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 .
Applicant’s amendments and remarks filed December 3, 2025 have been received and reviewed. Claims 1, 7, 9 and 30 are now pending in this application.
Claim 30 has approximately 250 species. This number of compounds cannot be considered a reasonable number according to rule 1.141(a). In re Fressola, 22 USPQ 2nd 1828, indicates that the Examiner may reject for Applicants failure to follow a Rule.
§ 1.141 Different inventions in one national application.
(a) Two or more independent and distinct inventions may not be claimed in one
national application, except that more than one species of an invention, not to
exceed a reasonable number, may be specifically claimed in different claims in
one national application, provided the application also includes an allowable claim
generic to all the claimed species and all the claims to species in excess of one are
written in dependent form (§ 1.75) or otherwise include all the limitations of the
generic claim.
Applicants need to rewrite the claim as a series of independent claims wherein each claim has a reasonable number of species or rewrite the claim as a dependent claim if all of the species are compounds of claim 1.
Election/Restrictions
Applicants are advised of MPEP 803.02 Restriction - Markush Claims [R - 2], fourth and fifth paragraph, where is stated:
“As an example, in the case of an application with a Markush - type claim drawn to the compound C - R, wherein R is a radical selected from the group consisting of A, B, C, D, and E, the examiner may require a provisional election of a single species, CA, CB, CC, CD, or CE. The Markush - type claim would then be examined fully with respect to the elected species and any species considered to be clearly unpatentable over the elected species. If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush - type claim and claims to the elected species shall be rejected, and claims to the non - elected species would be held withdrawn from further consideration. As in the prevailing practice, a second action on the rejected claims would be made final.” (emphasis added).
On the other hand, should no prior art be found that anticipates or renders obvious the elected species, the search of the Markush-type claim will be extended. If prior art is found that anticipates or renders obvious the Markush-type claim with respect to a non-elected species, the Markush-type claim shall be rejected and claims to the nonelected species held withdrawn from further consideration. The prior art search, however, will not be extended unnecessarily to cover all nonelected species. Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection, as by amending the Markush-type claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush-type claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during the reexamination that anticipates or renders obvious the amended Markush-type claim, the claim will be rejected and the action made final. Amendments submitted after the final rejection further restricting the scope of the claim may be denied entry.
Claim Rejections - 35 USC § 112
Claim 9 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 9 is still a duplicate of claim 1 as presented. A compound is still a compound no matter where it is present. If a pharmaceutical composition is intended, then language, such as, “A pharmaceutical composition comprising an effective amount of a compound according to claim 1 and a pharmaceutically acceptable carrier” is suggested.
Applicants have not addressed this rejection.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reyes et al. (US 8,722,742). The claim reads on the compound
RN 1181653-41-7 CAPLUS
CN 3-Piperidinecarboxylic acid, 1-[[4-(4-
morpholinylsulfonyl)phenyl]sulfonyl]-, (3S)- (CA INDEX NAME)
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221
456
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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.
Claims 1, 7, 9 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Koos et al. (US 11,241,427). The reference teaches the compound depicted below.
RN 460736-67-8 CAPLUS
CN 3-Piperidinecarboxylic acid, 1-[[4-[(diethylamino)sulfonyl]phenyl]sulfonyl]-, ethyl ester (CA INDEX NAME)
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265
488
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The claims differ by excluding this compound by proviso. However, this prior art compound renders homologues in the claims. That is, the claimed compound wherein R1 represents -N(Et)(Pr) or -N(CH((CH3)(CH3))(Et) or -N(Me)(Me) or -N(Pr)(Pr) are rendered obvious by the prior art species instantly excluded by proviso.
Compounds that differ only by the presence of an extra methyl group are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be prepareable by the same method and to have the same properties. This expectation is then deemed the motivation for preparing homologues. Homologues are obvious even in the absence of a specific teaching to methylate, In re Wood 199 USPQ 137; In re Hoke 195 USPQ 148; In re Lohr 137 USPQ 548; In re Magerlein 202 USPQ 473; In re Wiechert 152 USPQ 249; Ex parte Henkel 130 USPQ 474; In re Fauque 121 USPQ 425; In re Druey 138 USPQ 39. In all of these cases, the close structural similarity of two compounds differing by only one (or two) methyl groups sufficed; no specific teaching to methylate was present or required. None of these cases has been overruled and indeed the examiner is unaware of any post Lohr case in which motivation is required to put a methyl group on an old compound.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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December 31, 2025
/BRUCK KIFLE/Primary Examiner, Art Unit 1624