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 .
Formal Matters
Receipt of Applicant’s response, dated 09/22/2025, is acknowledged.
Claims 1-17 are pending.
Claims 9-10 are amended.
Claims 14-17 are new.
Claims 1-8 remain withdrawn from consideration as being drawn to a nonelected invention.
Claims 9-17 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, each of claims 9 and 14 are being examined to the extent of an extract of Murraya koenigii that comprises phenolic acids and is free of alkaloids.
OBJECTIONS/REJECTIONS WITHDRAWN
Claim Objections
The objection to claim 9 set forth in the Office action dated 03/24/2025 is hereby withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 112(b)
The indefiniteness rejection of claims 9-13 (rejection (a)) and the indefiniteness rejection of claim 10 (rejection (b)) set forth in the Office action dated 03/24/2025 are hereby withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 101
The rejection of claims 9-13 set forth in the Office action dated 03/24/2025 is hereby withdrawn in light of Applicant’s amendment to the claims and in favor of the new grounds of rejection set forth below as necessitated by Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 102
The anticipation rejections of claims 9-13 by Sharma et al and of claims 9 and 13 by Majeed set forth in the Office action dated 03/24/2025 is hereby withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 103
The obviousness rejections of claims 9, 11, and 13 over Majeed in view of Tan et al and Hyun et al and of claims 9-13 over Majeed in view of Sharma et al set forth in the Office action dated 03/24/2025 are hereby withdrawn in light of Applicant’s amendment to the claims and in favor of the new grounds of rejection set forth below as necessitated by Applicant’s amendment to the claims.
OBJECTIONS/REJECTIONS MAINTAINED
Specification
The disclosure remains objected to because of the recitation of “Amberlite” on Page 19 Line 26 and Page 20 Lines 5-6 of the specification, which is a trademark, but the recitation does not include the proper symbol.
The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant’s reply dated 09/22/2025 did not address this objection set forth in the Office action dated 03/24/2025 and therefore the rejection is maintained.
Appropriate correction is required. Applicant is requested to check the rest of the disclosure for informality errors and make changes accordingly.
The abstract of the disclosure remains objected to because it is too short and, thus, does not properly convey to the reader the subject matter of the invention.
Applicant’s reply dated 09/22/2025 did not address this objection set forth in the Office action dated 03/24/2025 and therefore the rejection is maintained.
A corrected abstract of the disclosure is required. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure:
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Rejections - 35 USC § 112(b)
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.
Claim 9 is 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 9 remains rejected because the phrase “advantageously” renders the claim indefinite because it is unclear whether the limitation following the phrase is a part of the claimed invention. See MPEP § 2173.05(d).
Applicant’s reply dated 09/22/2025 did not address this objection set forth in the Office action dated 03/24/2025 and therefore the rejection is maintained.
NEW GROUNDS OF OBJECTION/REJECTION
Claim Objections
Applicant is advised that should claim 9 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 9, 14, and 16-17 are objected to because of the following:
In the last line of claim 9, “the extract comprising” should be amended to “the extract comprises” in order to improve claim readability and consistency;
In line 2 of claim 14, “wherein” should be added so that the claim recites “…free of alkaloids, wherein the extract is…” for grammatical correctness;
In claim 16, “having flavonoid concentration” should be amended to “having a concentration of flavonoids” in order to improve the readability of the claim;
In claim 17, “having phenolic acids concentration” should be amended to “having a concentration of phenolic acids” in order to improve the readability of the claim; and
The language in claims 16 and 17 should be amended for claim consistency, e.g., either claim 16 can be amended to recite “higher than 50 mg per kg of the extract” to be consistent with claim 17 or claim 17 can be amended to recite “of more than 100 mg/100 g of extract” in order to be consistent with claim 16.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 9-17 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.
(a) Each of claims 9 and 14 are indefinite in the recitation of “a solvent consists of a mixture of betaine, propanediol, and water” because it is unclear whether ‘a solvent’ refers to the solvent in all of the first solid/liquid extraction step, the second solid/liquid separation step, and the third liquid phase recovery step, only the solvent in the first solid/liquid extraction step, only the solvent in the second solid/liquid separation step, only the solvent in the third liquid phase recovery step, one of the solvents in the first solid/liquid extraction step, the second solid/liquid separation step, or the third liquid phase recovery step, at least one of the solvents in the first solid/liquid extraction step, the second solid/liquid separation step, and the third liquid phase recovery step, or whether something else is meant by the phrase. As written, one skilled in the art would not be reasonably apprised of the metes and bounds of the claims. Claims 10-13 and 15-17 are rejected for depending from claim 9 without resolving the ambiguity of claim 9. As was suggested in the Office action dated 03/24/2025, the Examiner suggests amending this phrase to specify which step or steps the solvent is referring to in order to overcome this rejection.
