DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. According to the Amendment, filed 20 January 2026, the status of the claims is as follows:
Claims 1, 2, 5-7, and 10-15 are as originally filed;
Claims 3, 4, 8, 9, and 16 are previously presented;
Claims 32 and 33 are new; and
Claims 17-31 are cancelled.
Election/Restrictions
3. Applicant’s election without traverse of Group I, claims 1-16, 32, and 33, in the reply filed on 20 January 2026 is acknowledged.
Claims 17-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
4. Claim 8 is objected to because of the following informalities:
In lines 3-4, “the first inner balloon” and “the second outer balloon” lacks proper antecedent basis, and should be amended to “the firstsmaller balloon” and “the secondlarger balloon”, respectively.
Appropriate correction is required.
5. Claim 9 is objected to because of the following informalities:
In line 3, “said at least one balloon” lacks proper antecedent basis, and should be amended to “said at least one inflatable balloon”.
Appropriate correction is required.
6. Claim 10 is objected to because of the following informalities:
In line 3, “the balloon” lacks proper antecedent basis, and should be amended to “the at least one inflatable balloon”.
Appropriate correction is required.
7. Claim 12 is objected to because of the following informalities:
In line 4, “the balloon inflation lumen” lacks proper antecedent basis, and should be amended to “theat least one inflation lumen”.
Appropriate correction is required.
8. Claim 13 is objected to because of the following informalities:
In lines 3-5, “the balloon” lacks proper antecedent basis, and should be amended to “the at least one inflatable balloon”.
Appropriate correction is required.
9. Claim 32 is objected to because of the following informalities:
In lines 13-14, “restrictions. and a control unit” is a typographical error, and should be amended to “restrictions[[.]]; and a control unit” (“a control” should be indented on a new line, and “and” deleted in line 10).
Appropriate correction is required.
10. Claim 33 is objected to because of the following informalities:
In line 4, “positioning. wherein” is a typographical error, and should be amended to “positioning[[.]], wherein”.
Appropriate correction is required.
Claim Interpretation
11. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
12. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 5 uses “means for” for the limitation “adjusting the size of a flow restriction created by the variable flow restrictor”, and is thus, interpreted under 35 U.S.C. 112(f). The means for limitation is described in the specification as, for example, “control unit 906” (see para. [0025] of the original disclosure, filed 01 September 2023).
Claim Rejections - 35 USC § 102
13. 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.
14. 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.
15. Claims 1-16, 32, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams et al., U.S. Patent Application Publication No. 2019/0175186 A1 (“Williams”).
As to Claim 1, Williams teaches the following:
A vascular pressure differential diagnostic system (“endovascular occlusion device”) 100 (see “Referring now to the figures, and in particular to FIGS. 1 and 2, a method of using an endovascular occlusion device 100 according to a first embodiment of shown.” in para. [0053]), comprising:
a catheter (“catheter”) 116 having proximal and distal ends (see “The endovascular occlusion device 100, as shown in FIG. 2, includes a catheter 116 having a distal balloon portion 118 and a proximally positioned handle 120.” in para. [0056], and fig. 2), the distal end 118 configured for positioning within a patient's vasculature at a pressure monitoring site (see “In use, and with reference now to FIGS. 7A-7D, the balloon portion 118 of the occlusion device 100 is advanced in the direction of arrow 152 such that it is suitably positioned within the artery for which occlusion is desired (again, here illustrated as the abdominal aorta 114).” in para. [0061]);
a variable flow restrictor (“distal balloon portion”) 118 disposed adjacent the distal end of the catheter 116 (see “In use, and with reference now to FIGS. 7A-7D, the balloon portion 118 of the occlusion device 100 is advanced in the direction of arrow 152 such that it is suitably positioned within the artery for which occlusion is desired (again, here illustrated as the abdominal aorta 114). Blood flow, as illustrated by dashed arrows, opposes the advancing direction arrow 152. Once in place (FIG. 7B), the first balloon 128 of the balloon portion 118 may be inflated with a fluid, which may be saline with or without a contrast agent to facilitate localization via conventional medical imaging procedures. Blood flow, while somewhat diminished, continues by way of the lumen 136 of the first balloon 128 and around the outer surface 150 of the second balloon 130. Inflation of the first balloon 128, while limiting blood flow, provides the additional benefit of securing the balloon portion 118 within a lumen 154 of the abdominal aorta 114.” in para. [0061]; and see “As described herein, embodiments of the present invention provide endovascular occlusion while maintaining the ability to allow for controlled distal (anterograde) blood flow to varying degrees.” in para. [0127]);
