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 .
Claims 1-30, 32-34, 37, and 38 are cancelled.
Claims 31, 35, and 36 are pending and are currently under consideration.
Withdrawn Rejections
The rejection of claim 38 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of Applicant’s cancellation of said claim.
The rejection of claim 35 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicant’s amendment to claim 35 removing the narrow limitation within the broader limitation.
The rejection of claims 31-33 and 35-38 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn in view of Applicant’s amendment to claim 31 incorporating the limitations of claim 34 which included elements that rendered the claims no longer a naturally occurring composition.
Rejections Maintained and Made Again in view of Applicant’s Amendments
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, 35, and 36 (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
Applicant argues in the Remarks filed 07/07/2026 that the prior art does not teach all of the instantly claimed method steps. It is noted that the instant claims are directed to a product, wherein Applicant has not established that a product comprising the same components, in the same orientation, and the same amounts would be structurally different from the instantly claimed composition.
Conclusion
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.
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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.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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