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 .
Applicant' s arguments, filed 7/16/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 7/16/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-21 are the currently pending claims hereby under examination, with claims 1, 11, and 19 newly amended.
Claim Interpretation
Claim 12 recites “comprising wiring that is located on a single side of the substrate ”in lines 1-2 and Claim 14 recites “the sensor and the plurality of sensor electrodes are on a same side of the substrate" in lines 1-2. While this initially appears to conflict with the need for the electrodes to contact the patient’s skin and the sensor to be externally accessible, the specification (see ¶[0048]–[0051]) and Figures 18 and 19 support a configuration in which the substrate is folded along a folding line such that the sensor and electrodes (although initially positioned on the same side) become located on opposite effective sides after folding. This allows the electrodes to contact the skin while the sensor remains accessible. Additionally, under a broadest reasonable interpretation, the claim would also be satisfied by a configuration in which both the sensor and electrodes are mounted on the same side of the substrate, and the electrodes are configured to penetrate or extend through the substrate to contact the skin on the opposite side. Accordingly, the Examiner is interpreting this claim to cover either folding or through-substrate routing approaches.
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.
Claims 1, 6-7, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over by Hirschman (US 6408204 B1), hereto referred as Hirschman, and further in view of Ollmar et al. (US 20070161881 A1), hereto referred as Ollmar.
Regarding claim 1, Hirschman teaches that a sensor device (Hirschman, Abstract: "An apparatus for the detection of extravasation is positioned in a manner so that the vicinity of a site is available for palpation and is visible for visual inspection", describing a sensor apparatus for detecting extravasation) comprises a sensor that receives electrical signals from a patient's skin when the sensor device is attached to the patient's skin (Hirschman, col. 4, ll. 22–36: "The present invention also provides a system for the detection of extravasation... Such sensors can be formed as described above. For example, the first Sensor may include at least a first energy source to supply energy to tissue in the vicinity of a site and at least a first receiver for measuring a signal resulting from the energy supplied to the tissue by the first energy source", describing a sensor module including signal application and detection circuitry referred to as "electronic control 32g” (col. 6-7, ll. 57–12); col. 2–3, ll. 66–8: “the energy source and the receiver contact the skin of a patient”; this demonstrates that the sensor device is positioned so that its components make direct contact with the patient’s skin, thereby enabling the sensor to receive electrical signals from the skin when attached).
Also regarding claim 1, Hirschman partially teaches that the apparatus comprises a plurality of sensor electrodes including: a first sensor electrode electrically connected to the sensor and including a first inner electrode and a first outer electrode surrounding the first inner electrode; and a second sensor electrode electrically connected to the sensor and including a second inner electrode and a second outer electrode surrounding the second inner electrode. Specifically, Hirschman teaches the use of multiple electrodes sets, electrically connected to a sensor system, arranged around an injection site and selectable in pairs for applying energy and measuring signals (Hirschman, Abstract, FIG. 3B, 4; col. 6–7, ll. 57–12: “the electronic control 32g can switch in/on the outer electrode pair 31a·f and any of the inner electrode pairs such as 31b·c, 31b·d, 31c·e”). Hirschman, however, discloses these electrodes in a planar arrangement and does not describe a structure in which an inner electrode is surrounded by an outer electrode (concentric). Ollmar teaches a concentric electrode configuration in which an inner electrode is surrounded by an outer electrode for application to a patient’s skin (Ollmar, ¶[0033]–[0035]; FIG. 1). When the concentric geometry taught by Ollmar is applied to the multiple electrode sets of Hirschman, each planar electrode set in Hirschman is replaced with a corresponding concentric inner–outer set from Ollmar. The result is a first sensor electrode and a second sensor electrode, each comprising an inner electrode surrounded by an outer electrode, while maintaining the overall four-electrode configuration shown in Hirschman. 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 have modified Hirschman in view of Ollmar to implement concentric inner/outer geometry for Hirschman’s multiple electrode sets. This modification is feasible because both planar electrodes and concentric electrodes are designed for impedance measurement at the skin surface, and substituting one known electrode structure for another is a straightforward design choice. The predictable benefit of this substitution is improved current uniformity, reduced distortion, and enhanced accuracy of extravasation detection.
