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 .
Applicant’s amendment, filed on 11/25/2025, is acknowledged.
Claim 18 is cancelled.
Claims 1-17 and 19 are currently pending.
Claim 1 is the only independent claim.
Election/Restrictions
Applicants’ election without traverse of Group I, claims 1-17, directed to an engineered immune cell with at least one MHC and one NK activating receptor binding molecule is suppressed or silenced, and the species of: i) B2M; ii) B7-H6; iii) TRAC; iv) CD52; v) CD19; vi) CD4+/CD8+ T-cell; and vii) embryonic stem cell , filed on 11/25/2025, is acknowledged.
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and/or species.
Claims 1-17 are under examination.
The engineered immune cell that has suppressed/silenced expression of the elected species of NK activating receptor binding molecule is free of the prior art. The search has been extended to cover the next unexamined species, which in the instant case is MICA.
Priority
Applicant’s claim for the benefit of a prior-filed Chinese Patent Application No. 202010679530.9, filed on July 15, 2020, and of Chinese Patent Application No. 202011534699.1, filed on December 22, 2020, is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/11/2023, 2/13/2023, 1/18/2024, and 11/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner in their entireties.
Specification
The use of the terms DynaBeads® (¶[00091]-[00093], [00097]), BTXTM AgilePulseTM MAX (¶[00093]), OPTI-MEMTM (¶[000101]), and X-tremeGENETM HP (¶[000101]), which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 16 is 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.
The recitation "derived from" in claim 16 is indefinite because it is unclear what changes or how many changes could have occurred to result in a derivative. Derivation only describes the source and not the result.
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.
Claims 1-6, 16, and 17 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Bhattacharya et al. (WO 2018175390).
Bhattacharya et al. teaches human embryonic stem cells that have been genetically modified via CRISPR/Cas9 technology to have the B2M, TAP1, CD74, and CIITA (i.e., a “MHC related gene”) genes silenced (pg. 52 and 53): “Through CRISPR/Cas9-based targeted mutations, a karyotypically normal hES cell line that lacks HLA expression was generated. One clone carrying inactivating mutations in both alleles of B2M and TAP1 and one allele of CD74 was identified through MiSeq analysis of the targeted regions…[t]his HLA-I-deficient line subsequently re-targeted using CRISPR to ablate the remaining allele of CD74 and both alleles of CIITA, a transcription factor required for expression of HLA-II.”
Bhattacharya et al. further teaches that these human embryonic stem cells were further engineered via CRISPR to delete MICA and MICB (i.e., “at least one NK activating receptor binding molecule”; Bhattacharya et al. pg. 54 and 55): “This MICA/B fusion was retargeted with CRISPR/Cas9, to generate a clone with frameshift mutations in all 4 alleles of MICA and MICB (FIG. 118). This clone was validated for normal karyotype. HLA, MICA/B deficient hES cells will henceforth be referred to as HM-KO hES.”
Bhattacharya et al. additionally teaches differentiation of human embryonic stem cells, with and without gene deletion, into monocytes (i.e., B-cells or “immune cell”; Bhattacharya et al. pg. 54-55, Fig. 10 and claims 1 and 3): “A method of differentiating human embryonic stem cells (ES cells) into a plasma cell…”
Bhattacharya et al. teaches an engineered human embryonic stem cell with suppressed/silenced expression of at least B2M and MICA, and differentiated B-cells derived from the embryonic stem cells that have at least B2M and MICA expression silenced/suppressed, meeting the limitations of instant claims 1-6 and 16.
Regarding instant claim 17, Bhattacharya et al. teaches differentiation of the genetically modified human ESCs into myeloid cells (i.e., an “engineered immune cell”) in culture medium with GM-CSF (i.e., “a pharmaceutically acceptable excipient”; Bhattacharya et al. Figure 10), meeting the limitations of the claim.
The reference teachings anticipate the instantly claimed invention.
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 (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 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.
The factual inquiries 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 1-8, 10, 11, 13-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ren et al. (Clin Cancer Res. 2017 May 1;23(9):2255-2266. doi: 10.1158/1078-0432.CCR-16-1300. Epub 2016 Nov 4) in view of Fontaine et al. (Blood 2019; 134 (Supplement_1): 3931. doi: 10.1182/blood-2019-129998), as evidenced by Schmiedel et al. (Front Immunol. 2018 Sep 11;9:2040. doi: 10.3389/fimmu.2018.02040) and Zhang et al. (Biomark Res. 2017 Jun 24;5:22. doi: 10.1186/s40364-017-0102-y).
Ren et al. teaches use of genetically modified allogenic T cells to be used in CAR-T therapy to treat cancer (Abstract). Ren et al. teaches CRISPR/Cas9 can be used to delete TCR genes such as TRAC and MHC genes such as B2M from T-cells to reduce alloreactivity in patients (pg. 7-8, “Results” section): “An initial experiment targeting the TCR α constant region (TRAC) or β constant region (TRBC) with single electroporation resulted in 7.51% and 12% CD3-negative (CD3neg) T cells, respectively…Since disrupting either TCR α or β is sufficient to ablate TCR/CD3 expression and B2M is essential for the assembly and expression of HLA-I complex…, TCR and B2M double disruption was developed to generate gene-disrupted T cells…Four of the five mice infused with non-manipulated lymphocytes developed lethal xenogeneic graft-versus-host disease (GVHD) within 2 month after the infusion. GVHD was also evidenced by elevated number of CD8 positive cell infiltrating in different organs, as well as elevated CD45 positive cell counts in the peripheral blood. (Supplementary Figure 5a,b,c), whereas none of the mice receiving TCR single or TCR/HLA-I double ablated cells (n = 5, per group) developed GVHD (Fig. 3d,e).”
