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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
This office action is responsive to the amendment filed on 02/20/2026. As directed by the amendment: claim 94 has been amended and claims 1-93 have been cancelled. Thus, claims 94-113 are presently pending in this application with claim 113 withdrawn.
Response to Arguments
Applicant's arguments filed 02/20/2026 have been fully considered but they are not persuasive.
Applicant argues that Yaszemski does not disclose wherein an outer surface of the sheath entirely surrounds the longitudinal axis of the microchannel. The Office respectfully disagrees. Under broadest reasonable interpretation, surround is on all sides and the longitudinal axis of the microchannel has the outer surface on all sides of it. The device as a whole forms a spiral so the outer surface doesn’t form a perfect circle around the microchannel but it does surround it. Therefore, The Office maintains that Yaszemski discloses the invention of claim 1. Furthermore, The Office acknowledges that applicant disagrees with this interpretation of surround, so it would like to direct application to the new grounds of rejection below of Tuszynskim in view of Yaszemski. This new grounds of rejection is to show that even with applicant’s interpretation of surround, there is prior art that teaches claim 1 to assist applicant in formulating any future amendments.
Applicant argues that a person of ordinary skill in the art would not be motivated to combine Yaszemski and Tuszynski because Yaszemski and Tuszynski are directed to non-analogous field of endeavor with Yaszemski directed to the central nervous section and Tuszynski the peripheral nervous system. The Office respectfully disagrees. First, the test for analogous art is if both references are analogous to the claimed invention not if both references are analogous to each other (see MPEP 2141.01). The Office maintains that both Yaszemski and Tuszynski are analogous to the claimed invention as it is broadly directed to a tissue repair scaffold. Second, a person of ordinary skill in the art would have been motivated to look to Tuszynski to modify a device used in Yaszemski as both are used in the nervous system.
Furthermore, Yaszemski cites references discussing the peripheral nervous system (see [0570]) as well as indicating a desire to mimic the peripheral nervous system (see [0502]). Applicant further argues that “a person of ordinary skill in the art would not have been motivated to modify Yaszemski's device with the teachings of Tuszynski because doing so would fundamentally alter the structure and principle operation of Yaszemski's scaffold” because they are different shapes and operate differently. The Office respectfully disagrees. Yaszemski is simply being modified to have a the material be a biodegradable polymer, polycaprolactone, and not to change the structure or operation of Yaszemski. Additionlly, The Office notes that applicant has not specifically argued why modifying Yaszemski to have a biodegradable polymer, polycaprolactone, changes the structure or principal operation. Applicant further argues “a person of ordinary skill in the art would not have had a reasonable expectation of success in combining Yaszemski and Tuszynski. Given Yaszemski's emphasis on a spiral configuration as essential for achieving CNS regeneration, and given Tuszynski's silence on such geometries, a person of ordinary skill in the art would not have a reasonable expectation of success in modifying the non-spiral devices of Tuszynski to adopt a spiral form”. As explained above and herein no modifications to Tuszynski are being made. Instead Yaszemski is only being modified to have a biodegradable polymer, polycaprolactone rendering this argument moot. Thus The Office maintains that Yaszemski and Tuszynski teach the limitations of claim 109-111.
Applicant further argues that a person of ordinary skill in the art would not have had a reasonable expectation of success in modifying Yaszemski in view of specifically, substituting polycaprolactone would not have yielded predictable results, because the present application discloses that polymer composition affects degradation behavior and mechanical characteristics of the scaffold; The Office does not explain why substituting polycaprolactone into Yaszemski's scaffold would have predictably resulted in a scaffold having the same structural and mechanical properties relied upon in Yaszemski's disclosed configuration”. The Office respectfully disagrees. Even if the assertion made by applicant that polymer composition affects degradation behavior and mechanical characteristics of the scaffold, to which The Office does not concede, is true, that alone does not mean that it would not be obvious to substitute one material for another. First, The Office notes that the substitution need only produce predictable characteristics not identical ones as applicant has argued. Second, Yaszemski discloses the device can be made of a natural or synthetic polymer (see [0119]). Polycaprolactone is a known synthetic polymer that one of ordinary skill in the art would be able to predict it’s characteristics when used in the device of Yaszemski.
