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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/28/2026 has been entered.
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 01/28/2026. Claims 1-2 and 7-8 are amended. Claim 6 is cancelled. Claims 9-14 are new. Claims 1-5 and 7-14 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/28/2026, with respect to the rejection(s) of claim(s) 1-5 and 7-8 under 35 U.S.C. 103 as being unpatentable over Grace in view of Gustus and Soltani, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendments to the claims.
Applicant argues the combination of references do not disclose a diverter to direct light from the first light guide to the first pressure wave transducer (Remarks, pgs. 5-6).
In response to applicant’s argument, it is respectfully submitted Grace discloses layers of optical fibers which terminate in multiple laser emitters at varying locations within the balloon assembly (para. [0255]). No further structure is provided to the diverter itself, and para. [0121] of the published application describes the diverting feature as any feature of the system that diverts light from the light guide. Therefore, since the layers of optical fibers in Grace terminate in laser emitters at different locations within the balloon assembly, the light energy is considered to be diverted through the varying locations, therefore meeting the claimed limitation.
Applicant’s argument with respect to claims 9-14 have been fully considered, and new claims 9-14 are rejected as discussed below.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Grace (US 2016/0184023 A1) (previously of record) in view of Gustus (US 2010/0076299 A1) (previously of record) and Soltani (US 2011/0004105 A1) (previously of record).
Regarding claim 1, Grace discloses (see abstract; paras. [0224]-[0328]; figs. 1-19) a catheter (1200, para. [0314]) adapted for generating pressure waves within a blood vessel of a patient (abstract), the catheter comprising:
an elongate shaft (shaft forming inner lumen 110, para. [0224]; fig. 12) extending between a proximal region and a distal region (fig. 12);
a first light guide (optical fiber, para. [0314]) extending along the elongate shaft (fig. 12a);
a balloon (150) coupled to the elongate shaft (fig. 12), the balloon selectively expanding from a collapsed configuration (deflated configuration of balloon assembly, para. [0226]) suitable for advancing the catheter through a patient's vasculature to a first expanded configuration (inflated configuration, figs. 1-1b) suitable for anchoring the balloon in position relative to a treatment site within the blood vessel (inflated to a desired pressure to make contact with target, paras. [0229] and [0238]);
a first pressure wave transducer (first light absorbing material support structure 174, which generates a pressure wave, paras. [0314]-[0315]) disposed on the catheter (via port 172, para. [0314]), the first pressure wave transducer comprising a first photoacoustic transducer (considered to be a photoacoustic transducer since the laser light reacts with the light absorbing material to generate a pressure wave, para. [0315]);
a diverter (at least one laser emitter 300, 310 and 320, which are layered on each other and vary in location along the balloon assembly to activate light energy at different locations, therefore considered to function as a diverter, paras. [0255]-[0256] and [0314]) to direct light from the first light guide to the first pressure wave transducer (light absorbing material intersects with path of light, which is emitted at varying locations along the balloon assembly, paras. [0255]-[0256] and [0314]); and
a second pressure wave transducer (second, additional light absorbing material applied to a different surface within balloon assembly 150, para. [0315]) disposed on the catheter adjacent to the first pressure wave transducer (considered to be adjacent or near the first light absorbing material since both materials are applied within balloon assembly 150, para. [0315]).
However, Grace fails to disclose wherein the first photoacoustic transducer and the second pressure wave transducer are configured to generate pressure waves that constructively interfere to generate a higher peak pressure within the blood vessel at the treatment site, wherein the peak pressure is in the range of 1MPa to 25 MPa.
Gustus teaches (para. [0071]; fig. 5), in the same field of endeavor, a catheter adapted for generating pressure waves within a blood vessel of a patient (para. [0054]) comprising first and second transducers (34) configured to generate pressure waves (waves of ultrasonic energy) that constructively interfere (para. [0071]; fig. 5) to generate a higher peak pressure within the blood vessel at the treatment site (points with higher temperatures, considered to generate higher peak pressure since temperature and pressure have a direct relationship), for the purpose of modulating differences in wavelength between the transducers, allowing for focuses on different depths of plaque that are location specific (para. [0071]).