Ren et al. further teaches these genetically engineered T-cells can be induced to express an anti-CD19 CAR and retains antitumor efficacy (pg. 9, “Gene-disrupted CART cells retain antitumor efficacy” section): “Gene-disrupted CD19 CART cells were generated by combing CD19 CAR lentiviral transduction with the RNA electroporation of Cas9/gRNAs…Mice treated with CART cells with a disrupted endogenous TCR (LV-CD19 CAR TCRneg) or with a simultaneous disruption of TCR and HLA-I (LV-CD19 CAR TCR/HLA-Ineg) exhibited similar survival rates to that of mice treated with wild-type CD19 CART cells (LV-CD19 CAR) (Figure 4h). The numbers of human T cells in the peripheral blood of the Nalm6-bearing mice treated with TCRneg or TCR/HLA-Ineg were comparable to mice treated with wild type CD19 CART cells (Figure 4i), suggesting that the disruption of TCR alone or together with B2M does not significantly affect CART cell engraftment, in vivo proliferation and anti-tumor activity”
Given that Ren et al. teaches that either TRAC or TRBC can be ablated to reduce TCR/CD3 expression via CRISPR/Cas9, Ren et al. teaches engineered T-cells (i.e. “immune cell”) that has silenced expression of TRAC and B2M (i.e., the limitations of instant claims 2, 3, 7, and 14), as well as anti-CD19 CAR-T cells lacking TRAC and B2M (i.e., the limitations of instant claims 10-14). Ren et al. further teaches the T-cells are CD4+/CD8+ (i.e., the limitations of instant claim 15; Ren et al. pg. 2, “Materials and Methods” section): “[p]rimary human CD4 and CD8 T cells were isolated from healthy volunteer donors”.
Ren additionally teaches mixtures (i.e., “a pharmaceutical composition”) comprising the CAR-T cells in R10 medium (i.e., “one or more pharmaceutically acceptable excipients”), which are the limitations of instant claim 17.
Ren et al. does not teach engineered T-cells that have silenced or suppressed TRAC, B2M, and a NK activating receptor such as MICA (i.e., the limitations of instant claims 1, 3-6, and 8).
Fontaine et al., in the same field of endeavor, teaches (“Background”): “NKG2D ligands are transiently expressed on activated T cells… Here, we investigated the ability of an optimized short hairpin RNA (shRNA) technology to modulate NKG2DL expression on CYAD-01 cells and to determine if there is an increase in the anti-tumor activity of NKG2D-based CAR T-cells”
Fontaine et al. further teaches incorporation of a coding segment encoding shRNA that targets both MICA and MICB into an anti-CD19 CAR vector, which increases efficiency of T-cell engraftment (“Results”): “cells generated with the Optimab process showed 10-fold higher engraftment one week after injection and potent anti-tumor activity resulting in 2.6-fold increase of mouse survival…”
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the genetically engineered CAR-T cells taught by Ren et al. in view of Fontaine et al. to add shRNA targeting MICA and MICB to suppress expression of both proteins with a reasonable expectation of success, as Fontaine et al. teaches that the shRNA can be incorporated into the vector encoding a CAR to accomplish this. One would have been motivated to make this change for the purposes of generating anti-CD19 CAR-T cells that have enhanced engraftment when transplanted into a patient in need, such as the anti-CD19 CAR-T cells taught by Ren et al.
Regarding claim 4, Schmiedel et al. is provided as an evidentiary reference to demonstrate that MICA and MICB and ligands to NKG2D (Abstract): “…MICA, MICB, and ULBP1-6. All of them are recognized by a single receptor, NKG2D…”, meeting the limitations of the claim.
Regarding claim 10, Zhang et al. is provided as an evidentiary reference to teach that chimeric antigen receptors comprise at least an antigen recognition domain (i.e., “a ligand binding domain”), a transmembrane domain, and an intracellular domain (Fig. 2, cropped below, the extracellular portion of the CARs is a scFv):
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Therefore, the anti-CD19 CAR taught by Ren et al. is considered to inherently have at least a ligand binding domain, a transmembrane domain, and an intracellular signaling domain, meeting the limitations of instant claim 10.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ren et al. (supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra) as applied to claims 1-8, 10, 11, 13-15, and 17 above, and further in view of Graham et al. (Blood (2019) 134 (Supplement_1): 3228. doi: 10.1182/blood-2019-123018).
The teachings of Ren et al. in view of Fontaine et al., as evidenced by Schmiedel et al. have been discussed supra. The combined teachings do not teach engineered immune cells that further has CD52 silenced (i.e., the limitations of instant claim 9).
