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 .
Response to Argument and Amendment
The response filed on 1/14/26 has been entered.
Applicant’s arguments filed 1/14/26 have been fully considered but they are not deemed to be persuasive.
Claims 1-2, 5-6, 9, 11, 19, 21, 30-31, 36, 86 and 104 are pending in this office action.
Claims 1-2, 5-6, 9, 11, 19, 21, 30-31, 36, 86 and 104 are pending and under examination in this office action. Claim 97 remain withdrawn.
Claim 86 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn due to the amendment to the claim.
The rejection of Claim(s) 1 under 35 U.S.C. 102(a2) as being anticipated by Halachmi et al. (WO 2020/089919) is withdrawn due to the amendment to the claim.
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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) 1-2, 5-6, 9, 11, 19, 21, 30-31, 36, 86 and 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobilka (US2018/0280913A1) in view of Clarke et al. (US 2007/0087049).
Kobilka teaches a first and second microcapsule (see 0005) linked to a polymer (see 0006)wherein the polymer is a copolymer (as required by instant claims 1, 5, see 0030) wherein the functional group is an allyl (see 0036, as required by instant claim 6) and further teaches that the multi-component comprises epoxy and or polyurethane (see 0023, as required by instant claims 9, 11, and 36), covalently linked (see 0006) wherein the to another (see 0019). With regards to instant claim 104, Kobilka teaches the first and second capsules comprises microcapsule (see 0006-0007). Although the claims recites adhesives as polyurethathane and epoxy, one of ordinary skill in the art would recognize that the characteristics of epoxy and polyurethane as a product does not change. Therefore the reference teaches the instant claims.
Additionally teaches the multicomponent comprises a pharmaceutically active product (see 0024, as required by instant claim 31). With regards to instant claim30, the shell material is a formaldehyde (see 0034)
However Kobilka fails to a further substance N3 and K3 (as required by instant claim 19.
Clarke with regards to instant claim 1, teaches a multi-component system comprising a plurality of drug substance (see abstract) first substance ie., having a linker between 2 capsules (see col. 7, lines 26-41), wherein the multi-component dosage form comprises a polymer which contains a drug substance (i.e., a pharmaceutically active), wherein the polymer is a copolymer (see 0061) and may have three capsule compartments (see 0010; 0014) with an adhesive (see 0018) comprising an adhesive (see 0018).
It would have been obvious to one of ordinary skill in the art to have expanded the teachings of Kobilka to include Clarke and modify the teachings of Kobilka to result in the instant claimed invention with a reasonable expectation of success because they cited references are both drawn to the same technical feature and therefore with modifying and or combining Kobilka with Clarke would have resulted in the instant claimed invention at the time the claimed was filed.
Applicant argues that Kobilka does not disclose, teach, or suggest the presently claimed two capsules K1 and K2 in a multi-component system either.
In response, this is found unpersuasive because Kobilka teaches that their catcapsule for self-healing is a microcapsule component comprising a first and second microcapsule. In arguendo if this is true, note that this is a rejection under USC 103 and the combination of the prior art should be considered in totality. It should be noted that Clarke teaches a multi-component system comprising a plurality of drug substance (see abstract) first substance ie., having a linker between 2 capsules (see col. 7, lines 26-41), wherein the multi-component dosage form comprises a polymer which contains a drug substance. One of ordinary skill in the art would have been motivated to incorporate the teachings of a multi-component taught by Clarke to result in the instant claimed invention.
Maintained 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 1-2, 5-6, 9, 11, 19, 21, 30-31, 36 and 86are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-2, of U.S. Patent Application No. 17598146. 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 multi-component system comprising a first substance and a second substance, wherein the multi-component system can be activated, wherein the first substance and the second substance are present. The current application claims anticipate the copending application claims are obvious variation as the first linker and the second linker are each independently a biopolymer, a protein, silk, a polysaccharide, a cellulose, a starch, a chitin, nucleic acid, a synthetic polymer, a homopolymer, a polyethylene (see instant claim 5 and copending claim 1).
· Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other. It would have been obvious to employ the copending claims in practicing the instant claimed invention with a reasonable expectation of success as the claims are drawn to the same technical feature.
In view of the foregoing, the copending application claims and the current application claims are obvious variations.
Applicant’s argument that the claims of do not recite a multi-component. In response , Claim 2 which depends from claim 1 recites the multi-component system according to claim 1, wherein a conductivity of the one or more first portions of substance is an electrical conductivitv and/or a thermal conductivity
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 3/10/26