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 .
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 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.
Election/Restrictions
Applicant’s election of Group I (claims 1-5, 14-16), and “multiple sclerosis (MS)” in the reply filed on 05/04/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The elected species MS reads on claims 1-5, 14-16, and new claims 18-20. New claims 21 and 22, drawn to different conditions (RA and T1D) are withdrawn from consideration. Claims to RA and T1D have been crafted from species addressed in the restriction requirement of 3/3/26.
The prior art search of treating the elected species MS using sunitinib retrieved prior art (discussed below).
Status of the Claims
Claims 1-5, 14-16 and 18-20 have been examined on the merits.
Claims 18-22 are new. Claims 6-13 and 17 are canceled. New claims 21 and 22 are withdrawn. Claims 1-5, 14-16 are currently amended.
Priority
8. This application is a 371 of PCT/US2022/035290, filed 06/28/2022 and claims priority to US provisional 63215866, filed 06/28/2021. The effective filing date is 06/28/2021.
Information Disclosure Statement
9. The information disclosure statement (IDS) submitted on 05/04/2026, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
10. The abstract of the disclosure is objected to because the presence of a trademark of “(or SUTENTTM)” renders the abstract indefinite. The composition of a trademark could change over time. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
11. Claim 5 is objected to because of the following informalities:
(1). “The method of any of 1” should read “The method of claim 1”.
(2). Duplicate of a syringe, a cartridge, a disposable pen or jet injector.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
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.
12. Claim(s) 1-2 and 18, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HIESTAND (WO 2008/031835 A2).
The instant claims are drawn generally to treating a hyperactive ZAP70 kinase-related disease/condition comprising administration of sunitinib, one disease/condition being multiple sclerosis (MS).
HIESTAND teaches treating MS (claim 3) with sunitinib (claim 6, depending from claim 4) in a human (claim 7). HIESTAND also teaches the manufacture of a medicament comprising sunitinib for use in the treatment of autoimmune disease (e.g. claims 9 and 10).
It is noted that applicant’s claims are characterizing MS a hyperactive ZAP70 related disease/condition, and MS, an autoimmune disease, requires an allogenic HCT (as in instant claim 3, based on the election and identification of claims readable on the invention). Here, both the prior art and the instant claims are treating the same patient population- patients with MS, with the same drug- sunitinib.
Thus, claims 1-2 and 18, 20 are anticipated by HIESTAND.
Claim Rejections - 35 USC § 103
13. 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.
14. Claim(s) 1-2, 4-5, 14-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over TANG (US7572924 A1. Referenced in IDS of 12/28/2023) in view of SMALL (WO 2006/020145 A2/) and SHIFA (Shifa et al “Efficacy of Allogeneic Hematopoietic Cell Transplantation for Autoimmune Diseases” Transplantation and Cellular Therapy 27 (2021) 489.e1-489.e9. pub date: 21 March 2021) for claim 19.
Determining the scope and contents of the prior art
TANG teaches a method for treating disorders/disease by modulating protein kinase (PK) activity (Lns. 63-66, Col 3). The method comprising: administering to an individual in need thereof a formulation or product of manufacture (administering a pharmaceutical composition comprising a compound of Formula (I), Lns. 55-57, Col 5) comprising sunitinib, or salts or formulations thereof, preferably hydrochloric acid or (L)-malic acid such as the L-malate salt of 5-(5-fluoro-2-oxo-1,2 dihydroindol-3-ylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide. (sunitinib malate, Lns. 53-57, Col 14). Such diseases include … immune logical disease such as autoimmune disease… (Lns. 57-60, Col 5).
SMALL teaches methods for suppressing the immune response of a cell by decreasing its ability to activate T cells and treating immune related disorders (Ln 8-9, p 2). The small molecule is selected from one or more … SU11248 (sunitinib malate)… (Ln 1-2, p 3). The immune related disorder is one or more of … multiple sclerosis … (Lns 1-9, p 8). SU11248 is highlighted (1st compound, p 5; 3rd compound, p 29 and 1st compound, claim 12, p 56) among several compounds for the treatment.
SHIFA teaches the summary findings of long-term remission after HCT treatment of autoimmune disease (including, but not limited to, RA, MA, T1D etc) (see Table 1) –
for claim 19 only.
Ascertaining the differences between the prior art and the claims at issue
The claims are generally drawn to using the FDA-approved cancer drug sunitinib to treat diseases driven by overactive ZAP70 kinase and hyperactive T cells comprising autoimmune disease, transplant rejection, graft-versus-host disease, etc. The composition can be delivered in many pharmaceutical forms, including oral, topical, injectable, liposomal, or nanoparticle formulations and different kits, devices, and dosage regimens for administration.
TANG teaches a method for treating disorders/disease by modulating protein kinase (PK) activity (Lns. 63-66, Col 3) including autoimmune disease in general, but doesn’t specify multiple sclerosis and other species in particular.
SMALL teaches methods for suppressing the immune response to treat multiple sclerosis and other disease species within the genus of autoimmune disease using SU11248 (Ln 1-2, p 3), which cures the defects of TANG’s teaching.
