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 Preliminary Amendment
This Office Action is responsive to the amendment filed on 03 Feb 2026. As directed by the amendment: claims 1, 4, 6-8, and 16-22 have been amended, claims 3, 9-15, and 24-26 have been canceled, and no claims have been added. Thus, claims 1-2, 4-8, and 16-23 are presently pending in this application.
Response to Arguments
Claim Objections
Applicant’s arguments, see Remarks, filed 03 Feb 2026, with respect to the objections to the claims have been fully considered and are persuasive in light of the claim amendments. The objections to the claims have been withdrawn.
However, new objections are made below as necessitated by the claim amendments
Claim Rejections under 35 U.S.C. 112
Applicant's arguments filed 03 Feb 2026 have been fully considered but they are not persuasive.
The amendments made to claims 1, 8, and 22 do not obviate the clarity issues under 35 U.S.C. 112(b) addressed in the previous Office Action. Therefore, these rejections are maintained below.
Claim Rejections under 35 U.S.C. 103
Applicant's arguments filed 03 Feb 2026 have been fully considered but they are not persuasive.
Applicant argues that “in the Bardy's design, the tool is inserted in an arc, but by pressing. While in the present application, the monitor can be guided in a circle under the skin by turning; this is not possible with Bardy's design” (Remarks, page 9).
Examiner respectfully disagrees. As currently drafted, claim 1 recites “a handle … configured to hold and position the implantation tool by turning”. The claim does not specify which element is being turned, nor a direction of the turn, nor what the action of turning accomplishes. Under the broadest reasonable interpretation of the claim, it is possible for the handle to be turned in order to connect it to the base, to hold the implantation tool, and/or to position the implantation tool.
Applicant further argues that “Due to the nature of the actuation, there must always be a movement in an arc under the skin, with the distance to the patient's skin changing accordingly” (Remarks, page 9). This feature is not recited in the claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Bardy paragraph [0148] discloses “The curvature enables the implantable object to be more easily oriented parallel to the surface of the skin”; in other words, with Bardy’s invention, the distance between the implantable object and the patient’s skin does not change.
Applicant argues that “It is not clear at which point in Bardy a flexible monitor should be disclosed. Rather, Bardy contains no statement on the design of the monitor” (Remarks, page 9).
Bardy discloses that the implantable object may be a heart monitor (paragraph [0061]) and that the implantable object can ”include solid or semi-solid materials … Other sizes, shapes, and types of non-liquid implantable objects are possible.” (paragraph [0063]). Furthermore, in some embodiments (e.g. Fig. 2B) the insertion tool/shaft is curved, and therefore the implantable object (the monitor) must be at least partially flexible otherwise it would get stuck and not be able to slide through the curved shaft. Although Bardy does not explicitly disclose that the heart monitor is flexible, von Arx explicitly states that the implantable cardiac monitor can be flexible (paragraph [0034]).
Applicant argues that “It is not disclosed that the implantable flexible monitor includes an open circular shape. Although the implantation tool according to Figure 2b has a curved structure, this does not mean that the implant to be inserted also has such a structure. If the implant inserted is sufficiently short, it can also be inserted via the curve” (Remarks, page 9).
Examiner respectfully disagrees. The term “open-circular shape” is broadly recited. Thus, this term can be interpreted as any shape that is part of a circle, which includes shapes that are sufficiently short. Bardy discloses that “The critical dimension is the cross-sectional profile, that is, the height and width, of the implant, which must conform to passage through the syringe body and incising shaft bores. Other non-linear, prismatic shapes are equally usable provided the implantable object can fit within the confines of the syringe body and incising shaft bores” (paragraph [0063]). “Non-linear, prismatic shapes” includes shapes that are a part of a circle. Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). It is recommended by the Examiner that additional limitations be added to the independent claims further specifying the “open-circular shape” in order to overcome the current art of record.
Applicant further argues that “If it were as long as claimed by the examiner, this implant would be pushed back up out of the skin, as the existing bending direction of the tool would cause the implant to be aligned upwards.” (Remarks, page 10).
