DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant’s arguments, filed 10/27/2025, with respect to claims 1-12 and 14-20 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn, and a new reconsideration of the claims are below.
4. It is noted that Claim 13 is presently cancelled and Claim 21 is newly added.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 2, and 9-12, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fong U.S. 9,510,755 (herein referred to as “Fong”) and in view of Ly Hak U.S. 2023/0147529 (herein referred to as “Ly Hak”).
7. Regarding Claim 1, Fong teaches a patch (Figs. 2 and 4) comprising:
a. a pad (Fig. 2, ref num 22) including a back surface for attaching to a patient’s body (Col. 4, lines 63-65 – Col. 5, lines 2-5, “The patch is formed of a flexible substrate 22. On the back (patient-facing side) of the patch… The rest of the patient-facing side of the patch 20 is covered by a biocompatible adhesive which securely attaches the patch to the chest of a patient”) and including a front surface that is on an opposite side of the back surface (see Fig. 4, ref num 22 has a front surface, i.e., the right side as shown in the figure; Col. 5, line 7, “the outward-facing side of the patch”);
b. a shoe (Figs. 2 and 4, ref num 24) coupled to the front surface (Fig. 4, ref num 24 is coupled to front surface of ref num 22) and defining an internal cavity shaped to receive a monitor (Fig. 4, ref num 30 is received in a cavity defined by ref num 24; Col. 5, lines 11-14, “a plastic clip 24 with curved lips at the top and bottom into which an ECG monitor may be snapped and retained as shown in FIG. 4”), the shoe including or defining a sensory feedback feature (Fig. 4, ref num 28; Col. 5, lines 62-64, “the top of the monitor snaps under the top 28 of the clip 24. As the monitor snaps into place, providing a tactile indication to the patient that the monitor is in place”) configured to move into place to engage with the monitor (lines 62-66, “the top of the monitor snaps under the top 28 of the clip 24. As the monitor snaps into place, providing a tactile indication to the patient that the monitor is in place, the contacts 36 on the back of the monitor are aligned with and engage the row of contacts 26 of the clip”); and
c. an electrical connector positioned within the internal cavity (Fig. 2, ref num 26) and configured to mechanically and electrically couple to the monitor (Col. 5, lines 29-32, “three rows of electrical contacts 36. One of these rows makes connection with the elastomeric contacts 26 of the clip 24 and couples the ECG signals into the monitor”; the electrical contacts are what electrically couples the monitor, ref num 30, also see Figs. 3a and 3b).
Fong fails to teach a first and a second sensory feedback feature positioned on a first and second side of the shoe, respectively.
Ly Hak teaches a patch of analogous art (Figs. 4, 5a, 5b) comprising a shoe (Fig. 5a, ref num 480) and a monitor (Fig. 5a, ref num 12), such that the shoe defines a first and second sensory feedback feature (see Fig. 5a, two ref nums 44; para 0195, “two mechanical clips”). The first and second sensory feedback feature are positioned on a first and second side of the shoe, respectively (para 0183, “the side edges of each of the mechanical clips 44 are aligned with the side edges of the case 12”; see Figs. 4, 5a, 5b). The first and second sensory feedback feature provide the same expected result of engaging with the monitor (para 0183, “the side edges of each of the mechanical clips 44 are aligned with the side edges of the case 12”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have a second sensory feedback feature, since this produces the same expected result of engaging with the monitor. It has also been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
8. Regarding Claim 2, Fong teaches at least first or the second sensory feedback feature is further configured to lock the monitor into position (Col. 5, lines 62-64, “the top of the monitor snaps under the top 28 of the clip 24. As the monitor snaps into place, providing a tactile indication to the patient that the monitor is in place”; Col. 5, lines 10-13, “In the center of the patch on the outward-facing side is a plastic clip 24 with curved lips at the top and bottom into which an ECG monitor may be snapped and retained as shown in FIG. 4”).
