DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 9/16/2025.
Claims 3, 6-14, 16, 17, 23 and 26-30 are pending.
The application claims priority to U.S. Application 16/078,269, filed 8/21/2018, now U.S. Patent, 11,453,712 which claims priority under 371 to PCT/US2017/049923 filed 9/1/2017 which claims priority to provisional application 62/382,791 filed 9/2/2016.
Information Disclosure Statement
An information disclosure statement filed 12/10/2025 has been identified and the documents considered. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered. Applicants have submitted a statement that a large IDS size fee is not required.
Response to Amendments
Applicants have submitted a substitute specification and a marked up version. The marked up version is noted as not entered and a request for clarification has been made to the USPTO processing department. However, the marked up version has amended the disclosure to remove the sequence listing on pages 87-107. However, the objections to the specification due to lack of sequence compliance is not overcome. On new page 78, line 6 amendment, no sequence identifier has been added to GGGS or on page 81, line 20.
The objection to claim 5 is overcome by its cancellation.
The previous rejections under 35 USC 112, second have been overcome. How3ever, the amendment has triggered new rejections under 35 USC 112, second.
Applicants amendment is sufficient to indicate that claims 23 and dependent claims are drawn to cells that are modified with the duoCAR vectors. The disclosure indicates that these cells are modified in vitro and thereafter returned for in vivo expansion hence it is clear the pharmaceutical composition is an isolated population of cells.
The rejection under 35 USC 112, first is overcome by indicating that only the CAR not comprising SEQ ID NO:10 and 52 are being modified. These sequences do comprise a linker as set forth in claim 8.
Sequence Compliance
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below or on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Specifically, pages 78 and 81 contain sequences ((GGGGS)n, and (GGGGS)5) that are not identified by sequence identifier. If the sequences can be found in the sequence listing it would be remedial to insert the appropriate SEQ ID NO:s. If not, a substitute paper copy of the “Sequence Listing”, as well as an amendment directing its entry into the specification, CRF and letter stating that the contents of the sequence listing and the CRF are the same and contain no new matter is required. Applicants have not corrected the above noted sequence issues.
Claim Objections
Claims 3, 6-14, 16 and 17 are objected to because of the following informalities: it is newly noted that for completeness, the claims should refer to –the group consisting of the amino acid sequences of SEQ ID NO:10--. SEQ ID NO:s are place holders and should be referred to as the amino acid sequence of the SEQ ID NO:. It is further noted that claim 23 repeats SEQ ID NO: twice in a row and requires just one. This is a new observation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, second paragraph
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.
This rejection is necessitated by applicants’ amendment.
Claim 6-14, 16 and 17 depend from claim 3. Claim 3 establishes that there are two or more CAR. The claim only explicitly describes one of these sequences i.e. “wherein at least one of the two or more functional CARs comprises two non-identical extracellular antigen binding domains, a transmembrane domain and one or more non-identical signaling motifs and comprises an amino acid sequence selected from the group consisting of SEQ ID NO:10 and SEQ ID NO:52”. Reference is made to the “other” of the two or more functional CARs in claims 6-14, 16 and 17, i.e. “one of the at least two or more functional CARs that does not comprise the amino acid sequence selected from the group consisting of SEQ ID NO:10 and SEQ ID NO:52”. However, there is no explicit literal support for the limitations to “the extracellular antigen binding domain” recited in claims 6-11, “the one or more non-identical intracellular signaling motifs of each of the two or more functional CARS” in claims 8, 14, 16, “the transmembrane domain of claim 13” or “the costimulatory domain of claim 17 of any of the other CAR. This means the claims read on limitations that lack antecedent basis.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 23 and 26-30 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 38-42 of copending Application No. 18/347,644. As other rejections remain, this rejection is maintained.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 38-42 of copending Application No. 18/347,644. That is, the cited claims of copending Application No. 18/347,644 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, copending Application No. 18/347,644 is drawn to methods of using the claimed product in the instant claims. Because the cases are not related as divisionals, the safe harbor for non-statutory double patenting does not apply.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding copending Application No. 18/347,644, then two different assignees would hold a patent to the claimed invention copending Application No. 18/347,644, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 3, 6-14, 16, 17, 23 and 26-30 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent 11,453,712. This rejection stands unless a terminal disclaimer is filed.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-8 of U.S. Patent 11,453,712. That is, the cited claims of U.S. Patent 11,453,712 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, is drawn to methods of using the claimed product in the instant claims. Because the cases are not related as divisional, the safe harbor for non-statutory double patenting does not apply. Both claims recite CARs comprising SEQ ID NO:10 or 52.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 11,453,712, then two different assignees would hold a patent to the claimed invention of U.S. Patent 11,453,712, and thus improperly there would be possible harassment by multiple assignees.
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 MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached on 8 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA MARVICH/Primary Examiner, Art Unit 1633
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