Graham et al., in the same field of endeavor, teaches the CD52 gene can be genetically deleted from T-cells to make them resistant to lymphodepletion with an anti-CD52 antibody (pg. 1): “CAR T cell product expressing a second generation anti-CD19 CAR with TALEN®-mediated gene knockouts of T cell receptor alpha chain (TRAC) and CD52 to prevent graft versus host disease and to render them resistant to anti-CD52 antibody used for lymphodepletion”.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the CAR-T cell taught by Ren et al. in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., further in view of Graham et al. to delete the CD52 gene from the CAR-T cell with a reasonable expectation of success, as the references all concern engineering of CAR-T cells that one with ordinary skill would be able to apply to other CAR-T cells. One would have been motivated to make this change for the purposes of rendering the CAR-T cells of Ren et al. in view of Fontaine et al., as evidenced by Schmiedel et al. resistant to anti-CD52 antibody based lymphodepletion.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable Ren et al. (supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra) as applied to claims 1-8, 10, 11, 13-15, and 17 above, and further in view of Ghorashian et al. (Nat Med. 2019 Sept;25:1408-1414 doi: 10.1038/s41591-019-0549-5).
The teachings of Ren et al. in view of Fontaine et al., as evidenced by Schmiedel et al. have been discussed supra. The combined teachings do not teach a specific anti-CD19 CAR structure that comprises an antigen recognition domain, a TM domain, an intracellular signaling domain, and a co-stimulatory domain (i.e., the limitations of instant claim 12).
Ghorashian et al., in the same field of endeavor, teaches an anti-CD19 CAR that is improved over previous anti-CD19 CARs in that it caused increased proliferation an in vivo antitumor activity against ALL compared to other CARs, and the reason for this was the use of a low-affinity anti-CD19 scFv (Abstract). Ghorashian et al. further teaches the anti-CD19 CAR contains a CAT scFv, a CD8 TM domain, a 4-1BB co-stimulatory domain, and a CD3ζ intracellular domain (i.e., the limitations of instant claim 12; Ghorashian et al. Introduction): “We compared the function of T cells that were lentivirally transduced with either FMC63 or CAT in identical second-generation CAR formats. These cells had a CD8-derived stalk/transmembrane region, a 4-1BB co-stimulatory domain and a CD3ζ chain”.
Ghorashian et al. further teaches that T-cells expressing the anti-CD19 CAR with the low-affinity CAT scFv clone had a significant reduction in tumor burden when compared with an anti-CD19 CAR comprising the high-affinity FMC63 scFv in a mouse Nalm6 ALL xenograft model (Fig. 2B, cropped below):
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Ghorashian et al. teaches (Discussion): “…we report on a new, low-affinity CD19 CAR incorporating a CD19-specific scFv with a faster off-rate than the FMC63 CD19 binder used in many clinical studies. T cells expressing our low-affinity CAT CAR showed greater cytotoxic and proliferative responses in vitro. These data were supported by enhanced CAR T cell proliferation and antileukemic activity with our low-affinity CAT CAR in a xenogeneic model of ALL”.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the anti-CD19 CAR taught by Ren et al. in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al. further in view of Ghorashian et al. to try and use the CAT anti-CD19 CAR in place of the anti-CD19 CAR taught by Ren et al. with a reasonable expectation of success, as the references all concern CARs and CAR-T therapy that one with ordinary skill in the art would be able to apply to other CARs and CAR-T cells. One would have been motivated to make this change for the purposes of using an anti-CD19 CAR with increased potency to treat ALL in patients.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ren et al. (supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra) as applied to claims 1-8, 10, 11, 13-15, and 17 above, and further in view of Lee (Int J Mol Sci. 2019 Apr 12;20(8):1825. doi: 10.3390/ijms20081825).
The teachings of Ren et al. in view of Fontaine et al., as evidenced by Schmiedel et al. have been discussed supra. The combined teachings do not teach engineered immune cells that are derived from embryonic stem cells (i.e., the limitations of instant claim 16).
Lee, in the same field of endeavor, teaches (Abstract): “Pluripotent stem cell-derived immune cells such as natural killer cells, macrophages, and lymphoid cells, especially T cells, can be used in immune cell therapy to treat incurable cancers. Moreover, since the advent of chimeric antigen receptor (CAR) technology, the success of CAR-T cells in the clinic has galvanized new efforts to harness the power of CAR technology to generate CAR-engineered immune cells from pluripotent stem cells”.
Lee further teaches that primary immune cells (i.e., fully differentiated immune cells such as T-cells) have disadvantages over stem cells (Introduction): “primary immune cells are refractory to gene editing procedures and such cells have limited proliferation activity, which hinders clonal selection. Therefore, with their capacity for indefinite proliferation and their pluripotent character, human pluripotent stem cells could be a perfect alternative for generating an unlimited number of improved immune cells through gene modification and clonal selection”.
