DETAILED ACTION
This action is pursuant to the claims filed on 08/04/2023 Claims 1-12 and 14 are pending. A first action on the merits of claims 1-12 and 14 is as follows.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/04/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 9 and 12 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.
Claims 9 and 12 each recite the limitation "an electrode of the electrode member" while reciting reference to claim 1 in claims 7 and 10 respectively. Claim 1 recites “an electrode”, as such it is unclear if “an electrode” of claims 9 and 12 is attempting to claim antecedent basis to the electrode previously recited or if this limitation is attempting to recite a second distinct electrode.
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, 4-7, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshiyuki (JP 2005-161025) in view of Bremer (U.S. Patent No. 4,693,711).
Regarding claim 1, Yoshiyuki teaches An electrode member to be attached to a body surface of a user (Figs 2-4), comprising: an adhesion part including a through hole near a center and capable of adhering to a body surface of a user (Fig 3 main body 19 defines through hole through member 7; examiner notes the structure of main body 19 and corresponding through hole is interpreted as an adhesion part given it holds the electrode assembly to a user’s body. This interpretation is consistent with applicant’s specification in which paragraph [0059] of applicant’s PGPub discloses “The material of the adhesion part 2 is not particularly limited, but for example, an elastic material such as silicone can be preferably exemplified”); an electrode inserted into the through hole of the adhesion part (Fig 3 electrode body 15/15a); and a first retention part configured to retain a solution (Fig 3 piston 23 closes opening 19b of adhesion part to define storage container 17), wherein a flow channel including a gap is formed between an inner peripheral surface of the through hole of the adhesion part and the electrode (Fig 3 flow hole 21 is formed between inner through hole of member 7 and electrode 15), and the solution for dissolving sebum retained in the first retention part is able to flow out from one end side of the through hole through the flow channel (Fig 3 fluid flows from one end of through hole through the channel 21).
Yoshiyuki fails to explicitly teach wherein the solution is for dissolving sebum.
However, in related prior art, Bremer teaches a similar device comprising a similar solution for dissolving sebum (Col 4 lines 10-21; parameters of conductive gel are balanced to effectively dissolve sebum). 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 gel of Yoshiyuki in view of Bremer to effectively balance parameters of the gel to ensure the gel dissolves sebum to arrive at claim 1. Doing so would advantageously enable the gel to dissolve the sebum of the skin surface to increase conductivity of the electrode-skin interface.
Regarding claim 4, Yoshiyuki further teaches wherein the first retention part is provided on another end side of the through hole (Fig 3, piston 23 is provided on other side of through hole).
Regarding claim 5, Yoshiyuki further teaches a retention part configured to retain an electrolyte gel (Fig 3 electrolyte supply in storage container 17 is an electrolyte gel), wherein the electrolyte gel is able to flow out from the one end side of the through hole from the second retention part through the flow channel (Fig 3, electrolyte flows out from two flow holes 21).
Yoshiyuki fails to teach the second retention part distinct from the first retention part and the electrolyte gel distinct from the solution for dissolving sebum.
As stated above, Bremer teaches an electrolyte gel solution for both dissolving sebum and providing conductivity to the skin-electrode interface (Col 4 lines 10-21). 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 Yoshiyuki in view of Bremer to duplicate the first retention part and solution to incorporate a distinct second retention part holding a distinct second electrolyte gel to arrive at claim 5. Doing so 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, since applicant has not disclosed that the second retention part with a distinct electrolyte gel solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a single retention part with a single solution that functions both as a conductive electrolyte gel and a sebum dissolving solution as taught by the prior art. Furthermore, it has been held that the “mere duplication of parts has no patentable significance unless a new and unexpected result is produced”. In the instant case, duplicating the retention part and electrolyte gel taught by Yoshiyuki and Bremer to incorporate a second retention part with a second electrolyte gel would yield the same expected result of an electrolyte gel capable of dissolving sebum and providing increased conductivity to the skin/electrode interface.
Regarding claim 6, Yoshiyuki further teaches wherein the electrode member is used for massage or for PSG test (Yoshiyuki teaches the electrode for EEG measurements which is capable of use for a PSG test (i.e., sleep study)).
Regarding claim 7, Yoshiyuki/Bremer further teaches A head orthosis comprising: the electrode member according claim 1 (see rejection of claim 1 above); and a head mounted member (helmet 7).
Regarding claim 10, Yoshiyuki/Bremer further teaches A body orthosis comprising: the electrode member according to claim 1 (see rejection of claim 1 above); and a body mounted member (helmet 7; examiner notes the helmet 7 is configured to be mounted to a body (i.e., a head is part of a body).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshiyuki in view of Bremer, and in further view of Parvizi (U.S. PGPub No. 2017/0281036).
