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 .
The amendment filed 17 March 2026 is acknowledged and has been entered.
Status of the claims
Claims 1-15 have been cancelled.
Claim 21-24, 26-29 and 31-37 have been withdrawn.
Claims 16-20, 25 and 30 are presented for examination on the merits.
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 16-20, 25 and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 16 (and claims dependent thereon) are directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
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It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from its closest naturally occurring counterpart.
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When a claim recites a nature-based product limitation, examiners 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. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this analysis to identify product of nature exceptions. If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
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Nature-based Product Claim Analysis
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Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
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Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
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.
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Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
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When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. 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. 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).
Markedly changed characteristics can include structural, functional, chemical changes. In order 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, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
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If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
The claims are directed to a composition comprising nature-based components (i.e. Ocimum sanctum extract), which is not markedly different from its closest naturally-occurring counterpart because there is no indication that their combination or preparation has caused the nature-based product to have any characteristics that are markedly different from the closest naturally-occurring product and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The rationale for this determination is explained below:
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a composition of matter (i.e., a polyphenol-rich extract of aerial parts of Ocimum sanctum), which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception
(e.g., law of nature, natural phenomenon, or an abstract idea). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., Ocimum sanctum extract) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Note: with respect to extracts of natural products such as plants, the closest naturally-occurring counterpart is always the same compounds found in the extract, present in the non-isolated form in the source plant material. Extracts that are made simply by separating the extracted components from the non-extracted components, is a partitioning process that absent any specific chemical modification, merely separates the compounds leaving their activities unchanged.
Ingredients recited in the claims are natural products that would occur naturally; thus, the claims involve the use of judicial exceptions. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. For example, there is no evidence of record of a structural difference between the extract(s) in the claimed composition and that of their nature-based counterparts. Consequently, the claimed compositions are structurally the same as their closest naturally- occurring counterparts.
Nor is there any difference in functional characteristics. To show a marked difference, the characteristic(s) must be changed as compared it closest natural-occurring counterpart. For example, and assertion of changed functionality must be accompanied with evidence of a comparison of the claimed composition with its closest naturally-occurring counterpart and should apply to the full scope of the claim. Furthermore, inherent or innate characteristics of the naturally occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference.
The recitation of specific amounts of the ingredients does not affect this analysis because it is well known and routine in the art to mix specific amounts of active ingredients with additional ingredients. Therefore, the claim is not meaningfully limited and does not amount to significantly more than each product of nature by itself. Finally, the claimed mixture is like the novel bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture (like each component in the instantly claimed mixture) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117. While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk Brothers, 333 U.S. at 128 n.1.
Thus, there is no evidence of record to indicate that the claimed product is markedly different, structurally, chemically, functionally, than its closest naturally occurring counterpart.
PRONG TWO: Evaluate whether the judicial exception is integrated into a practical application. The claims are directed to a composition, not its practical use such as a particular treatment or prophylaxis for a disease or medical condition.
Thus the cited claims are directed to a judicial exception to patentable subject matter.
Step 2b: Determine whether the claim directed to a judicial exception provides an inventive concept. For example, the claims may recite additional elements that amount to significantly more than the judicial exception. In the instant case, NO, the claims are directed to an extract composition without any other components that could add significantly more to the exception. No other specific limitations other than what is well-understood, routine and conventional in the field at a high level of generality have been added to the claimed nature-based product (e.g., addition of well-known ingredients).
Thus, the claimed product is not eligible subject matter under current 35 USC 101 standards.
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.
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) 16-20, 25 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over for example Hakkim et al. (2007) [cited by Applicant in IDS filed 10/9/2023] in view of Redha (2021)
An extract of aerial parts of holy basil, Ocimum sanctum containing:
at least 6% by weight of polyphenols, at least 5% by weight of hydroxycinnamic derivatives and at least 2.5% by weight of flavonoids, relative to the total weight of the dry extract is claimed.
Hakkim et al. beneficially teach an extract of aerial parts of Ocimum sanctum comprising the active principles of the plant such as polyphenols, flavonoids and hydroxycinnamic derivatives.
