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 .
Claims 1-27 are presented for examination on the merits.
Claim Rejections - 35 USC § 112
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 1-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a composition comprising an admixture of botanical extracts (i.e. Gynostemma Powder Extract CAS # 80321-63-7; Sage Extract CAS # 84082-79-1; Cardamom Powder Extract CAS # 8000-66-6; Coffee Robusta Extract CAS # 97593-13-0; Notoginseng Extract CAS # 94279-78-4),
does not reasonably provide enablement for any and all extracts of :Gynostemma, Sage; Cardamom; Coffee Robusta and Notoginseng. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
See e.g. Genentech v. Novo Nordisk, 108 F. 3d 1361, 1366 “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 86 S. Ct. 1033, 1042-43, 16 L. Ed. 2d 69, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that "Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved." (Emphasis added)
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples provided in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are drawn to a composition containing an admixture of extracts of Gynostemma, Sage; Cardamom; Coffee Robusta and Notoginseng. However, the specification provides only one working example, that of an admixture of specific extracts of Gynostemma Powder Extract CAS # 80321-63-7; Sage Extract CAS # 84082-79-1; Cardamom Powder Extract CAS # 8000-66-6; Coffee Robusta Extract CAS # 97593-13-0; Notoginseng Extract CAS # 94279-78-4). Regarding the extraction solvent used to obtain the claimed product with functional properties, it is well known in the art that polarity of solvents plays a key role in determining the final product obtained by an extraction. However, because many phytochemicals remain undiscovered, the skilled artisan has to make his/her best educated guess as to what types of phytochemicals will be successfully extracted with a solvent of a particular polarity. Oftentimes, unless the constituents in a particular natural product extract have been well evaluated and documented in the literature, the skilled artisan must adhere to trial and error protocols in order to quantitatively determine phytochemical constituents present in samples obtained from respective extraction procedures. These procedures are common when, for example, a natural product or part thereof has been documented in the literature as possessing some medicinal quality. The skilled artisan will attempt numerous extraction protocols in an attempt to isolate particular ingredient(s) that have medicinal efficacy. Typically, beginning with the first crude extraction, it is a guess as to whether or not the extract will possess certain phytochemical constituents. For example, unpredictability with regard to natural extracts due to their highly complex nature has been well documented. Revilla et al. (J. Agric. Food Chem. (1998), vol. 46, pp. 4592-4597) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See tables 1, 2, 4, 5, 6 and 7 in Revilla). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction.
Consequently, given the unpredictability of the art, the lack of guidance from the specification and the quantity of experimentation needed to practice the claimed invention, the claims are not considered to be enabled for every extract of Gynostemma, Sage; Cardamom; Coffee Robusta and Notoginseng.
Claims 1-27 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116).
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.’ Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F. 2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, no that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F. 3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
In Ariad Pharm. Inc. v. Eli Lily & Co. 598 F ad 1336 (Fed. Cir. 2010) en banc}, the Federal Circuit noted the importance of an application's disclosure, stating, “the hallmark of written description is disclosure.” A disclosure adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1354. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbot Labs, 636 F.3d 1341, 1948 (Fed. Cir. 2011)
Satisfying the written description requirement “varies with the nature and scape of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F. 3d 1349, 1357 (Fed. Cir. 2005). The Federal Circuit explained what is required to meet the written description requirement in Ariad Pharm., Inc. v. Eli Lilly & Co:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue." Id. at 1359.
A written description of a genus in biotechnological arts “requires a precise definition, such as by structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit reflected on Eli Lilly in Ariad while explaining how to sufficiently describe a genus in biotechnological applications:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species fitting within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel 984 F.2d 1164, 1171 (Fed. Cir. 1993). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
A “representative number of species” must typify the entire claimed genus and account for variation between the species of the genus:
[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictably in the results obtained from species other than those specifically enumerated. Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Or. 2004).
In Ariad, the Court also addressed the presence of a genus within a method claim, in Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. Id. at 918. We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification’s function description, the specification did not provide an adequate written description of the claimed invention. Id. at 927-28. Ariad, at 1373.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” MPEP § 2163.
