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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/18/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 1/13/2026 and 2/18/2026.
Applicant' s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Response to Arguments
Applicant's arguments filed 1/13/2026 have been fully considered but they are not persuasive. Regarding claim 1, applicant argues that Miles in view of Witzel does not disclose the claim language “applying, based on a desired amount of shrinkage, an approximating force to at least one of the electrodes thereby reducing the distance between the electrodes and reducing a tension of the tissue in a direction of the approximating force". In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). While Witzel teaches compressively sandwiching tissue, in combination with Miles, the ability to apply an approximating force that reduces the distance between electrodes and reduces a tension of the tissue based on a desired amount of shrinkage would be combined with the first and second electrodes 52 and 54 of Miles. Thus, using balloons for compression as taught by Witzel would be used to compress the electrodes of Miles in combination. Therefore, the combination of Miles in view of Witzel does disclose the claim language “applying, based on a desired amount of shrinkage, an approximating force to at least one of the electrodes thereby reducing the distance between the electrodes and reducing a tension of the tissue in a direction of the approximating force" because Miles discloses two electrodes with tissue between them (electrodes 52 and 54) and Witzel discloses reducing the distance between two electrodes by applying an approximating force with balloons 91 and 59 based on a desired amount of shrinkage, , as seen in paragraphs [0063] and [0073] of Witzel.
Regarding claims 11 and 31, applicant argues that Engelman in view of Witzel does not disclose reducing a tension. However, this is an inherent property of compressing tissue, thus Engelman and Witzel do reduce a tension of tissue. Applicant argues that there is no evidence that tension exists. However, cardiac tissue has both passive and active tension and thus, the devices of Engelman and Witzel do not need to create a tension that must then be reduced because the tissue inherently has tension. Paragraph [0049] of applicant’s specification states “For example, the approximating mechanism can draw the guide tubes 108a- b together (i.e., approximate the guide tubes 108a-b) with sufficient force to overcome the naturally occurring tension in the tissue.” Thus, it is clear that the tissue has a naturally occurring tension in cardiac tissue that a force can overcome.
Regarding claim 22, applicant argues that Witzel does not disclose treating a cord of chordae tendineae. However, chordae tendineae are entirely made of cords. Thus, by treating chordae tendineae, one must treat at least one cord of chordae tendineae. The claim language does not require that only one cord is treated at a time. Applicant additionally argues that there is no tension in the tissue of Witzel inherently prior to being compressed. However, as stated above, cardiac tissue has both passive and active tension. Thus, there is tension inherent to the tissue. There is no requirement in the claim language that the tension in the tissue is created by the method or device of the claims. Also, there does not appear to be support in applicant’s specification for the method or device to create tension in the tissue.
Thus, applicant's arguments have been fully considered, but there are not persuasive. Therefore, the previous rejections of claims 1, 11, 22, and 31 stand.
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 limitations 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 limitations are: "a mechanism to actively increase the spacing" in claims 5 and 15; “a mechanism that actively decreases the spacing” in claim 10; “energy delivery mechanism” in claims 11 and 16; “a mechanism thereby decreasing the distance” in claim 19; “a mechanism to actively increase the spacing” in claim 25; “the mechanism thereby actively decreasing the spacing” in claim 28; “approximation mechanism configured to apply… a force” in claim 31; “energy delivery mechanism configured to deliver an energy modality” in claim 32; and “approximation mechanism” in claim 44.
"A mechanism to actively increase the spacing" is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“A mechanism that actively decreases the spacing” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“Energy delivery mechanism” is seen as an electrode in the specification ([0048]), or an equivalent thereof.
“A/the mechanism thereby decreasing the spacing” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“A mechanism actively increasing the spacing” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“Approximation mechanism configured to apply a force” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“Approximation mechanism” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid 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
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-7, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Miles et al., US 20150066016, herein referred to as “Miles”, in view of Witzel et al., US 20140163652, herein referred to as “Witzel”.
Regarding claim 1, Miles discloses a minimally invasive method for reducing a size of a cardiac valve annulus in a beating heart (Figures 1 and 7-7A and Abstract and [0057] and [0099]), comprising: advancing an energy delivery catheter system (Figure 1: medical device system 10) into the beating heart proximate a cardiac valve ([0057]: “With such a medical device system 10, a distal portion of the sheath 14 may be advanced and positioned in the left atrium of the heart so that the treatment catheter system 12 may then be advanced through the sheath 14 to, for example, a valve in the heart, such as a mitral valve 170 (see FIG. 4).”) of the beating heart ([0090]), the energy delivery catheter system including at least two electrodes (Figures 7-7A: first electrode 52 and second electrode 54); advancing the electrodes such that the electrodes pierce into an atrial surface or a ventricular surface of the cardiac valve annulus at a distance from one another (Figures 7-7A: first electrode 52 and second electrode 54 and [0098]: “upon contacting or securing the first and second electrodes 52, 54 to the posterior annulus 180 at the respective first and second target points 210, 212” wherein the surface that faces an atrium is considered an atrial surface and the surface that faces a ventricle is a ventricular surface; based on Figure 4, the surface that is being treated is the atrial surface), wherein tissue of the cardiac valve annulus is positioned between the electrodes (Figure 7); and applying energy between the electrodes ([0098]: “upon contacting or securing the first and second electrodes 52, 54 to the posterior annulus 180 at the respective first and second target points 210, 212, as depicted in FIGS. 6B and 7, the tissue between the first and second electrodes 52, 54 or a first tissue region 190 can be heated by activating the first and second electrodes 52, 54.”) thereby heating and shrinking the tissue in a direction ([0098]: “In one embodiment, the RF energy level may be modulated in the range of about 0 to 100 watts and for a period of time ranging between about twenty seconds to five minutes until the tissue is heated to a temperature in the range of approximately 50 degrees to 85 degrees Celsius.” And [0057]: “With this arrangement, the medical device system 10 may treat the valve by heating the tissue of the annulus, which results in the tissue shrinking, thereby, restoring the valve to normal size and function and to substantially reduce or prevent valve regurgitation.”). Miles does not explicitly disclose a method comprising applying, based on a desired amount of shrinkage, an approximating force to at least one of the electrodes thereby reducing the distance between the electrodes and reducing a tension of the tissue in a direction of the approximating force; and applying energy between the electrodes thereby heating and shrinking the tissue in the direction of the approximating force.
