DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-2, 6, 8-15, and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2009/0088650 to Corl in view of U.S. Patent Application Publication No. 2011/0213220 to Samuelsson et al. (hereinafter “Samuelsson”) and U.S. Patent Application Publication No. 2004/0010303 to Bolea et al. (hereinafter “Bolea”).
For claim 1, Corl discloses a system (Abstract), comprising:
a sensing guidewire (“sensing guidewire,” para [0029]), comprising:
a flexible elongate member (“flexible elongate member,” para [0001]) configured to (Examiner’s Note: functional language, i.e., capable of) be positioned within a blood vessel of a patient (para [0001]), the flexible elongate member comprising a central longitudinal axis (central longitudinal axis of “flexible elongate member,” para [0001]), a proximal portion (proximal portion of “flexible elongate member,” para [0001]), and a distal portion (distal portion of “flexible elongate member,” para [0001]);
a core wire (“core wire,” para [0033]) disposed within the flexible elongate member (para [0033]) (also see Fig. 3b), wherein the core wire comprises a distal surface disposed at a distal end of the core wire (unlabeled, but as can be seen in Figs. 9-10);
a plurality of electrical wires (105) (Fig. 3b) (para [0043]) (also see 218 in Figs. 9) extending proximate to the core wire (as can be seen in Fig. 3b) (also see para [0033]-[0034] that discloses that the core wire extends proximally to 58 and that the lines and cable extend beyond 58 to 50, as can be seen in Fig. 2) and in a direction of the central longitudinal axis along a length of the flexible elongate member from the proximal portion to the distal portion (as can be seen in Figs. 3b and 9); and
a sensor assembly (“sensor assembly,” para [0001]) disposed at the distal portion of the flexible elongate member (para [0001]), wherein the sensor assembly comprises:
a substrate (100/200) (Figs. 3a-b/9) (para [0042]/[0051]) comprising:
a semiconductor material (para [0023] and [0058]-[0060]) comprising a length defined along the central longitudinal axis (as can be seen in Figs. 3a-b), a width extending perpendicular to the central longitudinal axis (as can be seen in Figs. 3a-b), a distal surface disposed at a distal end of the length of the semiconductor material such that the distal surface of the semiconductor material is forward-facing (unlabeled, forward-facing distal surface of 200 shown in Fig. 9), and a proximal surface disposed at a proximal end of the length of the semiconductor material (unlabeled, but as can be seen in Figs. 9-10);
a plurality of electrodes (108) (Fig. 3a) (para [0043]) formed using semiconductor manufacturing (para [0027]) (also see para [0023] and [0058]-[0060]), wherein the plurality of electrodes is part of the substrate such that the plurality of electrodes extends through the semiconductor material is a direction of the length of the semiconductor material and in the direction of the central longitudinal axis (as can be seen in Figs. 3a and 4-5); and
a physiological sensor (202) (Fig. 9) para [0052]) disposed on the distal surface of the semiconductor material such that the physiological sensor is forward-facing (as can be seen in Fig. 9), wherein the physiological sensor comprises at least one of a pressure sensor or a flow sensor (para [0056]), wherein the physiological sensor is in communication with:
the plurality of electrodes (para [0038]) (also see para [0043]); and
the plurality of electrical wires via the plurality of electrodes (para [0038]) (also see para [0043]),
wherein the plurality of electrical wires is coupled to the plurality of electrodes (para [0043]) between the distal surface of the core wire and the proximal surface of the semiconductor material (as can be seen in Figs. 3a-b) (Examiner’s Note: 106 is part of 100 as evidenced by para [0042] and para [0033] state that the “core wire extends from the distal tip of the guidewire to the proximal (connector) end of the guidewire 56”).
Corl does not expressly disclose wherein the proximal surface of the semiconductor material abuts the distal surface of the core wire.
However, Samuelsson teaches wherein a proximal surface of a semiconductor material (see “sensor chip” in Figs. 7-8) abuts the distal surface of a core wire (see “core wire” in Figs. 7-8).
It would have been obvious to a skilled artisan to modify Corl wherein the proximal surface of the semiconductor material abuts the distal surface of the core wire, in view of the teachings of Samuelsson, as another medium by which the signals from the sensor can be transferred (see Abstract of Samuelsson).
Corl and Samuelsson do not expressly disclose wherein the plurality of electrodes is fully encapsulated by the substrate.
However, Bolea teaches wherein a plurality of electrodes is fully encapsulated by a substrate (as can be seen in Figs. 8-11) (also see para [0093]).
It would have been obvious to a skilled artisan to modify Corl wherein the plurality of electrodes is fully encapsulated by the substrate, in view of the teachings of Bolea, for the obvious advantage of protecting the electrodes on all sides.
For claim 2, Corl further discloses wherein the sensor assembly further comprises at least one of an application specific integrated circuit (ASIC), a signal conditioning circuit, an RF communication module, or a memory module (para [0031]-[0034]).
For claim 6, Corl further discloses wherein the plurality of electrodes extend in the direction of the length from the distal surface (para [0054]) to the proximal surface of the semiconductor material (as can be seen in Figs. 3a and 4-5).
For claim 8, Corl further discloses wherein the semiconductor material comprises at least one of silicon, germanium, a silicon-germanium alloy, silica, quartz, sapphire, a ceramic material, or a plastic material (para [0004] and [0059]).
For claim 9, Corl further discloses wherein the substrate is bonded to at least one of the flexible elongate member or the core wire using an adhesive (para [0048]).
