Prosecution Insights
Last updated: April 19, 2026
Application No. 18/285,853

ARM THERAPEUTIC COMPRESSION SYSTEM, APPARATUS & METHODS OF USE

Non-Final OA §102§103§112
Filed
Oct 05, 2023
Examiner
DVORAK, LINDA C
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Sun Scientific, Inc.
OA Round
1 (Non-Final)
12%
Grant Probability
At Risk
1-2
OA Rounds
2y 11m
To Grant
29%
With Interview

Examiner Intelligence

Grants only 12% of cases
12%
Career Allow Rate
13 granted / 113 resolved
-58.5% vs TC avg
Strong +17% interview lift
Without
With
+17.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
9 currently pending
Career history
122
Total Applications
across all art units

Statute-Specific Performance

§101
2.1%
-37.9% vs TC avg
§103
42.3%
+2.3% vs TC avg
§102
24.8%
-15.2% vs TC avg
§112
23.1%
-16.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 113 resolved cases

Office Action

§102 §103 §112
- 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. Specification The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claim 18 recites “ a secondary wrap having a proximal end and a distal end wherein the proximal end of the secondary wrap is connected to the distal end of the primary wrap”; however, support for this recitation is not found in the specification as originally filed. Applicants should add this descriptive material into the specification as the claims are part of the originally filed disclosure. Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “ secondary wrap having a proximal end and a distal end wherein the proximal end of the secondary wrap is connected to the distal end of the primary wrap” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 4-7, 11, 13, and 16-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 4 , line 2, the recitation "the at least one bladder" lack s antecedent basis in the claim. For the purpose of examination , as best understood, the claim is interpreted to read "the bladder". Regarding claim 5 , lines 2-3 recites "the at least one bladder". There is a lack of antecedent basis for this limitation in the claim. For the purpose of examination, as best understood, the claim is interpreted to read "the bladder". Regarding claim 6 , line 2 recites "the check valve". There is a lack of antecedent basis for this limitation in the claim. For the purpose of this examination , as best understood, the claim is interpreted to read "a check valve". Regarding claim 7 , line 1 re cites "the wrap member". There is a lack of antecedent basis for this limitation in the claim. For the purpose of this Examination, as best understood, the claim is interpreted to read "the wrap". Regarding claim 7 , line 2 recites "the inflated bladder". There is a lack of antecedent basis for this limitation in the claim. For the purpose of this examination , as best understood, the claim is interpreted to read "the bladder". Regarding claim 11 , lines 1 and 2 recite "the shape". There is a lack of antecedent basis for this limitation in the claim. For the purpose of this examination , as best understood, the claim is interpreted to read "a shape". Regarding claim 13 , line 2 re cites "the radius". There is a lack of antecedent basis for this limitation in the claim. For the purpose of this examination, as best understood, the claim is interpreted to read "a radius". Regarding claim 16 , line 1 re cites "the arm". There is a lack of antecedent basis for this limitation in the claim. For the purpose of examination , as best understood, the claim is interpreted to read "an arm". Regarding claim 16 , line 4 re cites "the at least one wrap". There is a lack of antecedent basis for this limitation in the claim. For the purpose of examination , as best understood, the claim is interpreted to read "the wrap". Regarding claim 17 , line 2 re cites "the at least one bladder". There is a lack of antecedent basis for this limitation in the claim. For the purpose of examination, as best understood, the claim is interpreted to read "the bladder". Regarding claim 18 , lines 4, 5, and 7 re cite "the primary wrap". There is a lack of antecedent basis for this limitation in the claim. For the purpose of examination , as best understood, the claim is interpreted to read "the at least one wrap". 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1-4 and 8-11 are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by US2020/0178983 to Wada et al (hereinafter Wada ). Regarding claim 1, WADA discloses an arm therapeutic compression apparatus for post-dialysis treatment of a patient (a hemostatic device 1 used to stop bleeding at a puncture site 510 following the removal of an instrument such as a catheter which was inserted percutaneously into an artery through a puncture formed somewhere on a limb, such as at a wrist 500, and so is capable of being used for post-dialysis treatment of a patient; paragraph [0023]) comprising: a wrap having an inner sheet and an outer sheet joined together by welds and lines to create a bladder (the hemostatic device 1 (wrap) comprises a balloon 5 made of sheets (inner and outer sheet) with edges welded together to form a pouch; figures 1, 2; paragraphs [0023], [0039], [0042]); the bladder including a