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 .
Priority
The instant application is a division of US Application 16/498,122 (filed September 26, 2019, now abandoned), which is a 35 USC 371 National Stage filing of international application PCT/US2018/025342, filed March 30, 2018, which claims the benefit of an effective US filing date from provisional applications 62/478,758 and 62/572,932, filed March 30, 2017 and October 16, 2017, respectively.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted in the application. Applicants are reminded of their duty to disclose any information which may be material to patentability in accordance with 37 CFR 1.56.
Election/Restrictions
Applicant’s election of the invention of Group I, drawn to a methods of treatment using compounds of the claimed formula, in the reply filed July 14, 2025 is acknowledged. Further, Applicant’s election without traverse of the species of Claim 1 (the compound ISP358-2) as the compound to be used, and diseases or disorders associated with memory loss or dysfunction as the condition to be treated, in the same reply is also acknowledged. Applicant contends that the elected species reads on each of claims 1, 5-7 and 10-14 within the elected group. However, claims 13-14 require a cyclohexenyl ring where the elected species has a cyclohexyl ring, differing in the requirement of a double bond. Accordingly, the elected species are deemed to read on claims 1, 5-7 and 10-12 within the elected group.
The requirement is still deemed to be proper and is made final.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species above, wherein: the elected species were not found to be allowable over the prior art. Accordingly, the search and consideration was not expanded beyond the scope of the elected species.
Status of Claims
Currently, claims 1-21 are pending in the instant application. Claims 2-4, 8-9 and 13-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species. Claims 1, 5-7 and 10-12 read on an elected invention and species and are therefore under consideration in the instant application to the extent that they read on the elected embodiment.
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5-7 and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/077611 (“the ‘611 publication”).
Regarding claim 1, the ‘611 publication teaches compounds of the formula
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(see page 12) and teaches the instantly claimed compound throughout the reference, in particular at claim 13 which defines that X is hydroxymethyl and Y is hydrogen. Further, pharmaceutical compositions of the prior art compounds are taught, for example, at paragraph [0064]. Notably, the broadest reasonable interpretation of the instantly claimed compound is that the claimed stereoisomer needs to be present in the composition, not isolated from all other stereoisomeric forms. Since the abovementioned compound of the ‘611 publication is a racemic mixture that contains both cis- and trains- enantiomeric forms, the abovementioned compound in the ‘611 publication meets all required limitations of the compound to be administered. With respect to the claimed method of treatment, it is initially noted that the term “treating” is given its broadest reasonable interpretation consistent with the specification. In paragraph [0074] the term is defined as including prevention of the condition/symptoms and encompassing both therapeutic and prophylactic administration. The prior art teaches that the compounds disclosed therein are used for treating diseases associated with estrogen receptor β activity, including cell proliferative diseases, psychiatric diseases, neurodegenerative diseases, bone metabolic diseases, or metabolic diseases or disorders (paragraph [0051], claims 18-20). It is noted that administration of an identical compound would necessarily have the claimed effect. Thus, the claims are anticipated.
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 obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 5-7 and 10-12 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent 10,570,077.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the compound and compositions used in the instantly claimed methods are anticipated by those in the patented claims. In particular, the conflicting claims recite compounds of the formula
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as well as, the particular example
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(claim 4) pharmaceutical compositions/combinations thereof (claims 7-8). By way of particular examples, many anticipatory compounds are explicitly claimed, including the elected species (see patented claim 6).
It is noted that the broadest reasonable interpretation of the instantly claimed compound is that the claimed stereoisomer needs to be present and NOT isolated. Since the abovementioned compound of the ‘077 patent is a racemic mixture that contains both enantiomeric forms, the abovementioned compound in the ‘077 patent claims meets all limitations of the compounds recited in the instant claims. With respect to the claimed method of treatment, it is initially noted that the term “treating” is given its broadest reasonable interpretation consistent with the specification. In paragraph [0074] of the instant specification, the term is defined as including prevention of the condition/symptoms and encompassing both therapeutic and prophylactic administration. The conflicting claims recite a method of using the anticipatory compounds for treating diseases associated with estrogen receptor β activity, including cell proliferative diseases, psychiatric diseases, neurodegenerative diseases, bone metabolic diseases, or metabolic diseases or disorders (patented claims 9-14 and 17-19). It is noted that administration of an identical compound would necessarily have the claimed effect. Thus, the claims are anticipated. Since the patented claims encompass all the required features of the instant claims, a double patenting rejection is appropriate.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699