DETAILED ACTION
This action is pursuant to the claims filed on 10/23/2025. Claims 1, 4-7, 9-17, 20-23 are pending. A first action on the merits of claims 1, 4-7, 9-17, 20-23 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/23/2025 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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, 7, 9-17, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gadsby (EP 0571120) in view of Lahr (U.S. Patent No. 3,774,592) as evidenced by Schoendorfer (U.S. Patent No. 5,438,984).
Regarding claim 1, Gadsby teaches A medical electrode (see Fig 1) comprising: an absorbent material in contact with an electrolyte, wherein the absorbent material comprises a plurality of strands such that each strand is infused with the electrolyte (Figs 2-6, Col 6 lns 17-20, conductive pad 22 is an open cell foam saturated with electrolyte gel); a press in contact with the absorbent material, the press comprising a plastic micro-bristle structure with a plurality of vertical plastic bristles (Figs 5-6, protrusions 18 are vertical and disclosed as plastic in Col 5 lines 55-58), an electrically conductive substrate adjacent to the press, the electrically conductive substrate in electrical contact with the absorbent material (bottom layer of eyelet 34 interpreted as conductive substrate; Col 6 lns 35-45), wherein each electrolyte infused strand of the absorbent material is configured to function as a conductive channel from a site of ingress in the stratum corneum to the electrically conductive substrate (Figs 3-4, each strand of open cell foam 22 acts as conductive channel from stratum corneum to eyelet 34); and a support configured to hold the medical electrode in contact with the target skin area (support structure 20).
Gadsby fails to teach the plurality of strands are formed of cotton gauze and sized to enable the plurality of vertical plastic bristles to push the plurality of strands of the absorbent material through a stratum corneum of a target skin area on a patient and to form channels that include the plurality of electrolyte infused strands within the stratum corneum.
In related prior art, Lahr teaches a similar device wherein the plurality of strands are formed of cotton gauze (Figs 1-3, Col 3 lns 50-55, pad material 20 can be cotton, gauze, or the like; examiner notes gauze is a well-known to be formed from cotton as evidenced by Schoendorfer (U.S. Patent No. 5,438,984) Col 6 lines 12-15) and are sized to enable the plurality of vertical plastic bristles to push the plurality of strands of the absorbent material through a stratum corneum of a target skin area on a patient and to form channels that include the plurality of electrolyte infused strands within the stratum corneum (Figs 3a-b, bristles 28 are sized to push strands of pad 20 through stratum corneum to form microchannels 32; examiner notes preceding limitation is functional language and must result in a structural difference between the claimed invention and prior art; in the instant case the prior art discloses plastic micro-bristles and cotton gauze such that piercing of the absorbent material with the micro-vertical bristles would push the strands through the stratum corneum as claimed). 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 absorbent material and bristles of Gadsby in view of Lahr to incorporate a cotton gauze material as the absorbent material and the bristles as micro-bristles such that the strands of cotton gauze are sized to enable the bristles to push the strands through a stratum corneum to form channels of electrolyte infused strands within the stratum corneum to arrive at claim 1. Providing the cotton gauze would be a simple substitution of one well-known absorbent material (open cell foam of Gadsby) for another well-known absorbent material (cotton, gauze, or the like of Lahr) for yielding the predictable result of an absorbent material for facilitating recording of physiological signals via electrolytic gel. Furthermore, providing the plastic vertical bristles as micro bristle structure would be obvious to one of ordinary skill in the art to effectively provide microchannels of conductive material through a stratum corneum of the target area to advantageously increase conductivity of the target area (Col 3 lines 27-38).
Regarding claim 7, Gadsby teaches wherein a top surface of the press is configured to distribute applied pressure on the medical electrode (see Figs 5-6).
Regarding claim 9, Gadsby teaches wherein the support comprises a foam material comprising a pressure-sensitive adhesive surrounding the absorbent material (Fig 2 and Col 6 lines 7-13, support structure 20 is foam with acrylic adhesive thereon surrounding absorbent foam 22; examiner notes acrylic adhesive is a pressure-sensitive adhesive).