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 first and second photoacoustic transducers of Grace to be configured to generate over-lapping wave patterns that constructively interfere, in order to allow for focuses on different depths of plaque that are location specific by modulating differences in wavelength between the transducers, based on the teachings of Gustus (para. [0071]).
Grace (as modified) still fails to teach wherein the peak pressure is in the range of 1MPa to 25 MPa.
Soltani teaches (para. [0086]), in the same field of endeavor, a catheter adapted for generating pressure waves (abstract), wherein the peak pressure of the pressure waves is in the range of 1MPa to 25MPa (para. [0086]), for the purpose of generating the appropriate amount of acoustic pressure to treat tissue, creating nonlinear acoustic pressure which enhances the removal of a thrombus (para. [0088]).
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 of Grace (as modified) to generate peak pressures in the claimed range, in order to create nonlinear acoustic pressure which enhances the removal of plaque and/or tissue when desired, based on the suggestions and teachings of Soltani (para. [0088]).
Regarding claim 3, Grace (as modified) teaches the catheter of claim 1. Grace (as modified) further teaches wherein the peak pressure is in the range of 5MPa to 25 MPa (para. [0086] of Soltani).
Regarding claim 4, Grace (as modified) teaches the catheter of claim 1. Grace (as modified) further teaches wherein the peak pressure is in the range of 5MPa to 10 MPa (para. [0086] of Soltani).
Regarding claim 5, Grace (as modified) teaches the catheter of claim 1. Grace (as modified) further teaches wherein the second pressure wave transducer comprises a second photoacoustic transducer (second, additional light absorbing material considered to be a second photoacoustic transducer) configured to generate a second pressure wave that constructively interferes with a first pressure wave from the first photoacoustic transducer (combination considered to further teach waves of light absorbing materials applied within the balloon assembly 150 of Grace to constructively interfere).
Regarding claim 10, Grace (as modified) teaches the catheter of claim 1. Grace further discloses wherein the first photoacoustic transducer is coupled to a portion of the balloon (considered to be coupled via inner lumen 110, see also para. [0315] describing light absorbing material applied to surfaces of the balloon assembly, figs. 12-12a), and wherein the first photoacoustic transducer forms a pattern on the balloon (combination considered to further teach over-lapping wave patterns forming a pattern on the balloon, para. [0071] of Gustus).
Regarding claim 2, Grace discloses (see abstract; paras. [0224]-[0328]; figs. 1-19) a method for generating pressure waves within a blood vessel having a vessel wall (abstract, paras. [0314]-[0316]), the method comprising:
advancing a balloon catheter (1200, para. [0314]) into the blood vessel to a treatment site (para. [0316]), the balloon catheter including:
an elongate shaft (shaft forming inner lumen 110, para. [0224]; fig. 12) extending between a proximal region and a distal region (fig. 12);
a first light guide (optical fiber, para. [0314]) extending along the elongate shaft (fig. 12a);
an expandable balloon (150) coupled to the elongate shaft (fig. 12);
a first pressure wave transducer (first light absorbing material support structure 174, which generates a pressure wave, paras. [0314]-[0315]) disposed on the catheter (via port 172, para. [0314]), the first pressure wave transducer comprising a first photoacoustic transducer (considered to be a photoacoustic transducer since the laser light reacts with the light absorbing material to generate a pressure wave, para. [0315]);
a diverter (at least one laser emitter 300, 310 and 320, which are layered on each other and vary in location along the balloon assembly to activate light energy at different locations, therefore considered to function as a diverter, paras. [0255]-[0256] and [0314]) to direct light from the first light guide to the first pressure wave transducer (light absorbing material intersects with path of light, which is emitted at varying locations along the balloon assembly, paras. [0255]-[0256] and [0314]); and
a second pressure wave transducer (second, additional light absorbing material applied to a different surface within balloon assembly 150, para. [0315]) disposed on the catheter adjacent to the first pressure wave transducer (considered to be adjacent or near the first light absorbing material since both materials are applied within balloon assembly 150, para. [0315]); and
generating a first pressure wave with the first photoacoustic transducer (produces propagating pressure waves, para. [0316]), and generating a second pressure wave with the second pressure wave transducer (sends pulses to areas where light absorbing material is located, para. [0316]).