However, Witzel teaches a method (Abstract and Figure 8) comprising applying, based on a desired amount of shrinkage ([0063]; wherein enhanced heat shrinkage/tightening is considered an increase in the amount of shrinkage, which is a desired amount of shrinkage since it is an enhancement), an approximating force to at least one of the electrodes thereby reducing the distance between the electrodes ([0063] and [0073]: wherein inflating the balloon causes the distance between electrode elements 96 and 98 to be reduced) and reducing a tension of the tissue in a direction of the approximating force ([0063]: according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force); and applying energy between the electrodes thereby heating and shrinking the tissue in the direction of the approximating force ([0063] and [0071] and [0031]: “This device, when heated, will place tension on adjacent structures, reducing the diameter and/or limiting the expansion of the mitral annulus and/or diastolic expansion of the left ventricle.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Miles so that it includes applying, based on a desired amount of shrinkage, an approximating force to at least one of the electrodes thereby reducing the distance between the electrodes as taught by Witzel to ensure effective application of tissue-shrinkable energy at a specific site (Witzel [0076]).
Regarding claim 2, Miles in view of Witzel teaches the method of claim 1 and Miles also teaches a method further comprising increasing a spacing between the electrodes (Figures 7-7A: first electrode 52 and second electrode 54) from a compact spacing to an extended spacing ([0009]: “The first and second sleeves each extend through the lumen of the treatment catheter and are moveable between a constricted or constrained position and an expanded position. The first sleeve includes a first electrode and the second sleeve includes a second electrode.”), wherein the spacing between the electrodes in the extended spacing is greater than the spacing between the electrodes in the compact spacing ([0009]: “Further, the first sleeve and the second sleeve are biased away from each other such that, upon being moved to the expanded position, the first and second sleeves splay outward to exhibit a v-configuration.”).
Regarding claim 3, Miles in view of Witzel discloses the method according to claim 2 and Miles further teaches a method wherein the electrodes (Figures 7-7A: first electrode 52 and second electrode 54) are configured to self-extend away from each other when unconstrained, and wherein increasing the spacing between the electrodes includes allowing the at least two electrodes to self-extend away from each other ([0009]: “The first and second sleeves each extend through the lumen of the treatment catheter and are moveable between a constricted or constrained position and an expanded position. The first sleeve includes a first electrode and the second sleeve includes a second electrode. Further, the first sleeve and the second sleeve are biased away from each other such that, upon being moved to the expanded position, the first and second sleeves splay outward to exhibit a v-configuration.”).
Regarding claim 5, Miles in view of Witzel teaches the method of claim 2 and Miles also teaches a method wherein increasing the spacing between the electrodes (Figures 7-7A: first electrode 52 and second electrode 54) includes actuating a mechanism to actively increase the spacing ([0009]: “The first and second sleeves each extend through the lumen of the treatment catheter and are moveable between a constricted or constrained position and an expanded position.” And [0012]: “the first sleeve and the second sleeve are each disposed within a tubular sleeve, the tubular sleeve moveable proximally and distally relative to the first and second sleeves so as to move the first and second sleeves between the constrained position and the expanded position.”).
Regarding claim 6, Miles in view of Witzel teaches the method of claim 1 and Miles also teaches a method wherein the electrodes include a first electrode and a second electrode (Figures 7-7A: first electrode 52 and second electrode 54), and wherein, after applying energy between the electrodes, the method further comprises: withdrawing the first electrode from the annulus ([0099]: “upon treating the tissue at the first tissue region 190 with RF energy, the first electrode may be withdrawn from the tissue and into the first sleeve 48 by rotating the first knob 126 of the first sleeve actuation member 114 at the handle 34.”) while leaving the second electrode in place ([0099]: “With this arrangement, the tubular sleeve 44 and the first and second sleeves 48, 50 rotate and, more particularly, pivot about the second sleeve 50 with the second electrode 54 maintaining its position in the tissue.”); pivoting the energy delivery catheter system about the second electrode to reposition the electrode ([0099]: “Movement of the first sleeve 48 to the third target point 214 may be employed by rotating the tubular sleeve 44 about 180 degrees, as indicated by rotational arrow 220, by rotating the knob 120 of the primary actuation member 112 at the handle 34 while the second electrode 54 maintains its secured position at the second target point 212 on the posterior annulus 180.”); advancing the repositioned first electrode such that the repositioned first electrode pierces into the cardiac valve annulus at a second distance from the second electrode, wherein further tissue of the cardiac valve annulus is positioned between the repositioned first electrode and the second electrode ([0099]: “Once the tubular sleeve 44 and first and second sleeves 48, 50 are pivoted with the first sleeve 48 positioned at the third target point 214 (as depicted in outline form in FIG. 7A), the first electrode 52 may be secured to the tissue of the posterior annulus 180 at the third target point 214 by rotating the first knob 126 to distally extend the first electrode 52 into the tissue.”); and applying energy between the repositioned first electrode and the second electrodes ([0098]: “upon contacting or securing the first and second electrodes 52, 54 to the posterior annulus 180 at the respective first and second target points 210, 212, as depicted in FIGS. 6B and 7, the tissue between the first and second electrodes 52, 54 or a first tissue region 190 can be heated by activating the first and second electrodes 52, 54.”) thereby heating and shrinking the further tissue in a direction ([0098]: “In one embodiment, the RF energy level may be modulated in the range of about 0 to 100 watts and for a period of time ranging between about twenty seconds to five minutes until the tissue is heated to a temperature in the range of approximately 50 degrees to 85 degrees Celsius.” And [0057]: “With this arrangement, the medical device system 10 may treat the valve by heating the tissue of the annulus, which results in the tissue shrinking, thereby, restoring the valve to normal size and function and to substantially reduce or prevent valve regurgitation.”). Further, Witzel discloses a method (Figures 6A-6C) comprising applying, based on a desired amount of shrinkage ([0063]; wherein enhanced heat shrinkage/tightening is considered an increase in the amount of shrinkage, which is a desired amount of shrinkage since it is an enhancement), an approximating force to at least one of the electrodes thereby reducing the distance between the first or second electrodes ([0063] and [0073]: wherein inflating the balloon causes the distance between electrode elements 96 and 98 to be reduced) and reducing a tension of the further tissue in a direction of the approximating force ([0063]: according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force); and applying energy between the first and second electrodes thereby heating and shrinking the tissue in a direction of the approximating force ([0063] and [0071]). In combination with Miles, the approximating force of Witzel is a second approximating force and the first electrode of Witzel is the repositioned first electrode.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Miles so that it includes applying an approximating force to at least one of the electrodes thereby reducing the distance between the electrodes as taught by Witzel to ensure effective application of tissue-shrinkable energy at a specific site (Witzel [0076]).
Regarding claim 7, Miles in view of Witzel teaches the method of claim 1 and Miles also teaches a method further comprising: terminating application of energy between the electrodes and allowing the annulus time to cool; and removing the electrodes from the annulus ([0101]: “Once the physician is satisfied that the valve has been restored to healthy valve function, the physician may then withdraw and remove the treatment catheter 20, imaging member 80, and sheath 14 from the heart and vascular system of the patient.”).