Also regarding claim 1, the combined Hirschman and Ollmar connotes that the first outer electrode of the first sensor electrode and the second outer electrode of the second sensor electrode detect a current applied between the first outer electrode and the second outer electrode. Specifically, the combination discloses concentric electrodes with an inner and outer electrode as discussed above. Hirschman further discloses the use of electrode pairs consisting of an energy source and a receiver positioned around an injection site for extravasation detection (Hirschman, FIG. 3B; col. 3, ll. 29–46). These electrodes function in a paired fashion, applying energy at one location and detecting a resulting signal at another, which is consistent with the functional concept of current flowing between electrodes. Furthermore, Hirschman explicitly describes that “the electronic control 32g can switch in/on the outer electrode pair 31a·f,” which provides direct evidence that current is applied across and measured between the outer electrodes spanning a tissue region (Hirschman, col. 6–7, ll. 57–12). This shows that Hirschman supports current delivery and signal response across a defined path through tissue—functionally equivalent to applying current between outer electrodes as claimed. However, Hirschman does not disclose a concentric configuration where outer electrodes surround inner ones. Ollmar fills this structural gap. While Ollmar elsewhere describes a four-electrode arrangement, ¶[0033] explicitly teaches “at least one pair of electrodes arranged concentrically around a center,” which directly supports the claimed configuration where each sensor electrode comprises an inner electrode and an outer electrode (Ollmar, ¶[0033]–[0035], FIG. 1). When Hirschman’s outer electrodes are implemented with Ollmar’s concentric geometry, each planar set in Hirschman is substituted with a concentric set. In this arrangement, the outer electrode of the first concentric set and the outer electrode of the second concentric set define the current path across the tissue, while maintaining the overall four-electrode configuration of Hirschman. This structural teaching enables a transition from the parallel electrode layout in Hirschman to a concentric arrangement, while still supporting the function of current injection and impedance measurement. 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 have modified Hirschman in view of Ollmar to detect current applied between outer electrodes that are concentric with inner electrodes. The benefit of this modification would be to enhance spatial targeting of current flow through the injection site region, reducing distortion in the impedance field and improving measurement uniformity and reliability.
Also regarding claim 1, the combined Hirschman and Ollmar connotes that the first inner electrode of the first sensor electrode and the second inner electrode of the second sensor electrode detect a voltage applied between the first inner electrode and the second inner electrode. Specifically, the combination discloses concentric electrodes with an inner and outer electrode as discussed above. Hirschman further teaches that signal detection can occur between specific electrode pairs. For example, “the electronic control 32g can switch in/on... any of the inner electrode pairs such as 31b·c, 31b·d, 31c·e,” enabling the system to select different pairs of electrodes for measurement depending on the targeted tissue region (Hirschman, col. 6–7, ll. 57–12). This language indicates that inner electrodes can be electrically paired and used to detect differential signals across tissue. Additionally, Hirschman explains that the sensor system includes “at least a first receiver for measuring a signal resulting from the energy supplied to the tissue” (Hirschman, col. 4, ll. 22–36), and earlier states that the signal comprises a voltage resulting from tissue interaction with applied electromagnetic energy (Hirschman, col. 2, ll. 53–65). These citations support the view that the system detects voltage between selected electrodes after current has been applied, consistent with the well-established Kelvin method. The paired orientation of electrodes across an injection site (Hirschman, col. 3, ll. 29–46; FIG. 3B) further reinforces the concept of voltage being sensed between designated electrodes. While Hirschman provides the functionality of selective voltage sensing between electrode pairs, it does not describe a concentric structural arrangement in which inner electrodes are surrounded by outer current-driving electrodes. Ollmar fills this structural gap. Ollmar teaches the use of “two sensing electrodes for measuring the voltage or potential of body tissue,” positioned within a set of concentric electrodes (Ollmar, ¶[0032]; FIG. 1). When Hirschman’s inner electrodes are implemented with Ollmar’s concentric geometry, each planar set in Hirschman is substituted with a concentric set. In this arrangement, the inner electrode of the first concentric set and the inner electrode of the second concentric set provide the differential voltage measurement across the tissue, while maintaining the overall four-electrode configuration of Hirschman. Although the overall system in Ollmar includes four electrodes, the relevant teaching here is the concentric positioning of inner electrodes within outer electrodes, which aligns with the claimed inner/outer relationship under the broadest reasonable interpretation. 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 have modified Hirschman in view of Ollmar to measure voltage between inner electrodes that are concentric to outer current electrodes. The benefit of this modification would be to reduce signal noise and measurement artifacts, enabling more reliable voltage detection for identifying changes in physiological conditions such as extravasation.
Regarding claim 6, in view of the modification established in the rejection of Claim 1, Hirschman is understood to teach wherein the plurality of sensor electrodes is four sensor electrodes (Hirschman, FIG. 4: shows an arrangement including four inner electrodes 54a–54d and four outer electrodes 52a–52d around opening 59; col. 7-8, ll. 65–25: describes inner and outer electrodes arranged around the site of interest). As established in the rejection of Claim 1, Hirschman describes electrode pairs in a parallel configuration, while Ollmar provides the concentric structure. Thus, Claim 6 does not require a new modification but rather follows directly from the combination already made. 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 interpret the four inner/outer electrode pairs of Hirschman as four sensor electrodes with a concentric structure, in light of the previously combined teachings of Ollmar. The benefit of this interpretation is the same as in the rejection of Claim 1: to enable complete and symmetric coverage of the injection site, allowing for precise impedance measurement from multiple directions around the target region.
