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 1-2 and 4-10 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 intended use of the composition of claim 1 is as a pharmaceutical. Thus, the claim should state that to particularly point out intention and also include a “pharmaceutically acceptable carrier.”
ii) The nature of the “ester” is unclear. Is the carboxyl group esterified by an alkyl or is something else intended, such as having an additional substituent which makes the compound an ester. A clarification and/or appropriate correction is required.
iii) The metes and bounds of a derivative cannot be ascertained. Applicants need to positively recite which derivative is intended and define the claimed formula to embrace such.
iv) Arriving at a prodrug requires research. One skilled in the art cannot say what the prodrug of a given compound looks like. It is improper to require research to understand the metes and bounds of a claim.
v) The variables R11 and R2 are defined, in part, as “an alkylamide, a cycloalkylamide or an alkyamine.” It is unclear what these groups look like. The group -C(O)-NH2 is a carboxamido. An alkylamide is a compound and does not have a point of attachment. Is a group R-NH-C(O)- wherein R is alkyl intended or is a group R-C(O)-NH- intended? A clarification, preferably with formula is required. The term “alkyamine” appears misspelled and is unclear. An alkylamine is a compound R-NH2. The amino group is H2N-, an alkylamino is the group R-NH-, wherein R is alkyl; a dialkylamino would then be R2N-. Claim 7 clearly points out the intended groups.
vi) In claim 7, the group SH lacks antecedent basis in claim 2. The compound of Formula (I) does not have a mercapto substituent (neither does the specification).
Claim 4 provides for the use of a composition, but, since the claim does 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.
Claim 4 is 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).
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Passaniti et al. (WO 2016/149667). The claim reads on the compositions comprising compound 1 in page 14 of the reference, as well as, compounds 2-10 disclosed in the figures in sheets 1-2. Intended use of a composition does not carry patentability weight. A drug is a drug no matter what it is used for.
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 2 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Passaniti et al. (WO 2016/149667) in view of Eliseev et al. (Oncogene (2008) 27, 3605-3614). The primary reference of Passaniti teaches the compound of formula (I), corresponding pharmaceutical compositions and their methods of use of “RUNX2 transcription factor inhibitors and their uses in cancer treatment.” (see page 1, lines 20-22). Passaniti does not explicitly teach a method to “treat osteosarcoma, Ewing sarcoma and/or a metastatic cancer originating from osteosarcoma or Ewing sarcoma.” However, the secondary reference of Elissev teaches the inhibition of RUNX2 for suppressing proliferation of osteosarcoma cells, see Abstract. Thus, the compound is known, inhibiting RUNX2 for treating osteosarcoma is known. Therefore, one skilled in the art would be motivated to use the compound of formula (I) to treat osteosarcoma with the expectation of success because the secondary reference teaches the usefulness of RUNX2 inhibitors to treat osteosarcoma. The skilled artisan would arrive at the instant claim by combining the teachings of these two references.
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.
August 6, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
Prosecution Insights