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 .
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 04/29/26 have been entered in the case. Claims 1-2, 4-16, 21-25 are pending for examination and claims 3, 17-20 are cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Based on the Exhibit #1 & Exhibit # below, the distal region 123 & 124 includes a proximal transition region 124; however, the outer liner 121 has a first hardness (65-70D). However, neither the outer liner 120 nor the first hardness are located in the proximal transition region 124, as required in the claim 16.
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Based on the Exhibit #1 (Fig. 1A) & #2 (Fig. 1B), the outer liner 121 (first hardness 65-70D) is located at a proximal region but is not located at the distal region 123. Although the distal region 123 includes a transition region 124; however, the transition region 124 has a hardness (20-30D) that is different with the first hardness ( 65-70D) of the first outer liner 121.
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.
Claims 1-2, 6-14, 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (US 7,938,820) in view of Podmore et al. (US 8,444,637).
Regarding claim 8, Webster discloses a clot removal system 100, comprising:
an aspiration catheter 106 defining a lumen (an interior lumen, col. 10, lines 6-10) and including a proximal region 104/106 and a distal region 108/160 (Figs. 1 & 3A), wherein the distal region 108/160 includes a deflectable member 164;
a handle coupled to the proximal region of the aspiration catheter; wherein the handle includes an actuator (e.g., proximal portion 104 comprises a handle, and other control structures of manipulating the aspiration catheter 100, col. 9, lines 57-60, or an actuation device, mentioned in see claim 1).
an aspiration source 102; and
a side port 120 between the aspiration source 102 and the aspiration catheter 106, wherein the aspiration source 102 is configured to aspirate the lumen of the aspiration catheter.
Webster does not disclose the limitation that: a pull wire extending between the actuator and the deflectable member, wherein actuation of the actuator is configured to pull the pull wire to deflect the deflectable member to deflect the distal region of the aspiration catheter relative to the proximal region.
Podmore discloses a catheter assembly in Figs. 1-10C comprising: a medical/catheter device includes a deflectable member 3 (Figs. 8-10C); a handle coupled to a proximal region of the medical device; wherein the handle includes an actuator, col. 4, lines 37-40, col. 5, lines 20-23);
a pull wire 10 extending between the actuator and the deflectable member 3, see col. 6, lines 24-26 & Figs. 8-9; wherein actuation of the actuator is configured to pull the pull wire 10 to deflect the deflectable member3 to deflect the distal region of the catheter relative to the proximal region.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the aspiration catheter device of Webster with providing a pull wire being connected in between an actuator and a pull wire, as taught by Podmore, for the benefit of maintaining the integrity of the shaft of the flexible/bendable region in order to improve the operating aspect to the device.
Regarding claim 1, Webster in view of Podmore discloses all claimed subject matter as required. Podmore discloses that wherein the deflectable member 3 includes a proximal ring (e.g., additional anchor member or proximal ring located at the proximal end of the flexible region 3, col. 5, lines 56-59); a distal ring 1 fixedly attached to the pull wire 10; and a tube portion (e.g., the flexible region formed by a tube portion, see Figs. 1-4 & 8-9, extending between the proximal and distal rings, wherein the tube portion includes a plurality of openings (at the flexible portion 3) extending therethrough to define a plurality of ribs, and wherein the ribs (bars) are configured to flex away from each other when the actuator pulls the pull wire, see Figs. 8-9.
Regarding claim 2, Webster in view of Podmore discloses all claimed subject matter as required. Podmore discloses that wherein the tube portion includes a spine 12 (Fig. 4) extending in a direction between the proximal and distal rings, wherein the ribs extend away from the spine 12 (e.g., the spine 12 is located outside of the ribs/bars), and wherein the spine is configured to extend generally parallel to and over the pull wire.
Regarding claim 6, Webster in view of Podmore discloses all claimed subject matter as required. Podmore discloses that wherein the tube portion 3 extends along a longitudinal axis in a relaxed state (Fig. 1), and wherein the openings extend circumferentially about the longitudinal axis and generally parallel to one another in the relaxed state.
Regarding claim 7, Webster in view of Podmore discloses all claimed subject matter as required. Podmore discloses that the distal ring 1 includes an annular member configured to slidably receive the pull wire 10 therethrough, see Fig. 4; as mentioned in the claim 1 above, the proximal ring is being added to the proximal end of the flexible member 3. Therefore, a person skilled in the art would recognize that the proximal ring can be formed and having a functional similar to the distal ring (e.g., the proximal ring includes an annular member configured to slidably receive the pull wire 10 therethrough) for purpose of simple design and easily put the device together before use.
