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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/26/2026 has been entered.
Response to Amendment
Upon entry of the RCE, the amendment and written response filed 05/26/2026 have been entered and considered.
Claim 1-20 were cancelled.
Claims 21 and 29 have been amended.
Claims 21-40 are pending.
Terminal Disclaimer
The terminal disclaimer filed on 05/27/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S Patent No. 11,847,844 and 10,311,281 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
The combination of Farah and More:
Applicant argues “neither Farah or More discloses or suggest ‘a method for assessing the quality of a nerve graft, the method comprising: ‘among other steps, ‘using an analysis function of an image processing application, analyzing a transformed image to identify one or more structures based on one or more recognition criteria, wherein the one or more recognition criteria comprises at least one of a size range of … one or more structures and a circularity range of the one or more structures’”. Upon further review of the references, and in light of applicant’s arguments, the examiner respectfully disagrees as follows: Farah teaches “the growth of BACE 1 KO axons” is the claimed “measurement of the one or more structure” in paragraph [0209]; and “BACE1 KO macrophages are larger in size and appear activated at 5 days post-cut” is the claimed “one of a size range of the one or more structures”.
Upon entry of the terminal disclaimer filed 05/27/2026, the double patenting rejections of claims 21-40 have been withdrawn.
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 recognition criteria comprises at least one of a size range of the one or more structures and a circularity range of the one or more structures (and “BACE1 KO macrophages are larger in size and appear activated at 5 days post-cut” is the claimed “one of a size range of the one or more structures”), 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.
Allowable Subject Matter
Claims 29 and 31 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.
Claims 33-40 are allowed.
Conclusion
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
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