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 .
Claims 1-23 are pending in the instant application. Claims 1-23 are rejected.
Information Disclosure Statement
The information disclosure statement filed on September 29, 2023 has been considered and a signed copy of form 1449 is enclosed herewith.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-21 and 23, in the response filed on May 29, 2026 is acknowledged. Upon further search and consideration, however, the restriction requirement has been withdrawn (i.e., the full scope of the subject matter of claims 1-23 has been searched and examined in its entirety).
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, 8, 9, 12, 13, and 19-23 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.
With regards to claims 1, 12 and 19-23, the limitation “a disease or disorder capable of being treated by an agonist of AdipoR” is unclear and renders the claims indefinite. The specification (see page 8, lines 16-23) does not clearly define what diseases or disorders can be considered a disease or disorder capable of being treated by an agonist of AdipoR; it merely gives “aspects” of the invention. Based upon the information readily available, the skilled person would not be aware of all the pathologies possibly involving these disease or disorders. Therefore, it is unclear what can and cannot be included as a disease or disorder capable of being treated by an agonist of AdipoR and the claims are indefinite.
This rejection can be overcome by amending the claims to include that the diseases or disorders cable of being treated by an agonist of AdipoR are metabolic diseases or disorders (e.g., as in claim 3) or to include the specific diseases or disorders (e.g., as in claims 4-7).
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.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being rejected by Ronsisvalle et al. (Future Medicinal Chemistry, Vol. 11, No. 11, 2019).
Ronsisvalle et al. discloses the compound (-)-MML1017 which is the same compound of formula (1) as in the claims (see abstract and graphical abstract).
With respect to the art rejection above, it is noted that the reference does not teach that the compound can be used in the manner instantly claimed (i.e., for use in the treatment of a disease or disorder capable of being treated by an agonist of AdipoR). However, the intended use of the claimed compound does not patentably distinguish the compound, per se, since such disclosed use is inherent in the reference compound. In order to be limiting, the intended use must create a structural difference between the claimed compound and the prior art compound. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries 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 10-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ronsisvalle et al. (Future Medicinal Chemistry, Vol. 11, No. 11, 2019).
Ronsisvalle et al. discloses the compound (-)-MML1017 which is the same compound of formula (1) as in the claims (see abstract and graphical abstract). It is also disclosed that the compound is a proposed dual MOR agonist/MMP-9 inhibitor agent (with a limited enzyme inhibition capability toward MMP-2), shows positive antioxidant properties and could potentially be used in the treatment of inflammation and pain (see abstract).
The reference does not specifically disclose a pharmaceutical composition (i.e., which can be administered to humans orally, transdermally, subcutaneously, intravenously, rectally or intranasally) or medicament comprising the compound, suitable for use in the treatment of a disease or disorder capable of being treated by an agonist of AdiopoR.
However, since it is disclosed in the reference that the compound (-)-MML1017 may have pharmaceutical worth, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to make a pharmaceutical composition and medicament comprising the compound in view of the reference and to arrive at those of the claims with a reasonable expectation of success. The motivation would have been to make pharmaceutical compositions and medicaments which can be used for the treatment of inflammation and pain.
Thus, a prima facie case of obviousness has been established.
With respect to the art rejection above, it is noted that the reference does not teach that the compound can be used in the manner instantly claimed (i.e., for use in the treatment of a disease or disorder capable of being treated by an agonist of AdipoR). However, the intended use of the claimed compound does not patentably distinguish the compound, per se, since such disclosed use is inherent in the reference compound. In order to be limiting, the intended use must create a structural difference between the claimed compound and the prior art compound. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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