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
Claims 18 and 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/08/2026.
Applicant’s election without traverse of group I in the reply filed on 01/08/2026 is acknowledged.
Claims 1-15 are hereby the present claims under consideration.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 line 7 it appears that “a circumferential direction of the stent body” should read “the circumferential direction of the stent body” to reference the same direction recited in claim 1
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 1-15 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 “a mechanical-sensing sensor comprising a plurality of flexible membrane members, including a first membrane member and a second membrane member, wherein the first membrane member is separated from the second membrane member across a dielectric member to form a capacitive structure” but it is unclear if the claim is intended to limit the first and second membrane members to conductive members to form a capacitive structure known in the art or if the claim is intended to encompass any material being the first or second membrane members and is intended to encompass the formation of a capacitive structure without requiring conductive elements. For the purposes of this examination, the limitation will be interpreted as requiring at least part of the membrane members to be conductive. It is further noted that if the scope is clarified to be forming a capacitive structure from any material then new grounds of rejection under 35 USC 112a may be necessitated.
Claims 2-15 are rejected by virtue of their dependance on claim 1.
Claim 6 recites “wherein the mechanical-sensing sensor is laminated on the stent body” but it is unclear how this attachment method relates to “one or more stretchable interconnects” used to attach the sensor to the stent in claim 1. It is unclear if the interconnects are laminated to the stent body or if the entire sensor is laminated to the stent body. For the purposes of this examination. The limitation will be interpreted as any portion of the sensor being laminated to the stent body.
Claim 7 recites “wherein the mechanical-sensing sensor is integrated into the mechanical-sensing sensor” but it is unclear what this limitation is meant to convey as it is unclear how a sensor may be “integrated into” itself. For the purposes of this examination, the limitation will be interpreted as only requiring the mechanical-sensing sensor.
Claim 9 recites “wherein the change of capacitance, strain, or mechanical property is employed to measure a state of restenosis of a patient” but it is unclear how the measured values are related to a state of restenosis. For the purpose of this examination, the limitation will be interpreted as the intended use of the stent and will not be interpreted as the stent itself evaluating a state of restenosis.
Claim 13 recites “a stretchable interconnect” in lines 4-5 but it is unclear if this recitation is the same as, related to, or different from “one or more stretchable interconnects” of claim 1. In particular, the stretchable interconnect of claim 13 appears to be formed as part of the structure of the stent but the stretchable interconnect of claim 1 is recited as the connection between the sensor and the stent. It is unclear if the interconnect is part of the stent body, the sensor structure, or is used to attach the two elements. Additionally, claim 13 recites that “a stretchable interconnect” is formed from “a plurality of bridges” each filled with polyimide. It is unclear if each filled bridge is considered “a stretchable interconnect” or if the stretchable interconnect is meant to refer to the plurality of filled bridges. For the purposes of this examination, the stretchable interconnect of claim 13 is interpreted as “a plurality of non-conductive interconnects” that are distinct from the stretchable interconnects of claim 1.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a plurality of annular struts positioned at intervals in a circumferential direction of the stent body” but it would seem that the specification is directed towards a plurality of annular struts positioned at intervals in a longitudinal direction rather than circumferential. In particular, a plurality of annular struts positioned at intervals in a circumferential direction appears to be directed towards a structure as illustrated in the annotated figure below:
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Such a structure does not appear to be described in the specification as the figures illustrate a plurality of annular struts but the struts are positional at intervals in the longitudinal or axial direction of the stent. The struts themselves appear to form the circumference of the stent and thus do not appear to be spaced at intervals in the circumferential direction.
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, 7, 9-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication Number US 2018/0103899 A1 hereinafter Cahan in view of Bihler US Patent Application Publication Number US 2019/0366057 A1 hereinafter Bihler further in view of Weber US Patent Application Publication Number US 2005/0033407 A1 hereinafter Weber.
Regarding claim 1, Cahan discloses a stent (paragraph 0058: the stent) comprising:
a mechanical-sensing sensor (paragraph 0058: strain sensor attached to the stent)
a stent body (paragraph 0058; Fig. 7A: the body of stent 702) comprising a plurality of struts in a circumferential direction of the stent body (Fig. 7A-B: the struts comprising the mesh of the stent body form a tube and extend in a circumferential direction), wherein the mechanical-sensing sensor is coupled, to the stent body to measure strain of the stent (paragraphs 0058-0060: the strain sensor is coupled to the stent body to measure strain of the stent).