(b) Claim 14 is indefinite in the recitation of “advantageously in molar proportions of 1:1:5” because it is unclear whether the limitation ‘advantageously in molar proportions of 1:1:5’ is a part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites “An extract according to claim 9, being free of alkaloids”, however claim 9 recites “wherein the extract is free of alkaloids”. Because the limitation of claim 11 is a repetition of the limitation of claim 9, i.e. the claim to which claim 11 depends, claim 11 is rejected for failing to further limit the subject matter of claim 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 9-17 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:
Claim 9, 11, and 14 recite an extract of Murraya koenigii that comprises phenolic acids and is free of alkaloids.
Claim 10 recites that the extract of Murraya koenigii is an extract of leaf stalks and/or dried leaves.
Claim 12 recites that the extract of Murraya koenigii has a mass ratio of leaf stems and/or leaves of Murraya koenigii/solvent of between 1:99 and 50:50.
Claim 13 recites a cosmetic composition comprising the extract of Murraya koenigii.
Claim 15 recites that the extract of Murraya koenigii comprises flavonoids.
Claim 16 recites that the extract of Murraya koenigii has a concentration of flavonoids of more than 50 mg/kg of extract.
Claim 17 recites that the extract of Murraya koenigii has a concentration of phenolic acids higher than 100 mg per 100 g of the extract.
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 for compounds to be extracted from of Murraya koenigii.
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, an extract of Murraya koenigii, lacks markedly different characteristics and is a product of nature exception (Step 2A, Prong 1: YES).
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 else, compositionally or structurally, which provides an inventive concept that departs from merely reciting a composition containing all naturally occurring components.
Regarding claims 9, 11, and 14, the extract of Murraya koenigii comprising phenolic acids and being free of alkaloids does not appear to add significantly more as the claim does not appear to offer any additional element other than natural components.
Regarding claim 10, the extract of Murraya koenigii being an extract of leaf stalks and/or dried leaves does not appear to add significantly more as the claim does not appear to offer any additional element other than natural components.
Regarding claim 12, the mass ratio of leaf stems and/or leaves of Murraya koenigii to solvent does not appear to add significantly more as the claim does not appear to offer any additional element other than natural components.
Regarding claim 13, the extract of Murraya koenigii in a cosmetic composition does not appear to add significantly more as the composition comprising the extract of Murraya koenigii is claimed generically and the claim does not require any further structural components.
Regarding claim 15, the extract of Murraya koenigii comprising flavonoids does not appear to add significantly more as the claim does not appear to offer any additional element other than natural components.
Regarding claim 16, the flavonoid concentration in the extract of Murraya koenigii does not appear to add significantly more as the claim does not appear to offer any additional element other than natural components.
Regarding claim 17, the phenolic acids concentration in the extract of Murraya koenigii does not appear to add significantly more as the claim does not appear to offer any additional element other than natural components.
Therefore, instant claims 9-17 are not patent eligible subject matter under 35 USC § 101.
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.
Claims 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al (Asian J. Pharm. Res., (2019) 9, 159, published 12/31/2019, cited in Notice of References Cited dated 01/13/2025) in view of Sablania et al (J. Food Sci. Technol., (2019), 56, 12, 5500-5508, published 08/14/2019).
Sharma et al teach extracts of Murraya koenigii leaves, stem bark, seeds, and root (See entire document, e.g., Abstract, “Chemical constituents” on Page 3). The extracts were obtained using a Soxhlet extraction process (e.g., “Extraction with soxhlet apparatus” on Page 4). The Murraya koenigii leaves were washed, the excess water was drained, and the leaves were dried in vacuum for one week; the dried leaves were then powdered to obtain a coarse powder used for the extraction (e.g., Par. 4 of “Extraction with soxhlet apparatus” on Page 5). Sharma et al teach that the extraction was carried out with 35 g of Murraya koenigii leaf powder and 250 mL of extraction solvent, where the extraction solvent was chloroform or ethanol (e.g., Par. 5 of “Extraction with soxhlet apparatus” on Page 5). Sharma et al teach that the chemical constituents obtained from extracts of leaves of Murraya koenigii was dependent on solvent (e.g., Par. 2 of Page 6, Tables 3 and 4). Table 3 shows the results of the chemical examination of various extracts of leaves of Murraya koenigii, wherein flavonoids were detected and alkaloids were not detected in the ethanol extract (Page 6 Table 3). Table 4 shows the results of TLC screening of various crude extracts of leaves of Murraya koenigii, wherein flavonoids were detected and alkaloids were not detected in the ethanol extract (Page 6 Table 4). The formulation of cream of essential oil of leaves of Murraya koenigii was found to have sun protection factor (e.g., Par. 5 of “In vitro studies” on Page 4).
Sharma et al do not teach the extracts being examined for the presence of phenolic acids and therefore are silent regarding whether the extracts comprise phenolic acids.
This deficiency is made up for in the teaching of Sablania et al.
Sablania et al teach the analysis of extracts of Murraya koenigii from dried leaves (See entire document, e.g., Title, Bottom of Col. 1 on Page 5501). Sablania et al teach that the ethanol extracts comprise phenolic acids and flavonoids (e.g., Bottom of Col. 2 on Page 5501, Table 1 on Page 5502, Top of Col. 2 on Page 5502, Conclusion on Page 5507). Sablania et al teach phytochemical analysis of Murraya koenigii extracts wherein the ethanol extract comprises 5.760 ± 0.12 μg/g of flavonoids and 63.055 ± 0.20 mg/g of phenolic acids (e.g., Table 4 on Page 5505).
