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 .
Claim status
In the reply on 24 June 2025, Applicant has amended claim 27. 1-26 have been cancelled and added new claims 30-40. Therefore, claims 27-40 are herein pending.
Election/Restrictions
Applicant’s election without traverse of Group 2 claims 27-28 drawn to a chimeric antigen receptor (CAR) or a polypeptide in the reply filed on 24 June 2025 is acknowledged.
For species election Applicant elects (1), Applicant selects SEQ ID NO:9 for the spacer; (2) SEQ ID NO: 43 for the scFv and (3) SEQ ID NOs: 40 for the CAR. Claims 27-40 read on these species.
Claims 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
Claims 27-32 and 36-40 are under current examination.
Priority
This application was filed 11/19/2021 and is a 371 application of PCT/US2020/034389 filed on 05/22/2020, which claims benefit to the Priority from Provisional Application 62852934 filed on 05/24/2019.
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 application, Application No. 62852934 Filing date 05/24/2019 fails 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.
The prior filed provisional application 62852934 does not disclose the SEQ ID Nos: 38-45, therefore claims 27, 36 and 37 are not found to have support in the 62852934 provisional application and have been examined with the effective filing date of the PCT/US2020/034389 parent application which is 05/22/2020. Thus, the earliest possible priority for the instant application is 05/22/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/24/2025, 08/19/2024, 04/17/2024 and 09/02/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Abstract Objection
The abstract of the disclosure filed 11/19/2021 is objected to because the abstract is only 17 words in length, and it is not submitted as a single paragraph on a separate sheet as required. Therefore, submitted abstract is considered non-compliant.
Applicant is reminded of the proper language and format for an abstract of the disclosure. MPEP §608.01(b) states that the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Therefore, appropriate correction is required.
Claim Objections
Claim 27 is objected to because of the following informalities: abbreviations such as “CCR4,” “scFv” should be spelled out in full at the first encounter in the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27-29, 32 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Waldmann et al., (WO2018057585; published on: 03/29/2018; cited in IDS filed 09/02/2022; hereinafter “Waldmann”), in view of Marasco et al., (US8962806B2, Date of Patent: Feb.24,2015; cited in PTO892; hereinafter “Marasco”) and further in view of Brown et al. (US9914909B2; Date of Patent: Mar. 13, 2018; cited in PTO892; hereinafter “Brown”)
Regarding claim 27, Waldmann discloses a chimeric antigen receptor (CAR) comprising a single-chain variable fragment (scFv) comprising a light chain variable domain (VL) and a heavy chain variable domain (VH), wherein the scFv specifically binds to C-C chemokine receptor type 4 (CCR4), a spacer region, a transmembrane domain, a 4-1BB co-signaling domain and CD3 [Symbol font/0x7A] signaling domain, wherein the spacer comprises an immunoglobulin CH2 and CH3 immunoglobulin G(lgG1) domain sequence (CH2CH3) (claims 1-51; Figure 1A; p. 33 lines 7-22).
With respect to claim 27, Waldmann is silent to the scFv comprises the amino acid sequence of amino acids 1-116 and 134-245 of SEQ ID NO: 43. However, such was known in the prior art.
Marasco teaches a monoclonal antibodies which bind the CC-chemokine receptor 4 (CCR4) (abstract, Col 1 lns 66-67 of Marasco), wherein a scFv polypeptide molecule is a covalently linked a heavy chain variable amino acid sequence containing SEQ ID NOS: 2, and a light chain variable amino acid sequence containing SEQ ID NOS: 4 (Col. 2 lns 10-13 of Marasco). The antibody is used in combination with vaccines to suppress the activity of regulatory T cells (abstract of Marasco). Amino acid sequence of SEQ ID NOs: 2 and 4 are 100% identical to the instant claimed amino acid sequence of amino acids 1-116 and 134-245 of SEO ID NO:43 respectively. See the ABSS rai (issued patents) result filed Sept 24 2025. Therefore, this disclosure is considered to read on claim 37.
MPEP 2143 (B) states that simple substitution of one known element for another to obtain predictable results. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Accordingly, it would have been obvious to practice the CAR comprising scFv of Waldmann and substitute the amino acid sequence of the antibody recognizing the CCR4 as taught by Marasco with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Marasco because antibody-based therapeutics for targeting claudins in cancer therapy promises a high level of therapeutic specificity and treating CCR4 positive cancers (Col 25 lns 47-67 of Marasco). The POSITA would have a reasonable expectation of success in combining the teachings of Waldmann and Marasco because each of these teachings both successfully generated CAR T-Cell Immunotherapy in combination with an anti-CCR4 scFv. Therefore, the products and method as taught by Waldmann et al. in view of Marasco et al. would have been prima facie obvious over the products and method of the instant application. In regard to the reasonable expectation of success in doing so, substitute the antibody recognizing antigen comprising the amino acid sequence SEQ ID NOs: 2 and 4 of Marasco had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
With respect to claim 27, Waldmann is silent to the spacer comprises SEQ ID NO: 9 However, such was known in the prior art.