Regarding claim 7, Hirschman indirectly teaches that the plurality of sensor electrodes is three sensor electrodes. Hirschman discloses two- and four-electrode configurations for measuring impedance around an injection site (Hirschman, FIG. 3B and FIG. 4). Additionally, Hirschman teaches that electrode pairs may be selectively activated or switched via electronic control 32g, allowing flexible use of different combinations of available electrodes (Hirschman, col. 6–7, ll. 57–12). This implies that not all electrodes need to be used at once, and that the number of active sensor electrodes can be varied based on the needs of the system. A person of ordinary skill in the art would understand from Hirschman that sensor design is flexible and adaptable, and would consider using three sensor electrodes as a natural variant between the disclosed two- and four-electrode designs. Such a configuration could be selected to optimize spatial resolution, signal balance, or physical fit depending on clinical requirements. 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 have modified the number of electrodes in Hirschman’s system to include three sensor electrodes. The benefit of this modification would be to reduce system complexity, conserve space on the substrate, and better accommodate patient-specific or application-specific constraints without impairing sensing functionality.
Regarding claim 18, the combined Hirschman and Ollmar teaches that the sensor detects intravenous infiltration or extravasation (Hirschman, FIG. 3A; Abstract: “An apparatus for the detection of extravasation is positioned in a manner so that the vicinity of a site is available for palpation and is visible for visual inspection”, and the figure depicts an intravenous needle 36).
Claims 2-5, 8-10, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over by Hirschman (US 6408204 B1), hereto referred as Hirschman, and further in view of Ollmar et al. (US 20070161881 A1), hereto referred as Ollmar, and further in view of Bay (US 20150250422 A1), hereto referred as Bay.
The combined Hirschman and Ollmar teaches claim 1 as described above.
Regarding claim 2, the combined Hirschman and Ollmar teaches that the device further comprises: a substrate including an opening (Hirschman, FIG. 3B and 4: shows a substrate structure, (44 and 46)/56 respectively, and an opening, 42/59 respectively, with electrodes positioned around an injection site).
Hirschman does not fully teach that the first sensor electrode and the second sensor electrode are on the substrate and are located about the opening. Rather, Hirschman describes sensors that are placed in proximity to an injection site but does not specify that the sensor is mounted on a substrate, although the figures imply a substrate (FIG. 3B, 4; col. 4, ll. 22–36). Bay, who investigates skin mounted electrode monitoring devices, teaches that a data collector includes a flexible foil (i.e. substrate) and a less flexible socket, where the socket is joined to the upper surface of the foil and includes a cavity that receives the processor (i.e. sensor)(Bay, ¶[0072], FIGs. 1-2). The processor engages electrical coupling elements integrated into the substrate structure, thereby completing an interface between the sensor and a foil-based substrate. The integrated foil and socket system functions as a structural platform for both adhesion and sensing, with the sensor seated directly onto the substrate structure. 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 have modified the combined Hirschman and Ollmar in view of Bay to position the sensor directly on the substrate to enable secure placement and electrical communication with electrode components. The benefit of this modification would be to enable integrated construction, modular design, and improved electrical coupling of the sensor to surrounding circuit elements, reducing complexity during assembly and use.
Regarding claim 3, the combined Hirschman and Ollmar does not fully teach that the substrate is flexible and includes an adhesive. Rather, Hirschman teaches that entire transducer 20 is flexible and that it includes stacked dielectric layers that serve as a substrate for supporting electrodes (Hirschman, col. 6, ll. 18–43). The electrodes are applied to a high dielectric layer, and a low dielectric layer is placed over the assembly. Hirschman explicitly states that “the various layers of transducer 20 can serve as a substrate” and the transducer as a whole is described as flexible (Hirschman, col. 6, ll. 18–43). Accordingly, the substrate formed by these dielectric layers is also flexible. However, Hirschman does not specify that the substrate includes an adhesive or explicitly teaches the attachment mechanism to the skin although figure 3A depicts the device attached to the skin (Hirschman, FIG. 3A). Bay teaches that the data collector comprises a flexible foil that includes an adhesive layer for adhesion to the skin surface (Bay, ¶[0072]). This adhesive component, such as a hydrocolloid adhesive, is specifically applied to the dermal side of the flexible foil. 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 have modified the combined Hirschman and Ollmar in view of Bay to include an adhesive layer as part of the flexible substrate. The benefit of this modification would be to enhance attachment of the sensor assembly to the body, improve electrical contact stability, and reduce the need for external securing mechanisms.
