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 without traverse of Group I, claims 63-66, 68, 71-79, 82-84, 86, 87, 89, 92 and 93, in reply filed on 02/09/2026 is acknowledged.
Claims 94-96, 98, 103, 104, 106, 110, 115, 121, 123-125, 127, 132, 133, 139, 144, 150, 152-155, 157, 162, 163, 165, 169, 174, and 180 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/07/2025.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 73, 75, 76, 79, 82-84, 86, 87, 89 and 93 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.
Regarding claims 73, 75, 82, 83, 84, 86, 87 and 89 the phrase "e.g.," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “formulated for topical administration” in claim 76 is a relative term which renders the claim indefinite. The term “formulated for topical administration” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base composition comprising a compound of an emblica or chebula extract and cosmetically or pharmaceutically acceptable vehicle one can deviate and still meet the requirement of the claim. For the purposes of examination the claim will be interpreted as: capable of being administered topically.
The term “formulated for parenteral of enteral” in claim 79 is a relative term which renders the claim indefinite. The term “formulated for parenteral or enteral” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base composition comprising a compound of an emblica or chebula extract and cosmetically or pharmaceutically acceptable vehicle one can deviate and still meet the requirement of the claim. For the purposes of examination the claim will be interpreted as: capable of being administered parenterally or enterally.
Regarding claim 87, the phrase "water/aqua (hydration)" renders the claim indefinite because it is unclear whether the limitation(s) “aqua (hydration)” are part of the claimed invention. See MPEP § 2173.05(d).
The term “formulated for administration in combination with” in claim 89 is a relative term which renders the claim indefinite. The term “formulated for administration in combination with” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base composition one can deviate and still meet the requirement of the claim. For the purposes of examination this will be interpreted as “capable of being administered in combination with”.
The term “fortified” in claim 93 is a relative term which renders the claim indefinite. The term “fortified” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base extract one can deviate and still meet the requirement of the claim. For the purposes of examination fortified will be interpreted to mean the composition further comprises an additional treatment agent.
Claim Rejections - 35 USC § 112 -- Improper Dependent Form
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.
Claims 66, 68, and 83 are 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 66 limits the compounds of 63 to be “derived from, purified from or isolated from an extract.” This fails to further limit claim 63 because the compounds of claim 63 are “compound constituent[s] of emblica extract, chebula extract”.
Claim 68 limits the compounds of 63 to be synthetic. This fails to further limits claim 63 because “[a] chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP2112.02 (II).
Claim 83 fails to further limit the claim from which it depends because a purified compound has the same chemical structure as a compound which is not purified. “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP2112.02 (II).
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 63-66, 68, 76, 83, 92 and 93 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (natural phenomenon) in the form of a composition comprising isolated compound constituent of emblica extract, chebula extract, a metabolite thereof or a compound having a similarity score of at least 95% of the compounds thereof without significantly more.
The claims are evaluated below using the “Subject Matter Eligibility Test for Products and Processes” flow chart as shown in MPEP § 2106 III.
Step 1: Are the claims to a process, machine, manufacture, or composition of matter?
Yes. Claim 63 is drawn to a composition.
Step 2A, Prong 1: Do the claims recite an abstract idea, law or nature, or natural phenomenon?
Yes. Claims 63-66, 68, 76, 83, 92 and 93 recite naturally occurring compounds from an extract of emblica or chebula. The MPEP states that “if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.” See MPEP 2106.04(c)(I). In the present case, instant claims fall under the product of nature exception because they claim a product that is naturally occurring, which by definition is directed to a naturally occurring product.
With respect to the claim 68, “[a] chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP2112.02 (II). Accordingly, a synthesized version of natural compound reads on the naturally occurring version of the same compound because the structure of the two compounds are the same.
With respect to claim 92, in order for a claimed product 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 naturally occurring counterpart. See MPEP 2106.04(c)(C). In the instant case there is no evidence the claimed concentrations provide characteristics that are not inherent, innate or an incidental change in the naturally occurring compounds when extracted from emblica or chebula.
Step 2A, Prong 2: Do the claims recite additional elements that integrate the judicial exception into a practical application?
No. The claims recite nothing more than a naturally occurring product. Therefore, the claims are not integrated into a practical application because there are no additional elements to demonstrate the claims are patent eligible.
Claim 92 is not integrated into a practical application because there is no indication the claimed concentration ranges change the naturally occurring compounds from emblica or chebula extract. See MPEP 2106.04(d).
Step 2B: Do the claims recite additional elements that amount to significantly more than the judicial exception?
No. Extracting naturally occurring products is well-understood, routine, and conventional.
