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
In response to the amendment filed on 03/30/2026, No Claims have been cancelled, and Claims 1-33 are pending. In view of the claim amendments, the previous 112(b) rejection of Claim 21 has been obviated.
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive.
Applicant argues, on Page 9, Nguyen fails to disclose “the elongate body having a distal portion to which the one or more shock wave emitters are mounted, wherein a distal end of the distal portion of the elongate body is configured to vibrate from shockwaves produced by the one or more shockwave emitters”, however the Examiner respectfully disagrees.
As Applicant and the Examiner discussed in the interview, the elongate body, in the claims, can be interpreted to be element 130, element 140, element 154, and element 156 since they are a unitary structure (See Figure 2, annotated below). The proximal and distal portions are outlined in the annotated Figure 2 below.
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In this interpretation, one can clearly see that shockwave emitters (160) are mounted to and over the distal portion of the elongate body at element 154. Applicant has not stated in the claims that the emitters are directly in contact with the distal portion of the elongate body. The claims only require “the elongate body having a distal portion to which the emitters are mounted.” It is the Examiner’s position that Nguyen does teach the elongate body has a distal portion (see Figure 2 above) to which the emitters are mounted, and at the very least, the emitters are mounted over the distal portion of the elongate body as seen in Figure 2. Should Applicant want the claims to be interpreted that the emitters are in direct contact with a distal portion of the elongate body, the claims should be amended as such.
In another interpretation, see the conclusion paragraph which introduces newly discovered relevant prior art documents which would also read on the newly added claim amendments.
As to Applicant’s arguments directed to the dependent claims as being patentable due to their dependency to Claim 1, 22 and 31, the rejection of Claims 1, 22 and 31 is being maintained in light of the teachings of Nguyen, Applicant has not separately argued the patentability of the dependent claims. Thus, the dependent claims are also being rejected.
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.
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) 1-9, 12-20, 22, 23, 25, 26, and 28-33 is/are rejected under 35 U.S.C. 102(b) as being anticipated by Nguyen (US PGPub 2023/0107690).
Regarding Claim 1, Nguyen teaches a catheter for treating occlusions in a body lumen, the catheter comprising:
a catheter enclosure (120; Figures 2-3; Paragraph 0043)
one or more shock wave emitters (160; Figures 2-3; Paragraph 0043) enclosed within the catheter enclosure (120; Figures 2-3; Paragraph 0043); and
an elongated body (130/140/154; Figures 2-3; Paragraph 0043) that extends to at least a distal end (124) of the catheter enclosure (120; Figure 3; Paragraph 0043), the elongate body (130) having a distal portion (the distal portion is the portion of element 154 which is more distal to cylinder element 152 and the proximal portion is the 156 which is inside cylinder element 152) to which the one or more shockwave emitters (160) are mounted (see Figures 2-3), wherein a distal end (135) of the distal portion of the elongated body (130) is configured to vibrate from shock waves produced by the one or more shock wave emitters (160; see Paragraph 0043 and see Figures 2-3 which show the vibrations) to deliver mechanical forces to an occlusion (1102) in the body lumen (1104; See Figures 11A-11B).
Regarding Claim 2, Nguyen teaches the catheter of claim 1, wherein the distal end (135) of the elongated body (130) extends distally past the distal end (124) of the catheter enclosure (120).
Regarding Claim 3, Nguyen teaches the catheter of claim 1, wherein the distal end (124) of the catheter enclosure (120) is sealed (125) to the distal end (135) of the elongated body (130; Figures 2-3; Paragraph 0051).
Regarding Claim 4, Nguyen teaches the catheter of claim 1, wherein the catheter enclosure (120) comprises an angioplasty balloon (Paragraph 0048).
Regarding Claim 5, Nguyen teaches the catheter of claim 4, wherein the catheter enclosure (120) forms a closed volume around the elongated body (130) (via seal 130 and also Paragraph 0048 reads on the claims when the enclosure is a flexible material which is inflatable).
Regarding Claim 6, Nguyen teaches the catheter of claim 1, wherein the catheter enclosure (120) comprises an opening (125) adjacent to one or more of the shock wave emitters (160; Figures 2-3; see also Paragraph 0051).
Regarding Claim 7, Nguyen teaches the catheter of claim 6, wherein the opening (125) is disposed in at least a tapered region (125) of the catheter enclosure (120; Figures 2-3) (see also 570 in Figures 5A-5C which comprises an opening for the elongate body (530)).
Regarding Claim 8, Nguyen teaches the catheter of claim 6, wherein the opening comprises a slit in (long openings in the outside surface formed by the splines/ridges; Paragraph 0059; Figure 5B), the slit (openings between ridges) longitudinally aligned with a longitudinal axis of the elongated body (530) (see Figure 5B).
Regarding Claim 9, Nguyen teaches the catheter of claim 1, wherein the elongated body (130) comprises a guide wire lumen (Paragraph 0052).