Regarding claim 9, Webster in view of Podmore discloses all claimed subject matter as required. Podmore discloses that wherein the catheter (Note: the catheter in Podmore can be an aspiration catheter) extends along an axis, and wherein the actuation of the actuator is configured to deflect the distal region of the aspiration catheter away from the axis by about 90 degrees or greater (e.g., about 60-100 degrees of deflection, col. 6, lines 12-14).
Regarding claim 10, Webster in view of Podmore discloses all claimed subject matter as required. Webster discloses that the aspiration catheter has a size of 3.0 mm (col. 10, lines 20-23). Meanwhile, the claimed invention requires that the size of 20 French (6.67 mm) or greater.
It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the aspiration catheter of Webster to be 20 French or greater, since it has been held that , “wherein 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 the prior art device., the claimed device was not patentably distinct from the prior art device" Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) ("design choice" is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Webster would not operate differently with the
claimed size. Further, Applicant assigned no criticality to the size limitation, indicating simply that the size limitation “can” be one of several sizes (Specification, para [0036]), reciting numerous sizes for the catheter, with 20 French being only one of many).
Regarding claim 11, Webster in view of Podmore discloses all claimed subject matter as required. Podmore discloses that wherein the deflectable member has a tubular shape that extends along a longitudinal axis, and wherein the deflectable member includes (a) a spine extending parallel to the longitudinal axis and (b) a plurality of ribs extending from the spine and circumferentially about the longitudinal axis, see marked up Fig. 10C below.
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Regarding claims 12-14, Webster in view of Podmore discloses all claimed subject matter as required. Podmore discloses that wherein the deflectable member has a distal portion and a proximal portion, and wherein the pull wire is attached to the distal portion of the deflectable member; wherein the actuation of the actuator is configured to pull the distal portion proximally relative to the proximal portion; wherein the ribs define a plurality of openings therebetween, and wherein the actuation of the actuator is configured pull the distal portion of the deflectable member proximally relative to the proximal portion to bend the spine and increase a size of the openings.
Regarding claim 22, Webster in view of Podmore discloses all claimed subject matter as required. Webster discloses that wherein the side port 120 is coupled to the handle distal to the hemostasis valve.
Regarding claim 23, Webster in view of Podmore discloses all claimed subject matter as required. Webster discloses that wherein the side port 120 includes a fluid control device (valve, i.e., elastomeric diaphragm) movable between a first/closed position in which the aspiration source 102 is fluidly decoupled from the lumen of aspiration catheter and a second/open position (in Fig. 1) in which the aspiration source 102 is fluidly coupled to the lumen of the aspiration catheter.
Regarding claim 24, the aspiration source comprises a syringe 102.
Regarding claim 25, Webster in view of Podmore discloses all claimed subject matter as required. This limitation is considered as method steps in the device claims. Therefore, the method limitation is considered as functional limitation and only require performing a function. In this case, Webster discloses that the aspiration catheter is configured to be intravascularly position within a blood vessel of a patient such that the distal region is positioned near treatment site, i.e., clot material in the blood vessel, and wherein the aspiration source 102 is configured to aspirate the lumen of the aspiration catheter to aspirate blood at least a portion of the clot material through the lumen of the aspiration catheter, col. 9, lines 20-40.
Claims 5 & 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (US 7,938,820) in view of Podmore et al. (US 8,444,637) and further in view of Kondo et al. (US 5,873,866).
Webster in view of Podmore discloses all claimed subject matter as required but does not disclose the limitations as required in the claims 5 & 15.
Kondo discloses a catheter 2, see marked-up Fig. 1 comprising: an intermediate region 2a between proximal and distal regions; an inner liner 35 extending through the proximal, intermediate and distal regions. Note: the inner liner 14 is formed over the entire length of the tube 10. A person skilled in the art would recognize that the inner liner 35 in Figs. 8-9 can be formed over the entire length of the tube 30; braid of wires 34 extending through the proximal and intermediate regions over the inner liner 35; a wire 31b extending through the intermediate region and coiled around the braid; and an outer liner extending through the proximal, intermediate and distal regions over the liner, the braid, and the wire, wherein the deflectable member is positioned between the inner and outer liner in the distal region.
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It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the aspiration catheter device of Webster (Webster in view of Podmore) with providing a wire extending through the intermediate region and coiled around the braid, as taught by Kondo, for the benefit of increasing the flexibility and strength in the catheter device.