Regarding claims 2, the Yoshiyuki/Bremer combination teaches the device of claim 1 as stated above.
Yoshiyuki fails to teach wherein the adhesion part includes a first concave portion formed around the one end side of the through hole and connected to the flow channel, and the solution for dissolving sebum is sent from the first retention part to the first concave portion through the flow channel.
In related prior art, Parvizi teaches a similar device including a first concave portion formed around the one end side of the through hole and connected to the flow channel (Fig 23, channels 310 are formed around flow lumens 308 to distribute fluids or gels), and the solution for dissolving sebum is sent from the first retention part to the first concave portion through the flow channel (Fig 23 and [0096], conductive fluid or gel is sent from an upper retention part through the lumen 308 and into the concave channels 310). 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 adhesion part of Yoshiyuki in view of Bremer and Parvizi to incorporate the concave portion formed around one side of the through connected to the flow channel to arrive at claim 2. Doing so would advantageously allow for the solution to be distributed at the lower surface while minimizing the leakage of said solution externally to the target skin surface.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshiyuki in view of Bremer, in view of Parvizi, and in further view of Tsang (WO 2013/124750).
Regarding claim 3, the Yoshiyuki/Bremer/Parvizi combination teach the device of lcaim 2 as stated above.
Yoshiyuki fails to teach wherein the adhesion part includes a second concave portion formed around the first concave portion and adheres to a body surface of a user via the second concave portion.
In related prior art, Tsang teaches a similar device wherein the adhesion part includes a second concave portion formed around the first concave portion and adheres to a body surface of a user via the second concave portion (Figs 1A-2, 3A-B, Pg 5 lines 24-29 and Pg 6 lines 5-10; gripping member grooves 16/26 “are sufficiently wide and deep so to grip the skin surface 2”). 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 the adhesion part of Yoshiyuki in view of Bremer, Parvizi, and Tsang to incorporate a second concave portion around the first concave portion to arrive at the device of claim 3. Providing the concave gripping member groove would advantageously ensure secure and quality contact of the electrode with the skin surface to minimize noise artifacts.
Claim(s) 8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshiyuki in view of Bremer, and in further view of Bordoley (U.S. Patent No. 9,408,575) and Connor (U.S. PGPub No. 2015/0366504).
Regarding claim 8, the Yoshiyuki/Bremer combination teaches the device of claim 7 as stated above.
Yoshiyuki fails to teach wherein the head mounted member includes a moisture absorbing layer configured to come in contact with a head surface, and an insulating layer laminated on the moisture absorbing layer.
In related prior art, Bordoley teaches the head mounted member includes a moisture absorbing layer configured to come in contact with a head surface (Figs 3-4, absorbent ring 414), and an insulating layer laminated on the moisture absorbing layer (Figs 3-4 headband 401 connected to absorbent ring 414). 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 head mounted member of Yoshiyuki in view of Bremer and Bordoley to incorporate the moisture absorbing layer and insulating layer on the head mounted member. Doing so would advantageously help inhibit or prevent leakage of conductive fluid, sweat or blood from the electrode site (Col 21 lines 61-65).
Yoshiyuki/Bremer/Bordoley fails to teach the insulated layer laminated on the moisture absorbing layer.
In related prior art, Connor teaches laminating layers together of a similar electrode device ([0071] alternatively disclosing weaving, sewing, layering, laminating, adhering, melting, fusing, printing, etc. of layers of a device). 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 Yoshiyuki in view of Bremer, Bordoley and Connor to incorporate the insulated layer and moisture absorbing layer being laminated to arrive at claim 8. Doing so would be obvious to one of ordinary skill in the art as the technique of laminating is well-known in the art to yield the predictable result of providing two layers together ([0071]).
Regarding claim 11, the Yoshiyuki/Bremer combination teaches the device of claim 10 as stated above.
Yoshiyuki fails to teach wherein the head mounted member includes a moisture absorbing layer configured to come in contact with a head surface, and an insulating layer laminated on the moisture absorbing layer.
In related prior art, Bordoley teaches the head mounted member includes a moisture absorbing layer configured to come in contact with a head surface (Figs 3-4, absorbent ring 414), and an insulating layer laminated on the moisture absorbing layer (Figs 3-4 headband 401 connected to absorbent ring 414). 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 head mounted member of Yoshiyuki in view of Bremer and Bordoley to incorporate the moisture absorbing layer and insulating layer on the head mounted member. Doing so would advantageously help inhibit or prevent leakage of conductive fluid, sweat or blood from the electrode site (Col 21 lines 61-65).
