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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-12, drawn to a liposome composition which, by weight percentage, comprises: 5.5%-50.5% fat-soluble active ingredient, 0.01%-0.1% piperine, optional 0.02%-0.05% antioxidant, 5%-25% phospholipid, 8%-75% cholesterol and 10%-20% modified starch, wherein, the modified starch is prepared by a method comprising the following steps: (1) in a supercritical carbon dioxide medium, starch is used as raw material, ethanol is used as an entrainer, and the reaction is carried out under supercritical CO2 conditions to obtain a pretreated product; (2) separating and purifying the pretreated product of step (1); (3) using the pretreated product obtained in step (2) to prepare modified starch; and (4) separating and purifying the modified starch prepared in step (3).
II. Claims 13-20, drawn to method for preparing the liposome composition according to claim 1, comprising the steps of:
1) preparing a fat-soluble nutrient-containing solution from phospholipid, cholesterol, fat-soluble nutrient, antioxidant, and absolute ethanol;
2) dissolving the modified starch in water to prepare an aqueous solution;
3) preparing a supercritical emulsion from the fat-soluble nutrient-containing solution of step 1) and the aqueous phase solution of step 2);
4) supercritical spray drying the supercritical emulsion of step 3) to obtain the liposome composition.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)).
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-7) in the reply filed on 6/22/26 is acknowledged via a telephone interview.
Claims 1-7 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II (claims 13-20), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/26.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed September 12, 2024. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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.
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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 106727441) in view Wang et al. (Food engineering Reviews (2021)13:570591, see IDS) and EP3421096.
With regards to instant claim 1, Liu teaches a composition comprising coenzyme Q from 1-20%, antioxidant 0.5-5% (see abstract); starch (see translation), fat-soluble vitamin E (see translation, as required by claim 4), piperine from 01-1% (see claim 1 and modified starch , see claim 1). Additionally teaches the antioxidant is from rosemary extract (as required by instant claims 6-7), soybean lecithin (example 1) in nanoparticles (see Example 1, as required by instant claims 8-9), wherein the particle size of the composition is 95 nm (as required by instant claims 9-11) and thus the encapsulation rate will be as recited by instant claim 12.
However Liu fails to teach instant claims 1 items 1-4) wherein the modified starch is prepared by the method recited in items 1-4 of claim 1.
Wang teaches with regards to instant claims 1, a method of supercritical carbon
dioxide (see title) wherein the modified starch is a starch alginates (see pg 575) such as
octenyl-succinate (see pgs 578- 579 as required by instant claim 2) carried out under
supercritical CO² condition wherein the cosolvent is ethanol (see pg 573) at a
temperature from 40-60° (as required by instant claim 5) and the condition includes
pressure, temperature, cosolvent addition (see pg 571, under Extraction) and pressure
from 33-205, see pg 574) wherein the ethanol is 25% from 0.5h (see pg 574) and the
starch is a modified starch).
EP3421096 teaches poorly water-soluble as coenzyme Q10, carotenoids, thus one of ordinary skill in the art would have been motivated to use a fat-soluble nutrient such as carotenoid as required by instant claim 3 with a reasonable expectation of success because the liposome composition as taught by the EP3421096 does teach comprising carotenoid, such as beta carotenoid, lycopene as required by instant claims 3,5 (see example 5), DHA, EPA as required by instant claim 5.
With regards to instant claim
Therefore it would have been obvious to one of ordinary skill in the art as MPEP 2143 states "when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." Therefore that the skilled artisan would have had reason to try these methods with a reasonable expectation that at least one would be successful.
It would have been obvious to one of ordinary skill in the art to combine the cited
prior art to result in the claimed invention. One would have been motivated to combine
these references and make the modification because they are drawn to same technical
fields (constituted with same ingredients and share common utilities, and pertinent to
the problem which applicant concerns about. MPEP 2141.01(a).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No. 12102106. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both sets of claims refer to a method of preparing method for preparing modified starch, comprising the steps of (1) in a supercritical carbon dioxide medium, starch is used as raw material, ethanol is used as an entrainer, and the reaction is carried out under supercritical CO.sub.2 conditions to obtain a pretreated product; (2) separating and purifying the pretreated product of step (1); (3) reacting the pretreated product obtained in step (2) with a chemical modifier to prepare modified starch; and (4) separating and purifying the modified starch prepared in step (3).
The steps of preparing is identical in both sets of claims. Therefore it would have been obvious to one of ordinary skill in the art to have used the method recited by the patented claims in view of Liu and Wang supra to result in the instant claimed invention with a reasonable expectation of success.
· In view of the foregoing, the patented claim 1 and the current claim 1 claims are obvious variations of each other..
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 6/22/26
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