a first pressure sensor (distal “pressure gauge”, not labeled) disposed distally with respect to the variable flow restrictor 118 (see “Backpressure was evaluated using a pig model comprising a 12.7 mm ID×1.5 mm wall silicone tubing (aorta), a flow regulator downstream of the “aorta,” and two pressure gauges on opposing ends of the aorta.” in para. [0124]); and
a second pressure sensor (proximal “pressure gauge”, not labeled) disposed proximally with respect to the variable flow restrictor 118 (see “Backpressure was evaluated using a pig model comprising a 12.7 mm ID×1.5 mm wall silicone tubing (aorta), a flow regulator downstream of the “aorta,” and two pressure gauges on opposing ends of the aorta.” in para. [0124]),
whereby a pressure differential between the first pressure sensor and second pressure sensor is measurable and mappable to varying flow restrictions (see “Table 1 summarizes measured flow measurements and backpressures: …” in para. [0124], Table 1; and see “Data of Table 1 are graphically illustrated in FIGS. 40 and 41.” in para. [0125], and figs. 40 and 41).
As to Claim 2, Williams teaches the following:
a sheath (“delivery sheath”, not labeled) configured to surround and guide the catheter 116 to the monitoring site (see “For example, a delivery sheath may be use to enclose the endovascular occlusion device so as to facilitate delivery of the device to the occluding site.” in para. [0119]);
a third pressure sensor (“One or more pressure sensors”, not labeled) disposed at a distal end of the sheath (see “One or more pressure sensors may be used with endovascular occlusion devices according to any embodiment of the present invention described herein.” in para. [0120]).
As to Claim 3, Williams teaches the following:
a guidewire (“guidewire”) 110 configured to be received in a guidewire lumen (see lumen of “catheter 116”, not labeled, in fig. 2) defined by the catheter 116 with an open distal end (see “The surgeon may then direct a guidewire 110 (for example, a 0.025 in guidewire) into the primary incision site 102, within the right femoral artery 108, superiorly through the common iliac artery 112, and up the abdominal aorta 114 to a desired location and site for occlusion (hereafter, the “occlusion site”). With the guidewire 110 suitably positioned, the endovascular occlusion device 100 may be back-loaded over the guidewire 110 and advanced to the location of occlusion.” in para. [0055]).
As to Claim 4, Williams teaches the following:
wherein:
the catheter 116 comprises a catheter body (see body of “catheter 116”, not labeled) defining at least one inflation lumen (“lumen”) 134 (see “As shown with greater detail in FIGS. 3-6A, the balloon portion 118 of the endovascular occlusion device 100 includes first, second, and third coextensive (and in some embodiments, collinear, coaxial, or both) balloons 128, 130, 132 arranged such that the third catheter balloon 132 resides within a lumen 134 of the second catheter balloon 130, which in turn resides within a lumen 136 of the first catheter balloon 128. Each of the balloons 128, 130, 132 includes a shaft 138, 140, 142 extending proximally therefrom and that is in fluid communication with the inflation line 124 (FIG. 2). The third balloon also includes a lumen 144 that is configured to receive and move in sliding relation to the guidewire 110 (FIG. 1).” in para. [0057]); and
the variable flow restrictor 118 comprises at least one inflatable balloon (“first, second, and third coextensive (and in some embodiments, collinear, coaxial, or both) balloons ”) 128, 130, 132 disposed adjacent the distal end of the catheter body and communicating with the at least one inflation lumen (see “As shown with greater detail in FIGS. 3-6A, the balloon portion 118 of the endovascular occlusion device 100 includes first, second, and third coextensive (and in some embodiments, collinear, coaxial, or both) balloons 128, 130, 132 arranged such that the third catheter balloon 132 resides within a lumen 134 of the second catheter balloon 130, which in turn resides within a lumen 136 of the first catheter balloon 128. Each of the balloons 128, 130, 132 includes a shaft 138, 140, 142 extending proximally therefrom and that is in fluid communication with the inflation line 124 (FIG. 2). The third balloon also includes a lumen 144 that is configured to receive and move in sliding relation to the guidewire 110 (FIG. 1).” in para. [0057]).
