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 Arguments
Applicant's arguments filed 10/23/2025 with regards to “the conduit is configured to insert into a lumen of a catheter” beginning on page two of pre-appeal brief are considered persuasive. See amended claim 1 and 22 rejections below.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 8-11, 14-29, 39-41 and 43-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culbert et al. (US 2017/0290598 A1) in view of Evans et al. (US 2011/0046542 A1) further in view of Webster et al. (US 7,938,820 B2), and Trott (US 4,228,802).
Culbert alternative embodiments considered usable together due to para. 169 “Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein”.
In regards to claim 1:
Culbert teaches, a medical device for thrombolysis (Fig. 1), comprising: a conduit (Fig. 1 element 16), the conduit including a supply lumen (para. 121 “a sterile fluid path is provided extending all the way from the fluid source 20 to the distal opening 40/open distal end 158 of the catheter 16”) configured to convey an aqueous thrombolytic composition from a supply reservoir thereof through an opening in a distal-end portion of the conduit for administration of the thrombolytic composition to an intraluminal clot in the lumen of the catheter (Examiner notes due to configured language these limitations are considered required capabilities of the conduit but are not positively recited parts of the claimed invention. Para. 121 “a sterile fluid path is provided extending all the way from the fluid source 20 to the distal opening 40/open distal end 158 of the catheter 16” and para. 120 “Some of the drugs 730 which may be delivered include thrombolytic agents (clot busting drugs)”. Therefore, conduit taught by Culbert considered fully capable of conveying thrombolytic as claimed.); a connector coupled to a proximal-end portion of the conduit (Fig. 1 element 44), the connector configured to fluidly connect the supply reservoir to the lumen of the catheter via the conduit passing through the connector (Fig. 1 elements 20 and 44, para. 87 “Attached to the hand piece 12 are a fluid source 20” and para. 121 “Para. 121 “a sterile fluid path is provided extending all the way from the fluid source 20 to the distal opening 40/open distal end 158 of the catheter 16” therefore connector 44 considered fully capable of fluidly connecting the supply reservoir to the lumen of the catheter as claimed. “sterile fluid path” is considered to be a recitation of the claimed conduit.);
Culbert does not appear to explicitly disclose the waste reservoir capability as claimed (Culbert teaches, para. 93 “The vacuum source 22 may instead be a 60 ml syringe whose plunger is pulled back after coupling to the connector 104. This may be a lockable plunger, which is locked in order to maintain the evacuated plunger position.”). Evans teaches, a waste reservoir (Fig. 15 element 282), the waste reservoir configured to collect waste from the lumen of the catheter including fibrin fragments, platelets, red blood cells, or spent solution of the thrombolytic composition used to break down the intraluminal clot in the lumen of the catheter (Considered fully capable of connecting to the lumen and of collecting the waste of the lumen as claimed due to para. 42 “and clot and/or fluid may be aspirated through the same lumen” and para. 96” Optionally, agitating means may be used to agitate the clot and aspiration means may be used to aspirate clot and/or fluid containing clot particles, blood, infusate and the like.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the vacuum source for thrombolysis taught by Culbert to include the waste reservoir containing vacuum source taught by Evans. This would have been motivated by design choice. It is known in the art the waste product must be collected and merely picking the type of container used to collect said waste is considered to be within the level of one of ordinary skill in the art. Examiner notes Culbert provides further motivation for this design choice (para. 3 “Several devices and systems already exist to aid in the removal of thrombotic material. These include simple aspiration tube type devices using vacuum syringes to extract thrombus into the syringe,”).
Culbert in view of Evans teaches, the connector further configured to fluidly connect the waste reservoir (Evans Fig. 15 element 282) to the lumen of the catheter (Culbert Para. 97 “FIGS. 9-11 show an open distal end 158 of an aspiration lumen 160 for aspirating thrombus. A skive 162 may be formed in the polymer jacket 146, to aid entry of thrombus 164 that is aspirated into the aspiration lumen 160 (in the direction of arrow 180) by the combination of the vacuum created by the vacuum source 22”. Fig. 1 element 22 vacuum source lumen passes through connector element 44 and therefore is considered fully capable of fluidly connecting the waste reservoir taught by Evans to the lumen of the catheter.
