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 .
Applicant’s election of Group II, claims 13-16, the therapeutic agent species of antibiotic, and the water soluble azide functionalized acrylate polymer species of claim 16, in the reply filed on 05/09/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-12, 17, and 18, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/09/2026.
Claim Status
Claims 1-18 are pending.
Claims 1-12, 17, and 18, are withdrawn.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the invention as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In the present instance, the drawings appear small, blurry, and in many cases, it is not possible to read the data presented in the figures.
Claim Objections
Claim 1 is objected to because of the following informalities: “water-soluble azide functionalized acrylate polymers have…” should read water-soluble azide functionalized acrylate polymers having…” The claim also recites “cyclic hydrocarbon hydrocarbon” in ln 12, and should be corrected to remove the repetitive “hydrocarbon” recitation. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “The aqueous formulation of any of claim 13” should “The aqueous formulation of claim 13,” where the claim only refers back to a single claim. Appropriate correction is required.
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 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Murthy et al (US 20190314506 A1, hereinafter “Murthy,” cited on IDS dated 11/17/2023), in view of Gao et al (US 20190256633 A1, hereinafter “Gao”) and Phelps et al (Adv Mater, 2012, 24(1): 64-2, pp. 1-12, hereinafter “Phelps”), as evidenced by Millipore Sigma (“Dibenzocyclooctyne-maleimide,” retrieved 2026).
Murthy teaches rapidly crosslinked polymer hydrogels that can be used in in vivo applications for the localized delivery of a therapeutic agent in aqueous solutions (abs). In embodiments, the polymer hydrogel can be a compound of Formula VI:
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R1 and R2 can each be independently hydrogen or a C1 to C6 hydrocarbon; R3 can be hydrogen or methyl; X can be —O, —S— or —NR5—; Z is —OR6, —SR6, or NR5R6; m can greater than or equal to 1; x can be an integer greater than zero and z can be zero or an integer greater than zero; R5 can be hydrogen or C1 to C6 hydrocarbon; R6 can be hydrogen, C1 to C6 hydrocarbon or a polyglycol chain of two to ten glycol units; Y1 and Y2 can each independently be —O—, —S—, or —NR4— wherein R4 can be hydrogen or a C1 to C6 hydrocarbon; and L can include a polyglycol (¶ 11). z is a non-zero integer (¶ 46). The polyglycol can be composed of 10-1000 glycol subunits, 10-100 glycol subunits, etc., which can vary depending on the application to which the polymer hydrogel is being applied (¶¶ 58, 61). The ratio of x to z is less then or equal to about 50:1, and can be greater than or equal to about 1:10 (¶ 46). The polyglycol can contain additional moieties that can allow further tailoring of the degradation or stability of the polymer hydrogel when used in a biological environment (¶ 59). The hydrogel crosslinks in less than 1 minute (¶ 64). Therapeutic agents can be included in the hydrogel, including antibiotics (¶¶ 65, 77). The compositions containing the polymer hydrogel can contain a substantial amount of water, as typical of hydrogels (¶ 69). The polymer hydrogels are tunable due to the different portions of the structure, sections can be varied including at least the polyglycol, varying the amount of crosslinking, varying the polyacrylate, etc. (¶ 70). With these tunable controls, the characteristics of polymer hydrogels can be changed to, for example, make the polymer hydrogel stiffer or more flexible, thereby matching the characteristics of the tissue to which it is being applied (¶ 70). Murthy teaches the invention is not limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings, and the invention is capable of other embodiments and of being practiced or carried out in various ways (¶ 21).
Murthy does not teach the dibenzocyclooctyne (DBCO) - maleimide group linked via dithiol.
Gao teaches DBCO-maleimide was a known crosslinker suitable for hydrogels taking place using non-radical, biorthogonal reactions such as copper free click chemistry (abs, ¶ 64). The linking chemistry between the monomers can be a maleimide-thiol reaction (¶ 65). As evidenced by Millipore Sigma, DBCO-maleimide comprises the structure:
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.
Additional teachings for maleimide-thiol hydrogel chemistry is provided by Phelps where it was known that maleimide crosslinked bioactive hydrogels exhibit improved reaction efficiency and wider range of Young’s moduli by utilizing maleimide cross-linking chemistry (abs). This hydrogel chemistry is advantageous for cell delivery due to the mild reaction that occurs rapidly enough for in situ delivery, while easily lending itself to “plug-and play” design variations (abs). The chemistry provides reaction time scales appropriate for clinical use for in situ gelation (pg 2 1st ¶). The maleimide reactive group is known for its fast reaction kinetics and high specificity for thiols at physiological pH (pg 2 1st ¶). The mass swelling ratio suggests that maleimide PEG gels over superior network-forming characteristics compared to vinylsulfone and acrylate (pg 4 1st ¶).