Brown teaches a chimeric antigen receptor (CAR) comprising a spacer, a transmembrane domain, a 4-1BB co-stimulatory domain, and CD3 [Symbol font/0x7A] signaling domain, wherein the spacer consisting of SEQ ID NO: 20. The spacer region located between targeted receptor or variant thereof and the transmembrane domain (Col. 1 lns 66-67 to Col. 2 lns 1-25; Col. 3 lns 20-27). The SEQ ID NO: 20 is 100% identical to the instant claim spacer sequence SEQ ID NO: 9. See ABSS us-17-612-794-9.rai search result no 1.
In regard to the reasonable expectation of success to choose the spacer sequence of SEQ ID NO: 20 as taught by Brown, this was a well-known choose at the time of filing and required no more than routine recombinant DNA technology. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015); See MPEP 2106.05(d).
MPEP 2143 (B) states that simple substitution of one known element for another to obtain predictable results. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Accordingly, it would have been obvious to practice the CAR comprising scFv of Waldmann and substitute the spacer sequence as taught by Brown with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Brown because CAT-T cell comprises spacer (i.g.. IgG4) exhibits efficient anti-tumor activity (Col 20 lns 27-34 of Brown). The POSITA would have a reasonable expectation of success in combining the teachings of Waldmann and Brown because each of these teachings both successfully generated CAR T-Cell Immunotherapy. Therefore, the products and method as taught by Waldmann et al. in view of Brown et al. would have been prima facie obvious over the products and method of the instant application. In regard to the reasonable expectation of success in doing so, substitute the spacer sequence SEQ ID NOs: 20 of Brown had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Regarding claim 28, Waldmann teaches that the polypeptide encoded CAR transfects human T cells and transform into human CAT T-cells (claim 27, p. 4 lns 3-5).
Regarding claim 29, Waldmann teaches that the transmembrane domain is selected from CD4, CD8 and/or CD28 (p. 33 lns 29-31; p. 34 lns 13-15).
Regarding claim 32, Waldmann teaches that the linker of 2 to 10 amino acids is located between the 4-1BB costimulatory domain and the CD3 [Symbol font/0x7A] signaling domain (p. 35 lns 29-33).
Regarding claim 38, Waldmann teaches that the population of human T cells comprise central memory T cells, naive memory T cells, CD4+ cells and CD8+ cells (p. 46 lns 23-28) enriched from PBMC cells, T cells isolated via negative depletion (p. 52 lns 18-25).
Regarding claim 39, Waldmann teaches that a method of treating T cell lymphoma in a patient comprising administering a population of autologous or allogeneic human T cells expressing the CAR T cell lymphoma comprises cells expressing CCR4 (p. 51 14-24; claim 1, p. 78 lns 9-11).
Regarding claim 40, Waldmann teaches that the population of human T cells expressing the chimeric antigen receptor is administered by single or repeat dosing (p. 28 lns 4-21).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Waldmann et al., (WO2018057585; published on: 03/29/2018; cited in IDS filed 09/02/2022; hereinafter “Waldmann”), in view of Marasco et al., (US8962806B2, Date of Patent: Feb.24,2015; cited in PTO892; hereinafter “Marasco”) and Brown et al. (US9914909B2; Date of Patent: Mar. 13, 2018; cited in PTO892; hereinafter “Brown”) as applied to claims 27-29 above, and further in view of June et al. (US9499629B2; Date of Patent: Nov. 22 2016; cited in PTO892; herein “June”)
As stated above, Waldmann discloses a chimeric antigen receptor (CAR) comprising a single-chain variable fragment (scFv) comprising a light chain variable domain (VL) and a heavy chain variable domain (VH), wherein the scFv specifically binds to C-C chemokine receptor type 4 (CCR4), a spacer region, a transmembrane domain, a 4-1BB co-signaling domain and CD3 [Symbol font/0x7A] signaling domain, wherein the spacer comprises an immunoglobulin CH2 and CH3 immunoglobulin G(lgG1) domain sequence (CH2CH3) (claims 1-51; Figure 1A; p. 33 lines 7-22).
With respect to claim 30, Waldmann is silent to the 4-1BB costimulatory domain comprises the amino acid sequence of SEQ ID NO: 24. However, such was known in the prior art.
Regarding claim 30, June teaches a genetically modified T cell to express a CAR wherein the CAR comprises an antigen binding domain, a transmembrane domain, a costimulatory signaling region, and a CD3 [Symbol font/0x7A] signaling domain, where in wherein the 4-1BB costimulatory domain comprises the amino acid sequence of SEQ ID NO: 23 (abstract, Fig. 1A, Table 5 Col. 61; Col. 23 lns 46-60 of June). The SEQ ID NO: 23 is 100% identical to the instant 4-1BB costimulatory amino acid sequence SEQ ID NO: 24. See ABSS us-17-612-794-24.rai search result no 1.