9. Regarding Claim 9, Fong fails to teach at least first or the second sensory feedback feature includes a bar having a first portion and a second portion, the bar being hinged such that the first portion of the bar is spaced from the monitor and the second portion of the bar can selectively engaged and disengage with the monitor.
Ly Hak teaches a patch of analogous art (Figs. 4, 5a, 5b) comprising a shoe (Fig. 5a, ref num 480) and a monitor (Fig. 5a, ref num 12), such that the shoe defines a sensory feedback feature (Fig. 5a, ref num 44) configured to move into place to engage with the monitor (see movement between Figs. 5a and 5b). The sensory feedback feature includes a bar having a first portion and a second portion , the bar being hinged such that the first portion of the bar is spaced from the monitor and the second portion of the bar can selectively engage and disengage with the monitor (Fig. 5a and 5b, ref num 44 has a bar that is hinged about ref num 45 and selectively engages and disengages with ref num 12; para 0189). This allows for the monitor to be selectively removed from the shoe (para 0197). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have the sensory feedback feature include a bar that is hinged for selectively engagement to the monitor, as this allows for the monitor to be removed/replaced as necessary.
10. Regarding Claims 10, 11, and 12, Fong teaches the shoe comprises plastic (limitation in claim 12; Fong, Col. 5, lines 11-12, “In the center of the patch on the outward-facing side is a plastic clip 24”).
Fong fails to teach a third sensory feedback feature is defined by the shoe and includes a keyhole-shaped opening and bendable arms, further that the bendable arms are integral portions of the shoe.
Ly Hak teaches the first and second sensory feedback features (Fig. 5a, looking at ref nums 44, there is a ref num 440 on each one that may be more specifically defined as the first and second sensory feedback features) and a third sensory feedback feature. The third sensory feedback feature is defined by the shoe and includes a keyhole-shaped opening and bendable arms (Fig. 5a, the arm portions of ref nums 44, not including ref nums 440, defined the third sensory feedback feature that are defined by ref num 480; ref num 480 also include a hole opening, see space defined by ref num 480; para 0148, “the sensor 30 is also received in the internal space of the box 20”; para 0205, “station 40 here has a U-shape”). The bendable arms are positioned on opposing sides of the hole shaped opening and integral portions of the shoe (see Fig. 5a, ref num 44 is on opposite sides of opening and integral to the shoe via ref num 45). The third sensory feedback feature provide the same expected result of engaging with the monitor (para 0183, “the side edges of each of the mechanical clips 44 are aligned with the side edges of the case 12”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have a third sensory feedback feature, since this produces the same expected result of engaging with the monitor. While Ly Hak fails to explicitly teach that the opening is keyhole-shaped, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
11. Regarding Claim 21, Fong fails to teach the first or the second sensory feedback feature is configured to move from an open position to a closed position, wherein the shoe is configured to engage with the monitor in the closed position and disengage with the monitor in the open position.
Ly Hak teaches the first and second sensory feedback features are configured to move from an open position to a closed position (see Figs. 5a and 5b, ref nums 44 move from closed to open positions; para 0173), wherein the shoe is configured to engage with the monitor in the closed position and disengaged with the monitor in the open position (see Figs. 5a, 5b; para 0173-0179, 0183). The first and second sensory feedback feature provide the same expected result of engaging with the monitor (para 0183, “the side edges of each of the mechanical clips 44 are aligned with the side edges of the case 12”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have the first or second sensory feedback feature move between an open and closed position, since this produces the same expected result of engaging with the monitor.
12. Claims 3-5, 7-8, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fong and Ly Hak, and further in view of Weinstein U.S. 2023/0137521 (earliest filing date 3/11/2020) (herein referred to as “Weinstein”).
13. Regarding Claims 3, 4, and 5, Fong as modified by Ly Hak teaches the sensory feedback features “click” (Ly Hak, para 0187), but fails to teach to explicitly teach at least the first or the second sensory feedback feature is further configured to create audible feedback (Claim 3), further that the audible feedback is a click noise (Claim 4), and that the audible feedback is caused by at least the first or the second the sensory feedback feature snapping into place (Claim 5).
