DETAILED ACTION
This action is pursuant to the claims filed on 10/10/25. Currently, claims 1-12 and 15-39 are pending with claims 1, 9, and 25 amended, and claims 13-14 previously canceled. Below follows a complete examination of claims 1-12 and 15-39.
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 02/26/2025.
Response to Amendment
Examiner acknowledges the amendments made to the independent claims 1, 9, and 25. Claims 1-12 and 15-39 are currently pending in the present application
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“mechanism” in claim 1; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claim 5; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claim 9; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“First mechanism” in claim 9; corresponding structure = first piston (at least [0043], [0049], [0056], [0060])
“Second mechanism” in claim 9; corresponding structure = second piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claims 10; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claim 11; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claim 17; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claim 20; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claim 25; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“First mechanism” in claim 25; corresponding structure = first piston (at least [0043], [0049], [0056], [0060])
“Second mechanism” in claim 25; corresponding structure = second piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claim 29; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“First mechanism” in claim 34; corresponding structure = first piston (at least [0043], [0049], [0056], [0060])
“Second mechanism” in claim 34; corresponding structure = second piston (at least [0043], [0049], [0056], [0060])
“mechanism” in claim 39; corresponding structure = piston (at least [0043], [0049], [0056], [0060])
“Third mechanism” in claim 39; corresponding structure = third piston (at least [0043], [0049], [0056], [0060])
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-3 and 5-31, and 34-38 are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al (US PGPUB: 2014/0371736) in view of Satake (US PGPUB: 2015/0148742), further in view of McMahon et al (US PGPUB: 2005/0020973) further in view of Bonnette (US PGPUB 2014/0257097).
Regarding independent claim 1, Levin discloses a method (Fig. 18) using a balloon catheter (Fig. 1-4B: 100) for ablation (at least [0121], [0123], [0177]), the method comprising:
positioning, at a first target site ([0053]; [0121] refers to positioning device 100 in a body lumen; Fig. 18: step 210, [0178]), the balloon catheter (100) having a catheter (110) and a balloon (120);
inflating the balloon to a first volume and pressure ([0121] discusses inflating the balloon with a fluid to “a predetermined delivery volume and/or when the pressure in balloon 120 reaches a pre-determined pressure; Fig. 18: step 230, [0181]); and
ablating a target tissue at the first target site ([0121], [0123], [0177]; Fig. 18: step 230; [0183], [0190]) by using a mechanism (combination of fluid extraction device 700 and fluid delivery device 600) to continuously direct a fluid into and out of the balloon through the catheter while maintaining a first volume and pressure of the balloon using the mechanism to simultaneously direct the fluid out of the first reservoir (600) and into the second reservoir (700) via the balloon catheter at equal flow rates ([0056] “a continuous flow of fluid to and from the treatment element”; [0128], [0133], [0137], [0142], refers to simultaneous delivery and withdrawal of fluid (i.e. same flow rates) into the balloon to maintain the pressure (and necessarily the volume); [0137] refers to the simultaneous and continuous delivery and withdrawal of fluid via the mechanism, note simultaneous delivery and withdrawal results in the first reservoir (600) decreasing in volume as fluid is delivered and the second reservoirs (700) increasing equally in volume as the fluid is extracted; Further note that it naturally follows that the flow rates into and out of the balloon are equal as the pressure inside the balloon is maintained, as unequal flow rates would result in a varying pressure).
While Levin disclose inflating the balloon, Levin does not explicitly disclose inflating the balloon by delivering inflation fluid to the balloon from an inflation chamber and wherein the inflation chamber is separate from the first reservoir and the second reservoir and wherein inflating the balloon includes activating a drive mechanism and a piston, the drive mechanism arranged partially within the inflation chamber.