Cahan fails to further disclose the stent wherein the mechanical sensing sensor comprises a plurality of flexible membrane members, including a first membrane member and a second membrane member, wherein the first membrane member is separated from the second membrane member across a dielectric member to form a capacitive structure, wherein the first membrane member is configured to move in a first direction in relation to the second membrane and the second membrane is configured to move in a second direction in relation to the first membrane member different from the first direction to change capacitance defined between the first membrane member and the second membrane member, and wherein the capacitance, or change of capacitance, corresponds to a measure of strain or mechanical properties; and wherein the stent body comprises comprising a plurality of annular struts positioned at intervals in a circumferential direction of the stent body, and wherein the mechanical-sensing sensor is coupled, via one or more stretchable interconnects, to the stent body
Bihler teaches a strain sensor for capacitive strain measurement has a flat and electrically conductive first conductor element and a flat and electrically conductive second conductor element. The two conductor elements oppose one another and are laterally displaceable relative to one another, so that the two conductor elements, proceeding from a first condition, may be displaced relative to one another into a second condition. An overlap between the two conductor elements is different in the first condition from the second condition (Abstract). The strain sensor is configured for use with implantable devices (paragraph 0067). Thus, Bihler falls within the same field of endeavor as Applicant’s invention.
Bihler teaches a mechanical sensing strain sensor (paragraph 0002) comprises a plurality of flexible membrane members (Paragraph 0084 and 0087: substrates 30 and 40; Fig. 1 references 30 and 40; The substrates may be a polymer film, polymers are flexible), including a first membrane member and a second membrane member (Paragraphs 0084 and 0087: the first and second substrates respectively), wherein the first membrane member is separated from the second membrane member across a dielectric member to form a capacitive structure (Paragraph 0082: capacitive strain sensing; Paragraph 0084: the conductive elements disposed on the substrates may be covered with an insulating film; The insulating film is considered the dielectric member), wherein the first membrane member is configured to move in a first direction in relation to the second membrane and the second membrane is configured to move in a second direction in relation to the first membrane member different from the first direction to change capacitance defined between the first membrane member and the second membrane member (Paragraphs 0082-0083; Fig. 1 references B and U: the first and second members, or substrates 30 and 40 are configured to move laterally with respect to one another. The arrows B and U indicate they may each move in different directions. The movements result in a change in capacitance.), and wherein the capacitance, or change of capacitance, corresponds to a measure of strain or mechanical properties (Paragraph 0082: the change in capacitance is used to measure strain); and wherein the mechanical-sensing sensor is coupled, via one or more stretchable interconnects, to the stent body (Paragraph 0085-0088; Fig. 2 references 31, 31a, and 32: the first attaching region may be connected via a winding strip that forms a first easily flexible spring element. The strain sensor is formed by placing two basic element, as depicted in Fig 2, on top of each other, with a 180 degree difference in rotation. Thus the strain sensor as a whole is connected by two easily flexible winding strips)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the strain sensor of Bihler into the stent system of Cahan because such an implementation is a mere substitution of one known element (the strain sensor of Cahan) with another known element (the strain sensor of Bihler) with no surprising technical effect (the stent system still performs the same purpose of sensing strain on the stent).
Cahan in view of Bihler fails to further teach the stent wherein the stent body comprises comprising a plurality of annular struts positioned at intervals in a circumferential direction of the stent body.
Weber teaches a medical device that inhibits distortion of medical resonance images taken of the device. In particular, various structures are utilized to allow visibility proximate, and inside of, a tubular member, such as a stent. In one embodiment, the stent is constructed such that any closed path encircling at least a circumference of the stent will pass through at least two materials to reduce or eliminate electrical loops formed in the stent (Abstract). Thus, Weber is reasonably pertinent to the problem at hand
Weber teaches a stent wherein the stent body comprises comprising a plurality of annular struts positioned at intervals in a circumferential direction of the stent body (Paragraphs 0033 and 0037: the cells are wrapped around a central axis and connected by connectors).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the stent of Cahan in view of Bihler to be constructed in the manner of the stent of Weber because such a construction would allow the user to use the stent body itself as the antenna of Cahan which may reduce the number of components attached to the stent and thus the bulk of the device. Weber teaches that its coil structure is readily adaptable to form LRC circuits (Weber: Paragraphs 0076-0077).
