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 09/20/24 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 8, 15, and 19 are objected to because of the following informalities:
Claim 1 lines 6-7 reads “wherein the second exchange segment is provided separately and independently from the tubular sheath;” but should likely read “wherein the [[second]] rapid exchange segment is provided separately and independently from the tubular sheath;” to provide proper antecedent basis for the exchange segment that has been previously referred to as the “rapid” exchange segment throughout the claim language
Claim 8 line 4 reads “distal portion of the tubular to each other” and should likely read “distal portion of the tubular sheath to each other” to align with the language as previously set forth for the structure
Claim 15 line 1 reads “wherein cylindrical tubular segment” and should likely read “wherein the cylindrical tubular segment” for grammatical reasons and to provide antecedent basis for cylindrical tubular segment
Claim 19 lines 2 reads “wherein optimizing includes providing the window section with ratio of” and should likely read “wherein optimizing includes providing the window section with a ratio of” to provide antecedent basis for the ratio as first introduced and for grammatical reasons
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-9, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zelenka et al. (U.S. PGPUB No. 2013/0023771), hereinafter Zelenka.
Regarding claim 1, Zelenka discloses a method of assembling a rapid-exchange catheter (see [0029]: catheter portions may be heated, re-shaped, and clamped to form a monolithic structure), comprising:
providing a tubular sheath (see ‘Modified FIG. 1’ below)
PNG
media_image1.png
392
853
media_image1.png
Greyscale
that is flexible (see [0002] & [0026]) and defines a first lumen (see ‘Modified FIG. 3’ below)
PNG
media_image2.png
254
616
media_image2.png
Greyscale
which extends from a proximal end (235, see FIG.1) to a distal end (27) of the tubular sheath (as seen in ‘Modified FIG. 1’ above);
providing a rapid exchange segment (see RX on ‘Modified FIG. 1’ above) that is flexible (see [0002] & [0026]) and defines a second lumen (60, see FIG.3) which extends from an entry port (distal opening on distal tip 53, see [0028]) to an exit port (55, see FIG. 3) of the rapid exchange segment (see RX on ‘Modified FIG. 1’ above), wherein the second exchange segment (see RX on ‘Modified FIG. 1’ above) is provided separately and independently from (see [0029]: Rx segment of catheter is attached to tubular sheath at joint 58 at distal end of tubular sheath 27—seen best in FIG.2. RX must be heat bonded and is therefore provided ‘separately and independently from’ the rest of the sheath) the tubular sheath (as seen in ‘Modified FIG. 1’ above);
coupling (see [0029] and coupling shown best in FIGS. 2-3) the tubular sheath (see ‘Modified FIG. 1’ above) and the rapid exchange segment (see ‘Modified FIG. 1’ above) in a lengthwise direction (as seen in FIGs. 1-3 and described in [0029]) such that a distal portion (distal portion of tubular sheath terminates at distal end 27 meeting joint 58, see FIG. 2) of the tubular sheath and a proximal portion (proximal portion ending at joint 58 as seen in FIG. 2) of the rapid exchange segment are coupled at an angle therebetween (see FIG. 3 and [0029]: different angles of 6-10 degrees), whereby the distal portion of the tubular sheath that couples with (coupling at 58) the proximal portion of the rapid exchange segment does not contain the first lumen (distal portion terminating at joint 58 does not have lumen because joint 58 is the heat bonded joint, see [0029]), and
optimizing one or more of the tubular sheath and the rapid exchange segment to prevent kinking and improve navigation of the rapid-exchange catheter through a bodily lumen (see [0007], [0025], and [0037]).
Regarding claim 2, Zelenka discloses the method according to claim 1, and Zelenka further discloses
wherein providing a tubular sheath (see ‘Modified FIG. 1’ above and [0021]) includes providing a first cylindrical shaft defining the first lumen that extends through a proximal shaft section (see ‘Modified FIG. 1’ above), a mid-shaft section (see ‘Modified FIG. 1’ above), and a distal shaft section (‘window section’ in ‘Modified FIG. 1’ above) of the tubular sheath (see ‘Modified FIG. 1’ above and [0022-0023]); and
wherein providing a rapid exchange segment (see ‘Modified FIG. 1’ above and [0021]) includes providing a second cylindrical shaft (50, see FIG. 3) that has a stub portion (58) formed at an angle (see [0029]: 58 has edge portion 57 that tapers upward while second lumen 60 tapers downward as shown in FIG. 3 and therefore the stub portion 58 is formed at an angle with respect to the second lumen) with respect to the second lumen (60, see FIG. 3).