The MPEP indicates:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
What constitutes a “representative number” is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
Applicant has provided evidence of only a single example of a composition (i.e., topical composition (5)) with the claimed functionality to reduce visceral fat deposition upon application to skin of a subject and/or preserve or enhance muscle mass in a body of a subject. This product with the specific composition was produced by a specific method and contains very specific botanical extracts (e.g. Gynostemma Powder Extract CAS # 80321-63-7; Sage Extract CAS # 84082-79-1; Cardamom Powder Extract CAS # 8000-66-6; Coffee Robusta Extract CAS # 97593-13-0; Notoginseng Extract CAS # 94279-78-4) in specified amounts.
There is well-known unpredictability regarding natural product extracts and their e.g., pharmaceutical capabilities. The resulting compositions and thus functional properties of an extraction process are highly dependent on the particular steps of the extraction and the extraction solvent employed
Raskin et al. clearly establish the grave unpredictability of elucidating active ingredients from natural sources:
Multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
Applicants’ claims are directed toward a composition comprising an extract of beeswax bloom which is capable of anti-inflammatory actions. The claims are broad enough to read on any extract from wax bloom which has the claimed effect. However, Applicants have disclosed only one very particular method for obtaining a very specific beeswax bloom extract which has the capability of inhibiting inflammation.
There is no known means for predicting the capability of other extracts, besides the extract(s) specifically described in the Instant disclosure, with regard to [e.g., anti-inflammatory effect]. The skilled artisan could not even relatively predict what other extracts would perform this function. Absent any discussion regarding correlation between structure and function, even the most skilled of artisans would need to guess what other extracts could potentially have the effect(s) listed in the claim(s).
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 1-27 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 is rendered vague and indefinite by the phrase “A composition including an admixture of dry ingredients, comprising”. It is unclear if Applicant’s the use of “including” is intending to have the same meaning as “comprising”. That is – the recited components are not the only components that can be included. If so, it is suggested that Applicant use the term “comprising” for consistency and clarity. Furthermore, it is unclear if the “comprising” is in reference to the admixture or the composition.
The claimed recited percentages are indefinite as it is unclear if the percentages is relative to the claimed composition or carrier composition or the admixture.
Claim 18 is rendered vague and indefinite by the phrase “wherein said carrier composition adapted to apply to a subject's skin”. It is unclear how this is meant to limit the claimed composition. Does the language mean that the claimed composition or only the carrier composition is “adapted to apply to a subject’s skin”? Does this mean that the composition of claim 3 is not adapted to be topically applied?
Claims 23-25 contain the trademark/trade names Acticire ® MB, Emulium® Dolcea and Emulium® Mellifera. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe carrier compounds and, accordingly, the identification/description is indefinite.
Claim 26 is rendered vague and indefinite by the phrase “wherein said carrier composition comprises said Phase A carrier composition combined with said Phase B carrier composition”. The limitation "said Phase" is unclear. There is insufficient antecedent basis for this limitation in the claim. What is the difference between phase A and B? What are the components of phase A and B carrier compositions?
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under U.S.C. 112, second paragraph, for the reasons set forth above.
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) 1-27 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art cited by Applicant and fully described in the Specification and cited in IDS filed 10/22/25 and 9/8/25.
Gynostemma Powder Extract (CAS # 80321-63-7): Gynostemma pentaphyllum is a climbing vine found in South and East Asia primarily. It is in the family Cucurbitaceae which includes cucumbers, gourds, and melons. Gynostemma Powder Extract can be an excellent source of saponins, chemicals that the body uses to create several compounds including steroidal hormones. A key saponin in Gynostemma are gypenosides. Gypenosides confer several documented benefits including reducing anxiety, decreasing mast cell production, thereby benefitting allergies, and regulating deposition of body fat. Studies have shown that gypenosides can increase the body's production of AMPK. Choi E. et al. Supplementation with extract of Gynostemma pentaphyllum leaves can reduce anxiety in healthy subjects with chronic psychological stress: A randomized, double-blind, placebo-controlled clinical trial. Phytomedicine. 52 (2019), pp. 198-205. <doi: 10.1016/j.phymed.2018.05.002>; Nguyen P. et al.
New dammarane-type glucosides as potential activators of AMP-activated protein kinase (AMPK) from Gynostemma pentaphyllum. Bioorg Med Chem. 19(21) (2011), pp. 6254-6260. <doi: 10.1016/j.bmc.2011.09.013>.
