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 .
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 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.
Response to Amendment
The Response filed September 22, 2025 has been entered. Claims 1 and 3-22 are pending in the application. Response to applicant's arguments can be found at the end of this Office action.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 7-10, 13-16, and 18-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moore et al. (U.S. Patent No. 4669465; hereinafter “Moore”).
Regarding claim 1, Moore discloses a catheter system (Figs. 1-2) for use by a user in treating a vascular lesion within or adjacent to a blood vessel within a body of a patient (col. 2, ll. 22-36) , the catheter system comprising:
a catheter shaft (2);
a handle assembly (including catheter manifold unit (12) and fiber advance manifold unit (14); Fig. 2) that is coupled to the catheter shaft, the handle assembly including an assembly housing (including body member (24) and strain relief member (26); annotated Fig. 3 below), the handle assembly being usable by the user to selectively position the catheter shaft near the vascular lesion (such as by manipulating the catheter manifold assembly (12) relative to a guide wire (col. 8, ll. 49-64)); and
a source manifold (combination of luers (70A, 70B, 70C) and connecting tubes (78, 80); Fig. 3; col. 11, ll. 10-38-59) that is positioned substantially within the assembly housing (Fig. 3), the source manifold including a manifold housing (defined by body structures of luers (70A,70B,70C) and connecting tubes (78, 80); Fig. 3) that is distinct from the assembly housing, the manifold housing having at least three ports (annotated Fig. 3 below) formed therein including a catheter shaft port (distal opening of portion (75) of luer (70A) receiving catheter (2) therethrough) that is configured to receive a portion of the catheter shaft so that the catheter shaft is coupled to the manifold housing, and at least two of (annotated Fig. 3 below)
(i) an energy guide port (opening of tubular member (78) receiving laser fiber (16) therethrough) that is configured to receive a portion of an energy guide,
(ii) a guidewire lumen port (proximal opening of portion (75) of luer (70A) receiving catheter (2) therethrough) that is configured to receive a portion of a guidewire lumen, and
(iii) a media inflation port (opening in portion (76) of luer (70A) in fluid communication with catheter (2)) that is configured to receive a portion of an inflation conduit, wherein
wherein the at least three ports are positioned entirely within the assembly housing (annotated Fig. 3 below).
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Regarding claim 3, Moore discloses the system further comprising a pressure sensor (120) that is coupled to the manifold housing (Fig. 5), the pressure sensor being configured to sense a fluid pressure of a catheter fluid within the catheter system (col. 14, ln. 59 – col. 15, ln. 8).
Regarding claim 7, Moore discloses wherein the manifold housing includes a sensor bore (coupling channel (76) to valve (120); Fig. 5), and the pressure sensor is positioned within the sensor bore (Fig. 5).
Regarding claim 8, Moore discloses wherein the manifold housing includes a first housing member (70A) and a second housing member (70B) that is attachable to the first housing member via an attachment assembly (including tubes (78, 80); Fig. 3).
Regarding claim 9, Moore discloses wherein the attachment assembly includes a first attachment member (80) that is coupled to the first housing member (Fig. 3) and a second attachment member (78) that is coupled to the second housing member (Fig. 3), the first attachment member being configured to engage the second attachment member when the first housing member is attached to the second housing member (Fig. 3).
Regarding claim 10, Moore discloses wherein the first attachment member includes an attachment channel (interior of tubing (80); Fig. 3), and the second attachment member includes an attachment projection (portion of tubular member (78) extending into tubing (80); Fig. 3).
Regarding claim 13, Moore discloses the system further comprising a balloon (18) that is coupled to the catheter shaft (Fig. 2), the balloon including a balloon wall that defines a balloon interior (Fig. 2), the balloon being configured to retain a catheter fluid within the balloon interior (col. 10, ln. 68 – col. 11, ln. 4).
Regarding claim 14, Moore discloses the system further comprising a pressure sensor (120) that is coupled to the manifold housing (Fig. 5), the pressure sensor being configured to sense a fluid pressure of the catheter fluid within the balloon interior (col. 14, ln. 59 – col. 15, ln. 8).
Regarding claim 15, Moore discloses the system further comprising an energy guide (16) that is coupled to the source manifold (Fig. 3), the energy guide including a guide distal end that is configured to be positioned within the balloon interior (col. 12, ll. 36-58), the energy guide is configured to guide energy from an energy source through the energy guide and into the balloon interior to generate a plasma bubble in the catheter fluid (e.g., laser fiber (16) is structured to be capable of guiding energy to a catheter fluid to generate a plasma bubble; col. 13, ln. 36- col. 14, ln. 14).
Regarding claim 16, Moore discloses wherein the energy guide includes an optical fiber (16) and the energy source includes a laser (8; Fig. 1; col. 5, ll. 57-59).
Regarding claim 18, Moore discloses wherein the manifold housing includes the energy guide port that receives a portion of the energy guide (annotated Fig. 3 above).
Regarding claim 19, Moore disclose the system further comprising a guidewire lumen (74; Fig. 3), and an inflation conduit (72) that is configured to guide the catheter fluid into the balloon interior (col. 10, ln. 68 – col. 11, ln. 4) and wherein the manifold housing further includes the guidewire lumen port that receives a portion of the guidewire lumen (annotate Fig. 3 above), and the media inflation port that receives a portion of the inflation conduit (annotated Fig. 3 above).
