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 .
Restriction/Election
Requirement for Restriction/Election was mailed 22 May 2026.
Applicant’s Response to Requirement for Restriction/Election was received 30 June 2026.
Applicant’s election with traverse of Group I (Claims 1-14) and Compound (Id), indicating claims 1-6 and 9-14 read on Compound (Id), in the Response filed 30 June 2026 is acknowledged. Regarding the restriction requirement, the traversal is on the grounds that the Office has failed to meet its burden for the restriction requirement and there is no search burden, with Applicant stating the Office has not established that the product can be used to perform another materially different process, citing MPEP 806.05(h). Regarding the election of species requirement, the traversal is on the grounds that patentable distinctness between species has not been demonstrated.
This is not found persuasive because MPEP 806.05(h) states, “The burden is on the examiner to provide an example, but the example need not be documented. If the applicant either proves or provides a convincing argument that the alternative use suggested by the examiner cannot be accomplished, the burden is on the examiner to support a viable alternative use or withdraw the requirement.” In the Requirement for Restriction/Election of 22 May 2026, the example provided was the instantly recited compounds in Group I could be used in a materially different process from treating cancer, said materially different process being in vitro testing. Examiner is unaware of any evidence which would suggest the instantly claimed compounds cannot be used in in vitro testing. Additionally, a search burden exists because Groups I and II are directed to different categories of statutory subject matter and Group II requires an investigation of enablement for treating cancer. Thus, the scope of the respective search results from one search may not be applicable to the other group. Furthermore, based on the current record, species having a five-membered ring versus a six-membered ring, for example, are not obvious variants of each other. Thus, formula (I) includes patentably distinct species. The restriction requirement and election of species requirement are maintained for reasons made of record in the Requirement for Restriction/Election mailed 22 May 2026.
Accordingly, the claims in Group II (Claims 15-20) and claims which do not read on the elected species (Claims 7-8) are withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
The listing of claims filed 11 March 2024 has been examined.
Claims 1-20 are pending.
Claims 7-8 and 15-20 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 11 March 2024 is acknowledged and has been considered.
Specification
Applicant is reminded of the proper language and format for 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.
The abstract of the disclosure is objected to because it contains Markush language, which is legal phraseology, specifically the phrase “selected from the group consisting of”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
Claim 1 recites, “… and an optionally substituted aryl, and...” [Emphasis added.] For consistency, Examiner requests the comma be replaced by a semicolon.
Claim 12 recites, “pharamceutical," which appears to be a misspelling of “pharmaceutical.”
Appropriate correction is requested.
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.
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.
Claims 1-6 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over El-Araby (US 10,844,022 B1; IDS dated 11 March 2024, Cite No. 12).
Regarding claims 1-5 and 11-13, El-Araby teaches compounds useful in treating cancer, including KIM-241C and KIM-111C (Drawings, Sheet 2 of 16, Fig. 2), shown below:
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Wherein, relative to a compound having instantly claimed formula (I), in KIM-241C, R1 is phenyl and R2 is an unsubstituted furyl. However, in the instantly claimed compounds, the central imidazole has a methyl substitution, as opposed to a phenyl substitution as in KIM-241C. In KIM-111C, R1 is phenyl, R2 is phenyl, and the central imidazole has a methyl substitution.
El-Araby discloses pharmaceutical compositions wherein the compounds shown above comprise 0.1-90 wt.%, including a preferred embodiment wherein the composition comprises at least 10 wt.% of the compound (Col. 29, Lines 50-57). The pharmaceutical composition may also comprise a pharmaceutically acceptable carrier or excipient (Col. 34, Lines 59-65), which can be a buffer, an inorganic salt, a fatty acid, a vegetable oil, a synthetic fatty ester, a surfactant, or a polymer (Col. 35, Lines 28-32).
El-Araby does not explicitly teach a compound of formula (I).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of El-Araby would have found it prima facie obvious to prepare a compound of formula (I) and a composition comprising a compound of formula (I) because El-Araby discloses structurally similar compounds, as well as suggests compositions containing said similar compounds, and a PHOSITA would have been motivated to try substituting the phenyl attached to the imidazole in KIM-241C with a methyl group, as in KIM-111C, since the group in this position is either methyl or phenyl in all the exemplary imidazole-containing compounds disclosed by El-Araby. Furthermore, El-Araby reports KIM-241C has improved potency compared to KIM-111C (Col. 56, Table 1), so a skilled artisan would have been motivated to try further optimizing KIM-241C’s pharmaceutical properties by replacing its imidazole-attached phenyl group with a methyl group. Additionally, El-Araby indicates the group in this position can be, “…an optionally substituted alkyl, an optionally substituted cycloalkyl, an optionally substituted arylalkyl, and an optionally substituted aryl...” (Col. 3, Lines 18-24). Thus, a skilled artisan would have been motivated to try further optimizing KIM-241C’s pharmaceutical characteristics based on the direction and data provided in El-Araby’s disclosure.