Examiner respectfully disagrees. Bardy discloses that “The curvature [of the curved incising shaft 24] helps regulate the penetration depth of the incising shaft” (paragraph [0070]) and that “The curvature enables the implantable object to be more easily oriented parallel to the surface of the skin” (paragraph [0148]). Thus, Bardy discloses that the curvature of the shaft aids in alignment of the implantable object with the surface of the skin.
Applicant argues:
The examiner claims that it is known from Bardy that the base bottom, the base sidewalls, and the base surface are arranged along the open circular shape of the implantation tool. In addition, the examiner adds to the arguments of the last response to the office action that it is not clear which surface would be the at least partially open surface. In addition, the examiner interprets the slanted opening as an at least partially open surface. However, if the examiner interprets this opening as an at least partially open surface, it is clear that it is straight in all embodiments. According to the claim, however, this at least partially open surface is arranged along the open circular shape of the implantation tool and thus follows the circular extension of the tool. Accordingly, this feature is neither known from Bardy nor suggested by it. There is no circular partially open surface disclosed.
(Remarks, page 10)
Examiner respectfully disagrees. There is no specific frame of reference recited in the claim for what directions the “bottom”, “base”, or “side” walls are located. Therefore, the claim can be interpreted such that “a base surface which is at least partially open” is any surface of the base. Therefore, the opening illustrated below in Bardy’s curved incising shaft is analogous to the partially open base surface.
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Applicant argues that “The examiner claims that it is known from von Arx that the cardiac monitor is made from an FPCB. Reference is made to paragraph 34 in this regard. However, this merely discloses control units and their function, as well as the possibility of making them flexible. This does not correspond to an FPCB. Nor is it disclosed that no housing is used, but rather that it can be flexible” (Remarks, page 10).
Examiner respectfully disagrees. Von Arx discloses that “the IMD 2 may include an IMD proximal portion 23 having a first electrically active area connected by the connection to an IMD distal portion 22 having a second electrically active area” (paragraph [0032]).
Applicant argues that “The statements regarding Cao's alleged disclosure are also incorrect. Cao does not disclose an open circular shape, but only three electrodes arranged at an angle. Figure 2 E shows a kind of boomerang shape, but not a partial circle shape. Here, only an opening angle between two vectors is disclosed, but not a circle on which these electrodes are arranged. Thus, it cannot be obvious to manufacture an implantation tool with a circular shape extending over an angle of 90 to 400°” (Remarks, page 10).
As explained above, the term “open-circular shape” is broadly recited and can be interpreted as any shape that is part of a circle, or a “partial circle shape”. A circle can be formed from any three points of a triangle (“Circumcircle of a Triangle.” Circumcircle of a Triangle - Math Open Reference, 2011, www.mathopenref.com/trianglecircumcircle.html). Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). It is recommended by the Examiner that additional limitations be added to the independent claims further specifying the “open-circular shape” in order to overcome the current art of record.
Applicant argues that “With regard to Rogers' alleged disclosure, it is also impossible to identify where in paragraph 198 an FPCB is disclosed, nor its exact structure. Paragraph 198 merely describes the structure of transistors, using different metallic layers, without disclosing whether any of these layers is used as a signal-transmitting layer, which would also be unusual since only one transistor is included” (Remarks, page 11).
Examiner respectfully disagrees. Claim 1 recites “a signal layer”, not “a signal transmitting layer”, as Applicant alleges. “A signal layer” can be interpreted as a layer capable of passing electrical signals through it, which includes the transistors and the layers of metal interconnect disclosed by Rogers. The structure of Rogers’s FPCB is illustrated in Figs. 1a and 1b, and described in paragraph [0198], which discloses that “transfer printing delivers to a flexible plastic substrate (polyimide; ~25 μm) an organized collection of single crystalline, semiconductor grade silicon nanomembranes (260 nm) with patterned regions of doping for ohmic contacts (FIG. 1a)”.
Therefore, the rejection of claim 1 under 35 U.S.C. 103 is maintained below.
