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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-10, in the reply filed on June 23rd, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and therefore made FINAL.
Applicant’s election without traverse of extract TC-1 in the reply filed on June 23rd, 2025 is acknowledged. Alternatives embodiments to those listed above for group D in the examiner’s requirement (group F in the applicant’s response), are withdrawn as being drawn to non-elected species. For compact prosecution, the species elections for all other groups are withdrawn.
Claims 1-10 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Republic of India on March 3rd 2020. It is noted, however, that applicant has not filed a certified copy of the IN202041008980 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed September 9th, 2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The applicant has not supplied a copy of the following non-patent literature document cited on the IDS: De Vreese, L. P.; et al. Memory rehabilitation in Alzheimer’s disease: a review in progress. Int. J. Geriatr. Psychiatry 2001, 16, 794-809. A copy of this document was retrieved by the examiner, uploaded, and cited on the PTO-892 form.
Drawings
The drawings were received on September 2nd, 2022. These drawings are acceptable.
Specification
The use of the terms gummy bear, Ultrasperse, Ultra-tex, Remi, Sigma, Falcon, Perkin-Elmer, EnSpire, ATCC, HiMedia, and Sprague-Dawley; each of which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, each 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.
Claim Objections
Claims 1, 2, 9, and 10 are objected to because of the following informalities: the. Appropriate correction is suggested.
Claim 3 is objected to because of the following informalities: the phrase "pharmaceutically or nutraceutically or dietically acceptable, excipients, carriers or diluents" should be . Appropriate correction is suggested.
Claim 4 is objected to because of the following informalities: the phrase "pharmaceutically or nutraceutically or dietically acceptable. Appropriate correction is suggested.
Claim 4 is objected to because of the following informalities: the term "monosaccharide’s" should be revised too "monosaccharides" for correct punctuation; the term "Poly carbohydrate" should be revised to "Polysaccharide" for consistency with commonly used language in the art. Appropriate correction is suggested.
Claim Rejections - 35 USC § 112
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 4 and 5 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.
Claim 4 contains the trademark/trade names "Ultra. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe certain and, accordingly, the identification/description is indefinite.
Claim 5 contains the trademark/trade name "gummy bear". Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a dosage form and, accordingly, the identification/description is indefinite.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the extract, fraction, active compound or phytochemical. It is unclear which ingredient is recited in the extract, fraction, active compound or phytochemical.
Regarding claim 8, the phrase "and the like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 11-13, and 16 of U.S. Patent No. US 10953067 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the overlapping subject matter presented below.
Instant claim 1 and reference claims 1-3, 9, and 16 recite an herbal composition comprising an extract from Terminalia chebula and an extract of a Boswellia serrata resin, that would not include Boswellic acids.
Instant claims 3 and 4 and reference claims 4 and 6 recite the composition according to claim 1 (an independent claim in both documents) comprising pharmaceutically, nutraceutically, or dietetically acceptable carriers, and pharmaceutically, nutraceutically, or dietetically acceptable excipients.
Instant claim 5 and reference claim 13 recite a capsule dosage form of the composition according to claim 1 . A capsule dosage form implies oral administration to one of skill in the art, so instant claim 5 is also rejected over reference claim 12 which recites oral administration of the composition according to claim 1.
Instant claim 6 recites food and beverages dosage forms that imply oral administration of the composition according to claim 1. Reference claim 12 recites oral administration of the composition according to claim 1. Instant claim 6 is rejected over reference claim 12.
Instant claim 7 and reference claims 5 and 16 recite sourcing extracts from fruit and gum resin.
Instant claim 8 and reference claims 1-3, 5, 9, 11, and 16 have overlapping categories of extraction solvents, recited as organic (reference claims 1-3, 9, and 16), and as aqueous, alcoholic, or hydroalcoholic (reference claims 5, 11, and 16).
Instant claim 9 and reference claims 1, 9, and 16 recite weight percentages within overlapping with the range of 10-90% for each extract: the extracts of Terminalia chebula and Boswellia serrata resin.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recites synergistic herbal compositions. This judicial exception is not integrated into a practical application because composition, as instantly claimed, lacks characteristics that markedly differentiate from its nat. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not recite biological activity beyond the activity of the source materials of the . The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 1-10 are directed to an herbal composition, the claims are directed to a composition.
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".
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.
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.
