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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/10/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1, 5, 6, 17, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. US 2010/0022948 A1 (hereinafter Wilson).
Regarding claim 1, Wilson discloses an outer sheath 206 (Fig. 19 – shaft 206) for surrounding and covering components of a delivery device 200a (Fig. 18 – steerable catheter 200a, and Par. 73 – “the steerable catheter 200a may include shaft 206 defining at least one lumen 202. The lumen 202 may be configured to receive the dilator 34 and/or an implant (not shown)”), the outer sheath 206 (Fig. 19) comprising:
a straight section 208n (Fig. 19 – segment 208n) including an aperture 202 (Fig. 19 – lumen 202) extending fully through the straight section 208n (Fig. 19); and
a pre-curved section 208b (Fig. 19 – segment 208b) extending distally from an end of the straight section 208n (Fig. 19), wherein the pre-curved section 208b (Fig. 19) includes an aperture 202 (Fig. 19) extending fully through the pre-curved section 208b (Fig. 19 – lumen 202, and Par. 81 – “the shaft 206… configured to provide a substantially seamless inner surface of the lumen 202”, thus the lumen 202 is continuous from segment 208n to segment 208b);
wherein the straight section 208n (Fig. 19) and the pre-curved section 208b (Fig. 19) include a varying stiffness along a length of the straight section 208n (Fig. 19) and the pre-curved section 208b (Fig. 19, and Par. 73 – “The shaft 206 may also include a plurality of segments or portions 208a-208n having different hardness or stiffness to produce the desired overall curvature”); and
wherein a distal end 236 (Fig. 19 – spiral reinforced section 236, including segment 208a and 208b) of the outer sheath 206 (Fig. 19) is softer than a proximal end 216 (Fig. 19 – proximal end 216) of the outer sheath 206 (Fig. 19, and Par. 75 – “According to at least one embodiment, the first segment 208a may be formed of PEBAX.TM. 2533 having a durometer of 25 D… the third segment 208n may be formed of PEBAX.TM. 7233 having a durometer of 72 D”; thus, the distal end 236/segment 208a of 25D is softer than segment 208n at proximal end 216; and Par. 76 – “an important aspect of the segments 208a-208n is that the softest segment is the first segment 208a”), allowing the distal end 236 (Fig. 19) of the outer sheath 206 (Fig. 19) to bend around a curved guidewire 30 (Fig. 18 – guide wire 30).
Regarding claim 5, Wilson discloses the invention of claim 1. Wilson further discloses wherein the pre-curved section 208b (Fig. 19) extends about a central axis (see annotated Fig. 28 below) with respect to a curvature of the pre-curved section (see annotated Fig. 28 below) at least 180 degrees (see annotated Fig. 28 below – 180 degrees) from a connection point of the pre-curved section 208b (Fig. 19 and Fig. 29 – after the break line) and the straight section 208n (Fig. 19 and Fig. 29 – before the break line).
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Annotated Fig. 28 of Wilson
Regarding claim 6, Wilson discloses the invention of claim 1. Wilson further discloses wherein the pre-curved section 208b (Fig. 19) extends about a central axis (see annotated Fig. 28 above) with respect to a curvature of the pre-curved section (see annotated Fig. 28 above) between a range of 170 degrees and 210 degrees (see annotated Fig. 28 above – 180 degrees) from a connection point of the pre-curved section 208b (Fig. 19 and Fig. 29 – after the break line) and the straight section 208n (Fig. 19 and Fig. 29 – before the break line).