However, Satake does disclose a balloon system (Fig. 2A-2B) comprising a first reservoir (28) and a second reservoir (21). The system further comprises an inflation chamber (56) to inflate the balloon (6; [0059]- [0061]). The inflation chamber (56) is separate from the first and second reservoir (Fig. 2A-2B), and wherein inflating the balloon includes activating a drive mechanism (syringe 55, [0045]) and a piston (see the stopcock system 32 which comprises a plug end 49 and in conjunction the plug end 49 and stopcock 32 are a slideable unit used for compressing and releasing the tank and thereby acting as a piston, [0043]), the drive mechanism being structurally separate from the inflation chamber (see the fig 2A for the stopcock or piston system 32 being in a structurally different location from the inflation chamber 56) and arranged partially within the inflation chamber (see fig 2A, in which the syringe 55 or drive mechanism is partially arranged in the inflation chamber 56). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Levin to incorporate the by delivering inflation fluid to the balloon from an inflation chamber and wherein the inflation chamber is separate from the first reservoir and the second reservoir of Satake. This configuration provides benefit of improve and uniform energy delivery to the tissue ([0061]), thereby increasing the efficiency of the device.
Further, Levin does not explicitly disclose the mechanism providing a direct physical connection between the first and second reservoir.
However, McMahon discloses a system (Fig. 14) comprising mechanism (93), a first reservoir (90), and a second reservoir (91). The mechanism (93) provides a direct physical connection between the first and second reservoirs to continuously and simultaneously direct fluid into and out of the system ([0086]- [0087]; Fig. 14). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Levin to incorporate the mechanism providing a direct physical connection between the first and second reservoir of McMahon. This configuration provides benefit of a simple compact arrangement ([0086]).
The previous combination does not explicitly disclose wherein the mechanism is coupled to i) a first lumen situated between the first reservoir and the mechanism and ii) a second lumen situated between the second reservoir and the mechanism, each of the first lumen and second lumen having a one-way valve disposed within the respective lumen such that fluid simultaneously flows into and out of the inflation chamber from the first reservoir and the second reservoir, respectively, during operation of the mechanism.
However, the analogous double action infusion pump system taught by Bonnette does teach a system in which the mechanism (see piston mechanism 204) is coupled to i) a first lumen situated (see a first inlet lumen 208 connected to the piston mechanism 204) between the first reservoir (in which the first inlet lumen is connected to the first reservoir 108, [0022]) and the mechanism and ii) a second lumen situated between the second reservoir and the mechanism (see in which there is a second inlet lumen 210 which is connected to both the piston mechanism 204 and the second reservoir 114, [0022]) , each of the first lumen and second lumen having a one-way valve disposed within the respective lumen (see in which both lumen inlets 208 and 210 contain unidirectional valves 220, [0027]) such that fluid simultaneously flows into and out of the inflation chamber from the first reservoir and the second reservoir, respectively, during operation of the mechanism (such that the unidirectional valves both feed into the main cylinder 202 which is connected to the inflation chamber during treatment, [0027]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the methods for using a ballon ablation catheter taught by the previous combination with that of the double lumen and double reservoir mechanism activation system taught by Bonnette, as a way to successfully inject multiple fluid sources into the inflation chamber while maintaining ideal balloon inflation size, as taught by Bonnette, [0027].
Regarding dependent claim 2, in view of the combination of claim 1, Levin further discloses further comprising heating the fluid to generate a heated fluid (at least [0121], [0129] discuss inflating the balloon with a heated fluid) and ablating the target tissue at the first target site with heat from the heated fluid (at least [0121], [0123] discusses ablating the tissue with heat from the heated fluid).
Regarding dependent claim 3, in view of the combination of claim 2, Levin further discloses wherein in the step of positioning, the balloon is configured to ablate the target tissue at the first target site in a desired pattern via the heat from the heated fluid ([0121] discusses ablating a body lumen; as broadly claimed, the balloon will ablate portions of the tissue in sufficient contact with the balloon in a circular pattern).
Regarding dependent claim 5, in view of the combination of claim 1, McMahon further discloses further comprising reversing operation of the mechanism to reverse the flow of the fluid in and out of the balloon, while maintaining the first volume and pressure of the balloon ([0086]- [0087]).