Nature-based Product Claim Analysis
Where the claim is to a nature-based product by itself, the markedly different
characteristics analysis should be applied to the entire product. 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. 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. 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. If there is no change in any characteristic, the claimed product lacks markedly
different characteristics, and is a product of nature exception.
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, 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; see MPEP 2106.04). YES, the claims are product claims reciting something that appears to be a nature-based product (an herbal composition) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Because the claim states the nature-based products which are plant extracts the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within Terminalia chebula and Boswellia serrata (instant claims 1, 2, 9, and 10), “vitamins” (instant claim 3), and “vitamin B group” (instant claim 4), which naturally occur in plants. This equates to a plant extract. The process of creating a plant extract is by partitioning the starting plant material into separate compositions based upon some property. The closest naturally occurring counterparts of extracted components are those same components when found existing in the plant in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found in the plant they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A: prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a)
identifying whether there are any additional recited elements in the claim beyond the judicial exception
and (b) evaluating those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application.
This judicial exception is not integrated into a practical application because the plant extract
composition is only comprising the nature-based components. The claims do not integrate the judicial
exceptions into a practical application because in this context, such integration for a claimed product
would be a physical form of the specific practical application instead of a more general composition that
is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more
than the judicial exception because these components and their activity are already found naturally
occurring in nature and the addition of an intended use does not impart any added benefit to the
compounds or integrate the composition into a practical application.
Step 2B evaluates whether the claim as a whole, amounts to significantly more than the recited
exception, i.e., whether any additional element, or combination of additional elements, adds an
inventive concept to the claim (see MPEP § 2106.05(b)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t
any other additional elements to consider, which does not add an inventive concept to the claims. Thus,
the claims are not eligible subject matter under current 35 U.S.C. 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.
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 1 and 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gokaraju et al. (WO 2011114350 A2, cited as Foreign Patent document 4 on the IDS received on September 2nd, 2022), abbreviated "Gokaraju", and further in view of Won and Kim (KR 20200000048 A), abbreviated "Won".
Claim 1 recites “Synergistic herbal compositions comprising a first ingredient selected from the extract(s), fraction(s), phytochemical(s) and mixtures thereof derived from Terminalia chebula in combination with a second ingredient selected from the oil extract(s)/fraction(s) derived from Boswellia serrata gum resin, after removing boswellic acids, for improving at least one cognitive function selected from memory, intelligence, learning, retention, recall information/communication, focus, concentration, attention, perception, reasoning, problem solving, decision making and mental fatigue”. Claim 3 recites “The synergistic compositions as claimed in claim 1, wherein the compositions contain optionally at least one additional component selected from the group consisting of biological agent(s), and Nootropic agent(s); pharmaceutically acceptable active ingredients, vitamins, minerals; pharmaceutically or nutraceutically or dietically acceptable, excipients, carriers or diluents”. Claim 4 recites
“The synergistic compositions as claimed in claim 3, wherein the pharmaceutically or nutraceutically or dietically acceptable excipients, carriers and diluents are selected from monosaccharide's such as glucose, dextrose, fructose, galactose etc.; Disaccharides such as but not limited to sucrose, maltose, lactose, lactulose, trehalose cellobiose, chitobiose etc.; Poly carbohydrates such as Starch and modified starch such as Sodium starch glycolate, pre gelatinized starch, soluble starch, and other modified starches such as but not limited to Ultrasperse A & Ultra-tex 4; Dextrins that are produced by hydrolysis of starch or glycogen such as yellow dextrin, white dextrin, Maltodextrin etc.; Polyhydric alcohols or sugar alcohols such as but not limited to Sorbitol, mannitol, inositol, xylitol, isomalt etc.; cellulose based derivatives such as but not limited to microcrystalline cellulose, hydroxy propyl methyl cellulose, hydroxy ethyl cellulose, sodium carboxy methyl cellulose (sodium CMC) etc.; silicates such as but not limited to neusilin, veegum, Talc, colloidal silicon dioxide etc.; metallic stearates such as but not limited to calcium stearate, magnesium stearate, zinc Stearate etc.; Organic acids such as citric acid, tartaric acid, malic acid, succinic acid, lactic acid, L-ascorbic acid etc.; Fatty acid esters and esters of poly sorbate, natural gums such as but not limited to acacia, carrageenan, Guar gum, Xanthan gum etc.; vitamin B group, nicotinamide, calcium pantothenate, amino acids, proteins such as but not limited to casein, gelatin, pectin, agar; organic metal salts such as but not limited to sodium chloride, calcium chloride, dicalcium phosphate, magnesium hydroxide, zinc Sulphate, zinc chloride etc.; Natural pigments, flavors, Class I & Class II preservatives and aqueous, alcoholic, hydro-alcoholic, organic solutions of above listed ingredients alone or in combination”.