Regarding claim 40, Miles in view of Witzel discloses the method of claim 1, and Miles discloses a method wherein applying energy between the electrodes comprises applying energy between the electrodes thereby shrinking the annulus in a circumferential direction around the cardiac valve annulus ([0057]: “With this arrangement, the medical device system 10 may treat the valve by heating the tissue of the annulus, which results in the tissue shrinking, thereby, restoring the valve to normal size and function and to substantially reduce or prevent valve regurgitation.” And Figure 7: target points 210-218 are all around the circumference of the valve annulus).
Claims 4, 8-10, 39 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Miles in view of Witzel, further in view of Engelman et al., US 20140018788, herein referred to as “Engelman”.
Regarding claim 4, Miles in view of Witzel teaches the method according to claim 2, but does not explicitly disclose a method wherein increasing the spacing between the electrodes includes inflating a bladder interposed between the electrodes.
However, Engelman teaches a method wherein increasing the spacing between the electrodes includes inflating a bladder interposed between the engagement members (Figure 19A and [0172]: “In this embodiment, the arms may be forced opened by an actuator that is an inflatable balloon. A balloon 387 positioned between the arms 386 is inflated causing the arms 386 to open. The greater the balloon is inflated, the wider the arms are opened.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed in Miles with the bladder taught by Engelman to control the opening and closing of the arms of the device ([0172]).
Regarding claim 8, Miles in view of Witzel teaches the method of claim 1, but does not explicitly disclose a method wherein applying the approximating force includes advancing a sheath catheter toward the at least two electrodes.
However, Engelman teaches a method wherein applying the approximating force includes advancing a sheath catheter toward the at least two electrodes ([0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship. In this embodiment arms 66 and 67 are constructed to be biased to an open configuration as depicted in FIG. 6B. When the arms sheath 63 is slidably advanced forward, arms 66 and 67 are forced towards one another by distal tip 71. When the arms sheath 63 is advanced over arms assembly 62 the ablation elements 68 and 69 are in a closed position as depicted in FIG. 6A and can be fully retracted into the sheath.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Miles so that it includes applying an approximating force by advancing a sheath catheter toward the at least two electrodes as taught by Engelman to control the opening and closing of the arms of the device ([0172]).
Regarding claim 9, Miles in view of Witzel discloses the method according to claim 1, but does not explicitly disclose a method wherein applying the approximating force includes deflating a bladder.
However, Engelman teaches a method wherein applying the approximating force includes deflating a bladder ([0172]: “In this embodiment, the arms may be forced opened by an actuator that is an inflatable balloon. A balloon 387 positioned between the arms 386 is inflated causing the arms 386 to open. The greater the balloon is inflated, the wider the arms are opened. A balloon is an example of an actuator and other mechanical urging devices can be envisioned. After the arms are positioned on the carotid septum in an opened configuration they may be closed to squeeze the septum or to bring electrodes into contact with the septum by deflating the balloon.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Miles with the step of deflating a bladder taught in Engelman to control the opening and closing of the arms of the device ([0172]).
Regarding claim 10, Miles in view of Witzel discloses the method of claim 1, but does not explicitly disclose a method wherein applying the approximating force includes actuating a mechanism that actively decreases the distance between the electrodes.
However, Engelman teaches a method wherein applying the approximating force includes actuating a mechanism that actively decreases the distance between the electrodes ([0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship. In this embodiment arms 66 and 67 are constructed to be biased to an open configuration as depicted in FIG. 6B. When the arms sheath 63 is slidably advanced forward, arms 66 and 67 are forced towards one another by distal tip 71. When the arms sheath 63 is advanced over arms assembly 62 the ablation elements 68 and 69 are in a closed position as depicted in FIG. 6A and can be fully retracted into the sheath.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Miles so that it includes applying an approximating force by actuating a mechanism that actively decreases the spacing between the electrodes as taught by Engelman to control the opening and closing of the arms of the device ([0172]).
Regarding claim 39, Miles in view of Witzel discloses the method of claim 1, and Miles discloses a method wherein the tissue treated is an annulus ([0057]: “With this arrangement, the medical device system 10 may treat the valve by heating the tissue of the annulus, which results in the tissue shrinking, thereby, restoring the valve to normal size and function and to substantially reduce or prevent valve regurgitation.”). Miles in view of Witzel does not explicitly disclose a method wherein applying the approximating force comprises pulling the electrodes together to cinch tissue.
However, Engelman teaches a method wherein applying the approximating force comprises pulling the electrodes together to cinch tissue ([00141]: “Central tube 70 is configured to work in conjunction with arms actuator 74 to apply a tensile force on the arms assembly 62 for advancement of arms sheath 63 over arms assembly 62 to close arms, and to apply a compressive force on the arms assembly 62 to withdraw arms sheath 63 from over arms assembly 62 to open arms or to apply torque to rotate arms.” And [0143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.” And [0156]: “Once the device is advanced over a carotid septum the arms may be closed to bring the ablation elements into contact with the carotid septum, such as is shown in FIG. 7.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Miles so that it includes applying an approximating force that comprises pulling the electrodes together to cinch tissue as taught by Engelman to reduce associated convective cooling normally associated with interstitial blood flow (Engelman [0143]).
Regarding claim 41, Miles in view of Witzel discloses the method of claim 1, and Miles discloses a method wherein the tissue treated is an atrial surface or a ventricular surface of the annulus ([0057]: “With this arrangement, the medical device system 10 may treat the valve by heating the tissue of the annulus, which results in the tissue shrinking, thereby, restoring the valve to normal size and function and to substantially reduce or prevent valve regurgitation.”). Miles in view of Witzel does not explicitly disclose a method wherein applying the approximating force comprises moving the at least one of the electrodes toward the other along an approximating path along the tissue.
Engelman further discloses a method wherein applying the approximating force comprises moving the at least one of the electrodes toward the other along an approximating path along the tissue ([0143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.” And [0156]: “Once the device is advanced over a carotid septum the arms may be closed to bring the ablation elements into contact with the carotid septum, such as is shown in FIG. 7.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Miles so that it includes applying the approximating force that comprises moving the at least one of the electrodes toward the other along an approximating path along the tissue as taught by Engelman to reduce associated convective cooling normally associated with interstitial blood flow (Engelman [0143]).
Claims 11-13, 15, 17, 19-20, 22-23, 25-26, 28-36, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Engelman in view of Witzel.
