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
Applicants’ election without traverse of Group I, claims 1-9, 11, and 12, and super disintegrants for the species in the reply filed on November 5, 2025 is acknowledged. Claim(s) 3-5, 7, and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking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(s) 1-2, 6, 8-9 and 11-12 are examined on the merits.
Withdrawn Objections
Applicants’ arguments filed July 13, 2026 have been fully considered. In regard to the objection to the specification, applicant has made appropriate corrections and therefore, the objection of the specification has been withdrawn.
Pending Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 6, 8-9, and 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The "composition" comprising a Basella alba leaf extract, red yeast rice extract, squalene extract, cordyceps extract, and a nutraceutically or pharmaceutically acceptable excipient of claims 1-2, 6, 8-9, and 11-12 encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claims recite extracts from Basella alba leaf, red yeast rice extract, squalene extract, Cordyceps extract. Basella alba is a naturally occurring green leafy vegetable, red yeast rice (M. purpureus) is a mold, squalene is naturally occurring within plants and mammals (e.g. sharks), Cordyceps is a fungus. In addition, the applicant's claims recite a nutraceutically or pharmaceutically acceptable excipient (e.g. super disintegrant), like lactose, that comes from milk. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception..." To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties..."
In this case, extraction of plants, mold, and fungus only concentrates and portions the naturally occurring compounds in the plants, mold, and fungus; substances which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant, mold, and fungus. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter, mold, and fungus away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material, mold, and fungus; i.e., the compound is not inventive or "man-made." Thus, each of the extracts in turn is a mixture of the naturally occurring compounds found in the particular plants, mold, and fungus. Combining the extracts from the individual plants with mold and fungus leads to a combination of the naturally occurring compounds from each of the plants, mold, and fungus. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant, mold, and fungus extracts are only a mixture of the naturally occurring compounds found in the plant, mold, and fungi. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are directed to a composition with an intended use of treating or preventing hypercholesterolemia and arteriosclerosis.
MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'treatment or prevention of hypercholesterolemia and arteriosclerosis consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself." In this case, the additional element in the claims is the combination of extracts. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds, such as Basella alba as taught by Ohizumi (EP 3466436 A1 - English translation provided), red yeast rice as taught by Liang (CN 105285978 A - English translation provided), Cordyceps as taught by Wang (CN 107616500 A - English translation provided), squalene as taught by Lee (KR 100207931 B1 - English translation provided), and a super disintegrant, like lactose as taught by Yee (KR 101962893 B1 - English translation provided) does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, using the mixture of Basella alba, red yeast rice, Cordyceps, and squalene and combining that with a super disintegrant, like lactose, is also considered to be a natural product and thus, mixing the ingredients together and administering in combination with a natural product such as lactose or by itself does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
Moreover, applicant's intended use of treating or the prevention of hypercholesterolemia and arteriosclerosis is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicants’ arguments filed July 13, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. § 101 for natural products are found to be non-persuasive.
Regarding the 35 U.S.C. § 101 rejection for natural products, beginning on page 16 of applicants’ arguments, applicant states “none of the cited documents teach or suggest a composition based on the combination of the said ingredients, let alone to suggest a synergistic enhancement in efficacy that amounts to significantly more than the judicial exception. Although the disclosed components are individually known for their use in lowering cholesterol and blood pressure have been reported for an individual fed on a normal diet, the claimed composition demonstrates maintaining the body weight of an individual in spite of a High Fat Diet (HFD) which was not possible for patients treated with statins”. In addition, in page 17 of applicants’ arguments, applicant provides additional information from the present specification, namely paragraphs 0136-0143 which discusses individuals maintaining body weight with a high fat diet (HFD) in comparison to statin, discusses reduction in total cholesterol, LDL and TG, discusses liver lipid peroxidation (liver LPO) and discusses the inhibition of in SGOT and SGPT. Moreover, on pages 18-21 of applicants’ arguments, applicant further discusses proposed benefits of the composition and discuss additional data (i.e. tables) that demonstrate synergistic enhancements of the composition. Based on applicants’ remarks in response to the 35 U.S.C. § 101, what the applicant is arguing is not commensurate in scope with the claims of the present invention, in other words, the arguments are more specific than what is presently claimed. In addition, each and every ingredient within the composition is a natural product/compound even if it is within an extracted form; in other words, each extract is a mixture of the naturally occurring compounds that are present in the extract. The plant, mold, and fungus extracts are only a mixture of the naturally occurring compounds found in the plant, mold, and fungi. Overall, although the applicant is arguing the proposed benefits of ingesting the composition and a synergistic and an enhanced therapeutic effect, the components are still naturally occurring and therefore, the argument does not overcome the 35 U.S.C. § 101 rejection for natural products and thus, the rejection over claim(s) 1-2, 6, 8-9 and 11-12 under 35 U.S.C. § 101 are maintained.