Regarding claim 10, Gadsby teaches wherein the electrically conductive substrate is in electrical contact with the absorbent material through a layer of electrolyte gel on the electrically conductive substrate (Col 6 lns 35-45, eyelet 34 is in electric contact with absorbent material 22 via a layer of the electrolyte gel touching (i.e., on) the eyelet 34).
Regarding claim 11, Gadsby teaches an electrical contact in electrical communication with the electrically conductive substrate that is configured to couple to an electrical cable (Figs 3-4, stud 36 and wire 40).
Regarding claim 12, Gadsby teaches a flexible base configured to removably engage with a measuring device (Fig 1, upper surface of electrode body 14 and resilient dome 16 define flexible base configured to removably engage with a measuring device via stud 36).
Regarding claim 13, Gadsby teaches wherein the electrically conductive substrate is offset from the press and absorbent material so that pressure applied by the press is applied directly over the absorbent material (Figs 3-4, substrate of eyelet 34 is offset from a center of absorbent material 22).
Regarding claim 14, Gadsby teaches A medical electrode comprising: an absorbent material in contact with a layer of an electrolyte gel, wherein the absorbent material comprises a plurality of strands, wherein each strand of the plurality of strands is infused with the electrolyte gel (Figs 2-6, Col 6 lns 17-20, conductive pad 22 is an open cell foam saturated with electrolyte gel); a press in contact with the absorbent material, the press comprising a plastic micro-bristle structure with a plurality of vertical plastic bristles (Figs 5-6, protrusions 18 are vertical and disclosed as plastic in Col 5 lines 55-58); an electrically conductive substrate in electrical contact with the absorbent material through the layer of electrolyte gel (bottom layer of eyelet 34 interpreted as conductive substrate; Col 6 lns 35-45), wherein each electrolyte infused strand of the absorbent material is configured to function as a conductive channel from a site of ingress in the stratum corneum to the electrically conductive substrate (Figs 3-4, each strand of open cell foam 22 acts as conductive channel from stratum corneum to eyelet 34); an electrical contact on an outer surface of the medical electrode and in electrical communication with the electrically conductive substrate (Figs 1-4, stud 36); and an adhesive support configured to secure the medical electrode in contact with the target skin area (Fig 2 and Col 6 lines 7-13, support structure 20 with acrylic adhesive).
Gadsby fails to teach wherein the plurality of strands are formed of cotton gauze and are sized to enable the plurality of vertical plastic bristles to drive the plurality of strands of the absorbent material through a stratum corneum of a target skin area on a patient and to form channels within the stratum corneum that include the plurality of electrolyte infused strands.
In related prior art, Lahr teaches a similar device wherein the plurality of strands are formed of cotton gauze (Figs 1-3, Col 3 lns 50-55, pad material 20 can be cotton, gauze, or the like; examiner notes gauze is a well-known to be formed from cotton as evidenced by Schoendorfer (U.S. Patent No. 5,438,984) Col 6 lines 12-15) and are sized to enable the plurality of vertical plastic bristles to push the plurality of strands of the absorbent material through a stratum corneum of a target skin area on a patient and to form channels that include the plurality of electrolyte infused strands within the stratum corneum (Figs 3a-b, bristles 28 are sized to push strands of pad 20 through stratum corneum to form microchannels 32; examiner notes preceding limitation is functional language and must result in a structural difference between the claimed invention and prior art; in the instant case the prior art discloses plastic micro-bristles and cotton gauze such that piercing of the absorbent material with the micro-vertical bristles would push the strands through the stratum corneum as claimed). 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 absorbent material and bristles of Gadsby in view of Lahr to incorporate a cotton gauze material as the absorbent material and the bristles as micro-bristles such that the strands of cotton gauze are sized to enable the bristles to push the strands through a stratum corneum to form channels of electrolyte infused strands within the stratum corneum to arrive at claim 14. Providing the cotton gauze would be a simple substitution of one well-known absorbent material (open cell foam of Gadsby) for another well-known absorbent material (cotton, gauze, or the like of Lahr) for yielding the predictable result of an absorbent material for facilitating recording of physiological signals via electrolytic gel. Furthermore, providing the plastic vertical bristles as micro bristle structure would be obvious to one of ordinary skill in the art to effectively provide microchannels of conductive material through a stratum corneum of the target area to advantageously increase conductivity of the target area (Col 3 lines 27-38).