Regarding claim 16, as shown in marked-up Fig. 1 above, Kondo discloses that the distal region wherein the distal region further includes a proximal transition region, a distal tip region, and a deflectable region between the proximal transition region and the distal tip region; the deflectable member is positioned in the deflectable region; the outer liner has a first hardness in the proximal transition region, a second hardness in the deflectable region, and a third hardness in the distal tip region; the deflectable region 2b is flexible or being bent in at least a half of circle. Therefore, the second hardness (in the deflectable region) is less than the first hardness (outer liner) and less than the third hardness (at distal tip 2c).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (US 7,938,820) in view of Podmore et al. (US 8,444,637) and further in view of Bagaisan et al. (US 6,152,909).
Regarding claim 21, Webster in view of Podmore discloses all claimed subject matter as required. Webster discloses that a fitting 22 provides a sealed connection, i.e. elastomeric diaphragm is equivalent to a valve. It is well-known in the art that the valve (or elastomeric diaphragm) can be used as a hemostasis valve (at suction port) to prevent significant blood loss or prevent leaking. Webster further discloses that the valve (i.e. hemostasis valve) coupled to the proximal portion of the handle, wherein the valve is configured to be actuated to an at least partially unsealed position (when the syringe 102 inserts through the valve, see Fig. 1) to provide fluid access to the lumen of the aspiration catheter.
In case Applicant disagrees with the Examiner, the Webster in view of Podmore is modified by Bagaoisan as follow.
Bagaoisan discloses an aspiration catheter comprising: an aspiration port 158; wherein a hemostasis valve coupled to a proximal portion of the handle of the aspiration catheter 136 to prevent the patient’s blood from flowing out around the aspiration catheter and to prevent collapse, or crushing the catheter during procedure, col. 13,lines 36-47.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to substitute the sealed connection or standard valve of Webster for the other, i.e. hemostasis valve, as taught by Bagaoisan, for the benefits of preventing the patient’s blood from flowing out around the aspiration catheter and preventing collapse or crushing the catheter during procedure.
Claims 1-2, 4, 6-14, 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (US 7,938,820) in view of Kauphusman et al. (US 2011/0112476).
Regarding claim 8, Webster discloses a clot removal system 100, comprising:
an aspiration catheter 106 defining a lumen (an interior lumen, col. 10, lines 6-10) and including a proximal region 104/106 and a distal region 108/160 (Figs. 1 & 3A), wherein the distal region 108/160 includes a deflectable member 164;
an aspiration source 102; and
a handle coupled to the proximal region of the aspiration catheter; wherein the handle includes an actuator (e.g., proximal portion 104 comprises a handle, and other control structures of manipulating the aspiration catheter 100, col. 9, lines 57-60, or an actuation device, mentioned in see claim 1).
an aspiration source 102; and
a side port 120 between the aspiration source 102 and the aspiration catheter 106, wherein the aspiration source 102 is configured to aspirate the lumen of the aspiration catheter.
Webster does not disclose the limitation that: a pull wire extending between the actuator and the deflectable member, wherein actuation of the actuator is configured to pull the pull wire to deflect the deflectable member to deflect the distal region of the aspiration catheter relative to the proximal region.
Kauphusman discloses a catheter assembly 20/50 (in Figs. 1A-15) comprising: a catheter 20/50 includes a deflectable member, i.e., strut 42 (Fig. 1A) or 58 (Figs. 2-15); a handle (convention handle, para [0042]) coupled to the proximal region of the catheter 50, wherein the handle includes an actuator (actuation mechanism, para [0008], knob, para [0034], or computer-controlled robotic catheter, para [0043]);
a pull wire 62/64 extending between the actuator (e.g., the actuator is located at a proximal end of the catheter) and the deflectable member 42/58, wherein actuation of the actuator is configured to pull the pull wire to deflect the deflectable member to deflect the distal region of the catheter relative to the proximal region 24.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the aspiration catheter device of Webster with providing a pull wire being connected in between an actuator and a pull wire, as taught by Kauphusman, for the benefit of reducing the axial shortening due to repeated deflection of a catheter without kinking during procedure.
Regarding claim 1, Webster in view of Kauphusman discloses all the claimed subject matter as required. Kauphusman discloses that wherein the deflectable member 58/58a-58e includes a proximal ring 80/92112/120/128, a distal ring 60/78/90/110/118/126 fixedly attached to the pull wire 62/64; and a tube portion (e.g., the deflectable/strut member 42 forms as a tube portion, see Fig. 1A) extending between the proximal and distal rings, wherein the tube portion (strut portion) includes a plurality of openings extending therethrough to define a plurality of ribs, and wherein the ribs are configured to flex away from each other when the actuator pulls the pull wire.