The ethanol extract of dried Murraya koenigii leaves being flavonoid-containing and alkaloid-free analyzed by Sharma et al in view of the ethanol extract of dried Murraya koenigii leaves comprising 5.760 ± 0.12 μg/g of flavonoids and 63.055 ± 0.20 mg/g of phenolic acids analyzed by Sablania et al renders obvious the extract of instant claims 9-17.
The steps of the Soxhlet extraction process taught by Sharma et al renders obvious the steps of a first solid/liquid extraction step, a second solid/liquid separation step, and a third liquid phase recovery step (See Par. 2 and 3 of “Extraction with soxhlet apparatus” on Page 4) of instant claims 9 and 14.
The extraction being carried out with 35 g of Murraya koenigii leaf powder and 250 mL of extraction solvent corresponds to the ratios of Murraya koenigii leaf to solvent of about 1:10.6, when the solvent is chloroform (i.e., 250 mL chloroform x 1.483 g/mL (density of chloroform) = ~371 g chloroform; 35 g: 371 g), and about 1:5.6 when the solvent is ethanol (i.e., 250 mL ethanol x 0.789 g/mL (density of ethanol) = ~197 g ethanol; 35 g: 197 g), which renders obvious the mass ratio of leaf stems and/or leaves of Murraya koenigii/solvent being between 1:99 and 50:50 of instant claim 12. The concentrations of flavonoids and phenolic acids in the ethanol extract determined by Sablania et al renders obvious the ranges of instant claims 16-17. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
The extract of Murraya koenigii having a sun protecting ability when formulated as a cream taught by Sharma et al renders obvious a cosmetic composition comprising an extract of Murraya koenigii of instant claim 13.
Response to Applicant’s Arguments
Applicant’s arguments filed on 09/22/2025 have been considered.
The arguments regarding the teachings of Majeed, Tan et al, and Hyun et al are moot because the rejections over these references have been withdrawn.
Applicant argues that the amendments to claim 9 to recite that the extract is free of alkaloids and comprises phenolic acids is a structural and compositional distinction that creates an extract that is not naturally occurring and that requires specific human intervention to obtain. Applicant argues that the cited prior art does not disclose, nor does nature produce, an extract with the precise phytochemical profile and the claimed extract exhibits markedly different biological activity including unexpected upregulation of elastin, fibrillin-1, fibrillin-2, and fibulin-5.
The above arguments have been fully considered by the Examiner but are not found persuasive because, firstly, no support has been provided for the argument that an extract of Murraya koenigii with this precise phytochemical profile is structurally and compositionally distinct from that which is naturally occurring and requires specific human intervention to obtain. In fact, analysis by Sharma et al and Sablania et al teach that extracts of Murraya koenigii were found to be alkaloid-free (See new grounds of rejection under 35 USC 103 above). Further, as evidenced by Page 12 of the specification, the extract of Murraya koenigii of the instant invention described as “alkaloid-free” allows for the presence of alkaloids at a concentration of less than 5 mg/100g of extract. The argued markedly different biological activity shown in the Examples including the unexpected upregulation of elastin, fibrillin-1, fibrillin-2, and fibulin-5 has been fully considered by the Examiner but is not found persuasive because the analysis of elastin, fibrillin-1, fibrillin-2, and fibulin-5 is performed with an extract that is not commensurate in scope with the extract of instant claims 9/14, i.e., ‘Extract 1’, which is argued as the extract of the instant claims, requires a specific plant/solvent ratio which is not a requirement of the extract of instant claims 9/14 and is obtained from dried and ground leaf stems and leaves which is not a requirement of the extract of instant claims 9/14. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Applicant argues that amended claim 9 is not disclosed in the prior art, that Sharma describes an ethanol fraction of Murraya koenigii obtained after successive Soxhlet extractions, which may be lower in alkaloids but is also described as lacking phenolic acids. Applicant argues that the cited prior art do not disclose an extract prepared by a defined three-step solid/liquid process using the closed solvent system and yielding the distinct phytochemical profile, and that the use of the ”consists of” language defining the solvent system expressly excludes the ethanol and other aqueous/organic solvents taught in Sharma.
The above arguments have been fully considered by the Examiner but are not found persuasive because, as can be seen in the new grounds of rejection under 35 USC 103 above, the ethanol extract of Murraya koenigii analyzed by Sharma et al in view of the analysis by Sablania et al render obvious the extract of the instant claims under consideration in the instant Office action. The Soxhlet extraction process of Sharma et al renders obvious the three-step solid/liquid process of the instant claims. The argument regarding the closed solvent system differing from that in the prior art has been fully considered by the Examiner but is not found persuasive because the recitation regarding the solvent in the instant claims is unclear and the issue of indefiniteness needs to be remedied in order to be distinguished from that taught by the prior art.
Conclusion
No claims are allowable.
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.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619