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 .
Amendments
Amendments filed 11/26/25 amend claims 1, and 15. Claims 18-20 were previously withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6-7, 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghaffari et al. [US 2010/0087782 A1, hereinafter “Ghaffari”].
Re. claim 1, Ghaffari discloses a medical device locator [Figs. 1 and 2. Note that this preamble is not itself limiting] comprising:
an elongate member [catheter 320] having a proximal end, a distal end, a longitudinal axis and a length extending along the longitudinal axis [left-right. See Annotated Fig. 2];
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an inflatable member [balloon 300] disposed about the distal end of the elongate member, the inflatable member having a first inflated volume [150 percent, Par. 0008] and a second inflated volume larger than the first inflated volume [300 percent, Par. 0008]; and
a first light emitting diode (LED) [210, in the embodiment in which it is an LED; see Par. 0023] disposed along the length of the inflatable member [Fig. 2];
wherein the elongate member comprises a fluid lumen extending therealong [partially shown in Fig. 2. The member is described as a catheter which inherently has a lumen];
the fluid lumen is in fluid communication with the inflatable member [because the catheter inflates the inflatable member, Par. 0020, it is inherently in communication with the inflatable member]; and the fluid lumen is configured to supply and/or return a fluid therethrough [Par. 0020] [“to pulsate the inflatable member with the first LED by repeatedly transitioning between the first inflated volume and the second inflated volume during a same medical procedure: this is the intended result of the inflation/deflation. Because Ghaffari’s device inflates and deflates the balloon, it is capable of pulsating the inflatable member repeatedly between the first and second inflated volumes during a medical procedure ]; and
in the second inflated volume, the inflatable member is configured to bring the first LED into contact with tissue and to stretch the tissue [Fig. 2 and Abstract: “The invention allows for such operative features [here, the LEDs] to come into direct contact with body structures, such as the inner wall of a lumen,” where the tissue is stretched as described in Par. 0020] [“so that light emitted from the first LED more easily passes through the stretched tissue” relates to the intended result of the above, and is not given further patentable weight. Ghaffari’s device is capable of achieving such a result due to its same structure].
Re. claim 2, Ghaffari discloses pulsation of the inflatable member is configured to move the wall of a body lumen [“inflatable balloon…is used…to enlarge a narrow…passage within the body,” Par. 0020]. Regarding the limitation “and to assist with identifying, when viewed externally from a body lumen, a desired portion of the body lumen in which the inflatable member is positioned:” this is the intended use of the device. Ghaffari’s device, by nature of the above recited structure, is capable of such a result.
Re. claim 6, Ghaffari discloses the first LED extends along the inflatable member substantially parallel with the longitudinal axis [Fig. 1].
Re. Claim 7. Ghaffari teaches a controller [Par. 0072]. It is not clear whether the controller communicates with the first LED. However, forming the controller to communicate with the LED would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this ensures that the controller can control all aspects of the apparatus, including the previously recited LED.
Re. claim 13, Ghaffari discloses the second inflated volume of the inflatable member is selected to have a first diameter larger than a second diameter of a relaxed body lumen in which the inflatable member is positioned [Par. 0020 describes the inflated balloon expanding the lumen. Thus, at least one of the inflated diameters, herein defined as the second inflated volume’s diameter, is larger than a diameter of a relaxed body lumen].
Re. claim 14, Ghaffari discloses the inflatable member in the first inflated volume is extendable within a body lumen and wherein the inflatable member in the second inflated volume is configured to stretch a wall of the relaxed body lumen [Par. 0020] such that the wall of the body lumen about the inflatable member is thinner than the wall about the inflatable member in the first inflated volume [the intended result of the above, this is achievable by the apparatus of Ghaffari].
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari in view of Gunday et al. [US 2010/0121270 A1, hereinafter “Gunday”]
Regarding claim 15, Ghaffari discloses the catheter substantially as set forth with respect to claim 1 above. Ghaffari further discloses the catheter is extendable within a first body lumen [Fig. 2], but fails to disclose an endoscope. However, Gunday teaches, in a balloon catheter system, an endoscope [Par. 0103] capable of being extended within a second body lumen toward the catheter between opposing walls of the first and second body lumens [see Par. 0103. The endoscope delivers the balloon catheter. The endoscope is inserted into the body at another location that the lumen shown in Fig. 7A, therefore it is capable of being extendable within a second body lumen toward the catheter between opposing walls of the first and second body lumens. Note that the body lumens are not positively recited elements of the claim], and the inflatable member being configured to pulsate between the first and second inflated volumes [Par. 0105].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Ghaffari by adding an endoscope as taught by Gunday in order to allow a surgeon to see inside a body cavity or organ during a medical procedure.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari in view of Troutman et al. [US 2017/0296795 A1, hereinafter “Troutman”].