Regarding dependent claim 6, in view of the combination claim 5, Levin further discloses further comprising repositioning the catheter to a different target site, and continuously directing the fluid into and out of the balloon through the catheter while maintaining a second volume and pressure within the balloon to ablate a target tissue at the second site ([0127] discusses repositioning the device 100 during treatment; it is noted that [0127] discusses this is done “between treatment of a first portion of tissue and a second portion of tissue”, thus the balloon will be maintained at second pressure/volume at this second portion (i.e. different target site)).
Regarding dependent claim 7, in view of the combination claim 1, Levin further discloses wherein in the step of positioning, the balloon catheter further comprises an infusion device (600) in fluid communication with the balloon catheter (Fig. 4A-4B; [0137] discusses the infusion device 600 coupled to the device).
Regarding dependent claim 8, in view of the combination claim 1, Levin further discloses further comprising after the positioning step, attaching an infusion device to the catheter, the infusion device configured to be in fluid communication with the balloon via the catheter ([0052] discusses positioning the balloon at the target site and [0056] discusses the method further comprises attaching a fluid delivering device to provide continuous flow of fluid).
Regarding independent claim 9, Levin discloses a system (Fig. 1-4B) for tissue ablation (at least [0121], [0123], [0177]), the system comprising:
a catheter (100) having an inflow lumen (160) and an outflow lumen (113);
a balloon (120) positioned at a distal end of the catheter (see Fig. 1-4B), the balloon being in fluid communication with the inflow lumen and the outflow lumen ([0137]); and
an infusion device (combination of 600 and 700) comprising:
a first reservoir (600) in fluid communication with the inflow lumen ([0137] 600 in fluid communication with inflow lumen 160 via port 161);
a second reservoir (700) in fluid communication with the outflow lumen ([0137] 700 in fluid communication with inflow lumen 113 via port 163); and
Satake discloses an inflation chamber in fluid communication with the balloon (56) and separate from the first reservoir and the second reservoir (see figs 2A-2B);
a mechanism (combination of fluid extraction device 700 and fluid delivery device 600) is configured to drive a fluid out of the first reservoir and into the balloon via the inflow lumen while simultaneously drawing the fluid into the second reservoir from the balloon via the outflow lumen at the same flow rate such that a total volume of the fluid in the first reservoir and the second reservoir remains constant during an entire infusion and the fluid is directed into and out of the balloon through the catheter while maintaining the balloon at a constant pressure and volume during the entire infusion to ablate a target tissue proximate the balloon ([0056] “a continuous flow of fluid to and from the treatment element”; [0128], [0133], [0137], [0142], refers to simultaneous delivery and withdrawal of fluid into the balloon via the reservoirs 600/700 to maintain the pressure (and necessarily the volume); ablation via hot fluid at [0121], [0123], [0177]; Fig. 18: step 230; [0183], [0190]); and
Satake discloses an inflation chamber mechanism including at least a piston (57) and a separate inflation chamber drive mechanism (syringe 55) configured to allow for delivery of fluid out of the inflation chamber and into the balloon (plunger 57 is associated with inflation chamber 56 to inflate and control the balloon, [0059]- [0061]); and
wherein separate chambers define the first reservoir and the second reservoir (Fig. 4A).
Satake does not explicitly disclose the piston extending perpendicular to the inflation chamber drive mechanism, however as seen in the figure 2A of Satake the fluid flow directions of the piston system 32 and the drive mechanism 55 are arranged in a perpendicular direction of each other and therefore the structural benefit is the same and would be obvious for one skilled in the art to have the piston and drive mechanism be perpendicular of each other.
Levin does not explicitly disclose the mechanism providing a direct physical connection between the first and second reservoir and wherein the mechanism includes a first mechanism associated with the first reservoir, a second mechanism associated with the second reservoir, and a mechanical link controlling motion of the first and second mechanisms relative to one another.
However, McMahon discloses a system (Fig. 4A) comprising first mechanism (23) associated with a first reservoir (3) a second mechanism (22) associated with a second reservoir (1), and a mechanical link (trigger 20; [0068]) controlling motion of the first and second mechanisms relative to each other ([0068]). The provides a direct physical connection between the first and second reservoirs to continuously and simultaneously direct fluid into and out of the system ([0068]; Fig. 4A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Levin to incorporate the mechanism providing a direct physical connection between the first and second reservoir and wherein the mechanism includes a first mechanism associated with the first reservoir, a second mechanism associated with the second reservoir, and a mechanical link controlling motion of the first and second mechanisms relative to one another of McMahon. This configuration provides benefit of a simple compact arrangement ([0086]).
