DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Applicant’s submission filed 10 February 2026 has been entered. Claims 1-17 are pending. Claims 1, 5, 8-9, 14, and 17 have been amended. Therefore, prosecution on the merits continues for claims 1-17. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Priority
Applicant filed a petition to perfect the priority claim to US Application 15/551862, International Application PCT/US2016/019953, and US Provisional Application 62/121842 on 03 March 2026. This petition was granted by the Office in a letter mailed on 26 March 2026.
Therefore, the effective filing date of the instant invention is now 27 February 2015.
RE: Objection to claims 1, 5, 8-10, 14, and 17
Applicant’s amendments to each of instant claims 1, 5, and 8-10 obviate the objections of record for each claim. In regards to instant claims 14 and 17, Applicant has failed to consistently recite “CD7CAR” and remove the incorrect recitation of “CTAL-4”.
Therefore, the objections are withdrawn for claims 1, 5, and 8-10, and maintained for claims 14 and 17.
RE: Rejection of claims 17 under 35 USC 112(a)
Applicant’s amendments to instant claim 17 removing the recitation of “functional fragments thereof” obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claim 8 under 35 USC 112(b)
Applicant’s amendments to instant claim 8 removing the exemplary language and correcting the claim scope obviate the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-10 and 13-17 under 35 USC 102(a)(1) and 35 USC 102(a)(2) over Ma et al (US 10,273,280 B2) as evidenced by Hampe
Applicant has filed a petition to perfect the priority claim on 03 March 2026, which was granted on 26 March 2026. Accordingly, Ma et al is no longer considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-9, 11-14, and 16-17 under 35 USC 102(a)(1) and 35 USC 102(a)(2) over Ma et al (US 2020/0223918 A1) as evidenced by Hampe
Applicant has filed a petition to perfect the priority claim on 03 March 2026, which was granted on 26 March 2026. Accordingly, Ma et al is no longer considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-4, 7-10, 13, and 16-17 under 35 USC 102(a)(1) and 35 USC 102(a)(2) over Kim et al as evidenced by Hampe
Applicant's arguments filed 10 February 2026 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, asserting in Pages 6-7 of the Remarks filed 10 February 2026 that Kim et al fail to disclose a method of using a CD3 CAR to delete or reduce T cells associated with autoimmune diseases. In response, the Examiner respectfully submits that the features upon which Applicant relies (i.e., the deletion or reduction of T cells associated with autoimmune diseases) are not recited in the rejected claims. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is also of note that Kim et al disclose chimeric antigen receptors comprising an extracellular domain recognized by an antibody that targets a cell surface protein of a T cell, including CD3, for the treatment of autoimmune diseases. See, for example, Paragraphs [034] and [052] of Kim et al. Therefore, the ordinary artisan would recognize that the CD3 CARs of Kim et al are capable of deleting or reducing T cells associated with autoimmune diseases.
Applicant has further traversed the rejection, asserting in Pages 6-7 of the Remarks filed 10 February 2026 that Kim et al teach the generation of a switch CAR, and is solely focused on the selective activation/deactivation of genetically modified T cells for safer, more versatile immunotherapy. In response, the Examiner respectfully submits that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP § 2123: Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989); Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). In the instant case, although Kim et al do disclose the generation of CAR switches that are bispecific for CD3 and a tumor antigen, Kim et al separately disclose CD3 CARs for the treatment of autoimmune diseases. See, for example, Paragraphs [034] and [052] of Kim et al.
Therefore, the rejection is maintained.
RE: Rejection of claims 1-17 under 35 USC 103 over Ma et al (US 10,273,280 B2) as evidenced by Hampe in view of Barker
Applicant has filed a petition to perfect the priority claim on 03 March 2026, which was granted on 26 March 2026. Accordingly, Ma et al is no longer considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-17 under 35 USC 103 over Ma et al (US 2020/0223918 A1) as evidenced by Hampe in view of Kim et al
Applicant has filed a petition to perfect the priority claim on 03 March 2026, which was granted on 26 March 2026. Accordingly, Ma et al is no longer considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-4, 7-13, and 16-17 under 35 USC 103 over Kim et al as evidenced by Hampe in view of Barker
Applicant's arguments filed 10 February 2026 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, citing the same assertions presented within Pages 6-7 of the Remarks filed 10 February 2026 in regards to the rejection over Kim et al as evidenced by Hampe. In response, the Examiner respectfully directs Applicant to the discussion of the 35 USC 102 rejection over Kim et al as evidenced by Hampe.
