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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4 December 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 4 December 2025 wherein Claims 2 and 6 are amended, Claim 9 is previously cancelled, Claims 18 – 20 are previously withdrawn, and no claims are newly added. Therefore, Claims 1 – 8 and 10 – 20 are currently pending wherein Claims 18 – 20 are withdrawn therefrom.
Response to Arguments
Applicant’s arguments, see pages 7 – 8, filed 4 December 2025, with respect to the 35 U.S.C. §§ 112(a) and 112(b) rejections set forth in the Final Rejection dated 4 September 2025 have been fully considered and are persuasive. The 35 U.S.C. §§ 112(a) and 112(b) of Claim 2 and its dependent claims has been withdrawn.
Applicant's arguments filed 4 December have been fully considered but they are not persuasive.
U.S.C. § 103
Claims 1 and 15 are rejected as being unpatentable over Gildoni et al. (US 2009/0099516 A1) and Zarembinski (US 2017/0135723 A1)
The Applicant alleges that the prior art of record does not disclose or suggest an apparatus that includes a double balloon attached to a distal end of a shaft, the double balloon including a first balloon, a second balloon, and a bridge extending between the first and second ballons, wherein “when the first balloon is inflated on a distal side of an atomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” as recited in claim 1. The Examiner respectfully disagrees.
Gildoni discloses in Figures 2A – 2C an apparatus that includes a double balloon (20, 21, 23) attached to a distal end of a shaft (see Fig. 2A at 13), the double balloon including a first balloon (23), a second balloon (21) and a bridge (20) extending between the first and second balloons (see Fig. 2A for the relative arrangement of the first and second balloons and the bridge). The claim language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g) and 2114. The claim is an apparatus claim and is to be limited by the structural limitations of the claim. The Office submits that the apparatus of Gildoni meets the structural limitations of the claim wherein the first balloon is capable of securing the double balloon to the anatomical opening. Support for the apparatus being capable of securing the double balloon to the anatomical opening can be found within [0082] – [0086] wherein when the distal balloon 23 occludes the vessel walls it also secures the double balloon in place. Gildoni also describes using the balloon catheter within the brain see [0127]. In view of the aforementioned rationale, the Applicant’s argument that Gildoni does not teach the claim limitation of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” is found to be unpersuasive. Therefore, the claimed apparatus of Claim 1 is anticipated by the apparatus of Gildoni under 35 U.S.C. 102.
Nonetheless an alternative 35 U.S.C. 103 rejection is provided modifying Gildoni in view of Zarembinski. Paragraphs [0007] and [0069] of Zarembinski further teaches the functional claim language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening.” Paragraph [0007] recites “inflating a balloon against a portion of the trigeminal ganglion” and paragraph [0069] recites “A pear-shaped balloon may, in some cases, improve outcome and correspond to the inner anatomy of the Meckel cave - the distal protrusion surrounding the trigeminal ganglion 302 and the distal part of the trigeminal root 304.” Here, the first balloon secures the double balloon to the anatomical opening because the balloon shape corresponds to the inner anatomy of the Meckel cave and surrounds the trigeminal ganglion when the balloon is inflated. The Applicant’s argument that Zarembinski does not teach the claim limitation of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” is found to be unpersuasive. Therefore, the claimed apparatus of Claim 1 is obvious in view of the apparatus of Gildoni and Zarembinski
A person having ordinary skill in the art would modify Gildoni in view of a teaching of Zarembinski because both consider treating the brain. Gildoni teaches that the embodiments of the device are suitable for augmenting blood perfusion to a specific area or organ such as the brain in order to enhance blood or fluid drainage from such areas or organs (see [0127] of Gildoni). Zarembinski teaches that this pear-shaped balloon, which is similar to the shape shown by Gildoni, improves the treatment outcome and corresponds to the inner anatomy of the Meckel cave (see [0069] of Zarembinski). Zarembinski further teaches that a balloon rhizotomy is a low cost, simple therapeutic modality that reduces sensory input thereby turning off the trigger for neuropathic trigeminal pain for treating trigeminal neuralgia (see [0048] of Zarembinski). Here, a person having ordinary skill in the art would recognize that the catheter of Gildoni, which is already capable of being used in the brain, could modified to perform the balloon rhizotomy procedure taught by Zarembinski in order to treat trigeminal neuralgia.
