DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation " the at least one distal orifice" in Line 7. There is insufficient antecedent basis for this limitation in the claim. Applicant has yet to define a distal orifice from the at least one orifice recited in the claims. The Examiner suggests amending the claims to recite “wherein of the at least one orifice of the supply lumen…” or a similar amendment to introduce a distal orifice of the at least one orifices.
Claims 2-5 are rejected for incorporating errors from the parent claim by dependency.
Claim 6 recites the limitation " the at least one distal orifice" in Line 7. There is insufficient antecedent basis for this limitation in the claim. Applicant has yet to define a distal orifice from the at least one orifice recited in the claims. The Examiner suggests amending the claims to recite “wherein of the at least one orifice of the supply lumen…” or a similar amendment to introduce a distal orifice of the at least one orifices.
Claims 7-25 are rejected for incorporating errors from the parent claim by dependency.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 13, the limitation “wherein the at least one distal orifice is proximal of the distal opening between 0.010 inches to about 50 inches” is not further limiting since a range of 0.010 to 50 inches is already recited in independent Claim 6, of which Claim 13 depends upon.
Claim 14 is rejected for incorporating errors from the parent claim by dependency.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 5-7, 9, 11, 13, 20 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madej (US PGPub 2024/0245423).
Regarding Claim 1, Madej teaches a thrombectomy system (Figure 1), comprising
an aspiration catheter (400; Figure 4) having an aspiration lumen (406 of catheter 402; Figure 4; Paragraph 0048) and a supply lumen (414 of fluid supply tube 410; Figure 4; Paragraph 0049), the aspiration catheter having a proximal end and a distal end (408; Figure 4; Paragraph 0048); and
a drive unit (12; Figure 1; Paragraph 0040) fluidly connected to the aspiration catheter (14 in Figure 1; see Paragraph 0040) and configured to provide pressurized fluid and vacuum through the aspiration catheter (Paragraph 0040; Figure 1),
wherein, the aspiration catheter (400; Figure 4) comprises a distal opening (408; Figure 4) and wherein the supply lumen (414) has at least one orifice (418 a-d in Figure 4), wherein the at least one distal orifice (418d; Figure 4; Paragraph 0055) of the supply lumen (414; Figure 4) is proximal of the distal opening (408) of the aspiration catheter (402; Figure 4; Paragraph 00055), so as to be proximally disposed relative to the distal opening (408; Figure 4)
Madej fails to explicitly disclose the at least one distal orifice (418d) is disposed proximally relative to the distal opening (408) between about 0.035 inches and about 0.060 inches.
Madej teaches, in Paragraph 0055, “The distally projecting jet orifice 418d may be proximally spaced a distance from the distal opening 408 of the catheter body 402. It is contemplated that the longitudinal location of the distally projecting jet orifice 418d on the supply tube wall 412 and relative to the distal opening 408 of the catheter body 402 may be varied based on a size of the aperture of the distally projecting jet orifice 418d, the velocity of the fluid within the lumen 414 of the supply tube wall 412, the angle of the distally projecting jet orifice 418d, or combinations thereof, etc. to ensure the distally oriented motive jetted fluid 420d impinges the inner surface of the catheter body 402.” Furthermore, Madej teaches “the distally projecting jet orifice 418d may be positioned such that the distally oriented motive jetted fluid 420d impinges an inner surface of the catheter body 402 in the range of about 0.070 inches (1.778 millimeters) to about 0.090 inches (2.286 millimeters) proximal to the distal end of the catheter body 402. This is just one example. The impingement location of the motive jetted fluid 420d of the distally projecting jet orifice 418d may be less than 0.070 inches (1.778 millimeters) or more than 0.090 inches (2.286 millimeters) proximal to the distal end of the catheter body 402, as desired.”
Since Madej teaches that the distance between the at least one distal orifice (418d) is disposed proximally relative to the distal opening (408) and that distance can be modified such that the fluid impinges on the inner surface of the catheter at the desired location, this distance is a result effective variable in that changing the distance between the distal orifice and the distal opening of the catheter the impingement of fluid on the inner surface of the catheter body.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Madej et al. device to have a spacing between the distal orifice and the distal opening within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Madej et al. by making the distance between the distal orifice and the distal opening be between about 0.035 inches and about 0.060 inches 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).