Culbert does not appear to explicitly teach the connector as claimed. Webster teaches, the connector configured to mate with a complementary connector on the catheter (col 9:65-col 10:5 “Generally, aspiration connection 120 can comprise a fitting 122 or the like to provide a sealed connection with suction device 102. Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock” (emphasis added)).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the connector taught by Culbert to be a luer lock connector as taught by Webster. This would have been motivated by design choice as merely picking between known connectors within the art is considered to be within the level of ordinary skill in the art. Considered to be well known in the art due to Webster col 9:65-Col10:5 “Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock.”(emphasis added). A conventional fitting is considered to be one that is regularly used by one of ordinary skill in the art and therefore well-known and understood within that skill level.
Culbert does not explicitly disclose the conduit being sized to be inserted into the lumen of a catheter. There exists a finite number of potential solutions for removing clots from within the lumen of a catheter without damaging the catheter or harming the patient if said catheter is within the patient. Such solutions involve mechanic removal, irrigation via thrombolytic, or vacuum suction. Trott teaches fitting a clot removal implement inside a catheter to remove clots from said catheter was known in the art. Fig. 2 element 12, paragraphs 12 and 13. The problem that existed at the time of filing was removal of clots within the lumen of catheter. One of ordinary skill in the art would have had a reasonable expectation of success at reducing the size of the catheter to fit within another catheter as such a modification involves a mere change in size of the catheter and is thus considered within the level of ordinary skill in the catheter art. Examiner concludes the limitation “a conduit configured to insert into a lumen of a catheter” would have been obvious to try to one of ordinary skill in the art at the time of filing.
In regards to claim 2:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, further comprising the supply reservoir optionally pre-filled with the thrombolytic composition (Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered an optional limitation upon the capability of the conduit. Examiner considered the conduit fully capable of connecting to the supply reservoir if it pre-filled or not.)
In regards to claim 3:
The medical device of claim 2, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the supply reservoir is a syringe optionally pre-filled with the thrombolytic composition (Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered to further demonstrate the capability of the conduit. Examiner considered the conduit fully capable of connecting to a supply reservoir that is a syringe if it is optionally pre-filled or not. Para. 120 “is desired to deliver drugs down the supply lumen and into the vessel, the tubing set 803 may be removed from the aspiration catheter 818 by disconnecting the male luer 854 of the tubing set 803 from the female luer 851 of the aspiration catheter 818, and the drug may be injected directly into the supply lumen at the female luer 851, for example, by a syringe or metering system” considered evidence of said capability.).
In regards to claim 4:
The medical device of claim 2, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the supply reservoir is an intravenous ("IV") bag optionally pre-filled with the thrombolytic composition (Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered a limitation upon the capability of the conduit. Examiner considered the conduit fully capable of connecting to the supply reservoir if it pre-filled or not. Para. 87 “(Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered an optional limitation upon the capability of the conduit. Examiner considered the conduit fully capable of connecting to the supply conduit full if it pre-filled or not.)” considered evidence of said capability.)
In regards to claim 5:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the waste reservoir is collapsed, partially evacuated, or a combination thereof in an initial state of the waste reservoir for subsequent collection of the waste (Para. 93 “The vacuum source 22 may instead be a 60 ml syringe whose plunger is pulled back after coupling to the connector 104.” considered evidence of the syringe being partially evacuated in an initial state as it is taught be pulled back to start the initial vacuum.).
In regards to claim 8:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the distal-end portion of the conduit includes an atraumatic tip (Figs. 9-11 element 140 para. 96 “A catheter tip portion 140 is described in more detail in relation to FIGS. 9-11.”. Considered an atraumatic tip as it follows guidewire 10 to reduce tissue damage), the opening in the distal-end portion of the conduit being an opening of the atraumatic tip (Figs. 9-11 elements 140 and 158).
In regards to claim 9:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein an abluminal surface of the conduit includes a hydrophilic coating to protect the lumen of the catheter from incidental damage, improve insertion of the conduit into the catheter, or improve withdrawal of the conduit from the catheter (Para. 164 “One or more hydrophilic or hydrophobic lubricious coatings may be used in order to improve trackability of the aspiration catheter 118 through the blood vessels.”, para. 166 “In some instances, some of the devices described herein may include a coating such as a lubricious coating or a hydrophilic coating.”).
In regards to claim 10:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the conduit further includes an ultrasonic transducer for application of ultrasound to the intraluminal clot in the lumen of the catheter to disaggregate fibrin strands of the intraluminal clot (Para. 160 “An ultrasound device 1112 having a handle 1157 is introduced through the working channel of the trocar 1156. Before the procedure, the physician directs the trocar 1156 under the visualization device 1158 to the location of the blood clots BC, and then positions the distal end of the ultrasound device 1112 inside the blood clots and activates ultrasound energy delivery.”.).