Each of the Applicant’s arguments pertaining to the rejection of Claim 1 have been found to be unpersuasive. Therefore the Examiner maintains the rejections in view of Gildoni and Zarembinski. Independent Claim 15 is unpatentable over the prior art of record for at least substantially the same reasons as claim 1.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites “fluid coupling tube includes a third port.” The Examiner suggests amending this to recite “the fluid coupling tube includes a third port” to provide proper antecedent basis for the claim language.
Appropriate correction is required.
Claim Rejections - 35 USC § 102 or 103
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.
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.
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Gildoni et al. (US 2009/0099516 A1; hereinafter referred to as “Gildoni”) or, in the alternative, under 35 U.S.C. 103 as obvious over Zarembinski (US 2017/0135723 A1).
Gildoni is cited in the Notice of References Cited form dated May 6, 2025.
Zarembinski is cited in the Notice of References Cited form dated 4 September 2025.
With regards to claim 1, Gildoni discloses (Figs. 2A – 2C) an apparatus (see [0053] “the balloon catheter”) comprising:
a shaft (13) (see [0081]) having proximal and distal ends (see Examiner annotated Fig. 2A below hereinafter referred to as “Fig. A”);
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a double balloon (20, 21, 23) (see [0081]) attached to the distal end of the shaft (see Fig. 2A), the double balloon comprising:
a first balloon (23) (see [0081]);
a second balloon (21) (see [0081]); and
a bridge (20) (see [0081]) extending between the first and second balloons (see Fig. 2A); and
one or more fluid lines (see [0081] “The lumen of the inflation/deflation channel off catheter 13” and [0082]) disposed in the shaft, the one or more fluid lines fluidly coupled to the double balloon and configured to change an inflation state of the double balloon (see [0081] and [0082]), wherein:
the second balloon (21) is located between the bridge (20) and the shaft (13), and
when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening (the language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g) and 2114. The claim is an apparatus claim and is to be limited by the structural limitations of the claim. The Office submits that the apparatus of Gildoni meets the structural limitations of the claim wherein the first balloon is capable of securing the double balloon to the anatomical opening. Support for the apparatus being capable of securing the double balloon to the anatomical opening can be found within [0082] – [0086] wherein when the distal balloon 23 occludes the vessel walls it also secures the double balloon in place. Gildoni also describes using the balloon catheter within the brain see [0127]).
However if it is determined that Gildoni is silent with regards to the functional claim language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” then the Examiner turns to the teachings of Zarembinski.
Zarembinski, which is within the analogous art of pear-shaped balloons (see [0069] and Fig. 8G), teaches when the first balloon (502) (see [0069]) is inflated on a distal side of an anatomical opening (see [0007] and [0069] “The balloon 502 can have any desired configuration, and can be pear-shaped in some embodiments. A pear-shaped balloon may, in some cases, improve outcome and correspond to the inner anatomy of the Meckel cave – the distal protrusion surrounding the trigeminal ganglion 302 and the distal part of the trigeminal root 304 as previously described.” Wherein the anatomical opening is the Meckel cave.),
the first balloon is configured to secure the double balloon to the anatomical opening (see [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first balloon of the apparatus of Gildoni in view of a teaching of Zarembinski such that when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening. One of ordinary skill in the art would have been motivated to make this modification because Zarembinski teaches that a pear-shaped balloon improves the treatment outcome and correspond to the inner anatomy of the Meckel cave (see [0069] of Zarembinski). Zarembinski further teaches that balloon rhizotomy is a low cost, simple therapeutic modality that reduces sensory neuronal input thereby turning off the trigger for neuropathic trigeminal pain for treating trigeminal neuralgia (see [0048] of Zarembinski).
The apparatus of Gildoni modified in view of a teaching of Zarembinski will hereinafter be referred to as the apparatus of Gildoni and Zarembinski.
