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 23 July 2026, the status of the claims is as follows:
Claims 1, 8-10, 12, 13, 32, and 33 are currently amended;
Claims 2, 5-7, 11, 14, and 15 are as originally filed;
Claims 3, 4, and 16 are previously presented;
Claims 34-37 are new; and
Claims 17-31 are cancelled.
3. The objections to claims 8-10, 12, 13, 32, and 33 because of minor informalities are withdrawn in view of the Amendment, filed 23 July 2026.
Response to Arguments
4. Applicant’s arguments, see Remarks, pp. 8-11, filed 23 July 2026, with respect to the rejection of claims 1-16, 32, and 33 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”), have been fully considered, and are persuasive in view of the Amendment, filed 23 July 2026. Therefore, the rejection has been withdrawn.
Claim Interpretation
5. 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.
6. 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).
7. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In claim 1, the limitation “whereby a pressure differential between the first pressure sensor and second pressure sensor is measurable and mappable to varying flow restrictions across a plurality of flow restriction sizes based on continuous measurement upstream and downstream of the variable flow restrictor while the variable flow restrictor is varied among the plurality of flow restriction sizes within the coronary sinus” is a recitation of the intended use of the claimed first pressure sensor, second pressure sensor, and variable flow restrictor.
Claim Rejections - 35 USC § 112
8. 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 applicant regards as his invention.
9. Claims 1-16 and 37 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.
Claim 1 recites the limitation “whereby a pressure differential between the first pressure sensor and second pressure sensor is measurable and mappable to varying flow restrictions across a plurality of flow restriction sizes based on continuous measurement upstream and downstream of the variable flow restrictor while the variable flow restrictor is varied among the plurality of flow restriction sizes within the coronary sinus”. It is not clear which structural element of the claimed system performs this function. It is not clear how either of the structural elements of the catheter, the variable flow restrictor, the first pressure sensor, and the second pressure sensor would logically perform the functional limitation recited above.
Based on the Specification, as originally filed on 01 September 2023, “Control unit 906 may be programmed by persons of ordinary skill in the art based on the teachings of the present disclosure to automatedly control and monitor balloon inflation, determine restriction size and measured ΔP, and to correlate restriction size, ΔP and, where desired, electrocardiogram features such as ST segment elevation (E) to produce pressure maps as described hereinabove.” (see para. [0025]). Also, claim 32 states “a control unit in communication with the catheter 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”. This supports that a “control unit” performs the function of measuring and mapping to varying flow restrictions across a plurality of flow restriction sizes based on continuous measurement upstream and downstream of the variable flow restrictor while the variable flow restrictor is varied, by the control unit, among the plurality of flow restriction sizes within the coronary sinus. However, claim 1 omits the “control unit” in the claim.
Claims 2-16 and 37 are rejected due to their dependencies, either directly or indirectly, to base claim 1.
Claim Rejections - 35 USC § 102
10. 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.
11. 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)(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.
12. Claims 1-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kapur et al., U.S. Patent Application Publication No. 2021/0077792 A1 (“Kapur”).
