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 .
Priority
This application claims benefit and priority to U.S. Provisional Application No. 63/302,782 filed on 01/25/22 and U.S. Provisional Application No. 63/306,737 filed on 02/04/22.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/18/2024, and 02/06/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of claims
Claims 1-17 are pending in this application and are currently under examination. Applicant' s arguments, filed 11/06/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
The limitation of claim 1 cited as “wherein the compound selectively inhibits microsomal prostaglandin E synthase-I (mPGES-1) activity while preserving prostacyclin synthase (PGIS) and cyclooxygenase-2 (COX-2) activity.” Is being interpreted as an inherent property of the compounds cited in the prior art. See MPEP 2112.01
For the purposes of this examination, claims 8-9, 11, 14, 16, and 17 are being interpreted as intended use claims as evidenced by absence of an active step or change in structure of the compounds of instant claim 1. See MPEP 2111.02, 2173.02 and 2111.02.
Claim Objections
Claim 4 is objected to because of the following informalities: the article “a” in claim 4 , line 1 appears and requires deletion. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: the article “a” in claim 5 , line 1 appears and requires deletion. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the term “mucosal” in claim 6, line 2 should be –mucosa— or alternatively –mucosal--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-17 are 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.
Claim 1 recites the limitation " FIG. 9," in claim 1, (i), line 2, “FIG. 8,” in claim 1, (ii), line 2, and “FIG. 19” in claim 1, (iii), line 2. Reference to figures or tables in the claim is generally not permitted as claims should be complete in themselves where possible. Further, Applicants have not demonstrated exceptional circumstances. As such, claim 1 is rejected under 2173.05(s) for improperly referencing a figure or table.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: “FIG 19” in claim 1, (iii), line 2, reference to which is not found in the claims, specification nor submitted drawings. A person of ordinary skill would not be able to determine what applicant means in claim 1, (iii) by “compound had a modification of the -OH group and the -NH group of 2,4-diaminophenol, as depicted in FIG. 19, by 4-(fluoro)-benzoic acid or 4-(difluoro)-benzoic acid resulting in compounds (VII) and (VIII)”, without being provided FIG 19. This rejection may be overcome by amending the claims to incorporate the information Applicants intended to include in Fig 19 or cancelling the claim.
Claims 2-19 are included in the rejection because each of these claims depend, directly or indirectly, from claim 1 and fail to sure the indefiniteness of claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lage (High antineoplastic activity of new heterocyclic compounds in cancer cells with resistance against classical DNA topoisomerase II-targeting drugs).
Lage teaches the compound of A26 (p. 215), CA plus Registry Number: RN l16248-09-0, 2-(4-Ethylphenyl)benzo[d]oxazol-5-amine. It is taught as a Topo II-inhibiting compound for cytotoxicity in human cancer cell lines and derived drug-resistant cell variants (pg. 215, fig. 1). Lage's teaching of compound A26 anticipates applicants administration of compound I of claim 1 to a subject for the treatment of an inflammatory disease.
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Lage’s compound A26 (Left) Applicant’s compound I (Right)
See MPEP 2112.01 Composition, Product, and Apparatus Claims, MPEP 2144.04(II) routine optimization, and MPEP 2111.02(II) which states;
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use.
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 102(a)(l) and 102(a)(2) as being
anticipated by Song (US 2015/0197498 Al).
Song teaches the compound of formula 6 [0038], CA plus Registry Number: RN 293738-21-3, (2-[4-(1,1-Dimethylethyl)phenyl]-5-benzoxazolamine). It is administered in oral formulations, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, or aerosols, external applications, suppositories, and sterile injectable solutions [0057]. Song's teaching of compound of formula 6 anticipates applicants structural limitations of compound III of claims 1-4 and 6-7 wherein the compound is administered in a method of treating pain and inflammation in a subject.
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Song’s formula 6 (Left) Applicant’s compound III (Right)
See MPEP 2112.01 Composition, Product, and Apparatus Claims, MPEP 2144.04(II) routine optimization, MPEP 2131.02, and MPEP 2111.02(II).
Claims 1, 8, 13-17 are rejected under 35 U.S.C. 102(a)(l) and 102(a)(2) as being anticipated by Hamanaka (WO 2005/092845 Al).
Hamanaka teaches the compound of 2-( 4-tert-butyl-phenyl)-5-nitro-benzooxazole, CA plus Registry Number: RN 112606-70-9 (2-[4-(1,1-Dimethylethyl)phenyl]-5-nitrobenzoxazole) in example 331 (pg. 135, lines 6-25). It is taught by Hamanaka as a method of treating diabetes mellitus (Type I and/or Type II), inflammation, and peripheral vascular disease (pg. 5, lines 7-15). Hamanaka discloses pulmonary vascular disease and “inflammatory disease, autoimmune disorders and other systemic diseases” as including rheumatoid arthritis, osteoarthritis, neurodegeneration, vascular disease, diabetes and colitis (pg. 11 line 30 - pg. 12, line 26). Hamanaka's compound of example 331 anticipates the structural limitations of applicants compound of formula VI of the instant application.
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Hamanaka’s compound 331 (Left) Applicant’s compound VI (Right)
See MPEP 2112.01 Composition, Product, and Apparatus Claims, MPEP 2144.04(II) routine optimization, MPEP 2131.02 and MPEP 2111.02(II).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hamanaka (WO 2005/092845 Al).