Weinstein teaches a patch of analogous art (Figs. 5-11), wherein the patch includes a pad (Fig. 10, ref num 351), a shoe (Fig. 10, ref num 352), and a monitor (Fig. 10, ref num 200). The shoe includes a sensory feedback feature that is configured to engage with the monitor (Fig. 10, ref num 353; para 0190, “The pivotable latch 202 is configured to engage… a corresponding catch 353 formed on or in the housing 352 of the patch 350”). The sensory feedback feature is further configured to create audible feedback (para 0192, “When the pivotable latch 202 comes into engagement with the catch 302, 353, the catch end of the pivotable latch 202 will snap into place over the catch 302, 353 producing a “snap” or “click” that may be heard or felt by the patient P when inserting the multi-mode sensor 200 into the holster 300 or the patch 350”). The audible feedback is a click noise (para 0192, “…“click” that may be heard”), as well as is caused by the sensory feedback feature snapping into place (para 0192, “When the pivotable latch 202 comes into engagement with the catch 302, 353, the catch end of the pivotable latch 202 will snap into place over the catch 302, 353 producing a “snap” or “click” that may be heard or felt by the patient P when inserting the multi-mode sensor 200 into the holster 300 or the patch 350”). This indicates to the patient/user that the monitor and shoe are correctly connected to one another in order to properly use the patch to monitor the patient (para 0192). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have the sensory feedback feature create audible feedback, such as a click noise, caused by the sensory feedback feature snapping into place, as this provides the patient with needed feedback in order to ensure proper placement of the shoe and monitor.
14. Regarding Claims 7 and 8, Fong fails to teach the sensory feedback feature is configured to create the audible feedback only once the monitor is connected to the electrical connector (claim 7) as well as the sensory feedback feature is configured to create the audible feedback only once the monitor is properly engaged with the shoe (claim 8).
Weinstein teaches a patch of analogous art (Figs. 5-11), wherein the patch includes a pad (Fig. 10, ref num 351), a shoe (Fig. 10, ref num 352), a monitor (Fig. 10, ref num 200), and an electrical connector (Figs. 11 and 16A, ref num 355). The shoe includes a sensory feedback feature that is configured to engage with the monitor (Fig. 10, ref num 353; para 0190, “The pivotable latch 202 is configured to engage… a corresponding catch 353 formed on or in the housing 352 of the patch 350”). The sensory feedback feature is further configured to create audible feedback (para 0192, “When the pivotable latch 202 comes into engagement with the catch 302, 353, the catch end of the pivotable latch 202 will snap into place over the catch 302, 353 producing a “snap” or “click” that may be heard or felt by the patient P when inserting the multi-mode sensor 200 into the holster 300 or the patch 350”). The audible feedback is created once the monitor is connected to the electrical connector, as well as once the monitor is properly engaged with the shoe (Fig. 11, ref num 200 is being connector to ref num 355 within shoe, ref num 352; para 0192, “the attachment mechanism 201 can produce visual, audible, and tactile feedback indicating that the multi-mode sensor 200 has been correctly positioned within… the housing 352 of the patch 350”; para 0191, “The receiver 301 of the holster 300 and the housing 352 of the patch 350 are configured to position the multi-mode sensor 200 such that the electrical contacts 210 on the multi-mode sensor 200 come into engagement with the corresponding electrical contacts 304, 355 on the holster 300 and the patch 350”). This indicates to the patient/user that the monitor and shoe are correctly connected to one another in order to properly use the patch to monitor the patient (para 0192). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have the sensory feedback feature create audible feedback once the monitor is connected to the electrical connector/the monitor is properly engaged with the shoe, as this provides the patient with needed feedback in order to ensure proper placement of the shoe/electrical connector and monitor.