As to Claim 1, Kapur teaches the following:
A vascular pressure differential diagnostic system (see “The system may include sensors to determine the degree of occlusion of the superior vena cava.” in Abstract), comprising:
a catheter (“catheter”) 31 having proximal and distal ends, the distal end configured for positioning within a patient's coronary sinus (the limitation “for positioning within a patient’s coronary sinus” is a matter of intended use, which Kapur’s “catheter 31” is capable of performing by positioning the “catheter 31” into the coronary sinus, as suggested by Kapur, see “The systems and methods of the present invention may be used alone, as described in the examples above, or in combination with other devices configured to assist cardiac function. For example, SVC occlusion in accordance with the principles of the present invention may be used in combination with a pump such as an intra-aortic balloon pump (“IABP”) or a percutaneous or surgical left ventricular assist device (“LVAD”), right ventricular assist device (“RVAD”) or any other cardiovascular (i.e., heart, venous, arterial) pump, whether used for full cardiac support or for temporary assistance, thereby allowing for synchronous or asynchronous (venous and arterial) unloading of cardiac preload and afterload, respectively. ” in para. [0209]) at a pressure monitoring site (“superior vena cava (“SVC”)”) (see “Catheter 31 may be introduced into the vasculature of the patient via introducer sheath 144.” in para. [0199]);
a variable flow restrictor (“flow limiting element”) 32 disposed adjacent the distal end of the catheter 31 (see “Referring now to FIG. 43C, the SVC occlusion system may alternatively include sensors 237 and 238, which may be used to determine whether the flow limiting element is occluding the SVC.” in para. [0199]) and configured for placement in the coronary sinus (the limitation “for placement in the coronary sinus” is a matter of intended use, which Kapur’s “flow limiting element 32” is capable of performing by positioning the “flow limiting element 32” in the coronary sinus, as suggested by Kapur, see para. [0209]);
a first pressure sensor (“sensor”) 238 disposed on the catheter 31 and distally with respect to the variable flow restrictor 32 (see “… sensor 238 may be disposed on catheter 31 distal to flow limiting element 32.” in para. [0197], and see fig. 43C); and
a second pressure sensor (“sensor”) 237 disposed on the catheter 31 and proximally with respect to the variable flow restrictor 32 (see “… sensor 237 may be disposed on catheter 31 proximal to flow limiting element 32 and …” in para. [0199], and see fig. 43C), whereby a pressure differential between the first pressure sensor 238 and second pressure sensor 237 is measurable and mappable (see “For example, sensors 237 and 238 may continuously measure the pressure proximal to and distal to the flow limiting element, respectively, and generate a first and second signal indicative of the pressure. The difference between the pressure signals proximal to and distal to the flow limiting element may indicate the degree of occlusion of the SVC.” in para. [0199]) to varying flow restrictions across a plurality of flow restriction sizes based on continuous measurement upstream and downstream of the variable flow restrictor while the variable flow restrictor is varied among the plurality of flow restriction sizes within the coronary sinus (the limitation “to varying flow restrictions across a plurality of flow restriction sizes based on continuous measurement upstream and downstream of the variable flow restrictor while the variable flow restrictor is varied among the plurality of flow restriction sizes within the coronary sinus” is a recitation of the intended use of Kapur’s “sensor 238”, “sensor 237”, and “flow limiting element 32”, which they are capable of performing by merely providing pressure signals when placed within the coronary sinus).
As to Claim 2, Kapur teaches the following:
a sheath (“introducer sheath”) 144 configured to surround and guide the catheter 31 to the monitoring site (see “Referring again to FIG. 44, yet another alternative embodiment is described that includes introducer sheath 144. The embodiment illustrated in FIG. 44 is similar to that of FIG. 43A except that flow limiting element 32 and sensor 145 and 146 are also incorporated into introducer sheath 144.” in para. [0203]);
a third pressure sensor (“sensor”) 146 disposed at a distal end of the sheath 144 (see “Sensor 146 is positioned near a distal end of introducer sheath 144, which is distal to flow limiting element 32 and positioned within the SVC to measure SVC or right atrium pressure.” in para. [0203]).
As to Claim 3, Kapur teaches the following:
a guidewire (“actuation wire”) 54 configured to be received in a guidewire lumen (“ring”) 55 defined by the catheter 31 with an open distal end (see “Ring 55 is disposed to slide on actuation wire 54 so that when actuation wire 54 …” in para. [0135]).
As to Claim 4, Kapur teaches the following:
wherein:
the catheter 31 comprises a catheter body (“flexible tube”, not labeled) (see “Preferably, catheter 31 comprises a flexible tube having distal portion 34 configured for placement in the SVC.” in para. [0123]) defining at least one inflation lumen (“inflation lumen”) 60 (see “Referring now to FIG. 7, catheter 31 preferably includes at least three lumens 60, 61, 62. Lumen 60 may be used as an inflation lumen …” in para. [0137]); and
the variable flow restrictor 32 comprises at least one inflatable balloon (“balloon”, not labeled) disposed adjacent the distal end of the catheter body (see “Flow limiting element 32 may be a balloon that preferably comprises a compliant or semi-compliant material, e.g., nylon, which permits the degree of expansion of the balloon to be adjusted to effectuate the desired degree of partial or complete occlusion of the SVC.” in para. [0124]) and communicating with the at least one inflation lumen 60 (see “Referring now to FIG. 7, catheter 31 preferably includes at least three lumens 60, 61, 62. Lumen 60 may be used as an inflation lumen …” in para. [0137]).