Claim 5 recites “The synergistic composition as claimed in claim 1, where in the composition is formulated into a dosage form selected from dry powder form, liquid form, beverage, food product, dietary supplement or any suitable form such as tablet, a capsule, a soft chewable tablet or gummy bear”. Claim 6 recites “The synergistic composition as claimed in claim 1, where in the composition is formulated into nutritional/dietary supplements that can be contemplated/made into the dosage form of healthy foods, or food for specified health uses such as solid food like chocolate or nutritional bars, semisolid food like cream, jam, or gel or beverage such as refreshing beverage, lactic acid bacteria beverage, drop, candy, chewing gum, gummy candy, yoghurt, ice cream, pudding, soft adzuki bean jelly, jelly, cookie, tea, soft drink, juice, milk, coffee, cereal, snack bar”. Claim 7 recites “The synergistic compositions as claimed in claim 1, wherein the extract, fraction, active compound or phytochemical is obtained from at least one plant part selected from the group consisting of leaves, stems, tender stems, tender twigs, aerial parts, whole fruit, fruit rind, seed, root, bark, bulb, hardwood, gum resin or whole plant or mixtures thereof”. Claim 8 recites “The synergistic compositions as claimed in claim 1, wherein the extract, fraction, active compound or phytochemical are produced using at least one solvent selected from but not limited to C1-C5 alcohols like ethanol, methanol, n-propanol, isopropyl alcohol; ketones like acetone, methylisobutyl ketone, chlorinated solvents like methylene dichloride and chloroform, water and mixtures thereof; C1-C7 hydrocarbons such as hexane; esters like ethyl acetate and the like and mixtures thereof”. Claim 9 recites “The synergistic herbal compositions comprising a first ingredient selected from the extract(s), fraction(s), phytochemical(s) and mixtures thereof derived from Terminalia chebula in combination with a second ingredient selected from the oil extract(s)/fraction(s) derived from Boswellia serrata gum resin, as claimed in claim 1, where in the weight of the first ingredient varies in the range of 10%-90% and the weight of the second ingredient varies in the range of 90% -10% in the composition”.
Gokaraju recites a non-acidic extract derived from the gum resin of Boswellia species for improving certain cognitive functions including memory: “The present invention discloses non-acidic extract/fraction selected from Boswellia low polar gum resin extract fraction (BLPRE), Boswellia volatile oil fraction (BVOIL) and Boswellia oil fraction (BOIL) derived from the gum resin of Boswellia species and their compositions for improving memory/mental condition, enhancing brain/mental functions such as cognition, memory, learning, communication and brain health, for treating impaired memory, and for preventing, control or treating memory and cognition related disorders/diseases” (Abstract; instant claims 1 and 7). Gokaraju recites the preparation of non-acidic Boswellia extract (BOIL), non-acidic Boswellia volatile oil fraction (BVOIL), and non-acidic Boswellia low polar gum resin extract fraction (BLPRE) from Boswellia serrata gum resin (Examples 1-3 and pages 9-12; instant claim 1). In the preparation of BOIL and BLPRE, the gum resin is extracted using a water immiscible organic solvent (Gokaraju, pages 9 and 10 and Examples 1 and 3; instant claim 8). Gokaraju recites hexane, chloroform, dichloromethane, ethyl acetate, and methyl isobutyl ketone as water-immiscible organic solvents (page 22, lines 8-10 from the bottom, and page 23 lines 4-6 from the top; instant claim 8). Gokaraju also recites under the heading “Synergistic compositions comprising Boswellia extracts” a composition comprising a Boswellia extract and α-mangostin: “Similarly, a composition (composition-34) containing low polar gum resin extract (BLPRE) in combination with [α]-mangostin offers better protection from neuronal damage (Table 6) and hence can improve brain health” (page 17, lines 4-9 from the top, see also Examples 41, 42, and 46 for Table 6; instant claim 1). It would be obvious to one of skill in the art to improve a composition comprising non-acidic Boswellia low polar gum resin extract fraction (BLPRE) by adding α-mangostin for a synergistic effect that benefits brain health, and therefore, cognitive functions (instant claim 1). The result of this improvement, offering protection from neuronal damage, would predictably improve the functions of the nervous system, including cognitive functions (instant claim 1).