In addition, Applicant has further traversed the rejection, asserting in Page 7 of the Remarks filed 10 February 2026 that Hampe et al and Barker fail to disclose a CD3 CAR. In response the Examiner respectfully submits that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Hampe is an evidentiary reference utilized to show that type I diabetes is inherently a T-cell and B-cell mediated disease, while Barker is a secondary reference relied upon to teach that patient suffering from type I diabetes are at risk of developing autoimmune thyroid disease, celiac disease, and Addison’s disease.
Therefore, the rejection is maintained.
RE: Rejection of claims 1-10 and 13-17 under 35 USC 103 over Kim et al as evidenced by Hampe in view of Mata-Fink et al and Aandahl et al
Applicant's arguments filed 10 February 2026 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, citing the same assertions presented within Pages 6-7 of the Remarks filed 10 February 2026 in regards to the rejection over Kim et al as evidenced by Hampe. In response, the Examiner respectfully directs Applicant to the discussion of the 35 USC 102 rejection over Kim et al as evidenced by Hampe.
In addition, Applicant has further traversed the rejection, asserting in Pages 8-9 of the Remarks filed 10 February 2026 that Hampe et al and Barker fail to disclose a CD3 CAR. In response the Examiner respectfully submits that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Hampe is an evidentiary reference utilized to show that type I diabetes is inherently a T-cell and B-cell mediated disease, while Mata-Fink et al and Aandahl et al are secondary references relied upon to respectively teach CD7 CARs and CD7 T cell surface expression.
Therefore, the rejection is maintained.
RE: Rejection of claims 1-17 over claims 4-5 of US Patent No. 11,820,819 B2 in view of Ma et al (US 2020/0223918 A1) as evidenced by Hampe and further in view of Kim et al
Applicant has requested in Page 10 of the Remarks filed 10 February 2026 that the nonstatutory double patenting rejection be held in abeyance. In response, the Examiner respectfully reminds Applicant that 37 CFR 1.111 requires that replies by Applicant or patent owner must reply to every ground of objection and rejection in the prior Office action. Only objections or requirements as to form not necessary to further consideration of the claims may be requested to be held in abeyance until allowable subject matter is indicated. Non-statutory double patenting rejections may not be held in abeyance. See MPEP §714.02. It is of note that Applicant did not traverse the NSDP rejection.
Therefore, the rejection is maintained and amended in accordance with the perfected priority claim.
RE: Rejection of claims 1-17 over claim 1 of US Patent No. 12,275,787 B2 in view of Ma et al (US 2020/0223918 A1) as evidenced by Hampe and further in view of Kim et al
Applicant has requested in Page 10 of the Remarks filed 10 February 2026 that the nonstatutory double patenting rejection be held in abeyance. In response, the Examiner respectfully reminds Applicant that 37 CFR 1.111 requires that replies by Applicant or patent owner must reply to every ground of objection and rejection in the prior Office action. Only objections or requirements as to form not necessary to further consideration of the claims may be requested to be held in abeyance until allowable subject matter is indicated. Non-statutory double patenting rejections may not be held in abeyance. See MPEP §714.02. It is of note that Applicant did not traverse the NSDP rejection.
Therefore, the rejection is maintained and amended in accordance with the perfected priority claim.
RE: Provisional rejection of claims 1-17 over claims 21-23 of copending Application No. 17/283,450 in view of Ma et al (US 2020/0223918 A1) as evidenced by Hampe and further in view of Kim et al
Applicant has requested in Page 10 of the Remarks filed 10 February 2026 that the nonstatutory double patenting rejection be held in abeyance. In response, the Examiner respectfully submits that
copending Application No. 17/283,450 has been abandoned (filed 08 December 2025).
