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previous 112(b) rejection over claim 8 filed 09/24/2025, the amendment to claim 8 is acknowledged and the rejection is withdrawn.
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
Applicant argues that Gabel fails to disclose or suggest “an inflation baffle within the expandable balloon” as required in amended claim 1. Applicant explains that because the inflatable balloon 112 is attached to the inner and outer shafts 124, 106, the interior of the inflatable balloon 112 is separated from the ends of the inner and outer shafts 124, 106. Thus, the inner and outer shafts 124, 106 cannot be considered to be located within the inflatable balloon
The examiner respectfully disagrees. Gabel discloses that the distal end of the balloon is attached to the distal end of inner shaft such that “when the balloon is inflated, the attachment of the distal end of the balloon to the distal end of the instrument is located inside the inflated balloon” (see col. 11, lines 9-17 of Gabel). The examiner also notes that Gabel illustrates the inner shaft 124 positioned within the balloon 112 in figures 9, 29-30 since inflation fluid is delivered into the balloon via. first conduit 140 which extends between the outer and inner shafts 106, 124 (col. 10, lines 39-42 of Gabel). Therefore, the rejection is maintained.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4, lines 2-3: “internal pressure” should recite “an internal pressure”.
Appropriate correction is required.
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 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gabel et al. (US 8366733) [hereinafter Gabel].
Regarding claim 1, Gabel discloses a hemorrhage control device (Figs. 1, 8A-B, col. 4 lines 42-48, col. 12 lines 25-36), comprising:
a trocar (not shown) having an opening at a distal end (col. 5 lines 21-30);
an expandable balloon 112 disposed within the trocar, the expandable balloon being collapsed within the trocar in a stored condition (col. 5 lines 21-30 and lines 57-62 disclose that the balloon is deflated when positioned within the trocar and that before reaching the surgical site, the balloon is disposed within the trocar.), and the expandable balloon 112 being movable out of the trocar, through the opening, into a deployed condition (col. 5 lines 24-30);
an inflation tube 106 fluidly connected to an interior of the expandable balloon 112 (Figs. 1, 3, col. 9 lines 49-53, col. 10 lines 39-42 and lines 54-58); and
an inflation baffle 124 within the expandable balloon 112, the inflation baffle being fluidly connected to the inflation tube 106 (Figs. 2, 6B, 9, col. 10 lines 39-43 and 56-60, col. 11, lines 9-17);
a source of pressurized fluid 186 connected to the inflation tube 106, for pressurized fluid to be introduced into the inflation tube 106 to pressurize and inflate the expandable balloon 112 in the deployed condition (Figs. 7A-8B, col. 12 lines 13-22 and lines 25-27).
Regarding claim 8, Gabel discloses wherein a length of the inflation baffle 124 is greater than 20% of a diameter of the expandable balloon, when the expandable balloon is inflated to an operating diameter (see Figs. 3 and 7B which illustrates a distal end of the inflation baffle 124 is secured to a distal end of the expandable balloon and the length of the inflation baffle 124 extends to hub connector 108, col. 10 lines 43-47; see Figs 8B which illustrates the length of inflation baffle 124 extending greater than 20% of the diameter of the expandable balloon).
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.
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) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gabel et al. (US 8366733) [hereinafter Gabel].
Regarding claim 3, Gabel discloses all of the limitations set forth above in claim 1. Gable further discloses wherein the expandable balloon is capable of containing internal pressures from about 0 mm hg to an internal pressure resulting in expansion (Figs. 7A, 8A-B, col. 12 lines 19-27). However, Gabel fails to disclose wherein the expandable balloon is capable of containing internal pressures from about 0 mm hg to about 200 mm hg.
There is no evidence of record that establishes that changing the internal pressure of the balloon would result in a difference in function of the Gabel balloon. Further, a person having ordinary skill in the art, being faced with modifying the balloon of Gabel to be capable of containing the claimed internal pressures, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed internal pressure dimension which is to achieve hemostasis (col. 4 lines 42-48, col. 12 lines 25-36 of Gabel). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating in para. 0018 of the instant application that “In another optional form, the expandable balloon is capable of containing internal pressures from about 0 mm hg to about 200 mm hg”. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify modifying the balloon of Gabel to be capable of containing the claimed internal pressures up to 200 mm hg as an obvious matter of design choice within the skill of the art.