Regarding claim 3, Zelenka discloses the method according to claim 2, and Zelenka further discloses wherein coupling the tubular sheath and the rapid exchange segment includes coupling the stub portion of the rapid exchange segment with the distal portion of the tubular sheath such that a longitudinal axis of the first lumen and a longitudinal axis of the second lumen are laterally offset from each other by an offset distance (as seen in FIGs. 1&3 and described in [0029]: lumen axes offset by an angle and therefore comprise an offset “distance” as well).
Regarding claim 4, Zelenka discloses the method according to claim 3, and Zelenka further discloses wherein the second lumen (60, see FIG. 3) that extends from the entry port (distal opening on distal tip 53, see [0028]) to the exit port (55) of the rapid exchange segment is configured to pass therethrough a guidewire having a guidewire diameter (see [0022] and [0028]: guidewire received into lumen 60), and wherein the offset distance is optimized (see [0029]: angle between 6-10degrees which optimizes an offset distance calculated from the angle range) to provide a straight path for the guidewire (lumen 60 is ‘straight’ as shown in FIG. 3) to minimize frictional resistance between guidewire and tubular sheath (see [0027-0029]: guidewire has lubricious liner and is inserted through straight path of lumen and therefore the presence of guidewire with lubricious liner will minimize frictional resistance between the two structures).
Regarding claim 7, Zelenka discloses the method according to claim 2, and Zelenka further discloses wherein coupling (see [0029]) the tubular sheath and the rapid exchange segment (as shown in ‘Modified FIG. 1’ above) includes bonding the stub portion (58) of the rapid exchange segment and the distal portion (‘window section’ in ‘Modified FIG. 1’ above) of the tubular sheath to form a monolithic catheter structure comprised of the tubular sheath and the rapid exchange segment (see FIG.1, FIG. 3 and [0029]: catheter heated, re-shaped, and clamped to form a monolithic structure).
Regarding claim 8, Zelenka discloses the method according to claim 7, and Zelenka further discloses wherein bonding includes one or more of melt-bonding with heat (see [0029]: tubular portions coupled such as by heat bonding), welding or gluing the stub portion (58) of the rapid exchange segment and the distal portion of the tubular to each other (see FIG. 3 and [0029]).
Regarding claim 9, Zelenka discloses the method according to claim 2, and Zelenka further discloses wherein coupling the tubular sheath and the rapid exchange segment includes melt-bonding (see [0029]: tubular portions coupled such as by heat bonding) or welding or gluing a proximal portion of the rapid exchange segment and the distal portion of the tubular sheath (as shown in FIG. 1, 3) such that the longitudinal axis of the first lumen is at an angle with respect to the longitudinal axis of the second lumen (see [0029]: mating to achieve angle of 6-10degrees), and wherein the angle between the longitudinal axis of the first lumen and the longitudinal axis of the second lumen is optimized to be in a range of 1 to 15 degrees (see [0029]: mating to achieve angle of 6-10degrees).
Regarding claim 16, Zelenka discloses the method according to claim 2, and Zelenka discloses further comprising: arranging an imaging core (35, see FIG. 3 and [0030]: imaging core 35 images through acoustically transparent/ window portion of sheath—see ‘Modified FIG. 1’ above for visual) inside the first lumen (see ‘Modified FIG. 3 above’) at a distance (see distance in FIG. 3 shown as [1.5 ± 1.0] from distal tip of core 35 to stub portion 58) from the stub portion (58) such that an unsupported gap (unsupported gap defined by the distance between imaging core and stub portion, aligning with Applicant disclosure in [0085]: the unsupported area is the portion of the sheath that the imaging core does NOT extend through and therefore has lower lateral rigidity) remains between the imaging core (35) and the stub portion (58) of the rapid exchange segment (Rx in ‘Modified FIG. 1’ above), wherein optimizing includes minimizing a length of the unsupported gap (see [0027] & [0039]: lengths of sheath structures are chosen to allow for imagine core to be advanced “farther distally” and [0036]: imaging core 35 placed within sheath prior to bonding to obtain accurate positioning of sheath relative to imaging core. Therefore, the unsupported gap/ distance between the imaging core and stub portion is minimized to allow for furthest distal advancement of core 35.), while providing sufficient space inside the first lumen for self-calibration or homing of the imaging core (see [0039]: imaging core rotates and moves longitudinally and therefore has ‘sufficient space’ for self-calibration and homing as described in [0088] of Applicant disclosure as a proximal longitudinal movement or the imaging core being pulled back).
