DETAILED ACTION
This action is pursuant to claims filed on 4/22/2024. Claims 1-9 are pending. A first action on the merits of claims 1-9 is as follows.
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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 4/26/2023. It is noted, however, that applicant has not filed a certified copy of the Japanese application as required by 37 CFR 1.55. Additionally, the attempt by the Office to electronically retrieve the priority document failed on 7/26/2024.
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 2-5 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 2-5 each recite “optionally” throughout the claims. Such as in claim 2, where it states “optionally substituted with a fluorine atom…” Similar instance are recited in claims 3-5. The phrase “optionally” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 nonobviousness.
Claim(s) 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama et al. (hereinafter ‘Hatakeyama’, US 20200317840 A1) in view of Voros et al. (hereinafter ‘Voros’, EP 3494875 A1).
Regarding independent claim 1, Hatakeyama discloses a bio-electrode, comprising:
a living-body contact layer (living body contact layer 3 in Fig. 1); and
a substrate (base 2 in Fig. 1), wherein
the living-body contact layer has an ionic polymer (A) as a material ([0013]-[0014]: the bio-electrode composition includes an ionic material (A)), and
the component (A) has a repeating unit-a of one or more selected from a fluorosulfonic acid, a fluorosulfonimide, and a fluorosulfonamide ([0013]-[0016]: the component (A) has a repeating unit-a having a structure selected from various salts of any of flurosulfonic acid, fluorosulfonimide, and a flurosulfonamide), and has a weight-average molecular weight within a range of 1,000 to 500,000 ([0088]: the weight average molecular weight is preferably between 2,000 and 500,000 which is entirely within the claimed range).
However, Hatakeyama does not disclose the living-body contact layer having a micropillar having a diameter within a range of 0.01 to 500 μm and a height within a range of 0.1 to 1,000 μm.
Voros teaches a sensor device designed for contacting the skin of a user and detecting an electrical signal, similar to the device of Hatakeyama ([Abstract]). The sensor is provided with protrusions that are rod shaped with a round foot on the end ([0021]). The protrusions have a cylindrical portion between 1 micrometer and 15 micrometers, a foot with a diameter between 3 and 19 micrometers, and a height between 1 and 5 micrometers ([0061]). The protrusions taught by Voros are micropillars as they are cylindrical, vertical protrusions and the dimensions taught are entirely within the claimed ranged as they have a diameter and a height within the claimed range. The protrusions are advantageous because they increase the adhesive force between the sensor device and the skin of the user ([0021]). Furthermore, modifying the shape of the living body contact layer of Hatakeyama would be of routine skill in the art and adding micropillars to the surface would lead to the expected outcome of increasing the adhesive force between the layer and the skin of the user. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the micropillars of Voros that are between 1 and 15 micrometers in diameter and between 1 and 5 micrometers in height in order to increase the adhesive force between the living body contact layer and the skin of the user.
Regarding claim 2, the Hatakeyama/Voros combination discloses the bio-electrode according to claim 1, wherein the repeating unit-a has a partial structure represented by the following general formulae (1)-1 to (1)-4 ([0018]: repeating unit a has a structure that matches the formulas below),
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wherein Rf1 and Rf2 represent a hydrogen atom, a fluorine atom, an oxygen atom, a methyl group, or a trifluoromethyl group, and when Rf1 and Rf2 represent an oxygen atom, Rf1 and Rf2 represent one oxygen atom bonded to one carbon atom to form a carbonyl group; Rf3 and Rf4 represent a hydrogen atom, a fluorine atom, or a trifluoromethyl group, and one or more of Rf1 to Rf4 represent a fluorine atom or a trifluoromethyl group; Rf5 represents a fluorine atom or a linear or branched alkyl group having 1 to 4 carbon atoms and having at least one or more fluorine atoms; Rf6 and Rf7 represent a linear, branched, or cyclic alkyl group having 1 to 10 carbon atoms, an alkenyl group having 2 to 6 carbon atoms, an alkynyl group having 2 to 6 carbon atoms, or an aryl group having 6 to 10 carbon atoms, and optionally substituted with a fluorine atom, Rf6 and Rf7 having at least one or more fluorine atoms; M+ represents an ion selected from an ammonium ion, a sodium ion, a potassium ion, and a silver ion; and “m” represents an integer of 1 to 4 ([0018]: the structure stated above is disclosed as there are options disclosed for each variable that are also claimed options).
