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 .
Status of Claims
Claims 1-14 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed December 04, 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) 1-14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Pawan et al. (Nanomaterials 2019, 9(2), 243 in view of Shikinaka et al. (JP 2021-017582) and Banerjee et al. (US 2017/0247493)
Pawan teaches self-assembly of lignin comprising bond linkages between the cellulose microfibrils wherein the bonds are beta linkages (see pg. 1, last para) and in some cases the bonds are designated as alpha, beta and gamma bonds (see pg. 2, 1st para) and has the property of self-aggregation (i.e., self-assembly as interpreted by the Examiner, see same) with a low molecular weight (see 2nd para pg. 60) as hollow nanoparticles (as required by instant claim 3).
However Pawan fails to teach that the assembly body is a lignin-saccharide complex, nonetheless, teaches carbohydrate polymers which can represent a polysaccharide. Although Pawan did not per-se teach the exact molecular weight, it is reasonable that one of ordinary skill in the art would use a low molecular weight in the recited range because 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 the skilled artisan would have had reason to try use a low molecular weight with the reasonable expectation that at least one would be successful.
Shikinaka teaches hollow spherical particles that is self-assembled body lignin comprising of beta-O-4 ether structure with a nanoparticle size of 30-40 nm which is less than 200 nm (see example 1 as required by instant claim 5) and therefore the negative zeta potential and if greater positive zeta (as required by instant claim 4).
With regards to instant claim 1, Banerjee teaches a hollow spherical particle (see 0052) that is self-assembled (see 0045) with bonds elf-aggregation and the complex formation with other carbohydrate polymers (cellulose, hemicelluloses, and pectin), which leads to the formation of lignin carbohydrates complexes (see introduction) and does teach with regards to instant claim 8, wherein the hollow spherical particle pharmaceutically important drugs (see 0059-0061) for drug delivery would have been obvious (see 0002) and therefore comprises an active agent 9as required by instant claim 7).
It would have been obvious to one of ordinary skill in the art to have combined the cited prior art to result in the instant claimed invention with a reasonable expectation because they 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)
And With regards to instant claim 2, the ratio is within the purview of the skilled artisan to determine based on the lignin-polysaccharide and the size of the active drug and therefore"[A] person of ordinary skill in the art has goodreason to pursue the known options within his or her technical grasp. If this leads to theanticipated success, it is likely the product not of innovation but of ordinary skill andcommon sense." KSR Intemational Co. v. Teleflex Inc., 82 USPQ2d 1385, 1390.
Claims 10-14 are rejected Again, it should be noted that “a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone”. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)
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 1-14 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 18 of U.S. Patent Application No. 18/853885. 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 hollow spherical particle that is a self-assembled body of a lignin. Both sets recite an ether bond between the lignin and polysaccharide with an overlapping molecular weight and particle size, same wavelength and active ingredients.
The compositions recited in the claims are obvious variation of each other.
· Therefore one of ordinary skill in the art would have used the cop ending application in practicing the instant claimed invention with a reasonable expectation of success.
In view of the foregoing, the copending application claims and the current application claims are obvious variations.
No claims are 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 9/2/26
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