No specific arguments were made regarding dependent claims 2, 4-8, and 16-23. Therefore, claims 2, 4-8, and 16-23 are also rejected below.
Claim Objections
Claims 1, 2, and 4 are objected to because of the following informalities:
Claim 1, page 2:
“the skin of a living body” in line 3 should read “a skin of a living body”
“open circular” in line 21 should be omitted
Claim 2: “wherein the main circuit (5) of the implantable, flexible multi-lead cardiac monitor (1) comprises a base made of the FPCB (5a)” in lines 2-3 should read “wherein the main circuit (5) of the implantable, flexible multi-lead cardiac monitor (1) further comprises”
“a base made of the FPCB” is already disclosed in claim 1
Claim 4: a comma should be added after “handle” in line 8
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 1-2, 4-8, and 16-23 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 “at least two sensing electrodes” on page 2, lines 9-10, and recites “at least three sensing electrodes” on page 3, lines 14-15. It is unclear as to how many electrodes are required, or whether the at least three sensing electrodes are part of the at least two sensing electrodes established on page 2. For the purposes of examination, “at least three sensing electrodes” will be interpreted as “the at least two sensing electrodes”.
Claims 2, 4-8, 10-11, and 16-25 are also rejected because they are dependent on claim 1.
Claim 8 recites “three or more sensing electrodes” in line 2. It is unclear as to whether these sensing electrodes are part of the “at least two sensing electrodes” established in claim 1. For the purposes of examination, “three or more sensing electrodes” will be interpreted as “three or more sensing electrodes of the at least two sensing electrodes”.
Claim 22 recites “three or more sensing electrodes” in line 2. It is unclear as to whether these sensing electrodes are part of the “at least two sensing electrodes” established in claim 1. For the purposes of examination, “three or more sensing electrodes” will be interpreted as “three or more sensing electrodes of the at least two sensing electrodes”.
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.
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.
Claims 1-2, 4-8, 10, 17-18, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bardy (US Publication No. 20100331868 A1, previously cited) in view of von Arx et al. (EP 3263056 A1, previously cited), hereinafter von Arx, Cao et al. (US Publication No. 20010034487 A1, previously cited), hereinafter Cao, and Rogers et al (US Publication No. 20120157804 A1, previously cited), hereinafter Rogers.
Regarding claim 1, Bardy discloses a kit configured for implanting an implantable, flexible multi-lead cardiac monitor configured for recording biosignals when the implantable, flexible multi-lead cardiac monitor is placed under the skin of a living body (Figs. 1-4; paragraphs [0019], [0059], [0061]), the kit comprising:
the implantable, flexible multi-lead cardiac monitor (paragraph [0061], implantable object may be a heart monitor),
an implantation tool configured for implanting the implantable, flexible multi-lead cardiac monitor under the skin (Figs. 1-4; paragraphs [0059], [0066], [0071]-[0078]; instrument 10),
wherein the implantable, flexible multi-lead cardiac monitor includes an open-circular shape (Fig. 2B, paragraph [0070], the implantable object must have a curved shape in order to fit into the curved implantation tool),
wherein the implantation tool exhibits an open-circular shape to reversibly receive the open-circular implantable, flexible multi-lead cardiac monitor (Fig. 2B, paragraph [0070]), the implantation tool including:
a base, configured to accommodate reversibly the implantable, flexible multi-lead cardiac monitor (Figs. 1, 2B, 5A-5B; paragraphs [0064], [0066]-[0068], [0112]; incising shaft 11, syringe body 15),
a handle connected to the base and configured to hold and position the implantation tool (Figs. 1, 2B; paragraph [0069]; collar 21), and
a slider, which is reversibly insertable into the base and configured to push the implantable, flexible multi-lead cardiac monitor out of the implantation tool to a final position (Figs. 1, 2B, 3; paragraphs [0059], [0065], [0068], [0071]; plunger 16, plunger assembly 20),
wherein the base includes a base bottom, base sidewalls, and a base surface (see annotated Fig. 1 below) which is at least partially open to allow the slider (plunger assembly 20) to slide along the base bottom to push the implantable, flexible multi-lead cardiac monitor out of the base (Figs. 29-30, paragraphs [0123], [0125], [0128]-[0130], [0133]-[0134]), and
wherein the base bottom, the base sidewalls and the base surface are arranged along the open-circular shape of the implantation tool (Fig. 2B, paragraph [0070]).
