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 .
Status of Claims
Claims 1 and 9 are currently amended.
Claims 6 and 10 are cancelled.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 1/27/2026, with respect to 35 U.S.C. 101 rejection have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of claims 9 and 11-14 has been withdrawn.
35 U.S.C. 101:
Regarding claim 1, applicant has amended the claim to recite “a device controller configured to automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter in response to a safety interlock condition in which the device is operating in contrast mode and the safety sensor detects that the light output aperture is not in the safe zone inside the containment sheath.” The examiner argues that the applicant’s amendments provided significant practical application, “automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter,” based on safety interlock condition in which the device is operating in contrast mode and the safety sensor detects that the light output aperture is not in the safe zone inside the containment sheath. The amendment integrates the abstract idea into a practical application; therefore, the 35 U.S.C. 101 rejection is withdrawn.
Applicant’s arguments, see pages 9-10, filed 1/27/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 102 and 103 rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Spohn.
35 U.S.C. 102 and 103:
Regarding claim 1, applicant argues that Zappia, alone or in combination with the prior art, does not teach “wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath, the device further comprising: a device controller configured to automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter in response to a safety interlock condition in which the device is operating in contrast mode and the safety sensor detects that the light output aperture is not in the safe zone inside the containment sheath.” After further search and consideration, the examiner respectfully argues that process limitation cannot impart patentability to a product claim where the product is not patentably distinguished over the prior art. A functional statement cannot serve to distinguish a claim, which is not a process claim, from a reference since it does not define any structure. This is particularly so where the functional statement is conditional in nature, as to a possibility that may or may not occur. In this case, there is no structure for the device to switch between a saline mode and a contrast mode. Furthermore, the catheter sheath from Zappia is fully capable of operating in both fluid modes.
However, in effort to proceed with prosecution, the examiner will rely on Spohn to teach this limitation (fig. 5-7; paragraph 93-94 and 113). A switch between injecting the contrast medium and injecting the saline into a sheath is disclosed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid system of Zappia to add the switching mechanism from Spohn for the benefit of efficiently switching between operation states during vascular therapy procedure.
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 1, 2, 4, 9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable by Zappia et
al. US Pub.: US 20130072753 A1, hereinafter Zappia in view of SPOHN et al. US Pub.: US 20190083699 A1, hereinafter Spohn.
Regarding claim 1, Zappia teaches a vascular therapy device, comprising:
a catheter including at least one optical fiber with a light output aperture a containment sheath having a sheath opening disposed at an end thereof, the catheter disposed inside the containment sheath and movable relative to the containment sheath to extend the light output aperture beyond the sheath opening such that the light output aperture is outside of the containment sheath (fig. 1; paragraph 27 and 46); Catheter/medical device 114 is configured to move within a containment sheath 102.
and a safety sensor configured to detect whether the light output aperture is in a safe zone inside the containment sheath (fig. 2; paragraph 27 and 34-43). The detection system 118 may detect the position of the catheter to ensure safety.
the device further comprising: a device controller configured to automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter in response to a safety interlock condition in which the safety sensor detects that the light output aperture is not in the safe zone inside the containment sheath (fig. 2-4; paragraph 27, 34-43, 49-52 and 58-59). If the laser unit 212 is accidently displaced or retracted back into elongate tube 102, detector 301 may once more raise the alert signal or stop the ready signal, signaling the operator to immediately power off the laser unit 212 or powering it off automatically.
However, Zappia does not teach wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath.
Spohn, in the same field of endeavor, teaches wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath (fig. 5-7; paragraph 93-94 and 113). A switch between injecting the contrast medium and injecting the saline into a sheath is disclosed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid system of Zappia to add the switching mechanism from Spohn for the benefit of efficiently switching between operation states during vascular therapy procedure.