In regards to claim 11:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the conduit further includes a pressure sensor for detection of back pressure as the conduit and the pressure sensor thereof approaches the intraluminal clot in the lumen of the catheter (Para. 91 “A vacuum line 56, connected to the vacuum source 22, may be connected to a pressure sensor 58. If the vacuum of the vacuum source 22 is low (i.e., the absolute value pressure has decreased) or if a leak is detected in the vacuum line 56, the control board 50 disables the pump 26 until the problem is corrected. The pressure sensor 58 may also be part of a safety circuit 60 that will not allow the pump 26 to run if a vacuum is not present. Thereby, a comprehensive safety system 62, including the safety circuit 60, the pressure sensor 64 and/or the optical device 66, and the pressure sensor 58, requires both pump pressure and vacuum pressure for the system to run. If a problem exists (for example, if there is either a unacceptably low pump pressure or an absence of significant vacuum), the control board 50 will not allow the user to operate the aspiration system 10 until all problems are corrected. This will keep air from being injected into a patient, and will assure that the aspiration system 10 is not operated at incorrect parameters. Alternatively, in lieu of a direct connection (e.g., electrical, optical), the pressure sensor 58 can be configured to send a wireless signal to the control board 50, or any other component (e.g., antenna) coupled to or in communication with the control board 50, to remotely control operation of the pump 26. The remote control may be possible, whether the pump is within the sterile filed or outside the sterile field.”. Para. 93 “A pressure transducer 106 capable of measuring vacuum (including positive pressure sensors that are configured to measure positive pressure, but are capable of measuring negative pressure) is coupled to a vacuum line 108 via a y-connector 110. Signals from the pressure transducer 106 travel along a cable 112 (FIG. 7), which also supplies voltage to the pressure transducer 106.”.)
In regards to claim 14:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the conduit further includes an auxiliary lumen (Fig. 14 element 160 auxiliary lumen).
In regards to claim 15:
The medical device of claim 14, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the auxiliary lumen is configured to accept an ultrasound catheter inserted into the auxiliary lumen for application of ultrasound to the intraluminal clot in the lumen of the catheter to disaggregate fibrin strands of the intraluminal clot (Fig. 14 element 160 considered fully capable of receiving an ultrasound catheter as claimed due to connector element 104).
In regards to claim 16:
The medical device of claim 14, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the auxiliary lumen is configured accept a pressure-sensing catheter inserted into the auxiliary lumen, the pressure-sensing catheter including a pressure sensor for detection of back pressure as the conduit including the pressure- sensing catheter approaches the intraluminal clot in the lumen of the catheter (Fig. 14 element 160 considered fully capable of receiving a pressure-sensing catheter including a pressure sensor as claimed due to connector element 104).
In regards to claim 17:
The medical device of claim 14, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the auxiliary lumen is configured accept an impedance catheter inserted into the auxiliary lumen, the impedance catheter including one or more electrodes for detection of impedance changes in a space between the conduit and the intraluminal clot in the lumen of the catheter as the thrombolytic composition breaks down the intraluminal clot (Fig. 14 element 160 considered fully capable of receiving an impudence catheter as claimed due to connector element 104).
In regards to claim 18:
The medical device of claim 14, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the auxiliary lumen is configured for application of at least a partial vacuum to a proximal-end portion thereof to induce flow or aspirate through the auxiliary lumen (Fig. 14 element 160 considered fully capable of receiving at least a partial vacuum as claimed due to connector element 104).
In regards to claim 19:
The medical device of claim 14, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the auxiliary lumen is configured for application of at least a partial vacuum to a proximal-end portion thereof to retrieve the waste or facilitate fluid displacement at the distal-end portion of the conduit inside the lumen of the catheter (Fig. 14 element 160 considered fully capable of receiving at least a partial vacuum as claimed due to connector element 104).
In regards to claim 20:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the thrombolytic composition includes tissue plasminogen activator ("TPA") exclusive of any other agents configured to break down the intraluminal clot in the lumen of the catheter (Examiner notes the thrombolytic composition is not positively recited within the claim and thus this limitation is considered to be of the capability of the conduit to deliver said thrombolytic. Conduit is considered fully capable of delivering the claimed thrombolytic composition as it is demonstrated as capable of delivering thrombolytics in para. 120 “Some of the drugs 730 which may be delivered include thrombolytic agents (clot busting drugs)”. Therefore, conduit taught by Culbert considered fully capable of conveying thrombolytic compositions as claimed).
