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
This office action is responsive to the amendment filed on 05/12/2026. As directed by the amendment: claims 47, 49, 51-53, 55, 56, 59-61, 63-71, 73-79, 81, 82, 84-94 have been amended and claims 1-46, 48, 50, 54, 57, 58 and 62 have been cancelled. Thus, claims 47, 49, 51-53, 55, 56, 59-61, 63-95 are presently pending in this application with claims 53, 77, 79-81, and 88 withdrawn.
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.
(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 47, 49, 51, 52, 55, 56, 59, 60, 63, 71, 75, 76, 91, and 93 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Droese (US 20040186488 A1).
Regarding claim 47 Droese discloses (fig. 2) a method for repairing, supporting, and/or guiding a lesioned nerve (see [0030]), the method comprising the steps of:
providing a nerve conduit comprising an elongated body (main conduit, see fig. 2 and [0023]-[0024]) comprising:
a central portion defining an inner cavity (see annotated fig. 2 below); and
a first end portion and a second end portion arranged adjacent to the central portion and at a longitudinally opposing ends of the elongated body, the first end portion defining a first opening to the inner cavity, and the second end portion defining a second opening to the inner cavity, wherein a cross-sectional area of at least one of the first openings or the second opening is larger than a cross-sectional area of the inner cavity of the central portion (see annotated fig. 2 below);
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wherein the inner cavity and the first opening and/or the second opening are formed by a single wall of the elongated body defining an inner diameter and an outer diameter of the elongated body (see fig. 2),
wherein the cross-sectional area of at least one of the first opening and/or the second opening increases in a longitudinal direction of the elongated body and away from the central portion (see fig. 2 and [0023]),
wherein the wall comprises an essentially continuous thickness along a circumferential direction and the longitudinal direction of the elongated body (see fig. 2),
inserting one end of a lesioned nerve into the nerve conduit via the first opening having the cross-sectional area larger than the cross-sectional area of the inner cavity of the central portion (see [0030]);
inserting another end of the lesioned nerve via the second opening (see [0030]); and
securing the lesioned nerve ends within the elongated body (see [0030]-[0031]).
Regarding claim 49 Droese discloses (fig. 2) a method for treating a peripheral lesioned nerve (see [0030]), the method comprising the steps of:
providing a nerve conduit comprising an elongated body (main conduit, see fig. 2 and [0023]-[0024]) comprising:
a central portion defining an inner cavity (see annotated fig. 2 below); and
a first end portion and a second end portion arranged adjacent to the central portion and at a longitudinally opposing ends of the elongated body, the first end portion defining a first opening to the inner cavity, and the second end portion defining a second opening to the inner cavity, wherein a cross-sectional area of the first opening and/or the second opening is larger than a cross-sectional area of the inner cavity of the central portion (see annotated fig. 2 below);
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wherein the inner cavity and the first opening and/or the second opening are formed by a single wall of the elongated body defining an inner diameter and an outer diameter of the elongated body (see fig. 2),
wherein the cross-sectional area of the first opening and/or the second opening increases in a longitudinal direction and away from the central portion (see fig. 2 and [0023]),
wherein the wall comprises an essentially continuous thickness along a circumferential direction and the longitudinal direction of the elongated body (see fig. 2),
inserting one end of a lesioned nerve into the nerve conduit via the first opening having the cross-sectional area larger than the cross-sectional area of the inner cavity of the central portion (see [0030]);
inserting another end of the lesioned nerve via the second opening (see [0030]); and
securing the lesioned nerve ends within the elongated body by applying a medical adhesive around the first opening and around the second opening (see [0030]-[0032]).
Regarding claim 51 Droese further discloses (fig. 2) the central portion is formed as an essentially tubular shape (see fig. 2).
Regarding claim 52 Droese further discloses (fig. 2) the first opening and/or the second opening and inner cavity define a single lumen or continuous through hole (see fig. 2).