transparent portion configured to be worn over a needle access site on an arm of a user allowing visualization of the needle access site (it is desirable for the balloon 5 to be substantially transparent to ensure that the puncture site is externally visible; paragraph [0040]); the wrap including a securing means to secure the wrap to the user's arm wherein a portion of the securing means is elongated and configured to allow the user to self-apply the wrap when in use (hemostatic device 1 has a band 2 which is adapted to be wrapped around the wrist 500, a surface fastener 3 (elongate securing means) for securing the band 2 in a wrapped state to the wrist 500, and so is capable of allowing the user to self-apply the wrap when in use; figure 1; paragraph [0023]); and an inflation port connected to the bladder configured to be accessible to both static and intermittent inflation means (tubular connector 73 for receiving the protruding tip of an inflation device for inflating the balloon 5, and so Is capable of being accessible to both static and intermittent inflation means; figure 1; paragraphs [0045], [0046]). Regarding claim 2, WADA discloses the therapeutic compression system of claim 1. WADA further discloses wherein the inflation means is selected from the group consisting of manual pumps (syringe; paragraph [0046]), static pumps, intermittent pumps , electrical inflation pumps, battery inflation pumps, gas powered inflation pumps, static pneumatic compression pumps, intermittent pneumatic inflation pumps, and the combinations thereof and the inflation means for the at least one bladder is selected from the group consisting of air, gas, fluid or combinations thereof (a syringe for injecting fluid into the balloon; paragraph [0046]). Regarding claim 3, WADA discloses the therapeutic compression system of claim 1. WADA further discloses wherein the inflation means incudes a manual pump including two check valves and configured to provide static inflation at a pressure of about 40 mm-Hg to about 70 mm-Hg (tubular connector 73 for receiving the protruding tip of an inflation device for inflating the balloon 5, and so is capable of being accessible to both static and intermittent inflation means, wherein the inflation means incudes a manual pump including two check valves and configured to provide static inflation at a pressure of about 40 mm-Hg to about 70 mm-Hg; figure 1; paragraphs [0045], [0046]). Regarding claim 4, WADA discloses the therapeutic compression system of claim 1. WADA further discloses wherein the inflation port is a self-sealing inflation port configured to prevent deflation of the bladder and includes a check valve (once fluid has been injected into the balloon 5 and the protruding tip of the syringe is withdrawn from the connector 73, a check valve within the connector 73 closes, preventing the fluid from leaking out and thus maintaining the balloon 5 in an inflated state; paragraph [0046]). Regarding claim 8, WADA discloses the therapeutic compression system of claim 1. WADA further discloses wherein the bladder is an air bladder configured to provide compression at the needle access site and a portion of the user's arm (the balloon 5 inflates when a fluid, a gas such as air, is introduced therein, thus applying pressure to the puncture site 510 on the wrist 500; paragraph [0037]). Regarding claim 9, WADA discloses the therapeutic compression system of claim 1. WADA further discloses wherein the inflation means includes a real-time pressure measurement mechanism (tubular connector 73 for receiving the protruding tip of an inflation device for inflating the balloon 5, and so is capable of being accessible to both static and intermittent inflation means, wherein the inflation means includes a real-time pressure measurement mechanism; figure 1; paragraphs [0045], [0046]). Regarding claim 10, WADA discloses the therapeutic compression system of claim 1. WADA further discloses wherein the inflation means includes a pulsometer configured to measure the pulse of a target vessel in the area of the needle access site (tubular connector 73 for receiving the protruding tip of an inflation device for inflating the balloon 5, and so is capable of being accessible to both static and intermittent inflation means, wherein the inflation means includes a pulsometer configured to measure the pulse of a target vessel in the area of the needle access site; figure 1; paragraphs [0045], [0046]). Regarding claim 11, WADA discloses the therapeutic compression system of claim 1. WADA further discloses wherein the transparent portion of the bladder is in a shape of a circle, cross, oval, kidney, elongated kidney, square (the balloon 5 is made of a transparent material and is square; figure 1; paragraph [0042]), rectangle, "U", "C" or the like shapes. 