With regards to claim 15, Gildoni discloses (Figs. 2A – 2c) a system (see Fig. 2A) comprising:
a shaft (13) (see [0081]) having proximal and distal ends (see Fig. A reiterated below);
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a double balloon (20, 21, 23) (see [0081]) attached to the distal end of the shaft (see Fig. 2A), the double balloon comprising:
a first balloon (23) (see [0081]);
a second balloon (21) (see [0081]); and
a bridge (20) (see [0081]) extending between the first and second balloons (see Fig. 2A);
one or more fluid lines (see [0081] “The lumen of the inflation/deflation channel off catheter 13” and [0082]) disposed in the shaft, the one or more fluid lines fluidly coupled to the double balloon and configured to change an inflation state of the double balloon (see [0081] and [0082]); and
a fluid reservoir (14) (see [0081]) fluidly coupled to the one or more fluid lines (see Fig. 2A and [0081] – [0082]), wherein:
the second balloon (21) is located between the bridge (20) and the shaft (13); and
when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening (the language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g) and 2114. The claim is an apparatus claim and is to be limited by the structural limitations of the claim. The Office submits that the apparatus of Gildoni meets the structural limitations of the claim wherein the first balloon is capable of securing the double balloon to the anatomical opening. Support for the apparatus being capable of securing the double balloon to the anatomical opening can be found within [0082] – [0086] wherein when the distal balloon 23 occludes the vessel walls it also secures the double balloon in place. Gildoni also describes using the balloon catheter within the brain see [0127]).
However if it is determined that Gildoni is silent with regards to the functional claim language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” then the Examiner turns to the teachings of Zarembinski.
Zarembinski, which is within the analogous art of pear-shaped balloons (see [0069] and Fig. 8G), teaches when the first balloon (502) (see [0069]) is inflated on a distal side of an anatomical opening (see [0007] and [0069] “The balloon 502 can have any desired configuration, and can be pear-shaped in some embodiments. A pear-shaped balloon may, in some cases, improve outcome and correspond to the inner anatomy of the Meckel cave – the distal protrusion surrounding the trigeminal ganglion 302 and the distal part of the trigeminal root 304 as previously described.” Wherein the anatomical opening is the Meckel cave.),
the first balloon is configured to secure the double balloon to the anatomical opening (see [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first balloon of the system of Gildoni in view of a teaching of Zarembinski such that when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening. One of ordinary skill in the art would have been motivated to make this modification because Zarembinski teaches that a pear-shaped balloon improves the treatment outcome and correspond to the inner anatomy of the Meckel cave (see [0069] of Zarembinski). Zarembinski further teaches that balloon rhizotomy is a low cost, simple therapeutic modality that reduces sensory neuronal input thereby turning off the trigger for neuropathic trigeminal pain for treating trigeminal neuralgia (see [0048] of Zarembinski).
The system of Gildoni modified in view of a teaching of Zarembinski will hereinafter be referred to as the system of Gildoni and Zarembinski.
Claim(s) 2, 3, and 5 – 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni and Zarembinski as applied to claim 1 above, and further in view of Jang (US 4,990,139 A).
Jang is cited in the Notice of References Cited form dated May 6, 2025.
With regards to claim 2, the apparatus of Gildoni and Zarembinski teaches the claimed invention of claim 1, however, Gildoni is silent with regards to the apparatus further comprising a fluid coupling tube disposed in the double balloon, the fluid coupling tube including first and second ports,
wherein the one or more fluid lines include:
a first fluid line fluidly coupled to the first balloon through the first port, and
a second fluid line fluidly coupled to the second balloon through the second port.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), teaches (see Fig. 21) the apparatus further comprising a fluid coupling tube (see Examiner annotated Fig. 21 below; hereinafter referred to as “Fig. B”) disposed in the double balloon (see Fig. B below wherein the annotated fluid coupling tube is located in the double balloon 16, 21), the fluid coupling tube including first and second ports (see at 28 and 24 respectively in Fig. 21),
wherein the one or more fluid lines (24, 26, 28; see Col. 21, lines 55 – 65) include:
a first fluid line (28; see Col. 21, lines 55 – 65) fluidly coupled to the first balloon (21; see Col. 21, lines 21 – 44) through the first port (see at 28 in Fig. 21), and
a second fluid line (24; see Col. 21, lines 55 – 65) fluidly coupled to the second balloon (16; see Col. 21, lines 21 – 44) through the second port (see at 24 in Fig. 21).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni and Zarembinski in view of a teaching of Jang such that the apparatus further comprises a fluid coupling tube disposed in the double balloon, the fluid coupling tube including first and second ports, wherein the one or more fluid lines include: a first fluid line fluidly coupled to the first balloon through the first port, and a second fluid line fluidly coupled to the second balloon through the second port. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches the first and second fluid lines provide for the independent inflation and deflation of the first and second balloons (see Col. 21, lines 55 – 65 of Jang).