Redha beneficially reviews the literature involving extraction using deep eutectic solvents, which fortunately, due to their unique properties, can significantly improve
extraction efficiency. The optimum extraction of phenolic compounds, using different types of green deep eutectic solvents is disclosed. For example, Polyalcohol-based DESs (sorbitol, ethylene glycol, 1,2-propanediol, glycerol, and 1,4-butanediol) were found to be more efficient in extracting neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, rutin, isoquercitin, and astragalin from mulberry leaves, than carboxylic acid-based (citric acid, lactic acid, and malic acid), amide-based (urea), and sugar-based (sucrose, fructose, and glucose) NADESs. A study targeting the phenolic compounds present in olive tree leaves using polyalcohols (1,4-butanediol, ethylene glycol, xylitol, and 1,2-propanediol), organic acids (lactic acid, oxalic
acid, and tartaric acid), sugar (maltose), and amide (urea)-based DESs concluded that
polyalcohol-based DESs were the most suitable solvents to extract the phenolic compounds from olive leaf compared to the other green solvents and methanolic
aqueous solvents tested due to their relatively low viscosity and high hydrogen bonding ability.
While Hakkim et al. do not explicitly disclose the relative amounts of the phytochemical constituents of the holy basil extract, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1254-1255, 195 U.S.P.Q. (BNA) 430, 432-33 (C.C.P.A. 1977).
Furthermore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the instant Application to extract beneficial bioactive phytochemicals from holy basil leaves such as polyphenols, flavonoids, and hydroxycinnamic derivatives as taught by Hakkim et al. In addition, it would have been well within the purview of the skilled practitioner to optimize the extraction of these beneficial bioactives by altering the extractions conditions, such as employing propandiol as taught by Redha.
Such adjustment of particular conventional working conditions (e.g., altering the extraction conditions, such as optimizing the solvent such as propanediol) to maximize extraction of desired bioactives) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Response to Arguments
Applicant’s arguments with respect to the 35 USC 112(b) rejection have been fully considered and are persuasive. The 35 USC 112 rejection of the previous Office action has been withdrawn.
Applicant's arguments filed with respect to the obviousness rejection have been fully considered but they are not persuasive.
Applicant respectfully traverses, because Hakkim and Redha provide no guidance for a POSITA to arrive at the present invention as claimed. Specifically, Hakkim disclosed chemical compositions of different parts of holy basil and their callus, without disclosing any basis to arrive at the particular composition presently claimed. Redha is silent on holy basil, and Rehsa does not emphasize biological properties of the disclosed extracts. Instead, Redha reviews use of deep eutectic solvents (DESs) for extracting phenolic compounds.
Hakkim discusses the chemical composition of different parts of holy basil and their callus. In Table 2 (page 9112) Hakkim discloses compositions of extracts of different parts of holey basil, e.g., the methanolic extract of leaves has a phenolic content of 3.05 mg/mL (shown as TPC or "Total Phenolic Content"). In Table 2 the highest phenolic content is 4.0 mg/mL for leaf callus. None of the extracts in Table 2 approaches 6% by weight of polyphenols, as recited in the present claims. Hakkim and Redha, inter alia, provide no guidance or motivation to lead a POSITA to approach 6% by weight of polyphenols.
The Office acknowledged that Hakkim fails to disclose the relative amounts of holy basil extract constituents. Indeed, Hakkim fails to even suggest how or why to arrive at an extract from the aerial parts of holy basil comprising at least 6% by weight of polyphenols relative to the total weight of the dry extract, at least 5% by weight of hydroxycinnamic derivatives relative to the total weight of the dry extract, and at least 2.5% by weight of flavonoids, expressed as rutin equivalent, relative to the total weight of the dry extract.
Redha fails to cure the deficiencies of Hakkim. A POSITA would not have considered Redha combinable with Hakkim and, even if combined, Redha and Hakkim would not have led a POSITA from Hakkim to the present invention. Redha's disclosures could not be universally applied to any extraction system, because Redha is a review article focused exclusively on a specific and non-conventional class of solvents called Deep Eutectic Solvents (DESs). The extraction efficiency of a DES relies on complex intermolecular interactions within the solvent system. As such, Redha's disclosure could not be directly transferable or predictable for a simpler extraction mixture.
Thus, a POSITA would have found no motivation to apply the specific optimization rules from Redha's teachings on DES to another solvent system with a reasonable expectation of success. In particular, a POSITA would have no idea how to achieve the results demonstrated in the present application for the present invention as claimed.
