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 .
Information Disclosure Statement
The information disclosure statement filed August 16, 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Specifically the crossed-out non-patent literature documents are not identified with date of publication, author(s), page numbers, and/or source sufficient to identify each one and determine their relevance. There are four documents submitted on August 16, 2023 which do not match the descriptions in the crossed-out references, and furthermore the documents appear to be copyright pages and the table of contents, or cover pages without any substantive content.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 2 “remedies’ ” should be “remedies”, and in line 3 “comprise” should be “comprising”. Appropriate correction is required.
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 17-19, 21, 23, 24, 26, and 29-31 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 17 recites “we mei”; however claims 18, 21, 23, and 24 recite “wu mei”. Because claim 1 recites “Mume Fructus (we mei)” it is unclear what “wu mei” is.
Similarly claim 21 recites “fan shi lui ye” and “sheng di huang” which do not appear in claim 17 from which claim 21 depends.
Similarly claims 19 and 23 recites “sheng di huang” which does not appear in claims 17 or 22.
Claim 24 recites “shui fen ji” which does not appear in claim 22.
It appears in the dependent claims Applicant chose to use the terms defined by following the Latin names that are provided in the first instance of the ingredient in the claims. The terms should be consistent in order to indicate which ingredient is being referred to.
Further regarding claim 17, “the component” in the last clause lacks antecedent basis; presumably it refers to the preceding groupings labeled “iii)” and “iv)”. However this clause contains further issues which render it indefinite. First the clause also recites “the other component is optional”. It is ambiguous whether “the other” refers to just one from the groupings labeled “iii)” and “iv)”, or all of the groups, including “i)” and “ii)”. “The other” is singular, i.e., just the other one from “iii)” and “iv)” which are labeled “component”. Thus if both radix Trichosanthis Kirilowii and gypsum are present, then none from group “iv)” is required.
Secondly within the same clause the next phrase is, “and wherein said ingredients comprise …”. “Ingredients” finds antecedent basis in lines 2-3 of claim 17, “Chinese remedies’ ingredients…”, meaning all those listed in “i)” through “iv)”. However this phrase immediately follows “the component iii) or iv) comprise all its ingredients” (last clause line 1), so “said ingredients” in line 2 of the last clause could refer to just the ones in “iii)” or “iv)”. In sum it is insolubly ambiguous whether “said ingredients” in line 2 of the last clause of claim 17 is referring to all those in “i)” through “iv)”, or just the ones in “iii)” or “iv)”.
For the purposes of examination now the last clause is construed as reciting that when all the ingredients of either of “iii)” or “iv)” are present, than an ingredient from the other of “iii)” or “iv)” is optional.
Regarding claim 26 which recites “according to traditional Chinese compounding practice”, the disclosure does not contain any discussion of which specific practice comprises the “traditional Chinese compounding practice” (see Specification para.[0050]). It is noted that those recited in claim 26, such as aqueous extract, tincture, etc., are not limited to traditional Chinese medicine, for example vanilla extract used in baking.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation “a portioned edible article”, and the claim also recites “preferably selected from the group consisting of chocolate… and films” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 29 and 30 it is noted that a “single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph”. MPEP § 2173.05(p)(II) (citations omitted). Claims 29 and 30 recite administering the composition of the prior claims, i.e., claims 1 and others from which they depend are product claims, not method of use claims. Consequently claims 29 and 30 raise confusion as to their scope and are rejected as indefinite. Claim 31 depends from claim 30 and does not resolve this issue and therefore is also rejected for this reason.
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 17-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims recite methods and composition for “sexual enhancement” involving a composition comprising twenty-five natural product ingredients. Thus, the claims fall into a statutory category of invention under 35 U.S.C. 101.
Claim 17 recites a combination of four or more natural product medicines in the raw material form such as Mume fructus. Each of the medicines represent a natural product found in nature.
“Where the claim is to a nature-based product produced by combining multiple components …, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts.” MPEP §2106.04(c)(I)(A). “If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics as compared to its naturally occurring counterpart in its natural state, then that limitation is a product of nature exception.” MPEP §2106.04(c)(II). The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. MPEP § 2106.04(c)(II)(A). When the nature-based product is a combination produced from multiple components, and there is no natural counterpart mixture in nature, as is the case in the present claims 1 and 2, the closest counterpart may be the individual nature-based components of the combination. See id.
The characteristic possessed by the claimed product is “useful for long-term management of hyperglycemia and symptoms thereof”. Here each of the nature-based ingredient, i.e., the counterparts, are known as aiding control of blood glucose levels as evidenced by Chang, Qi, and Huang (see citations below in the rejections under 35 U.S.C. 102, 103).
Next, comparing the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, it is determined that the characteristics of the claimed product are not markedly different. “The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart…. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.” MPEP § 2106.04(c)(II)(C)(citations omitted). Here there is no indication that their combination in the claimed composition changes the structure, function, or other properties in a markedly different way. In other words the resultant nature-based combination exhibits the biological or pharmacological functions or activities of the respective components as found in nature. Therefore the analysis indicates that here the nature-based product limitation does not exhibit markedly different characteristics, and the limitation is a product of nature exception.
