DETAILED ACTION
Status of Claims
Claims 1-8 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final
Claim Rejections – 35 U.S.C. § 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.
Claims 2 and 8 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 pre-AIA , that applicant regards as the invention.
A. Regarding claim 2, the use of “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase (i.e., “preferably between 5% and 40%, more preferably between 10% and 30%, and even more preferably between 15% and 25% by weight of Caralluma fimbriata”) are part of the claimed invention. It is noted that descriptions of examples and preferences are properly set forth in the specification rather than in a claim. See MPEP § 2173.05(c).
B. Claim 8 is drawn to:
8. Use of the composition, according to claim 1, wherein said composition is for weight and appetite reduction.
which is indefinite because it is unclear what method/process/product applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. “Use” claims additionally do not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. § 101 (process, machine, manufacture, or composition of matter). Please refer to MPEP § 2173.05(q).
Further clarification is required.
Claim Rejections – 35 U.S.C. § 102
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.
Claims 1-4 and 6-8 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by HEUER (US 2010/0124578 A1, Publ. May 20, 2010; on 11/08/2024 IDS; hereinafter, “Heuer”).
Heuer is directed to:
APPETITE-SUPPRESSING WEIGHT MANAGEMENT COMPOSITION
ABSTRACT
Compositions and related methods directed at supporting weight loss. Compositions combining at least one appetite suppressing ingredient with at least one other ingredient for maintaining or reducing body weight are provided. Additional embodiments provide for more than one ingredient with appetite suppressing activity combined with at least one other ingredient for maintaining or reducing body weight.
Heuer, title & abstract. In this regard, Heuer teaches a “capsule serving” containing “450 mg Green tea extract, (Camellia sinensis—leaf) and 10 mg Caralluma fimbriata extract (aerial parts)”:
Example 8
[0075] A composition for weight loss in individuals is provided as a serving of 3 liquid capsules to be taken twice daily prior to meal time. Each 3 capsule serving may comprise:
[0076] 450 mg Green tea extract, (Camellia sinensis—leaf) and 10 mg Caralluma fimbriata extract (aerial parts).
Heuer, par. [0075]-[0076], Ex. 8.
Regarding independent claim 1 and the requirements:
1. A dietary supplement composition comprising Caralluma fimbriata with at least one of the following ingredients: flaxseed, green tea, trivalent chromium, spirulina, hibiscus, psyllium, glucomannan, agar-agar, and chia seed.
Heuer clearly teaches a “capsule serving” containing “450 mg Green tea extract, (Camellia sinensis—leaf) and 10 mg Caralluma fimbriata extract (aerial parts)” (Heuer, par. [0075]-[0076], Ex. 8), WHEREBY it is noted:
“10 mg Caralluma fimbriata extract (aerial parts)” (Heuer, par. [0076], Ex. 8) reads on “Caralluma fimbriata” of claim 1; and
“450 mg Green tea extract, (Camellia sinensis—leaf)” (Heuer, par. [0076], Ex. 8) reads on “at least one of the following ingredients: […], green tea, […]” of claim 1.
Thus, Heuer anticipates claim 1.
Regarding claim x and the requirements:
2. The dietary supplement composition according to claim 1, wherein the said composition comprises between 1% and 50%, preferably between 5% and 40%, more preferably between 10% and 30%, and even more preferably between 15% and 25% by weight of Caralluma fimbriata.
Heuer teaches a “capsule serving” containing “450 mg Green tea extract, (Camellia sinensis—leaf) and 10 mg Caralluma fimbriata extract (aerial parts)” (Heuer, par. [0075]-[0076], Ex. 8), i.e., 10 mg Caralluma fimbriata extract of a total 460 mg dosage for about 2.17 wt.% Caralluma fimbriata extract. In this regard, it is noted that MPEP § 2131.03 states “[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is 'anticipated' if one of them is in the prior art.” Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)).
Thus, Heuer anticipates claim 2.
