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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 7/21/2026 is acknowledged.
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) 1, 2, 6-11, 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US 2021/0085348).
Regarding claim 1, Nguyen discloses a catheter system for treating an occlusion in a body lumen (page 1, para. 0002), the catheter system comprising a catheter 200 including: an elongated tube and an electrode assembly 202 (page 3, para. 0040; fig. 2A); the elongated tube comprising a first lumen 204 and a second lumen 210; the first lumen being configured to receive a guidewire (page 3, para. 0040); the second lumen having the electrode assembly disposed therein (page 3, para. 0041; fig. 2A); and the electrode assembly comprising a first cylindrical electrode (page 4, para. 0053: inner wire), an insulating layer arranged around the first cylindrical electrode (page 4, para. 0053: insulated layer around wire), and a second cylindrical electrode arranged around the insulating layer (page 4, para. 0053: outer electrode), the first cylindrical electrode and the second cylindrical electrode being electrically connected to a power source (fig. 3; page 2, para. 0035: positive and negative ports of a voltage generator), where when a voltage pulse is applied across the first cylindrical electrode and the second cylindrical electrode, current flows across an arcing region between the first cylindrical electrode and the second cylindrical electrode to generate one or more cavitation bubbles (page 2, para. 0031).
Regarding claim 2, Nguyen discloses that the elongated tube further comprises a third lumen 208, where the third lumen is configured to be an aspiration lumen (page 3, para. 0041).
Regarding claim 6, Nguyen discloses that the arcing region is located between a distal edge of the first cylindrical electrode and a distal edge of the second cylindrical electrode (fig. 4).
Regarding claim 7, Nguyen discloses that the catheter further comprises an atraumatic tip 230 arranged around the distal end of the catheter (fig. 2B).
Regarding claim 8, Nguyen discloses that the atraumatic tip 230 has a circumferential configuration (fig. 2B).
Regarding claim 9, Nguyen discloses a dual-pump module comprising an infusion pump and an aspiration pump (pages 3-4, para. 0047), wherein the second lumen is in fluid communication with the infusion pump (page 3, para. 0042), wherein an aspiration lumen is in fluid communication with the aspiration pump (page 3, para. 0044), and wherein the dual-pump module is in operational communication with the power source (page 3, para. 0042). The limitation “such that before a cycle of voltage pulses is applied across the first cylindrical electrode and the second cylindrical electrode the infusion pump will begin operation, and such that after the cycle of voltage pulses are concluded the aspiration pump will continue to operate for a period of time” is interpreted to be an intended use limitation. The pumps of Nguyen are capable of being operated as claimed.
Regarding claim 10, Nguyen discloses a catheter system for treating an occlusion in a body lumen (page 1, para. 0002), the catheter system comprising a catheter 200 comprising: an elongated tube (fig. 2A); a peripheral electrode disposed within the elongated tube (fig. 2A; page 4, para. 0053: outer electrode); an electrode assembly disposed within the peripheral electrode (fig. 2A; page 3, para. 0041), the electrode assembly comprising an electrode layer and an insulating layer (page 3, para. 0041: insulated wire); and a guidewire lumen 204 configured to receive a guidewire and disposed within the electrode assembly; where the peripheral electrode and the electrode layer of the electrode assembly are each electrically connected to a power source (fig. 3; page 2, para. 0035: positive and negative ports of a voltage generator), where when a voltage pulse is applied across the electrode layer and the peripheral electrode, current flows across an arcing region between the electrode layer and the peripheral electrode to generate one or more cavitation bubbles (page 2, para. 0031).
Regarding claim 11, Nguyen discloses that the peripheral electrode is a cylindrical electrode sheath (page 3, para. 0041; fig. 4).
Regarding claim 14, Nguyen discloses that the catheter further comprises an atraumatic tip 230 arranged around the distal end of the catheter (fig. 2B).
Regarding claim 15, Nguyen discloses that the atraumatic tip 230 has a circumferential configuration (fig. 2B).
Regarding claim 16, Nguyen discloses a dual-pump module comprising an infusion pump and an aspiration pump (pages 3-4, para. 0047), wherein the second lumen is in fluid communication with the infusion pump (page 3, para. 0042), wherein an aspiration lumen is in fluid communication with the aspiration pump (page 3, para. 0044), and wherein the dual-pump module is in operational communication with the power source (page 3, para. 0042). The limitation “such that before a cycle of voltage pulses is applied across the first cylindrical electrode and the second cylindrical electrode the infusion pump will begin operation, and such that after the cycle of voltage pulses are concluded the aspiration pump will continue to operate for a period of time” is interpreted to be an intended use limitation. The pumps of Nguyen are capable of being operated as claimed.
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.
Claim(s) 3, 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen.
Claim 3 calls for the third lumen to be D-shaped. Nguyen shows the third lumen 208 having an oblong shape (fig. 2A), but fails to specifically disclose that the lumen is D-shaped. Applicant has not disclosed that having a D-shaped lumen serves any advantage or particular purpose or solves a stated problem. Furthermore, one of ordinary skill in the art would expect the third lumen of Nguyen to perform equally well having either the shown shape or a D-shape because either provides a lumen for a catheter having an overall minimal diameter. Therefore, 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 third lumen of Nguyen to have a D-shape because such a modification is considered to be a mere design consideration which fails to patentably distinguish over the prior art of Nguyen.
Regarding claim 4, Nguyen discloses a fourth lumen 206 that is similar in size to the first lumen 204 (fig. 2A). Claim 4 further calls for the fourth to be located within the elongated tube in a position symmetrical to the first lumen. Nguyen discloses that the fourth lumen 206 is arranged across from the first lumen 204, but not that the lumens are symmetrical. Applicant has not disclosed that having the first and fourth lumens arranged symmetrical to each other serves any particular advantage or particular purpose or solves a stated problem. Furthermore, one of ordinary skill in the art would expect the catheter of Nguyen to perform equally well with the lumens arranged in any configuration. Therefore, 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 fourth lumens of Nguyen to be arranged symmetrically because doing so would have been a matter of obvious design choice which fails to patentably distinguish over the prior art of Nguyen.
Claim(s) 5, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Sypal et al (US 5,152,767).
Claim 5 differs from Nguyen in calling for the insulating layer to be formed of a ceramic or of a polymeric layer covered with a ceramic material. Sypal teaches a lithotripter including electrodes having an insulating member interposed between the electrodes (abstract) and further that the insulating member is formed from ceramic (col. 6, lines 11-12). 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 insulating member of Nguyen to be formed of ceramic as taught by Sypal because ceramic is a suitable non-reactive material that provides insulation between lithotripic electrodes.
Claim 12 differs from Nguyen in calling for the insulating layer to be formed of a ceramic or of a polymeric layer covered with a ceramic material. Sypal teaches a lithotripter including electrodes having an insulating member interposed between the electrodes (abstract) and further that the insulating member is formed from ceramic (col. 6, lines 11-12). 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 insulating member of Nguyen to be formed of ceramic as taught by Sypal because ceramic is a suitable non-reactive material that provides insulation between lithotripic electrodes.
Allowable Subject Matter
Claim 13 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach or fairly suggest a portion of the guidewire lumen being formed of a ceramic or a portion of the guidewire lumen being covered with a ceramic material, in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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