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 .
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.
Claim 7-9 recite the limitation "wherein the indirected AMPK activator is selected from Urolithins A, B, C, D, and isourolithins A and B". There is insufficient antecedent basis for this limitation in the claim. Claim 1 limits the substitution pattern of compound VII where R1-R4 are selected from substituents that do not include Hydrogen. Only Urolithin D is within the scope of claim 1. The other compounds lack antecedent basis.
Claims 11-13 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. Claims are directed to a method according to claim 1, however claim 1 is directed to a product, not a method.
Claims 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: administration of the composition to a subject.
Claims 1-13, 15-16 and 18 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. Claims require a combination comprising a direct AMPK activator of formula I and an indirect AMPK activator of formula VII. The entire scope of compound if formula VII is within the scope of compound I. It is unclear if the claims require to compounds of different structures or a single compound having both direct and indirect AMPK activating activity. Also, it is unclear which compounds are direct activators and which are indirect. Examiner will interpret a compound that meets the structural limitations of both formulas to meet the limitations directed to both direct and indirect activator of AMPK. Urolithin D meets the limitations of both compounds.
Claim 6 is 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. Claim 6 limits direct AMPK activator and lists 3 chemical IUPAC names which are not recited as alternative. Additionally, all three names refer to the same structure.
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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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 7-13, 15-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rinsch et al (WO 2014/004902).
Claim interpretation
The current specification provides the following definitions of terms derivative and analogue:
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In view of the above definition, Urolithin D is interpreted as meeting the limitations directed structure of indirect AMPK activator of herein rejected claims. Urolithin D has a structure similar to the claimed compounds but is different with respect to certain component. The certain component is the substitution pattern around the ring system. Urolithin D is therefore with in the scope of indirect AMPK activators.
Scope of prior art
Rinsch teaches a method of improving autophagy comprising administering to a subject in need urolithin D (see claim 91, 92, 95). Rinsch also teaches that a combination of Urolithins can be administered including urolithin B (see claims 93 and 95). In claim 107 Rinsch teaches administration to subjects with cardiovascular disease.
Ascertaining the difference
Rinsch is silent regarding activation of AMPK wither directly or indirectly.
Obviousness
A skilled artisan, prior to the earliest effective filing date of the current application, would have found it obvious to administer either: a) Urolithin D or b) combination of urolithins D and B to a subject with cardiovascular disease. Urolithin D meets the limitation directed combination of direct AMPK activator and indirect AMPK activator because it is within the scope of the definition of such compounds as recited in the claims in view of the definitions provided in the specification. Where claims require administration of Urolithin B as the direct activator, Rinsch teaches that administration of a combination of Urolithins is within the scope their invention.
Regarding activation of AMPK:
While Rinsch is silent regarding Urolithins D and B being direct or indirect activators of AMPK, this limitation is inherently met. The pharmacological activity of Urolithins D and B is a property derived from their chemical structure. Since a compound and its properties are inseparable it is inherent that Urolithins D and B are AMPK activators because they are within the scope of applicant’s definition of direct and indirect AMPK activators.
Regarding method for activation of AMPK (claim 10) it is inherent that when the method of treating cardiovascular disease by administration of Urolithin D, alone or in combination with Urolithin B, is practiced, the currently claimed method of activating AMPK is also practiced. Inherency is based on administration of the currently claimed agents (Urolithin D) to the claimed subject population (subject with cardiovascular disease).
Conclusion
Claims 1-13, 15-16 and 18 are pending
Claims 1-13, 15-16 and 18 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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