It is also noted that claims 17-22 and 25-31 do not recite specific amounts or concentrations of the claimed natural product ingredients. Thus even if the combinations of the nature-based ingredients had a markedly different characteristic wherein in combination, because there is no limitation of the amounts or concentrations, the claimed composition does not necessarily have any markedly different characteristics. Further, when specific amounts of concentrations are recited in the claims, those limitations might or might not impart markedly different characteristics. This is because it is routine and conventional to mix specific amounts or concentrations of medicinal herbs for a particular therapeutic target. Therefore merely reciting specific amounts or concentrations each nature-based ingredient, by itself, does not amount to establishing any markedly different characteristics of the claimed composition or method.
The next part of eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
Claims 17-31 are drawn only to the composition of nature-based product limitations application of the composition to their natural biological activities. Therefore, the claims do not integrate the judicial exceptions into practical applications.
The eligibility analysis further evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. For the ingredients in claims 17-31, each component is considered as an additional element to the other to determine whether their combination results in significantly more than the products of nature. As discussed, mixing the claimed natural products does not markedly change the characteristics of any of the components, which continue to have the same structure and function in the mixture as each had alone. Mixing of herbs known to be medically significant was, at the time of filing, well-understood, routine, and conventional activity as evidenced by the ubiquity of existing traditional Chinese medicines.
Accordingly, the claimed mixture of natural products recited at a high level of generality does not meaningfully limit the claims, and the claims do not amount to significantly more than each product of nature by itself, and the additional elements do not transform the claims into patent eligible subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17, 18, 22, 26-28, 30, and 32 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Chang (CN110721218A; citations are to the English abstract filed 05/01/2023 and the attached Machine translation of claims and description).
Chang teaches a composition for treating diabetes comprising (abstract; claims 1-8) any one or more from each of components A, B, and C,
guava leaves 8-12 parts in component B;
10-15 parts of Dendrobium and 0 to 10 parts of ume (Mume fructus) in components A and B, or 10-15 parts of Dendrobium in component C;
10 to 15 parts of gypsum in components A and B; and
2 to 5 parts of Coptis and10-25 parts of radix rehmanniae in component A, or Coptis chinensis 5-7 parts and 15-30 parts of radix rehmanniae in component B.
Regarding claim 22, Chang further teaches 0-10 parts of rhizoma anemarrhenae in components A and B, and 3-10 parts of cortex moutan in component A and 2-6 parts in component B.
Chang teaches administering a decoction of the medicinal material after it is combined and crushed (see, e.g., Example 1).
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) 17-32 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (CN110721218A; citations are to the English abstract filed 05/01/2023 and the attached Machine translation of claims and description) in view of Qi (Qi, L.-W., et al., Anti-Diabetic Agents from Natural Products—An Update from 2004 to 2009, Current Topics in Medicinal Chemistry, 2010, 10, 434-457) and Huang (Huang, D., et al., Evaluation of hypoglycemic effects of polyphenols and extracts from Penthorum chinense, Journal of Ethnopharmacology 163, 2 April 2015, Pages 256-263).
Chang does not expressly teach Trichosanthis Kirilowii, Radix et Rhizoma Rhei in claim 17, Crataegi fructus, Penthorum Chinensis, and Silybum marianum in claim 22, and Siraitia grosvenorii in claim 25.
Qi compiled prior art knowledge on herbal medicines for treating hyperglycemia or diabetes. Trichosanthes kirilowii has been used in anti-diabetic complex formulae (p.450 left col.). Rheum anthraquinones inhibited postprandial hyperglycemia by 29.5% -42.3% in ICR mice by oral glucose tolerance test (p.438 left col.). Hawthorn or Crataegi fructus has been known to have anti-diabetic potential (p.449 rt.col.). Silybum marianum seed extract (silymarin) produced “a significant decrease in hemoglobin A1c, FBS, total cholesterol, LDL, triglyceride serum glutamic-oxaloacetic transaminase” in type 2 diabetic patients in a randomized double-blind trial (p.447 rt.col.). Siraitia grosvenori extract can inhibit “hyperglycemia induced by DM, and the data suggest that administration of the extract may be helpful in the prevention of diabetic complications associated with oxidative stress and hyperlipidemia” (p.446 left col.). Qi further discusses antihyperglycemic effects of the other ingredients in claims 17 and 22 (see, e.g., Radix Rehmanniae and Rhizoma Coptidis in Table 1).
Huang evaluated hypoglycemic effects of polyphenols and extracts from Penthorum chinense and reports that “produced a moderated anti-hyperglycemic effect on STZ-induced diabetic rats and starch induced postprandial hyperglycemic mice “ (abstract; see title; Tables 1-5 and accompanying text).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Chang, Qi, and Huang and combine the antihyperglycemic medicines of Chang with those that Qi and Huang teach as recited in the instant claims. “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 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.” MPEP §2144.06 (I) (citations omitted).
Regarding the concentrations of the medicines in claims 23 and 24, as discussed above Chang teaches various concentrations of a medicine depending on the combinations in a single composition. For result-effective variables which includes concentration of medicinal ingredients, optimization through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614