As to Claim 5, Kapur teaches the following:
means (“drive mechanism”) 36 for adjusting the size of a flow restriction created by the variable flow restrictor 32 (see “Flow limiting element 32 preferably is sized and shaped so that it partially or fully occludes flow in the SVC in the expanded state. Catheter 31 is coupled at proximal end 35 to controller 33, which houses drive mechanism 36 (e.g., motor, pump) for actuating flow limiting element 32, processor 37 programmed to control signals to drive mechanism 36, and …” in para. [0123]).
As to Claim 6, Kapur teaches the following:
wherein:
the variable flow restrictor further comprises at least a first smaller balloon (“azygos vein occlusion balloon”) 142 disposed inside at least a second larger balloon (“SVC occlusion balloon”) 143 (see “Catheter 31 preferably includes two occlusion balloons, azygos vein occlusion balloon 142 and SVC occlusion balloon 143.” in para. [0205]); and
the catheter body defines separate inflation lumens for each said balloon (see “Referring now to FIG. 7, catheter 31 preferably includes at least three lumens 60, 61, 62. …” in para. [0137]).
As to Claim 7, Kapur teaches the following:
wherein the first 142 and second 143 balloons are disposed eccentrically around the catheter body (see “Catheter 31 preferably includes two occlusion balloons, azygos vein occlusion balloon 142 and SVC occlusion balloon 143.” in para. [0205], and see fig. 45).
As to Claim 8, Kapur teaches the following:
wherein:
the first inner smaller balloon 142 comprises a non-resilient fixed diameter balloon (see para. [0205]); and
the second outer larger balloon 143 comprises a resilient variable diameter balloon (see para. [0205]).
As to Claim 9, Kapur teaches the following:
a side port formed in the catheter and communicating with the guidewire lumen proximally with respect to said at least one inflatable balloon, whereby a variable flow passage through the guidewire lumen is controllable by selectively positioning a stylet or the guidewire over the side port (see para. [0124] and [0137]).
As to Claim 10, Kapur teaches the following:
wherein the at least one inflatable balloon comprises an annular balloon with an internal hourglass shape defining a variable flow orifice and an outer periphery configured to contact the vessel wall when inflated (see para. [0177]-[0178]).
As to Claim 11, Kapur teaches the following:
wherein:
the annular balloon has an outer wall formed of a non-resilient material and sized to engage the vascular wall when inflated (see para. [0177]); and
the annular balloon has an inner wall formed of a resilient material configured to vary the orifice diameter in response to varying inflation pressure (see para. [0178]).
As to Claim 12, Kapur teaches the following:
a cinch (“ring”) 55 disposed inside the annular balloon surrounding the variable flow orifice (see para. [0135], and fig. 6);
a control wire (“actuation wire”) 54 extending through the at least one inflation lumen 60 to the catheter 13 proximal end, the control wire 54 operatively connected to the cinch 55 whereby the cinch 55 may be opened or closed to reduce or increase the variable flow orifice (see para. [0135], and fig. 6).
As to Claim 13, Kapur teaches the following:
wherein:
the at least one inflatable balloon is configured to fully occlude the vascular lumen when inflated (see para. [0139]); and
the catheter body defines a variable flow passage through the at least one inflatable balloon having an entry port at the catheter distal end and an exit port at a proximal end of the at least one inflatable balloon (see para. [0140]).
As to Claim 14, Kapur teaches the following:
wherein the variable flow passages comprise a stylet (“actuation wire”) 54 moveable within the variable flow passage to variably obstruct the exit port (see para. [0135]).
As to Claim 15, Kapur teaches the following:
wherein:
the catheter body defines a stylet lumen communicating with the variable flow passage and extending to a proximal end of the catheter body (see para. [0135]); and
the stylet 54 extends through the stylet lumen into the variable flow passage and is manipulable at the proximal end of the catheter body (see para. [0135]).
