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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/11/2026 has been entered.
Formal Matters
Receipt of Applicant’s response dated 05/11/2026 is acknowledged.
Claims 1-9 and 13-14 are pending.
Claims 10-12 and 15-17 are canceled.
Claims 1-8 remain withdrawn from consideration as being drawn to a nonelected invention.
Claims 9 and 13-14 are under consideration in the instant Office action.
Claim Interpretation
Each of claims 9 and 14 is a product-by-process claim and therefore the product is given patentable weight, not the process by which the product is made. “[Elven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorne, 777 F.2d 695, 698, 227 USPQ S64, 966 (Fed. Cir. 1985). Therefore, claim 9 is being examined to the extent of the product, i.e., “an extract of Murraya koenigii obtained from crushed dried leaves, free of alkaloids, comprising phenolic acids in an amount greater than 100 mg per 100 g of the extract, and comprising flavonoids in an amount greater than 50 mg per kg of the extract” and not to the extent of the process of obtaining the product, i.e., “wherein the extract is obtainable by a process comprising a solid-liquid extraction step, a solid-liquid separation step, and a liquid phase recovery step, wherein a solvent used in the extraction step and in the recovery step consists of betaine, propanediol, and water, wherein the molar ratio of betaine to propanediol is from 1:1 to less than 1:1.5, and water represents from 15% to 35% by weight of the solvent, and wherein the plant-to-solvent ratio ranges from 3:97 to 10:90”. Similarly, claim 14 is being examined to the extent of the product, i.e., “an extract of Murraya koenigii obtained from crushed dried leaves, free of alkaloids, comprising phenolic acids in an amount greater than 100 mg per 100 g of the extract, and comprising flavonoids in an amount greater than 50 mg per kg of the extract” and not to the extent of the process of obtaining the product, i.e., “wherein the extract is obtainable using a solvent consisting of betaine, propanediol, and water, wherein the molar ratio of betaine to propanediol is from 1:1 to less than 1:1.5, and water represents from 15% to 35% by weight of the solvent, and wherein the plant-to-solvent mass ratio ranges from 3:97 to 10:90”.
OBJECTIONS/REJECTIONS WITHDRAWN
Specification
The objections to the specification and to the abstract set forth in the Office action dated 01/09/2026 are hereby withdrawn in light of Applicant’s amendments to the specification and to the abstract.
Claim Objections
The objections set forth in the Office action dated 01/09/2026 are hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(b)
The rejections set forth in the Office action dated 01/09/2026 are hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(d)
The rejection set forth in the Office action dated 01/09/2026 is hereby withdrawn in light of Applicant’s cancelation of claim 11.
Claim Rejections - 35 USC § 101
The rejection set forth in the Office action dated 01/09/2026 is hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new rejection set forth below.
Claim Rejections - 35 USC § 103
The rejection set forth in the Office action dated 01/09/2026 is hereby withdrawn in light of Applicant’s amendments to the claims.
NEW GROUNDS OF OBJECTION/REJECTION
Drawings
The drawings are objected to because there is only one figure and the drawing refers to it as “Figure 1”. 37 CFR 1.84(u)(1) indicates when there is only one drawing, it must not be numbered and the abbreviation “FIG.” must not appear. Therefore, “Figure 1” must be referred to as “The Figure”.
Appropriate correction is required.
Specification
The disclosure is objected to because “Figure 1” and “Fig 1” appearing on Pages 19 and 22 of the specification should be amended to “The Figure” (See objection to the Drawings above for more details).
Appropriate correction is required.
Claim Objections
Claims 9 and 14 are objected to because of the following:
In the last line of claim 9, “the plant-to-solvent ratio” should be amended to “the crushed dried leaves-to-solvent mass ratio” in order to improve claim readability and consistency; and
In the last line of claim 14, “the plant-to-solvent mass ratio” should be amended to “the crushed dried leaves-to-solvent mass ratio” in order to improve claim readability and consistency.
Appropriate correction is required.
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 9 and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e., natural phenomenon, without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon (Step 2A, Prong One). In the instant application, the claims recite the following limitations:
Claims 9 and 14 each recite an extract of Murraya koenigii obtained from crushed dried leaves, free of alkaloids, comprising phenolic acids in an amount greater than 100 mg per 100 g of the extract, and comprising flavonoids in an amount greater than 50 mg per kg of the extract. Each of claims 9 and 14 are product-by-process claims (See Claim Interpretation section above), and the recited process is merely how to obtain the extract of Murraya koenigii containing natural components of Murraya koenigii.
Claim 13 recites a cosmetic composition comprising the extract of Murraya koenigii, where “cosmetic” is merely intended use (See MPEP 2111.02).
Each of claims 9 and 13-14 broadly encompass the natural product of Murraya koenigii.
The claims are directed to a judicial exception, i.e., natural phenomenon (e.g., product of nature) because an extract of Murraya koenigii is naturally occurring from curry leaf.
MPEP 2106.04(c) states that the markedly different characteristics analysis is part of Step 2A Prong One: “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately. See subsection II, below, for further guidance on the markedly different characteristic analysis.”
Further, from MPEP 2106.04(c): “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, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.”
The guidelines for performing the markedly different characteristics analysis, include (a) selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation, (b) identifying appropriate characteristics for analysis, and (c) evaluating characteristics to determine whether they are "markedly different".
Regarding (a), MPEP 2106.04(c) recites: “When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil").”
In the instant case, the naturally occurring counterpart to the claimed Murraya koenigii extract is Murraya koenigii.