Regarding claims 2 and 3, Cahan in view of Bihler further in view of Weber teaches the stent of claim 1. Modified Cahan fails to further discloses the stent wherein the plurality of annular struts include a first annular strut and a second annular strut, wherein the first annular strut is configured as an electromagnetic radiating body to serve as an antenna for the stent, and wherein the second annular strut is configured as a second electromagnetic radiating body to serve as an antenna array for the stent with the first annular member.
Weber teaches the stent wherein the plurality of annular struts include a first annular strut and a second annular strut (Paragraph 0037; Fig. 3: the structure comprises a plurality of cells, or annular struts), and wherein the first annular strut is configured as an electromagnetic radiating body to serve as an antenna for the stent, and wherein the second annular strut is configured as a second electromagnetic radiating body to serve as an antenna array for the stent with the first annular member (Paragraphs 0037-0039: Each cell itself may form a coil and/or multiple cells can be connected to form multiple loops of a single coil. The electrically non-conducting portions may be included in specific connectors and/or loops; Paragraphs 0076-0077: The stent body may be configured to form ).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the stent of modified Cahan to include multiple tubular members to serve as antennas as described by Weber because Weber teaches that such a construction would allow the user to use the stent body itself as the antenna of Cahan which may reduce the number of components attached to the stent and thus the bulk of the device. Weber teaches that its coil structure is readily adaptable to form LRC circuits (Weber: Paragraphs 0076-0077). Furthermore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to form a plurality of separate antennas or coils since Weber is constructed in a modular manner where the plurality of annular struts are selectively electrically insulated from each other, each ring may be utilized as its own antenna or coil. Such a construction is a mere duplication of parts with no surprising technical effect. Forming a plurality of antennas, or antenna array may allow the data transmitter and power transmitter of Cahan (Cahan: Paragraph 0051; Fig. 5 references 510 and 506) each utilize their own antenna to potentially prevent interference, or may allow the device to select which strut, and therefor antenna, has the best alignment and/or connection strength with the external antenna for data receipt and power transmittal (Cahan: Paragraph 0054; Fig. 5 reference 512)
Regarding claim 4, Cahan in view of Bihler further in view of Weber teaches the stent of claim 2. Modified Cahan fails to further teach the stent wherein the first annular strut is connected to a second annular strut via a plurality of non-conductive interconnects.
Weber teaches the stent wherein the first annular strut is connected to a second annular strut via a plurality of non-conductive interconnects (Paragraphs 0037-0039: the electrically non-conductive bridges)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the non-conductive interconnects of Weber into the stent of Cahan in view of Bihler further in view of Weber because the interconnects created using non-conductive material allow the user to selectively create, join, and/or break coils in the stent body such that the body may be optimized to form the desired number of coils with the desired number of turns.
Regarding claim 5, Cahan in view of Bihler further in view of Weber teaches the stent of claim 2. Modified Cahan fails to further teach the stent wherein the first annular strut is configured as a wave-shaped strut.
Weber teaches the first annular strut is configured as a wave-shaped strut (Fig. 3 reference 302).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the sinusoidal struts of Weber into the stent of Cahan in view of Bihler further in view of Weber because a sinusoidal construction allows for a greater degree of expansion and contraction than a circular construction or a construction with sharp edges.
Regarding claim 7, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan further discloses the stent wherein the mechanical-sensing sensor is integrated into the mechanical-sensing sensor (Paragraph 0058: the strain sensor).
Regarding claim 9, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan further discloses the stent wherein the change of capacitance, strain, or mechanical property is employed to measure a state of restenosis of a patient (Paragraphs 0030 and 0056: the strain gauge may be used to measure restenosis).
Regarding claim 10, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan further discloses the stent wherein the mechanical-sensing sensor is configured to measure strain or a change in strain (Paragraphs 0030 and 0056: the device measures strain).
