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 .
DETAILED ACTION
Pursuant to the preliminary amendment dated 11/6/2024, claims 16-19 and 25-26 are cancelled and claims 1, 3-5, 7, 9-14 an 22-24 are amended. No claims are newly added.
Claims 1-15 and 20-24 are pending in the instant application and are examined on the merits herein.
Priority
The application is a National Stage entry of PCT/US2022/078944 filed on 10/28/2022, which claims priority to provisional applications 63/288906 and 63/272973 filed on 12/13/2021 and 10/28/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 8/29/2025 and 9/23/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 14 is objected to for reciting “and active agent”, when it appears the recitation should be “an active agent”.
Claim Rejections - 35 USC § 112
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.
Claims 6 and 20-24 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 recites the phrases “e.g.” and “such as”. These terms render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Preferences, options and examples are properly set forth in the specification, but when included in the claims lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation(s) will be considered without taking into account preferences or examples.
Claim 20 recites the limitation "the gel". There is insufficient antecedent basis for this limitation in the claim. Claims 21-24 are indefinite by depending on claim 20.
Claim 24 is further indefinite for reciting the limitation "the protecting group". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 –
(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.
(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.
Claims 1-4, 9, 11-13, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (Biomaterials, 2002, PTO-892).
Zhu et al. discloses the flowing modified alginate: (Figures 1-2; Sec. 2.1)
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where R= side chains for lysine, arginine, aspartic acid or phenylalanine, and the transformation is accomplished by EDC carbodiimide coupling. Zhu further discloses that the modified alginate was formed into a hydrogel by calcium ion crosslinking. (Sec 2.2)
Accordingly, the instant claims are anticipated by the prior art.
Claims 1-4, 9, 11, 12, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Joshy et al. (Inter. J. Bio. Mater., 2018, PTO-892).
Joshy et al. discloses the following modified alginate, prepared by a process using carbodiimide coupling: (Figure 1, Sec. 2.2)
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Accordingly, the instant claims are anticipated by the prior art.
Claims 1-4, 9, 11, 12, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang et al. (ACS Omega, Jan 2021, PTO-892).
Chang et al. discloses the following modified alginate, prepared by a process using carbodiimide coupling: (Figure 1, p. 1125)
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Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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 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.
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 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 5-8, 10, 12, 14, 15, 21, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (Biomaterials, 2002, PTO-892), or Joshy et al. (Inter. J. Bio. Mater., 2018, PTO-892), or Chang et al. (ACS Omega, Jan 2021, PTO-892), in view of Meija et al. (WO 2017/044983A1, PTO-892).
The disclosure of Zhu or Joshy or Chang is referenced as discussed above. None of the cited primary references disclose a modified alginate bearing a click motif or an active agent, or a method of preparing a modified alginate where an active agent is covalently bound thereto.
Mejia et al. discloses modified alginates bearing a click motif, such as azide or tetrazine, where the modified alginate is prepared by reacting the carboxyl group of alginate with an amie of the modification agent, to form an amide bond, facilitated by carbodiimide coupling. (Figure 50; Examples 10, 11; ¶00278-00283)
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Meija also discloses that the modified alginate could then be linked to an active agent (e.g. dexamethasone, doxorubicin) using click chemistry between the azide or tetrazine moiety, on the modified alginate, and a transcyclooctene moiety linked to the active agent. (Figures 9A, 9B) With respect to claims 23 and 24, Meija discloses that the modification agent may be in a protected form where the amine is protected by groups such as a benzyloxy or tert-butoxy group. (¶00209, 00213)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the modified alginates of Zhu or Joshy or Chang could be used in place of native alginate, in the process of preparing modified alginate of Meija, thereby arriving at the instant invention of a modified alginate bearing both a pendant carboxyl group and a click motif or active agent. One of ordinary skill in the art would have a reasonable assurance of success in substituting native alginate with modified alginate of the primary art, because the chemistry of Meija for adding a click motif or an active agent relies on the formation of an amide bond between a carboxyl group of alginate and an amine of the modification agent, where since the modified alginates of Zhu or Joshy or Chang all contain multiple carboxyl groups, the same amide formation chemistry would remain applicable. One of ordinary skill in the art could perform the method of Meija with any alginate bearing a free carboxyl group. Thus, the modified alginates of Zhu or Joshy or Chang are all functionally equivalent starting materials when compared to the native alginate used by Meija.
It is noted that the specification contains working examples demonstrating superior properties of “restorative gels” (i.e. gels containing an alginate modification with a pendant carboxyl group) compared to “depletive gels” (i.e. gels containing an alginate modification without a pendant carboxyl group). However, the working examples are of insufficient breadth to be representative of the entire claimed scope of compounds. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)(MPEP § 716.02(d)) Applicants’ showing of unexpected results are not commensurate in scope with that of the claimed invention.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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