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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/12/2026 has been entered.
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, 2, 4-8 and 12-17 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Gill et al. (US 2021/0251572, hereinafter “Gill”).
In regards to claims 1 and 12, Gill 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 (par. 0056; PPG sensor); and
a wearable device configured to cover and position the electronic device (Figs. 10a and 10b), the wearable device comprising:
a body portion comprising a first side, a second side opposite the first side, a cavity, 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 removably positioned within said cavity (Figs. 10a and 10b, element 500; claim 2: “said sealed unit being removably attached within said recess”); 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 (Figs. 10a and 10b, element 500);
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 (Figs. 10a and 10b); and
wherein the wearable device covers the electronic device such that a top of the electronic device is not physically accessible when the securement portion secures the body portion to the subject (par. 0039, “the enclosed combined sensor module 100 and battery module 200 facing the subject's body it is substantially concealed and inaccessible”).
In regards to claim 2, the electronic device further comprises: at least one ECG electrode and is configured to measure at least an ECG measurement; and a communication module configured to facilitate wireless communication with a separate device (pars. 0048, 0054, 0056).
In regards to claims 4 and 13, said securement portion comprises a strap, a band, or a garment (Figs. 10a and 10b).
In regards to claims 5 and 14, the said first side of said body portion does not comprise an opening (Fig. 10b, par. 0039).
In regards to claims 6 and 15, said body portion comprises a flexible, stretchy, and/or resilient material 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 (par. 0039, snap fit or interference fit).
In regards to claims 7 and 16, said body portion further comprises a frame positioned within said cavity configured to position the electronic device (Fig. 8, pars. 0039).
In regards to claims 8 and 17, said frame comprises a resilient material (par. 0039, snap fit or interference fit).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gill. Gill discloses the essential features of the claimed invention including wherein the electronic device comprises a rechargeable battery (par. 0051) and a port (102), and wherein the port is accessible when the electronic device is positioned at least partially within said cavity (Figs. 10a and 10b, par. 0063). Gill does not expressly disclose the that port is a charge port for charging the battery. However, it is notorious in the art to provide dual-use charging/data ports to provide the predictable results of minimizing the required connections for data transfer and rechargeable battery charging. 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 Gill by providing a dual-use charging/data port to provide the predictable results of minimizing the required connections for data transfer and rechargeable battery charging.
Claims 9, 10, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gill in view of De Begon (US 2025/0248610, hereinafter “De Begon”). Gill discloses the essential features of the claimed invention except for wherein said body portion and said securement portion are seamlessly integrated with one another and 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 are seamlessly integrated with one another and 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 Gill by providing a body portion and said securement portion that are seamlessly integrated with one another and 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 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gill and De Begon, as applied to claims 10 and 19 above, and further in view of Saroka et al. (US 2014/0378812, hereinafter “Saroka”). Gill’s modified invention discloses the essential features of the claimed invention, 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 Gill 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.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Gill 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 Gill 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.
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. Previously-applied US 2021/0161470 to Wu et al. appears to still apply to the claimed subject matter (although Gill above more explicitly discloses the claim language, as amended, and applied above). For instance, the new limitation drawn to allowing the electronic device to be removably positioned within the cavity is not explicitly, textually disclosed by Wu. However, Wu notes in paragraph 0025 that “the band 10 as a whole is an elastic textile and is made of pure cotton” and in paragraph 0028 that “[d]uring use, the monitor host 20 is inserted into the receiving cavity 11 through the window 12, and is fixed thereto.” It appears that a reasonable reading of a band made “as a whole” from “an elastic material” with a window suitable for inserting the monitor device would likewise render the monitor device “removable” because it would be removed through the same window from which it was inserted. There is an absence of disclosure of any sort of glue or permanent fixation structure within the band that would preclude it from being “removable” (with the “fixed thereto” language of Wu apparently being drawn to geometric fixation by virtue of having been inserted into the band, but nothing precluding removal in the opposite manner of insertion). Although Gill is applied because the required claim limitations are disclosed more explicitly, Wu will still be considered, depending on future claim language.
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.
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, 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
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