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 .
All previous claims (claims 1-30) are cancelled.
Claims 31-38 are newly added, are pending, and are currently under consideration.
All previous Grounds of Rejection are withdrawn since all previously pending claims are cancelled. Applicant’s arguments directed to the previous grounds of rejection are not found persuasive since all said grounds are withdrawn since said claims are cancelled.
All rejections made herein are New Grounds since only newly added claims are pending in the Application.
New Grounds of Rejection – Necessitated by Amendment
Claim Rejections - 35 USC § 112
35 USC 112(a) or 35 USC 112(pre-AIA ), First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 38 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The response filed 09/25/2025 has introduced NEW MATTER into the claims.
Claim 38 recites “a step of adding a surfactant to the results of step (ii) is inserted between steps (ii) and (iii)”, which was not previously encompassed by the claims or the specification as originally filed. While surfactants are taught, the specific location of this steps was not taught.
35 USC 112(b) or 35 USC 112(pre-AIA ), Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 35, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 35 recites the broad recitation of “acetone, ethanol, dichloromethane, isopropyl alcohol,” the claim also recites “preferably from dichloromethane, ethanol and isopropyl alcohol” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 31-33 and 35-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims, as written, do not sufficiently distinguish over compositions comprising curcumin, chlorogenic acid, catechin, and an encapsulating agent (such as starch) as they exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed composition and the naturally occurring compositions. The claimed composition reads upon naturally occurring green coffee, green tea, and turmeric, which comprise chlorogenic acid, catechin, curcumin, and starch.
In the absence of the hand of man, naturally occurring compositions (e.g. green coffee, green tea, and turmeric) are considered non-statutory subject matter (Diamond v. Chakrabarty, 206 U.S.P.Q. 193 (1980)). It should be noted that the mere purity of a naturally occurring product does not necessarily impart patentability (Ex parte Siddiqui, 156 U.S.P.Q. 426 (1996)). However, when purification results in a new utility, patentability is considered (Merck Co. v. Chase Chemical Co., 273 F. Supp 68 (1967), 155 U.S.P.Q. 139, (District Court, New Jersey, 1967)). The examiner suggests narrowing the scope of claim 31 to include the limitations of claim 34 which require modified starch or maltodextrin which are not naturally occurring. See MPEP 2105.
Response to Arguments
It is noted that the prior ground of rejection was withdrawn in view of Applicant’s cancellation of all previously pending claims, and the New Ground of Rejection set forth above is being made in light of the Newly Added claims. Applicant’s statements in the Remarks are not found persuasive.
Applicant has not established that the process limitations result in a composition that is materially different from the components as they exist in nature. Applicant has not established what the improved bioavailability is compared with, Applicant has not established if the solvent or other method steps result in a different product with significantly more properties compared with said components as they exist in nature. Further, the scope of claim 31 is significantly broader from any examples or data provided in the specification of declaration of the Instant Application.
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.
Claim(s) 31-38 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Ling (US 2017/0157194) as evidenced by Onsando et al (2016).
Ling teaches a composition comprising 30-75% green tea extract, 20-55% turmeric extract, and 25% or 45% green coffee bean extract (see entire document, for instance, claim 1 and [0045]). It is noted that the instant Specification evidences that turmeric comprises curcumin and green tea comprises catechin. It is further noted that Onsando evidences that green tea comprises chlorogenic acid (see Onsando, Abstract) and the Instant Specification evidences that green coffee beans comprise chlorogenic acid (see Instant Specification, [0004]). The composition can be in the form of a tablet, capsule, pill, granule, etc. (see entire document, for instance, [0028]). The green tea extract, green coffee extract, and turmeric extract are taught as being mixed with a pharmaceutically acceptable stabilizer or excipient to form capsules, tablets, film-coated tablets, or injection fluids (see entire document, for instance, [0015]). It is noted that film-coated tablets and capsules are by definition encapsulated, and the materials included within a tablet or the solvent utilized in a suspension could be considered encapsulating components. Ling further teaches that the amount of excipient will depend on the quality of the active, and an excipient can perform more than one function (see entire document, for instance, [0020]). The composition can further comprise a pharmaceutically acceptable carrier (see entire document, for instance, claim 4). Ling additionally teaches the presence of fillers such as maltodextrin (see entire document, for instance, [0023]). Ling further teaches that surfactants can be present, such as Tween 80 (see entire document, for instance, [0026]).
It is noted that properties of a composition are necessarily present when the composition is present. For instance, the effect of the combination on bioavailability, the improvements in therapeutic or pharmacological effects, the potential uses of the composition, are all aspects that are necessarily present when the composition is present. It is noted that MPEP 2112.01 states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” It is further noted that optional ingredients are not required to be present.
Ling, while teaching the use of encapsulated compositions, does not directly teach the amount of the encapsulating agent. Ling further, while teaching the inclusion of excipients, does not directly state that an encapsulating agent are present.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to optimize the amount of the excipients present. One would have been motivated to do so since Ling directly states that the amount of the excipient employed depends on the active agent. There would be a reasonable expectation of success since excipients and solvents are conventionally utilized in the formation of tablets, capsules, pills, granules, and injection fluids. It is further noted that in the instant claims, the solvent is removed, therefore, the final product does not comprise the solvent.
With regard to the process limitations present in the product claims, MPEP 2113 states that "product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps", and “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant Application the prior art teaches a composition comprising the same elements, wherein Applicant has not established that the specific method steps result in a structurally different composition from the prior art of record.
Response to Arguments and Declaration
It is noted that the prior ground of rejection was withdrawn in view of Applicant’s cancellation of all previously pending claims, and the New Ground of Rejection set forth above is being made in light of the Newly Added claims. Applicant argue in the Remarks filed 09/25/2025 that Ling teaches green tea extract but not green coffee extract. Applicant’s argument is not found persuasive against the ground of rejection set forth above which directly cites Ling teaching green coffee extract. As such, Applicant’s argument is not found persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/TREVOR LOVE/Primary Examiner, Art Unit 1611