Lastly, Applicant has failed to place criticality on the claimed range since Paragraph 0034 of the instant specification PGPub states “The orifice 194 is set proximally of the open distal end 107 by a set amount. For example, orifice 194 can be set proximally of the open distal end 107 by about 0.040 inches, and in one configuration by 0.051±0.003 inches or by another desired amount…In still other configurations, the open distal end 107 can be set proximally of the open distal end 107 by about 0.01 inches to about 50 inches, between about 0.010 inches and about 40 inches, or between about 0.010 inches and about 2 inches.”
Regarding Claim 2, Madej teaches the system of claim 1, but fails to explicitly teach the at least one distal orifice is proximal of the distal opening between about 0.040 inches and about 0.055 inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Madej et al. by making the distance between the distal orifice and the distal opening be between about 0.040 inches and about 0.055 inches 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). See rejection of Claim 1 above.
Regarding Claim 3, Madej teaches the system of claim 1, wherein the at least one orifice (418a-418d) is configured to form a spray pattern (420a-420d) of the pressurized fluid delivered along the supply lumen (414; Paragraph 0055).
Regarding Claim 5, Madej teaches a method of removing a thrombus, comprising the steps of:
providing the system of claim 1 (see rejection of Claim 1 above);
inserting the aspiration catheter percutaneously into a body vessel lumen (Paragraph 0039);
advancing the aspiration catheter to a region of interest (Paragraph 0039); and
operating the drive unit to provide pressurized fluid and aspiration through the aspiration catheter to draw the thrombus into the aspiration lumen (Paragraph 0039-0040).
Regarding Claim 6, Madej teaches a thrombectomy system (Figure 1), comprising
an aspiration catheter (400; Figure 4) having an aspiration lumen (406 of catheter 402; Figure 4; Paragraph 0048) and a supply lumen (414 of fluid supply tube 410; Figure 4; Paragraph 0049), the aspiration catheter having a proximal end and a distal end (408; Figure 4; Paragraph 0048); and
a drive unit (12; Figure 1; Paragraph 0040) fluidly connected to the aspiration catheter (14 in Figure 1; see Paragraph 0040) and configured to provide pressurized fluid and vacuum through the aspiration catheter (Paragraph 0040; Figure 1),
wherein, the aspiration catheter (400; Figure 4) comprises a distal opening (408; Figure 4) and wherein the supply lumen (414) has at least one orifice (418 a-d in Figure 4),
wherein the at least one distal orifice (418d; Figure 4; Paragraph 0055) of the supply lumen (414; Figure 4) is proximal of the distal opening (408) of the aspiration catheter (402; Figure 4; Paragraph 00055), so as to be proximally disposed relative to the distal opening (408; Figure 4)
Madej fails to explicitly disclose the at least one distal orifice (418d) is disposed proximally relative to the distal opening (408) between about 0.010 inches and about 50 inches.
Madej teaches, in Paragraph 0055, “The distally projecting jet orifice 418d may be proximally spaced a distance from the distal opening 408 of the catheter body 402. It is contemplated that the longitudinal location of the distally projecting jet orifice 418d on the supply tube wall 412 and relative to the distal opening 408 of the catheter body 402 may be varied based on a size of the aperture of the distally projecting jet orifice 418d, the velocity of the fluid within the lumen 414 of the supply tube wall 412, the angle of the distally projecting jet orifice 418d, or combinations thereof, etc. to ensure the distally oriented motive jetted fluid 420d impinges the inner surface of the catheter body 402.” Furthermore, Madej teaches “the distally projecting jet orifice 418d may be positioned such that the distally oriented motive jetted fluid 420d impinges an inner surface of the catheter body 402 in the range of about 0.070 inches (1.778 millimeters) to about 0.090 inches (2.286 millimeters) proximal to the distal end of the catheter body 402. This is just one example. The impingement location of the motive jetted fluid 420d of the distally projecting jet orifice 418d may be less than 0.070 inches (1.778 millimeters) or more than 0.090 inches (2.286 millimeters) proximal to the distal end of the catheter body 402, as desired.”