In regards to claim 21:
The medical device of claim 1, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the thrombolytic composition includes one or more agents other than tissue plasminogen activator ("TPA") configured to break down the intraluminal clot in the lumen of the catheter, the one or more agents optionally in combination with TPA (Examiner notes the thrombolytic composition is not positively recited within the claim and thus this limitation is considered to be of the capability of the conduit to deliver said thrombolytic. Conduit is considered fully capable of delivering the claimed thrombolytic composition as it is demonstrated as capable of delivering thrombolytics in para. 120 “Some of the drugs 730 which may be delivered include thrombolytic agents (clot busting drugs)”. Therefore, conduit taught by Culbert considered fully capable of conveying thrombolytic compositions as claimed).
In regards to claim 22:
Culbert teaches, a medical system for thrombolysis, comprising: a disposable medical device for the thrombolysis (Fig. 1) including: a conduit (Fig. 1 element 16), the conduit including a supply lumen (Fig. 14 element 176) and an auxiliary lumen (Fig. 14 element 160) in which at least the supply lumen is configured to convey an aqueous thrombolytic composition from a supply reservoir thereof through an opening in a distal-end portion of the conduit for administration of the thrombolytic composition to an intraluminal clot in the lumen of the catheter (Examiner notes due to configured language these limitations are considered required capabilities of the supply lumen but are not positively recited parts of the claimed invention. Para. 121 “a sterile fluid path is provided extending all the way from the fluid source 20 to the distal opening 40/open distal end 158 of the catheter 16” and para. 120 “Some of the drugs 730 which may be delivered include thrombolytic agents (clot busting drugs)”. Therefore, supply lumen taught by Culbert considered fully capable of conveying thrombolytic as claimed.); a connector coupled to a proximal-end portion of the conduit (Fig. 1 element 44), the connector configured to fluidly connect the supply reservoir to the lumen of the catheter via the conduit pass through the connector (Fig. 1 elements 20 and 44, para. 87 “Attached to the hand piece 12 are a fluid source 20” and para. 121 “Para. 121 “a sterile fluid path is provided extending all the way from the fluid source 20 to the distal opening 40/open distal end 158 of the catheter 16” therefore connector 44 considered fully capable of fluidly connecting the supply reservoir to the supply lumen as claimed. “sterile fluid path” is considered to be a recitation of the claimed conduit.); and one or more reusable medical devices for the thrombolysis (Para. 159 “an ultrasound device 1112”).
Culbert does not appear to explicitly disclose the waste reservoir capability as claimed. Evans teaches, a waste reservoir (Fig. 15 element 282), the waste reservoir configured to collect waste from the lumen of the catheter including fibrin fragments, platelets, red blood cells, or spent solution of the thrombolytic composition used to break down the intraluminal clot in the lumen of the catheter; (Considered fully capable of connecting to the lumen and of collecting the waste of the lumen as claimed due to para. 42 “and clot and/or fluid may be aspirated through the same lumen” and para. 96” Optionally, agitating means may be used to agitate the clot and aspiration means may be used to aspirate clot and/or fluid containing clot particles, blood, infusate and the like.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the device for thrombolysis taught by Culbert to include the waste reservoir taught by Evans. This would have been motivated by design choice. It is known in the art the biological waste product must be collected and disposed of properly per health regulations. This would have motivated one of ordinary skill in the art to pick a known waste reservoir to ensure compliance with health regulations.
Culbert in view of Evans teaches, the connector configured to fluidly connect the waste reservoir (Evans Fig. 15 element 282) to the lumen of the catheter (Culbert Para. 97 “FIGS. 9-11 show an open distal end 158 of an aspiration lumen 160 for aspirating thrombus. A skive 162 may be formed in the polymer jacket 146, to aid entry of thrombus 164 that is aspirated into the aspiration lumen 160 (in the direction of arrow 180) by the combination of the vacuum created by the vacuum source 22”. Fig. 1 element 22 vacuum source lumen passes through connector element 44 and therefore is considered fully capable of fluidly connecting the waste reservoir taught by Evans to the lumen of the catheter.
Culbert does not appear to explicitly teach the connector as claimed. Webster teaches, the connector configured to mate with a complementary connector on the catheter (col 9:65-col 10:5 “Generally, aspiration connection 120 can comprise a fitting 122 or the like to provide a sealed connection with suction device 102. Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock” (emphasis added)).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the connector taught by Culbert to be a luer lock connector as taught by Webster. This would have been motivated by design choice as merely picking between known connectors within the art is considered to be within the level of ordinary skill in the art. Considered to be well known in the art due to Webster col 9:65-Col10:5 “Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock.”(emphasis added). A conventional fitting is considered to be one that is regularly used by one of ordinary skill in the art and therefore well-known and understood within that skill level.
