DETAILED ACTION
The following is a 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/30/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 7/30/2025.
Applicant’s amendments to the drawings are sufficient to overcome the drawings objection set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Claim Objections
Claim 11 is objected to because of the following informalities: amend “electrode” to -electrodes- in ll. 2. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: amend “the ablation electrode” to -the one or more ablation electrodes- in ll. 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 & 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation “the one or more ablation electrodes is a coil-type ablation electrode which is wound in a shape of a coil around the body to improve flexibility”; however, claim 1, upon which claim 5 depends, recites the limitation “the one or more ablation electrodes are spirally wrapped around a surface of the catheter body and directly contacting the surface”. It is unclear how claim 5 further limits claim 1 since claim 1 already recites the ablation electrode as being spirally wrapped around and directly contacting the outer surface of the body.
Claim 7 recites the limitation "the either electrode" in ll. 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 depends from claim 7 and is thus also rejected.
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) 1-6 & 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (2003/0060822) in view of Bourang et al. (2002/0173835, previously cited), Schaer (5,782,760, previously cited) and Champeau (6,208,881, previously cited).
Concerning claims 1-3¸as illustrated in at least Fig. 7, Schaer et al. ‘822 disclose a catheter for treatment of atrial fibrillation of a heart (ablation member 12c; [0142]), the catheter comprising:
a body (comprised of elongated body 16, porous membrane 58c, braided structure 76c, and end cap 64; [0072], [0094], [0142]) which has one or more ablation electrodes formed on a distal part of the body wherein the one or more ablation electrodes are spirally wrapped around a surface of the catheter body and directly contacting the surface (helical wire electrodes 52c are placed about the braided structure 76c and porous membrane 58c; [0103], [0143]); 8and
a tapered tip which is connected to the body and becomes thinner toward an end thereof, wherein a guidewire lumen is formed in the body and fluidly connects to the tapered tip (end cap 64 has a tapering shape which decreases in diameter distally and has a port which aligns with the distal end of the guidewire tube 34; [0094]);
wherein the guidewire lumen is configured to insert a guidewire therein (distal port 67 is sized to receive a guidewire over which the elongated body 16 and the ablation member 12 track where the port, thus, allows the guidewire to pass through the end cap 64; [0099]);
Schaer et al. ‘822 fail to disclose the guidewire lumen fluidly connected to both the tip and outer surface of the body part proximal to the one or more ablation electrodes, the guidewire lumen formed from the end of the tip to a side hole formed in a side surface of an intermediate portion of the catheter and connected from the end of the tip toward a proximal part of the catheter. However, Bourang et al. disclose a catheter comprising a guidewire lumen connected to the tip and outer surface of the body part proximal to the one or more ablation electrodes, the guidewire lumen formed from the end of the tip to either a proximal end of the catheter or a side port formed in a side surface of an intermediate portion of the catheter and connected from the end of the tip toward a proximal part of the catheter. 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 Schaer et al. ‘822 such that the guidewire lumen fluidly connects to the tip and outer surface of the body part proximal to the one or more ablation electrodes, the guidewire lumen formed from the end of the tip to a side hole formed in a side surface of an intermediate portion of the catheter and connected from the end of the tip toward a proximal part of the catheter in order to provide the benefit of reducing the overall profile of the catheter and providing short and side exchange capabilities of the catheter as taught by Bourang et al. and since Bourang et al. teach termination of the lumen at the proximal end or a side port to be equivalents in the art for the purposes of guiding the catheter. ([0012])
Schaer et al. ‘822 in view of Bourang et al. fail to disclose one or more sensing electrodes spaced apart from the one or more ablation electrodes and configured to sense an electrical signal of the heart formed on a surface of the body and a sensing electrode wire connected to the sensing electrode. However, Schaer ‘760 disclose a catheter comprising one or more sensing electrodes (18) which are spaced apart from the ablation electrode (70) and configured to sense an electrical signal of the heart and formed on a surface of the body part (11) and a sensing electrode wire (16) connected to the sensing electrode (18) (Col. 5, ll. 11-30; Fig. 13-16). 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 Schaer et al. ‘822 in view of Bourang et al. to further comprise one or more sensing electrodes which are spaced apart from the ablation electrode and configured to sense an electrical signal of the heart are formed on a surface of the body part and a sensing electrode wire connected to the sensing electrode in order to provide the benefit of detecting electrical activity of the patient’s heart from within the blood vessel to ensure accurate placement and effective lesion formation as taught by Schaer ‘760. (Col. 2-3, ll. 45-4, Col. 7, ll. 12-21; Fig. 17-18)
Schaer et al. ‘822 in view of Bourang et al. and Schaer ‘760 fail to disclose the sensing electrode wire is a silver wire which is spirally wrapped around the catheter and covered with a material harmless to the human body. However, Champeau discloses a catheter (10) comprising an sensing electrode wire (18-26) connected to a sensing electrode (30, 32, 34, 36, 38) to be a silver wire which is spirally wrapped around the catheter (10) and covered with a material harmless (insulative coating) to the human body. 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 Schaer et al. ‘822 in view of Bourang et al. and Schaer ‘760 such that the sensing electrode wire is a silver wire which is spirally wrapped around the catheter and covered with a material harmless to the human body in order to provide the benefit of a suitable material and a small diameter catheter body as taught by Champeau. (Col. 4-5, ll. 66-21)
Concerning claim 4, Schaer et al. ‘822 disclose the tip (64) has an atraumatic tip structure in which an edge of an end of the tip has a round shape so that, when the catheter is inserted along a blood vessel, damage to the blood vessel does not occur (Fig. 7). Schaer et al. ‘822 fail to specifically disclose the tip is tapered. However, in an alternative embodiment of Fig. 2-3, an end cap (64) that has a tapering atraumatic tip. 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 Schaer et al. ‘822 in view of Bourang et al. and Schaer ‘760 such that the tip is a tapered atraumatic tip in order to provide the benefit of decreasing the diameter distally in order to provide the benefit of easier tracking through a venous or arterial access path as taught by Schaer et al. ‘822 ([0094], [0145]; Fig. 2-3)
Concerning claim 5, Schaer et al. ‘822 disclose the one or more ablation electrodes (52c) is a coil-type ablation electrode which is wound in the shape of a coil around the body (11) to improve flexibility ([0103], [0106]).
