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 . Claims 1-2, 4-10, 12, 14-17 and 21-23 are currently pending.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-10, 12, 14-17, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. US Publication 2015/0148646 (hereinafter Park) in view of Cross et al. US Publication 2008/0288026 (hereinafter Cross) and in further view of Bishay et al. US Publication 2016/0278701 (hereinafter Bishay).
Regarding claim 1, Park discloses a biomedical electrode (Figure 1) comprising: a hydrogel layer (layer 150 with hydrogels 110 as per [0047]); a trace layer above the hydrogel layer (120 coupled with 140 as per [0052][0053], the trace layer having a conductive trace ([0052]-[0053] details Ag/AgCl); a conductive adhesive layer above the trace layer (Figure 1 at 130 as per [0051]); and a terminal above the conductive adhesive layer (Figure 3 at 215), wherein the conductive adhesive layer provides a mechanical bond between the terminal and the conductive trace (conductive adhesive 130 sits directly between terminals 215 and traces 140, and is considered both a mechanical and electrical coupling), and wherein the conductive adhesive layer provides electrical continuity between the terminal and the conductive trace (Figure 3); and wherein the trace layer has a trace axis, the conductive adhesive layer has a conductive adhesive layer axis, and the terminal has a terminal axis, and the electrical continuity from the hydrogel layer to the terminal survives misalignment of at least two of the trace axis, the conductive adhesive layer axis, and the terminal axis (Figures 1 and 3, the elements remain unchanged and if there was a marginal misalignment the electrical path given the identical elements are claimed in the exact same location, it would be reasonably expected that the electrical connection would be maintained).
As mentioned previously, there is no detail regarding how much misalignment is acceptable in the original disclosure nor required by the claims, and given these are large flat/planar layers, they would have reasonably remained in electrical communication as intended by the overall purpose of the device. Further, this reads as a theoretical limitation amounting to an if/then statement, which does not appear to be required as there is a final functional product of Park, all of the elements are in alignment.
Though Park teaches a terminal (215) that rests directly on the conductive adhesive layer (Figure 3), there is no mention of the terminal being a pedestal/base. Cross teaches an ECG monitoring device that includes a terminal including a base and a pedestal projecting from the base (Figure 2 at 58 which shows a base and pedestal combo), wherein the pedestal is solid (the pedestal is a snap post which is a solid as it is not a gas or a liquid). It would have been obvious to the skilled artisan before the effective filing date to utilize the snap connector design (base and pedestal) as taught by Cross in lieu of the circular/planar terminal of Park as predictable results would have ensued (allow for easier connection/disconnection of the monitoring unit from the patch). The various types of electrical connectors/terminals are additionally considered art recognized equivalents of each other (male/female connectors in either order as well as two flush connectors).
Park teaches a conductive trace (140) on a label (120), where the trace includes a contact element (Figure 2 the thicker portion that directly contacts the hydrogel 110) and the rest of 140 (the thinner portion) could be considered a spur but no real detail is offered about it, the spur however is on the bottom of the trace layer and by extension not on the top. Bishay teaches an ECG monitoring device that includes a similar trace layer (Figure 5, also seen in Figure 7 near element 47) which includes an electrical contact (39) and spur forming a thin longitudinal portion that extends longitudinally from the contact element towards a center axis of the label (Figures 5, 7, with spur 37 extending as claimed along to the central axis of label 47 of Figure 7) which then goes on to electrically connect to a conductive adhesive layer (51). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the contact element and spur configuration as taught by Bishay in lieu of the trace layer design of Park as predictable results would have ensued (to allow for a more versatile shaping of the device as in Bishay).
Regarding claim 2, Park discloses that the conductive trace is printed onto the label (traces 140 can be printed on top of the hydrogel 110 as per [0053] or simply placed on top of the hydrogel [0055] which would have it in direct contact with the label when printed as the sides would be exposed to 120).
Regarding claims 4-7, as the final product/structure above is met and as the components are planar in nature, none of the components would reasonably be subject to or cause a piloting effect as previously argued. Further, this is being considered a method of manufacturing step that is being treated under MPEP 2113 as a product-by-process limitation where only the final product need be met, which is met above by Park in view of Cross above.
Regarding claim 8, Park discloses a biomedical electrode suite comprising: a hydrogel layer comprising first and second hydrogel elements (layer 150 with hydrogels 110 as per [0047]); a trace layer above the hydrogel layer (elements 140 as per [0052][0053]), the trace layer including a first trace in electrical contact with the first hydrogel element and a second trace in electrical contact with the second hydrogel element (elements 140 independently connected to their respective hydrogels 110 as per Figure 1); a conductive adhesive layer above the trace layer (130 as per [0051]); the conductive adhesive layer having a first conductive portion in electrical contact with the first trace and a second conductive portion in electrical contact with the second trace (Figure 1 with conductive adhesives 130 contacting traces 140); and a terminal array including a first terminal above and in contact with the first conductive portion of the conductive adhesive layer and a second terminal above and in contact with the second conductive portion of the conductive adhesive layer (elements 215 which contact their respective conductive adhesives 130 as per Figure 3), wherein the conductive adhesive layer provides a mechanical bond between each of the first and second terminals and the first and second traces of the trace layer (conductive adhesive 130 sits directly between terminals 215 and traces 140, and is considered both a mechanical and electrical coupling); wherein the first hydrogel element, the first trace, the first conductive portion, and the first terminal define a first electrical path (Figure 1 at elements 130, 140, and 110 from the processor to the skin), and the second hydrogel element, the second trace, the second conductive portion, and the second terminal define a second electrical path separate from the first electrical path (Figure 1 with one assembly to the left and the other to the right); and wherein the trace layer has a trace axis, the conductive adhesive layer has a conductive adhesive layer axis, the terminal array has a terminal axis (Figure 1 which shows the elements in general alignment), and the first electrical path from the first hydrogel element to the first terminal and the second electrical path from the second hydrogel element to the second terminal survive misalignment of at least two of the trace axis, the conductive adhesive layer axis, and the terminal axis (Figure 1, the elements remain unchanged and if there was a marginal misalignment the electrical path given the identical elements are claimed in the exact same location, it would be reasonably expected that the electrical connection would be maintained).