Regarding claim 17, Wilson discloses a delivery device 200a (Fig. 19 – steerable catheter 200a) for transporting and deploying a shunt device within a human body (Par. 73 – “The steerable catheter 200a… may be configured to receive the dilator 34 and/or an implant (not shown)”), the delivery device 200a (Fig. 19) comprising:
an outer sheath 206 (Fig. 19 – shaft 206) including:
a straight section 208n (Fig. 19 – segment 208n) including an aperture 202 (Fig. 19 – lumen 202) extending fully through the straight section 208n (Fig. 19); and
a pre-curved section 208b (Fig. 19 – segment 208b) extending distally from an end of the straight section 208n (Fig. 19), wherein the pre-curved section 208b (Fig. 19) includes an aperture 202 (Fig. 19) extending fully through the pre-curved section 208b (Fig. 19 – lumen 202, and Par. 81 – “the shaft 206… configured to provide a substantially seamless inner surface of the lumen 202”, thus the lumen 202 is continuous from segment 208n to segment 208b);
wherein the straight section 208n (Fig. 19) and the pre-curved section 208b (Fig. 19) include a varying stiffness along a length of the straight section 208n (Fig. 19) and the pre-curved section 208b (Fig. 19, and Par. 73 – “The shaft 206 may also include a plurality of segments or portions 208a-208n having different hardness or stiffness to produce the desired overall curvature”); and
a distal portion 214 (Fig. 21 – handle assembly 214) including a nosecone (see annotated Fig. 21 below) and a molded bridge (see annotated Fig. 21 below).
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Annotated Fig. 21 of Wilson
Regarding claim 18, Wilson discloses the invention of claim 17. Wilson further discloses wherein the straight section 208n (Fig. 19) of the outer sheath 206 (Fig. 19) is stiffer than the pre-curved section 208b (Fig. 19) of the outer sheath 206 (Fig. 19, and Par. 75 – “the second segment 208b… having a durometer of 40 D…. the third segment 208n… having a durometer of 72 D”; thus, segment 208n is stiffer than segment 208b due to higher durometer).
Regarding claim 19, Wilson discloses the invention of claim 17. Wilson further discloses wherein together the straight section 208n (Fig. 19) and the pre-curved section 208b (Fig. 19) form a hook-shaped outer sheath 206 (Fig. 24, and Par. 87 – “cause the shaft 206 to deflect” ).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Asleson et al. US 2012/0109079 A1 (hereinafter Asleson).
Regarding claim 2, Wilson discloses the invention of claim 1. Wilson further discloses wherein the straight section 208n (Fig. 19) and the pre-curved section 208b (Fig. 19) form hook-shaped outer sheath 206 (Fig. 24, and Par. 87 – “cause the shaft 206 to deflect”).
However, Wilson does not disclose a hook-shaped outer sheath in a relaxed state.
Asleson, in the same field of endeavor of catheter delivery system (Title), teaches wherein the straight section 305 (Fig. 3A – straight portion 305) and the pre-curved section 306 (Fig. 3B – curved portion 306) form a hook-shaped outer sheath 301 (Fig. 3A – tubular member 301) in a relaxed state (Fig. 3A-3B, and Par. 46 – “The second tubular member 301 also includes a generally straight portion 305 and, in a relaxed state, a curved portion 306 adjacent its distal end 304”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sections of Wilson to form a hook-shaped in a relaxed state as taught by Asleson, in order to provide a resilient, flexible curve in the catheter body which is well-known in the art (Par. 47 of Asleson). The resiliency of the curved portion to steer the delivery system can be utilized without the use of the deflectable catheter (Par. 47 of Asleson).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of McDonough US 2018/0126129 A1 (hereinafter McDonough), and evidenced by Arkema, “Pebax® Thermoplastic Elastomer Family” (hereinafter Arkema).
Regarding claim 3, Wilson discloses the invention of claim 1. Wilson further discloses wherein the outer sheath 206 (Fig. 19, and Fig. 21-24) is kink resistant (Par. 82 – “the shaft 206 may include three or more sections configured to provide kink resistance”), and wherein the outer sheath 206 (Fig. 19) is covered with a thermoplastic elastomer (Par. 75 – “the first segment 208a may be formed of PEBAX™ 2533… the second segment 208b may be formed of PEBAX™ 4033… the third segment 208n may be formed of PEBAX™ 7233…”, which is evidenced by Arkema on page 1 that Pebax® is a thermoplastic elastomer family).
