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/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 and 18 and the species elections: (a) polyethylene oxide segment as the hydrophilic polymer segment; (b) thiol group as the first reactive moiety; (c) sodium citrate as the stabilization agent; and (d) succinimide ester group as the second reactive moiety in the reply filed on 08/03/2026 is acknowledged.
Claims 15-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and claims 12 and 13 are withdrawn as being directed to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/03/2026.
Claims 1-11, 14, and 19 are under current examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 7, 10, 11, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Delany et al. (US 20210060183; publication date: 03/04/20221; cited in the IDS filed 10/15/2024) in view of Kumar et al. (Pharmaceutics 2022, 14, 70) and further in view of Hrabak WO 2021148063; publication date: 07/29/2021).
The claims are examined in view of the following species elections:
(a) polyethylene oxide segment as the hydrophilic polymer segment;
(b) thiol group as the first reactive moiety;
(c) sodium citrate as the stabilization agent; and
(d) succinimide ester group as the second reactive moiety
With regard to claims 1, 10, and 11, Delany discloses a multi-arm polymer (abstract) capable of forming a hydrogel either in vivo or ex vivo by crosslinking with a suitable crosslinking agent (0005, 0073). The multi-arm polymer comprises a reactive polymer having a plurality of polymer segments that in one embodiment are polyethylene oxide arms (elected species of polyethylene oxide segment) attached to a polyol core region (0055). The polymer arms have a reactive end group such as a N-hydroxysuccinimidyl ester that can covalently attached to a diagnostic group that is reactive with the reactive end group of the polyethylene oxide arms (0055). In certain embodiments, the reactive end groups may be nucleophilic groups selected from amine groups and/or thiol groups (0052). At para 0074 Delany teaches that in certain embodiments, the reactive multi-arm polymer may be crosslinked with a multifunctional compound having functional groups that are reactive with the reactive end groups of the multi-arm polymer. The respective reactive end groups of the reactive multi-arm polymer are nucleophilic groups or alternatively electrophilic groups and the functional groups of the multifunctional compound group correspondingly are electrophilic groups or alternatively nucleophilic groups, such that the multifunctional compound can bind to and crosslink the polymer arms. In particular embodiments, the functional groups of the multifunctional compound may be electrophilic groups selected from imidazole esters, imidazole carboxylates, benzotriazole esters, or imide esters, including N-hydroxysuccinimidyl esters (elected species of second reactive moiety, and a cyclic imide ester; limitation of instant claim 11; ). Functional groups of the polymer arms may be nucleophilic groups selected from amine groups and thiol groups (elected species of first reactive moiety; limitation of instant claim 11). The composition may contain further imaging agents such as gold nanoshells, which are taught to be NIR sensitive nanoparticles (0095).
Thus Delany teaches system for forming a hydrogel composition that comprises (a) a reactive polymer comprising a plurality of hydrophilic polymer segments and a plurality of first reactive moieties and (b) gold nanoparticles, wherein the system is configured to deliver the reactive polymer and the gold nanoparticles, wherein the hydrogel is formed by crosslinking between either electrophilic groups or nucleophilic groups on the polymer arms with corresponding nucleophilic or electrophilic groups, respectively, on a multifunctional compound having functional groups that are reactive with the reactive end groups of the multi-arm polymer; however, Delany does not disclose conditions such that covalent crosslinks are formed between the reactive polymer and the gold nanoparticles.
Kumar, in the analogous art of gold-polymer composites (title) teaches that gold nanoparticles can be functionalized with thiol groups (i.e. one of the nucleophilic groups suggested by Delany) and then bound to polymers (fig 2, page 4) and also teaches benefits of gold nanoparticle-containing hydrogels (page 19).
Hrabak, in the analogous art of metal-nanoparticle bound biomolecules, teaches that N-hydroxysuccinimide ester (NHS) functionalized gold nanoparticles were known and commercially available as of the instant effective filing date (page 13).
It would have been prima facie obvious to crosslink the Delany’s hydrogel-forming system using NHS-functionalized gold nanoparticles capable of binding thiol-end group containing PEG arms on the polymer segments. One having ordinary skill would have been motivated to do so in order to include the NIR reactive gold particles for NIR spectroscopy in a manner that simultaneously generates a hydrogel having the tunable properties noted by Hrabak. The skilled artisan would have had reasonable expectation of success because they would have recognized the NHS group as reactive to the thiol groups based on the description of this function in Delany and recognized NHS-functionalized gold nanoparticles as suitable multifunctional compounds (NIR sensitive and capable of crosslinking) per Delany’s invention.
