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 .
Detailed Action
This action is in response to the papers filed March 6, 2026.
Amendments
Applicant's response and amendments, filed March 6, 2026, are acknowledged. Applicant has cancelled Claims 3, 8-9, 12-13, and 15-61, and amended Claim 10.
Claims 1-2, 4-7, 10-11, and 14 are pending.
Election/Restrictions
Applicant has elected without traverse the invention of Group II. Claims 1-2, 4-7, 10-11, and 14, drawn to a composition comprising a population of isolated Vgamma4+ (Vg4+) cells expressing a heterologous protein, classified in C12N 5/0636.
Within Group II, Applicant has elected without traverse the following species, wherein:
i) the alternative heterologous protein to be expressed in the Vy4+ cells is Vy4, as recited in Claim 2.
Claims 1-2, 4-7, 10-11, and 14 are pending.
Claim 11 is/are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1-2, 4-7, 10, and 14 are under consideration.
Priority
This application is a continuation of application 16/646,914 filed on March 12, 2020, now abandoned, which is a 371 of PCT/EP2018/075102 filed September 17, 2018. Applicant’s claim for the benefit of a prior-filed application provisional application 62/559,225 filed on September 15, 2017 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The Examiner also acknowledges co-pending application 18/448807, which is a division of application 16/646,914 filed on March 12, 2020, now abandoned, which is a 371 of PCT/EP2018/075102 filed September 17, 2018.
Information Disclosure Statement
Applicant has filed an Information Disclosure Statement on January 9, 2024 that has been considered.
The information disclosure statement filed January 9, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because 37 CFR 1.98(b) requires that each item of information in an IDS be identified properly. Each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue.
See also MPEP 707.05(e) for electronic documents, including, but not limited to:
(D) reference to the unique Digital Object Identifier (DOI) number, or other unique identification number, if known.
NPL citation 1 has been lined through for being defective of one or more requirements.
The signed and initialed PTO Forms 1449 are mailed with this action.
Claim Objections
1. The prior objection to Claim is withdrawn in light of Applicant’s amendment to the claim.
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.
2. Claims 2, 4-7 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites embodiments (a), (b), (c), and (d) in the alternative “or”.
Claim 2(b) recites the limitation “the Vg4- cell” in reference to Claim 1. There is insufficient antecedent basis for this limitation in the claim because Claim 1 does not recite the Vg4+ cell to be a Vg4- cell.
To the extent Applicant is referring to the cell of Claim 2(a), then the Examiner suggests amending Claim 2(b) to recite ‘wherein the Vg4+ cell of 2(a) is…”, for example.
Claim 4 recites the limitation “the immune cell” in reference to Claim 2. There is insufficient antecedent basis for this limitation in the claim because, while it is clear that Claim 2(b) recites an immune cell, embodiments 2(a) and (c) recite the cell at a high level of generality. Thus, it is unclear if Claim 4 is in reference to only 2(b), or if it also refers back to 2(a) and/or 2(c).
To the extent Applicant is referring to the cell of Claim 2(b), then the Examiner suggests amending Claim 4 to recite ‘wherein the immune cell of Claim 2(b) is…”, for example.
The instant claims as a whole do not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s).
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 (i.e., changing from AIA to pre-AIA ) 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.
3. Claim(s) 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al (Naturally Activated Vgamma4 gamma/delta T cells Play a Protective Role in Tumor Immunity through Expression of Eomesodermin, J. Immunol. 185: 126-133, June 4, 2010; of record in IDS).
With respect to Claim 1, He et al is considered relevant prior art for having taught genetically modifying the Vg4+ gd T cells to express a heterologous protein (e.g. pg 130, col. 2, “transduced with…..”).
With respect to Claim 10, embodiment (b) directed to the product-by-process ‘derived from an iPSC’, the recitation of a process limitation in Claim 10(b) is not viewed as positively limiting the claimed product absent a showing that the process of making recited in Claim 10b imparts a novel or unexpected property to the claimed Vg4+ gd T cells expressing a heterologous protein of Claim 1, as it is assumed that equivalent products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the Vg4+ gd T cells expressing a heterologous protein were produced is immaterial to their patentability.
"Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Thus, He et al anticipate the claims.
4. Claim(s) 1-2, 4, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (Gamma delta T cell receptors confer autonomous responsiveness to the insulin-peptide B:9-23, J. Autoimmunity 34: 478-484, 2010; of record in IDS).
