DETAILED ACTION
This action is pursuant to the claims filed on 06/10/2026. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/10/2026 has been entered.
Claim Rejections - 35 USC § 112
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 13-17 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.
Claim 13 recites the limitation "the barrier" in line 3. There is insufficient antecedent basis for this limitation in the claim. Meanwhile, line 6 recites “a barrier”. These limitations should be swapped such that line 3 recites “a barrier” and line 6 recites “the barrier”. Claims 14-17 inherit this deficiency.
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.
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 nonobviousness.
Claim(s) 1-5, 8, 12-14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley (U.S. PGPub No. 2012/0143020) in view of Afanasewicz (U.S. PGPub No. 2013/0023748).
Regarding claim 1, Bordoley teaches A sensor assembly configured to be attached to a patient for at least one of detecting an electrical signal from the patient or providing an electrical signal to the patient (see Figs 3-4), wherein the sensor assembly comprises one or more electrode modules (Figs 3-4 electrode assemblies 302), wherein each of the one or more electrode modules comprises: an electrode (Fig 4A [0144], portion of conductive delivery channel 408 interpreted as electrode with connection to wire 410 to conduct physiological signals); electrode gel disposed in a storage location on the electrode module (Fig 4A, gel in reservoir 308), wherein the electrode gel is not in contact with the electrode in the storage location (Fig 4a, electrode gel in reservoir 308 is separated form electrode via frangible seal 406); a barrier to retain the electrode gel in the storage location (Fig 4A frangible seal 406); and a deformable cap configured to move the electrode gel from the storage location into contact with the electrode in response to a deformation of the deformable cap (Fig 4A [0144], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel to electrode); wherein the deformable cap and the barrier form the storage location (Fig 4A, plunger 306 and frangible seal 406 define the lower and upper limits the of reservoir 308, thus at least partly defining the form of the storage location 308), and wherein the deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed (Fig 4A [0144], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel to electrode).
Bordoley fails to teach wherein the deformable cap punctures the barrier.
However, an alternative embodiment of Bordoley discloses wherein depressing the plunger can puncture reservoir 308 to release the electrode gel into contact with the electrode ([0140]), thus the deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed ([0140] and Fig 4A; depressing (i.e., deforming) the plunger can puncture opening of reservoir 308).
Bordoley fails to explicitly teach wherein the deformable cap ruptures the barrier when the deformable cap is deformed.
In related prior art, Afanasewicz teaches a similar device wherein a similar deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed (Figs 6A-B deformable cap 62 is deformed to puncture the capsule 68 to release the hydrogel when the deformable cap is deformed). 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 the plunger of the first embodiment of Bordoley in view of the alternative embodiment of Bordoley and Afanasewicz to incorporate the plunger that can puncture, rather than rupture, the barrier due to deformation to allow the flow of electrode gel to arrive at the device of claim 1. Doing so would be a simple substitution of one well-known plunger mechanism ([0144] plunger to rupture seal 406) for another well-known plunger mechanism ([0140] disclosing puncture mechanism with plunger; Afanasewicz Figs 6A-B deformable actuation surface 62) to yield the predictable result of breaking a barrier to allow a sealed conductive gel to flow towards an electrode-skin interface.
Regarding claim 2, Bordoley teaches wherein each of the one or more electrode modules further comprises a gel-retaining structure configured to retain the electrode gel in contact with the electrode after the electrode gel has moved from the storage location into contact with the electrode (Fig 4A foam plug 310).
Regarding claim 3, Bordoley teaches wherein each of the one or more electrode modules further comprises a film disposed between the deformable cap and the electrode (Fig 4A frangible seal 406), wherein the storage location is a chamber defined by the deformable cap and the film (Fig 4A reservoir 308 located between plunger 306 and seal 406).
Regarding claim 4, Bordoley teaches wherein each of the one or more electrode modules further comprises a gel-retaining structure configured to retain the electrode gel in contact with the electrode after the electrode gel has moved from the storage location into contact with the electrode (Fig 3 has multiple electrode assemblies 302 each of which has own foam plug 310 as shown in Fig 4A).
Regarding claim 5, Bordoley teaches wherein the gel-retaining structure is an open-cell sponge ([0141] disclosing sponge plug 310).
