CTNF 18/572,454 CTNF 91704 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. This action is responsive to Applicant’s amendment/remarks filed 04/27/2026 and response to election/restriction filed 12/29/2025. It is noted the prior response to election/restriction has been reiterated in the present amendment/remarks. Claims 43-50 are currently pending. The Drawings filed 12/20/2023 are approved by the examiner. The IDS filed 12/20/2023 has been considered. An initialed copy accompanies this action. 06-49-06 AIA The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Election/Restrictions Applicant’s election without traverse of Group II (originally claims 19 & 20 but now claims 43-50) in the replies filed on 12/29/2025 and 04/27/2026 is acknowledged . Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 50 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claim 50, the term, and thus the following limitation, “the shaped gel” lacks sufficient antecedent basis in the claims. The parent claim recites a jelly ice cube or “JIC” comprising a cross-linked biodegradable polymer but not a shaped gel per se. It is unclear what the limitation and claim refers to. For purposes of further examination (or else the claim would not be considered relative to prior art), the limitation is construed as the JIC undergoes (i.e., is capable of undergoing) freezing at a temperature between -200°C to -5°C. If this interpretation is incorrect, then it is seriously unclear what the claim refers to and a person of ordinary skill in the art would not be apprised as to the scope of the invention. Appropriate correction/clarification is required. 07-30-03-h AIA Claim Interpretation For purposes of additional claim interpretation, “jelly ice cube” and “JIC” are construed as terminology and/or intended use of the recited composition/article. Also, the recitations to “the biodegradable polymer” among claims 44-49 are construed as clearly referring to the “cross-linked biodegradable polymer” of parent claim 43 as it is the only recited component of the JIC. Claim Rejections - 35 USC § 102 & 103 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-27-aia AIA Claim s 43-47 and 50 are rejected under 35 U.S.C. 102( a)(1,2 ) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Omidian et al. (US 2003/0232895 A1) . As to claim 43, Omidian et al. teach a jelly ice cube (hydrogel) comprising a cross-linked biodegradable polymer, particularly a cross-linked gelatin. See the abstract, para. 0160-0161, and para. 0371-0372. Also note other biodegradable polymers are disclosed in para. 0014 and the Examples, etc. Regarding the claimed limitation that the compressive modulus at break increases 1.5-10 times by cross-linking the gelatin/biodegradable compared to the same composition without cross-linking the gelatin/biodegradable polymer, Omidian et al. teach the cross-linked gelatin hydrogel shows an improved (resisted) compressive stresses (Id. in para. 0372) and the addition of cross-linked gelatin as a strengthening agent generally improves the mechanical strength of the hydrogel (e.g., abstract, para. 0008, 0014, etc.). The relative increase of compressive modulus at break imparted by cross-linking the gelatin (and other biodegradable/biopolymers) versus not crosslinking the polymer(s) is presumed inherent from the cited teachings of the reference as the reference amounts to teaching substantially the same composition/component as claimed. However, in the event the relative compressive modulus at break limitation is somehow not met by the above citations and inherency rationale under the meaning of anticipation, the limitation is nevertheless obvious over the teachings of the reference as Omidian et al. further teach provision of certain crosslinking chemical agents, techniques, and parameters to crosslink the strengthener (i.e., the gelatin and/or other biopolymers) (para. 0088-0091) in order to affect the crosslinking and the strength properties such that at the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to vary, tailor, and/or optimize the conditions of the gelatin/biopolymer crosslinking in order to affect the hydrogel’s gel breaking strength with a reasonable expectation of success. Essentially, the claimed relative compressive modulus at break would flow naturally from the cited teachings of the reference. As to claims 44-47, the hydrogel’s cross-linked gelatin meets the claimed limitations to being a protein, a particular derivable biopolymer, and gelatin. Additionally regarding claims 44 and 45, the alternative biopolymers that are crosslinked or may be crosslinked (e.g., para. 0014, 0086, 0133, etc.) meets the claimed limitations to the particular biopolymers and derivable biopolymers. As to claim 50, the hydrogel’s capability to undergo freezing at/within the specified temperature range is presumed inherent of the disclosed cross-linked gelatin hydrogel as the reference amounts to teaching substantially the same composition/component as claimed. In any event, if not anticipatory, the hydrogel’s capability to undergo freezing at/within the specified temperature range would flow naturally from the cited teachings of the reference in view of the cited modifications encompassed by the reference as the reference amounts to teaching substantially the same composition/component as claimed but with certain modifiable properties and features . 