Applicant further argues “although the Office relies on Tuszynski's disclosure of hydrogel microchannel walls and overhang structures for nutrient exchange and suturing, see Office Action at p. 8, the present application discloses that proper alignment of the scaffold is important for nerve regeneration, and that end-structure geometry, including overhang configuration and thickness, affects attachment and resistance to tearing during implantation. See application as-filed at [0047], [0049J-[OOS0], [0057]-[0060]. The present application also describes hydrogel materials in microchannel walls in connection with porosity and diffusion characteristics. See application as-filed at [0085]-[0087]. The Office does not explain why incorporating these features into Yaszemski's scaffold would have predictably maintained those characteristics”. The Office respectfully disagrees and notes that the structure that applicant is arguing is not in the claims. Claim 110 claims a hydrogel material but no specific structure or purpose for that material. Claim 111 claims an overhang structure but to specific structure or purpose for that overhang. In response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., end-structure geometry, thickness, hydrogel materials in microchannel walls in connection with porosity and diffusion characteristics) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 94-104, 107, 108, and 112 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yaszemski et al. (US 20220226543 A1).
Regarding claim 94, Yaszemski discloses (fig. 1) a tissue repair scaffold comprising: a cylindrical (see [0123]) sheath 100 having a first end and a second end (see fig. 1 lower right); a microchannel 115 disposed within an interior of the sheath (see fig. 1, [0121] and [0125]), wherein the microchannel 115 traverses the sheath from the first end to the second end (see [0125]); and a marker (108 and space between adjacent elements 108) disposed on an exterior surface of the sheath running substantially from the first end to the second end (see fig. 1 lower left, lower right, and [0128]), wherein an outer surface of the sheath entirely surrounds the longitudinal axis of the microchannel (see annotated fig. 1 below).
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Regarding claim 95, Yaszemski further discloses (fig. 1) the marker comprises a groove (space between adjacent 108, see fig. 1).
Regarding claim 96, Yaszemski further discloses (fig. 1) the marker comprises a feature 108 disposed on an exterior surface of the sheath running substantially from the first end to the second end (see fig. 1 and [0128]).
Regarding claim 97, Yaszemski further discloses (fig. 1) the exterior surface of the sheath comprises at least 2, 3, or 4 grooves (spaces between 108) disposed thereon (see fig. 1 and [0128]).
Regarding claim 98, Yaszemski further discloses (fig. 1) the grooves (spaces between 108) are about evenly dispersed about a circumference of the sheath (see fig. 1 and [0119]).
Regarding claim 99, Yaszemski further discloses (fig. 1) a plurality of markers (108 and space between adjacent elements 108), wherein the markers indicate the alignment of the scaffold and/or torsion placed upon the scaffold (108 extend in a straight line or a curved line the indication the alignment/torsion of the scaffold).
Regarding claim 100, Yaszemski further discloses (fig. 1) the groove has a width 109 or depth of at least about 50 microns (see [0119]).
Regarding claim 101, Yaszemski further discloses (fig. 1) the marker is substantially parallel with the microchannel (see fig. 1 and [0125]).
Regarding claim 102, Yaszemski further discloses (fig. 1) the tissue repair scaffold comprises a plurality of microchannels 115 disposed within the interior of the sheath (see fig. 1 and [0125]).
Regarding claim 103, Yaszemski further discloses (fig. 1) the plurality of microchannels 115 are substantially parallel (see fig. 1, [0122] and [0125]).
Regarding claim 104, Yaszemski further discloses (fig. 1) the marker (108 and space between adjacent elements 108) is substantially parallel to each of the plurality of microchannels 115 (see fig. 1, [0122] and [0125]).
Regarding claim 107, Yaszemski further discloses (fig. 1) the sheath, the microchannel, or both are made from a biodegradable polymer (see [0119] and [0161]-[0162]).
Regarding claim 108, Yaszemski further discloses (fig. 1) the biodegradable polymer is selected from polyethylene glycol (see [0119] and [0161]-[0162]).
Regarding claim 112, Yaszemski further discloses (fig. 1) the sheath has a thickness of at least about 250 microns (see [0124]).
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.
Claims 105 and 106 are rejected under 35 U.S.C. 103 as being unpatentable over Yaszemski.