The instant claims are directed to a method for treatment of inflammation, inflammatory diseases or disorders, pain or fever, in a subject comprising in vivo administering parenterally, orally, or topically through the skin, intramuscular, subcutaneous, intravenous, or intradermal injection or mucosal a compound selected from the group consisting of I-VIII or X-XII in a pharmaceutical composition, wherein the pharmaceutical composition is a liquid, powder, pill, tablet, capsule or any solid and semi-solid form, nanoparticle, polymer, semi-polymer, formulation.
Hamanaka et al. teach methods of treating diabetes mellitus (Type I and/or Type II), inflammation, peripheral vascular disease, cognitive dysfunction (pg. 5, lines 7-15). Hamanaka teaches the compound of 2-( 4-tert-butyl-phenyl)-5-nitro-benzooxazole, CA plus Registry Number: RN 112606-70-9 (2-[4-(1,1-Dimethylethyl)phenyl]-5-nitrobenzoxazole) in example 331 (pg. 135, lines 6-25). Hamanaka also discloses “inflammatory disease , autoimmune disorders and other systemic diseases” as including rheumatoid arthritis, osteoarthritis, neurodegeneration, lupus erythematosus, vascular disease, diabetes, colitis and neurodegeneration (including Parkinson’s, Huntington’s disease, amyloid deposition and amyotrophic lateral sclerosis) (pg. 12, line 17- 26). Hamanaka discloses “compounds of the present invention are generally administered in the form of a pharmaceutical composition comprising at least one of the compounds of this invention together with a pharmaceutically acceptable vehicle, diluent or carrier. Thus, the compounds of the present invention can be administered individually or together in any conventional oral, parenteral, rectal or transdermal dosage form” and that the pharmaceutical composition can take the form of solutions, suspensions, tablets, pills, capsules, powders, and for purposes of parenteral administration, these aqueous solutions are especially suitable for intravenous, intramuscular, subcutaneous, Transdermal (topical) and intraperitoneal injection purposes. (pg. 56, lines 1-31).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to administer a method of in vivo treatment for inflammation, arthritis, neurodegenerative, colitis, diabetes or vascular disease by orally of intravenously administering a pharmaceutical composition comprising the compound of example 331 (formula VI of the instant claims) to a subject in need thereof following the teachings of Hamanaka because a skilled artisan seeking to treat the medical conditions of an inflammatory disease of condition would have found it obvious to optimize the release properties of the compound by adjusting the particle size and as a result increase bioavailability with Hamanaka’s disclosed compounds which are taught for treating the same conditions. See MPEP 2111.02(II) and MPEP 2144.05(II).
A person of ordinary skill in the art would have been motivated to administer a compound of example 331 to a subject as a method of treating inflammation because Hamanaka’s disclosed compounds are taught in methods of treating inflammatory diseases, and autoimmune disorders including rheumatoid arthritis, osteoarthritis, neurodegeneration, lupus erythematosus, vascular disease, diabetes, colitis and neurodegeneration (including Parkinson’s, Huntington’s disease, amyloid deposition and amyotrophic lateral sclerosis). Therefore, a skilled artisan, following the teachings of Hamanaka would have had a reasonable expectation of success in a method of treating inflammatory conditions in a subject based on the current record.
Response to Applicants Arguments
Applicants argue that the claim amendments presented overcome the rejections of record. Specifically, none of the cited Lage, Karates, Ertan, Song, Hamanaka or the CA Plus Registry references teach or suggest the compounds with the recited features of amended independent claim I or their use for treatment of inflammation, inflammatory diseases or disorders, pain, or fever.
Applicants argument is found unpersuasive because as indicated in the 35 U.S.C. 102(a)(l) and 102(a)(2) rejection of claims 1-17 in the final rejection dated 08/06/2025, Hamanaka anticipates the compound of formula VI of the instant claims with the prior art compound of 2-( 4-tert-butyl-phenyl)-5-nitro-benzooxazole, CAplus Registry Number: RN 112606-70-9 in example 331 (pg. 135, lines 6-25). It is taught as a method of treating inflammatory disease, autoimmune disorders and other systemic diseases including rheumatoid arthritis, osteoarthritis, neurodegeneration, vascular disease, diabetes and colitis (pg. 11 line 30 - pg. 12, line 26). As an example to further clarify the record, the condition of Chron’s disease is cited in applicant’s specification as “More specifically, the inflammatory disease may be selected from the group consisting of interstitial lung disease (ILD), non-alcoholic steatohepatitis (NASH), Crohn's disease, ulcerative colitis, rheumatoid arthritis, type 1 diabetes, lupus, multiple sclerosis, Parkinson's disease, scleroderma and psoriasis.” (emphasis added) Chron’s disease is also cited within the prior art reference of Hamanaka pg. 12, lines 17-21 as “The terms “inflammatory disease, autoimmune disorders and other systemic diseases”, as used herein, are selected, but not limited to, the group consisting of multiple sclerosis, rheumatoid arthritis, osteoarthritis, irritable bowel syndrome, irritable bowel disease, Crohn’s disease, colitis, vasculitis, lupus erythematosis, sarcoidosis, amyloidosis, apoptosis, and disorders of the complement systems.” (emphasis added)
Applicants additionally argue none of the cited references teach or suggest "wherein the compound selectively inhibits microsomal prostaglandin E synthase-I (mPGES-1).
The amended limitation wherein the compound selectively inhibits microsomal prostaglandin E synthase-I (mPGES-1) is a natural result occurring in the body from the administration of the compound, See MPEP 2112.01. No additional structural changes nor method steps are cited in the claim limitations which rise to the level sufficient to overcome the rejection.
Conclusion
All claims are rejected, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623