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 .
Status of the Claims
Claims 13, 22, and 26-47 have been canceled by preliminary amendment. Claims 1-12, 14-21, and 23-25 remain pending in the application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/6/24 and 3/3/26 have been considered by the examiner.
Claim Objections
Claim 20 is objected to because of the following informalities: multiple recitations of the word “vitamin” are improperly capitalized. Appropriate correction is required.
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 17-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 17, the parenthetical recitation of “(e.g. a probiotic)" renders the claim indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention and required by the genus of, in this case, the live organism item listed. See MPEP § 2173.05(d). Claims 18-20 are rejected since they depend from a rejected base claim 17.
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.
Claims 1-12, 14-21, and 23-25 provisionally are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19115705(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method for preparing a biodegradable microcapsule including steps of combining plant-based protein component(s) in a solvent system according to the same isoelectric point parameters, applying shear to form a slurry, facilitating a sol-gel transition, dispersing an active ingredient, and drying the composition to form a microcapsule. It is noted that instant step “b” of claim 1 is named in analogy in copending claim 3. Both sets of claims include crosslinking, slurry mixture phase, and drying steps using specified plant-based proteins and the same first and second o-solvent components. Both sets of claims encompass hydrogel formation, steps of applying shear to fragmentation, and similar reduction and drying parameters. Because these features are arranged differently in the claim structure, the rejection is made using obviousness rationale, however it is noted that the instantly claimed elements are all disclosed in the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-12, 14-16, 21, and 23-25 are not reasonably suggested by the nearest art. WO2020177881 is considered the nearest prior art for its teaching of a method of making a biodegradable microcapsule using a plant-based protein in a solvent system of miscible cosolvents and inducing a plant-based solution to undergo a sol-gel transition and subsequently drying and evaporating co-solvent to form a microcapsule. However, there is no sufficient teaching in the prior art for additionally utilizing shear treatment and dispersion steps as claimed in combination and in addition to the additional steps claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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