Culbert teaches, wherein the supply reservoir is a syringe optionally pre-filled with the thrombolytic composition (Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered to further demonstrate the capability of the conduit. Examiner considered the conduit fully capable of connecting to a supply reservoir that is a syringe if it is optionally pre-filled or not. Para. 120 “is desired to deliver drugs down the supply lumen and into the vessel, the tubing set 803 may be removed from the aspiration catheter 818 by disconnecting the male luer 854 of the tubing set 803 from the female luer 851 of the aspiration catheter 818, and the drug may be injected directly into the supply lumen at the female luer 851, for example, by a syringe or metering system” considered evidence of said capability.).
In regards to claim 23:
The medical system of claim 22, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the disposable medical device further comprises the supply reservoir optionally pre-filled with the thrombolytic composition (Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered an optional limitation upon the capability of the conduit. Examiner considered the conduit fully capable of connecting to the supply reservoir if it pre-filled or not.).
In regards to claim 24:
The medical system of claim 23, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the supply reservoir is a syringe optionally pre-filled with the thrombolytic composition (Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered to further demonstrate the capability of the conduit. Examiner considered the conduit fully capable of connecting to a supply reservoir that is a syringe if it is optionally pre-filled or not. Para. 120 “is desired to deliver drugs down the supply lumen and into the vessel, the tubing set 803 may be removed from the aspiration catheter 818 by disconnecting the male luer 854 of the tubing set 803 from the female luer 851 of the aspiration catheter 818, and the drug may be injected directly into the supply lumen at the female luer 851, for example, by a syringe or metering system” considered evidence of said capability.).
In regards to claim 25:
The medical system of claim 24, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the one or more reusable medical devices comprises a syringe pump to dispense the thrombolytic composition from the syringe (Para. 120 “is desired to deliver drugs down the supply lumen and into the vessel, the tubing set 803 may be removed from the aspiration catheter 818 by disconnecting the male luer 854 of the tubing set 803 from the female luer 851 of the aspiration catheter 818, and the drug may be injected directly into the supply lumen at the female luer 851, for example, by a syringe or metering system” (emphasis added). Considered evidence of said capability. Considered a syringe pump as it is a syringe used for pumping thrombolytic into the supply lumen.)
In regards to claim 26:
The medical system of claim 23, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the supply reservoir is an intravenous ("IV") bag optionally pre-filled with the thrombolytic composition (Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered a limitation upon the capability of the conduit. Examiner considered the conduit fully capable of connecting to the supply reservoir if it pre-filled or not. Para. 87 “(Examiner notes the supply reservoir is not positively recited within the claim and this claim is considered an optional limitation upon the capability of the conduit. Examiner considered the conduit fully capable of connecting to the supply conduit full if it pre-filled or not.)” considered evidence of said capability.)
In regards to claim 27:
The medical system of claim 26, taught by Culbert in view of Evans further in view of Webster as described above in parent claim rejection.
Culbert does not explicitly teach a peristaltic pump as claimed, wherein the one or more reusable medical devices comprises a peristaltic pump to pump the thrombolytic composition along infusion-line tubing connected to the IV bag and the conduit.
Culbert teaches Para. 94 “Turning to FIG. 5, the spike 102 communicates with extension tubing 122. Liquid injectate is pumped downstream at the piston pump, which pulls more liquid injectate (for example from a saline bag) through a check valve 126 and through a supply tube 130.”. Webster teaches peristaltic pumps and piston pumps as known alternatives (Col 9:50-55 “Suitable suction devices 102 include, for example, suction device that draws a desired suction with respect to volumes in a selected period of time, such as a syringe, a pump, such as a peristaltic pump or a piston pump, a compressed bladder or the like”).
It would have been obvious, prior to the effective date of filing, to exchange the piston pump taught by Culbert to be a known alternative peristaltic pump as taught by Webster. This would have been a matter of design choice as merely picking between known alternatives is within the level of ordinary skill in the art. Webster teaches known alternatives col 9:50-55 “a pump, such as a peristaltic pump or a piston pump,”.
In regards to claim 28:
The medical system of claim 22, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the one or more reusable medical devices includes an ultrasound catheter (Fig. 59 element 1112, Para. 12 “and an ultrasound device at or adjacent the opening of the aspiration channel, and configured to operate at a frequency of between about 1 kHz and about 20 MHz”), the auxiliary lumen configured to accept the ultrasound catheter inserted into the auxiliary lumen for application of ultrasound to the intraluminal clot in the lumen of the catheter to disaggregate fibrin strands of the intraluminal clot (Auxiliary lumen considered fully capable of accepting the ultrasound catheter due to para. 12 “and an ultrasound device at or adjacent the opening of the aspiration channel, and configured to operate at a frequency of between about 1 kHz and about 20 MHz”).
