DETAILED ACTION
Claims 1-86 are pending in the present reissue application.
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 .
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 1-7, 9-27, 35-53, and 61-79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 12-15, 19, and 20 of U.S. Patent No. 11,065,239. Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons.
The ‘239 patent claims a method for treating a tumor in a subject by administering a combination of an EZH2 inhibitor and a BTK inhibitor. The claimed scope of the EZH2 inhibitor structure of ‘239 patent includes the compound used in the presently claimed method where ring A is heterocyclyl, R1 is alkyl substituted by heterocyclyl, p is 1, R2 is alkyl, R3 is alkyl, R4 is alkyl, n is 2, R5 is hydrogen.
Hence, claims 1, 2, 9-15, 35-41, and 61-67 are anticipated.
With respect to present claims 3-7, 16-27, 42-53, and 68-79, the ‘239 patent claims 12-15 claim the treatment, by the use of the claimed EZH2 inhibitor described above, of the lymphomas that are recited by the present claims. Therefore, the claims are anticipated.
Claims 1-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 of U.S. Patent No. 11,155,537. Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons.
Claims 15-17 of the ‘537 patent claim a method of treating a disease associated with EZH2 inhibitor in a subject by administering a particular crystalline form of the same compound as presently claimed. The lists of diseases include lymphomas, ovarian cancer, and leukemia, including the specific types of leukemia recited in ‘537 patent claim 17. Therefore, the claims are anticipated.
Claims 1-7, 9-16, 18-27, 35-42, 44-53, 61-68, and 70-79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-27 of copending Application No. 18/687,272 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
The ‘272 application claims a method for the treatment of T-cell lymphomas in a subject by administering a therapeutically effective amount of the same compound as presently claimed, which is a EZH2 inhibitor. Therefore, the claims are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
On pages 12-13 of the remarks, the Applicant argues:
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However, the prevention of a second, later-expiring patent is not the only consideration for a non-statutory double patenting rejection. As MPEP 804.02(VI) states:
There are at least two reasons for insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection in an application subject to a 20-year term under 35 U.S.C. 154(a)(2). First, 35 U.S.C. 154(b) includes provisions for patent term adjustment based upon prosecution delays during the application process. Thus, 35 U.S.C. 154 does not ensure that any patent issuing on a continuing utility or plant application filed on or after June 8, 1995 will necessarily expire 20 years from the earliest filing date for which a benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c). However, 35 U.S.C. 154(b)(2)(B) states that no patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer. As the presence of a terminal disclaimer affects whether the patent is granted an adjustment, it is necessary that the terminal disclaimer be filed in the application in order to accurately determine whether the patent is entitled to a term adjustment. Second, 37 CFR 1.321(c)(3) requires that a terminal disclaimer filed to obviate a nonstatutory double patenting rejection based on commonly owned conflicting claims include a provision that any patent granted on that application be enforceable only for and during the period that the patent is commonly owned with the application or patent which formed the basis for the rejection. 37 CFR 1.321(d) sets forth the requirements for a terminal disclaimer where the claimed invention resulted from activities undertaken within the scope of a joint research agreement and limits enforcement of the patent only to that period when the patent and the reference application or patent are not separately enforced. These requirements serve to avoid the potential for harassment of an accused infringer by multiple parties with patents covering the same patentable invention. See, e.g., In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). Not insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection in an application subject to a 20-year term under 35 U.S.C. 154(a)(2) would result in the potential for the problem that 37 CFR 1.321(c)(3) was promulgated to avoid. Further, as a terminal disclaimer is only effective in the application in which it is filed, it is necessary to require that the terminal disclaimer be filed in each application and/or patent that is subject to the common ownership requirement in order to provide complete notice to the public of this obligation.
Even if the reference patents are filed after the effective filing date of the underlying patent and would expire after the expiration of the underlying patent, the requirement for common ownership still requires that a terminal disclaimer be filed when the claims of the underlying patent are not patentably distinct with respect to the reference patents.
The Applicant then argues on pages 13-14 of the remarks:
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However, the case of Allergan is a unique situation. The patent at issue in Allergan was first filed, first issued, and later expiring when compared to the respective reference patents. Therefore, the Federal Circuit ruled that a terminal disclaimer over the reference patents would shorten the maximum term of the first filed, first issued, and later expiring patent that earned patent term adjustment due to delays in prosecution. In the present case, the underlying patent is not later expiring than the reference patents. Therefore, a terminal disclaimer would not unduly shorten the patent term of the underlying patent, and the decision in Allergan does not address the current fact pattern.
The Applicant then argues on pages 14-15 of the remarks:
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However, in the decision issued in Ex Parte Baurin is non-precedential. Therefore, Ex Parte Baurin is not binding on the Office. Additionally, the requirement of a terminal disclaimer to maintain common ownership of the respective patents prevents harassment of an accused infringer by multiple parties if one patent were to be reassigned and not the other.
Therefore, the rejections are maintained.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 11,059,811 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Conclusion
Claims 1-86 are rejected.
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 Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30.
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, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/Alan Diamond/
Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991