DETAILED ACTION
This action is pursuant to claims filed on 4/22/2026. Claims 1-9, 16, and 20 are pending, claims 10-15 and 17-19 have been cancelled. A final action on the merits of claims 1-9, 16, and 20 is as follows.
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 .
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.
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.
Claim(s) 1-9, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Weir (US 20210085251 A1) in view of Florence et al. (hereinafter ‘Florence’, US 9662030 B2) and in further view of Lake (US 5819381 A).
Regarding independent claim 1, Weir discloses a heart rate monitor system (heart rate monitoring system 100), comprising:
a number of electrodes (sensors 130 in Figs. 1A and B; [0008]: sensors are electrodes) configured to:
contact a chest of a user ([0020]: sensors contact the wearer’s body when worn; sensors contact the user’s chest as seen in Fig. 5E); and
detect electrical signals from a heart of the user ([0010]: the sensors may detect biometric signals such as the electric pulse of the heart);
a heart rate module (heart rate module 140 in Figs. 1A and B) configured to:
receive the electrical signals from the number of electrodes ([0020]: module 140 includes processing and/or monitoring elements which receive signals from the sensors); and
wirelessly transmit heart rate data based on the electrical signals ([0011]: the module 140 may include wireless transmitter for transmitting an electric pulse to a receiver and/or display unit such as a smart watch or smart phone); and
a strap (strap 110 in Figs. 1A and B) comprising
a non-looping strip of material (the strip of material that defines the strap 110 does not loop as seen in Figs. 1A and B and in Fig. 5E); and
a central attachment portion ([0009]: the sensor mount may be attached to a bra, like in Fig. 5E; [0020]: the substrate 120, which is located in the center of the strap as seen in Fig. 5E, may be foldable around a portion of a garment such that the bulk of the device 100 is outside of the bra), the central attachment portion comprising
a bottom portion (bottom portion 122 in Fig. 1A; corresponding to the portion contacting the body in Fig. 5E), one or more top portions (top portion 121 in Fig. 1A; corresponding to the portion outside of the clothing in Fig. 5E), and a hinge portion (hinge portion 125 in Fig. 1A; corresponding to portion connecting bottom and top portions in Fig. 5E),
wherein the top portion includes a distal end contact portion defining a substantially planar contact surface configured to contact the garment without localized protrusions (distal portion of 121 is substantially planar and there are no protrusions as highlighted below)
wherein the hinge portion comprises a pivotable member configured to rotate the top portion relative to the bottom portion between an open and closed position (as seen in Figs. 1A and 1B, the hinge is configured to open and close the top and bottom; furthermore, in Fig. 5E the hinge is capable of being slightly opened to remove the device from the bra),
wherein in the open position, a cavity between the top portions and the bottom portion is exposed to receive or release a portion of the garment of the user ([0020]: the substrate 120, which is in the center of the strap, may be foldable around a portion of a garment – the fold forms the cavity and it receives the garment into the cavity), and
wherein in the closed position, the strap is coupled to the garment (in the closed position in 5E, the garment is removably coupled to the strap).
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However, Weir is silent to the strap containing a first and second distal attachment portion each including a hinge portion configured to receive or release a portion of the garment in the open position and removably couple the strap to the garment of the user in a closed position.
Florence teaches a device for removably mounting electrodes to a garment ([Abstract]). The device comprises an elongated material where one electrode is disposed on a housing and the other electrode is disposed on a flexible substrate as seen in Fig. 4A. The device is configured to attach to various types of clothing as seen in Fig. 2, similar to the device of Weir. The device further includes two distal mounting portions 415a and 425a in Fig. 4A. These mounts are clips configured to removably mount the device to a garment of the user ([Col 17, line 42 – Col 18, line 6]). The clips in combination with the tight-fitting band of the garment allow for secure connections of the electrodes to the garment to prevent the electrodes from moving relative to the body ([Col 17, line 42 – Col 18, line 6]). Furthermore, it would be of routine skill in the art to add clips to the end portions of the device of Weir as doing so would not affect the operation of Weir and lead to the expected outcome of enhanced securement. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the distal end clips of Florence with the device of Weir to provide a more secure mount for the electrodes onto the garment, resulting in Weir comprising first and second distal attachment portions each including a hinge portion configured to receive or release a portion of the garment in the open position and removably couple the strap to the garment of the user in a closed position.