Regarding claim 20, Moore discloses wherein the manifold housing includes a first housing member (70B) and a second housing member (combination of luer (70A) and tubular member (78) Fig. 3) that are selectively attached to one another; and wherein each of the catheter shaft port, the energy guide port, the guidewire lumen port and the media inflation port are formed into the second housing member (annotated Fig. 3 below).
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Regarding claim 21, Moore discloses a method for treating a vascular lesion within or adjacent to a blood vessel within a body of a patient (13, ln. 32 – col. 14, ln. 14), the method including the step of providing the catheter system of claim 1 (see the rejection of claim 1 over Moore above).
Regarding claim 22, Moore discloses wherein the manifold housing has at least four ports formed therein (annotated Fig. 3 below) including the catheter shaft port that is configured to receive the portion of the catheter shaft so that the catheter shaft is coupled to the manifold housing, and each of (i) the energy guide port that is configured to receive a portion of an energy guide, (ii) the guidewire lumen port that is configured to receive a portion of a guidewire lumen, and (iii) the media inflation port that is configured to receive a portion of an inflation conduit.
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Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Moore in view of Abele et al. (U.S. Patent No. 5496311; hereinafter “Abele”).
Regarding claim 4, Moore discloses the invention substantially as claimed, except for the handle assembly including circuitry electrically coupled to the pressure sensor.
Abele, a reference in the vascular catheter field of endeavor, teaches providing a catheter system with a pressure sensor (9) coupled with a handle assembly, the pressure sensor being configured to sense a fluid pressure of a catheter fluid within the catheter system (Figs. 1-2; col. 8, ll. 46-67), wherein the handle assembly further includes circuitry (56) that is electrically coupled to the pressure sensor (col. 8, ll. 46-65) to allow the catheter system to adapt balloon pressure to tissue response when treating a patient (col. 2, ll. 14-25).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the catheter system with a pressure sensor that is coupled to the manifold housing, the pressure sensor being configured to sense a fluid pressure of a catheter fluid within the catheter system and provide the handle assembly with circuitry that is electrically coupled to the pressure sensor, in view of Abele, in order to improve blood vessel dilation during treatment by allowing the catheter system to adjust the balloon’s volume as the blood vessel responds to the treatment.
Regarding claim 5, the modified system discloses the invention substantially as claimed, except for the circuitry including a printed circuit board.
Applicant has not traversed the Examiner’s assertion of official notice in the previous Office action. As such, the assertion that providing circuitry on a printed circuit board was well known in the art before the effective filing date of the claimed invention is taken to be admitted prior art. See MPEP §2144.03(C).
It would have been an obvious matter of design choice to have the circuitry include a printed circuit board, since applicant has not disclosed that a printed circuit board solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the modified catheter system.
Regarding claim 6, Abele teaches wherein the handle assembly further includes an energy activator (including internal wiring and microprocessor elements for controlling the apparatus; col. 8, ll. 65-67) that is coupled to the circuitry, the energy activator being configured to activate the catheter system (col. 8, ll. 46-67).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Moore.
Regarding claim 11, Moore disclose the invention substantially as claimed, except for the first attachment member (80) and the second attachment member (78) being attached to one another with an adhesive material.
However, Moore teaches utilizing adhesive cement to bond attachment members (col. 9, ll. 54-57).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the first attachment member and the second attachment member be attached to one another with an adhesive material, in view of Moore, in order to provide a strong bond between the attachment members to prevent separation of the attachment members during use.
Regarding claim 12, Moore discloses the invention substantially as claimed, except for the first attachment member (80) and the second attachment member (78) being ultrasonically sealed to one another.
However, Moore teaches utilizing ultrasonic sealing to bond attachment members (col. 9, ll. 54-57).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the first attachment member and the second attachment member be ultrasonically sealed to one another, in view of Moore, in in order to provide a strong bond between the attachment members to prevent separation of the attachment members during use.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Moore in view of Adams et al. (U.S. Patent No. 9138249; hereinafter “Adams”).
Regarding claim 17, Moore discloses the invention substantially as claimed, except for the energy guide including an electrode pair.
Adams, a reference in the vascular catheter field of endeavor, teaches providing a catheter system (11) with an energy guide including an electrode pair having spaced apart electrodes (26, 28) that extend into a balloon (14) interior (Fig. 1), and an energy source that is a high voltage energy source (30; Fig. 2) that provides pulses of high voltage energy to the energy guide to generate an electrical arc across the electrodes (col. 3, ln. 57 – col. 4, ln. 8) to break up plaque around the balloon (col. 4, ll. 9-27).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the catheter system with an energy guide includes an electrode pair having spaced apart electrodes that extend into the balloon interior, and an energy source is a high voltage energy source that provides pulses of high voltage energy to the energy guide to generate an electrical arc across the electrodes, in view of Adams, in order to facilitate treating a patient’s blood vessels by allowing the catheter system to break up plaque around the balloon for removal.
Response to Arguments
Applicant's arguments filed September 22, 2025 have been fully considered but they are not persuasive.
On pages 6-7 of the Response, Applicant argues that the prior art does not disclose “wherein the at least three ports are positioned entirely within the assembly housing,” as recited in claim 1. This argument is not persuasive.
Under the new interpretation of Moore, the catheter shaft port, media inflation port, guidewire lumen port, and energy port are positioned within the assembly housing that includes body member (24) and strain relief member (26), as can be seen in annotated Fig. 3.
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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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771