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Bardy does not explicitly disclose that the implantable, flexible multi-lead cardiac monitor is based on a flexible printed circuit board (FPCB) with at least two sensing electrodes and optionally a ground electrode. Bardy also does not explicitly disclose that the implantable, flexible multi-lead cardiac monitor includes a main circuit based on the FPCB, and that the cardiac monitor is free of a casing.
However, von Arx teaches a tunneling-implantation tool used to carry an implantable medical device (Abstract), specifically a cardiac monitor (paragraph [0002]) that is based on a flexible printed circuit board (paragraph [0034]) with at least two sensing electrodes (paragraph [0033], first and second electrically active areas, electrodes 25 and 26).
Von Arx further teaches that the cardiac monitor includes a main circuit based on the FPCB (paragraph [0034]), and that the cardiac monitor is free of a rigid metal casing (paragraphs [0020], [0022]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy with the teachings of von Arx to use an FPCB with at least two sensing electrodes because a flexible printed circuit board enables better manipulation and positioning of the device for better sensing capabilities while also minimizing damage to the incision site (von Arx, paragraphs [0006]-[0013], [0031]), and because sensing electrodes enable monitoring of biological functions (von Arx, paragraphs [0002], [0032]). Furthermore, using a non-rigid casing reduces cosmetic visibility of the device (von Arx, paragraph [0004]) and minimizes the incision size, thus reducing the risk of infection (von Arx, paragraph [0004]).
Neither Bardy nor von Arx explicitly discloses that the open-circular shape of the flexible multi-lead cardiac monitor and of the implantation tool includes a circumference of an angle of between 90° and 400°, to allow placement of the at least two sensing electrodes at corners of an equilateral, isosceles or right-angled triangle have an angle of between 60° and 90°.
However, Cao teaches a medical device for multi-vector sensing of cardiac depolarization signals (Abstract) wherein the open-circular shape of the monitor and of the implantation tool includes a circumference of an angle of between 90° and 400° (Fig. 2E; paragraph [0031], multiple electrodes 3 may be circular; paragraph [0032], angle a may range from 45 to 170 degrees, which overlaps with the claimed range of 90° to 400°), to allow placement of the at least two sensing electrodes at corners of an equilateral, isosceles or right-angled triangle have an angle of between 60° and 90° (Figs. 2-3, paragraphs [0032], [0035], angle ß between the sensing electrodes 3 “may range from 45 to 170 degrees”, which includes the claimed range of 60° to 90°.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, and von Arx with the teachings of Cao to place the at least two sensing electrodes at corners of a triangle with an angle between 60° and 90° because doing so enables easy insertion while also enhancing the stability of the device within the body, and the sensitivity and ability to detect cardiac depolarization signals (Cao, paragraphs [0013], [0018], [0021]).
Furthermore, it would have been an obvious matter of design choice to make the implantable, flexible multi-lead cardiac monitor and the implantation tool have a circumference between 90° and 400°, for the purpose of making implantation easier, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Neither Bardy, nor von Arx, nor Cao explicitly discloses that the FPCB is a layered composite material comprising a first conductive material layer capable to act as electrodes, a first dielectric layer, a signal layer, and/or a further dielectric layer, wherein the at least two sensing electrodes and the base of the main circuit are made from the same FPCB.