Regarding claim 8, Bordoley/Afanasewicz teaches the device of claim 4 as stated above.
Bordoley fails to teach wherein the deformable cap includes at least one punch pin configured to puncture the film in response to the deformation of the deformable cap.
In related prior art, Afanasewicz teaches a similar electrode assembly comprising a deformable cap including at least one punch pin configured to puncture the film in response to the deformation of the deformable cap (Fig 6A-B, actuation surface 62 deforms to punch seal of capsule 68 to release conductive gel). 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 the deformable plunger of Bordoley in view of Afanasewicz to incorporate the deformable cap with at least one punch pin to arrive at claim 8. Doing so would be a simple substitution of one well-known deformable cap configuration to rupture a conductive gel seal (Bordoley [0144] plunger 306 ruptures seal 406) for another well-known deformable cap configuration to rupture a conductive gel seal (Afanasewicz Figs 6a-b, punch pins) to yield the predictable result of selectively releasing a conductive gel to an electrode for the collection of physiological signals.
Regarding claim 12, Bordoley teaches the device of claim 1 as stated above. Bordoley discloses wherein the plunger engages threads within a plunger receptacle ([0140] thus appearing to disclose a removable connection).
Bordoley fails to explicitly teach wherein the deformable cap is capable of being removed from the electrode module.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the deformable cap of Bordoely to make it removable after deformation, since applicant has not disclosed that the removal solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the cap being unremovable. Furthermore, it has been held that the making an object manually removable would be obvious to one of ordinary skill in the art “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.” In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). In the instant case, it would be obvious to make the plunger cap of Bordoley removable to enable the cleaning of said cap and to enable the refilling of the reservoir.
Regarding claim 13, Bordoley teaches A method of using a sensor assembly including one or more electrode modules, wherein each of the one or more electrode modules (Figs 3-4 electrode assemblies 302) comprises an electrode and a deformable cap (Fig 4A [0144], portion of conductive delivery channel 408 interpreted as electrode with connection to wire 410 to conduct physiological signals; plunger 306 is deformable cap), wherein the deformable cap and the barrier form a storage location containing the electrode gel (Fig 4A, plunger 306 and frangible seal 406 define the lower and upper limits the of reservoir 308, thus at least partly defining the form of the storage location 308), the method comprising: pressing the deformable cap into a deformed position; rupturing a barrier with the deformable cap (Fig 4A [0144], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel to electrode); and transferring electrode gel from a storage location into contact with the electrode in response to said pressing the deformable cap (Fig 4A [0144], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel to electrode).
Bordoley fails to teach wherein the deformable cap punctures the barrier.
However, an alternative embodiment of Bordoley discloses wherein depressing the plunger can puncture reservoir 308 to release the electrode gel into contact with the electrode ([0140]), thus the deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed ([0140] and Fig 4A; depressing (i.e., deforming) the plunger can puncture opening of reservoir 308).
Bordoley fails to explicitly teach wherein the deformable cap ruptures the barrier when the deformable cap is deformed.
In related prior art, Afanasewicz teaches a similar device wherein a similar deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed (Figs 6A-B deformable cap 62 is deformed to puncture the capsule 68 to release the hydrogel when the deformable cap is deformed). 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 the plunger of the first embodiment of Bordoley in view of the alternative embodiment of Bordoley and Afanasewicz to incorporate the plunger that can puncture, rather than rupture, the barrier due to deformation to allow the flow of electrode gel to arrive at the method of claim 13. Doing so would be a simple substitution of one well-known plunger mechanism ([0144] plunger to rupture seal 406) for another well-known plunger mechanism ([0140] disclosing puncture mechanism with plunger; Afanasewicz Figs 6A-B deformable actuation surface 62) to yield the predictable result of breaking a barrier to allow a sealed conductive gel to flow towards an electrode-skin interface.
Regarding claim 14, Bordoley/Afanasewicz teaches the method of claim 13 as stated above. Bordoley further teaches wherein each of the one or more electrode modules comprises a film attached to the deformable cap (Fig 4B frangible seal 406).