Regarding claim 105, Yaszemski discloses the claimed invention substantially as claimed, as set forth above for claim 94. Yaszemski further discloses a length of the scaffold is greater than 3mm.
Yaszemski does not expressly disclose a length of the scaffold is about 0.5 cm to about 30 cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the length of the scaffold of Yaszemski from greater than 3mm to between 0.5cm and 30cm as applicant appears to have placed no criticality on the claimed range (see specification [0011] indicating in some embodiments the length is within the claimed range) and 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).
Regarding claim 106, Yaszemski discloses the claimed invention substantially as claimed, as set forth above for claim 94. Yaszemski is silent regarding the inner diameter of the sheath is about 1.5 mm to about 10 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yaszemski to have the inner diameter of the sheath is about 1.5 mm to about 10 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Yaszemski would not operate differently with the claimed diameter since the claimed internal diameter would still result in a useable tubular scaffold. Further, applicant places no criticality on the range claimed, indicating simply that the diameter is the claimed ranges “in some embodiments” (specification [0011]).
Claim 109-111 are rejected under 35 U.S.C. 103 as being unpatentable over Yaszemski in view of Tuszynski et al. (US 20220167988 A1).
Regarding claim 109, Yaszemski discloses the claimed invention substantially as claimed, as set forth above for claim 107. Yaszemski is silent regarding the biodegradable polymer is polycaprolactone.
However Tuszynski, in the same filed of endeavor, teaches a sheath of a scaffold made of a biodegradable polymer that is polycaprolactone (see [0041]).
Therefore, the substitution of one known material (polycaprolactone as taught in Tuszynski) for another (polymer as taught in Yaszemski) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since Tuszynski teaches that polycaprolactone is a suitable alternative material form a scaffold out of and the substitution of the polycaprolactone as taught in Tuszynski would have yielded predictable results, namely, a scaffold structure of Yaszemski that would be biocompatible. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 110, Yaszemski discloses the claimed invention substantially as claimed, as set forth above for claim 107. Yaszemski is silent regarding walls of the microchannel comprise hydrogel materials.
However Tuszynski, in the same filed of endeavor, teaches a scaffold structure having a sheath with microchannels, wherein walls of the microchannel comprise hydrogel materials (see [0046]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Yaszemski to have walls of the microchannel comprise hydrogel materials as taught by Tuszynski, for the purpose of being able to exchange nutrients between the exterior of the scaffolds and the interior of the microchannel without the use of pores (see Tuszynski [0046]).
Regarding claim 111, Yaszemski discloses the claimed invention substantially as claimed, as set forth above for claim 107. Yaszemski is silent regarding an overhang structure, wherein the overhang structure extends beyond a first end or the second of a microchannel.
However Tuszynski, in the same filed of endeavor, teaches (fig. 1) an overhang structure (114, 118), wherein the overhang structure (114, 118) extends beyond a first end or a second of a microchannel 104 (see fig. 1 and 0031).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Yaszemski to have an overhang structure, wherein the overhang structure extends beyond a first end or the second of a microchannel as taught by Tuszynski, for the purpose of being able to suture the scaffold to tissue (see Tuszynski [0031]).
Claims 94-112 are rejected under 35 U.S.C. 103 as being unpatentable over Tuszynski in view of Yaszemski.
Regarding claim 94, Tuszynski discloses (fig. 1-2) a tissue repair scaffold comprising: a cylindrical sheath 102 having a first end and a second end (see fig. 1); a microchannel 104 disposed within an interior of the sheath (see fig. 2, [0030]), wherein the microchannel 104 traverses the sheath from the first end to the second end (see fig. 1 and [0030]); wherein an outer surface of the sheath entirely surrounds the longitudinal axis of the microchannel (see fig. 1-2).
Tuszynski is silent regarding a marker disposed on an exterior surface of the sheath running substantially from the first end to the second end.
