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 .
Applicant has elected to cancel claim(s) 2 and 9; claim(s) 1, 3-8 and 10-14 are examined on the merits.
Election/Restriction
Applicants’ election with traverse of the isomeric species corresponding to the compound 13 and the compound 16 for claims 7 and 14, respectively in the reply filed on January 26, 2026 is acknowledged. The traversal is on the ground(s) that searching all of the eight isomeric species present within both claims 7 and 14 would not present a serious search burden to the examiner. This is not found persuasive because each of the isomeric species found within claims 7 and 14 are very specific to some plant families, fungi, etc. In addition, some of the listed isomeric species are present under flavonoids, which are a very broad class that encompasses over three subclasses, in which, some, if not all the compounds stated within claims 7 and 14 are not guaranteed to be present within an extract of C. mimosoides as a result of some of the compounds having a greater natural presence in other plant families, fungi, etc.
In addition, in applicants’ arguments from June 17, 2026, applicant has elected to prosecute the species of KA-1 compound [(2S)-3',4,7-trihydroxylavan-(4ß->8)- catechin] represented by formula 13 in claim(s) 7 and 14. The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 1, 3-8 and 10-14 are examined on the merits.
Claim Objections
Claim 6 is objected to because of the following informalities:
In claim 6, “faction” should read “fraction”
Appropriate correction is required.
Withdrawn Objections
Applicants’ arguments filed June 17, 2026 have been fully considered. In regard to the objection of the specification due to informalities, applicant has made amendments as necessary and therefore, the objection of the specification has been withdrawn.
Withdrawn Rejections
Applicants’ arguments filed June 17, 2026 have been fully considered.
In regard to the rejection under 35 U.S.C. 112(b) for indefiniteness, applicant has amended the claims as appropriate. Thus, the rejection of claim(s) 1, 3, 5-8, 10 and 12-14 under 35 U.S.C. 112(b) has been withdrawn.
In regard to the rejection under 35 U.S.C. 102(a)(1) for anticipation, applicant has made substantial changes to the claims and therefore, the rejection of claim(s) 1, 4-8 and 11-14 under 35 U.S.C. 102(a)(1) has been withdrawn.
Proposed 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.
Claim(s) 1, 3-8 and 10-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The pharmaceutical or health food “composition” comprising a C. mimosoides extract of claim(s) 1, 3-8 and 10-14 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 an extract from Cassia mimosoides L. (C. mimosoides). Cassia mimosoides L. is a naturally occurring plant. 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, such as ethanol. 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, the extract in turn is a mixture of the naturally occurring compounds found in the particular plant. The extract from the individual plant leads to a combination of the naturally occurring compounds from the plant. Thus, the claim is drawn to a mixture of naturally occurring products.
There is no indication that the specified extract as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extract contains only a mixture of the naturally occurring compounds found in the plant. The 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 allergic respiratory diseases. 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 presence of an extract. 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. The presence of specific compounds within the extract of C. mimosoides, such as (2S)-3',4,7-trihydroxylavan-(4ß->8)- catechin ([compound 13 from claim(s) 7 and 14 of the current invention, respectively]) as taught by Kojima et al (Nippon Shokuhin Kagaku Kogaku Kaishi, (Year: 2012), vol. 59, no. 6, pp. 279-283) that are also stated within claims 7 and 14 of the present invention 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, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
In addition, applicant's intended use of treating allergic respiratory disease 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
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, 3-8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sato (U.S. Patent No. 6,054,129) in view of Kojima et al (Nippon Shokuhin Kagaku Kogaku Kaishi, (Year: 2012), vol. 59, no. 6, pp. 279-283), Yoo (KR 20120068074 A – English translation provided) and Ito (JP 2007186457 A – English translation provided).
Sato teaches an extract from Cassia mimosoides L. (abstract). Sato also teaches [that it is] preferable that ethanol is [mixed] with water, preferably at a ratio of 50% to 50% (paragraph 0042). Sato teaches extraction solvents [such as] ethanol [and] ethyl acetate [and that it is] possible to optionally select one or more kinds of those solvents for preparation [like] ethanol [and] ethyl acetate (paragraph 0042). Sato teaches the extract may be filled into capsules or soft capsules, may also be formed in tablet type or granular type [or] extract may also be mixed into materials for all foods and drinks [such as] nutrition drinks ([e.g. a health functional food or a pharmaceutical composition]) (paragraph 0048).