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.
Claim(s) 1-2, 6, 8-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN 107616500 A - English translation provided) in view of Liang (CN 105285978 A - English translation provided), Ohizumi (EP 3466436 A1 - English translation provided), Lee (KR 100207931 B1 - English translation provided), Yee (KR 101962893 B1 - English translation provided), Baskaran et al (Taylor & Francis Group, (Year: 2015), vol. 2015, issue. 5, pp. 509-517), Pan (CN 101987179 B - English translation provided), and Sasidharan et al (African Journal of Tradition, Complementary and Alternative Medicines, (Year: 2011), vol. 8, issue. 1, pp. 1-10).
Regarding claim(s) 1-2, 6 and 11-12, Wang teaches a health food composition containing [the] Cordyceps militaris extract that reduces blood cholesterol and low-density lipoprotein ([LDL]) (abstract).
Wang does not teach a composition that comprises all of the following: the Basella alba leaf extract in the range of 30 to 70 wt %, red yeast rice extract in the range of 5 to 50 wt %, squalene extract in the range of 1 to 30 wt %, Cordyceps extract in the range of 10 to 70 wt %, and at least one nutraceutically or pharmaceutically acceptable excipient (e.g. super disintegrant such as micro crystalline cellulose) in the range of 0.01% to 50% (as stated within claim(s) 1-2 and 6 of the present invention). Wang does not teach that the Basella alba extract in the composition within claim 1 comprises: polyphenols in an amount in the range of 0.5% to 2%; phenolics in an amount in the range of 0.5% to 2%; flavonoids in the range of 0.2% to 3%; and ascorbic acid in the range of 0.2% to 1% (as stated within claim 8 of the present invention). Wang does not teach the composition as claimed in claim 1, wherein the Monacolin K content in said red yeast rice extract is 0.1 ppm to 100 ppm and the Ankaflavin content in said red yeast rice extract is 0.2% to 5% (as stated within claim 9 of the present invention). Wang does not teach an anti-hypercholesterolemia composition for the treatment or prevention of hypercholesterolemia and arteriosclerosis comprising: Basella alba leaf extract in the range of 30 to 70 wt %; red yeast rice extract in the range of 5 to 50 wt %; squalene extract in the range of 1 to 30 wt %; Cordyceps extract in the range of 10 to 70 wt %; and at least one nutraceutically or pharmaceutically acceptable excipient (e.g. super disintegrant such as micro crystalline cellulose) in the range of 0.01 to 50 wt % (as stated across claim(s) 11-12 of the present invention).
Liang teaches 30-50 wt % of red yeast rice extract (abstract), Liang also teaches that red yeast rice extract reduces blood-fat and is ideal as a hyperlipidemia health food (abstract).
Ohizumi teaches [that] the Basella alba plant extract ([also referred to as Anredera cordifolia in the reference]) can inhibit an increase in blood total cholesterol (col. 1, lines 33- 35).
Lee teaches the production of vegetable squalene that has cholesterol lowering ability (abstract), produced vegetable squalene with a high purity of 99% (page 3).
Yee teaches a pharmaceutical composition that can be included in the Cordyceps extract such as sorbitol, lactose, and microcrystalline cellulose (page 5).
The health food composition as taught by Wang can be modified to include the extract of Cordyceps as taught by Wang, red yeast rice extract as taught by Liang, Basella alba plant as taught by Ohizumi, squalene as taught by Lee using the HPLC extraction method as taught by Sasidharan et al (page 4) in order to obtain a squalene extract with an even higher purity percentage to use within the composition, and sorbitol, lactose, or microcrystalline cellulose as a pharmaceutically acceptable excipient ([that is also a super disintegrant]) as taught by Yee. These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients within a composition that would treat or prevent an increase in blood cholesterol which would treat hypercholesterolemia and prevent the progression to arteriosclerosis.