However, Grace fails to disclose wherein the first and second pressure wave transducers are disposed on the catheter in a pattern that is configured to generate pressure waves that constructively interfere; and wherein the first and second pressure waves constructively interfere to generate a higher peak pressure within the blood vessel at the treatment site, wherein the peak pressure is in the range of 5MPa to 25 MPa.
Gustus teaches (para. [0071]; fig. 5), in the same field of endeavor, a method for generating pressure waves within a blood vessel having a vessel wall (para. [0054]) comprising first and second pressure wave transducers (34) disposed in a pattern that is configured to generate pressure waves (waves of ultrasonic energy) that constructively interfere (para. [0071]; fig. 5), and wherein the first and second pressure waves constructively interfere to generate a higher peak pressure within the blood vessel at the treatment site (points with higher temperatures, considered to generate higher peak pressure since temperature and pressure have a direct relationship), for the purpose of modulating differences in wavelength between the transducers, allowing for focuses on different depths of plaque that are location specific (para. [0071]).
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 first and second photoacoustic transducers of Grace to be disposed on the catheter in a pattern configured to generate pressure waves that constructively interfere, in order to allow for focuses on different depths of plaque that are location specific by modulating differences in wavelength between the transducers, based on the teachings of Gustus (para. [0071]).
Grace (as modified) still fails to teach wherein the peak pressure is in the range of 1MPa to 25 MPa.
Soltani teaches (para. [0086]), in the same field of endeavor, a catheter adapted for generating pressure waves (abstract), wherein the peak pressure of the pressure waves is in the range of 1MPa to 25MPa (para. [0086]), for the purpose of generating the appropriate amount of acoustic pressure to treat tissue, creating nonlinear acoustic pressure which enhances the removal of a thrombus (para. [0088]).
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 of Grace (as modified) to generate peak pressures in the claimed range, in order to create nonlinear acoustic pressure which enhances the removal of plaque and/or tissue when desired, based on the suggestions and teachings of Soltani (para. [0088]).
Regarding claim 7, Grace (as modified) teaches the method of claim 2. Grace (as modified) further teaches wherein the peak pressure is in the range of 5MPa to 10 MPa (para. [0086] of Soltani).
Regarding claim 8, Grace (as modified) teaches the method of claim 2. Grace (as modified) further teaches wherein the second pressure wave is generated with a second photoacoustic transducer of the second pressure wave transducer (second, additional light absorbing material considered to be a second photoacoustic transducer).
Claim(s) 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Grace in view of Gustus and Soltani as applied to claim 1 above, and further in view of Vrba (US 2011/0263921 A1).
Regarding claim 11, Grace (as modified) teaches the catheter of claim 10.
However, Grace (as modified) fails to specifically teach wherein the pattern includes a plurality of discrete circles.
Vrba teaches (paras. [0012] and [0107]-[0108]; figs. 12a-b), in the same field of endeavor, a catheter for generating pressure waves (para. [0012]) comprising a treatment element forming a pattern on a balloon, wherein the pattern includes a plurality of discrete circles (fig. 12b), for the purpose of treating an entirety of a desired portion of a vessel without having to move the treatment implement or arrangement to other vessel locations in order to complete the treatment procedure (paras. [0067] and [0097]).
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 pattern of transducers in Grace (as modified) to incorporate a plurality of discrete circles, in order to provide the capability of treating an entirety of a desired portion of a vessel without having to move the catheter or arrangement to other vessel locations in order to complete the treatment procedure (i.e. the catheter could be left in place and still treat different, specific portions of tissue via the discrete circles), based on the teachings of Vrba (paras. [0067] and [0097]).
Regarding claim 12, Grace (as modified) teaches the catheter of claim 10.
However, Grace (as modified) fails to specifically teach wherein the pattern includes a plurality of bars extending circumferentially around at least a portion of the balloon.
