DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-4, 8, 12-20, and 26-28 are currently pending in this Application.
Priority
This application claims priority benefit as follows:
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Response to Election/Restriction
Applicant's election of Group I, claims 1-4, 8, 12-20, and 26, drawn to compounds of formula I and compositions and species compound
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, in the reply filed on April 16, 2026 is acknowledged. Claims 1-4, 8, 12-15 and 26 read on the elected species. Because applicant did not distinctly and specifically point out the supposed errors in the Election Requirement the election has been treated as an election without traverse. There would be a serious search burden for the examiner if the full scope claimed would be examined due to the large number of compounds encompassed by the general formula.
Examination
The species elected by applicants (above) is free of the prior art. Pursuant to M.P.E.P. §803.02, the examination has been expanded to the compounds of formula
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of the prior art rejections below.
Claims 27-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim. The prior art search will not be extended unnecessarily to cover all non-elected species. Subject matter outside of the searched scope is withdrawn pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim.
Claims 1-4, 8, 12-20 and 26 are treated on the merits in this First Office Action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-4, 12, 14-15 and 26 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Momose et al. (US 2006/0004069).
The prior art teaches compounds such as Example 66 at column 61:
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and pharmaceutical compositions of the compounds with pharmaceutically acceptable carriers at [0418]. The compounds of Momose include all isomeric forms, see paragraph [0695].
Claims 1-3, 12-15 and 26 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Watkins et al. (US 2004/0092598).
The prior art teaches compounds such as Example 140 and 141 at page 100:
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and pharmaceutical compositions of the compounds with pharmaceutically acceptable carriers at [0077].
Claims 1-4, 12 and 14-15 are rejected under pre-AIA 35 U.S.C. 102(b) based upon a public use or sale of the invention. The compounds below were on public sale and available for use in the Chemical Abstract Registry from the dates entered in STN:
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.
Claims 1-3, 8, 12, 14-18 and 26 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Strobel et al. (US 2010/0016272).
The prior art teaches compounds such as Example 50(a) at page 28
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, Example 141
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at page 38, and pharmaceutical compositions of the compounds with pharmaceutically acceptable carriers at [0150]. The compounds of Strobel include both the E and Z forms. See paragraph [0050]: “In another embodiment of the invention a double bond, including the double bond depicted in formulae I and Ia between the carbon atoms to which the groups Ra and Rb are bonded, is present in the Z form or cis form or substantially in the Z form or cis form”. It is noted that Strobel et al. teach many other compounds that were not searched but read on the rejected claims. These are compounds wherein ring A is a 5 or 6-membered heteroaryl and R1 and R2 are other than what was search (such as Ex. 152). They are also rejected here for the purpose of a compact prosecution.
Claims 1-4, 8, 12, 14-20 and 26 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Shacham et al. (US2011/0275607-filed on March 5, 2010).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effective U.S. filing date of the reference, it constitutes prior art under pre-AIA 35 U.S.C. 102(e). This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
The reference teaches several compounds that read on the rejected claims, such as the following compounds:
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,
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,
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,
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for inhibiting CRM1. See Table 1.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 8, 12-20 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 9,079,865. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the method of making the compounds as claimed in the patent and the compounds as claimed here. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. No restriction was made in the prosecution of case US 9,079,865 between the compounds and the method of making them. The compound of claim 20 was covered by the genus of claim 8 of the patent, as seen in Example 26 (col. 87) of the patent. In addition, the compounds in the method of claim 1 read on the instant claimed compounds.
Claims 1-4, 8, 12-20 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,202,366. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the method of using the compounds as claimed in the patent and the compounds as claimed here. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. The compounds in the method of claim 1, such as compound B-1 and B-14, read on the instant claimed compounds.
Claims 1-4, 8, 12-20 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,428,490. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of claim 1 in the patent is narrower than and fully anticipates the instant claimed scope. The compound of claims 6 of the patent anticipates claims 1-4, 8, 12-20 and 26.
Claims 1-4, 8, 12-16 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-8 of U.S. Patent No. 9,714,226. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims disclose species that anticipate the rejected claims wherein R1 or R2 are a heterocyclic ring. See that the 3rd, 4th, 14th, 18th, 19th, 20th and 24th
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compound of claim 5 of the patent anticipate the claimed compounds.
Claims 1-4, 8, 12-20 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 8,513,230. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclose species that anticipate the rejected claims wherein R1 or R2 together form an azetidine ring. See compounds of formula
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and
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at claim 7 of the patent.
Claims 1-3, 8, 12, 14-16 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 8,304,438. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses species that anticipate the rejected claims wherein Ring A is thiophenyl, furanyl, imidazole, thiazole, pyridyl. The reference patent teaches compounds of Examples 141-152 and others as a representation of what is claimed at claims 1-9 of the patent. Such examples were prepared and tested and are the particular embodiments covered by the claims of the patent.
This rejection is proper under MPEP 804 II. B. 2. (a):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because ONLY "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Conclusion
Claims 1-4, 8, 12-20, 26 are reject. No claim is allowed. Note: the search was not expanded to the full scope of the compounds claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 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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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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