Regarding claim 17, Zelenka discloses the method according to claim 2, and Zelenka further discloses wherein the length of the unsupported gap (shown by the distance between the imaging core and stub portion as “[1.5 ± 1.0]” in FIG. 3) not containing the imaging core is optimized to have a gap distance in a range of 1 to 10 millimeters (see [0027]: “In FIG. 3 the unit of measurement inside the brackets is millimeters.”. Therefore, Zelenka discloses a gap distance of 1.5mm, which is within the claimed range).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zelenka as applied to claim 4 above, and further in view of Blank (U.S. PGPUB No. 2019/0240434).
Regarding claim 5, Zelenka discloses the method according to claim 4, and Zelenka further discloses an offset distance (vertical distance from first to second lumen) and a guidewire diameter (see [0028]: second lumen has diameter of 0.016inches—therefore guidewire diameter must be less than 0.016 inches to be inserted through the second lumen.).
Zelenka is silent to “wherein the offset distance is optimized to be in a range of about half to double of the guidewire diameter.”
However, Blank teaches a multi-lumen catheter (21, see FIG.2) with an offset (9, see [0045]: lateral inward beak offset) between a first lumen (33) and a second lumen (31) that may be half and up to about 100 percent the diameter of the inner lumen (see [0091-0099]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the offset distance disclosed in Zelenka to be optimized in a range of half to double the guidewire diameter as taught by Blank for the purpose of adapting the device for different applications (see Blank [0046-0047]), thus achieving “wherein the offset distance is optimized to be in a range of about half to double of the guidewire diameter.”
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zelenka as applied to claim 2 above, and further in view of Morriss et al. (U.S. PGPUB No. 2008/0183128), hereinafter Morriss.
Regarding claim 6, Zelenka discloses the method according to claim 2, and Zelenka further discloses wherein coupling (see [0029]: such as by heat bonding the segments together) the tubular sheath and the rapid exchange segment includes the stub portion (58) of the rapid exchange segment connects with the distal section (‘window section’ as shown in ‘Modified FIG.1’ above. See also FIG. 3) of the tubular sheath, whereby the stub portion (58) seals the first lumen at a distal end of the tubular sheath (as shown in FIG. 3) such that the first lumen is completely sealed and has no access to fluids (see FIG. 3 and [0029]—first lumen is completely sealed from second lumen and therefore has no access to fluids from at least the distal end).
Zelenka is silent to wherein coupling the tubular sheath and the rapid exchange segment includes “inserting the stub portion of the rapid exchange segment into the first lumen at the distal section of the tubular sheath in the lengthwise direction such that” the stub portion of the rapid exchange segment connects with the distal section of the tubular sheath.
