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 .
Status of Application/Election/Restrictions
Applicant’s election with traverse of Group I (Claims 1-5 and 31-33) and species (truncated CD64) in the reply filed on 2/19/2026 is acknowledged. Applicant’s traversal is on the grounds that Chaudhary does not mention “gene therapy” and discloses compositions and methods for improved safety and efficacy of adoptive cellular therapies. Applicant argues that Chaudhary relates to a very different technology from the instant invention, which provides a gene therapy viral vector that utilizes Fc receptors to evade immune destruction. This is not found persuasive since Chaudhary describes a retroviral gene therapy vector comprising a polynucleotide encoding a transgene and an antigen binding receptor with specific embodiments to CD16, CD32 and CD64 (Chaudhary, para 7, 85, 148). The retroviral gene therapy vector described by Chaudhary is foundational in creating the CAR T cells which make up the adoptive cell therapy. As the common technical feature was known in the art at the time of the invention, this cannot be considered a common special technical feature that would otherwise unify the groups. Accordingly, unity of invention is lacking. Accordingly, there is a search and examination burden to search these inventions in the same application. The requirement is still deemed proper and is therefore made FINAL.
Claims 3-4, 34-35 and 38-40 are canceled. Claim 42 is newly added. Claims 1-2 are amended. Claims 1-2, 5-33, 36-37 and 41-42 are pending. Claims 7-17, 19-30, 36-37 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-2, 5 and 33 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application PRO 63/158,204 and 371 of PCT/US2022/019203 filed on 3/8/2021 and 3/7/2022, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 3/8/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/21/2026 and 2/22/2026 were received. The submissions were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the examiner.
Claim Objections
Claim 1 is objected to for misspelling envelope as “envelop”.
Claim Rejections - 35 USC § 112a, Written Description
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 1-2, 5 and 33 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. This rejection is supported by Lacroix et al. US 2021/0228738, published 7/20/2021 (hereinafter Lacroix).
The genus of “transgenic genetic element” refers to a genus that is considered extraordinarily broad. It is thought to encompass ANY gene or regulatory sequence that treats ANY genetic disease, both known and yet to be discovered.
For each claim drawn to a genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in procession of the claimed genius. If a representative number of adequately descried species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The instant specification exemplifies treating genetic diseases including X-SCID, Stargardt disease, Usher syndrome, HGPS, Noonan syndrome among many others (Spec, para 23). The instant specification prophetically considers packaging cell lines which are used to generate the gene therapy vectors but are prophetic in nature with respect to the transgenic genetic elements described.
This is not considered a representative number of samples to support the claim to all transgenic genetic elements, in part because both genes and regulatory sequences have distinct modes of action but also because each may have a very distinct mode of action in treating a related genetic disease. Given the breadth of the genus of ANY gene or regulatory sequence that treats ANY genetic disease in contrast to the exemplified and prophetic proportions of the specification, which are largely drawn only to diseases with generalized gene targets, the instant specification does not adequately disclose a sufficient number of adequately described species of the genus of transgenic genetic element.
Furthermore, the prior art does not support the breadth of applicants claim to any transgenic genetic element that treats a genetic disease. In particular, the prior art reveals that the differentiation genes and regulatory sequences have different therapeutic mechanisms specific to each genetic disease. This is supported by Lacroix, wherein specific proteins and their related genetic diseases are listed (GAA for treatment of Pompe disease, ATP7B for treatment of Wilsons disease, ect) (Lacroix, para 268). Lacroix describes how each genetic disease and related gene treatment has a great deal of unpredictability in the art, where factors such as delivery and dose all collectively contribute towards treatment efficacy (Lacroix, para 279).
Thus, although the specification prophetically considers and discloses general methodologies directed towards treating different genetic diseases using transgenic genetic elements, the instant specification does not disclose a sufficient number of adequately described species to support the claim to all transgenic genetic elements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chaudhary et al. US 2022/0135678, published 5/5/2022, priority date 1/18/2019 (hereinafter Chaudhary).
Claim 1: Chaudhary describes a retroviral gene therapy vector comprising a polynucleotide encoding a transgene and an antigen binding receptor (ABR) with specific embodiments to CD64 (Chaudhary, para 7, 85, 148). Chaudhary describes a producer cell line (293 FT cells) which produce lentiviral vectors, wherein upon budding of the lentiviral vectors the CD64-CAR gets inserted into the envelope of the lentivirus containing the transgene (Chaudhary, para 27). Chaudhary describes vectors which comprise transgenic genetic elements that treat genetic diseases like ABR targeting cancer antigens (Chaudhary, para 7).
Claim 5: Chaudhary describes preferred embodiments to lentiviral vectors and retroviral vectors (Chaudhary, pg 147, 153).
Claim 33: Chaudhary describes further compositions comprising pharmaceutically acceptable carriers and excipients (Chaudhary, para 578, 617).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 5 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhary (supra) in view of Lacroix et al. US 2021/0228738, published 7/20/2021 (hereinafter Lacroix) and Van Sorge et al. "FcγR polymorphisms: implications for function, disease susceptibility and immunotherapy." Tissue antigens 61.3 (2003): 189-202 (hereinafter Van Sorge).
A description of Chaudhary can be found above. Chaudhary does not specifically describe that the membrane bound Fc receptor protein is a truncated CD64.
Claim 2: Van Sorge describes how CD64 (FcγRI) is the only human receptor with high affinity for monomeric IgG (Van Sorge, pg 190). Van Sorge discloses a truncated CD64 which shows a high affinity for IgG but lacks an intracellular signaling tail (Van Sorge, pg 190 and Fig 1).
Claim 2: Lacroix describes methods for enhancing the transduction of gene therapy vectors via reducing immunoglobulins (IgG) by expressing Fc receptors like CD64 (Lacroix, para 136-137). Lacroix found that Fc receptors like CD64 act to bind IgG and prevented them from triggering unintended signaling and mediating antibody-dependent cellular cytotoxicity (ADCC) (Lacroix, para 136).
It would have been prima facie obvious to one of ordinary skill in the art to express an Fc receptor protein like the truncated CD64 disclosed by Van Sorge on the viral envelope of the retroviral gene therapy vector described by Chaudhary in order to bind IgG and inhibit ADCC. It would have been a matter of combining prior art elements according to known methods to yield predictable results since Lacroix provides a mechanism wherein Fc receptors like CD64 act to bind IgG and inhibit ADCC (Lacroix, para 136). One would have been motivated to express a truncated CD64 given that CD64 is the only human receptor with high affinity for monomeric IgG and the truncated variant still shows high affinity for IgG but lacks an intracellular signaling tail (Van Sorge, pg 190 and Fig 1).Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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Alexander Nicol
Patent Examiner
Art Unit 1633
/ALEXANDER W NICOL/Examiner, Art Unit 1634
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633