The apparatus of Gildoni and Zarembinski modified in view of a teaching of Jang will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, and Jang.
With regards to claim 3, the apparatus of Gildoni, Zarembinski, and Jang teaches the claimed invention of claim 2, however, Gildoni is silent with regards to wherein the first balloon and the second balloon are fluidly isolated from each other, whereby an inflation state of the first balloon is independent from an inflation state of the second balloon.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), further teaches (see Fig. 21) wherein the first balloon (21; see Col. 21, lines 21 – 44) and the second balloon (16; see Col. 21, lines 21 – 44) are fluidly isolated from each other (see Col. 21, lines 55 – 65), whereby an inflation state of the first balloon is independent from an inflation state of the second balloon (see Col. 21, lines 55 – 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second balloon of the apparatus of Gildoni, Zarembinski, and Jang in view of a further teaching of Jang such that the first balloon and the second balloon are fluidly isolated from each other, whereby an inflation state of the first balloon is independent from an inflation state of the second balloon. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches the first and second fluid lines provide for the independent inflation and deflation of the first and second balloons (see Col. 21, lines 55 – 65 of Jang).
With regards to claim 5, the apparatus of Gildoni, Zarembinski, and Jang teaches the claimed invention of claim 3, and Gildoni further teaches (see Figs. 2A – 2C) wherein:
the bridge (20) comprises a bridge balloon having a bridge inflation state (see [0081] and [0082]), and the bridge balloon is fluidly coupled to the first balloon (23) or the second balloon (see [0081]), whereby:
when the bridge balloon is fluidly coupled to the first balloon, the bridge inflation state is the same as the inflation state of the first balloon (see [0081] and [0082] where the described inflation state of the first balloon is the inflation state of the bridge balloon), and when the bridge balloon is fluidly coupled to the second balloon, the bridge inflation state is the same as the inflation state of the second balloon.
With regards to claim 6, the apparatus of Gildoni, Zarembinski, and Jang teaches the claimed invention of claim 3, however, Gildoni is silent with regards to:
the bridge comprises a bridge balloon,
fluid coupling tube includes a third port,
the one or more fluid lines include a third fluid line fluidly coupled to the bridge balloon through the third port,
the first balloon, the second balloon, and the third balloon are fluidly isolated from each other,
whereby the inflation state of the first balloon, the inflation state of the second balloon, and an inflation state of the bridge balloon are independent from each other.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), teaches (see Fig. 21) wherein:
the bridge (20) comprises a bridge balloon (see [0081] and [0082]),
fluid coupling tube (see Fig. B reiterated below) includes a third port (see at 26 in Fig. 21),
the one or more fluid lines (24, 26, 28; see Col. 21, lines 55 – 65 “the first lumen 24 for inflating and deflating the first balloon 16 and the second lumen 26 for inflating the second balloon 20, it should also be provided with a third lumen 28 for inflating and deflating the third balloon 21.”) include a third fluid line (26) fluidly coupled to the bridge balloon (see Col. 21, lines 55 – 65) through the third port (see at 26 in Fig. 21),
the first balloon (21), the second balloon (16), and the third balloon (20) are fluidly isolated from each other (see Col. 21, lines 55 – 65),
whereby the inflation state of the first balloon, the inflation state of the second balloon, and an inflation state of the bridge balloon are independent from each other (see Col. 21, lines 55 – 65).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni, Zarembinski, and Jang in view of a further teaching of Jang such that the bridge comprises a bridge balloon, fluid coupling tube includes a third port, the one or more fluid lines include a third fluid line fluidly coupled to the bridge balloon through the third port, the first balloon, the second balloon, and the third balloon are fluidly isolated from each other, whereby the inflation state of the first balloon, the inflation state of the second balloon, and an inflation state of the bridge balloon are independent from each other. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches the first and second fluid lines provide for the independent inflation and deflation of the first and second balloons (see Col. 21, lines 55 – 65 of Jang).
