DETAILED ACTION
This is a Final Rejection for Application 18/015,123 filed 09 January 2023 which is the U.S. National Stage application of International Application No. PCT/GB2021/051762 filed 9 July 2021 which claims priority to British Patent Application GB2010588.8 filed 9 July 2020. Claims 1-12 are currently pending.
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 Amendment
Applicant has amended the claims to overcome the claim objections and 112(b) rejections indicated in the Office action filed 05/05/2025, which are hereby withdrawn.
The scope of claim 1 has been changed due to an amendment. New grounds of rejection are presented below as a result.
New claim 12 has been added and will be examined with claims 1-11.
Response to Arguments
Applicant's arguments filed 08/04/2025 have been fully considered but they are not persuasive.
Applicant argues that neither Raymond nor Freeman disclose a sensor strip in which the upper surface of each of the segments in outermost columns of the outer columns of segments is tapered outwardly towards the lower surface. Additionally, in view of Raymond, the skilled person would have no reason to taper the thickness of any segments (i.e. by tapering the upper surface towards the lower surface).
While Raymond and Freeman do not disclose the limitation, the limitation is obvious in view of US 2022/0054323 (Cameron et al.). Cameron discloses that by reducing the thickness, the sensor strip provides optimal conformation to facilitate comfort and minimize pressure points. Additionally, the limitation is present in US 2019/0358106 (Barney).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0358106 (Barney).
Regarding claim 1, Barney discloses a sensor strip (Barney discloses a foam block comprising sensors. See the abstract. Additionally, the foam block comprises 7 columns and 6 rows in an embodiment depicted in Fig. 1E which by definition is a strip as a strip is a long, narrow piece of material and the foam block is longer than it is wide.) comprising
an elongate member that is segmented (The foam block is longer than it is wide and is segmented into a plurality of support pylons 105, each being interpreted as a segment. See [0027].),
the segments each comprising an upper surface and a lower surface and being defined by continuous longitudinal and transverse grooves, such that adjacent segments are hinged together (As shown in Figs. 1A-1J, each support pylon 105 comprises an upper surface and a lower surface and is defined by trenches 114. Since the foam block is flexible, the support pylons are hinged together between adjacent pylons by the trenches.),
wherein the longitudinal grooves define a central column of segments and outer columns of segments (The trenches 114 define a central column and outer columns.),
wherein the upper surface of each of the segments in outermost columns of the outer columns of segments are is tapered outwardly towards the lower surface (The upper surface of the support pylons 105 are rounded which causes the upper surface of each pylon to taper outwardly toward the lower surface in all of the pylons, including the outermost column of pylons. This rounding is shown in Figs. 1A-1J.), and
wherein pressure-sensitive sensors are mounted in a plurality of the segments in the central column (The sensor 116 is a pressure sensor and is mounted in every pylon which includes a plurality of pylons in the central column. See [0028].).
Regarding claim 10, Barney discloses a sensor strip according to claim 1, further comprising an electrical connector to couple data signals from the pressure-sensitive sensors to a remotely coupled interrogator unit for data processing (The apparatus includes a transmitter capable of transmitting sensor information to a smart device using at least one of: wi-fi, Bluetooth, or cellular data such as 3G, 4G or 5G. See [0011].).
Regarding claim 12, Barney discloses a sensor strip according to claim 10, in which the segments are formed of a contiguous sheet of segmented material (The pylons 105 are formed of a contiguous sheet of segmented foam. See [0023].).
Claim Rejections - 35 USC § 103
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 1-5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0371566 (Raymond et al.) in view of US 2017/0087371 (Freeman et al.) and US 2022/0054323 (Cameron et al.). The rejections of claims 1 and 10 are in addition to the rejections in view of Barney above and do not replace the rejections.