Regarding claim 11, Engelman discloses a minimally invasive method for selectively reducing a dimension of cardiac tissue in a beating heart (Figures 6A-6C), comprising the steps of: advancing a catheter system (Figures 6A-6B: ETAP catheter 61), wherein the catheter system has at least two engagement members (Figures 6A-6C: ablation elements 68-69) and an energy delivery mechanism ([00142]: “an electrical generator may be configured for connection to electrical connector 75 and to supply RF ablation current to an electrode surface on ablation element 68 or an electrode surface on ablation element 69”); advancing the engagement members such that the engagement members engage the cardiac tissue at a distance from one another (Figure 7: ablation elements 68-69 are engaging tissue at a distance from one another); applying an approximating force to the engagement members to reduce a tension of the cardiac tissue between the engagement members ([00141]: “Central tube 70 is configured to work in conjunction with arms actuator 74 to apply a tensile force on the arms assembly 62 for advancement of arms sheath 63 over arms assembly 62 to close arms, and to apply a compressive force on the arms assembly 62 to withdraw arms sheath 63 from over arms assembly 62 to open arms or to apply torque to rotate arms.” And [0143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.” And [0156]: “Once the device is advanced over a carotid septum the arms may be closed to bring the ablation elements into contact with the carotid septum, such as is shown in FIG. 7.”), wherein the reduction of tension of the tissue occurs in a direction of the approximating force (according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force); and applying energy between the engagement members using the energy delivery mechanism ([00140]: “one ablation element, which may be referred to herein as a forceps pad, 68 mounted at the end of finger, or jaw strut, 66, and a second ablation element, or forceps pad, 69 mounted on the end of finger 67 as shown” and [00142]: “an electrical generator may be configured for connection to electrical connector 75 and to supply RF ablation current to an electrode surface on ablation element 68 or an electrode surface on ablation element 69”) thereby shrinking the tissue in the direction of the approximating force ([00143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.”; wherein reducing the distance between inner surfaces 80 and 84 in Figure 7 is shrinking the tissue in a direction of the approximating force; also, above 50 degrees Celsius, shrinkage occurs in all tissue due to protein denaturation, dehydration, and contraction of collagen). Engelman does not explicitly disclose a method of advancing a catheter system into the heart proximate a cardiac valve or for shrinking tissue that is specifically cardiac tissue, the method comprising applying, based on a desired amount of shrinkage, an approximating force to the engagement members to reduce a tension of the cardiac tissue between the engagement members.
However, Witzel teaches a method (Abstract and Figure 8) of advancing a catheter system into the beating heart proximate a cardiac valve of the beating heart (Abstract) and for shrinking tissue that is specifically cardiac tissue ([0021]), the method comprising applying, based on a desired amount of shrinkage ([0063]; wherein enhanced heat shrinkage/tightening is considered an increase in the amount of shrinkage, which is a desired amount of shrinkage since it is an enhancement), an approximating force to the engagement members ([0063] and [0073]: wherein inflating the balloon causes the distance between electrode elements 96 and 98 to be reduced) to reduce a tension of the cardiac tissue between the engagement members ([0063] and [0071]: according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to add the method of advancing a catheter system into the heart proximate a cardiac valve and shrinking cardiac tissue as disclosed in Witzel to the method taught by Engelman in order to treat diseases of the heart such as valve regurgitation (Witzel [0003]). It would also have been obvious to modify the method disclosed by Miles so that it includes applying, based on a desired amount of shrinkage, an approximating force to the engagement members to reduce a tension of the cardiac tissue between the engagement members as taught by Witzel to ensure effective application of tissue-shrinkable energy at a specific site (Witzel [0076]).
Regarding claim 12, Engelman in view of Witzel teaches the method of claim 11 and Engelman further teaches a method further comprising increasing a spacing between the engagement members from a compact spacing to an extended spacing (Figures 6A-6B: 6A demonstrates compact spacing and 6B shows extended spacing), wherein the extended spacing is greater than the compact spacing (Figures 6A-6B).
Regarding claim 13, Engelman in view of Witzel teaches the method of claim 12 and Engelman further teaches a method wherein the engagement members (Figures 6A-6C: ablation elements 68-69) are configured to self-extend away from each other when unconstrained, wherein increasing the spacing between the engagement members includes allowing the engagement members to self-extend away from each other ([0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship. In this embodiment arms 66 and 67 are constructed to be biased to an open configuration as depicted in FIG. 6B. When the arms sheath 63 is slidably advanced forward, arms 66 and 67 are forced towards one another by distal tip 71. When the arms sheath 63 is advanced over arms assembly 62 the ablation elements 68 and 69 are in a closed position as depicted in FIG. 6A and can be fully retracted into the sheath.”).
Regarding claim 15, Engelman in view of Witzel teaches the method of claim 12 and Engelman further teaches a method wherein increasing the spacing between the engagement members includes a step of actuating a mechanism to actively increase the spacing between the engagement members ([0140]: “The advancement and retraction of the arms sheath 63 over the arms assembly 62 may be controlled by actuator 74 mounted in proximal terminal handle 73.”).
Regarding claim 17, Engelman in view of Witzel teaches the method of claim 12 and Engelman further teaches a method wherein applying the approximating force includes advancing the catheter toward the engagement members ([0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship. In this embodiment arms 66 and 67 are constructed to be biased to an open configuration as depicted in FIG. 6B. When the arms sheath 63 is slidably advanced forward, arms 66 and 67 are forced towards one another by distal tip 71. When the arms sheath 63 is advanced over arms assembly 62 the ablation elements 68 and 69 are in a closed position as depicted in FIG. 6A and can be fully retracted into the sheath.”).
Regarding claim 19, Engelman in view of Witzel teaches the method of claim 11 and Engelman further teaches a method wherein applying the approximating force includes actuating a mechanism thereby decreasing the distance between the engagement members ([0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship. In this embodiment arms 66 and 67 are constructed to be biased to an open configuration as depicted in FIG. 6B. When the arms sheath 63 is slidably advanced forward, arms 66 and 67 are forced towards one another by distal tip 71. When the arms sheath 63 is advanced over arms assembly 62 the ablation elements 68 and 69 are in a closed position as depicted in FIG. 6A and can be fully retracted into the sheath.”).
Regarding claim 20, Engelman in view of Witzel teaches the method of claim 11 and Engelman further teaches a method wherein applying energy includes applying an energy modality selected from the group of bipolar, monopolar, resistive heating, ultrasound, laser, and microwave ([00135]: “Ablation elements may be, for example, a pair of bipolar radio frequency electrodes; a pair of bipolar irreversible electroporation electrodes; more than two electrodes; or a single monopolar radiofrequency electrode and second electrode used as current return or to measure properties of target tissue such as electrical impedance, temperature, or blood flow.”).