AMPK, an enzyme found in all cells regulates lipid metabolism and energy production. AMPK declines with advancing age. One of the key actions of AMPK is to trigger burning of stored fat for energy. Anaerobic glycolysis and metabolism, inducing energy conservation, can reduce circulating AMPK, which is a major contributor to abdominal fat formation and storage. Hardie G. AMPK: a key regulator of energy balance in the single cell and the whole organism. Int JObes (Lond). 32 (Suppl 4) (2008), pp. S7-S 12.
Increased AMPK production can support body fat reduction by promoting utilization and oxidation of glucose while decreasing appetite. AMPK can increase fatty acid oxidation (burning fat for energy) while simultaneously reducing fatty acid synthesis.
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Sage is a well-known and commonly used herb for both culinary and medicinal uses. Sage Officinalis contains several bioactive compounds including tannins salviatannin), essential oils including one or more of alpha-thujone, beta-thujone, cineole, camphor, flavones, phenolic acids, and various terpenes. Sage can be a source of ursolic acid which, as above described, can increase the expression of AMPK and irisin in skeletal muscles.
This directly leads to improved lipid metabolism and increase in lean tissue synthesis. Seo D. et al. Ursolic acid in health and disease. Korean JPhysiolPharmacol. 22(3) (2018), pp. 235-248. Additionally, ursolic acid can increase levels of Uncoupling Protein 1 (UPC1). UPC1 can be a respiration uncoupler responsible for generating non-shivering thermogenesis in brown fat tissue. Upon activation it stimulates the production of heat rather than ATP within brown adipose tissue. It is also thought to occur in beige adipocytes. Ursolic Acid has also been proven to upregulate Uncoupling Protein 3 (UPC 3). Specifically, UCP1 and UCP3 expression affects free fatty acid catabolism as a downstream target of AMPK activation in skeletal muscle. Chu X. et al. Ursolic acid increases energy expenditure through enhancing free fatty acid uptake and 3- oxidation via an UCP3/AMPK-dependent pathway in skeletal muscle. Mol Nutr Food Res. 59(8)
(2015), pp. 1491-503. <doi: 10.1002/mnfr.201400670>.
Coffee Robusta accounts for about 40% of global coffee production. It is grown in Africa, Indonesia, with the largest producer being Vietnam. Coffee Robusta Extract is derived from unroasted coffee bean to retain heat sensitive compounds. Coffee Robusta Extract can be standardized to 50% chlorogenic acid. Chlorogenic acid can improve cardiovascular health, normalize blood pressure, balance blood sugar, reduce inflammation, and reduce fatty liver disease. Tajik N., Tajik M., Mack I., Enck P. The potential effects of chlorogenic acid, the main phenolic components in coffee, on health: a comprehensive review of the literature. EurJNutr. 56(7) (2017), pp. 2215-2244. <doi: 10.1007/s00394-017-1379- 1>. Chlorogenic acid can increase browning of adipocytes by increasing expression of UCP1 and peroxisome proliferator-activated receptor-gamma coactivator 1 alpha (PGC lA). PGC lA is a member of a family of transcription coactivators that plays a central role in the regulation of cellular energy metabolism. Sudhakar M. et al. Chlorogenic acid promotes development of brown adipocyte-like phenotype in 3T3-L1 adipocytes. [online]. Journal of Functional Foods (74) (2020)
PGC lA can be involved in disorders such as obesity, diabetes, and cardiomyopathy. PGC1A was originally described as a coactivator of PPARy that modulated expression of uncoupling protein 1 (UCP1) and thermogenesis in brown fat. It has also been shown to control mitochondrial biogenesis and oxidative metabolism in many cell types. PGC1A can be induced in muscle by exercise and can stimulate beneficial effects of exercise in muscle.
Cardamom is a spice native to the Indian subcontinent and Indonesia. It is commonly used in Indian dishes and is a member of the Ginger family. Cardamom is a rich source of several terpenes including a-terpineol, myrcene and limonene. Clinical studies evidence that ingestion of cardamom can increase serum irisin levels as well as improve fasting blood sugar (FBS), insulin (FBI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol (HDL-c). Daneshi-Maskooni M. et al. Green cardamom supplementation improves serum irisin, glucose indices, and lipid profiles in overweight or obese non-alcoholic fatty liver disease patients: a double-blind randomized placebo-controlled clinical trial. BMC Complement Altern Med. 19(1) (2019), p. 59. <doi: 10.1186/s12906-019-2465-0>. Even moderately increased levels of30 cirlating irisin can increase energy expenditure, reduce body weight and improves diet-induced insulin resistance. Zhang Y. et al. Irisin stimulates browning of white adipocytes through mitogen- activated protein kinase p38 MAP kinase and ERK MAP kinase signaling. Diabetes, 63(2) (2014), pp. 514-525. <doi: 10.2337/dbl3-1106>.