Regarding claim 4, the combined Hirschman and Ollmar does not teach that the sensor is detachable from the substrate. The sensor, corresponding to electronic control 32g in Hirschman, is not shown as being located on the substrate or removable from it (Hirschman, FIG. 3A; Hirschman, col. 6-7, ll. 57–12). Bay teaches a system in which the processor (sensor) is removably inserted into a socket formed in the data collector substrate. Specifically, Bay teaches a releasable locking structure adapted to hold the processor in place, which may include snap-locking engagement or controlled destruction for removal (Bay, ¶[0041], FIGs. 1-2). This provides clear support for a sensor that is detachable from the substrate while maintaining electrical connectivity (Bay, ¶[0073], FIGs. 1-2). 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 have modified the combined Hirschman and Ollmar in view of Bay to configure the sensor as a detachable module interfacing with the substrate. The benefit of this modification would be to enable sensor reuse, simplify replacement or servicing of the sensor, and reduce cost by separating disposable and reusable components.
Regarding claim 5, the combined Hirschman and Ollmar do not teach that there is a socket attached to the substrate to which the sensor is attached. Rather Hirschman teaches that the electronic control 32g (sensor) is positioned separate from the transducer structure and is not described as being mounted to the substrate (Hirschman, FIG. 3A; col. 6–7, ll. 57–12). Bay teaches that the data collector includes a flexible foil, and that a socket is attached to the upper surface of the foil. This socket forms a cavity designed to receive the processor (sensor), enabling both mechanical attachment and electrical coupling (Bay, ¶[0072]–[0073], FIGs. 1-2). The socket is specifically described as being adhesively joined to the foil substrate, forming an integrated structure to which the processor is secured (Bay, ¶[0072]). 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 have modified the combined Hirschman and Ollmar in view of Bay to include a socket on the substrate for receiving and attaching the sensor. The benefit of this modification would be to improve modularity and integration of the sensor assembly, simplifying sensor replacement and electrical interfacing within a compact form factor.
Regarding claim 8, Hirschman teaches that each of the plurality of sensor electrodes is located equidistant from the opening (Hirschman, FIG. 3B and 4: shows two electrode pairs placed on either side of the opening (42), symmetrically positioned across the injection site, and FIG. 4: shows four inner electrodes (54a–54d) and four outer electrodes (52a–52d) arranged around the opening (59) in a symmetric, spaced configuration; Hirschman teaches sensor electrodes arranged equidistantly around an opening associated with an injection site. FIG. 3B shows a pair of electrodes symmetrically placed across the opening (42), and FIG. 4 shows four inner electrodes (54a–54d) and four outer electrodes (52a–52d) arranged in a quadrilateral configuration surrounding the open region (59), consistent with equal spacing. This spatial symmetry demonstrates that the plurality of sensor electrodes are located equidistant from the central opening, as recited in the claim. When interpreted in view of the combination established in the rejection of Claim 1, where each sensor electrode comprises an inner and outer concentric electrode (per Ollmar), FIG. 4 of Hirschman shows that each such sensor electrode (i.e., each inner/outer pair) is positioned symmetrically about opening 59. Although the individual inner electrodes are closer to the opening than the outer in the figures, the combined concentric pairs of sensor electrodes would be evenly distributed, supporting the idea of "equidistant from the opening").
Regarding claim 9, the combined Hirschman and Ollmar do not explicitly teach that the plurality of sensor electrodes includes a single-structure electrode. Rather, Hirschman describes electrode arrangements composed of multiple discrete electrode elements, including configurations of inner and outer electrodes in FIG. 4. However, Hirschman does not disclose a single structural element comprising both the inner and outer electrodes — i.e., a sensor electrode fabricated as one concentric or unified structure. Bay fills this structural gap. Bay teaches a laminated data collector structure in which layer 25 is a foldable PET foil printed with both conductors and conductive ink electrodes, including multiple patterns of electrically conductive material. Bay explicitly states that these electrode patterns are printed together on the same flexible substrate layer (Bay, ¶[0080]; Table 1 ¶[0081]). This demonstrates co-fabrication of electrode elements on a single structural layer, directly supporting the concept of a single-structure electrode. 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 have modified the combined Hirschman and Ollmar in view of Bay to implement sensor electrodes formed as single-structure printed units on a shared substrate layer. The benefit of this modification would be to simplify manufacturing, reduce part count, improve alignment of electrode features, and enhance structural integrity of the sensor assembly.
