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 .
CLAIM INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘bioresorbable conduit’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13) in the reply filed on 31 March 2026 is acknowledged.
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 March 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-2 and 6-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rodrigues De Carvalho et al. (US 2019/0167843A1, “Rodrigues De Carvalho”).
Regarding claims 1, 6, 7 and 8, Rodrigues De Carvalho discloses an implantable medical device including a tubular bioresorbable (silk, collagen; [0012, 0036, 0109]) nerve guidance conduit [0012]. An exterior surface of the conduit includes one or more weakened areas (Fig. 5) in the form of pores that are capable of degrading preferentially to a remainder of the bioresorbable conduit due to the difference in thickness and an interior surface (Fig. 7).
Regarding claim 2, Rodrigues De Carvalho discloses that the one or more weakened areas are surface depressions in the form of pores wherein a portion is lower than the surrounding area [0025; Fig. 5].
Regarding claim 9, Rodrigues De Carvalho discloses that the bioresorbable conduit has an internal diameter between 1mm and 10mm [0033; Rodrigues De Carvalho] which is within the claimed range of about 0.5mm to about 20mm.
Regarding claim 10, Rodrigues De Carvalho discloses that the bioresorbable conduit has a length of 5mm to 100mm which is within the claimed range of about 1 mm to about 200 mm [0034; Rodrigues De Carvalho].
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Downes et al. (US 2011/0245852A1, “Downes”).
Regarding claim 20, Downes discloses an implantable medical device including a first (inner) surface including one or more weakened areas (pits; [0060-0061]) that are capable of degrading preferentially to a remainder of the bioresorbable conduit due to the difference in thickness [0009]. A second (exterior) surface has a different density and/or degree of weakening of one or more weakened areas than another area of the first surface [0069-0072].
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(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodrigues De Carvalho in view of Archibald et al. (US 2019/0357910A1, “Archibald”).
Regarding claim 3, Rodrigues De Carvalho does not disclose that the one or more weakened areas each have a diameter of 50-2000µm. In the same field of endeavor, nerve regeneration devices, Archibald teaches a resorbable conduit including pores on an abluminal surface. Each pore has an average diameter of about 20µm to about 200µm [0048]. As seen in Rodrigues De Carvalho, the diameter of the one or more weakened areas are disclosed as result effective variables in that changing the diameter of the one or more weakened areas changes the permeability which affects the capability of capillary ingrowth. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Rodrigues De Carvalho to have a diameter within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. 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 the device of Rodrigues De Carvalho by making the diameter of the one or more weakened areas within the claimed range of 50-200µm, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodrigues De Carvalho in view of Yuan et al. (US 20190022276A1, “Yuan”).
Regarding claims 4 and 5, Rodrigues De Carvalho does not disclose that the weakened areas are capable of being obtained by chemically-treating, mechanically-treating or heat-treating the exterior surface. In the same field of endeavor, nerve conduits, Yuan teaches a nerve conduit including holes that are formed through heat-treating by way of laser [abs]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Rodrigues De Carvalho with means to form the one or more weakened areas via heat-treating/laser, as taught by Yuan, to provide means for capillary ingrowth production.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodrigues De Carvalho in view of Downes et al. (US 2011/0245852A1, “Downes”).
Regarding claim 11, Rodrigues De Carvalho does not disclose that the one or more weakened areas extend less than half of a thickness of the bioresorbable conduit from the exterior surface towards the interior surface. In the same field of endeavor, nerve growth conduits, Downes teaches a nerve conduit having a wall thickness within the range of 10µm and 300µm [0029] and weakened areas in the form of pits having a depth within the range of less than 1µm [0070] which is less than half of the thickness from the exterior surface towards the interior surface. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Rodrigues De Carvalho with the one or more weakened areas having a depth that is less than half of the thickness of the conduit, as taught by Downes, to provide means to prevent regenerating axons from escaping from the conduit and prevent ingrowth of fibrous tissues that lead to unwanted scarring [0077].
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodrigues De Carvalho in view of Rush (US 2005/0137677A1, “Rush”).
Regarding claims 12 and 13, Rodrigues De Carvalho does not disclose an area of the exterior surface has a different density and/or degree of weakening of weakened areas than another area of the exterior surface, wherein a density of weakened areas near distal ends of the bioresorbable conduit is higher than a density of weakened areas around a middle of a length of the bioresorbable conduit; and/or a degree of weakening of weakened areas near the distal ends of the bioresorbable conduit is higher than a degree of weakening of weakened areas around the middle of the length of the bioresorbable conduit.
In the same field of endeavor, porous conduits promoting tissue ingrowth, Rush teaches a conduit having end regions (3608) that are more porous than the central region (3606; Fig. 35; [0295]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided distal end regions of the conduit of Rodrigues De Carvalho with a higher density of weakened areas than a middle length of the conduit, as taught by Rush, to promote tissue ingrowth through the weakened areas and/or facilitation of controlled release of a bioactive agent [0295].
Claim(s) 1, 2 and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Valentini et al. (US 4,877,029. “Valentini”) in view of Rodrigues De Carvalho et al. (US 2019/0167843A1, “Rodrigues De Carvalho”).
Regarding claims 1, 6, 7, 8, Valentini discloses an implantable medical device including a biodegradable (C3;L15-25) tubular conduit (10;Fig. 3) that is a nerve guidance conduit. An exterior surface (14) of the conduit includes one or more weakened areas (Fig. 3; C3:L1-10) in the form of pores that are capable of degrading preferentially to a remainder of the bioresorbable conduit due to the difference in thickness and an interior surface (Fig. 3). However, Valentini does not disclose that the device is formed of a bioresorbable conduit.