Since Madej teaches that the distance between the at least one distal orifice (418d) is disposed proximally relative to the distal opening (408) and that distance can be modified such that the fluid impinges on the inner surface of the catheter at the desired location, this distance is a result effective variable in that changing the distance between the distal orifice and the distal opening of the catheter the impingement of fluid on the inner surface of the catheter body.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Madej et al. device to have a spacing between the distal orifice and the distal opening within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Madej et al. by making the distance between the distal orifice and the distal opening be between about 0.010 inches and about 50 inches 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).
Lastly, Applicant has failed to place criticality on the claimed range since Paragraph 0034 of the instant specification PGPub states “The orifice 194 is set proximally of the open distal end 107 by a set amount. For example, orifice 194 can be set proximally of the open distal end 107 by about 0.040 inches, and in one configuration by 0.051±0.003 inches or by another desired amount…In still other configurations, the open distal end 107 can be set proximally of the open distal end 107 by about 0.01 inches to about 50 inches, between about 0.010 inches and about 40 inches, or between about 0.010 inches and about 2 inches.”
Regarding Claim 7, Madej teaches the system of claim 6, but fails to explicitly disclose wherein the at least one orifice is proximal of the distal opening between about 0.010 inches to about 0.200 inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Madej et al. by making the distance between the distal orifice and the distal opening be between about 0.010 inches and about 0.2 inches 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). See rejection of Claim 6 above.
Regarding Claim 9, Madej teaches the system of claim 6, but fails to explicitly disclose wherein the at least one distal orifice is proximal of the distal opening between about 0.010 inches to about 2 inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Madej et al. by making the distance between the distal orifice and the distal opening be between about 0.010 inches and about 2 inches 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). See rejection of Claim 6 above.
Regarding Claim 11, Madej teaches the system of claim 6, but fails to explicitly disclose wherein the at least one distal orifice is proximal of the distal opening between 0.010 inches to about 40 inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Madej et al. by making the distance between the distal orifice and the distal opening be between about 0.010 inches and about 40 inches 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). See rejection of Claim 6 above.
Regarding Claim 13, Madej teaches the system of claim 6, wherein the at least one distal orifice is proximal of the distal opening between 0.010 inches to about 50 inches (see rejection of Claim 1 above).
Regarding Claim 20, Madej teaches the system of claim 6, further comprising a pump (56; Figure 2) operatively coupled to a canister (60) in fluid communication with the aspiration lumen (66 in Figure 2; Paragraph 0041).
Regarding Claim 25, Madej teaches a method of removing a thrombus, comprising the steps of:
providing the system of claim 6 (See rejection of Claim 6 above);
inserting the aspiration catheter percutaneously into a body vessel lumen (Paragraph 0039);
advancing the aspiration catheter to a region of interest (Paragraph 0039); and
operating the drive unit to provide pressurized fluid and aspiration through the aspiration catheter to draw the thrombus into the aspiration lumen (Paragraph 0039-0040).
Claim(s) 4 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madej (US PGPub 2024/0245423) as applied to claim 1 and 6 above, and further in view of Bonnette (US PGPub 2014/0155830).
Regarding Claim 4, Madej teaches the system of claim 1, but fails to teach wherein the drive unit comprises a vacuum regulator.
Bonnette teaches a thrombectomy system comprising a vacuum regulator (37; Figure 1; Paragraph 0064) which can be controlled for adjusting the rate of exhaust/vacuum (Paragraph 0077).
It would have been obvious to one of ordinary skill in the art to modify the drive of Madej, to include a vacuum regulator, as taught by Bonnette, for the advantage of carefully generating operating pressures and fluid flows that provide sufficient effluent aspiration (Paragraph 0077).
Regarding Claim 15, Madej teaches the system of claim 6, but fails wherein the drive unit comprises a vacuum regulator.
