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 .
The Track One request was granted 5/1/2026.
Claims 1-6, 9-16, 19-28 and 30 are pending.
This application is a continuation application of U.S. Application No. 18/919,103, filed October 17, 2024, now U.S. Patent 12,403,194, which is a continuation application of International Application No. PCT/US2024/048301, filed September 25, 2024, which claims the benefit of and priority to U.S. Provisional Application No. 63/540,336, filed September 25, 2023, and U.S. Provisional Application No. 63/618,878, filed January 8, 2024. The earlier filed provisional applications contain the sequences within the disclosure and not in a sequence listings. Hence the effective filing date of the claims is U.S. Provisional Application No. 63/540,336, filed September 25, 2023.
Parent application No. 18/919,103 is drawn to recombinant lentivirus that are claimed in terms of sequences that are distinct from those in the instant methods. However, the particles claimed in copending application 18/919,082, now U.S. Patent 12,440,564 are those particles used herein.
Information Disclosure Statement
Information disclosure statements filed 6/17/2026 have been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through. It is noted that a single reference could not be located and this is WO 2023115039 in the IDS filed 5/01/2026. In the case that only an English abstract was identified, this is indicated.
A replacement 1449 for the IDS field 10/17/2025 is attached as the time stamps were missing.
Response to Amendments
The amendment suggested by examiner in the previous action to establish the full sequence and not partial sequences in claims 3 and 11 where multiple sequences has not set this forth as intended. This is corrected below.
The remaining amendments are sufficient to overcome the objections to the claims as well as rejection of claim 2 (incorrectly listed as 34) under 35 USC 112, first paragraph. As well, the amendments are sufficient to overcome the rejection based upon lack of enablement. The remaining rejection, under non-statutory double patenting was not addressed by applicant and review suggests it is still valid despite amendments.
Claim Objections
Claims 3 and 11 are objected to because of the following informalities: upon reconsideration the recitation of “an amino acid sequence of any one of the amino acid sequences of SEQ ID NO:” should recited –one of the amino acid sequences of SEQ ID Nos--. This ensures the entirety of the amino acid sequence is recited.
Appropriate correction is required.
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 1-6, 9-16, 19-28 and 30 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-25 of U.S. Patent 12,440,564. This rejection is maintained. Applicants have not addressed this rejection.
The instant claims are drawn to methods of using the copending claimed lentivirus of U.S. Patent 12, 440,564. The safe harbor for non-statutory double patenting only applies for applications filed as divisional applications. Because all sets of claims are drawn to the lentivirus particles comprising a VSIV-G envelope glycoprotein with K47A/Q and R354A/Q modifications and a CD3e tropism molecule and lentivirus vector encoding BCMA CAR, the claims are related under the non-statutory double patenting statute.
Specifically, the particle of copending claim 1 is the same as that of instant claim 1 with the note that the recitation of CD138 in the copending claims is meant to be CD3e and comprises the same sequences and source (see copending claims 2 and 3). The particle of claims 11 and 16 are the same as those recited in instant claims 11 and 21. Because none of the applications are related as a divisional, there is no prohibition against double patenting. The courts have determined “[t]here is nothing that prevents us from looking to the specification [of the ’165 patent] to determine the proper scope of the claims.” Wherein the relevant claims of the two applications are not patentably distinct, when the claims at issue merely recited methods of administering therapeutically-effective amounts of the compositions claimed or means of making and no safe harbor exists. In this case, the copending claims are drawn to cells transduced with the particles wherein the particles of the instant claims are used to transduce immune effector cells. The use of the particles is to transduce subjects immune effector cells such that therapeutically they can be used to target multiple myeloma.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding U.S. Patent 12,440,564, then two different assignees would hold a patent to the claimed invention of U.S. Patent 12,440,564, and thus improperly there would be possible harassment by multiple assignees.
RELATED ART
Claim 1 is drawn to a lentiviral particle comprising several claims components. The first is an envelope with one of K47A/Q and one of R354A/Q mutations in the envelope protein from either VSIV-G or COCV-G. This is found in the art for example, US 20200216502 teaches this construct (see Figure 11 and ¶0278). Secondly, this envelope also comprises anti-CD3e scFV attached by a hinge and transmembrane domain as demonstrated by US 20170258835 is known in the art. Third the vector comprises a construct with an MND promoter which is shown in the art to express anti-BCMA CAR with a CD8a hinge and TM domain a co-stimulatory signaling domain from CD137 and CD3s primary signaling domain (see ¶0035, US 20210128619). The totality of sequences claimed as SEQ ID NO:62-64 and 66-68 were not known in the art
SEQ ID NO:62 and 63 are found together in in US 20140046039. However, SEQ ID NO:64 is not found in the art prior to the instant inventors. SEQ ID NO:66 and 67 are found in cases US 20230192798 and US 20130197201. However, SEQ ID NO:68 is not found in the art prior to the instant inventors.
Claims 11 and 21 are drawn to an envelope with one of K47A/Q and one of R354A/Q mutations in the envelope protein from VSIV-G that is i.e. SEQ ID NO:335. These sequences are taught in US 20200216502 (i.e. see SEQ ID NO:175 as an example as well as figure 11). Second, this envelope also comprises SEQ ID NO: 324-331 which are not known in the art. Third, the vector comprises a construct with SEQ ID NO: 266 which is not known in the art.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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