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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 April 2026 has been entered.
Status of Claims
The amendments and arguments filed 15 April 2026 are acknowledged and have been fully considered. Claims 1-2, 5, 7-9, 11, 19, 24-26, 30-31, 40-42, 45-46, 54, 66, and 81 are currently pending. Claim 1 is amended; claims 3-4, 6, 10, 12-18, 20-23, 27-29, 32-39, 43-44, 47-53, 55-65, and 67-80 are cancelled; claims 7, 9, 26, 31, 40-42, 45-46, 54, and 66 are withdrawn; no claims are new.
Claims 1-2, 5, 8, 11, 19, 24-25, 30, and 81 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claims 1-2, 5, 8, 11, 19, 24-25, and 81 are rejected under 35 U.S.C. 103 as being unpatentable over Hickey et al. (ACS Biomater. Sci. Eng., 1 January 2018, Vol. 4, 3726-3736; of record) in view of Zimmermann et al. (Mat. Sci. Eng. C, 2011, Vol. 31, 43-49) as evidenced by Cüneyt Tas (Biomaterials, 2000, Vol. 21, 1429-1438).
Claim 1 is drawn to a scaffold biomaterial comprising:
a decellularized plant tissue from which cellular materials and nucleic acids of the tissue are removed, the decellularized plant tissue comprising a 3-dimensional porous structure; and
a protein-based hydrogel;
wherein the decellularized plant tissue are mineralized.
Claim 2 is drawn to the scaffold biomaterial of claim 1, wherein the protein-based hydrogel comprises collagen (Applicant’s elected species).
Claim 11 is drawn to the scaffold biomaterial of claim 1, wherein the decellularized plant tissue is mineralized with apatite (Applicant’s elected species).
Claim 24 is drawn to the scaffold biomaterial of claim 1, wherein the decellularized plant tissue is cellulose-based.
Claim 25 is drawn to the scaffold biomaterial of claim 1, wherein the plant tissue comprises a tissue from apple hypanthium (Applicant’s elected species).
Hickey et al. teach plant derived cellulose scaffolds combined with hydrogels (Abstract). Hickey et al. further teach “Decellularization with the surfactant sodium dodecyl sulfate was used to obtain 3D cellulose scaffolds void of any native apple cells or nucleic acids” (Pg. 3727 right column second paragraph), wherein the plant tissue comprises apple hypanthium tissue (Pg. 3727 right column third paragraph) and the hydrogel comprising collagen (Pg. 3729 left column second paragraph).
As such, Hickey et al. teach a scaffold biomaterial comprising: a decellularized plant tissue from which cellular materials and nucleic acids of the tissue are removed, the decellularized plant tissue comprising a 3-dimensional porous structure; and a protein-based hydrogel, wherein the protein-based hydrogel comprises collagen, the decellularized plant tissue is cellulose based, and the plant tissue comprises tissue from apple hypanthium.
The scaffold biomaterial of Hickey et al. differs from the instantly claimed scaffold biomaterial in the following ways:
Hickey et al. do not teach the plant tissue being mineralized.
Yet, as to 1: Hickey et al. further teach the cellulose scaffolds being useful for numerous applications in tissue engineering (Abstract) as well as being versatile, easy to use, and displaying high biocompatibility with cell invasion occurring rapidly and more completely (Pg. 3727 left column third paragraph).
Zimmermann et al. also teach biocompatible scaffolds comprising cellulose (Abstract). Zimmermann et al. further teach cellulose scaffolds being an attractive material for bone repair due to the biocompatibility, tensile strength, and moldability (Pg. 43 right column second paragraph) as well as modifying the cellulose scaffolds by mineralizing them with hydroxyapatite to promote bone formation and provide stiffness (Pg. 44 left column first paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Hickey et al. by mineralizing the scaffold with apatite as taught by Zimmermann et al. It would have been obvious to combine the known cellulose and hydrogel scaffold with the known mineralization of cellulose scaffolds with apatite to yield the predictable result of a stiffened cellulose and hydrogel scaffold suitable for promoting bone repair, with a reasonable expectation of success.
Based on all of the foregoing, claims 1-2, 11, and 24-25 are rejected as prima facie obvious.
Claim 5 is drawn to the scaffold biomaterial of claim 1, wherein the decellularized plant tissue comprises a pore size of about 100 to about 200 µm.
Claim 81 is drawn to the scaffold biomaterial of claim 1, wherein the decellularized plant tissue comprises a pore size of about 150 to about 200 µm.
Hickey et al. further teach the pore size of the decellularized plant tissue between about 100 and 200 µm (Fig. 1), overlapping with the instantly claimed range.
As such, claims 5 and 81 are rejected as prima facie obvious.
Claim 8 is drawn to the scaffold biomaterial of claim 1, having a Young’s moduli between about 20 kPa and about 1 MPa.
Hickey et al. further teach the scaffold biomaterial having a Young’s moduli of 2.3 x 101 ±1.7 kPa (Pg. 3729 left column last paragraph), corresponding to a range of 21.3 kPa to 24.7 kPa, overlapping with the instantly claimed range.
As such, claim 8 is rejected as prima facie obvious.
Claim 19 is drawn to the scaffold biomaterial of claim 1, wherein the decellularized plant tissue is mineralized with apatite by alternating exposure to solutions of calcium chloride and disodium phosphate.
Zimmermann et al. further teach the alternating exposure of the scaffold to calcium chloride and simulated body fluid, further teaching the simulated body fluid being prepared with the same procedure found in Cüneyt Tas (Pg. 44 left column third paragraph). As evidenced by Cüneyt Tas, simulated body fluid comprises disodium phosphate (Pg. 1430 right column second paragraph).
As such, claim 19 is rejected as prima facie obvious.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Hickey et al. and Zimmermann et al. as applied to claims 1-2, 5, 8, 11, 19, 24-25, and 81 above, and further in view of Ivanovski et al. (J. Dent. Res. 2014, Vol. 93, 1212-1221).
The teachings of Hickey et al. and Zimmermann et al. have been set forth above.
Claim 30 is drawn to the scaffold biomaterial of claim 1, comprising two or more subunits which are glued together.
Hickey et al. and Zimmermann et al. do not teach the scaffold comprising two or more subunits.
Ivanovski et al. teach multiphasic scaffolds for periodontal tissue engineering (Title), further teaching the periodontium consisting of both soft and hard tissues (Pg. 1212 right column first paragraph). Ivanovski et al. further teach utilizing multiphasic scaffolds comprising a biomaterial scaffold with an osteoconductive bioceramic for regenerating bone combined with a soft porous scaffold for regenerating cartilage pgs. 1213 left column third paragraph), wherein the phases of the scaffold are joined with fibrin glue to ensure strong cohesion between the different phases (Pg. 1213 left column fourth paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Hickey et al. and Zimmermann et al. to include two subunits glued together as taught by Ivanovski et al. It would have been obvious to combine the known mineralized scaffold suitable for regenerating bone with the known soft porous scaffold for regenerating cartilage by attaching the scaffolds with fibrin glue to yield the predictable result of a multiphasic scaffold suitable for periodontal tissue engineering, with a reasonable expectation of success.
Based on all of the foregoing, claim 30 is rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 15 April 2026 have been fully considered but they are moot in view of the new grounds of rejection set forth above.
Conclusion
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611
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