DETAILED ACTION
Response to Amendment
This office action is responsive to the amendment filed on November 21, 2025. As directed by the amendment: claim(s) 1, 8, 10 and 49 have been amended, claim(s) 5-7 and 17-38 have been cancelled, and claim(s) 57-108 have been added. Thus, claims 1-22 and 38-108 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pgs. 13-14, filed November 21, 2025, with respect to 35 U.S.C. 112(b) rejection of claims 8, 10 and 49 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of claims 8, 10 and 49 has been withdrawn.
Applicant's arguments filed November 21, 2025 have been fully considered but they are not persuasive. The examiner has previously noted that claim 34 was allowable; however, upon further search and consideration it was determined that the prior art was able to read on the claim limitations. Therefore the claim limitations have been addressed in the rejection below and the use of the prior art maintained.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 16 and 47-51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkins (US 2014/0163592 A1)
Regarding claim 1, Hawkins discloses A catheter for treating a lesion in a body lumen, the catheter comprising: an elongated tube (e.g. [0033] Fig 5:112); an enclosure sealed to a distal end of the elongated tube (e.g. [0033] Fig 5:114); and an emitter assembly disposed within the enclosure (e.g. [0033] Fig 5:120), the emitter assembly comprising: at least one emitter configured to generate shock waves (e.g. [0033]-[0034]) inside the enclosure when power is supplied to the at least one emitter (e.g. [0008]-[0010]); and a support structure supporting the at least one emitter, the support structure configured to expand outwardly relative to a central longitudinal axis of the elongated tube to move the at least one emitter farther from the central longitudinal axis (e.g. [0033] Fig 5:122/124), wherein the at least one emitter comprises a first emitter and a second emitter (e.g. [0033] Fig 5:120), and wherein lateral expansion of the support structure moves the first emitter and the second emitter laterally away from the longitudinal axis in opposing directions along a first plane intersecting the longitudinal axis (e.g. [0033] Fig 5:120), emitters 120 on the support structure 124 are going in opposing directions).
Regarding claim 16, Hawkins discloses wherein the at least one emitter is oriented to generate shock waves outwardly from the longitudinal axis (e.g. [0033] Fig 5; claim 14)
Regarding claim 47, Hawkins discloses wherein the body lumen is a blood vessel or a valve (e.g. [0020]; [0033]).
Regarding claim 48, Hawkins discloses wherein the support structure is formed of a resilient material selected from the group consisting of a metal or a polymeric material (e.g. [0034] Fig 5:122/124 nitinol).
Regarding claim 49, Hawkins discloses wherein, after expansion of the support structure, the structure can return to substantially the same configuration in the collapsed state (e.g. [0034] Fig 5:122/124 nitinol is known for shape memory and super elasticity).
Regarding claim 50, Hawkins discloses wherein material properties of the support structure bias the support structure in a collapsed state (e.g. [0034] Fig 5:122/124 nitinol is known for shape memory and super elasticity ).
Regarding claim 51, Hawkins discloses wherein material properties of the support structure bias the support structure in an expanded state (e.g. [0034] Fig 5:122/124 nitinol is known for shape memory and super elasticity).
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.
Claim(s) 8 and 72, 80, 88-91 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins in view of Anderson (US 2022/0287732 A1).
Regarding claim 8, Hawkins is silent regarding the emitter assembly further comprising an elongate member that extends along the longitudinal axis through at least a portion of the support structure.
However, Anderson discloses an intravascular lithotripsy device wherein the emitter assembly further comprising an elongate member that extends along the longitudinal axis through at least a portion of the support structure (e.g.[0268]; [0343] guidewire Figs. 3 and 24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Hawkins to incorporate the teachings of Anderson to have an emitter assembly further comprising an elongate member that extends along the longitudinal axis through at least a portion of the support structure for the purpose of utilizing a known structure of an intravascular lithotripsy that has a guidewire that extends through the structure.
Regarding claim 72, Hawkins discloses A catheter for treating a lesion in a body lumen, the catheter comprising: an elongated tube (e.g. [0033] Fig 5:112); an enclosure sealed to a distal end of the elongated tube (e.g. [0033] Fig 5:114); and an emitter assembly disposed within the enclosure (e.g. [0033] Fig 5:120), the emitter assembly comprising: at least one emitter configured to generate shock waves (e.g. [0033]-[0034]) inside the enclosure when power is supplied to the at least one emitter (e.g. [0008]-[0010]); and a support structure supporting the at least one emitter, the support structure configured to expand outwardly relative to a central longitudinal axis of the elongated tube to move the at least one emitter farther from the central longitudinal axis (e.g. [0033] Fig 5:122/124), wherein the at least one emitter comprises a first emitter and a second emitter (e.g. [0033] Fig 5:120), and wherein lateral expansion of the support structure moves the first emitter and the second emitter laterally away from the longitudinal axis in opposing directions along a first plane intersecting the longitudinal axis (e.g. [0033] Fig 5:120), emitters 120 on the support structure 124 are going in opposing directions).
However, Anderson discloses an intravascular lithotripsy device wherein the emitter assembly further comprising an elongate member that extends along the longitudinal axis through at least a portion of the support structure (e.g.[0268]; [0343] guidewire Figs. 3 and 24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Hawkins to incorporate the teachings of Anderson to have an emitter assembly further comprising an elongate member that extends along the longitudinal axis through at least a portion of the support structure for the purpose of utilizing a known structure of an intravascular lithotripsy that has a guidewire that extends through the structure.
Regarding claim 80, modified Hawkins discloses wherein the at least one emitter is oriented to generate shock waves outwardly from the longitudinal axis (e.g. Hawkins [0033] Fig 5; claim 14)
Regarding claim 88, Hawkins discloses wherein the support structure is formed of a resilient material selected from the group consisting of a metal or a polymeric material (e.g. Hawkins [0034] Fig 5:122/124 nitinol).
Regarding claim 49, Hawkins discloses wherein, prior to expansion, the support structure is in a collapsed state, and after expansion of the support structure, the structure can return to substantially the same configuration in the collapsed state (e.g. Hawkins [0034] Fig 5:122/124 nitinol is known for shape memory and super elasticity).
Regarding claim 90, Hawkins discloses wherein material properties of the support structure bias the support structure in a collapsed state (e.g. Hawkins [0034] Fig 5:122/124 nitinol is known for shape memory and super elasticity ).
Regarding claim 91, Hawkins discloses wherein material properties of the support structure bias the support structure in an expanded state (e.g. Hawkins [0034] Fig 5:122/124 nitinol is known for shape memory and super elasticity).
Allowable Subject Matter
Claims 2-4,9-15, 39-46, 52-71, 73-79, 81-87, and 92-108 allowed.
The prior art fails to teach a catheter wherein the support structure comprises a plurality of segments connected by respective joints (claims 2-4,9-15, 39-46, 52-71),wherein movement of the elongate member causes expansion or change in the diameter of the support structure (claims 73-79, 81-87 and 92-93) one or more springs connected to a proximal end or a distal end of the support structure (claims 94-108).
Claims 2-4,9-15, 39-46, 52-56, 73-79, 81-87 and 92-93 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Laufer (US 6,488,673 B1) teaches a catheter with electrodes that has a center pull wire that extends through the lumen of the catheters and expands the basket shape by pulling on it (e.g. Fig 43C col 28 lines 58-65).
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 JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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Jessandra Hough January 24, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796