The previous combination does not explicitly disclose wherein the mechanism is coupled to i) a first lumen situated between the first reservoir and the mechanism and ii) a second lumen situated between the second reservoir and the mechanism, each of the first lumen and second lumen having a one-way valve disposed within the respective lumen such that fluid simultaneously flows into and out of the inflation chamber from the first reservoir and the second reservoir, respectively, during operation of the mechanism.
However, the analogous double action infusion pump system taught by Bonnette does teach a system in which the mechanism (see piston mechanism 204) is coupled to i) a first lumen situated (see a first inlet lumen 208 connected to the piston mechanism 204) between the first reservoir (in which the first inlet lumen is connected to the first reservoir 108, [0022]) and the mechanism and ii) a second lumen situated between the second reservoir and the mechanism (see in which there is a second inlet lumen 210 which is connected to both the piston mechanism 204 and the second reservoir 114, [0022]) , each of the first lumen and second lumen having a one-way valve disposed within the respective lumen (see in which both lumen inlets 208 and 210 contain unidirectional valves 220, [0027]) such that fluid simultaneously flows into and out of the inflation chamber from the first reservoir and the second reservoir, respectively, during operation of the mechanism (such that the unidirectional valves both feed into the main cylinder 202 which is connected to the inflation chamber during treatment, [0027]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the methods for using a ballon ablation catheter taught by the previous combination with that of the double lumen and double reservoir mechanism activation system taught by Bonnette, as a way to successfully inject multiple fluid sources into the inflation chamber while maintaining ideal balloon inflation size, as taught by Bonnette, [0027].
Regarding dependent claim 10, in view of the combination of claim 9, McMahon further discloses wherein the one or more mechanisms divide a chamber into a first portion defining the first reservoir and a second portion defining the second reservoir (Fig. 4A; Fig. 14).
Regarding dependent claim 11, in view of the combination of claim 10, McMahon further discloses wherein movement of the mechanism along the chamber drives the fluid out of the first reservoir while simultaneously drawing the fluid into the second reservoir ([0068]; Fig. 4A).
Regarding dependent claim 12, in view of the combination of claim 10, McMahon further discloses wherein the mechanism comprises a piston ([0068]) dividing the first reservoir and the second reservoir within the chamber ([0068]; Fig. 4A).
Regarding dependent claim 15, in view of the combination of claim 9, McMahon further discloses wherein the mechanism comprises the first mechanism including a first piston (23) in the first reservoir (3) mechanically-linked to a second mechanism including a second piston (22) in the second reservoir (1) such that motion of the first and second pistons is equal and opposite to one another ([0068]).
Regarding dependent claim 16, in view of the combination of claim 9, McMahon further discloses wherein the mechanism is configured to decrease a volume of the first reservoir to drive the fluid out of the first reservoir while simultaneously increasing a volume of the second reservoir to draw the fluid into the second reservoir ([0068]).
Regarding dependent claim 17, in view of the combination of claim 9, McMahon further discloses wherein the mechanism divides a chamber into a first portion defining the first reservoir and a second portion defining the second reservoir (Fig. 4A; Fig. 14), and wherein movement of the mechanism along the chamber causes the volumes of the first and second reservoirs to change at an equal and opposite rate relative to one another ([0068]; Fig. 14; Fig. 4A).
Regarding dependent claim 18, in view of the combination of claim 9, Levin further discloses wherein the mechanism comprises a first mechanism associated with the first reservoir ([0137] refers to 600 as a pump, interpreted as first mechanism) mechanically-linked to a second mechanism associated with the second reservoir ([0137] refers to 700 as a pump, interpreted as second mechanism) such that the volumes of the first and second reservoirs change at an equal and opposite rate relative to one another ([0137] refers to the simultaneous and continuous delivery and withdrawal of fluid via the first and second mechanism, where these mechanism are necessarily mechanically linked in order to simultaneously withdrawn and deliver; note simultaneous delivery and withdrawal results in the first reservoir (600) decreasing in volume as fluid is delivered and the second reservoirs (700) increasing equally in volume as the fluid is extracted).
