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 .
Election/Restrictions
Applicant’s election without traverse of claims 6-12 in the reply filed on 9/2/2026 is acknowledged.
Claim Objections
Claim 6 is objected to because of the following informality:
Claim 6, line 2: “a patient” should read --the patient--
Appropriate correction is required.
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.
Claims 6, 13-15, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson (US 20170274184) in view of O’Dea (US 9808179) and Leiner (WO 2009021066).
Regarding claim 6, Isaacson teaches a method of locating a treatment site of a patient, comprising (Paragraph [0030]): inserting a catheter (cannula 10) into a vessel (26) of a patient, (Fig. 3), the catheter including: a sheath (Fig. 3, catheter 20) having a working lumen, a proximal sheath end, and a distal sheath end opposite the proximal sheath end, (See Figs. 3, 5), and the distal sheath end is configured for insertion into a vessel of a patient (See Fig. 3, distal end of catheter 20 is configured for insertion into a vessel of a patient); and a wire (optical fiber 16) extending through the working lumen of the sheath to the distal sheath end (See Fig. 3), the wire having a proximal wire end and a distal wire end opposite the proximal wire end (Fig. 5).
Isaacson teaches a catheter sheath (catheter 20) that is advanced into a blood vessel a control device, (Paragraph [0042]), but does not specifically teach “wherein the proximal sheath end is coupled to a control device” and “a wire extending from the control device”. However, it would have been obvious to a person of ordinary skill in the art at the time of the invention to couple the proximal end of the sheath and wire to a control device. It is well-known in the art of medical devices to use control mechanisms (such as handles or actuators) to manipulate the advancement of catheters. One of ordinary skill would motivate this modification to provide a reliable, controlled, and ergonomic means of advancing the sheath and wire, achieving the predictable result of controlled vascular access.
However, Isaacson does not further teach “wherein at least one light-emitting diode (LED) is disposed in the distal wire end; illuminating, via the control device, the at least one LED within the vessel of the patient; locating, extracorporeally, the at least one LED, and positioning, via the at least one LED, the wire such that the distal end is located adjacent to the treatment site; and retracting the sheath to expose the distal wire end from the distal sheath end.”
O’Dea, in a related field of endeavor, teaches a catheter device (Fig. 1) wherein at least one light-emitting diode (20) is disposed in the distal wire end (distal end of wire 23) (See Fig. 1); illuminating, via the control device, the at least one LED within the vessel of the patient. (Col. 7, lines 53-56 electrical power from a power source (not shown) adjacent the proximal end 4 of the catheter member 3 is applied to the wires 23 for powering the light emitting diodes 20); locating, extracorporeally, the at least one LED, and positioning, via the at least one LED, the wire such that the distal end is located adjacent to the treatment site. (Col. 8, lines 12-26 with the light emitting diodes 20 powered up, light emitted from the light emitting diodes 20 is visible through the wall of the intestine which is translucent. Hence, the shape of the wire may be visible extracorporeally. The imaging device 27 captures an image of the portion 24 of the intestine 25 and the light emanating from the light emitting diodes 20 on the electrodes 7 of the catheter 1. The image captured by the imaging device 27 is displayed on a visual display screen 29 of the imaging system 26. Since the light emitting diodes 20 are located on the electrode 7 a surgeon can maneuver the catheter 1 within the intestine 25 while observing the image of the intestine and the light emitted from the light emitting diodes 20 on the visual display screen 29, until the catheter 1 with the electrodes 7 is accurately located in the portion 24 of the intestine 25).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson to teach “wherein at least one light-emitting diode (LED) is disposed in a distal portion of the wire, the distal portion adjacent the distal end; illuminating, via the control device, the at least one LED within the vessel of the patient; locating, extracorporeally, the at least one LED, and positioning, via the at least one LED, the wire such that the distal end is located adjacent to the treatment site” as taught by O’ Dea. Doing so assists in the accurate positioning of the catheter at the treatment site.
