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 .
Non-Final Rejection
Priority
This application was filed on 12/15/2023 and is a continuation of application 17/390,531, which was filed on 07/30/2021, issued 02/13/2024 as US 11,897,873, and is a Continuation of application 16/846136 which was filed on 04/10/2020, issued 09/21/2021 as US 11,124,504, and is a Divisional of application 15/924,119 which was filed on 03/16/2018, issued 06/09/2020 as US 10,676,469 and which claims priority to the following three Provisional Applications: 62/609,960, filed on 12/22/2017; 62/585,447, filed on 11/13/2017; and 62/473,209, filed on 03/17/2017.
Second Preliminary Amendment
Applicant’s amendment to the claims dated 08/27/2024 is acknowledged.
Information Disclosure Statement
The IDS dated 06/25/2024 has been received, entered and considered, a signed copy is included herein.
Claim Interpretation
The terms “lower alkyl”, “lower haloalkyl” and “lower haloalkoxy” are recited in the claims. These are relative terms which do not have an art-recognized distinct meaning. The specification however clearly provides a “special definition” for these terms. See page 10, lines 25-26, page 11, lines 5-6, 8-9 and 12-13. For example:
“As used herein, "lower alkyl" means a straight chain or branched alkyl group
having from 1 to 8 carbon atoms”
Thus, each of these groups is interpreted as having alkyl moieties with from 1-8 carbons.
Claimed Subject Matter
The claimed invention is directed to:
Methods of use comprising administering either a compound according to a Markush genus of formula (XI) per independent claim 149, or a species of compound (compound “142”) which falls into the scope of the genus per independent claim 166, or
The compound “142” or a salt of this compound according to independent claims 175-176.
Compounds according to the Markush genus of formula (XI), including the species of compound 142, were allowed in parent application 15/924,119 in issued US patent 10,676,469.
The compound required by the all of the presently pending claims is novel and non-obvious over the prior art for the reasons of record in the 15/924,119 application; see pages 4-6 of the notice of allowance dated 01/10/2020. For at least this reason all of the present claims are allowable over the prior art.
The application is not presently allowable in view of the below non-prior art issues.
PTO-892 Form
Anderson (BMJ 2012, 345, e8508) provides the art-recognized meaning of the term "a bipolar disorder" and describes the well-known features of such a disorder. For example, the different “poles” of the disorder (elevated mood/mania and depression) and the three common types (bipolar I, bipolar II and cyclothymia) are described.
Morrison is a post-dated review describing functional features and clinical development of the claimed compound “142” also now known as “Navacaprant”.
Status of the claims
Claims 1-148 were cancelled by the Applicant.
Claims 149-176 are pending and rejected.
Claim Objection
Claim 157 is objected to since it does not end with a period as is required.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 156 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 156 depends from itself. The scope of the claimed method is unclear since it is unknown which claim is meant to be limited.
This rejection can be overcome by amending claim 156 to depend from claim 155.
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.
[1] Claims 175-176 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 10,676,469. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are anticipated by and/or obvious or the reference claim.
Reference claim 2 recites a list of compounds which includes compound 142 at the bottom of column 272.
Regarding examined claim 175, the compound is anticipated by the reference claim since it is identically disclosed. Alternatively, it would be obvious to provide each of the listed compounds according to the reference claim.
Regarding examined claim 176, the reference claim provides that the listed compounds can be provided as a pharmaceutically acceptable salt thereof. It would at least be obvious to provide for salts of the listed compounds, for example in order to improve their pharmaceutical properties, etc.
[2] Claims 149-176 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-81 of U.S. Patent No. 11,124,504. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are anticipated by and/or obvious or the reference claims.
Reference claim 1 is a method for treating a malcondition for which antagonizing the kappa opioid receptor is medically indicated, comprising administering a compound according to the same genus of formula (XI) as recited in the method of examined claim 149.
Reference claim 2 recites a list of compounds to use in the method, which includes compound 142, at lines 15-25 of column 273.
Reference claim 53 specifies the use of the single species of compound 142.
Reference claims 9, 15 and 18 define the malcondition as an anxiety disorder, depressive disorder and mood disorder, respectively.
Regarding examined claim 149, it would be obvious to use the reference method to treat subjects having a bipolar disorder since it is known that the disorder is characterized by the different “poles” of mania (a mood disorder) and depression. One of ordinary skill in the art would have good reason to use the reference method to treat the clinical symptoms associated with the different poles of bipolar disorders at least since they substantially overlap with those of the disorders specified in the reference dependent claims.
Regarding examined claims 150-157, 166 and 175, compound 142 is specified in reference claim 53 and it would at least be obvious to provide this particular compound for administration in the reference method. This compound meets the structural limitations of all these claims. Regarding claim 175, one must necessarily be in possession of the compound in order to practice the method.
Regarding examined claim 176, reference claim 53 provides that compound 142 can be provided as a pharmaceutically acceptable salt thereof. It would at least be obvious to provide for a salts compound 142, for example in order to improve the pharmaceutical properties, etc.
Regarding examined claims 163-165 and 172-174, a skilled artisan would find reason to administer the compound to subjects with each of the three known subtypes of a bipolar disorder, at least since the symptoms associated with one or both of the poles of the disorder overlap with the disorders specified in the reference dependent claims.
Regarding examined claims 158-160 and 167-169 a skilled artisan would preferentially administer the compound orally, by means of a tablet or capsule, since oral administration allows for conveniently dispensing of doses and their self-administration as well as better patient compliance than other routes and tablets and capsules are routinely used for such a purpose.
Regarding examined claims 161-162 and 170-171 the frequency of administration would preferentially be selected as from once to three times a day at least for convenience and patient compliance and since medications are typically given at these intervals.
[3] Claims 175-176 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,897,873. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims are anticipated by and/or obvious or the reference claim.
Reference claim 1 is drawn to a pharmaceutical composition comprising a species of compound identical to that required by examined claims 175-176.
Regarding examined claim 175, the compound is anticipated by the reference claim since it is identically disclosed. Alternatively, one would necessarily be in possession of the compound and/or it would be obvious to provide for the compound, in order to produce the reference composition.
Regarding examined claim 176, the reference claim provides that the compound can be provided as a pharmaceutically acceptable salt thereof. It would at least be obvious to provide for salts of the listed compound, for example in order to improve pharmaceutical properties, etc.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL R CARCANAGUE whose telephone number is (571)270-3023. The examiner can normally be reached 9 am to 5 pm EST.
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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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/DANIEL R CARCANAGUE/ Primary Examiner, Art Unit 1621