With regards to claim 7, the apparatus of Gildoni and Zarembinski teaches the claimed invention of claim 1, however, Gildoni is silent with regards to wherein when the first and second balloons are inflated, a first dimension of the first balloon is larger than a corresponding second dimension of the second balloon.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), teaches (see Fig. 21) when the first and second balloons (21, 16; see Col. 21, lines 21 – 44) are inflated, a first dimension of the first balloon (21) is larger than a corresponding second dimension of the second balloon (16) (see Col. 21, lines 41 – 44 “The first balloon 16 has the smallest maximum inflated diameter, the second balloon 20 has the next largest diameter, and the third balloon 21 has the largest inflated maximum inflated diameter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to the apparatus of Gildoni and Zarembinski in view of a teaching of Jang such that the first and second balloons are inflated, a first dimension of the first balloon is larger than a corresponding second dimension of the second balloon. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches that the size of the balloon matches the size of the anatomy the balloon is intended to engage with (see Col. 3, lines 6 – 25 of Jang).
The apparatus of Gildoni and Zarembinski modified in view of Jang will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, and Jang.
With regards to claim 8, the apparatus of Gildoni, Zarembinski, and Jang teaches the claimed invention of claim 7, however, Gildoni is silent with regards to wherein when the first and second balloons are inflated, the first balloon has a larger diameter than the second balloon. Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), teaches (see Fig. 21) wherein when the first and second balloons (21, 16; see Col. 21, lines 21 – 44) are inflated, the first balloon (21) has a larger diameter than the second balloon (16) (see Fig. 21 and see Col. 21, lines 41 – 44 “The first balloon 16 has the smallest maximum inflated diameter, the second balloon 20 has the next largest diameter, and the third balloon 21 has the largest inflated maximum inflated diameter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second balloons of the apparatus of Gildoni, Zarembinski and Jang in view of a further teaching of Jang such that when the first and second balloons are inflated, the first balloon has a larger diameter than the second balloon. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches that the size of the balloon matches the size of the anatomy in which the balloon is intended to engage with (see Col. 3, lines 6 – 25 of Jang).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, and Jang as applied to claim 3 above, and further in view of Ishibashi et al. (US 2013/0165823 A1 hereinafter referred to as “Ishibashi”).
Ishibashi is cited in the Notice of References Cited form dated May 6, 2025.
With regards to claim 4, the apparatus of Gildoni, Zarembinski, and Jang teaches the claimed invention of claim 3, however, Gildoni is silent with regards to the first balloon has a first cavity to receive fluid from the first fluid line, the second balloon has a second cavity to receive fluid from the second fluid line, and the apparatus further comprises: a first pressure sensor in fluid communication with the first cavity; and a second pressure sensor in fluid communication with the second cavity.
Nonetheless Ishibashi, which is within the analogous art of balloons with pressure sensors (see Fig. 10 and [0024]), teaches (see Fig. 10) the first balloon (210) has a first cavity (see at 210 in Fig. 10) to receive fluid from the first fluid line (230) (see [0024]), the second balloon (220) has a second cavity (see at 220 in Fig. 10) to receive fluid from the second fluid line (235) (see [0024]), and the apparatus further comprises:
a first pressure sensor (240) (see [0024]) in fluid communication with the first cavity (see at 210 in Fig. 10 and [0024] “a first pressure sensor 240 is disposed to measure a pressure of the liquid in the first balloon 210”); and
a second pressure sensor (245) (see [0024]) in fluid communication with the second cavity (see at 220 in Fig. 10 and [0024] “a second pressure sensor 245 is disposed to measure a pressure of the liquid in the second balloon 220”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second ballons of the apparatus of Gildoni, Zarembinski, and Jang in view of a teaching of Ishibashi such that the first balloon has a first cavity to receive fluid from the first fluid line, the second balloon has a second cavity to receive fluid from the second fluid line, and the apparatus further comprises: a first pressure sensor in fluid communication with the first cavity; and a second pressure sensor in fluid communication with the second cavity. One of ordinary skill in the art would have been motivated to make this modification because Ishibashi teaches incorporating a first pressure sensor and a second pressure sensor within the first and second balloons, respectively, provides a means to measure the pressure of the liquid in the first and second balloons, respectively (see [0024] of Ishibashi). The pump control receives output values of the first and second pressure sensors and then controls the pump so that these pressure values are maintained (see [0033] of Ishibashi).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni and Zarembinski as applied to claim 1 above, and further in view of Altmann et al. (US 9,308,041 B2 hereinafter referred to as “Altmann”).