In regard to the reasonable expectation of success to choose the costimulatory domain sequence of SEQ ID NO: 23 as taught by June, this was a well-known choose at the time of filing and required no more than routine recombinant DNA technology. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015); See MPEP 2106.05(d).
MPEP 2143 (B) states that simple substitution of one known element for another to obtain predictable results. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Accordingly, it would have been obvious to practice the CAR comprising scFv of Waldmann and substitute the 4-1BB costimulatory domain amino acid sequence as taught by June with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by June because CAR that combines an antigen recognition domain of a specific antibody with an intracellular domain of CD3-zeta, CD28, 4-1BB mediated T-cell can target a tumor antigen for the purposes of treat cancer (Col. 34 lns 28-24; Col. 35 lns 15-20 of June). The POSITA would have a reasonable expectation of success in combining the teachings of Waldmann and June because each of these teachings both successfully generated CAR T-Cell Immunotherapy. Therefore, the products and method as taught by Waldmann et al. in view of June et al. would have been prima facie obvious over the products and method of the instant application. In regard to the reasonable expectation of success in doing so, substitute wherein the 4-1BB costimulatory domain comprises the amino acid sequence of SEQ ID NO: 23 of June had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Waldmann et al., (WO2018057585; published on: 03/29/2018; cited in IDS filed 09/02/2022; hereinafter “Waldmann”), in view of Marasco et al., (US8962806B2, Date of Patent: Feb.24,2015; cited in PTO892; hereinafter “Marasco”) and Brown et al. (US9914909B2; Date of Patent: Mar. 13, 2018; cited in PTO892; hereinafter “Brown”) as applied to claims 27-30 above, and further in view of Brogdon et al. (US 10221245B2; Date of Patent: Mar 5 2019; cited in PTO892; herein “Brogdon”)
As stated above, Waldmann discloses a chimeric antigen receptor (CAR) comprising a single-chain variable fragment (scFv) comprising a light chain variable domain (VL) and a heavy chain variable domain (VH), wherein the scFv specifically binds to C-C chemokine receptor type 4 (CCR4), a spacer region, a transmembrane domain, a 4-1BB co-signaling domain and CD3[Symbol font/0x7A] signaling domain, wherein the spacer comprises an immunoglobulin CH2 and CH3 immunoglobulin G(lgG1) domain sequence (CH2CH3) (claims 1-51; Figure 1A; p. 33 lines 7-22).
With respect to claim 31, Waldmann is silent to the CD3[Symbol font/0x7A] signaling domain comprises the amino acid sequence of SEQ ID NO: 21. However, such was known in the prior art.
Regarding claim 31, Brogdon teaches a genetically modified T cell to express a CAR wherein the CAR comprises an antigen binding domain, a transmembrane domain, a costimulatory signaling region, and a CD3 [Symbol font/0x7A] signaling domain, where in wherein the CD3[Symbol font/0x7A] signaling domain comprises the amino acid sequence of SEQ ID NO: 43 (abstract, Col 2 lns 14-25, Col. 4 lns 35-37; Col 5 lns 15-18 of Brogdon). The SEQ ID NO: 43 is 100% identical to the instant 4-1BB costimulatory amino acid sequence SEQ ID NO: 21. See ABSS us-17-612-794-21.rai search duplicate no 8 of result no 1.
In regard to the reasonable expectation of success to choose the CD3[Symbol font/0x7A] signaling domain amino acid sequence of SEQ ID NO: 43 as taught by Brogdon, this was a well-known choose at the time of filing and required no more than routine recombinant DNA technology. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015); See MPEP 2106.05(d).
MPEP 2143 (B) states that simple substitution of one known element for another to obtain predictable results. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Accordingly, it would have been obvious to practice the CAR comprising scFv of Waldmann and substitute the CD3[Symbol font/0x7A] signaling domain comprises the amino acid sequence as taught by Brogdon with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Brogdon because CAR that combines an antigen recognition domain of a specific antibody with an intracellular domain of CD3-zeta, CD28, 4-1BB, or any combinations mediated T-cell can target a tumor antigen for the purposes of treat cancer and that increases the efficacy of a cell expressing a CAR molecule (Col. 28 lns 21-25 of Brogdon). The POSITA would have a reasonable expectation of success in combining the teachings of Waldmann and Brogdon because each of these teachings both successfully generated CAR T-Cell Immunotherapy. Therefore, the products and method as taught by Waldmann et al. in view of Brogdon et al. would have been prima facie obvious over the products and method of the instant application. In regard to the reasonable expectation of success in doing so, substitute wherein the CD3[Symbol font/0x7A] signaling domain comprises the amino acid sequence of SEQ ID NO: 43 of Brogdon had a reasonable expectation of success since the steps thereof required no more than recombinant DNA and cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Allowable Subject Matter
Claim 36 objected to as being dependent upon a rejected base claim 27, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 36 is objected because art does not teach or reasonably suggest the SEQ ID NO: 40.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/Patent Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699