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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8, 10-13, in the reply filed on 2/17/2025 is acknowledged.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/17/2025.
Response to Arguments
Applicants' arguments, filed 9/17/2025, have been fully considered and are persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Applicant’s arguments, see pp. 5-6, filed 9/17/2025, with respect to the rejection(s) of claim(s) 1-8 and 10-13 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as set forth below.
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 (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 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.
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.
Claim(s) 1-6, 10-13 is/are rejected under 35 U.S.C. 103 as obvious over Beckett et al. (“Enhancement of the Mechanical Properties of Hydrogels with Continuous Fibrous Reinforcement”; 2020 Sept 25; ACS Biomater. Sci. Eng.; 6: 5453−5473; https://dx.doi.org/10.1021/acsbiomaterials.0c00911).
Beckett teaches enhancement of the mechanical properties of hydrogels with continuous fibrous reinforcement (title). Reinforcing mechanically weak hydrogels with fibers is a promising route to obtain strong and tough materials for biomedical applications which retaining a favorable cell environment (abstract)
A number of different methods for manufacturing a fibrous scaffold have been reported; depending on the method chosen, fibers can be produced with diameters from the nano- to microscale, and constructs can be assembled with thicknesses from the micro- to macroscale. Figure 6 depicts the range being considered. Weaving and 3D printing encompass fiber bundle layers of 100+ µm (i.e., on the order of fiber diameters of claims 5-6, 10-13) (5460, 2nd paragraph). Table 1 includes an example fibre diameter of 250 µm, and fiber spacing achiever of 500, 1000, 1500, 2000 µm (overlapping with intervals of claim 4.
Table 3 exemplifies the drug delivery application using nylon as fiber material and, inter alia, alginate (rendering obvious sodium salt of alginate) as hydrogel material, reading on the medical fiber composite combination when the instant claims recite nylon (claims 5-6, 10-13).
Lamination is depicted in Figure 14, and include angle -ply laminates. (e) show orthogonal layering, and 90 ° loading (orthogonal, claim 2) is in the darkest shading, which has higher tear toughness, relative to alginate.
In Figure 11, the 6th and 8th fiber spacing/architecture of composites with square pores, show orthogonal layers.
Regarding the chemical anchor points with chemical bonding to the sodium alginate hydrogel, crosslinking is one technique taught to tune mechanical properties (5453, 1st paragraph) and to form laminate structures, having higher modulus (5462, 5th paragraph).
Based on the teachings of Beckett, the materials of claims 1-6, fiber material nylon of claims 5-6 and 10-13, diameter of fiber range, and interval ranges are obvious over teachings, rendering these claimed high-strength medical fiber composite claims prima facie obvious.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beckett et al. (“Enhancement of the Mechanical Properties of Hydrogels with Continuous Fibrous Reinforcement”; 2020 Sept 25; ACS Biomater. Sci. Eng.; 6: 5453−5473; https://dx.doi.org/10.1021/acsbiomaterials.0c00911) as applied to claims 1-6, 10-13 above, and further in view of Thermo Scientific: Instructions: NHS and Sulfo-NHS; MAN0011309 Rev. C.0 Pub. Part No. 2160650; https://assets.fishersci.com/TFS-Assets/LSG/manuals/MAN0011309_NHS_SulfoNHS_UG.pdf; 2020).
The teachings of Beckett are set forth above, with reasons that render the high-strength medical fiber composite material of claim 1 obvious. While Beckett does teach cross-linking, the chemistry of amino silane functional groups, nor the specific surface treatment solution for crosslinking required by claim 8 are not taught. The skilled artisan would have referenced known materials and procedure for crosslinking, relevant to the materials being crosslinked.
Thermo Scientific discusses materials including Sulfo-NHS (N-hydroxysulfosuccinimide), CAS # 106627-54-7, and scheme 1, involving EDC with Sulfo-NHS, to crosslinked with an amend to give a stable amide bond; this occurs in MES buffer (middle p. 2). While specific amounts of claim 8 are not specified, considering the reaction, molar excesses of EDC taught, and molar considerations for crosslinking, the amounts of reactants would have been obvious to find workable concentrations, which renders the claims obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/ Primary Examiner, Art Unit 1614