Bordoley fails to teach wherein the deformable cap comprises at least one punch pin, wherein said pressing the deformable cap into the deformed position causes the at least one punch pin to puncture the film and allows the electrode gel to flow through the punctured film into contact with the electrode.
Afanasewicz teaches wherein the deformable cap comprises at least one punch pin, wherein said pressing the deformable cap into the deformed position causes the at least one punch pin to puncture the film and allows the electrode gel to flow through the punctured film into contact with the electrode (Fig 6A-B, actuation surface 62 deforms to punch seal of capsule 68 to release conductive gel). 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 the deformable plunger of Bordoley in view of Afanasewicz to incorporate the deformable cap with at least one punch pin to arrive at claim 14. Doing so would be a simple substitution of one well-known deformable cap configuration to rupture a conductive gel seal (Bordoley [0144] plunger 306 ruptures seal 406) for another well-known deformable cap configuration to rupture a conductive gel seal (Afanasewicz Figs 6a-b, punch pins) to yield the predictable result of selectively releasing a conductive gel to an electrode for the collection of physiological signals.
Regarding claim 16, Bordoley teaches the method of claim 13 as stated above. Bordoley discloses wherein the plunger engages threads within a plunger receptacle ([0140] thus appearing to disclose a removable connection after deformation).
Bordoley fails to explicitly teach a step of removing the deformable cap after said pressing a deformable cap on the sensor assembly into a deformed position, and attaching the sensor assembly to a skin surface of a patient after said removing the deformable cap.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the deformable cap and method of Bordoely to remove the deformable cap after pressing the deformable cap and attaching the sensor to skin after removing the cap, since applicant has not disclosed that the removal solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the cap remaining with the assembly after deformation and release of conductive gel. Furthermore, it has been held that the making an object manually removable would be obvious to one of ordinary skill in the art “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.” In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). In the instant case, it would be obvious to make the plunger cap of Bordoley removable to enable the cleaning of said cap and to enable the refilling of the reservoir.
Regarding claim 17, Bordoley teaches attaching the sensor assembly to a skin surface of a patient before said pressing the deformable cap (Fig 3 headset is attached to patient befor pressing the plunger to release the conductive fluid).
Regarding claim 18, Bordoley teaches a sensor assembly comprising: an electrode (Fig 4A [0144], portion of conductive delivery channel 408 interpreted as electrode with connection to wire 410 to conduct physiological signals); a gel or liquid retention structure in contact with the electrode (Fig 4A foam plug 310); a gel or liquid contained within a storage location (Fig 4A reservoir 308), wherein the gel or liquid is not in contact with the electrode while in the storage location (Fig 4a, electrode gel in reservoir 308 is separated form electrode via frangible seal 406); a barrier retaining the gel or liquid in the storage location (Fig 4A, frangible seal 406 retains electrode gel in the reservoir 308); and a deformable cap configured to move the gel or liquid from the storage location into the gel or liquid retention structure in contact with the electrode in response to a deformation of the deformable cap (Fig 4A [0144], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel to electrode); wherein the deformable cap and the barrier define the storage location (Fig 4A, plunger 306 and frangible seal 406 define the lower and upper limits the of reservoir 308, thus at least partly defining the form of the storage location 308); wherein the deformation of the deformable cap causes the deformable cap to rupture the barrier to move the gel or liquid from the storage location into the gel or liquid retention structure (Fig 4A [0144], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel from the storage location 308 to foam plug 310).
Bordoley fails to teach wherein the deformable cap punctures the barrier.
However, an alternative embodiment of Bordoley discloses wherein depressing the plunger can puncture reservoir 308 to release the electrode gel into contact with the electrode ([0140]), thus the deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed ([0140] and Fig 4A; depressing (i.e., deforming) the plunger can puncture opening of reservoir 308).
Bordoley fails to explicitly teach wherein the deformable cap ruptures the barrier when the deformable cap is deformed.
