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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 under a 102 rejection over Gabel have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Upon further consideration, a new ground(s) of rejection is made in view of Belfort et al. (US 20080215031) in view of Hudson et al. (US 20020058960).
Claim Objections
Claim 37 is objected to because of the following informalities:
Claim 37, line 2: “ballon” should recite “balloon”.
Appropriate correction is required.
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) 1, 3-4, 7-8, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Belfort et al. (US 20080215031) [hereinafter Belfort] in view of Hudson et al. (US 20020058960) [hereinafter Hudson].
Regarding claim 1, Belfort discloses hemorrhage control device 200 (Fig. 1, para. 0032), comprising:
a trocar having an opening at a distal end (para. 0048: “the apparatus may further comprise an introducer assembly for aiding insertion of the balloon tamponade apparatus into a pelvic or abdominal cavity from an opening in the body…The introducer assembly comprises a wire attached to a gripping means at a proximal end...The wire may comprise a trocar, guide, stem, stylet or other semi-rigid or rigid means to aid insertion of a tubular medical device (e.g., a catheter,) into a subject”. Therefore, Belfort does disclose a trocar having an opening at a distal end such that the device may be introduced therein)
an expandable balloon 100 (Fig. 1, para. 0032) disposed within the trocar, the expandable balloon being collapsed within the trocar in a stored condition, and the expandable balloon 100 being movable out of the trocar, through the opening, into a deployed condition (para. 0056: “Another aspect of the invention provides a method to control hemorrhage in a body cavity, by providing a balloon tamponade in an unfilled (non-inflated) state, implanting or inserting the balloon tamponade into a body cavity (with or without the assistance of an introducer), filling the balloon with a biologically and physiologically compatible fluid through the inflation lumen of the tube”. Since the trocar is used during insertion, the balloon must be disposed within the trocar in order to be inserted and in collapsed/deflated condition and must be movable out of the trocar to be inserted into the body cavity and inflated.);
an inflation tube 30 fluidly connected to an interior of the expandable balloon 100 (Fig. 1, para. 0032: “a conduit 30 having an inflation lumen 32…The inflation lumen provides a means to inflate or fill the balloon interior with a fluid medium (e.g., gas or liquid), thereby expanding the balloon to a shape within the body cavity”);
a source of pressurized fluid connected to the inflation tube 30, for pressurized fluid to be introduced into the inflation tube 30 to pressurize and inflate the expandable balloon 100 in the deployed condition (para. 0056: “filling the balloon with a biologically and physiologically compatible fluid through the inflation lumen of the tube…supplied from an external inflation media supply source, such as a filled IV bag or a syringe filled with the inflation medium”).
Belfort further discloses that the inflation tube 30 extends within the expandable balloon 100 such that a distal portion of the inflation tube 30 comprising a plurality of openings 34 is completely surrounded by the expandable balloon 100 (Fig. 1, para. 0032: “a conduit 30 having an inflation lumen 32 in communication with the interior 50 of the balloon through one or a plurality of openings 34”).
However, Belfort fails to disclose a separate inflation baffle fluidly connected to the inflation tube.
Hudson in the same field of endeavor of hemorrhage balloon devices (Figs. 19-22, para. 0133) teaches that it is known in the art to comprise a separate inflation baffle (interpreted as internal inflation tube 200) in fluid communication with an inflation tube 195, wherein the inflation baffle is within and completely surrounded by a balloon 191 (Figs. 21-22, para. 0128: “an inflation tube 200 actually extends into inflatable balloon 191”) as opposed to integral extension of the inflation tube 195 (Fig. 19, para. 0129: “Within inflation balloon 191 is internal inflation tube 200. Internal inflation tube 200 as shown in FIG. 20 is either an integral extension of an inflation tube 195 as seen in FIG. 19, or is a separate piece of tubing in fluid communication with an inflation tube 195”).