However, the Weir/Florence combination does not disclose each of the attachment portions comprising a locking portion with the hinge member comprising a second pivotable member configured to rotate the locking portion relative to the bottom portion in order to removably secure the garment between the top and bottom portion, and does not explicitly disclose the top portions of the distal attachment portions including a distal end contact portion defining a substantially planar contact surface configured to contact the garment without localized protrusions.
Lake teaches a gripping apparatus that can be used to grip garments and secure them in place ([Abstract]). While not particularly directed to an ECG device, the art is analogous because it is addressing the same problem of securely coupling one element to another. The clamp shown in Fig. 1 includes a first pivotable portion where the upper and lower jaws are connected and a second pivotable portion upon which the lever pivots. The locking member 16 rotates about the second pivotable portion ([Col 3, lines 34-45]). The locking member provides a fulcrum to close and lock the jaws together to provide a constant mechanical gripping load ([Col 3, lines 34-45]). As seen in Fig. 3, the distal contact portion 32 of the top jaw is flat ([Col 3, lines 46-67]). The flat, elastic surface helps protect the user’s garment when attached ([Col 4, lines 4-12]). This flat member does not have protrusions when it initially contacts the shirt, thus satisfying the claim language. Modifying the clamps of the Weir/Florence combination to locking clamps with a flat contact portion on the top portion as taught by Lake would be of routine skill in the art. It would simply require the substitution of one clamp type for another. Furthermore, the instant application does not provide any criticality to the type of clamp used as seen in Figs. 3A-14 of the instant application which show multiple different types of clamps used for the central and distal clamps to attach to the garment of the user. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine a locking feature and a flat distal contact surface on the attachment portions of the Weir/Florence combination, as taught by Lake, to provide a more secure attachment to the garment that also protects the garment during use.
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Regarding claim 2, the Weir/Florence/Lake combination discloses the heart rate monitor system of claim 1, wherein the strap is configured to removably receive the number of electrodes and/or the heart rate module ([0022]: the module 140 may be detachable from the substrate 120 which is connected to the strap, thus the strap removably receives the module – the recitation of “and/or” as broadly recited means either the electrodes are detachable or the heart rate module is detachable, or alternatively that both are detachable).
Regarding claim 3, the Weir/Florence/Lake combination discloses the heart rate monitor system of claim 1, wherein the strap is configured to removably couple the number of electrodes to the heart rate module ([0022]: the substrate 120, which connects to the strap, can detachably couple the electronics unit 140; thus, the strap removably couples the heart rate module to the electrodes because the electrodes are disposed on the substrate 120 as well).
Regarding claim 4, the Weir/Florence/Lake combination discloses the heart rate monitor system of claim 1, wherein the strap is elastic ([0015]: the strap portion 110 can be made of an elastic band).
Regarding claim 5, the Weir/Florence/Lake combination discloses the heart rate monitor system of claim 1, wherein the heart rate module comprises a processor, a memory, a wireless transmitter, a light emitting diode (LED), a speaker, a battery, and/or a global navigation satellite system (GNSS) receiver ([Claim 16]: the electronics unit 140 comprises a power supply and/or a processor; the recitation of “and/or” means if the module comprises any single unit or all of the units, the claim limitation is met).
Regarding claim 6, the Weir/Florence/Lake combination discloses the heart rate monitor system of claim 1, wherein the heart rate module is configured to transmit the heart rate data to a computing device via a wireless network ([0011]: the module 140 may include wireless transceiver to wirelessly communicate with other circuits, the module also includes a transmitter for transmitting an electric pulse to a receiver and/or display unit such as a smart watch or smart phone – the smart watch/phone are computing devices and the device is capable of wireless communication over a wireless network as that is the standard method of wireless communication; [0024]: the MCU of the module couples to a transceiver such as an RF interface, Bluetooth, etc. for sending and receiving data – Bluetooth is a form of a wireless network and the etc. means that it is capable of transferring data across other wireless methods).
Regarding claim 7, the Weir/Florence/Lake combination discloses the heart rate monitor system of claim 6, wherein the computing device is a wearable device, a smartphone, a laptop, a desktop, and/or a cloud device ([0011]: the computing device is a smart phone or smart watch).
Regarding claim 8, the Weir/Florence/Lake combination discloses the heart rate monitor system of claim 1, wherein the number of electrodes are encased in plastic ([0011]: the sensors may be coated with plastic).
