DETAILED ACTION
The papers submitted on 02 February 2026, amending claim 1, replacing the drawings, and adding claims 11-20, are acknowledged.
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 .
Drawings
The drawings were received on 02 February 2026. These drawings are acceptable.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,017,389. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Claim 1 is clearly anticipated by claim 1, 13 and 15 of US 12,017,389.
Claim 2 is clearly anticipated by claim 2 of US 12,017,389.
Claim 3 is clearly anticipated by claim 3 of US 12,017,389.
Claim 4 is clearly anticipated by claim 4 of US 12,017,389.
Claim 5 is clearly anticipated by claim 5 of US 12,017,389.
Claim 6 is clearly anticipated by claim 6 of US 12,017,389.
Claim 7 is clearly anticipated by claim 7 of US 12,017,389.
Claim 8 is clearly anticipated by claim 8 of US 12,017,389.
Claim 9 is clearly anticipated by claim 1 of US 12,017,389.
Claim 10 is clearly anticipated by claim 9 of US 12,017,389.
Claim 11 is clearly anticipated by claim 14 of US 12,017,389.
Claim 12 is clearly anticipated by claim 16 of US 12,017,389.
Claim 13 is clearly anticipated by claim 18 of US 12,017,389.
Claim 14 is clearly anticipated by claim 19 of US 12,017,389.
Claim 15 is clearly anticipated by claim 20 of US 12,017,389.
Claim 16 is clearly anticipated by claim 21 of US 12,017,389.
Claim 17 is suggested at 10:11+, 37:22+ of US 12,017,389.
Claim 18 is anticipated by claim 7-11 and suggested at 19:26+, 22:32+ of US 12,017,389.
Claim 19 is anticipated by claim 8 and suggested at 2:34+ of US 12,017,389.
Claim 20 is suggested at 16:13+ of US 12,017,389.
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.
Claims 1-3, 7-8, 10, 12-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Illeperuma et al. (US 10,975,205 B2) in view of Laferrière et al. (Syntheses of Water-Soluble Polyacrylamide-Containing Sialic Acid) and Freiburg et al. (US 2016/0242736 A1).
Regarding claim 1, Illeperuma discloses a method of manufacturing a hydrogel (title/abstract), the method comprising:
(a) forming a staged solution by adding together a stock solution comprising acrylamide, equated with the claimed monomer and alginate, equated with the claimed polymer, in water (10:45-53, 12:53-56) and a primed solution comprising a compound for cross-linking the alginate and acrylamide (e.g. N,N-methylenebisacrylamide), equated with the claimed covalent crosslinking agent, and an accelerator compound for the acrylamide (e.g. N,N,N′,N′-tetramethylethylenediamine), equated with the claimed catalyst, (10:54-11:9, 12:56-13:3);
(b) forming a gel-sol by mixing the staged solution with an initiator for the acrylamide (e.g., an ammonium persulfate photo-initiator), equated with the first network activator solution comprising a monomer activator, and an ionic cross-linking compound for the alginate (e.g., calcium sulfate dihydrate CaSO4·2H2O), equated with a second network activator solution comprising a polymer activator (10:54-11:9, 12:56-13:3);
(c) dispensing the gel-sol into a mold; and
(d) curing the gel-sol in the mold forming a semi-rigid hydrogel (7:7+, 11:10+, 13:4+).
Illeperuma does not appear to expressly disclose deoxygenated water, an inert atmosphere, or a semi-rigid acoustic couplant.
However, Laferrière discloses a similar acrylamide-based glycopolymers (pp. 271-272; § Introduction) by dissolving α-sialoside monomers and acrylamide in deoxygenated water in an inert nitrogen atmosphere (pp.277-279; § Syntheses of Glycopolymers).
At the time of invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the process of Illeperuma to include the deoxygenated water and inert atmosphere, in order to prevent oxygen contamination during the gel-sol synthesis.
Further, Freiburg discloses an acoustic signal transmission couplants (title/abstract) made from similar semi-rigid polyacrylamides and/or alginates (¶¶ 40, 76)
At the time of invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the process of Illeperuma to form the acoustic signal transmission couplants of Freiburg, because such intended uses are known in the art and could be made with expected results.
Regarding claim 2, Illeperuma suggest preparing the hydrogels at room temperature, e.g. 20-25° C. (6:52+), and Laferrière suggests mixing at room temperature (p. 279 § Syntheses of Glycopolymers).
Regarding claim 3, Illeperuma and Laferrière suggests room temperature preparation. Although they do not explicitly suggests adding the first and/or second network activators at temperatures of 15° C., the skilled artisan would find it prima facie obvious to adjust the temperature to about 15° C. in the course of ordinary experimentation in order to enhance the stability of the persulfate and dihydrate activator.
Regarding claim 7, Laferrière suggests heating prior to curing or adding more initiator and heating if curing is incomplete (p. 279 § Syntheses of Glycopolymers). Freiburg discloses freeze-thaw cycling in the range of -40° C. to 70° C. during cross-linking (¶¶ 101-107).
Regarding claim 8, Illeperuma suggests illuminating with UV light during curing (11:10+, 13:4+). Freiburg suggests curing with ultraviolet light or irradiation (¶¶ 101+).