However, Morriss teaches a catheter (see FIG. 3A and [0068-0069]) comprising a tubular sheath (10) and a rapid exchange segment (106), wherein coupling (see [0070] and [0079]: 10 and 106 mated together such as in manner described in [0087]) the tubular sheath (10) and the rapid exchange segment (106) includes inserting a stub portion (see proximal portion of 106 within 16 as shown in cross-section of FIG. 3G) of the rapid exchange segment (106) into a first lumen (see lumen formed in distal section as shown in cross-section of FIG. 3G) at a distal section (16) of the tubular sheath (10) in the lengthwise direction such that the stub portion (see proximal portion of 106 within 16 as shown in cross-section of FIG. 3G) of the rapid exchange segment (106) connects with the distal section (16) of the tubular sheath (10).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mated coupling between the tubular sheath and rapid exchange segment disclosed in the method of assembling of Zelenka to include a step of inserting the rapid exchange segment stub portion into the distal section of the tubular sheath as taught by Morris for the purpose of connecting the components such that the rapid exchange segment extends distally by a predetermined length (see [0079] and [0087]) and/or to establish a connection that does not require torquing of the rapid exchange segment to minimize kinking or other undesirable deformation during the connection process (see [0087]), thus achieving wherein coupling the tubular sheath and the rapid exchange segment includes “inserting the stub portion of the rapid exchange segment into the first lumen at the distal section of the tubular sheath in the lengthwise direction such that” the stub portion of the rapid exchange segment connects with the distal section of the tubular sheath.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zelenka as applied to claim 1 above, and further in view of Chou et al. (U.S. PGPUB No. 2019/0351182), hereinafter Chou.
Regarding claim 10, Zelenka discloses the method according to claim 1, and Zelenka further discloses wherein providing the tubular sheath includes forming the tubular sheath from polymeric materials (see [0026]).
Zelenka is silent to wherein providing the tubular sheath includes forming the tubular sheath “of multiple concentric layers including at least an inner polymer layer, an outer polymer layer, and a metal layer arranged between the inner polymer layer and the outer polymer layer.”
However, Chou teaches a method comprising providing a tubular sheath (see [0014]), wherein providing the tubular sheath (see FIG. 10C) includes forming the tubular sheath of multiple concentric layers including at least an inner polymer layer (382, see [0179]: layer 382 of pebax), an outer polymer layer (384, see [0179]: layer 384 of pebax), and a metal layer (380, see [0091] & [0130]: reinforcement layers/ braids of the invention formed of metals) arranged between (see FIG. 10C and [0179]: a reinforcement layer/braid) the inner polymer layer (382) and the outer polymer layer (384).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular sheath formed of polymeric materials disclosed in the method of Zelenka to be formed of multiple concentric layers including at least an inner polymer layer, an outer polymer layer, and a metal layer arranged between the inner polymer layer and the outer polymer layer as taught by Chou for the purpose of providing a reinforcement layer sandwiched between polymeric layers to improve torqueability of the catheter while maintaining sufficient flexibility through the polymeric layers (see [0091] and [0179]), thus achieving wherein providing the tubular sheath includes forming the tubular sheath “of multiple concentric layers including at least an inner polymer layer, an outer polymer layer, and a metal layer arranged between the inner polymer layer and the outer polymer layer.”
Regarding claim 11, the modified method of Zelenka teaches the method according to claim 10, but Zelenka is silent to “wherein the metal layer is a metallic hypotube with a laser-cut helical slot having a varying pitch that gradually changes from a first pitch at the proximal section of the tubular sheath to a second pitch smaller than the first pitch at or near a distal end of the mid-shaft section.”
However, Chou teaches a method comprising providing a tubular sheath (see [0014]), wherein providing the tubular sheath (see FIG. 10C) includes forming the tubular sheath of multiple concentric layers including at least an inner polymer layer (382, see [0179]: layer 382 of pebax), an outer polymer layer (384, see [0179]: layer 384 of pebax), and a metal layer (380, see [0091] & [0130]: reinforcement layers/ braids of the invention formed of metals) arranged between (see FIG. 10C and [0179]: a reinforcement layer/braid) the inner polymer layer (382) and the outer polymer layer (384), wherein the metal layer (see [0179]: a reinforcement layer described in [0091] as being metal) is a metallic hypotube (see [0091]: reinforcement layer can be Nitinol hypotube that is laser-cut) with a laser-cut helical slot having a varying pitch that gradually changes from a first pitch at a proximal section of the tubular sheath to a second pitch at or near a distal end of a mid-shaft section (see [0091]: reinforcement structure varies over length to provide varying flexibilities, such as by changing the pitch). Chou further teaches an embodiment where the second pitch is larger than the first pitch to increase flexibility at the distal end of the catheter (see [0130]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tubular sheath formed of the inner and outer polymeric materials with the metal layer between taught by the modified method of Zelenka to have the metal layer formed as a metal hypotube with a laser-cut helical slot having a varying pitch that gradually changes from a first pitch at a proximal section to a second pitch near a distal end as taught by Chou for the purpose of using the pitch of the metal layer hypotube to vary the flexibility of the catheter along the catheter length (see [0091]), thus achieving “wherein the metal layer is a metallic hypotube with a laser-cut helical slot having a varying pitch that gradually changes from a first pitch at the proximal section of the tubular sheath to a second pitch at or near a distal end of the mid-shaft section”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second pitch of the tubular sheath taught by Modified Zelenka to be smaller than the first pitch (suggested by Chou [0130]).