Considering objective evidence present in the application indicating obviousness or nonobviousne
Regarding claims 1 and 14, TANG teaches a method for treating disorders/ diseases by modulating protein kinase (PK) activity using SU11248 (sunitinib malate), thus making obvious of claims 1 and 14.
Regarding claims 2, 18 and 20 drawn to the diseases treated, Tang teaches the diseases comprise an autoimmune disease (Lns. 57-60, Col 5), an organ transplant rejection (Mesangial proliferative disorders include transplant rejection, Lns. 34-38, Col 117), and chronic lymphocytic leukemia (CLL) (Ln 9, Col 124). The compounds are therefore useful in treating disorders related to abnormal PK activity, Col. 1, Lns. 24-26; Zap70 has been implicated in T-cell signaling which may relate to autoimmune disorders (Lns. 59-60, Col 118). SMALL teaches the immune related disorder is one or more of organ rejection, bone marrow transplant rejection, non-myeloablative bone marrow transplant rejection,… type 1 diabetes mellitus, … graft-versus-host disease, … rheumatoid arthritis, Crohn's disease, multiple sclerosis, … among other autoimmune diseases (Ln 1-9, p 8). Thus, claims 2, 18 and 20 are obvious over TANG in view of SMALL.
Regarding Claims 4, 5, 15 and 16 directing to drug administration routes, pharmaceutical formulation and delivery device, TANG teaches the formulation or product of manufacture is administered by inhalation (For administration by inhalation, the compounds are delivered in the form of an aerosol spray using a pressurized pack or a nebulizer and a suitable propellant, Lns. 67-68, Col 120 - Lns. 1-2, Col 121), intravenously (IV) (Suitable routes of administration may include intravenous, Lns. 32-35, Col 119), intradermally, intrathecally (intrathecal, Lns. 34-35, Col 119), sub- or intra-dermally, topically intramuscularly (IM) (by intramuscular injection, Ln. 44, Col 121), or for enteral or parenteral administration (The preferred routes of administration are oral and parenteral, Lns. 36-37, Col. 119), or as a tablet (the compounds of the invention to be formulated as tablets, Ln. 1, Col. 120), pill, capsule lozenge, gel (Ln. 2, Col 120), hydrogel, liquid, lotion, aerosol (For administration by inhalation, the compounds for use according to the present invention are conveniently delivered in the form of an aerosol spray using a pressurized pack or a nebulizer and a suitable propellant, Lns. 67-68, Col 120 - Lns. 1-2, Col 121), patch, spray (aerosol spray, Ln. 1, Col 121), or implant (the compounds may also be formulated as depot preparations. Such long-acting formulations may be administered by implantation, Lns. 40-43, Col 121), and optionally the formulation is formulated as a liposome (in a liposome coated with tumor-specific antibody, Lns. 42-44, Col 119)
TANG also teaches the method of administering sunitinib, or salt using: a kit, a device (Lns. 39-45. Col 123), a subcutaneous infusion device, a continuous subcutaneous infusion device, an infusion pen, a needle, a syringe, an ampoule, a vial, a reservoir, a disposable pen or jet injector, a pen (The compounds may also be formulated for parenteral administration, e.g., by bolus injection or continuous infusion. Formulations for injection may be presented in unit dosage form, e.g., in ampoules or in multi-dose containers. Lns. 11-14, Col 121) , a cartridge (Capsules and cartridges of for example, gelatin for use in an inhaler. Lns. 6-7, Col 121), an implant (Lns. 40-43, Col 121). So, claims 4, 5, 15 and 16 are obvious over TANG.
Regarding claim 19, SHIFA teaches the HCT treatment of patients with autoimmune disease (including, but not limited to, RA, MA, T1D etc) (see Table 1). Thus, claim 19 is obvious over TANG and SHIFA.
Therefore, the instant claims are prima facie obvious TANG in view of SMALL and SHIFA.
15. Claim(s) 1-4, 14-16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over HIESTAND (WO 2008/031835 A2). Referenced in IDS of 12/28/2023) in view of VALIANTE (WO 2006/002422 A2) further in view of JENSEN (WO 2013/135800) for claim 16 and SHIFA (shifa et al “Efficacy of Allogeneic Hematopoietic Cell Transplantation for Autoimmune Diseases” Transplantation and Cellular Therapy 27 (2021) 489.e1-489.e9. pub date: 21 March 2021) for claim 19.
Determining the scope and contents of the prior art
HIESTAND’s teachings are presented above.
VALIANTE teaches a method of treating a subject suffering from an autoimmune disease, comprising administering to a subject in need thereof, a compound selected from the group consisting of … SU-11248,…. In a more particular embodiment said autoimmune disease is … or Crohn's disease, or Ulcerative Colitis, or diabetes, or Graft Versus Host Disease (GVHD), … or Multiple Sclerosis (para [00373], p 65). SU-11248 is the malate salt of sunitinib.
