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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/06/2026 has been entered.
Applicant’s amendment, filed on 4/06/2026, is acknowledged.
Claims 1-70, 84, and 85 are cancelled.
Claims 71-83 and 86-90 are currently pending.
Claims 87-90 stand as withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
Claims 71-83 and 86 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/06/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner in its entirety.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Specifically, browser-executable code is disclosed on pg. 37, line 34. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms:
Alexa Fluor® (pg. 9, lines 20-21;pg. 10, lines 1-2; pg. 23, line 13; pg. 30, line 14; pg. 34, line 8);
DyLight® (pg. 10, line 1); and
IRDye® (pg. 10, line 2);
which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 are 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 1/6/2026) 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 1/6/2026), as evidenced by Ruan et al. (Horiz Cancer Res. 2015 2nd Quarter;56:23-40. PMID: 26623174).
The instant claims have not been amended since 1/06/2026. The instant claims are rejected for the same reasons discussed in the Office Action 1/06/2026.
Applicant’s arguments, filed 4/6/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that there is no motivation to combine the references of Cox et al. and Sagiv Barfi et al. because knottin peptide promote internalization of a payload directly into tumor cells (Remarks pg. 5-6). Applicant further argues that Cox et al. teaches “knottin conjugate internalization by the tumor cells and how that leads to inhibition of tumor cell proliferation in cell culture studies and provides no expectation of in vivo success” (Remarks pg. 7) and CpG immunostimulants nucleotides do not slow proliferation of isolated tumor cells (Remarks pg. 7-8).
Applicant further provides a Declaration Under 37 CFR 1.132, to provide evidence to support that CpG immunostimulants do not function directly on tumor cells (Section IV and Fig. 1-6) to support the assertation of a lack of motivation to combine.
This has been found to be not convincing. In response to Applicants arguments that there is no articulated motivation for success in combining the references, it is noted that Cox et al. provides clear motivation to develop knottin-drug conjugates other that the specific knottin-gemcitabine conjugate structure (pg. 9897): “…these results motivate further development and testing of KDCs for applications in cancer therapy. In addition, this work supports strategies relying upon tumor-associated integrins as targets for drug delivery, and validates antibody-alternatives as scaffolds for drug conjugation.” Cox et al. provides clear motivation to one with ordinary skill in the art to use integrin binding knottin structures with other payloads in applications for cancer therapy. Cox et al. additionally teaches that this knottin scaffold is functional and can deliver a payload to an integrin expressing target, providing a reasonable expectation of success that the knottin would also function this was in an in vivo environment.
Sagiv-Barfi et al. teaches that CpG TLR9 ligands function in vivo not on tumor cells, but as an immunostimulant (Abstract): “…immune enhancing agents are injected locally into one site of tumor, thereby triggering a T cell immune response locally that then attacks cancer throughout the body.” Additionally, Sagiv-Barfi et al. teaches that CpG immunostimulants can act to reduce tumor growth with or without an anti-OX40 antibody (see, for example, Figure 2, and 103 rejection in the Office Action mailed on 8/11/2025). One with ordinary skill in the art would appreciate that a limitation to this in situ cancer vaccine method would be a suitable injection site, which the integrin-targeting knottin would be able to overcome. This provides motivation to combine the references to deliver a CpG immunostimulant in vivo to a target tumor site, which would then lead to the local antitumor T-cell response as taught by Sagiv-Barfi et al.
Therefore, in response to Applicant’s assertations and evidence that CpG immunostimulants do not directly act on tumor cells, one with ordinary skill in the art would appreciate that this is the case, as the CpG immunostimulants would be expected not to directly target tumor cells but instead induce a local anti-tumor response in vivo after administration, and when the knottin-CpG conjugate is localized to an integrin-expressing tumor site.