Regarding independent claim 9, Weir discloses the heart rate monitor system (heart rate monitoring system 100), comprising:
a number of electrodes (sensors 130 in Figs. 1A and B; [0008]: sensors are electrodes) configured to:
contact a chest of a user ([0020]: sensors contact the wearer’s body when worn; sensors contact the user’s chest as seen in Fig. 5E); and
detect electrical signals from a heart of the user ([0010]: the sensors may detect biometric signals such as the electric pulse of the heart);
a heart rate module (heart rate module 140 in Figs. 1A and B) configured to:
receive the electrical signals from the number of electrodes ([0020]: module 140 includes processing and/or monitoring elements which receive signals from the sensors); and
record a heart rate of the user based on the electrical signals ([0010]: the electronic unit 140 may be the POLAR heart rate monitor, a GARMIN heart rate monitor, or a SUUNTO heart rate monitor which are all capable of recording heart rate data from the sensed signals; [0024]: the electronics unit 140 comprises an MCU which are known in the art to have storage capable of recording the heart rate data); and
a strap (strap 110 in Figs. 1A and B) capable of length adjustment ([0021]: the strap may comprise a length adjustment mechanism) configured to:
couple the number of electrodes to the heart rate module ([0022]: the substrate 120, which connects to the strap, can detachably couple the electronics unit 140; thus, the strap removably couples the heart rate module to the electrodes because the electrodes are disposed on the substrate 120 as well); and
removably couple to a garment of the user ([0009]: the sensor mount may be attached to a bra, like in Fig. 5E; [0020]: the substrate 120 may be foldable around a portion of a garment such that the bulk of the device 100 is outside of the bra)
wherein the strap includes:
a central attachment portion ([0009]: the sensor mount may be attached to a bra, like in Fig. 5E; [0020]: the substrate 120, which is located in the center of the strap as seen in Fig. 5E, may be foldable around a portion of a garment such that the bulk of the device 100 is outside of the bra), the central attachment portion comprising
a bottom portion (bottom portion 122 in Fig. 1A; corresponding to the portion contacting the body in Fig. 5E), one or more top portions (top portion 121 in Fig. 1A; corresponding to the portion outside of the clothing in Fig. 5E), and a hinge portion (hinge portion 125 in Fig. 1A; corresponding to portion connecting bottom and top portions in Fig. 5E),
wherein the top portion includes a distal end contact portion defining a substantially planar contact surface configured to contact the garment without localized protrusions (distal portion of 121 is substantially planar and there are no protrusions as highlighted above)
wherein the hinge portion comprises a pivotable member configured to rotate the top portion relative to the bottom portion between an open and closed position (as seen in Figs. 1A and 1B, the hinge is configured to open and close the top and bottom; furthermore, in Fig. 5E the hinge is capable of being slightly opened to remove the device from the bra),
wherein in the open position, a cavity between the top portions and the bottom portion is exposed to receive or release a portion of the garment of the user ([0020]: the substrate 120, which is in the center of the strap, may be foldable around a portion of a garment – the fold forms the cavity and it receives the garment into the cavity), and
wherein in the closed position, the strap is coupled to the garment (in the closed position in 5E, the garment is removably coupled to the strap).
However, Weir is silent to the strap containing a first and second distal attachment portion each including a hinge portion configured to receive or release a portion of the garment in the open position and removably couple the strap to the garment of the user in a closed position.
Florence teaches a device for removably mounting electrodes to a garment ([Abstract]). The device comprises an elongated material where one electrode is disposed on a housing and the other electrode is disposed on a flexible substrate as seen in Fig. 4A. The device is configured to attach to various types of clothing as seen in Fig. 2, similar to the device of Weir. The device further includes two distal mounting portions 415a and 425a in Fig. 4A. These mounts are clips configured to removably mount the device to a garment of the user ([Col 17, line 42 – Col 18, line 6]). The clips in combination with the tight-fitting band of the garment allow for secure connections of the electrodes to the garment to prevent the electrodes from moving relative to the body ([Col 17, line 42 – Col 18, line 6]). Furthermore, it would be of routine skill in the art to add clips to the end portions of the device of Weir as doing so would not affect the operation of Weir and lead to the expected outcome of enhanced securement. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the distal end clips of Florence with the device of Weir to provide a more secure mount for the electrodes onto the garment, resulting in Weir comprising first and second distal attachment portions each including a hinge portion configured to receive or release a portion of the garment in the open position and removably couple the strap to the garment of the user in a closed position.