Regarding claim 10, the combined Hirschman and Ollmar does not teach that the sensor communicates with a remote monitor. Rather, Hirschman teaches that the sensor includes a transmitter operatively connected to a receiver to transmit measurement signals (Hirschman, col. 4, ll. 22–36; Abstract). However, Hirschman does not disclose that this transmission is to a remote monitor or external system. The described transmitter may operate locally or within an integrated unit. Bay fills this communication gap. Bay teaches that the processor may include features for communication with external devices, including wireless communication (Bay, ¶[0026]). Bay further states that the data collector may be connected to a processor that is part of a wireless network, allowing for remote access and monitoring of physiological signals (Bay, ¶[0090]). 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 have modified the combined Hirschman and Ollmar in view of Bay to enable communication with a remote monitor or network-connected system. The benefit of this modification would be to support real-time remote monitoring, data storage, clinical oversight, or integration with broader health systems and infrastructure.
Regarding claim 16, the combined Hirschman, Ollmar and Bay teaches that the opening defines an intravenous hole (Hirschman, FIG 3B and FIG 4: Both embodiments depict an open region (42/59) and an injection site (48/58) within the opening such that the open region is an opening and the injection site is an intravenous hole).
Regarding claim 17, the combined Hirschman, Ollmar and Bay teaches that the substrate has a U-shape that defines the opening (Hirschman, FIG. 3B; Claim 100: “the base is substantially U-shaped”; where the figure depicts a U-shaped substrate such that the central region defines an opening).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over by Hirschman (US 6408204 B1), hereto referred as Hirschman, and further in view of Ollmar et al. (US 20070161881 A1), hereto referred as Ollmar, and further in view of Goodman (US RE38695 E), hereto referred as Goodman.
The combined Hirschman and Ollmar teaches claim 1 as described above.
Regarding claim 11, the combined Hirschman and Ollmar does not disclose an intravenous (IV) stabilization device. Rather, Hirschman teaches a sensor device for detecting extravasation but does not disclose or suggest the presence of an IV stabilization device (Hirschman, Abstract). Goodman, who investigates extravasation with an electrode patch, describes a patch that is placed directly over the needle tip and covers the point of insertion, physically encompassing and aligning with the IV/catheter insertion site (Goodman, col. 2, lines 42–54; col. 4, lines 15–29). The Goodman patch supports or stabilizes the needle placement by providing a sensor patch that is affixed directly over the injection point (Goodman, FIGs. 4,5). 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 have modified the combined Hirschman and Ollmar in view of Goodman to include a patch or structure that aligns with and secures the needle insertion site, effectively acting as an IV stabilization device. Physically, this could be achieved by integrating the Goodman-style electrode patch—designed to be adhered over the insertion site and encompassing the needle tip—with the sensor architecture described in Hirschman. Since both devices are skin-mounted and configured for extravasation detection, one skilled in the art would recognize the compatibility of substituting or incorporating the Goodman patch design into Hirschman’s system. The patch's physical proximity and mechanical interface with the needle provide a stabilizing effect as a natural consequence of its positioning and adhesive contact. The benefit of making this combination would be to improve positional reliability of the sensor relative to the injection point and minimize patient movement artifacts, ensuring better detection of extravasation. Additionally, such a structure would help reduce misalignment of the sensor with the injection site, increasing diagnostic accuracy.
Claims 12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over by Hirschman (US 6408204 B1), hereto referred as Hirschman, and further in view of Ollmar et al. (US 20070161881 A1), hereto referred as Ollmar, and further in view of Bay (US 20150250422 A1), hereto referred as Bay, and further in view of Holzhacker (BR PI0704408 B8), hereto referred as Holzhacker.
The combined Hirschman, Ollmar and Bay teaches claim 2 as described above.
Regarding claim 12, the combined Hirschman, Ollmar and Bay do not teach that the device further comprises wiring that is located on a single side of the substrate and that connects the sensor and the plurality of sensor electrodes. Rather, Hirschman describes a sensor system for detecting extravasation, including a sensor adhered to a skin surface and connected to electrode structures, but does not disclose how wiring is routed or whether all wiring is constrained to a single side of the substrate (Hirschman, Abstract; Figs. 2–5). Holzhacker describes a flexible electrode strip (i.e. substrate) on which a conductive material is deposited onto a single face of the strip to form both the contact zone and the terminal area, connected by a continuous conductive path. Specifically, FIGS. 6 and 7 show the layout of contact zone 22 and terminal area 27, linked by a conductor 24 deposited on one side of the substrate (Holzhacker, FIGs. 6-7). The connector element 42 attaches to terminal 27 to interface with an external sensor. While the wiring is deposited on only one side, the folding of the substrate enables the electrode and terminal areas to occupy different effective positions relative to the final application face. This structure, though folded, maintains all conductive paths on the same side of the material, in line with the claim's intent. The specification clarifies that folding the substrate does not change the same-side classification, provided the sensor and electrodes remain on the same material surface (Instant Application, ¶[0051]). The architecture described in Holzhacker fulfills this principle, as folding is used to reposition rather than relocate electrical surfaces. 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 have modified the combined Hirschman, Ollmar and Bay in view of Holzhacker to adopt a foldable, single-layer substrate with conductive pathways on one face, for connecting a sensor and electrode zones. This combination is physically possible as both systems involve flexible, skin-adhered patches, and it leverages known manufacturing and design techniques. The benefit of this combination would be to reduce complexity and manufacturing costs by minimizing the need for multilayer routing or vias while enabling a compact, foldable structure that supports consistent electrical contact between the sensor and electrodes in a low-profile form factor.