Won recites a pharmaceutical composition and a health food composition comprising chebulanin for improving cognitive function or memory:
“The present invention relates to a composition for preventing or treating a cognitive impairment-related disease comprising chebulanin. Specifically, the present invention relates to a pharmaceutical composition, a health functional food composition and a feed composition for preventing or treating a cognitive impairment-related disease, and a health functional food for improving learning, cognitive function or memory comprising chebulanin or an acceptable salt thereof as an active ingredient; and a method of treating the cognitive impairment-related disease by using the pharmaceutical composition. The chebulanin prevents damages to cholinergic neurons and thus, can improve deteriorated cognitive function by exhibiting an inhibition effect with respect to acetylcholine esterase to maintain acetylcholine concentration in synapse. Therefore, the chebulanin according to the present invention can be useful in treatment of the cognitive impairment-related disease occurred by the damages to cholinergic neurons, improvement of learning, cognitive function and memory and the like” (Abstract; instant claims 1 and 6).
Won further recites the isolation of chebulanin from Terminalia chebula by means of methanolic extraction, filtering, lyophilization, solvent fractionation, and column chromatography (Example 1; instant claims 1 and 8). Wan is distinguished from instant claim 7 in that Wan does not explicitly recite extracting chebulanin from leaves, stems, tender stems, tender twigs, aerial parts, whole fruit, fruit rind, seed, root, bark, bulb, hardwood, gum resin or whole plant or mixtures thereof of the Terminalia chebula. However, one of skill in the art would have found a need to try different parts of the Terminalia chebula plant to prepare the composition for improving cognitive functions as recited by Wan. The leaves, stems, tender stems, tender twigs, aerial parts, whole fruit, fruit rind, seed, root, bark, bulb, hardwood, gum resin or whole plant or mixtures thereof comprise a finite number of plant materials to test for the extraction of chebulanin from Terminalia chebula. One of skill in the art could have pursued these potential solutions with a reasonable expectation of success given the method of isolating chebulanin recited by Wan in Example 1 (instant claim 7). Therefore, it would have been obvious to one of skill in the art to try preparing the composition recited in claim 1 using the leaves, stems, tender stems, tender twigs, aerial parts, whole fruit, fruit rind, seed, root, bark, bulb, hardwood, gum resin or whole plant or mixtures thereof of the Terminalia chebula plant (instant claim 7).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: all of the explicitly recited components of the composition of instant claim 1 are individually thought to possess activities that improve cognitive function, including memory. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also 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."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art”.
Gokaraju further recites capsule dosage forms for an invention encompassing the composition as instantly claimed in instant claims 1 and 5, and food and beverage forms as recited in instant claim 6:
“In yet another aspect, the invention provides use of therapeutically effective amount of BOIL, BVOIL or BLPRE alone or their compositions with one or more biological agents or Nootropic agents for administration in a specific dosage form such as orally, topically, transdermally, parenterally or in the form of a kit to a subject or patient in need thereof. Specific dosage form for formulation of the compositions of the present invention include but not limited to oral agents such as tablets, soft capsule, hard capsule, soft gel capsules, pills, granules, powders, emulsions, suspensions, syrups, pellets, food, beverages, concentrated shots, drops and the like; parenteral agents such as injections, intravenous drip and the like; suppositories; transdermal agents such as patches, topical creams and gel; ophthalmic agents and nasal agents” (page 24, third paragraph from the top, emphasis made by the examiner; instant claims 1, 5, and 6).
