DETAILED ACTION
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 .
The examiner acknowledges receipt of response to restriction requirement filed 01/06/2026 and IDS filed 04/23/2024 and 12/20/2023.
No claim is amended.
Claims 1-30 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 01/06/2026 is acknowledged. Applicant also elected medical device as the species. Applicant identifies claim 1-9 as reading on the elected group and species.
Therefore, claims 10-30 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/06/2026.
Claims 1-9 are under consideration.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kiwale et al. “Chitosan, chondroitin sulfate, and hyaluronic acid based in-situ forming scaffold for efficient cell =grafting” in International Journal of Biological Macromolecules, 225 (2023)938-951 (available online 21 November 2022).
Claim 1 is a biopolymer scaffold comprising chondroitin sulfate or hyaluronic acid and chitosan or collagen or alginate with the proviso that when the scaffold contains chondroitin sulfate and not hyaluronic acid, then the biopolymer does not contain collagen.
Kiwale discloses biopolymer polymeric scaffold that comprises chitosan, chondroitin sulfate and hyaluronic acid (see the whole document with emphasis on the title, abstract, page 938, left column of page 940 at fist and second paragraphs, sections 2.1 and 2.2, sections 3.7 and conclusion under section 4.
Therefore, for claims 1-4, biopolymer scaffold of Kiwale comprising chitosan, hyaluronic acid and chondroitin sulfate teaches the scaffold of claims 1-4.
Kiwale teaches claims 1-4.
Claim(s) 1-2, 5, 6 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davachi et al., “Development of chitosan/hyaluronic acid hydrogel scaffold via enzymatic reaction for cartilage tissue engineering” in Materials Today Communications 30(2022), pp 1-16 (available online on 03 February 2022).
For claims 1-2 and 9, Davachi teaches chitosan/hyaluronic acid hydrogel scaffold that can be used for cartilage engineering (see the whole document with emphasis on the abstract, title, sections 2.4, Table 1) meeting claims 1 and 2; and the hydrogel scaffold is in the form of a film meeting claim 9 with the cartilage tissue engineering scaffold meeting the limitation of medical device.
When the chitosan is at 55%, 70% and 80%, all of which are at least 50% or 75%, claims 5 and 6 are met. --- claim 5 contains chitosan or collagen or alginate; claim 6 contains chitosan or collagen or alginate. --- (Table 1).
Davachi teaches all the elements of claims 1-2, 5-6 and 9.
Claim(s) 1-2 and 5-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Correia et al., “Chitosan Scaffolds Containing Hyaluronic Acid for Cartilage Tissue Engineering” in Tissue Engineering: Part C, Vol. 17, No. 7, 2011.
For claims 1 and 2, Correia teaches biopolymer scaffold comprising hyaluronic acid and chitosan(see the whole document, abstract, page 718, column, second paragraph). Correia discloses the following types of scaffolds: 0% HA, 1% HA, 5% HA and 10% HA (CHT; CHT/1HA; CHT/5HA; CHT/10HA (page 718, column 2, second paragraph; page 721, Table 1).
For claim 5-6; Correia discloses scaffold comprising chitosan (CHT) at 100, 99, 95, 90% and hyaluronic acid (HA) at 0, 5, 10%) (Table 1 on page 721) and 99%, 95% and 90% are all at least 50% and at least 75%.
For claim 7, the scaffold having 10% hyaluronic acid (HA) (table 1 at page 721) meets the limitation.
For claim 8, the scaffold having hyaluronic acid (HA) at 5% (Table1, page 721) is a specific point within the claimed range of 3-8%.
Correia teaches all the elements of claims 1-2 and 5-8.
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KIM et al. (WO 2010107236 A2 cited by applicant in form 1449).
For claims 1 and 9, KIM teaches porous biopolymer scaffold that is a multilayered structure for regenerating cartilage; the scaffold comprises collagen and hyaluronic acid and a polymer layer (see paragraphs 1, 2 of section 1) and 5, 6 and 7 of section 2 of the Eng Trans’ claims 1 and 3).
Therefore, Kim teaches claims 1 and 9.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613