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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claims 1 and 12, the scope of the new limitation “such that the electronic device is not accessible” is unclear. Referring to Applicant’s originally-filed disclosure, paragraphs 0073 and 0076 and Figs. 1 and 2A, the disclosure appears to describe a wearable device that renders to electronic device “not visible when the securement portion secures the body portion 1102 to the subject” (par. 0076), and that “a lack of an opening in the first side 1102a can, as examples, prevent access to at least a portion of the electronic device 1200 (e.g., the top 1292)” (par. 0076), but paragraph 0073 indicates that “the one or more detectors 1208, and/or the one or more ECG electrodes 1209 of the electronic device 1200 are accessible to contact and/or face toward the tissue site of the subject via the opening 1108.” Accordingly, it is unclear whether the scope of “not accessible” includes being visible (i.e., is viewing a portion of the electronic device considered “accessing” the device?), whether the scope of “not accessible” requires only the functionality of not being able to access a portion of the electronic device, such as the top portion (the only scope apparently supported under section 112(a) in light of the original disclosure), whether the scope of “not accessible” means that the user cannot access the medical device in any way (which does not appear to be supported by the original disclosure in light of the last sentence of paragraph 0073 indicating that the medical device is being “accessed”), or some other scope.
Further, it is unclear what scope of activity is considered “accessing” -- again, it is unclear whether the inability to view the medical device from a given perspective is considered “not accessible”; whether the inability to view the medical device from any perspective is considered “not accessible”; whether the inability to view the medical device, but the ability to view indicator lights of the medical device is considered “not accessible”; whether being in contact with the subject’s skin is considered “not accessible” (in spite of paragraph 0073’s disclosure); whether “not accessible” merely requires a lack of openings in some portion or all of the wearable device; whether “not accessible” requires a lack of openings and a lack of ability to manipulate, e.g., buttons or interface ports in some portion or all of the wearable device; or some other scope. Since it appears that the scope most reasonably supported by the original disclosure is a lack of openings in the top of the wearable device, corresponding to the top of the medical device, the examiner is applying this interpretation for prior art purposes, but clarification is respectfully requested.
Claim Rejections - 35 USC § 102
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 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, 4, 5 and 12-14 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Yao et al. (US 2022/0218219, hereinafter “Yao”).
In regards to claims 1 and 12, Yao discloses a wearable system comprising:
an electronic device configured to measure one or more physiological parameters of a subject, the electronic device comprising at least one light emitter and at least one light detector and is configured to measure at least a pulse oximetry measurement (elements 3 and 5; pars. 0004, 0037); and
a wearable device (par. 0048, “a smartwatch, a smart band, or the like”) configured to cover and position the electronic device (par. 0037, “The smart wearable device includes a display screen 1 and a rear cover 2 that engages with the display screen 1, and further includes a light generator 3 and a light receiver 5”), the wearable device comprising:
a body portion (elements 1 and 2) comprising a first side (side of screen 1), a second side opposite the first side (side of rear cover 2), a cavity (par. 0037, “The light generator 3 and the light receiver 5 are disposed in a mounting cavity formed after the display screen 1 engages with the rear cover 2”), and an opening in the second side configured to allow the electronic device to be at least partially inserted through said opening and at least partially positioned within said cavity (par. 0037, “The light generator 3 and the light receiver 5 are disposed in a mounting cavity formed after the display screen 1 engages with the rear cover 2”); and
a securement portion connected to the body portion and configured to secure said body portion to the subject to prevent the electronic device from slipping or moving along a tissue site of the subject (par. 0062, a securing band a necessary feature of a smartwatch or smart band);
wherein said second side of said body portion is configured to face toward said tissue site of the subject when the wearable device is secured to the subject (pars. 0004, 0006, Fig. 2);
and wherein the wearable device covers the electronic device such that the electronic device is not accessible when the securement portion secures the body portion to the subject (Figs. 3, 4, 9; the electronic device (elements 3 and 5) is within the mounting cavity of par. 0037, in contact with the skin, and not accessible by virtue of the intervening screen 1 and remainder of the device).
In regards to claims 4 and 13, said securement portion comprises a strap, a band, or a garment (par. 0062, “smart band” and “smartwatch” necessarily including a band/strap).
In regards to claims 5 and 14, said first side of said body portion does not comprise an opening (Fig. 4; no opening in screen 1).
Claims 12-15 and 18 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Wu et al. (US 2021/0161470, hereinafter “Wu”).
