10(426):eaan4488. doi: 10.1126/scitranslmed.aan4488, on IDS submitted 12/20/2022, in Office Action mailed 8/11/2025).
Claims 71-83 and 86 stand rejected over Cox et al. in view of Sagiv-Barfi et al. for the reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s arguments, submitted 11/11/2025, have been fully considered, but have been found to be not persuasive.
Applicant argues that Cox et al. teaches internal delivery of a payload via knottin targeted delivery, and Sagiv-Barfi et al. provides no teaching or suggestion that CpG acts directly on solid tumor cells, and therefore one with ordinary skill in the art would not be motivated to try a knottin-CpG conjugate to treat cancer.
This has been found to be not persuasive. Applicant is arguing that the EETI-2.5F knottin taught by Cox et al. leads to internal payload delivery and there is no reasonable expectation of success that this knottin structure conjugated to a CpG immunostimulant would successfully treat cancer.
However, it is Examiner’s position that the EETI-2.5F knottin-CpG conjugate taught by Cox et al. in view of Sagiv-Barfi et al. is the same engineered knottin-CpG conjugate structure claimed by the instant application. For example, the instant specification discloses the EETI-2.5F knottin as an example structure of the genus claimed in instant claim 71 (Table 1). Given that there is no difference between the EETI-2.5F knottin-CpG conjugate taught by Cox et al. in view of Sagiv-Barfi et al. and the knottin-CpG conjugate structures encompassed by instant claim 71, these identical structures would have the same function as an immunostimulant. Additionally, as stated in the Office Action mailed on 8/11/2025, one would have been motivated to conjugate a CpG to the EETI-2.5F knottin to target the CpG to tumor sites, removing the need for intratumoral injection.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., only specific knottin-CpG structures in the claimed genus that function properly as immunostimulants) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant is invited to provide scientific evidence demonstrating that the EETI-2.5F knottin-CpG conjugate taught by Cox et al. in view of Sagiv-Barfi et al. would not function properly when compared to the knottin-immunostimulant conjugates in the genus encompassed by instant claim 71 to overcome this rejection.
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.
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 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9,587,001 (herein Pat '001, in Office Action mailed 8/11/2025) in view of Sagiv-Barfi et al. (Sci Transl Med. 2018 Jan 31;10(426):eaan4488. doi: 10.1126/scitranslmed.aan4488, on IDS submitted 12/20/2022, in Office Action mailed 8/11/2025, supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘001 in view of Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by Pat ‘001. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,407,477 (herein Pat ‘477, in Office Action mailed 8/11/2025) in view of Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘477 in view of Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by Pat ‘477. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,466,063 (herein Pat ‘063, in Office Action mailed 8/11/2025) in view of Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘063 in view of Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by Pat ‘063. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 10,888,603 (herein Pat ‘603, in Office Action mailed 8/11/2025) in view of Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘603 in view of Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by Pat ‘603. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,096,989 (herein Pat ‘989, in Office Action mailed 8/11/2025) in view of Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘989 in view of Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by Pat ‘989. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,765,625 (herein Pat ‘625, in Office Action mailed 8/11/2025) in view of Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘625 in view of Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by Pat ‘625. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,844,106 (herein Pat ‘106, in Office Action mailed 8/11/2025) in view of in view of Cox et al. (Angew Chem Int Ed Engl. 2016 Aug 16;55(34):9894-7. doi: 10.1002/anie.201603488. Epub 2016 Jun 15, on IDS submitted 12/20/2022, in Office Action mailed 8/11/2025, supra) and Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘106 in view of Cox et al. and Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by Pat ‘106. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,498,952 (herein Pat ‘952, in Office Action mailed 8/11/2025) in view of Cox et al. (supra) and Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘952 in view of Cox et al. and Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by Pat ‘952. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra.
Claims 71-83 and 86 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 85-104 of copending Application No. 17/609,284 (herein App '284) in view of Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘284 in view of Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by App ‘284. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 65-84 of copending Application No. 18/018,238 (herein App '238) in view of Cox et al. (supra) and Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘238 in view of Cox et al. and Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by App ‘238. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 71-83 and 86 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-38 and 41-45 of copending Application No. 18/055,297 (herein App '297) in view of Cox et al. (supra) and Sagiv-Barfi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘297 in view of Cox et al. and Sagiv-Barfi et al. for the same reasons discussed in the Office Action mailed 8/11/2025.
Applicant’s amendments and arguments, filed 11/11/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that for the same reasons argued for the 35 U.S.C § 103 rejection supra, neither Cox et al. nor Sagiv-Barfi et al. provide any motivation to conjugate an immunostimulant to the knottin peptide claimed by App ‘297. However, this has been found to be not convincing for the reasons discussed in the 35 U.S.C. § 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
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 ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641