Regarding Claim 12, Nguyen teaches the catheter of claim 9, wherein vibration of the distal end (135) of the elongated body (130) causes a guide wire (30) in the guide wire lumen to vibrate in conjunction with the distal end (135) of the elongated body (130) (Paragraph 0052; it’s the Examiners position that since the guidewire is within the lumen of the elongated body and the elongated body is vibrating, then the guidewire will vibrate with the elongate body; see also Paragraph 0088).
Regarding Claim 13, Nguyen teaches the catheter of claim 1, wherein the elongated body (130) comprises a polymeric material (Paragraph 0055).
Regarding Claim 14, Nguyen teaches the catheter of claim 1, wherein the elongated body (130) comprises a first material (Paragraph 0055; PEEK), wherein the catheter enclosure (120) comprises a second material (Paragraph 0046; PEBAX), and wherein the first material (PEEK) is more rigid than the second material (PEBAX).
Regarding Claim 15, Nguyen teaches the catheter of claim 1, wherein the one or more shock wave emitters (Paragraph 0072) comprises an electrode pair (Paragraph 0072).
Regarding Claim 16, Nguyen teaches the catheter of claim 15, wherein a first electrode (164) of the electrode pair comprises a conductive sheath (162) disposed around at least a portion of the elongated body (130; Paragraph 0053 states that impactor 130 passes through the deflector and to the centering mechanism (150) and thus would be disposed inside the conductive sheath (162) (Paragraph 0053; Figure 2-3).
Regarding Claim 17, Nguyen teaches the catheter of claim 16, wherein a second electrode of the electrode pair comprises a distal end of a conductive wire (Paragraph 0100; Figure 8).
Regarding Claim 18, Nguyen teaches the catheter of claim 1, wherein the one or more shock wave emitters comprises an optical fiber (Paragraph 0085).
Regarding Claim 19, Nguyen teaches the catheter of claim 1, wherein the one or more shock wave emitters comprises a first shock wave emitter and a second shock wave emitter (Paragraph 0072-0073).
Regarding Claim 20, Nguyen teaches the catheter of claim 19, wherein the second shock wave emitter is no greater than 90 degrees apart from the first shock wave emitter relative to a circumference of the elongated body (Paragraph 0082).
Regarding Claim 22, Nguyen teaches a method of treating an occlusion in a body lumen (Paragraph 0087-0089), the method comprising:
inserting a catheter into the body lumen (see Figure 1; Paragraph 0087), the catheter comprising:
one or more shock wave emitters enclosed within the catheter enclosure; and
an elongated body that extends to at least a distal end of the catheter enclosure;
a catheter enclosure (120; Figures 2-3; Paragraph 0043)
one or more shock wave emitters (160; Figures 2-3; Paragraph 0043) enclosed within the catheter enclosure (120; Figures 2-3; Paragraph 0043); and
an elongated body (130; Figures 2-3; Paragraph 0043) that extends to at least a distal end (124) of the catheter enclosure (120; Figure 3; Paragraph 0043), the elongate body (130) having a distal portion (the distal portion is the portion of element 154 which is more distal to cylinder element 152 and the proximal portion is the 156 which is inside cylinder element 152) to which the one or more shockwave emitters (160) are mounted (see Figures 2-3);
advancing the catheter within the body lumen until the distal end of the elongated body is positioned proximate to the occlusion (Paragraph 0087 and 0089); and
applying energy to the one or more shock wave emitters (160) to generate shock waves at the one or more shock wave emitters (160; Paragraph 0089), wherein a distal end of the distal portion of the elongated body (130) is configured to vibrate from the shock waves to deliver mechanical forces to the occlusion (Paragraph 0089) (See also Figures 2-3 and Figures 11A-11B).
Regarding Claim 23, Nguyen teaches the method of claim 22, wherein the catheter enclosure (120) comprises an opening (125) adjacent to one or more of the one or more shock wave emitters (160; Figures 2-3; see also Paragraph 0051).
Regarding Claim 25, Nguyen teaches the method of claim 24, wherein applying energy to the one or more shock wave emitters comprises applying a voltage to one or more of the one or more shock wave emitters (Paragraph 0080).
Regarding Claim 26, Nguyen teaches the method of claim 25, wherein applying energy to the one or more shock wave emitters comprises applying a series of voltage pulses to one or more of one or more the shock wave emitters (Paragraph 0080).
Regarding Claim 28, Nguyen teaches the method of claim 22, wherein applying energy to the one or more shock wave emitters comprises applying laser energy to one or more of the one or more shock wave emitters (Paragraph 0085).
Regarding Claim 29, Nguyen teaches the method of claim 22, wherein the elongated body (130) comprises a guide wire lumen (Paragraph 0052)., and wherein inserting the catheter into the body lumen comprises: inserting a guide wire into the body lumen; and inserting the catheter into the body lumen over the guide wire (Paragraph 0088).
Regarding Claim 30, Nguyen teaches the method of claim 29, wherein the vibration of the distal end of the elongated body causes the guide wire to vibrate in conjunction with the distal end of the elongated body such that the guide wire also delivers mechanical forces to treat the occlusion (Paragraph 0088 discloses leaving the guidewire in the impactor/elongate body during treatment and thus the guidewire will vibrate in conjunction with the impactor/elongate body).
