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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following feature must be shown or the feature canceled from the claim(s). No new matter should be entered.
In re claim 15, the feature “wherein the strap includes two bands that are removably and replacably coupled to one another”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
5. 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, 9, 12-13, 15, and 22-35 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 re claim 1, the limitation “removably and replacably”, promotes a clarity concern. Specifically, it is unclear what else the term “replaceably” seeks to require structurally given that any “removable” object would also reasonably be “replaceable”. For examination purposes, the limitation “removably and replacebly”, under the guidelines of BRI, is considered to be anything that can be removed. Examiner notes that dependent claims 9, 12-13, 15, and 22-35 inherit the same deficiencies.
In re claim 13, regarding the limitations “removable from and replacable to” see above (In re claim 1).
In re claim 15,
The limitation “wherein the strap includes two bands”, promotes a clarity concern. Specifically, as written the limitation could be interpreted in one of two ways: 1) the strap includes two bands, that is, one band attached to a side of the housing and another band attached to the opposite side of a housing or 2) the strap itself is one continuous piece of material comprised of two bands. For examination purposes, as best understood, the limitation “wherein the strap includes two bands that are removably and replaceable coupled to one another” will be examined according to interpretation (1).
Regarding the limitation “removably and replacably” see above (In re claim 1).
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.
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 8, 9, 12, 13, 15, 23, 24, 26, 27, 28, 29, 30, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over GuoJun et al. (CN 114431870), in view of Al-Ali et al. (US 2023/0058052).
In re claim 8, GuoJun discloses a wearable monitor (FIG. 1; [n0008]: “wrist type terminal”) comprising:
a housing (102) with an exterior surface (outer surface of 102) and an interior space (inside space of 102 that holds elements 4, 5; [n0030]: “inside the dial 102 are power supply components 5 located below the mainboard 4);
electrocardiogram circuitry (6; [n0041]: “ECG control processing module 6” and [n0030]: “ECG control calculation module” and [n0010, n0011]: “connecting wire”) in the interior space of the housing (FIG. 1; Examiner notes both the “ECG control processing module 6” and “ECG control calculation module” are located on the “mainboard 4” as described in [n0030, n0041]);
a first electrode (10), wherein:
the first electrode is positioned for access by a user when the wearable monitor is placed for use on the user (FIG. 1; [n0037, n0041]), and
the first electrode is coupled to the housing (FIG. 1; [n0037]);
a second electrode (FIG. 2: 12; [n0036]), wherein:
the second electrode is positioned to contact a skin of the user when the wearable monitor is placed for use on the user (FIGS. 1-2; Examiner notes that the second electrode is located on a strap of the wearable monitor [n0036] and thus would contact skin of a user when the wearable monitor is placed on the user’s wrist), and
the second electrode is coupled to the first electrode through the electrocardiogram circuitry in the housing [n0035];
a strap (101) for securing the housing to the user (apparent); and
a fastener (9) configured to releasably tighten the strap to retain the wearable monitor for use on the user (apparent as securing the strap to the housing via the fastener, “tightens” and secures the wearable monitor to the user),
wherein the fastener has an open position (13 not fastened to 9) and a closed position (13 fastened to 9), and further wherein:
in the open position of the fastener,
the wearable monitor is removable from the user (FIG. 1; apparent as strap is no longer connected to the housing when the fastener is in the open position) and
the first electrode is not electrically coupled to the electrocardiogram circuitry ([n0036]: Examiner notes that in the “open position” the first electrode is “not energized” and therefore not electrically coupled with part of the electrocardiogram circuitry), and
in the closed position,
the strap retains the housing of the wearable monitor against the skin of the user for acquisition of a physiological signal (FIG.1; apparent as strap is connected to the housing when the fastener is in the closed position) and
the first electrode is electrically coupled to the electrocardiogram circuitry ([n0035]: “after the tumbler 13 is fastened into the connecting buckle 9, the ECG electrodes (10, 12) are energized”).
GuoJun does not disclose wherein
the first electrode is removably and replaceably coupled to the housing
the second electrode is positioned on the exterior surface of the housing
Al-Ali discloses an analogous wearable monitoring device (abstract; FIGS. 1D-1F: 10) that, like GuoJun, includes two electrocardiogram electrodes (125, 124), herein referred to as a first electrocardiogram electrode (125) and a second electrocardiogram electrode (125). As shown in FIGS 1D-1F, the first electrocardiogram electrode is located on a top surface ([0282]: “ECG electrode 125 can form a part of the housing”) of the wearable monitoring device (FIG. 1D; [0282]), while the second electrocardiogram electrode is located on a bottom surface of the wearable monitoring device (FIG. 7B). As disclosed by Al-Ali, the second electrocardiogram electrode is positioned such that it is configured to contact a user’s skin while the wearable monitoring device is worn by a user [0282].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second electrode of GuoJun to be positioned on the exterior surface of the housing, as taught by Al-Ali. One would have been motivated to make this modification because both positions , that is, the position of the second electrode in GuoJun and position of the second electrode in Al-Ali, enable the second electrode to remain in contact with the user’s skin while they are wearing the wearable monitor. Examiner asserts that not only is it known in the art to place electrodes on the exterior surface of the housing, one of ordinary skill in the art would have the ability to select a position for the second electrode that would best meet their needs.