Regarding dependent claim 19, in view of the combination of claim 9, Levin further discloses wherein the infusion device is disposable (600/700 care capable of being detached and disposed).
Regarding dependent claim 20, in view of the combination of claim 9, Levin further discloses wherein the mechanism is manually activated (600/700 are capable of being manually activated, at least when powered on; note [0039] discloses the system is capable of utilizing a syringe for fluid delivery to the balloon).
Regarding dependent claim 21, in view of the combination of claim 9, Levin further discloses further comprising a heating mechanism to heat the fluid to generate a heated fluid in order to maintain a constant temperature in the balloon via the heated fluid ([0129] refers to the heating mechanism for heating the fluid in the balloon).
Regarding dependent claim 22, in view of the combination of claim 9, Levin further discloses configured to ablate malignant tumors or other non-malignant tissue (at least [0008], [0121] discusses ablating a target).
Regarding dependent claim 23, in view of the combination of claim 9, Levin further discloses wherein the tissue ablation is configured to perform cardiac tissue ablation to treat arrhythmias (at least [0008], [0121] discusses ablating a target, capable of performing cardiac ablation to treat arrhythmias).
Regarding dependent claim 24, in view of the combination of claim 9, Levin further discloses wherein the tissue ablation is configured to perform renal nerve ablation to treat refractory hypertension (at least [0008], [0121] discusses ablating a target, capable of performing renal nerve ablation to treat refractory hypertension).
Regarding independent claim 25, Levin discloses a method (Fig. 18) of using a balloon catheter (Fig. 1-4B: 100) for tissue ablation (at least [0121], [0123], [0177]), the method comprising:
positioning the balloon catheter (100) at a first target site ([0053]; [0121] refers to positioning device 100 in a body lumen; Fig. 18: step 210, [0178]), the balloon catheter comprising a catheter (110) and a balloon (120); inflating the balloon to a first volume and pressure by delivering inflation fluid to the balloon from an inflation chamber (wherein balloon 120 is configured to be inflated to a first volume via the syringe 150 through the lumen 113 which create an inflation chamber, [0121]),; and
using a mechanism (combination of fluid extraction device 700 and fluid delivery device 600) to drive fluid out of the first reservoir (600) and into the balloon via the catheter while simultaneously drawing the fluid into the second reservoir (700) from the balloon via the catheter at the same flow rate such that a total volume of fluid in the first reservoir and the second reservoir remains constant during an entire infusion and the fluid is directed into and out of the balloon through the catheter while maintaining the balloon at a constant pressure and volume during the entire infusion to ablate a target tissue at the target site ([0056] “a continuous flow of fluid to and from the treatment element”; [0128], [0133], [0137], [0142], refers to simultaneous delivery and withdrawal of fluid (i.e. same flow rate) into the balloon via the reservoirs 600/700 to maintain the pressure (and necessarily the volume); ablation via hot fluid at [0121], [0123], [0177]; Fig. 18: step 230; [0183], [0190]);
Levin does not explicitly disclose the mechanism providing a direct physical connection between the first and second reservoir; and wherein the mechanism includes a first mechanism associated with the first reservoir, a second mechanism associated with the second reservoir, and a mechanical link controlling motion of the first and second mechanisms relative to one another such that the step of driving the fluid out of the first reservoir while simultaneously drawing the fluid into the second reservoir using the mechanism includes moving one of the first or second mechanisms and allowing the mechanical link to move the other of the first or second mechanisms.