Regarding claim 22, Engelman discloses a minimally invasive method for reducing a length of a cord of a chordae tendineae in a beating heart (Figures 6A-6C), comprising the steps of: advancing a catheter system (Figures 6A-6B: ETAP catheter 61) into tissue, wherein the catheter system includes at least two engagement members (Figures 6A-6C: ablation elements 68-69); slidably attaching the engagement members onto a tissue ([0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship” and Figure 7: ablation elements 68-69 are engaging tissue), wherein a segment of the tissue extends between the engagement members; applying an approximating force to the engagement members and thereby decreasing a spacing therebetween ([00141]: “Central tube 70 is configured to work in conjunction with arms actuator 74 to apply a tensile force on the arms assembly 62 for advancement of arms sheath 63 over arms assembly 62 to close arms, and to apply a compressive force on the arms assembly 62 to withdraw arms sheath 63 from over arms assembly 62 to open arms or to apply torque to rotate arms.” And [0143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.” And [0156]: “Once the device is advanced over a carotid septum the arms may be closed to bring the ablation elements into contact with the carotid septum, such as is shown in FIG. 7.”) and reducing a tension of the tissue (according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force); and applying at least one of energy and/or a chemical agent to the tissue ([00140]: “one ablation element, which may be referred to herein as a forceps pad, 68 mounted at the end of finger, or jaw strut, 66, and a second ablation element, or forceps pad, 69 mounted on the end of finger 67 as shown” and [00142]: “an electrical generator may be configured for connection to electrical connector 75 and to supply RF ablation current to an electrode surface on ablation element 68 or an electrode surface on ablation element 69”) thereby shrinking the tissue ([00143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.”; wherein reducing the distance between inner surfaces 80 and 84 in Figure 7 is shrinking the tissue in a direction of the approximating force; also, above 50 degrees Celsius, shrinkage occurs in all tissue due to protein denaturation, dehydration, and contraction of collagen). Engelman does not explicitly disclose a method of advancing a catheter system into the heart proximate a cardiac valve or for attaching the device onto a cord of the chordae tendineae and treating that tissue specifically, the method comprising applying, based on a desired length of shrinkage, an approximating force to the engagement members thereby reducing a tension of the tissue between the engagement members.
However, Witzel teaches a method (Abstract and Figure 8) of advancing a catheter system into the heart proximate a cardiac valve (Abstract) and for attaching the device onto a cord segment of chordae tendineae and treating that tissue specifically ([0021]), the method comprising applying, based on a desired length of shrinkage ([0063]; wherein enhanced heat shrinkage/tightening is considered an increase in the amount of shrinkage, which is a desired amount of shrinkage; the ‘length’ dimension is not specified, so whatever direction shrinkage occurs is considered the length direction), an approximating force to the engagement members ([0063] and [0073]: wherein inflating the balloon causes the distance between electrode elements 96 and 98 to be reduced) thereby reducing a tension of the tissue between the engagement members ([0063] and [0071]: according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to add the method of advancing a catheter system into the heart proximate a cardiac valve and shrinking cardiac tissue as disclosed in Witzel to the method taught by Engelman in order to treat diseases of the heart such as valve regurgitation (Witzel [0003]). It would also have been obvious to modify the method disclosed by Miles so that it includes applying, based on a desired amount of shrinkage, an approximating force to the engagement members thereby reducing a tension of the tissue between the engagement members as taught by Witzel to ensure effective application of tissue-shrinkable energy at a specific site (Witzel [0076]).
Regarding claim 23, Engelman in view of Witzel teaches the method of claim 22 and Engelman further teaches a method wherein after slidably attaching the engagement members (Figures 6A-6B: ablation elements 68-69and [0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship.”), the method further comprises slidably increasing a spacing between the engagement members from a compact spacing to an extended spacing (Figures 6A-6B: 6A demonstrates compact spacing and 6B shows extended spacing), wherein the extended spacing is greater than the compact spacing (Figures 6A-6B).
Regarding claim 25, Engelman in view of Witzel teaches the method of claim 23, and Engelman further teaches a method wherein slidably increasing the spacing between the engagement members includes actuating a mechanism to actively increase the spacing between the engagement members ([0140]: “The advancement and retraction of the arms sheath 63 over the arms assembly 62 may be controlled by actuator 74 mounted in proximal terminal handle 73.”).
Regarding claim 26, Engelman in view of Witzel teaches the method of claim 22, and Engelman further teaches a method wherein applying the approximating force includes advancing a delivery catheter of the catheter system toward the engagement members ([0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship. In this embodiment arms 66 and 67 are constructed to be biased to an open configuration as depicted in FIG. 6B. When the arms sheath 63 is slidably advanced forward, arms 66 and 67 are forced towards one another by distal tip 71. When the arms sheath 63 is advanced over arms assembly 62 the ablation elements 68 and 69 are in a closed position as depicted in FIG. 6A and can be fully retracted into the sheath.”).
Regarding claim 28, Engelman in view of Witzel teaches the method of claim 25, and Engelman further teaches a method wherein applying the approximating force includes actuating the mechanism thereby actively decreasing the spacing between the engagement members ([0140]: “The arms assembly 62 resides within arms sheath 63 in a slidable relationship. In this embodiment arms 66 and 67 are constructed to be biased to an open configuration as depicted in FIG. 6B. When the arms sheath 63 is slidably advanced forward, arms 66 and 67 are forced towards one another by distal tip 71. When the arms sheath 63 is advanced over arms assembly 62 the ablation elements 68 and 69 are in a closed position as depicted in FIG. 6A and can be fully retracted into the sheath.”).
Regarding claim 29, Engelman in view of Witzel teaches the method of claim 22, and Engelman further teaches a method wherein applying energy includes applying an energy modality selected from the group of bipolar, monopolar, resistive heating, ultrasound, laser, and microwave ([00135]: “Ablation elements may be, for example, a pair of bipolar radio frequency electrodes; a pair of bipolar irreversible electroporation electrodes; more than two electrodes; or a single monopolar radiofrequency electrode and second electrode used as current return or to measure properties of target tissue such as electrical impedance, temperature, or blood flow.”).
Regarding claim 30, Engelman in view of Witzel teaches the method of claim 22, and Engelman further teaches a method wherein the chemical agent ([00132]: “Where catheter or sheath lumens are used for contrast injection they also can be used to inject drugs”) is selected from the group of phenol and glutaraldehyde ([00389]: “Examples of drugs … include… monophenol ester of homo-iso-muscarine and … dinitrophenol”).