However, Wilson does not disclose wherein the outer sheath is constructed from a stainless steel.
McDonough, in the same field of endeavor of an outer sheath (Par. 66), teaches wherein the outer sheath is constructed from a stainless steel (Par. 68 – “Materials most suitable for the outer sheath might be stainless steel…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Wilson to be constructed from a stainless steel as taught by McDonough, since McDonough has established that stainless steel is a well-known material for outer sheath in medical device uses (Par. 68 of McDonough). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the outer sheath of Wilson out of stainless steel, 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.
Claims 4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Ward et al. US 2011/0184504 A1 (hereinafter Ward).
Regarding claim 4, Wilson discloses the invention of claim 1. However, Wilson does not disclose wherein the straight section and the pre-curved section are constructed from a braided material having a constant weave pattern extending from a proximal end of the outer sheath to a distal end of the outer sheath.
Ward, in the same field of endeavor of outer sheath for deploying a shunt (Par. 24), teaches the outer sheath 228 (Fig. 4 – outer sheath 228) is constructed from a braided material having a constant weave pattern extending from a proximal end of the outer sheath to a distal end of the outer sheath (Par. 24 – “the hollow tubing for forming outer sheath 228 may be formed from polymeric tubing having a reinforced metallic braided layer extending there through”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Wilson, including the straight and pre-curved section, to be constructed from a braided material as taught by Ward, in order to provide sufficient stiffness to maintain the shunt inside until deployment (Par. 24 of Ward). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the outer sheath of Wilson out of a braided material, 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 claim 20, Wilson discloses the invention of claim 17. However, Wilson does not disclose wherein the straight section and the pre-curved section are constructed from a braided material having a constant weave pattern extending from a proximal end of the outer sheath to a distal end of the outer sheath.
Ward, in the same field of endeavor of outer sheath for deploying a shunt (Par. 24), teaches the outer sheath 228 (Fig. 4 – outer sheath 228) is constructed from a braided material having a constant weave pattern extending from a proximal end of the outer sheath to a distal end of the outer sheath (Par. 24 – “the hollow tubing for forming outer sheath 228 may be formed from polymeric tubing having a reinforced metallic braided layer extending there through”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Wilson, including the straight and pre-curved section, to be constructed from a braided material as taught by Ward, in order to provide sufficient stiffness to maintain the shunt inside until deployment (Par. 24 of Ward). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the outer sheath of Wilson out of a braided material, 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.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson.
Regarding claim 7, Wilson discloses the invention of claim 1. Wilson further discloses wherein the pre-curved section 208b (Fig. 19) extends about a central axis (see annotated Fig. 28 below) with respect to a curvature of the pre-curved section 180 degrees (see annotated Fig. 28 above – 180 degrees) from a connection point of the pre-curved section 208b (Fig. 19 and Fig. 29 – after the break line) and the straight section 208n (Fig. 19 and Fig. 29 – before the break line).
However, Wilson does not disclose 190 degrees.
Wilson, in another embodiment, teaches angles of curvature greater than 180 degrees (Par. 85 – “angles of curvature greater than 180 degrees are also possible depending on flexibility of the shaft 206”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the angle of curvature to be greater than 180 degrees, including the claimed 190 degrees, as taught by Wilson, in order to provide a more flexible shaft for a need to bend passively to accommodate the patient’s anatomy (Par. 85 of Wilson). Moreover, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the angle of curvature to be greater than 180 degrees, including the claimed 190 degrees, as taught by Wilson, as Wilson teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that 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 yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 8, Wilson discloses the invention of claim 1. However, Wilson does not disclose herein a diameter of an inner surface of the pre-curved section ranges between 2.40 inches (6.096 centimeters) and 3.20 inches (8.128 centimeters).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the diameter of an inner surface of the pre-curved section to be between 2.40 inches (6.096 centimeters) and 3.20 inches (8.128 centimeters), in order to fit the particular procedure being done since this claimed dimension of the inner surface does not change the outer sheath ability to curve and bend within the patient’s body. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 106-107 of Applicant’s PG-PUB), the Federal Circuit 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claims 9, 10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Ward.