In related prior art, Afanasewicz teaches a similar device wherein a similar deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed (Figs 6A-B deformable cap 62 is deformed to puncture the capsule 68 to release the hydrogel when the deformable cap is deformed). 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 the plunger of the first embodiment of Bordoley in view of the alternative embodiment of Bordoley and Afanasewicz to incorporate the plunger that can puncture, rather than rupture, the barrier due to deformation to allow the flow of electrode gel to arrive at the device of claim 18. Doing so would be a simple substitution of one well-known plunger mechanism ([0144] plunger to rupture seal 406) for another well-known plunger mechanism ([0140] disclosing puncture mechanism with plunger; Afanasewicz Figs 6A-B deformable actuation surface 62) to yield the predictable result of breaking a barrier to allow a sealed conductive gel to flow towards an electrode-skin interface.
Regarding claim 19, Bordoley teaches a film disposed between the storage location and the gel or liquid retention structure (Fig 4A frangible seal 406).
Regarding claim 20, in view of the combination of claim 19 as stated above. Bordoley further teaches wherein the deformation of the deformable cap is configured to move the gel or liquid from the storage location into the gel or liquid retention structure (Fig 4A [0144], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel to electrode).
Bordoley fails to teach wherein the deformable cap comprises at least one punch pin configured to puncture the film in response to the deformation of the deformable cap.
In related prior art, Afanasewicz teaches a similar electrode assembly comprising a deformable cap comprises at least one punch pin configured to puncture the film in response to the deformation of the deformable cap (Fig 6A-B, actuation surface 62 deforms to punch seal of capsule 68 to release conductive gel). 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 the deformable plunger of Bordoley in view of Afanasewicz to incorporate the deformable cap with at least one punch pin to arrive at claim 20. Doing so would be a simple substitution of one well-known deformable cap configuration to rupture a conductive gel seal (Bordoley [0144] plunger 306 ruptures seal 406) for another well-known deformable cap configuration to rupture a conductive gel seal (Afanasewicz Figs 6a-b, punch pins) to yield the predictable result of selectively releasing a conductive gel to an electrode for the collection of physiological signals.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley in view of Afanasewicz and Daniels (U.S. PGPub No. 2021/0244941).
Regarding claim 6, Bordoley teaches the device of claim 4 as stated above.
Bordoley fails to teach wherein the gel-retaining structure is a wire-frame sponge.
In related prior art, Daniels teaches a similar electrode assembly device comprising a wire-frame sponge as a gel-retaining structure ([0012] wire mesh is connected with hydrogel layer). 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 the sponge plug of Bordoley in view of Afanasewicz and Daniels to incorporate the wire frame sponge to arrive at the device of claim 6. Doing so would be a simple substitution of one well-known gel-retaining structure for another well-known gel retaining structure to yield the predictable result of a structure capable of electrically connecting with a hydrogel.
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley in view of Afanasewicz and Bare (U.S. Patent No. 4,365,634).
Regarding claim 7, Bordoley teaches the device of claim 4 as stated above.
Bordoley fails to teach wherein the gel-retaining structure is a deformable ring configured to retain the electrode gel within a center region defined by the deformable ring.
In related prior art, Bare teaches a similar electrode assembly wherein a similar gel-retaining structure is a deformable ring configured to retain the electrode gel within a center region defined by the deformable ring (Fig 1, base layer 36 with aperture 38 retains gel 54). 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 the sponge plug of Bordoley in view of Afanasewicz and Bare to incorporate the deformable ring to arrive at the device of claim 7. Doing so would be a simple substitution of one well-known gel-retaining structure for another well-known gel retaining structure to yield the predictable result of a structure capable of electrically connecting with a hydrogel.
Regarding claim 10, Bordoley/Afanasewicz teaches the device of claim 1 as stated above, and further teaches wherein each of the one or more electrode modules further comprises a gel-retaining structure configured to retain the electrode gel in contact with the electrode after the electrode gel has moved in response to the deformation of the deformable cap (Fig 3 has multiple electrode assemblies 302 each of which has own foam plug 310 as shown in Fig 4A).
Bordoley fails to teach wherein the storage location comprises a capsule disposed within the gel-retaining structure, and wherein the deformable cap is configured to burst the capsule when in a deformed position.
In related prior art, Bare teaches a similar electrode assembly wherein a similar gel-retaining structure is a deformable ring configured to retain the electrode gel within a center region defined by the deformable ring (Fig 1, base layer 36 with aperture 38 retains gel 54). 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 the sponge plug of Bordoley in view of Bare to incorporate the deformable ring. Doing so would be a simple substitution of one well-known gel-retaining structure for another well-known gel retaining structure to yield the predictable result of a structure capable of electrically connecting with a hydrogel.