Regarding claims 3 and 8, it is noted that the requirements:
3. The dietary supplement composition, according to claim 1, wherein the said composition is for oral administration.
[…]
8. Use of the composition, according to claim 1, wherein said composition is for weight and appetite reduction.
are recitations of intended use. It is further noted that claim 8 is interpreted as a recitation of intended use for not reciting any active steps. In this regard, it is noted that recitations of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it reads on the claim. See MPEP § 2103 (I)(C)). Since Heuer teaches the structure for the composition of instant claim 1, then it reasonably follows that Heuer’s composition would be capable of performing the intended use.
Thus, Heuer anticipates claims 3 and 8.
Regarding claims 4 and 7 and the requirements:
4. The dietary supplement composition, according claim 1, wherein the said composition is provided in the form of a capsule or tablet.
[…]
7. A solid oral dosage form comprising the dietary supplement composition according to claim 1.
Heuer teaches a “capsule serving” containing “450 mg Green tea extract, (Camellia sinensis—leaf) and 10 mg Caralluma fimbriata extract (aerial parts)” (Heuer, par. [0075]-[0076], Ex. 8), which reads on a “capsule” of claim 4, and “solid oral dosage form” of claim 7.
Thus, Heuer anticipates claims 4 and 7.
Regarding claims 6, it is noted that the requirement:
6. The dietary supplement composition according to claim 4, wherein the said composition is configured to be administered at least once a day.
is a recitation of intended use. In this regard, it is noted that recitations of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it reads on the claim. See MPEP § 2103 (I)(C)). Since Heuer teaches the structure for the composition of instant claim 6, then it reasonably follows that Heuer’s composition would be capable of performing the intended use.
Thus, Heuer anticipates claim 6.
Claim Rejections – 35 U.S.C. § 103
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 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 pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 1-8 are rejected under 35 U.S.C. § 103 as being unpatentable over HEUER (US 2010/0124578 A1, Publ. May 20, 2010; on 11/08/2024 IDS; hereinafter, “Heuer”), in view of GRATTAN (WO 97/34585, Publ. Sep. 25, 1997; hereinafter, “Grattan”).
The teachings of Grattan, as set forth in the above rejection of claims 1-4 and 6-8 under 35 U.S.C. § 102 (a)(1) are hereby incorporated. Although Grattan teaches an “acceptable oral dosage form,” including “hard and soft capsules” (Heuer, par. [0019]), Grattan DOES NOT EXPRESSLY TEACH a particularly “hard gelatin capsule size 1” per the requirements of claim 5:
5. The dietary supplement composition according to claim 4, wherein the said composition is provided in the form of a hard gelatin capsule size 1.
Based on the state of the art, an artisan of ordinary skill would have found this feature obvious.
Grattan, for instance, is directed to
Title: TRANSPARENT HARD CAPSULES
Abstract
This invention relates to oral dosage forms comprising partially or wholly transparent hard-shelled capsules comprising particles which contain a beneficial agent suspended in a liquid vehicle. The preferred dosage forms comprise hard-shelled gelatin capsules.
Grattan, title & abstract. In this regard, Grattan teaches a claim embodiment drawn to a “hard-shell gelatin capsule”:
1. An oral dosage form comprising a partially or wholly transparent hard-shelled capsule containing a translucent or transparent pharmaceutically acceptable liquid vehicle and particles containing a beneficial agent which are suspended in the liquid vehicle and which are substantially insoluble in the liquid and wherein the particles are not so numerous as to fill completely the capsule.
2. An oral dosage form according to claim 1 wherein the hard-shelled capsule is a hard-shell gelatin capsule.
(Grattan, claims 1-2), and further discloses “hard gelatin capsule shells (size 1)” (Grattan, p. 8, ln. 22), which is a “hard gelatin capsule size 1” of claim 5.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to manufacture Heuer’s “capsule serving” (Heuer, par. [0075]-[0076], Ex. 8) as “hard gelatin capsule shells (size 1)” per Grattan (Grattan, p. 8, ln. 22). One would have been motivated to do so with a reasonable expectation of success since it is well within the skill of the ordinary artisan to select a suitable “acceptable oral dosage form,” from “hard and soft capsules” (Heuer, par. [0019]). Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results. See MPEP § 2144.07 stating that the selection of a known material based on its suitability for its intended use is prima facie obvious, which cites Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), wherein “Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.”
Thus, the prior art renders claim 5 obvious.
Conclusion
Claims 1-8 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611