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 .
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.
Election/Restrictions
Applicant’s election of Group I, claims 1-9, in the reply filed on 4/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 10-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to because they contain gray and black shading in Figures 2 and 4-20 rendering them ineligible and of insufficient quality so that all details in the drawings or photographs are reproducible in the printed patent.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuszynski et al. (US 2022/0167988).
Regarding claim 1, Tuszynski discloses an engineered nerve graft (100) comprising a body (102) extending from a first end to a second end (the first and second ends of 102), the body being formed of a biocompatible hydrogel (see paragraphs [0054] and [0062]), and a plurality of microchannels (104) extending continuously through the body from the first end to the second end (see Fig. 1), wherein each of the plurality of microchannels (104) has an effective diameter of about 1 micrometer to about 200 micrometers (see paragraph [0038] describing, for example, an open diameter of about 200 micrometers).
Regarding claim 5, Tuszynski discloses one or more bioactive molecules distributed through the body (see paragraphs [0011], [0012], [0044], [0028], [0055], and [0058-0061]).
Regarding claim 6, Tuszynski discloses one or more bioactive molecules disposed within at least some of the plurality of microchannels (see paragraphs [0011], [0012], [0044], and [0058-0061]).
Regarding claim 7, Tuszynski discloses one or more bioactive molecules, wherein the one or more bioactive molecules comprise one or more of laminin, collagen, or collagen with hyaluronic acid (see paragraph [0061]) .
Regarding claim 8, Tuszynski discloses the body comprises one or more of polyethylene glycol diacrylate, hyaluronic acid, a collagen-based hydrogel, or a gelatin-based hydrogel (see paragraph [0062]).
Regarding claim 9, the claimed phrase “photo-crosslinked” is being treated as a product by process limitation; that is the hydrogel is made by photo-crosslinking. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Tuszynski is silent as to the process used to make the hydrogel, it appears that the engineered nerve graft would be the same as that claimed since both applicant’s engineered nerve graft and the prior art engineered nerve graft are formed of a suitable biocompatible hydrogel material.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tuszynski et al. as applied to claim 1 above, and further in view of Romero-Ortega et al. (US 2007/0010831).
Tuszynski discloses the claimed invention except for the plurality of microchannels each having an effective diameter of about 1 micrometer to about 100 micrometers. Romero-Ortega also discloses an engineered nerve graft (BNI; see Fig. 1) comprising a body (the external perforated conduit) and a plurality of microchannels (the internal multiluminal matrix; see paragraph [0020] and Figs. 1 and 12) extending continuously through the body (see Fig. 1). Romero-Ortega teaches each of the plurality of microchannels has an effective diameter of about 50 micrometers to about 500 micrometers (claim 11), which overlaps the claimed range. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the plurality of microchannels of Tuszynski to have an effective diameter of about 50 micrometers to about 500 micrometers, as taught by Romero-Ortega, as doing so would have yielded predictable results, namely, provided the microchannels with a diameter suitable for nerve repair (see paragraphs [0015-0018]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the plurality of microchannels of Tuszynski as modified by Romero-Ortega to have an effective diameter of about 1 micrometer to about 100 micrometers as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see paragraphs [0006] and [0032] of the instant specification indicating microchannels “may” have an effective diameter within the claimed ranges).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tuszynski et al.
Tuszynski discloses the plurality of microchannels are arranged at a density within the body of at least about 200 microchannels per square millimeter of the body (see paragraph [0053]), which overlaps the claimed range. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of microchannels of Tuszynski to be arranged at a density within the body of about 1,000 to about 30,000 microchannels per square millimeter of the body as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see paragraph [0032] of the instant specification indicating microchannels “may” have an effective diameter within the claimed ranges).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tuszynski et al. as applied to claim 1 above, and further in view of Simpson et al. (US 2012/0221025).
Tuszynski discloses the claimed invention except for a membrane at least partially extending around an outer surface of the body. Simpson also discloses a nerve graft (see Fig. 3C) comprising a body (sheath 40). Simpson teaches a membrane at least partially extending around an outer surface of the body (see [0054] describing that sheath 40 may be further coated with one or more layers of a suitable material or materials and/or therapeutic substances). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Tuszynski’s nerve graft with a membrane at least partially extending around an outer surface of the body, as taught by Simpson, in order to provide the nerve graft with anti-inflammatory properties (see paragraph [0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELANIE TYSON whose telephone number is (571)272-9062. The examiner can normally be reached M-F 8:00 AM - 4:00 PM (ET).
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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