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 arguments filed 7/15/2026 have been fully considered but they are not fully persuasive.
Claims 6-7 and 21 have been cancelled.
Applicant’s petition filed 7/15/2026 is acknowledged. This petition has not been decided.
The rejection of claims 1 and 11-20 under 35 U.S.C. 103 as being unpatentable over Pierce et al. (U.S. Patent Application Publication 2018/0318393 (and equivalent documents WO 2016/154473 and U.S. Patent No. 10,426,847) in view of Chen et al. (U.S. Patent Application Publication 2012/0121634), Jaroszeski et al. (U.S. Patent Application Publication 2018/0036529), and Donate et al. (2016) is withdrawn in view of the claim amendments.
The provisional rejection of claims 1 and 11-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,814,129 (of record) in view of Pierce et al. (U.S. Patent Application Publication 2018/0318393 and Chen et al. (U.S. Patent Application Publication 2012/0121634) is withdrawn in view of the claim amendments.
The provisional rejection of claims 1, 11-12, 14, and 17-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-11, 13-18 of U.S. Patent No. 11,123,554 in view of Pierce et al. (U.S. Patent Application Publication 2018/0318393 and Chen et al. (U.S. Patent Application Publication 2012/0121634).
The prior art does not teach or suggest delivering nucleic acids encoding PD-1 extracellular domain peptide to tumor tissue by electroporation so that the soluble PD-1 protein is produced locally and block PD-1/PD-L1 binding within the tumor as well as delivering nucleic acids encoding PD-L1 antigenic peptides to skin or muscle by electroporation where PD-L1 antibodies would be produced systemically
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 and 8-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “encoding a PD1 extracellular-domain peptide or subdomain thereof.” No specific basis has been pointed to and none is apparent. Paragraph [0074] of the specification discloses particular subdomains; however, the specification does not provide a limiting definition for a subdomain. As such, the claim is considered to include a nucleic encoding any fragment of the extracellular domain, including those that would not produce a peptide that blocked PD1-PDL1 binding locally within the tumor tissue. There is no basis for this.
Claim 1 has been amended to recite “encoding a PDL1 antigenic peptide or fragment thereof.” No specific basis has been pointed to and none is apparent. As written, the fragment of the antigenic peptide is not required to be antigenic itself. Nucleic acids encoding a fragment of an antigenic peptide that is not itself antigenic will not induce systemic polyclonal PD-L1 antibodies in the subject. There is no basis for this.
Claim 1 has been amended to recite that the first polynucleotide is delivered to the tumor tissue “in an amount effective to block PD1-PDL1 binding locally within the tumor tissue.” This implies that the polynucleotide is responsible for blocking binding rather than the encoded peptide once it is produced within the tumor tissue. There is no basis for this.
Claim 1 has been amended to recite “wherein, in steps (a)(3) and (b)(3), the desired impedance is at least a 10% reduction as compared to the measured impedance prior to each electroporation pulse. No specific basis has been pointed to and none is apparent. Paragraph [0069] of the specification discloses that the desired impedance may be at least 10% reduction in impedance as compared to pre-pulse impedance; however, this paragraph does not disclose a measurement step (as now implied by the amendment). The paragraph does not disclose this reduction with respect to every electroporation pulse in step (a)(3) and (b)(3). There is no basis for this.
Claim 3 has been amended to recite the “first polynucleotide encodes a PD1 peptide comprising the nivolumab binding region or the pembrolizumab binding region. No specific basis has been pointed to and none is apparent. Paragraph [0059] of the specification discloses SEQ ID NO: 1 as the subsequence of the soluble extracellular domain of human PD-1 that the nivolumab antibody binds. Paragraph [0060] of the specification discloses SEQ ID NO: 3 as the subsequence of the soluble extracellular domain of human PD-1 that the pembrolizumab antibody binds. To the degree that claim 3 is directed to other sequences, there is no basis. Note that the specification does not provide a definition for these binding regions and does not provide the homologous mouse sequences referenced in Example 1 or homologous sequences for any other species of PD-1. In addition, these sequences are disclosed as including an IgK secretion sequence in frame to produce a soluble protein. The specification does not support what is now claimed.
The claims constitute new matter.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as 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. Claim 12 depends upon claim 1. Claim 12 recites “further comprising monitoring temperature of the tumor tissue, the non-tumor tissue, or both. This claim does not appear to be properly dependent on claim 1 or further limit the subject matter of claim 1 as claim 1 implicitly requires monitoring tumor and non-tumor tissue temperatures as they are heated to a pre-set temperature. It is suggested that this claim be cancelled. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Honjo et al. (U.S. Patent Application Publication 2006/0110383) discloses a method of treating cancer by administering both soluble PD-1 and a PD-L1 antibody. See at least claims 13-14, 16, and 18-19. The reference does not teach delivering nucleic acids encoding a PD-1 extracellular domain peptide to tumor tissue by electroporation so that the soluble PD-1 protein is produced locally and block PD-1/PD-L1 binding within the tumor. The reference does not teach or suggest delivering nucleic acids encoding PD-L1 antigenic peptides to skin or muscle by electroporation where PD-L1 antibodies would be produced systemically.
He et al. (of record) discloses local gene therapy using nucleic acids encoding the extracellular domain of murine PD-1 (sPD-1) which could block PD-L1 and PD-1 interactions. The reference does not teach or suggest delivering nucleic acids encoding PD-L1 antigenic peptides to skin or muscle by electroporation where PD-L1 antibodies would be produced systemically.
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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