In regards to claim 29:
The medical system of claim 22, taught by Culbert in view of Evans as described above in parent claim rejection.
Culbert teaches, wherein the one or more reusable medical devices includes a pressure-sensing catheter (Para. 93 “A pressure transducer 106 capable of measuring vacuum (including positive pressure sensors that are configured to measure positive pressure, but are capable of measuring negative pressure) is coupled to a vacuum line 108 via a y-connector 110. Signals from the pressure transducer 106 travel along a cable 112 (FIG. 7), which also supplies voltage to the pressure transducer 106.”.) the auxiliary lumen configured to accept the pressure- sensing catheter inserted into the auxiliary lumen for detection of back pressure with a pressure sensor of the pressure-sensing catheter as the conduit including the pressure-sensing catheter approaches the intraluminal clot in the lumen of the catheter (auxiliary lumen Fig. Fig. 14 element 160 considered fully capable of receiving the pressure-sensing catheter due to para. 93).
In regards to claim 39:
The medical device of claim 1, taught by Culbert in view of Evans further in view of Webster as described in parent claim rejection above.
Culbert does not appear to explicitly teach the connector as claimed. Webster teaches, wherein the connector is a female Luer connector configured to mate with a male Luer connector on the catheter (col 9:65-col 10:5 “Generally, aspiration connection 120 can comprise a fitting 122 or the like to provide a sealed connection with suction device 102. Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock” (emphasis added)).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the connector taught by Culbert to be a luer lock connector as taught by Webster. This would have been motivated by design choice as merely picking between known connectors within the art is considered to be within the level of ordinary skill in the art. Considered to be well known in the art due to Webster col 9:65-Col10:5 “Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock.”(emphasis added). A conventional fitting is considered to be one that is regularly used by one of ordinary skill in the art and therefore well-known and understood within that skill level.
In regards to claim 40:
The medical device of claim 1, taught by Culbert in view of Evans as described in parent claim rejection above.
Culbert does not appear to explicitly teaches the connector as claimed. Evans teaches, wherein the connector is further coupled to a distal-end portion of the waste reservoir (Para. 95” Apparatus 260 may optionally further include a sheath 276 with a luminal opening 278 for infusing and/or aspirating fluids, an aspiration mechanism 282 and/or an infusion mechanism 280.”.)
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the connector taught by Culbert to be the connector at the distal end portion of the waste reservoir as taught by Webster. This would have been motivated by design choice as merely picking between known connectors within the art is considered to be within the level of ordinary skill in the art. Considered to be well known in the art due to Webster col 9:65-Col10:5 “Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock.”(emphasis added). A conventional fitting is considered to be one that is regularly used by one of ordinary skill in the art and therefore well-known and understood within that skill level.
In regards to claim 41:
The medical device of claim 1, taught by Culbert in view of Evans as described in parent claim rejection above.
Culbert in view of Evans teaches, (Evans teaches, the waste reservoir Fig. 15 element 282) wherein the connector is further coupled to tubing extending from the distal-end portion of the waste reservoir (Culbert teaches Para. 97 “FIGS. 9-11 show an open distal end 158 of an aspiration lumen 160 for aspirating thrombus. A skive 162 may be formed in the polymer jacket 146, to aid entry of thrombus 164 that is aspirated into the aspiration lumen 160 (in the direction of arrow 180) by the combination of the vacuum created by the vacuum source 22”. Fig. 1 element 22 vacuum source. Para. 3 “Several devices and systems already exist to aid in the removal of thrombotic material. These include simple aspiration tube type devices using vacuum syringes to extract thrombus into the syringe,”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to replace the vacuum source element 22 taught by Culbert with the waste reservoir/vacuum source taught by Evans. The combination thereof would yield the connector as claimed. This would have been motivated by design choice. It is known in the art the waste product must be collected and merely picking the type of container used to collect said waste is considered to be within the level of one of ordinary skill in the art. Examiner notes Culbert provides further motivation for this design choice (para. 3 “Several devices and systems already exist to aid in the removal of thrombotic material. These include simple aspiration tube type devices using vacuum syringes to extract thrombus into the syringe,”).
In regards to claim 43:
The medical system of claim 22, taught by Culbert in view of Evans further in view of Webster as described in parent claim rejection above.