With regard to claims 2 and 3, in certain beneficial embodiments, the polyol may contain two, three, four, five, six, seven, eight, nine, ten or more hydroxyl groups (0050). Thus, the polymer may contain at least as many polymer arms and plurality of first reactive moieties as hydroxyl groups in the polyol.
With regard to claim 3, the multitude of polymer segments may be reacted with a cyclic anhydride (0056).
With regard to claim 4, as noted above, the core comprises a polyol.
With regard to claim 5, as noted above, the polymer arms may be polyethylene oxide, which is a polyalkylene oxide.
With regard to claim 7, Delany teaches nanoparticles, i.e. particles whose dimensions can be measured in nanometers, therefore implicitly teaches a range that embraces the claimed range in longest gold nanoparticle dimension.
With regard to claim 14, Delany discloses that the system further comprises a delivery device (0029).
With regard to claim 19, it would have been obvious to form a hydrogel as this is one of the intentions taught by Delany and the compositions may contain radiocontrast groups (abstract) such as iodine (0008) which would make the hydrogel radiopaque.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Delany et al. (US 20210060183; publication date: 03/04/20221; cited in the IDS filed 10/15/2024) in view of Kumar et al. (Pharmaceutics 2022, 14, 70) and further in view of Hrabak WO 2021148063; publication date: 07/29/2021) as applied to claims 1-5, 7, 10, 11, 14, and 19 above, and further in view of Faure et al. (US 20050214376; publication date: 09/29/2005).
With regard to claim 6, The relevant disclosures of Delany, Kumar, and Hrabak are set forth above. None of these references disclose the number of repeat units in the PEG (i.e. polyethylene oxide) polymer.
Faure teaches that elasticity of a PEG-containing hydrogel may be modified by adjusting molecular weight of the PEG (0163). The examiner points out that the molecular weight of a polymer is a direct reflection of the number of monomers present.
It would have been prima facie obvious to one of ordinary skill to adjust the number of monomers of ethylene oxide in the PEG arms in Dulany’s hydrogel forming polymer as a means of optimizing the mechanical properties of the resulting hydrogel. See MPEP 2144.05(II)(A).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Delany et al. (US 20210060183; publication date: 03/04/20221; cited in the IDS filed 10/15/2024) in view of Kumar et al. (Pharmaceutics 2022, 14, 70) and further in view of Hrabak WO 2021148063; publication date: 07/29/2021) as applied to claims 1-5, 7, 10, 11, 14, and 19 above, and further in view of Mehtala et al. (Langmuir 2014, 30, 13727 – 13730).
With regard to claims 8 and 9, the relevant disclosures of Delany, Kumar, and Hrabak are set forth above. None of these references disclose the elected species, sodium citrate as a stabilizing agent for gold nanoparticles.
Mehtala teaches that citrate stabilizes gold nanorods (title, abstract) and used sodium citrate as the source of citrate ion (page 13727, right col, experimental section).
It would have been prima facie obvious to stabilize the gold nanoparticles taught by Delany with sodium citrate. The artisan of ordinary skill would have been motivated to do so in order to prevent aggregation of the particles, and had reasonable expectation of success because the citrate ion was known to provide such stability.
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 1-7, 10, 11, 14, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19177857 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the copending application embrace a hydrogel forming system comprising a hydrophilic polymer having a core that is a polyol and multiple arms formed from polyalkylene oxide crosslinkable with gold nanoparticles via a thiol on the polyalkylene oxide arm and a cyclic imide ester group on the gold nanoparticles, and a device.
Claims 8 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19177857 (reference application) as applied to claims 1-7, 10, 11, 14, and 19 above, and further in view of Mehtala et al. (Langmuir 2014, 30, 13727 – 13730).
With regard to claims 8 and 9, the relevant disclosures of Delany, Kumar, and Hrabak are set forth above. None of these references disclose the elected species, sodium citrate as a stabilizing agent for gold nanoparticles.
Mehtala teaches that citrate stabilizes gold nanorods (title, abstract) and used sodium citrate as the source of citrate ion (page 13727, right col, experimental section).
It would have been prima facie obvious to stabilize the gold nanoparticles taught by Delany with sodium citrate. The artisan of ordinary skill would have been motivated to do so in order to prevent aggregation of the particles, and had reasonable expectation of success because the citrate ion was known to provide such stability.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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