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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/10/2025 has been entered.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
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.
“The structure disclosed in the written description of the specification is the corresponding structure only if the written description of the specification or the prosecution history clearly links or associates that structure to the function recited in a means- (or step-) plus-function claim limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The requirement that a particular structure be clearly linked with the claimed function in order to qualify as corresponding structure is the quid pro quo for the convenience of employing 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, and is also supported by the requirement of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, that an invention must be particularly pointed out and distinctly claimed.” – MPEP 2181 II C.
In the instant case, the specification clearly links a single means for fusing a replication incompetent retroviral particle (RIP) to a T cell, the VSV-G protein. 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. The specification 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.
In the instant case, the specification clearly links a single means for binding a replication incompetent retroviral particle (RIP) to a T cell such that transduction and genetic modification of the T cell occur, CD3-specific scFvs. The specification lists molecules other than CD3-specific scFvs that might bind a T cell membrane in the context of the instant methods (i.e. as a component of a RIP in whole blood), but this is not considered to “clearly link” these structures with the recited function of “binding” a RIP with CD3 on a T cell membrane.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
This rejection affects dependent claims 44-49, 51-61.
Claim 51 recites the limitation "…the anti-CD3 scFv…" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 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 and for reasons set forth below.
The claims have been amended to recite “means for” limitations, the interpretation of which has been outlined above. The breadth of the possible claim elements for fusing a replication incompetent retroviral particle (RIP) to a T cell or for binding CD3 on a T cell in the context of the claimed methods is not considered to have changed significantly as set forth in the previous Office Actions.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) the claims use “means for” limitations and thus should be considered to meet the written description requirement for methods of using specific antibody binding; 2) the specification and an affidavit from Inventor Frost teaches various envelope proteins, e.g., in the Pseudotyping Elements section 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 instant methods are not directed to methods of treatment mediated by antibody binding to a cognate antigen. Rather, they recite the genetic modification of T cells by RIPs and thus require different structure (viral envelope proteins) and function(s) (viral mediated fusion of T cell membranes) than mere antibody binding of antigen. Thus, the PTAB decision mentioned by applicants is not on point as it does not consider these distinct structures and functions.
Regarding 2), the various envelope proteins mentioned by the specification (including Examples 2 and 3) do not necessarily mediate entry into the claimed T cells (or human T cells), let alone under the conditions of the instant methods (e.g. in whole blood). The only envelope protein taught to do so 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). The affidavit by Inventor Frost merely repeats the use of VSV-G envelope in both lentiviral vectors used in the T cell transduction experiments. Thus, the affidavit provides no more evidence than what has been previously stated by the Examiner regarding a viral envelope structure that provides the claimed function of T cell transduction. As previously set forth, in all cases, a “wild-type” VSV-G protein, and no other, was included in the viral particles.
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
Claim 50 is 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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638