However, the Weir/Florence combination does not disclose each of the attachment portions comprising a locking portion with the hinge member comprising a second pivotable member configured to rotate the locking portion relative to the bottom portion in order to removably secure the garment between the top and bottom portion, and does not explicitly disclose the top portions of the distal attachment portions including a distal end contact portion defining a substantially planar contact surface configured to contact the garment without localized protrusions.
Lake teaches a gripping apparatus that can be used to grip garments and secure them in place ([Abstract]). While not particularly directed to an ECG device, the art is analogous because it is addressing the same problem of securely coupling one element to another. The clamp shown in Fig. 1 includes a first pivotable portion where the upper and lower jaws are connected and a second pivotable portion upon which the lever pivots. The locking member 16 rotates about the second pivotable portion ([Col 3, lines 34-45]). The locking member provides a fulcrum to close and lock the jaws together to provide a constant mechanical gripping load ([Col 3, lines 34-45]). As seen in Fig. 3, the distal contact portion 32 of the top jaw is flat ([Col 3, lines 46-67]). The flat, elastic surface helps protect the user’s garment when attached ([Col 4, lines 4-12]). This flat member does not have protrusions when it initially contacts the shirt, thus satisfying the claim language. Modifying the clamps of the Weir/Florence combination to locking clamps with a flat contact portion on the top portion as taught by Lake would be of routine skill in the art. It would simply require the substitution of one clamp type for another. Furthermore, the instant application does not provide any criticality to the type of clamp used as seen in Figs. 3A-14 of the instant application which show multiple different types of clamps used for the central and distal clamps to attach to the garment of the user. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine a locking feature and a flat distal contact surface on the attachment portions of the Weir/Florence combination, as taught by Lake, to provide a more secure attachment to the garment that also protects the garment during use.
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However, the Weir/Florence/Lake combination is silent to the length of the strap.
In Fig. 5E, Weir clearly discloses the length of the strap is approximately the length of the width across the user’s chest. The width of a female’s chest averages 36cm as evidenced by Healthline. Because Weir discloses that the length of the strap is both adjustable and fits across the front of the user’s chest, it would be obvious for the strap to be approximately 36cm which is the average width of a user’s chest. Additionally, it would be obvious to adjust the length to fit the chest of a user that is larger or smaller than average. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the strap to be between 23cm and 41cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding independent claim 16, Weir discloses a heart rate monitor system (heart rate monitoring system 100), comprising:
a number of electrodes (sensors 130 in Figs. 1A and B; [0008]: sensors are electrodes) configured to:
contact a chest of a user ([0020]: sensors contact the wearer’s body when worn; sensors contact the user’s chest as seen in Fig. 5E); and
detect electrical signals from a heart of the user ([0010]: the sensors may detect biometric signals such as the electric pulse of the heart);
a heart rate module (heart rate module 140 in Figs. 1A and B) configured to:
receive the electrical signals from the number of electrodes ([0020]: module 140 includes processing and/or monitoring elements which receive signals from the sensors); and
record a heart rate of the user based on the electrical signals ([0010]: the electronic unit 140 may be the POLAR heart rate monitor, a GARMIN heart rate monitor, or a SUUNTO heart rate monitor which are all capable of recording heart rate data from the sensed signals; [0024]: the electronics unit 140 comprises an MCU which are known in the art to have storage capable of recording the heart rate data);
a non-looping strap (strap 110 in Figs. 1A and B; the strip of material that defines the strap 110 does not loop as seen in Figs. 1A and B and in Fig. 5E) configured to couple the number of electrodes to the heart rate module ([0022]: the substrate 120, which connects to the strap, can detachably couple the electronics unit 140; thus, the strap removably couples the heart rate module to the electrodes because the electrodes are disposed on the substrate 120 as well); and
an attachment device (attachment device 120 in Figs. 1A and B) configured to removably couple the strap to a garment of the user ([0009]: the sensor mount may be attached to a bra, like in Fig. 5E; [0020]: the substrate 120 may be foldable around a portion of a garment such that the bulk of the device 100 is outside of the bra), the attachment device including:
a central attachment portion ([0009]: the sensor mount may be attached to a bra, like in Fig. 5E; [0020]: the substrate 120, which is located in the center of the strap as seen in Fig. 5E, may be foldable around a portion of a garment such that the bulk of the device 100 is outside of the bra), the central attachment portion comprising
a bottom portion (bottom portion 122 in Fig. 1A; corresponding to the portion contacting the body in Fig. 5E), one or more top portions (top portion 121 in Fig. 1A; corresponding to the portion outside of the clothing in Fig. 5E), and a hinge portion (hinge portion 125 in Fig. 1A; corresponding to portion connecting bottom and top portions in Fig. 5E),
wherein the top portion includes a distal end contact portion defining a substantially planar contact surface configured to contact the garment without localized protrusions (distal portion of 121 is substantially planar and there are no protrusions as highlighted above)
wherein the hinge portion comprises a pivotable member configured to rotate the top portion relative to the bottom portion between an open and closed position (as seen in Figs. 1A and 1B, the hinge is configured to open and close the top and bottom; furthermore, in Fig. 5E the hinge is capable of being slightly opened to remove the device from the bra),
wherein in the open position, a cavity between the top portions and the bottom portion is exposed to receive or release a portion of the garment of the user ([0020]: the substrate 120, which is in the center of the strap, may be foldable around a portion of a garment – the fold forms the cavity and it receives the garment into the cavity), and
wherein in the closed position, the strap is coupled to the garment (in the closed position in 5E, the garment is removably coupled to the strap).