Regarding claims 13 and 16, it would have been obvious to modify the aqueous hydrogel formulation of Murthy, by substituting DBCO-maleimide with dithiol chemistry, for the DBCO comprising crosslinking member with polyethylene glycol of Murthy, where DBCO-maleimide was a known crosslinker suitable for linking polymeric hydrogels, as taught by Gao, as a matter of substituting equivalents known for the same purpose, and where Murthy teaches the hydrogels can be tuned in order to achieve desired strength, flexibility, etc. See MPEP 2143 (I)(B) and 2144.06 (II). Additionally, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. See MPEP 2144.09 (I).
Additional motivation is provided by Phelps, where it would have been obvious to select from hydrogel crosslinkers with maleimide-thiol chemistry, such as DBCO-maleimide as taught by Gao, where maleimide-thiol chemistry crosslinkers were known by Phelps to exhibit improved reaction efficiency, a wider range of Young’s moduli, fast reaction kinetics, high specificity for thiols at physiological pH, with good mass welling ratio compared to other known crosslinking chemistries, while easily lending itself to “plug-and-play” design variations; and where Murthy teaches rapid crosslinking is desired. Further, it would have been obvious for the skilled artisan to routinely optimize the hydrogel formulations in order to achieve desired properties, where Murthy teaches the crosslinking members can be tailored, and Phelps teaches maleimide containing crosslinkers can have plug-and-play design variations, in order to achieve desired hydrogel properties, crosslinking time, release kinetics, etc. See MPEP 2144.05(II)(A).
Regarding the n value, it would have been obvious to select from the range of 10-100, inclusive, as taught by Murthy, depending on the desired linker flexibility, pore size, etc. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding R1, R2, R3, X, Z, m, x, and z as instantly claimed, it would have been obvious to select from an ethyl group for R1 and R2 of Murthy; hydrogen for R3 of Murthy; O for X; OR6 for Z of Murthy, wherein R6 is a polyglycol chain of 4; an m value of 3; and x and z of Murthy as a non-zero integers, overlapping the claimed ranges, thereby appearing to arrive at the structure of claim 16 as elected by Applicants.
Regarding claim 14, it would have been obvious to further include a therapeutic agent to the aqueous composition, such as an antibiotic, as taught by Murthy, depending on the desired treatment.
Regarding claim 15, it would have been obvious to select from the range of 10-100 for n, as taught by Murthy, depending on the desired linker flexibility, pore size, etc., overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
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 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,039,831, hereinafter ‘831, in view of Gao et al (US 20190256633 A1, hereinafter “Gao”) and Phelps et al (Adv Mater, 2012, 24(1): 64-2, pp. 1-12, hereinafter “Phelps”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ’831 disclose polymer hydrogel comprising:
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The values for R1, R2, R3, X, Z, m, x, Y1, Y2, R5, and R6 overlap those instantly claimed. L comprises a polyglycol with 10-100 ethylene glycol units. The polymer hydrogel comprises water. The hydrogel further includes a therapeutic agent.
The claims of ‘831 do not disclose the DBCO-maleimide group with dithiol as instantly claimed.
Gao and Phelps are discussed above.
It would have been obvious to modify the hydrogel linkers of ‘831 with known linkers suitable for hydrogels, such as DBCO-maleimide with dithiol chemistry, for the same reasons discussed above by Gao and Phelps, thereby arriving at the instantly claimed hydrogel structure.
Claims 13-16 are also rejected over the following in view of Gao and Phelps based on the same reasoning:
U.S. Patent No. 11,253,597, hereinafter ‘597. The claims ‘597 disclose a polyacrylate azide with a crosslinker comprising two cyclooctynes linked to each other, but do not specifically teach the DBCO-maleimide linker with thiol chemistry. It would have been obvious to modify the claims of ‘597 to include DBCO-maleimide with thiol chemistry for the same reasons discussed above by Gao and Phelps.
U.S. Patent No. 11,707,526, hereinafter ‘526. The claims of ‘526 disclose a polyacrylate azide with a crosslinker comprising two cyclooctynes linked to each other, but do not specifically teach the DBCO-maleimide linker with thiol chemistry. It would have been obvious to modify the claims of ‘526 to include DBCO-maleimide with thiol chemistry for the same reasons discussed above by Gao and Phelps.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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