As to Claim 5, Williams teaches the following:
means for adjusting the size of a flow restriction created by the variable flow restrictor (see “Provided the three balloons 128, 130, 132 of the balloon portion 118 of the occlusion device 100, flow rate of blood along the vessel to be occluded may be controlled with particularity. For example, flow may range from full occlusion, 150 mL/min, 300 mL/min, 500 mL/min, to full flow depending on a degree of inflation of the second and third balloons 130, 132. Such finer control and management of blood flow overcomes several of the deficiencies of conventional devices that fail to offer such functionality.” in para. [0065]).
As to Claim 6, Williams teaches the following:
wherein:
the variable flow restrictor 118 further comprises at least a first smaller balloon (“catheter balloon”) 132 disposed inside at least a second larger balloon (“catheter balloon”) 128 (see “As shown with greater detail in FIGS. 3-6A, the balloon portion 118 of the endovascular occlusion device 100 includes first, second, and third coextensive (and in some embodiments, collinear, coaxial, or both) balloons 128, 130, 132 arranged such that the third catheter balloon 132 resides within a lumen 134 of the second catheter balloon 130, which in turn resides within a lumen 136 of the first catheter balloon 128. Each of the balloons 128, 130, 132 includes a shaft 138, 140, 142 extending proximally therefrom and that is in fluid communication with the inflation line 124 (FIG. 2). The third balloon also includes a lumen 144 that is configured to receive and move in sliding relation to the guidewire 110 (FIG. 1).” in para. [0057]); and
the catheter body defines separate inflation lumens (“lumens”) 134, 136, 144 for each said balloon 128, 130, 132 (see para. [0057], and fig. 3A).
As to Claim 7, Williams teaches the following:
wherein the first 132 and second 128 balloons are disposed eccentrically around the catheter body (see para. [0057], and fig. 3A).
As to Claim 8, Williams teaches the following:
wherein:
the first inner balloon 132 comprises a non-resilient fixed diameter balloon (see “The third balloon 132 may be constructed of a compliant material, such as those provided above with respect to the first balloon 128, such that when the third balloon 132 is fully inflated an outer surface 152 of the third balloon 132 contacts the lumen 134 of the second balloon 130.” in para. [0060]); and
the second outer balloon 128 comprises a resilient variable diameter balloon (see “The first balloon 128 may be constructed of a compliant or noncompliant material, such as Nylon-11, Nylon-12, polyurethane, polybutylene terephthalate (“PBT”), PEBAX (a brand of thermoplastic elastomer), or polyethylene terephthalate (“PET”), such that when the first balloon 128 is fully inflated an outer surface 146 of the first balloon 128 contacts an inner wall 148 of the artery to be occluded (illustrated in FIG. abdominal aorta 114 in FIG. 1). The first balloon 128 is further configured to expand to outer diameters ranging from 15 mm to 24 mm to accommodate various sizes of vasculature of humans (or sized according to the animal upon which surgery is performed).” in para. [0058]).
