DETAILED ACTION
Claims 1 and 32 are amended. A complete action on the merits of pending claims 1, 3-6, 10, 12-14, 16-18 and 32-33 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/09/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/09/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 02/09/2026 which are entered.
Claim Rejections - 35 USC § 103
Claim(s) 1, 3-6, 10, 12-14, 16-18 and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto (WO2017062845 (See attached document)), in view of Holmes (US PGPUB No. 20160067375 A1).
Regarding claim 1, Sakamoto teaches, a nerve repair scaffold (Figure 1, tissue scaffold (20); Paragraph [0054]) capable of being implanted in a subject (Paragraph [0057]), comprising:
a sheath (Figure 1, sheath (30); Paragraph [0054], line 27-29) having a proximal end (Figure 1, proximal end (52); Paragraph [0069], line 13-16) and a distal end (Figure 1, distal end (54); Paragraph [0069], line 13-16), the sheath (sheath (30)) housing a plurality of microchannels (Figure 1, microchannels (40); Paragraph [0054], line 27-29) traversing the sheath (sheath (30)) from the proximal end (proximal end (52)) to the distal end (distal end (54)), wherein the plurality of microchannels are linear (Figure 1 clearly shows microchannels (40) traversing sheath (30) linearly from proximal end (52) to distal end (54)), wherein each microchannel has a wall thickness of about 10 μm to about 50 μm (Paragraph [0064], line 15-27, “In certain aspects, suitable wall 42 thicknesses are the smallest thicknesses possible that retain structural integrity to the channel. In certain aspects, the wall has a thickness of less than or equal to about 500 μm. In other aspects, the wall has a thickness of less than or equal to about 100 μm. Where wall thicknesses are greater than 100 μm, they can reduce the amount of space available within the open central lumen 44 for axonal regeneration. In certain variations, the wall thickness may be greater than or equal to about 10 μm to less than or equal to about 100 μm, optionally greater than or equal to about 10 μm to less than or equal to about 70 μm, optionally greater than or equal to about 20 μm to less than or equal to about 70 μm, optionally greater than or equal to about 25 μm to less than or equal to about 67 μm, and in certain aspects, optionally greater than or equal to about 20 μm to less than or equal to about 50 μm. In certain other variations, the wall has a thickness of greater than or equal to about 10 μm to less than or equal to about 20 μm.” The range of about 10 μm to about 50 μm is clearly expressly disclosed as a preferred subset of broader ranges, and is selected to maintain structural integrity while allowing space for axonal growth) and the microchannels (microchannels (40)) are configured to promote growth of nerve tissue (Paragraph [0069], line 23-29); and
wherein the scaffold (tissue scaffold (20)) comprises a microchannel density from about 1 to about 300 microchannels per square millimeter (Paragraph [0066], line 21-24).
Sakamoto fails to teach, hexagonal microchannels; and wherein the scaffold is 3D printed.
Holmes discloses, 3D biologically inspired tissue engineered scaffolds. Holmes teaches, hexagonal microchannels (Figure 20; Paragraph [0161], hexagonal patterns in layered 3D structures forming elongated/linear features); and wherein the scaffold is 3D printed (Paragraph [0161]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the nerve repair scaffold of Sakamoto to include hexagonal microchannels and to form the scaffold using a 3D printing technique as taught by Holmes, as both references and the claimed invention are directed to nerve repair scaffolds (Holmes discloses in paragraph [0014], “In exemplary embodiments, nanomaterials and nano/microfabrication methods are used to create novel biologically inspired tissue engineered cartilage scaffolds for facilitating MSC chondrogenesis. The methods disclosed herein can be readily adapted by someone of ordinary skill in the art to create a variety of tissue scaffolds that can be used for the promotion and generation of tissue repair and/or production. In this sense, tissue can be interpreted as biological material that is made up of epithelial cells, muscle cells, connective tissue cells, nerve cells and/or blood cells.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nerve repair scaffold of Sakamoto to include hexagonal microchannels and to form the scaffold using a 3D printing technique as taught by Holmes, as such a modification would have been predictable, namely, to more specifically and/or efficiently promote the differentiation, growth, and/or production of cells and tissues specific to a particular biological environment and/or organ (Paragraph [0016] of Holmes).
