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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/892,283, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The new limitation of claim 1 and new claim 10 drawn to an anti-MASP-2 antibody comprised of heavy chain variable region of SEQ ID NO: 67 and light chain variable region of SEQ ID NO: 70 is not included in the disclosure of 61/892,283, and the claims are not entitled benefit to this prior application. The instant application claims benefit to U.S. Provisional Application No. 62/020,845, filed July 3, 2014, and are given an earliest effective filing date of July 3, 2014.
Claim Status
Claims 1, 8-9 and new claim 10 are under consideration in this office action.
Withdrawn Objections/Rejections
Any objection or rejection of record pertaining to cancelled claims 2-7 is rendered moot by applicant’s cancellation of said claims.
The rejection of claims 1 and 8-9 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of applicant’s amendment of claim 1 to include a specific anti-MASP-2 inhibitor monoclonal antibody and amendment of claim 8 to remove the limitation drawn to a human antibody.
The rejection of claims 1 and 8-9 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 20120225056 (“Rother”) is withdrawn in view of applicant’s amendment of claim 1 to include an anti-MASP-2 inhibitor monoclonal antibody not taught by Rother.
The rejections of claim 1 and 8-9 on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 8,951,522, U.S. Patent No. 9,644,035, and U.S. Patent No. 7,919,094 are withdrawn in view of applicant’s amendment to limit the MASP-2 inhibitor to a specific anti-MASP-2 antibody.
New Rejections Necessitated by Amendment
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.
Claims 1, 8-9 and new claim 10 are rejected under 35 U.S.C. 103 as being obvious over US 20130064820, published March 14, 2013 (“Magro”; instant PTO-892) in view of US 20130344073, filed June 18, 2013 (“’073”; see IDS from 11/8/2023, CU106).
The applied reference ‘073 has a common applicant and joint inventor 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).
Magro teaches compositions and methods for treating a patient with Degos disease (see abstract; [0013]); the method comprising administering a composition comprising an inhibitor of complement [0010], including an antibody to MASP-2 [0060], as in the method instant claim 1. Magro teaches that the inhibitor treatment reduces the level of complement activation in the blood of the patient for the duration of the treatment [0013], as in the limitation of claim 1 directed to inhibiting MASP-2 dependent complement activation.
The pharmaceutical compositions can be administered subcutaneously, intravenously, intra-arterially, intranasally, or intramuscularly [0143], as in the modes of administration of instant claim 9.
Magro does not teach the specific anti-MASP antibody of amended claim 1 nor the limitation of instant claim 8 directed to an anti-MASP-2 antibody selected from the group consisting of a recombinant antibody, an antibody having reduced effector function, a chimeric antibody, and a humanized antibody.
‘073 teaches an anti-MASP antibody comprising heavy chain variable region of SEQ ID NO: 15 and light chain variable region of SEQ ID NO: 17 [0134], which are identical to instant SEQ ID NO: 67 and SEQ ID NO: 70, respectively, as in the antibody of claim 1 and new claim 10. This antibody is an inhibitor of MASP-2 dependent complement activation [0025]. The anti-MASP-2 antibody is a chimeric or humanized antibody [0025], as in instant claim 8.
Given that Magro teaches a method of treating a patient with Degos disease by administering a the complement activation inhibitor anti-MASP-2 antibody and further given that ‘073 teaches the claimed anti-MASP-2 antibody in a method of inhibiting MASP-2-dependent complement activation, it would have been obvious to one of ordinary skill in the art to replace the anti-MASP-2 antibody of Magro with the anti-MASP-2 antibody of ‘073 in a method of decreasing complement activation in a patient with Degos disease. One of ordinary skill in the art would have been able to carry out such a substitution, and the results would have been reasonably predictable. As is stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an “express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)." Furthermore, it would have been obvious to one of ordinary skill in the art that a method of inhibiting MASP-2-dependent complement activation in a subject suffering from MASP-2-dependent complement activation that contributes to the pathogenesis of disease could also be applied to Degos disease. Based on the teachings of ‘073, the ordinary artisan would immediately envision the treatment of other disorders associated with MASP-2-dependent complement activation, and it would be obvious that treatment with an inhibitor of MASP-2 described for one disease would be applicable to another disease associated with the same defect; applying a known technique to a known disease ready for improvement will yield predictable results (see MPEP 2143).
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.
Claims 1, 8-9 and new claim 10 are rejected under 35 U.S.C. 103 as being obvious over US 20130064820, published March 14, 2013 (“Magro”) in view of US 20120282263, filed May 4, 2012 (“’263”; see IDS from 11/8/2023, CU104).
Magro teaches compositions and methods for treating a patient with Degos disease (see abstract; [0013]); the method comprising administering a composition comprising an inhibitor of complement [0010], including an antibody to MASP-2 [0060], as in the method instant claim 1. Magro teaches that the inhibitor treatment reduces the level of complement activation in the blood of the patient for the duration of the treatment [0013], as in the limitation of claim directed to inhibiting MASP-2 dependent complement activation.
