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 election without traverse filed May 20, 2026, is acknowledged and has been entered. Applicant has elected Group I. Applicant has elected the species of a KRAS.
The amendment filed May 20, 2026, is acknowledged and has been entered. Claim 9 has been canceled. Claim 21 has been newly added.
Claims 1-8 and 10-21 are pending. Claims 6, 8, 10-14 and 16-20 are withdrawn from further consideration, as being drawn to non-elected invention or species of invention. Claims 1-5, 7, 15 and 21 are under consideration.
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 1-5, 7, 15 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu, Yan (CN114457117, May 10, 2022, IDS, see machine translation attached as Exhibit A).
With respect to claims 1-2, Xu discloses an allogenic dendritic cell tumor vaccine comprising a chimeric antigen receptor for activating dendritic cells and a tumor antigen (see entire document, e.g. abstract and Exhibit A:
“The DC tumor vaccine provided in this article is available from any source. In certain embodiments, the
DC tumor vaccine provided herein is derived from immune cells isolated from subjects, such as human subjects.
In some embodiments, immune cells are obtained from the subject of concern or blood bank,
such as a subject suspected of having a specific disease or condition, suspected of being predisposed to
a particular disease or condition, a subject who will receive, is currently receiving or has been
receiving treatment for a specific disease or condition, or a subject acting as a healthy volunteer or
health donor. In some embodiments, immune cells are obtained from cancer subjects who respond
poorly to immunotherapies such as CAR-T therapy. The cells can be autologous or allogeneic to the
subject of interest”
(see Exhibit A, e.g., page 24).
By "allogeneic" cells is meant any cells derived from different subjects of the same species”
(see Exhibit A, e.g., page 8).
With respect to claim 3, instant SEQ ID NO:6 has the sequence of: MALPVTALLLPLALLLHAARPQVQLLESGGGLVQPGGSLRLSCAASGFTFSSYTMSWVRQAPGQALEWMGTISSRGTYTYYPDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAREAIFTHWGRGTLVTVSSGGGGSGGGGSGGGGSDIQLTQSPSSLSASVGDRVTITCKASQDINNYHSWYQQKPGQAPRLLIYRANRLVDGVPDRFSGSGYGTDFTLTINNIESEDAAYYFCLKYNVFPYTFGQGTKVEIKTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDIYIWAPLAGTCGVLLLSLVITLYCRWPPSAACSGKESVVAIRTNSQSDFHLQTYGDEDLNELDPHYEMRLKIQVRKAAITSYEKSDGVYTGLSTRNQETYETLKHEKPPQ.
Xu discloses that the CAR can comprise a signal peptide, an scFv, a hinge region, a transmembrane domin and an intracellular domain, wherein the signaling peptide includes the sequence shown in SEQ ID NO:5, the scFv includes the amino acid sequence shown in SEQ ID NO:18, the hinge region includes the sequence shown in SEQ ID NO:7, the transmembrane domain includes the sequence shown in SEQ ID NO:6 and the intracellular signaling domain includes the amino acid sequence shown in SEQ ID NO:3 (see Exhibit A, e.g., pages 15-17, Table 19 and sequences copied below).
MALPVTALLLPLALLLHAARP SEQ ID NO:5 QVQLLESGGGLVQPGGSLRLSCAASGFTFSSYTMSWVRQAPGQALEWMGTISSRGTYTYYPDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAREAIFTHWGRGTLVTVSSGGGGSGGGGSGGGGSDIQLTQSPSSLSASVGDRVTITCKASQDINNYHSWYQQKPGQAPRLLIYRANRLVDGVPDRFSGSGYGTDFTLTINNIESEDAAYYFCLKYNVFPYTFGQGTKVEIK SEQ ID NO:18
TTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACD SEQ ID NO:7
IYIWAPLAGTCGVLLLSLVITLYC SEQ ID NO:6
RWPPSAACSGKESVVAIRTNSQSDFHLQTYGDEDLNELDPHYEMRLKIQVRKAAITSYEKSDGVYTGLSTRNQETYETLKHEKPPQ SEQ ID NO:3
When these sequences are joined together they give the sequence of instant SEQ ID NO:6.
With respect to claims 4-5 and 7, Xu discloses that the tumor vaccine can comprise a KRAS G12Vmutant peptide with an amino acid encoded by SEQ ID NO: 35 which encodes the instant SEQ ID NO:8. (see exhibit A, e.g., page 31, “KRAS G12V vaccine gene (SEQ ID NO: 35)”).
With respect to claim 15, Xu discloses a composition comprising the allogenic dendritic cell tumor vaccine comprising a chimeric antigen receptor for activating dendritic cells and a tumor antigen and pharmaceutically acceptable vehicle (see exhibit A, e.g., page 26, “In another aspect, the present disclosure also provides a pharmaceutical composition comprising a population of DC tumor vaccines provided herein and a pharmaceutically acceptable vehicle”).
Accordingly, the reference anticipates the claimed invention.
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 1-5, 7, 15 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 19-21 of US Patent 12,097,259 in view of Xu, Yan (CN114457117, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the patent recite dendritic cells and compositions thereof comprising a CAR comprising an scFc and a tumor vaccine. The tumor vaccine can be a G12V KRAS peptide and the CAR can comprise: MALPVTALLLPLALLLHAARP SEQ ID NO:5
TTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACD SEQ ID NO:7
IYIWAPLAGTCGVLLLSLVITLYC SEQ ID NO:6
RWPPSAACSGKESVVAIRTNSQSDFHLQTYGDEDLNELDPHYEMRLKIQVRKAAITSYEKSDGVYTGLSTRNQETYETLKHEKPPQ SEQ ID NO:3.
The patented claims do not disclose that the dendritic cells are allogenic or the scFv having the amino acid sequence of SEQ ID NO:18.
CN114457117 discloses these limitations as set forth above.
Therefore, in view of the patented claims and the reference, it would have obvious to one of ordinary skill in the art to make allogenic dendritic cell tumor vaccine further comprising the scFv comprising the amino acid sequence of SEQ ID NO:18 because allogenic dendritic cells are a known and predictable dendritic cell that can be used to make dendritic cell tumor vaccines and the scFv comprising the amino acid sequence of SEQ ID NO:18 was a known and predictable scFv for use in CARs that are in dendritic cell tumor vaccines, which along with the claimed sequences in the patent would result in a CAR comprising instant SEQ ID NO: 6. Accordingly, such allogenic dendritic cell tumor vaccines and compositions thereof would be seen as combining prior are elements according to known methods to achieve predictable results.
Accordingly, one of skill in the art would consider the instant claims as an obvious variation of the patented claims, as evidenced by the reference.
Conclusion
No claims are allowed.
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 can normally be reached on Monday through Friday.
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
June 19, 2026
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