Bonnette teaches a thrombectomy system comprising a vacuum regulator (37; Figure 1; Paragraph 0064) which can be controlled for adjusting the rate of exhaust/vacuum (Paragraph 0077).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the drive of Madej, to include a vacuum regulator, as taught by Bonnette, for the advantage of carefully generating operating pressures and fluid flows that provide sufficient effluent aspiration (Paragraph 0077).
Regarding Claim 16, the combination of references teaches the system of claim 15, Bonnette teaches wherein the vacuum regulator (47) accommodates for variations in elevation within a location where the system is being operated (Paragraph 0077 discloses controlling the exhaust rate of the exhaust regulator and since the vacuum pump is adjustable, it is the Examiner’s position that it can be adjusted to accommodate for variations in elevation within a location where the system is being operated).
Regarding Claim 17, Madej teaches the system of claim 6, further comprising a pump (56; Figure 1; Paragraph 0041) operatively coupled to the supply lumen (64; Paragraph 0041) but fails to disclose the pump having an adjustable or variable speed.
Bonnette teaches a thrombectomy system comprising a pump (44) which is adjustable (Paragraph 0080 states the high pressure pump 44 pump rate is adjusted to achieve the proper efficacy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the pump of Madej, to be adjustable, as taught by Bonnette, for the advantage of achieving the proper set efficacy (Paragraph 0080; Bonnette).
Claim(s) 18, 19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madej (US PGPub 2024/0245423) and Bonnette (US PGPub 2014/0155830) as applied to claim 17 and 20 above, and further in view of Genin (US PGPub 2023/0047991)
Regarding Claim 18, the combination of references disclosed above teaches the system of claim 17, but fails to disclose wherein a controller of the drive unit controls and monitors a speed of the pump to maintain the speed within a predetermined range.
Genin teaches a system for the removal of thrombus (abstract) comprising a catheter (Figure 6) and a drive unit (200; Figure 6-7B), wherein a controller (210; Figure 6) of the drive unit controls and monitors a speed of the pump (202; Paragraph 0057-0059) to maintain the speed within a predetermined range (Paragraph 0060-0061).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the drive unit of Madej to include a controller capable of controlling, monitoring, and maintaining a predetermined speed of the motor within a predetermined range, as taught by Genin, for the advantage of supporting pressure compensation within the treatment region automatically (Paragraph 0011 and 0061; Genin)
Regarding Claim 19, the combination of references disclosed above teaches the system of claim 17, but fails to disclose wherein a controller of the drive unit controls and monitors a speed of the pump.
Genin teaches a system for the removal of thrombus (abstract) comprising a catheter (Figure 6) and a drive unit (200; Figure 6-7B), wherein a controller (210; Figure 6) of the drive unit controls and monitors a speed of the pump (202; Paragraph 0057-0061).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the drive unit of Madej to include a controller capable of controlling, monitoring, and maintaining a predetermined speed of the motor within a predetermined range, as taught by Genin, for the advantage of supporting pressure compensation within the treatment region automatically (Paragraph 0011 and 0061; Genin)
Regarding Claim 23, the combination of references disclosed above teaches the system of claim 19, wherein Genin teaches the controller comprises a potentiometer (Paragraph 0069).
Claim(s) 21, 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madej (US PGPub 2024/0245423) as applied to claim 7 and 20 above, and further in view of Genin (US PGPub 2023/0047991).
Regarding Claim 21, Madej teaches the system of claim 20, but fails to disclose wherein a controller of the drive unit controls the pump to operate between about 30% of maximum speed and about 100% maximum speed.
Genin teaches a system for the removal of thrombus (abstract) comprising a catheter (Figure 6) and a drive unit (200; Figure 6-7B), wherein a controller (210; Figure 6) of the drive unit controls and monitors a speed of the pump (202; Paragraph 0057-0061), the motors drives (206) which are connected to the pumps provide variable speed for the pumps (Paragraph 0058) and furthermore, Genin teaches a speed knob attached to the motor drives (Paragraph 0012) for controlling the pumping speed (Paragraph 0063).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the drive unit of Madej to include a controller capable of controlling the speed of the motor within a predetermined range (in this case 30% to 60% of the maximum speed), as taught by Genin, for the advantage of supporting pressure compensation within the treatment region automatically (Paragraph 0011 and 0061; Genin). Furthermore, it’s the Examiner’s position that Applicant has not placed criticality for this range (see Paragraph 0063 of instant specification PGPub which states “the controller 235 can vary the operating speed of the vacuum pump 266 to reduce the audible noise of the system 200, and more particularly noise from the vacuum pump 266. For instance, the controller 235 can operate the vacuum pump 266 at a reduced speed, such as approximately 60% of maximum speed, during start-up and then reduce the speed to about 30% of maximum when a desired vacuum is achieved, such as −27.5 inHg. Other start-up speeds can be achieved with other speed input signals.”)