Regarding claim 31, Engelman discloses a minimally invasive device for reducing a dimension of a cardiac valve annulus in a beating heart (Figures 6A-6C and [0006]: the device is capable of treating a portion of the carotid body, meaning it is capable of treating a cardiac valve annulus), comprising: an elongate delivery catheter (Figures 6A-6B: ETAP catheter 61); at least two engagement members carried by the elongate delivery catheter (Figures 6A-6C: ablation elements 68-69), wherein the engagement members are moveable between a retracted position in which the engagement members are contained within the elongate delivery catheter (Figure 6A: ablation elements 68-69) and an extended position in which the engagement members extend beyond a distal end of the elongate delivery catheter (Figure 6B: ablation elements 68-69), and wherein the engagement members are configured to engage tissue of the cardiac valve annulus in the extended position (Figure 7); a tissue shrinking component ([00143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.”; wherein reducing the distance between inner surfaces 80 and 84 in Figure 7 is shrinking the tissue in a direction of the approximating force; also, above 50 degrees Celsius, shrinkage occurs in all tissue due to protein denaturation, dehydration, and contraction of collagen) configured to deliver at least one of energy and/or a chemical agent between the engagement members ([00140]: “one ablation element, which may be referred to herein as a forceps pad, 68 mounted at the end of finger, or jaw strut, 66, and a second ablation element, or forceps pad, 69 mounted on the end of finger 67 as shown” and [00141]: “an electrical generator may be configured for connection to electrical connector 75 and to supply RF ablation current to an electrode surface on ablation element 68 or an electrode surface on ablation element 69”); and an approximation mechanism configured to apply a force having a direction to the engagement members, wherein the force is selected from the group of an approximating force and/or a separating force ([00141]: “Central tube 70 is configured to work in conjunction with arms actuator 74 to apply a tensile force on the arms assembly 62 for advancement of arms sheath 63 over arms assembly 62 to close arms, and to apply a compressive force on the arms assembly 62 to withdraw arms sheath 63 from over arms assembly 62 to open arms or to apply torque to rotate arms.” And [0143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.” And [0156]: “Once the device is advanced over a carotid septum the arms may be closed to bring the ablation elements into contact with the carotid septum, such as is shown in FIG. 7.”), and wherein the force is configured to reduce a tension of tissue between the engagement members, wherein the reduction of tension of the cardiac tissue occurs in a direction of the approximating force (according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force). Engelman does not explicitly disclose a device comprising an approximation mechanism configured to apply, based on a desired amount of shrinkage, a force to the engagement members, and wherein the selected force is configured to induce shrinking of the tissue in the direction of the force when the tissue shrinking component delivers the at least one of the energy and/or the chemical agent.
However, Witzel teaches a device (Abstract and Figure 8) comprising an approximation mechanism (Figure 8: balloons 59 and 91) configured to apply, based on a desired amount of shrinkage ([0063]; wherein enhanced heat shrinkage/tightening is considered an increase in the amount of shrinkage, which is a desired amount of shrinkage), a force to the engagement members, wherein the selected force is configured to induce shrinking of the tissue in the direction of the force ([0063]) when the tissue shrinking component delivers the at least one of the energy and/or the chemical agent ([0071]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Miles so that it includes applying, based on a desired amount of shrinkage, a force configured to induce shrinking of the tissue in the direction of the force when the tissue shrinking component delivers the energy as taught by Witzel to ensure effective application of tissue-shrinkable energy at a specific site (Witzel [0076]).
Regarding claim 32, Engelman in view of Witzel discloses a minimally invasive device according to claim 31, and Engelman further discloses a device wherein the tissue shrinking component (Figures 6A-6C: ablation elements 68-69) comprises an energy delivery mechanism configured to deliver an energy modality selected from the group of bipolar, resistive heating, ultrasound, laser, and microwave ([00135]: “Ablation elements may be, for example, a pair of bipolar radio frequency electrodes; a pair of bipolar irreversible electroporation electrodes; more than two electrodes; or a single monopolar radiofrequency electrode and second electrode used as current return or to measure properties of target tissue such as electrical impedance, temperature, or blood flow.”).
Regarding claim 33, Engelman in view of Witzel discloses a minimally invasive device according to claim 31, and Engelman further discloses a device wherein the tissue shrinking component (Figures 6A-6C: ablation elements 68-69) comprises a chemical agent ([00132]: “Where catheter or sheath lumens are used for contrast injection they also can be used to inject drugs”) selected from the group of phenol and glutaraldehyde ([00389]: “Examples of drugs … include… monophenol ester of homo-iso-muscarine and … dinitrophenol”).
Regarding claim 34, Engelman in view of Witzel discloses a minimally invasive device according to claim 31, and Engelman further discloses a device wherein the approximation mechanism is operably connected to the engagement members ([00141]: “Central tube 70 is configured to work in conjunction with arms actuator 74 to apply a tensile force on the arms assembly 62…Central tube 70 can be configured as an electrical conduit between ablation element 68 or ablation element 69 and electrical connector 75” and Figure 6C).
Regarding claim 35, Engelman in view of Witzel discloses a minimally invasive device according to claim 31, and Engelman further discloses a device wherein the approximation mechanism includes a linkage connecting the engagement members (Figure 6C: arms end piece 65).
Regarding claim 36, Engelman in view of Witzel discloses a minimally invasive device according to claim 35, and Engelman further discloses a device wherein the linkage includes a hinge (Figure 6C: arms end piece 65).
Regarding claim 38, Engelman in view of Witzel discloses a minimally invasive device according to claim 31, and Engelman further discloses a device wherein the approximation mechanism includes a sleeve (Figures 6A-6B: sheath shaft 72) surrounding at least a portion of the engagement members (Figure 6A: ablation elements 68 and 69 are partly surrounded by sheath shaft 72) wherein advancing the sleeve biases the engagement members together (Figure 6A: ablation elements 68 and 69 are biased together).
Regarding claim 42, Engelman in view of Witzel teaches the method of claim 11, and Engelman further teaches a method wherein the approximating force is sufficient to overcome the tension comprising a naturally occurring tension in the cardiac tissue between the engagement members ([0143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site” and according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force).
Claims 14, 18, 24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Engelman (Figures 6A-6C) in view of Witzel, further in view of Embodiment B of Engelman (Figure 19A).
Regarding claim 14, Embodiment A of Engelman in view of Witzel discloses the method according to claim 12, but does not disclose a method wherein increasing the spacing between the engagement members includes inflating a bladder interposed between the engagement members.
However, Embodiment B of Engelman teaches a method wherein increasing the spacing between the engagement members includes inflating a bladder interposed between the engagement members (Figure 19A and [0172]: “In this embodiment, the arms may be forced opened by an actuator that is an inflatable balloon. A balloon 387 positioned between the arms 386 is inflated causing the arms 386 to open. The greater the balloon is inflated, the wider the arms are opened.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed in Embodiment A of Engelman with the bladder taught in Embodiment B of Engelman to control the opening and closing of the arms of the device ([0172]).