Additionally, one with ordinary skill in the art would have a reasonable expectation of success that, for example, an EETI2.5F-CpG conjugate with a Val-Ala-PAB linker would lead to intratumoral release of the immunostimulant and not simply be internalized. For example, Cox et al. teaches that the Val-Ala-PAB linker used in the knottin-drug conjugates is cleaved by cathepsin B, which is expressed intracellularly in normal cells (pg. 9895): “…Val-Ala-PAB (valyl-alanyl-para-aminobenzyloxy) derivative (4d) that employs a linker known to be extracellularly stable but is cleaved upon internalization by proteases such as cathepsin B.”
Ruan et al. (Horiz Cancer Res. 2015 2nd Quarter;56:23-40. PMID: 26623174) is provided as an evidentiary reference to demonstrate that it is already known in the art that cathepsin B is abnormally expressed extracellularly by some tumors, including breast cancer (Abstract): “[a]berrant overexpression of cathepsin B has been reported in invasive and metastatic cancers, including breast cancer, melanoma and colorectal cancer. It has been shown that oncogenic activation, such as the signaling of the ErbB pathways, can lead to cathepsin B overexpression. The degradation of the extracellular matrix is a key factor for cathepsin B to contribute to development and metastasis of tumors”. (Section 3): “…[t]umor cells are reported to first produce pro-cathepsin B, which is secreted but tethered to the cell surface in a Ca2+ dependent manner… pro-cathepsin is converted to cathepsin B, it no longer binds to Annexin II and is released into the tumor microenvironment. Overexpression of cathepsin B has been linked to breast, cervix, bladder, stomach, colon, ovary, bladder, lung, prostate, and thyroid cancers…”
This provides additional expectation for success of a knottin-immunostimulant conjugate such as CpG to be cleaved at the Val-Ala-PAB linker by abnormally overexpressed cathepsin B in the tumor microenvironment of cancers such as breast cancer, leading to extracellular release of the immunostimulant where it can act to induce an antitumor T-cell response, as taught by Sagiv-Barfi et al.
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 are 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 1/06/2026) 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 1/06/2026, supra), as evidenced by Ruan et al. (Horiz Cancer Res. 2015 2nd Quarter;56:23-40. PMID: 26623174, 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., as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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, Sagiv-Barfi does not 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 are 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 1/06/2026) in view of Sagiv-Barfi et al. (supra), as evidenced by Ruan 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., as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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, Sagiv-Barfi does not 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 are 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 1/06/2026) in view of Sagiv-Barfi et al. (supra), as evidenced by Ruan 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., as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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, Sagiv-Barfi does not 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 are 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 1/06/2026) in view of Sagiv-Barfi et al. (supra), as evidenced by Ruan 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. as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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, Sagiv-Barfi does not 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 are 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 1/06/2026) in view of Sagiv-Barfi et al. (supra), as evidenced by Ruan 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. as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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, Sagiv-Barfi does not 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 are 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 1/06/2026) in view of Sagiv-Barfi et al. (supra), as evidenced by Ruan 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. as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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, Sagiv-Barfi does not 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 are 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 1/06/2026) 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 1/06/2026, supra) and Sagiv-Barfi et al. (supra), as evidenced by Ruan 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. as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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 are 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 1/06/2026) in view of Cox et al. (supra) and Sagiv-Barfi et al. (supra), as evidenced by Ruan 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. as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 85-96 and 100-104 of copending Application No. 17/609,284 (App '284, in Office Action mailed on 1/06/2026) in view of Sagiv-Barfi et al. (supra), as evidenced by Ruan 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. as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 65-84 of copending Application No. 18/018,238 (App '238) in view of Cox et al. (supra) and Sagiv-Barfi et al. (supra), as evidenced by Ruan 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. as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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, now Patent No. 12,240,882) in view of Cox et al. (supra) and Sagiv-Barfi et al. (supra), as evidenced by Ruan 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. as evidenced by Ruan et al. for the same reasons discussed in the Office Action mailed 1/06/2026.
Applicant’s amendments and arguments, filed 4/6/2026, 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.
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
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