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over WADA in view of WO 2014/121399 A1 (CIRJAK) and WO 2020/223721 A1 to Sun Scientific, Inc. (hereinafter 'SUN'). Regarding claim 5, WADA discloses the therapeutic compression system of claim 1 as discussed, supra . WADA further discloses a check valve (check valve within the connector 73; paragraph [0046]). WADA does not disclose an elbow connector and a valve cap wherein the valve cap is capable of releasing a pressure created by the inflation means within the bladder. CIRJAK discloses an elbow connector (an elbow coupler that connects the bladder to the inflator; page 3, lines 4-6). It would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the system of WADA , with an elbow connector, as taught by CIRJAK, for the advantage of coupling the inflator to the bladder without requiring the tubing to stick out from the bladder, thus reducing the space that the device takes up. Furthermore, elbow connectors are well known within the art, and thus such a modification would have required only routine skill in the art. SUN discloses a valve cap (valve cap 211; paragraph [0120]) wherein the valve cap is capable of releasing a pressure created by the inflation means within the bladder (At any point in use the patient, practitioner or care-giver can deflate the bladder by either inserting the valve cap so it depresses the valve spring and thus release the air or fluid in the bladder and decrease the pressure; paragraph [0120]). It would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the system of WADA , with a valve cap wherein the valve cap is capable of releasing a pressure created by the inflation means within the bladder, as taught by SUN, for the advantage of deflating the bladder and decreasing the pressure when necessary (SUN; paragraph [0121]). Claim s 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over WADA in view of WO 2020/223721 A1 to Sun Scientific, Inc. (hereinafter 'SUN'). Regarding claim 6, WADA discloses the therapeutic compression system of claim 1. WADA does not disclose a pressure sensor operatively connected to the inflation means to protect from over inflation and wherein a check valve is set to open at a predetermined pressure or a user selectable pressure. SUN discloses a pressure sensor operatively connected to the inflation means to protect from over inflation (the inflation means 150 includes a sensor 155 to measure the air pressure being applied, thus capable of preventing over inflation; paragraph [0115]) and wherein a check valve is set to open at a predetermined pressure or a user selectable pressure (a check valve is incorporated with inflation means 150 or bladder 202 to prevent over-inflation once a maximum pressure is detected; paragraph [0092]). It would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the device of WADA , with a pressure sensor operatively connected to the inflation means to protect from over inflation and wherein a check valve is set to open at a predetermined pressure or a user selectable pressure, as taught by SUN, for the advantage of preventing over-inflation once a maximum pressure is detected (SUN; paragraph [0092]). Regarding claim 7, WADA discloses the therapeutic compression system of claim 1. WADA does not disclose wherein the wrap further comprises a release valve or button for release of pressure within the inflated bladder. SUN discloses wherein the wrap further comprises a release valve or button for release of pressure within the inflated bladder (the therapeutic compression apparatus may be deflated by a button to deflate the bladder 202 and thus release the pressure and/or compression profile; paragraph [0107]). It would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the device of WADA , wherein the wrap member further comprises a release valve or button for release of pressure within the inflated bladder, as taught by SUN, for the advantage of manually deflating the bladder and releasing the pressure and/or compression profile as necessary (SUN; paragraph [0107]). Claim s 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over WADA in view of US 2007/0299409 A1 to Whitbourne et al. (hereinafter "WHITBOURNE'). Regarding claim, 12, WADA discloses the therapeutic compression system of claim 1. WADA does not disclose further comprising an absorbent dressing selected from the group of bandages, gauze, foam, PFAB and the like. WHITBOURNE discloses an absorbent dressing selected from the group of bandages, gauze, foam, PFAB and the like (disc 20 comprising an absorbent foam; paragraph [0111]). Since WADA discloses wherein the device is used to stop bleeding at a puncture site ( WADA ; paragraph [0011]), it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the device of WADA , with the absorbent foam of WHITBOURNE, for the advantage of applying an anti-infective agent to the puncture site (WHITBOURNE; paragraph [0028]) and if an exudate develops at the access site, it can be absorbed by the foam (WHITBOURNE; paragraph [0116]). Regarding claim 13, the combination of WADA and WHITBOURNE discloses the therapeutic compression system of claim 12. WADA does not disclose wherein the absorbent dressing is a foam disk including a center opening and a slit on a radius of the disk configured to accommodate a needle at the needle access site. WHITBOURNE discloses wherein the absorbent dressing is a foam disk including a center opening and a slit on a radius of the disk configured to accommodate a needle at the needle access site (the insertable portion of the device is passed through the center of the disc 20, wherein the absorbent foam disk 20 comprises an opening and a slit extending from a radially interior portion to its edge for accommodating a needle at the access site; paragraphs [0111], [0115]). Since WADA discloses wherein the device is used to stop bleeding at a puncture site ( WADA ; paragraph [0011]), it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the device of WADA , with the absorbent foam dis k of WHITBOURNE, for the advantage of applying an anti-infective agent to the puncture site (WHITBOURNE; paragraph [0028]) and if an exudate develops at the access site, it can be absorbed by the dis k (WHITBOURNE; paragraph [0116]). Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over WADA in view of US 4,954,054 A (NEWARD). Regarding claim 14, WADA discloses the therapeutic compression system of claim 1. WADA does not disclose an umbrella valve within the inflation means configured to prevent overinflation of the bladder on the needle access site. NEWARD discloses an umbrella valve within the inflation means configured to prevent overinflation of the bladder (a hand-held pressure pump comprising an umbrella valve for controlling air flow, and so is capable of preventing overinflation of the bladder; column 4, lines 54-68; column 5, lines 1-2). It would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the device of WADA , with the inflation means and umbrella valve of NEWARD, for the advantage of preventing the flow of gas when the air pressure is too great (NEWARD; column 4, lines 54-68; column 5, lines 1-2). Furthermore, an umbrella valve is a standard device and is well-known within the art (NEWARD; column 5, lines 1-2), and thus such a modification would have been obvious to one of ordinary skill in the art. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over WADA in view of US 2008/0249442 A1 to Brown et al. (hereinafter 'BROWN'). Regarding claim 15, WADA discloses the therapeutic compression system of claim 1. WADA does not disclose wherein the wrap includes an inner sheet of wicking material and an outer sheet partially elastic or having an elastic portion configured to securely wraparound the arm of the user prior to and after inflation of the bladder. BROWN discloses wherein the wrap includes an inner sheet of wicking material (a compression device for applying compression to a user's body comprises an inner wicking layer; paragraph [0050]) and an outer sheet partially elastic or having an elastic portion configured to securely wrap around the arm of the user prior to and after inflation of the bladder (an elastic outer layer for securely wrapping around the limb of the user prior to and after inflation; paragraph [0114]). It would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the device of WADA , wherein the wrap includes an inner sheet of wicking material and an outer sheet partially elastic or having an elastic portion configured to securely wrap around the arm of the user prior to and after inflation of the bladder, as taught by BROWN, for the advantage of improving comfort which increases patient compliance (BROWN; paragraph [0114]). Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over WADA in view of US 5,873,890 A (PORAT). Regarding claim 15, WADA discloses a method of applying compression pressure to a needle access site on an arm of a user (a hemostatic device 1 used to stop bleeding at a puncture site 510 following the removal of an instrument such as a catheter which was inserted percutaneously into an artery through a puncture formed somewhere on a limb, such as at a wrist 500, and so is capable of being used for post-dialysis treatment of a patient; paragraph [0023]) after dialysis treatment (not given patentable weight), comprising: placing a wrap on an arm of a user (hemostatic device 1 has a band 2 which is adapted to be wrapped around the wrist 500; figure 2; paragraph [0023]), wherein the wrap includes a) a bladder connected to an inflation means (hemostatic device 1 (wrap) comprises a balloon 5 connecting to a syringe via adapter 73 for inflation of the balloon 5; figure 1; paragraph [0046]) with the bladder having a transparent portion configured to allow visualization of the needle access site (it is desirable for the balloon 5 to be substantially transparent to ensure that the puncture site is externally visible; paragraph [0040]) and b) an elongated securing means configured to accommodate a temporary adhesive for self-application and securing of the wrap by the user without assistance (band 2 (elongated securing means) comprising a male side 32 and female side 31 comprising tape, and thus will inherently allow for self-application and securing of the wrap without assistance; figures 1, 2; paragraph [0029]); securing the wrap on the arm with the transparent portion of the bladder and needle access site on the arm of the user (the transparent balloon 5 is placed over the needle access site of the wrist; figure 2; paragraph [0023]); connecting an inflation means to an inflation port on the wrap (a syringe is connected to connector 73 (inflation port); paragraph [0046]); activating the inflation means and the bladder (inflation of the balloon 5 is carried out by