Further, whereas Redha refers to numerous plants and extracts (see Table 1, p. 881- 899), Redha is completely silent regarding holy basil.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of cited references teach that it was known in the prior art to extract phenolic compounds such as obtain extracts from holy basil, which are known to possess beneficial effects. One would therefore be motivated to obtain extracts with the most phenolic contents (“at least …”) from the holy basil extracts.
More convincing is Applicant’s assertion is that the present invention provides an extract exhibiting a particular combination of antioxidant, anti-inflammatory, anti-aging, and defensive activities against various external (e.g., pollution) or internal stresses, making the extract particularly useful for cosmetic and dermatological care.
Particularly in the extensive data in Example 3. This data demonstrates that the claimed extract:
" significantly stimulates gene expression of key dermal matrix components, including
Collagen I and Elastin, while significantly inhibiting gene expression of MMP1, an enzyme involved in dermal matrix degradation (see [0143]-[0144] and Table 10);
" provides remarkable pro-healing effect by stimulating fibroblast migration (see
[0195]-[0197]);
" provides moisturizing activity (see [0198]-[0201]); and
" shows anti-oxidant and anti-inflammatory activity (see [0107]-[0136]).
Further, the present application in Example 4 provides results of an in vivo clinical study demonstrating anti-aging efficacy of the extract, shown via test data on crow's fee wrinkles and forehead wrinkles.
With respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Applicant's arguments filed with respect to the 35 USC 101 rejection have been fully considered but they are not persuasive.
Applicant that because (a) the claimed composition possesses markedly different functional characteristics from its closest naturally occurring counterpart, i.e., compounds found in the extract, present in the non-isolated form in the source plant material. Applicant further asserts that:
As explained above in traversing the obviousness rejection, the specification provides in Example 3 extensive data demonstrating that the claimed extract:
" significantly stimulates gene expression of key dermal matrix components, including Collagen I and Elastin, while significantly inhibiting gene expression of MMP1, an enzyme involved in dermal matrix degradation (see [0143]-[0144] and Table 10);
" provides remarkable pro-healing effect by stimulating fibroblast migration (see
[0195]-[0197]);
" provides moisturizing activity (see [0198]-[0201]); and
" shows anti-oxidant and anti-inflammatory activity (see [0107]-[0136]).
In addition, Example 4 provides results of an in vivo clinical study demonstrating anti- aging efficacy of the extract, shown via test data on crow's fee wrinkles and forehead wrinkles.
Applicant further asserts:
B. Invention is an extract, not a mixture
In considering the specific limitations of independent claim 16, the Office stated as follows (Office action, page 9, 2nd paragraph): "The recitation of specific amounts of the ingredients does not affect this analysis because it is well known and routine in the art to mix specific amounts of active ingredients with additional ingredients."
The biological activities, such as anti-aging, pro-healing, moisturizing, and protective activities, result from the specific, claimed phytochemical composition, and would not be found in the naturally-occurring aerial parts of holy basil as they appear in nature, nor in the individual components of the claimed composition. Also, as explained in the specification at [0057]-[0058] and [0148] the claimed extract can be formulated in the form of various types of composition not found in nature and providing the advantageous activities demonstrated in the specification (as explained above).
Firstly, with respect to the Applicants argument that Invention is an extract, not a mixture. The language: "The recitation of specific amounts of the ingredients does not affect this analysis because it is well known and routine in the art to mix specific amounts of active ingredients with additional ingredients", is merely to point out that simply adding ingredients does not necessarily result in a markedly changed characteristic. This is more relevant to claim 25, which is directed to a composition comprising the extract along with anything else.
Secondly, the markedly changed functional characteristic analysis that Applicant applies is the correct one, further pointing out evidence earlier used in addressing the 35 USC 103 rejection. However, similar to that analysis the markedly changed characteristic must apply to the full scope of the claims. The Applicant pointing out of example 3 and 4 as evidence of nonobviousness is not commensurate in scope with the claims, neither is the same evidence show that the full scope of the claimed extract show the markedly changed functional characteristics.
THIS ACTION IS MADE FINAL. 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.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 5712720947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUSSELL G FIEBIG/ Examiner, Art Unit 1655
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