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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
The Response filed April 21, 2026 has been entered. Claims 1-9 and 21-30 are pending in the application. The previous objections to the abstract and rejections of claims under 35 U.S.C. 112(d) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Claim Objections
Applicant is advised that should claim 3 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a duplicate thereof. Additionally, should claim 21 be found allowable, claim 30 will be objected to under 37 CFR 1.75 as being a duplicate thereof.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 21-23, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (U.S. Patent No. 10702293; hereinafter “Adams ‘293”) in view of Debreczeny et al. (U.S. Patent Application Publication No. 20100016688; hereinafter “Debreczeny”).
Regarding claim 1, Adams ‘293 discloses an intravascular lithotripsy catheter system (80; Fig. 9) for use in providing an energy wave and a force to a thrombus or lesion within a vasculature (col. 5, ll. 3-31), the catheter system comprising:
a catheter (annotated Fig. 9 below) that extends from a proximal end to a distal end with a saline delivery lumen (annotated Fig. 9) open from the distal end of the catheter for creating a controlled volume or bolus of saline at a distal region of the catheter (col. 5, ll. 18-31), at least one pair of electrodes (82, 84) provided within the distal region of the controlled volume that are connectable with a high voltage pulse generator to create a spark across the electrode pair when inflated with a saline solution (col. 5, ll. 1-17); and
a sensor (combination of sensor (85) and its connectors extending to processors (88); Fig. 9) extending from the proximal end of the catheter distally to a position within the controlled volume of saline for directly observing an optical phenomenon (“reflected signals;” col. 6, ll. 5-9) within the controlled volume of saline when detectable light is generated by the optical phenomenon, the sensor connected with a processor (88) at the proximal end of the catheter.
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The device of Adams ‘293 discloses the invention substantially as claimed except for a sensor (85) positioned within the controlled volume of saline connected with a processor (88) at the proximal end of the catheter instead of an optical fiber connected with a photosensor at the proximal end of the catheter.
Debreczeny, a reference in the vascular treatment device field of endeavor, teaches providing a device with an optical fiber (“fiber optic”; para. [0033]) extending from a proximal end of a device to a distal position for directly observing an optical phenomenon (reflected light; para. [0103]) when detectable light is generated by the optical phenomenon, the optical fiber connected with a photosensor (photodiode; para. [0134]) and processor (paras. [0136]-[0143]) at the proximal end of the device (paras. [0146]-[0148]) to allow real-time monitoring of changes to patient’s tissue during a treatment (para. [0156]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor of Adams ‘293 as an optical fiber extending from the proximal end of the catheter distally to a position within the controlled volume of saline for observing an optical phenomenon within the controlled volume of saline when detectable light is generated by the optical phenomenon, the optical fiber connected with a photosensor at the proximal end of the catheter, in view of Debreczeny, to allow monitoring of how tissue is responding to the lithotripsy procedure in real time so that a physician may adjust the magnitude of shockwaves delivered by the lithotripsy device as needed to treat the patient.
Regarding claim 2, Adams ‘293 discloses the system further comprising a balloon (86) near a distal end of the catheter that is operatively connected with the saline delivery lumen and that can be expanded by delivery of the controlled volume of saline (Fig. 9; col. 6, ll. 4-9).
Regarding claim 3, Debreczeny discloses wherein the photosensor comprises a photodiode (para. [0134]).
Regarding claims 21 and 30, Adams ‘293 discloses an intravascular lithotripsy catheter system (80; Fig. 9) for use in providing an energy wave and a force to a thrombus or lesion within a vasculature (col. 5, ll. 3-31), the catheter system comprising:
a catheter (annotated Fig. 9 below) that extends from a proximal end to a distal end with a saline delivery lumen (annotated Fig. 9) open from the distal end of the catheter for creating a controlled volume or bolus of saline at a distal region of the catheter (col. 5, ll. 18-31), at least one pair of electrodes (82, 84) provided within the distal region of the controlled volume that are connectable with a high voltage pulse generator to create a spark across the electrode pair when inflated with a saline solution (col. 5, ll. 1-17); and
a sensor (combination of sensor (85) and its connectors extending to processors (88); Fig. 9) extending from the proximal end of the catheter distally to a position within the controlled volume of saline for observing an optical phenomenon (“reflected signals;” col. 6, ll. 5-9) within the controlled volume of saline when detectable light is generated by the optical phenomenon, the sensor connected with a processor (88) at the proximal end of the catheter.
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The device of Adams ‘293 discloses the invention substantially as claimed except for a sensor (85) positioned within the controlled volume of saline connected with a processor (88) at the proximal end of the catheter instead of an optical fiber connected with a photosensor at the proximal end of the catheter.
