DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/2026 has been entered.
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
3. Claims 24, 26-32, 35-36 and 38 are pending. Claims 1-23, 25, 33-34, 37 and 39-44 are canceled. Claim 24 has been amended
4. Claims 24, 26-32, 35-36 and 38 are under examination.
Rejections Withdrawn
5. The provisional rejection of claims 24, 26-32 and 38 on the ground of nonstatutory double patenting as being unpatentable over claims 31-50 of copending Application No. 17/921,128 is withdrawn in view of applicant’s amendments.
6. The provisional rejection of claims 24, 26-32 and 38 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 10-12, 14-20 and 24 of copending Application No. 17/927,919 is withdrawn in view of applicant’s amendments.
7. The rejection of claims 24, 26-32, 35-36 and 38 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,426,740B1 (PTO 892 dated 2/27/2024), in view of Burt et al. (Blood, 1998, 92(10): 3505-3514, PTO 892 dated 2/27/2024) and Chow et al. (US 2003/0099621A, pub. date: 5/29/2003, PTO 892 dated 2/27/2024) is withdrawn upon further consideration.
Rejections Maintained
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 24, 26-32, 35-36 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deisher (US 2012/0045435A1, pub. date: 2/23/2012, PTO 892 dated 2/27/2024).
Regarding claims 24, 26-32, 35-36 and 38, Deisher teaches a method of preconditioning a patient suffering from an autoimmune disease or infectious disease, the method comprising administering to the patient a therapeutic agent that inhibits binding of stem cells to lymphoid tissue, the therapeutic agent is a glucocorticoid such as dexamethasone, dexamethasone can be given 1-14 days, 3-7 days or 3-4 days prior to treatment with stem cells (preconditioning the patient for adoptive cellular therapy), the daily dose of dexamethasone can be for example 700 mg (claims 12, and [0044], [0184]). For a patient with a body weight of 50-70 kg, the dose would be 10-14 mg/kg. Deisher does not disclose that a chemotherapeutic agent is administered with dexamethasone (Example 8). A daily dose of 700 mg of dexamethasone (which is 10-14 mg/kg for a patient with a body weight of 50-70 kg) would inherently cause lymphodepletion and/or ablation of secondary lymphatic germinal centers. Deisher teaches that the autoimmune disease is multiple sclerosis, lupus erythematosus, type 1 diabetes (claim 12), and the patient is human ([0037]).
The limitation “in need of CAR therapy” does not differentiate the patient of the claims from the patient of the prior art because they all have same type of autoimmune disease, i.e. multiple sclerosis, lupus erythematosus, or type 1 diabetes. Patients suffering from autoimmune disease or infectious disease such as multiple sclerosis, lupus erythematosus or type 1 diabetes are considered in need of CAR therapy. The claimed method does not differentiate from the method of the prior art which comprises administering same drug (e.g. dexamethasone) at same dose (as claimed) to same patient (patients suffering type 1 diabetes, or multiple sclerosis).
Applicant’s Arguments
The response states that the Deisher publication fails to teach or suggest preconditioning a patient in need of administration of CAR-T cells or CAR-natural killer
(NK) cells for the treatment of the claimed autoimmune diseases or the infectious diseases.
Examiner’s Response
Applicant’s arguments have been carefully considered but are not persuasive. The limitation “in need of CAR therapy” does not differentiate the patient of the claims from the patient of the prior art because they all have same type of autoimmune disease, i.e. multiple sclerosis, lupus erythematosus, or type 1 diabetes. Patients suffering from autoimmune disease or infectious disease such as multiple sclerosis, lupus erythematosus or type 1 diabetes are considered in need of CAR therapy. The claimed method does not differentiate from the method of the prior art which comprises administering same drug (e.g. dexamethasone) at same dose (as claimed) to same patient (patients suffering type 1 diabetes, or multiple sclerosis).
Double Patenting
10. 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.