Regarding claim 18, Embodiment A of Engelman in view of Witzel discloses the method according to claim 11, but does not disclose a method wherein applying the approximating force includes deflating a bladder.
However, Embodiment B of Engelman teaches a method wherein applying the approximating force includes deflating a bladder ([0172]: “In this embodiment, the arms may be forced opened by an actuator that is an inflatable balloon. A balloon 387 positioned between the arms 386 is inflated causing the arms 386 to open. The greater the balloon is inflated, the wider the arms are opened. A balloon is an example of an actuator and other mechanical urging devices can be envisioned. After the arms are positioned on the carotid septum in an opened configuration they may be closed to squeeze the septum or to bring electrodes into contact with the septum by deflating the balloon.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed in Embodiment A of Engelman with the step of deflating a bladder taught in Embodiment B of Engelman to control the opening and closing of the arms of the device ([0172]).
Regarding claim 24, Embodiment A of Engelman in view of Witzel discloses the method according to claim 23, but does not disclose a method wherein slidably increasing the spacing between the engagement members includes inflating a bladder interposed between the engagement members.
However, Embodiment B of Engelman teaches a method wherein slidably increasing the spacing between the engagement members includes inflating a bladder interposed between the engagement members (Figure 19A and [0172]: “In this embodiment, the arms may be forced opened by an actuator that is an inflatable balloon. A balloon 387 positioned between the arms 386 is inflated causing the arms 386 to open. The greater the balloon is inflated, the wider the arms are opened.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed in Embodiment A of Engelman with the bladder taught in Embodiment B of Engelman to control the opening and closing of the arms of the device ([0172]).
Regarding claim 27, Embodiments A and B of Engelman in view of Witzel discloses the method according to claim 24, and further, Embodiment B of Engelman teaches a method wherein applying then approximating force includes deflating a bladder ([0172]: “In this embodiment, the arms may be forced opened by an actuator that is an inflatable balloon. A balloon 387 positioned between the arms 386 is inflated causing the arms 386 to open. The greater the balloon is inflated, the wider the arms are opened. A balloon is an example of an actuator and other mechanical urging devices can be envisioned. After the arms are positioned on the carotid septum in an opened configuration they may be closed to squeeze the septum or to bring electrodes into contact with the septum by deflating the balloon.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed in Embodiment A of Engelman with the step of deflating a bladder taught in Embodiment B of Engelman to control the opening and closing of the arms of the device ([0172]).
Claims 16, 21, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Engelman in view of Witzel, further in view of Miles.
Regarding claim 16, Engelman in view of Witzel discloses the method of claim 11, and Engelman further discloses a method wherein the engagement members include a first engagement member and second engagement members (Figures 6A-6C: ablation elements 68-69), and the method further comprises: applying an approximating force biasing the engagement members together ([00141]: “Central tube 70 is configured to work in conjunction with arms actuator 74 to apply a tensile force on the arms assembly 62 for advancement of arms sheath 63 over arms assembly 62 to close arms, and to apply a compressive force on the arms assembly 62 to withdraw arms sheath 63 from over arms assembly 62 to open arms or to apply torque to rotate arms.” And [0143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.” And [0156]: “Once the device is advanced over a carotid septum the arms may be closed to bring the ablation elements into contact with the carotid septum, such as is shown in FIG. 7.”); and applying at least one of energy and/or a chemical agent between the engagement members ([00142]: “an electrical generator may be configured for connection to electrical connector 75 and to supply RF ablation current to an electrode surface on ablation element 68 or an electrode surface on ablation element 69”) thereby shrinking the cardiac tissue in the direction of the approximating force ([00143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.”; wherein reducing the distance between inner surfaces 80 and 84 in Figure 7 is shrinking the tissue in a direction of the approximating force; also, above 50 degrees Celsius, shrinkage occurs in all tissue due to protein denaturation, dehydration, and contraction of collagen). Witzel further discloses a method comprising applying, based on a desired amount of shrinkage ([0063]; wherein enhanced heat shrinkage/tightening is considered an increase in the amount of shrinkage, which is a desired amount of shrinkage since it is an enhancement), an approximating force to the engagement members ([0063] and [0073]: wherein inflating the balloon causes the distance between electrode elements 96 and 98 to be reduced) to reduce a tension of the further cardiac tissue in a direction of the approximating force ([0063]: according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force). Engelman in view of Witzel does not explicitly disclose a method wherein, after applying energy between the engagement members, the method further comprises: withdrawing the first engagement member from the cardiac tissue while leaving the second engagement member engaged with the cardiac tissue; pivoting the energy delivery mechanism about the second engagement member to reposition the first engagement member; and advancing the repositioned first engagement member into engagement with the cardiac tissue at a second distance from the second engagement member, wherein further cardiac tissue is positioned between the repositioned first engagement member and the second engagement member.
However, Miles teaches a method wherein, after applying energy between the electrodes, the method further comprises: withdrawing the first engagement member from the cardiac tissue ([0099]: “upon treating the tissue at the first tissue region 190 with RF energy, the first electrode may be withdrawn from the tissue and into the first sleeve 48 by rotating the first knob 126 of the first sleeve actuation member 114 at the handle 34.”) while leaving the second engagement member engaged with the cardiac tissue ([0099]: “With this arrangement, the tubular sleeve 44 and the first and second sleeves 48, 50 rotate and, more particularly, pivot about the second sleeve 50 with the second electrode 54 maintaining its position in the tissue.”); pivoting the energy delivery catheter system about the second engagement member to reposition the first engagement member ([0099]: “Movement of the first sleeve 48 to the third target point 214 may be employed by rotating the tubular sleeve 44 about 180 degrees, as indicated by rotational arrow 220, by rotating the knob 120 of the primary actuation member 112 at the handle 34 while the second electrode 54 maintains its secured position at the second target point 212 on the posterior annulus 180.”); and advancing the repositioned first engagement member into engagement with the cardiac tissue at a second distance from the second engagement member, wherein further cardiac tissue is positioned between the repositioned first engagement member and the second engagement member ([0099]: “Once the tubular sleeve 44 and first and second sleeves 48, 50 are pivoted with the first sleeve 48 positioned at the third target point 214 (as depicted in outline form in FIG. 7A), the first electrode 52 may be secured to the tissue of the posterior annulus 180 at the third target point 214 by rotating the first knob 126 to distally extend the first electrode 52 into the tissue.”); and applying at least one of energy and/or a chemical agent between the repositioned first engagement member and the second engagement member ([0098]: “upon contacting or securing the first and second electrodes 52, 54 to the posterior annulus 180 at the respective first and second target points 210, 212, as depicted in FIGS. 6B and 7, the tissue between the first and second electrodes 52, 54 or a first tissue region 190 can be heated by activating the first and second electrodes 52, 54.”) thereby shrinking the further cardiac tissue in a direction ([0098]: “In one embodiment, the RF energy level may be modulated in the range of about 0 to 100 watts and for a period of time ranging between about twenty seconds to five minutes until the tissue is heated to a temperature in the range of approximately 50 degrees to 85 degrees Celsius.” And [0057]: “With this arrangement, the medical device system 10 may treat the valve by heating the tissue of the annulus, which results in the tissue shrinking, thereby, restoring the valve to normal size and function and to substantially reduce or prevent valve regurgitation.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Engelman so that it includes applying based on a desired amount of shrinkage an approximating force to at least one of the engagement members as taught by Witzel to ensure effective application of tissue-shrinkable energy at a specific site (Witzel [0076]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Engelman so that it includes withdrawing the first engagement member from the cardiac tissue while leaving the second engagement member engaged with the cardiac tissue, pivoting the energy delivery mechanism about the second engagement member, and advancing the first engagement member into engagement with the cardiac tissue as taught by Miles to minimize valve regurgitation (Miles [0019]).
