DETAILED ACTION
The following is a 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.
Response to Amendment
Acknowledgment is made to the amendment received 7/27/2026.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
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).
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the heated liquid source” to -the heated liquid- in ll. 13. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: amend “maintains” to -is configured to maintain- in ll. 2. Appropriate correction is required.
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.
Claim(s) 1-5, 12, 15, 18 & 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mori et al. (JP 2004-275452, using machine translation).
Concerning claim 1, as illustrated in at least Figs. 1-2, Mori et al. disclose a liquid system (system 10; [0031]) comprising:
a heated liquid source (a heated device 13 for supplying a heat transfer medium to the catheter 11; [0031], [0053]); and
a catheter coupled to the heated liquid source (catheter 11; [0031]), the catheter including:
a liquid delivery channel for delivery of a treatment liquid from a distal end portion of the catheter (therapeutic agent container 12 containing a therapeutic agent to be supplied to the catheter 11 via injection lumen 21 and out of tip 21a that is open; [0031], [0033]);
a circulation supply channel extending along the liquid delivery channel, the circulation supply channel configured to convey a heated liquid from the heated liquid source toward the distal end portion of the catheter; 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 (heat transfer recirculation lumen 22 comprises forward lumen 23 and return lumen 24, both surrounding injection lumen 21, where heat transfer medium is supplied to catheter 11 in heat transfer recirculation lumen 22; [0031], [0033]),
wherein the heated liquid source is configured to provide the heated liquid to the circulation supply channel such that the heated liquid source maintains a temperature of the treatment liquid within the liquid delivery channel (therapeutic agent enters injection lumen 21 and proceeds toward distal end side 21b, as the treatment agent flows through the forward lumen 23 to the tip side 23b, the inner wall 30 maintains a temperature of the therapeutic agent in the injection lumen 21; [0009], [0038-0039], [0053]).
Concerning claim 2, Mori et al. disclose the circulation supply channel (23) is separated from the circulation return channel (24) by a septum (28) and a distal end (23b) of the circulation supply channel (23) and a distal end (24b) of the circulation return channel (24) are sealed ([0034]; Fig. 2).
Concerning claim 3, Mori et al. disclose the septum (28) terminates proximally of the distal ends (23b, 24b) of the circulation return channel (24) and the circulation supply channel (23) ([0034]; Fig. 2).
Concerning claim 4, Mori et al. disclose the septum (28) is perforated to allow flow of the heated liquid through the septum (28) ([0035]; Fig. 2).
Concerning claim 5, Mori et al. disclose the liquid delivery channel (21) includes a distal opening (21b) and wherein the liquid delivery channel (21) is configured to direct the treatment liquid to the distal opening (21b) ([0031], [0033]; Fig. 1-2).
Concerning claim 12, Mori et al. disclose the circulation supply channel (23) extends around at least a portion of the liquid delivery channel (21) and the circulation return channel (24) extends around at least a portion of the liquid delivery channel (21) ([0033]; Fig. 2).
Concerning claim 15, Mori et al. disclose the circulation supply channel (23) and circulation return channel (24) have C-shaped cross-sections (Fig. 2a).
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Concerning claim 18, Mori et al. disclose a heating device (heating device for heating a heated medium instead of cooling device 13, where coils 16, 17 exchange heat; [0032], [0053]; Fig. 1) coupled to the heated liquid source (13) and the heating device configured to heat the treatment liquid to a temperature of less than a vaporization temperature for the treatment liquid (“when the heating medium or the heat transfer member is heated by the heating device, the heat heats the therapeutic agent in the injection lumen, and maintains the liquid or high fluidity”).
Concerning claim 40, Mori et al. disclose the heated liquid within the circulation supply channel (23) maintains the temperature of the treatment liquid within the liquid delivery channel (21) by having a temperature greater than or equal to the temperature of the treatment liquid ([0009], [0038-0039], [0053]).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (JP 2004-275452, using machine translation), as applied to claim 5, in further view of Glaze et al. (2009/0306640, previously cited).
Concerning claim 6, Mori et al. fail 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 Mori et al. 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) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (JP 2004-275452, using machine translation), as applied to claim 1, in view of Sharma (2017/0367755, previously cited).
Concerning claim 17, Mori et al. fail 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, Sharma discloses various embodiments of a system (Fig. 4A or 7A-B) comprising a catheter (400/700), a liquid delivery channel (420/705) for delivery of a treatment liquid (421/716) form a distal end portion (415/716) of the catheter (400/700). Sharma further discloses either separate treatment liquid and thermal liquid sources (Fig. 4A) or a single thermal liquid source (721 & 722) that includes a first reservoir (first now shown/721) coupled to the liquid delivery channel (420/705) and a second reservoir (722) coupled to a circulation supply channel (425/720) and the circulation return channel (430/710). 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 Mori et al. 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.
Claim(s) 1-5, 12, 22 & 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (2014/0371736) in view of Mori et al. (JP 2004-275452, using machine translation).
Concerning claim 1, as illustrated in at least Figs. 1, Levin et al. disclose a liquid system (device 100; [0121]) comprising:
a catheter (shaft 110 having a proximal end 111 connected to syringe 150 and distal end 112; [0121]), the catheter including:
a liquid delivery channel for delivery of a treatment liquid from a distal end portion of the catheter (heated fluid is introduced into lumen 113 which exits shaft 110 through opening 114; [0016], [0121], [0130]).