The Sato reference does not explicitly state that the composition contains the compound (e.g. compound 13) from claim(s) 7 and 14 of the present invention. Sato does not teach that the pharmaceutical composition or health food composition contains 60% (v/v) to 100% (v/v) ethanol extract of Cassia mimosoides L., or an ethyl acetate fraction of a 60% (v/v) to 80% (v/v) ethanol extract of Cassia mimosoides L., as an active ingredient, wherein the extract or fraction inhibits secretion of beta-hexosaminidase, an allergy- inducing substance present in granules of mast cells, and wherein the allergic respiratory disease is allergic asthma, allergic bronchitis, or allergic rhinitis (as stated in claim(s) 1 and 8 of the present invention). Sato does not teach that the pharmaceutical or health food composition has a 70% (v/v) ethanol extract or that the ethyl acetate fraction is an ethyl acetate fraction of a 70% (v/v) ethanol extract of Cassia Mimosoides L (as stated across claim(s) 3-4 and 10-11 of the present invention). Sato does not teach that the pharmaceutical or health food composition wherein the extract of fraction inhibits the production of histamine, TNF-α, interleukin-4 (IL-4), or prostaglandin E2 secreted by mast cells (as stated across claim(s) 5 and 12). Sato does not teach that the extract or fraction reduces the number of eosinophils or inflammatory cells in the bronchial tubes; decreases eosinophil infiltration; or suppresses or improves allergic symptoms by reducing IgE in serum (as stated across claim(s) 6 and 13).
Kojima et al demonstrates that the compound: (2S)-3',4,7- trihydroxylavan-(4B->8)-catechin intrinsically occurs within the C. mimosoides extract (abstract, pg. 281 and fig. 3).
Yoo teaches a cosmetic composition that includes the extract of C. mimosoides (abstract). Yoo teaches [that] the organic solvent usable in the present invention [extraction] may be selected from ethanol, ethyl acetate or a mixed solvent of these organic solvents (pg. 3). Yoo teaches [that] 70% ethanol [is preferred] (pg. 3). Yoo teaches [that] for example, the chapul ([i.e. C. mimosoides]) of the present invention is finely chopped and dried, and then water or an organic solvent is added, reflux extraction is carried out, and the residue and the filtrate are separated by filtration and centrifugation. The separated filtrate is concentrated under reduced pressure to obtain an extract… After obtaining the extract using the solvent in the above can be obtained by cooling, heating and filtration at room temperature in a conventional manner known in the art to obtain a liquid, or may further evaporate the solvent, spray drying or freeze drying (pg. 3).
Ito teaches a [medication or a food or drink composition] containing a plant or plant extract for improving allergic disease (pg. 1). Ito teaches [that] Cassia mimosoides [can be used for plant extraction] (pg. 8).
One of ordinary skill in the art would use Yoo’s method of using 70% ethanol and/or 70% ethyl acetate as solvents in order to obtain the C. mimosoides extract within Sato. In addition, Ito’s teachings can be used to further establish that the extract of C. mimosoides in Sato can be used across pharmaceuticals and foods in which, the composition can help towards allergic diseases. In addition, within the specification of the present invention, paragraphs 0050-0052 and 0065-0101 teaches that compound 13 is isolated using an ethanol and/or ethyl acetate fraction making Kojima et al’s reference a good combination with Sato. In addition, within the specification, namely paragraphs 0050-0052 and 0065-0101 also teaches that administration of the C. mimosoides extract would meet the claim limitations of claim(s) 5-6 and 12-13 of the present invention. Thus, the extract produced by Sato using Yoo’s method with Kojima et al’s teaching that compound 13 is intrinsically occurring within the C. mimosoides extract along with additional teachings from Ito to further establish that the pharmaceutical or health food composition that contains C. mimosoides would intrinsically work to meet the intended uses stated across claim(s) 1, 5-6, 8 and 12-13.
Response to Arguments
Applicants’ arguments filed June 17, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. § 101 for natural products and the rejection under 35 U.S.C. § 103 for obviousness are found to be non-persuasive.
Regarding the 35 U.S.C. § 101 rejection for natural products, beginning on page 13 and moving into page 14 of applicant arguments, applicant states “applicant has amended claims 1 and 8 in the interest of expediting prosecution…the claimed compositions shows the markedly different characteristics compared to the naturally occurring counterpart, i.e., naturally occurring extract of Cassia mimosoides L… the water extract – closest to the natural state – exhibits no pharmacological function…in other words, the natural product itself – in the form most closely approximating its natural state – does not possess the anti-allergic pharmacological function on which the invention is predicated… the claimed high-ethanol extract and ethyl acetate fraction exhibit the function… By contrast, the claimed high-concentration ethanol extract (60% or more) and its ethyl acetate fraction exhibited strong inhibitory activity. Through human intervention – the selection of a particular solvent system – the claimed composition has acquired a new functional property that does not exist in the natural product. The claimed composition therefore possess markedly different characteristics relative to its closest naturally occurring counterpart and is not a “product of nature””. Moving towards page 15 of applicant arguments, applicant also states “the effect is not a monotonic function of solubility…instead, the activity appears discontinuously above a threshold (50% ethanol), with little or no activity below it…[in addition, applicant states] activity is selectively partitioned among fractions – not explicable by concentration. Among fractions obtained from the same extract, the water and hexane fractions exhibited little activity, whereas activity was selectively concentrated in the ethyl acetate fraction… the selective appearance of the function in a particular fraction reflects a qualitative separation and acquisition of a pharmacologically active component set, not a quantitative concentration of an unchanged property”. Based on applicant arguments, the arguments are not found to be persuasive solely because the extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent, such as ethanol. 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 (which is also stated within the 35 U.S.C. § 101 rejection above). Although there are varying concentrations of the ethanol extract or an ethyl acetate fraction of an ethanol extract of the C. mimosoides, that does not take away from the fact that all of the compounds present within the extract will still be naturally occurring. Besides the proposed activity that specific solvents would produce within the C. mimosoides extract, applicant is reminded that the components found in a ethanol extract versus a hexane extract of C. mimosoides for example, may be slightly different in the compounds obtained, based on applicants remarks, however, regardless of the solvent used and the proposed functional properties provided based on a specific type of solvent extraction, the compounds are found in nature and therefore, the argument does not overcome the 35 U.S.C. § 101 rejection for natural products, thus, the rejection over claim(s) 1, 3-8 and 11-14 under 35 U.S.C. § 101 for natural products is maintained.