Debreczeny, a reference in the vascular treatment device field of endeavor, teaches providing a device with an optical fiber (“fiber optic”; para. [0033]) extending from a proximal end of a device to a distal position for observing an optical phenomenon (reflected light; para. [0103]) when detectable light is generated by the optical phenomenon, the optical fiber extending proximally along the catheter (Fig. 16) and connected with a photosensor (photodiode; para. [0134]) and processor (paras. [0136]-[0143]) at the proximal end of the device (paras. [0146]-[0148]) to allow real-time monitoring of changes to patient’s tissue during a treatment (para. [0156]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the sensor of Adams ‘293 as an optical fiber extending from the proximal end of the catheter distally to a position within the controlled volume of saline for observing an optical phenomenon within the controlled volume of saline when detectable light is generated by the optical phenomenon, the optical fiber extending proximally along the catheter and connected with a photosensor at the proximal end of the catheter, in view of Debreczeny, to allow monitoring of how tissue is responding to the lithotripsy procedure in real time so that a physician may adjust the magnitude of shockwaves delivered by the lithotripsy device as needed to treat the patient.
Regarding claim 22, Adams ‘293 discloses the system further comprising a balloon (86) near a distal end of the catheter that is operatively connected with the saline delivery lumen and that can be expanded by delivery of the controlled volume of saline (Fig. 9; col. 6, ll. 4-9).
Regarding claim 23, Debreczeny discloses wherein the photosensor comprises a photodiode (para. [0134]).
Claims 4-6 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Adams ‘293 in view of Debreczeny, as applied to claim 1 or claim 21 above, and further in view of Ryan et al. (U.S. Patent Application Publication No. 2007078500; hereinafter “Ryan”).
Regarding claim 4 and claim 24, the modified device discloses the invention substantially as claimed, except for the optical fiber terminating within the controlled volume of saline with a distal tip directed toward a gap of the electrode pair.
Ryan, a reference in the vascular lithotripsy instrument field of endeavor, teaches configuring an optical fiber (113) to terminates within a controlled volume of saline with a distal tip that is directed toward a light source (415; Figs. 13A-13B) to receive light emitted from the light source (paras. [0257]-[0258]).
Adams ‘293 discloses that an arc is formed in the gap between electrodes as a source of light during a procedure (col. 5, ll. 1-43).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the optical fiber to terminates within the controlled volume of saline with a distal tip that is directed toward a gap of the electrode pair, in view of Ryan and Adams, in order to facilitate receiving light into the optical fiber during a procedure.
Regarding claim 5 and claim 25, the modified device discloses the invention substantially as claimed, except for the optical fiber including a cladding layer and a polished distal end.
Ryan teaches providing an optical fiber with a cladding layer to allow transmission of light from the distal end of the fiber to the proximal end of the fiber (paras. [0207]-[0209]). Ryan also teaches polishing a distal end of an optical fiber to receive detectable light within a desired window pertaining to a specific portion of a balloon (Figs. 10A-10B; para. [0246]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the optical fiber to include a cladding layer and the distal end is polished to receive the detectable light from the optical phenomenon, in view of Ryan, in order to facilitate receiving light from a specific window and transmitting the light through the optical fiber to monitor tissue along a specific portion of the balloon.
Regarding claim 6 and claim 26, the modified device discloses the invention substantially as claimed, except for the system including multiple optical fibers.
Ryan teaches providing a catheter system with multiple optical fibers connected with an optical sensor (1131, 1132; Figs. 9A-9B), each optical fiber connected with an optical sensor (171, 172; Figs. 9A-9B; paras. [0243]-[0245]) to capture highly accurate signal data (para. [0245]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the system to include multiple optical fibers, each optical fiber connected with an optical sensor, in view of Ryan, in order to facilitate capturing highly accurate signal data during a procedure.
Claims 7 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Adams ‘293 in view of Debreczeny and Ryan, as applied to claim 6 above, and further in view of Adams et al. (U.S. Patent Application Publication No. 20140243820; hereinafter “Adams ‘820”).
Regarding claim 7 and claim 27, Ryan discloses wherein the multiple optical fibers are directed to delivery fibers (112; Figs. 9A-9B). The device of Ryan discloses the invention substantially as claimed, except for the system comprising delivery fibers (112) to deliver energy to create a shockwave inside of a balloon instead of a plural pairs of electrodes.
Adams ‘820, a reference in the vascular lithotripsy instrument field of endeavor, teaches providing a system with a plurality of pairs of electrodes (332, 342; Fig. 5) to produce shockwaves along the length of a balloon (para. [0063]) for optimal effect at treating a lesion (para. [0015]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute plural electrodes for the delivery fibers in the device of Ryan such that the catheter system includes plural electrode pairs, and wherein the multiple optical fibers are directed to the plural electrode pairs, in view of Adams ‘820, in order to produce shockwaves along the length of the catheter for more optimal treatment of a lesion.