Leiner, in a related field of endeavor, teaches (Fig. 2-3) retracting the sheath (18) to expose the distal wire end (image conduit 20) from the distal sheath end. (Abstract; Paragraphs [0016]-[0018]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson to teach “retracting the sheath to expose the distal wire end from the distal sheath end” as taught by Leiner. Doing so exposes the sharpened distal end to enable an incision to be made in the tissue. (Paragraph [0017] of Leiner; Paragraph [0047] of Isaacson teaches a sharpened distal end).
Regarding claim 13, Isaacson teaches a medical device for locating a treatment site (Paragraph [0030]), comprising: a sheath (Fig. 3, catheter 20) having a working lumen, a proximal sheath end, and a distal sheath end opposite the proximal sheath end, (See Figs. 3, 5), and the distal sheath end is configured for insertion into a vessel of a patient (See Fig. 3, distal end of catheter 20 is configured for insertion into a vessel of a patient); and a wire (optical fiber 16) extending through the working lumen of the sheath to the distal sheath end (See Fig. 3), the wire having a proximal wire end and a distal wire end opposite the proximal wire end (Fig. 5).
Isaacson teaches a catheter sheath (catheter 20) that is advanced into a blood vessel a control device, (Paragraph [0042]), but does not specifically teach “wherein the proximal sheath end is coupled to a control device” and “a wire extending from the control device”. However, it would have been obvious to a person of ordinary skill in the art at the time of the invention to couple the proximal end of the sheath and wire to a control device. It is well-known in the art of medical devices to use control mechanisms (such as handles or actuators) to manipulate the advancement of catheters. One of ordinary skill would motivate this modification to provide a reliable, controlled, and ergonomic means of advancing the sheath and wire, achieving the predictable result of controlled vascular access.
However, Isaacson does further not teach “at least one light-emitting diode (LED) disposed in a distal portion of the wire, the distal portion adjacent to the distal wire end, the at least one LED configured to radially illuminate a treatment site such that the treatment site is visible extracorporeally, wherein the control device is configured to provide power to the at least one LED.”
O’Dea, in a related field of endeavor, teaches a catheter device (Fig. 1) wherein at least one light-emitting diode (20) is disposed in a distal portion of the wire (23), the distal portion adjacent the distal wire end (distal end of wire 23) (See Fig. 1); the at least one LED configured to radially illuminate a treatment site, such that the treatment site is visible extracorporeally, wherein the control device is configured to provide power to the at least one LED. (Col. 7, lines 53-56; Col. 8, lines 12-26).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson to teach “at least one light-emitting diode (LED) disposed in a distal portion of the wire, the distal portion adjacent to the distal wire end, the at least one LED configured to radially illuminate a treatment site such that the treatment site is visible extracorporeally, wherein the control device is configured to provide power to the at least one LED” as taught by O’ Dea. Doing so assists in the accurate positioning of the catheter at the treatment site.
Regarding claim 14, Isaacson does not teach “a distal LED located at the distal wire end”.
O’Dea, as previously discussed, teaches a distal LED (20) located at the distal wire end (distal end of wire 23) (See Fig. 1).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson to teach “a distal LED located at the distal wire end” as taught by O’ Dea. Doing so provides illumination at a distal end to assist in the accurate positioning of the catheter at the treatment site.
Regarding claim 15, Isaacson does not teach “wherein a plurality of LEDs of the at least one LED is located throughout the wire at various positions of the distal portion.”.
O’Dea teaches wherein a plurality of LEDs of the at least one LED is located throughout the wire at various positions of the distal portion. (See Fig. 1; Col. 7, lines 20-30 plurality of light sources 19 comprises one single light emitting diode 20 at various positions of the distal portion).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson to teach “wherein a plurality of LEDs of the at least one LED is located throughout the wire at various positions of the distal portion” as taught by O’ Dea. Doing so provides illumination at a distal end to assist in the accurate positioning of the catheter at the treatment site. Doing so provides a plurality of illuminative indicating means at a distal end to assist in the accurate positioning of the catheter at the treatment site.
Regarding claim 20, Isaacson teaches wherein a shape of the wire is configured to be visible extracorporeally. (Paragraphs [0034]-[0035], [0039], [0045]).
