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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on August 20, 2024 and January 24, 2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action. However, the non-patent literature document #1 in IDS from August 20, 2024 were lined through and not considered. The information disclosure statement filed August 20, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Election/Restrictions
Applicant’s election without traverse of Group I, claim(s) 1-17 and species election for claim 8 (quillaia extract) and claim 5 (omega-3) in the reply filed on April 15, 2026 are acknowledged. Group II, claim(s) 18-21 and group III, claim(s) 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1-8 and 11-17 are examined on the merits.
Specification
The abstract of the disclosure is objected to because it is not a single paragraph preferably within the range of 50 to 150 words in length. A corrected abstract of the disclosure within the preferred ranges disclosed is required. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 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.
Claim(s) 1-2, 5-8, 11-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noel (WO 2021092054 A1).
Regarding claim(s) 1-2, 5-8, 11-14 and 16, Noel teaches a water-miscible composition (paragraph 0059). Noel teaches that the composition can contain canola oil, corn oil [which is a poor water-soluble agent] (paragraph 0076). Noel teaches that the composition can further comprise suitable phospholipids ([that are also suitable surfactants and are poor water-soluble agents]) include, but are not limited to lecithin, including phosphatidylcholine (PC), phosphatidylethanolamine (PE) (paragraph 0225). Noel teaches that the composition can be formulated with any non-polar ingredient [such as] omega-3 fatty acids (paragraph 0082). Noel teaches the surfactant as a percentage (%) by weight, of the composition can be less than 10% (paragraph 0224). Noel teaches that the composition can comprise quillaia extract (paragraph 0142). Noel teaches that the composition can comprise a sugar fatty acid ester, a sucrose fatty acid ester [and] a phospholipid (paragraph 0221). Noel teaches [that] typically, non-polar ingredients are poorly water-soluble, for example, water insoluble or compounds having low water solubility. Exemplary non-polar ingredients include ingredients that contain one or more non-polar compounds, for example, lipid-soluble drugs, hormones, essential fatty acids, for example, polyunsaturated fatty acids (PUFA), for example, omega-3 and omega-6 fatty acids (paragraph 0082). Noel teaches that the composition can be formulated with any non-polar ingredient [such as] omega-3 fatty acids (paragraph 0082). Noel teaches [that] "poorly water-soluble" can be used to refer to compounds, for example, non-polar compounds, that are water insoluble or have low water solubility (paragraph 0085).
The Noel reference does not specifically teach that the composition comprises a first surfactant, a second surfactant and a third surfactant in general and a first surfactant, a second surfactant and a third surfactant that is present at about 1 wt% to about 3 wt%, 2 wt% to about 4 wt% and about 5 wt% to about 8 wt%, respectively. However, the Noel reference does teach that there can be more than one surfactant present within the composition, thus naturally, each surfactant within the composition would be labeled in numerical order in which they are deposited into the composition. In addition, the Noel reference teaches low water-soluble agents (e.g. canola oil or phospholipids), therefore, those low water-soluble agents would naturally have improved water solubility characteristics. Moreover, the Noel reference also teaches that the surfactant as a percentage by weight of the composition can be less than 10%, therefore, that would be sufficient to incorporate three surfactants that would not pass a total of 10%, which would be within range based on the limitations of the present invention.
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, 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.
Claim(s) 1-4, 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Noel (WO 2021092054 A1).
The teachings of Noel are above.
Regarding claim(s) 3-4, 15 and 17, Noel does not teach a total weight percentage of the one or more lipids is present at least about 5 wt%, a total weight percentage of the one or more lipids is present at about 10 wt% to about 50 wt%, a total weight percentage of the one or more low-water-soluble agents is present at least about 5 wt%, and that the composition has a pH value of about 5.5. However, as discussed in MPEP section 2144.05(II)(A), "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)." The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant's claimed invention.
One of ordinary skill in the art would reasonably expect to optimize the percentages of lipids and the one or more low water-soluble agents. In addition, one of ordinary skill within the field of analytical chemistry would reasonably expect that regardless of the ingredients chosen to compensate for the combination of the low water-soluble component(s) with surfactant(s), that would intrinsically produce a solution that would be of a pH value of around or up to 5.5 naturally. The aforementioned reference by Noel would create the ideal water-miscible composition as long as the composition specifically included ingredients that are satisfactory as a low water-soluble component and surfactant that can achieve the pH mentioned within the claims of the present invention, in which, that composition can safely be incorporated within food, drinks or nutritional supplements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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