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 Claims 1-15 and 19-24 are currently pending, with claims 6 and 11-15 being withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I and Species I in the reply filed on 01/15/2026 is acknowledged.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 8-10, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sandmore US Patent 9,220,436 (hereinafter Sandmore) in view of Willis et al. US Patent 11,324,429 (hereinafter Willis).
Regarding claim 1, Sandmore discloses a sensor (10), comprising: an electrode assembly having an electrode well (the well within 78 of 18, see Figures 2, 10); and a containment assembly comprising: a deformable housing configured to house an electrically conductive material (column 9 lines 12-20); but is light on detail regarding the burst container mentioned above.
Willis details an EEG headset that includes hurst style housings that include a deformable housing (21b) that is formed with one or more apertures (Figure 16 near 33), and at least one membrane (21s) configured, in an undeformed state of the housing, to cover at least one aperture of the one or more apertures to contain the electrically conductive material in the housing (Figures 16-17 as well as column 17 lines 6-66), wherein upon application of a sufficient force to the housing, the housing is configured to assume a deformed state in which the at least one membrane is configured to at least partially uncover the at least one aperture to enable the electrically conductive material to be released from the housing (Figures 16-17 as well as column 17 lines 6-66). It would have been obvious to the skilled artisan before the effective filing date to utilize the housing type as taught by Willis in lieu of the burst container as taught by Sandmore as predictable results would have ensued (preserve the electrolytic gel/fluid until required for sensing). The housing of the burst container is replacing the one lightly detailed in Sandmore which is designed to sit within the electrode well. Therefore the resultant combination would have afforded a design that would force the conductive material from the housing into the well via the at least one aperture.
Regarding claim 8, Sandmore is silent on the membrane. Willis teaches that the at least one membrane is configured to be breached in response to the application of the force thereby allowing the electrically conductive material to be released from the housing through the at least one aperture (Figures 16-19 which show the before and after the breaching of the seal and the following conductive material exiting the device, see also column 17 lines 6-66). It would have been obvious to the skilled artisan before the effective filing date to utilize the housing type as taught by Willis in lieu of the burst container as taught by Sandmore as predictable results would have ensued (preserve the electrolytic gel/fluid until required for sensing).
Regarding claim 9, Sandmore discloses that the electrically conductive material housed within the housing (column 9 lines 12-20, see also element 96).
Regarding claim 10, Sandmore discloses that the electrode assembly comprises: a backing layer (60); at least one electrode disposed on the backing layer (Figure 10 elements 16, 84); a foam layer disposed on at least a portion of the backing layer (62); and an adhesive disposed on at least a portion of the foam layer and configured to adhere the sensor to a patient (64), wherein the electrode well is defined by the foam layer and the backing layer (Figure 10).
Regarding claim 19, the claim does not actually change the structure given there is already a final product (see the contents of rejected claim 1 above).
Claims 2-3, 5, 7, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Sandmore in view of Willis, and in further view of Parvizi et al. US Publication 2017/0281036 (hereinafter Parvizi).
Regarding claims 2-3, Sandmore as modified by Willis teaches the base device as mentioned above but is silent on the material choice. Parvizi teaches an EEG headset that includes a housing and at least one membrane that have a moisture vapor transmission that prevents drying of the electrically conductive material ([0014][0069] which details that the housing and the frangible portion that becomes the opening for the gel to expel through can be made of silicone which also has moisture transmission rate that would reduce if not prevent outright drying out of the gel; the housing 21b of Figures 13, 6-17 can be considered a bag as bag doesn’t have a set shaping). Willis details that another comparable polymer/plastic could be utilized so long as the purpose is unaffected (flexible enough to deform, column 16 lines 26-38). It would have been obvious to the skilled artisan before the effective filing date to utilize the silicone material as taught by Parvizi with the device of Sandmore and Willis as predictable results would have ensued (allowing for a deformable housing to force conductive material towards skin contact).
Regarding claims 5 and 21-22, Sandmore as modified by Willis includes a single aperture and is silent on more being available. Parvizi teaches that the one or more apertures include at least one of a plurality of apertures distributed along an inner perimeter of the housing (holes shown in Figures 6A-C, with 6B showing the actual opened apertures) or a slit along at least a portion of an inner perimeter of the housing (Figure 6B with the housing being 70), where the apertures are arranged in a symmetrical configuration (Figure 6B). It would have been obvious to the skilled artisan before the effective filing date to utilize the additional apertures as taught by Parvizi with the device of Sandmore and Willis as a straightforward duplication of parts. Modifying the number of apertures generates predictable results with respect to flow rate, more apertures equals greater outflow over the same amount of time. Given there is no criticality to having an asymmetrical arrangement, it would have been further obvious to the skilled artisan before the effective filing date to utilize an asymmetrical pattern of apertures as a matter of design choice.
Regarding claim 7, Sandmore is silent on the apertures. Willis teaches that there is one aperture and one membrane attached to the one aperture to allow a rupture to occur when enough force has been transmitted (column 17 lines 6-66), but is silent on there being more apertures as well.
Parvizi teaches that the one or more apertures include a plurality of apertures (as mentioned above, see also Figure 3 with two apertures created by two rupture openings at 40A-B in response to a force). It would have been obvious to the skilled artisan before the effective filing date to utilize the additional apertures as taught by Parvizi with the device of Sandmore and Willis as a straightforward duplication of parts. Modifying the number of apertures generates predictable results with respect to flow rate, more apertures equals greater outflow over the same amount of time. The resultant combination would have included a final design that included a housing and aperture/membrane combo (of Willis), and the additional apertures (of Parvizi), where each aperture of Parvizi would have a complimentary membrane type as described by Willis.
Regarding claim 20, see contents of rejected claim 19 above.
Regarding claim 23-24, see contents of rejected claims 21-22 above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sandmore in view of Willis, and in further view of Hulings et al. US Publication 2019/0232071 (hereinafter Hulings).
Regarding claim 4, Sandmore as modified by Willis teaches various housings (circular/spherical in nature), but is silent on it being toroidal. Hulings teaches a sensing device that includes a housing with a toroidal shape (Figures 2C, 3B which shows a housing for the gel at 232 and 300). There does not appear to be any criticality as to the claimed shaping being advantageous over any other shaping for the conductive material containing housing. Therefore, it would have been obvious to the skilled artisan before the effective filing date to change the shaping of the housing of Sandmore as modified by Willis to the toroidal shaping as taught by Hulings as predictable results would have ensued (maintaining a reservoir of conductive gel/material).
Conclusion
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