DETAILED ACTION
Claims 3-33 are currently pending in the instant application.
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 Amendments/Arguments
Applicant’s amendments and arguments in a response filed 03/30/2026 have been fully considered and entered into the application. Applicant has overcome
The 35 U.S.C. 112(b) rejection of claim 10 in view of Applicant’s amendment to the claim.
The 35 U.S.C. 102(a)(1) rejection of claims 3-4, 8-10 and 12 over Lu et al in view of Applicant’s arguments.
The 35 U.S.C. 103 rejection of claims 3 and 11 over Lu et al in view of Applicant’s arguments.
Election/Restrictions
Applicant's election with traverse of Group I, drawn to compounds and pharmaceutical compositions
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in the reply filed on 11/24/2025 is acknowledged. The traversal is on the ground that the common structure, Formula II, constitutes a structurally distinctive compounds over the cited art of WO 2013/019662. However, the common structure of Formula II is not a significant structural element as prior art has been applied as discussed below. Thus, claims 13-32 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 timely traversed the restriction (election) requirement in the reply filed on 11/24/2025.
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.
Applicant's elected species appears allowable over the prior art of record. Therefore, the search of the Markush-type claim has been extended to the non-elected species
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.
As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 3-12 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
The remaining subject matter of claim 33 that are not drawn to the above elected invention stand withdrawn under 37 CFR 1.142(b) as being non-elected subject matter. The remaining compounds which are not within the elected invention are independent and distinct from the elected invention as they differ in structure and composition. Therefore the compounds, which are withdrawn, have been restricted as the withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference, which anticipates one group, would not render obvious the other. Thus all claims containing compounds falling outside the search strategy of the elected compound and structure shown above are heretofore directed to non-elected subject matter and are withdrawn from consideration under 35 U.S.C. § 121 and 37 C.FR. § 1.142(b). A complete reply to the non-final rejection must include cancellation of non-elected claims include cancellation of non-elected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
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).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 3-4, 8-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA Reg No. 1054646-22-8, entered into STN on 09/29/2008. CA Reg No. 1054646-22-8 corresponds to compound
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. This corresponds to a compound of Formula II wherein R1, R4, R5, R6 , R9 are H, R10 and R11 taken together form oxo, R2 and R3 are -OR26 and R26 is hydrocarbyl, R7 and R8 taken together with the carbon atoms to which they are attached to form a cyclic group comprising 1 to 30 plural valence atoms selected from carbon and oxygen (specifically a 5-membered heterocyclyl – methylenedioxy group), R19 is optionally substituted monosaccharide, R21 is OR25 wherein R25 is H and R29 is OR26 and R26 is heterocyclyl substituted with hydroxy.
Regarding the composition of claim 12, comprising the anticipatory compound and an excipient, the Registry entry for Registry no. 1054646-22-8 discloses a mass solubility of 0 g/L, in unbuffered water at pH 7.00. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
Allowable Subject Matter
Claims 5-7 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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