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 .
DETAILED ACTION
Claims 1-20 are pending.
Election/Restrictions
Applicant’s election without traverse of the species of olive oil as the edible oil; lecithin and beeswax as the suspending and wetting agents; and an oil-soluble vitamin as the second active agent in the reply filed on 5/21/26 is acknowledged.
Claim 13 is withdrawn as not being directed to the elected species.
Claims 1-12 and 14-20 are under consideration to the extent that the composition comprises the elected species.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 2/28/24. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 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.
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 1-12 and 14-20 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 the applicant regards as the invention.
Claim 1 recites the limitation "the liquid fill material" in lines 8 and 9. There is insufficient antecedent basis for this limitation in the claim. Line 2 recites the phrase “a liquid fill composition”. Claims 2-12 and 14-20 are rejected as depending from and not clarifying claim 1.
Claim 7 recites the limitation "the liquid fill material" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, line 2 recites the phrase “a liquid fill composition”.
Claim 18 recites the limitation "the liquid fill material" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1, line 2 recites the phrase “a liquid fill composition”.
Claim Rejections - 35 USC § 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 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(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.
Claims 1, 5-12 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sang (CN 108403703 A; 2018) in view of Ndife et al. (US 2024/0373895).
Sang teaches soft capsules comprising vitamin D3 (i.e. an oil-soluble vitamin) and asparagus extract (i.e. herbal extract) (e.g. abstract). Sang teaches that the compositions improve the health of people by reducing obesity, diabetes, metabolic syndrome, osteoporosis, and tumour caused by vitamin D deficiency (e.g. page 9, step 5). Sang teaches that the fill composition comprises 25-45 parts olive oil, 0.4-3 parts beeswax (i.e. suspending agent) and 0.5-4 parts lecithin (i.e. wetting agent) (in a total of 0.9-7 parts) in an outer shell (e.g. claim 1), which overlaps with the claimed ranges. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Sang does not teach the inclusion of mineral acetate powder or apple cider vinegar powder. This is made up for by the teachings of Ndife et al.
Ndife et al. teach a supplement formulation containing vinegar and salts of acetic acid in various supplement delivery forms to deliver a meaningful amount of acetic acid to support health benefits such as healthy blood glucose, cholesterol, and weight levels (e.g. paragraph 0003). Ndife et al. teach that the supplements comprise apple cider vinegar powder and an acetate salt (e.g. claim 1). Ndife et al. teach that the acetate salt may be sodium, potassium, or dipotassium (i.e. does not contain disodium acetate) (e.g. claims 3, 4 and 7). Ndife et al. teach that the compositions further comprise vitamin D3 (e.g. Examples; claim 2).
Regarding Claims 1, 5, 6, 8, and 10-12, it would have been obvious to one of ordinary skill in the art at the time of filing to include the apple cider vinegar and acetate salts of Ndife et al. in the formulations of Sang. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions comprise vitamin D3 and are useful for the treatment of weight and diabetes, and one of ordinary skill would have been motivated in order to provide the health benefits of apple cider vinegar (Ndife paragraph 0007). In addition, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the formulations of Sang and Ndife into a single capsule. "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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding the concentration of acetate powder, calculating based on claim 2 of Ndife et al., the composition comprises about 14-42 wt% acetate salt, which overlaps with the claimed range. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I). In addition, in combining the compositions of Sang and Ndife et al., it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the acetate salt concentration through routine experimentation to arrive at the concentration of 0.2-30% in order to optimize the resulting product.
Regarding Claim 7, calculating based on claim 2 of Ndife et al., the composition comprises 0.001 wt% vitamin D3 and Sang teaches 25-45 wt% vitamin D3 (e.g. claim 1), which are below and above the claimed range respectively. However, in combining the compositions of Sang and Ndife et al., it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the vitamin D3 concentration through routine experimentation to arrive at the concentration of 0.2-10% in order to optimize the resulting product. In addition, Sang teaches the inclusion of 1-8 % of asparagus extract (herbal extract), which is within the claimed range.
Regarding Claim 9, Sang teaches that the fill composition comprises 0.4-3 parts beeswax (i.e. suspending agent) and 0.5-4 parts lecithin (i.e. wetting agent), which results in ratios which overlap the claimed value. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claim 14, Sang teaches that the capsule shell comprises gelatin and glyerol (i.e. plasticizer) (e.g. Claim 5).
Regarding Claim 15, Sang teaches that the fill composition comprises 25-45 parts olive oil, 0.4-3 parts beeswax (i.e. suspending agent) and 0.5-4 parts lecithin (i.e. wetting agent) (in a total of 0.9-7 parts), which overlaps with the claimed ranges. In addition, based on claim 2 of Ndife et al., the composition comprises about 14-42 wt% acetate salt. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claim 16, Sang teaches that the capsule shell comprises gelatin and glyerol (i.e. plasticizer) (e.g. Claim 5).
Regarding Claims 17 and 18, calculating based on claim 2 of Ndife et al., the composition comprises 0.001 wt% vitamin D3 and Sang teaches 25-45 wt% vitamin D3 (e.g. claim 1), which are below and above the claimed range respectively. However, in combining the compositions of Sang and Ndife et al., it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the vitamin D3 concentration through routine experimentation to arrive at the concentration of 0.2-10% in order to optimize the resulting product. In addition, Sang teaches the inclusion of 1-8 % of asparagus extract (herbal extract), which is within the claimed range.
Claims 2-4, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sang (CN 108403703 A; 2018) in view of Ndife et al. (US 2024/0373895) as applied to Claims 1, 5-12 and 14-18, and further in view of Bentz (US 2022/0249505).
Regarding Claims 1, 5-12 and 14-18, the teachings of Sang and Ndife et al. are described supra. Neither teaches that the mineral acetate powder is a blend of calcium acetate and zinc acetate. This is made up for by the teachings of Bentz.
Bentz teaches an appetite suppressant composition may comprise at least one anorectic active ingredient; at least one of a nutritive substance, a cofactor; and optionally, an excipient (e.g. abstract). Bentz teaches that the cofactor includes a mixture of calcium acetate and zinc acetate (e.g. paragraphs 0013, 0082; Claim 4).
Regarding Claims 2-4, 19 and 20, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the formulations of Sang, Ndife and Bentz into a single capsule. "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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In combining the formulations it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the calcium and zinc acetate concentrations through routine experimentation to arrive at the claimed concentrations of in order to optimize the resulting product. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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