Regarding claims 6, 9, and 14, El-Araby teaches all of the claimed elements as stated above.
El-Araby does not explicitly teach a compound of formula (I) wherein R2 is an alkyl-substituted furyl.
Prior to the filing of the instant application, a PHOSITA following the teachings of El-Araby would have found it prima facie obvious to prepare a compound of formula (I) having a methyl-substituted furyl group in the R2 position because El-Araby’s compounds and the instantly claimed compounds have close structural similarity (MPEP 2144.09(I)). El-Araby states R2 is, “…an optionally substituted aryl, or an optionally substituted heteroaryl…” (Col. 3, Lines 24-26) and provides an exemplary compound wherein R2 is an unsubstituted furyl (i.e., KIM-241C). Furthermore, El-Araby states, “In another embodiment, R2 is an optionally substituted heteroaryl. Exemplary applicable heteroaryls include, but are not limited to, 2-furanyl, 2-thienyl, 3-methy[l]-2-furanyl, 3-methyl-2-thienyl, 3-methyl-2-pyridinyl, and 4-methyl-2-pyridinyl. In a most preferred embodiment, R2 is furanyl.” [Emphasis added.] (Col. 11, Line 65 – Col. 12, Line 2). Thus, El-Araby provides a motivation to try substituting the R2 heterocycle with a methyl group, specifically, indicating furanyl in particular is preferred. MPEP 2144.09(I) states, “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).” The instantly compounds are structurally similar to those disclosed by El-Araby. Furthermore, a skilled artisan would have been motivated to make the aforementioned modifications to El-Araby’s compounds based on the information provided in El-Araby’s disclosure (i.e., exemplary structures provided by El-Araby and El-Araby’s disclosed embodiments).
Regarding claim 10, El-Araby teaches all of the claimed elements as stated above.
El-Araby does not explicitly teach a compound of formula (I) having a maximum kinetic aqueous solubility of greater than 75 µM.
Prior to the filing of the instant application, a PHOSITA following the teachings of El-Araby would have found it prima facie obvious to prepare a compound of formula (I) according to El-Araby’s teachings, which, meeting all the structural limitations required by claim 1 would be expected to exhibit the same physiochemical properties as recited in claim 10. Claim 10 recites, “The compound of claim 1, having a maximum kinetic aqueous solubility of greater than 75 µM.” Kinetic aqueous solubility is a physiochemical property. An identical compound must inherently have the same physiochemical effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, a compound of claim 1, upon which claim 10 depends, having a general formula (I) would inherently fulfill the limitations regarding parameters of physiochemical properties recited by claim 10.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,844,022 B1 and claims 1-11 of U.S. Patent No. 11,180,458 B2.
Patent ‘022 claims a composition comprising a compound of formula (I), shown below (Claim 1):
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Relative to the instantly claimed formula (I), in the compound claimed by ‘022 R1 is phenyl and R2 is -OCH3-substituted phenyl.
Patent ‘022 does not claim a compound having instantly claimed formula (I).
Patent ‘458 claims a compound of formula (I), shown below (Claim 1), as well as a pharmaceutical composition comprising a compound of formula (I) (Claims 9-11):
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Patent ‘458 recites, “…R1 is methyl, or phenyl.” (Claim 2).
Patent ‘458’s formula encompasses
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, which is recited by claim 8.
Patent ‘458 does not claim a compound having instantly claimed formula (I).
MPEP 804(II)(B)(1) states, “According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’ In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims at issue are drawn to structurally similar compounds. See rejection under 103 supra for rationale which applies in equal or greater force to the issued claims. The utility of the claims is disclosed by the Specification, therefore rendering the instant claims obvious. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010).
Because claims 1-6 and 9-14 in the instant application would have been obvious over claims 1-2 of U.S. Patent No. 10,844,022 B1 and claims 1-11 of U.S. Patent No. 11,180,458 B2 in view of El-Araby, claims 1-6 and 9-14 in the instant application are not patentably distinct from claims 1-2 of U.S. Patent No. 10,844,022 B1 and claims 1-11 of U.S. Patent No. 11,180,458 B2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ADAM C 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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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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