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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 recites the limitation "wherein the colored diaphragm is configured to move in a direction normal to the diaphragm and frosted lens". There is insufficient antecedent basis for “the diaphragm”. For purposes of examination this will be interpreted as wherein the colored diaphragm is configured to move in a direction normal to the colored diaphragm and frosted lens.
Claim Rejections - 35 USC § 103
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, 6-7, 9, 11-13, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur (US 20190217097) in view of Willis (US 20220047303).
In re claim 1, Thakur discloses medical lead system (Fig. 6A) comprising:
a lead (Fig. 6A: 600, 604, and 608) comprising:
a lead body (Fig. 6A: 600) comprising a distal end (602) configured to extend through vasculature to a chamber of a heart of a patient [0094, 0033396],
a fixation member (608, [0094]: “fixation helix”) configured to extend distal to the distal end of the lead body [0094]: “extends through a central passageway or opening in the expandable balloon”,
wherein the fixation member is configured to be secured to tissue of the heart [0094]: “fixation helix 608 is configured to anchor the lead body to the tissue wall about the HIS bundle”; and
a distal balloon (604)
connected to an exterior surface of the distal end of the lead body (604 connected to 602) and
wherein the distal balloon defines a deflated configuration and an inflated configuration ([0094]: “expandable balloon”; note: expanded between a not expanded and an expanded configuration), and
further wherein the distal balloon is configured to
expand radially outward from the exterior surface of the lead body (Fig. 6A: 604 extends radially out from 600) and
extend distally beyond the distal end of the lead body when the distal balloon inflates from the deflated configuration to the inflated configuration ([0094]: “The expandable balloon 604 is arranged to extend outwardly from the distal end portion 602 of the lead body”); and
a pressure sensor [0109];
wherein the fixation member is further configured to extend distal to the distal balloon when the distal balloon is in the inflated configuration (Fig. 6A: 608 extends past 604).
Thakur lacks:
wherein the lead body further comprises
a lumen that extends along the lead body between an inlet adjacent to a proximal end of the lead body and an outlet adjacent to the distal end of the lead body;
a distal balloon
fluidly connected to the outlet of the lumen,
a pressure sensor
fluidly connected to the inlet of the lumen of the lead body and
configured to
sense a pressure within an interior volume of the distal balloon and
communicate a signal indicative of the pressure to a clinician.
Willis discloses a delivery system (Fig. 2: 240) configured to deliver an implantable medical device to tissue [0025] that, like the medical lead system of Thakur, has a balloon on a distal portion of a sheath ([0016]; i.e. lead) and a receiver-stimulator (310, i.e. fixation member) which is positioned (i.e. secured) in the heart [0035-0036]. Additionally, Willis discloses a fluid line (259, i.e. lumen) that extends along the sheath between an inlet (where conduit 269 meets 259; [0027]) and an outlet (where 259 meets at 255), wherein the fluid line is fluidly connected to the balloon [0027], and a pressure sensor, for example a pressure transducer [0027], fluidly connected to the balloon [0027], configured to monitor the pressure of the balloon, wherein the pressure sensor is connected to a digital pressure readout (272) which displays the pressure of the balloon ([0029]; i.e. communicate a signal indicative of the pressure).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system disclosed by Thakur by providing a fluid line extending along a sheath between an inlet and an outlet, wherein the fluid line is fluidly connected to the balloon and a pressure sensor is also fluidly connected to the balloon configured to monitor the pressure of the balloon, which is connected to a digital pressure readout which displays the pressure of the balloon as taught by Willis because the pressure of the balloon can be used to determine is the balloon is in contact with the wall of the heart chamber, the motion of the heart chamber, or the blood flow characteristics within the heart chamber (Willis: [0017]) and the lumen would allow for a pressure to move between a pressure source, balloon, and pressure sensor (Willis: [0028]).
In re claim 2, Thakur lacks an inflation mechanism configured to
be fluidly connected to the inlet of the lumen of the lead body and
manipulate the distal balloon between the deflated configuration and the inflated configuration.