The judicial exception is not integrated into a practical application because the additional elements, in this case the claimed concentrations, amount to simply the extracted natural product (e.g., emblicanin A). There is no indication that these concentrations meaningfully differentiate the claimed extracted compounds from their naturally occurring counterparts. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitations of specific concentration ranges read on conventionally extracted natural compounds of emblica extract or chebula extract and do not provide the composition with characteristics different than the naturally occurring counterparts. Therefore, claims 63-66, 68, 76, 83, 92 and 93 are drawn to ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1) Claims 63-66, 68, 76-78, 83, 86-87 and 89 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akhtar et al. (Journal of Pharmacy and Alternative Medicine, 2012, vol. 1, p. 32-37).
Akhtar discloses “hydroalcoholic Emblica officinalis fruit extract cream on human skin trans-epidermal water loss” [abstract]. According to Akhtar “Emblica officinalis contain a profile of potent antioxidants such as low molecular weight (<1000) hydrolyzable gallotannins comprising emblicanin A, emblicanin B, punigluconin and pedunculagin” [p. 35, last 3 lines of the third paragraph]. Akhtar also discloses that “Emblica fruit contains ascorbic acid (0.40%, w/w), and that the Ayurvedic method of processing enhances the healthy characteristics of the fruit thanks to a higher content of ascorbic acid (1.28%, w/w)” [p. 35, para. 3].
The prior art anticipates instant claim 63-66, 76-78, 86-87 and 89 because it discloses a cream for topical (parenteral) application (cosmetically acceptable vehicle) comprising emblica extract (Emblica officinalis) which includes emblicanin A, emblicanin B (i.e., ellagitannins; instant specification at p. 37, Table 1) and vitamin C (ascorbic acid). Wherein the composition comprises skin penetration enhancers (alcohols) and is formulated to be administered with vitamin C (ascorbic acid). The prior art anticipates instant claims 68 and 83 because “[a] chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP2112.02 (II).
2) Claims 63-66, 68, 76-79, 83, 86-87, 89 and 93 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh-Verma et al. (CA 1,334.578, publication date 02/28/1995; cited in IDS 04/02/2025), as evidenced by Chhabra et al. (Medicinal and Aromatic Plants Abstracts, Phytotherapy Research, 2017, p. 1463-1474; cited in IDS 04/02/2025).
Singh-Verma discloses an after shave lotion composition (i.e., instant claims 76-79) comprising ethanol (i.e., penetration enhancer; instant claims 86-87) chebula kernel oil (i.e., chebula extract; instant claim 93), and alma tincture [p. 6, lines 10-19]. According to Singh-Verma “the tincture derived from fruits, which may be processed either fresh or dried. Fresh amla fruits are rich in oleo resin, rubber, pectin and contain 0.415% of well stabilized ascorbic acid. In the dried condition at least 13 different polyphenols are distinguishable in the ethanolic extract, among them ethyl gallate, gallic acid (5%), trigallyl glucose, terchebin, corilagin, chebulinic acid, chebulaginous acid and chebulinin acid” (i.e., instant claim 65) [p. 3, lines 1-15].
Chebulinic acid is an elligatannin, as evidenced by Chhabra at the abstract.
The prior art anticipates the instant claims 63-66, 76-79, 86-87 and 93 because it discloses lotion for topical administration comprising a chebula extract fortified with chebulinic acid, an ellagitannin (treatment agent) and a penetration enhancer (ethanol). The prior art anticipates instant claims 68 and 83 because “[a] chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP2112.02 (II). The prior art anticipates instant claims 89 because a skill artisan would have expected it to be capable of being administered in combination with caffeine considering the prior art has substantially the same components.
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.
1) Claims 63-66, 68 89 76-79 and 92 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20170151297 A1, publication date 06/01/2017).
Regarding instant claims 63-66, 68 and 89, Cheng discloses a “a method for improving mitochondria in a cell, comprising step of treating the cell with an extraction of Emblica ojficinalis” [abstract]. According to Cheng “the extraction of Emblica ojficinalis includes 35% to 55% by weight of a mixture of Emblicanin-A and Emblicanin-B” [0030]. Cheng discloses the composition may also comprise starches (i.e., cosmetically acceptable vehicle1) [0043]. Finally, Cheng discloses the composition may further comprise an antioxidant (i.e., instant claim 89) [0044].
Emblicanin A and emblicanin B are ellagitannins according to the instant specification at page 37, Table 1.
The prior art does not anticipate the instant claims because it does not disclose one example or embodiment comprising a cosmetically or pharmaceutically acceptable vehicle.
However, given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, at the time of filling, to have selected and combined known components for their established functions with predictable results by following the teachings of Cheng. MPEP 2143 and 2144.06(I). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition comprising emblicanin A, emblicanin B (ellagitannins), a cosmetically acceptable vehicle (starch) and an antioxidant, i.e., wherein the composition is formulated to be administered in combination with an antioxidant. Instant claims 66, 68 and 83 read on the emblicanin A and emblicanin B of the prior art because “[a] chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP2112.02 (II).