Culbert does not appear to explicitly teach the connector as claimed. Webster teaches, wherein the connector is a female Luer connector configured to mate with a male Luer connector on the catheter (col 9:65-col 10:5 “Generally, aspiration connection 120 can comprise a fitting 122 or the like to provide a sealed connection with suction device 102. Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock” (emphasis added)).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the connector taught by Culbert to be a luer lock connector as taught by Webster. This would have been motivated by design choice as merely picking between known connectors within the art is considered to be within the level of ordinary skill in the art. Considered to be well known in the art due to Webster col 9:65-Col10:5 “Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock.”(emphasis added). A conventional fitting is considered to be one that is regularly used by one of ordinary skill in the art and therefore well-known and understood within that skill level.
In regards to claim 44:
The medical system of claim 22, taught by Culbert in view of Evans as described in parent claim rejection above.
Culbert does not appear to explicitly teach the connector as claimed. Evans teaches, wherein the connector is further coupled to a distal-end portion of the waste reservoir or tubing extending from the distal-end portion of the waste reservoir (Para. 95” Apparatus 260 may optionally further include a sheath 276 with a luminal opening 278 for infusing and/or aspirating fluids, an aspiration mechanism 282 and/or an infusion mechanism 280.”.)
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the connector taught by Culbert to be the connector at the distal end portion of the waste reservoir as taught by Webster. This would have been motivated by design choice as merely picking between known connectors within the art is considered to be within the level of ordinary skill in the art. Considered to be well known in the art due to Webster col 9:65-Col10:5 “Suitable fittings include, for example, a conventional fitting, such as an elastomeric diaphragm through which a syringe needle can be inserted or a Luer lock.”(emphasis added). A conventional fitting is considered to be one that is regularly used by one of ordinary skill in the art and therefor well-known and understood within that skill level.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culbert et al. (US 2017/0290598 A1) in view of Evans et al. (US 2011/0046542 A1), further in view of Webster et al. (US 7,938,820 B2) and Nash et al. (US 7,666,161 B2).
In regards to claim 6:
The medical device of claim 1, taught by Culbert in view of Evans further in view of Webster as described above in parent claim rejection.
Culbert does not explicitly teach a waste reservoir as claimed. Nash teaches, wherein the waste reservoir includes a one- way valve configured to ensure flow directionality or relieve pressure build-up in an active state of the waste reservoir while the waste reservoir collects the waste (Fig. 2a. element 66. Col 19:30-55 “As the pressure continues to increase, a second safety valve 66 is actuated. This second safety valve is actuated when the pressure within the aspiration fluid pathway, most preferably within the evacuation chamber 60, is at least as high as is required to activate the first safety valve 64. The second safety valve 66 remains closed at the lower pressures (e.g., blood pressure) and prevents fluid flow from the evacuation chamber towards the waste reservoir. Additionally, the second safety valve prevents the reverse flow of infusate fluid from the infusate bypass lumen 68 and first safety valve 64 into the evacuation chamber 60, and potentially through to the body via the aspiration pump 40. The second safety valve, while closed serves to prevent fluid flow between the evacuation chamber and the waste lumen 56. Upon actuation of the second safety valve 66, fluid flow from the evacuation chamber 60 towards the waste lumen 56 is allowed, and continues until the pressure actuating the second safety valve 66 drops below the pressure level required to maintain the second safety valve in an open state. The second safety valve may also be mechanically or electronically actuated. Most preferably, the second safety valve is a mechanical valve (e.g., a ball and spring check-valve arrangement) wherein the pressure within the evacuation chamber 60 causes the valve to open and allow fluid flow.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the waste reservoir taught by Culbert to include the safety valve taught by Nash. This would have been motivated improving patient safety by reducing the chance of waste product back-flowing into the patient. Culbert Col 19:30-55 Additionally, the second safety valve prevents the reverse flow of infusate fluid from the infusate bypass lumen 68 and first safety valve 64 into the evacuation chamber 60, and potentially through to the body via the aspiration pump 40.”
In regards to claim 7:
The medical device of claim 1, taught by Culbert in view of Evans further in view of Webster as described above in parent claim rejection.
Culbert does not explicitly teach a waste bag as claimed. Nash teaches, wherein the waste reservoir is a waste bag (Col 17:31-44 “the evacuation chamber 60 may be a waste collection vessel (e.g., a bag, bottle, receptacle, etc.)”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the waste reservoir taught by Culbert to be a bag as taught by Nash. This would have been motivated as design choice as merely picking between known art alternatives is within the level of ordinary skill in the art. Examiner further notes this would have been further motivated as biological waste is considered a biohazard and must be disposed of properly as per health regulations to reduce the spread of diseases. This would lead one of ordinary skill in the art to look for an appropriate waste receptacle to collect the biological waste.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culbert et al. (US 2017/0290598 A1) in view of Evans et al. (US 2011/0046542 A1), further in view of Webster et al. (US 7,938,820 B2) and Sahota (US 4,509,528).