Regarding claim 2, Zappia in view of Spohn teaches the claimed invention and Zappia further
teaches wherein the safety sensor includes: a proximity sensor configured to detect passage events in which the light output aperture passes through the sheath opening (fig. 2; paragraph 38); The detection system 118 is positioned at or proximate the distal-most end 104 of the lumen 108.
and an electronic processor configured to detect whether the light output aperture is in the safe zone based at least on the passage events detected by the proximity sensor (fig. 2; paragraph 35-41, 50-51, and 61). The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
Regarding claim 4 and 14, Zappia in view of Spohn teaches the claimed invention and Zappia
further teaches wherein the safety sensor further includes: a backside proximity sensor configured to detect passage events in which the light output aperture passes through an interior boundary of the safe zone wherein the interior boundary is located inside the containment sheath (fig. 2; paragraph 38); The detection system 118 is positioned at or proximate the distal-most end 104 of the lumen 108. In other configurations, detection system 118 may be coupled to any part of elongate tube 102.
wherein the electronic processor is configured to detect whether the light output aperture is in the safe zone further based on the passage events detected by the backside proximity sensor (fig. 2; paragraph 35-41, 50-51, and 61). The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
Regarding claim 9, Zappia teaches a vascular therapy device, comprising:
a catheter including at least one optical fiber with a light output aperture a containment sheath having a sheath opening disposed at an end thereof, the catheter disposed inside the containment sheath and movable relative to the containment sheath to extend the light output aperture beyond the sheath opening such that the light output aperture is outside of the containment sheath (fig. 1; paragraph 27 and 46); Catheter/medical device 114 is configured to move within a containment sheath 102.
a proximity sensor configured to detect passage events in which the light output aperture passes through the sheath opening (fig. 2; paragraph 27 and 34-43). The detection system 118 may detect the position of the catheter to ensure safety.
and an electronic processor configured to detect whether the light output aperture is in the safe zone based at least on the passage events detected by the proximity sensor (fig. 2; paragraph 35-41, 50-51, and 61). The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
the device further comprising: a device controller configured to automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter in response to a safety interlock condition in which the safety sensor detects that the light output aperture is not in the safe zone inside the containment sheath (fig. 2-4; paragraph 27, 34-43, 49-52 and 58-59). If the laser unit 212 is accidently displaced or retracted back into elongate tube 102, detector 301 may once more raise the alert signal or stop the ready signal, signaling the operator to immediately power off the laser unit 212 or powering it off automatically.
However, Zappia does not teach wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath.
Spohn, in the same field of endeavor, teaches wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath (fig. 5-7; paragraph 93-94 and 113). A switch between injecting the contrast medium and injecting the saline into a sheath is disclosed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid system of Zappia to add the switching mechanism from Spohn for the benefit of efficiently switching between operation states during vascular therapy procedure.
Claims 3, 5-8, 10-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over
Zappia In view of Spohn in view of Tschida et al. US Pub.: US 20200046429 A1, hereinafter Tschida.
Regarding claim 3 and 11, Zappia in view of Spohn teaches wherein the proximity sensor
includes: an aperture marker disposed on the catheter and is a passive marker (fig. 2-3; paragraph 44 and 54); Aperture marker 210.
However, Zappia does not teach a sheath opening marker disposed on the containment sheath wherein the sheath opening marker is an active marker configured to detect proximity of the passive marker.
Tschida, in the same field of endeavor, teaches a sheath opening marker disposed on the containment sheath wherein the sheath opening marker is an active marker configured to detect proximity of the passive marker (paragraph 378). In order to visualize the respective locations of the laser catheter 1010 and the sheath 1120 under fluoroscopy, the laser catheter 1010 and the sheath 1120 may include radiopaque markers at any corresponding locations along their lengths.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter sheath from Zappia in view of Spohn with the marker from Tschida for the benefit of visualizing the respective locations of the laser catheter 1010 and the sheath 1120 under fluoroscopy.
Regarding claim 5, Zappia in view of Spohn in view of Tschida teaches the claimed invention and
Zappia further teaches wherein the safety sensor includes: a radiopaque aperture marker disposed on the catheter (fig. 2-3; paragraph 44 and 54);
and an electronic processor configured to: receive images from an interventional radiology imaging device that depict the radiopaque aperture marker and the radiopaque sheath opening marker (paragraph 33);
and detect whether the light output aperture is in the safe zone based on the received images (fig. 2; paragraph 27 and 34-43). The detection system 118 may detect the position of the catheter to ensure safety.
Zappia does not teach a radiopaque sheath opening marker disposed on the containment sheath.
Tschida, in the same field of endeavor, teaches a radiopaque sheath opening marker disposed on the containment sheath (paragraph 378);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter sheath from Zappia in view of Spohn with the marker from Tschida for the benefit of visualizing the respective locations of the laser catheter 1010 and the sheath 1120 under fluoroscopy.
