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 .
Election/Restrictions
Applicant’s election without traverse of Group I, encompassed by claims 1-3, 5, 7-12, and 17, drawn to a compound genus having the structure depicted in claim 1, in the reply filed on 05/04/2026 is acknowledged.
Applicant further elected the following species, without traverse, as described below:
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Applicant submits that claims 1-3, 5, 7-8, 30, and 31 read on elected species.
The guidelines in MPEP § 803.02 provide that upon examination, if prior art is found for elected species, the examination will be limited to the elected species. The elected species was found in the prior art and search was not expanded to the broader genus.
Claims 10-12, 14-15, 17, 19, 21, 26, 32-33, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/04/2026.
Application and Claims Status
Claims 1-3, 5, 7-12, 14-15, 17, 19, 21, 26, and 30-33 were pending. In the reply as filed on 05/04/2026, applicants have amended claims 30; cancelled claim 9; added new claim 41; and withdrew claims 10-12, 14-15, 17, 19, 21, 26, and 32-33, and 41, as detailed in “Election/Restrictions” section above. Therefore, claims 1-3, 5, 7-8, and 30-31 are currently pending.
Priority
The instant application is a continuation of PCT International Application No. PCT/US2022/033891, filed June 16, 2022, claiming the benefit of U.S. Provisional Application No. 63/212,384, filed June 18, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/18/2023 is in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action.
Specification
Acknowledgement is made of the drawings received 3/11/2024.
The drawings are objected to because:
FIG. 1A should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
In FIG. 2C, 4A-4C, 5C-D, 6B, 6D, 7, 8B, 8C, 8E, 8G, the various texts are illegible. As recited in 37 CFR 1.84:
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant is reminded of the proper content of an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because: the abstract length is too short, the abstract uses phrases which can be implied, and the use of the compound or composition is not provided. Furthermore, the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. In the instant case, the title of the patent is also on the abstract page. See MPEP § 608.01(b).
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Objections
Claims 1-3 are objected to because of the following informality:
In the listing of integers for the limitation of m, it should read “…m is 0, 1, or 2”. Optional formatting could also include “…m is an integer selected from 0, 1, or 2”. Similar corrections should be made for the limitations of m, n, and o in claims 1-3. Appropriate correction is required
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 1-3, 5, 7-8, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Scott et al. (WO 2009/045479 A1, published April 9, 2009)(hereinafter, ‘Scott’) in view of Lücking (“Sulfoximines: A Neglected Opportunity in Medicinal Chemistry”, published August 9, 2013) (hereinafter, ‘Lücking’).
Scott teaches, on page 323, the following species, wherein the structural difference between the reference compound and instantly claimed species is circled.
Scott: Instant Application:
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Scott teaches sulfone compounds and compositions for the same instantly disclosed utility as a treatment for age-related macular degeneration (AMD) and Stargardt’s Disease via inhibition of lipofuscin accumulation through RPE65 binding (See Abstract, [0003], [0013], claims 1-2, 20-27).
Scott does not teach sulfoximine (the monoaza analogs of sulfones) compounds.
Lücking teaches that a sulfoximine is a bioisostere for sulfone (Table 1, page 9400) and the reference provides many examples as such. For example, on page 9403, Lücking teaches that sulfone 32 had an IC50 of 28 nM, whereas sulfoximine analog 33 has an improved IC50 of 7.4 nM. In yet another example, Lücking teaches, on page 9405, “the significant activity of sulfone 40 in a dofetilide binding assay, an effective screening tool for assessing hERG blockade and proarrhythmia, raised safety concerns.” When the sulfone was replaced with sulfoximine, “sulfoximine (S)-42 revealed a 4.3-fold improvement in a hERG patch-clamp K+ channel assay. Furthermore, (S)-42 was shown to have good
oral exposure in a rat pharmacokinetic model” (emphasis added).
Lücking concludes, on page 9407, with:
Significant research has been conducted in which the sulfoximine group is used in opportunistic approaches and as a bioisoster for a surprising variety of functional groups, such as alcohols, acids, amidines, sulfones, and sulfonamides. In particular, the switch from sulfones and sulfonamides to sulfoximines has raised some interest; however, as shown in this Minireview, the results to be expected remain unpredictable. In some cases the corresponding sulfoximines indeed displayed similar or superior properties, whereas in others the exchange led to significant loss of activities. Drug discovery, however, still requires experimentation. The underrepresented sulfoximine moiety certainly deserves to be added to the medicinal chemist’s toolbox, thereby broadening the chemical repertoire in drug discovery to tackle an ever-increasing number of biological targets even more multifacetedly.
The varied results from the replacement of sulfone with sulfoximine is, of course, the natural course of drug discovery and routine optimization. A small change can either favorably increase or decrease any of the standard drug parameters that are profiled in a Structure-Activity Relationship (SAR) campaign, such as: in vitro potency, in vivo potency, selectivity, permeability, hERG activity, lysosomal stability, CYP inhibition, drug metabolism, drug clearance, etc. The major point, however, is that the replacement of sulfone with sulfoximine is obvious, as taught by Lücking.
Per 2144.09(I): A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below)
In In re Dillon, applicant claimed a composition comprising a hydrocarbon fuel and a sufficient amount of a tetra-orthoester of a specified formula to reduce the particulate emissions from the combustion of the fuel. The claims were rejected as obvious over a reference which taught hydrocarbon fuel compositions containing tri-orthoesters for dewatering fuels, in combination with a reference teaching the equivalence of tri-orthoesters and tetra-orthoesters as water scavengers in hydraulic (nonhydrocarbon) fluids. The Board affirmed the rejection finding "there was a ‘reasonable expectation’ that the tri- and tetra-orthoester fuel compositions would have similar properties based on ‘close structural and chemical similarity’ between the tri- and tetra-orthoesters and the fact that both the prior art and Dillon use these compounds ‘as fuel additives’." 919 F.2d at 692, 16 USPQ2d at 1900. The court held "it is not necessary in order to establish a prima facie case of obviousness . . . that there be a suggestion or expectation from the prior art that the claimed [invention] will have the same or a similar utility as one newly discovered by applicant," and concluded that here a prima facie case was established because "[t]he art provided the motivation to make the claimed compositions in the expectation that they would have similar properties." 919 F.2d at 693, 16 USPQ2d at 1901 (emphasis in original)
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time before the effective filing date of the claimed invention, to use the teachings of Lücking to modify the known compound of Scott to arrive at the instantly claimed invention. One of ordinary skill in the art would have had a reason expectation of success because the sulfoximine functional group is known in the prior art as a bioisostere of the sulfone functional group.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
All claims are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
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/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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