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 Amendment
The amendments filed on 06/16/2025 have been entered. Claims 1-15 remain pending in the application.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 06/16/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Arkans to teach the newly recited limitations.
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.
Claim(s) 1-8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Arkans (US 2011/0196269) in view of Haeussinger (US 2018/0193032).
Regarding claim 1, Arkans discloses a vascular compression device (400, FIG 8) comprising: a first non-inflatable compression loop (120, FIG 7, [0052] discloses the venous pressure device can apply pressure through focused application of pressure to an area rather than a perimeter. It is understood that in this particular configuration, not shown, that the loop is non-inflatable except for at the area of focused pressure) configured to extend around a first limb (FIG 7 shows placement around a leg) having a first pneumatic bulb configured to inflate and deflate (The bladder 116 is interpreted as the bulb, [0050-0051]. Since [0052] discloses the application of pressure to an area rather than a perimeter, it is understood that the bulb can be a localized pressure point) while disposed between the first compression loop and the first limb (FIG 6), towards a center of the first non-inflatable compression loop (the inflation bulb is at least configured to inflate towards the center i.e. inward against the leg in order to apply the compression force); a second non-inflatable compression loop (146, 142, FIG 7, [0056] discloses that 142 has an inflatable chamber 144, therefore it is understood that the entire sleeve is not inflatable but only at the location of inflatable chamber 144. U.S. Pat. No. 6,358,219, which is incorporated herein by reference, teaches the loop 30 is formed of a pile material col 7 lines 29-45) configured to extend around a second limb (Although shown as being used on the same leg, the second loop is at least configured to extend around a second limb because it is independently movable and securable) having a second pneumatic bulb configured to inflate and deflate (144, [0056]) while disposed between the second non-inflatable compression loop and the second limb (the compression loop is at least configured to be positioned around a leg such that the bulb is between the loop and the limb), towards a center of the second non-inflatable compression loop (the inflation bulb is at least configured to inflate towards the center i.e. inward against the leg in order to apply the compression force); and a pneumatic pump system (200, FIG 8, [0060-0061]) connected via tubing to the first and second pneumatic bulbs (Tubing 130/402, 156, [0055, 0059]).
Arkans is silent regarding the first and second pneumatic bulbs having a first and second convex and spherical surface configured to inflate towards a center of the first and second compression loops respectively.
However, Haeussinger discloses in the same field of endeavor of compression loops (10 or 100) for applying a point specific pressure to a limb (Abstract, [0040], FIG 5 and 13 show application to an artery 78 of a leg) wherein targeting compression can be applied using a bulb having a convex and spherical surface configured to extend towards a center of a compression loop (spherical ball compression device 102, FIG 16, [0095]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the shape of the first and second inflatable chambers of Arkans to each comprise a convex and spherical surface configured to extend towards a center of the first and second compression loops, as taught by Haeussinger, for the purpose of providing an isolated point of pressure to restrict the flow of blood through an artery to achieve the predictable result of occluding uncontrolled hemorrhage of a major blood vessel in a wounded limb, and further since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
Regarding claim 2, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses the first non-inflatable compression loop comprises a first strap and a first fastener ([0050] discloses a suitable covering 120 and a retaining structure 122 such as Velcro used to secure the strap at a desired tension around the patient’s leg) and the second non-inflatable compression loop comprises a second strap and a second fastener ([0057] discloses positioning strap 146 is secured in place with Velcro or other fastening devices).
Regarding claim 3, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses the pneumatic pump system comprises a manual pump ([0014, 0060] discloses manual control of the pressure generation and [0055] discloses inflation bulb 134).
Regarding claim 4, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses the pneumatic pump system comprises an electric air pump ([0050 and 0060] discloses inflation using air and [0043] discloses the actuator/pump can be a powered pump).
Regarding claim 5, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses the pneumatic pump system is configured to be inflated with compressed air ([0050 and 0060] disclose the use of air to fill the bladders), 02 or C02.
Regarding claim 6, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses a pressure gauge (138, [0055]) connected to the tubing between the first and second pneumatic bulbs and the pneumatic pump system (It is understood that in order to measure pressure within the system that the location would include connection to the tubing and placement between the bulbs and pump system, FIG 7).
