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 .
Priority
The instant application is continuation of US Application No. 17/291853 (now US Patent No. 12,161,704 B2), filed 06 May 2021, which is a national stage entry under 35 USC 371 of PCT/US2019/060593, filed 08 November 2019. Acknowledgment is made of Applicant’s claim for benefit under 35 USC 119(e) to US Provisional Application No. 62/757313, filed 08 November 2018.
Status of the Claims
Claims 1-18, of record 06 December 2024, are pending. Therefore, prosecution on the merits continues for claims 1-18.
Drawings
Acknowledgment is made of Applicant’s granted petition under 37 CFR 1.84(a)(2), filed 29 January 2025, for the colored drawings filed 06 December 2024.
Claim Objections
Claims 4 and 14 are objected to because of the following informalities:
Regarding claim 4: The instant claim is objected to for reciting “intracellular domain” instead of “intracellular signaling domain”, as is recited in parent claim 1.
Appropriate correction is required.
Regarding claim 14: The instant claim is objected to for reciting “an effective amount of an immunoresponsive cell of claim 1” instead of “an effective amount of [[an]]the immunoresponsive cell of claim 1”.
Appropriate correction is required.
Claim Interpretation
Instant claim 1 is directed to an immunoresponsive cell comprising a chimeric antigen receptor (CAR) that binds to glutamic acid decarboxylase 65 kDA (GAD65). The instant claim requires the CAR to comprise an extracellular polypeptide which is a GAD65 monoclonal antibody (MAb) antigen binding domain and which recognizes at least a part of an amino acid sequence selected from the amino acids having SEQ ID Nos: 1-6; or, at least one complete amino acid sequence selected from the amino acids having SEQ ID Nos: 1-6 (emphasis added).
With that, dependent claims 8-13 require the extracellular polypeptide to recognize an amino acid sequence having SEQ ID Nos: 1-6, respectively (emphasis added). Therefore, the broadest reasonable interpretation of these limitations in claims 8-13 encompasses the full-length amino acid sequences of SEQ ID NOs: 1-6, or any consecutive amino acid portion of SEQ ID NOs: 1-6.
Claim Rejections - 35 USC § 112
Claims 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 17-18: Independent claim 17 recites the limitation "the subject" in Lines 2-3.
There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of “a subject” within the independent claim. See MPEP § 2173.05(e).
Instant claim 18 depends from independent claim 17 and fails to correct the deficiencies of the parent claim, thus rendering the scope of the instant claim indefinite as well.
Appropriate correction is required.
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 1-2, 4-7, 9, and 12-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Reiter et al (US 2019/0031759 A1, of record on IDS filed 06 January 2025). Reiter et al has an effective filing date of 30 April 2015.
Reiter et al disclose chimeric antigen receptors (CARs), cells transduced with the CARs, and methods of using the transduced cells for treating autoimmune diseases (Abstract; Paragraph [0001]).
As such, Reiter et al disclose that the CARs comprise an extracellular antigen-binding domain comprising an antigen binding domain, a transmembrane domain, and an intracellular signaling domain (Paragraphs [0011], [0027], [0074]-[0084], [0238]-[0241]). Reiter et al further disclose that the intracellular signaling domain is derived from the intracellular domain of CD3ζ with the co-stimulatory signaling domain of CD28 (Paragraphs [0039], [0225]-[0235], [0237]). Reiter et al further disclose that the transmembrane domain is a CD28 transmembrane domain (Paragraphs [0238]-[0239]). Reiter et al further disclose that the CAR further comprises a spacer domain between the extracellular antigen-binding domain and the transmembrane domain, or the transmembrane domain and intracellular signaling domain, wherein the spacer is comprised of glycine and serine (Paragraphs [0238], [0241]).
Reiter et al further disclose that, in the particular embodiment wherein the autoimmune disease is type 1 diabetes, the antigen binding domain is specific for a glutamic acid decarboxylase-65 (GAD65) monoclonal antibody, as detailed in SEQ ID NO: 4 (Paragraphs [0027], [0032], [0180], [0185]-[0188]; Table 3). It is of note that SEQ ID NO: 4 of Reiter et al has 39.5% identity to instant SEQ ID NO: 6, as well as a consecutive amino acid portion with instant SEQ ID NOs: 2 and 5. See sequence alignments at end of Office action.