Therefore, the rejection is withdrawn.
RE: Provisional rejection of claims 1-17 over claims 1-3, 8-11, 14-16, and 18-19 of copending Application No. 17/994,787 in view of Ma et al (US 2020/0223918 A1) as evidenced by Hampe and further in view of Kim et al
Applicant has requested in Page 10 of the Remarks filed 10 February 2026 that the nonstatutory double patenting rejection be held in abeyance. In response, the Examiner respectfully reminds Applicant that 37 CFR 1.111 requires that replies by Applicant or patent owner must reply to every ground of objection and rejection in the prior Office action. Only objections or requirements as to form not necessary to further consideration of the claims may be requested to be held in abeyance until allowable subject matter is indicated. Non-statutory double patenting rejections may not be held in abeyance. See MPEP §714.02. It is of note that Applicant did not traverse the NSDP rejection.
Therefore, the rejection is maintained and amended in accordance with the perfected priority claim.
RE: Provisional rejection of claims 1-17 over claims 1, 3, 5-6, 12-16, and 19-20 of copending Application No. 18/520,972 in view of Ma et al (US 2020/0223918 A1) as evidenced by Hampe and further in view of Kim et al
Applicant has requested in Page 10 of the Remarks filed 10 February 2026 that the nonstatutory double patenting rejection be held in abeyance. In response, the Examiner respectfully reminds Applicant that 37 CFR 1.111 requires that replies by Applicant or patent owner must reply to every ground of objection and rejection in the prior Office action. Only objections or requirements as to form not necessary to further consideration of the claims may be requested to be held in abeyance until allowable subject matter is indicated. Non-statutory double patenting rejections may not be held in abeyance. See MPEP §714.02. It is of note that Applicant did not traverse the NSDP rejection.
Therefore, the rejection is maintained and amended in accordance with the perfected priority claim.
New/Maintained Grounds of Rejection
Priority
The instant application is a continuation-in-part of US Application No. 16/371501, filed 01 April 2019, which is continuation of US Application No. 15/551862, filed 17 August 2017, which is a national stage entry under 35 USC 371 of PCT/US2016/019953, filed 26 February 2016. Acknowledgment is made of Applicant’s claim for benefit under 35 USC 119(e) to US Provisional Application No. 62121842, filed 27 February 2015.
As copendency between all appropriate application has been established, the effective filing date of the instant invention is now 27 February 2015.
Claim Objections
Claims 8, 14, and 17 are objected to because of the following informalities:
Regarding claim 8: The instant claim is objected to for comprising an extraneous parenthesis and dash in the recitation of “(Acute inflammatory demyelinating polyneuropathy –“ in Line 8. Applicant must delete this parenthesis and dash using either a strikethrough or double bracket around each mark.
It is of note that this objection is due to Applicant’s amendments to the instant claim.
Appropriate correction is required.
Regarding claim 14: The instant claim is objected to for reciting the term “CD7 CAR” in Line 2, while instant claims 5-6 recite the term as “CD7CAR” in Line 1. Applicant must utilize a uniform recitation of the term throughout the claim language.
Appropriate correction is required.
Regarding claim 17: The instant claim is objected to for still reciting the incorrect recitation of “CTAL-4”in Line 2. Applicant must delete the incorrect recitation of “CTAL-4”.
Appropriate correction is required.
Claim Interpretation
The instant Specification defines an “enhancer” on Page 69 as a biological molecule that
promotes or enhances the activity of the engineered cell having the chimeric antigen receptor polypeptide.
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 1-4, 7-10, 13, and 16-17 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim et al (WO 2016/054520 A2, of record) as evidenced by Hampe (Scientifica, 2012, of record). Kim et al has an effective filing date of 03 October 2014.
Kim et al disclose engineered cell surface proteins, effector cells expressing said engineered cell surface proteins, and methods of using the effector cells for the treatment of disease or condition in a subject in need thereof (Abstract).
As such, Kim et al disclose engineered effector cells expressing a chimeric antigen receptor (CAR) that is specific for CD3 that are administered to a subject suffering from an autoimmune disease, wherein the autoimmune disease is type I diabetes or rheumatoid arthritis (Paragraphs [011], [013], [034], [037], [042], [052], [088]-[089], [094], [0128], [0153]).
