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 Objections
Claim 12 is objected to because of the following informalities: Claim 12 recites “wherein the first braided material comprises a first braid density that is within a range” in lines 1-2. Claim 12 depends from claim 11 which recites “a first braid density”. Therefore, the limitation of claim 12 should read “wherein the first braid density is within a range” for consistency purposes. Appropriate correction is required.
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, 6-9 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larson et al. (US 2017/0246017 A1).
Regarding claim 1, Larson discloses a delivery apparatus (stent delivery system 110; it is noted system 110 is similar in form and function to system 10 disclosed with the exception of outer shaft 28; Figs. 2, 5; [0068]) comprising: a handle body (handle 14) comprising a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end (Fig. 2); an outer shaft (deployment sheath 16) comprising a proximal end movably coupled to the handle body (as deployment of the stent includes proximal retraction of deployment sheath 16 via actuation member 18 disposed in handle 14; [0066]; Fig. 2); and an inner shaft (including inner shaft 24 and bumper shaft 38) extending through a lumen of the outer shaft (16; Figs. 2, 6; [0080]) and fixed relative to the handle body (as deployment sheath 16 is configured to shift relative to inner member 24 and bumper shaft 38 to deploy the stent; [0066]; [0080]), wherein the inner shaft (24, 38) comprises a first reinforcement layer (inner shaft 24 may include a reinforcement braid along the entire length of the inner shaft 24; [0072]) and a second reinforcement layer (bumper shaft 38 may include a reinforcement braid along the entire length of the bumper shaft 38; [0077]), wherein the first reinforcement layer (reinforcement braid of 24) extends from a proximal end portion of the inner shaft (proximal end of 24, 38) to a first distal location of the inner shaft (to distal tip 26; along the entire length of 24; [0072]), wherein the second reinforcement layer (reinforcement braid of 38) extends from the proximal end portion of the inner shaft (proximal end of 24, 38) to a second distal location of the inner shaft (to distal end of 38; along the entire length of 38; [0077]), and wherein the second distal location is proximal to the first distal location (Figs. 5-6).
Regarding claim 6, Larson discloses wherein the second distal location (distal end of 38) is proximal to a proximal end of a frame connector (separate bumper 45; Fig. 5) couped to the inner shaft (as bumper 45 may be coupled to the inner member 24; thus, the distal end of 38 would necessarily be proximal to 45; [0079]).
Regarding claim 7, Larson discloses wherein the first reinforcement layer (reinforcement braid of 24) and the second reinforcement layer (reinforcement braid of 38) extend proximally to a proximal end of the inner shaft (as the reinforcement braids extend the entire length of 24 and 38; [0072]; [0077]).
Regarding claim 8, Larson discloses wherein the proximal end portion of the inner shaft is configured to be disposed outside of a patient’s body during an implantation procedure (as the shaft 12, which includes 24 and 38 is connected at its proximal end to handle 14 and handle 14 is positioned outside of a patient’s body for a user to manually rotate actuation member 18; [0066]).
Regarding claim 9, Larson discloses wherein the first reinforcement layer (reinforcement braid of 24) comprises a first braided material ([0072]).
Regarding claim 17, Larson discloses a shaft (including inner shaft 24 and bumper shaft 38) for a delivery apparatus (stent delivery system 10 or 110; Figs. 1-2), comprising: a proximal end (towards handle 14); a distal end (towards distal tip 26); a first reinforcement layer (reinforcement braid of 24; [0072]) extending from a first proximal location of the shaft (proximal end of 24) to a first distal location of the shaft (to distal tip 26; along the entire length of 24; [0072]); and a second reinforcement layer (reinforcement braid of 38) extending from a second proximal location (proximal end of 38) of the shaft to a second distal location of the shaft (to distal end of 38; along the entire length of 38; [0077]), wherein the second distal location is proximal to the first distal location (Figs. 5-6).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson et al. (US 2017/0246017 A1) in view of Landon et al. (US 2019/0008639 A1).
Regarding claim 2, Larson discloses wherein the first distal location is at the distal end of the inner shaft (distal end of 24) and a nosecone (distal tip 26) may be attached to or otherwise disposed at the distal end of the inner shaft (24; [0075]; Fig. 5), but Larson fails to explicitly disclose how the nosecone is attached to the inner shaft i.e., that the first distal location axially overlaps with the nosecone coupled to the inner shaft.