Afanasewicz teaches wherein the storage location comprises a capsule disposed, and wherein the deformable cap is configured to burst the capsule when in a deformed position (Fig 1, capsule 18 that bursts with deformation of actuation surface 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 the deformable plunger of Bordoley in view of Bare and Afanasewicz to incorporate the deformable cap configured to burst the capsule within the gel-retaining structure to arrive at claim 10. Doing so would be a simple substitution of one well-known deformable cap configuration to rupture a conductive gel seal (Bordoley [0144] plunger 306 ruptures seal 406 to release gel from reservoir) for another well-known deformable cap configuration to rupture a conductive gel seal (Afanasewicz Figs 6a-b, punch pins with capsule) to yield the predictable result of selectively releasing a conductive gel to an electrode for the collection of physiological signals.
Claim(s) 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley in view of Afanasewicz and Sackellares (U.S. PGPub No. 2016/0022165).
Regarding claim 9, Bordoley/Afanasewicz teaches the device of claim 4 as stated above. Bordoley teaches wherein the deformable cap applies pressure to the electrode gel reservoir to rupture a frangible seal to release said electrode gel to the electrode upon deformation of said deformable cap ([0144]).
Bordoley fails to teach wherein the film is perforated with a plurality of perforations, wherein the plurality of perforations are sized to allow the passage of the electrode gel from the storage location into contact with the electrode in response to pressure exerted on the film from the electrode gel in response to the deformation of the deformable cap.
In related prior art, Sackellares teaches a similar electrode assembly wherein a film is perforated with a plurality of perforations (Fig 1 reservoir 1 with perforations), wherein the plurality of perforations are sized to allow the passage of the electrode gel from the storage location into contact with the electrode in response to pressure exerted on the film from the electrode gel in response to the deformation of the deformable cap ([0048-0049] Figs 1 and 5A-B; pressure from elastic cap 12 forces deformation of reservoir 1 to cause fluid to pass from reservoir 1 through holes to skin surface). 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 the frangible seal of Bordoley in view of Sackellares to incorporate a film with perforations that are sized to allow gel to pass through when under pressure to arrive at claim 9. Doing so would be a simple substitution of one well-known deformable cap configuration (Bordoley [0144] plunger 306 ruptures seal 406 via pressurization) for another well-known deformable cap configuration (Sackellares Fig 1 and [0048-0049] pressure forces gel through perforations) to yield the predictable result of selectively releasing a conductive gel to an electrode for the collection of physiological signals.
Regarding claim 15, Bordoley teaches the method of claim 13 as stated above. Bordoley further teaches wherein each of the one or more electrode modules comprises a film (Fig 4B frangible seal 406).
Bordoley fails to teach the film with a plurality of perforations, wherein pressing the deformable cap into the deformed position exerts pressure on the film and allows the electrode gel to flow through at least some of the plurality of perforations.
In related prior art, Sackellares teaches a similar electrode assembly wherein a film is perforated with a plurality of perforations (Fig 1 reservoir 1 with perforations), wherein pressing the deformable cap into the deformed position exerts pressure on the film and allows the electrode gel to flow through at least some of the plurality of perforations ([0048-0049] Figs 1 and 5A-B; pressure from elastic cap 12 forces deformation of reservoir 1 to cause fluid to pass from reservoir 1 through holes to skin surface). 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 the frangible seal of Bordoley in view of Sackellares to incorporate a film with perforations that are sized to allow gel to pass through when under pressure to arrive at claim 15. Doing so would be a simple substitution of one well-known deformable cap configuration (Bordoley [0144] plunger 306 ruptures seal 406 via pressurization) for another well-known deformable cap configuration (Sackellares Fig 1 and [0048-0049] pressure forces gel through perforations) to yield the predictable result of selectively releasing a conductive gel to an electrode for the collection of physiological signals.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bordoley in view of Afanasewicz and Yamamoto (U.S. PGPub No. 2013/0085366).