Regarding claim 7, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses the tubing comprises a first branch connected to the first pneumatic bulb (130/402, FIGs 7-8) and a second branch connected to the second pneumatic bulb (156), and wherein the first and second branch merge into a third branch connected to the pneumatic pump system (See retaining ring at the interface between the tubing and controller 200, FIG 8).
Regarding claim 8, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses a controller (200, FIG 8) configured to communicate with the pneumatic system for inflating, holding inflation, or deflating the first and second pneumatic bulbs ([0060, 0070-0071]).
Regarding claim 14, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses at least one end of the of the firsts and second compression loops has a cuff slide portion comprising a firm, low friction surface (The interior surface of the loops which contacts the leg is interpreted as the cuff slide portion. It is firm enough to apply a compression force and is interpreted as low friction at least relative to the Velcro sections of the strap).
Regarding claim 15, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1. Arkans further discloses the tubing is configured to detach from the first and second pneumatic bulbs ([0059] removable connector 160; [0070] discloses 402 is removable from 112).
Claim(s) 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Arkans (US 2011/0196269) in view of Haeussinger (US 2018/0193032), further in view of McEwen (US 2010/0191277).
Regarding claim 9-12, Arkans /Haeussinger disclose the invention substantially as claimed, as set forth above for claim 1.
Arkans is silent regarding at least one of the first and second pneumatic bulbs comprising a pressure/physiological sensor communicatively connected to the controller, wherein the first pneumatic bulb has a first sensor communicatively connected to the controller and configured to detect flow occlusion, and the second pneumatic bulb has a second sensor communicatively connected to the controller and configured to detect flow occlusion and wherein the controller is configured to generate signals for inflating or deflating the first and second pneumatic bulbs based on feedback from first and second pressure sensors.
However, McEwen discloses a vascular compression device (FIG 1) having a first and second compression loop (22 and 24, paragraph [0021]) each comprising a pneumatic bulb (proximal cuff bladder 28 and distal cuff bladder 30, paragraph [0022]) and a controller (10/46, FIG 1 and 4) configured to communicate with a pneumatic pump system (48, 50, FIG 4, paragraph [0026]), wherein at least one of the first and second pneumatic bulbs comprising a pressure/physiological sensor communicatively connected to the controller (FIG 4, first and second pressure regulator 54, 56, [0027]. It is understood that maintaining the pressure in proximal cuff bladder 28 near the level of the first cuff pressure reference level requires a sensor to determine the current pressure. The pressure sensor is interpreted as a physiological sensor because it is sensing a physiological characteristic such as the force being applied to the limb) and wherein the first pneumatic bulb has a first sensor (One of 8, paragraph [0018]) communicatively connected to the controller and configured to detect flow occlusion (Paragraph [0018, 0028-0031]), and the second pneumatic bulb has a second sensor (Another of 8) communicatively connected to the controller and configured to detect flow occlusion (Paragraph [0018, 0028-0031]), and wherein the controller is configured to generate signals for inflating or deflating the first and second pneumatic bulbs based on feedback from first and second pressure sensors (Paragraph [0025-0031]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Arkans / Haeussinger to comprise a controller in communication with a first and second sensor associated with respective pneumatic bulbs to detect flow occlusion and generate signals for inflating or deflating the first and second pneumatic bulbs based on feedback from first and second pressure sensors, as taught by McEwen, for the purpose of measuring limb occlusion pressure and operating the device to stop the flow of arterial blood into the limb distal to the cuff, with the added benefit of having individual control over each of the first and second pneumatic bulbs for increased precision.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Arkans (US 2011/0196269) in view of Haeussinger (US 2018/0193032), in view of McEwen (US 2010/0191277), further in view of Johnson et al. (US 2017/0312165).
Regarding claim 13, Arkans /Haeussinger/McEwen discloses the invention substantially as claimed, as set forth above for claim 8.
Arkans is silent regarding the controller being configured to generate a sound cue based on feedback from first and second pressure sensors.
However, Johnson et al. discloses a vascular compression device (300, FIG 3A) wherein an indicator capable of creating an audible sound can generate feedback regarding a pressure sensor used within the device (Paragraph [0125]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to apply this user feedback mechanism to the device of Arkans such that an indication from first and second pressure sensors can be generated, for the purpose of informing the user a particular physiological condition has been met.
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771