However, Landon teaches a delivery apparatus (delivery system 10) with a handle body (handle 14); an outer shaft (outer sheath assembly 22); and an inner shaft (including nosecone shaft 27 and inner shaft assembly 18), wherein the distal end of the inner shaft at a first distal location (distal end of nosecone shaft 27) axially overlaps with a nosecone (nosecone 28) coupled to the inner shaft (Figs. 2A-2B).
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 inner member 24 of Larson to be positioned within the nosecone as taught by Landon. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of fixing the distal end of the inner member to the nosecone.
Regarding claims 3-5, Larson discloses wherein the second distal location is at the distal end of the bumper shaft (38) and the distal end of the bumper shaft is coupled to a frame connector (separate bumper 45 that may be coupled to the bumper shaft 38 and/or the inner member 24; [0079]; Fig. 5), but Larson fails to explicitly disclose how the frame connector is attached to the bumper shaft i.e., wherein the second distal location axially overlaps with the frame connector coupled to the inner shaft, wherein the second distal location is proximal to a distal end of the frame connector coupled to the inner shaft, and distal to a proximal end of the frame connector.
However, Landon teaches a delivery apparatus (delivery system 10) with a handle body (handle 14); an outer shaft (outer sheath assembly 22); and an inner shaft (including nosecone shaft 27 and inner shaft assembly 18), wherein a distal end of the inner shaft assembly (18) is proximal to a distal end of a frame connector (40) coupled to the inner shaft assembly (18) and distal to a proximal end of the frame connector (40; see annotated Fig. 2B below).
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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 bumper shaft 38 of Larson to be positioned within the frame connector as taught by Landon, such that the distal end of the bumper shaft 38 is proximal to a distal end of the frame connector and distal to a proximal end of the frame connector. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of fixing the distal end of the bumper shaft to the frame connector.
Claim(s) 10-15 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson et al. (US 2017/0246017 A1) in view of Lombardi et al. (US 2016/0262884 A1).
Regarding claim 10, Larson fails to disclose wherein the first braided material comprises metal wires.
However, Lombardi teaches a delivery apparatus (Figs. 1, 4) comprising: an outer shaft (flexible tube 30); and an inner shaft (flexible tubes 28, 26; Fig. 4), the inner shaft comprising a first reinforcement layer (flexible tube 28 may optionally include a reinforcement metal braid; [0193]; [0195]) and a second reinforcement layer (flexible tube 26 may optionally include a reinforcement metal braid; [0193]; [0195]), the first reinforcement layer comprises a first braided material comprising metal wires ([0195]).
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 first braided material of Larson to comprise metal wires as taught by Lombardi, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 11-15, Larson fails to disclose wherein the first braided material comprises a first braid density that is within a range of 5-60 PPI, wherein the first braid density is within a range of 40-60 PPI, wherein the first braid density is 45 PPI, wherein the first braid density is within a range of 5-20 PPI, and/or wherein the first braid density is 10 PPI.
However, Lombardi teaches a delivery apparatus (Figs. 1, 4) comprising: an outer shaft (flexible tube 30); and an inner shaft (flexible tubes 28, 26; Fig. 4), the inner shaft comprising a first reinforcement layer (flexible tube 28 may optionally include a reinforcement metal braid; [0193]; [0195]) and a second reinforcement layer (flexible tube 26 may optionally include a reinforcement metal braid; [0193]; [0195]), wherein the braided material comprises a braid density that may be for example about 10 PPI or about 50 PPI (as one tube may have a braid PPI of 10 or one tube may have a braid PPI of about 50 PPI [0195]). Lombardi teaches that a lower braid density may provide for greater torque transmission ([0195]) while a higher density may provide for greater column strength and the combination of two different braid densities may provide better characteristics than an identical braid in both tubes ([0195]).
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 first braided material of Larson to have a first braid density that is 45 PPI or 10 PPI in light of the teachings of Lombardi as applicant appears to have placed no criticality on the claimed range (see [0111], [0141] indicating the braid density “can” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, a higher braid density of 45 PPI would provide for greater column strength while a lower braid density of 10 PPI would provide for greater torque transmission.