Regarding claim 9, Wilson discloses an outer sheath 206 (Fig. 19 – shaft 206) for surrounding and covering components of a delivery device 200a (Fig. 18 – steerable catheter 200a, and Par. 73 – “the steerable catheter 200a may include shaft 206 defining at least one lumen 202. The lumen 202 may be configured to receive the dilator 34 and/or an implant (not shown)”), the outer sheath 206 (Fig. 19) comprising:
a straight section 208n (Fig. 19 – segment 208n) including an aperture 202 (Fig. 19 – lumen 202) extending fully through the straight section 208n (Fig. 19); and
a pre-curved section 208b (Fig. 19 – segment 208b) extending distally from an end of the straight section 208n (Fig. 19), wherein the pre-curved section 208b (Fig. 19) includes an aperture 202 (Fig. 19) extending fully through the pre-curved section 208b (Fig. 19 – lumen 202, and Par. 81 – “the shaft 206… configured to provide a substantially seamless inner surface of the lumen 202”, thus the lumen 202 is continuous from segment 208n to segment 208b);
wherein the straight section 208n (Fig. 19) and the pre-curved section 208b (Fig. 19) include a varying stiffness along a length of the straight section 208n (Fig. 19) and the pre-curved section 208b (Fig. 19, and Par. 73 – “The shaft 206 may also include a plurality of segments or portions 208a-208n having different hardness or stiffness to produce the desired overall curvature”).
However, Wilson does not disclose wherein the straight section and the pre-curved section are constructed from a braided material having a constant weave pattern extending from a proximal end of the outer sheath to a distal end of the outer sheath.
Ward, in the same field of endeavor of outer sheath for deploying a shunt (Par. 24), teaches the outer sheath 228 (Fig. 4 – outer sheath 228) is constructed from a braided material having a constant weave pattern extending from a proximal end of the outer sheath to a distal end of the outer sheath (Par. 24 – “the hollow tubing for forming outer sheath 228 may be formed from polymeric tubing having a reinforced metallic braided layer extending there through”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Wilson, including the straight and pre-curved section, to be constructed from a braided material as taught by Ward, in order to provide sufficient stiffness to maintain the shunt inside until deployment (Par. 24 of Ward). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the outer sheath of Wilson out of a braided material, 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 claim 10, Wilson in view of Ward discloses the invention of claim 9. However, the combination does not disclose wherein the braided material includes between 30 and 40 picks per inch (between about 11.811 and about 15.748 picks per centimeter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the braided material of the combination to be between 30 and 40 picks per inch (between about 11.811 and about 15.748 picks per centimeter), in order to fit the particular procedure being done since this claimed dimension of the braided material does not change the outer sheath ability to curve and bend within the patient’s body. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 93 of Applicant’s PG-PUB), the Federal Circuit 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 12, Wilson in view of Ward discloses the invention of claim 9. The combination further discloses wherein a proximal end 216 (Fig. 19 of Wilson – proximal end 216) of the outer sheath 206 (Fig. 19 of Wilson) is stiffer than a distal end 236 (Fig. 19 of Wilson – section 236, including segment 208a and 208b) of the outer sheath 206 (Fig. 19 of Wilson, and Par. 75 of Wilson – “According to at least one embodiment, the first segment 208a may be formed of PEBAX.TM. 2533 having a durometer of 25 D… the third segment 208n may be formed of PEBAX.TM. 7233 having a durometer of 72 D”; thus, segment 208n at proximal end 216 of 72D is stiffer than the distal end 236/segment 208a of 25D; and Par. 76 of Wilson – “an important aspect of the segments 208a-208n is that the softest segment is the first segment 208a”), allowing a user to push and pull on the proximal end 216 (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson – user is highly capable of pushing and pulling the proximal end 216 via the handle assembly 214), and wherein the distal end 236 (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson) is softer than the proximal end 216 (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson), allowing the distal end 236 (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson) to bend around a curved guidewire 30 (Fig. 18 of Wilson – guide wire 30).
