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 .
Response to Amendment
The amendment and written response filed 03/13/2026 have been entered and considered.
Claims 1-20 were cancelled.
Claims 21-40 were added.
Claims 21-40 are pending.
Upon entry of the claim amendment, the rejection and objection of claims 1-20 have been withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 21-28, 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Farah (U.S. Publication No. 2013/0108645 A1) in view of More et al (“More” hereinafter, “A semi-automated method for identifying and measuring myelinated nerve fibers in scanning electron microscope images”, see IDS filed 08/18/2020).
As per claim 21, Farah discloses a method for assessing the quality of a nerve graft, the method comprising: obtaining an image identifying laminin-containing tissue (paragraph [0241], basal lamina is the claimed “laminin-containing tissue”) in the nerve graft (paragraph [0209], WT nerve grafts); using an analysis function of the image processing application, analyzing the image to identify one or more structure based on one or more recognition criteria (paragraphs [0077], [0242]-[0243], [0246], “axons” in figures 5A-5G are recognized, and the “axons” are the claimed “structure”, which are identified and analyzed); and determining one or more structural characteristic of the nerve graft based on a measurement of the one or more structure (paragraph [0209], “accelerated axonal regeneration” is the claimed “structural characteristic”; and “the growth of BACE1 KO axons" is the claimed "measurement of the one or more structure"), wherein the one or more structural characteristics comprise at least a portion of a perineurium and/or one or more endoenurial tubes (paragraph [0200] for endoneurial blood vessels, images in figures 3A-3I comprises a number of the endonuerial blood vessel), assessing the quality of the nerve graft based upon, at least in part, the determined one or more structural characteristics of the nerve graft (abstract). Farah teaches microscopy program such as "Openlab software”, “Sigmaplot” and etc to for imaging processing and analysis. However, Farah does not explicitly teach "creating a transformed image using a transformation function of an image processing application on the image". More discloses a method for identifying and measuring myelinated nerve fibers in scanning electron microscope images, in which More teaches a plurality of image transformation functions, such as image stitching, denoising, binary conversion, small area removal and etc (see figure 2 in More).
Farah & More are combinable because they are from the same field of endeavor, nerve microscopic imaging. At the time of the invention, it would have been obvious to a person of ordinary skill in the art to modify Farah in light of More’s image transformation functions. The suggestion/motivation for doing so would have been it would allow Farah to better analyze axonal regeneration in the transformed/enhanced images. Therefore, it would have been obvious to combine Farah with More to obtain the invention as specified in claim 1.
As per claim 22, More teaches wherein the identified one or more structures meet the one or more recognition criteria (paragraph [0076]-[0077]: “…images of sections of nerves filled with neurobiotin to anterogradely label regenerating axons at 5 days post-crush…” the criteria is 5 days of post-crush).
As per claim 23, More teaches wherein the identified one or more structures do not meet the one or more recognition criteria (paragraph [0076]: axonal images of 3 days post-crush do not meet the 5 days post-crush criteria).
For claims 24-25, the examiner notes More in figure 1 shows an entire fascicle is delineated from the rest of the sample tissue.
As per claim 26, as explained above, the axonal images include an endoneurial tube.
As per claim 27, the examiner notes denoising and binary converting both require thresholding (see table 1 in More for axon binary threshold value)
As per claim 28, as explained above, denoising and binary converting in More require a threshold method.
As per claim 30, Farah at paragraph [0242] teaches “a total number of regenerating axons per nerve” corresponds to the claimed “the number of endoneurial tubes per area”.
As per claim 32, Farah teaches BACE1 KO fibers have 2 or more regenerating sprouts compared to 31% of the WT fibers.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12-13, 16 and 18 of U.S. Patent No. 11,847,844 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
All elements in claim 21 are encompassed in claim 1 of ‘844 patent.
All elements in claim 22 are encompassed in claim 2 of ‘844 patent.
All elements in claim 23 are encompassed in claim 3 of ‘844 patent.
All elements in claim 24 are encompassed in claim 4 of ‘844 patent.
All elements in claim 25 are encompassed in claim 5 of ‘844 patent.
All elements in claim 26 are encompassed in claim 6 of ‘844 patent.
All elements in claim 27 are encompassed in claim 7 of ‘844 patent.
All elements in claim 28 are encompassed in claim 8 of ‘844 patent.
All elements in claim 29 are encompassed in claim 12 of ‘844 patent.
All elements in claim 30 are encompassed in claim 13 of ‘844 patent.
All elements in claim 31 are encompassed in claim 16 of ‘844 patent.
All elements in claim 32 are encompassed in claim 18 of ‘844 patent.
Claims 33-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,311,281 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
All elements in claim 33 are encompassed in claim 17 & 1 of ‘281 patent.
All elements in claim 34 are encompassed in claim 2 of ‘281 patent.
All elements in claim 35 are encompassed in claim 17, 1 and 7 of ‘281 patent.
All elements in claim 36 are encompassed in claim 17, 1 and 10 of ‘281 patent.
All elements in claim 37 are encompassed in claim 18 of ‘281 patent.
All elements in claim 38 are encompassed in claims 17 and 1 of ‘281 patent.
All elements in claim 39 are encompassed in claim 18 of ‘281 patent.
All elements in claim 40 are encompassed in claim 19 of ‘281 patent.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOM Y LU whose telephone number is (571)272-7393. The examiner can normally be reached Monday - Friday, 9AM - 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at (571) 272 - 7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOM Y LU/ Primary Examiner, Art Unit 2667