07-21-aia AIA Claim s 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Omidian et al. (US 2003/0232895 A1) . The disclosure of Omidian et al. is relied upon as set forth above. Regarding the claimed concentrations of the cross-linked biopolymer, Omidian et al. further teach the hydrogels are water-swellable (para. 0008) and, while it is noted none of the examples are the relied upon cross-linked gelatin-containing hydrogels, examples indicate Omidian et al.’s hydrogels are capable of swelling approximately 20 to 100 times their weight with water (Table 2 on p.12 and Fig. 1), meaning water-swelled hydrogels contain about 1-5 wt.% of the actual hydrogel with the cross-linked biopolymer, overlapping that claimed. If a portion of the solids of the hydrogel is the cross-linked biopolymer, please note that the concentration of cross-linked biopolymer still overlaps and encompasses the ranges claimed. Furthermore, as similarly set forth regarding the independent claim, at the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to vary, tailor, and/or optimize the conditions of the gelatin/biopolymer crosslinking, including the concentration of the cross-linked gelatin strengthening agent, in order to affect the hydrogel’s gel breaking strength with a reasonable expectation of success. This meets, overlaps, and/or arrives within the claimed concentration ranges. Additionally, it would also be within the purview of a person of ordinary skill in the art to partially load but not fully swell the cross-linked gelatin/biopolymer hydrogels of the reference with water in order to obtain a partially swollen hydrogel with a larger cross-linked gelatin/biopolymer concentration (due to less water being present/absorbed by the hydrogel) with a reasonable expectation of success . 07-27-aia AIA Claim s 43-50 are rejected under 35 U.S.C. 102( a)(1 ) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Dong et al. ("Preparation and characterization of enzymatically cross-linked gelatin/cellulose nanocrystal composite hydrogels", RSC Adv., 2021, 11, 10794-10803) . As to claim 43, Dong et al. teach a jelly ice cube (hydrogel) comprising a cross-linked biodegradable polymer, particularly a cross-linked gelatin. See the abstract, § 1 on p.10794, § 2.2 on p.10795 and Fig. 1. Regarding the claimed limitation that the compressive modulus at break increases 1.5-10 times by cross-linking the gelatin/biodegradable compared to the same composition without cross-linking the gelatin/biodegradable polymer, Dong et al. appears to precisely teach such by disclosing the gel strength of Gel-CNC hydrogels is 3 times higher than pure gelatine hydrogels and then that the gel strength is further enhanced by forming covalent cross-linking among gelatin chains via the addition of transglutaminase (TG) (see § 3.4 on p. 10798-10799). See also Fig. 5 showing the increase of gel breaking strength magnitudes compared to a base gelatin (Gel) hydrogel, a gelatin+cellulose nanocrystal (Gel-CNC) hydrogel, a cross-linked gelatin (Gel-TG), and a gross-linked gelatin + cellulose nanocrystal (Gel-TC-CNC) hydrogel that are within 1.5 to 10 times one of the references base or +CNC reference hydrogels. The reference meets the claimed limitations under the meaning of anticipation. However, in the event the relative compressive modulus at break limitation is somehow not directly met by § 3.4 and Fig. 5 of Dong et al. under the meaning of anticipation and/or that the disclosed gel strengths is not one-to-one equivalent to the claimed relative compressive modulus at break, the limitation is nevertheless obvious over the cited teachings of the reference as Dong et al. effectively teach the hydrogel gel breaking strength may be increased and tailored by provision of a cross-linking agent (TG) and cellulose nanocrystal (CNC) such that at the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to vary, tailor, and/or optimize the concentrations of the TG and/or CNC added to the hydrogel in order to affect the hydrogel’s gel breaking strength with a reasonable expectation of success. See also the conclusion section on p.10801. As to claims 44-47, the hydrogel’s cross-linked gelatin meets the claimed limitations to being a protein, a particular derivable biopolymer, and gelatin. As to claims 48 and 49, regarding the claimed concentrations of the cross-linked biopolymer, Dong et al. further teach their cross-linked gelatin hydrogel is water swellable and give swelling behavior of the exemplary gelatin-based hydrogels (§ 2.8, § 3.6, and Fig. 7). Fig. 7 plots swelling behavior of the gelatin-based hydrogels at different pH as equilibrium water content of the hydrogels. While the Figure demonstrates the swelling behavior depends on the pH values, the Figure demonstrates the equilibrium water content (a dimensionless value equal to the difference of the masses of hydrogel in the swollen state and dried state divided by the mass of the hydrogel in the dried state) varies from about 6 to about 13. This means, depending on pH, there is 6 to 13 times more water in a swelled hydrogel than in a dry hydrogel, and the wt.