Concerning claim 6, Schaer et al. ‘822 disclose an electrode wire (54) connected to the one or more ablation electrodes (52) ([0105]). Schaer et al. ‘822 in view of Bourang et al., Schaer ‘760 and Champeau fail to disclose the electrode wire is a silver wire which is spirally wrapped around the body and covered with a material harmless to the human body. However, Champeau discloses a catheter (10) comprising an electrode wire (18-26) connected to an electrode (30, 32, 34, 36, 38) to be a silver wire which is spirally wrapped around the catheter (10) and covered with a material harmless (insulative coating) to the human body. 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 Schaer et al. ‘822 in view of Bourang et al., Schaer ‘760 and Champeau such that the electrode wire is a silver wire which is spirally wrapped around the catheter body and covered with a material harmless to the human body in order to provide the benefit of a suitable material and a small diameter catheter body as taught by Champeau. (Col. 4-5, ll. 66-21)
Concerning claim 11, Schaer ‘760 further disclose the sensing electrode (18) has a smaller width than the ablation electrode (70) (Fig. 17).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (2003/0060822) in view of Bourang et al. (2002/0173835, previously cited), Schaer (5,782,760, previously cited) and Champeau (6,208,881, previously cited), as applied to claim 1, in further view Maguire et al. (5,755,760, previously cited).
Concerning claim 7, Schaer et al. ‘822/Bourang et al./Schaer ‘760/Champeau combination fail to disclose wherein, in order to measure a temperature of the electrode, two strands of a thermocouple wire from a proximal part to the distal part. However, Maguire et al. disclose a catheter comprising a thermocouple(s) for measuring temperature(s) of adjacent electrode(s). 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 Schaer et al. ‘822/Bourang et al./Schaer ‘760/Champeau combination to further comprise a thermocouple in order to provide the benefit of measuring electrode temperature and regulating power applied to the electrode as taught by Maguire et al. (Col. 2, ll. 17-26, Col. 5, ll. 8-19). The Schaer et al. ‘822/Bourang et al./Schaer ‘760/Champeau/Maguire combination fail to specifically disclose the two strands of the thermocouple wire are spirally wrapped around the catheter body from the proximal part to the distal part while being wound together. However, Champeau teaches spirally wrapping sensing wires around the catheter from the proximal part to the distal part while being wound together. 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 Schaer et al. ‘822/Bourang et al./Schaer ‘760/Champeau/Maguire combination such that the two strands of the thermocouple wire are spirally wrapped around the catheter body from the proximal part to the distal part while being wound together in order to provide the benefit a small diameter catheter body as taught by Champeau. (Col. 4-5, ll. 66-21)
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (2003/0060822) in view of Bourang et al. (2002/0173835, previously cited), Schaer (5,782,760, previously cited) and Champeau (6,208,881, previously cited), as applied to claim 7, in further view of Thermocouple Info (Wayback Machine 2014, previously cited).
Concerning claim 8, Schaer/Bourang et al./Champeau/Maguire et al. combination fails to disclose one of the thermocouple wire is a nickel-chromium wire that is harmless to the human body, and a second strand of the thermocouple wire is a nickel-alumel wire that is harmless to the human body. However, Thermocouple Info teaches that Type K thermocouples are the most common type of thermocouple and are comprised of nickel-chromium and nickel-alumel wires. 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 Schaer/Bourang et al./Champeau/Maguire et al. combination such that one of the thermocouple wire is a nickel-chromium wire that is harmless to the human body, and the second strand of the thermocouple wire is a nickel-alumel wire that is harmless to the human body in order to provide the benefit of a thermocouple that is inexpensive, accurate, reliable, and has a wide temperature range as taught by Thermocouple Info.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 & 11 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.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794