Regarding claim 13, Wilson in view of Ward discloses the invention of claim 9. The combination further discloses wherein a distal end 236 (Fig. 19 of Wilson – section 236) of the outer sheath 206 (Fig. 19 of Wilson) includes a first length 208a (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson) having a stiffness of 25 durometer (Par. 75 of Wilson – “he first segment 208a… having a durometer of 25 D”).
However, the combination does not disclose a stiffness of 35 durometer.
Wilson, in another embodiment, teaches a stiffness of 35 durometer (Fig. 12, and Par. 58 – “the first segment 97a… having a durometer of 35 D”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination’s stiffness of the first length of the distal end to be 35 durometer, as taught by Wilson, in order to facilitate advancing the tip of the device into the percutaneous puncture site (Par. 57 of Wilson).
Furthermore, according to the discussion of Wilson in Par. 73 reciting “The shaft 206 may also include a plurality of segments or portions 208a-208n having different hardness or stiffness to produce the desired overall curvature”, the durometer of the outer sheath would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said stiffness directly affects the overall curvature (Par. 73 of Wilson), kink resistance, pushability, and flexibility of the outer sheath (Par. 82 of Wilson). Therefore, a sufficient stiffness is desired to produce an outer sheath with proper degree of curvature, flexibility, kink resistance, and pushability (Par. 73 and Par. 82 of Wilson). As such, without showing unexpected results, the claimed 35 durometer cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the stiffness of the distal end of the outer sheath to 35 durometer in the device of the combination to obtain the desired curvature for the outer sheath, as taught by Wilson (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claim 14, Wilson in view of Ward discloses the invention of claim 13. The combination further discloses wherein a second length 208b (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson) is positioned adjacent to the first length 208a (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson, and Par. 75 of Wilson – “The second segment 208b may be adjacent to the first segment 208a”), wherein the second length 208b (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson) has a stiffness of 40 durometer (Par. 75 of Wilson – “the second segment 208b… having a durometer of 40 D”).
However, the combination does not disclose a stiffness of 45 durometer, and wherein the second length of the outer sheath is greater than the first length of the outer sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the second length of the outer sheath is greater than the first length of the outer sheath, in order to fit the particular procedure being done since this claimed dimension of the distal end of the outer sheath does not change the outer sheath ability to curve and bend within the patient’s body. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 92 of Applicant’s PG-PUB), the Federal Circuit 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Also, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the second length of the outer sheath is greater than the first length of the outer sheath, since Wilson discusses that one of ordinary skill in the art would have been motivated to adjust or change depending upon the circumstances of its intended use (Par. 76 of Wilson).
In addition, according to the discussion of Wilson in Par. 73 reciting “The shaft 206 may also include a plurality of segments or portions 208a-208n having different hardness or stiffness to produce the desired overall curvature”, the durometer of the outer sheath would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said stiffness directly affects the overall curvature (Par. 73 of Wilson), kink resistance, pushability, and flexibility of the outer sheath (Par. 82 of Wilson). Therefore, a sufficient stiffness is desired to produce an outer sheath with proper degree of curvature, flexibility, kink resistance, and pushability (Par. 73 and Par. 82 of Wilson). As such, without showing unexpected results, the claimed 45 durometer cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the stiffness of the distal end of the outer sheath to 45 durometer in the device of the combination to obtain the desired curvature for the outer sheath, as taught by Wilson (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claim 15, Wilson in view of Ward discloses the invention of claim 14. The combination further discloses wherein a third length 208n (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson) is positioned at a proximal end 216 (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson), wherein the third length 208n (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson) has a stiffness of 72 durometer (Par. 75 of Wilson – “the third segment 208n… having a durometer of 72 D”).
