Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
Applicants filed claims 1 – 13 with the instant application on 29 September 2023. Upon finalization and entry of the Restriction/Election Requirement (see below), claims 1 – 6 will be available for substantive examination.
Response to Restriction/Election
The Examiner acknowledges Applicants’ election, without traverse, of the invention of Group I, claims 1 – 6, in the Response filed on 8 October 2025. The Examiner further acknowledges Applicants’ election of the species, turmeric, from the genus defined as herbal extracts for further examination.
Claims 7 – 13 are hereby withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1 - 6 are under consideration to the extent that turmeric is the herbal extract.
Information Disclosure Statements
The Examiner has considered the Information Disclosure Statements (IDS’s) filed 25 September 2023, 31 January 2024, and 20 May 2025, which are now of record in the file.
Claim Issues
The Examiner notes that claim 1 is directed to a “capsule encapsulating an herbal extract.” The claim goes on to recite that the capsule comprises organic pullulan, an herbal extract, and a mixture of a plant-based oil and a plant-based lecithin. It is the Examiner’s position that one of ordinary skill in the art would recognize that capsule dosage forms typically comprise a capsule shell and a capsule fill. Claim 1 is logically and grammatically read to be directed to a capsule, but the wording of the claim does not indicate whether the recited components are part of the shell or the fill. In looking to Applicants’ specification, there is disclosure that can be reasonably read to indicate that the pullulan is a component of the shell (see, for example, ¶[0015] (referring to “a capsule portion”)), as well as disclosure directed to the lecithin/oil mixture being “included in the capsule” (see ¶[0016]). In a similar manner, the specification provides disclosure that is reasonably read to be directed to the extract being in the capsule (“capsule . . . filled with . . . extract” (see ¶[0021])). Although the specification provides a basis for interpreting the claims appropriately, the Examiner would suggest that, in the interests of clarity, Applicants amend the claims to more clearly reflect the difference between a “capsule” and the “contents” of the capsule, provided that the specification provides clear support for such amendments.
Rejections Pursuant to 35 U.S.C. § 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.
Claim 2 is rejected pursuant to 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The claim recites a limitation directed to the ratio between the plant-based oil and the plant-based lecithin being “about 4:1 to about 1:4.” No unit are recited for the quantities of oil and lecithin. Consequently, one of ordinary skill in the art would be uncertain whether the claimed range of ratios is based on mass amounts or volume amounts. Appropriate correction or cancelation is necessary.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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 – 6 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2022/0273520 A1 to Kato, N. and M. Honda, published 1 September 2022, and claiming priority to 2 August 2019, identified on the Information Disclosure Statement (IDS) filed 25 September 2023, cite no. 7 (USPATAPP) (“Kato ‘520”), in view of US 2017/0216146 A1 to Hutchison, K. and T. Takubo, published 3 August 2017 (“Hutchison ‘146), and US 2023/0372252 A1 to Fang, Q. and K. Sukuru, published 23 November 2023, claiming priority to 16 October 2020 (“Fang ‘252”).
The Invention As Claimed
Applicants claim an organic or plant-based cellulose derivative free capsule encapsulating turmeric, the capsule comprising organic pullulan, turmeric as a powder, or as an aqueous alcoholic extract, and a mixture of plant-based oil and a plant-based lecithin, wherein the viscosity of the mixture of turmeric and plant-based oil and plant-based lecithin has a viscosity of about 1000 to 2500 cP at 25°C, wherein the ratio of plant-based oil to plant-based lecithin is about 4:1 to about 1:4, wherein the capsule further comprises an excipient, wherein the excipient is carnauba wax, and wherein the herbal material is extracted using supercritical extraction.
