DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 06/26/2023, has been entered.
Claims 1, 4, 6-7, 15, 18, 20-22, 31-37 are pending and currently under examination.
Independent Claims
1. (Currently Amended) A method of treating celiac disease or non-celiac gluten sensitivity in a subject in need thereof, comprising administering a therapeutically effective amount of an anti-IL-15 antibody or antigen-binding fragment thereof to the subject, wherein the therapeutically effective amount comprises 1-20 unit doses each administered at about [[1- 12]]2 week intervals, each unit dose independently comprising about , wherein the anti- IL-15 antibody or antigen-binding fragment thereof comprises a heavy chain variable region comprising complementarity determining regions (CDRs) set forth in SEQ ID NOs: 5-7, and a light chain variable region comprising CDRs set forth in SEQ ID NOs: 8-10.
15. (Currently Amended) A method of treating refractory celiac disease in a subject in need thereof, comprising administering a therapeutically effective amount of an anti-IL-15 antibody or antigen-binding fragment thereof to the subject, wherein the therapeutically effective amount comprises 1-20 unit doses each administered at about [[1-12]] 2 week intervals, each unit dose , wherein the anti-IL-15 antibody or antigen-binding fragment thereof comprises a heavy chain variable region comprising complementarity determining regions (CDRs) set forth in SEQ ID NOs: 5-7, and a light chain variable region comprising CDRs set forth in SEQ ID NOs: 8-10.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 4, 6-7, 33-34, 36 are rejected under 35 U.S.C. 103(a) as being unpatentable over Van de Winkel et al, (U.S. Patent 7,153,507; cited in IDS)) as evidenced by Ab04702-10.0 Datasheet (2026).
The instant claims encompass a method of treating celiac disease or non-celiac gluten sensitivity in a subject in need thereof, comprising administering a therapeutically effective amount of an anti-IL-15 antibody (AMG 714, aka 146B7), wherein said antibody comprises the heavy chain of SEQ ID NO:2 and light chain of SEQ ID NO:4.
Van de Winkel et al discloses an anti-IL-15 antibody (146B7) that shares 100% identity to the heavy chain and light chain of SEQ ID NO:2, 4, respectively, and a method of treating celiac disease comprising administering said antibody, (see column 18, lines 6-24 and column 33, lines 28-59). Moreover, prior art also taught intravenous and subcutaneous administration (column 27, second paragraph).
Van de Winkel et al reference does not teach that the dosages and the regimen recited in the instant claims. However, it would also have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the method of Van de Winkel et al by optimizing the dosage and the treatment schedule, because Van de Winkel et al teach that their anti-IL-15 antibody is used to treat celiac disease. Although the Van de Winkel et al reference does not explicitly teach the dosage and the interval periods recited in the instant claims, a person of ordinary skill in the art would have both the motivation and the ability to optimize these parameters in order to practice the most effective methods of treatment. MPEP 2144.05 states:
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 454, 105 USPQ 223, 235, (CCPA 1955).
The person of ordinary skill in the art would have been motivated to make that modification to in order to improve upon what is already known, thus determining the optimum dose. The person of ordinary skill in the art reasonably would have expected success because optimization of dose is routine in the art. See In re Aller 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". See also In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1, 4, 6-7, 15, 18, 20-22, 31-37 are rejected under 35 U.S.C. 103(a) as being unpatentable over Leon et al, (Drug Discovery World; March 2015; Vol. 16, No. 2, pp. 73-78; cited in IDS).
The instant claims encompass a method of treating celiac disease or non-celiac gluten sensitivity or refractory celiac disease in a subject in need thereof, comprising administering a therapeutically effective amount of an anti-IL-15 antibody (AMG 714), wherein said antibody comprises the heavy chain of SEQ ID NO:2 and light chain of SEQ ID NO:4.
Leon et al teach an anti-IL-15 antibody known as AMG 714 is used for the treatment of refectory celiac disease and diet non-responsive celiac disease, (see page 76, column 2). Given that there are only two types of refractory celiac disease (type I and type II), it would retreat one or the other.
However, Leon et al reference does not teach the dosages and the regimen recited in the instant claims.
It would have been obvious to the person of ordinary skill to use the antibody taught Leon et al reference, for the treatment of celiac disease and refractory celiac disease, because the reference teaches that the anti-IL-15 antibody, AMG 714, which is the same antibody recited in instant claims, (see instant specification at page 6, paragraphs 0037-0038) is being studied for the treatment of celiac and refractory celiac disease in phase II study.
It would also have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the method of Leon et al by optimizing the dosage and the treatment schedule, because Leon et al teach that IL-15, is considered to be a central
regulator of celiac disease immunopathology and that an anti-IL-15 antibody it is used for the treatment of refractory celiac disease and celiac disease. Although the Leon et al reference does not explicitly teach the dosage and the interval periods recited in the instant claims, a person of ordinary skill in the art would have both the motivation and the ability to optimize these parameters in order to practice the most effective methods of treatment. MPEP 2144.05 states:
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 454, 105 USPQ 223, 235, (CCPA 1955).
The person of ordinary skill in the art would have been motivated to make that modification to in order to improve upon what is already known, thus determining the optimum dose. The person of ordinary skill in the art reasonably would have expected success because optimization of dose is routine in the art. See In re Aller 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". See also In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing 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 1, 4, 6-7, 15, 18, 20-22, 31-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,655,294.
The patent claims and the present claims are directed to the same method of treating celiac disease comprising administering anti-IL-15 antibody (AMG 714). Although the patent claims did not recite the same dosages and regimen as recited in the present claims, it would have been obvious to one of ordinary skill in the art to arrive at the claimed dosages and regimen because those are result-effective variables and the person of ordinary skill in the art would have been motivated to make that modification to in order to improve upon what is already known, thus determining the optimum dose. Therefore, the patent claims would render obvious of the present claims.
Closest Prior Art:
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Malamut et al, (The Journal of Clinical Investigation, 2010, Vol. 120, No. 6, pages 2131-2143; cited in the IDS) teach that IL-15 is overexpressed in the enterocytes of individuals with celiac disease, (CD) and disease and type II Refractory celiac disease, (RCDII), (see abstract and page 2131, column 2 and figure 5). The reference also teaches that AMG714, (a humanized anti–IL-15 monoclonal antibody), treatment of mice overexpressing human IL-15 in their gut epithelium restores intestinal lymphocytes’ apoptosis and reduces their massive accumulation, (see page 2136, column 2 and figures 8B and 8C). The authors conclude that blocking IL-15 signaling may both alleviate epithelial damage and eradicate transformed IELs in RCDII, (see page 2140).
Conclusion
No claim is allowed.
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/SHARON X WEN/Primary Examiner, Art Unit 1641