inserting the protruding tip of a syringe into the connector 73 and pushing a plunger on the syringe so as to introduce fluid within the syringe through the inflator 7 into the balloon 5; paragraph [0046]); and monitoring bleeding at the needle access site via the transparent portion of the bladder (it is desirable for the balloon 5 to be substantially transparent to ensure that the puncture site is externally visible; when bleeding is determined to have stopped to a sufficient degree, the hemostatic device 1 of the invention is removed from the puncture site 510; paragraphs [0040], [0066]). WADA does not disclose placing a dressing over a needle and needle access site on the arm of a user; when a needle is in the arm of the user; removing the needle from the user leaving an absorbent dressing on the needle access site. PORAT discloses a method of applying compression pressure to a needle access site on the arm of a user after dialysis treatment (a method of applying pressure to a needle access site on the arm of a user after dialysis treatment; column 3, lines 35-42; column 6, lines 60-67), comprising: placing a dressing over a needle and needle access site on the arm of a user (an absorbent pad 4 is placed over a needle and a needle access site on the arm of a user; figures 1-3, 8; column 5, lines 10-25); when a needle is in the arm of the user (as shown; figures 1-3, 8); removing the needle from the user leaving an absorbent dressing on the needle access site (the needle is removed from the patient leaving the absorbent pad; figures 8, 9; column 5, lines 25-30; column 7, lines 10-15). It would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the method of WADA , with placing a dressing over a needle and needle access site on the arm of a user and removing the needle from the user leaving an absorbent dressing on the needle access site, as taught by PORAT, for the advantage of maintaining sufficient even pressure on the wound to prevent spurting of blood therefrom after removal of the needle and without cutting off circulation to the arm (PORAT; abstract). Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over WADA in view of PORAT and in further view of SUN. Regarding claim 17, the combination of WADA and PORAT discloses the method of claim 16 as discussed, supra . WADA does not disclose further including the step of deflating the inflated bladder by opening a release valve or button on the wrap and releasing a pressure within the bladder. SUN discloses deflating the inflated bladder by opening a release valve or button on the wrap and releasing a pressure within the bladder (the therapeutic compression apparatus may be deflated by a button to deflate the bladder 202 and thus release the pressure and/or compression profile; paragraph [0107]). It would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed , to have modified the device of WADA , with deflating the inflated bladder by opening a release valve or button on the wrap and releasing a pressure within the bladder, as taught by SUN, for the advantage of manually deflating the bladder and releasing the pressure and/or compression profile as necessary (SUN; paragraph [0107]). Allowable Subject Matter Claim 18 is allowed. The following is a statement of reasons for the indication of allowable subject matter : Claim 18 is allowable because the prior art does not teach or fairly suggest a therapeutic compression system configured to control external bleeding at a needle access site on an arm of a patient post-dialysis treatment, comprising: at least one wrap having a proximal end configured to be located along a wrist, elbow, shoulder or arm of a user and a distal end of the at least one wrap configured to be located at a wrist, elbow, shoulder or arm of a user, the at least one wrap including at least one bladder; a secondary wrap having a proximal end and a distal end wherein the proximal end of the secondary wrap is connected to the distal end of the at least one wrap; the at least one bladder having a translucent or transparent portion configured for visualization of a needle access site on the user; an inflation means connected to the bladder via a universal inflation port on the at least one bladder wherein the inflation port includes a check valve and is configured to be capable of connection to a manual or powered pump, and an assembly comprising: a) pressure mechanism having a flexible member for attachment around a limb and an air chamber which assumes a first pressurized stated, said air chamber having a length and a width, said width being less than half the at least one bladder; b) a pre-filled air bladder having a length and a width smaller than the width of the air chamber; c) an absorbent foam, sponge or dressing coupled to the pre-filled air bladder; and d) a suction conduit in fluid communication with the absorbent foam, sponge or dressing and adapted for coupling to a source of negative pressure. Regarding claim 18, WADA discloses a therapeutic compression system configured to control external bleeding at a needle access site on an arm of a patient post-dialysis treatment (a hemostatic device 1 used to stop bleeding at a puncture site 510 following the removal