Regarding instant claims 76-79, Cheng discloses the composition may comprise a gelatinizer [0044].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition taught be Cheng as a gel because Cheng discloses gelatinizer. One would have been motivated to and had an expectation of success in doing so because Cheng discloses gelatinizers are appropriate for the compositions disclosed therein.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the compositions taught by Cheng as a gel. According to instant claims 77 and 78 gels are suitable for topical (parenteral) administration. Therefore, the gel composition taught by Cheng would have been capable of being administered topically (parenterally).
Regarding instant claim 92, Cheng teaches the extracts comprise emblicanin A and emblicanin B [0030] and the extracts may be present in composition from about 20 ug/ml [p. 7, claim 2] to about 1200ug/ml [p. 7, claim 11].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition comprising emblicanin A or B within the instantly claimed amounts through routine optimization. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). A skilled artisan would have recognized that the concentration of the extract, and therefore the concentration of emblicanin A and emblicanin B, was a result effective variable because Cheng teaches they are the therapeutic agents. As such, one of ordinary skill in the art would have been motivated to optimize the amount of extract in the composition disclosed by Cheng to optimize the therapeutic effect. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the compositions disclosed by Cheng wherein the concentration of the compound constituents of the emblica extract fall within the instantly claimed range.
2) Claims 69, 71-73 and 86-87 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20170151297 A1, publication date 06/01/2017) as applied to claims 63-66, 68 89 76-79 and 92 above, and further in view of Wang et al. (Asian Journal of Pharmaceutical Sciences, 2017, vol. 12, p. 498-508).
Cheng, which is taught above, differs from the instant claims insofar as it does not teach a nanoparticles-based delivery carrier. The disclosed purpose of Cheng is “for improving ability of mitochondria to perform oxidative phosphorylation and synthesize adenosine triphosphate” [abstract].
Wang relates to nanopreparations for mitochondria targeting drug delivery system [title]. Wang discloses that “[t]overcome multiple barriers for targeting mitochondria, the researchers developed various pharmaceutical preparations such as liposomes, polymeric nanoparticles and inorganic nanoparticles modified by mitochondriotropic moieties like dequalinium (DQA), triphenylphosphonium (TPP), mitochondrial penetrating peptides (MPPs) and mitochondrial protein import machinery that allow specific targeting. The targeted formulations exhibited enhanced pharmacological effect and better therapeutic effect than their untargeted counterpart both in vitro and in vivo” [abstract]. In the examples, Wang teaches nanocarriers have particle sizes from about 40 nm to 400 nm (see Table 1 on page 504).
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the targeted nanocarriers of Wang with the mitochondrial affecting compositions of Cheng. One would have been motivated to combined these prior art elements because Wang discloses that delivering actives with targeted nanocarrier improves the therapeutic affect on the mitochondria, which is the purpose of Cheng. One would have had an expectation of success because the nanocarriers of Wang are specifically for therapeutic molecules targeting the mitochondria. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed particle size range of 50-5000 nm overlaps with the range of the prior art (40-400 nm) and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition taught by Cheng to comprise the Emblica officinalis extracts in nanoparticle-based delivery carrier (liposome) having a size within the instantly claimed range. Wherein the liposomes are functionalized with a mitochondrial targeting agent (triphenylphosphine (TPP)). Furthermore, liposomes are skin penetration enhancers according to instant claim 87 (i.e., instant claims 86-87).
3) Claims 74 and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20170151297 A1, publication date 06/01/2017) as applied to claims 63-66, 68 89 76-79 and 92 above, and further in view of Battogtokh et al. (Acta Pharm Sin B, 2018, v. 6, p. 862-880).
Cheng, which is taught above, differs from the instant claims insofar as it does not teach a mitochondrial targeting agent conjugated to the therapeutic agents. The disclosed purpose of Cheng is “for improving ability of mitochondria to perform oxidative phosphorylation and synthesize adenosine triphosphate” [abstract].
Battogtokh discloses “[m]itochondrial targeting is a promising approach for solving current issues in clinical application of chemotherapy and diagnosis of several disorders. Here, we discuss direct conjugation of mitochondrial-targeting moieties to anticancer drugs, antioxidants and sensor molecules. Among them, the most widely applied mitochondrial targeting moiety is triphenylphosphonium (TPP)” [abstract]. Battogtokh further discloses that “[d]irect conjugation of mitochondrial targeting moieties to anticancer drugs, antioxidants and sensors results in increased cytotoxicity, anti-oxidizing activity and sensing activity, respectively, compared with their non-targeting counterparts, especially in drug-resistant cells” [abstract].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have conjugated the mitochondrial affecting compounds of Cheng with the triphenylphosphonium (TPP) of Battogtokh. One would have been motivated to conjugate TPP with the compounds of Cheng because Battogtokh teaches that drug conjugates have the desirable effect of improved therapeutic effectiveness. One would have had a reasonable expectation of success because Battogtokh specifically discloses mitochondrial targeting conjugates and Cheng discloses therapeutic molecules to treat mitochondria. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the compositions of Cheng to provide a composition comprising the therapeutic molecules of the extracts conjugated with mitochondrial targeting agent that is a lipophilic cation (TPP).