Lee teaches there are at least three different protocols to generate T-cells from pluripotent stem cells (i.e., embryonic stem cells), including the use of the OP9 cell line genetically modified to express DLL-1 or DLL-4, or using an organoid culture (section 2.2 and Figure 1): “Using the OP9-DL1 cell line, human pluripotent stem cells were differentiated into T cells… The protocol generated functionally mature CD4+ and CD8+ TCR αβ T cells. Recently, T cell differentiation using DLL-4 instead of Dll-1 was reported. Montel-Hagen et al., showed conventional T cell differentiation from human pluripotent stem cells using organoid”.
Lee further teaches that there are efforts to generate CAR-T cells from human embryonic stem cells, and induced pluripotent stem cells have been successfully differentiated into CAR-T cells (section 4, final ¶): “Human iPS-derived CAR-NK cells showed in vivo cytotoxic activity toward tumor cells comparable to CAR-T cells, but with less overall toxicity…These results indicate that CAR-NK cells derived from human pluripotent stem cells could be a valuable method for generating “off-the-shelf” allogeneic therapeutics”.
Lee provides motivation for one with ordinary skill in the art to make CAR-T cells from embryonic stem cells (Conclusion): “A recent paper showed that TALEN-mediated genetic
ablation of the gene encoding GM-CSF in CAR-T cells can prevent CRS…These results could be applied to human pluripotent stem cells to generate cells that were less prone to causing CRS using CRISPR/Cas9, after which the engineered cells could be clonally selected and differentiated into CAR-T cells. Therefore, through the deployment of CRISPR/Cas9 technology and fourth generation CARs, human pluripotent stem cells could enhance next generation immune cell therapy in terms of safety, cost, and activity… The resulting next generation
immune cell therapy may solve limitations of current therapies by achieving improvements such as off-the-shelf availability, increased potency, increased cost-effectiveness, and increased precision of anti-tumor activity”. Furthermore, Lee provides an example of a method of generating such CAR-T-cells (Figure 3):
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It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the CAR-T cell taught by Ren et al. in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., further in view Lee to derive the T-cells from embryonic stem cells with a reasonable expectation of success, as Lee provides an example of such an experiment, and teaches multiple methods of differentiating T-cells from human embryonic stem cells. One would have been motivated to make this change for the purposes of generating CAR-T cells with off-the-shelf capability, increased potency, increased cost-effectiveness, and increased anti-tumor precision, as taught by Lee.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 10, 11, 13-14, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,203,758 (herein Pat ‘758) in view of Ren et al. (Clin Cancer Res. 2017 May 1;23(9):2255-2266. doi: 10.1158/1078-0432.CCR-16-1300. Epub 2016 Nov 4, supra) and Fontaine et al. (Blood 2019; 134 (Supplement_1): 3931. doi: 10.1182/blood-2019-129998, supra), as evidenced by Schmiedel et al. (Front Immunol. 2018 Sep 11;9:2040. doi: 10.3389/fimmu.2018.02040, supra) and Zhang et al. (Biomark Res. 2017 Jun 24;5:22. doi: 10.1186/s40364-017-0102-y, supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘758 claims methods of generating genetically modified T-cells (i.e., “engineered immune cell”) comprising a CRISPR system that causes downregulated TCR α chain expression with the nucleic acid sequence of SEQ ID NO: 1 (claim 1). Col. 55, lines 38-42 of Pat ‘758 demonstrates the identity of the structure of SEQ ID NO: 1, which is guide RNA specifically targeting the TRAC gene (i.e., the elected species of TCR gene in instant claim 7). Pat ‘758 further claims modified T-cells expressing a chimeric membrane protein comprising a chimeric antigen receptor with an antigen binding domain, a CD28 intracellular domain, and a 4-1BB co-stimulatory domain (claims 6 and 8), which are the limitations of instant claims 10-12. One with ordinary skill in the art would appreciate that the method of generating the modified T-cell will lead to the T-cell product itself.
Pat ‘758 does not claim T-cells with reduced expression of B2M and MICA (i.e., the limitations of instant claims 1-6), or cells expressing an anti-CD19 chimeric antigen receptor (i.e., the limitations of instant claim 13).
Ren et al., in the same field of endeavor, teaches use of genetically modified allogenic T cells to be used in CAR-T therapy to treat cancer (Abstract). Ren et al. teaches CRISPR/Cas9 can be used to delete TCR genes such as TRAC and MHC genes such as B2M from T-cells to reduce alloreactivity in patients (pg. 7-8, “Results” section).
Ren et al. further teaches these genetically engineered T-cells can be induced to express an anti-CD19 CAR and retains antitumor efficacy (pg. 9, “Gene-disrupted CART cells retain antitumor efficacy” section). Ren et al. teaches that the anti-CD19 CAR-T cells can effectively delay Nalm6 (which are acute lymphoblastic leukemia) tumor progression in a mouse xenograft model (last ¶ of pg. 7, Fig. 2, cropped below):
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Given that Ren et al. teaches that either TRAC or TRBC can be ablated to reduce TCR/CD3 expression via CRISPR/Cas9, Ren et al. teaches engineered T-cells (i.e. “immune cell”) that has silenced expression of TRAC and B2M (i.e., the limitations of instant claims 2, 3, 7, and 14), as well as anti-CD19 CAR-T cells lacking TRAC and B2M (i.e., the limitations of instant claims 13 and 14). Ren et al. further teaches the T-cells are CD4+/CD8+ (i.e., the limitations of instant claim 15; Ren et al. pg. 2, “Materials and Methods” section).
