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
Claims 1-14 are pending in the application and are under examination.
Claim Objections
Claim 7 is objected to for reciting “the composition the NRP1-specific binding peptide”.
The objection could be obviated by amending the claim to recite “the composition comprising the NRP1-specific binding peptide”.
Appropriate correction is required.
Claim Rejections-35 U.S.C. § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-10 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second 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.
The claims are indefinite because claims 3, 6, 7, 10 and 14 recite, “the NRP 1-specific binding peptide”. This recitation renders the claim indefinite because the claims ultimately depend from claim 1, which recites “one or more neuropilin-1 (NRP1)-specific binding peptide(s) selected from the group consisting of SEQ ID NOS: 1 to 3”, such that it is unclear if the reference to “the NRP 1-specific binding peptide” is intended to refer to all the peptides of claim 1, or, if not, which peptide of claim 1 is being referred to in these claims. Then the dependent claims are included here as they do not rectify this issue.
Accordingly, the claims fail to delineate the metes and bounds of the subject matter that is regarded as the invention with the requisite clarity and particularity to permit the skilled artisan to know or determine infringing subject matter, so as to satisfy the requirements set forth under 35 U.S.C. § 112(b).
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to KR 10-2017-0037741 and KR 10-2016-0037876. Certified copies have been filed in parent Application No. 16/081,342, filed on August 30, 2018.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d), a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Similarly, PCT/KR2017/003365 was not filed in English.
A certified translation of every foreign benefit application or Patent Cooperation Treaty (PCT) application not filed in English is required. See 35 U.S.C.119 (b)(3) and 372(b)(3) and 37 CFR 1.55(g)(3)(i) and 41.154(b). If no certified translation is in the official record for the application, the examiner must require the applicant to file a certified translation. The applicant should provide the required translation if applicant wants the application to be accorded benefit of the non-English language application. Any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b) and 41.202(e) and MPEP 2304.01(c).
Failure to provide certified translations may result in no benefit being accorded for the non-English applications.
Accordingly, the effective filing date of the instant claims is the filing date of parent Application No. 16/081,342, namely August 30, 2018.
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.
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.
Conclusion
No claims are allowed.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
December 18, 2025