Panax Notoginseng Extract (CAS# 94279-78-4): Panax Notoginseng is a species of Panax that grows naturally in China. It is also known as Chinese or Tienchi Ginseng. Panax Notoginseng contains several dammarane type ginsenosides. Zhang X. et al. Effect of Panax notoginsengSaponins and Major Anti-Obesity Components on Weight Loss [online]. Pharmacol. 11 (2020),p. 601751 [retrieved on June 2, 2023]. Dammarane type ginsenosides are tetracyclic triterpenes and form triterpene saponins such as those found in certain Ginsengs. Dammaranes are known for improving energy, immunity, lowering lipid levels and blood pressure, reducing osteoporosis, protecting the liver, and increasing longevity. Dammaranes are also neuroprotective, cardioprotective, and have exhibited anti-cancer potential. Yoshikawa M. et al. Bioactive saponins and glycosides. XIX. Notoginseng (3): immunological adjuvant activity of notoginsenosides and related saponins: structures of notoginsenosides-L, -M, and -N from the roots of Panax notoginseng. Chem Pharm Bull (Tokyo) 49(11) (2001), pp. 1452-1456. . Notoginseng can affect weight through a number of pathways. The ginsenosides impact UCP1 and AMPK which help to increase the browning of white adipose tissue. Notoginseng can also improve glucose metabolism by stimulating Insulin Receptor Substrate-1 (IRS1) to increase insulin sensitivity, and improve skeletal muscle glucose uptake through its effect on Glucose transporter 4 (GLUT4). T.C. Chang, et al. Effect of ginsenosides on
glucose uptake in human Caco-2 Cells is mediated through altered Na+/glucose cotransporter 1 expression. Journal of Agricultural Food Chemistry 55 (2007), pp. 1993-1998. Additional benefits include upregulating AMPK, PGC 1A and Sirtuin1 (SIRT1). SIRT1 is a cellular energy sensor involved in glucose and lipid metabolism, browning of white fat, and mitochondrial biogenesis. Y.C. Huang, et al. Effect and mechanism of ginsenosides CK and Rgl on stimulation of glucose uptake in 3T3-L1 Adipocytes. Journal of Agricultural Food Chemistry 58 (2010), pp. 6039-6047. ; Y.C. Huang, et al. An essential role of cAMP response element binding protein in ginsenoside Rg1-mediated inhibition of Na⁺/glucose cotransporter 1 gene expression. Molecular Pharmacology 88(6) (2015), pp. 1072-83. bi:10.1124/mol.114.097352>; W.L. Chang, et al. The inhibitory effect of ginsenoside Rg1 on glucose and lipid production in human HepG2 Cells. Adaptive Medicine 5(4) (2013), pp. 181-188.
Mulberry (Morus alba) is a shrub or tree native to Asia. One of the constituent compounds in the Mulberry Leaf Extract, 1- deoxynojirimycin, inhibits the breakdown of ingested sugars and starches into glucose. This inhibition translates into less insulin output and ultimately into reduced fatty acid synthesis and fat deposition. Mulberry Leaf Extract also contains chlorogenic acid and its related chemicals (isomers), rutin, quercetin, resveratrol, quercetin, p-hydroxycinnamic acid, and caffeic acid. Mulberry Leaf Extract can activate UCP-1, AMPK, PPAR alpha, and PGC 1 alpha. Lim H., Lee
O., Kim Y., Yang J, Lim Y. Anti-inflammatory and anti-obesity effects of mulberry leaf and fruit extract on high fat diet-induced obesity. Exp Biol Med. 238 (2013), pp. 1160-1169. Mulberry Leaf Extract can activate brown adipose tissue and can induce browning of inguinal white adipose tissue in type 2 diabetic rats through regulating the AMP-activated protein kinase signaling pathway. Cheng L. et al. Mulberry leaf activates brown adipose tissue and induces browning of inguinal white adipose tissue in type 2 diabetic rats through regulating AMP-activated protein kinase signalling pathway [online]. Br J Nutr. (2022) 127(6), pp. 810-822.