Though Park teaches a terminal (215) that rests directly on the conductive adhesive layer (Figure 3), there is no mention of the terminal being a pedestal/base. Cross teaches an ECG monitoring device that includes first and second terminals each include a base and a pedestal projecting from the base (Figure 2 at 58 which shows a base and pedestal combo), wherein the pedestal is solid (the pedestal is a snap post which is a solid as it is not a gas or a liquid). It would have been obvious to the skilled artisan before the effective filing date to utilize the snap connector design (base and pedestal) as taught by Cross in lieu of the circular/planar terminal of Park as predictable results would have ensued (allow for easier connection/disconnection of the monitoring unit from the patch). The various types of electrical connectors/terminals are additionally considered art recognized equivalents of each other (male/female connectors in either order as well as two flush connectors).
Park teaches a conductive trace (140) on a label (120), where the trace includes a contact element (Figure 2 the thicker portion that directly contacts the hydrogel 110) and the rest of 140 (the thinner portion) could be considered a spur but no real detail is offered about it, the spur however is on the bottom of the trace layer and by extension not on the top. Bishay teaches an ECG monitoring device that includes a similar trace layer (Figure 5, also seen in Figure 7 near element 47) which includes an electrical contact (39) and spur forming a thin longitudinal portion that extends longitudinally from the contact element towards a center axis of the label (Figures 5, 7, with spur 37 extending as claimed along to the central axis of label 47 of Figure 7) which then goes on to electrically connect to a conductive adhesive layer (51). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the contact element and spur configuration as taught by Bishay in lieu of the trace layer design of Park as predictable results would have ensued (to allow for a more versatile shaping of the device as in Bishay).
Regarding claim 9, Park discloses that the hydrogel layer has a hydrogel element (elements 110, Figure 1 and [0047]) and an enclosure element that circumscribes the hydrogel element (150), and wherein the conductive adhesive layer seals the hydrogel element from fluid ingress (130 which prevents ingress from the top where the enclosure is not located, Figure 1).
Regarding claim 10, Park discloses that the first and second conductive traces are printed onto the label (traces 140 can be printed on top of the hydrogel 110 as per [0053] or simply placed on top of the hydrogel [0055] which would have it in direct contact with the label when printed as the sides would be exposed to 120).
Regarding claim 12, Park discloses a nonconductive spacer in the conductive adhesive layer electrically isolating the first conductive portion from the second conductive portion (120 as per [0049][0050], see Figure 1); but is silent on the non-conductive medial portion electrically isolating the terminals. Cross teaches an ECG monitoring patch that includes a nonconductive medial portion in the terminal array electrically isolating the first terminal from the second terminal (Figure 17A which is the top of the patch that includes terminals 150 with non-conductive medial portions 152 that electrically isolate the terminals from each other). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the non-conductive portion as taught by Cross with the terminals of Park in order to aid in preventing shorting, noise, or crosstalk between electrical pathways as is known in the art.
Regarding claims 14-17, as the final product/structure above is met and as the components are planar in nature, none of the components would reasonably be subject to or cause a piloting effect as previously argued. Further, this is being considered a method of manufacturing step that is being treated under MPEP 2113 as a product-by-process limitation where only the final product need be met, which is met above by Park in view of Cross above.
Regarding claim 21, Park discloses that the hydrogel layer has a hydrogel element (elements 110, Figure 1 and [0047]) and an enclosure element that circumscribes the hydrogel element (150), and wherein the conductive adhesive layer seals the hydrogel element from fluid ingress (130 which prevents ingress from the top where the enclosure is not located, Figure 1).
Regarding claim 22, Park discloses that the conductive adhesive layer (130 and [0051]) has a profile that aligns with a patch of the conductive trace when the trace axis and the conductive adhesive layer axis are aligned (Figure 1 which shows that the hydrogel, patch of trace, and conductive adhesive can all share the same axis).
Regarding claim 23, Park discloses that the biomedical electrode is symmetrical about the trace axis, the conductive adhesive layer axis, and the terminal axis when aligned together (Figure 1, which shows two bioelectrodes as detailed in claim 1, the pedestal/base is rendered obvious above, see contents of rejected claim 1).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 8 have been considered but
are moot in view of the new ground(s) of rejection. New art has been applied above to address the newly added limitations regarding the trace/label configuration.
Conclusion
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 Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794