However, McMahon discloses a system (Fig. 4A) comprising first mechanism (23) associated with a first reservoir (3) a second mechanism (22) associated with a second reservoir (1), and a mechanical link (trigger 20; [0068]) controlling motion of the first and second mechanisms relative to each other ([0068]) such that the step of driving the fluid out of the first reservoir while simultaneously drawing the fluid into the second reservoir using the mechanism includes moving one of the first or second mechanisms and allowing the mechanical link to move the other of the first or second mechanisms ([0068]). The provides a direct physical connection between the first and second reservoirs to continuously and simultaneously direct fluid into and out of the system ([0068]; Fig. 4A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Levin to incorporate providing a direct physical connection between the first and second reservoir; and wherein the mechanism includes a first mechanism associated with the first reservoir, a second mechanism associated with the second reservoir, and a mechanical link controlling motion of the first and second mechanisms relative to one another such that the step of driving the fluid out of the first reservoir while simultaneously drawing the fluid into the second reservoir using the mechanism includes moving one of the first or second mechanisms and allowing the mechanical link to move the other of the first or second mechanisms of McMahon. This configuration provides benefit of a simple compact arrangement ([0086]).
Levin furthermore does not explicitly state wherein inflating the balloon includes activating a drive mechanism and a piston, the drive mechanism arranged partially within the inflation chamber and the piston extending perpendicular to the inflation chamber drive mechanism.
However, Satake does teach inflating the balloon includes activating a drive mechanism (syringe 55, [0045]) and a piston (plunger 57, [0045], the drive mechanism arranged partially within the inflation chamber and (see fig 2A, in which the syringe 55 or drive mechanism is partially arranged in the inflation chamber 56). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Levin to incorporate the by delivering inflation fluid to the balloon from an inflation chamber and wherein the inflation chamber is separate from the first reservoir and the second reservoir of Satake. This configuration provides benefit of improve and uniform energy delivery to the tissue ([0061]), thereby increasing the efficiency of the device.
Satake does not explicitly disclose the piston extending perpendicular to the inflation chamber drive mechanism, however as seen in the figure 2A of Satake the fluid flow directions of the piston system 32 and the drive mechanism 55 are arranged in a perpendicular direction of each other and therefore the structural benefit is the same and would be obvious for one skilled in the art to have the piston and drive mechanism be perpendicular of each other.
The previous combination does not explicitly disclose wherein the mechanism is coupled to i) a first lumen situated between the first reservoir and the mechanism and ii) a second lumen situated between the second reservoir and the mechanism, each of the first lumen and second lumen having a one-way valve disposed within the respective lumen such that fluid simultaneously flows into and out of the inflation chamber from the first reservoir and the second reservoir, respectively, during operation of the mechanism.
However, the analogous double action infusion pump system taught by Bonnette does teach a system in which the mechanism (see piston mechanism 204) is coupled to i) a first lumen situated (see a first inlet lumen 208 connected to the piston mechanism 204) between the first reservoir (in which the first inlet lumen is connected to the first reservoir 108, [0022]) and the mechanism and ii) a second lumen situated between the second reservoir and the mechanism (see in which there is a second inlet lumen 210 which is connected to both the piston mechanism 204 and the second reservoir 114, [0022]) , each of the first lumen and second lumen having a one-way valve disposed within the respective lumen (see in which both lumen inlets 208 and 210 contain unidirectional valves 220, [0027]) such that fluid simultaneously flows into and out of the inflation chamber from the first reservoir and the second reservoir, respectively, during operation of the mechanism (such that the unidirectional valves both feed into the main cylinder 202 which is connected to the inflation chamber during treatment, [0027]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the methods for using a ballon ablation catheter taught by the previous combination with that of the double lumen and double reservoir mechanism activation system taught by Bonnette, as a way to successfully inject multiple fluid sources into the inflation chamber while maintaining ideal balloon inflation size, as taught by Bonnette, [0027].
Regarding dependent claim 26, in view of the combination of claim 25, McMahon further discloses wherein the step of driving the fluid out of the first reservoir while simultaneously drawing fluid into the second reservoir includes decreasing a volume of the first reservoir to drive the fluid out of the first reservoir while simultaneously increasing a volume of the second reservoir to draw the fluid into the second reservoir ([0068]).
Regarding dependent claim 27, in view of the combination of claim 26, McMahon further discloses dividing a chamber into a first portion defining the first reservoir and a second portion defining the second reservoir with a mechanism (Fig. 4A; Fig. 14), and moving the mechanism along the chamber causing the volumes of the first and second reservoirs to change at an equal and opposite rate ([0068]; Fig. 14; Fig. 4A).