11. Claims 24, 26-32, 35-36 and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,446,314B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the patent disclose a method of treating a lymphocyte mediated disease in a subject, comprising administering a pharmaceutical composition comprising dexamethasone or betamethasone and one or more pharmaceutically acceptable carriers, preservatives, and/or chelating agents, to the subject at a dose of about 9 to about 26 mg/kg human equivalent dose (HED) of dexamethasone base, wherein administering the pharmaceutical composition depletes splenic, peripheral blood, thymic and bone marrow lymphocytes in the subject by at least 50%; wherein the method does not comprise co-administration of a chemotherapy agent; and
wherein the lymphocyte mediated disease is an autoimmune disease, residual HIV disease, wherein the glucocorticoid is dexamethasone, the autoimmune disease is type 1 diabetes or multiple sclerosis.
wherein the dexamethasone is selected from dexamethasone base, dexamethasone sodium phosphate and dexamethasone acetate,
wherein the pharmaceutical composition is administered as a single acute dose or a total dose given over about a 72 hour period,
wherein the pharmaceutical composition is administered at a dose of at least about 9 mg/kg, at least about 10 mg/kg, at least about 11 mg/kg, at least about 12 mg/kg, at least about 15 mg/kg, at least about 18 mg/kg, or at least about 24 mg/kg of a human equivalent dose (HED) of dexamethasone base.
The limitation “in need of CAR therapy” does not differentiate the patient of the claims from the patient of the patent because they all have same type of autoimmune disease, i.e. type 1 diabetes, multiple sclerosis, or HIV disease. The subject suffering from type 1 diabetes, multiple sclerosis, or residual HIV disease is considered as in need of CAR therapy. The claimed method does not differentiate from the method of the patent which comprises administering same drug (e.g. dexamethasone) at same dose (as claimed) to same patient (patients suffering type 1 diabetes, multiple sclerosis or HIV infection).
Applicant’s Arguments
Applicant submits that the '314 Patent is not a proper reference to support a nonstatutory double patenting because the effective filing date of the '314 Patent is October 3, 2018, which is after the effective filing date of the present application, which is April 1, 2017. There is no indication that a patent issuing from the present application would expire after the expiration of the '314 Patent. Thus, there is no unjustified or improper timewise extension of the right to exclude if the present claims are allowed, which is the public policy behind the doctrine of double patenting.
Examiner’s Response
Applicant’s arguments have been carefully considered but are not persuasive. While it’s true that “preventing the unjustified extension of patent exclusivity beyond the term of a patent” is one of the goals for double patenting rejections, it is NOT the only goal. See In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (“There are two justifications for obviousness-type double patenting. The first is "to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about." Van Ornum, 686 F.2d at 943-44 (quotation and citation omitted). The second rationale is to prevent multiple infringement suits by different assignees asserting essentially the same patented invention. Fallaux, 564 F.3d at 1319 (recognizing that "harassment by multiple assignees" provides "a second justification for obviousness-type double patenting"); see also Chisum on Patents § 9.04[2][b][ii] ("The possibility of multiple suits against an infringer by assignees of related patents has long been recognized as one of the concerns behind the doctrine of double patenting.") … .”). For the foregoing reasons, the rejection is deemed proper and is therefore maintained.
12. Claims 24, 26-32, 35-36 and 38 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,048,705 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the patent disclose a method of treating a lymphocyte mediated disease in a subject, comprising administering a pharmaceutical composition comprising a glucocorticoid and one or more pharmaceutically acceptable carriers, preservatives, and/or chelating agents to the subject to deliver the glucocorticoid at a dose equivalent to 6-26 mg/kg human equivalent dose (HED) of dexamethasone base, wherein the lymphocyte mediated disease is selected from: an autoimmune disease, cancer, residual HIV disease, graft versus host disease, and an allergic disorder,
wherein the lymphocyte mediated disease is an autoimmune disease selected from Type 1 diabetes, multiple sclerosis, amyotrophic lateral sclerosis, scleroderma, pemphigus, and lupus,
wherein the glucocorticoid comprises dexamethasone,
wherein the pharmaceutical composition is administered at a dose equivalent to at least about 7 mg/kg, at least about 8 mg/kg, at least about 9 mg/kg, at least about 10 mg/kg, at least about 11 mg/kg, at least about 12 mg/kg, at least about 15 mg/kg, at least about 18 mg/kg, or at least about 24 mg/kg of a human equivalent dose (HED) of dexamethasone base.
The limitation “in need of CAR therapy” does not differentiate the patient of the claims from the patient of the patent because they all have same type of autoimmune disease, i.e. type 1 diabetes, multiple sclerosis, or HIV disease. The subject suffering from type 1 diabetes, multiple sclerosis, or residual HIV disease is considered as in need of CAR therapy. The claimed method does not differentiate from the method of the patent which comprises administering same drug (e.g. dexamethasone) at same dose (as claimed) to same patient (patients suffering type 1 diabetes, multiple sclerosis or HIV infection).