In light of this teaching, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal portion of the inflation tube comprising the plurality of openings of Belfort to be a separate piece of tubing in fluid communication with the inflation tube, thereby forming the inflation baffle, as taught by Hudson, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Newin v. Erlichman, 168 USPQ 177 (BdPatApp&Int 1969).
Regarding claim 3, modified Belfort discloses all of the limitations set forth above in claim 1. Modified Belfort further discloses wherein the expandable balloon is suitable for treating the abdominal cavity (para. 0032 of Belfort: “FIG. 1 is shown a balloon tamponade apparatus 200 for controlling hemorrhage in a pelvic or abdominal body cavity”) and capable of containing internal pressures from about 0 mm hg to an internal pressure resulting in expansion (para. 0036 of Belfort). However, modified Belfort 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 expandable balloon of modified Belfort. Further, a person having ordinary skill in the art, being faced with modifying the balloon of modified Belfort 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 control hemorrhaging in the abdominal cavity (para. 0032 of Belfort). 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 the expandable balloon of modified Belfort 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.
Regarding claim 4, modified Belfort discloses wherein the expandable balloon 100 has an external diameter of between about 5 cm and about 60 cm when an internal pressure of the expandable balloon is at an operating pressure and not externally constrained (para. 0036 of Belfort: “a balloon suitable for a vaginal cavity may be of a size having a diameter of 10 centimeters…when fully inflated, preferably a diameter of 12 centimeters”).
Regarding claim 7, modified Belfort discloses wherein the inflation baffle includes a plurality of fluid openings 34 distributed along a length of the inflation baffle (Fig. 1, para. 0032 of Belfort: “a conduit 30 having an inflation lumen 32 in communication with the interior 50 of the balloon through one or a plurality of openings 34”).
Regarding claim 8, modified Belfort discloses wherein a length of the inflation baffle is greater than 20 % of a diameter of the expandable balloon, when the expandable balloon is inflated to an operating diameter (see Fig. 22 of Hudson which illustrates the inflation baffle 200 having a length greater than 20% of the diameter of the expandable balloon).
Regarding claim 37, modified Belfort discloses wherein the inflation baffle is located entirely within the interior, pressurized portion, of the inflatable ballon (wherein only 200 within 191 is interpreted as the baffle; see Fig. 22 of Hudson, para. 0129: “Within inflation balloon 191 is internal inflation tube 200”).
Regarding claim 38, modified Belfort discloses wherein the inflatable balloon has a spherical shape (Fig. 1, para. 0034 of Belfort: “Shapes particularly suited to the pelvic and abdominal cavities include spherical”).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Belfort et al. (US 20080215031) [hereinafter Belfort] in view of Hudson et al. (US 20020058960) [hereinafter Hudson] as applied to claim 1 above, and further in view of Marx (US 20120116303).
Regarding claim 5, modified Belfort discloses all of the limitations set forth above in claim 1. Modified Belfort further discloses that the expandable balloon has a cross-sectional diameter being measured when the expandable balloon is inflated to an operating pressure, wherein the cross-sectional diameter may expand up to 12 centimeters in diameter (para. 0036 of Belfort).
However, modified Belfort fails to disclose wherein the trocar has a first cross-sectional diameter such that the cross-sectional diameter of the expandable balloon is a second cross-sectional diameter, 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 used to penetrate the abdominal wall of a patient to have a first cross-sectional diameter between 4 mm to 8 mm (Fig. 1, abstract, para. 0020).
Thus, one skilled in the art would have readily recognized that providing modified Belfort with a trocar having cross-sectional diameter between 4 mm to 8 mm, as taught by Marx, would provide the trocar with a diameter range to accommodate both children and adults, thereby preventing injury during insertion into the abdominal cavity (para. 0020 of Marx).
The combination of modified Belfort in view of Marx would result in a product wherein the second cross-sectional diameter of the expandable balloon (10-12 cm or 100 - 120 mm) as discussed in modified Belfort is capable of being greater than 5 times larger than the first cross-sectional diameter of the trocar (4-8 mm) taught by Marx.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Belfort et al. (US 20080215031) [hereinafter Belfort] in view of Hudson et al. (US 20020058960) [hereinafter Hudson] as applied to claim 1 above, and further in view of Flom et al. (US 5817062) [hereinafter Flom].