Regarding claim 11, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan fails to further disclose the stent wherein the first membrane member has a first protruding structure, wherein the second membrane member has a second protruding structure, and wherein the first protruding structure is parallel to the second protruding structure.
Bihler teaches the stent wherein the first membrane member has a first protruding structure, wherein the second membrane member has a second protruding structure, and wherein the first protruding structure is parallel to the second protruding structure (Paragraph 0085-0087: the attaching region 33 and 43 on both of the first and second members “protrudes” from the members themselves; Fig. 2 reference 33; Fig. 3 reference 43).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the attachment regions taught by Bihler into the stent of modified Cahan because the attachment regions serve as anchoring points to allow the strain sensor to stretch with the stent and are thus a simple substitution of one know element (the anchoring method of Cahan) for another (the anchoring method of Bihler) with no surprising technical effect (the strain sensor is anchored and functions as intended).
Regarding claim 14, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan fails to further disclose the stent wherein the mechanical-sensing sensor is fabricated by: fabricating the first membrane member for a strain sensor; fabricating the second membrane member for the strain sensor; assembling the first membrane over a first side of a dielectric layer; and assembling the second membrane over a second side of the dielectric layer.
Bihler teaches a mechanical-sensing sensor is fabricated by: fabricating the first membrane member for a strain sensor; fabricating the second membrane member for the strain sensor (Paragraphs 0084 and 0087: each of the first and second member for the strain sensor are formed);
Bihler fails to further disclose forming the sensor by assembling the first membrane over a first side of a dielectric layer; and assembling the second membrane over a second side of the dielectric layer.
An obvious variation of Bihler would be to form the sensor by assembling the first membrane over a first side of a dielectric layer; and assembling the second membrane over a second side of the dielectric layer. Such a variation is obvious because Bihler teaches that a dielectric layer is present between the two electrode members (Paragraph 0084; the insulative layer). While Bihler teaches forming this layer on the electrodes and thus their corresponding membranes, one of ordinary skill in the art would recognize that there are a finite number of identified, predictable solutions, with a reasonable expectation of success for implementing the dielectric layer between the two electrodes of Bihler. In particular, one could implement the dielectric layer by applying it to the surface of both electrodes as taught by Bihler, one could apply the layer to only a single one of the electrodes, or one could implement the layer separate from either electrode as its own sheet of dielectric or insulative material. The capacitive measurement of Bihler requires the presence of an insulative or dielectric material between the electrodes and there are a finite number of identifiable and predictable solutions with a reasonable expectation of success for implementing this layer. Thus constructing Bihler by incorporating a separate layer of dielectric or insulative material between the two electrodes would be obvious to try.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct the strain sensor of Bihler as implemented into modified Cahan according to the method of the obvious variation of Bihler described above because such a method is a simple substitution of one known element (the construction method taught by Bihler) for another known element (the construction method of the obvious variation of Bihler) with no surprising technical effect (the sensor of Bihler operates in the same manner, the insulative layer is simply formed as a separate layer from either membrane member).
Regarding claim 15, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan further discloses the stent wherein the mechanical-sensing sensor is configured as: a strain sensor (Paragraphs 0030 and 0056: the device measures strain)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication Number US 2018/0103899 A1 hereinafter Cahan in view of Bihler US Patent Application Publication Number US 2019/0366057 A1 hereinafter Bihler further in view of Weber US Patent Application Publication Number US 2005/0033407 A1 hereinafter Weber as applied to claim 1 above and further in view of Spillman US Patent Number US 6206835 B1 hereinafter Spillman.
Regarding claim 6, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan fails to further teach the stent wherein the mechanical-sensing sensor is laminated on the stent body.
Spillman teaches an implant device is provided which is responsive to an external interrogation circuit. The implant device includes a structure implantable within a living animal and operatively configured to carry out or assist in carrying out a function within the living animal. The device further includes an electrically passive sensing circuit integral with the structure for sensing a parameter associated with the function. In particular, the sensing circuit includes an inductive element wherein the sensing circuit has a frequency dependent variable impedance loading effect on the interrogation circuit in response to an interrogation signal provided by the exciter/interrogator element, the impedance loading effect varying in relation to the sensed parameter (Abstract). Thus, Spillman is reasonably pertinent to the problem at hand.
