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 .
Status of Claims
Currently, claims 21-23, 26-32, 36-38, 43, 50 and 51 are pending in the instant application. Claims 37 and 38 are withdrawn from consideration as directed to non elected subject matter. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are modified to correct an obvious typographical error and to address the amendment to the claims. They constitute the complete set being presently applied to the instant Application. This action is Final.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated is withdrawn in view of the amendments to the claims.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 21-23, 26-32, 36, 43, 50 and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of US Patent 12,391,752. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to detecting the same polymorphisms (eg rs, or proxy polymorphisms with the same r2 value, in the same patients (with inflammatory bowel disease), and treating with the same TL1A antibodies. While the claims of the ‘752 patent do not recite the sequence of SEQ ID NO: 4, 7, 29, 39, 40, or 57-59, the instant specification (page 301) teaches the recited rs numbers with their corresponding SEQ ID NO: (rs6478109-SEQ ID NO: 39; rs7935393-SEQ D NO: 4; rs7278257-SEQ ID NO: 40). Since the claims of the ‘752 patent teaches determining the same polymorphisms as those claimed using PCR, sequencing, array genotyping, allele specific hybridization, etc, they inherently teach contacting the sample with a composition comprising 95% sequence identity to any of the SEQ ID NOS recited in the claims and detecting the nucleotides at position 501 of SEQ ID NOS 4, 39, and 40.
The claim of the instant application and that of the ‘752 patent have the same effective patent term date.
Claims 21-23, 26-32, 36, 43, 50, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of US Patent 12,215,147 view of Arch.
The instant claims and the claims of the ‘147 patent are directed to producing a plurality of target nucleic acids that comprise the same polymorphisms, or proxy polymorphisms with the same r2 value, in the same patients (IBD, Crohn’s disease) and treating the patients with an inhibitor of TL1A. The ‘147 claims do not teach the TL1A antibodies required by the instant claims, however Arch teaches antibodies for treatment of IBD, including CD, comprising the sequences of instantly claimed SEQ ID NOS 133-145. Therefore, it would have been prima facie obvious to the ordinary artisan prior to applicants invention to administer anti-TL1A antibodies as taught by Arch, to the patients of the ‘147 claims for the obvious benefit of treating CD and IBD. While the ‘147 claims do not recite the sequence of SEQ ID NO: 4, 7, 29, 39, 40, or 57-59, the instant specification (page 301) teaches the recited rs numbers with their corresponding SEQ ID NO: (rs6478109-SEQ ID NO: 39; rs7935393-SEQ D NO: 4; rs7278257-SEQ ID NO: 40). Since the claims of the ‘147 patent require contacting targets with oligonucleotides for detecting the targets comprising the recited polymorphisms they necessarily teach contacting the sample with a composition comprising 95% sequence identity to any of the SEQ ID NOS recited in the claims and detecting the nucleotides at position 501 of SEQ ID NOS 4, 39, and 40.
The claim of the instant application and that of the ‘147 patent have the same effective patent term date.
Conclusion
No claims are 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 examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682