Ren additionally teaches mixtures (i.e., “a pharmaceutical composition”) comprising the CAR-T cells in R10 medium (i.e., “one or more pharmaceutically acceptable excipients”), which are the limitations of instant claim 17.
Pat ‘758 does not claim and Ren et al. does not teach engineered T-cells that have silenced or suppressed TRAC, B2M, and a NK activating receptor such as MICA (i.e., the limitations of instant claims 1, 3-6, and 8).
Fontaine et al., in the same field of endeavor, teaches (“Background”): “NKG2D ligands are transiently expressed on activated T cells… Here, we investigated the ability of an optimized short hairpin RNA (shRNA) technology to modulate NKG2DL expression on CYAD-01 cells and to determine if there is an increase in the anti-tumor activity of NKG2D-based CAR T-cells”
Fontaine et al. further teaches incorporation of a coding segment encoding shRNA that targets both MICA and MICB into an anti-CD19 CAR vector, which increases efficiency of T-cell engraftment (“Results”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the genetically engineered T-cells expressing a CAR claimed by Pat ‘758 in view of Ren et al. and Fontaine et al. to genetically delete B2M and TRAC using CRISPR technology and have the cells express an anti-CD19 CAR (taught by Ren et al.) and shRNA targeting MICA and MICB to suppress expression of both proteins (taught by Fontaine et al.) with a reasonable expectation of success, as Ren et al. teaches methods of gene deletion via CRISPR and methods of expressing an anti-CD19 CAR, and Fontaine et al. teaches that the shRNA can be incorporated into the vector encoding a CAR to accomplish this.
One would have been motivated to make this change for the purposes of generating anti-CD19 CAR-T cells that have less graft-vs-host disease via deletion of TRAC and B2M, and reduced killing by NK cells via having the cells express shRNA against MICA and MICB, all to enhance engraftment when transplanted into a patient in need. Additionally, one would have been motivated to have the modified T-cells express an anti-CD19 CAR for the purposes of treating acute lymphoblastic leukemia, as taught by Ren et al.
Regarding claim 4, Schmiedel et al. is provided as an evidentiary reference to demonstrate that MICA and MICB and ligands to NKG2D (Abstract): “…MICA, MICB, and ULBP1-6. All of them are recognized by a single receptor, NKG2D…”, meeting the limitations of the claim.
Regarding claim 10, Zhang et al. is provided as an evidentiary reference to teach that chimeric antigen receptors comprise at least an antigen recognition domain (i.e., “a ligand binding domain”), a transmembrane domain, and an intracellular domain (Fig. 2). Therefore, the CAR claimed by Pat ‘758 is considered to have the elements listed above as well as a TM domain, meeting the limitations of instant claims 10 and 11.
Therefore, the instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘758 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., especially in absence of evidence to the contrary.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,203,758 (Pat ‘758, supra) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10, 11, 13-14, and 17 above, and further in view of Graham et al. (Blood (2019) 134 (Supplement_1): 3228. doi: 10.1182/blood-2019-123018, supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘758 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,203,758 in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra) as applied to claims 1-8, 10, 11, 13-14, and 17 above, and further in view of Ghorashian et al. (Nat Med. 2019 Sept;25:1408-1414 doi: 10.1038/s41591-019-0549-5, supra).
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘758 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,203,758 (Pat ‘758, supra) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10, 11, 13-14, and 17 above, and further in view of Lee (Int J Mol Sci. 2019 Apr 12;20(8):1825. doi: 10.3390/ijms20081825, supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘758 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 1-8, 10, 11, 13-14, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,029,760 (herein Pat ‘760) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘760 claims methods of editing a cell comprising administration of CRISPR and guide RNA (claim 1), wherein the cell is a T-cell of primary T-cell (claims 2 and 3), and wherein the gene editing comprising mutating TRAC and B2M (claim 12). One with ordinary skill in the art would appreciate that this method, if done for both TRAC and B2M, would lead to edited T-cells (i.e., “engineered immune cell”) without the TRAC and B2M genes (i.e., “suppressed or silenced”).
The invention encompassed by the instant application was a prima facie obvious variant of the invention claimed by Pat ‘760 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al. for the same reasons discussed for Pat ‘758 supra.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,029,760 (herein Pat ‘760) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10, 11, 13-14, and 17 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘758 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,029,760 (herein Pat ‘760) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10, 11, 13-14, and 17 above, and further in view of Ghorashian et al. (supra).
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘758 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,029,760 (herein Pat ‘760) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10, 11, 13-14, and 17 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘758 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 1-8, 10-15, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,896,620 (herein Pat ‘620) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘620 claims engineered immune cells comprising a chimeric antigen receptor (claims 1 and 2), wherein the CAR contains a ligand binding domain, a TM domain, a co-stimulatory domain, and an intracellular signaling domain (claim 3), meeting the limitations of instant claims 10-12. Pat ‘620 additionally claims the CAR binds to CD19 (claim 10), and the immune cell is a CD4+/CD8+ T-cell (claim 8), meeting the limitations of instant claims 13 and 14-15, respectively.
