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 .
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 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.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/01/2026 has been entered.
Status of claims
The amendment filed on 04/01/2026 is acknowledged. Claims 2, 4, 12, and 13 have been canceled and claims 9-11, 14, and 15 have been withdrawn. Claims 1, 3, 5-8, and 16-19 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 04/01/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of objection
Upon reconsideration the following new ground of objection.
Claim Objection
Claim 1 is objected to because of the following informalities: extra “n” which does not appear in either of the two formulas. Appropriate correction is required.
Rejections maintained
The following rejection of the claims is maintained for reasons of record and the following.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 3, 5-8, and 16-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bouhadir et al. (US 2004/0028745 A1) as evidenced by Mooney et al. (WO 1998012228 A1) in view of Karlsson et al. (US 2018/0244807 A1).
Bouhadir et al. teach a carrier/drug compound comprising an oxidized alginate polymer containing aldehyde groups which is crosslinked (claims 1-3) by a crosslinking compound having two or more hydrazide groups such as adipic dihydrazide (
PNG
media_image1.png
352
1139
media_image1.png
Greyscale
, the claimed hydrazide of formula II with p=4 in the instant claims 1 and 5) (paragraph 11 and claim 15);
wherein the oxidized alginate is an alginate which is oxidized so that 5-50% corresponding to the equivalent% of periodate used (1:1 ratio) (paragraph 9, i.e., potential crosslinking of 5-50% based on the available aldehyde groups on the alginate (example 22) and;
wherein the oxidized alginate polymer has a molecular weight (MW) of ≤300,000 daltons and is optionally lowered (paragraph 11);
wherein 5% oxidized alginate has a MW of 147 kDa (table 2).
Bouhadir et al. teach PCT/US97/16890 (Mooney et al., WO 1998012228 A1) being incorporated by reference as a whole (paragraph 5). According to Mooney et al. alginate polymer being oxidized therefor containing aldehyde groups, followed by being crosslinked and the crosslinked oxidized alginate polymer being used for human cell transplantation (the instant claim 8) (abstract, paragraph bridges page 3 and 4, and claim 13) and crosslinkers including diamine crosslinker such as diamino alkanes and dihydrazide crosslinker such as adipic dihydrazide (page 18, line 4-14).
With respect to the art rejection above, it is noted that the reference does not teach that the composition is capable of being used in the manner instantly claimed, [3D printable and injectable in the instant claim 1, bioprintable in the instant claim 18, and suitable for injection into tissue or bioprinted using a 3D printer in the instant claim 19]; please note that the claim element that uses capable of-type language does not impose any requirement that the device or composition actually perform the function. A claim that uses “capable of”-type language covers devices/compositions that have the recited components and which are capable of performing the recited functions. MPEP 2114.IV.
Bouhadir et al. do not expressly teach the property of a crossover point 100-400% shear strain in the instant claim 19. The claimed crossover point 100-400% shear strain is the property of 15% oxidized alginate crosslinked with a single crosslinker adipic dihydrazide (figure 2b in the instant specification of hydrazone: the table on page 20 and page 23 line 1-22). As a result of the hydrogel taught by Bouhadir et al. being the same oxidized alginate polymer (5-50% oxidation being obvious to 15% oxidation of the example in figure 2b) being crosslinked with the same single crosslinker adipic dihydrazide as in figure 2b, the hydrogel taught by Bouhadir et al. would necessarily have the claimed property, whether expressly recognized by Bouhadir et al. or not. Please refer to MPEP 2112.01.II:
A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Bouhadir et al. do not specify the same oxidation level and the subsequent crosslinking level as claimed in the instant claims 6, 7, 16, and 17.
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with or lie inside the range disclosed in the prior art, such as in the instant rejection.
The claimed ranges of oxidation level and the subsequent crosslinking level are 2-20% and 5-15% and the range of oxidation level and the subsequent crosslinking level taught in the prior art is 5-50% and therefor, overlaps with or includes the claimed ranges.
