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 claims filed on September 17th, 2025, have been entered. Claims 1-16 remain pending in the Application. Claims 10 and 14-16 were previously withdrawn by the Applicant.
Response to Arguments
Applicant's arguments filed September 17th, 2025, have been fully considered but they are not persuasive.
Applicant first argues that Leschinsky (Pub. No. 2010/0324429) does not disclose maintaining the cuff pressure at the desired percentage of LOP between 50%-80% based on a user selection because maintaining cuff pressure at a minimum limb occlusion state from 98 mmHg to 110 mmHg ([0044]) is a very different concept. Examiner respectfully disagrees. Both the claim and Leschinsky disclose maintaining the cuff pressure at a user selected value, and the user selected value can be any pressure, including the claimed range of LOP, which is simply a specific expression of the amount of pressure being selected.
Applicant then argues that Leschinsky does not disclose maintaining the pressure at the selected percentage of LOP, keeping the pressure constant in this zone, allowing for adjustments with limb/body movement.” Examiner respectfully disagrees. Examiner pointed out that Leschinsky is designed to be used when moving a subject ([0036]) when the subject is having their limb occluded due to an injury, and if the pressure does not adjust for the movement, then the subject could have serious impacts.
In response to applicant's argument that Leschinsky does not disclose the concept of maintain the LOP within a specifically defined range, a recitation of the intended use of the claimed invention 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. Applicant admits in their argument that the electronic controller of Leschinsky is capable of being set at the claimed range by a user, even if by coincident or accident, and therefore since the controller of Leschinsky can be programmed in the same way as claimed, it satisfies the claim limitation.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, 7, 9, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leschinsky (Pub. No. 2010/0324429).
Regarding claim 1, Leschinsky discloses a remote-controlled blood flow restriction cuff (100; [0037]; FIGs. 1-4) comprising:
an air bladder (112; [0039]; FIG. 4) configured to be positioned around a limb (FIG. 1);
a compact air pump (140; [0060]; FIG. 4) located on the cuff to pressurize the air bladder (FIG. 1);
a pressure sensor (190; [0064]; FIG. 4) to sense bladder air pressure;
an electronic controller (120; [0060]; FIGs. 1 and 4) to control operation of the air pump; the controller adjustable for a predetermined pressure range ([0057]: ranges of acceptable pressures can be preselected), and receptive and responsive to signals from the pressure sensor ([0067]: 120 brings the cuff to the preselected signals in response to indicates from 190 of what the pressure in the cuff is); and
a power supply (122; [0066]; FIG. 4) located on the cuff to provide power to the air pump, controller, and pressure sensor ([0066]);
wherein the electronic controller is configured to:
inflate the cuff until a pulse rate is no longer detected ([0109] the device is considered to be properly functioning when lack of distal pulse has been achieved, so the controller is capable of inflating until a pulse rate is no longer detected);
determine a limb occlusion pressure (LOP) of a user at the point at which minimal pressure is required to stop blood flow to the limb extremity ([0054]: the controller monitors the pressure and calculates the LOP of the subject);
inflate the cuff to a desired percentage of LOP of between 50%-80% based on a user selection ([0054]: the controller inflates to achieve the desired LOP; [0075]: users can manually enter their desired cuff inflation pressure upper limit, which can include entering a percentage of LOP of between 50%-80%); and
maintain the pressure at the selected percentage of LOP, keeping pressure constant in this zone ([0046] 150, which includes 120, can be programmed to maintain the cuff pressure at the predetermined pressure throughout the duration of use), allowing for adjustments with limb/body movement ([0036] the device is designed to be used when moving a subject, which means the pressure will adjust for limb/body movement).
Regarding claim 3, Leschinsky further discloses the air pump is a battery-operated air pump ([0066]: 122 can be batteries).
Regarding claim 4, Leschinsky further discloses the power supply is a rechargeable battery power supply ([0066] 122 can be rechargeable batteries).
Regarding claim 5, Leschinsky further discloses the air pump, power supply, pressure sensor, and controller are housed in a module proximal to the air bladder (FIGs. 1 and 4: 140, 122, 190, and 120 are housed in 150, which is proximal to 112 and located on the cuff), which are all located on the cuff.
Regarding claim 7, Leschinsky further discloses pressure in the cuff is maintained at the percentage of LOP ([0054] the controller inflates or deflates to achieve the desired LOP) based on the user selection by the controller operating the air pump ([0075] users can manually enter their cuff inflation pressure) in response to signals from the pressure sensor detecting pressure in the cuff ([0067] 120 brings the cuff to this pressure in response to signals from 190).
Regarding claim 9, Leschinsky further discloses the cuff is configured to be positioned around a limb by a releasable fastening means ([0098] cuff closure means can be Velcro).
Regarding claim 12, Leschinsky further discloses the cuff is configured to be worn on at least one of a proximal upper limb (e.g. upper arm) and a proximal lower limb (e.g. upper thigh) (FIG. 1: the cuff worn on the arm).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky in view of Fraden (Pub. No. 2014/0159912).