Regarding claim 6, Zappia in view of Spohn in view of Tschida teaches the claimed invention and
Tschida further teaches a device controller configured to automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter in response to a safety interlock condition in which the device is operating in contrast mode and the safety sensor detects that the light output aperture is not in the safe zone inside the containment sheath (paragraph 46, 50 and 59).
Zappia in view of Spohn in view of Tschida, as modified, does not teach wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath.
Tschida further teaches wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath (paragraph 534-536). The valves 4028 thereby deliver one or more liquid media to the lumen of the sheath 4014 (for example, a contrast medium and saline).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter sheath from Zappia in view of Spohn with the valve from Tschida for the benefit of performing a procedure in which the system creates laser-induced pressure waves in the presence of a liquid medium to thereby disrupt a portion of a vascular occlusion.
Regarding claim 7 and 12, Zappia in view of Spohn in view of Tschida teaches the claimed
invention and Zappia further teaches wherein the electronic processor is programmed to implement a state machine by:
determining an inside state of the light output aperture indicative of whether the light output aperture is inside of the containment sheath; update the state machine from the inside state to an outside state after determining that the light output aperture is outside of the containment sheath (fig. 2-3; paragraph 35-41, 44, 50-51, 54, and 61). Aperture marker 210. The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
However, Zappia in view of Spohn in view of Tschida, as modified, does not teach to determine whether the catheter is in the saline mode or the contrast mode; and cease supplying optical energy to the at least one optical fiber when (i) the catheter is in the contrast mode and (ii) the state of the light output aperture is in the outside state.
Tschida further teaches to determine whether the catheter is in the saline mode or the contrast mode; and cease supplying optical energy to the at least one optical fiber when (i) the catheter is in the contrast mode and (ii) the state of the light output aperture is in the outside state (paragraph 534-536). The valves 4028 thereby deliver one or more liquid media to the lumen of the sheath 4014 (for example, a contrast medium and saline).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter sheath from Zappia in view of Spohn with the valve from Tschida for the benefit of performing a procedure in which the system creates laser-induced pressure waves in the presence of a liquid medium to thereby disrupt a portion of a vascular occlusion.
Regarding claim 8 and 13, Zappia in view of Spohn in view of Tschida teaches the claimed
invention and Zappia further teaches wherein the electronic processor is further programmed to: update the state machine of the light output aperture from the outside state to the inside state (fig. 2-3; paragraph 35-41, 44, 50-51, 54, and 61). Aperture marker 210. The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
However, Zappia does not teach a sheath opening marker.
Tschida, in the same field of endeavor, teaches a sheath opening marker (paragraph 378);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter sheath from Zappia in view of Spohn with the marker from Tschida for the benefit of visualizing the respective locations of the laser catheter 1010 and the sheath 1120 under fluoroscopy.
Regarding claim 10, Zappia in view of Spohn teaches a device controller configured to
automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter in response to a safety interlock condition in which the device is operating wherein the proximity sensor detects that the light output aperture is not in the safe zone inside the containment sheath (fig. 2; paragraph 35-41, 46, 50-51, and 61). The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
Zappia does not teach wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath.
Tschida, in the same field of endeavor, teaches wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath (paragraph 534-536). The valves 4028 thereby deliver one or more liquid media to the lumen of the sheath 4014 (for example, a contrast medium and saline).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter sheath from Zappia in view of Spohn with the valve from Tschida for the benefit of performing a procedure in which the system creates laser-induced pressure waves in the presence of a liquid medium to thereby disrupt a portion of a vascular occlusion.
Regarding claim 15, Zappia teaches a vascular therapy device, comprising:
a catheter including at least one optical fiber with a light output aperture a containment sheath having a sheath opening disposed at an end thereof, the catheter disposed inside the containment sheath and movable relative to the containment sheath to extend the light output aperture beyond the sheath opening such that the light output aperture is outside of the containment sheath (fig. 1; paragraph 27 and 46); Catheter/medical device 114 is configured to move within a containment sheath 102.
and a safety sensor configured to detect whether the light output aperture is in a safe zone inside the containment sheath (fig. 2; paragraph 27 and 34-43); The detection system 118 may detect the position of the catheter to ensure safety.
a device controller configured to automatically turn off a laser operating to inject light into the at least one optical fiber of the catheter in response to a safety interlock condition in which the device is operating in contrast mode and the safety sensor detects that the light output aperture is not in the safe zone inside the containment sheath (fig. 2; paragraph 35-41, 46, 50-51, and 61). The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
However, Zappia does not teach wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath.
