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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 11/10/2025 is acknowledged. The traversal is on the ground(s) that Groups I and II and Groups I and III are related to a single inventive concept. This is not found persuasive because the claimed technical features in claim 1 (Group I) are not special technical features that overcome the prior art noted in the restriction. Therefore, the independent claims differ in aspects and lack a corresponding technical feature, thus dose not relate to a single general inventive concept. Applicant assertion of the groups being directed to a single inventive concept incorrect because it does not meet the guidelines of a single inventive concept under PCT Rule 13.1-13.2.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
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.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “Sensor” in claim 1 is referring to a pressure, flow, temperature, imaging sensor or a combination of the above sensors (¶[0041]).
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 12-13 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 12 recites “the processing system” in the last line, but is indefinite. Is the processing system referring to the processor circuit or is it being introduced for the first time? For examination purposes, it is interpreted to be the processor circuit. Clarification required.
Claims not listed are rejected by virtue of claim dependency.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Burkett (US 20140187972) in view of Miesel et al. (US 20140276573), hereinafter Miesel.
Regarding claim 1, Burkett teaches an intraluminal sensing device, comprising: a guidewire configured to be positioned within a body lumen of a patient, wherein the guidewire comprises (abstract and ¶[0032], the guidewire comprises sensing devices):
a core wire (¶[0007,0043-44,0047,0049,0053,0058-59] and figs. 2-8, there’s a plurality of core wires, 226,246,302,304,401,402,404,502,504, etc.);
a first insulative coating covering at least a portion of a circumference of the core wire along at least a portion of a length of the core wire (¶[0007-12], “each wire has an insulating coating disposed thereover sufficient to electrically isolate each from the other” indicating that each wire and core wire comprises and insulating coating );
at least two conductive cables, each comprising a thickness and a width and extending longitudinally along at least the portion of the length of the core wire over an outer surface of the first insulative coating, wherein each conductive band comprises a cross-sectional shape conforming to a curvature of the first insulative coating, wherein the at least two conductive cables and the core wire are insulated from one another (¶[0042,0046,0052], conductive bands 248, at least 3, are concentrically disposed on an outer surface. The communication cable 232, which includes more than one cable because there are at least 3 bands, extends longitudinally therefrom the bands 248 to sensors 220).
Burkett fails to teach wherein the communication cables are conductive traces, and a second insulative coating covering an outer surface of the at least two conductive traces along at least the portion of the length of the core wire.
Miesel teaches a transdermal sensing device comprising an insertion elongate member (core member) that is formed with insulation layers and conductive traces (abstract and ¶[0036]). The core member is formed with its own insulative coating (¶[0036,0058], 671 insulative coating) and conductive traces (610A-B, at least two conductive traces extending from the electrodes) thereon the surface (¶[0057-58] and fig. 2 and 6, the traces conform to a curvature of the first insulative coating 671). Portions of conductive traces (610A-B) are then covered with insulative layer-672 (fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burkett, such that conductive traces, each comprising a thickness and a width and extending longitudinally along at least the portion of the length of the core wire over the insulative coating, as taught by Miesel, because Burkett requires conductive bands to electrically connect a communication cable that connect to a sensor, but fails to provide details, and Miesel teaches that sensors (electrodes) can be connected via traces to an electrical circuit (¶[0034] of Miesel). The modification is merely substituting of one known element (sensors of an electrical circuit are electrical traces and/or are connected via electrical traces) for another (sensor components connected to a communication cable) to obtain predictable results. As such, the components will allow for a lower profiled guidewire and simpler manufacturing.
In addition, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burkett, such that there is a second insulative coating covering an outer surface of the at least two conductive traces along at least the portion of the length of the core wire, as taught by Miesel, to provide a redundant sensor if one traces/electrodes are damaged during insertion (¶[0056] of Miesel).
As such, Burkett-Miesel teach a sensor configured to obtain physiological data while positioned within the body lumen, wherein the sensor is positioned at a distal portion of the guidewire and in electrical communication with the at least two conductive traces (¶[0036] of Burkett, “is configured to sense or detect a physiological characteristic of one or more conditions of a patient.” ¶[0047-38,0042,0052,0063] and figs. 2-3 of Burkett, the distal portion comprises the sensor assembly with a plurality of sensors for detecting physiological characteristics); and
a connector positioned at a proximal portion of the guidewire and in electrical communication with the at least two conductive traces (¶[0052] of Burkett, “Proximal portions of the conductive communication cable 232 are separately coupled to the conductive bands 248” and “conductive bands 248 are connected to one of the conductors of the trifilar, for example by soldering each of the conductive bands to the respective conductor or by adhering each conductive band 248 to the respective conductor of the communication cable 232 with solder or another conductive connector.” Therefore, the conductive connector places the communication trace 232 in communication with bands 248).
Regarding claim 2, Burkett fails to teach comprising a third insulative coating surrounding an entire circumference of the core wire, over a top surface of the second insulative coating along at least the portion of the length of the core wire. However, the combination of the insulative layer with the conductive trace of Miesel requires that there is a third insulative layer (674), which surrounds the entire circumference of the core member (205), over the top of the second insulative coating (fig. 6). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burkett-Miesel, such that a third insulative coating is applied on the second insulative coating, as taught by Miesel, because it acts as an outer layer that protects the inner contents (¶[0057] of Miesel).