Regarding Claim 22, the combination of references disclosed above teaches the system of claim 21, but fails to explicitly state wherein the controller of the drive unit controls the pump to operate at about 60% of maximum speed during start-up of the drive.
Genin teaches a controller (210; Figure 6) of the drive unit controls and monitors a speed of the pump (202; Paragraph 0057-0061), the motors drives (206) which are connected to the pumps provide variable speed for the pumps (Paragraph 0058) and a speed knob attached to the motor drives (Paragraph 0012) for controlling the pumping speed which is capable of being 60% of the maximum speed (Paragraph 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the drive unit of Madej to include a controller capable of controlling the pump to operate at about 60% of maximum speed during start-up of the drive, as taught by Genin, for the advantage of having a motor/pump which has a large range of capable pressures.
Furthermore, it’s the Examiner’s position that Applicant has not placed criticality for the pump to operate at 60% maximum speed during start up (see Paragraph 0063 of instant specification PGPub which states “Other start-up speeds can be achieved with other speed input signals.”)
Regarding Claim 24, Madej teaches the system of claim 7, further comprising but fails to disclose a controller operatively coupled to a display, wherein the controller is configured to provide at least one of alarms, warnings, pressure, or flow information, or other information via the display.
Genin teaches a system for the removal of thrombus (abstract) comprising a catheter (Figure 6) and a drive unit (200; Figure 6-7B), further comprising a controller (210; Figure 6 and 7A) operatively coupled to a display (214; Figure 7A), wherein the controller (210) is configured to provide at least one of alarms, warnings, pressure, or flow information, or other information via the display (214; Paragraph 0063; Figure 7A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the drive unit of Madej to include a controller connected to a display, as taught by Genin, for the advantage of providing a user interface to see current data of the system.
Claim(s) 8, 10, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madej (US PGPub 2024/0245423) as applied to claim 7, 11, and 13 above, and further in view of Bonnette (US PGPub 2014/0277006)
Regarding Claims 8, 10, 12, and 14, Madej teaches the system of claim 7 and 11 but fails to disclose wherein the aspiration catheter has a size ranging from about 3 Fr to about 8 Fr (Claim 8), wherein the aspiration catheter has a size ranging from about 9 Fr to about 11 Fr (Claim 10), wherein the aspiration catheter has a size ranging from about 12 Fr to about 16 Fr (Claim 12), and wherein the aspiration catheter has a size ranging from about 17 Fr to about 26 Fr (Claim 14).
Bonnette teaches a thrombectomy system (abstract) comprising an aspiration catheter (10; Figure 1). Bonnette teaches, in Paragraph 0048, “In one or more embodiments, different portions of the thrombectomy catheters described herein may have external dimensions that range from, e.g., 14 French to 3 French, although thrombectomy catheters having external dimensions outside of that range may also be provided.”
Since Bonnette teaches that the aspiration catheter can be between 14 Fr and 3F, as well as dimensions outside of that range, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the aspiration catheter of Madej to be sized 3 Fr to 26 Fr mm since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Madej would not operate differently with the claimed diameter and since Bonnette discloses the use of different sized catheters for thrombectomy systems. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the catheter size ranging from 3 Fr to about 50 Fr (Paragraph 0035 instant specification PGPub) and Applicant states, in Paragraph 0036, “In other configurations, the ranges can include any combination of a range defined by any two of the foregoing proximal location of the orifice 194 with a range defined by any two of the foregoing catheter sizes.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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