Regarding claim 15, Gadsby teaches A method of using a medical electrode, the method comprising: placing a medical electrode on a target skin area of a patient (Fig 3-6); pressing on a press of the medical electrode, the press comprising a plastic micro-bristle structure with a plurality of vertical plastic bristles (Figs 5-6, protrusions 18 are vertical and disclosed as plastic in Col 5 lines 55-58), wherein pressing on the press causes the plurality of vertical plastic bristles to drive a plurality of strands of an absorbent material through a stratum corneum of the target skin area (See Fig 4), wherein each strand of the plurality of strands is infused with an electrolyte gel (Fig 4, absorbent material 22 saturated with electrolytic gel and protrusions 18); forming an electrically conductive channel, from a site of ingress in the stratum corneum to an electrically conductive substrate of the medical electrode through the plurality of strands (Col 6 lns 35-45); and detecting a signal from the electrically conductive substrate (Col 3 lines 11-14 disclosing detecting and receiving signals).
Gadsby fails to teach wherein the plurality of strands are formed of cotton gauze; forming an electrically conductive channel, which includes the plurality of strands infused with the electrolyte gel, from a site of ingress in the stratum corneum to an electrically conductive substrate of the medical electrode through the plurality of strands.
In related prior art, Lahr teaches a similar device wherein the plurality of strands are formed of cotton gauze (Figs 1-3, Col 3 lns 50-55, pad material 20 can be cotton, gauze, or the like; examiner notes gauze is a well-known to be formed from cotton as evidenced by Schoendorfer (U.S. Patent No. 5,438,984) Col 6 lines 12-15) and forming an electrically conductive channel, which includes the plurality of strands infused with the electrolyte gel, from a site of ingress in the stratum corneum to an electrically conductive substrate of the medical electrode through the plurality of strands (Figs 3a-b, bristles 28 push strands of pad 20 through stratum corneum to form microchannels 32; examiner notes the prior art discloses the same structure and process of pushing plastic micro-bristles through cotton gauze such that piercing of the absorbent material with the micro-vertical bristles would push the strands through the stratum corneum as claimed). 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 absorbent material and bristles of Gadsby in view of Lahr to incorporate a cotton gauze material as the absorbent material and the bristles as micro-bristles such that the strands of cotton gauze form a site of ingress in the stratum with the electrolyte gel to arrive at claim 15. Providing the cotton gauze would be a simple substitution of one well-known absorbent material (open cell foam of Gadsby) for another well-known absorbent material (cotton, gauze, or the like of Lahr) for yielding the predictable result of an absorbent material for facilitating recording of physiological signals via electrolytic gel. Furthermore, providing the plastic vertical bristles as micro bristle structure would be obvious to one of ordinary skill in the art to effectively provide microchannels of conductive material through a stratum corneum of the target area to advantageously increase conductivity of the target area (Col 3 lines 27-38).
Regarding claim 16, Gadsby teaches wherein placing the medical electrode on the target skin area comprises adhesively securing the medical electrode to the target skin area (Fig 2 and Col 6 lines 7-13, support structure 20 with acrylic adhesive to secure the electrode to the target skin area).
