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 of
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212
288
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in the reply filed on 06/01/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3-6, 8, and 10-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
The present application is a U.S. National Stage application under 35 U.S.C. 371 of International Application PCT/US2023/012726 (published as WO 2023/154412), filed on February 9, 2023, which claims priority under 35 U. S. C. 119 to U.S. Provisional application 63/309524, filed February 12, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/17/2024 has been considered by the examiner.
Status of Claims
Claims 1-13 are pending. Claims 3-6, 8, and 10-13 are withdrawn. Claims 1-2, 7, and 9 are examined in accordance to the elected species.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks working examples directed to the preparation or use of the claimed compounds, In particular, the specification provides no synthetic examples, no reaction schemes, no intermediates, no reaction condition, no purification methods, and no characterization data for the elected compound or its pharmaceutically acceptable salts, esters, or solvates. Paragraph [0034] merely refer generally to literature references and state that esters and ethers may be prepared by known methods, but fail to provide guidance sufficient to enable one of ordinary skill in the art to prepare the full scope of the compounds claimed.
Furthermore, the specification contains no experimental evidence demonstration anti-inflammatory activity. Although, the specification asserts that the compounds possess anti-inflammatory activity and may be useful for treating disorders associated with chronic inflammation, the specification provides no in vitro assays, no cell-based studies, no animal studies, no cytokine measurements, no dose-response data, no IC50 values, and no examples establishing therapeutically effective amounts.
The Wands factors weigh in favor of nonenablment”
First, the quantify of experimentation required would be extensive because one of ordinary skill in the art would be required to develop synthetic routes, prepare salts, esters, and solvates, determine whether the compounds possess anti-inflammatory activity, and identify therapeutically effective amounts.
Second, the amount of guidance provided in the specification is minimal. The specification merely cites literature references and contain prophetic statements regarding utility without providing working examples.
Third, the specification provides no working examples.
Fourth, the nature of the invention concerns medicinal chemistry and treatment of inflammatory disorders, both of which are highly unpredictable fields.
Fifth, the state of the art demonstrates that medicinal chemistry is an uncreating discipline. Fraser et al. (Cell. 2024 February 01; 187(3): 517–520) explain that “medicinal chemistry is full of uncertainty” and further teach that even with structural information, it is difficult to know what molecules to synthesize and that cellular assays and animal models are only approximations of the human disease process. (See Abstract; “introduction” section of page 1.)
Additionally, Mehta et al. (European Journal of Medicinal Chemistry 263 (2024) 115942, pages 1-23) teaches that the mechanisms underlying chronic inflammation are highly complex, involve numerous signaling pathways, and biomarkers, and present substantial challenges for drug discovery. Mehta also explain that prediction of anti-inflammatory activity remains difficult even with animal models. (See section 3 of page 7 and section 7 of page 19.)
Sixth, the predictability of the art is low. The cited references demonstrate that biological activity and therapeutic efficacy cannot be reliably inferred from structure alone and require empirical evaluation.
Finally, the breadth of the claims encompasses the elected compound and other unrelated compounds and pharmaceutically acceptable salts, esters, and solvates thereof, pharmaceutical compositions containing therapeutically effective amounts thereof, and treatment of disorders associated with chronic inflammation.
Accordingly, one of ordinary skill in the art would be required to engage in undue experimentation to practice the full scope of the claimed invention, and therefore the specification fails to comply with the enablement requirement.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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.
It is unclear whether the claim is directed to a pharmaceutical composition or to a method of treatment, thereby rendering the metes and bounds of the claim unclear. Specifically, the claim recites “a pharmaceutical composition according to claim 7 for use in a method of treating a disorder associated with chronic inflammation comprising administering to an individual in need thereof.” Thus, the claims recites both a composition and an affirmative process step, making it unclear whether infringement would occur upon making or possessing the composition or only upon performing the recited administration step. Furthermore, the clause “comprising administering to an individual in need thereof.” Fails to identify what is being administered, thereby further obscuring the scope of the claim. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claim.
Claims 1, 2, 7, and 9 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a compound selected from a group consisting of a plurality of structurally diverse compounds, including, inter alia, an oxicam derivative, a dichlorephenyl pyrroline acetic acid derivative, an acetoxy cyclopentene carboxylic acid derivative, an acetamide cyclopentenol derivative, a methoxyindene propionic acid derivative, a terpenoid carboxylic acid derivative, and an arylpropionic acid derivative is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
A proper Markush grouping requires that the alternatively claimed species shares a substantial structural feature essential to a common utility and that the shared utility be recognized in the art. See MPEP 803.02.
In the present case, the specification merely states that the disclosed compounds possess anti-inflammatory activity. However, the specification contains no examples, no in vitro assays, no in vivo studies, no cytokine measurements, no IC50 values, and no experimental data demonstrating that the claimed compounds share a common anti-inflammatory property. The specification further fails to identify any common structural feature responsible for the alleged anti-inflammatory activity.
Because the claimed compounds are structurally unrelated and because the alleged common utility is unsupported and not shown to arise from a common substantial structural feature, the recited Markush grouping is improper.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Conclusion
Claims 1, 2, 7, and 9 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached Monday-Thursday from 7.00am-5.30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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