VALIANTE further teaches that the compounds may be administered enterally, orally, parenterally, sublingually, by inhalation spray, rectally, or topically … suitable modes of administration include oral, subcutaneous, transdermal, transmucosal,
iontophoretic, intravenous, intramuscular, intraperitoneal, intranasal, subdermal, rectal, and the like. Topical administration may also involve the use of transdermal administration such as transdermal patches or ionophoresis devices. The term parenteral as used herein includes subcutaneous injections, intravenous, intramuscular, intrastemal injection, or infusion techniques (para [00440], p 84-85).
JENSEN teaches liposomal drug delivery systems. It claims as an alternative sunitinib/SU-11248 in the composition (claim 28), where it is for IV administration (claim 34), and the delivery is for treating an autoimmune disease (e.g. claim 37) including rheumatoid arthritis, MS, Crohn's disease, ulcerative colitis, etc.(e.g. claim 46).
SHIFA teaches the summary findings of long-term remission after HCT treatment of autoimmune disease (including, but not limited to, RA, MA, T1D etc) (see Table 1) – for claim 19 only.
Ascertaining the differences between the prior art and the claims at issue
The instant claims are generally drawn to treat disease/condition related to hyperactive ZAP70 kinase comprising administration of sunitinib or a salt thereof, one disease/condition being autoimmune disease.
HIESTAND teaches treating MS (claim 3) with sunitinib (claim 6, depending from claim 4) in a human (claim 7). HIESTAND also teaches the manufacture of a medicament comprising sunitinib for use in the treatment of autoimmune disease (e.g. claims 9 and 10). HIESTAND doesn’t teach dosage forms, delivery device or formulations.
VALIANTE teaches a method of treating a subject suffering from an autoimmune disease, comprising administering to a subject in need thereof, using SU-11248. VALIANTE also teach dosage forms, delivery device and formulations. But, VALIANTE doesn’t teach the liposome formulation.
JENSEN teaches liposomal drug delivery systems. It claims as an alternative sunitinib/SU-11248 in the composition (claim 28), where it is for IV administration (claim 34), and the delivery is for treating an autoimmune disease.
A combination of VALIANTE and JENSEN teachings cures the defects of HIESTAND on the drug’s dosage forms, delivery device or formulations.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Regarding claims 1-3, 14, 18 and 20 of treating disease using sunitinib/sunitinib malate, HIESTAND teaches treating MS (claim 3) with sunitinib (claim 6, depending from claim 4) and the manufacture of a medicament comprising sunitinib for use in the treatment of autoimmune disease (e.g. claims 9 and 10). VALIANTE teaches a method of treating a subject suffering from an autoimmune disease comprising Crohn's disease, Ulcerative Colitis, diabetes, Graft Versus Host Disease (GVHD), Multiple Sclerosis, by administering to a subject in need thereof, a compound selected from the group consisting of … SU-11248 (malate salt of sunitinib) (para [00373], p 65). JENSEN teaches liposomal drug delivery systems for treating an autoimmune disease (e.g. claim 37) including rheumatoid arthritis, MS, Crohn's disease, ulcerative colitis, etc.(e.g. claim 46).
It is noted that Graft Versus Host Disease (GVHD) (cited in instant claim 2) occurs exclusively after an allogeneic Hematopoietic Cell Transplant (HCT) (cited in instant claim 3). Treating GVHD means a patent has been gone HCT. Claim 3 is inherent to claim 2.
Therefore, claims 1-3, 14, 18 and 20 are obvious over a combination of VALIANTE, JENSEN and HIESTAND.
Regarding claims 4 and 15 of pharmaceutical formulations and drug delivery, VALIANTE teaches that in treating disease the compounds may be administered enterally, orally, parenterally, sublingually, by inhalation spray, rectally, or topically … suitable modes of administration include oral, subcutaneous, transdermal, transmucosal, iontophoretic, intravenous, intramuscular, intraperitoneal, intranasal, subdermal, rectal, and the like. Topical administration may also involve … transdermal patches or ionophoresis devices. The term parenteral as used herein includes subcutaneous injections, intravenous, intramuscular, intrasternal injection, or infusion techniques (para [00440], p 84-85). So, claims 4 and 15 are obvious over VALIANTE.
Regarding claim 16, JENSEN teaches liposomal drug delivery systems of sunitinib/SU-11248 in the composition (claim 28), where it is for IV administration (claim 34), and the delivery is for treating an autoimmune disease. Thus, claim 16 is obvious over JENSEN.
Regarding claim 19, SHIFA teaches the HCT treatment of patients with autoimmune disease (including, but not limited to, RA, MA, T1D etc) (see Table 1). Thus, claim 19 is obvious over VALIANTE and SHIFA.
Therefore, the instant claims are prima facie obvious over HIESTAND in view of VALIANTE further in view of JENSEN and SHIFA.
Conclusion
16. No claims are allowable as presently written.
17. Art to make of record, US 20050152943 A1- teaches SU-11248 as an implantable medical device for treating restenosis.
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/B.T./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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