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 § 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 1-9, 16, 24-26 and 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (US 2017/0312780) in view of Hadlock et al. (US 2001/0031974).
Regarding claim 1, Schwartz et al. disclose a matrix for neuron regeneration (¶[0002], [0129]) the matrix comprising: a sheet (¶[0072]; Figure 1) having a first surface and a second surface opposite the first surface, the second surface having a plurality of integrally formed ridges (¶[0036]; Figure 19E); wherein the sheet including the integrally formed ridges, comprises oligo(poly(ethylene glycol) fumarate) (¶[0012], [0129]).
Schwartz et al. fail to disclose that the sheet has a spiral shape, such that the first surface of the sheet faces the second surface of the sheet. Schwartz et al. disclose that the sheet can be a tube-like structure which is rolled or rolled-up (¶[0013]).
Hadlock et al. disclose a tube for neuron regeneration (Abstract; Figure 2C) being a spiral having a first surface (115) facing an opposite second surface (113). Hadlock et al. teach that the spiral geometry permits the formation of multiple functional layers lining the lumen of the tube for neuron growth (¶[0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Hadlock et al. to have formed the tube of Schwartz et al. as a spiral in order to permit the formation of multiple functional layers lining the lumen of the tube for neuron growth.
Regarding claim 2, Schwartz et al. fail to disclose that the first surface includes a patterned surface, the patterned surface including a plurality of channels; and wherein the plurality of channels are substantially parallel. Shwartz et al. use the patterned second surface to promote the growth and alignment of neural cells (Abstract; ¶[0085], [0086]). Schwartz et al. effectively disclose that the cells can be grown on concave or convex surfaces (¶[0090]).
Hadlock et al. teach using both the first and second surfaces of the spiral to grow neural cells (¶[0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Hadlock et al. to have provided the pattern of Schwartz et al. (having channels between the ridges) to both surfaces so that the neural cells could be grown on either surface, thus promoting increased cell growth.
Regarding claim 3, Schwartz et al. disclose that each of the plurality of channels have a width and a depth; wherein the width is in a range of 10 μm to 80 μm (¶[0058], [0129]; Figure 20A; and elsewhere) and wherein the depth is in a range of 10 nm to 70 nm (¶[0034], [0036] and elsewhere).
Regarding claim 4, Schwartz et al. disclose that the first surface includes a metal oxide layer, the metal oxide layer covering at least a portion of the second surface, and wherein the metal oxide layer includes a plurality of channels directed into the metal oxide layer, the plurality of channels being substantially parallel to each other (¶[0014], ¶[0055], [0073] and elsewhere; note that the channels do not cover the entire suface of the sheet - Figure 1).
Regarding claim 5, Schwartz et al. disclose that the metal oxide layer comprises a material selected from the group consisting of titanium dioxide, zirconium dioxide, and combinations thereof (¶[0014], ¶[0055], [0073] and elsewhere).
Regarding claim 6, Schwartz et al. disclose that the matrix comprises a self-assembled alkylphosphonate monolayer disposed on at least a portion of the metal oxide layer (Abstract).
Regarding claim 7, the alkylphosphonate monolayer is disposed on the metal oxide layer, and wherein the alkylphosphonate monolayer further defines the plurality of channels, such that a height of each channel is defined by a height of the metal oxide layer and a height of the alkylphosphonate monolayer (Abstract of Schwartz et al.).
Regarding claim 8, the metal oxide layer and the alkylphosphonate monolayer defines a patterned surface, and wherein the plurality of channels extend through the entirety of the patterned surface, such that the first surface of the sheet lines a bottom surface of each channel (Abstract, Figure 1 of Schwartz et al.).
Regarding claim 9, Schwann cells are disposed on the alkylphosphonate monolayer, or within the plurality of channels (¶[0072], [0122] of Schwartz et al.).
Regarding claim 16, in addition to the limitations already addressed above, Schwartz et al. disclose that the sheet comprises a hydrogel (¶[0129]).
Regarding claims 24 and 25, the plurality of ridges are longitudinally spaced apart from each other at a first distance wherein the first distance is in a range of 0.1 mm to 2.0 mm (Figure 9 of Schwartz et al.).
Regarding claim 26, the plurality of ridges are laterally spaced apart from each other at a second distance (Figure 21A of Schwartz et al. and elsewhere).
Regarding claims 36-39, the claim limitations have effectively been addressed above.
Allowable Subject Matter
Claims 10-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, filed August 20th 2025 with regard to Schwartz et al. (WO 2019/036594) not being qualified as prior art have been fully considered and are persuasive. The rejection in view of Schwartz et al. has been withdrawn. Accordingly this Office action is non-final.
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771