Goji Berry Powder Extract (CAS# 85085-46-7): Goji Berry, also known as Wolfberry, is a bright red fruit native to Asia. Goji Berries offer a wide range of nutrients including vitamins, minerals and anti-oxidants. A constituent of Goji Berry Powder Extract comprises a water-soluble polysaccharide fraction (glycoconjugates) clinically demonstrated to have beneficial effects on blood sugar metabolism and body composition. Masci A., Carradori S., Casadei M.A., Paolicelli P., Petralito S., Ragno R., Cesa S. Lycium barbarum polysaccharides: Extraction, purification, structural characterisation and evidence about hypoglycaemic and hypolipidaemic effects. A review. Food Chem. 254 (2018), pp. 254:377-389. Polysaccharides contained in Goji Berry Powder Extract can activate AMPK and suppress sterol regulatory element-binding protein-1c (SREBP-1c). SREBP-1c is a transcription factor required for glucose utilization and fatty acid and lipid production. SREBP-1c activated in the liver by insulin results in insulin output and ultimately produces excessive fat storage. Inhibition of SREB-1c has been clinically shown to reduce fat deposition. Lee W., Lee Y., Wang Q., Yang Y. Crude extracts from Lycium barbarum can suppress SREBP-1c expression and prevent diet- induced fatty liver through AMPK activation. Biomed Res Int. (2014) p. 196198. ; Samar E., Beyleroglu M. The effect of goji berry consumption on weight
loss in boxers [online]. Progress in Nutrition 22(1-S) (2020), pp.103-110.
Astragalus Root Extract (CAS# 94166-93-5): Astragalus is a genus comprised of over 3000 herbs and shrubs. It is in the legume family and grown in climates in the northern hemisphere. It has been used for centuries in and considered one of the most useful herbs in traditional Chinese medicine. Astragalus's constituents include astragalosides. Astragalosides are terpene glycoside compounds that have a wide range of action including anti-oxidant, anti-cancer, immune enhancement, improved digestion, increased energy while reducing fatigue, and can also be used to protect cellular integrity during chemotherapy. Recent evidence shows that Astragalus can improve leptin sensitivity. Leptin is essential for appetite control, but leptin resistance is a common problem with overweight individuals. Consequently, reestablishing leptin sensitivity can act to reduce excess weight, and adipose tissue. Astragalus root can increase the transport of leptin across the blood brain barrier, thereby inhibiting obesity. Blood leptin concentration can be up to three times higher in people with obesity than in
lean people, but the blood leptin concentration in the cerebrospinal fluid of people with obesity can be only 30% of that of lean people. Astragalus also helps to reduce inflammation, a major contributing factor to visceral fat chronicity. Shao J. et al. Recent evidence in support of traditional Chinese medicine to restore normal leptin function in simple obesity [online]. Heliyon (2022 May 19). Another component of Astragalus is formononetin. Formononetin can upregulate UCP1 and PPARγ. Formononetin regulates adipocyte thermogenesis as a non-classical PPARγ agonist. Nie T. et al. The natural compound, formononetin, extracted from Astragalus membranaceus increases adipocyte thermogenesis by modulating PPARγ activity. Br J Pharmacol. 175(9) (2018), pp. 1439- 1450.
As Applicant has shown, the prior art provides evidence that each of the individual components of the admixture is known to provide beneficial effects regarding lipid metabolism/obesity. Thus, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: 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 which is 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.
The adjustment of particular conventional working conditions (e.g., employing one or more commonly-employed adjuvants/carriers compounds) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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) (Claimed process which was performed at a temperature between 40oC and 80oC and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100oC and an acid concentration of 10%); See also, Peterson, 315 F.3d at 1330, 65 USPQ 2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references where held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ 2d 1843 (Fed. Cir.), cert denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ 2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ 2d 1362 (Fed. Cir. 1997).
Applicant’s invention is predicated on an unexpected result, which typically involves synergism - an unpredictable phenomenon, highly dependent upon specific proportions and/or amounts of particular ingredients. With respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Conclusion
No claims are allowed.
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/RUSSELL G FIEBIG/ Examiner, Art Unit 1655
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