However Yaszemski, in the same filed of endeavor, teaches (fig. 1) a tissue repair scaffold comprising: a cylindrical (see [0123]) sheath 100 having a first end and a second end (see fig. 1 lower right); a microchannel 115 disposed within an interior of the sheath (see fig. 1, [0121] and [0125]), wherein the microchannel 115 traverses the sheath from the first end to the second end (see [0125]); and a marker (108 and space between two adjacent elements 108) disposed on an exterior surface of the sheath running substantially from the first end to the second end (see fig. 1 lower left, lower right, and [0128]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Tuszynski to have a marker disposed on an exterior surface of the sheath running substantially from the first end to the second end as taught by Yaszemski, for the purpose of increasing the surface area of the exterior surface to improve cell attachment and neural alignment (see Yaszemski [0168]).
Regarding claims 95, 96, 99, 100, 101, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94.
Yaszemski further teaches the marker comprises a groove (space between adjacent 108, see fig. 1); the marker comprises a feature 108 disposed on an exterior surface of the sheath running substantially from the first end to the second end (see fig. 1 and [0128]); a plurality of markers (108 and space between two adjacent elements 108), wherein the markers indicate the alignment of the scaffold and/or torsion placed upon the scaffold (108 extend in a straight line or a curved line the indication the alignment/torsion of the scaffold); the groove has a width 109 or depth of at least about 50 microns (see [0119]); the marker is substantially parallel with the microchannel (see fig. 1 and [0125]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Tuszynski to have a marker disposed on an exterior surface of the sheath running substantially from the first end to the second end the marker comprises a groove; the marker comprises a feature disposed on an exterior surface of the sheath running substantially from the first end to the second end; a plurality of markers, wherein the markers indicate the alignment of the scaffold and/or torsion placed upon the scaffold; the groove has a width or depth of at least about 50 microns; the marker is substantially parallel with the microchannel as taught by Yaszemski, for the purpose of increasing the surface area of the exterior surface to improve cell attachment and neural alignment (see Yaszemski [0168]).
Regarding claims 97 and 98, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94.
Yaszemski further teaches the exterior surface of the sheath comprises at least 2, grooves (spaces between the other ridges 108) disposed thereon (see fig. 1 and [0128]); the grooves (spaces between the other ridges 108) are about evenly dispersed about a circumference of the sheath (see fig. 1 and [0119]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Tuszynski to have the exterior surface of the sheath comprises at least 2, 3, or 4 grooves disposed thereon; the grooves are about evenly dispersed about a circumference of the sheath as taught by Yaszemski, for the purpose of increasing the surface area of the exterior surface to improve cell attachment and neural alignment (see Yaszemski [0168]).
Regarding claim 102, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) the tissue repair scaffold comprises a plurality of microchannels 104 disposed within the interior of the sheath (see fig. 2 and [0030]).
Regarding claim 103, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) the plurality of microchannels 104 are substantially parallel (see fig. 1).
Regarding claim 104, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski as modified further teaches the marker is substantially parallel to each of the plurality of microchannels (Tuszynski has microchannels that run parallel to a longitudinal axis and is modified to have markers that run parallel to the longitudinal axis).
Regarding claim 105, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) a length of the scaffold is about 0.5 cm to about 30 cm (see [0039]).
Regarding claim 106, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) the inner diameter of the sheath is about 1.5 mm to about 10 mm (see [0066]).
Regarding claim 107, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) the sheath, the microchannel, or both are made from a biodegradable polymer (see [0041]).
Regarding claim 108, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) the biodegradable polymer is selected from polyethylene glycol, polyethylene glycol diacrylate, gelatin,methacrylated gelatin, collagen, methacrylated collagen, polylactic acid, poly glycolic acid,poly(lactic-co-glycolic acid), polycaprolactone, and acrylated polycaprolactone, or any combination thereof (see [0041]).
Regarding claim 109, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) the biodegradable polymer is polycaprolactone (see [0041]).
Regarding claim 110, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) walls of the microchannel comprise hydrogel materials (see [0046]).
Regarding claim 111, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) an overhang structure 118, wherein the overhang structure extends beyond a first end or a second end of the microchannel (see fig. 1 and [0031]).
Regarding claim 112, Tuszynski as modified discloses the claimed invention substantially as claimed, as set forth above for claim 94. Tuszynski further discloses (fig. 1-2) the sheath has a thickness of at least about 250 microns (the inner diameter of the sheath can be 1.6mm, see [0066], and the outer diameter can be 2.5 mm to about 3.5 mm, see [0040], meaning that the sheath thickness would be at least 250 microns).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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