As to Claim 9, Williams teaches the following:
a side port (“ports 314” and “at least one port 320”) 314/320 formed in the catheter and communicating with the guidewire lumen proximally with respect to said at least one balloon 128, 130, 132, whereby a variable flow passage through the guidewire lumen is controllable by selectively positioning a stylet or the guidewire 110 over the side port 314/320 (see “The flow port catheter 304, proximal to the balloon 306, includes a plurality of ports 314 extending from a surface 316 to a lumen 318 of the catheter 304 to provide fluid communication therebetween. In a similar manner, the distal tip 310 of the flow port catheter 304 may include at least one port 320 that also extends from the surface 312 to the lumen 318 of the catheter 304.” in para. [0096]).
As to Claim 10, Williams teaches the following:
wherein the balloon 128, 130, 132 comprises an annular balloon (“occluding balloon”) 224 with an internal hourglass shape (see figs. 19A-C) defining a variable flow orifice (“channel”) 232 and an outer periphery configured to contact the vessel wall when inflated (see “With the guidewire 110 in place, the occluding portion 220 of the occlusion device 222, while deflated, may be advanced over the guidewire 110 (in a direction of the arrow 242) to the occlusion site (FIG. 19A). When suitable or appropriately positioned at the occlusion site, the occluding balloon 224 may be inflated such that an outer surface 230 of the occluding balloon 224 contacts the inner wall 148 of the abdominal aorta 114, thereby securing the occluding portion 220 within the lumen 154 of the abdominal aorta 114. As explicitly illustrated in FIG. 19B, blood flow through the abdominal aorta 114 is stopped with the fully inflated occluding balloon 224 contacting the inner wall 148 (see dashed arrows).” in para. [0081]).
As to Claim 11, Williams teaches the following:
wherein:
the annular balloon 224 has an outer wall (“outer surface”) 230 formed of a non-resilient material and sized to engage the vascular wall when inflated (see para. [0081], and see figs. 19A-C); and
the annular balloon 224 has an inner wall (“side”) 234 formed of a resilient material configured to vary the orifice diameter in response to varying inflation pressure (see para. [0081], and see figs. 19A-C).
As to Claim 12, Williams teaches the following:
a cinch (“non-compliant balloon”) 238 disposed inside the annular balloon 224 surrounding the variable flow orifice 232;
a control wire (not labeled, see wire extending from the “non-compliant balloon 238” in figs. 15 and 16) extending through the balloon inflation lumen (“lumen”) 144 to the catheter 116 proximal end (“occluding portion”) 220,
the control wire operatively connected to the cinch 238 whereby the cinch 238 may be opened or closed to reduce or increase the variable flow orifice 232 (see “When blood flow is desired or necessary, as illustrated in FIG. 19C, the non-compliant balloon 238 may be inflated such that the outer surface 240 contacts the sides 234, 236 of the channel 232 of the occluding balloon 224, thereby opening the channel 232 to a degree related to a degree of inflation of the non-compliant balloon 238.” in para. [0082]).
As to Claim 13, Williams teaches the following:
wherein:
the balloon 128, 130, 132 is configured to fully occlude the vascular lumen when inflated (see “Provided the three balloons 128, 130, 132 of the balloon portion 118 of the occlusion device 100, flow rate of blood along the vessel to be occluded may be controlled with particularity. For example, flow may range from full occlusion, 150 mL/min, 300 mL/min, 500 mL/min, to full flow depending on a degree of inflation of the second and third balloons 130, 132.” in para. [0065]); and
the catheter body defines a variable flow passage through the balloon 128, 130, 132 having an entry port (“at least one port 320”) 320 at the catheter distal end and an exit port (“ports 314”) at a proximal end of the balloon 128, 130, 132 (see fig. 29).
As to Claim 14, Williams teaches the following:
wherein the variable flow passages comprise a stylet (“flow restrictor”) 324 moveable within the variable flow passage to variably obstruct the exit port 314 (see para. [0099] and [0103], and figs. 2 and 31).