Regarding claim 11, modified Belfort discloses all of the limitations set forth above in claim 1. However, modified Belfort 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: “The trocar 2 includes a body 4…The body 4 includes a number of arms 12 which are movable from the closed position of FIG. 2 to the open position of FIG. 3”).
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 modified Belfort o include the deformable tip of Floom in order to anchor the trocar to a patient (col. 4 lines 47-53 of Flom: “When the trocar 2 is used in the thoracic cavity, the arms 12 engage the thoracic wall and the resilient member 8 engages the patient's chest. The resilient member 8 is compressed thereby providing a clamping action on the body cavity wall between the resilient member 8 and the arms 12 to anchor the trocar 2. The clamping action secures the trocar 2 to the body wall and minimizes the length of the trocar 2 extending beyond the body wall and into the patient”).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Belfort et al. (US 20080215031) [hereinafter Belfort] in view of Hudson et al. (US 20020058960) [hereinafter Hudson] as applied to claim 1 above, and further in view of Robich (US 20190231388).
Regarding claim 12, modified Belfort discloses all of the limitations set forth above in claim 1. However, modified Belfort 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 modified Belfort to include the curved tip of Robich in order to provide a safer way of positioning the distal end of the trocar within a patient as opposed to a traditional trocar that is straight (non-angled) (para. 0052 of Robich).
Claim(s) 14 are rejected under 35 U.S.C. 103 as being unpatentable over Belfort et al. (US 20080215031) [hereinafter Belfort] in view of Hudson et al. (US 20020058960) [hereinafter Hudson] as applied to claim 1 above, and further in view of Ward (US 20020016608).
Regarding claim 14, modified Belfort discloses all of the limitation set forth above in claim 1. Modified Belfort further discloses wherein the expandable balloon is suitable for treating the abdominal cavity (para. 0032 of Belfort: “FIG. 1 is shown a balloon tamponade apparatus 200 for controlling hemorrhage in a pelvic or abdominal body cavity”). However, modified Belfort 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 modified Belfort to include the rigid external support member of Ward 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. 0073 of Ward).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Belfort et al. (US 20080215031) [hereinafter Belfort] in view of Hudson et al. (US 20020058960) [hereinafter Hudson] as applied to claim 1 above, and further in view of Kassab (US 20190343449).
Regarding claim 16, modified Belfort discloses all of the limitations set forth above in claim 1. Modified Belfort further discloses that when the balloon is inflated, “the shape, contour, size and volume are such that when inflated the balloon will generally conform to the body cavity where hemorrhage is to be controlled (i.e., the interior wall or surface or structure of the pelvis or abdominal cavity)” (para. 0034 of Belfort). Therefore, monitoring and controlling the expansion of the balloon is important during use.
However, modified Belfort 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).
Thus, 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 of modified Belfort 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).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Belfort et al. (US 20080215031) [hereinafter Belfort] in view of Hudson et al. (US 20020058960) [hereinafter Hudson] as applied to claim 7 above, and further in view of Isham (US 20160184559).
Regarding claim 22, modified Belfort discloses all of the limitations set forth above in claim 7. However, modified Belfort fails to disclose wherein at least two openings in the plurality of fluid openings are not axially aligned with one another.
Isham in the same field of endeavor of balloon catheters teaches that it is known in the art to arrange a plurality of fluid openings 48 (para. 0067: “A plurality of holes 48 may be formed in the shaft 12 through which the balloon 14 is filled with air or other fluid”) such that at least two openings in the plurality of fluid openings 48 are not axially aligned with one another (see annotated Fig. 5 of Isham below).
Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the arrangement of the plurality of openings of modified Belfort such that at least two openings in the plurality of fluid openings 34 of modified Belfort are not axially aligned with one another, as taught by Isham, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
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Annotated Fig. 5 of Isham
Conclusion
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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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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