In regards to claim 12, Wu discloses a wearable device configured to cover and position an electronic device configured to measure a physiological parameter of a subject (abstract, Fig. 5), the wearable device comprising:
a body portion (portion of band 10 housing monitor 20) comprising a first side (Fig. 5, outer side), a second side opposite the first side (Fig. 5, inner side), a cavity (Fig. 5, portion housing element 20), and an opening in the second side configured to allow the electronic device to be at least partially inserted through said opening and at least partially positioned within said cavity (par. 0028, “During use, the monitor host 20 is inserted into the receiving cavity 11 through window 12 and is fixed thereto”); and
a securement portion connected to the body portion and configured to secure said body portion to the subject to prevent the electronic device from slipping or moving along a tissue site of the subject (Fig. 5, band portions of element 10);
wherein said second side of said body portion is configured to face toward said tissue site of the subject when the wearable device is secured to the subject (Fig. 5); and
wherein the wearable device covers the electronic device such that the electronic device is not accessible when the securement portion secures the body portion to the subject (Figs. 3-5, monitor is completely contained within band 10 except for window 12).
In regards to claim 13, said securement portion comprises a strap, a band, or a garment (Fig. 5).
In regards to claim 14, said first side of said body portion does not comprise an opening (Figs. 1, 3, 5).
In regards to claim 15, said body portion comprises a flexible, stretchy, and/or resilient material (par. 0025, “an elastic textile and is made of pure cotton”) configured to allow a size of said opening to be increased to allow the electronic device to be at least partially inserted through said opening and at least partially positioned within said cavity (Figs. 4 and 5; par. 0028, “During use, the monitor host 20 is inserted into the receiving cavity 11 through window 12 and is fixed thereto”; as the monitor 20 is larger than window 12, the textile material is necessarily flexible to allow for insertion of the monitor).
In regards to claim 18, said body portion and said securement portion are seamlessly integrated with one another (Figs. 1, 2 and 5).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Trapero Martin (US 11,156,965, hereinafter “Trapero Martin”).
In regards to claim 1, Wu discloses a wearable device configured to cover and position an electronic device configured to measure a physiological parameter of a subject (abstract, Fig. 5), the wearable device comprising:
a body portion (portion of band 10 housing monitor 20) comprising a first side (Fig. 5, outer side), a second side opposite the first side (Fig. 5, inner side), a cavity (Fig. 5, portion housing element 20), and an opening in the second side configured to allow the electronic device to be at least partially inserted through said opening and at least partially positioned within said cavity (par. 0028, “During use, the monitor host 20 is inserted into the receiving cavity 11 through window 12 and is fixed thereto”); and
a securement portion connected to the body portion and configured to secure said body portion to the subject to prevent the electronic device from slipping or moving along a tissue site of the subject (Fig. 5, band portions of element 10);
wherein said second side of said body portion is configured to face toward said tissue site of the subject when the wearable device is secured to the subject (Fig. 5); and
wherein the wearable device covers the electronic device such that the electronic device is not accessible when the securement portion secures the body portion to the subject (Figs. 3-5, monitor is completely contained within band 10 except for window 12).
Although Wu discloses that “the monitor host 20 can detect various human health indexes such as human body temperature, heart rate, and the like” (par. 0028) and “[t]he specific structure and working principle inside the monitor host 20 are all prior art, and the internal structure and working principle of the monitor host 20 are not described in detail here” (par. 0026), Wu does not expressly disclose the electronic device comprising at least one light emitter and at least one light detector and is configured to measure at least a pulse oximetry measurement.
However, Trapero Martin in the same field of endeavor of wearable physiological monitors teaches providing an electronic device comprising at least one light emitter and at least one light detector and is configured to measure at least a pulse oximetry measurement (col. 23, line 53 to col. 24, line 6) to provide the predictable results of determining blood oxygen levels, which is known as an important vital sign for assessing a user’s health (col. 23, lines 53-57).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wu by providing an electronic device comprising at least one light emitter and at least one light detector and is configured to measure at least a pulse oximetry measurement to provide the predictable results of determining blood oxygen levels, which is known as an important vital sign for assessing a user’s health.
In regards to claim 2, Wu discloses the essential features of the claimed invention, including a communication module configured to facilitate wireless communication with a separate device (par. 0028, “Bluetooth”) and detecting heart rate (par. 0028), but does not expressly disclose wherein the electronic device further comprises at least one ECG electrode and is configured to measure at least an ECG measurement.
However, Trapero Martin in the same field of endeavor of wearable physiological monitors teaches providing at least one ECG electrode and is configured to measure at least an ECG measurement (col. 17, lines 34-42) to provide the predictable results of a variety of sensors in a compact form factor for determining the health status of a user (col. 1, lines 13-20).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wu by providing at least one ECG electrode and is configured to measure at least an ECG measurement to provide the predictable results of a variety of sensors in a compact form factor for determining the health status of a user.