Allowable Subject Matter
14. Claims 16 and 37 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, and if rewritten to overcome the rejection(s) under 35 U.S.C. 112, set forth in this Office Action.
15. Claims 32-36 are allowed.
16. The following is an examiner’s statement of reasons for allowance:
As to Claims 1 and 32, Kapur teaches the following:
A vascular pressure differential diagnostic system (see “The system may include sensors to determine the degree of occlusion of the superior vena cava.” in Abstract), comprising:
a catheter (“catheter”) 31 having proximal and distal ends, the distal end configured for positioning within a patient's coronary sinus (the limitation “for positioning within a patient’s coronary sinus” is a matter of intended use, which Kapur’s “catheter 31” is capable of performing by positioning the “catheter 31” into the coronary sinus, as suggested by Kapur, see “The systems and methods of the present invention may be used alone, as described in the examples above, or in combination with other devices configured to assist cardiac function. For example, SVC occlusion in accordance with the principles of the present invention may be used in combination with a pump such as an intra-aortic balloon pump (“IABP”) or a percutaneous or surgical left ventricular assist device (“LVAD”), right ventricular assist device (“RVAD”) or any other cardiovascular (i.e., heart, venous, arterial) pump, whether used for full cardiac support or for temporary assistance, thereby allowing for synchronous or asynchronous (venous and arterial) unloading of cardiac preload and afterload, respectively. ” in para. [0209]) at a pressure monitoring site (“superior vena cava (“SVC”)”) (see “Catheter 31 may be introduced into the vasculature of the patient via introducer sheath 144.” in para. [0199]);
a variable flow restrictor (“flow limiting element”) 32 disposed adjacent the distal end of the catheter 31 (see “Referring now to FIG. 43C, the SVC occlusion system may alternatively include sensors 237 and 238, which may be used to determine whether the flow limiting element is occluding the SVC.” in para. [0199]) and configured for placement in the coronary sinus (the limitation “for placement in the coronary sinus” is a matter of intended use, which Kapur’s “flow limiting element 32” is capable of performing by positioning the “flow limiting element 32” in the coronary sinus, as suggested by Kapur, see para. [0209]);
a first pressure sensor (“sensor”) 238 disposed on the catheter 31 and distally with respect to the variable flow restrictor 32 (see “… sensor 238 may be disposed on catheter 31 distal to flow limiting element 32.” in para. [0197], and see fig. 43C); and
a second pressure sensor (“sensor”) 237 disposed on the catheter 31 and proximally with respect to the variable flow restrictor 32 (see “… sensor 237 may be disposed on catheter 31 proximal to flow limiting element 32 and …” in para. [0199], and see fig. 43C), whereby a pressure differential between the first pressure sensor 238 and second pressure sensor 237 is measurable and mappable (see “For example, sensors 237 and 238 may continuously measure the pressure proximal to and distal to the flow limiting element, respectively, and generate a first and second signal indicative of the pressure. The difference between the pressure signals proximal to and distal to the flow limiting element may indicate the degree of occlusion of the SVC.” in para. [0199]) …
As to Claim 16, neither Kapur, Williams, nor the prior art of record teaches the vascular pressure differential diagnostic system of base claim 1, including the following, in combination with all other limitations of the base claim:
a control unit 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.
As to Claims 32-36, neither Williams nor the prior art of record teaches the vascular pressure differential diagnostic system of base claim 32, including the following, in combination with all other limitations of the base claim:
a control unit in communication with the catheter 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.
As to Claim 37, neither Kapur, Williams, nor the prior art of record teaches the vascular pressure differential diagnostic system of base claim 1, including the following, in combination with all other limitations of the base claim:
a control unit operatively coupled to the catheter and configured to receive information indicating measured pressures from the first and second pressure sensors and information indicating respective sizes of flow restriction produced by the variable flow restrictor, and to generate a pressure differential map correlating pressure differential to flow restriction size across the plurality of flow restriction sizes based on continuous measurement upstream and downstream of the variable flow restrictor while the variable flow restrictor is varied within the coronary sinus.
Conclusion
17. 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.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 10/06/2026
