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
Applicant’s arguments, see pages 1 and 2, filed 09/04/2025, with respect to the rejection(s) of claim(s) 1 and 12 under Franklin in view of Mohl and Lampropoulos have been fully considered and are persuasive. The examiner agrees that the previous interpretation of references fails to disclose or suggest “wherein the hypotube originates from, and is anchored within, the display hub” as required by claims 1 and 12. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of Franklin (WO 2015035393) in view of Mohl (US 20110295177) and Lampropoulos et al. (US 20160250444).
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
Claim 1, lines 10-11 and 23: “the proximal internal lumen” which should recite “the first, proximal internal lumen”.
Claim 1, line 16: “the sensor lumen” which should recite “second, sensor lumen”.
Claim 12, lines 10-11 and 24: “the proximal internal lumen” which should recite “the first, proximal internal lumen”.
Claim 12, line 20: “second sensor” which should recite “a second sensor”.
Claim 12, line 22: “the proximal sensor or the distal sensor” which should recite “the first sensor or the second sensor”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 7 and 17 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 7 (lines 1-2) and claim 17 (lines 1-2) recite the limitation “an inflation port”. It is unclear to the examiner if “an inflation port” is meant to further define the inflation port introduced in claim 1 of if it is a new, additional, inflation port. For examination purposes, “an inflation port” is interpreted as “the inflation port”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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, 5-8, 10 and 12-13, 15-17, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Mohl (US 20110295177) and Lampropoulos et al. (US 20160250444) [hereinafter Lampropoulos].
Note: The paragraphs cited in Franklin (WO 2015035393) are the paragraphs under “Detailed Description of The Invention”.
Regarding claims 1 and 12-13, Franklin discloses a vascular occlusion catheter 100 for at least partial occlusion of a target vessel (Fig. 1, para. 010, 012), the vascular occlusion catheter comprising:
a proximal shaft 110 (Fig. 1, para. 012);
a distal shaft 120 (Fig. 1, para. 012);
an occlusion balloon 140 connected to the proximal shaft at a proximal end 144 and the distal shaft at a distal end 146 (Fig. 1, para. 013);
the proximal shaft having a first, proximal internal lumen 210 (Fig. 3, para. 012) and the first, proximal internal lumen being in fluid communication with the occlusion balloon 140 (Fig. 3, para. 012);
the distal shaft 120 having a distal internal lumen 220 (Fig. 5, para. 012);
a hypotube 130 having an internal hypotube lumen 230 (Figs. 3, 5, para. 012), the hypotube extending through the proximal internal lumen 210, through the occlusion balloon 140 and into communication with the distal internal lumen 220 (Figs. 1, 3, 5, para. 012);
a distal side port 170 formed through a sidewall of the distal shaft 120 and in fluid communication with the internal hypotube lumen 230 (Fig. 5, para. 015); and
a distal sensor positioned within the distal internal lumen 220 and facing an opening formed in the distal shaft 120 (Fig. 5, para. 015); and
Franklin further discloses a proximal hub 190 mounted to the proximal shaft 110 (Fig. 6, para. 012), wherein the hypotube 130 extends into the proximal hub 190 (Fig. 6, para. 012, 025). The proximal hub 190 may be configured to have more than two fluid pathways, with each fluid pathway communicating with a different lumen in the occlusion catheter system (Fig. 5, para. 025) and may be connected to an external pressure sensor via fluid pathway 192, which would transduce pressure from a fluid column within the first lumen and through the second port (interpreted as the opening 170 formed in the distal shaft 120) (Fig. 6, para. 025).
However, Franklin fails to disclose a second, sensor lumen, a proximal sensor positioned within the sensor lumen and facing an opening formed in the proximal shaft, and a display hub having a display screen, the display hub being electrically connected with the distal sensor and the proximal sensor, the display hub being configured to display a reading from at least one the proximal sensor or the distal sensor on the display screen.