Gokaraju further recites an invention encompassing the composition as instantly claimed in claims 1, 3, and 4 comprising at least one at least one pharmaceutically/dietetically acceptable excipients/diluents, and recites microcrystalline cellulose as an excipient :
“In another embodiment the invention provides the composition comprising at least one Boswellia derived non-acidic extract/fraction in combination with at least one pharmaceutically/dietetically acceptable excipients/diluents, wherein said pharmaceutically or dietetically acceptable excipients, carriers, vehicles and diluents include but not limited to glucose, fructose, sucrose, maltose, lactose, yellow dextrin, white dextrin, silicon dioxide, microcrystalline cellulose powder, calcium stearate, magnesium stearate, sorbitol, stevioside, corn syrup, citric acid, tartaric acid, malic acid, succinic acid, lactic acid, L-ascorbic acid, dl-alpha-tocopherol, glycerin, propylene glycol, glycerin fatty ester, poly glycerin fatty ester, sucrose fatty ester, sorbitan fatty ester, propylene glycol fatty ester, acacia, carrageenan, casein, gelatin, pectin, agar, nicotinamide, calcium pantothenate, calcium salts, pigments, flavors, preservatives, distilled water, saline, aqueous glucose solution, alcohol, propylene glycol and polyethylene glycol, various animal and vegetable oils, white soft paraffin, paraffin and wax” (page 19, second paragraph from the top, emphasis made by the examiner; instant claims 1, 3, and 4).
The instant claims are distinguished from Gokaraju and Wan in that neither explicitly recite the synergistic herbal compositions comprising a first ingredient selected from the extract(s), fraction(s), phytochemical(s) and mixtures thereof derived from Terminalia chebula in combination with a second ingredient selected from the oil extract(s)/fraction(s) derived from Boswellia serrata gum resin, as claimed in claim 1, where in the weight of the first ingredient varies in the range of 10%-90% and the weight of the second ingredient varies in the range of 90% -10% in the composition (instant claim 9). However, these weight percents are obvious over routine optimization to one of skill in the art. One of skill in the art could vary these weight percentages by using a scale instrument to weight the ingredients of the instantly claimed composition before combining them to form the composition. One of skill in the art could test different compositions, with varying weight percents as recited in instant claim 9, on rats, and compare improvements in spatial learning and memory, as recited by Gokaraju in Example 49 (instant claim 9). Therefore, the weight percent limitations recited in instant claim 9 would be obvious to one of skill in the art over routine optimization.
Gokaraju and Wan are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the weight percents recited in instant claim 9, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the synergistic herbal compositions), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Gokaraju in view of Wan the invention as a whole, drawn to a synergistic herbal composition as described in Claims 1 and 9, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gokaraju (WO 2011114350 A2), and further in view of Won (KR 20200000048 A) as applied to claims 1 and 3-9 above, and further in view of Won (KR 20200000048 A); Se et al. (Biol. Pharm. Bull. 2014, 37 (7), 1207–1213), abbreviated "Se"; and Al-Harrasi et al. (PLoS One. 2018, 13 (6), e0198666), abbreviated "Al-Harrasi".
Claim 2 recites “The synergistic compositions as claimed in claim 1, wherein the compositions contain Terminalia chebula extract standardized to at least one compound selected from chebulagic acid, chebulinic acid, gallic acid and ellagic acid; and Boswellia serrata oil excluding boswellic acids, standardized to at least one compound selected from epi-a- amyrin, epi-β- amyrin and a-amyrin”. Claim 10 recites “The Synergistic herbal composition as claimed in claim 1, wherein the composition is standardized to at least one Terminalia chebula marker compound selected from gallic acid, ellagic acid, chebulagic acid, chebulinic acid and at least one Boswellia serrata gum resin marker compound selected from serratol, epi-a-amyrin, epi-β-amyrin and a-amyrin; wherein the markers of each of Terminalia chebula and Boswellia serrata gum resin in the composition is in the range of 0.1 to 50% by weight of the composition”.
Claims 1 and 3-9, and the teachings of the cited references Gokaraju and Won, are of record above.
It would be obvious to one of skill in the art to make a composition as recited in instant claim 1, standardized to compounds, or containing extracts standardized to compounds, that are known active ingredients for improving a cognitive function as recited in instant claim 1 (instant claims 2 and 10). Such standardization would improve the uniformity of the composition in terms of its activity, per unit weight, for achieving the intended biological effect of improving a cognitive function as recited in instant claim 1. One of skill in the art would have a reasonable expectation of success at standardization of these extracts by following the same processes for performing the extraction and analyzing the extraction using high performance liquid chromatography (HPLC). One of skill in the art could perform HPLC analysis of samples of extract, with an internal standard, to measure the concentration of the standardized compound(s) in the extract.