Regarding claim 18, Larson discloses a delivery apparatus (stent delivery system 10 or 110; Figs. 1-2) comprising: a handle body (handle 14) including a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end (Figs. 1-2); an outer shaft (deployment sheath 16) including a proximal end movably coupled to the handle body (as deployment of the stent includes proximal retraction of deployment sheath 16 via actuation member 18 disposed in handle 14; [0066]; Fig. 2); and an inner shaft (including inner shaft 24 and bumper shaft 38) extending through a lumen of the outer shaft (16; Figs. 2, 6; [0080]) and fixed relative to the handle body (as deployment sheath 16 is configured to shift relative to inner member 24 and bumper shaft 38 to deploy the stent; [0066]; [0080]), wherein the inner shaft (24, 38) includes a first braided material (inner shaft 24 may include a reinforcement braid along the entire length of the inner shaft 24 or alternatively bumper shaft 38 may include a reinforcement braid along the entire length of bumper shaft 38; [0072]; [0077]) and a second braided material (bumper shaft 38 may include a reinforcement braid along the entire length of the bumper shaft 38 or alternatively inner shaft 24 may include a reinforcement braid along the entire length of the inner shaft 24; [0077]; [0072]).
Larson fails to disclose wherein the first braided material includes a first braid density, the second braided material includes a second braid density, wherein the second braid density is less than the first braid density.
However, Lombardi teaches a delivery apparatus (Figs. 1, 4) comprising: a handle body (handle 100; Figs. 1, 16) including a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end (Figs. 1, 16; [0252]); an outer shaft (flexible tube 30) and an inner shaft (flexible tubes 28, 26; Fig. 4), the inner shaft comprising a first reinforcement layer (flexible tube 28 or flexible tube 26 may optionally include a reinforcement metal braid; [0193]; [0195]) and a second reinforcement layer (flexible tube 26 or flexible tube 28 may optionally include a reinforcement metal braid; [0193]; [0195]), wherein the braided material comprises a braid density that may be for example about 10 PPI for one tube and about 50 PPI for the other tube (as one tube may have a braid PPI of 10 and one tube may have a braid PPI of about 50 PPI; [0195]). Lombardi teaches that a lower braid density may provide for greater torque transmission ([0195]) while a higher density may provide for greater column strength and the combination of two different braid densities may provide better characteristics than an identical braid in both tubes ([0195]).
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 first braided material and the second braided material of Larson such that a second braid density of the second braided material is less than a first braid density of the first braided material in light of the teachings of Lombardi in order to provide an inner shaft with improved characteristics for greater torque transmission and column strength.
Regarding claim 19, Larson modified discloses the invention as claimed above and Larson further discloses wherein the first braided material is disposed radially inwardly relative to the second braided material (when the reinforcement of 24 is interpreted as the first braided material; Figs. 4-5).
Regarding claim 20, Larson modified discloses the invention as claimed above and Larson further discloses wherein the first braided material is disposed radially outwardly relative to the second braided material (when the reinforcement of 38 is interpreted as the first braided material; Figs. 4-5).
3. Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson et al. (US 2017/0246017 A1) in view of Baker et al. (US 2013/0289697 A1).
Regarding claim 16, Larson fails to disclose wherein the first reinforcement layer is a triaxial braided material, and wherein the second reinforcement layer is a triaxial braided material.
However, Baker teaches a delivery apparatus (sheath for deploying a medical device to a target site; abstract) comprising: a sheath (10) with a reinforcement layer (reinforcing member 40) comprising a triaxial braided material (triaxial braid; [0031]; Fig. 1) for the purpose of enabling the sheath to maintain a sufficient inner diameter to enable deployment of a stent therefrom ([0041]). The presence of the longitudinal strands addresses the problems associated with conventional biaxial braids that provide less resistance to elongation ([0041]).
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 first and second reinforcement layers of Larson to be triaxial braided materials in light of the teachings of Baker in order to provide more resistance to elongation of the inner shaft and maintain a sufficient inner diameter of the inner shaft during deployment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dorn (US 2021/0393423 A1) is noted for teaching reinforcement braids on an inner shaft.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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