Mohl in the same field of endeavor teaches an occlusion catheter 120” comprising shaft comprising a proximal portion having a first, proximal internal lumen 133 and a second, sensor lumen 136” (Figs. 5, 15-16, para. 0048, 0079, 0082), the first, proximal internal lumen 133 being in fluid communication with an occlusion balloon 122” (Figs. 5, 15-16, para. 0048), a distal portion comprising a distal sensor (para. 0038) positioned within a distal internal lumen 135” and facing an opening (interpreted as one of the plurality of distal ports described in para. 0079) formed in the distal portion of the shaft (Figs. 15-16, para. 0079) and a proximal sensor (para. 0039) positioned within the sensor lumen 136” and facing an opening (interpreted as the one or more ports along a circumferential wall of the catheter shaft as described in para. 0079) formed in the proximal portion of the shaft (Figs. 15-16, para. 0079), and a control system 160 (Fig. 1, para. 0031) comprising a display hub 119 having a display screen (shown in Fig. 1, para. 0031), the display hub 119 being electrically connected with the distal sensor and the proximal sensor (para. 0038-0039, 0078-0083), the display hub being configured to display a reading from at least one of the proximal sensor or the distal sensor on the display screen (para. 0046, 0079-0083).
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 proximal shaft in Franklin to include the second, sensor lumen, the proximal sensor within the sensor lumen and the opening formed in the proximal shaft of Mohl and to modify the proximal hub of Franklin to connect to the control system comprising the display hub of Mohl in order to analyze and monitor the blood pressure of the patient during the procedure by measuring the blood pressure at a position distal and proximal of the balloon (para. 0079 of Mohl), thereby improving the accuracy of measuring a flow rate of blood passing along the entire length of the balloon (para. 0079-0083 of Mohl).
Modified Franklin further discloses an inflation port 194 (Fig. 6, para. 025 of Franklin) in fluid communication with the proximal internal lumen 210 (Figs. 1, 6, para. 012 of Franklin), the inflation port 194 being engageable with an inflation instrument (para. 014 of Franklin), wherein the hypotube 130 originates from, and is anchored within, the proximal hub (Fig. 6, para. 012 of Franklin).
However, Franklin in view of Mohl fails to disclose that the display hub is mounted upon the proximal shaft, the inflation port fluidically proximally positioned relative to the display hub and in fluid communication with the proximal internal lumen, wherein the hypotube originates from, and is anchored within, the display hub.
Lampropoulos in the same field of endeavor teaches a pressure sensing catheter 100 (Fig. 1, para. 0026) comprising a display hub 160 mounted upon a proximal shaft 140 (Figs. 1, 3-4, para. 0029, 0039), an inflation port 118 fluidically proximally positioned relative to the display hub 160 and in fluid communication with a proximal internal lumen 110 of the proximal shaft 140 (Figs. 2-3, para. 0031, 0037), the display screen 162 being electrically connected with a first sensor 124 and a second sensor 134 (Figs. 3-4, para. 0039), wherein a hub (interpreted as structure provided within display hub 160 comprising tubes 125, 115, 135) originates from, and is anchored within, the display hub 160 (Fig. 3, para. 0037) and having a display screen 162 (Fig. 4, para. 0039), the display hub being configured to display a reading from at least one of the first sensor or the second sensor on the display screen (Fig. 4, 0039) as a known alternative to a display hub in a form of a desktop or monitoring station (para. 0041).
The substitution of one known element (display hub comprising the display screen mounted upon the proximal shaft and positioned around a hub of Lampropoulos) for another (display hub comprising display screen remotely connected to the proximal hub of modified Franklin) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of displaying the pressure data via. the display screen of the display hub shown in Lampropoulos would have yielded predictable results, namely, an alternative way for the user to analyze and monitor the blood pressure of the patient during the procedure (para. 0039, 0041 of Lampropoulos).
Modified Franklin would result in a product wherein the inflation port 118 fluidically proximally positioned relative to the display hub 160, as taught by Lampropoulos (see Fig. 3, para. 0037-0038 Lampropoulos) and in fluid communication with the proximal internal lumen 210 (Figs. 1, 6, para. 012 of Franklin), wherein the hypotube 130 of Franklin (Fig. 6, para. 012, 025 of Franklin) originates from, and is anchored within, the display hub 160 of Lampropoulos since the proximal hub 190 of Franklin is modified to be positioned within the display hub 160 of Lampropoulos (Fig. 3, para. 0039 of Lampropoulos.