In regards to claim 4, Wu discloses said securement portion comprises a strap, a band, or a garment (Fig. 5).
In regards to claim 5, Wu discloses said first side of said body portion does not comprise an opening (Figs. 1, 3, 5).
In regards to claim 6, Wu discloses said body portion comprises a flexible, stretchy, and/or resilient material (par. 0025, “an elastic textile and is made of pure cotton”) configured to allow a size of said opening to be increased to allow the electronic device to be at least partially inserted through said opening and at least partially positioned within said cavity (Figs. 4 and 5; par. 0028, “During use, the monitor host 20 is inserted into the receiving cavity 11 through window 12 and is fixed thereto”; as the monitor 20 is larger than window 12, the textile material is necessarily flexible to allow for insertion of the monitor).
In regards to claim 9, Wu discloses said body portion and said securement portion are seamlessly integrated with one another (Figs. 1, 2 and 5).
Claims 16, 17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Nousiainen et al. (US 2020/0146625, hereinafter “Nousiainen”).
Wu discloses the essential features of the claimed invention except for wherein said body portion further comprises a frame positioned within said cavity configured to position the electronic device, said frame integrally formed with said body portion, wherein said frame comprises a resilient material, or wherein said resilient material of the frame is more rigid than a material comprising a remainder of the body portion.
However, Nousiainen in the same field of endeavor of wearable physiological monitors teaches providing a body portion that further comprises a frame positioned within a cavity configured to position the electronic device, said frame integrally formed with said body portion, wherein said frame comprises a resilient material, or wherein said resilient material of the frame is more rigid than a material comprising a remainder of the body portion (par. 0074, metal or polymeric more rigid than the elastic material of the strap) to provide the predictable results of holding the biometric monitor module in a designed aperture even though the surrounding parts would be stretched, deformed or otherwise bent (par. 0074).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wu by providing a body portion that further comprises a frame positioned within a cavity configured to position the electronic device, said frame integrally formed with said body portion, wherein said frame comprises a resilient material, or wherein said resilient material of the frame is more rigid than a material comprising a remainder of the body portion to provide the predictable results of holding the biometric monitor module in a designed aperture even though the surrounding parts would be stretched, deformed or otherwise bent.
Claims 3, 7, 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wu and Trapero Martin as applied to claim 1 above, and further in view of Nousiainen.
Wu’s modified invention discloses the essential features of the claimed invention except for wherein the electronic device comprises a battery and a charge port, and wherein the charge port is accessible for charging the battery of the electronic device when the electronic device is positioned at least partially within said cavity; or wherein said body portion further comprises a frame positioned within said cavity configured to position the electronic device, said frame integrally formed with said body portion, wherein said frame comprises a resilient material, or wherein said resilient material of the frame is more rigid than a material comprising a remainder of the body portion.
However, Nousiainen in the same field of endeavor of wearable physiological monitors teaches providing an electronic device that comprises a battery and a charge port (element 33 and “battery”; pars. 0092, 0106), and wherein the charge port is accessible for charging the battery of the electronic device when the electronic device is positioned at least partially within said cavity (par. 0106, Fig. 10) to provide the predictable results of powering the device from within the monitor itself (par. 0092); and a body portion that further comprises a frame positioned within a cavity configured to position the electronic device, said frame integrally formed with said body portion, wherein said frame comprises a resilient material, or wherein said resilient material of the frame is more rigid than a material comprising a remainder of the body portion (par. 0074, metal or polymeric more rigid than the elastic material of the strap) to provide the predictable results of holding the biometric monitor module in a designed aperture even though the surrounding parts would be stretched, deformed or otherwise bent (par. 0074).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Wu by providing an electronic device that comprises a battery and a charge port, and wherein the charge port is accessible for charging the battery of the electronic device when the electronic device is positioned at least partially within said cavity to provide the predictable results of powering the device from within the monitor itself; and a body portion that further comprises a frame positioned within a cavity configured to position the electronic device, said frame integrally formed with said body portion, wherein said frame comprises a resilient material, or wherein said resilient material of the frame is more rigid than a material comprising a remainder of the body portion to provide the predictable results of holding the biometric monitor module in a designed aperture even though the surrounding parts would be stretched, deformed or otherwise bent.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of De Begon (US 2025/0248610, hereinafter “De Begon”). Wu discloses the essential features of the claimed invention except for wherein said body portion and said securement portion comprise a first layer, a second layer, and a third layer, said second layer disposed in between said first and third layers, wherein said first side of the body portion comprises said first and second layers, and wherein said second side of the body portion comprises said third layer.
