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 .
Response to Remarks and Amendments
Applicant’s response and amendments filed March 17, 2026 have been entered and are considered herein. Any rejection not reiterated herein is withdrawn.
With respect to the rejections of claims 55-56, 58, 60, 67 and 79-81 under 35 USC 102(a)(1) (paragraphs 10-15 of the previous Office action), the rejections are withdrawn in view of the claim amendments to specify that when R6 is unsubstituted 3-pyridyl, R1 is -CONH2, n = m = 1, and R2, R3 and R5 are all H, then R4 is not ethyl or neopentyl; and that when R6 is 2-chloro-3-pyridyl, R1 is -CONH2, n = m = 1, then R2, R3 and R5 are all H, then R2 is not methyl or neopentyl.
With respect to the rejections of claims 55-56, 58, 60, 67 and 79-81 under 35 USC 102(a)(1) as anticipated by CAS RN 353478-63-4 (paragraphs 16-17 of the previous Office action), Applicants contend that the amendment to claim 55 overcomes the rejection. However, the claim definitions still encompass the prior art compound where R1 is CONR7R8 where each of R7 and R8 is H; R6 is 3-pyridyl; n=m=1; R2 is ethyl; and each of R3-R5 is H.
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 actions, the Examiner searched the claims based on the elected species, wherein no prior art was found for the elected species. Accordingly, the scope of the search and examination was expanded further in accordance with MPEP 803.02 to include the compounds described in the rejections set forth in the previous action. Since this considered scope was remains unallowable, the scope of the search and consideration was not expanded further.
Status of Claims
Currently, claims 55-56, 58, 60-61, 67, 79-87 and 90-92 are pending in the instant application, all of which read on an elected invention and species and therefore remain under consideration to the extent that the claims read on the elected species and the expanded scope described above.
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.
It is noted that with respect to the rejection below, for the purposes of determining if a reference is a “printed publication” for the purposes of 102(a)(1), MPEP 2128 states the following:
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99
480
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Specifically regarding electronic publications, such as online databases, as prior art the following is noted:
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78
750
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since the database entries below list the dates that the compounds were entered into the on-line database, the compounds were made publicly available as of those dates in the citation, and the claims are anticipated.
Claim(s) 55-56, 58, 60, 67 and 79-81 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the STN Registry database entry for CAS RN 353478-63-4, which has an entry date of 29 Aug 2001.
Since the entry date represents the date that the compound entered a publicly available database on STN, this represents the date that each compound was made accessible to the public.
The STN Registry database entry listed above discloses the compound
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129
242
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which reads on the formula (I) where R1 is CONR7R8 where each of R7 and R8 is H; R6 is 3-pyridyl; n=m=1; R2 is ethyl; and each of R3-R5 is H. Since the compound disclosed in the prior art has the same structure as the instantly claimed compound, each and every required element of the claim is taught and the claim is anticipated. With respect to the instantly claimed pharmaceutical composition, it is noted that the prior art discloses molar solubility data which describes the anticipatory compound in unbuffered water, which is a pharmaceutically acceptable carrier. Accordingly, the claims are anticipated.
Conclusion
Claims 61, 82-87 and 90-92 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 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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