The instant invention encompassed by the claims are a prima facie obvious variant of the invention claimed by Pat ‘620 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed for Pat ‘758 supra.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,896,620 (Pat ‘620, supra) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10-15, and 17 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘620 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,896,620 (Pat ‘620, supra) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10-15, and 17 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘620 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 1-8, 10-14, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,344,843 (herein Pat ‘843) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘843 claims CAR-T cells genetically modified by CRISPR/Cas9 to have downregulated gene regulation (i.e., “suppressed or silenced”) of the TRAC gene and the B2M gene (claim 1), as well as anti-CD19 CAR-T cells (claim 4), and pharmaceutical compositions comprising the modified CAR-T cell and an acceptable carrier (i.e., “an acceptable excipient”; Pat ‘843 claim 7). Pat ‘843 further claims the CAR comprises a hinge domain, a TM domain (claim 5), a co-stimulatory domain, and an intracellular domain (claim 6), meeting the limitations of instant claims 10-12.
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘843 in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al. for the same reasons discussed in the U.S.C. 103 rejection supra.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,344,843 (Pat ‘843, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10-14, and 17 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘843 in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,344,843 (Pat ‘843, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10-14, and 17 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘843 in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 1-8, 10, 11, 14, 15, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,208,661 (herein Pat ‘661) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘661 claims CRISPR modified T-cells (i.e., “engineered immune cell”) comprising a CRISPR-mediated deletion of TRAC and a TCR (claim 1). Pat ‘661 additionally claims pharmaceutical compositions comprising the modified T-cells and an acceptable carrier (i.e., “an acceptable excipient”; Pat ‘661 claim 11). Pat ‘661 additionally claims cells comprising TCRs comprising two co-stimulatory domains (i.e., “an intracellular signaling domain” and “a co-stimulatory domain”) wherein one of the domains is 4-1BB (claims 5 and 6), meeting the limitations of instant claims 10 and 11.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘661 in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,208,661 (Pat ‘661, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10, 11, 14, 15, and 17 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘661 in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,208,661 (Pat ‘661, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra) and Zhang et al. (supra), as applied to claims 1-8, 10, 11, 14, 15, and 17 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘661 in view of Fontaine et al., as evidenced by Schmiedel et al. and Zhang et al., and further in view of Lee et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 1-8, 10-15, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 16, 20-26, 28, 30, and 32-34 of copending Application No. 17/910007 (herein App ‘007) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘007 claims engineered immune cells comprising a NK inhibitory molecule and having the expression of at least one MHC related gene suppressed or silenced (claim 20). App ‘007 claims the immune cells can be CD4+/CD8+ T-cells (claims 32 and 33), meeting the limitations of instant claims 14 and 15. App ‘007 claims the engineered immune cell further comprising a CAR comprising a ligand binding domain, a TM domain, an intracellular signaling domain, and a co-stimulatory domain (claim 22), and the ligand binding domain specifically binds CD19 (claim 30) meeting the limitations of instant claims 10-13. App ‘007 additionally claims engineered immune cells having the expression of B2M (claim 23) and TRAC (claim 28) silenced. App ‘007 further claims pharmaceutical compositions comprising the invention and a pharmaceutically acceptable excipient (claim 34), meeting the limitations of instant claim 17.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by Pat ‘007 in view of Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 16, 20-26, 28, 30, and 32-34 of copending Application No. 17/910007 (App ‘007, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-15, and 17, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘007 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 16, 20-26, 28, 30, and 32-34 of copending Application No. 17/910007 (App ‘007, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-15, and 17, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘007 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10-14, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/034177 (herein App ‘177) in view of Ren et al. (supra), Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘177 claims engineered immune cells comprising a chimeric antigen receptor, and has suppressed or silenced expression of CD7, at least one TCR/CD3 gene, and a MHC-II related gene (i.e., “a MHC related gene”; App ‘177 claim 1). App’ 177 further claims the CAR comprising an anti-CD19 antibody (claim 4), a TM domain (claim 6), an intracellular signaling domain (claim 7), and a co-stimulatory domain (claim 8), meeting the limitations of instant claims 10-13. App ‘177 claims that the TCR gene can be TRAC (claim 9), meeting the limitations of instant claim 7. App ‘177 further claims the immune cell is a T cell (claim 16), and pharmaceutical composition comprising the cell and an acceptable excipient (claim 17), meeting the limitations of instant claims 11 and 17, respectively.