Regarding claim 3, Ghaffari discloses the apparatus set forth above but fails to teach the catheter being a multilumen catheter. However, Troutman teaches, in a medical device locator the elongate member is a multilumen catheter [“the distal end of tubular body 112 can include a plurality of lumens 174,” Par. 0036] including a second lumen extending along the longitudinal axis of the catheter [Par. 0036], the second lumen comprising a lead [Par. 0043].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ghaffari in view of Troutman in order to allow electrical leads and other devices to be placed inside the lumen, which simplifies the overall structure and operation of the device.
Regarding the lead being electrically coupled to the first LED, one of ordinary skill would reasonably be apprised of connecting this lead to the LED to provide the same benefits.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari and Troutman as applied to claim 3 above and further in view of Schneider et al. [US 20070164900 A1, hereinafter “Schneider”].
Regarding claim 4, Ghaffari discloses the apparatus set forth above but fails to teach the contrast agent. However, Schneider teaches, in a catheter, a third lumen extending along the longitudinal axis of the catheter distally past the inflatable member, the third lumen configured to deliver a flow of contrast fluid [“Lumen 230 may be used to deliver a diagnostic agent, for example a contrast agent,” Par. 0019].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Ghaffari to have a third lumen which delivers contrast fluid as taught by Schneider in order to aid in fluoroscopic guidance [Schneider Par. 0019].
Regarding the third lumen being a separate lumen, given the above teachings of Troutman, forming the contrast agent lumen as a third lumen would have been obvious since in a multilumen catheter one of ordinary skill would reasonably be apprised of the benefits of forming each lumen as a separate lumen.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari in view of Neustadter et al. [US 20070055144 A1, hereinafter “Neustadter”].
Regarding claim 5, Ghaffari discloses the apparatus with respect to claim 1 above including the LED, but fails to teach the color. However, Neustadter teaches, in a medical device, red and green LEDs are used [Par 0249]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Ghaffari by forming the first LED is actuatable to emit a light having a wavelength corresponding to a green light, a red light, or both, as taught by Neustadter (here, both), because this allows the light to indicate if a tool is or is not correctly positioned [Neustadter Par. 0249].
Claim(s) 8-9, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari, or Ghaffari in view of Gunday as applied to claim 15 above, and further in view of Leone et al. [US 5885244 A, hereinafter “Leone”]
Regarding claim 8 , Ghaffari or Ghaffari-Gunday discloses the apparatus with respect to claim 7 or 15 above including the LED, and further teaches a controller [see claim 7 above], but fails to teach the controller configured to actuate the LED in a pulsating fashion. However Leone teaches a balloon catheter medical device wherein the controller is configured to actuate the first LED in a pulsating fashion [“One such LED is associated with the heartbeat, or pulse of the patient that is received as an input to the control apparatus 50 and is indicated at 56. This LED 56 flashes in synchronization with the pulse input of the patient,” Leone Col. 5 lines 1-4]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ghaffari by configuring the LED to be pulsed as taught by Leone in order to allow a controller to easily visually observe a heartbeat or pulse of a patient [Leone Col. 5 lines 3-6] which is useful in certain procedures.
Claim 9. Ghaffari teaches a controller and a fluid supply [the fluid supply inflates/deflates], but is silent regarding a controller in communication with the reciprocating fluid supply and configured to synchronize.
Gunday teaches a reciprocating fluid supply [Par. 0116]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ghaffari by using a reciprocating fluid supply as the fluid supply because this amounts to a simple substitution of one type of fluid supply known in the art for another with predictable results.
Leone teaches a controller [50] in communication with a reciprocating fluid supply configured to substantially synchronize inflation and deflation of the inflatable member with the actuation and deactivation of the first LED [“the synchronization of the balloon inflation and deflation with the heartbeat,” which is in turn synchronized with the LED on/off cycle; Col. 4 line 63-Col. 5 line 5]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ghaffari by configuring the controller of Ghaffari [which controls inflation to the first and second inflated volumes] to substantially synchronize the second inflated volume of the inflatable member with actuation of the first LED and substantially synchronize the first inflated volume of the inflatable member with a deactivation of the first LED because this allows the balloon to be easily inflated/deflated synchronously with the pulse, which is useful in certain medical procedures such as angioplasty. [see Leone Col. 3 lines 28-38].
Regarding claim 16. The modified Ghaffari discloses the apparatus as set forth with respect to claims 7-9 above.
Claim(s) 8 (in the alternate) and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari in view of Gunday and further in view of Simms [US Pat. 4757194].
Claim 8 (alternate) and 10. Ghaffari discloses the controller is in communication with a fluid supply and wherein the controller is configured to transition the inflatable member between the first inflated volume and the second inflated volume at a first frequency [inherent], but fails to teach the controller configured to operate the LED in a pulsating fashion, the controller configured to actuate the first LED at a second frequency that is larger than the first frequency.
Gunday teaches a reciprocating fluid supply [Par. 0116]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ghaffari by using a reciprocating fluid supply as the fluid supply because this amounts to a simple substitution of one type of fluid supply known in the art for another with predictable results.
Simms teaches, in a balloon catheter with an LED, the controller is configured to actuate the LED so it is pulsed [Col. 5 lines 35-43]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Ghaffari by pulsing the LED as taught by Simms in order to increase the lifetime of the LED [Col. 5 line 40]. Furthermore, regarding the first and second frequency, the controller is able to select the frequency at which the LED is activated, so changing the second frequency such that it is larger than the inflation frequency of Ghaffari is readily performed by one of ordinary skill, and because the pulse frequency affects the battery life as taught by Simms, this amounts to optimizing a result effective variable.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari in view of Rabinovitz et al. [US 2014/0296666 A1, hereinafter “Rabinovitz”].
Claim 11. Ghaffari discloses the first LED and controller as set forth with respect to claims 7 above, but fails to teach a second LED and sequential activation.
However, Rabinovitz teaches, in a medical device locator (endoscope) a first “one LED 4113, Par. 0176] and a second LED [“second LED 4113,” Par. 0276] disposed along a member and electrically communicative with a controller, wherein the controller is configured to sequentially actuate the first LED and the second LED [“The LEDs 4113 may operate in an alternating or sequential mode,” Par. 0276]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ghaffari to add a second LED and configure the controller to sequentially activate the first and second LEDs because this allows for different bodily fluid components to be detected, which is useful in GI applications [Rabinovitz Par. 0278]
Regarding the second LED being disposed along the inflatable member and electrically communicative with the controller, as the first LED meets these limitations, one of ordinary skill would reasonably expect the second LED to be similarly located and connected.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari in view of Friedman et al. [US 20050106710 A1, hereinafter “Friedman”]
Regarding claim 12, Ghaffari discloses the apparatus with respect to claim 1 above including the LED, but fails to teach the light extending helically. However, Friedman teaches, in a medical device using LEDs, a first LED extends helically about the longitudinal axis along a length [Fig. 5, LEDs 212]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Ghaffari by forming the LEDs to extend helically along the length as taught by Friedman because this amounts to a simple substitution of one LED placement pattern known in the art for another with predictable results.
Regarding the length being along the length of the inflatable member, when combining Ghaffari and Friedman, one of ordinary skill would reasonably be apprised of the benefits of forming the LEDs as claimed.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghaffari in view of Gunday, as applied to claim 15 above, and further in view of Brisken et al. [US 5846218 A, hereinafter “Brisken”].
Claim 17. Ghaffari-Gunday teaches the apparatus set forth above but fails to disclose the oscillator. However, Brisken teaches a balloon catheter comprising an oscillator [“oscillatory drive assembly 50] coupled to the catheter configured to oscillate the distal end of the catheter across a longitudinal axis when actuated [“the distal end of the balloon 80 may be directly vibrated by the distal tip 42 in order to impart oscillatory energy to the balloon,” Col. 8 lines 39-42. Regarding the direction see e.g. Fig. 8]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Ghaffari by adding an oscillator configured to oscillate the end of the catheter across a longitudinal axis as taught by Brisken because “ultrasonic energy has been proposed both to mechanically disrupt clot and to enhance the intravascular delivery of drugs to dissolve clot and inhibit restenosis” [Brisken Col. 1 lines 60-65]
Response to arguments
The arguments against the prior art rejections filed 7/8/25 have been considered but are not persuasive. Applicant argues that Ghaffari fails to teach pulsing a balloon by repeatedly transitioning between inflated/deflated configurations during the same medical procedure. However, this limitation is related to the intended use of the device and therefore is satisfied by a device capable of performing this step. Because Ghaffari teaches a medical balloon which is deflated, inflated, and deflated again during a medical procedure [Par. 0020], and the balloon is disclosed as being made of a flexible material, Ghaffari’s balloon does not differ structurally from one which is intended to be repeatedly inflated and deflated during a medical procedure. The claimed balloon differs only in the specifics of its use, not in its structure, from that of Ghaffari. Thus, Ghaffari continues to anticipate the amended claims.
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.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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