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 .
Receipt and entry of the response dated 6/26/2026 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos 62/821,434; 62732,528; 62/728,056; 62/726,293 and 62/726,924, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. These applications do not disclose contacting blood cells that have not been to PBMC enrichment with a recombinant retrovirus, or the inclusion of 10% neutrophils in the reaction mixture. The first disclosure of such is found in 62/894,853, thus, claims 43-61 are granted a priority date of 9/1/2019.
Claim Rejections - 35 USC § 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.
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In claim 43, the limitations “means for fusing a replication incompetent retroviral particle to a T cell” and “means for binding CD3” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. This rejection affects dependent claims 44-49, 51-61, 64.
This claim interpretation and rejection are maintained for reasons mase of record in the Office Action dated 1/28/2026 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 6/26/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) means for fusing a recombinant retroviral particle to a T cell are provided in Table 1 of the response; 2) means for binding CD3 are listed in Table 2 of the response.
Regarding 1), as stated in the previous Office Action, the means for fusing listed in Table 1 do not provide such a means as claimed. Note “fusing” is not the same as binding to a T cell, the means must mediate fusion of the viral and T cell membranes allowing transduction of the T cell by the RIP to occur. Table 1 lists viral envelope proteins other than VSV-G that might mediate fusion with a T cell membrane in the context of the instant methods (i.e. in whole blood), but this is not considered to “clearly link” these structures with the recited function of “fusing” a RIP with a T cell membrane because the specification and relevant art indicate these additional means do not fuse the viral and cellular membranes.
Regarding 2), such means are accepted, however, the claims require “means for binding CD3” when expressed in the context (i.e. on the surface) of a retroviral particle, which is the crux of this rejection.
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 43-49, 51-61, 64 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. This rejection is maintained for reasons made of record in the Office Action dated 8/15/2024, 4/10/2025, 7/30/2025, 8/13/2025, 1/28/26 and for reasons set forth below.
Response to Arguments
Applicants’ arguments filed 6/26/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) the claims are directed to genetically modifying T cells, not means for fusing a retrovirus to a T cell, and the Examiner misinterprets Ex parte Chamberlain; 2) the specification and an affidavit from Inventor Frost teaches various envelope proteins, e.g., in the Pseudotyping Elements section or Table 1 can be used in the claimed invention; 3) the specification and an affidavit from Inventor Frost teaches various CD3-binding activation elements.
Regarding 1), the fusion of the retroviral particles with the T cell membrane is an essential function of the claimed methods, otherwise genetic modification of T cells would not occur. The fact remains that the only envelope protein taught to mediate fusion in the context of the claimed recombinant viral particles is the VSV-G protein (Figs 3 and 4, Examples 2 and 3, and the Frost Declaration). None of the other viral envelope proteins listed in Table 1 are taught to provide the claimed means of membrane fusion, a necessary function of the claimed methods. This leads back to the attempts to apply Chamberlain to the instant claims. The analysis of Chamberlain stands; applicants have not convincingly explained why Chamberlain applies to the instant methods that require a genus of means that mediate membrane fusion, not several species of antibody binding to an antigen or epitope. Again, disclosure of a single species, VSV-G, that provides means for membrane fusion as claimed is not in accord with Chamberlain or this statute.
Regarding 2), this assertion has been discussed and answered at length in the previous Office Actions. As previously set forth, in all cases of successful membrane fusion, a “wild-type” VSV-G protein, and no other, was included in the viral particles. Neither the specification nor relevant art provide for any other means to mediate the claimed fusion.
Regarding 3), the various CD3 binding elements mentioned by the specification do not necessarily activate the claimed T cells (or human T cells) in the context of a retroviral particle. The affidavit by Inventor Frost merely repeats the use of CD3-specific scFv domains as CD3 binding elements in both lentiviral vectors used in the T cell transduction experiments. Thus, it remains that the only CD3-specific element taught to provide the claimed function in the context of the claimed recombinant viral particles is a CD3-specific scFv (Figs 3 and 4, Examples 2 and 3, and the Frost Declaration). As above, in all cases, a “wild-type” VSV-G protein was included in the viral particles.
Allowable Subject Matter
Claims 50 and 65 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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