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘177 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed for Pat ‘758 supra.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/034177 (App ‘177, supra) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-14, and 17 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘177 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/034177 (App ‘177, supra) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-14, and 17 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘177 in view of ren et al. and Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10-14, 16, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12, 13, and 15-20 of copending Application No. 18/025558 (herein App ‘558) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘558 claims chimeric antigen receptors comprising a ligand binding domain, a TM domain, a intracellular signaling domain, and a co-stimulatory domain (claim 1), the ligand binding domain binds to CD19 (claim 7), as well as engineered immune cells comprising the CAR (claim 12), meeting the limitations of instant claims 10-13. App ‘558 further claims the immune cell having silenced TRAC expression and silenced B2M (claim 15), meeting the limitations of instant claims 2, 3, and 7, as well as the engineered stem cells as T-cells (claim 16) that are derived from embryonic stem cells (claim 17), meeting the limitations of instant claims 14 and 16. App ‘558 additionally claims pharmaceutical compositions comprising the engineered cell and an acceptable excipient (claim 20), meeting the limitations of instant claim 17.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘558 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12, 13, and 15-20 of copending Application No. 18/025558 (App ‘558, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-14, 16, and 17 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘558 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10-12, 14, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, 9-16, and 18-24 of copending Application No. 18/254037 (herein App ‘037) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘037 claims engineered immune cells comprising an anti-NKG2A CAR (claims 1, 11, and 16), and further claims the engineered immune cell has suppressed or silenced expression of B2M (claim 16) and TRAC (claim 18), meeting the limitations of instant claims 2-3 and 7, respectively. App ‘037 additionally claims that the CAR further comprising a TM (claim 11), an intracellular signaling domain (claim 14), and a co-stimulatory domain (claim 13), meeting the limitations of instant claims 10-12. App ‘037 further teaches pharmaceutical compositions comprising the engineered cell and an acceptable excipient (claim 23), and the immune cell is a T-cell (claim 20), meeting the limitations of instant claims 17 and 14, respectively.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘037 in view of Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, 9-16, and 18-24 of copending Application No. 18/254037 (App ‘037, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-12, 14, and 17 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘037 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, 9-16, and 18-24 of copending Application No. 18/254037 (App ‘037, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-12, 14, and 17 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘037 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10-12, 14, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, 10-14, 17-21, and 23-25 of copending Application No. 18/260905 (herein App ‘905) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘905 claims engineered immune cells comprising an anti-ROR1 CAR (claims 1 and 12), and further claims the engineered cell has suppressed or silenced expression of B2M and TRAC (claim 20), meeting the limitations of instant claims 2-3 and 7, respectively. App ‘905 additionally claims the CAR further comprising a TM domain (claims 13 and 14), an intracellular domain (claim 14), and a co-stimulatory domain (claim 14), meeting the limitations of instant claims 10-12. App ‘905 further claims the immune cell is a T-cell (claim 8) and pharmaceutical compositions comprising the engineered immune cell and an acceptable excipient (claim 24), meeting the limitations of instant claims 14 and 17, respectively.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘905 in view of Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, 10-14, 17-21, and 23-25 of copending Application No. 18/260905 (App ‘905, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-12, 14, and 17 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘905 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, 10-14, 17-21, and 23-25 of copending Application No. 18/260905 (App ‘905, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-12, 14, and 17 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘905 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10, 11, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-40, 48-57, and 60-63 of copending Application No. 17/456436 (herein App ‘436) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘436 claims pharmaceutical compositions comprising a CRISPR-modified T-cell with downregulated expression of the TRAC and B2M genes (claim 36), as well as the cell comprising a TCR (i.e., the limitations of instant claims 10 and 11; App ‘436 claims 36 and 46) that bind to tumor cell associated antigens (claim 55).
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘436 in view of Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional double patenting rejection.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-40, 48-57, and 60-63 of copending Application No. 17/456436 (App ‘436, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10, 11, and 14 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘436 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-40, 48-57, and 60-63 of copending Application No. 17/456436 (App ‘436, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10, 11, and 14 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘436 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10, 11, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41, 43, and 48-59 of copending Application No. 17/550455 (herein App ‘455) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘455 claims pharmaceutical compositions comprising a CRISPR-modified T-cell with downregulated expression of the TRAC and B2M genes, as well as comprising a TCR (i.e., the limitations of instant claims 10 and 11; App ‘455 claims 41 and 60) that bind to tumor cell associated antigens (claim 41).
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘455 in view of Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional double patenting rejection.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41, 43, and 48-59 of copending Application No. 17/550455 (App ‘455, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10, 11, and 14 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘436 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41, 43, and 48-59 of copending Application No. 17/550455 (App ‘455, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10, 11, and 14 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims were a prima facie variant of the invention claimed by App ‘455 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10-14, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-12, 15, 18-20, 23-26, and 29-31 of copending Application No. 18/263439 (herein App ‘439) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘439 claims CARs comprising a ligand binding domain that specifically targets CD7, a TM domain, an intracellular signaling domain, and a co-stimulatory domain (claims 1 and 2), as well as CARs that further comprise another antigen binding region that specifically binds to CD19 (claim 9 and 10), meeting the limitations of instant claims 10-13. App ‘439 additionally claims engineered immune cells comprising the CAR (claim 15), wherein the immune cell has suppressed or silenced expression of TRAC (claim 19), meeting the limitations of instant claims 7. App ‘439 additionally claims pharmaceutical compositions comprising the engineered immune cell and an acceptable excipient (claim 29), meeting the limitations of instant claim 17.