Accordingly, Kim et al anticipate the claims as follows:
Regarding claims 1-2: Kim et al disclose the treatment of an autoimmune disease, wherein effector cells expressing CARs specific for CD3 (claim 2) are administered to the subject in need thereof. This therefore reads on the method of instant claim 1.
Regarding claims 3-4 and 8-10: Following the discussion of claim 1, Kim et al further disclose that the autoimmune disease is type I diabetes (claims 8-10) or rheumatoid arthritis. As rheumatoid arthritis and type I diabetes are each inherently a T-cell and B-cell mediated disease, as evidenced by Pages 4-7 of Hampe, this therefore reads on the method of instant claims 3-4.
Regarding claim 7: Following the discussion of claim 1, Kim et al further disclose that the subject is further administered steroids (Paragraphs [0158]-[0161]). This therefore reads on the method of the instant claim.
Regarding claim 13: Following the discussion of claim 1, Kim et al further disclose that the subject is treated prior to the administration of the CAR-expressing effector cells such that the native lymphocytes – or T cells – are depleted (Paragraphs [088], [091]-[094]). This therefore reads on the method of the instant claim.
Regarding claim 16: Following the discussion of claim 1, Kim et al further disclose that the disease or condition is an alloimmune reaction or response caused by a transplant of a tissue from a donor to the subject (Paragraph [0154]). This therefore reads on the method of the instant claim.
Regarding claim 17: Following the discussion of claim 1, Kim et al further disclose that the CAR-expressing effector cells are treated with IL-2 (Paragraphs [083], [088], [091]). This therefore reads on the method of the instant claim given the definition of “enhancer” aforementioned in the Claim Interpretation section above.
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 1-4, 7-13, and 16-17 remain rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (WO 2016/054520 A2, of record) as evidenced by Hampe (Scientifica, 2012, of record) in view of Barker (Journal of Clinical Endocrinology & Metabolism, 2006, of record).
The discussion of Kim et al as evidenced by Hampe regarding claims 1, 4, and 10 can be
observed above and is relied upon herein, the content of which is incorporated in its entirety. Kim as
evidenced by Hampe anticipate claims 1-4, 7-10, 13, and 16-17. Barker is considered prior art under 35 USC 102(a)(1).
Regarding claims 11-12: As aforementioned in the discussion of claim 4, Kim et al as evidenced by Hampe disclose that type I diabetes is inherently a T-cell and B-cell mediated disease.
Kim et al as evidenced by Hampe fail to disclose that the subject suffering from type I diabetes is at risk for a combination of T-cell and B-cell mediated disorders, as required by instant claims 11-12.
Barker, however, discloses that patients suffering from type I diabetes have a risk of developing autoimmune thyroid disease, celiac disease, and Addison’s disease (Pages 1210, 1214; Tables 1-2).
Therefore, it would have been prima facie obvious for the subjects suffering from type I diabetes in Kim et al to be at risk for a combination of type I diabetes and autoimmune thyroid disease, celiac disease, and/or Addison’s disease, as detailed in Barker. One of ordinary skill before the effective filing date of the invention would have recognized that the subject’s suffering from type I diabetes have a predisposition for autoimmune thyroid disease, celiac disease, and/or Addison’s disease, and would have been motivated to treat such subjects suffering from the combination of T-cell and B-cell mediated disorders. Furthermore, the ordinary artisan would have had a reasonable expectation of success given that Kim et al disclose treating subjects suffering from all of type I diabetes, celiac disease, Hashimoto’s disease – an autoimmune thyroid disease – and Addison’s disease (Paragraphs [0153], [0155]). See MPEP § 2143(I)(G).
Consequently, Kim et al as evidenced by Hampe as modified by Barker render obvious a method of treating a subject suffering from autoimmune disease, wherein the subject is at risk for a combination of type I diabetes and at least one of autoimmune thyroid disease, celiac disease, and/or Addison’s disease, which are inherently T-cell and B-cell mediated disorders. This therefore renders obvious the method of instant claims 11-12.
