DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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.
Election/Restrictions
Applicant’s election without traverse of Species A: Fig. 5A-C in the reply filed on 4/29/2026 is acknowledged.
Claims 7, 9, 13-14 & 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/29/2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. PCT/US2021/064411 & 63/130149 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 12/23/2020.
Specification
The amendment filed 6/22/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the PCT application is regarded as new matter since it was made after the applicant’s filing date, which is the date of the PCT, not the national stage entry. See MPEP 608.01(p) & 1893.03(b).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “maintain” to -is configured to maintain- in the last line. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: delete “any of” in ll. 1. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 8, 12, 15 & 25 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Sharma et al. (2017/0367755).
Concerning claim 1, as illustrated in at least Figs. 4A, 7A-B, 9A-10B, 22C, Sharma discloses a heated liquid system (Fig. 4A or 9A as example embodiments) comprising:
a catheter (multiple lumen ablation catheter 400; [0218] // or // ablation catheter 905; [0229]) including:
a liquid delivery channel for delivery of a treatment liquid from a distal end portion of the catheter (ablative agent 421 is introduced into the first lumen 420 at an ablative agent input port 401 at the proximal end of the catheter 400 and exits through the infusion ports 415 for ablation; [0217] // or // Vapor 915 passes from the proximal end of the body or shaft 907 into the inner lumen 911 to emanate from the distal end of the body or shaft 907; [0229]);
a circulation supply channel extending along the liquid delivery channel, the circulation supply channel configured to convey a heated liquid from a heated liquid source toward the distal end portion of the catheter (fluid 426 is introduced into the second lumen 425 at a fluid input port 402 at the proximal end of the catheter 400 and exits through the fluid delivery port 427; [0218] // or // coolant 913, such as, but not limited to, air, water or saline, passes from the proximal end of the body or shaft 907 into the first outer lumen 909a; [0229]); and
a circulation return channel extending along the liquid delivery channel, the circulation return channel configured to convey the heated liquid from the distal end portion toward a proximal end portion of the catheter (negative pressure is applied, using a pump, to the third lumen 430 at a suction input port 403 at the proximal end of the catheter 400 to enable suction of the fluid, delivered from the fluid delivery port 427 and the infusion ports 415 respectively, via the suction port 432; [0218] // or // coolant 913, such as, but not limited to, air, water or saline, is discharged through the second outer lumen 909b, also at the proximal end of the body or shaft 907; [0229]),
wherein the heated liquid maintains a temperature of the treatment liquid (when appropriate fluids are supplied via the lumens of Sharma, the prior art meets the claim language).
Concerning claim 2, Sharma discloses the circulation supply channel (909a) is separated from the circulation return channel (909b) by a septum (wall shown in Fig. 9b) and a distal end of the circulation supply channel (909a) and a distal end of the circulation return channel (909b) are sealed (fluid 913 is circulated) ([00229]; Fig. 9A-B).
Concerning claim 3, Sharm discloses the septum (wall) terminates proximally of the distal ends of the circulation return channel (909b) and the circulation supply channel (909a) (Fig. 9A-B).
Concerning claim 5, Sharma discloses the liquid delivery channel (911) includes a distal opening (915) and wherein the liquid delivery channel (911) is configured to direct the treatment liquid to the distal opening (915) ([0229]; Fig. 9A-B).
Concerning claim 8, Sharma discloses an occlusion device (410) coupled to the catheter (400) proximal to the distal opening (415) ([0218]; Fig. 4A).
Concerning claim 12, Sharma discloses the circulation supply channel (909a) extends around at least a portion of the liquid delivery channel (911) and the circulation return channel (909b) extends around at least a portion of the liquid delivery channel (911) (Fig. 10B).
Concerning claim 15, Sharma discloses the circulation supply channel (909a) and the circulation return channel (909b) have C-shaped cross-sections (Fig. 10B).
Concerning claim 25, Sharma discloses the circulation supply channel (909a) is further configured to convey a cooling liquid (913) from a cooling liquid source toward a distal end portion of the catheter (905) ([0229]; Fig. 9A).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (2017/0367755), as applied to claim 2, in further view of Pham et al. (2003/0078644).
Concerning claim 4, Sharma fails to disclose the septum is perforated to allow flow of the heated liquid through the septum. However, Pham et al. disclose perforations (412) within a wall between two fluid lumens (410, 414) (Fig. 17) as an alternative to a distal end connection lumen (131) (Fig. 4-5). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sharma such that the septum is perforated to allow flow of the heated liquid through the septum in order to provide the benefit of circulating the fluid as taught by Pham et al. ([0103]) and since Pham et al. teach the use of wall perforations to be equivalent in the art to a distal end connection to provide the predictable result of circulating fluid.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (2017/0367755), as applied to claim 5, in further view of Glaze et al. (2009/0306640).
