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 .
Election/Restrictions
Applicant’s election without traverse of group II, species F in the reply filed on 11/10/2025 is acknowledged.
Claims 53, 77 and 79-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species A-E and G, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025.
Additionally, claim 88 is withdrawn. Claim 88 recites “the respective end portion comprises at least two grooves extending in opposing circumferential directions and intersecting each other” which is specific to non-elected species G.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 47 and 49-95 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 47 recites the limitation "the lesioned nerve" in lines 9 and 11. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 47 recites “the opening having the cross-sectional area” in line 9-10. It is unclear which opening is being referred to since multiple openings are claimed and the language recites “at lease one” of the openings having the cross-sectional area (meaning more than one can have the claimed cross-sectional area). Appropriate correction is required.
Claim 47 line 11 recites “an opening at an end portion”. It is unclear if this opening and end portion are one of the previously recited openings and end portions or an addition opening and end portion. For examination purposes, the limitation will be interpreted as one of the previously recited openings and end portions. Appropriate correction is required.
Claim 49 recites “the opening having the cross-sectional area” in line 8-9. It is unclear which opening is being referred to since multiple openings are claimed and the language recites “at lease one” of the openings having the cross-sectional area (meaning more than one can have the claimed cross-sectional area). Appropriate correction is required.
Claim 49 line 11 recites “an opening at an end portion”. It is unclear if this opening and end portion are one of the previously recited openings and end portions or an addition opening and end portion. For examination purposes, the limitation will be interpreted as one of the previously recited openings and end portions. Appropriate correction is required.
Claim 55 recites the limitation “the at least one end portion” in line 1. It is unclear which end portion is referred to in this limitation because multiple end portions are claimed but none of them are specifically referred to as the at least one end portion. For examination purposes, the limitation will be interpreted as one of the end portions. Appropriate correction is required.
Claim 55 recites the limitation "the corresponding opening" in line 1-2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 70 recites the limitation "the length of the elongate body" in line 2-3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 70 recites the limitation "the length of one of the end portions" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 71 recites the limitation "respective end portions and/or corresponding opening" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required. It is unclear if this opening and end portion are one of the previously recited openings and end portions or an addition opening and end portion. For examination purposes, the limitation will be interpreted as one of the previously recited openings and end portions. Appropriate correction is required.
Claim 71 recites the limitation "respective opening and/or end portion" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required. It is unclear if this opening and end portion are one of the previously recited openings and end portions or an addition opening and end portion. For examination purposes, the limitation will be interpreted as one of the previously recited openings and end portions. Appropriate correction is required.
Claim 76 recites the limitation "the inner diameter and outer diameter" in line 9. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 90 recites the limitation "the extension" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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.
Claims 47, 49 and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lieberman (US 20100016874 A1).
Regarding claims 47 and 49 Lieberman discloses (fig. 1-9) a method for repairing, supporting, and/or guiding neural tissue and of treating a peripheral nerve lesion (see [0015]), comprising the steps of:
providing a nerve conduit 100 comprising an elongated body comprising:
a central portion (center of 100) defining an inner cavity (see fig., 2); and
end portions defining a respective opening (114, 116, see fig. 1-2 and [0019]) to the inner cavity and arranged adjacent to the central portion and at a longitudinally opposing ends of the elongated body 100 (see fig. 1-2), wherein a cross-sectional area of at least one of the openings is larger than a cross-sectional area of the inner cavity of the central portion (see fig. 2)
inserting one end 128 of the lesioned nerve into the nerve conduit via the opening 114 having the cross-sectional area larger than the cross-sectional area of the inner cavity of the central portion (see fig. 4 and [0029]);
inserting another end 130 of the lesioned nerve via an opening 116 at an end portion at a longitudinally opposing end of the elongate body (see fig. 7 and [0034]); and
securing the lesioned nerve ends within the elongate body (via compressive forces, see [0036]-[0037]).
Regarding claim 62 Lieberman further discloses (fig. 1-9) a maximum diameter of the at least one opening (114, 116) is smaller than the outer diameter of the central portion (see fig. 2).
Claims 47, 49 and 75 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arthur (US 2,127,903).
Regarding claims 47 and 49 Arthur discloses (fig. 6*) a method for repairing, supporting, and/or guiding neural tissue and of treating a peripheral nerve lesion (see pg. 3, right col. ln. 55-70), comprising the steps of:
providing a nerve conduit 8 comprising an elongated body comprising:
a central portion defining an inner cavity (center of 8, see fig. 6); and
end portions (ends of 8) defining a respective opening (openings at ends of 8) to the inner cavity and arranged adjacent to the central portion and at a longitudinally opposing ends of the elongated body (see fig. 6), wherein a cross-sectional area of at least one of the openings is larger than a cross-sectional area of the inner cavity of the central portion (see fig. 6 and pg. 2 ln. 25-30 and pg. 1 left col. ln. 48 – pg. 1 right col. ln. 9)
inserting one end of the lesioned nerve into the nerve conduit (see pg. 3, right col. ln. 55-70) via the opening having the cross-sectional area larger than the cross-sectional area of the inner cavity of the central portion (see fig. 6);
inserting another end of the lesioned nerve via an opening at an end portion at a longitudinally opposing end of the elongate body (see pg. 3, right col. ln. 55-70); and
securing the lesioned nerve ends within the elongate body (via sutures, see pg. 3, right col. ln. 55-70).