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that treat or prevent hypercholesterolemia and arteriosclerosis. It is well known that it is prima facie obvious to combine two or more ingredients 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 useful for the same purpose. The idea for combining them flows logically from them having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to treat or prevent hypercholesterolemia and arteriosclerosis, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat or prevent hypercholesterolemia and arteriosclerosis. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
In addition, regarding claim(s) 8-9 and 11, the references do not specifically teach adding the ingredients together in the amounts as claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), "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)." The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant's claimed invention. Therefore, an artisan of ordinary skill would be motivated to optimize each extract and the excipient in order to obtain a composition to help with cholesterol.
Regarding claim(s) 8-9, the Baskaran et al reference teaches the presence of ascorbic acid in Basella alba leaf extract (table 5, page 514), the reference also teaches the presence of phenolic compounds and flavonoids from the B. alba extract (page 512).
Pan teaches red yeast rice extract produces monacolin K (paragraph 0009), Pan also teaches the presence of ankaflavin in red yeast rice extract (paragraph 0008).
Further, in the above composition as taught by Wang, the teachings of the B. alba leaf extract as taught by Baskaran et al and red yeast rice extract as taught by Pan can be included within Wang’s composition. In addition, polyphenols are a subgroup under phenolic compounds, therefore proving that B. alba covers a broad range of classes of compounds under phenolic compounds that can be applied to the composition as stated in claim 8 of the present invention. The Baskaran et al and Pan references do not specifically teach the exact amounts of the polyphenols, phenolics, flavonoids, and ascorbic acid as claimed by applicant but does specify concentrations found for that particular study. However, as discussed in MPEP section 2144.05(II)(A), "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)." The references teach the presence of specific compounds within a Basella leaf extract and red yeast rice extract. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant's claimed invention. Therefore, an artisan of ordinary skill would be motivated to optimize each extract component as stated by the applicant in claims 8 and 9 to obtain a composition to help with cholesterol.
Response to Arguments
Applicants’ arguments filed July 13, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. § 103 for obviousness are found to be non-persuasive.
Regarding the rejection under 35 U.S.C. § 103 for obviousness, within page 22 of applicants’ arguments, applicant states that “none of the cited documents teach or suggest a composition based on the combination of the said ingredients, let alone to suggest a synergistic enhancement in efficacy”. Within pages 22-25, applicant emphasizes that each of the references cited by the examiner does not teach a composition which demonstrates maintaining the body weight of an individual in spite of a High Fat Diet (HFD) and which was not possible for patients treated with statins. On page 23 of applicant arguments, applicant states that Ohizumi is a pharmaceutical composition for preventing and treating central nervous system diseases and that Yee relates to a composition comprising a Cordyceps sinensis extract cultivated using a brown goat or a pupa and for preventing or treating blood cancer. Additionally, applicant arguments on page 25 state that Ohizumi and Yee teach compositions which are not directed towards the lowering of cholesterol formation. Moreover, on pages 25-27, applicant states additional extended benefits of the composition of the present invention and ends by stating “in view of the forgoing, it is submitted that the claimed anti-hypercholesterolemia composition is a new composition which demonstrates a synergistic and an enhanced therapeutic effect which was not known earlier. Hence, the pending claims are not obvious to a person skilled in the art. Accordingly, the Applicant respectfully requests the Examiner to reconsider and withdraw the rejection of the claims under Section 103”. Applicants’ reference towards the fact that the references cited by the examiner does not teach a composition which demonstrates maintaining the body weight of an individual in spite of a High Fat Diet (HFD) and which was not possible for patients treated with statins is not commensurate in scope with the claims of the present invention, in other words, the arguments are more specific than what is presently claimed. In addition, although the Ohizumi and Yee reference teaches a composition targeted towards a different intended use, that does not mean that the composition that contains the ingredient(s) specified in the present invention would not have the same intended use of the invention of the present invention; it is all dependent upon what the inventor wants to focus on within an invention and therefore, a composition can have a multitude of effects but are silent on most effects because there can be one particular focus of the composition at hand. Lastly, applicant states that the composition of the present invention “demonstrates a synergistic and an enhanced therapeutic effect which was not known earlier”; what applicant is arguing in terms of the composition exhibiting a synergistic and an enhanced therapeutic effect is not commensurate in scope with the claims of the present invention, in other words, the arguments are more specific than what is presently claimed. Thus, based on applicants’ arguments and examiners’ presented art, namely Wang, Liang, Ohizumi, Lee, Yee, Pan, Baskaran et al and Sasidharan et al effectively overcome the limitations of the present invention and therefore, the rejection under 35 U.S.C. § 103 for obviousness for claim(s) 1-2, 6, 8-9 and 11-12 are maintained.
No claim(s) are allowed.
Conclusion
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 Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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