Further, Sakamoto in view of Holmes teaches the claimed invention except for, “wherein the scaffold is formed from a mixture comprising poly(ethylene glycol) diacrylate and methacrylated gelatin.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the scaffold from a mixture comprising poly(ethylene glycol) diacrylate and methacrylated gelatin, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. This is further evidenced by the disclosure in paragraph [0058] of Sakamoto, “For example, a scaffold structure can comprise microchannels formed from biocompatible and biodegradable polymers, such as polyester polymers. Suitable biodegradable polymers for forming the microchannels include a polylactic acid, polycaprolactone (PCL), polyglycolic acid, poly(lactide-co-glycolide polymer (PLGA), and copolymers, derivatives, and mixtures thereof. In certain preferred aspects, the biocompatible and biodegradable material is selected the group of polymers consisting of: polycaprolactone (PCL), poly(lactic-co-glycolic acid) (PLGA), and combinations thereof.” and the disclosure of paragraph [0067], line 28-29, “The sheath 30 may be formed of a biocompatible and/or biodegradable material that may be the same as or different from the microchannels 40.” As such, given that the two key components/structures that comprise the scaffold are formed from the mixture, the scaffold is by virtue also formed from the same mixture. In re Leshin.
Regarding claim 3, Sakamoto in view of Holmes teaches the claimed invention except for, “wherein the scaffold comprises about 7 to about 200 microchannels.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the scaffold to comprise about 7 to about 200 microchannels, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. This is further evidenced by the disclosure of Sakamoto in paragraph [0075], line 10-13, “Figures 2B-2C show cross-sectional schematics of two different high lumen volume nerve repair scaffolds which ideally match or emulate a nerve's native architecture according to certain aspects of the present disclosure. The design in Figure 2C has a higher microchannel density than a microchannel density in Figure 2B.” In re Aller.
Regarding claim 4, Sakamoto further teaches, wherein a length of the scaffold is about 0.5 cm to about 15 cm (Paragraph [0056], line 16-21, disclose, “For example, depending on the application, microchannels in accordance with certain variations of the present disclosure may have a length of greater than or equal to about 500 μm to less than or equal to 30 cm, optionally greater than or equal to about 500 μm to less than or equal to about 10 cm, and in certain variations, optionally greater than or equal to about 500 μm to less than or equal to about 3 cm, by way of non-limiting example.” Further, paragraph [0067], line 2-7, “The sheath 30 may have a length that is the same as the microcylinders 40 or may be longer for additional protection and securing to a portion of a nerve 50 or surrounding tissue {e.g., by anastomosing). In this manner, the tissue scaffold 20, including the sheath 30 and microchannels 40 can extend over any distance to match injuries of individual subjects/patients.” As such 0.5cm to about 15cm falls within the range recited).
Regarding claim 5, Sakamoto in view of Holmes teaches the claimed invention except for, “wherein an outer diameter is about 1.5 mm to about 10 mm.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the outer diameter to be about 1.5 mm to about 10 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. This is further evidenced by the disclosure of Sakamoto in paragraph [0088], line 3-7, “The template may have a diameter corresponding to the desired diameter of the microchannel to be formed (for example, for a solid template, the outer diameter of the template corresponds to the inner diameter of the microchannel). Thus, any of the diameters discussed above in the context of the microchannel may be appropriate diameters for the template.” and further in paragraph [0056], line 9-16, “In certain aspects, each microchannel has an inner diameter of greater than or equal to about 10 μm to less than or equal to about 1,000 μm, optionally greater than or equal to about 10 μm to less than or equal to about 500 μm, optionally greater than or equal to about 50 μm to less than or equal to about 450 μm, optionally greater than or equal to about 50 μm to less than or equal to about 300 μm. It should be noted that so long as at least one dimension of the microchannel falls within the above- described micro-sized scale (for example, diameter), one or more other axes may well exceed the micro-size (for example, length and/or width).” In re Aller.
Regarding claim 6, Sakamoto further teaches, wherein each microchannel has an inner diameter from about 150 μm to about 250 μm (Paragraph [0056], line 9-13, “In certain aspects, each microchannel has an inner diameter of greater than or equal to about 10 μm to less than or equal to about 1,000 μm, optionally greater than or equal to about 10 μm to less than or equal to about 500 μm, optionally greater than or equal to about 50 μm to less than or equal to about 450 μm, optionally greater than or equal to about 50 μm to less than or equal to about 300 μm.” As such 150 μm to about 250 μm falls within the range recited).