*Note that fig. 1-6 show different shapes of tubes that may be used while fig. 21 shows the method of treating a nerve.
Regarding claim 75 Arthur further discloses (fig. 6) the inner cavity of the central portion defines a single lumen and the nerve conduit comprises two of the end portions, which are located at either end of the central portion (see fig. 6), 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. 6).
Claims 47, 49, 51, 52, 54-60, 63, 71, 76, and 91-93 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishii et al. (WO 2012133019 A1).
All references to Ishii herein refer to the translation provided by applicant.
Regarding claims 47 and 49 Ishii discloses (fig. 1-3 and 6) a method for repairing, supporting, and/or guiding neural tissue and treating a peripheral nerve lesion (see [0030]) comprising the steps of:
providing a nerve conduit 101 comprising an elongated body comprising:
a central portion 110 defining an inner cavity 111 (see fig. 1 and [0031]): and
end portions 131 each defining a respective opening (113, 114) to the inner cavity 111 (see fig. 3) and arranged adjacent to the central portion and at a longitudinally opposing ends of the elongated body (see fig. 3 and [0037]), wherein a cross-sectional area of at least one of the openings is larger than a cross-sectional area of the inner cavity 111 of the central portion (see fig. 3 and [0037]).
inserting one end of the lesioned nerve 30 into the nerve conduit via the opening having the cross-sectional area larger than the cross-sectional area of the inner cavity of the central portion (see fig. 6A and [0049]);
inserting another end of the lesioned nerve 30 via an opening at an end portion at a longitudinally opposing end of the elongate body (see fig. 6A and [0049]); and
securing the lesioned nerve ends within the elongate body (via 141, see [0039]).
Regarding claim 51 Ishii further discloses (fig. 1-3 and 6) the central portion 110 is formed as an essentially tubular shape (see fig. 1 and 3) and the elongate body comprises two of the end portions 131 (see fig. 1 and 3).
Regarding claim 52 Ishii further discloses (fig. 1-3 and 6) the openings (113, 114) and inner cavity 111 define a single lumen or continuous through hole (see fig. 3).
Regarding claim 54 Ishii further discloses (fig. 1-3 and 6) the cross-sectional area of the at least one opening increases in the longitudinal direction and away from the central portion 110 (see fig. 3 and [0037]).
Regarding claim 55 Ishii further discloses (fig. 1-3 and 6) the at least one end portion and the corresponding opening are formed as a rotationally symmetric shape along a longitudinal axis defined by the elongate body, conical shape or funnel shape (see fig. 1 and 3).
Regarding claim 56 Ishii further discloses (fig. 1-3 and 6) the end portions 131 are equally formed (see fig. 1 and 3).
Regarding claim 57 Ishii further discloses (fig. 1-3 and 6) the inner cavity 111 and the openings (113, 114) are formed by a single wall of the elongate body defining an inner diameter and outer diameter of the elongate body (see fig. 3).
Regarding claim 58 Ishii further discloses (fig. 1-3 and 6) the wall comprises an essentially continuous thickness along the circumferential and longitudinal direction of the elongate body (see fig. 3).
Regarding claim 59 Ishii further discloses (fig. 1-3 and 6) the inner diameter and outer diameter of the central portion 110 are essentially continuous in the longitudinal direction of the elongate body (see fig. 3).
Regarding claim 60 Ishii further discloses (fig. 1-3 and 6) the diameter of the at least one opening (113, 114) increases in the longitudinal direction away from the central portion 110 (see fig. 3 and [0037]).
Regarding claim 63 Ishii further discloses (fig. 1-3 and 6) an outer surface of the end portions 131 extending from the central portion 110 is free of steps or edges with the outer surface of the central portion (see fig. 3, the outer surface is a smooth surface).