Regarding claims 2 and 15, modified Franklin discloses wherein the distal sensor is a pressure sensor configured to measure central aortic pressure upstream of the occlusion balloon (Fig. 5, para. 015, 021, 029 of Franklin).
Regarding claims 3 and 16, modified Franklin discloses wherein the proximal sensor is a pressure sensor configured to measure central aortic pressure downstream of the occlusion balloon (Figs. 15-16, para. 0079-0083 of Mohl; see note below).
Note: “configured to measure central aortic pressure downstream of the occlusion balloon” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Mohl teaches all of the structure provided in claim 3 to necessitate the functional language of claim 3 i.e. the proximal pressure sensor (para. 0079-0093 of Mohl). Mohl further teaches that the proximal sensor is a pressure sensor used to measure blood pressure downstream of the occlusion balloon (para. 0079-0083 of Mohl). Therefore, the proximal pressure sensor of Mohl is capable of measuring a central aortic pressure downstream of the occlusion balloon. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality 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.
Regarding claim 5, modified Franklin discloses wherein the distal sensor is in wired connection with the display hub (as taught by Mohl, Fig. 1, para. 0038-0039, 0078-0083 of Mohl).
Regarding claim 6, modified Franklin discloses wherein the proximal sensor is in wired connection with the display hub (as taught by Mohl, Fig. 1, para. 0038-0039, 0078-0083 of Mohl).
Regarding claims 7 and 17, modified Franklin discloses further comprising an inflation port 194 in fluid communication with the display hub (Fig. 6, para. 025 of Franklin), the first, proximal internal lumen 210 also being in fluid communication with the display hub (Figs. 1, 6, para. 012 of Franklin), wherein the inflation port 194 is fluidly connected with the first, proximal internal lumen 210 via the display hub (Figs. 1, 6, para. 012 of Franklin).
Regarding claim 8, modified Franklin discloses wherein the hypotube 130 is constructed of nitinol or a metallic material (para. 018 of Franklin).
Regarding claims 10 and 19, modified Franklin discloses wherein the display hub is connectable to a remote central processor 162 for data transmission, via a wired or wireless connection (as taught by Mohl; Fig. 1, para. 0031, 0046 of Mohl).
Regarding claims 21-22, modified Franklin discloses wherein the inflation port is proximally positioned relative to the display hub (as taught by Lampropoulos, see Fig. 3, para. 0037, 0039).
Claim(s) 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Mohl (US 20110295177) and Lampropoulos et al. (US 20160250444) [hereinafter Lampropoulos] as applied to claims 1 and 12 above, and further in view of Helkowski et al. (US 20150165174) [hereinafter Helkowski].
Regarding claims 9 and 18, modified Franklin discloses all of the limitations set forth above in claims 1 and 12. However, modified Franklin fails to disclose further comprising an internal balloon pressure sensor.
Helkowski in the same field of endeavor teaches a balloon catheter 40 comprising an internal balloon pressure sensor 106 for the purpose of measuring the interior/internal pressure of a balloon (Fig. 5, para. 0025).
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 Franklin to include the internal balloon sensor of Helkowski in order to allow the user to monitor the internal pressure of the balloon (para. 0025 of Helkowski), and thereby allow the user to select a desired inflation pressure, vessel occlusion, and/or prevent overinflation, bursting, or rupturing of the balloon (para. 0025 of Helkowski).
Claim(s) 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (WO 2015035393) in view of Mohl (US 20110295177) and Lampropoulos et al. (US 20160250444) [hereinafter Lampropoulos] as applied to claims 1 and 12 above, and further in view of Levit et al. (US 20110196412) [hereinafter Levit].
Regarding claims 11 and 20, modified Franklin discloses all of the limitations set forth above in claims 1 and 12. However, modified Franklin is silent on the material forming the balloon and therefore fails to disclose wherein the occlusion balloon is constructed of a compliant material.
Levit in the same field of endeavor teaches an occlusion balloon catheter 10 (Fig. 7C, para. 0081) comprising an occlusion balloon 5 constructed of a compliant material (para. 0079).
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 occlusion balloon in modified Franklin to include the compliant material of Levit since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use (In re Leshin 125 USPQ 416; MPEP 2144.07).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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 on 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