Yoshiyuki/Bremer/Bordoley fails to teach the insulated layer laminated on the moisture absorbing layer.
In related prior art, Connor teaches laminating layers together of a similar electrode device ([0071] alternatively disclosing weaving, sewing, layering, laminating, adhering, melting, fusing, printing, etc. of layers of a device). 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 Yoshiyuki in view of Bremer, Bordoley and Connor to incorporate the insulated layer and moisture absorbing layer being laminated to arrive at claim 11. Doing so would be obvious to one of ordinary skill in the art as the technique of laminating is well-known in the art to yield the predictable result of providing two layers together ([0071]).
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshiyuki in view of Bremer, in view of Bordoley, Connor, and in further view of Connor-2 (U.S. PGPub No. 2018/0303383).
Regarding claims 9 and 12, in view of the combination of claims 8 and 11 respectively as stated above.
Yoshiyuki further teaches a conductive wire connected to an electrode of the electrode member (Fig 3 wire 11).
Yoshiyuki fails to teach wherein in the conductive wire, a mesh structure in which units of a substantially regular hexagon in a front view are continuous is formed, and a surface of the head mounted member on a side of the insulating layer is covered with the conductive wire.
In related prior art, Connor-2 teaches the use of a mesh structure in which units of a substantially regular hexagon in a front view are continuous is formed (Fig 43, energy pathways 4302 with non-conductive layer 4301 thereon; examiner notes “units of a substantially regular hexagon” is being interpreted as a honeycomb structure), and a surface of the head mounted member on a side of the insulating layer is covered with the conductive wire (non conductive layer 4301). 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 head mounted member and wires of Yoshiyuki in view of Connor-2 to incorporate a substantially regular hexagon mesh wire structure covering a surface of the head mounted member and insulating layer to arrive at claims 9 and 12. Doing so 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, since applicant has not disclosed that substantially regular hexagon mesh units solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the wire structure and head mounted member of Yoshiyuki.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshiyuki in view of Bremer, and in further view Besio (WO 2009/134763).
Regarding claim 14, Yoshiyuki teaches A wear set comprising a head orthosis (see Figs 1-3), and an electrode member attached to a body surface of a user (see Figs 1-3), wherein the head orthosis comprises a head mounted member (Figs 1-3, head mounted member 7), and wherein the electrode member comprises: an adhesion part including a through hole near a center and capable of adhering to a body surface of a user (Fig 3 main body 19 defines through hole through member 7; examiner notes the structure of main body 19 and corresponding through hole is interpreted as an adhesion part given it holds the electrode assembly to a user’s body. This interpretation is consistent with applicant’s specification in which paragraph [0059] of applicant’s PGPub discloses “The material of the adhesion part 2 is not particularly limited, but for example, an elastic material such as silicone can be preferably exemplified”); an electrode inserted into the through hole of the adhesion part (Fig 3 electrode body 15/15a); and a first retention part configured to retain a solution (Fig 3 piston 23 closes opening 19b of adhesion part to define storage container 17), wherein a flow channel including a gap is formed between an inner peripheral surface of the through hole of the adhesion part and the electrode (Fig 3 flow hole 21 is formed between inner through hole of member 7 and electrode 15), and the solution for dissolving sebum retained in the first retention part is able to flow out from one end side of the through hole through the flow channel (Fig 3 fluid flows from one end of through hole through the channel 21).
Yoshiyuki fails to explicitly teach wherein the solution is for dissolving sebum.
However, in related prior art, Bremer teaches a similar device comprising a similar solution for dissolving sebum (Col 4 lines 10-21; parameters of conductive gel are balanced to effectively dissolve sebum). 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 gel of Yoshiyuki in view of Bremer to effectively balance parameters of the gel to ensure the gel dissolves sebum. Doing so would advantageously enable the gel to dissolve the sebum of the skin surface to increase conductivity of the electrode-skin interface.
Yoshiyuki fails to teach a body orthosis having a body mounted member.
In related prior art, Besio teaches a similar device and generally discloses that the electrodes may be used for “recording the electroencephalogram (EEG), electrocardiogram (ECG), electroniyogram (EMG), electrooculogram (EOG) etc” (Pg 17 lines 5-8). 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 system of Yoshiyuki in view of Bremer and Besio to incorporate a second mounting member as a body orthosis having a body mounted member to arrive at claim 14. Doing so would advantageously enable the system to measure ECG or EMG signals from a user to provide a fuller diagnostic picture to a user and/or physician.
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794