However, Rogers teaches an implantable, flexible biomedical device (Abstract, Fig. 1) wherein the FPCB is a layered composite material comprising:
a first conductive material layer capable to act as electrodes (paragraph [0198], "The top metal layer defines surface electrodes ... that contact the cardiac tissue and connect to the underlying circuits through via holes"),
a first dielectric layer (paragraph [0198], gate dielectric, interlayer dielectric),
a signal layer (paragraph [0198], "first layer of metal interconnect"), and/or
a further dielectric layer (paragraph [0198], gate dielectric, interlayer dielectric),
wherein the at least two sensing electrodes and the base of the main circuit are made from the same FPCB (paragraph [0198], electrodes are integrated with the flexible device).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Cao with the teachings of Rogers so that the FPCB is a layered composite material comprising a first conductive material layer capable to act as electrodes, a first dielectric layer, a signal layer, and/or a further dielectric layer, wherein the at least two sensing electrodes and the base of the main circuit are made from the same FPCB, because doing so enables a high density of active electrodes on an EP device, without the need for a connecting wire between each element (Rogers, paragraph [0196]).
Regarding claim 2, the kit according to claim 1 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Bardy does not disclose that the main circuit of the implantable, flexible multi-lead cardiac monitor comprises a base, an amplifier, a controller, a battery, a memory, a transmitter or transceiver, a DC-restorer, or a feedback circuit. Von Arx further teaches that the main circuit of the cardiac monitor comprises a base layer of the FPCB (paragraph [0034], circuit boards), an amplifier (paragraph [0034], amplifiers), a controller (paragraph [0034], control unit), a battery (paragraph [0034], batteries), a memory (paragraph [0034], memory), and a transmitter or transceiver (paragraph [0034], transmitters, transceiver circuitry).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy with the teachings of von Arx to provide a main circuit with a base layer of the FPCB, an amplifier, a battery, a memory, and a transmitter or transceiver because doing so enables the cardiac monitor to transmit, receive, store, and acquisition analog and digital signals and perform signal processing remotely (von Arx, paragraph [0034]).
Regarding claim 4, the kit according to claim 1 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Bardy further discloses that the base (incising shaft 11 and syringe body 15) and handle (collar 21, which is part of syringe body 15 per paragraph [0069]) are made of stainless steel or synthetic materials (paragraphs [0066], [0082], [0096], [0128]-[0129]). Bardy also discloses that the slider (plunger assembly 20) is made of stainless steel or synthetic material (paragraphs [0091], [0104], [0133]).
Regarding claim 5, the kit according to claim 1 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Neither Bardy nor von Arx discloses that the outer diameter of the implantable, flexible multi-lead cardiac monitor ranges from 3 to 20 cm; and/or the inner diameter of the implantable, flexible multi-lead cardiac monitor ranges from 2 to 18 cm.
However, Rogers teaches an implantable, flexible biomedical device (Abstract, Fig. 26) wherein the inner diameter of the device is about 5 cm (paragraph [0200], radius of curvature R is about 2.5 cm), which is within the claimed range of 2 to 18 cm.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Cao with the teachings of Rogers to make the cardiac monitor with an inner diameter of 2 to 18 cm because doing so lends itself to incorporation with existing long-term monitoring devices (Rogers, paragraph [0345]), and allows the device to be delivered percutaneously or endovascularly (Rogers, paragraph [0339]).
Furthermore, it would have been an obvious matter of design choice to make the cardiac monitor with an outer diameter of 3 to 20 cm; and/or an inner diameter of 2 to 18 cm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 6, the kit according to claim 1 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Neither Bardy nor von Arx explicitly discloses that the electrodes and the optional ground electrode are integrated into the flexible printed circuit board (FPCB), wherein the sensing electrodes are arranged to form the corners of a polygon, in particular an equilateral, right-angled or equiangular polygon, and wherein the sensing electrodes comprise a pre-amplifier or buffer.
However, Rogers teaches an implantable, flexible biomedical device (Abstract, Fig. 26) wherein the sensing electrodes are integrated into the FPCB (paragraphs [0254], [0256]), and wherein the sensing electrodes comprise an amplifier (paragraphs [0038], [0060], [0197], [0199], [0204], [0357]).
It would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Cao with the teachings of Rogers because integrating sensing electrodes into the FPCB eliminates spatial constraints of the device (Rogers, paragraph [0194]), and the amplifier provides significant current gain to enable fast switching of multiplexers (Rogers, paragraph [0204]).