Regarding claim 55 Droese further discloses (fig. 2) the first end portion and/or the second end portion and the first opening and/or the second opening are formed as a rotationally symmetric shape along a longitudinal axis defined by the elongated body, said shape being an essentially U-shape, sigmoidal shape, conical shape, concave shape, funnel shape, or parabolic shape (see fig. 2).
Regarding claim 56 Droese further discloses (fig. 2) the first end portion and/or the second end portion are equally formed (see fig. 2).
Regarding claim 59 Droese further discloses (fig. 2) the inner diameter and the outer diameter of the central portion are essentially continuous in the longitudinal direction of the elongated body (see fig. 2).
Regarding claim 60 Droese further discloses (fig. 2) the inner diameter and the outer diameter of the first opening and/or the second opening increases in the longitudinal direction away from the central portion (see fig. 2).
Regarding claim 63 Droese further discloses (fig. 2) an outer surface of the first end portion and/or the second end portion extending from the central portion is aligned with an outer surface of the central portion and/or is free of steps or edges with the outer surface of the central portion (see fig. 2).
Regarding claim 71 Droese further discloses (fig. 2) the central portion is defined by an interface region between the first end portion and/or the second end portion and/or the first opening and/or the second opening (point where flare begins), wherein an extension of the central portion in the longitudinal direction is less than about 10 percent of a smallest extension (portion of flared section) of the first end portion and/or the second end portion and/or the first opening and/or the second opening in the longitudinal direction (The Office notes that the claims do not specify any specifics for the “extensions” therefore they can be any length of the central/end portions; as such the claim extension of the central portion is chosen as the portion that is less than 10 percent of the extension of the end portion).
Regarding claim 75 Droese further discloses (fig. 2) the inner cavity of the central portion defines a single lumen and the nerve conduit comprises the first end portion and the second end portion, which are located at either end of the central portion (see fig. 2 and [0023]-[0024]), wherein a maximum outer diameter of the end portions is larger than an outer diameter of the central portion and an outer end of the end portion is provided by a continuous edge (see fig. 2).
Regarding claim 76 Droese further discloses (fig. 2) the cross-sectional area of the first opening and/or the second opening increases in the longitudinal direction and away from the central portion (see fig. 2 and [0023]); the first end portion and/or the second end portion and the first opening and/or the second opening are formed as a rotationally symmetric funnel along a longitudinal axis defined by the elongated body (see fig. 2); the inner diameter and outer diameter of the central portion of the elongated body are essentially continuous in the longitudinal direction of the elongated body (see fig. 2).
Regarding claim 91 Droese further discloses (fig. 2) the elongated body is formed of a biocompatible material, an inert material, a bioimplantable material, and/or biodegradable material (see [0023]).
Regarding claim 93 Droese further discloses (fig. 2) the central portion, the first end portion, and the second end portion are or formed of a single piece (see fig. 1-2 and [0023]).
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 61, 67-40, and 72-74 are rejected under 35 U.S.C. 103 as being unpatentable over Droese.
Regarding claim 61 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a ratio between a maximum diameter of the first opening and/or the second opening and a diameter of the inner cavity is between 1.05:1.0 and 1.5:1.0, or between 1.05:1.0 and 1.2:1.0.
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 Droese to a ratio between a maximum diameter of the first opening and/or the second opening and a diameter of the inner cavity is between 1.05:1.0 and 1.5:1.0, or between 1.05:1.0 and 1.2:1.0 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings. Further, applicant places no criticality on the range claimed, indicating simply that the ratio is “preferably” within the claimed range (specification [0049]).
Regarding claim 64 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a ratio between a length of the central portion and a length of the first end portion and/or the second end portion in the longitudinal direction is from 1.2:1.0 to 15:1.0; or from 1.2:1.0 to 12:1.0; or from 1.2:1.0 to 10:1.0.
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 Droese to a ratio between a length of the central portion and a length of the first end portion and/or the second end portion in the longitudinal direction is from 1.2:1.0 to 15:1.0; or from 1.2:1.0 to 12:1.0; or from 1.2:1.0 to 10:1.0 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the ratio is “preferably” within the claimed range (specification [0056]).
