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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 06/22/2026. Claims 1 and 13 are amended. Claims 1-21 are currently pending.
The objection of claim 1 has been withdrawn due to applicant’s amendment.
The objection of claim 13 is maintained; see below.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/22/2026, with respect to the rejection(s) of claim(s) 1-9 under 35 U.S.C. 102(a)(1) as being anticipated by Anderson; claim 10 under 35 U.S.C. 103 as being unpatentable over Anderson in view of Cioanta; and claims 11-12 under 35 U.S.C. 103 as being unpatentable over Anderson in view of Beach, have been fully considered and are persuasive, in combination with the amendments to the claims. Therefore, the rejection has been withdrawn.
Applicant’s arguments with respect to the rejection of claims 13-20 under 35 U.S.C. 102(a)(1) as being anticipated by Anderson; and claim 21 under 35 U.S.C. 103 as being unpatentable over Anderson in view of Beach, 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 Anderson does not disclose the emitters configured to emit waves toward the distal port of the device (Remarks, pgs. 8 and 10).
In response to applicant’s argument, it is respectfully submitted Anderson discloses reflector 2702 being semi-circular and extending proximally and distally, such that a semi-circular shape is considered to reflect waves in proximal and distal directions due to the shape of the reflector (e.g. waves reflected at angles would include proximal and distal components). Further, para. [0361] of Anderson describes the material of the balloon being strategically varied to provide for directionally targeted wave emission, such that a wave redirected by the half-moon shape of the reflector would be considered to have a proximal and distal component to some degree, and the direction of impact of the wave can be changed based on the location of the intended target.
Claim Objections
Claims 3, 11, 13, 17 and 21 are objected to because of the following informalities:
In claim 3, lines 2-3, the phrase “a longitudinal axis of the housing” should read “the longitudinal axis of the housing”.
In claim 11, line 3, the phrase “a longitudinal axis of the housing” should read “the longitudinal axis of the housing”.
In claim 13, line 8, the phrase “first insulated wire comprises a second exposed portion” should read “second insulated wire comprises a second exposed portion”.
In claim 17, the phrase “a longitudinal axis of the housing” should read “the longitudinal axis of the housing”.
In claim 21, the phrase “a longitudinal axis of the housing” should read “the longitudinal axis of the housing”.
Appropriate correction is required.
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.
Claim 2 is 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.
Regarding claim 2, the claim recites “wherein at least one of the first exposed portion or the second exposed portion faces away from the distal end of the housing”. Amended claim 1 now recites the first exposed portion facing opposite from the distal end of the housing (lines 7-8) and the second exposed portion facing opposite from the distal end of the housing (lines 13-14), such that claim 2 fails to further limit the claim limitations of claim 1, which already recites the first and second exposed portions facing away from the distal end.
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
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 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(s) 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson (US 2022/0287732 A1) (all references previously of record).
Regarding claim 13, Anderson discloses (see abstract; paras. [0078]-[0370]; figs. 1-29b) an intravascular lithotripsy device configured to modify vascular plaque (paras. [0256] and [0260]; fig. 1), comprising:
a housing (110, para. [0261]) configured to hold a fluid (para. [0261]), the housing comprising a distal end along a longitudinal axis of the housing (fig. 1);
a first insulated wire (406a, considered to be insulated within 412 which includes insulating materials, paras. [0270] and [0272]; fig. 4b) at least partially housed within the housing (fig. 1), wherein the first insulated wire comprises a first exposed portion (includes 402a) positioned within the housing (emitter array positioned within balloon, figs. 1 and 3); and
a second insulated wire (406b, considered to be insulated within 412 which includes insulating materials, paras. [0270] and [0272]; fig. 4b) at least partially housed within the housing (fig. 1), wherein the first insulated wire comprises a second exposed portion (includes 402c, fig. 4b) positioned within the housing (emitter array positioned within balloon, figs. 1 and 3), wherein the first exposed portion and the second exposed portion are configured to form a spark (at spark gaps 404a and 404b, fig. 4b) adjacent to the distal end of the housing (considered to be adjacent to the distal end of the balloon due to being located within the balloon, fig. 1) responsive to an energy differential between the first exposed portion and the second exposed portion exceeding a threshold (resulting spark, para. [0270]), wherein the spark is configured to induce sonic waves configured to travel through the fluid along the longitudinal axis of the housing (spark gap extends along longitudinal axis, fig. 4a) and perpendicular to a circumference of the housing (pressure waves propagate radially outward, considered to travel perpendicular relative to a circumference of the balloon, paras. [0262] and [0270]; fig. 3),
wherein at least one of the first exposed portion or the second exposed portion faces away from the distal end of the housing (extends circumferentially, considered to encompass portions facing away from the distal end of the balloon, figs. 1-4b).