Reiter et al further disclose that the transduced cells are regulatory T cells (Tregs) (Paragraphs [0042], [0085], [0279]-[0281], [0289]).
Reiter et al further disclose that the GAD65 CAR Tregs are comprised within a pharmaceutical composition with a pharmaceutically acceptable carrier (Paragraphs [0015], [0313]-[0337]).
Reiter et al further disclose that the GAD65 CAR Tregs are administered in a therapeutically effective amount to a subject suffering from type 1 diabetes, such that the subject is treated or has a prolonged survival (Paragraphs [0032], [0174], [0180], [0182]-[0189], [0313], [0331], [0351]-[0352], [0365]). Reiter et al further disclose that the subject is a human (Paragraphs [0353], [0366]-[0368]).
Accordingly, Reiter et al anticipate the claims as follows:
Regarding claims 1 and 13: Reiter et al disclose a Treg comprising an anti-GAD65 CAR, wherein the CAR comprises an extracellular antigen-binding domain that recognizes SEQ ID NO: 4 of Reiter et al, a transmembrane domain, and an intracellular signaling domain. As SEQ ID NO: 4 of Reiter et al has 39.5% identity to instant SEQ ID NO: 6 – and therefore recognizes at least a part of instant SEQ ID NO: 6 (claim 13) – this therefore reads on the immunoresponsive cell of instant claim 1. See sequence alignment at end of Office action and Claim Interpretation section above.
Regarding claims 2: Following the discussion of claim 1, Reiter et al further disclose that the intracellular signaling domain is derived from the intracellular domain of CD3ζ. This therefore reads on the immunoresponsive cell of the instant claim.
Regarding claims 4-5: Following the discussion of claim 1, Reiter et al further disclose that the CAR further comprises a spacer domain between the extracellular antigen-binding domain and the transmembrane domain, or the transmembrane domain and intracellular signaling domain, wherein the spacer is comprised of glycine and serine (claim 5). This therefore reads on the immunoresponsive cell of instant claim 4.
Regarding claims 6-7: Following the discussion of claim 1, Reiter et al further disclose that the anti-GAD65 CAR Treg specifically binds an autoantigen expressed on pancreatic islets associated with type 1 diabetes, which is an organ-specific autoimmune disease (claim 7) (Paragraph [0180]). As the anti-GAD65 CAR Treg specifically binds an autoantigen expressed on pancreatic islets, the immune response will inherently be enhanced. See MPEP § 2112. This therefore reads on the immunoresponsive cell of instant claim 6.
Regarding claim 9: As aforementioned in the discussion of claim 1, Reiter et al disclose an extracellular antigen-binding domain of a CAR that recognizes SEQ ID NO: 4. As SEQ ID NO: 4 of Reiter et al has two consecutive amino acids with instant SEQ ID NO: 2, this therefore reads on the immunoresponsive cell of the instant claim. See sequence alignment at end of Office action and Claim Interpretation section above.
Regarding claim 12: As aforementioned in the discussion of claim 1, Reiter et al disclose an extracellular antigen-binding domain of a CAR that recognizes SEQ ID NO: 4. As SEQ ID NO: 4 of Reiter et al has two consecutive amino acids with instant SEQ ID NO: 5, this therefore reads on the immunoresponsive cell of the instant claim. See sequence alignment at end of Office action and Claim Interpretation section above.
Regarding claim 14: Following the discussion of claim 1, Reiter et al further disclose that the GAD65 CAR Tregs are comprised within a pharmaceutical composition with a pharmaceutically acceptable carrier. This therefore reads on the pharmaceutical composition of the instant claim.
Regarding claims 15 and 17: Following the discussion of claim 1, Reiter et al further disclose that the GAD65 CAR Tregs are administered in a therapeutically effective amount to a subject suffering from type 1 diabetes, such that the subject is treated (claim 17) or has a prolonged survival (claim 15). This therefore reads on the methods of the instant claims.
Regarding claims 16 and 18: Following the discussion of claims 15 and 17, Reiter et al further disclose that the subject is a human. This therefore reads on the methods of the instant claims.
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 1-2 and 4-18 are rejected under 35 U.S.C. 103 as being unpatentable over Reiter et al (US 2019/0031759 A1, of record on IDS filed 06 January 2025).
The discussion of Reiter et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Reiter et al anticipate claims 1-2, 4-7, 9, and 12-18.
