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
To summarize the current election, the applicant elected Group II and Species B, per the revised restriction organization detailed in the Office action mailed November 27, 2024, drawn to a method of achieving improvement in at least one of muscle functionality, muscle performance, or muscle strength in the tibialis comprising orally administering effective amount of calcium and at least one of oleuropein, oleuropein aglycone, hydroxytyrosol, homovanillyl alcohol, isohomovanillyl alcohol to an individual.
Claims 10-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
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 1-4, 18-20, and 27-32 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.
Claim 1 recites “a composition consisting essentially of the combination of a calcium source and oleuropein”. Claim 32 recites “a composition consisting essentially of the combination of a calcium source, oleuropein, and an excipient”. The instant specification defines a composition “consisting essentially of” their recited components as a composition that “does not include any additional compound that affects mitochondrial calcium import other than the combination of calcium and at least one of oleuropein or metabolite thereof”. There is no additional description of the excluded components. This purely functional description of impermissible chemical compounds with no additional suggestion as to their identity makes the scope of excluded components unclear because no identifying structural features have been detailed.
Claim 30 recites that the claimed combination of calcium and oleuropein “improves vitality and/or energy in the individual”. It is unclear how this recitation changes the scope of the method of the parent claim. Specifically, the additional structural requirements (e.g., dosing levels, dosing frequencies, additional actives, etc.) of the method are not clear. Thus the scope of the claim is unclear.
Claims that are rejected but are not elaborated upon are also indefinite because the depend from an indefinite claim and do not add clarity.
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.
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.
Claims 1-4, 18-20, and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. (previously cited) in view of Horcajada et al. (previously cited).
Coxam et al. teach orally administering oleuropein compositions composed of oleuropein or a metabolite/derivative formulated as an oral nutritional composition intended to support bone health (see abstract and paragraphs 49, 75, 107, and 114; instant claims 11-13). The oleuropein occurs in olive fruit and may be purified from an extract (see paragraphs 78 and 87). They go on to teach the inclusion of a calcium source in the nutritional composition as an additional nutritional compound in various salt forms that are envisioned as calcium carbonate, calcium chloride, and calcium citrate (see paragraph 133-134; instant claim 20). Coxam et al. teach the composition in various forms such as tablets and capsules as well as liquid forms such as aqueous/oily suspensions and emulsions (see paragraphs 115-116 and 165-166). Aqueous emulsions or suspensions implicitly include water, which is an excipient (see instant claim 32). Various amounts for daily administration of the oleuropein or a metabolite/derivative is detailed as 0.01 to 200 mg and that for calcium is detailed as 100 to 1000 mg (see paragraphs 130 and 134; instant claims 18-19 and 27-28). They teach administration to pets as well as young developing humans, and aging humans (see paragraphs 94 147, and 151; instant claims 2 and 31). An example explicitly pairing calcium and oleuropein is not provided nor is the composition discussed in regard to its impact on muscles.
Horcajada et al. teach increasing (improving) muscle functionality in an individual by administering a composition with a therapeutically effective amount of oleuropein (see claim 10 and paragraph 57). Muscles impacted by the method are preferably skeletal muscle and include the tibialis amongst particular envisioned varieties (see paragraph 59; instant claim 3). Daily administration of the composition is taught as is an administration duration of 30 days and longer (see paragraph 82; instant claim 4). The oleuropein is envisioned as a variety of polyphenol in the composition and this category of ingredient is present at 0.01 mg to 1000 mg per serving (see paragraphs 64-65; instant claims 18-19). Horcajada et al. teach that muscle functionality decreases as part of the later portion of the aging process of animals (see paragraph 107). They orally administer the composition to advanced age mammals as part of the diet over the course of three months and assess the impact on walking (gait) speed (see paragraph 107; instant claim 31). Walking is a variety of exercise and administration as part of the diet equates to administration before and after exercise (see instant claim 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the embodiment of Coxam et al. where a named calcium compound is included with the oleuropein because they teach to do so. More specifically, administering this composition to the populations of relevant subjects they teach including pets, young humans, and late in life adult humans would have been obvious for this same reason. Providing a daily dose of oleuropein at 0.01 to 200 mg daily and calcium at 100 to 1000 mg as a suspension in water (excipient) or in a capsule also would follow as would taught dosing ranges of and dosing forms detailed by Coxam et al. These dosing ranges overlap with those instantly recited, thereby rendering the claimed ranges obvious (see instant claim 18-19 and 26-27). “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)” (see MPEP 2144.05). Horcajada et al. teach the daily oral administration of a similar concentration of oleuropein and detail that it also improves functionality in muscle in general and in the tibialis, in particular. The application of their administration duration would have been obvious since it is the same main active compound that is also administered as part of daily nutrition. Daily administration over this duration meets the limitation of before and after exercise timing amongst the walking subset of the subject population. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Here the instantly claimed composition is administered at the instantly claimed dose, via the instantly claimed route, to the instantly claimed patient population, therefore the instantly claimed outcomes should be the result, absent evidence to the contrary (see instant claims 1 and 30-32). Thus claims 1-4, 18-20, and 27-32 are obvious over Coxam et al. in view of Horcajada et al.