In the same field of endeavor, nerve guidance conduits, Rodrigues De Carvalho discloses a bioresorbable implantable medical device formed of silk and collagen [0036,0109] conduit [0012]. An exterior surface of the conduit includes one or more weakened areas (Fig. 5) in the form of pores that are capable of degrading preferentially to a remainder of the bioresorbable conduit due to the difference in thickness and an interior surface (Fig. 7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the conduit of Valentini with the bioresorbable material, as taught by Rodrigues De Carvalho, as this modification involves the simple substitution of one biocompatible material for another for the predictable result of being degraded within the body, avoiding the need to re-enter the body for removal. Furthermore, bioresorbability provides means for the material to gradually be broken down and absorbed by the body.
Regarding claim 2, the combination of Valentini and Rodrigues De Carvalho discloses that the one or more weakened areas are surface depressions in the form of pores wherein a portion is lower than the surrounding area (Fig. 3; Valentini).
Regarding claim 9, the combination of Valentini and Rodrigues De Carvalho that the bioresorbable conduit has an internal diameter between 1mm and 10mm [0033; Rodrigues De Carvalho] which is within the claimed range of about 0.5mm to about 20mm.
Regarding claim 10, the combination of Valentini and Rodrigues De Carvalho the bioresorbable conduit has a length of 5mm to 100mm which is within the claimed range of about 1 mm to about 200 mm [0034; Rodrigues De Carvalho].
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Valentini in view of Rodrigues De Carvalho, as applied to claim 1 above, and further in view of Archibald et al. (US 2019/0357910A1, “Archibald”).
Regarding claim 3, the combination of Valentini and Rodrigues De Carvalho discloses weakened areas or pores that are relatively large (C2: L60-68; Valentini) to optimize nerve regrowth conditions but does not disclose that the one or more weakened areas each have a diameter of 50-2000µm. In the same field of endeavor, nerve regeneration devices, Archibald teaches a resorbable conduit including pores on an abluminal surface. Each pore has an average diameter of about 20µm to about 200µm [0048]. As seen in the combination of Valentini and Rodrigues De Carvalho, the diameter of the one or more weakened areas are disclosed as result effective variables in that changing the diameter of the one or more weakened areas changes the permeability which affects the capability of capillary ingrowth. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the combination of Valentini and Rodrigues De Carvalho to have a diameter within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. 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 the device of the combination of Valentini and Rodrigues De Carvalho by making the diameter of the one or more weakened areas within the claimed range of 50-200µm, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Valentini in view of Rodrigues De Carvalho, as applied to claim 1 above, and further in view of Yuan et al. (US 20190022276A1, “Yuan”).
Regarding claims 4 and 5, the combination of Valentini and Rodrigues De Carvalho does not disclose that the weakened areas are capable of being obtained by chemically-treating, mechanically-treating or heat-treating the exterior surface. In the same field of endeavor, nerve conduits, Yuan teaches a nerve conduit including holes that are formed through heat-treating by way of laser [abs]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the combination of Valentini and Rodrigues De Carvalho with means to form the one or more weakened areas via heat-treating/laser, as taught by Yuan, to provide means for capillary ingrowth production.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Valentini in view of Rodrigues De Carvalho, as applied to claim 1 above, and further in view of Downes et al. (US 2011/0245852A1, “Downes”).
Regarding claim 11, the combination of Valentini and Rodrigues De Carvalho does not disclose that the one or more weakened areas extend less than half of a thickness of the bioresorbable conduit from the exterior surface towards the interior surface. In the same field of endeavor, nerve growth conduits, Downes teaches a nerve conduit having a wall thickness within the range of 10µm and 300µm [0029] and weakened areas in the form of pits having a depth within the range of less than 1µm [0070] which is less than half of the thickness from the exterior surface towards the interior surface. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the combination of Valentini and Rodrigues De Carvalho with the one or more weakened areas having a depth that is less than half of the thickness of the conduit, as taught by Downes, to provide means to prevent regenerating axons from escaping from the conduit and prevent ingrowth of fibrous tissues that lead to unwanted scarring [0077].
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Valentini in view of Rodrigues De Carvalho, as applied to claim 1 above, and further in view of Rush (US 2005/0137677, “Rush”).
Regarding claims 12 and 13, the combination of Valentini and Rodrigues De Carvalho does not disclose an area of the exterior surface has a different density and/or degree of weakening of weakened areas than another area of the exterior surface, wherein a density of weakened areas near distal ends of the bioresorbable conduit is higher than a density of weakened areas around a middle of a length of the bioresorbable conduit; and/or a degree of weakening of weakened areas near the distal ends of the bioresorbable conduit is higher than a degree of weakening of weakened areas around the middle of the length of the bioresorbable conduit.
In the same field of endeavor, porous conduits promoting tissue ingrowth, Rush teaches a conduit having end regions (3608) that are more porous than the central region (3606; Fig. 35; [0295]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided distal end regions of the conduit of the combination of Valentini and Rodrigues De Carvalho with a higher density of weakened areas than a middle length of the conduit, as taught by Rush, to promote tissue ingrowth through the weakened areas and/or facilitation of controlled release of a bioactive agent [0295].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Li et al. (US 2003/0028204A1) discloses a nerve guidance conduit formed of bioresorbable material.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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