Furthermore, Rogers does not disclose that the sensing electrodes are arranged to form the corners of a polygon. However, Cao discloses a medical device for multi-vector sensing of cardiac depolarization signals (Abstract) wherein the sensing electrodes are arranged to form the corners of a polygon, in particular a right-angled polygon (Fig. 2, paragraph [0032], angle ß can be 90°). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Rogers with the teachings of Cao to arrange the sensing electrodes to form the corners of a right-angled polygon because doing so enables easy insertion while also enhancing the stability of the device within the body, and the sensitivity and ability to detect cardiac depolarization signals (Cao, paragraphs [0013], [0018], [0021]).
Furthermore, it would have been an obvious matter of design choice to arrange the sensing electrodes to form the corners of a polygon, for the purpose of improving signal quality and accuracy, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to arrange the at least two sensing electrodes to form the corners of a polygon, for the purpose of improving signal measurement accuracy, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 7, the kit according to claim 2 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Although both Bardy (paragraphs [0004]-[0005], [0061]) and von Arx (paragraphs [0002], [0033]-[0034]) disclose a cardiac monitor with electronic components, neither explicitly discloses that the at least two sensing electrodes, the base of the main circuit and the optional ground electrode are made from the same flexible printed circuit board (FPCB), the amplifier, the controller, the optional battery, the memory, and the optional transmitter or transceiver, the optional DC-restorer, and/or the optional feedback circuit are connected to the base and thus to the main circuit, by soldering, welding, bonding, and/or gluing; and optionally at least the side of the FPCB, which is opposite to the electrodes is coated with the dielectric coating.
However, Rogers further teaches that the at least two sensing electrodes and the base of the main circuit are made from the same FPCB (paragraph [0198], electrodes are integrated with the flexible device), and circuit elements, control elements, microprocessors are connected to the base by wire bonding (paragraphs [0161]-[0162]).
It would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Cao with the teachings of Rogers to include the sensing electrodes and the base of the main circuit on the same FPCB, to connect the electronic components to the main circuit by wire bonding, and to apply a dielectric coating to the FPCB. Integrating sensing electrodes into the FPCB eliminates spatial constraints of the device (Rogers, paragraph [0194]). Using a flexible connection establishes and maintains electrical contact between device components while also enabling movement and bending of the device in response to a patient's anatomy (Rogers, paragraph [0161]). A dielectric barrier layer protects tissue and electronic components from damage due to leakage current (Rogers, paragraphs [0043], [0166]).
Regarding claim 8, the kit according to claim 7 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Neither Bardy, nor von Arx, nor Rogers explicitly disclose that the open-circular shape of the implantable, flexible multi-lead cardiac monitor and of the implantation tool includes a circumference of an angle of between 90° and 400°, to allow placement of the at least two sensing electrodes at corners of an equilateral, isosceles or right-angled triangle have an angle of between 60° and 90°.
However, Cao teaches a medical device for multi-vector sensing of cardiac depolarization signals (Abstract) wherein the open-circular shape of the monitor and of the implantation tool includes a circumference of an angle of between 90° and 400° (Fig. 2E; paragraph [0031], multiple electrodes 3 may be circular; paragraph [0032], angle a may range from 45 to 170 degrees, which overlaps with the claimed range of 90° to 400°), to allow placement of the at least two sensing electrodes at corners of an equilateral, isosceles or right-angled triangle have an angle of between 60° and 90° (Figs. 2-3, paragraphs [0032], [0035], angle ß between the sensing electrodes 3 “may range from 45 to 170 degrees”, which includes the claimed range of 60° to 90°.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Rogers with the teachings of Cao to place the at least two sensing electrodes at corners of a triangle with an angle between 60° and 90° because doing so enables easy insertion while also enhancing the stability of the device within the body, and the sensitivity and ability to detect cardiac depolarization signals (Cao, paragraphs [0013], [0018], [0021]).
Regarding claim 17, the kit according to claim 2 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Von Arx further teaches that the cardiac monitor further comprises a battery (paragraph [0034]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy and Cao with the teachings of von Arx to include a battery because doing so enables the device to operate independently of an external power source.