% of hydrogel/gelatin can be calculated as one divided by the equilibrium water content plus 1 (i.e., 1/(EWC+1)). This means Fig. 7 shows the cross-linked gelatin content is about 7-14 wt.% of the swelled hydrogel. While it is noted the hydrogels contain 0% to 2.0% by weight of cellulose nanocrystals (CNC), 0% CNC reads on the hydrogel being made of (100%) the crosslinked gelatin and 2% CNC means the hydrogel is made of 98% crosslinked gelatin and 2% of CNC. 0% CNC in the crosslinked gelatin hydrogel means the swelled hydrogels contain about 4.76-14.29 wt.% of the crosslinked gelatin depending on pH, of course. A maximum 2% of CNC hydrogel is practically negligible when calculating the concentration of crosslinked gelatin from the swelled hydrogels containing about 7.14-14.29 wt.% and the remainder water; however, 2% CNC in the crosslinked gelatin hydrogel means the swelled hydrogels contain about 7.00-14.00 wt.% of the crosslinked gelatin, calculated by multiplying the prior 100% range by 98%. The reference meets the claimed limitations under the meaning of anticipation. However, in the event the reference’s exemplary swelling behavior is not directly met by the cited Figure under the meaning of anticipation and/or that a slight modification is needed to attain both the claimed concentration and the claimed compressive modulus at break (Id.), the limitation(s) is/are nevertheless obvious over the cited teachings of the reference as Dong et al. effectively teach the hydrogel gel breaking strength may be increased and tailored by provision of a cross-linking agent (TG) and cellulose nanocrystal (CNC) and the equilibrium content may be tailored by changing pH such that at the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to vary, tailor, and/or optimize the concentrations of the TG and/or CNC added to the hydrogel as well as the pH in order to affect the hydrogel’s gel breaking strength and final cross-linked gelatin content in a swollen hydrogel with a reasonable expectation of success. It would also be within the purview of a person of ordinary skill in the art to partially load but not fully swell the cross-linked gelatin hydrogels of the reference with water in order to obtain a partially swollen hydrogel with a larger cross-linked gelatin concentration (due to less water being present/absorbed by the hydrogel) with a reasonable expectation of success. As to claim 50, the hydrogel’s capability to undergo freezing at/within the specified temperature range is presumed inherent of the disclosed cross-linked gelatin hydrogel as the reference amounts to teaching substantially the same composition/component as claimed. In any event, if not anticipatory, the hydrogel’s capability to undergo freezing at/within the specified temperature range would flow naturally from the cited teachings of the reference in view of the cited modifications encompassed by the reference as the reference amounts to teaching substantially the same composition/component as claimed but with certain modifiable properties and features. The remaining references listed on Forms 892, 1449, and PCT 210 have been reviewed by the examiner and are considered to be cumulative to or less material than the prior art references relied upon or described above. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R DIAZ whose telephone number is 571-270-0324. The examiner can normally be reached Monday-Friday 9:00a-5:00p EST. Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at https://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Angela Brown-Pettigrew can be reached on 571-272-2817. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MATTHEW R DIAZ/Primary Examiner, Art Unit 1761 /M.R.D./ May 28, 2026 Application/Control Number: 18/572,454 Page 2 Art Unit: 1761 Application/Control Number: 18/572,454 Page 3 Art Unit: 1761 Application/Control Number: 18/572,454 Page 4 Art Unit: 1761 Application/Control Number: 18/572,454 Page 5 Art Unit: 1761 Application/Control Number: 18/572,454 Page 6 Art Unit: 1761 Application/Control Number: 18/572,454 Page 7 Art Unit: 1761 Application/Control Number: 18/572,454 Page 8 Art Unit: 1761 Application/Control Number: 18/572,454 Page 9 Art Unit: 1761 Application/Control Number: 18/572,454 Page 10 Art Unit: 1761 Application/Control Number: 18/572,454 Page 11 Art Unit: 1761 Application/Control Number: 18/572,454 Page 12 Art Unit: 1761
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