A person of ordinary skill in the art would have been motivated and capable of achieving this modification because it would have been obvious to try from the identified (pitch can increase, stay the same, or decrease), predictable (a larger pitch increases flexibility as in Chou [0130]) solutions with a reasonable expectation of success for forming the second pitch smaller than the first pitch, perhaps to increase the stiffness/ decrease the flexibility at the distal end of the catheter (See Chou [0130]), thus achieving the second pitch “smaller than the first”.
Regarding claim 12, the modified method of Zelenka teaches the method according to claim 10, and Zelenka further discloses wherein providing the tubular sheath includes providing a cylindrical shaft having a varying stiffness that tapers from the proximal section to the mid-shaft section of the tubular sheath (see [0007]: tapered portion increases stiffness towards proximal end for pushability and [0034]: hub of the mid-shaft section, as seen in ‘MODIFIED FIG. 1’ above, provides gradual decrease in stiffness toward the distal end by way of strain relief 230, best seen in FIG. 7).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zelenka in view of Chou as applied to claim 10 above, and further in view of Barone et al. (U.S. Patent Application No. 2019/0083062).
Regarding claim 13, the modified method of Zelenka teaches the method according to claim 10, and Zelenka further discloses wherein the proximal section of the tubular sheath is optimized to have a stiffness, and the stiffness of the tubular sheath gradually tapers towards the distal end of the mid-shaft section to a stiffness (see [0034]: hub of the mid-shaft section, as seen in ‘MODIFIED FIG. 1’ above, provides gradual decrease in stiffness toward the distal end by way of strain relief 230, best seen in FIG. 7. Therefore proximal end inherently has an optimized stiffness and the distal end of the mid-shaft section distal of the strain relief 230 also has a stiffness).
Zelenka is silent to the proximal section is optimized to have a stiffness “in a range of 5.0 to 4.41 milli-Newton-meters (mN-m)” and the stiffness tapers toward the distal end of the mid-shaft section to a stiffness “in a range of 0.20 to 0.17 mN-m”.
However, Barone teaches that a catheter’s strength and stiffness can easily be modified by adding different material layers to the sheath (see [0047-0049]). Therefore, Barone teaches that adding material layers of different material types/thicknesses will modify the stiffness of a tubular sheath/ catheter. Therefore, a person of ordinary skill in the art would consider stiffness to be a result effect variable that is optimized through routine experimentation of changing/modifying the thickness and material type of the sheath layers to obtain a stiffness in a range from about 5.0 to about 4.41 milli-Newton-meters (mN-m) and a stiffness in a range of about 0.20 to about 0.17 mN-m.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the stiffness of the tubular sheath taught by the modified method of Zelenka by modifying the thickness and material type of the sheath layers to obtain a desired stiffness range of the different portions of the sheath 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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Zelenka as applied to claim 2 above, and further in view of Yang et al. (U.S. Patent No. 10,653,434), hereinafter Yang.
Regarding claim 14, Zelenka discloses the method according to claim 2, and Zelenka further discloses wherein providing the rapid exchange segment (Rx in ‘Modified FIG. 1’ above) having a stub portion (58) includes a cylindrical tubular segment (50) with the entry port (53) and the exit port (where guidewire is inserted near 55 as shown in FIG. 3) connected by the second lumen (60), and forming the stub portion (58) at an angle with respect to the cylindrical tubular segment (see [0029]). Zelenka further discloses that the sheath may be formed of medical grade plastics (see [0026]).
Zelenka is silent to the stub portion includes “injection molding” a cylindrical tubular segment with the entry port and exit port.