O’Dea teaches a catheter device (Fig. 1) wherein the shape of the wire is configured to be visible extracorporeally. (Col. 8, lines 12-26 with the light emitting diodes 20 powered up, light emitted from the light emitting diodes 20 is visible through the wall of the intestine which is translucent. Hence, the shape of the wire may be visible extracorporeally).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “wherein a shape of the wire is configured to be visible extracorporeally” as taught by O’Dea. Doing so provides visualization of the illuminated with to assist in the accurate positioning of the catheter at the treatment site.
Regarding claim 21, Isaacson does not teach “wherein the sheath is retractable about the wire”.
Leiner teaches (Fig. 2-3) wherein the sheath (18) is retractable about the wire (20). (Abstract; Paragraphs [0016]-[0018]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson to teach “wherein the sheath is retractable about the wire” as taught by Leiner. Doing so exposes the sharpened distal end to enable an incision to be made in the tissue. (Paragraph [0017]).
Claims 7-8, 10-11, 16-17, 19 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson in view of O’Dea and Leiner, further in view of Fleming (US 20180317956) and McGuckin (US 7037316).
Regarding claim 7, Isaacson as modified does not teach “wherein the control device further includes a motor configured to provide rotational output, wherein the distal sheath end is coupled to the motor, and an actuator electronically coupled to the motor whereby the actuator is configured to activate and deactivate the motor, the method further comprising activating the motor, and rotating the sheath and the wire in response to activating the motor.”
Fleming, in a related field of endeavor, teaches a tissue-removing catheter wherein the control device (handle 40) further includes a motor (43) configured to provide rotational output, wherein the distal sheath end is coupled to the motor, and an actuator (42) electronically coupled to the motor whereby the actuator is configured to activate and deactivate the motor, the method further comprising activating the motor, and rotating the sheath (outer layer 12) in response to activating the motor. ((Paragraph [0021] actuator 42 (e.g., a lever, a button, a dial, a switch) configured for selectively actuating a motor 43 disposed in the handle to drive rotation of the outer layer 12); Paragraph [0038] rotating outer layer 12).
However, Fleming does not additionally teach “rotating the sheath and the wire in response to activating the motor”.
McGuckin, in a related field of endeavor, teaches a rotational thrombectomy device (Fig. 3) comprising a sheath (support tube 36) and a wire (60) and teaches rotating the sheath (36) and the wire (60) in response to activating the motor (22). (Col. 6, lines 3-17).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “wherein the control device further includes a motor configured to provide rotational output, wherein the distal sheath end is coupled to the motor, and an actuator electronically coupled to the motor whereby the actuator is configured to activate and deactivate the motor” as taught by Fleming, “the method further comprising activating the motor, and rotating the sheath and the wire in response to activating the motor”, as taught by McGuckin. The modification merely combines known mechanical elements (a driven sheath and a driven wire) operated by a single common actuator (the motor) according to known methods to achieve a predictable result, i.e., rotate multiple concentric mechanical components simultaneously.
Regarding claim 8, Isaacson as modified does not teach “wherein the wire comprises an at least partially sinusoidal shape, the method further comprising abrading the treatment site in response to rotating the sheath and the wire.”
McGuckin teaches wherein the wire comprises an at least partially sinusoidal shape. (Col. 2, lines 62-63), the method further comprising abrading the treatment site in response to rotating the sheath (36) and the wire (60). (Col. 7, lines 3-19).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “wherein the wire comprises an at least partially sinusoidal shape, the method further comprising abrading the treatment site in response to rotating the sheath and the wire” as taught by McGuckin. Doing so provides a kink-resistant wire that macerates and liquefies the thrombus into small particles within the vascular lumen. (Col. 7, lines 17-19).
Regarding claim 10, Isaacson as modified does not teach “deactivating the motor”.
Fleming teaches an actuator (42) electronically coupled to the motor (43) whereby the actuator is configured to deactivate the motor. (Paragraph [0021] actuator 42 (e.g., a lever, a button, a dial, a switch) configured for selectively actuating a motor 43 disposed in the handle to drive rotation of the outer layer 12). (Paragraph [0038])
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “deactivating the motor” as taught by Fleming. Doing so allows the clinician to safely reposition, advance, or withdraw the catheter without the risk of the spinning tip engaging unintended structures.