Regarding claims 8 and 10-11: As aforementioned in the discussion of claim 1 above, Reiter et al disclose in an embodiment of the invention wherein the anti-GAD65 CAR comprises an extracellular antigen-binding domain that recognizes SEQ ID NO: 4, which is the diabetes-associated autoantigenic peptide GAD555-567.
Reiter et al further disclose that in other embodiments of the invention, the diabetes-associated autoantigenic peptide is a GAD65-derived peptide, such as those detailed within Table 3 of the disclosure or a variant thereof, so long as anchor amino acids are present (Paragraphs [0185]-[0189], [0210]-[0215]; Table 3).
Reiter et al does not explicitly disclose the GAD65 peptide epitopes are those as detailed in instant SEQ ID NOs: 1 or 3-4, as required by instant claims 8 and 10-11.
Reiter et al do, however, disclose the entire pancreatic GAD65 peptide sequence in SEQ ID NO: 38 (Paragraph [0186]). It is of note that this pancreatic GAD65 peptide sequence comprises each of instant SEQ ID NOs: 1 and 3-4 in their entirety. See sequence alignment at end of Office action.
Therefore, it would have been prima facie obvious to have modified the GAD65 peptide sequence comprised within the CAR molecules of Reiter et al such that the extracellular peptide recognizes an amino acid sequence having instant SEQ ID NOs: 1 or 3-4. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to try and have an antigen recognition domain with the highest specificity and/or binding affinity for the target, and would have had a reasonable expectation of success with predictable results when using the defined pancreatic GAD65 peptide sequence coupled with epitope generation techniques that are well-known in the art (Paragraphs [0180], [0185], [0189]). See MPEP § 2143(I)(E) and MPEP § 2143(I)(G).
Consequently, Reiter et al render obvious an anti-GAD65 CAR Treg, wherein the extracellular binding domain specifically recognizes each of instant SEQ ID NO: 1 (claim 8), instant SEQ ID NO: 3 (claim 10), or instant SEQ ID NO: 4 (claim 11). This therefore reads on the immunoresponsive cells of the instant claims.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Reiter et al (US 2019/0031759 A1, of record on IDS filed 06 January 2025) in view of Gacerez et al (Journal of Cellular Physiology, 2016, of record on IDS filed 06 January 2025).
The discussion of Reiter et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Reiter et al anticipate claims 1-2, 4-7, 9, and 12-18. Reiter et al render obvious claims 1-2 and 4-18. Gacerez is considered prior art under 35 USC 102(a)(1).
Regarding claim 3: As aforementioned in the discussion of claim 1 above, Reiter et al disclose an anti-GAD65 CAR Treg, wherein the CAR comprises an extracellular antigen-binding domain that recognizes SEQ ID NO: 4 of Reiter et al, a transmembrane domain, and an intracellular signaling domain.
Reiter et al further disclose that the intracellular signaling domain is derived from the intracellular domain of CD3ζ with the co-stimulatory signaling domain of CD28, and that the transmembrane domain is a CD28 transmembrane domain (Paragraphs [0039], [0225]-[0235], [0237]-[0239]).
Reiter et al further disclose that the intracellular signaling domain can comprise a CD8 hinge region (Paragraph [0240]).
Reiter et al do not disclose that the anti-GAD65 CAR comprises a CD28 hinge region in addition to the CD28 co-stimulatory signaling domain and transmembrane domain, as required by instant claim 3.
Gacerez et al, however, disclose that chimeric antigen receptors are highly modular and comprised of swappable domains (Abstract). As such, Gacerez et al further disclose that the hinge region of CARs are most known in the art to be derived from CD8, CD28, and immunoglobulin Fc (Page 2593, Hinge/Spacer Region).
Therefore, it would have been prima facie obvious to have substituted the CD8 hinge region within the CAR of Reiter et al with the CD28 hinge region of Gacerez et al, as doing so would have been a simple substitution of one hinge region for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the two hinge regions are functionally comparable, as they are well-known alternate hinge regions within CARs, and would have thereby been able to substitute the two hinge regions with predictable results (Gacerez et al, Page 2593, Hinge/Spacer Region).
Consequently, Reiter et al as modified by Gacerez et al render obvious an anti-GAD65 CAR Treg wherein the CAR comprises a CD28 co-stimulatory hinge-transmembrane-intracellular domain. This therefore reads on the immunoresponsive cell of the instant claim.