Regarding claim 10, Sakamoto in view of Holmes teaches the claimed invention except for, “wherein the scaffold is prepared from about 25% poly(ethylene glycol) diacrylate and about 1-7% methacrylated gelatin.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to prepare the scaffold from about 25% poly(ethylene glycol) diacrylate and about 1-7% methacrylated gelatin, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. This is further evidenced by the disclosure in paragraph [0058] of Sakamoto, “For example, a scaffold structure can comprise microchannels formed from biocompatible and biodegradable polymers, such as polyester polymers. Suitable biodegradable polymers for forming the microchannels include a polylactic acid, polycaprolactone (PCL), polyglycolic acid, poly(lactide-co-glycolide polymer (PLGA), and copolymers, derivatives, and mixtures thereof. In certain preferred aspects, the biocompatible and biodegradable material is selected the group of polymers consisting of: polycaprolactone (PCL), poly(lactic-co-glycolic acid) (PLGA), and combinations thereof.” and the disclosure of paragraph [0067], line 28-29 of Sakamoto, “The sheath 30 may be formed of a biocompatible and/or biodegradable material that may be the same as or different from the microchannels 40.” As such, given that the two key components/structures that comprise the scaffold are formed from the mixture, the scaffold is by virtue also formed from the same mixture. In re Leshin.
Regarding claim 12, Sakamoto further teaches, wherein the scaffold (tissue scaffold (20)) further comprises a biofunctional agent (Paragraph [0060], line 26-27, “In certain aspects, the microchannels may be treated with a biofunctional agent…” Given that the microchannels are a component that comprise the overall tissue scaffold (20) is a clear indication that tissue scaffold (20) comprises a biofunctional agent).
Regarding claim 13, Sakamoto further teaches, wherein the biofunctional agent comprises fibronectin, collagen, laminin, keratin, a growth factor, or a stem cell-promoting factor (Paragraphs [0070]-[0072]).
Regarding claim 14, Sakamoto further teaches, wherein the scaffold (tissue scaffold (20)) comprises an open volume of greater than or equal to about 70% (Paragraph [0065]).
Regarding claim 16, Sakamoto further teaches, further comprising a first overhang at the proximal end and a second overhang at the distal end, wherein the first overhang and the second overhang are configured for suturing of nerve tissue (Figure 21A; Paragraph [0035]).
Regarding claim 17, Sakamoto further teaches, further comprising a growth factor (Paragraph [0068]) wherein, the growth factor is a nerve growth factor (Paragraph [0072], disclose, “Such a biofunctional agent may be introduced after the microcylinders 40 are formed, for example, by coating, infusing, or otherwise incorporating the biofunctional agent onto one of more surfaces {e.g., internal surface 46) of the microchannel wall 42. In certain aspects, a surface of the porous wall 42 has a coating comprising a material for promoting growth of the neural tissue selected from the group consisting of: fibronectin, keratin, laminin, collagen, and combinations and equivalents thereof. In certain variations, the walls may be coated with fibronectin, which has been found after screening over a dozen compounds to be particularly advantageous with the biocompatible polymers forming the microchannel walls to optimize cell and axon attachment.” Given the optimization of cell and axon attachment through the application of the biofunctional agent on the microchannel walls to promote growth of neural tissue, give a clear indication of a nerve growth factor).
Regarding claim 18, Sakamoto further teaches, wherein each of the microchannels (microchannels (40)) comprise an open dimeter of about 200 μm to about 500 μm (Paragraph [0056], line 9-13 and Paragraph [0066], line 9-11; As such 200 μm to about 500 μm falls within the range recited).