Regarding claim 14, Anderson discloses the intravascular lithotripsy device of claim 13. Anderson further discloses further comprising a reflective surface (2702, which may include electrodes 402, paras. [0358]-[0360]; fig. 27) positioned proximal to the first exposed portion and the second exposed portion (extends proximally and distally, considered to encompass a proximal position, para. [0357]), wherein the reflective surface is configured to reflect the sonic waves toward the distal end (reflects pressure waves circumferentially and extends proximally and distally, considered to encompass reflecting waves in a distal direction, paras. [0357] and [0359]).
Regarding claim 15, Anderson discloses the intravascular lithotripsy device of claim 13. Anderson further discloses wherein the first exposed portion is at a proximally facing end of the first insulated wire (wire 406a extends longitudinally such that a longitudinal end/side of the wire is considered to have a proximally facing component, as the limitation does not specify the specific end of the wire, and further, the device could be oriented in a different way such that the longitudinal end of the wire is proximally facing, and therefore, 402a would be positioned at a proximally facing end of 406a, figs. 4a-b and 7a), wherein the second exposed portion is at a proximally facing end of the second insulated wire (wire 406b extends longitudinally such that a longitudinal end/side of the wire is considered to have a proximally facing component, as the limitation does not specify the specific end of the wire, and further, the device could be oriented in a different way such that the longitudinal end of the wire is proximally facing, and therefore, 402c would be positioned at a proximally facing end of 406b, figs. 4a-b and 7a), wherein the spark is configured to induce the sonic waves to travel proximally through the fluid away from the distal end (waves travel circumferentially which encompasses proximal travel of the waves, para. [0359]).
Regarding claim 16, Anderson discloses the intravascular lithotripsy device of claim 13. Anderson further discloses wherein the first exposed portion faces the second exposed portion (at sides, see figs. 4b and 7a).
Regarding claim 17, Anderson discloses the intravascular lithotripsy device of claim 13. Anderson further discloses wherein the first exposed portion and the second exposed portion are configured to form the spark across a longitudinal axis of the housing (spark gap extends longitudinally, considered to encompass forming a spark across a longitudinal component of the balloon, figs. 4a-b).
Regarding claim 18, Anderson discloses the intravascular lithotripsy device of claim 13. Anderson further discloses wherein the first exposed portion and the second exposed portion are configured to form the spark independently from forming another spark (multiple spark gaps, para. [0273]).
Regarding claim 19, Anderson discloses the intravascular lithotripsy device of claim 13. Anderson further discloses wherein the first insulated wire is curved adjacent to the first exposed portion (extends along circumference, considered to be curved, fig. 4b).
Regarding claim 20, Anderson discloses the intravascular lithotripsy device of claim 13. Anderson further discloses further comprising: an irrigation lumen (320, which delivers fluid to balloon and is therefore considered an irrigation lumen, para. [0267]) positioned at least partially within the housing (fig. 3) and configured to conduct the fluid through the housing toward the distal end to flush a vicinity of a spark gap to inhibit gasses from accumulating in the vicinity of the spark gap and interfering with the sonic waves (considered to conduct fluid through balloon via inflation and capable of flushing spark gap locations as inflation fluid is moved through balloon, such that the functional limitation of inhibiting gasses from accumulating and interfering with sonic waves is considered to be accomplished, para. [0259]).
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.
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) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Beach (US 2023/0405268 A1).
Regarding claim 21, Anderson discloses the intravascular lithotripsy device of claim 13.
Anderson further discloses further comprising: a guidewire sheath (420, para. [0275]; fig. 4b) configured to guide the intravascular lithotripsy device along a guidewire (para. [0268]).
However, Anderson fails to disclose wherein the guidewire sheath is offset from a longitudinal axis of the housing.
Beach teaches (para. [0136]; figs. 17-21), in the same field of endeavor, an intravascular lithotripsy device (abstract) comprising a guidewire sheath (513) offset from a longitudinal axis of a housing (offset from 520, fig. 21), for the purpose of providing a rapid exchange lumen for a guidewire for the device (para. [0142]).
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 guidewire sheath of Anderson to be located offset from the balloon, as taught by Beach, in order to provide the capability of rapid exchange of the guidewire, based on the suggestions and teachings of Beach (para. [0142]).
Allowable Subject Matter
Claims 1 and 4-10 are allowed.
Claims 2-3 and 11-12 would be allowable if rewritten to overcome the objections and rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding base claim 1, the closest prior art of record cited to Anderson fails to disclose the newly added limitations, specifically the configuration of the first and second insulated wires, each including exposed portions facing opposite from the distal end along the longitudinal axis of the housing. Further, Anderson does not disclose the first insulated wire comprising a third portion including a turn as claimed.
Additional references including Crowley (US 2001/0003800 A1) teach a pair of electrodes facing each other (fig. 5a), but fails to teach the electrodes facing opposite to the distal end as claimed. Betelia (US 2018/0098779 A1) teaches turns in a shock wave applicator (fig. 1c), but does not teach the exposed portions facing opposite from the distal end as claimed.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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