However, De Begon in the same field of endeavor of physiological monitors teaches providing a body portion and said securement portion that comprise a first layer, a second layer, and a third layer, said second layer disposed in between said first and third layers, wherein said first side of the body portion comprises said first and second layers, and wherein said second side of the body portion comprises said third layer (Figs. 1A and 3, elements 22 and 23; note that cuff 2 includes the two layers 22 and 23 and the cuff completely wraps around itself in Fig. 1A, providing from the skin surface: layer 22, monitor 4, upper layer 23, layer 22, and layer 23) to provide the predictable results of allowing the cuff to be properly wrapped around the limb of the subject leading to a better fixation of the device on the limb of the subject, and more repeatable and accurate pressure measurements (par. 0013).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wu by providing a body portion and said securement portion that comprise a first layer, a second layer, and a third layer, said second layer disposed in between said first and third layers, wherein said first side of the body portion comprises said first and second layers, and wherein said second side of the body portion comprises said third layer to provide the predictable results of allowing the cuff to be properly wrapped around the limb of the subject leading to a better fixation of the device on the limb of the subject, and more repeatable and accurate pressure measurements.
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wu and De Begon, as applied to claim 19 above, and further in view of Saroka et al. (US 2014/0378812, hereinafter “Saroka”). Wu discloses the essential features of the claimed invention, including that the layers are made of fabric (De Begon, par. 0036) and may comprise Velcro (De Begon, par. 0070), but does not expressly disclose wherein said second layer comprises an unbroken loop fabric material.
However, Saroka in the same field of endeavor of garment-based sensor mounting means teaches providing a hook and loop fastener in the form of unbroken loop fabric material (par. 0171) to provide the predictable results of a material that is durable and unstretchable (low elasticity coefficient) so that when bound to its binding member the garment will retain shape and position despite being under stretching force when worn (par. 0172).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wu by providing a hook and loop fastener in the form of unbroken loop fabric material to provide the predictable results of a material that is durable and unstretchable (low elasticity coefficient) so that when bound to its binding member the garment will retain shape and position despite being under stretching force when worn.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wu and Trapero Martin, and further in view of De Begon. Wu’s modified invention discloses the essential features of the claimed invention except for wherein said body portion and said securement portion comprise a first layer, a second layer, and a third layer, said second layer disposed in between said first and third layers, wherein said first side of the body portion comprises said first and second layers, and wherein said second side of the body portion comprises said third layer.
However, De Begon in the same field of endeavor of physiological monitors teaches providing a body portion and said securement portion that comprise a first layer, a second layer, and a third layer, said second layer disposed in between said first and third layers, wherein said first side of the body portion comprises said first and second layers, and wherein said second side of the body portion comprises said third layer (Figs. 1A and 3, elements 22 and 23; note that cuff 2 includes the two layers 22 and 23 and the cuff completely wraps around itself in Fig. 1A, providing from the skin surface: layer 22, monitor 4, upper layer 23, layer 22, and layer 23) to provide the predictable results of allowing the cuff to be properly wrapped around the limb of the subject leading to a better fixation of the device on the limb of the subject, and more repeatable and accurate pressure measurements (par. 0013).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Wu by providing a body portion and said securement portion that comprise a first layer, a second layer, and a third layer, said second layer disposed in between said first and third layers, wherein said first side of the body portion comprises said first and second layers, and wherein said second side of the body portion comprises said third layer to provide the predictable results of allowing the cuff to be properly wrapped around the limb of the subject leading to a better fixation of the device on the limb of the subject, and more repeatable and accurate pressure measurements.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wu, Trapero Martin, and De Begon, as applied to claim 10 above, and further in view of Saroka. Wu’s modified invention discloses the essential features of the claimed invention, including that the layers are made of fabric (De Begon, par. 0036) and may comprise Velcro (De Begon, par. 0070), but does not expressly disclose wherein said second layer comprises an unbroken loop fabric material.
However, Saroka in the same field of endeavor of garment-based sensor mounting means teaches providing a hook and loop fastener in the form of unbroken loop fabric material (par. 0171) to provide the predictable results of a material that is durable and unstretchable (low elasticity coefficient) so that when bound to its binding member the garment will retain shape and position despite being under stretching force when worn (par. 0172).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Wu by providing a hook and loop fastener in the form of unbroken loop fabric material to provide the predictable results of a material that is durable and unstretchable (low elasticity coefficient) so that when bound to its binding member the garment will retain shape and position despite being under stretching force when worn.
Response to Arguments
Applicant’s arguments with respect to claims 1-22 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nuovo et al. (US 2016/0022210) is another example of a wearable device configured to house an electronic device.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792