Regarding claim 6, Leschinsky discloses the invention substantially as claimed in claim 1, as discussed above, and further discloses the cuff is operated remotely ([0036]: remote ischemic preconditioning is provided by the cuff). Leschinsky does not disclose the operation of the cuff is controlled remotely over a wireless protocol such as Bluetooth, associated with a Smart computer or phone application (app).
Fraden teaches in the same field of endeavor of pressure cuffs (Abstract), and discloses a cuff (1; [0016]; FIG. 1) whose operation is controlled remotely over Bluetooth by a smartphone (2; [0016]; FIG. 1) for the purpose of separating functions to optimize size, complexity, and efficiency ([0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the operation of the cuff of Leschinsky to be by Bluetooth through a smartphone, as taught by Fraden, for the purpose of separating functions to optimize size, complexity, and efficiency.
Regarding claim 11, Leschinsky discloses the invention substantially as claimed in claim 1, as discussed above, and further discloses the cuff is used as a medical tourniquet ([0041] the device is operated by occluding the limb to reduce most or all blood flow through the limb, just as a medical tourniquet does) which allows pressure to be electronically increased and decreased ([0054] the controller uses electronics to increase or decrease the pressure), wherein pressure is set at a desired level ([0075] users can select their cuff inflation pressure), and the pressure sensor and air pump make micro adjustments to keep the cuff pressure constant at the desired level ([0045] the controller uses 190 and 140 to maintain the cuff pressure at the selected levels through use). Leschinsky does not disclose that these functions are accomplished via a smart phone application.
Fraden teaches in the same field of endeavor of pressure cuffs (Abstract), and discloses a cuff (1; [0016]; FIG. 1) whose operation is controlled remotely by a smartphone (2; [0016]; FIG. 1) for the purpose of separating functions to optimize size, complexity, and efficiency ([0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the operation of the cuff of Leschinsky to be done through a smartphone, as taught by Fraden, for the purpose of separating functions to optimize size, complexity, and efficiency.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky in view of McEwen et al. (Pub. No. 2017/0112504).
Regarding claim 8, Leschinsky discloses the invention substantially as claimed in claim 1, as discussed above. Leschinsky does not disclose the controller is receptive to signals from the pressure sensor accounts for variance in pressure due to limb movement.
McEwen et al. teaches in the same field of endeavor of tourniquet cuffs (Abstract) and discloses the controller is receptive to signals from the pressure sensor accounts for variance in pressure due to limb movement ([0054] instrument 6 determines if noise is created by limb movement and will stop the estimation if there is too much movement).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the controller of Leschinsky to be receptive to signals from the pressure sensor accounts for variance in pressure due to limb movement, as taught by McEwen et al., for the purpose of avoiding the collection of inaccurate data (McEwen et al. [0054]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky in view of Glover (U.S. Patent No. 5,201,758).
Regarding claim 13, Leschinsky discloses the invention substantially as claimed in claim 1, as discussed above, and further discloses the cuff is a ratchet or buckle or loop Velcro fastening system ([0098] cuff closure means can be Velcro). Leschinsky does not disclose the cuff is leather or nylon or silicon 5 or 10 cm cuff.
Glover teaches in the same field of endeavor of tourniquet cuffs (Abstract) and discloses a cuff made of nylon (C3:L44-46: cuff is made of nylon stitching) and 5 or 10 cm cuff (C4:L11-17: a width of 10 cm is typically selected).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified cuff of Leschinsky to be made of nylon, as taught by Glover, for the purpose of providing permanent stitching (Glover C3:L44-46), and to have modified the cuff of Leschinsky to be 5 or 10 cm wide, as taught by Glover, as 10 cm is typically selected for tourniquet cuffs (Glover C4:L11-17).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leschinsky in view of Fraden and McEwen et al.
Regarding claim 2, Leschinsky discloses the invention substantially as claimed in claim 1, as discussed above. Leschinsky does not disclose the controller enables the cuff to be inflated to and retained at a pressure up to 350 mmHg, though Leschinsky does disclose that levels higher than 200 mmHg may be required in certain patients ([0007]).
Fraden teaches in the same field of endeavor of pressure cuffs, and discloses a cuff (1; [0016]; FIGs. 1-2) with a controller (18; [0019]; FIG. 2) which enables the cuff to be inflated to a pressure up to 350 mmHg ([0019]), as this compressing air pressure is below the diastolic pressure and above the systolic pressure ([0019]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the controller in Leschinsky to enable the cuff to be inflated to a pressure up to 350 mmHg, as taught by Fraden, to keep the pressure within desired levels. This would enable the cuff to be retained at a pressure up to 350 mmHg, as Leschinsky discloses allowing a patient to select the upper limit of the retained pressure exerted by the cuff ([0075]).
Conclusion
THIS ACTION IS MADE FINAL. 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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771