Regarding claim 1, Raymond discloses a sensor strip (Raymond discloses a conforming patient interface, which is shown in Figs. 1-5, comprising a patient contact assembly 100 made up of patient contact elements 101. According to [0032], the patient contact assembly 100 is rectangular and shown in Fig. 4. Additionally, [0027] discloses that the patient contact element 101 include sensors. Since the conforming patient interface is rectangular and includes sensors, the conforming patient interface is interpreted as a sensor strip. According to [0018], the conforming patient contact interfaces may be used with any consumer device or medical device in which it is desirable to have a conforming patient contact interface that may, for example, conform to a patient.) comprising
an elongate member that is segmented (According to [0032], the patient contact assembly 100 is rectangular and shown in Fig. 4. Additionally, [0027] discloses that the patient contact element 101 include sensors. The patient contact assembly 100 is interpreted as an elongate member that is segmented as it is rectangular and each of the patient contact elements 101 are interpreted as a segment. See Fig. 1.),
the segments each comprising an upper surface and a lower surface and being defined by continuous longitudinal and transverse grooves, such that adjacent segments are hinged together (According to [0029], the patient contact assembly 100 comprises a longitudinal linear spring spine with radiating arms 202 as shown in Fig. 3. According to [0033] the radiating arms 202 allow the patient contact assemblies 101 to flex to conform to a patient. As shown in Figs. 1-5, the patient contact assembly 100 comprises gaps between each of the patient contact elements 101. The longitudinal gaps are interpreted as continuous longitudinal grooves and the transverse gaps are interpreted as continuous transverse grooves. See the annotated figure below. The examiner is making the interpretation that the gaps are interpreted as grooves since Google’s English Dictionary defines a groove as a long, narrow cut and a cut is defined by Google’s English Dictionary as a long, narrow opening made in a piece of material. The adjacent patient contact elements 101 are hinged together by the longitudinal linear spring spine with radiating arms 202 and are able to flex partially due to the gaps between the patient contact elements 101. The patient contact elements 101 each have an upper surface and a lower surface.),
wherein the longitudinal grooves define a central column of segments and outer columns of segments (A representative embodiment as shown in Fig. 1 shows a central column of patient contact elements 101 and four outer columns of patient contact elements. See the annotated figure below.),
wherein a sensor is mounted in a plurality of the segments in the central column (According to [0027], the patient contact elements 101 are interspersed with sensors. The sensors are strain gauges in an embodiment. According to [0026], each patient contact element 101 receives an interrogating signal and supplies a signal via an electrically conductive pathway. Fig. 2 shows each of the patient contact elements 101 comprise a flexible interconnecting circuit 203. Therefore, it is implied that, in an embodiment, each of the patient contact elements 101 comprise a strain gauge.).
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Annotated Fig. 1 of Raymond
Raymond does not disclose wherein the upper surface of each of the segments in outermost columns of the outer columns of segments is tapered outwardly towards the lower surface and pressure-sensitive sensors.
However, Cameron discloses a pressure sensing device with a pressure sensing region 10. By reducing the thickness of the pressure sensing region 10, the device 1 provides optimal conformation to facilitate comfort and minimize pressure points. See [0286] and Figs. 33-42.
Additionally, Freeman discloses an ambulatory medical device, including a defibrillator, comprising pressure-sensing strain gauges. According to [0234], the wearable medical device 100 includes a pressure sensor 802 which comprises a strain gauge.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the thickness of the patient contact elements 101 of Raymond such that the upper surface tapers outwardly toward the lower surface as taught by Cameron. A skilled artisan would have been motivated to do so because Cameron teaches that the reduced thickness provides optimal conformation to facilitate comfort and minimize pressure points ([0286]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to sensing devices that are applied to a patient’s skin.
It would have been obvious to an artisan of ordinary skill before the effective filing date for the strain gauges of Raymond to be pressure-sensing as taught by Freeman. A skilled artisan would have been motivated to do so because Freeman teaches that the pressure sensor 802 comprising a strain gauge is used to indicate whether a patient is sitting or lying down ([0238]). Both Raymond and Freeman comprise an embodiment where the strain gauges are used in a defibrillator and Freeman teaches that the strain gauge is useful with a defibrillator so that parameters for detecting a cardiac condition can be automatically adjusted to suit the environment such that the cardiac events are properly detected while reducing the likelihood of false alarms ([0076]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to medical devices with strain gauges including defibrillators with strain gauges.
As a result of the combinations, Raymond in view of Cameron and Freeman discloses wherein the upper surface of each of the segments in outermost columns of the outer columns of segments is tapered outwardly towards the lower surface (In view of Cameron, the patient contact elements 101 taper in thickness outwardly.), and
a pressure-sensitive sensor (In view of Freeman, the sensors in the patient contact elements 101 are strain gauges specifically used to measure pressure.).
Regarding claim 2, Raymond in view of Cameron and Freeman, as applied to claim 1, discloses a sensor strip according to claim 1, which comprises at least 3 pressure-sensitive sensors (In an embodiment, each of the patient contact elements 101 comprise a strain gauge. Figs. 1-5 all show 25 patient contact elements which meets the limitation of at least 3 pressure-sensitive sensors.).
Regarding claim 3, Raymond in view of Cameron and Freeman, as applied to claim 1, discloses a sensor strip according to claim 1, which comprises up to 6 pressure-sensitive sensors (According to claim 11 of Raymond, at least one of the patient contact elements is a sensor. Therefore, it is within the scope of Raymond for two of the patient contact elements in the central column to comprise a strain gauge which meets the limitation of up to 6 pressure-sensitive sensors, which is interpreted as being 6 or less pressure-sensitive sensors.).
Regarding claim 4, Raymond in view of Cameron and Freeman, as applied to claim 1, discloses a sensor strip according to claim 1.
Raymond does not directly disclose wherein the pressure-sensitive sensors are mounted in non-adjacent segments.