Applicant’s Arguments
Applicant submits that the '705 Patent is not a proper reference to support a nonstatutory double patenting because the effective filing date of the '705 Patent is October 3, 2018, which is after the effective filing date of the present application, which is April 1, 2017. Here again, there is no indication that a patent issuing from the present application would expire after the expiration of the '705 Patent, and there is no indication that there would be an unjustified or improper timewise extension of the right to exclude if the present claims are allowed.
Examiner’s Response
Applicant’s arguments have been carefully considered but are not persuasive. While it’s true that “preventing the unjustified extension of patent exclusivity beyond the term of a patent” is one of the goals for double patenting rejections, it is NOT the only goal. See In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (“There are two justifications for obviousness-type double patenting. The first is "to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about." Van Ornum, 686 F.2d at 943-44 (quotation and citation omitted). The second rationale is to prevent multiple infringement suits by different assignees asserting essentially the same patented invention. Fallaux, 564 F.3d at 1319 (recognizing that "harassment by multiple assignees" provides "a second justification for obviousness-type double patenting"); see also Chisum on Patents § 9.04[2][b][ii] ("The possibility of multiple suits against an infringer by assignees of related patents has long been recognized as one of the concerns behind the doctrine of double patenting.") … .”). For the foregoing reasons, the rejection is deemed proper and is therefore maintained.
13. Claims 24, 26-32, 35-36 and 38 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31 and 40-51 of copending Application No. 17/801, 293. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31 and 40-51 of copending Application No. 17/801, 293 disclose a method of treating autoimmune disease, or infectious disease in a subject, the method comprising administering to a subject a glucocorticoid receptor (GR) modulating agent at a dose equivalent to about at least 6 mg/kg human equivalent dose (HED) of dexamethasone base, isolating a population of NKT cells from the subject or from a sample derived from the subject-optionally wherein the step of isolating is performed: i) at least18 hours after glucocorticoid administration; or ii) between18 hours and 13 days after glucocorticoid administration, administering a therapeutically effective dose of the isolated NKT cells to the subject, wherein a glucocorticoid receptor (GR) modulating agent is a glucocorticoid and is administered at a dose equivalent to about 6-45 mg/kg or 6-12 mg/kg human equivalent dose (HED) of dexamethasone base, the glucocorticoid is selected from dexamethasone, hydrocortisone, methylprednisolone, prednisone, prednisolone, prednylidene, cortisone, budesonide, betamethasone, flumethasone and beclomethasonek, wherein the autoimmune diseases is multiple sclerosis, or type 1 diabetes.
The limitation “in need of CAR therapy” does not differentiate the patient of the claims from the patient of the copending application because they all have same type of autoimmune disease, i.e. type 1 diabetes, multiple sclerosis. The subject suffering from type 1 diabetes, multiple sclerosis is considered as in need of CAR therapy. The claimed method does not differentiate from the method of the patent which comprises administering same drug (e.g. dexamethasone) at same dose (as claimed) to same patient (patients suffering type 1 diabetes, or multiple sclerosis).
Applicant’s Arguments
The claims of the reference patent application do not teach or suggest preconditioning in a patient in need of CAR therapy and thus do not render the instant claims obvious. Moreover, as previously argued, the effective filing date of the present application is April 1, 2017, while the effective filing date of US Application No. 17/801,293 is February 28, 2020. See MPEP § 804(B)(1)("If a 'provisional' nonstatutory double patenting rejection is the only rejection remaining in an application having the earliest effective U.S. filing date (including any benefit claimed under 35 U.S.C. 120, 121, 365(c), or 386(c)) compared to the reference application(s), the examiner should withdraw the rejection in the application having the earliest effective U.S. filing date and permit that application to issue as a patent..."). See Response filed March 18, 2025; Response filed October 1, 2024; and Response filed May 23, 2024.
Examiner’s Response
Applicant’s arguments have been carefully considered but are not persuasive. The limitation “in need of CAR therapy” does not differentiate the patient of the claims from the patient of the copending application because they all have same type of autoimmune disease, i.e. type 1 diabetes, multiple sclerosis. The subject suffering from type 1 diabetes, multiple sclerosis is considered as in need of CAR therapy. The claimed method does not differentiate from the method of the patent which comprises administering same drug (e.g. dexamethasone) at same dose (as claimed) to same patient (patients suffering type 1 diabetes, or multiple sclerosis).