Claims 1-10 and 13-17 remain rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (WO 2016/054520 A2, of record) as evidenced by Hampe (Scientifica, 2012, of record) in view of Mata-Fink et al (WO 2015/153102 A1, of record) and Aandahl et al (The Journal of Immunology, 2003, of record).
The discussion of Kim et al regarding claims 1, 3, and 13 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Kim as evidenced by Hampe anticipate claims 1-4, 7-10, 13, and 16-17. Mata-Fink et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 5-6: As aforementioned in the discussion of claims 1 and 3, Kim et al as evidenced by Hampe disclose the treatment of a T cell-mediated autoimmune disease, wherein effector cells expressing CARs specific for CD3 are administered to the subject in need thereof.
Kim et al further disclose that the administration of the CD3 CARs results in the cytotoxic depletion of target cells expressing the CD3 surface antigen (Paragraphs [082], [0171]-[0174]).
Kim et al as evidenced by Hampe fail to disclose that the CARs are specific for CD7, as required by instant claims 5-6.
Mata-Fink et al, however, disclose circulating cells – which include T cells – containing exogenous antigens and uses thereof (Abstract; Paragraphs [0005], [00247]; Table A). As such, Mata-Fink et al disclose that the exogenous antigen is a CD7, and is located on the extracellular surface of the T cell (Paragraphs [00248], [00270]-[00271], [00284], [00306], [00309]-[00310], [00573], Tables A-B). Mata-Fink et al further disclose that the antigen is a chimeric polypeptide (Paragraphs [0078], [00229]).
Mata-Fink et al further disclose that the cells may be administered to a subject suffering from an autoimmune disease, including type 1 diabetes or rheumatoid arthritis, or other T cell-mediated autoimmune diseases (Paragraphs [00473]-[00475], [00479], [00514], [00572]).
It is also of note that subsets of T cells are known to have endogenous CD7 surface expression. See Aandahl et al, Page 1.
Therefore, it would have been prima facie obvious to have substituted the CD3 extracellular domain of the CAR detailed in Kim et al for the extracellular CD7 of Mata-Fink et al, as doing so would have been a simple substitution of one known T cell-associated extracellular antigen 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 extracellular antigens are functionally comparable, as both are expressed on the surface of T cells and can be utilized to treat T cell-mediated autoimmune diseases, and thereby would have been able to substitute the two antigens with predictable results.
Consequently, Kim et al as evidenced by Hampe and as modified by Mata-Fink et al and Aandahl et al render obvious the treatment of a T cell-mediated autoimmune disorder within a subject, wherein an effector cell expressing a CAR specific for CD7 is administered to the subject and results in the depletion of target cells expressing the CD7 surface antigen. As subsets of T cells are known to have endogenous CD7 surface expression (see Aandahl et al, Page 1), this therefore renders obvious the method of instant claims 5-6.
Regarding claim 14: As aforementioned in the discussion of claim 13, Kim et al disclose that the subject is treated prior to the administration of the CAR-expressing effector cells such that the native lymphocytes – or T cells – are depleted (Paragraphs [088], [091]-[094]).
Kim et al as evidenced by Hampe fail to disclose that the lymphodepletion is by CARs specific for CD7, as required by instant claim 14.
Kim et al as evidenced by Hampe and as modified by Mata-Fink et al and Aandahl et al, however, render obvious the administration of CD7-CAR effector cells for the depletion of T cells. See the discussion of claims 5-6 above.
Therefore, it would have been prima facie obvious to modify the substitute the lymphodepletion technique of Kim et al such that the preliminary lymphodepletion is via the administration of CD7-CAR effector cells. MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the administration of CD7-CAR effector cells results in the depletion of T cells, and thereby would have been able to substitute the treatments with predictable results.
Consequently, Kim et al as evidenced by Hampe and as modified by Mata-Fink et al and Aandahl et al render obvious the administration of CD7-CAR effector cells for the preliminary depletion of T cells. This therefore renders obvious the method of the instant claim.