Claim(s) 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gabel et al. (US 8366733) [hereinafter Gabel] as applied to claim 1 above, and further in view of Ward (US 20020016608).
Regarding claim 4, Gabel discloses all of the limitations set forth above in claim 1. However, Gabel fails to disclose wherein the expandable balloon has an external diameter of between about 5 cm and about 60 cm when internal pressure of the expandable balloon is at an operating pressure and not externally constrained.
Ward in the same field of endeavor of hemorrhage control devices (Figs. 5-6, para. 0025, 0070-0071) teaches that it is known in the art for an expandable balloon 54 to have an external diameter of between about 5 cm and about 60 cm when internal pressure of the expandable balloon is at an operating pressure (para. 0072 discloses that the inflatable member has an external diameter ranging between approximately 1 to approximately 6 inches which is within the claimed range of about 5 cm and about 60 cm or 1.97 inches to 23.62 inches) and not externally constrained (The examiner notes that “not externally constrained” is functional language that describes the intended use of the device. Since Ward teaches that the balloon expands within the claimed range when externally constrained, the balloon would also be able to expand within the claimed range when not externally constrained).
Ward expressly states that having a balloon that expands to a diameter with the claimed range allows for effective hemorrhage control at a target site (para. 0072 of Ward). Thus, one skilled in the art would have readily recognized that providing Gabel with a balloon that expands to a diameter with the claimed range of 5 cm to 60 cm as taught by Ward, would provide effective hemorrhage control at a target site (para. 0072 of Ward).
Regarding claim 14, Gabel discloses all of the limitation set forth above in claim 1. However, Gabel fails to disclose further comprising a rigid external support member.
Ward in the same field of endeavor of hemorrhage control devices (Figs. 9-11, para. 0073) teaches that it is known in the art to further comprise a rigid external support member 66 (para. 0075) for the purpose of applying a force externally to the patient (para. 0075).
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 Gabel to include the rigid external support member of Gabel in order to assist in hemorrhage control in the abdominal area by applying additional force to the expandable balloon to fully occlude a descending aorta (para. 0024, 0030, 0073 of Ward).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gabel et al. (US 8366733) [hereinafter Gabel] as applied to claim 1 above, and further in view of Marx (US 20120116303) and Ward (US 20020016608).
Regarding claim 5, Gabel discloses all of the limitations set forth above in claim 1. However, Gabel fails to disclose wherein the trocar has a first cross-sectional diameter and the expandable balloon has a second cross-sectional diameter, the second cross-sectional diameter being measured when the expandable balloon is inflated to an operating pressure, and the second cross-sectional diameter capable of being greater than 5 times larger than the first cross-sectional diameter.
Marx in the same field of endeavor of balloon devices (Figs. 1, 6, para. 0107-0108) teaches that it is known in the art for a trocar 1 to have a first cross-sectional diameter (Fig. 1, para. 0020, 0094, 0100) and an expandable balloon 14 have a second cross-sectional diameter (Fig. 1, para. 0108).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Marx to utilize a trocar having a known diameter range in the art of 4 mm to 8 mm to the trocar of Gabel would have yielded predicable results, namely provide the trocar with a diameter range to accommodate both children and adults (para. 0020).
However, Gabel in view of Marx fails to disclose that the second cross-sectional diameter being measured when the expandable balloon is inflated to an operating pressure, and the second cross-sectional diameter capable of being greater than 5 times larger than the first cross-sectional diameter.
Ward in the same field of endeavor of hemorrhage control devices (Figs. 5-6, para. 0025, 0070-0071) teaches that it is known in the art for an expandable balloon 54 to have a cross-section diameter ranging between approximately 1 to approximately 6 inches measured when the expandable balloon is inflated to an operating pressure (para. 0072).