Regarding claim 32, Sakamoto teaches, a method of restoring nerve function in a subject in need thereof with a nerve repair scaffold (tissue scaffold (20); Paragraph [0054] and [0069]) capable of being implanted in a subject (Paragraph [0057]), the method comprising:
providing the nerve repair scaffold (tissue scaffold (20)), the nerve repair scaffold (tissue scaffold (20)) comprising:
a sheath (sheath (30)) having a proximal end (proximal end (52)) and a distal end (distal end (54)), the sheath (sheath (30)) housing a plurality of microchannels (microchannels (40); Paragraph [0054], line 27-29) traversing the sheath (sheath (30)) from the proximal end (proximal end (52)) to the distal end (distal end (54)), wherein the plurality of microchannels are linear (Figure 1 clearly shows microchannels (40) traversing sheath (30) linearly from proximal end (52) to distal end (54)), wherein each microchannel has a wall thickness of about 10 μm to about 50 μm (Paragraph [0064], line 15-27, “In certain aspects, suitable wall 42 thicknesses are the smallest thicknesses possible that retain structural integrity to the channel. In certain aspects, the wall has a thickness of less than or equal to about 500 μm. In other aspects, the wall has a thickness of less than or equal to about 100 μm. Where wall thicknesses are greater than 100 μm, they can reduce the amount of space available within the open central lumen 44 for axonal regeneration. In certain variations, the wall thickness may be greater than or equal to about 10 μm to less than or equal to about 100 μm, optionally greater than or equal to about 10 μm to less than or equal to about 70 μm, optionally greater than or equal to about 20 μm to less than or equal to about 70 μm, optionally greater than or equal to about 25 μm to less than or equal to about 67 μm, and in certain aspects, optionally greater than or equal to about 20 μm to less than or equal to about 50 μm. In certain other variations, the wall has a thickness of greater than or equal to about 10 μm to less than or equal to about 20 μm.” The range of about 10 μm to about 50 μm is clearly expressly disclosed as a preferred subset of broader ranges, and is selected to maintain structural integrity while allowing space for axonal growth) and the microchannels (microchannels (40)) are configured to promote growth of nerve tissue (Paragraph [0069], line 23-29); and
a first overhang at the proximal end and a second overhang at the distal end, wherein the first overhang and the second overhang are configured for suturing of nerve tissue (Figure 21A; Paragraph [0035]),
aligning a first nerve epineurium to the first overhang, and aligning a second nerve epineurium to the second overhang (Figure 21A; Paragraph [0035]);
suturing the first nerve epineurium to the first overhang, and suturing the second nerve epineurium to the second overhang (Figure 21A; Paragraph [0035]),
thereby allowing restoration of nerve function across an injury site (Paragraph [0061], line 15-17, Paragraph [0063], line 11-13, Paragraph [0073], line 33-34).
Sakamoto fails to teach, hexagonal microchannels; and wherein the nerve repair scaffold is 3D printed.
Holmes teaches, hexagonal microchannels (Figure 20; Paragraph [0161], hexagonal patterns in layered 3D structures forming elongated/linear features); and wherein the nerve repair scaffold is 3D printed (Paragraph [0161]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the nerve repair scaffold of Sakamoto to include hexagonal microchannels and to form the scaffold using a 3D printing technique as taught by Holmes, as both references and the claimed invention are directed to nerve repair scaffolds (Holmes discloses in paragraph [0014], “In exemplary embodiments, nanomaterials and nano/microfabrication methods are used to create novel biologically inspired tissue engineered cartilage scaffolds for facilitating MSC chondrogenesis. The methods disclosed herein can be readily adapted by someone of ordinary skill in the art to create a variety of tissue scaffolds that can be used for the promotion and generation of tissue repair and/or production. In this sense, tissue can be interpreted as biological material that is made up of epithelial cells, muscle cells, connective tissue cells, nerve cells and/or blood cells.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nerve repair scaffold of Sakamoto to include hexagonal microchannels and to form the scaffold using a 3D printing technique as taught by Holmes, as such a modification would have been predictable, namely, to more specifically and/or efficiently promote the differentiation, growth, and/or production of cells and tissues specific to a particular biological environment and/or organ (Paragraph [0016] of Holmes).
Further, Sakamoto in view of Holmes teaches the claimed invention except for, “wherein the scaffold is formed from a mixture comprising poly(ethylene glycol) diacrylate and methacrylated gelatin.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the scaffold from a mixture comprising poly(ethylene glycol) diacrylate and methacrylated gelatin, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. This is further evidenced by the disclosure in paragraph [0058] of Sakamoto, “For example, a scaffold structure can comprise microchannels formed from biocompatible and biodegradable polymers, such as polyester polymers. Suitable biodegradable polymers for forming the microchannels include a polylactic acid, polycaprolactone (PCL), polyglycolic acid, poly(lactide-co-glycolide polymer (PLGA), and copolymers, derivatives, and mixtures thereof. In certain preferred aspects, the biocompatible and biodegradable material is selected the group of polymers consisting of: polycaprolactone (PCL), poly(lactic-co-glycolic acid) (PLGA), and combinations thereof.” and the disclosure of paragraph [0067], line 28-29, “The sheath 30 may be formed of a biocompatible and/or biodegradable material that may be the same as or different from the microchannels 40.” As such, given that the two key components/structures that comprise the scaffold are formed from the mixture, the scaffold is by virtue also formed from the same mixture. In re Leshin.