4) Claims 79, 82 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20170151297 A1, publication date 06/01/2017) as applied to claims 63-66, 68 89 76-79 and 92 above, and further in view of Tu et al. (TW I728079B, publication date 10/01/2018; citing English machine translation) and Maderuelo et al. (European Journal of Pharmaceutical Sciences, 2019, vol. 138, 105019).
Cheng, which is taught above, differs from the instant claims insofar as it does not teach enteric delivery.
Tu discloses a teaches an emblica extract for improving the function of mitochondria [abstract]. According to Tu the composition may be formulated as a gel [p. 16, para. 2] or in a capsule [p. 16, para. 5].
Maderuelo relates to enteric coating of oral solid dosage forms as a tool to improve drug bioavailability [abstract]. Maderuelo discloses that “[t]here are numerous possible motivations for using enteric coating, including altering the odor or taste of the drug adding protection against environmental conditions (especially pH), the protection of gastric mucosa against the irritating action of some drugs or allowing for site or time specific drug release” [p. 2, col. 2, section 3, para. 1]. Additionally, Maderuelo discloses that in some cases enteric delivery improves bioavailability [p. 1, paragraph spanning columns 1 and 2].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the capsule of Tu and the enteric delivery of Maderuelo with the compositions of Cheng. One would have been motivated to do so for the reasons disclosed by Maderuelo, e.g., altering the odor or taste of the drug adding protection against environmental conditions (especially pH), the protection of gastric mucosa against the irritating action of some drugs or allowing for site or time specific drug release. One would have had a reasonable expectation of success because Tu discloses emblica extracts can be delivered in a capsule and Maderuelo discloses that enteric delivery may improve bioavailability. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the extract composition of Cheng in an enteric capsule. Enteric capsule is a form of controlled release, i.e., instant claim 84.
5) Claim 93 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20170151297 A1, publication date 06/01/2017) as applied to claims 63-66, 68 89 76-79 and 92 above, and further in view of Federoff et al. (WO 2020/227366 A1, publication date 11/12/2020).
Cheng, which is discussed above, differs from the instant claims insofar as it does not disclose an additional treatment agent. The disclosed purpose of Cheng is “for improving ability of mitochondria to perform oxidative phosphorylation and synthesize adenosine triphosphate” [abstract].
Federoff discloses a “treatment of age-related macular degeneration by administering a combination of fenofibrate and an esterase inhibitor (e.g., kaempferol or telmisartan)” [abstract]. Such a treatment includes a “method of increasing mitochondrial load in a retinal pigment epithelium (RPE) cybrid cell comprising contacting the cell with fenofibrate. In some embodiments, the method further comprises administering an esterase inhibitor (e.g., kaempferol or telmisartan) to the subject” [0010]. Federoff discloses that “fenofibrate drug: 1) regulated the mitochondrial biogenesis pathway, 2) improved mitochondrial function” [0115].
"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 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." MPEP 2144.06 (I).
In the present case it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the fenofibrate and kaempferol composition of Federoff with the emblica extract composition of Cheng because they were disclosed for the very same purpose, improving mitochondrial function. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the emblica extract composition of Cheng to further comprise a treatment agent (kaempferol; instant claim 65).
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 63-66, 68, 71-79, 82-84, 86-87, 89, 92, and 93 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-15, 17, 18, 20-36, 38-63 and 65 of copending Application No. 17/806,014 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims teach a “composition comprising an effective amount of isolated chebulinic acid, or a pharmaceutically acceptable form thereof, or one or more compounds having a similarity score of at least 95% with the isolated chebulinic acid, or a pharmaceutically acceptable form thereof” [claim 1]. The copending claims also disclose the same formulations as the instant claims at copending claims 17, 18, 38-38. Wherein the compositions of the copendng claims are used for the same purpose as the instant claims, i.e., mitochondrial function, and may comprise mitochondrial-targeting agent [claim 54].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Technological Background
The prior art made of record is considered pertinent to applicant's disclosure. Marto et al., Toxicology and Applied Pharmacology Volume 342, 1 March 2018, Pages 14-21. Marto is pertinent for teaching starch is a cosmetically acceptable vehicle at the abstract.
Conclusion
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
1 Marto et al., Toxicology and Applied Pharmacology Volume 342, 1 March 2018, Pages 14-21