Willis discloses an inflation and monitoring circuit (262) with a pressure source (Fig. 2: 262, i.e. inflation mechanism), which is a syringe, pump, blower, and/or other suitable pressure source, is fluidly connected to the ballon (via fluid line 259), and which is configured to move the balloon between an inflated configuration and a deflated configuration [0027-0028, 0054].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system disclosed by Thakur by providing a pressure source which is a syringe, pump, blower, and/or other suitable pressure source, is fluidly connected to the balloon, and is configured to move the balloon between an inflated and a deflated configuration as taught by Willis because it would provide the user with a method for increasing or decreasing the pressure in the balloon as needed [0031].
In re claim 3, regarding the limitation “wherein the inflation mechanism comprises a syringe or a pump”, see above 35 U.S.C. 103 rejection, In re claim 2.
In re claim 6, Thakur lacks wherein the pressure sensor comprises a pressure transducer.
Willis discloses wherein the pressure sensor comprises a pressure transducer [0027].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system disclosed by Thakur by providing a pressure source comprises a pressure transducer as taught by Willis because it would convert a mechanical pressure of the balloon into an analog or digital signal.
In re claim 7, Thakur lacks:
wherein the pressure sensor comprises an indicator light,
wherein the indicator light is configured to
emit light comprising a first wavelength when the distal balloon is in the deflated configuration and
emit light comprising a second wavelength when the distal balloon is in the inflated configuration.
Willis discloses wherein the delivery system comprises an indicator, for example, a light, indicated that the ballon is in an inflated configuration [0026], and where the indicator can illuminate at different colors (i.e. wavelengths), for example red, blue, and yellow to indicate proper contact, no contact and/or improper contact ([0036]; which can be determined by the balloon pressure [0017]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system disclosed by Thakur by providing a an indicator light to indicate when the balloon is in an inflated configuration and an indicator that can illuminate at different colors to confirm contact configuration as taught by Willis because it would it would provide a quick confirmation to a user, such as a physician implanting an implantable device, that the balloon is inflated or that the balloon has made contact with the wall of the heart chamber, without requiring the physician to read the pressure measurement during the delivery procedure. It would be obvious to use a light indicator to indicate both inflated and deflated configurations, where the indicator can illuminate at different colors to indicate the inflated or deflated configuration. Such a combination would yield wherein the pressure sensor comprises an indicator light, wherein the indicator light is configured to emit light comprising a first wavelength when the distal balloon is in the deflated configuration and emit light comprising a second wavelength when the distal balloon is in the inflated configuration.
In re claim 9, see above 35 U.S.C. 103 Rejection, In re claim 1. In addition to these limitations, Thakur discloses:
an implantable medical device (Fig. 1: 100; [0095])
comprising:
a housing (112) and
an electronics module disposed within the housing ([0061, 0062]: “a housing 112, which contains and houses electronic and other components”) and
comprising
a power source ([0066]: “current generators may be used to supply current-regulated amplitudes to selectively generate independent current sources for one or more of the electrode”) and
circuitry electrically connected to the power source (116; [0066]: “pulse generation circuitry”).
wherein at least a proximal portion of the lead body is configured to be inserted into a lead bore (110) of the housing (106 connects 110; [0061]).
In re claim 11, Thakur discloses wherein the implantable medical device is one of an implantable defibrillator or a neuromodulation device ([0003]: “implantable cardioverter defibrillators (ICDs)”).
In re claim 12, see above 35 U.S.C. 103 rejection, In re claim 12.
In re claim 13, Thakur lacks wherein the pressure sensor is connected to the inflation mechanism.
Willis discloses an inflation and monitoring circuit (Fig. 2: 260) wherein the inflation mechanism (262) is connected to the pressure sensor (264) through the connector (270, [0027]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system disclosed by Thakur by providing wherein the pressure system is connected to the inflation mechanism as taught by Willis because if all are connected to the lumen, the inflation mechanism would be able to inflate the balloon and the pressure sensor would be able to detect the pressure within the ballon via the lumen, additionally, the pressure sensor would be able to monitor the applied pressure from the inflation mechanism.
In re claim 16, see above 35 U.S.C. 103 rejection, In re claim 6.
In re claim 17, Thakur lacks wherein the pressure sensor comprises an audible alarm.
