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 Arguments
Applicant’s arguments, see pages 1-3, filed 12/10/2025, with respect to the rejection(s) of claim(s) 1, 20, and 24 under a 103 rejection over Ward in view of Nentwick and Franklin have been fully considered and are persuasive. The examiner agrees that Franklin fails to teach “the second opening fluidly connecting a distal end of the catheter to ambient pressure when the gastroesophageal resuscitative aortic occlusion device is in use, thereby equalizing fluid pressure between the second opening and ambient pressure through the second lumen”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ward (US 20020016608) in view of Onat (US 4114625).
Claim Objections
Claims 1, 20, and 24 are objected to because of the following informalities:
Claim 1 (line 8), claim 20 (line 8), claim 24 (line 8): “ambient pressure” should recite “the ambient pressure”.
Appropriate correction is required.
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.
Claim(s) 1-3, 5-6, 8, 10, 14, and 17, 19-20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ward (US 20020016608) in view of Onat (US 4114625).
Regarding claims 1 and 20, Ward discloses a gastroesophageal resuscitative aortic occlusion device 52 (Fig. 5, para. 0068, 0070-0071) comprising:
a catheter 56, the catheter including a body having a first lumen (interpreted as lumen of catheter 56 which introduces inflation medium therethrough via. inflation mechanism 58, Fig. 5, para. 0070), an inflatable balloon 54 disposed on the catheter (Fig. 5, para. 0070), the inflatable balloon 54 having an inflated diameter of between approximately 3 inches and approximately 8 inches (para. 0072); and
an inflation device 58 operably connected to the catheter 56 and fluidly coupled to the first lumen (Fig. 5, para. 0070), wherein activation of the inflation device 58 forces fluid into the interior of the inflatable balloon through the first lumen (Figs. 5-8, para. 0071), and
further comprising an external pressure device 66 (para. 0073) that comprises a circumferential compression device (best shown in Fig. 10 of Ward, para. 0075; Note: Para. 0093 of Ward discloses that “the various elements of each illustrated embodiment of the invention can be combined and substituted with other of the embodiments”).
However, Ward fails to disclose the body also having a first lumen and a second lumen, the body also having a distal end including a first opening fluidly coupled to the first lumen and a second opening coupled to the second lumen, the second opening fluidly connecting a distal end of the catheter to ambient pressure when the gastroesophageal resuscitative aortic occlusion device is in use, thereby equalizing fluid pressure between the second opening and ambient pressure through the second lumen; the inflatable balloon displaced from the distal end of the catheter such that a portion of the catheter extends distally beyond the inflatable balloon, the interior of the inflatable balloon being fluidly coupled to the first opening, and wherein activation of the inflation device forces fluid into the interior of the inflatable balloon through the first lumen and the first opening.
Onat in the same field of endeavor of gastroesophageal occlusion devices (Figs. 1-2) teaches a tube body 10 having a first lumen 16 and a second lumen 12 (Figs. 3-5, col. 2 lines 24-27), the body having a distal end including a first opening 32 fluidly coupled to the first lumen 16 (col. 2 lines 46-49) and a second opening (interpreted as one opening of a plurality of openings 38) coupled to the second lumen 12, the second opening 38 fluidly connecting a distal end of the tube body 10 to ambient pressure when the gastroesophageal occlusion device is in use, thereby equalizing fluid pressure between the second opening 38 and ambient pressure through the second lumen 12 when suction is applied through a third opening 36 from a third lumen 14 (Figs. 1-5, col. 2 lines, 59-68 and col. 3 lines 1-3); an inflatable balloon 26 displaced from the distal end of the tube body 10 such that a portion of the tube body 10 extends distally beyond the inflatable balloon 26 (Figs. 1-2), an interior of the inflatable balloon 26 being fluidly coupled to the first opening 32, and wherein activation of an inflation device forces fluid into the interior of the inflatable balloon through the first lumen 16 and the first opening 32 (Fig. 1, col. 2 lines 46-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the device in Ward to include the first opening fluidly coupled to the first lumen, the second opening fluidly coupled to the second lumen, and the third opening fluidly coupled to the third lumen, as taught by Onat, in order to provide a way to deliver fluid directly to the interior of the balloon in order to inflate the balloon via. the first lumen/opening (col. 2 lines 46-53 of Onat) and increase the utility of the device with the inclusion of the second opening/lumen and third opening/lumen such that the user may suction contents of the stomach during use (col. 2 lines, 59-68 and col. 3 lines 1-3 of Onat).
Regarding claim 2, modified Ward discloses all of the limitations set forth above in claim 1. However, modified Ward fails to disclose a first vacuum device operably connected to the catheter, the first vacuum device activating to remove the fluid from the inflatable balloon.
Onat further teaches a first vacuum device (interpreted as a source of pressurized air or water which controls the inflation and deflation of the balloon) operably connected to the tube body 10 (Fig. 1, col. 2 lines 46-53), the first vacuum device activating to remove the fluid from the inflatable balloon 26 (Fig. 1, col. 2 lines 46-53).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Onat (utilizing a first vacuum device to remove fluid) to the device of modified Ward would have yielded predicable results, namely, a way to deflate the balloon (col. 2 lines 46-53 of Onat); (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 3, modified Ward discloses wherein the first vacuum device is fluidly coupled to the first lumen (col. 2 lines 46-53 of Onat).
Regarding claims 5-6, modified Ward discloses a third lumen 14 and the distal end further including a third opening (interpreted as one of the plurality of openings 36 of Onat) fluidly coupled to the third lumen 14 and a second vacuum device fluidly coupled to the third lumen 14 and a distal end further including a third opening fluidly coupled to the third lumen (Figs. 1-5, col. 2 lines, 59-68 and col. 3 lines 1-3 of Onat).
Regarding claim 8, modified Ward discloses all of the limitations set forth above in claim 1. However, modified Ward fails to disclose wherein the inflatable balloon is displaced from the distal end of the catheter by between about 20 mm and about 150 mm, preferably between about 30 mm and about 100 mm.
There is no evidence of record that establishes that changing the distance of the inflatable balloon displaced from the distal end of the catheter would result in a difference in function of the modified Ward device. Further, a person having ordinary skill in the art, being faced with modifying the distance of modified Ward, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed displacement dimension. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “In yet other optional forms, the inflatable balloon may be displaced from the distal end of the catheter by a distance, preferably by at least 20 mm.” in para. 0018 and “In yet other optional forms, the inflatable balloon is displaced from the distal end of the catheter by between about 20 mm and about 150 mm, preferably between about 30 mm and about 100 mm” in para. 0019 of the instant application. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the displacement between the inflatable balloon and the distal end of the catheter of modified Ward to be about 20 mm and about 150 mm, preferably between about 30 mm and about 100 mm as an obvious matter of design choice within the skill of the art.
Regarding claim 10, modified Ward discloses all of the limitations set forth above in claim 1. Modified Ward further discloses wherein the inflatable balloon 54 further comprises a wall (see Fig. 6, para. 0070-0071 of Ward). However, modified Ward fail to disclose the wall having a thickness of between 0.003 in and 0.015 in.
There is no evidence of record that establishes that changing the thickness of the wall of the inflatable balloon would result in a difference in function of the modified Ward device. Further, a person having ordinary skill in the art, being faced with modifying the thickness of the wall of the inflatable balloon of modified Ward, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed wall thickness dimension. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “In yet other optional forms, the inflatable balloon further comprises a wall having a thickness of between 0.003 in and 0.015 in.” in para. 0020 of the instant application. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the wall of the inflatable balloon of modified Ward to be between 0.003 in and 0.015 in as an obvious matter of design choice within the skill of the art.
Regarding claim 14, modified Ward disclose all of the limitations set forth above in claim 1. However, modified Ward fails to disclose wherein operation of the inflation device may be reversed to remove the fluid from the inflatable balloon.
Onat further teaches that it is known in the art wherein operation of an inflation device used to inflate an inflatable balloon may also be reversed to remove the fluid from the inflatable balloon (col. 2 lines 46-53 of Onat teaches as a source of pressurized air or water which controls the inflation and deflation of the balloon).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Onat (using a single inflation device to inflate and deflate the inflatable balloon) to the device of modified Ward would have yielded predicable results, namely, a way to introduce and remove fluid from the inflatable balloon without the need for an additional device (col. 2 lines 46-53 of Onat); (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 17, modified Ward discloses wherein the distal end of the catheter comprises a blunt end (best shown in Fig. 5 of Ward, para. 0070 of Ward).
Regarding claim 19, modified Ward discloses wherein the inflatable balloon 54 comprises an annular shape when fully inflated (Figs. 6-8, para. 0070-0071 of Ward).
Regarding claim 24, Ward discloses gastroesophageal resuscitative aortic occlusion kit 52, 66 (Fig. 5, para. 0070, 0073; Note: Para. 0093 of Ward discloses that “the various elements of each illustrated embodiment of the invention can be combined and substituted with other of the embodiments”) comprising:
an occlusion device 52 comprising a catheter 56, the catheter including a body having a first lumen (interpreted as lumen of catheter 56 which introduces inflation medium therethrough via. inflation mechanism 58, Fig. 5, para. 0070) and a distal end (Figs. 5-6, para. 0070);
an inflatable balloon 54 disposed on the catheter (Fig. 5, para. 0070); and
an inflation device 58 operably connected to the catheter 56 and fluidly coupled to the first lumen (Fig. 5, para. 0070), wherein activation of the inflation device 58 forces fluid into the interior of the inflatable balloon through the first lumen (Figs. 5-8, para. 0071); and
an external pressure device 66 (para. 0073) that comprises a circumferential compression device (best shown in Fig. 10 of Ward, para. 0075).
However, Ward fails to disclose the body also having a first lumen and a second lumen, the body also having a distal end including a first opening fluidly coupled to the first lumen and a second opening coupled to the second lumen, the second opening fluidly connecting a distal end of the catheter to ambient pressure when the gastroesophageal resuscitative aortic occlusion device is in use, thereby equalizing fluid pressure between the second opening and ambient pressure through the second lumen; the inflatable balloon displaced from the distal end of the catheter such that a portion of the catheter extends distally beyond the inflatable balloon, the interior of the inflatable balloon being fluidly coupled to the first opening, and wherein activation of the inflation device forces fluid into the interior of the inflatable balloon through the first lumen and the first opening.
Onat in the same field of endeavor of gastroesophageal occlusion devices (Figs. 1-2) teaches a tube body 10 having a first lumen 16 and a second lumen 12 (Figs. 3-5, col. 2 lines 24-27), the body having a distal end including a first opening 32 fluidly coupled to the first lumen 16 (col. 2 lines 46-49) and a second opening (interpreted as one opening of a plurality of openings 38) coupled to the second lumen 12, the second opening 38 fluidly connecting a distal end of the tube body 10 to ambient pressure when the gastroesophageal occlusion device is in use, thereby equalizing fluid pressure between the second opening 38 and ambient pressure through the second lumen 12 when suction is applied through a third opening 36 from a third lumen 14 (Figs. 1-5, col. 2 lines, 59-68 and col. 3 lines 1-3); an inflatable balloon 26 displaced from the distal end of the tube body 10 such that a portion of the tube body 10 extends distally beyond the inflatable balloon 26 (Figs. 1-2), an interior of the inflatable balloon 26 being fluidly coupled to the first opening 32, and wherein activation of an inflation device forces fluid into the interior of the inflatable balloon through the first lumen 16 and the first opening 32 (Fig. 1, col. 2 lines 46-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Ward to include the first opening fluidly coupled to the first lumen, the second opening fluidly coupled to the second lumen, and the third opening fluidly coupled to the third lumen, as taught by Onat, in order to provide a way to deliver fluid directly to the interior of the balloon in order to inflate the balloon via. the first lumen/opening (col. 2 lines 46-53 of Onat) and increase the utility of the device with the inclusion of the second opening/lumen and third opening/lumen such that the user may suction contents of the stomach during use (col. 2 lines, 59-68 and col. 3 lines 1-3 of Onat).
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ward (US 20020016608) in view of Onat (US 4114625) as applied to claim 1 above, and further in view of Mantri et al. (US 20180264247) [hereinafter Mantri].
Regarding claims 11 and 12, modified Ward discloses all of the limitations set forth above in claim 1. However, modified Ward fails to disclose further comprising a pressure sensor that senses internal pressure in the inflatable balloon or a pulsatile flow sensor.
Mantri in the same field of endeavor teaches an occlusion balloon used to treat many types of closed tissue volumes such as the stomach (para. 0190) comprising a pressure sensor positioned within the balloon that senses internal pressure in an inflatable balloon 2803 in order to allow the user to monitor the amount of compression applied to the internal surface of the body cavity (para. 0372) and a pulsatile flow sensor (interpreted as a blood pressure sensor, para. 0372) in order to allow the user to monitor and regulate the amount of expansion of the balloon from the received blood pressure of the patient (para. 0372).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in modified Ward to include the pressure sensor positioned within the balloon and the pulsatile flow sensor, as taught by Mantri, in order to allow the user to monitor the amount of compression applied to the internal surface of the body cavity (para. 0372 of Mantri) and to monitor and regulate the amount of expansion of the balloon from the received blood pressure of the patient (para. 0372 of Mantri).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable Ward (US 20020016608) in view of Onat (US 4114625), as applied to claim 1 above, and further in view of Doty (US 20070060883).
Regarding claim 15, modified Ward discloses all of the limitations set forth above in claim 1. However, modified Ward fails to disclose wherein the distal end of the catheter comprises a plurality of cutouts distal to the inflatable balloon to increase flexibility.
Doty teaches a balloon catheter 10 (Fig. 1, para. 0023) comprising a distal tip 64 at a distal end of the catheter 10 (Fig. 1, para. 0023), wherein the distal tip of the distal end of the catheter comprises a plurality of cutouts 63a distal to an inflatable balloon 60 to increase flexibility (Figs. 2, 3A, para. 0029, 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the catheter, distal to the inflatable balloon in modified Ward to include the plurality of cutouts, as taught by Doty, in order to facilitate maneuverability and positioning of the distal end of the device through a body lumen of a patient (para. 0035 of Doty).
Claim(s) 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ward (US 20020016608) in view of Onat (US 4114625) as applied to claim 1 above, and further in view of Nentwick (US 20110245665).
Regarding claim 16, modified Ward discloses all of the limitation set forth above in claim 1. However, modified Ward fails to disclose wherein the distal end of the catheter comprises a softer material than the catheter proximate the inflatable balloon.
Nentwick further teaches that it is known in the art to have a distal end of a catheter comprising a softer material than the catheter proximate the inflatable balloon (para. 0055) for the purpose of increasing the flexibility of the distal end of the catheter compared to the catheter proximate the inflatable balloon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the catheter in modified Ward to include the softer material of Nentwick in order to allow the distal end of the catheter to be more easily navigated into a body lumen (para. 0055 of Nentwick).
Regarding claim 18, modified Ward discloses all of the limitations set forth above in claim 1. However, modified Ward fails to disclose further comprising a removable sheath that covers the inflatable balloon.
Nentwick further discloses that it is known in the art to include a removable sheath that covers the inflatable balloon (para. 0091-0092) for the purpose of protecting the inflatable balloon during delivery (para. 0091-0092).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in modified Ward to include the removable sheath of Nentwick in order to protect the inflatable balloon during delivery of the device to a target site (para. 0091-0092 of Nentwick).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771