Regarding claim 33, Sakamoto further teaches, wherein the nerve is a peripheral nerve (Paragraph [0073], line 33-34).
Response to Arguments
Applicant's arguments filed on 02/09/2026 have been fully considered but they are not persuasive.
Regarding Sakamoto failing to teach hexagonal microchannels and 3D printing: The point is acknowledged. However, the rejection is properly based on obviousness under 35 U.S.C. 103, not anticipation under 35 U.S.C. 102. Holmes teaches the use of hexagonal microchannel-like structures that form elongated, linear features in 3D printed scaffolds (See Figure 20 and Paragraph [0161], hexagonal patterns in layered constructs creating interconnected, elongated features suitable for tissue guidance). Holmes further discloses that such scaffolds are fabricated using 3D printing techniques (Paragraph [0161]). Moreover, Holmes expressly contemplates adaptation of the disclosed methods to a variety of tissues, including those involving nerve cells (Paragraph [0014], “nerve cells”; Paragraph [0016], promotion of differentiation, growth, and/or production of cells and tissues specific to a particular biological environment and/or organ).
Regarding Holmes discloses pores, not linear hexagonal microchannels: The argument is not persuasive. The hexagonal “pores” disclosed in Holmes are arranged in stacked 3D layers to produce elongated, linear structures that function as channels with an evident longitudinal direction (Paragraph [0161], interconnected pores forming long, directional features; Figure 20 clearly illustrates layered hexagonal patterns exhibiting linear traversal through the scaffold). The specification of the current application/invention defines a “microchannel” as a structure having an “evident longitudinal axis” and an ”elongated axial dimension” that is “linear” (Paragraph [0034]). Holmes’ stacked hexagonal features satisfy this definition, as they provide directional, elongated pathways suitable for tissue guidance.
Regarding Holmes is directed only to hard tissue and there is no motivation to combine: This argument is not persuasive. Holmes explicitly states that the disclosed methods and scaffolds “can be readily adapted… to create a variety of tissue scaffolds” and are suitable for tissues including those involving “nerve cells” (Paragraph [0014]). The reference furth emphasizes promotion of “differentiation, growth, and/or production of cells and tissue specific to a particular biological environment and/or organ” (Paragraph [0016]). The field of endeavor is tissue scaffold fabrication for guided regeneration, and the problem addressed (precise microstructural control for tissue guidance) is common to both references. Thus, the filed of endeavor overlap (see In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)). A clear motivation exists to modify Sakamoto’s nerve repair scaffold by incorporating Holmes’ hexagonal, 3D-printed structures: to achieve more precise, customizable linear hexagonal microchannels that enhance packing density, open volume, and directional nerve guidance (predictable outcome per KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Regarding PEGDA + methacrylated gelatin not taught or suggested: Sakamoto expressly permits the selection of known biocompatible and biodegradable polymers for the microchannels and sheath, including polyesters and alternatives to PCL/PLGA (Paragraphs [0058] and [0067], “The sheath 30 may be formed of a biocompatible and/or biodegradable material that may be the same as or different from the microchannels 40”). It would have been obvious to one of ordinary skill in the art to select a photopolymerizable hydrogel mixture comprising poly(ethylene glycol) diacrylate and methacrylated gelatin as the material of construction, as such a selection represents no more than the exercise of ordinary skill in choosing a known material suitable for the intended use (In re Leshin, 277 F.2d 197 (CCPA 1960)). Holmes further supports the use of PEG-based variants and hydrogel printing (Paragraph [0015], and [0060]-[0062]), rendering the combination predictable and within the level of ordinary skill.
Therefore, the combination of Sakamoto and Holmes renders the amended claims obvious. The rejections is maintained.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771