Regarding claim 65 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a ratio between a length of the central portion and a length of the first end portion and/or the second end portion in the longitudinal direction is between 1.2:1.0 and 6.0:1.0; or between 1.2:1.0 and 1.4:1.0; or between 1.8:1.0 and 2.2:1.0; or between 4.4:1.0 and 5.4:1.0.
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 Droese to have a ratio between a length of the central portion and a length of the first end portion and/or the second end portion in the longitudinal direction is between 1.2:1.0 and 6.0:1.0; or between 1.2:1.0 and 1.4:1.0; or between 1.8:1.0 and 2.2:1.0; or between 4.4:1.0 and 5.4:1.0 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the ratio is “preferably” within the claimed range (specification [0056]).
Regarding claim 66 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a ratio between a length of the central portion and a length of the elongated body in the longitudinal direction is from 0.3:1.0 to 1:1.0, or between 0.3:1.0 and 0.8:1.0.
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 Droese to have a ratio between a length of the central portion and a length of the elongated body in the longitudinal direction is from 0.3:1.0 to 1:1.0, or between 0.3:1.0 and 0.8:1.0 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the ratio is “preferably” within the claimed range (specification [0058]).
Regarding claim 67 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a length of the central portion in a longitudinal direction is from 3 mm to 40 mm, or from 4 mm to 30 mm, or from 4.5 mm to 25 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 Droese to have a length of the central portion in a longitudinal direction is from 3 mm to 40 mm, or from 4 mm to 30 mm, or from 4.5 mm to 25 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the length “may be” within the claimed range (specification [0060]).
Regarding claim 68 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a length of the elongate body in a longitudinal direction is between 5 mm and 50 mm, or from 6 mm to 40 mm, or from 7 mm to 30 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 Droese to have a length of the elongate body in a longitudinal direction is between 5 mm and 50 mm, or from 6 mm to 40 mm, or from 7 mm to 30 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the length “may be” within the claimed range (specification [0060]).
Regarding claim 69 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a length of the first end portion and/or the second end portion in the longitudinal direction is from 1 mm to 8 mm, or between 1.3 mm and 6.5 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 Droese to have a length of the first end portion and/or the second end portion in the longitudinal direction is from 1 mm to 8 mm, or between 1.3 mm and 6.5 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the length “may be” within the claimed range (specification [0060]).
Regarding claim 70 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a length of the central portion in the longitudinal direction is between 5 mm and 10 mm, or between 6.5 mm and 8.5 mm, wherein a length of the elongated body in the longitudinal direction is between 7 mm and 25 mm, or between 9 mm and 22 mm, and/or wherein a length of the first end portion and/or the second end portion in the longitudinal direction is between 1 mm and 8 mm, or between 1.3 mm and 6.5 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 Droese to have a length of the central portion in the longitudinal direction is between 5 mm and 10 mm, or between 6.5 mm and 8.5 mm, wherein a length of the elongated body in the longitudinal direction is between 7 mm and 25 mm, or between 9 mm and 22 mm, and/or wherein a length of the first end portion and/or the second end portion in the longitudinal direction is between 1 mm and 8 mm, or between 1.3 mm and 6.5 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the ranges claimed, indicating simply that the lengths “may be” within the claimed ranges (specification [0060]).
Regarding claim 72 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a length of one of the end portions in a diameter of the inner cavity is from 1 mm to 15 mm, or from 1 mm to 12 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 Droese to have a diameter of the inner cavity is from 1 mm to 15 mm, or from 1 mm to 12 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the diameter is “preferably” within the claimed range (specification [0061]).
Regarding claim 73 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a maximum diameter of the first opening and/or the second opening is from 1 mm to 15 mm, or from 1.5 mm to 13 mm, or from 1.75 mm to 7 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 Droese to have a maximum diameter of the first opening and/or the second opening is from 1 mm to 15 mm, or from 1.5 mm to 13 mm, or from 1.75 mm to 7 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the diameter is “preferably” within the claimed range (specification [0061]).