Furthermore, the instant rejection is not an only rejection remaining in the application as this time, as such cannot be withdrawn..
14. Claims 24, 26-32, 35-36 and 38 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 9, 14, 21 and 40-42 of copending Application No. 18/683,814. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of copending application disclose a method of producing a population of natural killer T-cell like cells (NKT-like cells), the method comprising administering to a human subject a glucocorticoid-receptor (GR) modulating agent at a dose equivalent to about at least 6 mg/kg human equivalent dose (HED) of dexamethasone base;
wherein the glucocorticoid-receptor (GR) modulating agent is a glucocorticoid, the glucocorticoid is dexamethasone, hydrocortisone, methylprednisolone, prednisone,
wherein the glucocorticoid is administered at a dose equivalent to about: i) at least 6-12 mg/kg human equivalent dose (HED) of dexamethasone base; ii) at least 6 mg/kg human equivalent dose (HED) of dexamethasone base; iii) at least 12 mg/kg human equivalent dose (HED) of dexamethasone base; iv) at least 15 mg/kg human equivalent dose (HED) of dexamethasone base; v) at least 21 mg/kg human equivalent dose (HED) of dexamethasone base; vi) at least 24 mg/kg human equivalent dose (HED) of dexamethasone base; vii) 15 mg/kg human equivalent dose (HED) of dexamethasone base; viii) 24 mg/kg human equivalent dose (HED) of dexamethasone base; or ix) 45 mg/kg human equivalent dose (HED) of dexamethasone base,
wherein the method further comprising a step of administering an NKT cell activator, T cell activator, and / or NK cell activator to the subject,
wherein the subject has, is suspected of having, or has been diagnosed with a disease selected from the group consisting of: cancer, autoimmune disease, or infectious disease,
wherein the autoimmune disease is selected from the group consisting of: multiple sclerosis, systemic sclerosis, amyotrophic lateral sclerosis, type 1 diabetes mellitus, scleroderma, pemphigus, and lupus; or (b) the infectious disease is HIV or a disease resulting from infection with a coronavirus, such as COVID-19.
The limitation “in need of CAR therapy” does not differentiate the patient of the claims from the patient of the copending application because they all have same diseases i.e. multiple sclerosis, type 1 diabetes, or HIV disease. The subject suffering from these diseases is considered as in need of CAR therapy. The claimed method does not differentiate from the method of the patent which comprises administering same drug (e.g. dexamethasone) at same dose (as claimed) to same patient (patients suffering multiple sclerosis, type 1 diabetes, HIV infection).
Applicant’s Arguments
The claims of the reference patent application do not teach or suggest preconditioning in a patient in need of CAR therapy and thus do not render the instant claims obvious. Moreover, the effective filing date of the present application is April 1, 2017, while the effective filing date of US Application No. 18/683,814 is September 1, 2021. The present application is the earlier- filed application, and the provisional obviousness-type double patenting rejection should be withdrawn once the present claims are otherwise allowable.
Examiner’s Response
Applicant’s arguments have been carefully considered but are not persuasive. The limitation “in need of a CAR therapy” does not differentiate the patient of the claims from the patient of the copending application because they all have same diseases i.e. multiple sclerosis, type 1 diabetes, or HIV disease. The subject suffering from these diseases is considered as in need of CAR therapy. The claimed method does not differentiate from the method of the patent which comprises administering same drug (e.g. dexamethasone) at same dose (as claimed) to same patient (patients suffering multiple sclerosis, type 1 diabetes, HIV infection).
Furthermore, the instant rejection is not an only rejection remaining in the application as this time, as such cannot be withdrawn.
Examiner Notes:
Applicant’s arguments with respect to enablement rejection have not been considered at this time because the claims as currently amended do not require an active step of administration of CAR-T cells or CAR-natural killer (NK) cells to the patient to treat systemic lupus erythematosus, multiple sclerosis, arthritis, type 1 diabetes, human immunodeficiency virus, influenza or hepatitis. The claims only recite “a patent suffering from an autoimmune disease or an infectious disease and in need of CAR therapy”.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1643