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 .
Applicant’s amendments and remarks filed February 12, 2026 have been received and reviewed. Claims 1, 2, 4-15 and 17-28 are now pending in this application.
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, 2, 4-15 and 17-28 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.
i) In claim 1, the thienyl group may be substituted by acyl or sulfamoyl. These groups are unclear. Is only alkanoyl (R-C(O)-, wherein R is alkyl), which is derived from a carboxylic acid intended or are acyls derived from other acids (such as, phosphonic, arsenic, etc.) also intended? A clarification is required. Regarding sulfamoyl, this group refers to R-S(O)2-NR’R”. It is unclear what is intended. Is the group sufonamido, -S(O)2NH2 intended or is more intended? A clarification is required.
iv) In the definition of R7, Applicants need to state which groups are intended as “hydrolysable group.” A halogen, phosphates, alkanoyloxy, etc. are known hydrolysable groups. If only these are intended, insertion of these into the claims is required so the metes and bounds could be ascertained. Applicants have not responded to this.
v) Claim 2 still requires experimentation to understand which compounds are embraced by the claim. One skilled in the art still has to make each and every one of the hundreds of compounds of formula (II), then do “column separation (column type: CHIRAL ART Cellulose-SC, and elution solvent: 40/60/0.1 mixed solvent of n-hexane/ethanol/trifluoroacetic acid” to know which compounds are part of the claim. This rejection remains.
viii) The pharmaceutical composition should still require “an effective amount” of the compound in order to work. Appropriate insertion of such phrase is suggested for claim 10 and 23. Applicants have not responded.
Claims 11 and 24 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 claims contain 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 use the invention.
The treatment of brain disease, a lung disease, a skin disease, an otologic disease, a kidney disease, or an ophthalmic disease generally cannot possibly be considered enabled. The basis of this rejection is the same as given in the previous office action and is incorporated herein fully by reference.
The scope of use is not remotely possible given what is known in medicine.
Brain disease includes epilepsy, infections, cancers, mental illness, neurodegenerative diseases, stroke and autism, to name a few.
Lung disease includes infectious diseases, obstructive diseases, circulatory diseases and restrictive lung diseases.
Skin diseases include autoimmune diseases, tumors of the skin, infectious diseases, allergic diseases, etc.
Otologic diseases include hearing loss, vertigo, infections, Meniere’s disease, eardrum perforation as examples.
Kidney disease includes kidney stones, kidney cysts, chronic kidney disease, nephropathy, polycystic kidney diseases, kidney failures, etc.
Ophthalmic diseases include any disease of the eye, such as, glaucoma, short-sightedness, pink eye, dry eye, retinal detachment, astigmatism, etc.
The notion that a single drug can treat these diseases is absolutely contrary to what is known in the art.
Double Patenting
Claims 1, 2, 4-15 and 17-28 are again provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 20-22 of copending Application No. 17,623,983 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because an optically active isomer is unpatentable over a prior art racemate or optical isomer of opposite rotation in the absence of unexpected or unobvious beneficial properties. In re Adamson et al. (CCPA 1960) 275 F2d 952, 125 USPQ 233. See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).”
Therefore, in the absence of a showing that the instant compounds demonstrate unexpected and unobvious results over the compounds of the reference application, the obviousness type double patenting rejection remains. The claimed compounds differ from the compounds of the reference application only in their stereochemistry.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
March 6, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624