With respect to Claim 1, Zhang et al is considered relevant prior art for having taught genetically modifying a cell to express a heterologous protein, to wit, a heterologous Vg4+ protein (e.g. pg 480, col. 1, “virally transduced cells expresss…”; Figure 3, legend, “TCRgamma…genes were expressed by viral transduction”, panel a, Vg4).
With respect to Claims 2(a), 2(b), and 4, Zhang et al taught the host cell is Vg4- cell, e.g. a SF9D11 murine hybridoma cell).
With respect to Claim 10, embodiment (b) directed to the product-by-process ‘derived from an iPSC’, the recitation of a process limitation in Claim 10(b) is not viewed as positively limiting the claimed product absent a showing that the process of making recited in Claim 10b imparts a novel or unexpected property to the claimed cells expressing a heterologous Vg4+ protein of Claim 1, as it is assumed that equivalent products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the cells expressing a heterologous Vg4+ protein were produced is immaterial to their patentability.
"Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Thus, Zhang et al anticipate the claims.
5. Claim(s) 1-2, 4-7, 10, and 14 are rejected under 35 U.S.C. 102(a)(1) and/or under 35 U.S.C. 102(a)(2) as being anticipated by Jacobavits et al (U.S. 2016/0175358; filed November 17, 2015; priority to November 17, 2014) is considered relevant prior art for having disclosed gamma/delta (gd) T cells genetically modified to express a heterologous protein (e.g. Abstract; Figure 1).
With respect to Claim 1, Jacobavits et al disclosed the engineered gd T cell express a cloned TCR that recognizes, e.g. a tumor, bacterial, or viral antigen (e.g. [0030]), and disclosed cloning cDNAs encoding, e.g. Vg4 (e.g. [0010]; Example 22, [0168], “co-transfected with gamma TCR chains using… Vg4”; [0030], “expression cassette comprising the engineered gd TCR”).
With respect to Claims 2(a), 2(b), and 4-5, Jacobavits et al disclosed the host cell may be a Vg4- cell, e.g. a T cell (e.g. [0031]).
With respect to Claim 2(c), Jacobavits et al disclosed the engineered cell is a human cell (e.g. [0031], “human cells”).
With respect to Claims 6-7, Jacobavits et al disclosed the engineered cell is a gd T cell (e.g. [0039]), including a Vdelta2 (Vd2)- cell (e.g. [0039], “Vd1+, Vd2+, Vd3+”; [0067], “derived from a human gd T cell”; [0089], “such as g9d2 T cells”, “such as g2d2 T cells”).
With respect to Claim 10, embodiment (b) directed to the product-by-process ‘derived from an iPSC’, the recitation of a process limitation in Claim 10(b) is not viewed as positively limiting the claimed product absent a showing that the process of making recited in Claim 10b imparts a novel or unexpected property to the claimed cells expressing a heterologous Vg4+ protein of Claim 1 as it is assumed that equivalent products are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. The method in which the cells expressing a heterologous Vg4+ protein were produced is immaterial to their patentability.
"Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
With respect to Claim 14, Jacobavits et al disclosed a pharmaceutical composition comprising at least 1x10^6 genetically engineered cells expressing the heterologous TCR (e.g. [0126-129]; Example 35, [0207], “engineered gd T cells grown exponentially to about 1x10^6”), said cellular composition being at least 10% pure or enriched for the desired genetically engineered gd T cells (e.g. [099-101], “fewer than 90%” undesired cells).
The Examiner acknowledges that Jacobavits et al do not disclose a working example reducing to practice a human T cell genetically modified to express a heterologous Vg4+ protein.
However, the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).
A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the date of invention. "Such possession is effected if one of ordinary skill in the art could have combined the publication's description of the invention with his [or her] own knowledge to make the claimed invention." In re Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985).
Jacobavits et al clearly demonstrated the ability to clone and express a heterologous Vg4 protein in a heterologous host cell (e.g. [0030]), and disclosed cloning cDNAs encoding, e.g. Vg4 (e.g. [0010]; Example 22, [0168], “co-transfected with gamma TCR chains using… Vg4”; [0030], “expression cassette comprising the engineered gd TCR”).
Jacobavits et al clearly demonstrated the ability to clone a heterologous TCR into an expression vector (e.g. Example 27, [0190], “TCRs genes are cloned and inserted into…vectors”) and introducing the heterologous TCR expression vector into gd T cells (e.g. Example 28, “Engineering gd T cells with a… TCR construct”).
All that is needed is art-recognized, decades old, molecular biology routinely used in the art. See also, for example, He et al (2010) and/or Zhang et al (2010), above.
Thus, no undue experimentation is required.
Thus, Jacobavits et al anticipate the claims.
Conclusion
6. No claims are allowed.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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