For claim 10, Corl further discloses wherein the flexible elongate member comprises a hole configured to expose the physiological sensor to blood within the blood vessel (101) (Fig. 3b) (para [0045]).
For claim 11, Corl further discloses a control console (52) in communication with the sensing guidewire (as can be seen in Fig. 2).
For claim 12, Corl further discloses an interface device (50) (Fig. 2) communicatively disposed between the control console and the sensing guidewire (as can be seen in Fig. 2), wherein the interface device is configured to provide power to the physiological sensor and process a signal from the physiological sensor (para [0035]).
For claim 13, Corl further discloses wherein the interface device comprises an analog to digital converting circuit configured to provide a digital signal to the control console (para [0032] and [0038]).
For claim 14, Corl further discloses wherein the control console is configured to output a visual representation of data obtained by the physiological sensor (as can be seen in Fig. 2).
For claim 15, Corl further discloses wherein the physiological sensor comprises a micromechanical system (MEMS) sensor (para [0007]).
For claim 20, Corl further discloses wherein the substrate further comprise a plurality of conductors (204a, 204b, 204c) in communication with the plurality of electrodes (as can be seen in Figs. 6-7) (para [0052]), wherein the plurality of conductors form part of the substrate such that the plurality of conductors extend along the distal surface of the semiconductor material in a direction of the width of the semiconductor material (as can be seen in Figs. 6-7), and wherein the physiological sensor is in communication with the plurality of electrical wires via the plurality of electrodes and the plurality of conductors (para [0052]).
Claim(s) 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Corl in view of Samuelsson and Bolea, and further in view of U.S. Patent Application Publication No. 2011/0072659 to Swanson et al. (hereinafter “Swanson”).
For claim 3, Corl, Samuelsson, and Bolea do not expressly disclose wherein the substrate comprises an elongated cylinder.
However, Swanson teaches wherein the substrate comprises an elongated cylinder (Abstract) (Fig. 3) (para [0009]).
It would have been obvious to a skilled artisan to modify Corl wherein the substrate comprises an elongated cylinder, in view of the teachings of Swanson, because such a combination could be achieved by known methods (such as the semiconductor manufacturing methods disclosed in Corl) and would have each element perform the same together as they do separately that the combination would lead to the predictable purpose of intravascular use, which is what Corl wants to do (see Abstract of Corl).
Claim(s) 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Corl in view of Samuelsson and Bolea, and further in view of U.S. Patent Application Publication No. 2013/0324863 to Yu et al. (hereinafter “Yu”).
For claim 16, Corl, Samuelsson, and Bolea do not expressly disclose wherein the physiological sensor comprises an ultrasound transducer.
However, Yu teaches wherein the physiological sensor comprises an ultrasound transducer (para [0041]).
It would have been obvious to a skilled artisan to modify Corl wherein the physiological sensor comprises an ultrasound transducer, in view of the teachings of Yu, because such a modification would be the simple substitution of one sensor type for another sensor type that would lead to the predictable result of sensing properties of the patient’s blood.
Claim(s) 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Corl in view of Samuelsson and Bolea, and further in view of U.S. Patent Application Publication No. 2011/034912 to de Graff et al. (hereinafter “de Graff”).
For claim 17, Corl, Samuelsson, and Bolea do not expressly disclose wherein the physiological sensor is flip-chip bonded to the distal surface of the substrate.
However, de Graff teaches wherein the physiological sensor is flip-chip bonded to the distal surface of the substrate (para [0099]).
It would have been obvious to a skilled artisan to modify Corl wherein the physiological sensor is flip-chip bonded to the distal surface of the substrate, in view of the teachings of de Graff, because such a modification would be the simple substitution of the medium by which to bond the sensor to the surface of the substrate.
Response to Arguments
Applicant’s arguments filed 4/13/26 have been fully considered, but they are not persuasive. In response, para [0001] of Applicant’s specification as originally filed states “[t]he present disclosure relates generally to intravascular devices.” Therefore, the field of endeavor of the invention is “intravascular devices.” Bolea is directed towards the application of electrodes (302) around a vascular wall (para [0086]) “minimally invasive surgical approach” (para [0068]). So although Bolea doesn’t explicitly teach that its surgical approach is intravascullary, both the invention and Bolea deal with medical devices that interact with blood vessels.
Even if Bolea is not in the same field of endeavor, it still is applicable to the problem faced by the inventor. The response may address the problem faced by the inventor for the overall device, but Bolea is being used to modify the electrodes and substrate, not any other part of the device. Therefore, the inquiry is what is the problem faced by the inventor that is solved by encapsulating the electrodes within the substrate? Well, the substrate insulates the electrodes because the only way to connect a conductor to the electrodes is through the vias/recesses (see “In that regard, by keeping space within the through vias and/or the recesses in the outer surface of the substrate 210, conductors that are to be electrically coupled to the electrodes 230 can be at least partially positioned within the through vias and/or recesses where they are electrically coupled to the electrodes,” para [0038] of Applicant’s specification as originally filed). That is, by encapsulating the electrodes 230 in the substrate 210, the only means of connection to the electrodes 230 is through the vias/recesses because the substrate 210 otherwise insulates the electrodes. Bolea’s substrate does the exact same thing (see para [0093] of Bolea, which discloses “…a substrate or base structure 306 which may encapsulate and insulate the electrodes 302…”). Therefore, Bolea’s substrate is relevant to the pertinent problem faced by the inventor of insulating/protecting/shielding the electrodes.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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