Claims 8-9 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Adams ‘293 in view of Debreczeny, as applied to claim 1 above, and further in view of Adams ‘820” and Tu et al. (U.S. Patent No. 7004911; hereinafter “Tu”).
Regarding claim 8 and claim 28, the modified device discloses the invention substantially as claimed, except for the system comprising plural pairs of electrodes
Adams ‘820, a reference in the vascular lithotripsy instrument field of endeavor, teaches providing a system with a plurality of pairs of electrodes (332, 342; Fig. 5) to produce shockwaves along the length of a balloon (para. [0063]) for optimal effect at treating a lesion (para. [0015]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the system with plural electrode pairs, in view of Adamas ‘820, in order to produce shockwaves along the length of the catheter for more optimal treatment of a lesion.
The modified device discloses the invention substantially as claimed, except for the optical fiber being modified along its length to have plural fiber side portions that can receive light energy at plural locations.
Tu, a reference in the vascular treatment device field of endeavor, teaches modifying an optical fiber (10) along its length to have plural fiber side portions (51, 52, 53, 54) that can receive light energy at plural locations along its length to be transmitted back to one or more photosensors (Figs. 1-2; col. 6, ln. 37 – col. 7, ln. 57) to monitor a vulnerable plaque along the length of the plaque (col. 6, ll. 37-42).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the optical fiber along its length to have plural fiber side portions that can receive light energy at plural locations along its length to be transmitted back to one or more photosensors, in view of Tu, to enable monitoring the status of a lesion along the length of the catheter as shockwaves are delivered along the length of the catheter during treatment of the lesion.
Regarding claim 9 and claim 29, Tu discloses the system further comprising a Bragg grating more distal than the plural fiber side portions for reflecting light energy at a select wavelength proximally to the one or more photosensors (col. 6, ll. 50-51).
Response to Arguments
Applicant's arguments filed April 21, 2026 have been fully considered but they are not persuasive.
On pages 10-11 of the Response, Applicant argues that the proposed combination of Adams ‘293 and Debreczeny does not disclose an optical fiber “for directly observing an optical phenomenon within the controlled volume of saline when detectable light is generated by the optical phenomenon,” as recited in claim 1. This argument is not persuasive.
Adams ‘293 discloses a sensor (85) that directly observes an optical phenomenon (i.e., reflected signals; col. 6, ll. 5-9) within the controlled volume of saline when detectable light is generated by the optical phenomenon.
Debreczeny teaches an optical fiber (“fiber optic;” para. [0033]) that directly observes an optical phenomenon (i.e., reflected light travelling to the fiber optic; para. [0103]) when detectable light (i.e., the reflected light) is generated by the optical phenomenon.
Thus, configuring the sensor of Adams ‘293 that detects optical phenomenon within the controlled volume of saline as a fiber optic, as taught by Debreczeny, results in an optical fiber “for observing an optical phenomenon within the controlled volume of saline when detectable light is generated by the optical phenomenon,” as recited in claim 1.
On pages 10-11 of the Response, Applicant argues that the proposed combination of Adams ‘293 and Debreczeny does not disclose an optical fiber “extending proximally along the catheter and connected with a photosensor at the proximal end of the catheter,” as recited in claims 21 and 30. This argument is not persuasive.
Debreczeny teaches an optical fiber (“fiber optic”; para. [0033]) proximally along the catheter (Fig. 16) and connected with a photosensor (photodiode; para. [0134]) and processor (paras. [0136]-[0143]) at the proximal end of the device (paras. [0146]-[0148]) to allow real-time monitoring of changes to patient’s tissue during a treatment (para. [0156]).
Thus, the modified device of Adams ‘293 and Debreczeny meets the limitation of the optical fiber “extending proximally along the catheter and connected with a photosensor at the proximal end of the catheter,” as recited in claims 21 and 30.
Applicant’s further argument that Debreczeny does not teach or suggest “the creation of an optical phenomenon . . . that is monitored to learn and evaluate treatments as applied to an organ,” (Response pg. 11) is not persuasive because such features are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, Examiner also notes that the limitation “for directly observing an optical phenomenon within the controlled volume of saline when detectable light is generated by the optical phenomenon,” as recited in claim 1, and the limitation “for observing an optical phenomenon within the controlled volume of saline when detectable light is generated by the optical phenomenon,” as recited in claim 21 and claim 30, are recitations of the intended use of a respective claimed optical fiber.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
For all the reasons above, Examiner maintains that the claimed invention is not allowable over the prior art of record.
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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H./Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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