*Regarding the limitation “removably and replaceably”, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first electrode the proposed combination, to be removable since the court has held that making components separable may be considered obvious to one of ordinary skill in the art. (see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), the claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art' s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose." MPEP § 2144.04-V-C). Accordingly, such a modification would yield “wherein the first electrode is removably and replaceably coupled to the housing”.
In re claim 9, the proposed combination yields (all mapping directed to GuoJun), wherein the wearable monitor includes a photoplethysmography monitor (FIG. 3: 14, 15; [n0030]: “reflective blood oxygen sensor (14, 15)”).
In re claim 12, regarding the limitations “wherein the first electrode is positioned on a surface of the faster”, it would have been obvious to one of ordinary skill in the art to try to position the first electrode on a surface of the fastener. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Since there are a finite number of locations on the housing of the wearable monitor, it would have been obvious to one of ordinary skill in the art to try to position the first electrode on a surface of the fastener. Moreover, such a location would be deemed appropriate given that the surface of the fastener is easily accessible to a user’s finger.
In re claim 13, the proposed combination yields (all mapping directed to GuoJun) wherein the strap is removable from and replaceable to the housing (FIG. 1).
The proposed combination does not yield
wherein the fastener and the strap are removable and replaceable to the housing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device of the proposed combination, to be removable since the court has held that making components separable may be considered obvious to one of ordinary skill in the art. (see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), the claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art' s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose." MPEP § 2144.04-V-C). Accordingly, such a modification would yield “wherein the fastener and the strap are removable and replaceable to the housing”.
In re claim 15, the proposed combination yields (all mapping directed to GuoJun) wherein the strap includes two bands (band to the left of 102, band to the right of 102) that are removably and replaceably couplable to one another (apparent, as the device would not be wearable if a coupling mechanism between the two straps did not exist).
In re claim 23, the proposed combination yields (all mapping directed to GuoJun) further comprising photoplethysmography circuitry (7; [n0030]: “blood oxygen monitoring control analysis module”) configured to acquire heart rate data [n0043] from the user when the wearable monitor is placed for use on the user (FIG. 3 shows a more detailed few of the bottom of the housing which contains through holes (16) for light source emitter and light source receiver to contact a user’s wrist).
In re claim 24, the proposed combination yields (all mapping directed to GuoJun) wherein the fastener is removable from and replaceable to the strap (see FIG. 1 which shows fastener and strap not connected).
In re claim 26, the proposed combination yields (all mapping directed to GuoJun) wherein at least one of the first electrode and the second electrode includes an electrically conductive coating (Fig. 1; [n0033]: first electrode (10) contains a “conductive sheet” located at the bottom of “the electrode groove 2”; Examiner notes that under the broadest reasonable interpretation a “coating” is being interpreted as a layer of material applied to a surface of an object.).
In re claim 27, wherein at least a portion (inside of buckle 9) of the fastener is formed of an electrically conductive material (8; [n0032]; Examiner notes text refers to the conductive sheet as “a8” instead of 8) shaped and size to couple the first electrode to the electrocardiogram circuitry when the fastener is in the closed position (FIG. 1; [n0036]).
In re claim 28, the proposed combination yields (all mapping directed to GuoJun) wherein the fastener includes an electrically conductive coating ([n0032]: “connecting buckle 9 contains a conductive sheet a8”).
In re claim 29, the proposed combination yields (all mapping directed to GuoJun), wherein the electrically conductive coating is selectively applied to a contact region (inner portions of connecting buckle 9 that contacts connecting mechanism (13) shown in FIG. 2) of the fastener.
In re claim 30, the proposed combination yields (all mapping directed to GuoJun) further comprising computer executable code embodied in a non-transitory computer readable medium that, when executed on one or more computing devices, causes the one or more computing devices to acquire an electrocardiogram based on signals measured between the first electrode and the second electrode [n0041].
In re claim 33, the proposed combination yields (all mapping directed to Al-Ali) wherein the second electrode (see modification above (In re claim 1)) is in continuous contact with the user (FIG. 1H shows electrode 124 located on bottom of the housing which remains in contact with a user’s wrist while the wearable device is worn (FIG. 1F)).
In re claim 34, the proposed combination yields (all mapping directed to GuoJun) further comprising one or more additional electrodes (FIG. 1 depicts two electrodes located on housing (102); [n0037]).
In re claim 35, the proposed combination yields (all mapping directed to GuoJun), wherein the one or more additional electrodes are positioned on at least one of the housing (FIG. 1 depicts two electrodes (10) located on the housing (102)), the strap, and the fastener.
Claims 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over GuoJun et al. (CN 114431870), in view of Al-Ali et al. (US 2023/0058052), in view of Frey et al. (US 2020/0301372).