Levin et al. fail to disclose the system comprising a heated liquid source; and a circulation supply channel extending along the liquid delivery channel, the circulation supply channel configured to convey a heated liquid from the heated liquid source toward the distal end portion of the catheter; 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, wherein the heated liquid source is configured to provide the heated liquid to the circulation supply channel such that the heated liquid source maintains a temperature of the treatment liquid within the liquid delivery channel. However, Mori et al. disclose a liquid system (10) comprising: a catheter (11) coupled to a heated liquid source (13), a liquid delivery channel (21) for delivery of a treatment liquid (12) from a distal end portion (21a) of the catheter (11), a circulation supply channel (23) extending along the liquid delivery channel (21) and configured to convey a heated liquid from the heated liquid source (13) toward the distal end portion of the catheter (11); and a circulation return channel (24) extending along the liquid delivery channel (21) and configured to convey the heated liquid from the distal end portion toward a proximal end portion of the catheter (11), wherein the heated liquid source is configured to provide the heated liquid to the circulation supply channel (23) such that the heated liquid source maintains a temperature of the treatment liquid within the liquid delivery channel (21). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Levin et al. to further comprise a heated liquid source; and a circulation supply channel extending along the liquid delivery channel, the circulation supply channel configured to convey a heated liquid from the heated liquid source toward the distal end portion of the catheter; 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, wherein the heated liquid source is configured to provide the heated liquid to the circulation supply channel such that the heated liquid source maintains a temperature of the treatment liquid within the liquid delivery channel in order to provide the benefit of maintaining the treatment liquid at a sufficiently required temperature as taught by Mori et al. ([0009], [0020], [0023], [0031], [0033], [0038-0039], [0053]; Fig. 1-2).
Concerning claim 2, Mori et al. disclose the circulation supply channel (23) is separated from the circulation return channel (24) by a septum (28) and a distal end (23b) of the circulation supply channel (23) and a distal end (24b) of the circulation return channel (24) are sealed ([0034]; Fig. 2).
Concerning claim 3, Mori et al. disclose the septum (28) terminates proximally of the distal ends (23b, 24b) of the circulation return channel (24) and the circulation supply channel (23) ([0034]; Fig. 2).
Concerning claim 4, Mori et al. disclose the septum (28) is perforated to allow flow of the heated liquid through the septum (28) ([0035]; Fig. 2).
Concerning claim 5, Mori et al. disclose the liquid delivery channel (21) includes a distal opening (21b) and wherein the liquid delivery channel (21) is configured to direct the treatment liquid to the distal opening (21b) ([0031], [0033]; Fig. 1-2).
Concerning claim 12, Mori et al. disclose the circulation supply channel (23) extends around at least a portion of the liquid delivery channel (21) and the circulation return channel (24) extends around at least a portion of the liquid delivery channel (21) ([0033]; Fig. 2).
Concerning claim 22, Levin et al. further disclose a treatment balloon (120) coupled to the distal end portion of the catheter (110) and configured to receive the treatment liquid (150) from a distal opening (114) at the distal end portion of the catheter (110) ([0121]; Fig. 1).
Concerning claim 40, Mori et al. disclose the heated liquid within the circulation supply channel (23) maintains the temperature of the treatment liquid within the liquid delivery channel (21) by having a temperature greater than or equal to the temperature of the treatment liquid ([0009], [0038-0039], [0053]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (2014/0371736) in view of Mori et al. (JP 2004-275452, using machine translation), as applied to claim 5, in further view of Sharma (2017/0367755, previously cited).
Concerning claim 8, Levin et al. in view of Mori et al. fail to disclose Sharma discloses an occlusion device coupled to the catheter proximal to the distal opening. However, Sharma discloses various embodiments of a system (Fig. 4A or 7A-B) comprising a catheter (400/700), a liquid delivery channel (420/705) for delivery of a treatment liquid (421/716) form a distal end portion (415/716) of the catheter (400/700). Sharma further discloses an positioning device (410) capable of occlusion coupled to the catheter (400) proximal to the distal opening (415) ([0218]; Fig. 4A). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Levin et al. in view of Mori et al. to further comprise an occlusion device coupled to the catheter proximal to the distal opening in order to provide the benefit of positioning the distal opening of the treatment liquid as taught by Sharm ([0217]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (2014/0371736) in view of Mori et al. (JP 2004-275452, using machine translation) and Sharma (2017/0367755, previously cited), as applied to claim 8, in further view of Slater et al. (2005/0107738, previously cited).
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) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (2014/0371736) in view of Mori et al. (JP 2004-275452, using machine translation), as applied to claim 1, in further view of Caplan et al. (2016/0354144, previously cited).
Concerning claim 27, Levin et al. in view of Mori et al. fail 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 Levin et al. in view of Mori et al. 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)
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments regarding the specification have been fully considered but are not found persuasive. The objection is to the “incorporation by reference” of the PCT itself. MPEP §1893.03(b) states: “An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date.” and MPEP §608.01(p) I B states: “An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)).” In this case, the filing date of the application is the filing date of the PCT: 12/20/2021. The specification amendment that incorporates by reference the PCT was made 6/22/2023. The objection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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