However, according to [0027] of Raymond, the patient contact elements 101 are interspersed with sensors. Additionally, according to claim 11 of Raymond, at least one of the patient contact elements is a sensor. Therefore, it is within the scope of Raymond for two of the non-adjacent patient contact elements in the central column to comprise a strain gauge.).
It would have been an obvious matter of design choice to for the sensors to be mounted in non-adjacent patient contact elements 101, since such a modification would have involved a mere rearrangement of parts. The court has held that the particular placement of a component is an obvious matter of design choice absent criticality of the placement. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). One of ordinary skill in the art may want to mount the sensors in non-adjacent patient contact elements so that less sensors may be used to cover a greater area, thereby reducing costs and reducing interference of the sensors.
As a result of the modification, Raymond in view of Cameron and Freeman, as modified above, discloses wherein the pressure-sensitive sensors are mounted in non-adjacent segments (Two of the non-adjacent patient contact elements in the central column comprise a strain gauge.).
Regarding claim 5, Raymond in view of Cameron and Freeman, as applied to claim 1, discloses a sensor strip according to claim 1, which comprises at least 2 outer columns to both sides of the central column (A representative embodiment as shown in Fig. 1 shows a central column of patient contact elements 101 and two outer columns on both sides of patient contact elements.).
Regarding claim 10, Raymond in view of Cameron and Freeman, as applied to claim 1, discloses a sensor strip according to claim 1, further comprising an electrical connector to couple data signals from the pressure- sensitive sensors to a remotely coupled interrogator unit for data processing (According to [0026], the patient contact assembly 100 comprises a flexible interconnecting circuit which forms an electrically conductive pathway. Further, the electrically conductive pathway allows electrical signals to be communicated to/from each patient contact element 101, such as an interrogating signal to each patient contact element 101.).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0371566 (Raymond et al.) in view of US 2017/0087371 (Freeman et al.) and US 2022/0054323 (Cameron et al.) as applied to claim 1, and further in view of US 10,034,622 (Mahmoud).
Regarding claim 6, Raymond in view of Cameron and Freeman, as applied to claim 1, discloses a sensor strip according to claim 1.
Raymond in view of Cameron and Freeman, as applied to claim 1, does not disclose a reference, non-pressure-sensitive sensor.
However, Mahmoud discloses an in-shoe monitoring system comprising force sensors and is therefore in analogous art to Raymond. The in-shoe monitoring system comprises a plurality of force sensors 106 and a temperature sensor to compensate for the temperature drift in the force sensor’s linear behavior. See Col. 2, Lns. 39-52 and Col. 3, Lns. 1-10. The temperature sensor is interpreted as the non-pressure-sensitive sensor.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing to add the temperature sensor of Mahmoud to a patient contact element 101 of Raymond. A skilled artisan would have been motivated to do so because Mahmoud teaches that the temperature sensor relays information to compensate for temperature drift in the force sensor’s linear behavior (Col. 3, Lns. 1-10). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to pressure sensing devices for a human body.
As a result of the combination, Raymond in view of Cameron, Freeman and Mahmoud, as modified above, discloses a reference, non-pressure-sensitive sensor (The sensor strip of Raymond comprises the temperature sensor of Mahmoud which is a reference, non-pressure-sensitive sensor.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0371566 (Raymond et al.) in view of US 2017/0087371 (Freeman et al.) and US 2022/0054323 (Cameron et al.) as applied to claim 1, and further in view of US 5,253,654 (Thomas et al.).
Regarding claim 7, Raymond in view of Cameron and Freeman, as applied to claim 1, discloses a sensor strip according to claim 1.
Raymond in view of Cameron and Freeman, as applied to claim 1, does not disclose wherein a base of each segment in which one of the pressure-sensitive sensors is mounted, is rigid.
However, Thomas discloses a pressure-sensitive sensor comprising a rigid base. According to Col. 8, Ln. 61 – Col. 9, Ln. 20, the device of Thomas comprises a sensor 50 made up of a thin, rigid rectangular plate 52 having a foil strain gauge 54 in order to measure the applied pressure of a user’s heel. Fig. 4 shows the rigid plate 52 and the strain gauge 54 wherein the rigid plate backs the strain gauge.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for each of the patient contact elements 101 of Raymond to include a thin, rigid rectangular plate attached as a backing as taught by Thomas. A skilled artisan would have been motivated to do so because Thomas teaches that the plate 52 acts as a simple beam and creates deflection when under load that can be measured by the strain gauge (Col. 9, Lns. 37-44). Additionally, one of ordinary skill in the art would recognize that a rigid plate would better distribute pressure applied at a point to the strain gauge. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to pressure sensing devices comprising strain gauges.