15. Regarding Claim 16, Fong fails to teach the patch is a single-use patch.
Weinstein teaches the patch is single-use (para 0186). A single-use patch is commonly used in the art and allows for it to be replaced as necessary to the user (para 0186). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have the patch be a single-use patch, as this is common to one of ordinary skill, and provides the opportunity to replace the patch as necessary.
16. Regarding Claim 18, Fong teaches an assembly (Figs. 2-4) comprising:
a. a monitor that is reusable and that includes a recess and a first electrical connector (Figs. 3a and 3b, ref num 30, 32, and 36); and
b. a patch (Figs. 2 and 4) comprising
b.1 a shoe (Figs. 2 and 4, ref num 24) defining an internal cavity, wherein the monitor is positioned within the internal cavity (Fig. 4, ref num 30 is received in a cavity defined by ref num 24; Col. 5, lines 11-14, “a plastic clip 24 with curved lips at the top and bottom into which an ECG monitor may be snapped and retained as shown in FIG. 4”), the shoe including or defining a sensory feedback feature (Fig. 4, Col. 5, lines 48-52, “The plastic case is keyed on the bottom with an indentation 32 that matches the shape of the bottom of the clip 24 of the electrode patch 20. A notch 34 is also formed in the bottom of the case, which matches a projection inside the bottom of the clip”); and,
b.2 a second electrical connector positioned within the internal cavity (Fig. 2, ref num 26) and mechanically and electrically coupled to the first electrical connector (Col. 5, lines 29-33, “three rows of electrical contacts 36. One of these rows makes connection with the elastomeric contacts 26 of the clip 24 and couples the ECG signals into the monitor and applies a small signal to the reference electrode”).
Fong fails to teach the patch is single-use and a first and a second sensory feedback feature positioned on a first and second side of the shoe, respectively.
Ly Hak teaches a patch of analogous art (Figs. 4, 5a, 5b) comprising a shoe (Fig. 5a, ref num 480) and a monitor (Fig. 5a, ref num 12), such that the shoe defines a first and second sensory feedback feature (see Fig. 5a, two ref nums 44; para 0195, “two mechanical clips”). The first and second sensory feedback feature are positioned on a first and second side of the shoe, respectively (para 0183, “the side edges of each of the mechanical clips 44 are aligned with the side edges of the case 12”; see Figs. 4, 5a, 5b). The first and second sensory feedback feature provide the same expected result of engaging with the monitor (para 0183, “the side edges of each of the mechanical clips 44 are aligned with the side edges of the case 12”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have a second sensory feedback feature, since this produces the same expected result of engaging with the monitor. It has also been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Weinstein teaches the patch is single-use (para 0186). A single-use patch is commonly used in the art and allows for it to be replaced as necessary to the user (para 0186). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have the patch be a single-use patch, as this is common to one of ordinary skill, and provides the opportunity to replace the patch as necessary.
17. Regarding Claims 19 and 20, Fong teaches the sensory feedback feature snapping into the recess (see Fig. 4; Col. 5, lines 11-14, “a plastic clip 24 with curved lips at the top and bottom into which an ECG monitor may be snapped and retained as shown in FIG. 4”), but fails to teach the sensory feedback feature is further configured to create audible feedback (claim 19), further that it is caused by the snapping (claim 20).
Weinstein teaches a patch of analogous art (Figs. 5-11), wherein the patch includes a pad (Fig. 10, ref num 351), a shoe (Fig. 10, ref num 352), and a monitor (Fig. 10, ref num 200). The shoe includes a sensory feedback feature that is configured to engage with the monitor (Fig. 10, ref num 353; para 0190, “The pivotable latch 202 is configured to engage… a corresponding catch 353 formed on or in the housing 352 of the patch 350”). The sensory feedback feature is further configured to create audible feedback (para 0192, “When the pivotable latch 202 comes into engagement with the catch 302, 353, the catch end of the pivotable latch 202 will snap into place over the catch 302, 353 producing a “snap” or “click” that may be heard or felt by the patient P when inserting the multi-mode sensor 200 into the holster 300 or the patch 350”). The audible feedback is caused by the sensory feedback feature snapping into place (para 0192, “When the pivotable latch 202 comes into engagement with the catch 302, 353, the catch end of the pivotable latch 202 will snap into place over the catch 302, 353 producing a “snap” or “click” that may be heard or felt by the patient P when inserting the multi-mode sensor 200 into the holster 300 or the patch 350”). This indicates to the patient/user that the monitor and shoe are correctly connected to one another in order to properly use the patch to monitor the patient (para 0192). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have the sensory feedback feature create audible feedback caused by the sensory feedback feature snapping into place, as this provides the patient with needed feedback in order to ensure proper placement of the shoe and monitor.
18. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fong, Ly Hak, and Weinstein, and further in view of Kumar U.S. 2020/0282225 (herein referred to as “Kumar”).
19. Regarding Claim 6, Fong as modified fails to teach the sensory feedback feature is configured to create the audible feedback only once the monitor is locked into position.
Kumar teaches a patch of analogous art (Figs. 33A-33B), wherein the patch comprises a shoe (Fig. 33, ref num 504) and a monitor (Fig. 33A, ref num 502). The shoe defines a sensory feedback feature (Fig. 333A, ref num 506), such that is creates audible feedback only once the monitor is locked into position (Fig. 33B displays that the monitor is locked into position; para 0098, “In addition to the snapping sound or other audible indication of a successful mechanical connection between the disposable component and the reusable component, some embodiments provide an electronically-generated feedback of successful mechanical connection, such as an indicator light, vibration or generated sound… When the microprocessor 514 detects that the circuit 512 is closed, it announces the successful mechanical connection between all of
the mechanical connectors 506 with their corresponding mechanical connectors 508 by… emitting a sound via a speaker 520”). This indicates a successful connection between the monitor and shoe, which allows for the patch to be used properly (para 0098). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Fong to create the audible feedback only once the monitor is locked into position, as this indicates a successful connection for proper use of the patch.
20. Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fong and Ly Hak, and further in view of Kumar.
21. Regarding Claims 14 and 15, Fong fails to teach the keyhole-shaped opening is positioned on a proximal end of the shoe (claim 14), and the keyhole-shaped opening includes a proximal channel leading to a distal circular hole (claim 15).
Kumar teaches a patch of analogous art (Figs. 3A-3B), wherein the patch comprises a shoe (Fig. 3A, ref num 24) and a monitor (Fig. 3B, ref num 28). The shoe defines a sensory feedback that is a keyhole-shaped opening (Fig. 3A, ref num 26 has a keyhole shape), such that the keyhole-shaped opening is on a proximal end of the shoe (see Fig. 3A), as well as it includes a proximal channel leading to a distal circular hole (Fig. 3A, ref nums 34 and 36). This opening is configured to receive the monitor for coupling (para 0084). Therefore, It would have been an obvious matter of design choice to make the different portions of the sensory feedback feature whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. It also would have been obvious to one having ordinary skill in the art at the time the invention was made to have the sensory feedback feature be positioned on a proximal end of the shoe, as well as have the channel be proximal and the hole distal, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. This configuration also produces the expected result of coupling the shoe and monitor together.
22. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fong and Ly Hak, and further in view of Gumiero U.S. 2020/0221968 (herein referred to as “Gumiero”).
23. Regarding Claim 17, Fong fails to teach the electrical connector is a USB electrical connector.
Gumiero teaches a patch of analogous art (Fig. 1, ref num 1) comprising a shoe (Fig. 4, ref num 7). The shoe defines a cavity (Fig. 5, ref num 30) and has an electrical connector position within the internal cavity (Figs. 4 and 5, ref num 28). The electrical connector is a USB electrical connector (para 0032, “recharging connector 28, for example a USB connector”). This provides connection between the shoe, monitor, and power source (para 0032). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fong to have a USB electrical connector, as this is a widely used typed of electrical connector.
Conclusion
24. 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.
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794