Spillman teaches that sensing circuitry may be laminated at least in part to a surface of a stent (Claim 9; Col 3 lines 34-41).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct the stent of modified Cahan by laminating the strain sensor to the stent body because Spillman teaches that such an attachment method is acceptable for capacitive sensors (Col 5 lines 1-15: capacitive sensors, claim 9: the sensor may be laminated to the body) and such a construction is a simple substitution of one known element (the attachment mechanism of Bihler) for another known element (the lamination of Spillman) with no surprising technical effect (the sensor is attached to the stent).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication Number US 2018/0103899 A1 hereinafter Cahan in view of Bihler US Patent Application Publication Number US 2019/0366057 A1 hereinafter Bihler further in view of Weber US Patent Application Publication Number US 2005/0033407 A1 hereinafter Weber as applied to claim 1 above and further in view of Jan US Patent Application Publication Number US 2007/0106363 A1 hereinafter Jan.
Regarding claim 8, Cahan in view of Bihler further in view of Weber teaches the stent of claim 2. Modified Cahan fails to further teach the stent wherein each of the plurality of annular struts comprises a laminated structure comprising: a metal core; a conductive layer that surrounds the metal core; and a coating.
Jan teaches various medical devices, including implantable or insertable medical devices, are provided, which comprise at least one particle-containing region whose surface is at least partially coated with a diamond-like coating (Abstract). Thus, Jan is reasonably pertinent to the problem at hand.
Jan teaches a stent (Paragraph 0017) which may be formed with a metallic core, covered with a particle contained layer, and having a diamond like coating (Paragraph 0089; Fig. 4C). The particle containing layer may be a conductive particle containing layer (Paragraph 0096: layer 436 may be conductive).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct the stent of modified Cahan using the coatings as taught by Jan because Jan teaches that the diamond-coated layers can be applied to virtually any substrate and are desirable for a wide range of medical devices because they provide benefits such as wear resistance, biocompatibility, flexibility and may be adapted to have surface topology that influences cell growth or may be adapted to include therapeutic agents (Jan: Paragraphs 0090-0092) and Weber further teaches that the stent may have additional coatings (Weber: Paragraph 0067)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication Number US 2018/0103899 A1 hereinafter Cahan in view of Bihler US Patent Application Publication Number US 2019/0366057 A1 hereinafter Bihler further in view of Weber US Patent Application Publication Number US 2005/0033407 A1 hereinafter Weber as applied to claim 1 above and further in view of Boutry “A stretchable and biodegradable strain and pressure sensor for orthopedic application” published by Nature electronics in May 2018, pages 1-10 hereinafter Boutry.
Regarding claim 12, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan fails to further teach the stent wherein the first membrane member has a plurality of conductive non-parallel members.
Boutry teaches an implantable pressure and train sensor (Abstract). Thus, Boutry is reasonably pertinent to the problem at hand.
Boutry teaches an implantable strain sensor comprising comb shaped electrodes on a substrate. The strain electrodes are separated by a dielectric layer which allows each of the top and bottom electrode sheets to slide relative to each other (Fig. 1 and its description, Page 2 right column last paragraph). The electrodes are formed as a plurality of parallel members centered on a protruding member which connects to measurement circuitry (Fig. 1b: the arrangement of the strain sensor electrodes).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the conductor elements of Bihler in modified Cahan to be structured similarly to the electrodes of Boutry. Such a construction would be obvious because both Bihler and Boutry measure strain using the same principle of two electrodes disposed on top of each other and separated by a dielectrics layer and wherein the amount of overlap between the electrode’s changes based on strain as the two electrode members are pushed or pulled to change the alignment of the electrodes. The construction of Boutry may also improve the sensitivity of the sensor as Boutry teaches that the strain sensor has a high degree of sensitivity as compared to other strain sensors (Page 5). It is noted that the conductive member which serves to connect the three parallel conductive members is not parallel to the others and thus constitutes “a plurality of non-parallel conductive members”.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication Number US 2018/0103899 A1 hereinafter Cahan in view of Bihler US Patent Application Publication Number US 2019/0366057 A1 hereinafter Bihler further in view of Weber US Patent Application Publication Number US 2005/0033407 A1 hereinafter Weber as applied to claim 1 above and further in view of Alt US Patent Number US 6099561 A hereinafter Alt.
