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 .
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 1-16 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) The claim language “ small molecule TNF-α inhibitor” should be changed to “compound” throughout the claims because this is extraneous and confusing text. The structural compound fully defines the claimed compound. The intended use of a compound or composition does not carry patentability weight.
ii) Claim 2, in part, is drawn to the same racemic compound of formula (I) according to claim 1. Thus, in this regard fails to narrow the claim from which it depends. The same compound is named “formula (I)” and “formula (II), as well as, (+)-STU104 (II). Appropriate correction is required. A single compound should carry a single name.
iii) Also in claim 2, the phrase “i.e.,” is inappropriate and should be deleted or replaced with definite language, such as, “which is” or similar language.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (Journal of Organic Chemistry (2011), 76(16), 6611-6618). The reference teaches the claimed compound of formula (I), formula (II) or (+)-STU104, depicted below, as the compound 10b in Scheme 1, page 6612.
RN 1319025-06-3 CAPLUS
CN 1H-Inden-1-one, 2,3-dihydro-4,6-dimethoxy-3-(4-methoxyphenyl)- (CA
INDEX NAME)
PNG
media_image1.png
229
378
media_image1.png
Greyscale
.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable independently over Lee et al. (Journal of Organic Chemistry (2011), 76(16), 6611-6618) and Fudan (CN107082743).
The claimed compound differs from the compound of the references only in its stereochemistry. This close structural similarity between any two compounds can pose a problem in patent prosecution. Under the Patent Act, 35 U.S.C. § 103, the existence of the second discovered epimer is presumed to be “obvious,” and hence unpatentable, absent a showing that it has unexpected beneficial properties. See generally Note, Standards of Obviousness & the Patentability of Chemical Compounds, 87 Harv. L. Rev. 607 (1974). Further problems can result if the evidence suggests that the second-discovered compound was previously coproduced (as a byproduct) or otherwise disclosed in the prior art so as to defeat its "novelty" within the meaning of 35 U.S.C. § 102.
Similarly, 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.
Therefore, in the absence of a showing that the instant compound demonstrates unexpected and unobvious results over the prior art compound, the claims are deemed obvious over Lee and/or Fudan.
See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).”
Thus, in the absence of a showing that the epimer of the instant formula (III) demonstrates unexpected and/or unobvious results over the compound taught by the references, the claims are deemed obvious over the reference.
Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Fudan (CN107082743). The reference teaches a similar process for making an epimer of the compound (R)-STU104 (III). The claims differ by requiring a racemic starting material over the S-form of the prior art process. One skilled in the art can easily substitute either the R or S starting material in the prior art process with the expectation of achieving consistent results of either form of the compound. Therefore, one skilled in the art would be motivated to replace the racemic starting material with the R compound and arrive at the instant claims because the reference teaches that the compound 6b, which is the optical isomer of instantly claimed compound, is produced by a similar process. The claims differ by varying the process conditions. Selection of the appropriate process conditions would have been prima facie obvious because where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955).
Claims 9-16 provide for the use of a compound, but, since the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claims 9-16 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Should Applicants convert these claims to method of use claims, enablement (how to use) and indefinites rejections (e.g., “includes but not limited to”) will be made.
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.
February 7, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624