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 1-16 as filed January 29, 2025 are under consideration.
PIER Pilot
Applicant’s response filed July 31, 2026 opting to proceed with examination without amendment based on a review of the international phase work products is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 29, 2025 was not considered because the submitted document is blank. The IDS has been placed in the application file.
Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
The abstract of the disclosure is objected to because it is too short, because it is not a complete sentence, and because it is not in narrative form. Correction is required. See MPEP § 608.01(b).
Claim Objections
Claims 2-16 are objected to because of the following informalities:
Claim 2: “omega-3” should recite “omega-3 fatty acids” or some variation thereof consistent with paragraph [0007] of the instant specification.
Claim 2: “or” should be “and” in view of the usage of Markush language “selected from the group consisting of”. See MPEP 2173.05 (h) I Markush groups
Claims 3, 4, 7-10: the preamble should recite “The orodispersible tablet according to claim” consistent with claim 2. Alternatively, the preamble of all dependent claims should be the same.
Claims 5, 11-13: “a proportion” is properly “the proportion” because antecedent basis is implicit and “higher than proportion” is incomplete.
Claims 5, 6, 11-16: the second recitation of “phosphatidylcholine” should presumable reference “the disaccharide” consistent with paragraph [0023] of the instant specification.
Appropriate correction or/and clarification is required.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 112(b)
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 5, 6 and 11-16 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.
Claims 5 and 11-13 recite a proportion by weight of phosphatidylcholine is at least 50% higher than proportion by weight of phosphatidylcholine. Because it is impossible for the amount of PC to be anything other than the amount of PC (e.g., the amount of PC is necessarily 100% the amount of PC), it is unclear how to interpret an amount of PC that differs from the amount of PC as claimed. Claims 6 and 14-16 are included in this rejection because they independently depend from claims 5 and 11-13, respectively, and because they recite the nonsensical limitation that the proportion by weight of phosphatidylcholine is at least twice the proportion by weight of phosphatidylcholine.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-7, 11, 12, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikehara et al. (US 2009/0004170, published January 1, 2009).
Regarding claims 1, 2
Ikehara teaches compositions superior in water-dispersibility (orodispersible) and tabletability comprising coenzyme Q10 (ubiquinone), a saccharide inclusive of a disaccharide, and a surfactant inclusive of lecithin (phosphatidylcholine) (title; abstract; claims; paragraph [0002]). The compositions can be utilized as a nutritional supplement (abstract). Ikehara teaches tablets (paragraph [0060]).
Regarding claims 3, 7
Ikehara teaches disaccharides such as trehalose (paragraph [0021]).
Regarding claims 5, 6, 11, 12, 14, 15
Ikehara teaches 0.1 to 20 wt% of surfactants inclusive of lecithin (claims 2, 6). The lecithin is necessarily 100 wt% of the lecithin (see rejection under 112(b) supra).
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Riva et al. (WO 2023/148670, filed February 3, 2023 and claiming priority to February 7, 2022).
Regarding claims 1, 4
Riva teaches compositions in the form of oro-dispersible tablets comprising quercetin (active), a phospholipid inclusive of sunflower lecithin (phosphatidylcholine) and a water very soluble carrier selected from disaccharides (title; abstract; claims, in particular 1-3, 5, 6).
Regarding the recitation for use as a food supplement, a recitation of the intended use of the claimed invention 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 meets the claim. See MPEP 2111.02.
The above teachings therefore anticipate the claims.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ikehara et al. (US 2009/0004170, published January 1, 2009) in view of Kaspar et al. (US 2015/0011515, published January 8, 2015).
Ikehara is also applied herewith under a different interpretation of the ratio of claims 5, 6, 11-16 in the interest of compact prosecution
The teachings of Ikehara have been described supra with regard to the anticipation of claims 1-3, 5-7, 11, 12, 14 and 15. Claims 1-3, 5-7, 11, 12, 14 and 15 are therefore also obvious over Ikehara.
Ikehara teaches 0.1 to 20 wt% of surfactants inclusive of lecithin (claims 2, 6). The lecithin is necessarily 100 wt% of the lecithin (see rejection under 112(b) supra), as required by instant claims 13, 16.
Ikehara further teaches 5 to 89 wt% of saccharides inclusive of disaccharides inclusive of trehalose (claims 1, 5; paragraph [0021]).
Ikehara further teaches lecithins include egg-yolk lecithin and soybean lecithin (paragraph [0031]).
Ikehara does not specifically teach sunflower lecithin as required by claims 4, 8-10.
This deficiency is made up for in the teachings of Kaspar.
Kaspar teaches emulsions comprising an emulsifier inclusive of egg lecithin, soya lecithin and sunflower oil lecithin (title; abstract; claims, in particular 1, 10; paragraph [0084]), as required by instant claims 4, 8-10.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute emulsifiers inclusive of sunflower oil lecithin as taught by Kaspar for the lecithin surfactants of the compositions of Ikehara because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary.
Regarding claims 5, 6, 11-16 which recite the PC is at least 50% higher, is at least twice (200%) the PC, presuming these claims are intended to recite the PC relative to the disaccharide consistent with paragraph [0023] of the instant specification, Ikehara renders obvious ratios ranging from 0.1/89 to 20/5 which overlaps the ratios instantly claimed, sufficient for prima facie obviousness. See MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yu (CN 101444273 B, as evidenced by the Google translation) teaches health product oral fast-release products comprising a health raw material, an oily dispersant inclusive of lecithin and a water-soluble dispersant inclusive of trehalose (title; abstract; claims; page 5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