Regarding claim 17, Gadsby teaches wherein placing the medical electrode on the target skin area comprises placing the medical electrode without exfoliating the target skin area first (See Figs 3-4, skin is exfoliated at Fig 4 after the medical electrode is placed on skin 30)
Regarding claims 21-23, in view of the combination of claim 1 as stated above, Gadsby further teaches wherein the press is coupled with the absorbent material (Figs 5-6, press 52 is coupled to absorbent material 22); wherein the plurality of vertical plastic bristles are vertical with respect to each other when the medical electrode is not pushed (See Figs 5-6).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gadsby in view of Lahr and Bare (U.S. Patent No. 4,126,126).
Regarding claims 4-5, Gadsby/Lahr teaches the device of claim 1 as stated above. Gadsby further teaches wherein the electrically conductive substrate and is configured to face the target skin area (Figs 3-4, bottom layer of eyelet 32 is configured to face the target skin area 30)
Gadsby is silent to the material of the electrically conductive substrate.
However, in related prior art, Bare teaches a similar device wherein a similar electrically conductive substrate s a plastic substrate coated with a conductive silver/silver chloride layer (Col 2 lines 25-44 and Col 3 lines 29-34, disclosing well-known use of silver/silver chloride coated plastic as conductive materials). 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 substrate of Gadsby in view of Bare to incorporate the Ag/AgCl coated plastic eyelet 32 to arrive at the device of claims 4-5 respectively. Doing so would be obvious to one of ordinary skill in the art as the use of silver/silver chloride coated plastic snap fasteners is well-known in the art to yield predictable results therein (Col 2 lines 25-44 and Col 3 lines 29-34).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gadsby in view of Lahr and Bare as applied to claim 4, and in further view of James (U.S. PGPub No. 2009/0076341).
Regarding claim 6, Gadsby/Lahr/Bare teaches the device of claim 4 as stated above. Gadsby teaches wherein the conductive substrate is connected to medical and diagnostic equipment (Col 4 lines 46-49, wire 40 is connected to medical and diagnostic equipment downstream).
Gadsby fails to teach wherein the plastic substrate is connected to a flexible printed circuit board.
In related prior art, James teaches a similar device wherein a similar substrate is connected to a printed circuit board or a flexible printed circuit board ([0059]). 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 device and conductor 40 of Gadsby in view of Bare and James to incorporate the flexible printed circuit board to arrive at the device of claim 6. Doing so would advantageously allow the device to be connected to medical and diagnostic equipment downstream (Col 4 lines 46-49) while maintaining the device’s flexibility on the user’s skin.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gadsby in view of Lahr and Sandmore (U.S. PGPub No. 2013/0079618).
Regarding claim 20, Gadsby/Lahr teaches the method of claim 15 as stated above.
Gadsby fails to teach displaying the signal detected on a measuring device.
In related prior art, Sandmore teaches a similar device and method comprising displaying the signal detected on a measuring device (See Fig 1, display 34 showing detected physiological signals). 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 method Gadsby in view of Sandmore to incorporate the step of displaying the signal detected on a measuring device to arrive at the method of claim 20. Doing so would advantageously enable a user or physician to view and analyze the recording results in real-time for diagnosis and other clinical needs as would be expected by one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive to overcome the prior art of record.
The Gadsby reference teaches a plurality of vertical micro-bristles as shown in Figs 5-6 and discloses said bristles as being formed from rigid plastic in Column 5 lines 55-58. Column 3 lines 50-55 of the Lahr reference discloses the use of cotton gauze as the absorbent material as evidenced by the Schoendorfer reference disclosing cotton gauze in Column 6 lines 12-15.
Applicant’s arguments on page 8 stating Gadsby describes “avoiding introducing material within the skin” in reference to paragraph [0033] is unpersuasive. Paragraph [0033] is in reference to Figure 8, which is directed to an entirely different embodiment than that relied upon by the Examiner. This disclosure refers to the material of conductive layer 76 which is designed to form an electrical connection to diagnostic equipment downstream of the device via alligator clips 78. As such, these arguments are unpersuasive.
In response to applicant's argument that the Gadsby/Lahr references don’t teach “driving strands of a cotton gauze through the stratum corneum, as recited”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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