Regarding claim 13, Cahan in view of Bihler in view of Weber teaches the stent of claim 1. Modified Cahan fails to further teach the stent was fabricated by providing a substrate metal core; cutting, via a laser operation, a plurality of bridges in the substrate metal core; filling each of the plurality of bridges with a printed polyimide to form a stretchable interconnect; cutting, the substrate metal core to form the plurality of annular struts positioned at intervals in a circumferential direction of the stent body; electroplating the plurality of annular struts; and coating the plurality of electroplated annular struts.
Weber teaches that a stent may be fabricated by traditional methods such as laser cutting and electropolishing (Paragraph 0042). Weber further teaches that interconnects may be formed from polyimides (Paragraphs 0067-0068) and may serve to connect the plurality of annular struts together (Paragraphs 0037-0040: portions of each connector may be replaced with electrically non-conductive bridges). Weber teaches a method of first obtaining the metal stent then cutting in the plurality of openings to be filled with a non conductive material such as polyimide while the stent is supported by a gypsum rod (Paragraphs 0042-0043: the construction method; Fig. 5C; Paragraphs 0067-0068: the non-conductive portions may be polyimide). Weber further contemplates additional construction methods that may be less laborious such as forming each of the metallic components separately and combining the various loose metallic components to form the final stent by joining the components using the non-conductive bridges (Paragraphs 0072-0075)
An obvious variation of Weber would be to form the stent by first cutting and forming the plurality of non-conductive interconnects and then cutting the shape of the annular struts. Such a variation in the manufacturing process would be obvious because there is a finite number of identified, predictable solutions, with a reasonable expectation of success to produce the stent and thus would be obvious to try. The completed stent of Weber must be formed to have a plurality of annular struts with a plurality of non-conductive bridges at various locations (Paragraphs 0037-0040; Fig. 5G). Weber explicitly recites performing this process by obtaining a solid metal stent, supporting it, cutting in the bridges, and forming the bridges in paragraphs 0042-0043. Weber further explicitly contemplates that other manufacturing methods which may be less labor intensive may be used in paragraph 0072. Weber provides an additional example of first cutting the metal components separately then attaching them with the bridges to form the completed stent in paragraphs 0073-0075. There are a finite number of ways to produce the final stent of Weber including: starting with the complete stent and adding the bridges; starting with the cut bridges and assembling the stent using bridge material, starting with the bridge material and assembling the stent around them using pre-cut pieces, and starting with the bridges in the base substrate and cutting the stent structure around them. The claimed method of forming the bridges and then cutting the stent structure around them is considered to be obvious to try and thus an obvious variation of the methods of Weber. Applicant does not indicate that a surprising technical effect is achieved by creating the stent in the claimed manner and thus it is considered obvious to try.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct the stent of modified Cahan using the above obvious variation of the construction methods of Weber because such methods are a simple substitution of one known method of forming the stent (the method of Cahan) with another known method of forming the stent (the obvious variation method described above) with no surprising technical effect (the same stent structure is produced).
Cahan in view of Bihler in view of Weber fails to further teach the stent wherein the stent is produced by electroplating the plurality of annular struts; and coating the plurality of electroplated annular struts.
Alt teaches a vascular or endoluminal stent is adapted for deployment in a vessel or tract of a patient to maintain an open lumen therein (Abstract). Thus, Alt falls within the same field of endeavor as Applicant’s invention.
Alt teaches that a stent may be fabricated with a metal core such as stainless steel which is electroplated with gold (Col 9 lines 11-44). An additional layer is then deposited over the gold layer to form a biocompatible layer that prevents tissue irritation (Col 9 line 66- Col 10 line 13). The layered structure provides the advantages of avoiding galvanic potential using the noble metal layer over the base layer and providing a highly biocompatible surface with the outermost layer (Col 11 lines 31-45).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the electroplating and coating processes taught by Alt into the stent of Cahan in view of Bihler in view of Weber as described above because the electroplating and coating steps taught by Alt provide the stent with the advantages of avoiding galvanic potential and having a highly biocompatible external surface as taught by Alt (Alt: Col 11 lines 31-45)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached on Monday-Friday from 9:00AM – 4:00PM 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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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791