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,161,704 B2 in view of Reiter et al (US 2019/0031759 A1, of record on IDS filed 06 January 2025). The instant application is a CONTINUATION of U.S. Patent No. 12,161,704 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims either anticipate or render obvious the instant claims. More specifically, in regard to rendering obvious the instant claims, the patent claims are not identical because no single patent claim discloses the limitations of the instant claims; however, the limitations of the instant claims are rendered obvious by the accompanying prior art.
Patent claim 1 is directed to an immunoresponsive cell comprising: a chimeric antigen receptor (CAR) that binds to glutamic acid decarboxylase 65 kDA (GAD65);
the CAR comprising:
a) an intracellular signaling domain of a CD3ζ polypeptide and an intracellular signaling domain of CD28 hinge-transmembrane-intracellular region, and
b) an extracellular polypeptide which is a GAD65 monoclonal antibody (MAb) antigen binding domain and which recognizes at least a part of an amino acid sequence selected from the amino acids having SEQ ID Nos: 1-6; or, at least one complete amino acid sequence selected from the amino acids having SEQ ID Nos: 1-6; and
wherein the immunoresponsive cell is a regulatory T cell.
This therefore directly reads on the immunoresponsive cell of instant claims 1-3.
With that, each of patent claims 2-14 are exactly or substantially identical to each of instant claims 6-18, respectively.
Furthermore, although the patent does not disclose the limitations from instant claims 4-5, the subject matter is known from the prior art and can be further incorporated into the method taught by patent claim 1:
Reiter et al teach the limitations in instant claims 4-5.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, and 10 of U.S. Patent No. 11,766,457 B2 in view of Reiter et al (US 2019/0031759 A1, of record on IDS filed 06 January 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims render obvious the instant claims. More specifically, the patent claims are not identical because no single patent claims discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate patent claims. The fact that each of the elements were claimed in the patent, just not in a single claim, still renders obvious the instant invention because each of the features, though separately claimed, can be physically combined into a single embodiment.
Patent claim 1 is directed to an immunoresponsive cell comprising: a chimeric antigen receptor (CAR) that binds to glutamic acid decarboxylase 65 kDA (GAD65) in the cell;
the CAR comprising:
a) an intracellular signaling domain of a CD3ζ polypeptide and an intracellular signaling domain of CD28 hinge-transmembrane-intracellular region, and
b) an extracellular polypeptide comprising an amino acid sequence that is a GAD65 MAb antigen binding domain;
wherein the extracellular polypeptide comprises SEQ ID NO: 7, or an amino acid sequence having at least 95% identity to SEQ ID NO: 7.
It is of note that patent SEQ ID NO: 7 has a sequence that reads on at least part of instant SEQ ID NO: 1. See sequence alignment at end of Office action.
Patent claim 8 further limits the immunoresponsive cell of patent claim 1 as being a regulatory T cell.
This therefore renders obvious the immunoresponsive cell of instant claims 1-3 and 8.
With that, each of patent claims 2-3 and 10 are exactly or substantially identical to each of instant claims 4-5 and 14, respectively.
Furthermore, although the patent does not disclose the limitations from instant claims 6-7 and 9-13, the subject matter is known from the prior art and can be further incorporated into the method taught by patent claims 1 and 8:
Reiter et al teach the limitations in instant claims 6-7 and 9-13.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, and 10 of U.S. Patent No. 12,144,829 B2 in view of Reiter et al (US 2019/0031759 A1, of record on IDS filed 06 January 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims render obvious the instant claims. More specifically, the patent claims are not identical because no single patent claims discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate patent claims. The fact that each of the elements were claimed in the patent, just not in a single claim, still renders obvious the instant invention because each of the features, though separately claimed, can be physically combined into a single embodiment.
Patent claim 1 is directed to an immunoresponsive cell comprising: a chimeric antigen receptor (CAR) that binds to glutamic acid decarboxylase 65 kDA (GAD65) in the cell;
the CAR comprising:
a) an intracellular signaling domain of a CD3ζ polypeptide and an intracellular signaling domain of CD28 hinge-transmembrane-intracellular region, and
b) an extracellular polypeptide comprising an amino acid sequence that is a GAD65 MAb antigen binding domain;
wherein the extracellular polypeptide comprises SEQ ID NO: 8, or an amino acid sequence having at least 95% identity to SEQ ID NO: 8.