Regarding claim 14, the combined Hirschman, Ollmar and Bay do not teach that the sensor and the plurality of sensor electrodes are on a same side of the substrate. Rather, Hirschman describes a sensor system for detecting extravasation, including a sensor adhered to a skin surface and connected to electrode structures, but does not disclose how wiring is routed or whether the sensor and electrodes are constrained to a single side of the substrate (Hirschman, Abstract; Figs. 2–5). Holzhacker describes a flexible electrode strip (i.e. substrate) on which a conductive material is deposited onto a single face of the strip to form both the contact zone and the terminal area, connected by a continuous conductive path. Specifically, FIGS. 6 and 7 show the layout of contact zone 22 and terminal area 27, linked by a conductor 24 deposited on one side of the substrate (Holzhacker, FIGs. 6–7). The connector element 42 attaches to terminal 27 to interface with external electronics (Holzhacker, p. 11). While the wiring is deposited on only one side, the folding of the substrate enables the electrode and terminal areas to occupy different effective positions relative to the final application face. This structure, though folded, maintains all conductive paths on the same side of the material, in line with the claim's intent. The specification clarifies that folding the substrate does not change the same-side classification, provided the sensor and electrodes remain on the same material surface (Instant Application, ¶[0051]). The architecture described in Holzhacker fulfills this principle, as folding is used to reposition rather than relocate electrical surfaces. While Holzhacker does not expressly disclose a sensor, it teaches a terminal area (27) and a contact zone (22) electrically connected by a single-sided conductive trace (24), demonstrating how two separate electronic regions can be electrically interfaced from the same face of the substrate. This enables a sensor module, such as that disclosed in Ollmar and mounted to the substrate, to be electrically connected to the electrode region via the same conductive side—consistent with the claimed configuration. 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 have modified the combined Hirschman, Ollmar and Bay in view of Holzhacker to adopt a foldable, single-layer substrate with conductive pathways on one face, for connecting a sensor and electrodes on the same side. This combination is physically possible as both systems involve flexible, skin-adhered patches, and it leverages known manufacturing and design techniques. The benefit of this combination would be to reduce complexity and manufacturing costs by minimizing the need for multilayer routing or vias while enabling a compact, foldable structure that supports consistent electrical contact between the sensor and electrodes in a low-profile form factor.
Regarding claim 15, the combined Hirschman, Ollmar and Bay do not teach that the sensor is located in a first region of the substrate; the plurality of sensor electrodes is located in a second region of the substrate separate from the first region; and the first and second regions are divided along a folding line of the substrate. Rather, Hirschman describes a wearable sensor and electrode assembly for monitoring extravasation, but does not specify the spatial relationship of sensor and electrode placement or describe folding along the substrate (Hirschman, Abstract; Figs. 2–5). Holzhacker describes a flexible strip (i.e., substrate) with a contact zone (22) and terminal area (27) connected by a conductor (24), all formed on a single face (Holzhacker, FIGs. 6–7). FIGS. 6 and 7 show that the electrode and terminal regions are located on opposite sides of a fold line (44) in the strip, dividing the structure into two functional regions. The connector (42) interfaces with the terminal area (27), which could receive a sensor module as described in Ollmar. Thus, the electrode region and sensor region are disposed in separate regions of the substrate, with the fold line defining the boundary between them. 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 have modified the combined Hirschman, Ollmar and Bay in view of Holzhacker to implement a folding substrate with separate but electrically connected sensor and electrode on either side of a fold line that creates specific regions. This combination is physically possible given the foldable and skin-mounted nature of both systems, and follows known strategies in flexible circuit layout. The benefit of this combination would be to allow spatial separation of sensor and electrode regions for ergonomic or functional reasons while maintaining a compact, single-sided flexible design that simplifies electrical routing and assembly.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over by Hirschman (US 6408204 B1), hereto referred as Hirschman, and further in view of Ollmar et al. (US 20070161881 A1), hereto referred as Ollmar, and further in view of Bay (US 20150250422 A1), hereto referred as Bay, and further in view of Woodford et al. (US 20180224384 A1), hereto referred as Woodford.