of an instrument such as a catheter which was inserted percutaneously into an artery through a puncture formed somewhere on a limb, such as at a wrist 500, and so is capable of being used for post-dialysis treatment of a patient; paragraph [0023]), comprising: at least one wrap having a proximal end configured to be located along a wrist, elbow, shoulder or arm of a user and a distal end of the at least one wrap configured to be located at a wrist, elbow, shoulder or arm of a user (band 2 (wrap) is shown comprising a proximal end and distal end, wherein the wrap is located on the wrist of a user; figures 1, 2; paragraphs [0023], [0024]), the at least one wrap including at least one bladder (the hemostatic device 1 (wrap) comprises a balloon 5 made of sheets with edges welded together to form a pouch; figures 1, 2; paragraphs [0023], [0039], [0042]); the at least one bladder having a translucent or transparent portion configured for visualization of a needle access site on the user (it is desirable for the balloon 5 to be substantially transparent to ensure that the puncture site is externally visible; paragraph [0040]); an inflation means connected to the bladder via an inflation port wherein the inflation port includes a check valve and is configured to be capable of connection to a manual or powered pump (tubular connector 73 for receiving the protruding tip of an inflation device for inflating the balloon 5, and so is capable of connection to a manual or powered pump; wherein the connector 73 comprises a check valve; figure 1; paragraphs [0045], [0046]). WADA does not disclose a secondary wrap having a proximal end and a distal end wherein the proximal end of the secondary wrap is connected to the distal end of the at least one wrap; an inflation means connected to the bladder via a universal inflation port on the at least one bladder; and an assembly comprising: a) pressure mechanism having a flexible member for attachment around a limb and an air chamber which assumes a first pressurized stated, said air chamber having a length and a width, said width being less than half the at least one bladder; b) a pre-filled air bladder having a length and a width smaller than the width of the air chamber; c) an absorbent foam, sponge or dressing coupled to the pre-filled air bladder; and d) a suction conduit in fluid communication with the absorbent foam, sponge or dressing and adapted for coupling to a source of negative pressure. US 2013/0237866 A1 to Cohen et al (hereinafter Cohen ) discloses a therapeutic compression system configured to control external bleeding at a needle access site on an arm of a patient post-dialysis treatment (a hemostasis device that provides compression to a puncture site, and so is capable of being used on the arm of a patient post-dialysis treatment; abstract; paragraph [0050]), comprising: at least one wrap having a proximal end configured to be located along a wrist, elbow, shoulder or arm of a user and a distal end of the at least one wrap configured to be located at a wrist, elbow, shoulder or arm of a user (apparatus is shown comprising a proximal and distal end and is located on the wrist of the user; figure 8a; paragraph [0552]), the at least one wrap including at least one bladder (pressure component 108 will be a substantially transparent balloon such as the balloon 140; paragraph [0120]); the at least one bladder having a translucent or transparent portion configured for visualization of a needle access site on the user (pressure component 108 will be a substantially transparent balloon such as the balloon 140, and so is capable of visualization of a needle access site; paragraph [0120]); an inflation means connected to the bladder via an inflation port wherein the inflation is configured to be capable of connection to a manual or powered pump (an inlet 144 into the balloon is the means by which the balloon 140 is inflated, and so is capable of connection to a manual or powered pump; figure 8b; paragraph [0128]), and an assembly as recited. COHEN does not disclose a secondary wrap having a proximal end and a distal end wherein the proximal end of the secondary wrap is connected to the distal end of the at least one wrap; an inflation means connected to the bladder via a universal inflation port on the at least one bladder wherein the inflation port includes a check valve; and an assembly comprising: a) pressure mechanism having a flexible member for attachment around a limb and an air chamber which assumes a first pressurized stated, said air chamber having a length and a width, said width being less than half the at least one bladder; b) a pre-filled air bladder having a length and a width smaller than the width of the air chamber; c) an absorbent foam, sponge or dressing coupled to the pre-filled air bladder; and d) a suction conduit in fluid communication with the absorbent foam, sponge or dressing and adapted for coupling to a source of negative pressure. SUN discloses a therapeutic compression system configured to control external bleeding at a needle access site on an arm of a patient post-dialysis treatment (a therapeutic compression system for providing pressure to a limb or other body