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 .
Status of Claims
Claims 1-16 are pending in the instant application.
Priority
Acknowledgement is made of Applicant’s claim for foreign priority based on the EP21305586.6 application filed in the European Union on May 6th, 2021.
Information Disclosure Statement
The Information Disclosure Statements filed on November 3rd, 2023 and January 29th, 2024 have been fully considered, except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Drawings
Acknowledgement is made of the drawings received November 3rd, 2023. These drawings are acceptable.
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 2, 4, and 13-15 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.
Regarding claims 2, 4, and 13-15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Auwerx et. al. (WO 2018/108991 A2; hereinafter referred to as Auwerx).
At Page 17, Paragraph 0063, Auwerx teaches compounds that enhance mitochondrial proteostasis can be compounds that induce mitophagy, which would include Urolithin A and Urolithin B. As noted at Claim 2, Urolithin A and B are each compounds of formula I as recited at instant Claim 1.
Beginning at Page 17, Paragraph 0064, Auwerx teaches compounds that enhance mitochondrial proteostasis can be compounds that module lipid metabolism, including bezafibrate and fenofibrate, both which are recited as PPAR-modulators at instant Claim 4.
At Claim 1, Auwerx teaches a method of treating an amyloid-b peptide disease comprising administering a compound that enhances mitochondrial proteostasis. Further, at Claims 31-32 Auwerx teaches the method of claim 1 in which at least two compounds, each of which enhances mitochondrial proteostasis, are administered sequentially or simultaneously.
Auwerx does not explicitly teach a composition comprising a compound of formula I and a PPAR-modulator.
Given that Auwerx teaches simultaneous administration of two compounds that enhance mitochondrial proteostasis, in view of the teaching that Urolithin A, Urolithin B, bezafibrate, and fenofibrate each enhance mitochondrial proteostasis, it would have been prima facie obvious to a person having ordinary skill in the art to formulate a pharmaceutical composition comprising one of Urolithin A or Urolithin B in combination with either bezafibrate or fenofibrate, especially in view of Auwerx’s statement at Page 20, Paragraph 0074, “In the methods of the invention, the compounds herein described in detail can form the active ingredient, and are typically administered in admixture with suitable pharmaceutical diluents, excipients or carriers”. Per MPEP 2144.06, I., “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”.
Taken together, this would result in the practice of Claims 1-5 with reasonable expectation of success.
Regarding Claims 6-7, at Page 19, Auwerx teaches the dose of compounds used is from about 0.2 to 1000 mg/kg of body weight. This range overlaps the instantly recited ranges at Claims 6-7. Per MPEP 2144.05, I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding each of Claims 8-16, each of these claims are drawn to the composition of Claim 1, further stating an intended use of the composition. This recitation of intended use, however, does not render these claims patentably distinct from that of Claim 1, as the statement of intended use does not introduce further limitations of the composition. Per MPEP 2111.02, II., “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963)”. In this case, the recited intended use does not provide any additional limitations to the composition of Claim 1. As such, for the reasons noted above, Claims 8-16 are unpatentable over Auwerx.
Conclusion
Claims 1-16 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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