Regarding claim 15: Following the discussion of claim 14, Kim et al further disclose that the subject may be administered the CAR-expressing cells in combination with cyclophosphamide or fludarabine (Paragraph [0158]). This therefore reads on the method 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 1-4, 7-10, 13, and 16-17 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. US 11,820,819 B2 in view of Kim et al (WO 2016/054520 A2, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim renders obvious the instant claims. More specifically, the patented claim is not identical because no single patent claim 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, or rendered obvious by the accompanying prior art. 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 4 is directed to a method for depleting antibody producing B cells and/or plasma cells in a patient with an autoimmune condition, said method comprising:
administering to said patient in need thereof a composition comprising an engineered T cell or NK cell co-expressing two distinct chimeric antigen receptor (CAR) units at the cell surface, wherein the engineered T cell or NK cell comprises a nucleotide sequence comprising from 5′ to 3′ a promoter selected from human elongation factor-1 alpha (EF-1α) or spleen focus forming virus (SFFV), a first polynucleotide encoding a first chimeric antigen receptor polypeptide (CAR), a nucleotide encoding a first, self-cleavage peptide, a second polynucleotide encoding a second chimeric antigen receptor polypeptide (CAR) a nucleotide encoding a second self-cleavage peptide, and a third polynucleotide encoding a fusion protein consisting of IL-15 linked to a soluble domain of IL-15Rα (sushi) and secreted as a soluble IL-15/IL-15 sushi complex wherein:
(i) the first CAR comprises a first signal peptide, a first antibody binding domain, a first hinge region, a first transmembrane domain, a first CD28 or 4-1BB co-stimulatory domain, and a first signaling domain; and
(ii) the second CAR comprises a second signal peptide, a second antibody binding domain, a second hinge region, a second transmembrane domain, a second CD28 or 4-1BBz co-stimulatory domain, and a second signaling domain;
and wherein the first antibody binding domain and the second antibody binding domain are different from each other, and each bind to a different target,
wherein the wherein the targets of the first and second antibody binding domains irrespective of order are BCMA and CD19 or BCMA and CS-1, wherein the first and second co-stimulatory domains are intracellular,
and wherein the cleavage site is selected from the group consisting of porcine teschovirus-1 2A (P2A), thoseaasigna virus 2A (T2A), equine rhinitis A virus (ERAV) 2A (E2A), and FMDV 2A (F2A), and wherein said patient's autoimmune condition improves as a result of said depletion of antibody producing B cells and/or plasma cells.
Therefore, instant claims 1 and 17 are obvious variant of patent claim 4. More specifically, although patent claim 4 is not explicitly directed to a method of treating an autoimmune disease, the ordinary artisan would recognize that the depletion of antibody producing B cells and/or plasma cells in a patient with an autoimmune condition reads on the treatment of the autoimmune condition.
With that, instant claims 2-4, 7-10, 13, and 16 are known from the patent claims or prior art and can be further incorporated into the method rendered obvious by patent claim 4:
Patent claim 5 teaches the limitations recited in instant claims 8-9.
Kim et al teach the limitations of instant claims 2-4, 7, 10, 13, and 16.