Regarding claim 74 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding a diameter of the inner cavity is between 1 mm and 12 mm, or between 1.5 mm and 6.5 mm, and/or wherein a maximum diameter of the first opening and/or the second is between 1.5 mm and 11 mm, or between 1.75 mm and 6.5 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 Droese to have a diameter of the inner cavity is between 1 mm and 12 mm, or between 1.5 mm and 6.5 mm, and/or wherein a maximum diameter of the first opening and/or the second is between 1.5 mm and 11 mm, or between 1.75 mm and 6.5 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 Droese would not operate differently with the claimed ratio as the nerve ends would still be able to be inserted into the openings and secured within the tube. Further, applicant places no criticality on the range claimed, indicating simply that the diameters are “preferably” within the claimed ranges (specification [0061]).
Claims 78, 82-87, 89, and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Droese in view of Paulos et al. (US 20110282448 A1).
Regarding claims 78 and 82-87 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding the first end portion and/or the second end portion comprise one or more retention surfaces at an outer surface of the elongated body and are configured for securing a medical adhesive to the respective end portion; the one or more retention surfaces are formed as at least one groove extending in a helical direction along a longitudinal axis defined by the elongate body; the at least one groove comprises rounded edges and/or wherein the at least one groove defines at least one undercut; the at least one groove defines an outermost edge of the respective end portion in a longitudinal direction of the elongate body; the at least one groove comprises a radial depth varying in accordance with an increase of a cross-sectional area of the first opening and/or the second opening in the longitudinal direction and away from the central portion; the at least one groove extends between 0.5 and 10 revolutions around a longitudinal axis defined by the elongate body; the at least one groove extends between 2 and 6 revolutions around the longitudinal axis defined by the elongate body.
However Paulos, in the same field of endeavor, teaches (fig. 20H) of an end portion of a tube comprising one or more retention surfaces at an outer surface of the elongate body (ridges of the rough surface, see fig. 20H and [0180]) and being configured for securing a medical adhesive to the respective end portion (the ridges are capable of receiving a medical adhesive therein); the one or more retention surfaces of a respective end portion are formed as at least one groove (portion in between ridges in fig, 20GH extending in a helical direction along a longitudinal axis defined by the elongate body (see fig. 20H); the at least one groove comprises rounded edges (see fig. 20H); the at least one groove defines an outermost edge of the respective end portion in a longitudinal direction of the elongate body (see fig. 20H); the at least one groove comprises a radial depth (measure between the ridges) varying in accordance with an increase of a cross-sectional area of the at least one opening in the longitudinal direction and away from the central portion (the space between the ridges can be seen to increase with an increase in cross-sectional area; see fig. 20H and [0180]); the at least one groove extends between 0.5 and 10 revolutions around a longitudinal axis defined by the elongate body (see fig. 20H); the at least one groove extends between 2 and 6 revolutions around the longitudinal axis defined by the elongate body (see fig. 20H).
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 Droese to have the first end portion and/or the second end portion comprises one or more retention surfaces at an outer surface of the elongate body and being configured for securing a medical adhesive to the respective end portion; the one or more retention surfaces of a respective end portion are formed as at least one groove extending in a helical direction along a longitudinal axis defined by the elongate body; the at least one groove comprises rounded edges; the at least one groove defines an outermost edge of the respective end portion in a longitudinal direction of the elongate body; the at least one groove comprises a radial depth varying in accordance with an increase of a cross-sectional area of the at least one opening in the longitudinal direction and away from the central portion; the at least one groove extends between 0.5 and 10 revolutions around a longitudinal axis defined by the elongate body; the at least one groove extends between 2 and 6 revolutions around the longitudinal axis defined by the elongate body as taught by Paulos, for the purpose of having a more secure connection to the location the device is places (see Paulos [0099]).