The pharmaceutical compositions can be administered subcutaneously, intravenously, intra-arterially, intranasally, or intramuscularly [0143], as in the modes of administration of instant claim 9.
Magro does not teach the specific anti-MASP antibody of amended claim 1 nor the limitation of instant claim 8 directed to an anti-MASP-2 antibody selected from the group consisting of a recombinant antibody, an antibody having reduced effector function, a chimeric antibody, and a humanized antibody.
‘263 teaches an anti-MASP antibody comprising heavy chain variable region of SEQ ID NO: 20 and light chain variable region of SEQ ID NO: 24 ([0206], Table 1), which are identical to instant SEQ ID NO: 67 and SEQ ID NO: 70, respectively, as in the antibody of claim 1 and new claim 10. This antibody is an inhibitor of MASP-2 dependent complement activation [0026]. The anti-MASP-2 antibody is a chimeric or humanized antibody [0163], as in instant claim 8.
Given that Magro teaches a method of treating a patient with Degos disease by administering the inhibitor of complement activation anti-MASP-2 antibody and further given that ‘263 teaches the claimed anti-MASP-2 antibody in a method of inhibiting MASP-2-dependent complement activation, it would have been obvious to one of ordinary skill in the art to replace the anti-MASP-2 antibody of Magro with the anti-MASP-2 antibody of ‘263 in a method of inhibiting complement activation in a patient with Degos disease. One of ordinary skill in the art would have been able to carry out such a substitution, and the results would have been reasonably predictable. As is stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an “express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)." Furthermore, it would have been obvious to one of ordinary skill in the art that a method of inhibiting MASP-2-dependent complement activation in a subject suffering from MASP-2-dependent complement activation that contributes to the pathogenesis of disease could also be applied to Degos disease. Based on the teachings of ‘263, the ordinary artisan would immediately envision the treatment of other disorders associated with MASP-2-dependent complement activation, and it would be obvious that treatment with an inhibitor of MASP-2 described for one disease would be applicable to another disease associated with the same defect; applying a known technique to a known disease ready for improvement will yield predictable results (see MPEP 2143).
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, 8-9 and new claim 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,525,011 in view of US 20130064820, published March 14, 2013 (“Magro”). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to overlapping embodiments: method for inhibiting MASP-2 dependent complement activation in subjects with the same inhibitory anti-MASP-2 antibody
Claim 1-12 of ‘011 are directed to a method of inhibiting MASP-2-dependent complement activation in a subject suffering from catastrophic antiphospholipid syndrome by administering a MASP-2 antibody comprising a heavy chain variable region of SEQ ID NO: 67 and light chain variable region of SEQ ID NO: 70, which is identical to the antibody of claims 1 and new claim 10 (same SEQ ID NOs). The anti-MASP-2 antibody may be a recombinant antibody, an antibody having reduced effector function, a chimeric antibody, a humanized antibody, or a human antibody, and the antibody may be administered subcutaneously, intramuscularly, intraarterially, intravenously, or as an inhalant, as in instant claims 8 and 9.
‘011, however, does not explicitly teach that the antibody inhibits MASP-2-dependnet complement activation in a subject suffering from Degos disease, as required by instant claim 1.
Magro teaches compositions and methods for treating a patient with Degos disease (see abstract; [0013]); the method comprising administering a composition comprising an inhibitor of complement [0010], including an antibody to MASP-2 [0060], as in the method instant claim 1.
Given that the claims of ‘011 teach the claimed anti-MASP-2 antibody in a method of inhibiting MASP-2-dependent complement activation and further given that Magro teaches a method of treating a patient with Degos disease by administering an anti-MASP-2 antibody, it would have been obvious to one of ordinary skill in the art to replace the anti-MASP-2 antibody in the method of treating Degos disease of Magro with the anti-MASP-2 antibody of ‘011. One of ordinary skill in the art would have been able to carry out such a substitution, and the results would have been reasonably predictable. As is stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an “express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)." Furthermore, it would have been obvious to one of ordinary skill in the art that a method of inhibiting MASP-2-dependent complement activation in a subject suffering from MASP-2-dependent complement activation that contributes to the pathogenesis of disease could also be applied to Degos disease. Based on the teachings of ‘011, the ordinary artisan would immediately envision the treatment of other disorders associated with MASP-2-dependent complement activation, and it would be obvious that treatment with an inhibitor of MASP-2 described for one disease would be applicable to another disease associated with the same defect; applying a known technique to a known disease ready for improvement will yield predictable results (see MPEP 2143).
The scope of the ‘011 claims in view of Magro fully overlaps with the instant claims, and thus, it would have been obvious to one of ordinary skill in the art that the methods of treating disease associated with elevated MASP-2 complement activation are not patentably distinct from each other.
Response to Arguments
Applicant’s arguments filed May 4, 2026 with respect to claims 1 and 8-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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