It is of note that patent SEQ ID NO: 8 has a sequence that reads on at least part of instant SEQ ID NO: 1. See sequence alignment at end of Office action.
Patent claim 8 further limits the immunoresponsive cell of patent claim 1 as being a regulatory T cell.
This therefore renders obvious the immunoresponsive cell of instant claims 1-3 and 8.
With that, each of patent claims 2-3 and 10 are exactly or substantially identical to each of instant claims 4-5 and 14, respectively.
Furthermore, although the patent does not disclose the limitations from instant claims 6-7 and 9-13, the subject matter is known from the prior art and can be further incorporated into the method
taught by patent claims 1 and 8:
Reiter et al teach the limitations in instant claims 6-7 and 9-13.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-12 and 16 of copending Application No. 18/931782 in view of Reiter et al (US 2019/0031759 A1, of record on IDS filed 06 January 2025) and Gacerez et al (Journal of Cellular Physiology, 2016, of record on IDS filed 06 January 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims either anticipate or render obvious the instant claims. More specifically, in regard to rendering obvious the instant claims, the copending claims are not identical because no single copending claim discloses the limitations of the instant claims; however, the limitations of the instant claims are rendered obvious by the accompanying prior art.
Copending claim 10 is directed to an immunoresponsive cell comprising: a chimeric antigen receptor (CAR) that binds to glutamic acid decarboxylase 65 kDA (GAD65) in the cell;
the CAR comprising:
a) an intracellular signaling domain, and
b) an extracellular polypeptide comprising SEQ ID NO: 7 or SEQ ID NO: 8, or an amino acid sequence having at least 95% identity to SEQ ID NO: 7 or SEQ ID NO: 8,
wherein the immunoresponsive cell is a regulatory T cell.
It is of note that copending SEQ ID NO: 7 and SEQ ID NO: 8 each has a sequence that reads on at least part of instant SEQ ID NO: 1. See sequence alignment at end of Office action.
This therefore renders obvious the immunoresponsive cell of instant claims 1 and 8.
With that, each of copending claims 11-12 and 16 are exactly or substantially identical to each of instant claims 4-5 and 14, respectively.
Furthermore, although the copending application does not disclose the limitations from instant claims 2-3, 6-7, and 9-13, the subject matter is known from the prior art and can be further incorporated into the method taught by copending claim 10:
Reiter et al teach the limitations in instant claims 2, 6-7, and 9-13.
Gacerez et al teach the limitation in instant claim 3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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/ALYSSA G WESTON/Examiner, Art Unit 1633
Sequence Alignment
Query Match 39.5%; Length 13; Best Local Similarity 100.0%; Matches 12; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 FFRMVISNPAAT 12 (INSTANT SEQ ID NO: 6)
||||||||||||
Db 2 FFRMVISNPAAT 13 (REITER ET AL SEQ ID NO: 4)
Query Match 9.6%; Length 13; Best Local Similarity 100.0%; Matches 2; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 9 NP 10 (INSTANT SEQ ID NO: 2)
||
Db 9 NP 10 (REITER ET AL SEQ ID NO: 4)
Query Match 14.6%; Length 13; Best Local Similarity 50.0%; Matches 2; Conservative 1; Mismatches 1; Indels 0; Gaps 0;
Qy 7 YEMV 10 (INSTANT SEQ ID NO: 5)
: ||
Db 3 FRMV 6 (REITER ET AL SEQ ID NO: 4)
Query Match 100.0%; Length 585; Best Local Similarity 100.0%; Matches 135; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 FTYEIAPVFVLLEYVTLKKMREIIGWPGGSGDGIFSPGGAISNMYAMMIARFKMFPEVKE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 205 FTYEIAPVFVLLEYVTLKKMREIIGWPGGSGDGIFSPGGAISNMYAMMIARFKMFPEVKE 264