Regarding claims 78, 89 and 90 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding the first end portion and/or the second end portion comprise one or more retention surfaces at an outer surface of the elongated body and are configured for securing a medical adhesive to the respective end portion; the one or more retention surfaces are formed as one or more circumferential ribs extending from an outer surface of the elongate body; the extension of the one or more ribs extends linearly to a circumferential direction or comprises an offset to the circumferential direction in a longitudinal direction of the elongate body.
However Paulos, in the same field of endeavor, teaches (fig. 20H) of an end portion of a tube comprising one or more retention surfaces body (ridges of the rough surface, see fig. 20H and [0180]) at an outer surface of the elongate body and being configured for securing a medical adhesive to the respective end portion (the ridges are capable of receiving a medical adhesive therein); the one or more retention surfaces of a respective end portion are formed as one or more circumferential ribs extending from an outer surface of the elongate body (see fig. 20H); the extension of the one or more ribs offset to the circumferential direction in a longitudinal direction of the elongate body (spiral configuration, see fig. 20H).
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 Droese to have at least one of the end portions comprises one or more retention surfaces at an outer surface of the elongate body and being configured for securing a medical adhesive to the respective end portion; the one or more retention surfaces of a respective end portion are formed as one or more circumferential ribs extending from an outer surface of the elongate body; the extension of the one or more ribs comprises an offset to the circumferential direction in a longitudinal direction of the elongate body as taught by Paulos, for the purpose of having a more secure connection to the location the device is places (see Paulos [0099]).
Claims 92 and 94 is rejected under 35 U.S.C. 103 as being unpatentable over Droese in view of Bright et al. (US 20210315587 A1).
Regarding claims 92 and 94 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding the elongated body is formed of a polymer-based material, or an elastomer; the elongate body is formed of a polymerized and/or crosslinked polymer unit comprising an ester group component and an acid ester group component, the ester group component being a polyol and the acid ester group component being a polyacid.
However Bright, in the same filed of endeavor, teaches an elongate body is formed of a polymerized and/or crosslinked polymer unit comprising an ester group component and an acid ester group component, the ester group component being a polyol (see [0259]) and the acid ester group component being a polyacid (see [0294]).
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 Droese have the elongate body is formed of a polymerized and/or crosslinked polymer unit comprising an ester group component and an acid ester group component, the ester group component being a polyol and the acid ester group component being a polyacid as taught by Bright, for the purpose of improving degradation of the device in the body (see Bright [0259], [0294]).
Claim Rejections - 35 USC § 102/103
Claim 95 is rejected under 35 U.S.C. 102 as anticipated by Droese or in the alternative under 35 U.S.C. 103 as obvious over Droese.
Regarding claim 95 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding the nerve conduit is formed by a 3D-printing process. The claimed phrase “formed by a 3D-printing process” is being treated as a product by process limitation; that is, that the nerve conduit is made by 3D printing. 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. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Droese is silent as to the process used form the nerve conduit, it appears that the product in Droese would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a biodegradable material.
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over Droese in view of Romero-Ortega et al. (US 20150374887 A1).
Regarding claim 95 Droese discloses the claimed invention substantially as claimed, as set forth above for claim 49. Droese is silent regarding the nerve conduit is formed by a 3D-printing process. The claimed phrase “formed by a 3D-printing process” is being treated as a product by process limitation; that is, that the nerve conduit is made by 3D printing.
Romero-Ortega teaches of a nerve conduit formed from 3D printing (see [0047]).
Therefore, even if “3D printing” results in different structural characteristics of the end product than other manufacturing methods, it still would have been prima facie obvious before the effective filing date of the claimed invention to use a “3D printing” to form the device of Droese as claimed since Romero-Ortega teaches that 3D printing is recognized as a useful technique for forming nerve conduits.
Response to Arguments
Applicant’s arguments, see pg. 12, filed 05/12/2026, with respect to the rejection of claims 47 and 49-95 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 47 and 49-95 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments with respect to claim(s) 47, 49, 51-52, 54-60, 62, 63, 71, 75, 76, 91-93, and 95 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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