Regarding claim 21, Engelman in view of Witzel and Miles discloses the method according to claim 16, and Engelman further discloses a method wherein the chemical agent ([00132]: “Where catheter or sheath lumens are used for contrast injection they also can be used to inject drugs”) is selected from the group of phenol and glutaraldehyde ([00389]: “Examples of drugs … include… monophenol ester of homo-iso-muscarine and … dinitrophenol”).
Regarding claim 44, Engelman in view of Witzel discloses a minimally invasive method for selectively reducing an overall diameter of a tissue using the minimally invasive device of claim 31, with Engelman disclosing a method comprising: moving the engagement members from the retracted position to the extended position (Figures 6A-B); engaging the tissue with the engagement members, wherein c tissue is positioned between the engagement members ([00143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site”); applying a force to the engagement members with the approximation mechanism to reduce a tension of the tissue ([00141]: “Central tube 70 is configured to work in conjunction with arms actuator 74 to apply a tensile force on the arms assembly 62 for advancement of arms sheath 63 over arms assembly 62 to close arms, and to apply a compressive force on the arms assembly 62 to withdraw arms sheath 63 from over arms assembly 62 to open arms or to apply torque to rotate arms.” And [0143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.” And [0156]: “Once the device is advanced over a carotid septum the arms may be closed to bring the ablation elements into contact with the carotid septum, such as is shown in FIG. 7.”), wherein the reduction in tension of the tissue occurs in a direction of the force (according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force); and delivering at least one of energy and/or a chemical agent to the tissue with the tissue shrinking component thereby shrinking the tissue in the direction of the force, wherein shrinking of the tissue causes a reduction in size of tissue ([00143]: “During RF ablation the squeezing force of arms 62 may enhance ablation by compressing the intercarotid septum 114 to achieve apposition of electrodes to a target ablation site (e.g., the inner surface of internal and external carotid arteries forming the V surface of an intercarotid septum) or to reduce the distance of the carotid body 27 from the inner surfaces 80 and 84, or to reduce the blood flow within the intercarotid septum, and associated convective cooling normally associated with interstitial blood flow.”; above 50 degrees Celsius, shrinkage occurs in all tissue due to protein denaturation, dehydration, and contraction of collagen). Witzel teaches a method comprising applying, based on a desired amount of shrinkage ([0063]; wherein enhanced heat shrinkage/tightening is considered an increase in the amount of shrinkage, which is a desired amount of shrinkage since it is an enhancement), an approximating force to the engagement members ([0063] and [0073]: wherein inflating the balloon causes the distance between electrode elements 96 and 98 to be reduced) to reduce a tension of the cardiac tissue between the engagement members ([0063] and [0071]: according to applicant’s specification [0047], reducing a tension is an inherent consequence to an approximating force). Engelman in view of Witzel does not explicitly disclose a minimally invasive method wherein the tissue is specifically a cardiac valve annulus, the method comprising shrinking the tissue causes a reduction of an overall diameter of the cardiac valve annulus such that the cardiac valve annulus retains a new smaller circumference.
However, Miles teaches a minimally invasive method wherein the tissue is specifically a cardiac valve annulus (Figures 1 and 7-7A and Abstract and [0057] and [0099]), the method comprising shrinking the tissue causes a reduction of an overall diameter of the cardiac valve annulus such that the cardiac valve annulus retains a new smaller circumference ([0057]: “With this arrangement, the medical device system 10 may treat the valve by heating the tissue of the annulus, which results in the tissue shrinking, thereby, restoring the valve to normal size and function and to substantially reduce or prevent valve regurgitation.” And Figure 7: target points 210-218 are all around the circumference of the valve annulus).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Engelman so that it includes applying based on a desired amount of shrinkage an approximating force to at least one of the engagement members as taught by Witzel to ensure effective application of tissue-shrinkable energy at a specific site (Witzel [0076]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Engelman so that shrinking the tissue causes a reduction of an overall diameter of the cardiac valve annulus such that the cardiac valve annulus retains a new smaller circumference as taught by Miles to restore the valve to its normal size and function and to substantially reduce or prevent valve regurgitation (Miles [0057]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Engelman (Figures 6A-6C) in view of Witzel, further in view of Embodiment C of Engelman (Figure 19B).
Regarding claim 37, Embodiment A of Engelman in view of Witzel teaches the device according to claim 35 but does not explicitly teach a device wherein the approximation mechanism comprises a pull-wire connected to a linkage such that pulling on the pull-wire applies a biasing force to the engagement members.
However, Embodiment C of Engelman discloses a device wherein the approximation mechanism comprises a pull-wire wire connected to a linkage ([0173]: “In another example embodiment shown in FIG. 19B arms 388 are connected to the shaft of the catheter with a hinge joint 389 and are opened or closed with a pull wire that is actuated by a lever at a proximal end of the ETAP catheter.”) such that pulling on the pull-wire applies a biasing force to the engagement members (Figure 19B and [0173]: “A spring (not shown) may be used to cause an opening force on the arms 388 when tension on a pull wire is released. When the pull wire is pulled a torque may be applied to the arms to oppose the spring causing the arms to close. Conversely, a spring and pull wire may be configured so the spring causes the arms to close and the pull wire causes the arms to open.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed in Embodiment A of Engelman with the pull wire taught in Embodiment C of Engelman to control the opening and closing of the arms of the device ([0173]).
Conclusion
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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