DETAILED ACTION
Notice of 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 .
Requirement for Restriction
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or correspond-ing special technical features. The expression “special technical features” shall mean those technical features that define a contri-bution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made with-out regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be con-sidered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manu-facture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufac-ture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufac-ture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-4, 6-11 and 13-18, drawn to a compound of Formula (IA) and compositions thereof, classified in Cooperative Patent Classification C07D 487/10.
II. Claims 20-23, drawn to a method of using the invention of Group I for treatment of a disease/condition relating to aberrant function or activity of a T-type calcium channel in a subject in need thereof, classified in Cooperative Patent Classification C07D 487/10.
As set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art."
The inventions listed as Groups I-II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The technical feature of Group I is a compound of Formula (IA). The compound of claim 1 does not present a contribution over the prior art in view of CAS RN 959853-37-3 (entered into STN on 1/02/2008), having the following structure:
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which reads on a compound of Formula (IA) wherein X1 is Formula (b) wherein A1 and A1 are each independently CH, and R7 is F; X2 is CH2; and X3 is (iii) unsubstituted phenyl. As such, Group I does not share a special technical feature with the instant claims of Group II. Therefore, the claims are not so linked within the meaning of PCT Rule 13.2 so as to form a single inventive concept, and unity between Groups I-II is broken.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Election of Species
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
If any of Groups I-II is elected, the following species election is required:
(1) Elect a single compound species of formula I by defining with specificity each of X1, X2, X3 and any additional variables as required to provide a single compound species. Applicant is further required to provide or point out both the chemical structure and chemical name of the elected compound species.
The species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons: even though the species require the technical feature of a compound of Formula (IA), this technical feature is not a special technical feature as it does not make a contribution of the prior art as discussed above. Accordingly, Applicant is required to (i) elect a single disclosed species for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable even though the requirement may be traversed (37 CFR 1.143); and (ii) identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election. Currently, claims 1 and 17-18 as to Group I are generic, and claims 20-23 as to Group II are generic.
The election of the species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species.
Should applicant traverse on the ground that the species are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Telephonic Response to Requirement for Restriction
Applicant’s election without specifying traverse of Group I by telephone on 7/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is still deemed proper and is therefore made FINAL.
Claims 20-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election with traverse of a single species (Example 23 (Specification, Page 69, Table 2)) by telephone on 7/16/2026 is also acknowledged.
The elected species read upon claims 1-2, 6-7, 9-11, 15 and 17-18. Claims 3-4, 8, 13-14 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
As indicated above, the elected species reads upon claims 1-2, 6-7, 9-11, 15 and 17-18.
The elected species has been searched and is deemed to be free of the prior art and non-obvious. Accordingly, the search has been expanded as called for under current Office Markush practice – a compound-by-compound search – to include a single additional species (M.P.E.P. § 803.02). That species is:
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wherein, in Formula (IA), X1 is Formula (b) wherein A1 and A1 are each independently CH, and R7 is F; X2 is CH2; and X3 is (iii) unsubstituted phenyl – which reads on pending claims 1-2, 6 and 9. A rejection to those claims follows. Additionally, claim 17, drawn to a pharmaceutical composition comprising a compound of Formula (IA) and a pharmaceutically acceptable carrier, is rejected.
Since the search has not been expanded beyond the single additional species identified above, claims 7, 11, 15 and 18, which are directed to the elected species but which do not include the single additional species, are objected to as indicated below, and have not been further examined.
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.
Claims 1-2, 6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS RN 959853-37-3 (entered into STN on 1/02/2008).
Claim 1 is drawn to a compound of Formula (IA), which embraces the following compound species:
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wherein X1 is Formula (b) wherein A1 and A1 are each independently CH, and R7 is F; X2 is CH2; and X3 is (iii) unsubstituted phenyl – which reads on pending claims 1-2, 6 and 9.
The compound is taught by CAS RN 959853-37-3.
Accordingly, claims 1-2, 6 and 9 are anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 17 is rejected under 35 U.S.C. 103(a) as being unpatentable over CAS RN 959853-37-3 (entered into STN on 1/02/2008) as applied to claims 1-2, 6 and 9 above, in further view of Ito et al (Cancer Science 94:3-8, 2003).
Claim 17 is drawn to a pharmaceutical composition comprising:
(a) a compound of Formula (IA) which embraces the following species
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(b) and a pharmaceutically acceptable carrier.
As discussed above, the compound of Formula (IA) is taught by CAS RN 959853-37-3.
However, CAS RN 959853-37-3 does not teach a pharmaceutical composition comprising said compound along with a pharmaceutically acceptable carrier as instantly claimed.
Yet, Ito et al teach “[a] reliable medium-term bioassay system for rapid detection of carcinogenic potential of chemicals in the human environment” (Abstract). As further taught by Ito et al, the “test chemicals are usually given in the diet or the drinking water” – i.e. a pharmaceutically acceptable carrier (Abstract).
Based further on Ito et al, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to prepare a pharmaceutical composition of the compound CAS RN 959853-37-3 by combining it with a pharmaceutically acceptable carrier in an effort to identify the carcinogenic potential of said compound. The issue of carcinogenicity is of interest to every chemist that is exposed to any compound, irrespective of the known uses of the compound, since a chemist would always want to know if a compound she or he is handling has carcinogenic potential.
In view of all of the foregoing, instant claim 17 is rejected as prima facie obvious.
Claim Objections
Claims 7, 11, 15 and 18 are objected to as depending from a rejected base claim. Since the search has not been expanded beyond the single additional species identified above, claims 7, 11, 15 and 18, which are directed to the elected species but which do not include the single additional species, are objected to as indicated below, and have not been further examined.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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