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 .
Election/Restrictions
Applicant’s election without traverse of the compounds oleuropein and quercetin for treatment of improving a physiological state linked to metabolic fatigue in one or more cells in the reply filed on 4/22/26 is acknowledged. It is noted that the examiner has withdrawn the species requirement and will examine the claims in their entirety.
Claim Rejections - 35 USC § 112 – 1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims of the present application are drawn to methods of i) improving a physiological state linked to metabolic fatigue in one or more cells, (ii) increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells, and (iii) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, (iv) treating or preventing a calcium deficiency/depletion disorder in an individual comprising administering to the individual a composition comprising a combination of oleuropein and/or a metabolite thereof and quercetin and/or a derivative, in a therapeutically effective amount. Dependent claims limit the cells, the dosing, define the metabolites and derivatives of the compounds, add additional agents and limit the form of the composition. Also claimed are methods of reducing an incidence of, and/or reducing a severity of a mitochondria-related disease or a condition associated with altered mitochondrial function in an individual in need thereof or at risk thereof, wherein the mitochondria-related disease or condition is selected from the group consisting of stress, physiological ageing, obesity, reduced metabolic rate, metabolic syndrome, diabetes mellitus, complications from diabetes, hyperlipidemia, neurodegenerative disease, cognitive disorder, stress-induced or stress-related cognitive dysfunction, mood disorder, anxiety disorder, age-related neuronal death or dysfunction, musculoskeletal disorder, frailty, pre-frailty, chronic kidney disease, kidney failure, trauma, infection, cancer, hearing loss, macular degeneration, myopathies and dystrophies, and combinations thereof. Also claimed are methods for delaying off-set of metabolic decline, maintaining muscle mass and/or muscle function, decreasing oxidative stress, maintaining immune function and/or maintaining cognitive function in a healthy older adult comprising administering a composition comprising a combination of oleuropein and/or a metabolite thereof and quercetin and/or a derivative in a therapeutically effective amount. As such, the claims are drawn to treating a wide variety of diseases embracing thousands of disorders with a very large group of compounds embraced by oleuropein and/or a metabolite thereof and quercetin and/or a derivative thereof which each embrace thousands of different compounds.
The specification however showed that mitochondrial calcium levels increased with either a combination of oleuropein and quercetin or oleuropein aglycone and quercetin. This very limited display of results – synergism of oleuropein and quercetin to increase calcium levels/uptake in mitochondria, is not seen to support the tremendously large group of diseases/disorders/activities with the various derivatives and metabolites thereof as in the claims.
The data presented shows very limited synthetic variation to the compounds tested and the activities produced therefrom. An adequate representation of a species requires that the species which are expressly described are recognized in the art as representative of the entire genus. Various conditions/activities claimed can occur without a requirement for mitochondrial calcium uptake to be improved – such as treating or preventing a calcium depletion disorder, as this would require increased calcium levels in the blood, not the mitochondria. Currently, one of skill in the art would not recognize the limited disclosure as representative of the genus claimed.
It is noted that a single species is seldom, if ever, sufficient to support a generic claim. See In re Shokal, 242 F.2d 771, 113 USPQ 283, 285 (CCPA 1957). See also, In re Grimme, 274, F.2d 949, 124 USPQ 499, 501 (CCPA 1960).
Claim Rejections - 35 USC § 112 – 2nd paragraph
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 1-10 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 1 is indefinite wherein the claims is drawn to a method from (i), (ii), and (iii), (iv). It is unclear if these are alternative embodiments or all must be accomplished at once since there is an “and” between (ii) and (iii) and nothing between (iii) and (iv).
All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
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.
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) 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over 2017/0027902 in view of WO10/118789.
The claims of the present application are drawn to methods of i) improving a physiological state linked to metabolic fatigue in one or more cells, (ii) increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells, and (iii) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, (iv) treating or preventing a calcium deficiency/depletion disorder in an individual comprising administering to the individual a composition comprising a combination of oleuropein and/or a metabolite thereof and quercetin and/or a derivative, in a therapeutically effective amount. Dependent claims limit the cells, the dosing, define the metabolites and derivatives of the compounds, add additional agents and limit the form of the composition. Also claimed are methods of reducing an incidence of, and/or reducing a severity of a mitochondria-related disease or a condition associated with altered mitochondrial function in an individual in need thereof or at risk thereof, wherein the mitochondria-related disease or condition is selected from the group consisting of stress, physiological ageing, obesity, reduced metabolic rate, metabolic syndrome, diabetes mellitus, complications from diabetes, hyperlipidemia, neurodegenerative disease, cognitive disorder, stress-induced or stress-related cognitive dysfunction, mood disorder, anxiety disorder, age-related neuronal death or dysfunction, musculoskeletal disorder, frailty, pre-frailty, chronic kidney disease, kidney failure, trauma, infection, cancer, hearing loss, macular degeneration, myopathies and dystrophies, and combinations thereof. Also claimed are methods for delaying off-set of metabolic decline, maintaining muscle mass and/or muscle function, decreasing oxidative stress, maintaining immune function and/or maintaining cognitive function in a healthy older adult comprising administering a composition comprising a combination of oleuropein and/or a metabolite thereof and quercetin and/or a derivative in a therapeutically effective amount.
‘902 teaches that quercetin compositions can be used to mitigate oxidative damage arising from mitochondrial dysfunction (see abstract) and that quercetin increases mitochondrial calcium concentrations by activating MCU (see [0058]). ‘902 also teaches to treat diseases such as Parkinson’s disease, Huntington’s disease, etc. (see abstract) with the same. What is not taught is to additionally administer oleuropein.
‘789 teaches that hydroxytyrosol in combination with various agents, including optionally quercetin synergistically enhance the body’s own energy metabolism by inducing mitochondrial biogenesis (which would increase mitochondrial energy) and increase mitochondrial function (see page 3, lines 16-24). The effects of the increased mitochondrial function include reducing muscle fatigue, protect against exercise induced oxidative stress, etc. (see page 5). Hydroxytyrosol is known to be a metabolite of oleuropein (see claim 5 herein).
While no specific combinations of hydroxytyrosol and quercetin were made in ‘789, the examiner believes with the teachings of ‘902 it would have been obvious to combine hydroxytyrosol with quercetin since ‘902 teaches that quercetin mitigate oxidative damage arising from mitochondrial dysfunction. That is, ‘902 provides guidance for picking quercetin from the list of additional agents to be combined with hydroxytyrosol in ‘789. As such, the present methods of administering a combination of oleuropein and/or a metabolite thereof (such as hydroxytyrosol) in combination with quercetin to increase mitochondrial energy would be prima facia obvious. The examiner would like to note any showing of unexpected results must be commensurate in scope with the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-11, and 16-18 of copending Application No. 18/253,426.
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are drawn to overlapping subject matter. The claims of ‘426 are drawn to methods of treating cartilage degeneration by increasing mitochondrial levels comprising administering a composition comprising oleuropein and quercetin to synergistically activate mitochondria by mitochondrial calcium rise. The present claims, which are drawn to various elements including improving a physiological state linked to metabolic fatigue in one or more cells, methods of increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells with the same combination of agents, oleuropein and quercetin, would be anticipated by ‘426 as their methods administered the same drugs to increase mitochondrial calcium levels. Both applications also are administered in the same form and amounts and contain the same optional additional agents.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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