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 .
Claims 1-24 are pending in the application.
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.
4. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
5. Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar (J. Med. Chem., 2016, cited on applicant’s form 1449).
Kumar discloses dopamine D3 receptor antagonists (see compounds 18-40 in table 2 on page 7639) for treating opioid abuse or dependence. The method for treating opioid abuse or dependence by D3 antagonists disclosed by Kumar meets all the limitations of instant claims except that Kumar does not mention addition of opioid agonist or opioid partial agonist along with D3 antagonists. However, Kumar does teach treating opioid abuse or dependence by D3 receptor antagonists. Therefore, it would have been obvious to one skilled in the art to add opioid agonist or opioid partial agonist along with D3 antagonists for treating opioid abuse or dependence with reasonable expectation of success since opioid agonist or opioid partial agonist will be inherently present in the subject being treated for opioid dependence or abuse.
6. Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Newman (WO 2017/160552 A1, cited on applicant’s form 1449).
Newman discloses dopamine D3 receptor antagonists (see compounds on pages 7-10).
The method for treating opioid abuse or dependence by D3 antagonists disclosed by Newman (see claims 1-14 and 18-20) meets all the limitations of instant claims except that Newman does not mention addition of opioid agonist or opioid partial agonist along with D3 antagonists. However, Newman does teach treating opioid abuse or dependence by D3 receptor antagonists. Therefore, it would have been obvious to one skilled in the art to add opioid agonist or opioid partial agonist along with D3 antagonists for treating opioid abuse or dependence with reasonable expectation of success since opioid agonist or opioid partial agonist will be inherently present in the subject being treated for opioid dependence or abuse.
Double Patenting
7. 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.
8. Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5-8 of U.S. Patent No. 11,299,476, cited on applicant’s form 1449. Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to one skilled in the art to add opioid agonist or opioid partial agonist along with D3 antagonists for treating opioid abuse or dependence with reasonable expectation of success since opioid agonist or opioid partial agonist will be inherently present in the subject being treated for opioid dependence or abuse.
9. Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-13 of U.S. Patent No. 12,162,861. Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to one skilled in the art to add opioid agonist or opioid partial agonist along with D3 antagonists for treating opioid abuse or dependence with reasonable expectation of success since opioid agonist or opioid partial agonist will be inherently present in the subject being treated for opioid dependence or abuse.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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