However, Weir is silent to the strap containing a first and second distal attachment portion each including a hinge portion configured to receive or release a portion of the garment in the open position and removably couple the strap to the garment of the user in a closed position.
Florence teaches a device for removably mounting electrodes to a garment ([Abstract]). The device comprises an elongated material where one electrode is disposed on a housing and the other electrode is disposed on a flexible substrate as seen in Fig. 4A. The device is configured to attach to various types of clothing as seen in Fig. 2, similar to the device of Weir. The device further includes two distal mounting portions 415a and 425a in Fig. 4A. These mounts are clips configured to removably mount the device to a garment of the user ([Col 17, line 42 – Col 18, line 6]). The clips in combination with the tight-fitting band of the garment allow for secure connections of the electrodes to the garment to prevent the electrodes from moving relative to the body ([Col 17, line 42 – Col 18, line 6]). Furthermore, it would be of routine skill in the art to add clips to the end portions of the device of Weir as doing so would not affect the operation of Weir and lead to the expected outcome of enhanced securement. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the distal end clips of Florence with the device of Weir to provide a more secure mount for the electrodes onto the garment, resulting in Weir comprising first and second distal attachment portions each including a hinge portion configured to receive or release a portion of the garment in the open position and removably couple the strap to the garment of the user in a closed position.
However, the Weir/Florence combination does not disclose each of the attachment portions comprising a locking portion with the hinge member comprising a second pivotable member configured to rotate the locking portion relative to the bottom portion in order to removably secure the garment between the top and bottom portion, and does not explicitly disclose the top portions of the distal attachment portions including a distal end contact portion defining a substantially planar contact surface configured to contact the garment without localized protrusions.
Lake teaches a gripping apparatus that can be used to grip garments and secure them in place ([Abstract]). While not particularly directed to an ECG device, the art is analogous because it is addressing the same problem of securely coupling one element to another. The clamp shown in Fig. 1 includes a first pivotable portion where the upper and lower jaws are connected and a second pivotable portion upon which the lever pivots. The locking member 16 rotates about the second pivotable portion ([Col 3, lines 34-45]). The locking member provides a fulcrum to close and lock the jaws together to provide a constant mechanical gripping load ([Col 3, lines 34-45]). As seen in Fig. 3, the distal contact portion 32 of the top jaw is flat ([Col 3, lines 46-67]). The flat, elastic surface helps protect the user’s garment when attached ([Col 4, lines 4-12]). This flat member does not have protrusions when it initially contacts the shirt, thus satisfying the claim language. Modifying the clamps of the Weir/Florence combination to locking clamps with a flat contact portion on the top portion as taught by Lake would be of routine skill in the art. It would simply require the substitution of one clamp type for another. Furthermore, the instant application does not provide any criticality to the type of clamp used as seen in Figs. 3A-14 of the instant application which show multiple different types of clamps used for the central and distal clamps to attach to the garment of the user. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine a locking feature and a flat distal contact surface on the attachment portions of the Weir/Florence combination, as taught by Lake, to provide a more secure attachment to the garment that also protects the garment during use.
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Regarding claim 20, the Weir/Florence/Lake combination discloses the heart rate monitor system of claim 16, wherein the attachment device is comprised at least partially of plastic ([0015]: the attachment device 120 may be made of a material like a thermoplastic).
Response to Arguments
Applicant' s arguments with respect to claim(s) 1-9, 16, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argues that Angus does not teach the flat portion on the top contact portions and that Angus is non-analogous art. These arguments are moot because the new rejection no longer relies on Angus.
