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 .
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.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NPL “A novel injectable tissue adhesive based on oxidized dextran and chitosan” to Balakrishnan et al.
As to Claim 1, Balakrishnan discloses a biocompatible composition, comprising a chitosan-based hydrogel and a dextran solution (abstract, “we developed an in situ setting adhesive based on biopolymers such as chitosan and dextran”).
As to Claim 2, Balakrishnan discloses a biocompatible composition wherein the chitosan-based hydrogel is crosslinked with the dextran solution (pp. 345, section 2.2.4).
As to Claim 3, Balakrishnan discloses a biocompatible composition wherein the chitosan-based hydrogel is 2 % to 90 % by weight of the biocompatible composition (pp. 345, section 2.2.5).
As to Claim 4, Balakrishnan discloses a biocompatible composition wherein the chitosan-based hydrogel comprises a chitosan, and a hydrochloride salt (pp. 344, section 2.2.1).
As to Claim 5, Balakrishnan discloses a biocompatible composition wherein the chitosan is 2 % to 85 % by weight of the biocompatible composition, and the hydrochloride salt is 0.1 % to 5 % by weight of the biocompatible composition (pp. 344-345, section 2.2.1, 2.2.2, and 2.2.5).
As to Claim 6, Balakrishnan discloses a biocompatible composition wherein the dextran solution is 2 % to 20 % by weight of the biocompatible composition (pp. 345, section 2.2.5).
As to Claim 7, Balakrishnan discloses a biocompatible composition wherein the dextran solution comprises a dextran (pp. 344, section 2.1), a sodium metaperiodate solution (pp. 344, section 2.1), a sodium bicarbonate solution (pp. 344-345, section 2.2.2), and a potassium iodide solution (pp. 344-345, section 2.2.2).
As to Claim 8, Balakrishnan discloses a biocompatible composition wherein the dextran is 5 % to 10 % by weight of the biocompatible composition (pp. 345, section 2.2.5), the sodium metaperiodate solution is 0.1 % to 10 % by weight of the biocompatible composition (pp. 344, section 2.1), the sodium bicarbonate solution is 0.1 % to 5 % by weight of the biocompatible composition (pp. 344-345, section 2.2.2), and the potassium iodide solution is 0.05 % to 20 % by weight of the biocompatible composition (pp. 344-345, section 2.2.2).
As to Claim 9, Balakrishnan discloses a biocompatible composition wherein the ratio of dextran solution to sodium metaperiodate solution is 1:0.1 to 1:8 (pp. 344-345, section 2.2.2).
As to Claim 10, Balakrishnan discloses a method for preparing the biocompatible composition of claim 1, comprising reacting the chitosan-based hydrogel with the dextran solution via a cross-linking reaction (pp. 345, section 2.2.4).
As to Claim 11, Balakrishnan discloses a method wherein the cross-linking reaction has a gelation time of 0.5 min to 10 min (pp. 345, section 2.2.4).
As to Claim 12, Balakrishnan discloses a method wherein the chitosan-based hydrogel is 2 % to 90 % by weight of the biocompatible composition (pp. 345, section 2.2.5).
As to Claim 13, Balakrishnan discloses a method further comprising preparing the chitosan-based hydrogel by mixing a chitosan powder and an ethanolic HCl (pp. 344, section 2.2.1).
As to Claim 14, Balakrishnan discloses a method wherein the dextran solution is 2 % to 20 % by weight of the biocompatible composition (pp. 345, section 2.2.5).
As to Claim 15, Balakrishnan discloses a method further comprising preparing the dextran solution by mixing a dextran (pp. 344, section 2.1), a sodium metaperiodate solution (pp. 344, section 2.1), a sodium bicarbonate solution (pp. 344-345, section 2.2.2), and a potassium iodide solution (pp. 344-345, section 2.2.2).
As to Claim 16, Balakrishnan discloses a method wherein the ratio of dextran solution to sodium metaperiodate solution is 1:0.1 to 1:8 (pp. 344-345, section 2.2.2).
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.
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.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over NPL “A novel injectable tissue adhesive based on oxidized dextran and chitosan” to Balakrishnan et al. in view of U.S. Patent Pub. No. 2025/0018085 to Genin et al.
As to Claims 17-20, Balakrishnan discloses the claimed invention except for administering the biocompatible composition of claim 1 to a subject in need thereof, wherein the biocompatible composition is topically administered to the subject, wherein the biocompatible composition is topically administered to the cartilage tissue of the subject, and wherein the cartilage tissue is a fibrocartilaginous structure.
Genin discloses a method [0017, 0135] including administering a biocompatible composition including dextran and chitosan [0126] to a subject in need thereof [0145], wherein the biocompatible composition is topically administered to the subject [0141], wherein the biocompatible composition is topically administered to the cartilage tissue of the subject [0141], and wherein the cartilage tissue is a fibrocartilaginous structure [0053, 0182] in order to allow the composition to be delivered to a tissue defect/injury site to allow for enhanced healing [0108].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the biocompatible composition and method of Balakrishnan with the application modification of Genin in order to allow the composition to be delivered to a tissue defect/injury site to allow for enhanced healing.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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