The Teachings of the Cited Art
Kato ‘520 discloses a capsule formulation in which a film of the capsule contains a base and a component other than the base, the base being one or more of gelatin, cellulose compounds, polyvinyl alcohol, polyvinyl alcohol copolymers and pullulan, and the component other than the base is one or more of gelling agents, gelation aids, plasticizers, lubricants, metal sequestering agents, coloring agents, light-shielding agents, and residual moisture (see ¶[0022]; see also, ¶[0081]), wherein the capsule formulation further comprises cottonseed oil-soybean oil mixtures (see ¶[0073]), and lecithin (see ¶[0075]), and, wherein the capsule formulation is prepared by producing a capsule film and content is then filled into the capsule film, wherein the lubricant can be carnauba wax (see ¶[0076]), and wherein the fill of the capsule formulation can include herbs such as turmeric extract (see ¶[0088]). The reference does not explicitly disclose a capsule formulation wherein the fill, in addition to the one or more pharmaceutically active ingredients, comprises a mixture of plant-based lecithin and a plant-based oil, with the fill having a viscosity of about 1000 to 2500 cP at 25° C. The teachings of Hutchison ‘146 and Fang ‘252 remedy those deficiencies.
Hutchison ‘146 discloses a capsule fill formulation comprising an active ingredient and oil (see Abstract), wherein the oil comprises safflower oil, olive oil, soybean oil, linseed oil, rice germ oil, wheat germ oil, coconut oil, com oil, cottonseed oil, palm oil, palm nucleus oil, peanut oil, rapeseed oil, sesame oil, sunflower oil, almond oil, cashew oil, hazelnut oil, macadamia nut oil, mongongo oil, pecan oil, pine nut oil, pistachio oil, walnut oil, calabash seed oil, buffalo gourd oil, pumpkin seed oil, watermelon seed oil, acai berry extract, blackcurrant seed oil, borage seed oil, evening primrose oil, amaranth oil, apricot oil, apple seed oil, argan oil, artichoke oil, avocado oil, babassu oil, ben oil, cape chestnut oil, carob oil, cohune palm oil, coriander oil, dica oil, false flax oil, grape seed oil, hemp oil, kapok seed oil, lallemantia oil, marula oil, meadowfoam seed oil, mustard oil, okra seed oil (hibiscus oil), papaya oil, perilla oil, poppyseed oil, prune kernel oil, quinoa oil, ramtil oil, camellia oil, thistle oil, tomato oil, saw palmetto oil, lecithin, and combinations thereof (see ¶[0014]), wherein the amount of oil in the contents encapsulated in said the capsule is not less than 40% wgt (see ¶[0015]), wherein the active ingredient can include plant extracts (see ¶[0019]), wherein the plant extract is a turmeric extract (see ¶[0040]), wherein the lecithin in the oil is obtained from plants such as soy, rice, rapeseed, safflower, or the like (see ¶[0044]), and wherein the amount of oil with respect to all of the encapsulated content is included in an amount that can exert an expected degree of effect under given conditions (an active ingredient or the like, excipient, capsule, their capacity, or others), that amount ranging from 30 to 99.9% wgt, as can be determined by one skilled in the art according to the type of active ingredient and oil, with a higher amount of encapsulated oil being preferred (see ¶[0047]).