Regarding claim 11, Bordoley teaches A sensor assembly configured to be attached to a patient for at least one of detecting an electrical signal from the patient or providing an electrical signal to the patient (see Figs 3-4), wherein the sensor assembly comprises one or more electrode modules (Figs 3-4 electrode assemblies 302), wherein each of the one or more electrode modules comprises: an electrode (Fig 4B [0145], portion of conductive delivery channel 418 interpreted as electrode with connection to wire 410 to conduct physiological signals); electrode gel disposed in a storage location on the electrode module (Fig 4B [0145], gel 420 behind seal 406), wherein the electrode gel is not in contact with the electrode in the storage location (Fig 4B, electrode gel 420 is separated form electrode via frangible seal 406); a barrier to retain the electrode gel in the storage location (Fig 4A frangible seal 406); and a deformable cap configured to move the electrode gel from the storage location into contact with the electrode in response to a deformation of the deformable cap (Fig 4B [0145], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel to electrode); wherein the deformable cap and the barrier form the storage location (Fig 4A, plunger 306 and frangible seal 406 define the lower and upper limits the of reservoir 308, thus at least partly defining the form of the storage location 308); wherein the deformable cap is configured to move the saturated gel-retaining structure from a first position to a second position in response to the deformation of the deformable cap (Fig 4B [0145] depression of plunger ruptures seal 406 which moves gel from first position to second position in contact with conductive delivery channel 418 and skin), wherein the electrode gel is not in contact with the electrode when the saturated gel-retaining structure is in the first position (Fig 4B, before seal 406 is broken the gel is not in contact with electrode structure) and wherein the electrode gel is in contact with the electrode when the saturated gel-retaining structure is in the second position ([0145] after seal is broken gel comes into contact with electrode structures in second position).; wherein the deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode (Fig 4A [0144], plunger 306 depresses (i.e., deforms) to rupture seal 406 to flow gel to electrode).
Bordoley fails to teach wherein the deformable cap punctures the barrier.
However, an alternative embodiment of Bordoley discloses wherein depressing the plunger can puncture reservoir 308 to release the electrode gel into contact with the electrode ([0140]), thus the deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed ([0140] and Fig 4A; depressing (i.e., deforming) the plunger can puncture opening of reservoir 308).
Bordoley fails to explicitly teach wherein the deformable cap ruptures the barrier when the deformable cap is deformed.
In related prior art, Afanasewicz teaches a similar device wherein a similar deformable cap ruptures the barrier to move the electrode gel from the storage location into contact with the electrode when the deformable cap is deformed (Figs 6A-B deformable cap 62 is deformed to puncture the capsule 68 to release the hydrogel when the deformable cap is deformed). 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 the plunger of the first embodiment of Bordoley in view of the alternative embodiment of Bordoley and Afanasewicz to incorporate the plunger that can puncture, rather than rupture, the barrier due to deformation to allow the flow of electrode gel to arrive at the device of claim 18. Doing so would be a simple substitution of one well-known plunger mechanism ([0144] plunger to rupture seal 406) for another well-known plunger mechanism ([0140] disclosing puncture mechanism with plunger; Afanasewicz Figs 6A-B deformable actuation surface 62) to yield the predictable result of breaking a barrier to allow a sealed conductive gel to flow towards an electrode-skin interface.
Bordoley fails to explicitly teach a gel-retaining structure that is saturated with the electrode gel such that gel-retaining structure moves from the first to the second position.
In related prior art, Yamamoto teaches a similar electrode assembly comprising a gel-retaining structure saturated with electrode gel (Fig 3 beads 102 are impregnated with conductive fluid [0044]). 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 the conductive gel 420 of Bordoley in view of Yamamoto to incorporate the saturated gel-retaining structure of Yamamoto such that the saturated gel retaining structure is configured to move from a first position to a second position to arrive at claim 11. Doing so would be a simple substitution of one well-known gel-retaining structure (Bordoley Fig 4B and [0145] teaching thicker conductive paste/gel) for another well-known gel-retaining structure (Fig 3 impregnated beads 102) to yield the predictable result of a conductive gel being brought into contact between a skin surface and electrode to improve conductivity and increase signal acquisition quality.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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