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
Claims 1-12 and 14-44 are pending. Claims 1-3, 6-9, 14, 15, 17, and 18 are amended. Claims 4, 5, 10-12, 16, 19 and 20 are original. Claims 21-44 are new.
Reissue Application
The present reissue application is a reissue of United States Patent No. 10,800,770 (hereafter “the ’770 patent”). The ‘770 patent claims priority to provisional application 62/947,213 which was filed on December 12, 2019.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “C1-C3 alkyl” in line 6 which should read “C1-C3 alkyl” wherein the number “3” is in subscript.
Appropriate correction is required.
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 1-12, 14-16, and 24-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-9 of U.S. Patent No. 11,261,178 (“the ‘178 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same art specific subject matter. Claim 1 of the ‘178 patent is drawn to a method of preparing a compound chosen from the following chemical structures:
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While instantly pending claims 1-12, 14-16, and 24-29 are compound claims and the ‘178 patent claims are drawn to a method for preparing compounds which fall within the scope of instantly pending claims 1-12, 14-16, and 24-29 the method recited in claims 1 and 6-9 of the ‘178 patent would have necessarily produced a compound that falls within in the scope of instantly pending reissue claims 1-12, 14-16, and 24-29.
Claims 1-12, 14-18, and 23-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 16-19, 29, 58, 122, and 131 of copending Application No. 19/216,567 (“the ‘567 application”). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same art specific subject matter.
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The ‘567 application is drawn to a method of treating breast cancer comprising administering a therapeutically effective amount of a compound having the following formula (I):
The compounds recited in claims 1, 11, 16-19, 29, 58, and 122 of the ‘567 application encompass the compound(s) recited in claims 1-12, 14-16, and 24-29 of the instant reissue application. Additionally, the specification of the instantly pending reissue application discloses that the claimed compound(s) is/are suitable for treating breast cancer (col. 60 lines 36-54, claim 18).
While instantly pending claims 1-12, 14-18, and 23-36 are compound/composition claims and the ‘567 application claims are drawn to the method of using the same compound, the courts have ruled that when the use in disclosed in both documents the claims will conflict. Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F. 3d 1373, 1385-86, 68 USPQ2d 1865, 1874 (Fed. Cir. 2003). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12, 14-16, and 24-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6-10, 18, 23-26, and 31-40 of copending Application No. 18/591,704 (“the ‘704 application”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the process recited in claims 1, 6-10, 18, 23-26, 31-40 of the ‘704 application would have necessarily produced a compound which is encompassed by the scope of the claims 1-12, 14-16, and 24-29 of the instant reissue application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Closest Prior Art
The closest identified prior art is described below.
US 2018/0155322 to Crew et al. discloses several compounds which are similar to the compounds encompassed by instantly pending claims 1 and 16. For example, in Figure 5 - Example 56, Crew et al. disclose a compound of the formula shown below.
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While, the compound of Example 56 of Crew et al. is similar to compounds recited in or encompassed by the claims, it differs from the instantly claimed compounds in that the moiety on the left side of the compound is a tetralin group not a chroman group. It is noted that instantly pending independent claims 1 and 16 require the presence of a chroman group. A search of the relevant prior art did not reveal a reference or combination of references which provides a reasonably motivation to substitute the tetralin group of the compound of Crew et al. with a chroman group.
It is also noted that instantly pending claim 1 requires R5 to be selected from a halogen, hydrogen, hydroxy, C1-C3 alkyl, C1-C3 alkoxy, C1-C3 haloalkyl, -N(R7)2 and CN, each of which is substituted with 0, 1, 2, or 3 R6. In the molecules disclosed by Crew et al. the group which corresponds to the claimed R5 group is a hydrogen which falls outside the scope of the claim 1. For these reasons, Crew et al. fail to teach or suggest the instantly claimed compounds.
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. 10,800,770 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 1-12, 14-18, and 23-36 are rejected. Claims 19-22 and 37-44 are objected to for depending from a rejected claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEE E SANDERSON whose telephone number is (571)270-1079. The examiner can normally be reached M-F: 9:30AM to 7:00PM.
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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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/LEE E SANDERSON/ Reexamination Specialist, Art Unit 3991
Conferees:
/JOSEPH R KOSACK/Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
Prosecution Insights