Qy 61 KGMAALPRLIAFTSEHSHFSLKKGAAALGIGTDSVILIKCDERGKMIPSDLERRILEAKQ 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 265 KGMAALPRLIAFTSEHSHFSLKKGAAALGIGTDSVILIKCDERGKMIPSDLERRILEAKQ 324
Qy 121 KGFVPFLVSATAGTT 135 (INSTANT SEQ ID NO: 1)
|||||||||||||||
Db 325 KGFVPFLVSATAGTT 339 (REITER ET AL SEQ ID NO: 38)
Query Match 100.0%; Length 585; Best Local Similarity 100.0%; Matches 83; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 KMFPEVKEKGMAALPRLIAFTSEHSHFSLKKGAAALGIGTDSVILIKCDERGKMIPSDLE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 257 KMFPEVKEKGMAALPRLIAFTSEHSHFSLKKGAAALGIGTDSVILIKCDERGKMIPSDLE 316
Qy 61 RRILEAKQKGFVPFLVSATAGTT 83 (INSTANT SEQ ID NO: 3)
|||||||||||||||||||||||
Db 317 RRILEAKQKGFVPFLVSATAGTT 339 (REITER ET AL SEQ ID NO: 38)
Query Match 100.0%; Length 585; Best Local Similarity 100.0%; Matches 52; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AISNMYAMMIARFKMFPEVKEKGMAALPRLIAFTSEHSHFSLKKGAAALGIG 52
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Db 244 AISNMYAMMIARFKMFPEVKEKGMAALPRLIAFTSEHSHFSLKKGAAALGIG 295
Qy: INSTANT SEQ ID NO: 4 Db: REITER ET AL SEQ ID NO: 38
Query Match 100.0%; Length 585; Best Local Similarity 100.0%; Matches 25; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ERANSVTWNPHKMMGVPLQCSALLV 25 (INSTANT SEQ ID NO: 2)
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Db 385 ERANSVTWNPHKMMGVPLQCSALLV 409 (REITER ET AL SEQ ID NO: 38)
Query Match 100.0%; Length 585; Best Local Similarity 100.0%; Matches 25; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 IKNREGYEMVFDGKP 15 (INSTANT SEQ ID NO: 5)
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Db 485 IKNREGYEMVFDGKP 499 (REITER ET AL SEQ ID NO: 38)
Query Match 100.0%; Length 585; Best Local Similarity 100.0%; Matches 30; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 FFRMVISNPAATHQDIDFLIEEIERLGQDL 30 (INSTANT SEQ ID NO: 6)
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Db 556 FFRMVISNPAATHQDIDFLIEEIERLGQDL 585 (REITER ET AL SEQ ID NO: 38)
Query Match 4.1%; Length 271; Best Local Similarity 38.5%; Matches 5; Conservative 2; Mismatches 6; Indels 0; Gaps 0;
Qy 30 SGDGIFSPGGAIS 42 (INSTANT SEQ ID NO: 1)
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Db 152 SGPGLLKPSETLS 164 (US 11766457 B2 SEQ ID NO: 7)
Query Match 4.9%; Length 268; Best Local Similarity 23.1%; Matches 18; Conservative 5; Mismatches 27; Indels 28; Gaps 2;
Qy 30 SGDGIFSPGGAISNMYAMMIARFKMFPEVKEKGMAALPRLIAFTS--EHSHFSLKKGAAA 87
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Db 150 SGGGVVQPGRSL--------------------------RLSCAASGLTFSHHGMHWVRQA 183
Qy 88 LGIGTDSVILIKCDERGK 105 (INSTANT SEQ ID NO: 1)
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Db 184 PGKGLEWVAFISYDETKK 201 (US 12144829 B2 SEQ ID NO: 8)
Query Match 4.1%; Length 271; Best Local Similarity 38.5%; Matches 5; Conservative 2; Mismatches 6; Indels 0; Gaps 0;
Qy 30 SGDGIFSPGGAIS 42 (INSTANT SEQ ID NO: 1)
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Db 152 SGPGLLKPSETLS 164 (18931782 SEQ ID NO: 7)
Query Match 4.9%; Length 268; Best Local Similarity 23.1%; Matches 18; Conservative 5; Mismatches 27; Indels 28; Gaps 2;
Qy 30 SGDGIFSPGGAISNMYAMMIARFKMFPEVKEKGMAALPRLIAFTS--EHSHFSLKKGAAA 87
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Db 150 SGGGVVQPGRSL--------------------------RLSCAASGLTFSHHGMHWVRQA 183
Qy 88 LGIGTDSVILIKCDERGK 105 (INSTANT SEQ ID NO: 1)
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Db 184 PGKGLEWVAFISYDETKK 201 (18931782 SEQ ID NO: 8)
Prosecution Insights