In regards to claim 12:
The medical device of claim 1, taught by Culbert in view of Evans further in view of Webster as described above in parent claim rejection.
Culbert does not appear to explicitly teach the conductive leads as claimed. Sahota teaches, wherein the conduit includes conductive leads electrically coupled to one or more electrodes for detection of impedance changes in a space between the conduit and the intraluminal clot in the lumen of the catheter as the thrombolytic composition breaks down the intraluminal clot (Fig. 1 element 21, Col 4:34-66 “a transducer for impedance plethysmography”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the conduit taught by Culbert to include the transducer for impedance plethysmography taught by Sahota. This would have been motivated by improving physician real time data about the clot being removed. Include said sensor would give the physician more information about the clot being removed real time so the physician could better decide when the clot started breaking apart and being aspirated. This would allow the physician to make better decisions during treatment that would yield better outcomes for the procedure.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culbert et al. (US 2017/0290598 A1) in view of Evans et al. (US 2011/0046542 A1), further in view of Webster et al. (US 7,938,820 B2) and Caillouette et al. (US 3,847,157).
In regards to claim 13:
The medical device of claim 1, taught by Culbert in view of Evans further in view of Webster as described above in parent claim rejection.
Culbert does not appear to explicitly teach the magnetic elements as claimed. Caillouette teaches, wherein the conduit further includes one or more magnetic or electromagnetic elements in the distal-end portion of the conduit for detection of the distal-end portion of the conduit by a tip-location sensor configured to detect the magnetic or electromagnetic elements, thereby providing a means for ensuring the conduit is not pushed beyond the catheter unless desired (Fig. 3 element 28 col 3:35-55 “In using the tube T after magnetization, it is significant that the magnetic field provided by the strip 28 as well as the inherent magnetic material in the strip provide the basis for sensing the location of the tube T”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the conduit taught by Culbert to include the magnetic element taught by Caillouette. This would have been motivated by Caillouette (Col 130-35 “Accordingly, a need exists for a medico-surgical tube, the location of which is readily detectable as indicated above, and additionally which has certain electrical characteristics. Other desirable characteristics for a medico-surgical tube include flexibility and transparency to permit observing the tube interior. (5) In general, the present invention relates to a medico-surgical tube system whereby the location of a tube within living tissue may be simply, accurately and easily determined.”).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culbert et al. (US 2017/0290598 A1) in view of Evans et al. (US 2011/0046542 A1), further in view of Webster et al. (US 7,938,820 B2) and Schwartz et al. (US 8,430,861 B2).
In regards to claim 30:
The medical system of claim 22, taught by Culbert in view of Evans further in view of Webster as described above in parent claim rejection.
Culbert teaches, the auxiliary lumen configured to accept the impedance catheter inserted into the auxiliary lumen for detection of impedance changes with one or more electrodes of the impedance catheter in a space between the conduit and the intraluminal clot in the lumen of the catheter as the thrombolytic composition breaks down the intraluminal clot (Auxiliary lumen Fig. 14 element 160 considered fully capable of accepting the impedance catheter due to element 104, connector).
Culbert does not appear to explicitly teach the impedance catheter as claimed. Schwartz teaches, wherein the one or more reusable medical devices includes an impedance catheter (col 3:15-32 “In another preferred embodiment, microvascular obstruction is detected by measuring vascular impedance within a patient. Vascular impedance is generally defined as blood pressure divided by the blood flow and therefore is obtained by measuring blood pressure and blood flow (e.g., velocity or volumetric) within a vessel. Preferably, these readings are measured by inflating a balloon of a catheter within a vessel, then measuring relevant data such as pressure, flow, and volume or flow caused by the dispensed treatment agents while the balloon causes obstruction of the vessel.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the medical system for thrombolysis taught by Culbert to include the impedance catheter taught by Schwartz. This would have been motivated by improving the patient treatment. Including the impedance catheter would facilitate the physician to test the vessel impedance before and after treatment to verify successful completion of the treatment prior to removal of the medical system for thrombolysis. Thus, reducing the need to remove the medical system to insert a separate impedance catheter and then reinserting the medical system again after a negative result of impedance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm EST.
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, Bhisma Mehta can be reached at (571) 272-3383. 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.
/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights