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 .
Response to Amendment
The claims filed on February 19th, 2026, have been entered. Claims 1-20 remain pending in the Application. Claims 19-20 were previously withdrawn by the Applicant.
Response to Arguments
Applicant's arguments filed February 19th, 2026, have been fully considered but they are not persuasive.
Regarding the interpretation of “fixation member” under 112(f), Applicant argues that one of ordinary skill in the art would not understand “fixation member” to be a “non-structural term having no specific structural meaning” and that no reasoning was provided by the examiner for this conclusion. Examiner respectfully disagrees. The term “member” is a non-structural generic placeholder, as listed in MPEP 2181.A., and is modified by the functional language “fixation” and “configured to extend to the distal end” with no other structure recited for achieving the “fixation” or “extending” functions.
Regarding claims 1 and 16, Applicant argues that Ning (Pub. No. 2022/000896) does not disclose the limitations “a portion of an outer surface of the balloon faces away from the longitudinal axis in the deflated configuration,” “the portion of the outer surface of the balloon faces toward the longitudinal axis in the inflated configuration,” or “the portion of the outer surface of the balloon is configured to define a distal cavity surrounding at least a portion of the fixation member when the balloon expands radially outward” because Ning does not describe or show the balloon in a deflated configuration, where FIG. 5B has no numeral labeling and is described as showing a catheter in absence of a balloon, and while Ning teaches a toroidal balloon when expanded, Ning does not explicitly disclose that the balloon has a portion that faces away from the longitudinal axis when deflated and towards the longitudinal axis when inflated to form a distal cavity. Examiner respectfully disagrees. The citation of FIG. 5B was in the absence of a clear figure showing the balloon and catheter in the deflated configuration, which would most closely resemble FIG. 5B. In [0338], Ning discloses that the length of the balloon 107 may increase upon expansion, and that the unexpanded diameter be the same or less than the inner or outer diameters of 110 while the expanded diameter is the same or larger than the diameter of the artery that 110 is inserted into. For this combination to function, where both the length and diameter of a toroidal balloon to increase upon expansion, a portion of the outer surface of the balloon 107 must be initially facing away from the catheter (as in FIG. 5B, where the balloon in the unexpanded state is the same diameter and length as the catheter deploying the balloon), and is shifted to face toward the catheter, as shown in FIG. 2B.
Regarding claims 12 and 18, Applicant argues that Ning does not disclose “in the deflated configuration, the balloon body is folded at the fixation location such that a first portion of the balloon is positioned between a second portion of the balloon and the exterior surface” because the deflated configuration is not shown and does not explicitly describe a fold in that configuration. Examiner respectfully disagrees. While Ning does not explicitly state a fold is in the deflated configuration, Ning does disclose that the inflated configuration has a fold, and Applicant provides no evidence that the inflation of the balloon creates that fold nor that deflation of the balloon erases that fold.
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: fixation member in claims 1 and 16.
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.
Fixation member is interpreted under 112(f) because the generic placeholder “fixation member” is modified by the functional language “configured to extend to the distal end” and does not recite sufficient structure to perform the extension. The fixation member is interpreted as helices, tines, screws, rings, and equivalent thereof.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-8, 10-13, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (Pub. No. 2019/0217097) in view of Ning (Pub. No. 2022/0000896).
Regarding claim 1, Thakur et al. discloses a medical lead system ([0094-96] and FIGs. 6A-6B) comprising:
an elongated lead body (600) including a distal end (602), wherein the lead body is configured to extend through vasculature of a patient ([0095] 600 can be guided to a therapy location in the body of a patient);
a fixation member (608) fixed to the lead body ([0094] 608 is attached to 602; FIG. 6A) and configured to extend distal to the distal end (FIG. 6A: 608 extends distally to 602), wherein the lead body defines a longitudinal axis extending through the distal end (FIG. 6A: 600 defines a longitudinal axis along its length), and
a balloon (604) affixed to an exterior surface of the lead body (FIG. 6A: part of the proximal surface of 604 is attached to the outer surface of 600) and defining a deflated configuration ([0094] 604 is an expandable balloon, which has a deflated configuration when not expanded) and an inflated configuration ([0094] 604 is an expandable balloon, which has an inflated configuration when expanded as shown in FIG. 6A),
wherein the balloon is configured to expand radially outward from the exterior surface and extend distally beyond the distal end of the lead body when the balloon inflates from the deflated configuration to the inflated configuration (FIG. 6A: when 604 inflates, 604 expands radially outward from the outer surface of 600 and extends distally beyond 600),
wherein a portion of an outer surface of the balloon is configured to define a distal cavity surrounding at least a portion of the fixation member when the balloon expands radially outward (FIG. 6A: 604 defines an internal distal cavity when inflated, where at least part of 608 is within 604), and
wherein the portion of the outer surface is configured to flare radially away from the fixation member as the portion of the outer surface extends distally beyond the distal end of the lead body (FIG. 6A: the distal portion of 604 flares away from 608 as the outer surface of 604 extends away from 600).
Thakur et al. does not disclose a portion of an outer surface of the balloon faces away from the longitudinal axis in the deflated configuration and the portion of the outer surface faces towards the longitudinal axis in the inflated configuration.
Ning teaches in the same field of endeavor of medical balloon delivery systems ([0070]), and discloses a medical lead system (100; FIG. 2B; [0342]) comprising a balloon (107) and a tubular member (114) defining a longitudinal axis, where a portion of an outer surface of the balloon faces away from the longitudinal axis in the deflated configuration ([0338] the length of 107 may increase upon expansion to the state shown in FIG. 2B, where 107 does not initially extend distally beyond 114; the balloon, when deflated such as in FIG. 5B, has the outer surface facing outward away from the longitudinal axis of the system) and the portion of the outer surface faces towards the longitudinal axis in the inflated configuration (FIG. 2B: 107 is inflated, and 107 extends distally beyond 114, and portions of the outer surface now face toward the longitudinal axis defined by 114) for the purpose of using the balloon anchor the system to the wall ([0338]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the balloon of Thakur et al. to have a portion of an outer surface of the balloon faces away from the longitudinal axis in the deflated configuration and the portion of the outer surface faces towards the longitudinal axis in the inflated configuration, as taught by Ning, for the purpose of using the balloon anchor the system to the wall.
Regarding claim 2, Thakur et al. as modified by Ning further discloses the fixation member is configured to extend distal to the balloon when the balloon is in the inflated configuration (Thakur et al. FIG. 6A: 608 extends distally to 604 while 604 is inflated, and FIG. 2B of Ning indicates the modification does not change this).
Regarding claim 3, Thakur et al. as modified by Ning discloses the balloon is configured to extend distal to the fixation member when the balloon is in the inflated configuration (Ning FIG. 2B: before anything is advanced through 114 is advanced distally, 107 is inflated while distal to 114).
Regarding claim 4, Thakur et al. as modified by Ning further discloses the balloon includes a balloon body (Thakur et al. FIG. 6A: 604 has a body) affixed to the exterior surface at a first location (Thakur et al. FIG. 6A: the proximal-most point where 604 attaches to 600) and affixed to the exterior surface at a second location distal to the first location (Thakur et al. FIG. 6A: the distal-most point where 604 attaches to 600), wherein the balloon includes a balloon portion configured to be distal to the first location and proximal to the second location when the balloon is in the deflated configuration (Thakur et al. FIG. 6A: the mid-point between the proximal-most and distal-most points of attachment of 604 to 600), and wherein the balloon is configured to extend distal to the second location and beyond the distal end when the balloon inflates from the deflated configuration to the inflated configuration (Ning FIG. 2B: before anything is advanced through 114 is advanced distally, 107 is inflated while distal to 114).
Regarding claim 5, Thakur et al. as modified by Ning further discloses the balloon defines an interior volume (Thakur et al. FIG. 6A: 604 has an internal volume) configured to contain an inflating medium when the balloon inflates (Thakur et al. FIG. 6A: 604 is capable of being filled with a medium), and wherein the interior volume is configured to define a first center of volume in the deflated configuration (Thakur et al. [0094] 604 is an expandable balloon, which has a deflated configuration when not expanded, and that deflated configuration will have a center) and a second center of volume in the inflated configuration (Thakur et al. FIG. 6A: 604 has a center of volume while inflated), wherein the second center of volume is distal to the first center of volume (Ning FIG. 2B: the center of volume of 107 moves distally as the length increases in the distal direction).
Regarding claim 6, Thakur et al. as modified further discloses the balloon is configured to extend radially around the portion of the fixation member when the balloon is in the inflated configuration (Thakur et al. FIG. 6A: 604 radially surrounds 608 while 604 is inflated).
Regarding claim 7, Thakur et al. as modified further discloses the balloon is configured to substantially surround the portion of the fixation member when the balloon is in the inflated configuration (Thakur et al. FIG. 6A: 604 radially surrounds 608 while 604 is inflated).
Regarding claim 8, Thakur et al. as modified further discloses the portion of the outer surface is configured to increase a radial displacement from the longitudinal axis to the portion of the outer surface when the portion of the outer surface flares radially away from the fixation member (Thakur et al. FIG. 6A: 604 expands radially away from the longitudinal axis as 604 inflates and flares away from 608).
Regarding claim 10, Thakur et al. as modified by Ning further discloses the balloon includes a balloon body (Thakur et al. FIG. 6A: 604 has a body) affixed to the exterior surface at a fixation location (Thakur et al. FIG. 6A: the distal-most point where 604 attaches to 600), wherein the balloon is configured such a portion of the balloon body is proximal to the fixation location when the balloon is in the deflated configuration (Thakur et al. FIG. 6A: a portion of 604 is proximal to the distal-most point where 604 attaches to 600) and the portion of the balloon body is distal to the fixation location when the balloon is in the inflated configuration (Ning FIG. 2B: the portion of 107 which extends beyond 114 after inflation).
Regarding claim 11, Thakur et al. as modified by Ning further discloses the fixation location is proximal to the distal end (Ning FIG. 2B: the attachment of 107 is proximal to the distal end of 114), and wherein the exterior surface defines a supporting area between the fixation location and the distal end (Ning FIG. 2B: 114 has a surface between 107 and the distal end of 114), wherein the supporting area is configured to contact the portion of the balloon body when the balloon is in the inflated configuration (Ning FIG. 2B: when 107 inflates and extends over the distal end of 114, 107 contacts the area between the fixation location and the distal end).
Regarding claim 12, Thakur et al. as modified by Ning further discloses in the deflated configuration, the balloon body is folded at the fixation location such that a first portion of the balloon body is positioned between a second portion of the balloon body and the exterior surface (Ning FIG. 2B: 107 folds over itself so that part of 107 shifts between 107 and 114 when inflated).
Regarding claim 13, Thakur et al. as modified further discloses the fixation member is configured to penetrate tissue of a patient (Thakur et al. [0094] 608 anchors 600 by penetrating the tissue wall), and further comprising: an electrode supported by the fixation member (Thakur et al. [0094] 608 can function as an electrode); and processing circuitry electrically connected to the electrode (Thakur et al. [0096] the electrode can have communication with circuitry which processes signals from the tissues), wherein the processing circuitry is configured to perform pace mapping of a tissue wall using the electrode when the outer surface of the balloon defines the distal cavity (Thakur et al. [0096] the signals from the electrode are used to pace map the HIS bundle).
Regarding claim 16, Thakur et al. discloses a medical lead system ([0094-96] and FIGs. 6A-6B) comprising:
an elongated lead body (600) including a distal end (602), wherein the lead body is configured to extend through vasculature of a patient ([0095] 600 can be guided to a therapy location in the body of a patient);
a fixation member (608) fixed to the lead body ([0094] 608 is attached to 602; FIG. 6A) and configured to extend distal to the distal end (FIG. 6A: 608 extends distally to 602), wherein the longitudinal axis extends through at least a portion of the fixation member (FIG. 6A: 600 defines a longitudinal axis through 608), and wherein the fixation member is configured to penetrate tissue of a patient ([0094] 608 anchors 600 by penetrating the tissue wall);
an electrode supported by the fixation member ([0094] 608 can function as an electrode); and
a balloon (604) affixed to an exterior surface of the lead body (FIG. 6A: part of the proximal surface of 604 is attached to the outer surface of 600) and defining a deflated configuration ([0094] 604 is an expandable balloon, which has a deflated configuration when not expanded) and an inflated configuration ([0094] 604 is an expandable balloon, which has an inflated configuration when expanded as shown in FIG. 6A),
wherein the balloon is configured to expand radially outward from the exterior surface and extend distally beyond the distal end of the lead body when the balloon inflates from the deflated configuration to the inflated configuration (FIG. 6A: when 604 inflates, 604 expands radially outward from the outer surface of 600 and extends distally beyond 600),
wherein a portion of an outer surface of the balloon is configured to define a distal cavity surrounding at least a portion of the fixation member when the balloon expands radially outward (FIG. 6A: 604 defines an internal distal cavity when inflated, where at least part of 608 is within 604), and
wherein the portion of the outer surface is configured to flare radially away from the fixation member as the portion of the outer surface extends distally beyond the distal end of the lead body (FIG. 6A: the distal portion of 604 flares away from 608 as the outer surface of 604 extends away from 600),
wherein the portion of the outer surface is configured to increase a radial displacement from the longitudinal axis to the portion of the outer surface when the portion of the outer surface flares radially away from the fixation member (FIG. 6A: the distal portion of 604 is radially displaced from the longitudinal axis running through 600 and 608 when the distal portion of 604 is inflated away from 608); and
processing circuitry electrically connected to the electrode ([0096] the electrode can have communication with circuitry which processes signals from the tissues), wherein the processing circuitry is configured to perform pace mapping of a tissue wall using the electrode when the outer surface of the balloon defines the distal cavity ([0096] the signals from the electrode are used to pace map the HIS bundle).
Thakur et al. does not disclose a portion of an outer surface of the balloon faces away from the longitudinal axis in the deflated configuration and the portion of the outer surface faces towards the longitudinal axis in the inflated configuration.
Ning teaches in the same field of endeavor of medical balloon delivery systems ([0070]), and discloses a medical lead system (100; FIG. 2B; [0342]) comprising a balloon (107) and a tubular member (114) defining a longitudinal axis, where a portion of an outer surface of the balloon faces away from the longitudinal axis in the deflated configuration ([0338] the length of 107 may increase upon expansion to the state shown in FIG. 2B, where 107 does not initially extend distally beyond 114; the balloon, when deflated such as in FIG. 5B, has the outer surface facing outward away from the longitudinal axis of the system) and the portion of the outer surface faces towards the longitudinal axis in the inflated configuration (FIG. 2B: 107 is inflated, and 107 extends distally beyond 114, and portions of the outer surface now face toward the longitudinal axis defined by 114) for the purpose of using the balloon anchor the system to the wall ([0338]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the balloon of Thakur et al. to have a portion of an outer surface of the balloon faces away from the longitudinal axis in the deflated configuration and the portion of the outer surface faces towards the longitudinal axis in the inflated configuration, as taught by Ning, for the purpose of using the balloon anchor the system to the wall.
Regarding claim 17, Thakur et al. as modified further discloses the balloon includes a balloon body (Thakur et al. FIG. 6A: 604 has a body) affixed to the exterior surface at a fixation location (Thakur et al. FIG. 6A: 604 is attached to 600 at a fixation location at the proximal-most point of attachment), wherein the fixation location is proximal to the distal end (Thakur et al. FIG. 6A: the proximal-most point of attachment between 600 and 604 is proximal to 602), and wherein the exterior surface defines a supporting area between the fixation location and the distal end (Thakur et al. FIG. 6A: 600 has a surface extending from the proximal-most point of attachment and 602), wherein the supporting area is configured to contact the portion of the balloon body when the balloon is in the inflated configuration (Thakur et al. FIG. 6A: the surface of 600 between the proximal-most point of attachment and 602 is in contact with 604 while 604 is inflated).
Regarding claim 18, Thakur et al. as modified by Ning further discloses the balloon includes a balloon body (Thakur et al. FIG. 6A: 604 has a body) affixed to the exterior surface at a fixation location (Thakur et al. FIG. 6A: the distal-most point where 604 attaches to 600), and in the deflated configuration, wherein the balloon body is folded at the fixation location such that a first portion of the balloon body is positioned between a second portion of the balloon body and the exterior surface (Ning FIG. 2B: 107 folds over itself so that part of 107 shifts between 107 and 114 when inflated ).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. in view of Ning, and in further view of Eversull et al. (Pub. No. 2007/0083217.
Regarding claim 9, Thakur et al. as modified by Maini discloses the invention as claimed in claim 1, as discussed above, and further discloses the balloon includes a balloon body defining a proximal balloon portion (Thakur et al. FIG. 6A: 604 has a proximal portion overlapping with 600) and defining a distal balloon portion distal to the proximal balloon portion (Thakur et al. FIG. 6A: 604 has a distal portion overlapping 608), wherein the proximal balloon portion is configured to radially expand away from the longitudinal axis at a first expansion rate when an inflating medium exerts a pressure on the proximal balloon portion (Ning FIG. 2B: the proximal portion of 107 radially expands away from the longitudinal axis at a first rate while 107 is being inflated), and wherein the distal balloon portion is configured to radially expand away from the longitudinal axis at a second expansion rate when the inflating medium exerts the pressure on the distal balloon portion (Ning FIG. 2B: the distal portion of 107 radially expands away from the longitudinal axis at a second rate while 107 is being inflated). Thakur et al. does not explicitly disclose that the first expansion rate is greater than the second expansion rate.
Eversull et al. teaches in the same field of endeavor of implantable medical leads (Abstract), and discloses a medical lead system (10; FIGs. 1A-1C; [0033]) comprising an elongated lead body (12) and a balloon (50) where the lead body defines a longitudinal axis extending through the distal end (18), wherein the balloon includes a balloon body ([0033] 50 has a body) defining a proximal balloon portion (FIG. 1B: 50 has a proximal section) and defining a distal balloon portion distal to the proximal balloon portion (FIG. 1B: 50 has a distal section), wherein the proximal balloon portion is configured to radially expand away from the longitudinal axis at a first expansion rate when an inflating medium exerts a pressure on the proximal balloon portion ([0040] an inflation medium is introduced to 50, which first causes the proximal portion to radially expand away from 18), wherein the distal balloon portion is configured to radially expand away from the longitudinal axis at a second expansion rate when the inflating medium exerts the pressure on the distal balloon portion ([0040] an inflation medium is introduced to 50, which eventually causes the distal portion to radially expand away from 18), and the first expansion rate is greater than the second expansion rate ([0040] and FIG. 1B: the expansion of 50 first occurs in the proximal portion, then in the distal portion, so the initial expansion rates are higher in the proximal portion than in the distal portion) for the purpose of expanding the balloon in the longitudinal direction of the tissue wall that the balloon will be placed against ([0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the balloon of Thakur et al. to have the first expansion rate be greater than the second expansion rate, as taught by Eversull et al., for the purpose of expanding the balloon in the longitudinal direction of the tissue wall that the balloon will be placed against.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. view of Ning, and in further view of Oral et al. (Pub. No. 2013/0018413).
Regarding claim 14, Thakur et al. as modified by Ning discloses the invention as claimed in claim 13, as discussed above, and further discloses the processing circuitry is configured to perform pace mapping of the tissue wall when the balloon extends distal to the fixation member ([0096] the signals from the electrode are used to pace map the HIS bundle). Thakur et al. does not disclose a fluid substantially fills the distal cavity and fluidically couples the electrode and the tissue wall, and the electrode is displaced from the tissue wall.
Oral et al. teaches in the same field of endeavor of implantable medical leads (Abstract), and discloses a medical lead system (120; [0058] FIGs. 6A-6G) comprising an elongated lead body (190), a fixation member (106), a balloon (617; FIG. 6G; [0075]), and an electrode (182; FIG. 2B) supported by the fixation member, where a fluid substantially fills the distal cavity and fluidically couples the electrode and the tissue wall ([0079] activation of 106 can occur after the filler material expands the balloon to contact the LAA), and the electrode is displaced from the tissue wall ([0079] activation of 106 can occur while 106 is not attached to the LAA tissue wall) for the purpose of improving the electrical connection between the electrode and the tissue wall ([0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Thakur et al. to have a fluid fill the distal cavity and fluidically couple the electrode and the tissue wall, as taught by Oral et al., for the purpose of improving the electrical connection between the electrode and the tissue wall.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. in view of Ning, and in further view of Brandner et al. (Pub. No. 2023/0256252).
Regarding claim 15, Thakur et al. as modified by Ning discloses the invention as claimed in claim 1, as discussed above. Thakur et al. does not disclose a second balloon, wherein the second balloon is affixed to the exterior surface of the lead body and defines a second deflated configuration and a second inflated configuration, wherein the second balloon is configured to expand radially outward from the exterior surface and extend distally beyond the distal end of the lead body when the second balloon inflates from the second deflated configuration to the second inflated configuration, and wherein the fixation member is configured to extend distal to the second balloon when the second balloon is in the inflated configuration.
Brandner et al. teaches in the same field of endeavor of implantable medical leads (Abstract), and discloses a medical lead system (4900) comprising two balloons (4904a and 4904b; FIG. 49A; [1299]) for the purpose of being able to control the shape and profile of the balloons when inflated ([1299]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Thakur et al. to include two balloons instead of a single balloon, as taught by Brandner et al., for the purpose of being able to control the shape and profile of the balloons when inflated. The subdivision of the single balloon of Maini would result in two balloons which are affixed to the exterior surface of the lead body and having a deflated configuration and an inflated configuration, where both balloons expand radially outward from the exterior surface. Brandner et al. further discloses that the balloons can be parallel and aligned such that each balloon would form a hemisphere in the system of Thakur et al., which would result in both balloons extending beyond the distal end of the lead body when the balloons inflate from the deflated configuration to the inflated configuration, and the fixation member would be configured to extend distally to both balloons when the balloons are in the inflated configuration.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771