Regarding claim 11, Isaacson in view of O’Dea teaches the complete sequence of positioning, rotating, and abrading a first treatment site using the LED-guided sheath and wire, as discussed above.
It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the method of Isaacson as modified by O’Dea to include repositioning the sheath and wire via the LED to a second treatment site, activating the motor, and abrading the second site. One of ordinary skill in the art would recognize that medical abrasion procedures frequently require the clearance of multiple target sites or lesions within a patient. Merely repeating the steps of positioning, activating, and abrading at a second location represents nothing more than the predictable repetition of a known technique to achieve its expected result (i.e., clearing a second blockage). The practitioner would be motivated to do so to complete a comprehensive therapeutic treatment during a single clinical procedure without the need to withdraw and re-insert the device, thereby increasing operational efficiency and reducing patient risk.
Regarding claim 16, Isaacson as modified does not teach “wherein the wire comprises an at least partially sinusoidal shape.”
McGuckin, as previously discussed, teaches wherein the wire comprises an at least partially sinusoidal shape. (Col. 2, lines 62-63).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “wherein the wire comprises an at least partially sinusoidal shape” as taught by McGuckin. Doing so enables the wire to navigate highly tortuous anatomical pathways, such as blood vessels, without kinking or puncturing tissue.
Regarding claim 17, Isaacson teaches wherein a shape of the wire is configured to be visible extracorporeally. (Paragraphs [0034]-[0035], [0039], [0045]).
O’Dea teaches a catheter device (Fig. 1) wherein the shape of the wire is configured to be visible extracorporeally. (Col. 8, lines 12-26 with the light emitting diodes 20 powered up, light emitted from the light emitting diodes 20 is visible through the wall of the intestine which is translucent. Hence, the shape of the wire may be visible extracorporeally).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “wherein a shape of the wire is configured to be visible extracorporeally” as taught by O’Dea. Doing so provides extracorporeal visualization of the illuminated with to assist in the accurate positioning of the catheter at the treatment site.
Regarding claim 19, Isaacson as modified does not teach “wherein the control device comprises a motor and an actuator, the motor coupled to the proximal wire end, and wherein the actuator is electronically coupled to the motor, and the actuator is configured to activate and deactivate the motor.”
Fleming, in a related field of endeavor, teaches a tissue-removing catheter wherein the control device (handle 40) further includes a motor (43) and an actuator (42), the motor coupled to the proximal wire end (See Fig. 1, proximal wire end of wire 26), and wherein the actuator is electronically coupled to the motor, and the actuator is configured to activate and deactivate the motor. (Paragraph [0021] actuator 42 (e.g., a lever, a button, a dial, a switch) configured for selectively actuating a motor 43 disposed in the handle to drive rotation of the outer layer 12).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “wherein the control device comprises a motor and an actuator, the motor coupled to the proximal wire end, and wherein the actuator is electronically coupled to the motor, and the actuator is configured to activate and deactivate the motor” as taught by Fleming. Doing so enables rotation of the outer layer to remove tissue from a body lumen. (Paragraph [0020]).
Regarding claims 24 and 25, Isaacson as modified does not teach “wherein the wire is configured to rotate in response to an input of the control device” (claim 24) and “wherein the sheath is configured to rotate in response to the input of the control device” (claim 25).
McGuckin, as previously discussed, teaches a rotational thrombectomy device (Fig. 3) comprising a sheath (support tube 36) and a wire (60), wherein the wire (60) is configured to rotate in response to an input of the control device (22) and wherein the sheath (36) is configured to rotate in response to the input of the control device (22). (Col. 6, lines 3-17).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “wherein the wire is configured to rotate in response to an input of the control device” (claim 24) and “wherein the sheath is configured to rotate in response to the input of the control device” (claim 25)”, as taught by McGuckin. The modification merely combines known mechanical elements (a driven sheath and a driven wire) operated by a single common actuator (the motor) according to known methods to achieve a predictable result, i.e., rotate multiple concentric mechanical components simultaneously.