Regarding dependent claim 28, in view of the combination of claim 25, Levin further discloses wherein separate chambers define the first reservoir and the second reservoir (see Fig. 4a, where 600 and 700 are separate chambers).
Regarding dependent claim 29, in view of the combination of claim 25, McMahon further disclose further comprising reversing operation of the mechanism to reverse a flow of the fluid in and out of the balloon, while maintaining the volume and pressure of the balloon ([0068]; [0087]- [0086]; Fig. 4A; Fig. 14).
Regarding dependent claim 30, in view of the combination of claim 25, Levin further discloses further comprising heating the fluid to generate a heated fluid (at least [0121], [0129] discuss inflating the balloon with a heated fluid) and ablating a target tissue at the target site with heat from the heated fluid (at least [0121], [0123] discusses ablating the tissue with heat from the heated fluid).
Regarding dependent claim 31, in view of the combination of claim 25, Levin further discloses further comprising ablating malignant tumors or other non-malignant tissue with the balloon catheter (at least [0008], [0121], [0123] discusses ablating tissue).
Regarding dependent claim 34, in view of the combination of claim 25, McMahon further discloses wherein moving one of the first or second mechanisms and allowing the mechanical link to move the other of the first or second mechanisms causes a volume of the first reservoir and a volume of the second reservoir to change at an equal and opposite rate relative to one another ([0068]; Fig. 14; Fig. 4A).
Regarding dependent claim 35, in view of the combination of claim 1, Levin further discloses further comprising selecting a size and shape of the balloon based on one of a type, location, size, shape, and adjacent structures to the target tissue ([0147] discusses the shape (e.g. cylinder) and size (i.e. diameter/wall thickness) of the balloon as selected in order to prevent contact between the target tissue and the balloon until the pressure threshold is reached (i.e. based on at least the location/size/shape of the target tissue)). Examiner notes the remainder of the limitations are in the alternative.
Regarding dependent claim 36, in view of the combination of claim 9, Levin further discloses wherein at least one of a size and shape of the balloon is based on one of a type, location, size, shape, and adjacent structures to the target tissue ([0147] discusses the shape (e.g. cylinder) and size (i.e. diameter/wall thickness) of the balloon as selected in order to prevent contact between the target tissue and the balloon until the pressure threshold is reached (i.e. based on at least the location/size/shape of the target tissue)). Examiner notes the remainder of the limitations are in the alternative.
Regarding dependent claim 37, in view of the combination of claim 2, Levin further discloses further comprising: allowing the heated fluid to flow to deliver specific amount of energy to the target tissue (Fi. 18: 230; [0181]- [0184]); deflating the balloon (Fig. 18: 250; [0185] “the expandable treatment element is deflated”); and removing the catheter (Fig. 18: 250; [0185] “such as to remove the treatment element from the target tissue site and the body”).
Regarding dependent claim 38, in view of the combination of claim 2, Levin further discloses further comprising reheating the heated fluid after directing the fluid into and out of the balloon and recirculating it through the balloon ([0012], [0013], [0056], [0116], [0128] discuss the continuously circulation of heated fluid).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Levin et al (US PGPUB: 2014/0371736) in view of Satake (US PGPUB: 2015/0148742) and McMahon et al (US PGPUB: 2005/0020973), further in view of Bonnette (US PGPUB 2014/0257097) further in view of Tihon et al (US Patent No.: 5,335,669).
Regarding dependent claim 4, in view of claim 1, while Levin discloses monitoring the ablation, Levin does not explicitly disclose further comprising monitoring a location and orientation of the balloon relative to the target tissue.
However, Tihon discloses it is known in the art to monitor the position and orientation of a balloon in a body lumen in order to determine it the balloon is property posited and conforming to the lumen walls (Col. 3, Lines 11-21). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Levin to incorporate the step of monitoring a location and orientation of the balloon relative to the target tissue of Tihon. This configuration provides the benefit of ensuring the balloon is property positioned and in contact with the wall of the body lumen (Col. 3, Lines 11-21).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Levin et al (US PGPUB: 2014/0371736) in view of Satake (US PGPUB: 2015/0148742), further in view of McMahon et al (US PGPUB: 2005/0020973), further in view of Bonnette (US PGPUB 2014/0257097) further in view of Stolen et al (US PBPUB: 2009/0054883).