Vrba teaches (paras. [0012] and [0110]-[0112]; figs. 13a-b), in the same field of endeavor, a catheter for generating pressure waves (para. [0012]) comprising a treatment element forming a pattern on a balloon, wherein the pattern includes a plurality of bars extending circumferentially around at least a portion of the balloon (treatment pattern 59c considered to be bars, fig. 13b, see also figs. 10c-g), for the purpose of treating an entirety of a desired portion of a vessel without having to move the treatment implement or arrangement to other vessel locations in order to complete the treatment procedure (paras. [0067] and [0097]).
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 pattern of transducers in Grace (as modified) to incorporate a plurality of bars extending circumferentially around at least a portion of the balloon, in order to provide the capability of treating an entirety of a desired portion of a vessel without having to move the catheter or arrangement to other vessel locations in order to complete the treatment procedure (i.e. the catheter could be left in place and still treat different, specific portions of tissue via the plurality of bars), based on the teachings of Vrba (paras. [0067] and [0097]).
Regarding claim 13, Grace (as modified) teaches the catheter of claim 10.
However, Grace (as modified) fails to specifically teach wherein the pattern includes a plurality of bars extending longitudinally along at least a portion of the balloon.
Vrba teaches (paras. [0012] and [0110]-[0112]; figs. 13a-b), in the same field of endeavor, a catheter for generating pressure waves (para. [0012]) comprising a treatment element forming a pattern on a balloon, wherein the pattern includes a plurality of bars extending longitudinally along at least a portion of the balloon (treatment pattern 59c considered to be bars which include a longitudinal component and therefore extend along the balloon, fig. 13b, see also figs. 10c-g), for the purpose of treating an entirety of a desired portion of a vessel without having to move the treatment implement or arrangement to other vessel locations in order to complete the treatment procedure (paras. [0067] and [0097]).
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 pattern of transducers in Grace (as modified) to incorporate a plurality of bars extending longitudinally along at least a portion of the balloon, in order to provide the capability of treating an entirety of a desired portion of a vessel without having to move the catheter or arrangement to other vessel locations in order to complete the treatment procedure (i.e. the catheter could be left in place and still treat different, specific portions of tissue via the plurality of bars), based on the teachings of Vrba (paras. [0067] and [0097]).
Regarding claim 14, Grace (as modified) teaches the catheter of claim 10.
However, Grace (as modified) fails to specifically teach wherein the balloon includes a longitudinal axis, and wherein the pattern includes a plurality of bars extending diagonally relative to the longitudinal axis along at least a portion of the balloon.
Vrba teaches (paras. [0012], [0018], [0096] and [0100]-[0101]; figs. 10c-13b), in the same field of endeavor, a catheter for generating pressure waves (para. [0012]) comprising a treatment element (50) forming a pattern on a balloon including a longitudinal axis (treatment element 50 may be a balloon or separate sleeve affixed to a balloon, para. [0018]), wherein the pattern includes a plurality of bars extending diagonally relative to the longitudinal axis along at least a portion of the balloon (figs. 10c-d depict treatment pattern extending diagonally along treatment element 50), for the purpose of treating an entirety of a desired portion of a vessel without having to move the treatment implement or arrangement to other vessel locations in order to complete the treatment procedure (paras. [0067] and [0097]).
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 pattern of transducers in Grace (as modified) to incorporate a plurality of bars extending diagonally relative to the longitudinal axis along at least a portion of the balloon, in order to provide the capability of treating an entirety of a desired portion of a vessel without having to move the catheter or arrangement to other vessel locations in order to complete the treatment procedure (i.e. the catheter could be left in place and still treat different, specific portions of tissue via the plurality of bars), based on the teachings of Vrba (paras. [0067] and [0097]).
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 9, Grace (as modified) teaches the catheter of claim 1, however, Grace (as modified) fails to teach wherein a wall of the balloon comprises integrated fluid bubbles. Grace discloses bubbles passing through the balloon assembly (para. [0255]), but fails to disclose the bubbles integrated within a wall of the balloon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5860974 to Abele, disclosing a balloon catheter including conductive dots.
US 2004/0243119 A1 to Lane, disclosing a balloon catheter including patterns on the balloon (figs. 3a-d).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771