However, the combination does not disclose wherein the third length of the outer sheath is greater than the first length of the outer sheath and the second length of the outer sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the third length of the outer sheath greater than the first length of the outer sheath and the second length of the outer sheath, in order to fit the particular procedure being done since this claimed dimension of the third length of the outer sheath does not change the outer sheath ability to curve and bend within the patient’s body. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 92 of Applicant’s PG-PUB), the Federal Circuit 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Also, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the third length of the outer sheath greater than the first length of the outer sheath and the second length of the outer sheath, since Wilson discusses that one of ordinary skill in the art would have been motivated to adjust or change depending upon the circumstances of its intended use (Par. 76 of Wilson).
Regarding claim 16, Wilson in view of Ward discloses the invention of claim 15. The combination further discloses wherein a fourth length (Fig. 19 of Wilson – the length of shaft 206 represented by the break line) of the outer sheath 206 (Fig. 19 of Wilson) extends between the second length 208b (Fig. 19 of Wilson) of the outer sheath 206 (Fig. 19 of Wilson) and the third length 208n (Fig. 19 of Wilson – the length represented by the break line is between length 208b and 208n) of the outer sheath 206 (Fig. 19 of Wilson).
However, the combination does not disclose wherein the fourth length of the outer sheath has a stiffness of 55 durometer, wherein the fourth length of the outer sheath is greater than the first length of the outer sheath and the second length of the outer sheath, and wherein the fourth length of the outer sheath is less than the third length of the outer sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the fourth length of the outer sheath greater than the first length of the outer sheath and the second length of the outer sheath, and made the fourth length of the outer sheath less than the third length of the outer sheath, in order to fit the particular procedure being done since this claimed dimension of the lengths of the outer sheath does not change the outer sheath ability to curve and bend within the patient’s body. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 92 of Applicant’s PG-PUB), the Federal Circuit 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777. Also, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the dimension changes, since Wilson discusses that one of ordinary skill in the art would have been motivated to adjust or change depending upon the circumstances of its intended use (Par. 76 of Wilson).
In addition, according to the discussion of Wilson in Par. 73 reciting “The shaft 206 may also include a plurality of segments or portions 208a-208n having different hardness or stiffness to produce the desired overall curvature”, the durometer of the outer sheath would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, because said stiffness directly affects the overall curvature (Par. 73 of Wilson), kink resistance, pushability, and flexibility of the outer sheath (Par. 82 of Wilson). Therefore, a sufficient stiffness is desired to produce an outer sheath with proper degree of curvature, flexibility, kink resistance, and pushability (Par. 73 and Par. 82 of Wilson). As such, without showing unexpected results, the claimed stiffness of 55 durometer cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the stiffness of the fourth length to be 44 durometer in the device of the combination to obtain the desired curvature for the outer sheath, as taught by Wilson (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Ward as applied to claim 9 above, and further in view of McDonough, evidenced by Arkema.
Regarding claim 11, Wilson in view of Ward discloses the invention of claim 9. The combination further discloses wherein the braided material (Par. 24 of Ward) is a metallic layer (Par. 24 of Ward – “the hollow tubing for forming outer sheath 228 may be formed from polymeric tubing having a reinforced metallic braided layer extending there through”) covered with a thermoplastic elastomer (Par. 75 of Wilson – “the first segment 208a may be formed of PEBAX™ 2533… the second segment 208b may be formed of PEBAX™ 4033… the third segment 208n may be formed of PEBAX™ 7233…”, which is evidenced by Arkema on page 1 that Pebax® is a thermoplastic elastomer family).
However, the combination does not disclose wherein the braided material is a stainless steel.
McDonough, in the same field of endeavor of an outer sheath (Par. 66), teaches wherein the outer sheath is constructed from a stainless steel (Par. 68 – “Materials most suitable for the outer sheath might be stainless steel…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of the combination to be constructed from a stainless steel as taught by McDonough, since McDonough has established that stainless steel is a well-known material for outer sheath in medical device uses (Par. 68 of McDonough). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the braided material of the combination out of stainless steel, 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Haarer US 9,757,541 B2 teaches dilator systems with curved outer sheaths
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/QUYNH DAO LE/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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