As to Claim 15, Williams teaches the following:
wherein:
the catheter body defines a stylet lumen (“lumen”) 326 communicating with the variable flow passage and extending to a proximal end of the catheter body; and
the stylet (“flow restrictor”) 324 extends through the stylet lumen 326 into the variable flow passage and is manipulable at the proximal end of the catheter body (see para. [0099] and [0103], and figs. 2 and 31).
As to Claim 16, Williams teaches the following:
a hub (“proximally positioned handle”) 120 at the proximal end of the catheter 116 configured to control sheath movement, balloon inflation and guidewire or stylet positioning (see “The endovascular occlusion device 100, as shown in FIG. 2, includes a catheter 116 having a distal balloon portion 118 and a proximally positioned handle 120. As shown, the handle 120 is a manual flow control handle, described in greater detail below.” in para. [0056]); and
a control unit (“external control devices”, not labeled) in communication with the hub configured to receive information indicating measured pressures and size of flow restriction and to generate a pressure differential map across a plurality of flow restriction sizes (see “Additionally or alternatively, the blood pressure information may be processed by an external control devices so as to adjust flow restriction. For example, a rotary or stepper motor operably coupled to such external control devices may be operable to inflate/deflate balloons, reposition flow restrictors, advance/retract delivery sheaths, and so forth. The external control devices may also incorporate an algorithm configured to determine a physiological status of the patient given the blood pressure information with or without additional measurements.” in para. [0120]).
As to Claim 32, Williams teaches the following:
A vascular pressure differential diagnostic system (“endovascular occlusion device”) 100 (see “Referring now to the figures, and in particular to FIGS. 1 and 2, a method of using an endovascular occlusion device 100 according to a first embodiment of shown.” in para. [0053]), comprising:
a catheter (“catheter”) 116 having proximal and distal ends (see “The endovascular occlusion device 100, as shown in FIG. 2, includes a catheter 116 having a distal balloon portion 118 and a proximally positioned handle 120.” in para. [0056], and fig. 2), the distal end 118 configured for positioning within a patient's coronary sinus at a pressure monitoring site (see “In use, and with reference now to FIGS. 7A-7D, the balloon portion 118 of the occlusion device 100 is advanced in the direction of arrow 152 such that it is suitably positioned within the artery for which occlusion is desired (again, here illustrated as the abdominal aorta 114).” in para. [0061]), the catheter comprising a catheter body (see body of “catheter 116”, not labeled) defining at least one inflation lumen (“lumen”) 134 (see “As shown with greater detail in FIGS. 3-6A, the balloon portion 118 of the endovascular occlusion device 100 includes first, second, and third coextensive (and in some embodiments, collinear, coaxial, or both) balloons 128, 130, 132 arranged such that the third catheter balloon 132 resides within a lumen 134 of the second catheter balloon 130, which in turn resides within a lumen 136 of the first catheter balloon 128. Each of the balloons 128, 130, 132 includes a shaft 138, 140, 142 extending proximally therefrom and that is in fluid communication with the inflation line 124 (FIG. 2). The third balloon also includes a lumen 144 that is configured to receive and move in sliding relation to the guidewire 110 (FIG. 1).” in para. [0057]);
a variable flow restrictor (“distal balloon portion”) 118 disposed adjacent the distal end of the catheter 116 (see “In use, and with reference now to FIGS. 7A-7D, the balloon portion 118 of the occlusion device 100 is advanced in the direction of arrow 152 such that it is suitably positioned within the artery for which occlusion is desired (again, here illustrated as the abdominal aorta 114). Blood flow, as illustrated by dashed arrows, opposes the advancing direction arrow 152. Once in place (FIG. 7B), the first balloon 128 of the balloon portion 118 may be inflated with a fluid, which may be saline with or without a contrast agent to facilitate localization via conventional medical imaging procedures. Blood flow, while somewhat diminished, continues by way of the lumen 136 of the first balloon 128 and around the outer surface 150 of the