Regarding claim 18, the kit according to claim 4 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Neither Bardy, nor von Arx, nor Cao explicitly discloses that the flexible printed circuit board (FPCB) of the implantable, flexible multi-lead cardiac monitor further comprises an adhesive layer, a further signal layer, and/or a solder mask layer.
However, Rogers teaches an implantable, flexible biomedical device (Abstract, Fig. 26) wherein the flexible printed circuit board (FPCB) of the implantable, flexible multi-lead cardiac monitor comprises an adhesive layer (paragraphs [0018], [0038], [0205]-[0206], [0264]-[0266]) and a further signal layer (paragraph [0060], semiconductor and metal layers; paragraph [0154], functional layer; paragraph [0156], conducting layer).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Cao with the teachings of Rogers so that the FPCB further comprises an adhesive layer and a further signal layer, because doing so enables the electronic components to be attached to a variety of flexible substrates (Rogers, paragraph [0264]), and using a flexible connection establishes and maintains electrical contact between device components while also enabling movement and bending of the device in response to a patient's anatomy (Rogers, paragraph [0161]).
Regarding claim 21, the kit according to claim 17 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Although both Bardy (paragraphs [0004]-[0005], [0061]) and von Arx (paragraphs [0002], [0033]-[0034]) disclose a cardiac monitor with electronic components, neither explicitly discloses that the battery, the DC-restorer, and/or the feedback circuit are connected to the base and thus to the main circuit, by soldering, welding, bonding, and/or gluing.
However, Rogers teaches an implantable, flexible biomedical device (Abstract, Fig. 26) wherein the circuit elements, control elements, microprocessors are connected to the base by wire bonding (paragraphs [0161]-[0162]).
It would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Cao with the teachings of Rogers to include the sensing electrodes and the base of the main circuit on the same FPCB, to connect the electronic components to the main circuit by wire bonding, and to apply a dielectric coating to the FPCB because using a flexible connection establishes and maintains electrical contact between device components while also enabling movement and bending of the device in response to a patient's anatomy (Rogers, paragraph [0161]).
Regarding claim 23, the kit according to claim 4 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above.
Bardy further discloses that the base (incising shaft 11 and syringe body 15) and handle (collar 21, which is part of syringe body 15 per paragraph [0069]) are made of stainless steel or synthetic materials (paragraphs [0066], [0082], [0096], [0128]-[0129]). Bardy also discloses that the slider (plunger assembly 20) is made of stainless steel or synthetic material (paragraphs [0091], [0104], [0133]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the base and handle from stainless steel, titanium, nickel-titanium, cobalt-chrome, and/or alloys, for the purpose of making the device biocompatible and sterilizable (Bardy, paragraph [0082]), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 16, 19-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bardy (US Publication No. 20100331868 A1, previously cited) in view of von Arx et al. (EP 3263056 A1, previously cited), hereinafter von Arx, Cao et al. (US Publication No. 20010034487 A1, previously cited), hereinafter Cao, and Rogers et al (US Publication No. 20120157804 A1, previously cited), hereinafter Rogers, and further in view of Acquista et al. (US 20140275928 A1, previously cited), hereinafter Acquista.
Regarding claim 16, the kit according to claim 1 is obvious over Bardy, von Arx, Cao, and Rogers, as explained above. Bardy further discloses that the implantation tool further comprises a surgical knife (Fig. 1, paragraph [0060], surgically sharp cutting edge 13). Although Cao further teaches that any combination of electrodes can be used to take measurements (paragraph [0041], neither Bardy nor von Arx, nor Cao explicitly discloses that the flexible printed circuit board further comprises a ground electrode.
However, Acquista teaches a device for detecting an ECG signal of a subject (Abstract) comprising a ground electrode in addition to three sensing electrodes (paragraph [0060]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, and Cao with the teachings of Acquista to include a ground electrode because doing so helps reduce artefacts in the measured signal (Acquista, paragraph [0060]).