Regarding (b), MPEP 2106.04(c) recites: “Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility). Examiners can identify the characteristics possessed by the claimed product by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. In some claims, a characteristic may be explicitly recited.”
In the instant case, the appropriate characteristic of Murraya koenigii is the ability to extract, from crushed dried leaves of Murraya koenigii, phenolic acids in an amount greater than 100 mg per 100 g of the extract, flavonoids in an amount greater than 50 mg per kg of the extract, and no alkaloids.
Regarding (c), MPEP 2106.04(c) recites: “The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are 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. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. 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.
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.”
In the instant case, the claimed product lacks markedly different characteristics and is a product of nature exception (Step 2A, Prong 1: YES).
The claimed product of an extract of Murraya koenigii lacks markedly different characteristics because isolating and concentrating naturally occurring components of Murraya koenigii does not change the structure, function or other properties.
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2).
This judicial exception is not integrated into a practical application because there are no additional elements recited in the claims beyond the judicial exception. From MPEP 2106.04(d): “Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application.” (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B).
As noted above, there are no additional elements recited in the claims beyond the judicial exception, and a judicial exception alone is not eligible subject matter (Step 2B: NO).
The claims do not recite anything which provides an inventive concept that departs from merely reciting an extract containing all naturally occurring components.
The extract of each of claims 9 and 14 does not appear to add significantly more as each of the claims do not appear to offer any additional element other than natural components endogenous to Murraya koenigii.
The cosmetic composition of claim 13 does not appear to add significantly more as the composition comprising the extract of Murraya koenigii is claimed generically, “cosmetic” is merely intended use, and the claim does not require any further structural components.
Therefore, instant claims 9 and 13-14 are not patent eligible subject matter under 35 USC § 101.
Response to Applicant’s Arguments
Applicant’s arguments filed on 05/11/2026 have been considered.
Regarding the rejection under 35 USC 101, Applicant argues that claim 9 has been amended to define the extract by a specific combination of structural, quantitative, and unique process-linked extract features, which materially narrow the claims and define an extract that is not merely a natural Murraya koenigii material. Applicant argues that the claimed extract is
characterized by a specific quantitative compositional profile and by a specific solvent system and extraction conditions that produce an enriched extract, and the claimed combination of being free of alkaloids while containing phenolic acids and flavonoids above the recited thresholds is not a mere statement that the extract contains natural plant components but rather defines a human-made composition having a modified and enriched phenolic profile resulting from controlled extraction conditions. Applicant argues that the solvent system of betaine, propanediol, and water is not a naturally occurring plant environment, and therefore the claimed extract is the result of human-controlled extraction using defined solvent composition, defined plant material, and defined plant-to-solvent ratio. Applicant argues that amended claims 9 and 14 are not directed merely to a natural product as such, but to a defined extract having a human-made, enriched, quantitative compositional profile imparted by the claimed solvent system and extraction conditions, and claim 13 reciting a cosmetic composition comprising the extract of claim 9 is likewise patent eligible.
The above arguments have been fully considered by the Examiner but are not found persuasive because the claimed extract of each of claims 9 and 14 being an extract with a modified and enriched phenolic profile having differing concentrations of alkaloids, phenolic acids, and flavonoids from naturally occurring Murraya koenigii does not meet the threshold for markedly different characteristics as all of alkaloids, phenolic acids and flavonoids are all endogenous to Murraya koenigii. Applicant has not shown that the claimed extract and endogenous naturally occurring compounds obtained differ in structure, function, or other properties from its naturally occurring counterpart, i.e. Murraya koenigii. See the above rejection under 35 USC 101 and/or MPEP 2106.04(c). The composition of claim 13 merely recites intended use (“cosmetic”) of the claimed extract as the composition comprising the extract of Murraya koenigii is claimed generically and the claim does not require any further structural components that are non-naturally occurring sufficient to overcome the rejection. Further, each of claims 9 and 14 are broad as each of the claims are product-by-process claims and therefore, the product is being given patentable weight, not the process by which the product is made, and therefore, the arguments regarding the solvent system of betaine, propanediol, and water that is used in the process of obtaining the extract being non-naturally occurring and the defined plant-to-solvent ratio used in the process of obtaining the extract are not appliable. Further, each of claims 9 and 14 are directed to the extract and not directed to a method of making the extract and Applicant has not shown that the recited process results in a change in structure, function or other properties. The Examiner notes that Pages 25-26 of the specification mentions Applicant’s surprising results that the inventive Murraya koenigii extract significantly increase the protein expression of elastin, fibrillin-1, fibrillin-2, and fibulin-5 in normal human dermal fibroblasts and states that the other 3 extracts obtained from different solvent systems have no effect of elastic fiber proteins, however, the data is not shown for the other 3 extracts. By Applicant not showing this data comparison, the threshold of markedly different characteristics cannot be met with regards to the claimed extract exhibiting the alleged differing function from its naturally occurring counterpart, i.e. Murraya koenigii. Further, Applicant has not chosen to amend claims 9 and 14 to a composition comprising the claimed extract further comprising non-naturally occurring/synthetic component(s), which also may be a way to meet the threshold of markedly different characteristics with regards to the claimed extract differing in structure and/or properties from its naturally occurring counterpart, i.e. Murraya koenigii.
The arguments regarding the rejection under 35 USC 103 are moot as the rejection has been withdrawn.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAELEIGH ELIZABETH OLSEN whose telephone number is (703)756-1962. The examiner can normally be reached M-F 8-5 PM.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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