Tschida further teaches wherein the device is configured to operate in a saline mode in which saline flows through the containment sheath and in a contrast mode in which contrast medium flows through the containment sheath (paragraph 534-536). The valves 4028 thereby deliver one or more liquid media to the lumen of the sheath 4014 (for example, a contrast medium and saline).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter sheath from Zappia with the valve from Tschida for the benefit of performing a procedure in which the system creates laser-induced pressure waves in the presence of a liquid medium to thereby disrupt a portion of a vascular occlusion.
Regarding claim 16, Zappia in view of Tschida teaches the claimed invention and Zappia further
teaches wherein the safety sensor includes: a proximity sensor configured to detect passage events in which the light output aperture passes through the sheath opening (fig. 2; paragraph 38); The detection system 118 is positioned at or proximate the distal-most end 104 of the lumen 108.
and an electronic processor configured to detect whether the light output aperture is in the safe zone based at least on the passage events detected by the proximity sensor (fig. 2; paragraph 35-41, 50-51, and 61). The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
Regarding claim 17, Zappia teaches wherein the proximity sensor includes: an aperture
marker disposed on the catheter and is a passive marker (fig. 2-3; paragraph 44 and 54); Aperture marker 210.
However, Zappia does not teach a sheath opening marker disposed on the containment sheath wherein the sheath opening marker is an active marker configured to detect proximity of the passive marker.
Tschida, in the same field of endeavor, teaches a sheath opening marker disposed on the containment sheath wherein the sheath opening marker is an active marker configured to detect proximity of the passive marker (paragraph 378). In order to visualize the respective locations of the laser catheter 1010 and the sheath 1120 under fluoroscopy, the laser catheter 1010 and the sheath 1120 may include radiopaque markers at any corresponding locations along their lengths.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter sheath from Zappia with the marker from Tschida for the benefit of visualizing the respective locations of the laser catheter 1010 and the sheath 1120 under fluoroscopy.
Regarding claim 18, Zappia in view of Tschida teaches the claimed invention and Zappia further
teaches wherein the safety sensor further includes: a backside proximity sensor configured to detect passage events in which the light output aperture passes through an interior boundary of the safe zone wherein the interior boundary is located inside the containment sheath (fig. 2; paragraph 38); The detection system 118 is positioned at or proximate the distal-most end 104 of the lumen 108. In other configurations, detection system 118 may be coupled to any part of elongate tube 102.
wherein the electronic processor is configured to detect whether the light output aperture is in the safe zone further based on the passage events detected by the backside proximity sensor (fig. 2; paragraph 35-41, 50-51, and 61). The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
Regarding claim 19, Zappia in view of Tschida teaches the claimed invention and Zappia
further teaches wherein the electronic processor is programmed to implement a state machine by:
determining an inside state of the light output aperture indicative of whether the light output aperture is inside of the containment sheath; update the state machine from the inside state to an outside state after determining that the light output aperture is outside of the containment sheath (fig. 2-3; paragraph 35-41, 44, 50-51, 54, and 61). Aperture marker 210. The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
However, Zappia in view of Tschida, as modified, does not teach to determine whether the catheter is in the saline mode or the contrast mode; and cease supplying optical energy to the at least one optical fiber when (i) the catheter is in the contrast mode and (ii) the state of the light output aperture is in the outside state.
Tschida further teaches to determine whether the catheter is in the saline mode or the contrast mode; and cease supplying optical energy to the at least one optical fiber when (i) the catheter is in the contrast mode and (ii) the state of the light output aperture is in the outside state (paragraph 534-536). The valves 4028 thereby deliver one or more liquid media to the lumen of the sheath 4014 (for example, a contrast medium and saline).
Regarding claim 20, Zappia in view of Tschida teaches the claimed invention and Zappia
further teaches wherein the electronic processor is further programmed to:
update the state machine of the light output aperture from the outside state to the inside state by determining whether the aperture marker no longer extends past the sheath opening marker (fig. 2-3; paragraph 35-41, 44, 50-51, 54, and 61). Aperture marker 210. The ready or alert signals may be visual, auditory, or tactile signals informing the operator whether it is safe or unsafe to actuate medical device 114. The control unit is used with the detection system to provide an alert.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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, Benjamin Klein can be reached at 571-270-5213. 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.
/T.J.T./Examiner, Art Unit 3792
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
Prosecution Insights