Regarding claim 19, the kit according to claim 16 is obvious over Bardy, von Arx, Cao, Rogers, and Acquista, as explained above. Although both Bardy (paragraphs [0004]-[0005], [0061]) and von Arx (paragraphs [0002], [0033]-[0034]) disclose a cardiac monitor with electronic components, neither explicitly discloses that the ground electrode is integrated into the flexible printed circuit board.
However, Rogers teaches an implantable, flexible biomedical device (Abstract, Fig. 26) wherein electrodes and the base of the main circuit are made from the same FPCB (paragraphs [0254], [0256]).
It would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, Cao, and Acquista with the teachings of Rogers to integrate the ground electrode into the flexible printed circuit board, because doing so eliminates spatial constraints of the device (Rogers, paragraph [0194]).
Regarding claim 20, the kit according to claim 16 is obvious over Bardy, von Arx, Cao, Rogers, and Acquista, as explained above. Although both Bardy (paragraphs [0004]-[0005], [0061]) and von Arx (paragraphs [0002], [0033]-[0034]) disclose a cardiac monitor with electronic components, neither explicitly discloses that the ground electrode is made from the same flexible printed circuit board (FPCB) as the at least two sensing electrodes, and the base of the main circuit, and/or at least the side of the FPCB, which is opposite to the electrodes, is coated with the dielectric coating.
However, Rogers teaches an implantable, flexible biomedical device (Abstract, Fig. 26) wherein electrodes and the base of the main circuit are made from the same FPCB (paragraphs [0254], [0256]).
Rogers further teaches that the FPCB is coated with a dielectric coating (paragraphs [0011], [0014]-[0015], [0024], [0044], [0179], [0257], barrier layer comprising dielectrics).
It would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, Cao, and Acquista with the teachings of Rogers so that the ground electrode is made from the same flexible printed circuit board (FPCB) as the at least two sensing electrodes, and the base of the main circuit, and/or at least the side of the FPCB, which is opposite to the electrodes, is coated with the dielectric coating. Integrating sensing electrodes into the FPCB eliminates spatial constraints of the device (Rogers, paragraph [0194]). A dielectric barrier layer protects tissue and electronic components from damage due to leakage current (Rogers, paragraphs [0043], [0166]).
Regarding claim 22, the kit according to claim 20 is obvious over Bardy, von Arx, Cao, Rogers, and Acquista, as explained above. Although Acquista teaches a cardiac monitor comprising three sensing electrodes and a ground electrode (paragraph [0060], neither Bardy, nor von Arx, nor Rogers explicitly disclose that the at least three sensing electrodes are arranged on the same surface of the implantable, flexible multi-lead cardiac monitor to form the corners of an equilateral, isosceles or right-angled triangle having an angle of between 60° and 90°, in particular between 75° and 90°, in order to make use of Eindhoven's triangle, and wherein the ground electrode is arranged between two sensing electrodes, preferably on the same surface of the implantable, flexible multi-lead cardiac monitor.
However, Cao teaches a medical device for multi-vector sensing of cardiac depolarization signals (Abstract) wherein three sensing electrodes are arranged on the same surface of the medical device (Fig. 2E; paragraph [0031]), to form the corners of an equilateral, isosceles or right-angled triangle have an angle of between 60° and 90° (Figs. 2-3, paragraphs [0032], [0035], angle ß between the sensing electrodes 3 “may range from 45 to 170 degrees”, which includes the claimed range of 60° to 90°.). Cao further teaches that one of the three electrodes is arranged between two sensing electrodes on the same surface of the medical device (Fig. 2C, paragraph [0035], electrode b).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bardy, von Arx, Acquista and Rogers with the teachings of Cao to place the at least two sensing electrodes at corners of a triangle with an angle between 60° and 90° because doing so enables easy insertion while also enhancing the stability of the device within the body, and the sensitivity and ability to detect cardiac depolarization signals (Cao, paragraphs [0013], [0018], [0021]).
Furthermore, would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to arranged the ground electrode between two sensing electrodes, for the purpose of improving signal accuracy, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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