In re claim 22, the proposed combination yields (all mapping directed to GuoJun), further wherein the electrocardiogram circuitry is configured to capture an electrocardiogram of the user when the use contacts the first electrode with a digit of a hand of the user [n0037].
The proposed combination does not yield
wherein the fastener includes a first arm, and a second arm pivotally mounted to the housing, and
wherein the first arm includes the first electrode
Frey discloses a device that, like GuoJun, is configured to be worn on a user’s wrist (abstract). As shown in FIG. 3a, the device includes a housing (15), a strap (6), and a fastening assembly (20, 21, 22 3, 4). As shown in FIG. 3a, the fastening assembly includes a first clasp portion (20), and a second clasp portion (21) connected together via a pivoting element (3). To attach the device the user pivots the second clasp portion about the axis of a coupling (22) so that the second clasp portion is folded over the housing (Fig. 3b) which causes the first clasp portion to become positioned around an upper side of the housing (Fig. 3b; [0020]). The second clasp portion additionally comprises a snap-action closure (23) configured to snap into a pin (24) located on a left side (side of 15 closest to reference number 16) of the housing [0020].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fastener of the proposed combination to be the fastening assembly, taught by Frey. One would have been motivated to make this modification because the fastener of the proposed combination and fastening assembly of Frey are functionally equivalent, that is, they both serve as a mechanism to secure the wearable device to a user’s wrist. Moreover, one of ordinary skill in the art would have the ability to choose the type of fastener that would best meet their needs. Accordingly, such a modification would yield “wherein the fastener includes a first arm, and a second arm pivotally mounted to the housing”.
Regarding the limitation, “wherein the first arm includes the first electrode”:
As shown by looking at FIG. 3 of Frey it is possible that the proposed modification described above could result in the first electrode of the proposed combination being covered by the fastening assembly (see FIG. 3 of Frey which shows fastening assembly in a closed position). Examiner asserts however, that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to include wherein an arm of the fastener includes the first electrode. One would have been motivated to make this modification to ensure the user could still use the first electrode even after the modification of the fastener described above. Regarding the limitation “first arm”, given that there is a limited number of locations on the fastening assembly (Frey, Figs, 3a-3b), it would have been obvious to one of ordinary skill in the art to try to place the first electrode on the first arm. Accordingly, such a modification would yield “wherein the first arm includes the first electrode”.
In re claim 25, the proposed combination yields (all mapping directed to Frey) wherein the fastener includes a clasp (21) pivotally mounted to the housing ([0020]: “clasp portion 21 is pivoted by the wearer about the axis of coupling 22”).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over GuoJun et al. (CN 114431870), in view of Al-Ali et al. (US 2023/0058052), in view of Rothkopf (US 2016/0058375).
In re claim 21, the proposed combination does not yield, wherein the housing is waterproof.
Rothkopf discloses an analogous wearable device with a waterproof housing (FIG. 8; [0134]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of the proposed combination to be waterproof, as taught by Rothkopf. One would have been motivated to make this modification because doing so would help protect the devices internal components, ultimately promoting longevity of the wearable device. Examiner notes that one would be further motivated to make such a modification given that the wearable device of the proposed combination is used for monitoring athletic individuals (GuoJun, [n0006]).
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over GuoJun et al. (CN 114431870), in view of Al-Ali et al. (US 2023/0058052), in view of Kwon et al. (US 2023/0233153).
In re claim 31, the proposed combination does not yield further comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more computing devices, causes the one or more computing devices to guide the user through a process for acquiring an electrocardiogram.
Kwon discloses an analogous wearable device (abstract, FIG. 1) that also has the ability to record a user’s electrocardiogram (abstract). As shown in FIGS. 10-11, the wearable device of Kwon additional also provides visual/audio queues, which help guide a user through a process of acquiring an electrocardiogram [0106, 0109, 0111].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device of the proposed combination to guide the user through a process for acquiring an electrocardiogram, as taught by Kwon. One would have been motivated to make this modification because doing so would help facilitate a more accurate electrocardiogram recording (Kwon, [0015]).
In re claim 32, the proposed combination yields wherein the wearable monitor is configured to guide the user through a process of acquiring an electrocardiogram (Kwon, FIGS. 10-11; [0106, 0109, 0111]).
The proposed combination does not yield
wherein the wearable monitor is in a communicating relationship with a user device
Kwon further discloses an embodiment in which the wearable device is in communication with one or more external devices [0141]. As discussed in [0141], all operations executed on the wearable device may also be executed at the one or more external devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination, to be in a communicating relationship with a user device, as taught by Kwon. One would have been motivated to make this modification to have an alternative means of displaying instructions to the user. Moreover, provided that something happens to the display functionality of the wearable device, such a modification would allow the user to still receive information about how to appropriately acquire an electrocardiogram.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yang (US 2025/0114040) discloses an analogous wearable device (Fig. 2; abstract) with an electrode (420) located on a buckling mechanism (210) of the wearable device.
English (US 11,478,606) discloses an analogous wearable device (FIG. 4) with the ability to monitor various physiological parameters of a user (abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796