Regarding claim 2, Webster in view of Kauphusman discloses all the claimed subject matter as required. Kauphusman (or Webster in view of Kauphusman) discloses that a spine 981-n extending in a direction between the proximal and distal rings; wherein the ribs 961-n extends away from the spine, and wherein the spine is configured to extend generally parallel to and over the pull wire.
Note: other strut (tube portion of the deflectable member) in Figs. 4-15 discloses the limitations as required in the claim 2. However, Examine only picks the tube portion of the strut in Figs. 5-6 for mapping out the claim invention.
Regarding claim 4, Webster in view of Kauphusman discloses all the claimed subject matter as required. Kauphusman (or Webster in view of Kauphusman) discloses that wherein the aspiration catheter 50 further comprising comprises an intermediate region 68 between the proximal and distal regions, and wherein the proximal region and the intermediate region 68 include a braid of wires 66 extending therethrough.
Regarding claim 6, Webster in view of Kauphusman discloses all the claimed subject matter as required. Kauphusman (or Webster in view of Kauphusman) discloses that wherein the tube portion extends along a longitudinal axis in a relaxed state (Figs. 2, 4-12), and wherein the openings extend circumferentially about the longitudinal axis and generally parallel to one another in the relaxed state.
Regarding claim 7, Webster in view of Kauphusman discloses all the claimed subject matter as required. Kauphusman (or Webster in view of Kauphusman) discloses that wherein the proximal ring includes an annular member; however, it does not disclose that the annular member of the proximal ring being configured to slidably receive the pull wire therethrough. It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain the annular member of the proximal ring being slidable (e.g., detached/attached to the strut) receive the pull wire, since it has been held that constructing a formerly integral or separate structure in various elements involves only routine skill in the art.
Regarding claim 9, Webster in view of Kauphusman discloses all the claimed subject matter as required. Kauphusman (or Webster in view of Kauphusman) discloses that wherein the catheter (Note: the catheter in Kauphusman can be an aspiration catheter) extends along an axis, and wherein the actuation of the actuator is configured to deflect the distal region of the aspiration catheter away from the axis by about 90 degrees or greater (e.g., about 180-270 degrees of deflection, para [0040]).
Regarding claim 10, Webster in view of Kauphusman discloses all claimed subject matter as required. Webster discloses that the aspiration catheter has a size of 3.0 mm (col. 10, lines 20-23). Meanwhile, the claimed invention requires that the size of 20 French (6.67 mm) or greater.
It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the aspiration catheter of Webster to be 20 French or greater, since it has been held that , “wherein 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 the prior art device., the claimed device was not patentably distinct from the prior art device" Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) ("design choice" is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Webster would not operate differently with the
claimed size. Further, Applicant assigned no criticality to the size limitation, indicating simply that the size limitation “can” be one of several sizes (Specification, para [0036]), reciting numerous sizes for the catheter, with 20 French being only one of many).
Regarding claim 11, Webster in view of Kauphusman discloses all the claimed subject matter as required. Kauphusman (or Webster in view of Kauphusman) discloses that wherein the deflectable member 58b (in Fig. 6) has a tubular shape that extends along a longitudinal axis, and wherein the deflectable member includes (a) a spine 981-98n extending parallel to the longitudinal axis and (b) a plurality of ribs 961-96n extending from the spine 981-98n and circumferentially about the longitudinal axis.
Note: The Figs. 7-15 show the deflectable member includes the spines and the ribs also. However, for convenience purpose, Examiner only use Figs. 5-6 for mapping out the claimed invention.
Regarding claims 12-14, Webster in view of Kauphusman discloses all the claimed subject matter as required. Kauphusman discloses that wherein the deflectable member has a distal portion and a proximal portion, and wherein the pull wire is attached to the distal portion of the deflectable member; wherein the actuation of the actuator is configured to pull the distal portion proximally relative to the proximal portion; wherein the ribs define a plurality of openings therebetween, and wherein the actuation of the actuator is configured pull the distal portion of the deflectable member proximally relative to the proximal portion to bend the spine and increase a size of the openings.
Regarding claim 21, Webster in view of Kauphusman discloses all claimed subject matter as required. Webster discloses that a fitting 22 provides a sealed connection, i.e. elastomeric diaphragm is equivalent to a valve. It is well-known in the art that the valve (or elastomeric diaphragm) can be used as a hemostasis valve (at Y-site branch) to prevent significant blood loss or prevent leaking. Webster further discloses that the valve (i.e. hemostasis valve) coupled to the proximal portion of the handle, wherein the valve is configured to be actuated to an at least partially unsealed position (when the syringe 102 inserts through the valve, see Fig. 1) to provide fluid access to the lumen of the aspiration catheter.
