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 .
DETAILED ACTION
The amendment filed May 4, 2026, is acknowledged and has been entered. Claims 3, 6-7, 10 and 1 have been amended.
Claims 1-14 are pending in the application and are under examination.
Grounds of Rejection Withdrawn
Unless specifically reiterated below, Applicant's amendment or arguments have obviated or rendered moot the grounds rejection set forth in the previous Office action.
Claim Rejections Maintained
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (Journ. Contr. Rel., 216:56-68, 2015).
With respect to claims 1, 3-5 and 11-14, Kim et al disclose methods of treating cancer by administering compositions comprising a neuropilin-1 (NRP1)-specific binding peptide comprising the instantly claimed SEQ ID NO:1 and EGFR-targeting cetuximab antibody where the peptide is fused to the cetuximab antibody construct such that the antibody and peptide are administered simultaneously (see abstract and Figure 1). With respect to claims 6-10, Kim et al disclose the methods use a peptide comprising the instantly claimed SEQ ID NO:1 and a (GGGGS)3 linker where the peptide is fused to the Fc of the EGFR-targeting cetuximab (see page 58, Figure 1 and description of Figure 1). With respect to claim 2, the cancer is a lung cancer (see pages 59 and 65 and Figure 7).
Therefore, the methods of Kim et al are deemed to anticipate the claimed methods absent a showing otherwise.
In the response filed May 4, 2026, Applicant submits that Kim et al. (Journ. Contr. Rel., 216:56-68, 2015) is not available as prior art because “two named inventors of this application, Yong Sung KIM and Ye Jin KIM, are co-authors of the Kim et al. (2015) reference (listed as Yong-Sung Kim and Ye-Jin Kim, respectively). The Kim et al. reference was published on August 8, 2015, and the earliest Korean priority date (KR 10-2016-0037876) is March 29, 2016. The interval between the publication date and the priority date is within the one-year grace period under 35 U.S.C. § 102(b)(1)(A). Therefore, Kim et al. qualifies for the grace period inventor exception and is not prior art under 35 U.S.C. § 102(a)(1)”.
In response, this statement is not sufficient to establish that that Kim et al. (Journ. Contr. Rel., 216:56-68, 2015) is not prior art under 35 U.S.C. § 102(a)(1) because Kim et al. includes additional authors (see MPEP § 2155.01 and 717.01).
Claim Rejections - 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 19-21 of US Patent 10,400,022 in view of Kim et al (Journ. Contr. Rel., 216:56-68, 2015) and Pirker, Robert (Transl Lung Cancer Res, 1(4):269-275, 2012).
Claims 1-17 and 19-21 of US Patent 10,400,022 recite compositions comprising antibodies fused via a (GGGGS)3 linker to a peptide comprising the instant SEQ ID NO:1 that is tissue penetrating and the instant linker for treating cancer.
Kim et al disclose methods of treating cancer by administering compositions comprising a neuropilin-1 (NRP1)-specific binding peptide comprising the instantly claimed SEQ ID NO:1 and EGFR-targeting cetuximab antibody where the peptide is fused to the cetuximab antibody construct such that the antibody and peptide are administered simultaneously (see abstract and Figure 1). Kim et al disclose the methods use a peptide comprising the instantly claimed SEQ ID NO:1 and a (GGGGS)3 linker where the peptide is fused to the Fc of the EGFR-targeting cetuximab (see page 58, Figure 1 and description of Figure 1)
Pirker teaches the antibody cetuximab for treating lung cancer.
Although the claims at issue are not identical, they are not patentably distinct from each other because one would have been motivated to fuse a peptide comprising the instant SEQ ID NO:1 and the instant linker to the Fc of cetuximab and then use the construct to treat lung cancer by administering compositions comprising the peptide and antibody fusion simultaneously in order to have the advantage of increasing tissue penetration of the fusion with cetuximab as compared to cetuximab alone.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of US Patent 11,548,915 in view of Kim et al (Journ. Contr. Rel., 216:56-68, 2015) and Pirker, Robert (Transl Lung Cancer Res, 1(4):269-275, 2012).
Claims 1-14 of US Patent 11,548,915 recite compositions comprising antibodies including the antibody cetuximab fused via a (GGGGS)3 linker to a peptide (SEQ ID NO:1) comprising the instant SEQ ID NO:1 that is tissue penetrating and the instant linker for treating cancer.
Kim et al disclose methods of treating cancer by administering compositions comprising a neuropilin-1 (NRP1)-specific binding peptide comprising the instantly claimed SEQ ID NO:1 and EGFR-targeting cetuximab antibody where the peptide is fused to the cetuximab antibody construct such that the antibody and peptide are administered simultaneously (see abstract and Figure 1). Kim et al disclose the methods use a peptide comprising the instantly claimed SEQ ID NO:1 and a (GGGGS)3 linker where the peptide is fused to the Fc of the EGFR-targeting cetuximab (see page 58, Figure 1 and description of Figure 1)
Pirker teaches the antibody cetuximab for treating lung cancer.
Although the claims at issue are not identical, they are not patentably distinct from each other because one would have been motivated to use the construct to treat lung cancer by administering compositions comprising the peptide and antibody fusion simultaneously in order to have the advantage of increasing tissue penetration of the fusion with cetuximab as compared to cetuximab alone.
In the response filed May 4, 2026, Applicant request these rejections be held in abeyance.
In response, the rejections will be maintained until appropriately resolved.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
July 15, 2026
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