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 and Arguments
Claims 1-22 are pending with claims 6-7 have been withdrawn from further consideration as being drawn to a nonelected invention and claims 1-5 and 8-22 are under examination.
In view of the amendment filed on October 29, 2025, independent claim 1 has been amended.
As to the rejection of claims 1, 3 and 19-22 under 35 U.S.C. 102(a)(1) as being anticipated by Ramsey (US 6,306,154), applicant’s arguments have been fully considered and persuasive. Examiner notes that the amendment to claim 1 overcome the rejection of claims 1, 3 and 19-22 under 35 U.S.C. 102(a)(1) as being anticipated by Ramsey (US 6,306,154). Therefore, the rejection is hereby withdrawn.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 3-5 and 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramsey et la. (US 2008/0119785, hereinafter “Ramsey”).
Referring to claim 1, Ramsey discloses a method of controlling bleeding (¶ [0091] and Figs. 2, 9 and 10A-10C) comprising:
providing a bleeding control device (Figs. 2 and 9), the bleeding control device comprising:
an inflatable balloon 12 (Figs. 2 and 9; ¶ [0115]);
inflation means 20 (Fig. 3; ¶ [0121], ¶ [0100]: “a means for inflation of the tamponadding balloon is required, and one such inflation method is to pump air into the tamponade balloon with a hand bulb attached to the catheters Luer fitting (some such hand bulbs, called sphygmomanometers, are often used for measuring blood pressure and hence are readily available).”); and
a gas supply line 14 (Fig. 2; ¶ [0117]);
inflating the inflatable balloon with the inflation means such that the inflatable balloon inflates within a puncture wound of a patient, thereby mitigating bleeding from the wound (Figs. 10A-10C; ¶ [0163]: “After the catheter has been fully inserted into the wound track, the sheath 150 is fully removed and the balloon is inflated to effect the desired tamponade of the bleeding within the wound track.”).
Referring to claim 3, Ramsey discloses the method according to claim 1, wherein the inflation means comprises a hand pump (¶ [0100]).
Referring to claim 4, Ramsey discloses the method according to claim 1, wherein the wound is a bullet wound (¶¶ [0007] and [0091]).
Referring to claim 5, Ramsey discloses the method according to claim 1, wherein a pressure within the balloon is maintained with a pressure regulator of the bleeding control device (¶ [0103]: “In a further enhancement to this electronic measurement and indicator system, the system could be equipped with an electronic pressure release valve and a very small air pump to constantly and automatically maintain the pressure within the balloon at the desired level, alerting when major adjustments are required since such required adjustments may indicate a leak in the balloon. This automatic control mechanism is particularly desirable when my catheter system is to be used for many hours and when the presence of trained personnel will not be constantly in attendance.”).
Referring to claim 19, Ramsey discloses the method according to claim 1, wherein the inflatable balloon 12 comprises a tubing (catheter 14 as shown in Figs. 3-4) running along a length of the balloon (Fig. 6) and a one-way valve configured to allow gas to exit the tubing (¶ [0117]: “In use, the Luer fitting will usually have a check valve or a stopcock attached to it to aid in the inflation and pressure maintenance process. In one embodiment, such devices are a permanent part of the catheter.”).
Referring to claim 20, Ramsey discloses the method according to claim 1, wherein a removable sheath 50 (Fig. 4; ¶ [0123]) is provided covering the inflatable balloon 12 prior to inflating the inflatable balloon.
Referring to claim 21, Ramsey discloses the method according to claim 1, wherein the inflation means 20 inflates the inflatable balloon 12 through an external gas input connection fluidly connected to the inflatable balloon through the gas supply line (Figs. 3; ¶ [0121]: “As in FIG. 2, in FIG. 3 the tamponade catheter assembly 10 has been removed from its wound track insertion system, its stylet 40 has been removed, and its balloon 12 has been partially inflated using the hand bulb 20 with integral pressure gauge 22 which is connected to the Luer fitting 16 on the proximal end of the catheter shaft 14 by the inflation hose 18 and a mating Luer fitting.”).
Referring to claim 22, Ramsey discloses the method according to claim 21, wherein the external gas input connection comprises a Luer lock (Figs. 3; ¶ [0121]: “As in FIG. 2, in FIG. 3 the tamponade catheter assembly 10 has been removed from its wound track insertion system, its stylet 40 has been removed, and its balloon 12 has been partially inflated using the hand bulb 20 with integral pressure gauge 22 which is connected to the Luer fitting 16 on the proximal end of the catheter shaft 14 by the inflation hose 18 and a mating Luer fitting.”).
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.
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(s) 2 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramsey in view of Brister et al. (US 2013/0226219, which is cited in the most recent Office action, hereinafter “Brister”).
Referring to claims 2 and 5, Ramsey discloses the method according to claim 1 but fails to disclose wherein the inflation means comprises a compressed gas canister and a pressure within the balloon is maintained with a pressure regulator of the bleeding control device.
Referring again to claims 2 and 5, however, Brister discloses using a compressed gas canister to inflate a balloon of a balloon catheter is old and well known in the art (¶¶ [0182]-[0185]). Brister also discloses an air chamber and a regulator (FIG. 14C), wherein the gas canister is fluidly connected to the inflatable balloon through the air chamber and the regulator (air chamber, which is located above canister, and the canister is connected to tubing and valve as shown in FIGS. 14A-14C), and wherein the air chamber and regulator are configured to maintain the inflatable balloon at a predetermined pressure or at a selected pressure (¶¶ [0182]-[0185]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have substitute the syringe of Ramsey with a compressed gas canister and the controller, which includes pressure gauge valve warning (FIGS. 14A-14C, ¶¶ [0182]-[0185]) as suggested by Brister to quickly inflating the balloon and provide the surgeon the ability to control the air pressure supply to the balloon, thereby, provide safety to the patient.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramsey in view of Samuels et al. (US 2002/0161388, which is cited in the most recent Office action, hereinafter “Samuels”).
Referring to claim 8, Ramsey discloses the method according to claim 1 but fails to disclose wherein a mesh is arranged on and/or within the inflatable balloon, wherein the mesh prevents the inflatable balloon from being inflated beyond a predetermined size and/or shape during the inflating the inflatable balloon.
Referring to claim 8, however, Samuels discloses adding an elastomeric mesh (FIGS. 1A-2A) to a balloon will provide the advantages minimize the size of the balloon when the balloon is in a collapsed configuration and increase resistance to further extension of the balloon, thereby, improve burst resistance of the balloon (para [0024] and [0030]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided a braided mesh as suggested by Samuels to the balloon of Ramsey so that it too would have the same advantages.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramsey in view of Gerrans et al. (US 2011/0152683, which is cited in the most recent Office action, hereinafter “Gerrans”).
Referring to claim 9, Fig. 11a of Ramsey appears to disclose the gas supply line 14 includes a plurality of holes to supply air from the pump 20 to the balloon 12. In alternative. Gerrans discloses a balloon catheter (FIGS. 1 and 4A) includes balloon 32 and a gas supply line comprises a plurality of holes 44 (¶ [0070]) to inflate the balloon. Apparently, the advantage of having plurality of holes is to allow the surgeon to inflate the balloon quickly and to provide an additional safety feature in case one of the hole is blocked, thereby, improve the effectiveness of the device. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have provided more opening to the balloon of Ramsey to improve the effectiveness of the device.
Allowable Subject Matter
Claims 10-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771