The invention encompassed by the instant application was a prima facie obvious variant of the invention claimed by App ‘439 in view of Ren et al. and Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed for Pat ‘758 supra. This is a provisional nonstatutory double patenting rejection.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-12, 15, 18-20, 23-26, and 29-31 of copending Application No. 18/263439 (herein App ‘439) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-14, and 17, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘439 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-12, 15, 18-20, 23-26, and 29-31 of copending Application No. 18/263439 (herein App ‘439) in view of Ren et al. (supra) and Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8, 10-14, and 17 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims were a prima facie variant of the invention claimed by App ‘455 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claims 1-8 and 10-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-17 of copending Application No. 18/861006 (herein App ‘006) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘006 claims methods of knocking out the CIITA gene in an immune cell (claims 4 and 6), including T-cells and CD4+/CD8+ T-cells (claims 6 and 7, respectively), wherein the immune cell also expressed a chimeric antigen receptor (claim 8), meeting the limitations of instant claims 14 and 15. One with ordinary skill in the art would appreciate that if a T-cell has an introduced CAR and genetic deletion of one or more genes, it is an “engineered” T-cell. Additionally, App ‘006 claims an engineered immune cell (claim 15).
App ‘006 further claims the CAR comprises a ligand binding domain that specifically targets CD19, a TM domain, a co-stimulatory domain, and a primary signaling domain (i.e., “an intracellular signaling domain”; App ‘006 claims 9-11), meeting the limitations of instant claims 10-13. App ‘006 claims the engineered immune cell also has suppressed or silenced expression of TRAC and B2M (claim 16), meeting the limitations of instant claims 2, 3, and 7.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘006 in view of Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-17 of copending Application No. 18/861006 (App ‘006, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8 and 10-15 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘006 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-17 of copending Application No. 18/861006 (App ‘006, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8 and 10-15 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims were a prima facie variant of the invention claimed by App ‘006 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 17 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-17 of copending Application No. 18/861006 (App ‘006, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8 and 10-15 above, and further in view of An et al. (Oncotarget. 2016 Mar 1;7(9):10638-49. doi: 10.18632/oncotarget.7079). Although the claims at issue are not identical, they are not patentably distinct from each other.
The invention encompassed by App ‘006 in view of Fontaine et al., as evidenced by Schmiedel et al. has been discussed supra. The combined references do not teach a pharmaceutical composition comprising the engineered CAR-T cell.
An et al., in the same field of endeavor, teaches anti-CD19 CAR-T cells can be formulated into compositions comprising the CAR-T cell and RPMI 1640 culture medium (i.e., “a pharmaceutical composition” comprising the CAR-T cell and “an acceptable excipient”; An et al. “T cells isolation and transduction” section): “T cells maintained in RPMI 1640… An et al. additionally teaches treatment of subjects with B-ALL comprising administration of pharmaceutical compositions of the CAR-T cells (“Establishment of murine B-ALL model and in vivo treatment with CAR-T cells” section).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the invention claimed by App ‘006 in view of Fontaine et al, as evidenced by Schmiedel et al., further in view of An et al. to make pharmaceutical compositions comprising the genetically engineered CAR-T cell and an acceptable excipient such as culture medium with a reasonable expectation of success, as An et al. teaches such a composition. One would have been motivated to make this change to formulate the CAR-T cells into pharmaceutical compositions to treat ALL, as taught by An et al.
The instant invention encompassed by the claims were a prima facie variant of the invention claimed by App ‘006 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of An et al. This is a provisional nonstatutory double patenting rejection.
Claims 1-8 and 10-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-17 of copending Application No. 18/861000 (herein App ‘000) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘000 claims methods of knocking out the CD7 gene in an immune cell (claims 4 and 6), including T-cells and CD4+/CD8+ T-cells (claims 6 and 7, respectively), wherein the immune cell also expressed a chimeric antigen receptor (claim 8), meeting the limitations of instant claims 14, and 15. One with ordinary skill in the art would appreciate that if a T-cell has an introduced CAR and genetic deletion of one or more genes, it is an “engineered” T-cell. Additionally, App ‘000 claims an engineered immune cell (claim 15).
App ‘000 further claims the CAR comprises a ligand binding domain that specifically targets CD19, a TM domain, a co-stimulatory domain, and a primary signaling domain (i.e., “an intracellular signaling domain”; App ‘000 claim 9), meeting the limitations of instant claims 10-13. App ‘000 claims the engineered immune cell also has suppressed or silenced expression of TRAC and B2M (claim 16), meeting the limitations of instant claims 2, 3, and 7.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘000 in view of Fontaine et al., as evidenced by Schmiedel et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-17 of copending Application No. 18/861000 (App ‘000, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8 and 10-15 above, and further in view of Graham et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims are a prima facie variant of the invention claimed by App ‘000 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Graham et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-17 of copending Application No. 18/861000 (App ‘000, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8 and 10-15 above, and further in view of Lee (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims were a prima facie variant of the invention claimed by App ‘000 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of Lee for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. This is a provisional nonstatutory double patenting rejection.
Claim 17 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-17 of copending Application No. 18/861000 (App ‘000, supra) in view of Fontaine et al. (supra), as evidenced by Schmiedel et al. (supra), as applied to claims 1-8 and 10-15 above, and further in view of An et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant invention encompassed by the claims were a prima facie variant of the invention claimed by App ‘000 in view of Fontaine et al., as evidenced by Schmiedel et al., and further in view of An et al. the same reasons discussed for App ‘006 supra. This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641