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 .
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.
Current Status of 18/847,249
This Office Action is responsive to the amended claims of 15 September 2024.
Claims 1-15 have been examined on the merits. Claims 1-6 are original. Claims 7-14 are currently amended. Claim 15 is new.
Priority
The effective filing date is 9 March 2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6 January 2026; 31 August 2025; and 15 September 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 7-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification and/or prior art, while being enabling for treating and/or ameliorating “inflammatory disease” with the compounds of Chemical Formula 1, does not reasonably provide enablement for preventing “inflammatory diseases”. The specification and/or prior art do not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The Wands Factors used in an (scope of) enablement rejection include (per MPEP 2164.01(a)):
The breadth of the claims:
The broadest reasonable interpretation (BRI) of the method claims 7 and 14 are each drawn to a method of treating and/or ameliorating and/or preventing any inflammatory disease (since claims 7 and 14 do not further define the scope of inflammatory diseases to be treated, ameliorated, and/or prevented) by administering the pharmaceutical compositions of claims 7 and 14.
The nature of the invention:
The invention belongs to biotechnology, more specifically, to managing inflammatory disease.
The state of the prior art:
A review of STN’s Registry, HCaplus, and Casreact databases does not find prior art for compounds of Chemical Formula 1 of instant claims 7 and 14.
Furthermore, there is no known prior art that would support treating, ameliorating, or preventing the unlimited scope of inflammatory diseases or disorders per the BRI (see, above) of instant claims 7 and 14.
For example, the reference IBD (WeillCornell.org. “Ulcerative Colitis and Crohn’s Disease (IBD)” Available to the public: 8 August 2019. Accessed on 29 September 2026. Available from: < https://weillcornell.org/inflammatory-bowel-disease > ), proves that inflammatory bowel disease (IBD) cannot be prevented (page 2).
Furthermore, the reference OA (Nebraska Medicine. “How to relieve the aches and pains of osteoarthritis.” Available to the public: 11 November 2016. Accessed: 29 September 2026. Available from: < https:// www.nebraskamed.com/how-to-relieve-the-aches-and-pains-of-osteoarthritis > ), discloses that there are no known ways to prevent osteoarthritis (page 3).
Also, the reference PSORIASIS (Stanford Medicine. “Can you prevent psoriasis?” Available to the public: 19 September 2018. Accessed: 29 September 2026. Available: < https://stanfordhealthcare.org/medical-conditions/skin-hair-and-nails/psoriasis/prevention.html > ), discloses that there is no known way to prevent psoriasis (page 1).
The level of one of ordinary skill:
The level of one of ordinary skill includes the knowledge/skill to engage in a reasonable amount of experimentation to make and use the pharmaceutical compositions of claims 7 and 14 based on the disclosure in the Specification (pages 27-69 and 74-78 of the instant Specification).
The one of ordinary skill also has the knowledge to engage in a reasonable amount of experimentation to treat and ameliorate some inflammatory diseases, such as bronchitis, asthma, diabetes, myocardial infarction, and psoriasis. However, no one has skill to engage in the undue burdensome level of experimentation required to provide guidance/enablement for preventing, treating, and/or ameliorating the unlimited/undefined scope of inflammatory diseases/disorders of the claims 7 and 14.
The level of predictability in the art:
The art is predictable to make the instantly claimed pharmaceutical compositions. However, the art does not provide predictability as to which inflammatory diseases and disorders can be treated, ameliorated, or prevented. To generate this level of guidance, one has to engage in undue burdensome experimentation (since no predictability in the art) to test the pharmaceutical composition against every inflammatory disease known to humanity to determine if the pharmaceutical composition can treat, ameliorate, and/or prevent said disease(s) as per the BRI of the scope of instant claims 7 and 14. This level of experimentation would be required to match the scope of instant claims 7 and 14.
The amount of direction provided by the inventor:
Inventors have provided direction as to making the pharmaceutical composition (pages 27-69 and 74-78 of the instant Specification). Inventors have also provided direction as to treating and ameliorating (but not preventing) the diseases of claim 13 with the pharmaceutical composition of Chemical Formula 1 per claims 7 and 14 (see pages 74-78 of the Specification).
The existence of working examples; and
Applicants’ Specification provides guidance/enablement with working examples of how Applicants synthesized their compounds of genus formula 1 (see pages 27-69 of the Specification).
Also, Applicants’ bioassay data within pages 74-78 of the Specification provides enablement for treating or ameliorating (but not preventing) the diseases of claim 13 with the compounds of Chemical Formula 1.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
Applicants’ invention comprising using compounds of Chemical Formula 1 to treat, ameliorate, or prevent any inflammatory disease (per BRI of independent claims 7 and 14) require a high level/quantity of experimentation to make/use the invention. While Applicants have provided guidance in their Specification for making the pharmaceutical composition of compounds of Chemical Formula 1 (see pages 27-69 of the Specification), they have not provided enough evidence that said pharmaceutical composition can be used to treat, ameliorate, and/or prevent the unlimited / undefined scope of inflammatory diseases or disorders per the BRI of instant claims 7 and 14. At best, the Specification does provide enablement/guidance for using the instantly claimed pharmaceutical composition to treat or ameliorate (but not prevent) the inflammatory diseases of claim 13.
Therefore, claims 7 and 14 are rejected under 35 USC 112(a) for lacking scope of enablement for the scope of treating, ameliorating, or preventing an undefined number (unlimited number) of inflammatory diseases or disorders.
Claims 8-13 are similarly rejected under 35 USC 112(a) scope of enablement since these claims refer back to claim 7 but do not remedy the rationale underpinning the basis for rejecting claim 7.
To render moot this scope of enablement rejection:
(1) Applicants should delete “prevent” and/or “prevention”/”preventing” from the claims; and
(2) Applicants should define what specific inflammatory diseases within broad independent claims 7 and 14 they believe the Specification and/or prior art provides guidance / enablement to treat or ameliorate. Examiner recommends rolling the specific diseases of claim 13 into both independent claims 7 and 14, perhaps in Markush limitation format. For example, -- A method of treating or ameliorating inflammatory disease, wherein the inflammatory disease is selected from the group consisting of: [insert claim 13 diseases here] -- .
Conclusion
Claims 7-14 are not presently allowable as written.
Claims 1-6 and 15 are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a compound of Chemical Formula 1 according to instant claims 1, 7, and 14-15.
The reference ACS (American Chemical Society. Chemical Abstract Service. RN 1333406-27-1. Entered into STN: 27 September 2011), discloses the compound:
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(see enclosed ACS reference).
However, the compound exemplified by reference ACS, above, is structurally distinct from the instantly claimed genus of compounds in at least three ways (see arrows, above): (1) the instant invention does not permit a plurality of R1 moieties to join together to form another (fused) ring; and (2) the moiety -SO2, above, is distinct from the -S- moiety attached to the R2-phenyl; and (3) and R2 cannot be methoxy.
The three distinctions, above, are too many differences to make a viable obviousness rejection. Moreover, there is no known rationale (or prior art providing said rationale) that would permit altering the above compound to arrive at the instant invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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