Altmann is cited in the Notice of References Cited form dated May 6, 2025.
With regards to claim 10, the apparatus of Gildoni and Zarembinski teaches the claimed invention of claim 1, however, Gildoni is silent with regards to further comprising an electrode contact arm attached to the shaft, the electrode contact arm including a plurality of electrical contacts.
Nonetheless Altmann, which is within the analogous art of electrode contact arms (see Fig. 2A), teaches the apparatus (24; see Col. 4, lines 53 – 61 “catheter 24”) further comprising an electrode contact arm (52; see Col. 4, line 62 – Col. 5, line 6 “End section 52”) attached to the shaft (54; see Col. 4, line 62 – Col. 5, line 6 “an insertion shaft 54, and an end section 52 that is connected to the distal end of the insertion shaft”), the electrode arm including a plurality of electrical contacts (56, 58; see Col. 5, lines 33 – 39 “End section 52 comprises an array of electrodes along its length, including, in this example, a tip electrode 56”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shaft of the apparatus of Gildoni and Zarembinski in view of a teaching of Altmann such that the apparatus further comprising an electrode contact arm attached to the shaft, the electrode arm including a plurality of electrical contacts. One of ordinary skill in the art would have been motivated to make this modification because the electrode contact arm can be used for ablating tissue when the end section is positioned against the tissue (see Col. 1, lines 61 – 67).
The apparatus of Gildoni and Zarembinski modified in view of Altmann will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, and Altmann.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, and Altmann as applied to claim 10 above, and further in view of Corvi et al. (US 2013/0110104 A1 hereinafter referred to as “Corvi”).
Corvi is cited in the Notice of References Cited form dated May 6, 2025.
With regards to claim 11, the apparatus of Gildoni, Zarembinski, and Altmann teaches the claimed invention of claim 10, however, Gildoni is silent with regards to further comprising one or more wires mechanically coupled to the electrode contact arm to steer the electrode contact arm independently of the shaft.
Nonetheless Corvi, which is within the analogous art of electrode contact arms (see Fig. 2), teaches the apparatus further comprising one or more wires (see [0031] “One or more internal push/pull wires may also be provided in the medical device 16, and in particular, coupled to the handle assembly 22…a full length pull wire (or double pull wires such as in the case with bi-directional steering, neither of which is shown) may be secured to the a distal portion of the end of the shaft 42 and/or carrier assembly 36” and [0037]) mechanically coupled to the electrode arm (36; see [0021] and [0031] “carrier assembly 36”) to steer the electrode arm independently of the shaft (18; see [0020] “flexible catheter body 18”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni, Zarembinski, and Altmann in view of a teaching of Corvi such that the apparatus further comprising one or more wires mechanically coupled to the electrode arm to steer the electrode arm independently of the shaft. One of ordinary skill in the art would have been motivated to make this modification because Corvi teaches the incorporation of one or more wires facilitates single or bi-directional steering and control of the distal treatment assembly (see [0031] of Corvi).
Claim(s) 12 – 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni and Zarembinski as applied to claim 1 above, and further in view of Altmann and Govari et al. (US 2014/0163546 hereinafter referred to as “Govari”).
Govari is cited in the Notice of References Cited form dated May 6, 2025.