As a result of the combination, Raymond in view of Cameron, Freeman and Thomas, as modified above, discloses wherein a base of each segment in which one of the pressure-sensitive sensors is mounted, is rigid (The patient contact elements 101 of Raymond comprise a backing made of a thin, rigid rectangular plate.).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0371566 (Raymond et al.) in view of US 2017/0087371 (Freeman et al.) and US 2022/0054323 (Cameron et al.) as applied to claim 1, and further in view of US 5,253,654 (Thomas et al.).
Regarding claim 8, Raymond in view of Cameron and Freeman, as applied to claim 1, discloses a sensor strip according to claim 1.
Raymond in view of Cameron and Freeman, as applied to claim 1, does not disclose wherein each of the segments is formed from a rigid material.
However, Thomas discloses a pressure-sensitive sensor comprising a rigid material. According to Col. 8, Ln. 61 – Col. 9, Ln. 20, the device of Thomas comprises a sensor 50 made up of a thin, rigid rectangular plate 52 having a foil strain gauge 54 in order to measure the applied pressure of a user’s heel. Fig. 4 shows the rigid plate 52 and the strain gauge 54 wherein the rigid plate backs the strain gauge.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for each of the patient contact elements 101 of Raymond to include a thin, rigid rectangular plate attached as a backing as taught by Thomas. A skilled artisan would have been motivated to do so because Thomas teaches that the plate 52 acts as a simple beam and creates deflection when under load that can be measured by the strain gauge (Col. 9, Lns. 37-44). Additionally, one of ordinary skill in the art would recognize that a rigid plate would better distribute pressure applied at a point to the strain gauge. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to pressure sensing devices comprising strain gauges.
As a result of the combination, Raymond in view of Cameron, Freeman and Thomas, as modified above, discloses wherein each of the segments is formed from a rigid material (The patient contact elements 101 of Raymond comprise a backing made of a thin, rigid rectangular plate are interpreted as the segments after the combination. The combination forming the segments are at least partially formed from a rigid material.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0371566 (Raymond et al.) in view of US 2017/0087371 (Freeman et al.) and US 2022/0054323 (Cameron et al.) as applied to claim 1, and further in view of WO 2006/030405 (Casey).
Regarding claim 9, Raymond in view of Cameron and Freeman discloses a sensor strip according to claim 1.
Raymond in view of Cameron and Freeman does not disclose in which the segments are formed from a rubber material.
However, Casey discloses a flexible transducer for measuring pressure under a bandage which is found in analogous art to Raymond. Casey discloses that the encapsulation polymer layer 5 is made from rubber. See Pg. 16, Lns. 17-20.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing for the patient contact element 101 of Raymond to be made of rubber as taught by Casey. A skilled artisan would have been motivated to do so because Casey teaches that the rubber material allows for flexibility of the device and is a biomedically approved material (Pg. 16, Lns. 17-20). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to pressure sensor devices interfacing with a patient.
As a result of the combination, Raymond in view of Cameron, Freeman and Casey discloses in which the segments are formed from a rubber material (The patient contact element 101 of Raymond is made of rubber.).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0371566 (Raymond et al.) in view of US 2017/0087371 (Freeman et al.) and US 2022/0054323 (Cameron et al.) as applied to claim 1, and further in view of WO 2006/030405 (Casey).
Regarding claim 11, Raymond in view of Cameron and Freeman discloses a sensor strip according to claim any preceding claim (Raymond discloses the sensor strip of at least claim 1).
Raymond in view of Cameron and Freeman does not disclose a method of testing the pressure under a bandage, which comprises recording the pressure under the bandage at each of the pressure-sensitive sensors.
However, Casey discloses a flexible transducer for measuring pressure under a bandage which is found in analogous art to Raymond. Casey discloses a transducer 1 having an active part 2 that is disposed between a limb 9 and a compression bandage 8. The transducer 1 and processing electronics include a Universal Transducer Interface (UTI) module 11 connected to the transducer 1 via a screened cable 10, for monitoring changes in capacitance between the electrodes to determine pressure. See Pg. 8, Lns. 3-23.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to dispose the patient contact assembly 100 of Raymond between a limb and a compression bandage as taught by Casey. A skilled artisan would have been motivated to do so because Casey teaches that measuring the pressure applied by a bandage to the underlying tissue is to ensure a good fit during use in a continuous manner (Pg. 1 Lns. 23-29). Additionally, Raymond states that the conforming patient contact interfaces may be used with any consumer device or medical device in which it is desirable to have a conforming patient contact interface that may, for example, conform to a patient ([0018]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to pressure sensor devices interfacing with a patient.
As a result of the combination, Raymond in view of Cameron, Freeman and Casey discloses a method of testing the pressure under a bandage, which comprises recording the pressure under the bandage at each of the pressure-sensitive sensors (The patient contact assembly 100 of Raymond is positioned between a limb and a compression bandage and records the pressure using a strain gauge.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786