Bouhadir et al. do not teach the diamine crosslinker such as diamino alkanes including O,O′-1,3-Propanediylbis-hydroxylamine (the claimed formula I in the instant claims 1 and 5) as the additional crosslinker besides adipic dihydrazide.
This deficiency is cured by Karlsson et al. who teach both adipic dihydrazide and diamine crosslinkers including O,O′-1,3-Propanediylbis-hydroxylamine are suitable crosslinkers (abstract and paragraph 37).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to modify the crosslinker taught by Bouhadir et al. and add O,O′-1,3-Propanediylbis-hydroxylamine taught by Karlsson et al. as an additional crosslinker. It is generally considered to be prima facie obvious to combine compounds each of which is taught by the prior art to be useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from both having been used individually in the prior art, and from them being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicants argue that Bouhadir et al. teach a carrier/drug compound, not the claimed end use.
However, this argument is not deemed persuasive. As stated in the rejection above and in the previous office action, please note that the claim element that uses capable of-type language does not impose any requirement that the device or composition actually perform the function. A claim that uses “capable of”-type language covers devices/compositions that have the recited components and which are capable of performing the recited functions. MPEP 2114.IV.
Applicants argue that Bouhadir et al. teach oxidation lowering alginate MW with 5% oxidation giving 147 kDa and the higher oxidation the lower MW, thus, Bouhadir et al. do not teach the claimed dual-crosslinked hydrogel architecture.
However, this argument is not deemed persuasive. First, the oxidation lowering alginate MW with 5% oxidation giving 147 kDa taught by Bouhadir et al. reads on the claimed MW of crosslinked oxidized alginate is ≥ 80 kDa.
Second, with regard to Bouhadir et al. not teaching the claimed dual-crosslinked hydrogel architecture, this is a 35 USC 103(a) rejection and not a 35 USC 102 rejection and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the instant rejection is based on Bouhadir et al.’s teaching of adipic dihydrazide crosslinker crosslinking an oxidized alginate polymer containing aldehyde groups in view of Karlsson et al.’s teaching of both adipic dihydrazide and O,O′-1,3-Propanediylbis-hydroxylamine being suitable crosslinkers and it would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to modify the crosslinker taught by Bouhadir et al. and add O,O′-1,3-Propanediylbis-hydroxylamine taught by Karlsson et al. as an additional crosslinker. Furthermore, a single crosslinker for crosslinking an oxidized alginate polymer containing aldehyde groups was previously claimed and is disclosed in the instant specification as suitable.
Applicant’s argument with regard to Mooney and Karlsson et al. are basically the same as the argument in the previous response, thus the response discussed previously in the office action date 10/09/2025 (page 7-8) applies here as well and is not persuasive for reason discussed.
Applicants argue that there is the examiner acknowledged the favorable results of AADH/PDHA
However, this argument is not deemed persuasive. As stated in the response to applicants’ 37 CFR 1.132 declaration in the office actions dated 04/22/2025 and 10/09/2025, the evidence of surprising benefits of using a combination of crosslinkers in exhibition A does appear to have the benefit of controlled stiffness, stress relaxation, and self-healing as a result of a combination of adipic dihydrazide and O,O′-1,3-Propanediylbis-hydroxylamine, two specific compounds, as crosslinkers; however, the scope of the instant claim 1 is much broader, with regard to the combination of crosslinkers, than the scope of the combination of adipic dihydrazide and O,O′-1,3-propanediylbis-hydroxylamine: the scope of the instant claim 1 is not limited to the two specific compounds, but rather with m and p being 2-12 and especially with one or more carbon atoms in
PNG
media_image2.png
200
400
media_image2.png
Greyscale
being optionally replaced by a heteroatom selected from O, S, and N. There is no adequate basis for reasonably concluding that the great number and variety of compositions included by the claims would behave in the same manner as the single tested composition. In other words, Applicant has not shown that based on this single example, it is reasonable to expect that other embodiments falling within the scope of the claims will behave similarly.
MPEP 716.02(b) III.: Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
Examiner interviews are available via telephone, in-person, 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 http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG YU/
Primary Examiner, Art Unit 1614
Prosecution Insights