Se suggests alpha-amyrin having activity for ameliorating cognitive impairment: “The aim of the present study was to evaluate the effect of α- or β-amyrin, a type of pentacyclic triterpene, on the cognitive impairment induced by scopolamine, a muscarinic acetylcholine receptor antagonist. To measure the abilities of various types of learning and memory, we conducted step-through passive avoidance task. Scopolamine induced deficits in learning and memory processes in mice, which were antagonized by a single administration of α-amyrin (2 or 4 mg/kg) or β-amyrin (4 mg/kg), respectively. … Finally, the memory ameliorating effects of α- or β-amyrin on the scopolamine-induced cognitive impairments were significantly blocked by ERK inhibitor U0126. The present study suggests that α- and β-amyrin may ameliorate the cognitive impairment induced by hypocholinergic neurotransmission via the activation of ERK as well as GSK-3β signaling” (Abstract; instant claims 2 and 10). Al-Harrasi recites alpha-amyrin as a component of Boswellia serrata resin (Quantification of α-amyrin and BAs in different Boswellia tree parts and resins, Table 2). Alpha-amyrin, comprising 30 carbon atoms and only one heteroatom (oxygen), is a primarily non-polar organic compound, so one of skill in the art would have a reasonable expectation of success at extracting alpha amyrin from Boswellia serrata resin using a non-polar solvent such as hexane, and alpha-amyrin reasonably comprises an oil along with other low-polar, and nonpolar, compounds extracted from Boswellia serrata (instant claims 2 and 10). Therefore, it would be obvious to one of skill in the art to standardize Boswellia serrata oil (instant claim 2) or a composition comprising Boswellia serrata resin compound(s) (instant claim 10) to alpha-amyrin, as a suggested active ingredient for improving cognitive function (instant claims 2 and 10).
Won recites the importance of acetylcholine neurons for cognitive function and treating Alzheimer’s disease using inhibitors of acetylcholine degrading enzymes:
“Neurodegenerative disorders that cause progressive loss of cognitive function and memory, such as cognitive impairment, have a variety of causes, but one of them is known to be caused by damage to the acetylcholine neurons in the base of the cerebral base. Agonists for the muscarinic acetylcholine receptor that prevents the breakdown of choline and maintains acetylcholine levels at synapses, improving cognitive function, acetylcholine production promoters, and acetylcholine degrading enzymes. Depending on various mechanisms of action, such as acetylcholinesterase (AChE) inhibitors, drugs have been developed that can enhance the function of acetylcholine neurons. Indeed, the treatment of Alzheimer's disease currently used in various countries is the most of these inhibitors of acetylcholine degrading enzymes, such as tacrine (donrinezil) and donepezil (donepezil). In addition, rivastigmin and galatamine are used” (Background Art, paragraph 2).
Won recites ellagic acid inhibiting an acetylcholine degrading enzyme (Experimental Example 1); therefore, ellagic acid is reasonably an active ingredient for improving cognitive function. Won recites isolating ellagic acid from Terminalia chebula through methanolic extraction (Example 1: see 1-1, 1-2, and Experimental Example 1; instant claims 2 and 10). Therefore, it would be obvious to one of skill in the art to standardize a Terminalia chebula extract, or a composition comprising compounds from Terminalia chebula, to ellagic acid, as an active ingredient for improving cognitive function (instant claims 2 and 10).
The instant claims are distinguished from Gokaraju, Wan, Se, and Al-Harrasi in that markers of each of Terminalia chebula and Boswellia serrata gum resin in the composition are not recited in the weight percent range of 0.1 to 50% (instant claim 10). However, these weight percents are obvious over routine optimization to one of skill in the art. One of skill in the art could vary these weight percentages by using a scale instrument to weight the ingredients of the instantly claimed composition before combining them to form the composition. One of skill in the art could test different compositions, with varying weight percents as recited in instant claim 10, on rats, and compare improvements in spatial learning and memory, as recited by Gokaraju in Example 49 (instant claim 10). Therefore, the weight percent limitations recited in instant claim 10 would be obvious to one of skill in the art over routine optimization.
Gokaraju, Wan, Se, and Al-Harrasi are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the weight percents of markers of each of Terminalia chebula and Boswellia serrata gum resin in the composition recited in instant claim 10, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the synergistic herbal compositions), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Gokaraju in view of Wan, Se, and Al-Harrasi, the invention as a whole, drawn to a synergistic herbal composition as described in Claims 1 and 10, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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