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.
Election/Restriction
Applicant’s election without traverse of Invention Group I, claims 1-9 in the reply filed on October 20, 2025 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 21, 2023; July 24, 2024; September 4, 2024; October 30, 2024; October 2, 2025; October 14, 2025; and November 5, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites a “catheter system of claim comprising multiple optical fibers” without specifying the claim from which it depends. Thus, claim 6 fails to “contain a reference to a claim previously set forth,” as required by § 112(d).
Claim 7 is rejected as being dependent upon rejected claim 6 and failing to remedy the issue under § 112(d).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 6 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryan et al. (U.S. Patent Application Publication No. 2007078500; hereinafter “Ryan”).
Regarding claim 6, Ryan discloses a catheter system comprising 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]).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Adams et al. (U.S. Patent Application Publication No. 20140243820; hereinafter “Adams ‘820”).
Regarding claim 7, 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 1-3 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 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 optical fiber 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 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]).
Claims 4 and 5 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 Ryan.
Regarding claim 4, 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, 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.
Claims 8 and 9 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, 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, 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Asokan et al. (U.S. Patent Application Publication No. 20090161272) disclosing an arc detection system (Figs. 1-2); and
Cook et al. (U.S. Patent Application Publication No. 20220354578) disclosing a fiber optic observing plasma creation in a lithotripsy device (Figs. 1-3F).
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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/JONATHAN A HOLLM/Examiner, Art Unit 3771