Regarding claim 22, Webster in view of Kauphusman discloses all claimed subject matter as required. Webster discloses that wherein the side port 120 is coupled to the handle distal to the hemostasis valve.
Regarding claim 23, Webster in view of Kauphusman discloses all claimed subject matter as required. Webster discloses that wherein the side port 120 includes a fluid control device (valve, i.e., elastomeric diaphragm) movable between a first/closed position in which the aspiration source 102 is fluidly decoupled from the lumen of aspiration catheter and a second/open position (in Fig. 1) in which the aspiration source 102 is fluidly coupled to the lumen of the aspiration catheter.
Regarding claim 24, the aspiration source comprises a syringe 102.
Regarding claim 25, Webster in view of Kauphusman discloses all claimed subject matter as required. This limitation is considered as method steps in the device claims. Therefore, the method limitation is considered as functional limitation and only require performing a function. In this case, Webster discloses that the aspiration catheter is configured to be intravascularly position within a blood vessel of a patient such that the distal region is positioned near treatment site, i.e., clot material in the blood vessel, and wherein the aspiration source 102 is configured to aspirate the lumen of the aspiration catheter to aspirate blood at least a portion of the clot material through the lumen of the aspiration catheter, col. 9, lines 20-40.
Claims 5 & 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (US 7,938,820) in view of Kauphusman et al. (US 2011/0112476) and further in view of Kondo et al. (US 5,873,866).
Webster in view of Kauphusman discloses all claimed subject matter as required but does not disclose the limitations as required in the claims 5 & 15.
Kondo discloses a catheter 2, see marked-up Fig. 1 comprising: an intermediate region 2a between proximal and distal regions; an inner liner 35 extending through the proximal, intermediate and distal regions. Note: the inner liner 14 is formed over the entire length of the tube 10. A person skilled in the art would recognize that the inner liner 35 in Figs. 8-9 can be formed over the entire length of the tube 30; braid of wires 34 extending through the proximal and intermediate regions over the inner liner 35; a wire 31b extending through the intermediate region and coiled around the braid; and an outer liner extending through the proximal, intermediate and distal regions over the liner, the braid, and the wire, wherein the deflectable member is positioned between the inner and outer liner in the distal region.
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It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the aspiration catheter device of Webster (Webster in view of Kauphusman) with providing a wire extending through the intermediate region and coiled around the braid, as taught by Kondo, for the benefit of increasing the flexibility and strength in the catheter device.
Regarding claim 16, as shown in marked-up Fig. 1 above, Kondo discloses that the distal region wherein the distal region further includes a proximal transition region, a distal tip region, and a deflectable region between the proximal transition region and the distal tip region; the deflectable member is positioned in the deflectable region; the outer liner has a first hardness in the proximal transition region, a second hardness in the deflectable region, and a third hardness in the distal tip region; the deflectable region 2b is flexible or being bent in at least a half of circle. Therefore, the second hardness (in the deflectable region) is less than the first hardness (outer liner) and less than the third hardness (at distal tip 2c).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (US 7,938,820) in view of Kauphusman et al. (US 2011/0112476) and further in view of Bagaisan et al. (US 6,152,909).
Regarding claim 21, Webster in view of Kauphusman discloses all claimed subject matter as required. Webster discloses that a fitting 22 provides a sealed connection, i.e. elastomeric diaphragm is equivalent to a valve. It is well-known in the art that the valve (or elastomeric diaphragm) can be used as a hemostasis valve (at suction port) to prevent significant blood loss or prevent leaking. Webster further discloses that the valve (i.e. hemostasis valve) coupled to the proximal portion of the handle, wherein the valve is configured to be actuated to an at least partially unsealed position (when the syringe 102 inserts through the valve, see Fig. 1) to provide fluid access to the lumen of the aspiration catheter.
In case Applicant disagrees with the Examiner, the Webster in view of Podmore is modified by Bagaoisan as follow.
Bagaoisan discloses an aspiration catheter comprising: an aspiration port 158; wherein a hemostasis valve coupled to a proximal portion of the handle of the aspiration catheter 136 to prevent the patient’s blood from flowing out around the aspiration catheter and to prevent collapse, or crushing the catheter during procedure, col. 13,lines 36-47.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to substitute the sealed connection or standard valve of Webster for the other, i.e. hemostasis valve, as taught by Bagaoisan, for the benefits of preventing the patient’s blood from flowing out around the aspiration catheter and preventing collapse or crushing the catheter during procedure.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-16, 21-25have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