Fang ‘252 discloses a controlled-release fill composition for use in hard or soft capsules, the fill composition including an active pharmaceutical ingredient, and two controlled-release components, wherein one of the components is present in an amount of at least 21.5% wgt and the other is present at up to 65% wgt (see Abstract), wherein controlled release softgel capsules deliver drug substances over a prolonged period of time from 8 to 24 hours (see ¶[0004]), wherein the active pharmaceutical ingredient may comprise from about 1 to about 60% wgt of the fill composition (see ¶[0016]), wherein any pharmaceutically active ingredient may be used in the compositions (see ¶[0116]), including herbal supplement active agents, such as turmeric (see ¶[0130]), wherein the ratio of the controlled release components of the fill composition may be adjusted to attain a target release profile for the API, such as from about 10:1 to about 1:10 (see ¶[0145]), wherein the loadings of the controlled release, and other, components can be adjusted so that the fill composition has a viscosity in the range of 1000 cP to 100,000 cP at 20° C (see ¶[0152]), wherein the dry shell accounts for about 30 to about 60% wgt, based on the total weight of the filled soft capsule, and the fill composition accounts for about 40 to about 70% wgt, based on the total weight of the filled capsule (see ¶[0156]), wherein an advantage of non-gelatin soft capsules is that higher encapsulation temperatures of up to 70° C can be employed in the encapsulation step to ensure that the fill composition is sufficiently flowable to allow for high viscosity fills (see ¶[0158]), wherein the fill composition may comprise one or more optional ingredients including surfactants, plasticizers, and release rate controlling components, such as carnauba wax (see ¶[0163]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a capsule formulation in which a film of the capsule contains pullulan as a base, and a component other than the base, such as one or more of gelling agents, gelation aids, plasticizers, lubricants, metal sequestering agents, coloring agents, light-shielding agents, and residual moisture, wherein the lubricant is carnauba wax, wherein the capsule fill formulation further comprises cottonseed oil-soybean oil mixtures and lecithin, and wherein the fill of the capsule formulation includes herbs such as turmeric extract, as taught by Kato ‘520, wherein the capsule fill formulation comprises an active ingredient, such as turmeric extract and one or more oils, wherein the amount of oil in the fill composition of the capsule is not less than 40% wgt, wherein the lecithin in the oil is obtained from plants such as soy, rice, rapeseed, safflower, or the like, and wherein the amount of oil with respect to all of the encapsulated content is included in an amount that can exert an expected degree of effect under given conditions (an active ingredient or the like, excipient, capsule, their capacity, or others), that amount ranging from 30 to 99.9% wgt, as can be determined by one skilled in the art according to the type of active ingredient and type of oil, as taught by Hutchison ‘146, and wherein the fill composition includes at least two controlled-release components, wherein the active pharmaceutical ingredient, such as turmeric, may comprise from about 1 to about 60% wgt of the fill composition, wherein the ratio of the components of the fill composition may be adjusted to attain a target release profile for the API, wherein the loadings of the components of the fill composition can be adjusted so that the fill composition has a viscosity in the range of 1000 cP to 100,000 cP at 20° C, wherein an advantage of non-gelatin soft capsules is that higher encapsulation temperatures of up to 70° C can be employed in the encapsulation step to ensure that the fill composition is sufficiently flowable to allow for high viscosity fills, and wherein the fill composition includes carnauba wax, as taught by Fang ‘252. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Hutchison ‘146 and Fang ‘252 to the effect that inclusion of oil components in the fill composition can be adjusted to achieve optimal clinical results, and to achieve targeted fill composition viscosities.
With respect to the limitation recited in claim 1 directed to a range of viscosities of the capsule fill compositions, the Examiner notes that the cited references disclose a range of viscosities that encompasses the claimed range, rendering it obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
With respect to the limitation recited in claim 2 directed to the ratio between the oil and lecithin being about 4:1 to about 1:4, the Examiner notes that the cited references do not expressly disclose such ratios. However, the cited references disclose a range of relative mass content of the oil and lecithin component of the capsule fill compositions, and further disclose that the relative amounts of those components can be adjusted based on the identities of the oils and the active ingredient, as well as the desired clinical effect upon administration of the capsule dosage forms. Consequently, it is the Examiner’s position that adjustment of the relative mass loadings of the oil and the lecithin in the capsule fill compositions amounts to nothing more than an optimization of a result-effective variable, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
With respect to claim 6, it is the Examiner’s position that the limitations recited therein are directed to the process used to prepare the turmeric extract, and not to any structural or compositional properties of the capsule of the invention, rendering it a product-by-process claim, wherein the recited process steps do not serve to distinguish the claimed invention from the prior art. See MPEP § 2113:
Even though product-by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 6 would have been obvious within the meaning of 35 USC § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/-interviewpractice.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619