part, and so is capable of controlling external bleeding at a needle access site on an arm of a patient post-dialysis treatment; abstract), comprising: at least one wrap having a proximal end configured to be located along a wrist, elbow, shoulder or arm of a user and a distal end of the at least one wrap configured to be located at a wrist, elbow, shoulder or arm of a user (as shown; figure 2), the at least one wrap including at least one bladder (the therapeutic compression apparatus 200, 300 may be comprised of a bladder 202 such as a compression bladder; paragraph [0087]); a secondary wrap (secondary wrap; paragraph [0056]); an inflation means connected to the bladder via a universal inflation port on the at least one bladder wherein the inflation port includes a check valve and is configured to be capable of connection to a manual or powered pump (bladder 202 comprising a universal inflation port 212 for connection to a manual or powered pump; The inflation port includes a check vale so as to maintain a given pressure within the bladder of the therapeutic compression apparatus; paragraphs [0053], [0095]), and an assembly comprising: a) pressure mechanism having a flexible member for attachment around a limb (a pressure mechanism having a flexible member for attachment to a limb; paragraph [0057]) and an air chamber which assumes a first pressurized stated (and an air chamber which may be pumped up into a desired pressurized state; paragraph [0057]); b) a pre-filled air bladder (a separate relatively small pre-filled air bladder; paragraph [0057]); c) an absorbent foam, sponge or dressing coupled to the pre-filled air bladder (an absorbent foam, sponge or dressing coupled to the pre-filled air bladder; paragraph [0057]); and d) a suction conduit in fluid communication with the absorbent foam, sponge or dressing and adapted for coupling to a source of negative pressure (and a suction conduit coupled to a source of negative pressure and in fluid communication with the absorbent foam, sponge or dressing; paragraph [0057]). SUN does not disclose a secondary wrap having a proximal end and a distal end wherein the proximal end of the secondary wrap is connected to the distal end of the at least one wrap; the at least one bladder having a translucent or transparent portion configured for visualization of a needle access site on the user; said air chamber having a length and a width, said width being less than half the at least one bladder; a pre-filled air bladder having a length and a width smaller than the width of the air chamber. Thus, it would not have been obvious to one of ordinary skill in the art at the time of the invention to have modified WADA , COHEN , and SUN, with a therapeutic compression system configured to control external bleeding at a needle access site on an arm of a patient post-dialysis treatment, comprising: at least one wrap having a proximal end configured to be located along a wrist, elbow, shoulder or arm of a user and a distal end of the at least one wrap configured to be located at a wrist, elbow, shoulder or arm of a user, the at least one wrap including at least one bladder; a secondary wrap having a proximal end and a distal end wherein the proximal end of the secondary wrap is connected to the distal end of the at least one wrap; the at least one bladder having a translucent or transparent portion configured for visualization of a needle access site on the user; an inflation means connected to the bladder via a universal inflation port on the at least one bladder wherein the inflation port includes a check valve and is configured to be capable of connection to a manual or powered pump, and an assembly comprising: a) pressure mechanism having a flexible member for attachment around a limb and an air chamber which assumes a first pressurized stated, said air chamber having a length and a width, said width being less than half the at least one bladder; b) a pre-filled air bladder having a length and a width smaller than the width of the air chamber; c) an absorbent foam, sponge or dressing coupled to the pre-filled air bladder; and d) a suction conduit in fluid communication with the absorbent foam, sponge or dressing and adapted for coupling to a source of negative pressure, as described, because the references of record fail to disclose all of the elements of the inventive system. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LINDA C DVORAK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-4764 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 7 am-4 pm EST . 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, Jonathan Moffat can be reached at 571-272-4764 . 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. FILLIN "Examiner Stamp" \* MERGEFORMAT LINDA C. DVORAK Supervisory Patent Examiner Art Unit 3739 /LINDA C DVORAK/ Primary Examiner, Art Unit 3794
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Prosecution Timeline

Oct 05, 2023
Application Filed
Mar 25, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
12%
Grant Probability
29%
With Interview (+17.2%)
2y 11m
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Low
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