DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed 10/24/2025 has been entered. Claims 1, 3, 5-20 are pending in the application. Claims 10-12 are withdrawn. Applicant’s amendments to the claims have overcome the 112(d) rejection previously set forth in the Non-final Office Action mailed 07/28/2025.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9: On line 3, “two or more insulators is” is grammatically incorrect and should recite “two or more insulators are”.
Appropriate correction is required.
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, 3, 5-7 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).
Regarding Claim 3, Lamb discloses a fluid, the rod (122, Fig 4) being a solid rod that is sized to at least partially obstruct a portion of the fluid delivery conduit to regulate a flow of the fluid (Col 8, lines 30-55).
Regarding Claim 5, Lamb discloses the rod (122, Fig 4) may be advanced and retracted within the fluid delivery conduit to selectively control fluid flow through the fluid delivery conduit (Col 8, lines 30-55).
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 (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 plurality of first openings is positioned outside the delivery manifold (Col 11, lines 57-62; the openings are positionable in any number of locations relative to one another, thus, the device is capable of moving to the second position).
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 Lee (US 6,235,023).
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.
Lee teaches an analogous medical device comprising a thermally transmissive region (56, Fig 9) and two or more insulators (54, Fig 9) movably coupled to the distal portion of the catheter body, each insulator from the two or more insulators obscuring at least a portion of the outer surface of the thermally transmissive region (Col 7, lines 3-21; the insulators can be adjustable and the number, size, and shape of the insulator(s) can be adjusted to define a desired energy delivery surface(s)).
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 insulative sleeve to include two or more sleeves as taught by Lee in order to have a plurality of thermally transmissive regions and be able to tailor the geometry and size of the thermally transmissive region (Col 7, lines 3-21).
Regarding Claim 9, the modified invention of Santoianni and Lee discloses the two or more insulators (54, Fig 9 -Lee) is movably coupled to the distal portion of the catheter body 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 7, lines 3-6 -Lee).
Regarding Claim 13, the modified invention of Santoianni and Lee discloses the two or more insulators (54, Fig 9 -Lee) are composed of a thermally insulating material (Col 10, lines 50-58 – Santoianni; Col 7, lines 3-21 -Lee).
Regarding Claim 14, the modified invention of Santoianni and Lee 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 10/24/2025, on pages 5-6, regarding Lamb failing to teach a fluid conduit that defines a tapered section as claimed have been fully considered but are not persuasive. As detailed in Col 8, lines 56-65, Lamb teaches that delivery tube 120 allows fluid to be delivered to the tip member 126. Therefore, it can be interpreted as a fluid delivery conduit. As can be seen in Fig 4, the conduit 120 has a tapered (which Applicant seems to agree on). However, Applicant appears to be asserting that a needle valve can not be interpreted as a fluid conduit. Examiner would like to point out that a conduit is a broad term is defined as “ a natural or artificial channel through which something (such as a fluid) is conveyed” (Merriam-Webster dictionary). Therefore, the needle valve and specifically the delivery tube 120 meets the definition of a conduit. Examiner recommends that more specific language to claim the conduit to overcome the current art of record.
Applicant’s arguments filed 10/24/2025, on pages 6-7, regarding Santoianni failing to teach two or more insulators have been fully considered but are moot in view of the current rejection that relies on Lee to teach the new limitations.
Applicant’s arguments filed 10/24/2025, on pages 7-8, 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 plurality of first openings is positioned outside the delivery manifold” have been fully considered but is not persuasive. In Col 11, lines 57-62 of Lehmann, it is described that the injection tube 260 is positionable in any number of locations relative to the overtube, not just the positions shown. As there is nothing preventing the described second position, Lehmann’s device is capable of being movable to the second position as claimed. Further, Col 12, lines 5-18 of Lehmann details that a forward-most position would expose the opening outside of the overtube 270 to provide colling fluid to the tip of the catheter. Therefore, Lehmann discloses all of the claimed limitations of claim 15.
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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783