Regarding claim 71 Ishii further discloses (fig. 1-3 and 6) the central portion 110 is defined by an interface region (point where ends 131 begin to flare, see fig. 3 and [0037]) between respective end portions and/or corresponding openings, wherein an extension (a portion of 110)) of the central portion in a longitudinal direction is less than about 10 percent of a smallest extension (a portion of 131) of a respective opening and/or end portion 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 76 Ishii further discloses (fig. 1-3 and 6) the cross-sectional area of the at least one opening (113, 114) increases in a longitudinal direction and away from the central portion (see fig. 3 and [0037]);
the at least one end portion 131 and the corresponding opening (113, 114) are formed as a rotationally symmetric funnel along a longitudinal axis defined by the elongate body (see fig. 3);
the inner cavity and the openings (113, 114) are formed by a single wall of the elongate body defining an inner diameter and outer diameter of the elongate body and having an essentially continuous thickness along the circumferential and longitudinal direction of the elongate body (see fig. 3); and
the inner diameter and outer diameter of the central portion are essentially continuous in the longitudinal direction of the elongate body (see fig. 3).
Regarding claim 91 Ishii further discloses (fig. 1-3 and 6) the elongate body is formed of a biocompatible material, a bioimplantable material, and/or biodegradable material (see [0032]).
Regarding claim 92 Ishii further discloses (fig. 1-3 and 6) the elongate body is formed of a polymer- based material (see [0032]).
Regarding claim 93 Ishii further discloses (fig. 1-3 and 6) the central portion and the end portions are integrally formed or formed of a single piece (see fig. 3).
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.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Ishii in view of Juhn (US 3,916,905).
Regarding claim 50, Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding the securing of the lesioned nerve ends is performed by applying a medical adhesive outside of the inner cavity and/or into the openings via at least one of the openings and/or around the openings.
However Juhn, in the same filed of endeavor, teaches securing lesioned nerve ends by applying a medical adhesive around openings of a tube (col. 7 ln. 60 – col. 8 ln. 3).
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 Ishii have the securing of the lesioned nerve ends include applying a medical adhesive around the openings as taught by Juhn, for the purpose of having a more secure connection of the nerve ends in the tube (see Juhn col. 7 ln. 60 – col. 8 ln. 3).
Claims 61, 64-70, and 72-74 are rejected under 35 U.S.C. 103 as being unpatentable over Ishii.
Regarding claim 61 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding a ratio between a maximum diameter of the at least one opening and the 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 Ishii to have a ratio between a maximum diameter of the at least one opening and the 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding a ratio between a length of the central portion and a length of one of the end portions in a 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 Ishii to have a ratio between a length of the central portion and a length of one of the end portions in a 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding a ratio between a length of the central portion and a length of one of the end portions in a 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 Ishii to have a ratio between a length of the central portion and a length of one of the end portions in a 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding a ratio between a length of the central portion and a length of the elongate body in a 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 Ishii to have a ratio between a length of the central portion and a length of the elongate body in a 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii 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 Ishii 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii 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 Ishii 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding a length of one of the end portions in a 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 Ishii to have a length of one of the end portions in a 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding a length of the central portion in a longitudinal direction is between 5 mm and 10 mm, or between 6.5 mm and 8.5 mm, wherein the length of the elongate body in the longitudinal direction is between 7 mm and 25 mm, or between 9 mm and 22 mm, and/or wherein the length of one of the end portions 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 Ishii to have a length of the central portion in a longitudinal direction is between 5 mm and 10 mm, or between 6.5 mm and 8.5 mm, wherein the length of the elongate body in the longitudinal direction is between 7 mm and 25 mm, or between 9 mm and 22 mm, and/or wherein the length of one of the end portions 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii 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 Ishii 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding a maximum diameter of the at least one 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 Ishii to have a maximum diameter of the at least one 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 Ishii 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding the diameter of the inner cavity is between 1 mm and 12 mm, or between 1.5 mm and 6.5 mm, and/or wherein the maximum diameter of the at least one opening 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 Ishii to have the diameter of the inner cavity is between 1 mm and 12 mm, or between 1.5 mm and 6.5 mm, and/or wherein the maximum diameter of the at least one opening 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 Ishii 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 Ishii in view of Paulos et al. (US 20110282448 A1).
Regarding claims 78 and 82-87 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding 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 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 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.
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 Ishii 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 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 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding 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 is linear 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 Ishii 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]).
Claim 94 is rejected under 35 U.S.C. 103 as being unpatentable over Ishii in view of Bright et al. (US 20210315587 A1).
Regarding claim 94 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii is silent regarding 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 Ishii 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 Ishii or in the alternative under 35 U.S.C. 103 as obvious over Ishii.
Regarding claim 95 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii 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 Ishii is silent as to the process used form the nerve conduit, it appears that the product in Ishii 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 Ishii in view of Romero-Ortega et al. (US 20150374887 A1).
Regarding claim 95 Ishii discloses the claimed invention substantially as claimed, as set forth above for claim 49. Ishii 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 Ishii as claimed since Romero-Ortega teaches that 3D printing is recognized as a useful technique for forming nerve conduits.
Conclusion
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771