Concerning claim 6, Sharma fails to discloses the distal opening includes a guide, wherein the guide includes a proximally angled surface. However, Glaze et al. disclose a distal fluid opening that includes a guide (flair or umbrella) that includes a proximally angled surface. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sharma such that the distal opening includes a guide, wherein the guide includes a proximally angled surface in order to provide the benefit of angling the fluid as taught by Glaze et al. ([0072]; Fig. 10A-D)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (2017/0367755), as applied to claim 2, in further view of Slater et al. (2005/0107738).
Concerning claim 10, Sharm fails to disclose the catheter further comprises an inflation medium delivery channel coupled to the occlusion device. However, Slater et al. disclose a liquid system comprising a catheter having fluid channels (16 // or // 1002, 1004) and a separate inflation medium delivery channel (14 // or // 1006, 1014) coupled to an occlusion device (20 // or // balloon, not shown). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sharma to further comprise an inflation medium delivery channel coupled to the occlusion device in order to provide the benefit of independently inflating and deflating the occlusion device at a desired pressure as taught by Slater et al. ([0019], [0115], [0135], [0138], [0196]; Fig. 2 & 33).
Claim(s) 17 & 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (2017/0367755), as applied to claim 1.
Concerning claim 17, while Sharma discloses a heated liquid source (vapor ablative agent) in the embodiments referred to in claim 1, Sharma fails to disclose the heated liquid source includes a first reservoir coupled to the liquid delivery channel and a second reservoir coupled to the circulation supply channel and the circulation return channel. However, in the embodiment of Fig. 7A, Sharma discloses a heated liquid source includes a first reservoir (721) coupled to a liquid delivery channel (705) and a second reservoir (722) coupled to a circulation supply channel (720) and the circulation return channel (710). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the embodiment of Fig. 4A or 9A such that the heated liquid source includes a first reservoir coupled to the liquid delivery channel and a second reservoir coupled to the circulation supply channel and the circulation return channel in order to provide the benefit of a single fluid source as taught by Sharma ([0227]; Fig. 7A-B) since Sharma teaches the use of a single fluid source or two fluid sources to be equivalents in the art to provide the predictable result of delivering the fluid.
Concerning claim 22, Sharma fails to disclose a treatment balloon coupled to the distal end portion of the catheter and configured to receive the treatment liquid from the distal opening at the distal end portion of the catheter in the embodiments of Fig. 4A & 9A. However, the embodiment of Fig. 22C, Sharma discloses a treatment balloon (2222) coupled to the distal end portion of the catheter (2220) and configured to receive the treatment liquid (2208) from the distal opening at the distal end portion of the catheter (2220) ([0297]; Fig. 22C). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the embodiment of Fig. 4A or 9A to further comprise a treatment balloon coupled to the distal end portion of the catheter and configured to receive the treatment liquid from the distal opening at the distal end portion of the catheter in order to provide the benefit of defining a hot ablation zone as taught by Sharma ([0285-0286], [0297])
Claim(s) 18 & 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (2017/0367755), as applied to claim 1, in further view of Caplan et al. (2016/0354144).
Concerning claim 18, Sharma discloses a heated liquid source (inherent, e.g., 1310, 1505) further comprising a heating device (heating coil, e.g., 1340, 1507) coupled to the heated liquid source, the heating device configured to heat the treatment liquid to a temperature of less than a vaporization temperature for the treatment liquid when appropriate power is supplied to the heating coil for an appropriate amount of time ([0235], [0239]; Fig. 13A & 15A). Sharma fails to disclose the heated liquid source to be the circulation liquid. However, Caplan discloses a liquid system (10) comprising both a treatment liquid source (331) that can be either a heated fluid or a cryogenic fluid and a neutralizing liquid (333) that can be either a cooling fluid or a heated fluid. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sharma such that the liquid source is a heated liquid source and the treatment liquid source is a coolant since Caplan et al. teaches the treatment liquid as a heated liquid or a coolant liquid and the associated neutralizing liquids to be equivalents in the art to provide the predictable result of treating tissue ([0128-0130]; Fig. 1).
Concerning claim 27, Sharma fails to disclose a control system configured to: receive a sensed temperature of the treatment liquid near the distal end portion of the catheter and responsive to the sensed temperature, adjust a temperature or a flow rate of the heated liquid. However, Caplan further discloses a control system (330) configured to: receive a sensed temperature of a treatment liquid near a distal end portion (114) of a catheter (100) and responsive to the sensed temperature, adjust a temperature or a flow rate of the neutralizing heated liquid. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sharma to further comprise a control system configured to: receive a sensed temperature of the treatment liquid near the distal end portion of the catheter and responsive to the sensed temperature, adjust a temperature or a flow rate of the heated liquid in order to provide the benefit of adjusting operating parameters for optimal treatment as taught by Caplan. ([0131-0133], [0145]; Fig. 1)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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