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 03/04/2025, has been entered.
Claims 1-64, 66-67 have been canceled.
Claims 65, 68-92 are pending and currently under examination as they read on a method of treating cardiovascular disease comprising administering an anti-IL-6 antibody.
This Office Action will be in response to Applicant’s argument/remarks, filed 03/04/2025.
The Rejections of Record can be found in the previous Office Action, mailed 12/04/2024.
The previous rejection under 35 U.S.C. 103 as being unpatentable over Ridker et al. view of Rajpal et al. has been withdrawn in view of Applicant’s remarks regarding unexpected results, filed 03/04/2025.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 65, 68-72, 74-75, 82-84, 87, 89-92 stand rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Rajpal et al. (US Patent 8,188,235; cited in IDS; see entire document).
Applicant’s arguments, in conjunction with deGoma’s 132 declaration, have been considered in full but have not been found convincing for reasons of record. The Rejection of Record can be found in the previous Office Action, mailed 12/04/2024.
Applicant argues that the rejection is improper picking, choosing and combining of various disclosures in Rajpal with no direction to do so. In response, it is noted that the prior art is considered in its entirety, i.e., as a whole; and that a reference serves as prior art for all that it teaches. A reference may anticipate without using the same language as the claim: “The invention is not the language of the [claim] but the subject matter thereby defined. Thus, a prior art inventor need not conceive of its invention using the same words as the patentee would later use to claim it.” Adasa (Fed. Cir. 12/16/22) (rev’g Summ. J. of no anticipation).
Here, Rajpal clearly disclosed the same antibody with the same VH and VL sequences, a point Applicant has not contested. Turning to the diseases which Applicant argues is a laundry list, it is noted that atherosclerosis was clearly disclose by Rajpal and that it was also disclosed in the instant specification (paragraph [0012]) as a species of cardiovascular diseases. As such, Rajpal’s disclosure of atherosclerosis reads on cardiovascular disease as species reads on genus. Furthermore, it is noted that Rajpal taught another example of cardiovascular disease in addition to atherosclerosis, vascular restenosis (column 15, line 17). Taken together, one of ordinary skill in the art, upon reading the prior art, would at once envisage the claimed arrangement of combination, i.e., using the anti-IL-6 antibody for treating atherosclerosis or vascular restenosis, even though the prior art reference does not expressly spell out all the limitations arranged the same way as in the present claims.
Applicant also argues that the prior art is not enabled. In response, it is noted that "the standard for enablement of a prior art reference for purposes of anticipation under section 102 differs from the enablement standard under 35 USC § 112” and that “anticipation does not require actual performance of suggestions in a disclosure. Rather, anticipation only requires that those suggestions be enabled to one of skill in the art.” (See, Impax Laboratories Inc., 81 U.S.P.Q.2d 1001, 1012, citing Novo Nordisk Pharms., Inc v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005)). Here, Rajpal is enabled in the sense that it describeds the claimed invention sufficiently to enable a sperson of ordinary skill in the art to carry out the claimed method of treating a cardiovascular disease (e.g., atherosclerosis or vascular restenosis) by administering the art-disclosed antibody. Essentially, Applicant is applying a higher standard of enablement to the anticipatory reference than is warranted. Also see Rasmusson at 1325 (“The standard for what constitutes proper enablement of a prior art reference for purposes of anticipation under section 102, however, differs from the enablement standard under section 112. In In re Hafner, 56 C.C.P.A. 1424, 410 F.2d 1403 (Cust. & Pat.App. 1969), the court stated that "a disclosure lacking a teaching of how to use a fully disclosed compound for a specific, substantial utility or of how to use for such purpose a compound produced by a fully disclosed process is, under the present state of the law, entirely adequate to anticipate a claim to either the product or the process and, at the same time, entirely inadequate to support the allowance of such a claim." Id. at 1405; see Schoenwald, 964 F.2d at 1124; In re Samour, 571 F.2d 559, 563- 64 (Cust. & Pat.App. 1978).”)
Applicant’s argument has not been found convincing. Therefore, the rejection is maintained as it applies to amended claims.
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 65, 68-72, 74-75, 82-84, 87, 89-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of co-pending applications in view of Rajpal et al. (US Patent 8,188,235).
Co-pending application
claims
18721038
1-10, 23, 29, 33-34, 37, 42-46
18721059
1-19, 41
18888320
35-64
The above mentioned co-pending claims disclosed TOUR006 antibody that is the same as recited in the present claims. Even though the copending claims did not disclose a method of treating cardiovascular disease, it would have been obvious to arrive at the claimed method of the present application in view of the teachings of Rajpal as discussed above. Therefore, the co-pending claims would render obvious the present claims.
This is a provisional nonstatutory double patenting rejection.
Applicant’s argument and Examiner’s response are same as above. Therefore, the rejection is maintained.
THIS ACTION IS MADE FINAL. 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 SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641
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