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 § 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.
Claim(s) 1-10 and 13-20 is/are rejected under 35 U.S.C. 103 as being obvious over Lampropoulos et al (US 5,458,571), in view of Bhagchandani et al (US 2014/0074021).
As to claims 1, 15 and 18, Lampropoulos teaches a device and method for collecting a biological sample in a patient (the device in fig.1-3, the device is more than capable to collect biological samples from body lumens, col.3, lines 25-50), the device comprising:
providing a catheter having an expandable member sized for placement within the patient (providing catheter 10 having expandable balloon inside lumen/artery, col.6, lines 1-20, fig.1-2),
the expandable member having a plurality of sizes in a plurality of states (the ballon having plurality of sizes when being deflated and being inflated with different pressures, col.6, lines 10-20, fig.1A-1C),
the expandable member designed to transition between a plurality of states including a collapsed state and a sampling state (inflated and deflated states of the balloon, as best seen in fig.1A-1B, col.6, lines 1-20);
and a tube extending from the expandable member (tube 38 of syringe 16 is extended through catheter 10 and its balloon, col.11, lines 1-10, fig.1-2);
a pressure source fluidly connected to the tube and configured to provide a pressure to the expandable member to actuate the expandable member to the plurality of sizes (syringe 16, col.10-col.11, fig.2);
a handle in fluid communication with the expandable member/catheter (handle 29 and plunger 24 of syringe 16, col.10-col.11, fig.2-3); and
an indicator configured to identify a size and status of the expandable member in response to the expandable member transitioning from one state to another/plurality of sizes (digital readout 66 having plurality of alphabetical/numerical indicators 68-72, that indicates plurality of parameters, such as, time, duration of inflation, inflation/deflation pressure, maximum inflation pressure reached, end of col.13-col.14, lines 1-20)(Examiner respectfully notes that indicating inflation and deflation pressure is an indication of collapsed and expandable/sampling state),
performing a procedure by pressurizing or depressurizing the expandable member (inflating and deflating of the balloon plurality of times, col.6, lines 10-20, fig.1);
wherein the indicator being independent from the handle (readout 66 is independent from handle 29 and plunger 24, as best seen in fig.2).
Still regarding claims 1, 15 and 18, Lampropoulos teaches the invention substantially as claimed above, but failed to explicitly teach the indicator configured to indicate a discrete operational state of the expandable member, the discrete operational state corresponding to at least two operational states of the expandable member, and wherein the indicator to identify a size of the plurality of sizes of the expandable member, wherein the size corresponds to a discrete expanded diameter range of the expandable member.
However, Bhagchandani teaches an analogous catheter system having an inflatable balloon (abstract, par.20, fig.1-7), wherein the indicator configured to indicate a discrete operational state of the expandable member, the discrete operational state corresponding to at least two operational states of the expandable member, and wherein the indicator to identify a size of the plurality of sizes of the expandable member, wherein the size corresponds to a discrete expanded diameter range of the expandable member (an external visual indicator of the inflation/deflation condition of the balloon inside the body, par.20, a visual inflation/deflation indicator device 25, par.22-23, and marking indicia 37 may also be placed along the outer surface of the catheter 10 to aid in the visualization of the inflated/deflated positions of the indicator strip 26. Marking indicia 37 may optionally be placed at multiple locations along catheter 10, including marking the fully inflated, fully deflated, and one or more intermediate locations indicating partially inflated/deflated conditions of balloon 11, par.24, fig.1-4)(Examiner respectfully notes that the size/diameter of the balloon is broadly interpreted as the inflation and/or deflating size, where the balloon’s diameter changes).
Since balloon inflate/deflate indicators are well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filling date of the invention to in substitute the indicator taught by Lampropoulos’s invention and/or include an indicator to Lampropoulos’s invention, as indicator taught by Bhagchandani’s invention, without changing its respective function, to indicate the inflatable status of the balloon inside the surgical site and to indicate a potential failure (e.g., slow leak) versus a full failure/rupture of the balloon, as taught by Bhagchandani’s invention (par.22-25).
As to claim 2, Lampropoulos teaches the device, wherein the indicator is an immovable indicator (digital readout 66 having plurality of alphabetical/numerical indicators 68-72, is a digital read out and not movable, as best seen in fig.2).
As to claim 3, Lampropoulos teaches the device, wherein the indicator is a visual indicator that includes a plurality of icons, each of the plurality of icons corresponding to one of the plurality of states (digital readout 66 having plurality of visual alphabetical/numerical indicators 68-72, that indicates plurality of parameters, such as, time, duration of inflation, inflation/deflation pressure, maximum inflation pressure reached, end of col.13-col.14, lines 1-20) Examiner respectfully notes that indicating inflation and deflation pressure is an indication of collapsed and expandable/sampling state).
As to claim 4, Lampropoulos teaches the device, wherein the indicator further includes a processor configured and arranged to activate one of the plurality of icons based on a pressure within the device (processor 90 in controller 20 that controls pressure to the balloon and controls/activates the readout 66 to display specific parameters regarding the pressure in the balloon, col.13-col.14, and col.15-col.16, fig.2-4).
As to claim 5, Lampropoulos teaches the device, wherein the indicator further includes a memory to record at least one of pressure data and volumetric data during a procedure (component of controller 20 memory is updated to store the event that a note line was requested by the system user, col.13, lines 40-45, lines 54-56, col.14, lines 25-50, and memory 96 in col.15-16).
As to claim 6, Lampropoulos teaches the device, wherein the processor is configured and arranged to differentiate between inflation and deflation of the expandable member (processor 90 is programmed to differentiate between inflation and deflation of the balloon by displaying negative pressure for deflation and positive pressure of inflation, col.15-col.16, fig.1-2).
As to claim 7, Lampropoulos teaches the device, wherein the processor is configured and arranged to activate an icon associated with the sampling state only when the expandable member reaches a predetermined volumetric or pressure range as the expandable member is being deflated (processor 90 is programmed to differentiate between inflation and deflation of the balloon by displaying negative pressure for deflation and positive pressure of inflation, col.15-col.16, fig.1-2).
As to claim 8, Lampropoulos teaches the device, wherein the processor is configured to activate an icon associated with the sampling state only when the expandable member reaches a predetermined volumetric or pressure range and stays within a range for a duration of more than 3 seconds (digital processor 90 will cause the pressure display portion 72 to flash to signal the system user that the maximum positive pressure has been reached, col.16, lines 23-26, count will be output by digital processor 90 at time display portion 70, and will flash once the selected duration has been reached to signal the system user that positive inflation pressure has been applied for the desired length of time, col.16, lines 30-45, fig.2 and 4)(Examiner respectfully notes the selected duration can be more than seconds).
As to claim 9, Lampropoulos teaches the device, wherein the immovable indicator includes three icons digital (readout 66 having plurality of visual alphabetical/numerical indicators 68, 70 and 72, col.14, fig.2).
As to claim 10, Lampropoulos teaches the device, wherein the immovable indicator includes four icons (readout 66 having plurality of visual alphabetical/numerical indicators 68, 70 and 72, wherein indicator 72 displays two digital values, col.14, fig.2).
As to claim 13, Lampropoulos teaches the device, wherein the expandable member has a first volume in the sampling state (volume of balloon when deflated, as best seen in fig.1A, col.6 and col.13-14).
As to claim 14, Lampropoulos teaches the device, further including an indexing condition that corresponds to inflating the expandable member to a second volume, the second volume being greater than the first volume (volume of balloon when inflated having greater volume than deflated, as best seen in fig.1A-1B, col.6 and col.13-col.16).
As to claim 16, Lampropoulos teaches the device, the plurality of sizes includes a collapsed state, a sampling state, and an indexing state, and the expandable member having a different size and shape in each of the plurality of sizes (delated state, inflated state and state where the balloon/catheter reaches a specific location in the body lumen, col.6, and col.13-16, as best seen in fig.1-2).
As to claim 17, Lampropoulos teaches the device, wherein the indicator is an electronic visual indicator that includes a collapsed indicator, a sampling indicator, and an indexing indicator (digital readout 66 having plurality of alphabetical/numerical indicators 68-72, that indicates plurality of parameters, such as, time, duration of inflation, inflation/deflation pressure, maximum inflation pressure reached, col.6, and end of col.13-col.14, lines 1-20)(Examiner respectfully notes that indicating inflation and deflation pressure is an indication of collapsed and expandable/sampling state, and the balloon/catheter reaches a specific location in the body lumen, col.15-16, fig.1-2).
As to claim 19, Lampropoulos teaches the device, further comprising the step of differentiating between inflation and deflation of the expandable member (processor 90 is programmed to differentiate between inflation and deflation of the balloon by displaying negative pressure for deflation and positive pressure of inflation, col.15-col.16, fig.1-2), and activating an icon associated with the sampling state only when the expandable member reaches a predetermined volumetric or pressure range as the expandable member is being deflated (processor 90 in controller 20 that controls pressure to the balloon and controls/activates the readout 66 to display specific parameters regarding the pressure in the balloon, col.13-col.14, wherein display 72 flashes when inflation of the balloon reaches a selected pressure for a selected time, col.15-col.16, fig.2-4).
As to claim 20, Lampropoulos teaches the device, further comprising the step of recording at least one of volumetric data or pressure data during the procedure (in step 234, fig.6d, the programmed processor determine whether the inflation pressure reached any selected maximum positive pressure for inflation, if the user selected maximum inflation pressure is reached the program moves to step 238 and causes pressure display portion 72 on control panel 64 to begin flashing so as to signal the system user that the selected maximum inflation pressure has been reached, col.21, lines 45-58).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being obvious over Lampropoulos et al (US 5,458,571) in view of Bhagchandani et al (US 2014/0074021).
As to claim 11, Lampropoulos/ Bhagchandani combination teaches the invention substantially as above, wherein, Lampropoulos teaches the immovable indicator includes a plurality of icons (readout indicators 66, fig.2), but failed to explicitly teach a plurality of icons arranged in a circle.
However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made to arrange indicators 66 taught by Lampropoulos’s invention in a circle because the Applicant has not disclosed that the circle arrangement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the device of Lampropouloss inventiom and the Applicant’s invention, to perform equally well with either the indicators arrangement taught by Lampropoulos or the claimed circle arrangement because both devices would perform the same function of indicating/displaying the inflation/deflation pressure values.
Therefore, it would have been prima facie obvious to modify Lampropoulos’s invention to obtain the invention as specified in Claim 11because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Lampropoulos’s invention In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being obvious over Lampropoulos et al (US 5,458,571) and Bhagchandani et al (US 2014/0074021), in further view of Phung et al (US 2016/0128830).
As to claim 12, Lampropoulos/ Bhagchandani teaches the invention substantially as above having a visual indicator, but failed to explicitly teach further comprising an audible indicator corresponding to the immovable indicator.
However, Phung discloses an analogous catheter device, wherein the device further comprising an audible indicator corresponding to the immovable indicator (audible indicators to prevent premature balloon catheter deployment, par.117).
As audible indicators are well-known in catheter art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to include an audible indicator in Lampropoulos’a invention, as taught by Phung’s invention, along with the digital indicator to monitor the pressure of the catheter’s balloon while being inflated, and to prevent premature balloon catheter deployment/balloon inflation, as taught by Phung’s invention (par.117).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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