Ward expressly states that having a balloon that expands to a diameter with the claimed range allows for effective hemorrhage control at a target site (para. 0072 of Ward). Thus, one skilled in the art would have readily recognized that providing Gabel with a balloon that expands to a second cross-section diameter ranging from approximately 1 to approximately 6 inches as taught by Ward, would provide effective hemorrhage control at a target site (para. 0072 of Ward).
The combination of Gabel in view Marx and Ward would result in a product wherein the second cross-sectional diameter of the expanded balloon as taught by Ward (approximately 1 to approximately 6 inches or 25.4 mm to 152.4 mm, para. 0072) capable of being greater than 5 times larger than the first cross-sectional diameter of the trocar as taught by Marx (4 mm to 8 mm, para. 0100).
Claim(s) 7 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Gabel et al. (US 8366733) [hereinafter Gabel] as applied to claim 1 above, and further in view of Ravikumar (US 20080086166).
Regarding claim 7, Gabel discloses all of the limitations set forth above in claim 1. Gabel further discloses wherein the inflation baffle 124 includes a fluid opening 3140 (shown in Fig. 3, but best described and labeled in Fig. 19A-B, col. 14 lines 46-52) distributed along a length of the inflation baffle 124 (see Fig. 3). Gabel further discloses an alternative inflation mechanism, wherein the inner shaft is used to inflate the balloon via. the fluid opening (Fig. 19A-B, col. 14 lines 46-52 and col. 17 lines 63-67). However, Gabel fails to disclose wherein the inflation baffle includes a plurality of fluid openings distributed along a length of the inflation baffle.
Ravikumar in the same field of endeavor of balloon devices 14 (Fig. 2, para. 0033) teaches that it is known in the art for an inflation baffle 15 to include a plurality of fluid openings 83 distributed along a length of the inflation baffle (Fig. 2, para. 0033).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the inflation baffle of Gable to include a plurality of fluid openings, as taught by Ravikumar, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 22, modified Gabel discloses wherein at least two openings in the plurality of fluid openings 83 are not axially aligned with one another (Fig. 2, para. 0033 of Ravikumar).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gabel et al. (US 8366733) [hereinafter Gabel] as applied to claim 1 above, and further in view of Flom et al. (US 5817062) [hereinafter Flom].
Regarding claim 11, Gabel discloses all of the limitations set forth above in claim 1. However, Gabel fails to disclose wherein a distal end of the trocar comprises a deformable tip.
Flom in the same field of endeavor of trocars teaches that a distal end of a trocar 2 comprises a deformable tip 12 (Figs. 2-3, col. 3 lines 30-38).
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 distal end of the trocar in Gabel to include the deformable tip of Floom in order to anchor the trocar to a patient (col. 4 lines 47-53 of Floom).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gabel et al. (US 8366733) [hereinafter Gabel] as applied to claim 1 above, and further in view of Robich (US 20190231388).
Regarding claim 12, Gabel discloses all of the limitations set forth above in claim 1. However, Gabel fails to disclose wherein a distal end of the trocar comprises a curved tip.
Robich in the same field of endeavor of trocars 10 teaches that a distal end 12 of trocar 10 comprises a curved tip (Fig. 3, para. 0055).
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 distal end of the trocar in Gabel to include the deformable tip of Robich in order to be more safely and more predictably positioned within a patient than a traditional trocar that is straight (non-angled) (para. 0052 of Robich).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gabel et al. (US 8366733) [hereinafter Gabel] as applied to claim 1 above, and further in view of Kassab (US 20190343449).
Regarding claim 16, Gabel discloses all of the limitations set forth above in claim 1. However, Gabel fails to disclose further comprising a physiological sensor connected to the expandable balloon or to the inflatable tube.
Kassab in the same field of endeavor of balloon catheters teaches that it is known in the art to include a physiological sensor 112 connected to an expandable balloon 102 to monitor the pressure inside the expandable balloon 102 (Fig. 1, para. 0045).
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 Gabel to include the physiological sensor connected to the expandable balloon, as taught by Kassab, in order to monitor the pressure inside the expandable balloon 102 (Fig. 1, para. 0045, 0056 of Kassab), thereby improving the control of inflation and prevention of overinflation (para. 0018 of Kassab).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771