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 1-8 are currently pending.
Priority
3. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on June 14, 2021. It is noted, however, that applicant has not filed a certified copy of the 202141026454 application as required by 37 CFR 1.55.
Information Disclosure Statement
4. In regards to the Information Disclosure Statement filed December 14, 2023, copies were not provided of NPL documents numbers 2 and 3. Thus, these documents could not be considered and their citations have been lined through.
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.
5. Claims 1-8 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 extracts from Elettaria cardamomum, Salvia rosmarinus, and piperine, does not reasonably provide enablement for a “synergistic” composition containing these components. 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.
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 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, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are drawn to a “synergistic phytoextract” formulation comprising 40% of an extract from Elettaria cardamomum, 40% of an extract from Salvia rosmarinus, and 2% of an extract from piperine. However, applicant’s specification does not provide any evidence to support the claimed limitation that the composition is “synergistic.” Applicant’s specification states that the extract can be made by “methods of extraction such as steam distillation, solvent extraction, hydro-distillation, microwave extraction, etc. (see page 8).” But there is no evidence to show that extraction with of the claimed ingredients any of these methods produces a composition with synergistic results. In addition, it is unclear what extraction techniques would be included in the “etc.” portion of the above statement. There are hundreds of different types of extracts that could be considered “phytoextracts.” Given that synergism is unpredictable, in order to determine if the claimed composition is actually synergistic, the artisan would be forced to create numerous types of extracts from each ingredient. The artisan would then have to test each of these extracts in order to determine which extracts are actually able to produce a synergistic combination. This clearly a burden of undue experimentation. Thus, the claims are not considered to be enabled for “synergistic” compositions.
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 1-8 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. Claims 1-8 are indefinite because it is unclear what characteristics an extract must have in order to be considered a “phytoextract.”
7. Claim 1 is indefinite because it states that Elettaria cardamomum is present in “the range of 40%,” that Salvia rosmarinus is present in “the range of 40%”, and piperine is present in “the range of 2%”. However, the use of “range” in combination with a single value is confusing because it is unclear what would be considered the upper and lower values of the “range”.
8. Claim 4 is indefinite because there is a lack of antecedent basis for “the active molecule” as recited in lines 1 and 2. In addition, the phrase “1,8 Cineol exhibits excellent muscle relaxant effects…and analgesic effects” is unclear because it is unclear what effects are considered to be encompassed by “excellent.” In addition, the phrase uses passive narrative language and it is unclear how the claimed effects are considered to further limit the 1,8 Cineol ingredient.
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.
9. Claims 1-4 and 7-8 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 extracts from Elettaria cardamomum, Salvia rosmarinus, and piperine. Elettaria cardamomum, Salvia rosmarinus, and piperine 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 naturally occurring plants and substances only concentrates and portions the naturally occurring compounds in the 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. 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 ingredient. 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 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 ingredients. Combining the extracts from the individual ingredients leads to a combination of the naturally occurring compounds from each of the ingredients. 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 extract is only a mixture of the naturally occurring compounds found in the naturally occurring substance. 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 concentration produces any sort of marked distinction. As discussed above, while the claims state that they are drawn to a “synergistic” composition, there is no evidence to support the assertion that synergism is present in the combination. 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 an anti-inflammatory, muscle relaxant, analgesic, anti-oxidant, anti-viral, or anti-bacterial formulation. 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 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 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 uses are also 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.
10. Claim(s) 1 and 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vieira (US 2019/0209634) in view of Saloum (US 2008/0038367).
Vieira teaches a composition comprising rosemary extract and piperine extracted from Piper nigrum. The reference teaches that the composition has anti-inflammatory, anti-oxidant, anti-viral, and anti-bacterial properties. The reference teaches that the piperine boost the absorption of the other nutrients in the composition. The reference teaches that the composition is formulated into capsules. The reference teaches that the rosemary is from Rosmarinus officinalis (see abstract and paragraphs 38, 39, 53 and the Table). Please note that R. officinalis has been reclassified Salvia rosmarinus. Vieira does not teach using an extract from Elettaria cardamomum in the composition.
Saloum teaches that cardamom (Elettaria cardamomum) extract has anti-inflammatory properties and is also useful to treat infections. The reference teaches that the cardamom extract contains 1,8-cineol (see paragraph 50).
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 inflammation. 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 treat inflammation, 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 inflammation. 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 adding the ingredients together in the amounts 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, as discussed above in paragraph 5, 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.
11. Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vieira (US 2019/0209634) in view of Saloum (US 2008/0038367) as applied to claims 1 and 5-8 above, and further in view of Majeed (US 5,536,506).
The teachings of Vieira and Saloum are discussed above in paragraph 10. The references do not teach that the piperine is extracted from both Piper nigrum and Piper longum. However, Majeed teaches that both Piper nigrum and Piper longum are sources of piperine (see column 4, lines 19-23). Thus, an artisan of ordinary skill would reasonably expect that both of these plants could be used as the source of the piperine ingredient in the composition taught by the combination of Vieira and Saloum. This reasonable expectation of success would have motivated the artisan to modify the references to include the use of both P. nigrum and P. longum as sources for the piperine.
12. Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vieira (US 2019/0209634) in view of Saloum (US 2008/0038367) as applied to claims 1 and 5-8 above, and further in view of Cummins (US 2009/0087501)
The teachings of Vieira and Saloum are discussed above in paragraph 10. The references do not teach that the rosemary extract contains 1,8-cineole. However, Cummins teaches that 1,8-cineole is an active ingredient found in rosemary that has anti-inflammatory and anti-bacterial properties (see paragraph 15). Thus, an artisan of ordinary skill would reasonably expect that the anti-inflammatory composition taught by Vieira and Saloum would be improved if the rosemary extract contained 1,8-cineole. This reasonable expectation of success would have motivated the artisan to modify the references to include the use of a rosemary extract that contains 1,8-cineole.
13. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655