Regarding the rejection under 35 U.S.C. § 102 for anticipation, as stated above, applicant has made substantial changes to the claims and therefore the arguments regarding the 35 U.S.C. § 102 rejection is rendered moot.
Regarding the rejection under 35 U.S.C. § 103 for obviousness, beginning on page 17 of applicant arguments, applicant states “applicant respectfully submits that Sato, even evidenced by Kojima, is insufficient to establish a prima facie case of obviousness of claims 1 and 8 and at least for the following reasons…however, applicant respectfully submits that In re Aller does not apply where the parameter is shown to be critical… extracts of 50% or less ethanol are inactive while activity appears only at 60% or more. This is not a gradual optimum reached by routine experimentation, but a critical, non-linear emergence of activity under specific conditions”. Moving on to page 18 of applicant arguments, applicant states that “Sato’s purpose is “flavor improvement,” and it does not suggest the claimed anti-allergic function. Kojima discloses only lipase-inhibitory activity, a mechanistically unrelated property having no bearing on inhibition of mast-cell degranulation. Therefore, neither reference provides a reasonable basis to predict the claimed anti-allergic effect, thus to arrive at the claimed invention from the teachings of Sato evidence by Kojima would be impermissible hindsight drawn from Applicant’s own disclosure…[in addition applicant states] furthermore, the claimed extract/fraction additionally inhibits production of histamine, TNF-α, IL-4 and PGE2 and ameliorates asthma in an animal model, constituting unexpected results beyond what Sato and Kojima would suggest”. Going in order based on applicant’s response, examiner agrees that Sato combined with Kojima et al does not teach the present claim amendments within claim(s) 1 and 8, however, the Yoo reference is able to remedy that deficiency by providing a method of using 70% ethanol and/or 70% ethyl acetate fraction in order to retrieve the extract of C. mimosoides found within Sato with additional teachings from Ito that the composition that comprises C. mimosoides has the capability of treating allergic diseases in which, allergic diseases (which is consider broader than allergic respiratory disease) would encompass the claim limitations present within claim(s) 1 and 8. In addition, the specification of the present invention, specifically within paragraphs 0050-0052 and 0065-0101 are able to provide additional data and insights that using specific solvents to create a C. mimosoides extract is sufficient enough to have specific effects on a cellular level when administered to a subject, thus making Sato’s reference in view of Kojima et al, Yoo and Ito obvious to one of ordinary skill in the art to combine the references in order to meet the claim limitations of the present invention, which is to provide a C. mimoisoides extract prepared by 70% ethanol and/or 70% ethyl acetate fraction which would produce specific molecules or compounds of interest that would be collected which would then be prepared in the form of a pharmaceutical or health food composition to be administered to a subject in need. Moreover, applicant argues that Sato and Kojima et al only discloses specific functions, namely for flavor improvement in Sato and for lipase-inhibitory activity in Kojima et al. Although the Sato and Kojima et al references discuss specific functions or results due to administering the C. mimosoides extract, that does not mean that will be the sole function or result of administering the extract (i.e. Cassia mimosoides L.); it is only what the authors and/or applicant of the present invention sought to focus on based on their own invention or research priority is what will be recognized when analyzing the C. mimosoides extract. Therefore, Sato and Kojima et al’s reference both teaches a composition that would intrinsically possess the characteristics that are claimed in the present invention with Yoo and Ito as additional references for why one of ordinary skill in the art would be motivated to combined all of the four aforementioned references. Thus, based on applicants’ claim amendments and examiners’ additional art, namely Yoo and Ito that can be used in combination with Sato and Kojima 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, 3-8 and 11-14 is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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