However, Yang teaches a method including injection molding (see col 13 lines 1-3) a cylindrical tubular segment (18, see FIG. 1) with an entry port and exit port (see col. 12 line 57- col. 13 line 3: guidewire provided via port 20 and through tubular segment 18).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rapid exchange portion formed of a cylindrical tubular segment with an entry port and exit port disclosed in Zelenka to be formed specifically by injection molding as taught by Yang for the purpose of using a known manufacturing method for forming tubular components of catheters from medical grade plastics (see col. 12 line 57- col. 13 line 3), thus achieving the stub portion includes “injection molding” a cylindrical tubular segment with the entry port and exit port.
Claims 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zelenka in view of Yang as applied to claim 14 above, and further in view of Ship et al. (U.S. PGPUB No. 2020/0330664), hereinafter Ship and Chou (U.S. PGPUB No. 2019/0351182).
Regarding claim 15, the modified method of Zelenka teaches the method according to claim 14, and Zelenka further discloses wherein cylindrical tubular segment of the rapid exchange segment has an optimized outer diameter (see [0028]: outer diameter less than 0.045 inches), and wherein the entry port (53) have smooth and rounded edges radiused so as to hug the guidewire and prevent catching or damaging the bodily lumen (see [0028]:53 has bevel/chamfer/curved surface to enhance catheter crossibility).
Zelenka is silent to the outer diameter “that tapers in a direction from the proximal end to the distal end from about 0.0300 inches at the exit port thereof to about 0.0220 inches at the entry port thereof” and “the exit port” also has have smooth and rounded edges radiused so as to hug the guidewire and prevent catching or damaging the bodily lumen.
However, Ship teaches a method comprising providing a tubular catheter comprising a distal extension comprising a tubular body (100, see FIG. 1 for full catheter view), where the extension has an outer diameter (302, see FIG. 3) tapered in the lengthwise direction (see ‘Modified FIG. 3’ below)
PNG
media_image3.png
529
785
media_image3.png
Greyscale
of the tubular body (300, see FIG. 3), the outer diameter tapers in a direction from the proximal end to the distal end from about 0.0300 inches at the proximal end thereof to about 0.0220 inches at the distal end thereof (see [0008]: 1mm at proximal end, or .0393inches/ “about 0.03 inches and 0.6 mm, or .0236inches/ “about” 0.022 inches at distal end).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer diameter of the second lumen (which is the distal-most lumen) between the proximal exit port and distal entry port disclosed in Zelenka with the proximal to distal outer diameter tapering as taught by Ship for the purpose of decreasing the stiffness in the distal direction and/or fine-tuning the stiffness profile along the length (see [0041]), thus achieving the outer diameter “that tapers in a direction from the proximal end to the distal end from about 0.0300 inches at the exit port thereof to about 0.0220 inches at the entry port thereof”.
Zelenka in view of Ship remain silent to “the exit port” also has smooth and rounded edges radiused so as to hug the guidewire and prevent catching or damaging the bodily lumen.
However, Chou teaches a method comprising provided a catheter having a proximal exit port (238, see FIG. 5B) with smooth and rounded edges (see [0148]) so as to hug the guidewire and prevent catching or damaging the bodily lumen.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal exit port disclosed in Zelenka to include smooth and rounded edges as taught by Chou for the purpose of avoiding any flat edges that can abut/catch the tubular component as it is inserted, thus facilitating pushing and reducing likelihood of kinking (see [0148]), thus achieving “the exit port” also has smooth and rounded edges radiused so as to hug the guidewire and prevent catching or damaging the bodily lumen.
Regarding claim 19, Zelenka discloses the method according to claim 15, and Zelenka further discloses wherein optimizing includes providing the window section (portion of sheath 25 that imaging core extends through, see FIG. 3, FIG. 1, and the modified figures above. See also [0030]: this portion of sheath is acoustically transparent and therefore a window section) with ratio of wall thickness to inner diameter of the window section in a range of about 0.15 to 0.20 (see [0025]: sheath portion 25 has outer diameter of .039 inches and wall thickness of .006inches. Therefore the inner diameter is .033 inches due to the difference between outer diameter and wall thickness. The ratio of wall thickness/ inner diameter is then calculated as .006/.033 = .18, within the claimed range) to prevent kinking in the unsupported area of the rapid-exchange catheter (Zelenka discloses the ratio as claimed and therefore will function ‘to prevent kinking in the unsupported area’ as asserted by applicant).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Zelenka as applied to claim 2 above, and further in view of Zelenka et al. (U.S. PGPUB No. 2017/0055943), hereinafter Zelenka2, Chou (U.S. PGPUB No. 2019/0351182), and Typical Properties of Polyethylene, hereinafter NPL.