second balloon 130. Inflation of the first balloon 128, while limiting blood flow, provides the additional benefit of securing the balloon portion 118 within a lumen 154 of the abdominal aorta 114.” in para. [0061]; and see “As described herein, embodiments of the present invention provide endovascular occlusion while maintaining the ability to allow for controlled distal (anterograde) blood flow to varying degrees.” in para. [0127]) and configured for placement in the coronary sinus, the variable flow restrictor 118 comprises at least one inflatable balloon (“first, second, and third coextensive (and in some embodiments, collinear, coaxial, or both) balloons ”) 128, 130, 132 disposed adjacent the distal end of the catheter body and communicating with the at least one inflation lumen (“lumens”) 134, 136, 144 (see “As shown with greater detail in FIGS. 3-6A, the balloon portion 118 of the endovascular occlusion device 100 includes first, second, and third coextensive (and in some embodiments, collinear, coaxial, or both) balloons 128, 130, 132 arranged such that the third catheter balloon 132 resides within a lumen 134 of the second catheter balloon 130, which in turn resides within a lumen 136 of the first catheter balloon 128. Each of the balloons 128, 130, 132 includes a shaft 138, 140, 142 extending proximally therefrom and that is in fluid communication with the inflation line 124 (FIG. 2). The third balloon also includes a lumen 144 that is configured to receive and move in sliding relation to the guidewire 110 (FIG. 1).” in para. [0057]);
a first pressure sensor (distal “pressure gauge”, not labeled) disposed on the catheter 116 and distally with respect to the variable flow restrictor 118 (see “Backpressure was evaluated using a pig model comprising a 12.7 mm ID×1.5 mm wall silicone tubing (aorta), a flow regulator downstream of the “aorta,” and two pressure gauges on opposing ends of the aorta.” in para. [0124]); and
a second pressure sensor (proximal “pressure gauge”, not labeled) disposed on the catheter 116 and proximally with respect to the variable flow restrictor 118 (see “Backpressure was evaluated using a pig model comprising a 12.7 mm ID×1.5 mm wall silicone tubing (aorta), a flow regulator downstream of the “aorta,” and two pressure gauges on opposing ends of the aorta.” in para. [0124]), whereby a pressure differential between the first pressure sensor and second pressure sensor is measurable and mappable to varying flow restrictions (see “Table 1 summarizes measured flow measurements and backpressures: …” in para. [0124], Table 1; and see “Data of Table 1 are graphically illustrated in FIGS. 40 and 41.” in para. [0125], and figs. 40 and 41), and
a control unit (“external control devices”, not labeled) in communication with the catheter 116 (see “Additionally or alternatively, the blood pressure information may be processed by an external control devices so as to adjust flow restriction. For example, a rotary or stepper motor operably coupled to such external control devices may be operable to inflate/deflate balloons, reposition flow restrictors, advance/retract delivery sheaths, and so forth. The external control devices may also incorporate an algorithm configured to determine a physiological status of the patient given the blood pressure information with or without additional measurements.” in para. [0120]) is configured to receive information indicating measured pressures and a size of flow restriction and to generate a pressure differential map across a plurality of flow restriction sizes based on continuous measurement upstream and downstream of the variable flow restrictor 118 (see “Table 1 summarizes measured flow measurements and backpressures: …” in para. [0124], Table 1; and see “Data of Table 1 are graphically illustrated in FIGS. 40 and 41.” in para. [0125], and figs. 40 and 41).
As to Claim 33, Williams teaches the following:
a hub (“proximally positioned handle”) 120 at the proximal end of the catheter 116 configured to control sheath movement, balloon inflation and guidewire or stylet positioning, wherein the control unit in communication with the catheter via the hub 120 (see “The endovascular occlusion device 100, as shown in FIG. 2, includes a catheter 116 having a distal balloon portion 118 and a proximally positioned handle 120. As shown, the handle 120 is a manual flow control handle, described in greater detail below.” in para. [0056]).
Conclusion
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 03/11/2026