The combined Hirschman, Ollmar and Bay teaches claim 2 as described above.
Regarding claim 13, the combined Hirschman, Ollmar and Bay do not teach that the device further comprises wiring that is located on opposing sides of the substrate and that connects the sensor and the plurality of sensor electrodes. Rather, Hirschman teaches a sensor and electrode structure for detecting extravasation, with flexible support surfaces but no express disclosure of how the wiring is arranged across or within the substrate (Hirschman, Abstract; Figs. 2–5). Woodford describes a flexible patch-like device with electrodes (110, 120) and a conductive trace (150) that runs through one side of the substrate (130) to the other, allowing electrical connection to another component located on the opposite side (Woodford, ¶[0030], FIGs. 1B, 4). Although the processor or controller is not explicitly labeled, the purpose of the trace and its through-substrate routing implies that it connects to signal processing circuitry or a control module situated on the other side. 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 have modified the combined Hirschman, Ollmar and Bay in view of Woodford to implement a through-substrate trace such that the wiring is located on opposing sides of the substrate to connect the sensor and the plurality of sensor electrodes. This is physically possible because both Hirschman and Woodford describe flexible sensing devices designed for skin application, and it is a well-known design strategy to use through-substrate traces to separate sensing components from electrode areas while maintaining electrical continuity. The benefit of this combination would be to reduce the size and profile of the device by separating electrodes from signal processing elements, improving layout flexibility and allowing for thinner, more modular wearable sensor patches.
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over by Bay (US 20150250422 A1), hereto referred as Bay, and further in view of Ollmar et al. (US 20070161881 A1), hereto referred as Ollmar, and further in view of Hirschman (US 6408204 B1), hereto referred as Hirschman.
Regarding claim 19, Bay teaches a substrate for adhering to a patient's skin (Bay, ¶[0072]: "The data collector comprises a flexible foil... On a dermal side surface 5, the foil comprises an adhesive, e.g. a hydrocolloid adhesive for adhesion of the data collector to a skin surface of a subject to be monitored."; Bay teaches a substrate for adhering to a patient’s skin that includes a dermal adhesive on a flexible foil) , the substrate including: a socket that receives a sensor (Bay, ¶[0072]: "On an opposite, upper surface of the foil, the data collector comprises a socket 6 made from a rigid plastic material...", ¶[0073]: "The socket forms a cavity 7 for receiving the processor"; Bay teaches a socket positioned on the substrate that is shaped to receive and retain a processor module, functioning as the claimed sensor) , wherein the sensor receives electrical signals from the patient's skin when the substrate is adhered to the patient's skin (Abstract: “ the foil forms a dermal side surface of the data collector for adhesion to a skin surface of a subject to be monitored”, demonstrating the device is meant to collect signals when adhered to the skin; ¶ [0027]-[0028]: “The sensor(s) may be configured for measuring one or more physiological signal selected from electrocardiography (ECG), electromyography (EMG) electroencephalography (EEG), galvanic skin response (GSR)… the physiological signal will be recognized and picked up from the individual by a structure which in the following will be referred to as "the detecting component". This component can e.g. include electrodes”, demonstrating that the sensor receives electrical signals from the skin); first and second sensor electrodes (Bay, ¶[0072]: "The data collector comprises a number of electrodes 3...", ¶[0073]: "The electrical coupling 11 of the data collector is connected to the electrodes 3"; Bay teaches a plurality of electrodes on the substrate including first and second electrodes electrically coupled to the socket); and a first wiring that connects the first sensor electrode to the socket; and a second wiring that connects the second sensor electrode to the socket (Bay, ¶[0073]: "At this point, the electrical coupling 10 of the processor and the electrical coupling 11 of the data collector are joined, and electrical communication between the data collector and the processor is established"; Bay teaches electrical connections (i.e., wiring) between the electrodes and the processor through integrated couplings in the socket interface).
