DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/23/2026 has been entered.
Response to Amendment
The amendment filed 04/23/2026 has been entered. Claims 1, 6-20 are pending in the application. Claims 10-12 are withdrawn. Applicant’s amendments to the claims have overcome the objections previously set forth in the Office Action mailed 02/23/2026.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1, 6-7 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Lamb (US 3,398,738).
Regarding Claim 1, Lamb discloses a medical device (100, Fig 4), comprising: a catheter (130, Fig 4); a fluid delivery conduit (120, Fig 4) entirely disposed within a portion of the catheter, the catheter having a thermally transmissive region (126, Fig 4) in fluid communication with the fluid delivery conduit; and a rod (122, Fig 4) disposed within at least a portion of the fluid delivery conduit (See Fig 4; Col 8, lines 56-65), wherein the fluid delivery conduit defines a tapered section (tapered distal end of the conduit 120, Fig 4), and the rod is sized to at least partially obstruct the tapered section of the fluid delivery conduit to regulate a flow of a fluid, wherein the rod is configured to be advanced and retracted within the fluid delivery conduit to selectively control fluid flow through the tapered section of the fluid delivery conduit (Col 8, lines 30-55; The rod advances and retracts relative to the fluid delivery conduit. The claim language does not require the fluid delivery conduit to be stationary or that the rod moves relative to the catheter).
Regarding Claim 6, Lamb discloses the thermally transmissive region (126, Fig 4) defines a chamber (interior chamber of tip 126, Fig 4).
Regarding Claim 7, Lamb discloses the fluid delivery conduit (120, Fig 4) further includes an outlet distal opening of tube 120 that receives rod 122), the outlet being in fluid communication with the chamber of the thermally transmissive region (Col 8, lines 30-55).
Claims 15, 16, 20 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Lehmann (US 6,235,019).
Regarding Claim 15, Lehmann discloses a medical device (Device of Fig 31) comprising: a fluid delivery conduit (260, Fig 31) within a delivery manifold (270, Fig 32) in the medical device, the fluid delivery conduit defining a first plurality of openings (262, 264, Fig 32) and the delivery manifold defining a second plurality of openings (272, 274, Fig 31); a distal tip, a first thermally transmissive region (34, Fig 3), and a second thermally transmissive region (32, Fig 3), the first thermally transmissive region being proximate the delivery manifold and the second thermally transmissive region being disposed at the distal tip (Col 11, line 63 – Col 12, line 4; the outer member 250 can have the thermally transmissive elements as taught in the embodiment of Fig 3); and the fluid delivery conduit being movable to a first position and a second position, in the first position the first plurality of openings is substantially aligned with the second plurality of openings to direct fluid toward the first thermally transmissive region (Col 11, lines 51-56; See Fig 31) and in the second position the second plurality of openings are obstructed by the fluid delivery conduit and at least one of the first plurality of openings is positioned outside the delivery manifold to direct the fluid toward the second thermally transmissive region (Col 12, lines 14-18).
Regarding Claim 16, Lehmann discloses the second plurality of openings (272, 274, Figs 33-34) is asymmetrically disposed about a longitudinal axis of the delivery manifold (as seen in Figs 33 and 34, if the tube 270 is split by a plane along the longitudinal axis wherein the openings are only on one side of the plane, they are asymmetrically placed).
Regarding Claim 20, Lehmann discloses an actuator (16, Fig 1), the actuator being in communication with the fluid delivery conduit and movement of the actuator is configured to move the fluid delivery conduit (Col 3, lines 29-53; Col 11, lines 50-62).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 8-9, 13-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Santoianni (US 6,270,476) in view of Avitall (US 5,733,280).
Regarding Claim 8, Santoianni discloses a medical device (10, Fig 1) comprising: a catheter body (18, Fig 1) defining a distal portion (20, Fig 1); a thermally transmissive region (54, Fig 7A) having an outer surface being coupled to the distal portion of the catheter body (Col 6, lines 49-65); and at least one insulator (80, Fig 7) movably coupled to the distal portion of the catheter body, each insulator from the at least one insulator obscuring at least a portion of the outer surface of the thermally transmissive region (Col 10, line 34 - Col 11, line 5).
Santoianni is silent regarding two or more insulators.