Regarding claim 18, Zelenka discloses the method according to claim 2, and Zelenka further discloses wherein the distal section of the tubular sheath includes a window section made of transparent material (see ‘Modified FIG. 1’ above and [0030]: acoustically transparent sheath portion for imaging core 35), and wherein the window section includes a cylindrical surface (outer surface at distal end of the window section) which has an outer diameter of about 0.0310 inches and a wall-thickness of about 0.0040 inches (see [0025]: portion 25 with window section as shown in Fig.2&3 have outer diameter of .033 inches and wall thickness of .003inches at distal end. Therefore, the outer diameter is disclosed “about” .0310 and the wall thickness “about” .004 inches). Zelenka further discloses that the sheath, including section 25 which comprises the window section, may be formed of polymeric materials such as PTFE, polyethylene, PEEK, PEBAX, and the like (see [0026]).
Zelenka is silent to the window section includes a cylindrical surface which has “a flexural modulus of about 500 MPa, a hardness durometer of about 72D Shore, and a stiffness of about 0.075 mN-m.”
However, Zelenka2 teaches a cylindrical window section (320)(see FIG. 3) made from polyethylene (see [0026]) which has an outer diameter of about 0.0310 inches (see about .0335” or 0.024” to 0.038” in [0025]), a wall-thickness of about 0.0040 inches (.001” to .007” see [0030]), and a flexural modulus of about 500 MPa (35ksi to 85ksi (~241 to 586 MPA ) see [0027]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have fabricated the cylindrical window section formed of polyethylene disclosed in Zelenka with the polyethylene material and dimensions as taught in Zelenka2 for the purpose of forming the imaging window from a known material suitable for the purpose (see Zelenka2 [0026]), thus achieving the window section includes a cylindrical surface which has “a flexural modulus of about 500 MPa”.
Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a polyethylene material forming an acoustically transparent sheath in Zelenka) for another known element (a polyethylene material forming an acoustically transparent sheath with a specific flexural modulus in Zelenka) in the art to obtain the predictable result of forming a tubular sheath capable of providing imaging therethrough (see MPEP § 2143.I.B).
Zelenka in view of Zelenka2 remain silent to the window section includes a cylindrical surface which has “a hardness durometer of about 72D Shore, and a stiffness of about 0.075 mN-m.”
However, Chou teaches a sheath formed of polyethylene (see [0091]) with a hardness durometer of 72D Shore (see [0091]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select the polyethylene material taught by Modified Zelenka to be of 72D hardness as taught by Chou for the purpose of forming the sheath with a desirable hardness (see [0091]), thus achieving the window section includes a cylindrical surface which has “a hardness durometer of about 72D Shore”.
Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a polyethylene material with a specific flexural modules forming an acoustically transparent sheath in Modified Zelenka) for another known element (a polyethylene material forming a sheath with a specific hardness in Chou) in the art to obtain the predictable result of forming a tubular sheath with a stiffness capable of traversing patient vasculature (see MPEP § 2143.I.B).
Zelenka in view of Zelenka2 and Chou remain silent to the window section includes a cylindrical surface which has “a stiffness of about 0.075 mN-m.”
However, NPL teaches that modifying the density of the polyethylene will vary the stiffness range (see for example tensile strength, elastic modulus, etc. in tabulated results shown in NPL 2). Therefore, a person of ordinary skill in the art would consider stiffness to be a result effect variable that is optimized through routine experimentation of changing/modifying the polyethylene density to obtain “a stiffness of about 0.075 mN-m.”.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the stiffness of the polyethylene material taught by Modified Zelenka by modifying the density of the polyethylene material as taught by NPL to obtain “a stiffness of about 0.075 mN-m” 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights