Prosecution Insights
Last updated: April 19, 2026
Application No. 17/581,134

SYSTEM AND METHOD FOR LOW PROFILE OCCLUSION BALLOON CATHETER

Final Rejection §103
Filed
Jan 21, 2022
Examiner
DUBOSE, LAUREN
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Prytime Medical Devices Inc.
OA Round
4 (Final)
60%
Grant Probability
Moderate
5-6
OA Rounds
3y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
79 granted / 132 resolved
-10.2% vs TC avg
Strong +45% interview lift
Without
With
+44.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
56 currently pending
Career history
188
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
50.2%
+10.2% vs TC avg
§102
23.5%
-16.5% vs TC avg
§112
22.8%
-17.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 132 resolved cases

Office Action

§103
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 Regarding the previous 112(a) rejection, the cancellation of claim 32 is acknowledged and the 112(a) rejection is withdrawn. Applicant’s arguments, see pages 1-2, filed 11/04/2025, with respect to the rejection(s) of claim(s) 4 under Franklin in view of Fry have been fully considered and are persuasive. The examiner agrees that Franklin in view of Fry fails to disclose “a distal port, coaxial with the internal lumen of the stiffener member and positioned at a base of the atraumatic tip” as required by claim 4. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Franklin in view of Tremulis et al. (US 20070219466). Claim Objections Claim 25 is objected to because of the following informalities: Claim 25 (line 3): “the vessel upstream of the occlusion balloon” should recite “a vessel upstream of the occlusion balloon”. Appropriate correction is required. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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) 4, 8, 22-23, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) [see attached Foreign document filed with previous office action on 09/23/2024] in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis]. Regarding claim 4, Franklin discloses an occlusion catheter system 100 (Fig. 1, para. 012) for at least partial occlusion of an aorta having an internal aortic wall (para. 010), the occlusion catheter system comprising: an inflation hub 190 (Fig. 1, para. 012); a proximal catheter member 110 extending from the inflation hub (Figs. 1, 6, para. 012, 025); a distal catheter member 120 distally terminating with an atraumatic tip 150 (Figs. 1, 5, para. 012, 016); an occlusion balloon 140 interposed between the proximal catheter member and the distal catheter member (Figs. 1, 3-4, para. 012), the occlusion balloon 140 defining an external balloon surface and an internal balloon space 142 (Fig. 1, para. 012); a stiffener member (interpreted as first catheter member 130 which is described as an element used to lend column strength to the occlusion catheter system and to provide a functional backbone to the system in para. 018), fixed to, and extending from, the inflation hub 190, through the proximal catheter member 110 and the occlusion balloon 140 and into the distal catheter member 120 (Figs. 1, 5-6, para. 012), the stiffener member defining an internal lumen 230 in fluid communication with the inflation hub 190 at a proximal end (Fig. 6, para. 012); an inflation lumen 210 defined between the stiffener member 130 and the proximal catheter member 110 (Fig. 3, para. 012), the inflation lumen 210 extending between, and being in fluid communication with, the inflation hub 190 at a proximal end of the inflation lumen 210 and the internal balloon space 142 at a distal end of the inflation lumen 210 (Figs. 3, 5-6, para. 012, 014); only one pressure sensor (interpreted as the external pressure sensor described in para. 025); a distal port 170 fluidly communicating an exterior of the occlusion catheter system 100 with the pressure sensor (para. 015, 025), the pressure sensor being positioned remotely from distal port 170 (para. 025) and configured to measure central aortic pressure distal of the occlusion balloon (para. 021, 025, 029; see note below); and the internal lumen 230 of the stiffener member 130 being in fluid communication with the distal port 170 at a distal end of the stiffener member 130 (Fig. 5, para. 015); and a pump (interpreted as the syringe described in para. 014) in selective fluid communication with the inflation hub 190 (para. 014) and configured to at least one of introduce or withdraw a pressurized fluid from the internal balloon space 142 (para. 014), whereby at least portions of the external balloon surface is configured to contact the internal aortic wall upon introduction of the pressurized fluid via the pump, through the inflation hub, the inflation lumen and into the internal balloon space (para. 014, 026). Franklin further discloses that the distal port 170 is positioned adjacent the internal lumen 230 of the stiffening member 130 and proximate the atraumatic tip 150 (see Fig. 5 of Franklin). However, Franklin fails to disclose that the distal port is coaxial with the internal lumen of the stiffener member and positioned at a base of the atraumatic tip. Tremulis in the same field of endeavor of catheter tips teaches that it is known in the art to position a distal port 54B coaxial with an internal lumen 44 of an elongate shaft 12B and positioned at a base of an atraumatic tip 56B (Figs. 5A, 6A-C, para. 0037, 0039; The examiner notes that Fig. 6C which illustrates a coaxial relationship between the internal lumen of the elongated shat and the distal port is mislabeled as Fig. 6D). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of the distal port of Franklin such that the distal port is positioned coaxial with the internal lumen of the stiffener member and at the base of the atraumatic tip, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C. Note: “configured to measure central aortic pressure distal of the occlusion balloon” is interpreted as functional language and intended use of the claimed invention. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Franklin discloses a pressure sensor used to measure arterial pressure (para. 025, 029 of Franklin) and is stated to “transduce pressure from a fluid column within the first lumen 230 and through the second port 170”. Therefore, the pressure sensor measures arterial pressure from a distal end of the device, distal of the occlusive balloon via. the second port 170 located at the distal end (Fig. 5, para. 015, 021). Since Franklin discloses the structural component required i.e. a pressure sensor for the functional limitation, Franklin thereby discloses the functional limitation of a pressure sensor capable of measuring central aortic pressure distal of the occlusion balloon. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Regarding claim 8, modified Franklin discloses wherein the inflation hub 190 comprises a first port (interpreted as opening defined by second fluid pathway 194) in fluid communication with the inflation lumen 210 (Fig. 6, para. 025 of Franklin) and a second port (interpreted as opening defined by first fluid pathway 192) in fluid communication with the internal lumen 230 of the stiffener member 130 (Fig. 6, para. 025 of Franklin). Regarding claim 22, modified Franklin discloses wherein the pump comprises a syringe (para. 014 of Franklin). Regarding claim 23, modified Franklin discloses wherein the stiffener member 130 is comprised of nitinol (para. 018 of Franklin). Regarding claim 34, modified Franklin discloses the stiffener member 130 extend to the distal port 170 in order to allow continuous fluid flow from the distal port to the lumen of the stiffener member (Fig. 6, para. 015). Claim(s) 10, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis], as applied to claim 4 above, and further in view of Frost (US 20170151381). Regarding claim 10, modified Franklin discloses all of the limitations set forth above in claim 4. However, modified Franklin fails to disclose a control hub in communication with the pressure sensor and having a display screen configured to display central aortic pressure measurements received from the pressure sensor. Frost in the same field of endeavor teaches an occlusion balloon system configured to be positioned within the aorta of a patient (Fig. 1, para. 0042, 0088, 0132-0143) comprising a control hub 1 in communication with a pressure sensor (Fig. 1, para. 0041, 0043, 0132, 0135; The examiner notes that embodiment described in para. 0053-0054 which utilizes “at least one first sensor” is relied upon. However, information in the disclosure is referenced for details not described in this embodiment.), and having a display screen 3 configured to display central aortic pressure measurements received from the pressure sensor (Fig. 1, para. 0066, 0069, 0137). 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 Franklin in to include the control hub of Frost in order to receive data from the pressure sensor, thereby allowing the user to identify physiological characteristic of a patient during a procedure (para. 0135 of Frost). Regarding claim 14, modified Franklin discloses wherein the control hub 1 is mounted to the proximal catheter member (see Fig. 1 of Frost which illustrates the device 1 mounted on a proximal end of occlusion catheter 2). Regarding claim 15, modified Franklin discloses wherein the control hub 1 further comprises a controller (interpreted as CPU described in para. 0135 of Frost) and a power source (para. 0132 of Frost), the controller being configured to receive the central aortic pressure measurements from the pressure sensor (para. 0053-0054, 0099, 0135 of Frost) and communicate with the pump to at least one of introduce or withdraw the pressurized fluid from the internal balloon space (Fig. 1, para. 0059, 0062 of Frost). Regarding claim 16, modified Franklin discloses wherein the control hub further includes the pump (para. 0144 of Frost). Regarding claim 17, modified Franklin discloses all of the limitations set forth above in claim 4. However, modified Franklin fails to disclose a controller configured to receive the central aortic pressure measurements from the pressure sensor and communicate with the pump to at least one of introduce or withdraw the pressurized fluid from the internal balloon space. Frost in the same field of endeavor teaches an occlusion balloon system configured to be positioned within the aorta of a patient (Fig. 1, para. 0042, 0088, 0132-0143) comprising a control hub 1 in communication with a pressure sensor (Fig. 1, para. 0041, 0043, 0132, 0135; The examiner notes that embodiment described in para. 0053-0054 which utilizes “at least one first sensor” is relied upon. However, information in the disclosure is referenced for details not described in this embodiment.), wherein the control hub 1 further comprises a controller (interpreted as CPU described in para. 0135 of Frost) configured to receive central aortic pressure measurements from the pressure sensor (para. 0053-0054, 0099, 0135) and communicate with the pump to at least one of introduce or withdraw the pressurized fluid from the internal balloon space (Fig. 1, para. 0059, 0062). 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 Franklin in to include the control hub of Frost in order to receive data from the pressure sensor, thereby allowing the user to identify physiological characteristic of a patient during a procedure (para. 0135 of Frost). Claim(s) 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis] as applied to claim 4 above, and further in view of Williams et al. (US 20050015108) [hereinafter Williams]. Regarding claim 18, modified Franklin discloses all of the limitations set forth above in claim 4. However, modified Franklin fails to disclose wherein the occlusion balloon is a first balloon and further comprising at least a second, independently inflatable balloon. Williams in the same field of endeavor teaches a balloon catheter (see Fig. 2) used for vasculature dilation (Figs. 3-5, para. 0050; The examiner notes that the balloon angioplasty catheter embodiment is relied upon. Para. 0039, 0047 states that the device can be used alone without a stent), comprising an occlusion balloon 28 as a first balloon and further comprising at least a second, independently inflatable balloon 32 (Fig. 2, para. 0040, 0044). 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 occlusion balloon in modified Franklin to include the first and second balloons of Williams in order to allow controlled dilatation of a target vessel during deployment, para. 0050 of Williams via. sequential expansion of the balloons (para. 0044, 0051 of Williams). Regarding claim 19, The combination of Franklin in view of Williams further discloses wherein the first and second balloons 28, 32 are interposed between the proximal catheter member and the distal catheter member (Figs. 1-2, para. 0040 of Williams teaches that the first and second balloons are interposed between a proximal end 14 and a distal end 16 of the balloon catheter). Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis] as applied to claim 4 above, and further in view of Allen et al. (US 20140364835) [hereinafter Allen]. Regarding claim 20, modified Franklin discloses all of the limitations set forth above in claim 4. However, modified Franklin fails to disclose wherein the occlusion balloon includes an internal flow channel selectively fluidly communicating an upstream portion of the aorta with a downstream portion of the aorta to selectively permit partial flow of blood past the occlusion balloon. Allen teaches a balloon catheter 2 used for at least partial occlusion of vasculature (para. 0018, 0106) comprising an occlusion balloon 8 including an internal flow channel 38 selectively fluidly communicating an upstream portion of vasculature with a downstream portion of the vasculature to selectively permit partial flow of blood past the occlusion balloon 8 (Fig. 2, para. 0020, 0110; Figs. 14-15 best illustrates the selectivity of the internal flow channel 38 when the balloon transitions between an inflated state and a deflated state). 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 occlusion balloon in modified Franklin to include the internal flow channel of Allen in order to allow perfusion of blood through the aorta during the procedure (para. 0020 of Allen). Claim(s) 24, 30, 31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis] as applied to claim 4 above, and further in view of Hoem et al. (US 20110202084) [hereinafter Hoem]. Regarding claim 24, modified Franklin discloses all of the limitations set forth above in claim 4. However, modified Franklin fails to disclose a control system in combination with the occlusion catheter system of claim 4, the control system comprising: a controller in electrical communication with the pump and the pressure sensor, the controller being configured to: receive the data from the pressure sensor, the data representing one or more blood pressure values, and in an auto mode of operation: (a) receive at least one pressure setpoint value, and (b) control, using the pump, an amount of fluid in the occlusion balloon to bring the one or more blood pressure values to the at least one pressure setpoint value or maintain the one or more blood pressure values at the at least one pressure setpoint value. Hoem teaches a control system 140 in combination with the occlusion catheter system 120, the control system 140 (Figs. 2, para. 0014) comprising: a controller (interpreted an internal control circuit described in para. 0025) in electrical communication with a pump 211 (para. 0043) and a pressure sensor (interpreted as the pressure sensor device 136 described in para. 0020-0021) (Figs. 1-2, para. 0016, 0025-0026), the controller being configured to: i. receive data from the pressure sensor, the data representing one or more blood pressure values (para. 0025-0026) in an auto mode of operation: (a) receive at least one pressure setpoint value (para. 0029), and (b) control, using the pump, an amount of fluid in an occlusion balloon 122 to bring the one or more blood pressure values to the at least one pressure setpoint value (para. 0029). 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 occlusion catheter system in modified Franklin to include the control system of Hoem in order to provide the system with automated control of the occlusion catheter system and to provide the user with real-time data indicative of the occlusion procedure being performed such that the user can readily monitor the patient’s condition (para. 0016 of Hoem). Regarding claim 30, modified Franklin discloses wherein the controller is further configured to output the data received from the pressure sensor to an external device 142 (Fig. 2, para. 0016 of Hoem). Regarding claim 31, modified Franklin discloses wherein the pump and the controller are arranged in a common housing (Fig. 2, para. 0023 of Hoem). Regarding claim 33, modified Franklin discloses all of the limitations set forth above in claim 4 above. However, Franklin fails to disclose “a monitor in communication with the pressure sensor and having a display screen configured to display central aortic pressure measurements received from the pressure sensor”. Hoem teaches a control system 140 in combination with the occlusion catheter system 120, the control system 140 (Figs. 2, para. 0014) comprising a monitor 142 in communication with a pressure sensor (interpreted as the pressure sensor device 136 described in para. 0020-0021) and having a display screen configured to display central aortic pressure measurements received from the pressure senso a pressure sensor (Figs. 1-2, para. 0016, 0025-0026). 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 occlusion catheter system in Franklin to include the control system including the monitor and display screen of Hoem in order to provide the system with automated control of the occlusion catheter system and to provide the user with real-time data indicative of the occlusion procedure being performed such that the user can readily monitor the patient’s condition (para. 0016 of Hoem). Claim(s) 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis] and Hoem et al. (US 20110202084) [hereinafter Hoem] as applied to claim 24 above, and further in view of Mulligan et al. (US 20150065826) [hereinafter Mulligan]. Regarding claim 25, modified Franklin discloses all of the limitations set forth above in claim 24. Modified Franklin further discloses that the one or more blood pressure values acquired by the pressure sensor in the vessel upstream of the occlusion balloon (para. 015, 025, 029 of Franklin). However, modified Franklin fails to disclose wherein the one or more blood pressure values acquired by the pressure sensor include a mean arterial pressure (MAP) value. Mulligan teaches a blood pressure monitoring system (Fig. 2, para. 0091) used to analyze a patient’s blood pressure. The reference teaches a mean arterial blood pressure value is a known blood pressure value in the art for analyzing the patient’s blood pressure (para. 0091). 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 controller in modified Franklin to analyze and measure the mean arterial blood pressure, as taught by Mulligan, since such a modification is a substitution for one known blood pressure value for another, and would yield a predictable result, namely, a controller that utilizes the mean arterial blood pressure to analyze the condition of the patient and control the inflation/deflation of the balloon (para. 0091 of Mulligan; para. 0016 of Hoem). Regarding claim 26, the combination of modified Franklin in view of Mulligan would result in a product wherein the one or more blood pressure values include the MAP value in the vessel upstream of the occlusion balloon (as taught by Mulligan, para. 0091; see rejection of claim 25 above), and the at least one pressure setpoint value, as taught by Hoem (para. 0016, 0029 of Hoem) includes an upstream MAP setpoint value as set forth by Mulligan since the controller is programmed to monitor MAP blood pressure values. Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis] and Hoem et al. (US 20110202084) [hereinafter Hoem] as applied to claim 24 above, and further in view of Gelfand et al. (US 20060064059) [hereinafter Gelfand]. Regarding claim 27, modified Franklin discloses all of the limitations of claim 24 above. However, modified Franklin fails to disclose wherein the controller is further configured to receive a selection of the at least one setpoint value from a user. Gelfand in the same field of endeavor teaches a balloon heart pumping system (Fig. 1, para. 0012) comprising a controller 201 (Fig. 2, para. 0051), wherein the controller is further configured to receive a selection of an at least one setpoint value from a user (para. 0053) as a known alternative to at least one set point value calculated by the processor of the controller (para. 0053). The substitution of one known element (operator selected set point value in Gelfand) for another (controller calculated set point value in modified Frank) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of operator selected set point value shown in Gelfand would have yielded predictable results, namely, an alternative way to analyze the physiological information of patient using the controller (para. 0053 of Gelfand). Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis] and Hoem et al. (US 20110202084) [hereinafter Hoem] as applied to claim 24 above, and further in view of Pranevicius et al. (US 20060064059) [hereinafter Pranevicius]. Regarding claim 28, modified Franklin discloses all of the limitations of claim 24 above. However, modified Franklin fails to disclose wherein the controller includes a manual mode of operation in which the controller is configured to permit manual introduction and withdrawal of the fluid from the occlusion balloon. Pranevicius in the same field of endeavor teaches a balloon heart pumping system (Fig. 1, para. 0024-0026) comprising a controller 22 (Fig. 1, para. 0030-0031), wherein the controller includes a manual mode of operation in which the controller is configured to permit manual introduction and withdrawal of the fluid from the occlusion balloon (para. 0035) as a known alternative to automatic control by the controller 22. The substitution of one known element (manual control in Pranevicius) for another (controller controlled in modified Franklin) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of manual control shown in Pranevicius would have yielded predictable results, namely, an alternative way to control the introduction/withdrawal of fluid, and thereby inflation/deflation of the balloon (para. 0035 of Pranevicius). Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Tremulis et al. (US 20070219466) [hereinafter Tremulis] and Hoem et al. (US 20110202084) [hereinafter Hoem] as applied to claim 24 above, and further in view of Pranevicius et al. (US 20060064059) [hereinafter Pranevicius] and Christopher et al. (US 20080178882) [hereinafter Christopher]. Regarding claim 29, modified Franklin discloses all of the limitations of claim 24 above. However, modified Franklin fails to disclose wherein the controller includes a manual plus alert mode of operation in which the controller is configured to permit manual introduction and withdrawal of the fluid from the occlusion balloon and to provide a visual and/or audible alarm when the one or more blood pressure values exceed one or more pre-set parameters. Pranevicius in the same field of endeavor teaches a balloon heart pumping system (Fig. 1, para. 0024-0026) comprising a controller 22 (Fig. 1, para. 0030-0031), wherein the controller includes a manual mode of operation in which the controller is configured to permit manual introduction and withdrawal of the fluid from the occlusion balloon (para. 0035) as a known alternative to automatic control by the controller 22. The substitution of one known element (manual control in Pranevicius) for another (controller controlled in modified Franklin) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of manual control shown in Pranevicius would have yielded predictable results, namely, an alternative way to control the introduction/withdrawal of fluid, and thereby inflation/deflation of the balloon (para. 0035 of Pranevicius). However, modified Franklin in view of Pranevicius fails to disclose wherein the controller includes a manual plus alert mode of operation in which the controller is configured to provide a visual and/or audible alarm when the one or more blood pressure values exceed one or more pre-set parameters. Christopher teaches a controller 21 (Fig. 1, para. 0071-0072) comprising a manual plus alert mode of operation in which the controller is configured to provide a visual and audible alarm when the one or more pressure values exceed one or more pre-set parameters (Fig. 1, para. 0073). 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 controller in modified Franklin to include the manual plus alert mode of operation in which the controller is configured to provide the visual and audible alarm of Christopher in order to alert the user that unsafe blood pressure levels were reached during the procedure (para. 0073 of Christopher). 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. 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, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LAUREN DUBOSE/Examiner, Art Unit 3771 /SARAH A LONG/Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Jan 21, 2022
Application Filed
Mar 31, 2022
Response after Non-Final Action
May 24, 2022
Response after Non-Final Action
May 26, 2023
Response after Non-Final Action
Oct 23, 2023
Response after Non-Final Action
Sep 20, 2024
Non-Final Rejection — §103
Feb 07, 2025
Response Filed
May 24, 2025
Final Rejection — §103
Jul 25, 2025
Request for Continued Examination
Jul 31, 2025
Response after Non-Final Action
Aug 08, 2025
Non-Final Rejection — §103
Nov 04, 2025
Response Filed
Mar 05, 2026
Final Rejection — §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
60%
Grant Probability
99%
With Interview (+44.9%)
3y 1m
Median Time to Grant
High
PTA Risk
Based on 132 resolved cases by this examiner. Grant probability derived from career allow rate.

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