Regarding claim 10, Illeperuma suggests sealing the hydrogels after formation (4:47+, 11:22+); the skilled artisan would recognize that it would be prima facie obvious maintain the inert atmosphere during sealing, in order to prevent oxygen contamination during the gel-sol synthesis.
Regarding claim 12, Illeperuma discloses an the copolymer is an alginate (10:45-53, 12:53-56); Freiburg discloses the copolymer is and alginate such as sodium alginate (¶ 100).
Regarding claim 13, Illeperuma discloses the covalent crosslinking agent includes an acrylamide, such as N',N'-methylenebisacrylamide (10:54-11:9, 12:56-13:3).
Regarding claim 14, Illeperuma and Laferrière disclose the catalyst is N,N,N',N'-tetramethylethylenediamine (Illeperuma 10:54-11:9, 12:56-13:3; Laferrière p. 279).
Regarding claim 15, Illeperuma and Laferrière discloses the monomer activator is ammonium persulfate (Illeperuma 10:54-11:9, 12:56-13:3; Laferrière p. 277).
Regarding claim 16, Illeperuma discloses the polymer activator includes a block copolymer activator comprising calcium sulfate (10:54-11:9, 12:56-13:3).
Regarding claim 18, Laferrière suggests heating prior to curing or adding more initiator and heating if curing is incomplete (p. 279 § Syntheses of Glycopolymers). Illeperuma suggests sealing the hydrogels after formation (4:47+, 11:22+); the skilled artisan would recognize that it would be prima facie obvious maintain the inert atmosphere during sealing, in order to prevent oxygen contamination during the gel-sol synthesis. Illeperuma suggests packing the hydrogel and shipping (4:47+, 6:64+).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Illeperuma et al. (US 10,975,205 B2) in view of Laferrière et al. (Syntheses of Water-Soluble Polyacrylamide-Containing Sialic Acid) and Freiburg et al. (US 2016/0242736 A1) as applied to claim 1 above, further in view of Alpenfels et al. (US 5,753,095 A).
Illeperuma does not appear to expressly disclose that the mold material is metal or plastic.
However, Alpenfels discloses an improved mold for polyacrylamide gels (1:47+) which are made from plastics formed by injection molding (4:43+, 8:54+) such as polyethylene terephthalate, polyvinyl chloride, polycarbonate, polymethyl-methacrylate, polystyrene, polyethylene, polypropylene and cellulose acetates or any of their various co-polymers (5:18+).
At the time of invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the mold of Illeperuma to include the injection molded plastics of Alpenfels, because such materials are known in the art and could replace the mold materials with expected results.
Claim 9, and 19-20 is rejected under 35 U.S.C. 103 as being unpatentable over Illeperuma et al. (US 10,975,205 B2) in view of Laferrière et al. (Syntheses of Water-Soluble Polyacrylamide-Containing Sialic Acid) and Freiburg et al. (US 2016/0242736 A1) as applied to claim 1 above, further in view of Rau et al. (US 8,986,609 B2).
Illeperuma discloses post-cure processing (11:18+). Laferrière discloses checking cure amount and residual monomer content and further rinsing (p. 279).
Illeperuma does not appear to explicitly disclose sterilizing, accelerate curing or reducing monomers.
However, Rau discloses a method for sterilizing acrylamide hydrogels by irradiation with with UV or gamma rays (title/abstract, 3:54+, 4:33+, 7:31+).
At the time of invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the process of Rau to include the sterilization of Rau, in order to ensure the hydrogels are decontaminated and able to be used in medical applications such as the ultrasound process of Freiburg.
Claim 11 rejected under 35 U.S.C. 103 as being unpatentable over Illeperuma et al. (US 10,975,205 B2) in view of Laferrière et al. (Syntheses of Water-Soluble Polyacrylamide-Containing Sialic Acid) and Freiburg et al. (US 2016/0242736 A1) as applied to claim 1 above, further in view of Zheng et al. (US 10,336,896 B2).
Illeperuma does not appear to expressly disclose dimethylacrylamide.
However, Zheng discloses a similar hydrogel (title/abstract) which includes N,N’-dimethylacrylamide monomer (7:21+).
At the time of invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the process of Illeperuma to include the dimethylacrylamide of Zheng, because such alternative materials can be substitute with expected results and are suitable for the same intended purpose.
Allowable Subject Matter
Claim 17 would be allowable except for the double patenting rejection(s) set forth in this Office action including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art taken either singularly or in combination fails to anticipate or fairly suggest the limitations of the independent claims, in such a manner that a rejection under 35 U.S.C. §102 or §103 would be proper. Specifically, the closest prior art does not suggest the newly claimed steps for forming the staged solution, including preparing the first and second solutions, filtering the first solution, adding the second solution to the filtered first solution to form a stock solution and mixing the stock solution with the primed solution to form the staged solution.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Benjamin A Schiffman whose telephone number is (571)270-7626. The examiner can normally be reached M-F 9a-530p EST.
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/BENJAMIN A SCHIFFMAN/ Primary Examiner, Art Unit 1742
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