Regarding Claim 31, Nguyen teaches a system for treating occlusions in a body lumen, the system comprising:
a catheter comprising:
a catheter enclosure (120; Figures 2-3; Paragraph 0043)
one or more shock wave emitters (160; Figures 2-3; Paragraph 0043) enclosed within the catheter enclosure (120; Figures 2-3; Paragraph 0043); and
an elongated body (130; Figures 2-3; Paragraph 0043) that extends to at least a distal end (124) of the catheter enclosure (120; Figure 3; Paragraph 0043), the elongate body (130) having a distal portion (the distal portion is the portion of element 154 which is more distal to cylinder element 152 and the proximal portion is the 156 which is inside cylinder element 152) to which the one or more shockwave emitters (160) are mounted (see Figures 2-3)
wherein a distal end (135) of distal portion the elongated body (130) is configured to vibrate from shock waves produced by the one or more shock wave emitters (160; see Paragraph 0043 and see Figures 2-3 which show the vibrations) to deliver mechanical forces to an occlusion (1102) in the body lumen (1104; See Figures 11A-11B); and
an energy generator (28; Figure 1) configured to deliver energy to one or more of the one or more shock wave emitters (160) to generate the shock waves (Paragraph 0041 and Paragraph 0080).
Regarding Claim 32, Nguyen teaches the system of claim 31, wherein the one or more shock wave emitters (160) comprises one or more electrode pairs (Paragraph 0089), and wherein the energy generator (28) is configured to deliver a voltage to the one or more shock wave emitters (Paragraph 0080).
Regarding Claim 33, Nguyen teaches the system of claim 31, wherein the one or more shock wave emitters (160) comprises one or more optical fibers (Paragraph 0085), and wherein the energy generator is configured to deliver laser energy to the one or more optical fibers (Paragraph 0089).
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.
Claim(s) 10, 11, 21 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US PGPub 2023/0107690) as applied to claim 26 above, and further in view of Phan (US PGPub 2021/0085347).
Regarding Claims 10-11, Nguyen teaches the catheter of claim 9, but fails to disclose wherein the guide wire lumen is sized to receive a 0.014” diameter guide wire or the diameter of the guide wire lumen is at least 0.0141”. Nguyen teaches that a guidewire “lumen sized to receive a guidewire” (Paragraph 0039, 0042, 0052, 0057) but fails to disclose particular sizes.
Phan teaches catheter for treating a lesion (abstract; Figure 1) wherein the guide wire lumen is sized to receive a 0.014” diameter guide wire or the diameter of the guide wire lumen is at least 0.0141” (Paragraph 0065 and 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the size of the guidewire lumen taught by Nguyen to have the sizes claimed, as taught by Phan, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984). (See MPEP 2144.04)
Regarding Claim 21, Nguyen teaches the catheter of claim 19, but fails to disclose wherein the second shock wave emitter is approximately 60 degrees apart from the first shock wave emitter relative to the circumference of the elongated body.
Phan teaches catheter for treating a lesion (abstract; Figure 1) comprising a plurality of electrode pairs (Paragraph 0093), wherein the plurality of electrode pairs are spaced circumferentially in consistent increments such as 180 degrees, 90 degrees, or 60 degrees apart (Paragraph 0093).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of Nguyen such that the second shock emitter is approximately 60 degrees apart from the first shock wave emitter, as taught by Phan, for the advantage of generating shockwaves more evenly around the catheter (Paragraph 0093).
Regarding Claim 27, Nguyen teaches the method of claim 26, but fails to disclose wherein the series of voltage pulses are applied at a frequency between 4 Hz and 8 Hz. Nguyen teaches that the frequency is between 10-100hz.
However, Phan teaches a legion crossing shock wave catheter (see Figure 1A; abstract), wherein the series of voltage pulses are applied at a frequency between 4 Hz and 8 Hz in that Phan teaches the applied pulses may be between 1 hz and 10 hz, however Phan teaches “the preferred voltage and repetition rate may vary depending on, e.g., the size of the lesion, the extent of calcification, the size of the blood vessel, the attributes of the patient, or the stage of treatment.” in Paragraph 0054.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of Nguyen with the frequency teachings of Phan as applicant appears to have placed no criticality on the claimed range (see pp. [0047 of instant specification pgpub] indicating the frequency “may” be within the claimed range (4-8 hz) or can be between 1-10 hz or 100hz to 10 khz) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Allowable Subject Matter
Claim 24 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.
Claim 24: The prior art of record fails to disclose wherein the opening is configured to open responsive to the generation of a shock wave, and wherein the opening is configured to close after termination of a shock wave
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Grace (US PGPub 2016/0184022) teaches, in Paragraph 0099, a pressure wave emitting catheter “wherein the means for directing laser light emitted from the emitter towards the guidewire lumen or a guidewire within the guidewire lumen induces vibrations within the guidewire.” Furthermore, see Paragraph 0309-0311 and Figures 13 and 20, which shows the elongate body (1620) having a distal portion to which the shock wave emitters (1616) are mounted to vibrate a distal end of the distal portion of the elongated body (1620). The guidewire does extend back proximally towards the handle at a proximal portion.
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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