With regards to claim 12, the apparatus of Gildoni and Zarembinski teaches the claimed invention of claim 1, however, Gildoni is silent with regards to further comprising an injectrode attached to the shaft.
Nonetheless Altmann, which is within the analogous art of electrode contact arms (see Fig. 2A), teaches the apparatus (24; see Col. 4, lines 53 – 61 “catheter 24”) further comprising an electrode contact arm (52; see Col. 4, line 62 – Col. 5, line 6 “End section 52”) attached to the shaft (54; see Col. 4, line 62 – Col. 5, line 6 “an insertion shaft 54, and an end section 52 that is connected to the distal end of the insertion shaft”), the electrode arm including a plurality of electrical contacts (56, 58; see Col. 5, lines 33 – 39 “End section 52 comprises an array of electrodes along its length, including, in this example, a tip electrode 56”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shaft of the apparatus of Gildoni and Zarembinski in view of a teaching of Altmann such that the apparatus further comprising an electrode contact arm attached to the shaft, the electrode arm including a plurality of electrical contacts. One of ordinary skill in the art would have been motivated to make this modification because the electrode contact arm can be used for ablating tissue when the end section is positioned against the tissue (see Col. 1, lines 61 – 67).
The apparatus of Gildoni and Zarembinski modified in view of Altmann will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, and Altmann.
However, none of Gildoni, Zarembinski, or Altmann teach that the electrode contact arm is an injectrode attached to the shaft.
Nonetheless Govari, which is within the analogous art of perforated electrodes (see [0013] and Fig. 5), teaches a perforated tip electrode extends over the tip and a plurality of perforated proximal electrodes distributed along the end section (see [0013], [0032] “To provide local cooling and prevent adhesion during ablation, electrodes 58 and 60 may have perforations for irrigation…The perforations are coupled to one or more lumens in end section 52, which carries irrigation fluid from shaft 54 to the electrodes and to the tissue surrounding them”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the electrodes of the electrode contact arm of the apparatus of Gildoni, Zarembinski, and Altmann in view of a teaching of Govari such that the electrode contact arm is an injectrode attached to the shaft. One of ordinary skill in the art would have been motivated to make this modification because Govari teaches that modifying the electrode contact arm such that it can provide an injection provides for local cooling and prevents adhesion during ablation (see [0032] of Govari).
The apparatus of Gildoni, Zarembinski and Altmann modified in view of a teaching of Govari will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, Altmann, and Govari.
With regards to claim 13, the apparatus of Gildoni, Zarembinski, Altmann, and Govari teaches the claimed invention of claim 12, however, Gildoni is silent with regards to wherein the injectrode includes:
a lumen to deliver a therapeutic agent; and
one or more electrodes disposed on the lumen.
Nonetheless Govari, which is within the analogous art of perforated electrodes (see [0013] and Fig. 5), further teaches the injectrode including:
a lumen (82, 84; see [0041] “supplies irrigation fluid to catheter 24 via both of lumens 82 and 84”) to deliver a therapeutic agent (see [0041] “irrigation fluid”); and
one or more electrodes (58, 60; see [0039] “electrodes 58 and 60”) disposed on the lumen (see Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni, Zarembinski, Altmann, and Govari in view of a further teaching of Govari such that the injectrode includes: a lumen to deliver a therapeutic agent; and one or more electrodes disposed on the lumen. One of ordinary skill in the art would have been motivated to make this modification because Govari teaches that modifying the electrode contact arm such that it can provide an injection provides for local cooling and prevents adhesion during ablation (see [0032] of Govari).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, Altmann, and Govari as applied to claim 13 above, and further in view of Corvi.
With regards to claim 14, the apparatus of Gildoni, Zarembinski, Altmann and Govari teaches the claimed invention of claim 13, however, Gildoni is silent with regards to further comprising one or more wires mechanically coupled to the lumen to steer the injectrode independently of the shaft.