Claims 1-4, 7-10, 13, and 16-17 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12,275,787 B2 in view of Kim et al (WO 2016/054520 A2, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim renders obvious the instant claims. More specifically, the patented claim is not identical because no single patent claim 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, or rendered obvious by the accompanying prior art. 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 a method for treating an autoimmune disease, said method comprising administering to a patient in need thereof an ex vivo engineered T cell or NK cell co-expressing two distinct chimeric antigen receptor (CAR) units at the cell surface, wherein the engineered T cell or NK cell comprises a nucleotide sequence comprising from 5′ to 3′ a nucleotide encoding a promoter selected from human elongation factor-1 alpha (EF-1α) or spleen focus forming virus (SFFV), a first polynucleotide encoding a first chimeric antigen receptor polypeptide (CAR), a nucleotide encoding a first cleavage peptide, and a second polynucleotide encoding a second chimeric antigen receptor polypeptide (CAR), wherein the engineered cell further comprises a nucleotide encoding secreted IL-15/IL-15sushi or a functional fragment thereof, wherein the nucleotide encoding said enhancer is attached to the nucleotide encoding the first CAR or the nucleotide encoding the second CAR by a nucleotide encoding a second cleavage peptide that flanks either end of the two distinct encoded CAR units, wherein:
the first CAR comprises a first signal peptide, a first antibody binding domain, a first hinge region, a first transmembrane domain, a first co-stimulatory domain, and a first signaling domain; and
the second CAR comprises a second signal peptide, a second antibody binding domain, a second hinge region, a second transmembrane domain, a second co-stimulatory domain, and a second signaling domain; and
wherein the first antibody binding domain and the second antibody binding domain are different and each bind to a different target, wherein the targets of the first and second antibody binding domains irrespective of order are CD19 and BMCA (CD269), wherein the first and second co-stimulatory domains are intracellular, and wherein the first and second cleavage peptides are selected from the group consisting of porcine teschovirus-1 2A (P2A), thoseaasigna virus 2A (T2A), equine rhinitis A virus (ERAV) 2A (E2A), and FMDV 2A (F2A), and wherein said autoimmune disease is systemic lupus erythematosus (SLE).
This therefore reads on the methods of instant claims 1, 8, and 17.
With that, instant claims 2-4, 7, 9-10, 13, and 16 are known from the prior art and can be further incorporated into the method anticipated by patent claim 1:
Kim et al teach the limitations of instant claims 2-4, 7, 9-10, 13, and 16.
Claims 1-4, 7-13, and 16-17 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-11, 14-16, and 18-19 of copending Application No. 17/994,787 in view of Kim et al (WO 2016/054520 A2, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims renders obvious the instant claims. More specifically, the copending claims are not identical because no single copending claim discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate copending claims, or rendered obvious by the accompanying prior art. The fact that each of the elements were claimed in the copending application, 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.
Copending claim 1 is directed to a method for treating an autoimmune disorder, the method comprising administering to a patient in need thereof a dual CAR, wherein the dual CAR binds to an antigen expressed on T- cells and an antigen on the surface of B-cells or plasma cells, wherein the antigen expressed on T cells is CD2, CD3, CD4, CD5, or CD7, and wherein the antigen on the surface of B cells or plasma cells is CD19, CD20, CD22, BCMA, CD38, CD138, CS1, or GPRC5D. This therefore reads on the methods of instant claims 1-2.
With that, instant claims 3-4, 7-13, and 16-17 are known from the copending claims or prior art and can be further incorporated into the method anticipated by copending claim 1:
Copending claims 2-3, 8-11, 14-16, and 18-19 teach the limitations recited in instant claims 3-4, 7-12, and 16-17.
Kim et al teach the limitation of instant claim 13.
This is a provisional nonstatutory double patenting rejection.
Claims 1-13 and 16-17 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, 12-16, and 19-20 of copending Application No. 18/520,972 in view of Kim et al (WO 2016/054520 A2, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims renders obvious the instant claims. More specifically, the copending claims are not identical because no single copending claim discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate copending claims, or rendered obvious by the accompanying prior art. The fact that each of the elements were claimed in the copending application, 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.
Copending claim 1 is directed to a method for treating an autoimmune disorder in a patient in need thereof, the method comprising administering to said patient a dual CAR, wherein the dual CAR binds to a first antigen and a second antigen, wherein the first antigen is expressed on T- cells or NK-cells and is selected from the group consisting of CD2, CD3, CD4, CD5, or CD7, and wherein said second antigen is expressed on B-cells or plasma cells and is selected from the group consisting of CD19, CD20, CD22, BCMA, CD38, CD138, CS1, or GPRC5D, and wherein said dual CAR is either a tandem CAR or compound CAR (cCAR). This therefore reads on the methods of instant claims 1-2.
With that, instant claims 3-12 and 16-17 are known from the copending claims or prior art and can be further incorporated into the method anticipated by copending claim 1:
Copending claims 3, 5-6, 12-16, and 19-20 teach the limitations recited in instant claims 3-12.
Kim et al teach the limitations of instant claims 13 and 16-17.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633