Claims 1-4, 18-20, and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. in view of Horcajada et al. as applied to claims 16-24 and 16 above, and further in view of García-Villalba et al. (previously cited).
Coxam et al. in view of Horcajada et al. render obvious the limitations of instant claims 1-4, 18-20, and 27-32. They additionally teach capsule dosage forms (see paragraph 165). An explicit example in a particular vehicle is not detailed.
García-Villalba et al. teach an oleuropein rich extract from the olive leaf in a hard gelatin capsule for oral administration (see abstract and page 1017 first column second partial paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition of Coxam et al. in view of Horcajada et al. as just a calcium compound in combination with oleuropein in a hard gelatin capsule. This choice would have been obvious in light of García-Villalba et al. who detail a hard gelatin capsule as the sole carrier for oleuropein containing extracts. This modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-4, 18-20, and 27-32 are obvious over Coxam et al. in view of Horcajada et al. and García-Villalba et al.
Response to Arguments
Applicant's arguments filed October 13, 2025 have been fully considered and are not persuasive.
Regarding rejection under 35 USC 112:
The applicant notes several case law quotations in response to the rejection, but do not point to any way in which the scope of excluded components in the product of the claimed method has a “reasonable degree of certainty”, based upon being recited on a purely functional basis. For example, Coxam et al. teach foods and beverages, such as fruit juices, soups, condiments, fats, seasoning, as vehicles for their nutritional composition (see paragraph 114). Such vehicles have numerous chemical components. The instant specification defines a composition “consisting essentially of” their recited components as a composition that “does not include any additional compound that affects mitochondrial calcium import other than the combination of calcium and at least one of oleuropein or metabolite thereof”. The identity of each of the chemical components in a vehicle would have to be known and then each assessed as to whether they ‘affect mitochondrial calcium import’ in any way in order to determine whether they are within the claim scope. The disclosure offers no guidance as to which compounds, other than oleuropein and at least some of oleuropein derivatives, have such an impact. As a result, the scope of permissible components in the claim is not “reasonably certain”, thus the claims are indefinite.
Regarding rejection under 35 USC 103 over Coxam et al. in view of others:
The applicant argues that the artisan of ordinary skill would not make a composition consisting of a calcium source and oleuropein as instantly claimed based upon Coxam et al. As a point of clarification, the claims do not require a composition consisting of a calcium source and oleuropein. Instead the claims employ “consisting essentially of” language to delineate the composition that is administered by its methods. Thus the applicant’s argument that the presence of excipients in the composition of Coxam et al. precludes its use in the instantly claimed method are not relevant to the pending claims.
The applicant asserts that the claimed method has unexpectedly superior results in regard to the method of new claim 32. The applicant describes the unexpected result as the recognition of oleuropein or its metabolites paired with extracellular as bioactives that activate mitochondrial calcium. The elected method is the improvement in at least one of muscle functionality, muscle performance, or muscle strength in the tibialis. There is no demonstration of an unexpected degree of this outcome due to the administration of calcium paired with oleuropein or its metabolite. The mitochondrial calcium activation seen in the studies in cells provided by the disclosure has not been connected with the claimed changes in muscle function in an individual. The touted showing does not appear to demonstrate the practice of the elected method outcome to an unexpected degree since no individuals were tested. In addition, the expected outcome of treatment with calcium paired with oleuropein or its metabolite was not established by the applicant such that their obtained result could be categorized as expected or unexpected. Therefore the assertion of unexpected results is insufficient to overcome the prime facia case of obviousness set forth by the rejections.
The applicant argues that the teachings of Horcajada et al. and García-Villalba et al. do not motivate arriving at a composition consisting of a calcium source and oleuropein. As noted above, such a composition is not instantly claimed, therefore this argument is not relevant to the current claims under examination.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615