Nonetheless Corvi, which is within the analogous art of electrode contact arms (see Fig. 2), teaches the apparatus further comprising one or more wires (see [0031] “One or more internal push/pull wires may also be provided in the medical device 16, and in particular, coupled to the handle assembly 22…a full length pull wire (or double pull wires such as in the case with bi-directional steering, neither of which is shown) may be secured to the a distal portion of the end of the shaft 42 and/or carrier assembly 36” and [0037]) mechanically coupled to the lumen to steer the injectrode independently of the shaft (18; see [0020] “flexible catheter body 18”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni, Zarembinski, Altmann, and Govari in view of a teaching of Corvi such that the apparatus further comprises one or more wires mechanically coupled to the lumen to steer the injectrode independently of the shaft. One of ordinary skill in the art would have been motivated to make this modification because Corvi teaches the incorporation of one or more wires facilitates single or bi-directional steering and control of the distal treatment assembly (see [0031] of Corvi).
Claim(s) 16 – 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni and Zarembinski as applied to claim 15 above, and further in view of Ishibashi.
With regards to claim 16, the system Gildoni and Zarembinski teaches the claimed invention of claim 15, however, Gildoni is silent with regards to the system further comprising a pressure sensor configured to measure a pressure of the one or more fluid lines.
Nonetheless Ishibashi, which is within the analogous art of balloons with pressure sensors (see Figs. 1 and 10 and [0024]), teaches the system (see Fig. 1) further comprising a pressure sensor (240; see [0024] “a first pressure sensor 240 is disposed to measure a pressure of the liquid in the first balloon 210”) configured to measure a pressure of the one or more fluid lines (230; see [0024] “a first tube 230” and [0043] “It is to be noted that the first pressure sensor 240 does not have to be present in the first balloon 210, and may be disposed, for example, in the vicinity of the first three-way valve 180 of the first tube 230”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Gildoni and Zarembinski in view of a further teaching of Ishibashi such that the system further comprising a pressure sensor configured to measure a pressure of the one or more fluid lines. One of ordinary skill in the art would have been motivated to make this modification because incorporating a first pressure sensor within the first balloon provides a means to measure the pressure of the liquid in the first balloon (see [0024] of Ishibashi). The pump control receives output values of the first pressure sensor and then controls the pump so that these pressure value is maintained within the first balloon (see [0033] of Ishibashi).
The system of Gildoni and Zarembinski modified in view of a teaching of Ishibashi will hereinafter be referred to as the system of Gildoni, Zarembinski and Ishibashi.
With regards to claim 17, the system of Gildoni, Zarembinski and Ishibashi teaches the claimed invention of claim 16, however Gildoni is silent with regards to the system further comprising:
a pump fluidly coupled to the fluid reservoir; and a controller in electrical communication with the pressure sensor and the pump, the controller configured to control the pump to inflate the first and second balloons while using the pressure of the one or more fluid lines as feedback.
Nonetheless Ishibashi, which is within the analogous art of balloons with pressure sensors (see Figs. 1 and 10 and [0024]), further teaches the system (see Fig. 1) further comprising:
a pump (170; see [0028] “the first pump 170 feeds the liquid from the liquid tank 190 toward the first tube 230 and the second tube 235”) fluidly coupled to the fluid reservoir (190); and
a controller (160; see [0026] “The pump control section 160 controls operations of the first pump 170…the pump control section 160 is connected to the first pressure sensor 240”) in electrical communication with the pressure sensor (240) and the pump (170), the controller configured to control the pump to inflate the first and second balloons (210, 220; see [0026] “first balloon 210…second balloon 220”) while using the pressure of the one or more fluid lines as feedback (see [0024], [0026], and [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Gildoni, Zarembinski, and Ishibashi in view of a further teaching of Ishibashi such that the system further comprising: a pump fluidly coupled to the fluid reservoir; and a controller in electrical communication with the pressure sensor and the pump, the controller configured to control the pump to inflate the first and second balloons while using the pressure of the one or more fluid lines as feedback. One of ordinary skill in the art would have been motivated to make this modification because incorporating a pressure sensor within the first balloon provides for a means to measure the pressure of the liquid in the first balloon (see [0024] of Ishibashi). The pump control receives output values of the first pressure sensor and then controls the pump so that these pressure value is maintained within the first balloon (see [0033] of Ishibashi).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vrba et al. (US 2019/0069949 A1) see Figs. 29C-1 and 29C-2.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
02/09/2026