However, Lake, which is used to replace Angus, is also not directed towards an ECG monitoring device.
The art is analogous because it is solving the same problem of securing one element to another element. The Weir/Florence combination already teaches using multiple clips to secure an electrode band to a garment and Lake is simply used to teach the claimed type of clip. Selecting one clip type over another for the attachment portions of the electrode band is routine and within ordinary skill in the art. Furthermore, the clip-type in the instant application has no criticality as the drawings cite multiple different styles of clips to secure the device to the garment of the user and locking clamps, such as those claimed, are very well known. See US 11209667 B1, US 20170238874 A1, US 9402483 B2, US 7174607 B1, US 5177813 A, US 5063643 A, US 763014 A which all teach locking clamps with planar distal portions on their top side used in a variety of different scenarios. Utilizing a locking clamp to secure two things together has been done for over a hundred years and it would be obvious to combine this style of clip with any device attached to a garment of a user.
Therefore, the rejections to claims 1-9, 16, and 20 remain.
Response to Affidavit
The affidavit under 37 CFR 1.132 filed 4/22/2026 is insufficient to overcome the rejection of claims 1, 9, and 16 based upon the Weir/Florence/Angus 35 U.S.C. 103 obviousness rejection as set forth in the last Office action because:
It states that the claimed subject matter solved a problem that was long standing in the art. However, there is no evidence that if persons skilled in the art who were presumably working on the problem knew of the teachings of the above cited references, they would still be unable to solve the problem.
The applicant states that the prior approach was centered around chest-strap monitors that wrap around the entire chest (See “Prior Heart Rate Monitoring Approach”) while others tried to utilize lubricants, tape, bandages (See “Attempts to Work Around these Problems”). The Applicant goes on to state that other companies tried to reposition the strap or utilize bras with snaps or sleeves for attaching the heart rate monitor (See “Attempts to Work Around these Problems”). Additionally, the applicant states that the other alternatives were to utilize wrist straps which were not as effective (See “Attempts to Work Around these Problems”). Applicant further states that this issue has persisted since at least 2012 (See “How Long these Problems Existed”).
While these are some of the methods tried to address the problems stated by the Applicant, clip based attachment methods, like those claimed, have also been tried as disclosed by Weir and Florence. As seen in Fig. 5E of Weir, a clip is used to mount the device to a bra without a strap that surrounds the chest and without snaps embedded in the bra. Similarly, Florence teaches utilizing a strap with multiple clip-style attachment points as seen in Fig. 4A. These clips can be used to secure the device to multiple styles of garments, including the bra of a user, as seen in Fig. 2. Florence was published in 2017 and Weir in 2021, both before the effective filing date of the claimed invention. Utilizing these two references, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the invention that a multi-clip approach can be used to securely attach an electrode device to a sports bra of a user.
The Applicant goes on to state that before the design of the present application, there were no commercially available devices that attached directly to a sports bra or similar garment, avoided a full wraparound chest strap, and provided accurate and reliable heart rate measurements during exercise. The devices of Weir and Florence accomplish all of these goals (See Fig. 5E and paragraph [0008] of Weir, and Fig. 2 and [Col 3, lines 52-64] of Florence).
The applicant states that their design utilizes multiple discrete attachment portions, eliminates the need for a wraparound strap, and maintains the electrodes in a stable, fixed position relative to the wearer during movement. Florence alone does all of these things (Fig. 2 and [Col 3, lines 52-64]).
The Applicant goes on to state that the industry has praised the applicants solution to the problems stated above (See “Industry Response and Praise”). While this praise is documented, Weir and Florence both take an extremely similar approach to mounting an electrode system to a sports bra and this praise does not outweigh the prior art.
The Applicant lastly states that reviewers and users consistently focused on the clip-based attachment to a garment, the absence of a traditional chest strap, the ability to securely attach and remove the device, and improving comfort during use. Weir and Florence accomplish all of these as stated above.
The combination of record teaches a three-point, bra-mounted clip system. The combination of record satisfies the current claim language and the affidavit does not address the prior art of record nor does it address specific claim language as it relates to the prior art of record. Therefore, while the applicant introduces evidence showing a problem and some of the solutions presented to solve the problem, the Applicant does not address the prior art of record which teaches a detachable, multi-point, clip-based device which can be attached to a sports bra or similar garment for long-term patient monitoring.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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