The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-5 are pending and under consideration.
Priority: This application claims benefit to foreign application MX/A/2023/008088, filed July 6, 2023. A copy of the foreign priority document has been received in the instant application on July 5, 2024 and is not in the English language.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code: see at least paragraphs 0005, 0006, 0008, 0011, 0012, 0016, 0017, 0018, 0076 (of the application publication US 20250009857). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1-5 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 1-5 recite that the nutraceutical composition based on pineapple and plant extracts is “characterized” by comprising the recited components. It is not clear why the composition has to be characterized to comprise the recited components. The claims should just clarify that it is composition “comprising” the recited components. Further clarification and/or correction is requested.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Daikeler et al. (US 20100291050) in view of Wan et al. (US 20210369805) and Qa’dan et al. (2005 The American Journal of Chinese Medicine 33(2): 197-204). Daikeler et al. disclose a nutritional composition for providing nutrients to provide and support an effective antioxidant system in the body (at least paragraphs 0001, 0008-0009). Daikeler et al. disclose a composition comprising an optimal combination of antioxidants, enzymes, probiotics, vitamins, and minerals, allowing for the oxidative reactions necessary to sustain vital biological functions (at least paragraph 0009). Daikeler et al. disclose the composition comprises a blend of superfoods high in antioxidant and anti-inflammatory activities, digestive enzymes, probiotics, plant products (at least p. 2-4). Daikeler et al. disclose a nutritional composition comprising ingredients including pineapple powder as part of a fruit powder blend (1500 g), bromelain as part of an enzyme blend (130 mg), and plant leaf extracts (at least paragraph 0040, example 1 Table). Daikeler et al. disclose the compositions may be formulated in form of a solid, liquid or emulsion (at least paragraph 0037) and the composition is formulated for oral consumption (at least paragraph 0038). Daikeler et al. disclose that plant products are a source of numerous phytonutrients and phytochemicals having numerous beneficial health properties, i.e. anticancer, anti-inflammatory, anti-viral, and anti-bacterial; and polyphenol antioxidants and anti-inflammatory effects (at least paragraph 0030). Daikeler et al. disclose that by including plant products, the composition provides beneficial reduction in oxidative damage (at least paragraph 0031). Daikeler et al. do not explicitly teach citrus pectin or plant leaf extracts of Juglans regia (walnut) and Psidium guajava (guajava).
Wan et al. disclose a nutraceutical composition comprising the same blends of beneficial ingredients noted in Daikeler et al., in a gummy formula or gummy composition (at least p. 15 claim 1). Wan et al. disclose the nutraceutical composition comprises an active component, which includes an antioxidant composition and an anti-inflammatory composition (at least p. 15 claim 1). Wan et al. disclose the anti-inflammatory composition comprises a bromelain from pineapple, a walnut leaf extract (at least p. 15 claim 8). Wan et al. disclose the gelling component is a citrus pectin and that water is incorporated into the nutraceutical gummy composition (examples 1-2, 5, 8-9). Wan et al. disclose the active component comprises about 5-15% by weight of the composition (at least paragraph 0031) and that a gelling agent concentration is about 0.1% to 7% (at least paragraph 0166).
Qa’dan et al. disclose that Psidium guajava and Juglans regia leaf extracts contain polyphenols and the extracts have anti-inflammatory and anti-oxidative activities (at least p. 203).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the prior art and arrive at the claimed nutraceutical composition comprising citrus pectin, pineapple powder, bromelain, Juglans regia leaf extract, Psidium guajava leaf extract, and a volume of water (instant claims 1, 4-5). The motivation to do so is given by the prior art. The combination of the prior art references disclose bringing together effective amounts of agents having antioxidative and anti-inflammatory activities to form a nutraceutical composition, where the recited components pineapple powder, bromelain, Juglans regia leaf extract, and Psidium guajava leaf extract are well-known and recognized agents having antioxidative and anti-inflammatory activities and it is already known that agents having antioxidative and anti-inflammatory activities, including pineapple powder, bromelain, plant extract material including Juglans regia leaf extract, Psidium guajava leaf extract, can be combined together with citrus pectin to form an oral nutraceutical composition in gel form.
Additionally, regarding the instant concentrations recited in instant claim 1, including 6.58% to 8.58% w/w citrus pectin, 33.3% w/w pineapple powder, 3.33% w/w bromelain 80 GDU, 1% w/w aqueous extract Juglans regia leaf extract, 1% w/w aqueous extract Psidium guajava leaf, and a volume of water to complete 100% w/w, it is known that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the recited amounts of citrus pectin, pineapple powder, bromelain, Juglans regia leaf extract, Psidium guajava leaf extract, and volume of water by routine optimization because Daikeler et al. and Wan et al. disclose incorporating amounts of the same types and/or kinds of anti-inflammatory and anti-oxidant activities also into an oral nutraceutical composition in a gummy formulation (instant claims 1, 4).
Regarding instant claim 2, Wan et al. disclose the nutraceutical composition further comprises an acid/buffer system, 1.33% of a 54% citric acid solution (at least paragraphs 0110-0111); the amount of acid will be in the typical range of from about 0.5 to about 2% by weight (at least paragraph 0112, see also examples 1-2, 5-8). Wan et al. also disclose that a preservative selected from sodium benzoate (at least paragraph 0156) at about 0-2% by weight of the composition (at least paragraph 0157) may be incorporated into the nutraceutical composition (see also examples 3-4). Therefore, it would have been obvious to further incorporate citric acid and sodium benzoate at the recited amounts of 2.5 g and 2 g, respectively, by routine optimization.
Regarding instant claim 3, Wan et al. disclose that the pectin is a high methoxy pectin (at least paragraph 0165).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marsha Tsay whose telephone number is (571)272-2938. The examiner can normally be reached M-F.
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/Marsha Tsay/Primary Examiner, Art Unit 1656
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