The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Applicant’s amendment, filed 07/30/2025, has been entered.
Claims 1-61 have been canceled.
Claims 62-82 are pending and currently under examination as they read on a method for treating lupus nephritis comprising administering obinutuzumab.
Independent Claims
Claim 62. A method for treating lupus nephritis in an individual that has active lupus nephritis, comprising administering to the individual at least a first antibody exposure to obinutuzumab and a second antibody exposure to obinutuzumab;
wherein the first antibody exposure comprises two doses of obinutuzumab administered about 2 weeks apart, wherein both doses of the first antibody exposure are about 1000mg of obinutuzumab administered intravenously;
wherein the second antibody exposure comprises two doses of obinutuzumab administered about 2 weeks apart, wherein both doses of the second antibody exposure are about 1000mg of obinutuzumab administered intravenously;
wherein the first dose of the second antibody exposure is not provided until about 24 weeks after the first dose of the first antibody exposure; and
wherein the individual is a human.
Claim 74. A method for treating lupus nephritis in an individual that has active class III or class IV lupus nephritis, comprising administering to the individual: (a) at least a first antibody exposure to obinutuzumab and a second antibody exposure to obinutuzumab, and (b) a standard of care treatment; wherein the first antibody exposure comprises two doses of obinutuzumab administered about 2 weeks apart, wherein both doses of the first antibody exposure are about 1000mg of obinutuzumab administered intravenously;
wherein the second antibody exposure comprises two doses of obinutuzumab administered about 2 weeks apart, wherein both doses of the second antibody exposure are about 1000mg of obinutuzumab administered intravenously;
wherein the first dose of the second antibody exposure is not provided until about 24 weeks after the first dose of the first antibody exposure; and
wherein the individual is a human.
Claim 82. A method for treating lupus nephritis in an individual that has active class III or class IV lupus nephritis, comprising administering to the individual: (a) at least a first antibody exposure to obinutuzumab and a second antibody exposure to obinutuzumab, (b) mycophenolate mofetil (MMF), and (c) a glucocorticoid or corticosteroid;
wherein the first antibody exposure comprises two doses of obinutuzumab administered about 2 weeks apart, wherein both doses of the first antibody exposure are about 1000mg of obinutuzumab administered intravenously;
wherein the second antibody exposure comprises two doses of obinutuzumab administered about 2 weeks apart, wherein both doses of the second antibody exposure are about 1000mg of obinutuzumab administered intravenously;
wherein the first dose of the second antibody exposure is not provided until about 24 weeks after the first dose of the first antibody exposure;
wherein the individual is a human; and wherein the method results in the individual achieving a urinary protein to creatinine ratio (UPCR) of <0.5g/g.
Claim Rejections - 35 USC § 103
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.
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.
Claims 62-82 are rejected under 35 U.S.C. 103 as being unpatentable over Brunetta et al. (US 20060024295) in view of Reddy et al. (Annals of the Rheumatic Diseases 2013; 72:A162), Bai et al. (Clin Pharmacokinet 2012; 51:119-135) and Totoritis et al. (US 2009/0238762 A1).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The present claims are directed to a method for treating lupus nephritis comprising administering a first and a second antibody exposures to obinutuzumab wherein the first exposure and the second exposure each comprises two doses of obinutuzumab that are two weeks apart and the two exposures are 24 weeks apart. It is noted that obinutuzumab is a type II anti-CD20 antibody, aka GA101.
Brunetta et al. taught a method for treating lupus nephritis in individual with active lupus comprising administering an anti-CD20 antibody intravenously in two exposures, wherein each exposure comprises two separate doses of the antibody (see, e.g., claim 1 and paragraphs 0105-0106, 0109, 0261). Furthermore, Brunetta taught that the two exposures are 24 weeks apart and each dose is about 14 days apart (see paragraphs 0105-0106). Furthermore, Brunetta taught class III or class IV lupus nephritis and further administering an immunosuppressive agent that is mycophenolate mofetil, a mycophenolic acid, or prednisone (paragraph 0025, 0085 0087, 0236). Moreover, Brunetta taught that the primary goal of the treatment method is to achieve complete renal response measured in urinary protein to creatinine ratio < 0.5 (paragraphs 0026-0230).
Brunetta differs from the present claims in the antibody. Brunetta taught using rituximab, a type I anti-CD20 antibody, whereas the present claims recite obinutuzumab, a type II anti-CD20 antibody. However, it would have been obvious to substitute the antibody taught in Brunetta for obinutuzumab because Reddy et al. taught that Obinutuzumab is superior to type I anti-CD20 antibody at inducing in vitro cytotoxicity in B cells from SLE patients (see entire document). Upon reading the teaching of Reddy et al., one of ordinary skill in the art would have been motivated to use obinutuzumab for treating SLE patients and thereby ameliorate or delaying the onset of lupus nephritis because Reddy taught that obinutuzumab would provide higher efficacy in B cell depletion. Therefore, it would have been obvious to treat SLE or lupus nephritis comprising administering obinutuzumab in the method treating lupus nephritis according to the teachings of Brunetta.
With regards to the dosing regimen as recited in the present claims, i.e., two exposures of the antibody, wherein each exposure comprises one or two doses of about 1000 mg each at about 2 weeks apart, it is noted that determination of dosing regimen is routinely determined by the ordinary artisan as of the effective filing date of the claimed invention and was known as result effective variables that depend on the conditions of the patients and pharmacokinetics. For example, Bai et al. taught that determination of the dosing regimen of monoclonal antibody therapies would depend on multiple factors including pharmacokinetics, pharmacodynamics, exposure-response (efficacy/safety) relationship, disease burden, patient characteristics, compliance and pharmacoeconomics (see, e.g., Introduction). The multitude of monoclonal antibodies shown in Table I of Bai supports that dosing regimen is a result effective variable and can be assessed as part of technical skill of ordinary artisan in the pertinent art. Moreover, Brunetta et al. (US 20060024295) has shown similar dosing regimen for another anti-CD20 monoclonal antibody for treating lupus nephritis with respect to two exposures and two dosages within each exposure (see, e.g., Treatment section starting paragraph [0102]). Therefore, the recited dosing regimen in the present claims would be obvious to one of ordinary skill in the art through routine practice. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). One of ordinary skill in the art would appreciate the amount or dosage of the antibody in the therapy could be adjusted to achieve optimum therapeutic efficacy.
With regards to the administration of methylprednisolone, diphenhydramine and acetaminophen prior to intravenous administration of the antibody, it is note that such premedication is part of standard of care treatment for antibody infusion well-known in the art before the effective filing date of the claimed invention. For example, Totoritis et al. taught that premedication with 1000 mg oral acetaminophen and 50 mg oral diphenhydramine is recommended for all subjects, and 100 mg IV methylprednisolone to be completed within 30-60 minutes prior to each rituximab/placebo infusion is required (paragraph 0679). Moreover, Brunetta taught that 80-120 mg i.v. methylprednisolone was administered before the infusion of the antibody (paragraph 0110). Therefore, one of ordinary skill in the art would have been motivated to use the standard of care taught by Totoritis et al. for the i.v. infusion of obinutuzumab.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 62-82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 7-8, 10, 15-16, 18, 20, 22, 24, 26, 28-29, 42, 43, 54, 87, 93-95, 100, 107, 109, 112 of copending Application No. 18/465,854 and claims 114, 171-198 of copending Application 18/814,259. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims disclosed the same method of treating LN comprising administering 2 exposures of obinutuzumab and further comprising administering mycophenolate mofetil, and the same premedication.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/SHARON X WEN/Primary Examiner, Art Unit 1641
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