Regarding dependent claim 32, in view of the combination of claim 25 while Levin disclose ablating target tissue, Levin does not explicitly disclose wherein the tissue ablation is cardiac tissue ablation to treat arrhythmias.
However, Stolen discloses a balloon ablation device (Fig. 8: 854) for performing cardiac tissue ablation to treat arrhythmias ([0001], [0005]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Levin to incorporate the step of performing cardiac tissue ablation to treat arrhythmias of Stolen because this provides a controlled destruction of arrhythmia- generating tissue ([0003]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Levin et al (US PGPUB: 2014/0371736) in view of Satake (US PGPUB: 2015/0148742), further in view of McMahon et al (US PGPUB: 2005/0020973), further in view of Bonnette (US PGPUB 2014/0257097) further in view of Squire et al (US PGPUB: 2014/0257281).
Regarding dependent claim 33, in view of the combination of claim 25, while Levin disclose ablating target tissue, Levin does not explicitly disclose wherein the tissue ablation is renal nerve ablation to treat refractory hypertension.
However, Squire discloses a similar balloon device (Fig. 2: 12) that performs renal nerve ablation for treating hypertension ([0026]- [0028]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Levin to incorporate the step of performing renal nerve ablation to treat refractory hypertension of Squire because this reduces are eliminates sympathetic function, which provides a corresponding reduction in the associated undesired symptoms ([0026]).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Levin et al (US PGPUB: 2014/0371736) in view of McMahon et al (US PGPUB: 2005/0020973), further in view of Bonnette (US PGPUB 2014/0257097) further in view of Satake (US PGPUB: 2015/0148742).
Regarding dependent claim 39, in view of the combination of claim 9, the combination does not explicitly disclose wherein the mechanism further includes a third mechanism associated with the inflation chamber.
However, Satake discloses a balloon system (Fig. 2A-2B) comprising a first reservoir (28) and a second reservoir (21). The system further comprises a mechanism (57) that is associated with the inflation chamber (56) to inflate the balloon (6; [0059]- [0061]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Levin to incorporate the wherein the mechanism further includes a third mechanism associated with the inflation chamber of Satake. This configuration provides benefit of improve and uniform energy delivery to the tissue ([0061]), thereby increasing the efficiency of the device.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,9 and 25 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.
Specifically, the examiner agrees with the arguments presented that the previous prior art of record combination did not teach the multi-lumen and multi-reservoir mechanism activation system as required by the newly amended claim limitations of claims 1, 9 and 25. However, upon further search and consideration necessitated by the amended claim language, it has been found that the new prior art of record of Bonnette does disclose all the new claim language as presently amended. Specifically the analogous art of Bonnette does teach a system in which the mechanism (see piston mechanism 204) is coupled to i) a first lumen situated (see a first inlet lumen 208 connected to the piston mechanism 204) between the first reservoir (in which the first inlet lumen is connected to the first reservoir 108, [0022]) and the mechanism and ii) a second lumen situated between the second reservoir and the mechanism (see in which there is a second inlet lumen 210 which is connected to both the piston mechanism 204 and the second reservoir 114, [0022]) , each of the first lumen and second lumen having a one-way valve disposed within the respective lumen (see in which both lumen inlets 208 and 210 contain unidirectional valves 220, [0027]) such that fluid simultaneously flows into and out of the inflation chamber from the first reservoir and the second reservoir, respectively, during operation of the mechanism (such that the unidirectional valves both feed into the main cylinder 202 which is connected to the inflation chamber during treatment, [0027]).
Therefore, claims 1, 9, and 25 remain rejected under the new prior art of record of Levin with those of Satake and MacMahon further in view of Bonnette. As no further arguments or limitations have been presented the remainder of the dependent claims also remain rejected under the prior art of record rejection set forth in the previous office action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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