Bay does not fully teach that the first sensor electrode includes a first inner electrode and a first outer electrode surrounding the first inner electrode; the second sensor electrode includes a second inner electrode and a second outer electrode surrounding the second inner electrode. While Bay discloses multiple electrodes, it does not disclose the presence of a first or second concentric electrode. Ollmar, who investigates skin mounted electrodes, teaches such a concentric configuration, explicitly stating that the electrode probe surface can consist of concentric electrodes, with a central electrode surrounded by at least one ring-shaped electrode (Ollmar, FIG. 1, ¶[0032]-[0035]). This clearly discloses the geometric layout required by the claim, where the inner electrode is encircled by the outer electrode within each sensor electrode. 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 have modified Bay in view of Ollmar such that a plurality of the electrodes in Bay are substituted with the concentric style electrode of Ollmar, thus incorporate a first and second concentric electrode geometry into the substrate-mounted electrode configuration. Bay supports a flexible layout by describing the substrate as a foil made of elastically or at least flexible material, and that the electrodes and wiring are integrated into the foil using conductive structures that connect to a socketed processor (Bay, ¶[0072]–[0073]). While Bay does not explicitly describe its system as modular, the separate socket and embedded wiring suggest that electrode components could be reconfigured or replaced without modifying the underlying substrate or processor interface. This supports the physical possibility of replacing Bay’s planar electrodes with concentric electrode pairs as taught by Ollmar. The benefit of this combination would be to enhance the electrode functionality with concentric geometry that provides better localized signal acquisition and controlled current flow paths. This improves impedance measurement resolution, ensures stronger signal-to-noise performance, and simplifies alignment of current and voltage vectors relative to physiological targets.
Bay does not fully teach that the first outer electrode of the first sensor electrode and the second outer electrode of the second sensor electrode detect a current applied between the first outer electrode and the second outer electrode; the first inner electrode of the first sensor electrode and the second inner electrode of the second sensor electrode detect a voltage applied between the first inner electrode and the second inner electrode. Bay does not describe how the electrodes function to apply current or detect voltage. Hirschman teaches using outer electrodes to inject current into a monitored tissue region and using inner electrodes to detect the resulting signal (i.e., voltage). Hirschman, who investigates extravasation detection with electrodes, describes activating outer electrode pairs such as 31a·f to apply current and using selectively chosen inner electrodes (e.g., 31b·c, 31b·d, 31c·e) to sense resulting voltage differences, enabling impedance-based measurements across the region (Hirschman, col. 6–7, ll. 57–12). This directly supports the functional roles of the outer and inner electrodes as claimed. However, Hirschman discloses electrodes in a planar arrangement around an injection site, it does not teach a concentric structure. As previously described above, Ollmar fills this structural gap by describing a concentric configuration in which the outer electrode surrounds the inner electrode and teaches their use for injecting current and sensing voltage in a physiological tissue monitoring application (Ollmar, ¶[0032]–[0035]). Thus, Ollmar enables the implementation of Hirschman’s functional electrode behavior in a concentric layout where each planar electrode set in Hirschman is replaced with a corresponding concentric inner–outer set from Ollmar. The result is a first sensor electrode and a second sensor electrode, each comprising an inner electrode surrounded by an outer electrode, while maintaining the overall four-electrode configuration shown in Hirschman. 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 have modified the combined Bay and Ollmar in view of Hirschman to implement concentric inner and outer sensor electrodes in which outer electrodes apply current and inner electrodes detect voltage across a physiological region. The benefit of this combination would be to integrate a spatially-distributed impedance sensing system into a compact and practical form factor. It supports improved electrode alignment for current and voltage pathways, enhances physiological monitoring accuracy, and enables simplified manufacturing and patient application using a flexible, adhesive-backed platform with socketed sensor integration.
Regarding claim 20, the combined Bay, Ollmar and Hirschman do not teach that the substrate of claim 19, further comprising an opening. As previously described, Bay teaches a substrate but does not disclose an opening formed in the substrate (Bay, ¶[0072]). Hirschman describes an injection monitoring system that includes a substrate positioned on a patient’s skin and surrounding an injection site, which is represented by an opening (42/59) (Hirschman, FIG. 3B and 4). The opening is used to align the system with the injection location (48/58) and allows direct observation or interaction with the underlying site (Hirschman, FIG. 3B and 4; Abstract). 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 have modified the combined Bay, Ollmar and Hirschman in view of Hirschman to form an opening in the substrate of Bay’s adhesive patch such that the substrate has an opening. The benefit of this combination would be to facilitate accurate sensor placement and ensure unobstructed monitoring, injection, or treatment through the central opening while maintaining secure contact and sensor function through the surrounding electrode array.
Regarding claim 21, the combined Bay, Ollmar and Hirschman do not teach that the substrate of claim 20, wherein the opening defines an intravenous hole. Rather, Bay teaches a substrate but does not disclose an opening formed in the substrate (Bay, ¶[0072]). Bay does not describe any particular function or an opening in the substrate. Hirschman teaches that the central opening in the sensor assembly aligns with the intravenous injection site and serves to expose the skin for visual inspection and treatment (Hirschman, Abstract; FIG. 3A-B, 4). This clearly defines the purpose of the opening as an intravenous hole. 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 have modified the combined Bay,