DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments and Amendments
Applicant’s arguments and amendments filed June 12, 2026 have been entered. All rejections and objections not explicitly maintained herein are withdrawn. The rejections below constitute the full set of rejections being applied to the instant claims.
With respect to the rejections of claims 55, 59, 61, 63 and 71-72 under 35 USC 112(b), applicants contend that the claim amendments are sufficient to overcome the rejections. The rejection over claim 61 is withdrawn in view of the claim cancellation. The rejection of claim 72 is withdrawn in view of the claim amendment such that it depends from allowable claim 62. With respect to the remaining claims, the rejections are withdrawn. Claim 55 still recites a second instance of R7 definition in the definitions of R14 and R4. Each of these two instances should be replaced with R20. Further, claim 59 still recites a second instance of R7 within the definition of R4. Each instance should be replaced with OR20. Further, clam 59 still recites the divalent groups S, S(O) and S(O)2 in the R4 definition. Appropriate correction of each instance is required. All dependent claims remain rejected for failing to correct the same deficiencies.
With respect to the rejection of claims 59 and 71 under 35 USC 102(a)(1), the rejection is withdrawn in view of the claim amendment to require that at least one of W,X, Y and Z is N. Since the prior art does not teach a compound falling within the amended claim scope, the rejection is withdrawn.
Election/Restrictions
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 in the previous action, the Examiner searched the claimed invention based on the elected species, wherein: no prior art was discovered over the elected species and the scope was expanded as described in the previous action. In view of the amendment to overcome the prior art, the scope of the search and examination was again expanded to include the compound described in the rejection herein, having the structure
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.
Status of Claims
Currently, claims 55-56 and 59-80 are pending in the instant application. Claims 56, 60, 64-70 and 73-80 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species. Claims 55, 59, 61-63, and 71-72 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 U.S.C. § 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.
Claims 55, 59, 63, and 71 are 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 pre-AIA the applicant regards as the invention.
The claims are rejected as indefinite because the variable R7 appears twice in the recited chemical formulae and is given two different definitions. In claim 55, the first instance is as a phenyl substituent
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, where the variable is defined as
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. The variable appears again in the definition of R4 and R14, where OR7 is listed as an aryl or heteroaryl substituent, and is set forth with a new definition
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. In claim 59, the first instant is as a nitrogen substituent depicted in formula (V), where it is defined as
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. The variable appears again in the definition of R4 and R14, where OR7 is listed as an aryl or heteroaryl substituent, and is set forth with a new definition
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. Any given variable can only have one definition in a chemical formula to avoid confusion and ambiguity in the structure. Appropriate clarification/correction is required.
The claims are rejected because they recite the limitation that R4 may be S, S(O) or S(O)2. These definitions represent a divalent substituent (i.e. another chemical moiety would be required in order to fill the valence of each of these groups), but the substituents are defined for a monovalent position. It is unclear how this monovalent position could be defined by substituents which are necessarily divalent without also defining what else the moieties are bound to. Any dependent claims that do not recite a particular compound or list of compounds by exact structure does not remedy this issue; therefore, the dependent claims are also rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 59 and 71 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 99/06024.
The prior art teaches a pharmaceutical composition (claim 1) comprising a lipophilic pharmaceutically active agent. The reference goes on to exemplify that the agent is PNU-2 (claim 2), which has the structure
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. The prior art compound reads on the claimed Formula (V) where R13 is
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, where X and Z are each N and W and Y are each CR14, where R14 is heterocyclyl (pyrrolidine); p is 0’; G is alkyl; and R7 and R8 together form a heterocyclyl (pyrrolidine). Since the prior art teaches all required limitations of the instant claims, the claims are anticipated.
Conclusion
Claims 62 and 72 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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