Willis discloses wherein the delivery system is configured to provide auditory feedback to indicate that contact has occurred ([0036]; which can be determined by the balloon pressure [0017]) and to provide an indicator configured to indicate that the balloon is in the inflated configuration [0026].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system disclosed by Thakur by providing wherein the pressure system comprises an audible alarm as taught by Willis because it would it would provide confirmation to a user, such as a physician implanting an implantable device, that the balloon is inflated or that the balloon has made contact with the wall of the heart chamber (Willis: [0036]), which would be able to get the user’s attention when they are visually engaged with the delivery procedure.
In re claim 18, see above 35, U.S.C. 103 rejection, In re claim 7.
Claims 4-5, 14-15, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur (US 20190217097) in view of Willis (US 20220047303) in further view of Howell (US 20110196341).
In re claim 4, the proposed system lacks wherein the pressure sensor comprises an indicator balloon that defines a deflated configuration and an inflated configuration,
wherein the indicator balloon is in the deflated configuration when the distal balloon is in the deflated configuration, and further
wherein the indicator balloon is in the inflated configuration when the distal balloon is in the inflated configuration.
Howell discloses a medical device [0023, 0034] with an internal balloon (Fig. 1A: 30) and a deflation indicator system (i.e. pressure sensor) that pushes outward when filled with fluid pressure (Fig. 1A: 40; [0032]; i.e. indicator ballon) that indicates the inflation status of the internal balloon; wherein the indicator comprises a deflated configuration (Fig. 1A) when the balloon is in a deflated state [0030] and an inflated configuration (Fig. 2A) when the balloon is in an inflated state [0031].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system of the proposed combination by providing wherein the pressure sensor comprises an indicator that is in a deflated configuration when the distal ballon is in the deflated configuration and in an inflated configuration when the distal balloon is in the inflated configuration as taught by Howell because it would enable a user to ascertain from an external vantage point whether the internal balloon is sufficiently inflated (Howell: [0023]).
In re claim 5, the proposed system lacks:
wherein the pressure sensor comprises
a disk and
a base configured to receive the disk,
wherein a major surface of the disk faces a major surface of the base,
wherein the signal comprises
a first configuration and
a second configuration
of the disk,
wherein a first distance between a center portion of the major surface of the disk and the major surface of the base when the disk is in the first configuration as measured along a normal to the major surface of the disk and the major surface of the base is less than a second distance between the center portion of the major surface of the disk and the major surface of the base when the disk is in the second configuration,
wherein the disk is
in the first configuration when the distal balloon is in the deflated configuration and
in the second configuration when the distal balloon is in the inflated configuration.
Howell discloses a medical device with an internal balloon [0023] and a deflation indicator system (Fig. 1A: 40; i.e. pressure sensor) that indicates the inflation status of a balloon (30), wherein the indicator comprises an indicator (50; i.e. major surface of a disk) and a head portion and outer perimeter (20 and 46; i.e. a base) of an elongate body; wherein the indicator (i.e. signal) comprises a first position (Fig. 1A; i.e. configuration) when the balloon is in a deflated state [0030] and a second position (Fig. 2A) when the balloon is in an inflated state [0031]; wherein the first configuration has a concave shape towards the atmosphere (Fig. 1A) and the second configuration has a convex shape (Fig. 2A; i.e. a distance between the center of the indicator surface and a major surface of the head portion normal to the indicator surface and head portion is less in the first configuration than in the second configuration).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system of the proposed combination by providing wherein the pressure sensor comprises a disk and a base wherein the disk if in a first configuration when the distal ballon is in an deflated configuration and in a second configuration when the distal balloon is in an inflated configuration, wherein a distance between the center of the indicator surface and a major surface of the head portion is less in the first configuration than in the second configuration as taught by Howell because it would enable a user to ascertain from an external vantage point whether the internal balloon is sufficiently inflated (Howell: [0023]).
In re claim 14, see above 35 U.S.C. Rejection, In re claim 4.
In re claim 15, see above 35 U.S.C. rejection, In re claim 5.
In re claim 20, the proposed system lacks:
wherein the pressure sensor comprises a mechanical switch,
wherein the signal comprises a change of shape of the mechanical switch.
Howell discloses a medical device [0023, 0034] with an internal balloon (Fig. 1A: 30) and a deflation indicator system (i.e. mechanical switch; note: under broadest reasonable interpretation, change from an inflated to deflated ballon comprises a change of shape and is mechanical in nature) that pushes outward when filled with fluid pressure (Fig. 1A: 40; [0032]; i.e. a change of shape of the mechanical switch mechanical switch).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system of the proposed combination by providing wherein a deflation indicator system (i.e. mechanical switch) that pushes outward when filled with fluid pressure (i.e. a change of shape of the mechanical switch mechanical switch) as taught by Howell because it would enable a user to ascertain from an external vantage point whether the internal balloon is sufficiently inflated (Howell: [0023]).
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur (US 20190217097) in view of Willis (US 20220047303) in further view of Huthsing (US 3703879).
In re claim 8, the proposed combination lacks:
wherein the pressure sensor comprises
a colored diaphragm and
a frosted lens,
wherein the colored diaphragm is configured to move in a direction normal to the diaphragm and frosted lens,
wherein a contact area between the colored diaphragm and the frosted lens corresponds to a pressure within the interior volume of the distal balloon.
Huthsing discloses a device that indicates the pressure within a vessel (abstract), similar to the pressure sensor of the proposed combination. In addition, Huthsing discloses wherein the pressure sensor comprises a frosted surface (71; col. 6, ln. 25-30; i.e. frosted lens) and a diaphragm with brightly colored indicia (34 and 72; col. 6, ln. 40-42; i.e. colored diaphragm), wherein the colored diaphragm moves into contact with the frosted surface (i.e. moves in a direction normal to the diaphragm and frosted lens), wherein the contact area between the diaphragm raised portions and the frosted surface indicated the pressure within an interior volume of a vessel (Col. 6, ln. 30-37; note: the contact area of the indicia would functionally correspond to a pressure within the vessel)
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system of the proposed combination by providing wherein the pressure sensor comprises a colored diaphragm and frosted lens wherein the colored diaphragm is configured to move in a direction normal to the diaphragm and frosted lens and wherein a contact area between the colored diaphragm and the frosted lens corresponds to a pressure within the interior volume of a vessel as taught by Huthsing because it is a simply constructed and inexpensive device for indicating pressure (Col. 1, ln. 11-12 and 34-37).
In re claim 19, see above 35 U.S.C. rejection, In re claim 8.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thakur (US 20190217097) in view of Willis (US 20220047303) in further view of Taepke (US 20130192611).
In re claim 10, the proposed system lacks:
wherein the lead bore of the implantable medical device comprises a contact that is electrically connected to the circuitry of the electronics module by a conductor,
wherein a lead contact of the lead is configured to be electrically connected to the contact of the lead bore when the at least a portion of the lead is disposed within the lead bore.
Taepke discloses a fixation device (Fig. 2; abstract) that, similar to the medical lead system of Thakur, is configured to anchor an implantable medical device within a patient (abstract) and uses an expandable structure, for example a balloon, to fix the medical device [0054, 0065]. In addition, Taepke discloses a connection block (34 and connectors on leads 18, 20, and 22; i.e. lead bores) which comprises contacts that are electrically connected that couples to leads (18, 20, and 22) of the implantable medical device and electrically couples the leads to a stimulation generation and/or sensing circuitry ([0003, 0041]; note: conductor is inherent in the electric circuit), and discloses lead contacts which are electrically connected to the contact of the lead bore when mechanically coupled to the connection block via connectors (Fig. 2; [0041]) and are electrically coupled to their respective electrodes via coiled conductors [0042-0043].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the medical lead system of the proposed combination by providing a connection block with connectors that comprises a contact that is electrically coupled to the circuitry of the electronics module by a conductor and wherein a lead contact of the lead is configured to be electrically connected to the contact of the lead bore when the at least a portion of the lead is disposed within the lead bore as taught by Taepke because it would electrically connect the implantable device and electronics module to the lead system and pressure sensor, permitting a controller to direct stimulation or the fixation device of the lead based on the pressure sensor, for example determining the location from the pressure sensor.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Aklog (US 20200360667) discloses a catheter device system comprising a balloon on the working end (i.e. distal end) and an indicator membrane (i.e. indicator ballon) located outside a patient to mirror the size, shape and state of the working end.
Edward (WO 2014202962) discloses a visual pressure indicator comprising a transparent or translucent viewing window and a diaphragm with a colored lower membrane wherein a displacement of the diaphragm is observable through the viewing window.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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