Avitall teaches a catheter (52, Fig 2a) having a thermally transmissive region and two or more insulators (54, 56, Fig 2a) movably coupled to the thermally transmissive region, each insulator from the two or more insulators obscuring at least a portion of the outer surface of the thermally transmissive region (Col 9, lines 46-51).
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 insulator to include an additional insulator movably coupled to the thermally transmissive region as taught by Avitall in order to further adjust the ablation pattern (Col 9, lines 46-51).
Regarding Claim 9, the modified invention of Santoianni and Avitall discloses the two or more insulators (54, 56, Fig 2a -Avitall) are movably coupled to thermally transmissive region such that the two or more insulators are movable proximally and distally relative to the thermally transmissive region (Col 10, line 34 - Col 11, line 5 -Santoianni; Col 9, lines 46-51-Avitall).
Regarding Claim 13, the modified invention of Santoianni and Avitall discloses the two or more insulators (54, 56, Fig 2a -Avitall) are composed of a thermally insulating material (Col 10, lines 50-58 – Santoianni; Col 9, lines 46-51-Avitall).
Regarding Claim 14, the modified invention of Santoianni and Avitall discloses the thermally insulating material is flexible (Col 10, lines 50-58 - Santoianni; The insulating material comprises some degree of flexibility as the cited passage considers including a thin layer of metal to achieve sufficient stiffness for varying the position of the sheath).
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehmann (US 6,235,019) in view of Lane (US 2002/0045893).
Regarding Claim 17, Lehmann discloses the first thermally transmissive region (34, Fig 3), however, is silent regarding the region includes an inflatable element.
Lane teaches an analogous device wherein a thermally transmissive region includes an inflatable element (60, Fig 2) (Par 0042).
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 thermally transmissive region to include a balloon as taught by Lane in order to have a device that can displace blood from treatment site to allow for more effective cooling and physically distend the affected vessel to break up accumulations of plaque (Para 0004).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehmann (US 6,235,019) in view of Lehmann (US 6,235,019).
Regarding Claim 18, Lehmann discloses the first thermally transmissive region (34, Fig 3), however, is silent regarding the region includes at least one electrode.
Lehmann, in the embodiment of Fig 25, teaches thermally transmissive region (207, 2088, 209, Fig 25) that comprises at least one electrode (Col 12, lines 19-23).
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 thermally transmissive region to include at least one electrode as taught by Lehmann in order to have a thermal transmitter that can also serve as an electrical conductor (Col 12, lines 19-23).
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehmann (US 6,235,019) in view of Abboud (US 2007/0032783).
Regarding Claim 19, Lehmann discloses all of the elements of the invention as discussed above, however, is silent regarding the fluid delivery conduit includes a radiopaque marker.
Abboud teaches an analogous device wherein the fluid delivery conduit includes a radiopaque marker (M, Fig 1A) (Para 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify fluid delivery conduit to include radiopaque markers as taught by Abboud in order to have a maker that can aid in positioning and tracking of the device (Para 0034).
Response to Arguments
Applicant’s arguments filed 06/23/2026, on pages 6-7, regarding Lamb failing to teach “the rod is configured to be advanced and retracted within the fluid delivery conduit” have been fully considered but is not persuasive. As detailed in the rejection of claim 1 above, Lamb still reads on the claim language because the rod 122 advances and retracts relative to the fluid delivery conduit 120 even though the relative to the catheter, the rod is stationary and the delivery conduit moves. The claim language should specify the fluid delivery conduit is stationary or that the rod moves relative to the catheter to clearly differentiate from Lamb.
Applicant’s arguments filed 06/23/2026, on pages 7-8, regarding Lee failing to teach two or more insulators moveably coupled to the thermally transmissive region have been fully considered but are moot in view of the current rejection that relies on Avitall to teach the amended limitations.
Applicant’s arguments filed 06/23/2026, on pages 8-9, regarding Lehmann failing to teach “in the second position the second plurality of openings are obstructed by the fluid delivery conduit and at least one of the first plurality of openings is positioned outside the delivery manifold to direct fluid toward the second thermally transmissive region” have been fully considered but are not persuasive. As pointed out in the rejection of claim 15 above, Col 12, lines 14-18 of Lehmann describes the arrangement of the second position even though it is not illustrated in the figures.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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