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson in view of O’Dea, Leiner, Fleming and McGuckin, further in view of Wisnosky (US 20200113577).
Regarding claim 9, Isaacson as modified does not teach “injecting sclerosant through the working lumen of the sheath to the treatment site”.
Wisnosky, in a related field of endeavor, teaches (Fig. 1) a vascular treatment apparatus that injects sclerosant through the working lumen of the sheath (intraluminal member 125) to the treatment site. (Paragraphs [0050], [0060]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “injecting sclerosant through the working lumen of the sheath to the treatment site”, as taught by Wisnosky. Doing so enables passage of the sclerosant through the working lumen to cause endothelial cellular destruction and/or exposure of the underlying subendothelial cell layer, thus utilizing the lumen's primary structural purpose (fluid delivery) to transport the agent to the known destination (the treatment site). (Paragraph [0023]).
Regarding claim 12, Isaacson as modified does not teach “injecting sclerosant through the working lumen of the sheath to a treatment site selected from the group consisting of the first treatment site, the second treatment site, and combinations thereof”.
Wisnosky teaches (Fig. 1) a vascular treatment apparatus that injects sclerosant through the working lumen of the sheath (intraluminal member 125) to the treatment site. (Paragraphs [0050], [0060]).
Here, substituting a generalized "treatment site" with a specific "first, second, or combination" of sites yields no unexpected results. The sclerosant performs the exact same chemical and therapeutic function, and the sheath lumen performs the exact same fluid-conveying function, regardless of which specific treatment site is chosen. Applying the known injection method to a first site and then a second site uses the device exactly as intended by the prior art to address the standard anatomical spread of a condition.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “injecting sclerosant through the working lumen of the sheath to a treatment site selected from the group consisting of the first treatment site, the second treatment site, and combinations thereof” as taught by Wisnosky. Doing so enables passage of the sclerosant through the working lumen to cause endothelial cellular destruction and/or exposure of the underlying subendothelial cell layer, thus utilizing the lumen's primary structural purpose (fluid delivery) to transport the agent to the known destination (the treatment site). (Paragraph [0023]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson in view of O’Dea, Leiner, Fleming and McGuckin, further in view of Dziura (US 20230285607).
Regarding claim 18, Isaacson as modified does not teach “wherein a plurality of LEDs of the at least one LED is located along the at least partially sinusoidal shape”.
Dziura, in related field of endeavor, teaches light emitting catheter (Fig. 1) comprising a plurality of LEDs (120) of the at least one LED is located along the at least partially sinusoidal shape. (Paragraph [0036]).
As a result, it would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the catheter of Isaacson as modified by McGuckin to arrange “a plurality of LEDs of the at least one LED is located along the at least partially sinusoidal shape”, as taught by Dziura. A person having ordinary skill in the art would be motivated to use a sinusoidal configuration to maximize the mechanical flexibility of the catheter while maintaining the functionality of the light-emitting array. The combination yields the predictable result of providing localized illumination along a highly flexible, kink-resistant portion of a catheter.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson in view of O’Dea, Leiner, further in view of Wisnosky.
Regarding claims 22 and 23, Isaacson as modified does not teach “wherein the working lumen is configured to receive a drug at the proximal sheath end and deliver the drug to the distal sheath end” (claim 22), “wherein the drug is sclerosant” (claim 23).
Wisnosky, as previously discussed, teaches (Fig. 1) a vascular treatment apparatus wherein the working lumen (intraluminal member 125) is configured to receive a drug at the proximal sheath end and deliver the drug to the distal sheath end, wherein the drug is sclerosant. (Paragraphs [0050], [0060]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Isaacson as modified to teach “wherein the working lumen is configured to receive a drug at the proximal sheath end and deliver the drug to the distal sheath end” (claim 22), “wherein the drug is sclerosant” (claim 23), as taught by Wisnosky. Doing so enables passage of the sclerosant through the working lumen to cause endothelial cellular destruction and/or exposure of the underlying subendothelial cell layer, thus utilizing the lumen's primary structural purpose (fluid delivery) to transport the agent to the known destination (the treatment site). (Paragraph [0023]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