Regarding claim 3, Burkett-Miesel teach wherein the third insulative coating (674 of Miesel) covers portions of at least one of the conductive traces (610A-B of Miesel and 248 of Burkett), the first insulative coating, and the core wire (figs. 3-8 of Burkett and fig. 6 of Miesel).
Regarding claim 4, Burkett teaches wherein the conductive trace comprises three conductive traces (fig. 2 and ¶[0046], there are three conductive traces because there are three bands 248. “the communication cable 232 may include one or more of an electrical conductor, an optical fiber, and/or combinations thereof.”).
Regarding claim 5, Meisel teaches wherein the conductive traces comprises conductive ink (¶[0058]).
Regarding claim 8, Miesel teaches wherein the conductive ink comprises particles of at least silver (¶[0058]).
Regarding claims 9 and 10, Burkett-Miesel teach that the first, second, or third insulative coatings comprise the same insulative material or different insulative material (¶[0057] of Burkett, “Different insulating materials may be used on the different wires 304”). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burkett-Miesel, such that the first, second, or third insulative coatings comprise the same insulative material or different insulative material, as taught by Burkett, because it is merely using prior art elements (core wire insulating materials) according to known methods (same or different insulative materials for coating core wires) to yield predictable results.
Regarding claim 11, Burkett-Miesel teach further comprising at least two additional conductive traces (¶[0052] of Burkett, “a plurality of conducting bands 248 are disposed concentrically” which would require a plurality of communication traces 232). While at least 4 conductive traces is not explicitly, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burkett-Miesel, such that there are four conductive traces, because it would merely be duplicating one conductive trace and would not have impacted mode of operation of the device. Moreover, Burkett acknowledges that a plurality, e.g., more than four, five, six, conductive traces can be incorporated for each sensor.
As such, Miesel-Burkett teach each having a thickness and a width, each running longitudinally along at least the portion of the length of the core wire over an outer surface of the second insulative coating (fig. 2 and 7 of Miesel as modified with Burkett. See fig. 6 of Burkett),
wherein each conductive trace comprises a cross-sectional shape conforming to a curvature of the first insulative coating (¶[0046,0052] of Burkett, “the communication cable 232 may include one or more of an electrical conductor, an optical fiber, and/or combinations thereof” and “a plurality of conducting bands 248 are disposed concentrically around the core wires ”),
and wherein the at least two conductive traces, the at least two additional conductive traces, and the core wire are all mutually insulated from one another (¶[0007,0052] of Burkett, “each wire has an insulating coating disposed thereover sufficient to electrically isolate each from the other,” “An insulating layer or sleeve 250 preferably separates the conductive bands 248 from the core wires” indicating that each wire, core wire and conductive traces are insulated from each other).
Regarding claim 12, Burkett-Miesel teach the intraluminal sensing guidewire of claim 1; and
a processor circuit in communication with the intraluminal sensing guidewire, wherein the processor circuit is configured to receive physiology data obtained by the sensor, process the physiology data, and output a graphical representation of the physiology data to a display in communication with the processing system (¶[0032] of Burkett, “a flexible elongate member may include one or more of the following types of components: a pressure sensor, a temperature sensor, an imaging element, an optical fiber, an ultrasound transducer, a reflector, a minor, a prism, an ablation element, an RF electrode, a conductor, and/or combinations thereof . . . . these components are configured to obtain data related to a vessel or other portion of the anatomy in which the flexible elongate member is disposed. Often the components are also configured to communicate the data to an external device for processing and/or display,” and “Imaging of an inner vessel surface, particularly the interior walls of human vasculature can be accomplished by a number of different techniques, including ultrasound (often referred to as intravascular ultrasound ("IVUS") when used in connection with vascular imaging, as well as intracardiac echocardiography”).
Regarding claim 12, Burkett-Miesel teach comprising a patient interface module (PIM) (¶[0032] of Burkett, “an external device for processing and/or display” indicating the external device is the patient interface module using the broadest reasonable interpretation of PIM.)
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Burkett in view of Miesel, as applied to claim 5, further in view of Albu et al. (US 20190328245- Cited by applicant), hereinafter Albu.
Regarding claim 6 and 7, Burkett-Miesel fail to explicitly disclose wherein the conducive ink is colloidal or sintered.
Albu teaches a catheter system comprising a catheter shaft and a sensor disposed on the tip (abstract). The sensor at the tip is formed using nanoparticles of silver (colloidal) and optimized via an ink sintering process (¶[0068], the sensor is a pressure sensor).
Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Burkett-Miesel, such that the conducive ink is colloidal or sintered, as taught by Albu, because Burkett requires measuring pressure via a sensor with pressure sensing capabilities, but fails to provide details, and Albu teaches a tip formed using nanoparticles of silver and ink sintering process will aid in detecting force exerted on the tissue during insertion (¶0028,0065,0068] of Albu). The combination is merely substituting one known element (colloidal and sintered conductive ink) for another (silver ink) to obtain predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burkett et al. teaches an intravascular guidewire includes a flexible elongate member configured to be positioned within a vessel of a patient, the flexible elongate member comprising a proximal portion and a distal portion; an electronic component secured to the distal portion of the flexible elongate member. US 20190046118
Richardson teaches a solid core proximal section and a slotted, tubular distal section. In some aspects, a sensing guide wire is provided. US 20180184981
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791