DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-15 and 17-21 are currently pending.
Election/Restrictions
3. Applicant’s election without traverse of Group I, claims 1-14 and 17-21, and the combination of Opuntia ficus indica, bergamot and phytosterols for the species in the reply filed on February 3, 2026 is acknowledged.
4. Claims 2, 4, 9, 10, 12, 15, and 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Please note that claim 2 is withdrawn because it does not require the elected combination of Opuntia ficus indica, bergamot and phytosterols, and claims 4, 9, 10, 12, and 17-21 are withdrawn because they require the presence of trace elements which are a non-elected ingredient.
5. Claims 1, 3, 5-8, 11, 13, and 14 are examined on the merits solely in regards to the elected species.
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, 3, 5-8, 11, 13, and 14 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.
6. Claim 1 is indefinite because the multiple uses of “and/or” make it unclear which elements can be selected as alternatives. The use of proper Markush phrasing is suggested.
7. Claim 8 is indefinite because “and” or “or” is missing between the last two compounds. Thus, it is unclear if all of the claimed phytosterols are required.
8. Claim 11 is indefinite because the multiple uses of “and/or” make it unclear which elements can be selected as alternatives. The use of proper Markush phrasing is suggested. Claim 11 is also indefinite due to the use “selected from the group comprising…” in line 3. The use of “comprising” in a Markush phrase is improper because it implies that there are other members of the group without identifying them. “Comprising” needs to be changed to “consisting of”.
9. Claim 13 is indefinite due to the lack of antecedent basis for “The pharmaceutical composition” as recited in line 1 of the claim.
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.
10. Claims 1, 3, 5-8, 11, 13, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more.
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 a combination of Opuntia ficus indica extract, bergamot extract and phytosterols. Opuntia ficus indica, bergamot and phytosterols are all naturally occurring. 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 only concentrates and portions the naturally occurring compounds in the plants 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. 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 away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; 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. Combining the extracts from the individual plants leads to a combination of the naturally occurring compounds from each of the plants. 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, each plant extract is only a mixture of the naturally occurring compounds found in the plant. The closest naturally occurring counterpart for the phytosterols is the phytosterols themselves. Each extract and phytosterol in the 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 as a pharmaceutical, food, or drink in combination with carriers and vehicles. Carriers and vehicles can be naturally occurring such as water. 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 prophylaxis’ 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 the ingredients. 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 does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together 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, applicant’s intended use of as a pharmaceutical, food, or drink 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.
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.
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.
11. Claim(s) 1, 3, 5-8, 11, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riccioni (WO 2015/136441) in view of Figueroa-Perez (International Journal of Food Properties (2018), vol. 21, no. 1, pp. 1728-1742) with Registry data for beta-sitostanol providing definitions.
Riccioni teaches a composition for lowering blood lipid levels which comprises bergamot extract in combination with phytosterols. The reference teaches that the bergamot extract contains brutieridin and melitidin. In addition, the reference teaches that the phytosterols include beta-sitosterol, campesterol, and stigmasterol. The reference teaches that the composition is formulated into liquid or pharmaceutical compositions using excipient and carriers (see pages 1, 2, 5, 6, page 7, line 21, and page 8, line 26 - page 9, line 17). The reference does not teach including Opuntia ficus indica extract, beta-sitostanol, delta-7-stigmasterol, or campestanol in the composition.
Figueroa-Perez teaches that cladodes extract from Opuntia ficus indica contain soluble and insoluble dietary fiber and the phytosterols beta-sitosterol, stigmastanol, campesterol, delta-7-stigmasterol, and campesterol. The reference teaches that these ingredients are useful in lowering blood lipid levels (see pages 1733, 1736, and 1737). Stigmastanol is synonymous with beta-sitostanol (see Registry data for beta-sitostanol).
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 lower blood lipid levels. 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 their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to lower blood lipid levels, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to lower blood lipid levels. 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).
The references do not specifically teach combining the ingredients in the concentrations 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.
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/ Primary Examiner, Art Unit 1655