Regarding claim 3, the Hatakeyama/Voros combination discloses the bio-electrode according to claim 1, wherein the repeating unit-a has one or more selected from repeating units-A1 to -A4 represented by the following general formulae (2) ([0020]: repeating unit-a has the formulas shown by the general formula (2) – the last 3 formulas match with formulas A2-A4 below, which means the claim limitation is disclosed because the claim only requires “one or more” and in this case 3 of them match),
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wherein R1, R3, R4, and R6 each independently represent a hydrogen atom or a methyl group; R2, R5, and R7 each independently represent a single bond or a linear, branched, or cyclic hydrocarbon group having 1 to 13 carbon atoms and optionally having an ester group, an ether group, or both of them; X1, X2, X3, and X4 each independently represent any one of a single bond, a phenylene group, a naphthylene group, an ether group, an ester group, and an amide group; Rf1 and Rf2 represent a hydrogen atom, a fluorine atom, an oxygen atom, a methyl group, or a trifluoromethyl group, and when Rf1 and Rf2 represent an oxygen atom, Rf1 and Rf2 represent one oxygen atom bonded to one carbon atom to form a carbonyl group; Rf3 and Rf4 represent a hydrogen atom, a fluorine atom, or a trifluoromethyl group, and one or more of Rf1 to Rf4 represent a fluorine atom or a trifluoromethyl group; Rf5 represents a fluorine atom or a linear or branched alkyl group having 1 to 4 carbon atoms and having at least one or more fluorine atoms; Rf6 and Rf7 represent a linear, branched, or cyclic alkyl group having 1 to 10 carbon atoms, an alkenyl group having 2 to 6 carbon atoms, an alkynyl group having 2 to 6 carbon atoms, or an aryl group having 6 to 10 carbon atoms, and optionally substituted with a fluorine atom, Rf6 and Rf7 having at least one or more fluorine atoms; “m” represents an integer of 1 to 4; a1, a2, a3, and a4 satisfy 0≤a1≤1.0, 0≤a2≤1.0, 0≤a3≤1.0, 0≤a4≤1.0, and 0<a1+a2+a3+a4≤1.0; and M+ represents an ion selected from an ammonium ion, a sodium ion, a potassium ion, and a silver ion ([0020]: the structure stated above is disclosed as there are options disclosed for each corresponding variable that are also claimed options).
Regarding claim 5, the Hatakeyama/Voros combination discloses the bio-electrode according to claim 2, wherein the repeating unit-a contains an ammonium ion represented by the following general formula (3) as the ammonium ion constituting the ammonium salt ([0022]: the repeating unit a contains an ammonium ion shown by the formula (3)),
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wherein R101d, R101e, R101f, and R101g each represent a hydrogen atom, a linear, branched, or cyclic alkyl group having 1 to 15 carbon atoms, a linear, branched, or cyclic alkenyl group or alkynyl group having 2 to 12 carbon atoms, or an aromatic group having 4 to 20 carbon atoms, optionally having one or more selected from an ether group, a carbonyl group, an ester group, a hydroxy group, a carboxyl group, an amino group, a nitro group, a sulfonyl group, a sulfinyl group, a halogen atom, and a sulfur atom; R101d and R101e, or R101d, R101e, and R101f optionally form a ring together with a nitrogen atom to which these groups are bonded, and when forming the ring, R101d and R101e, or R101d, R101e, and R101f form an alkylene group having 3 to 10 carbon atoms or a heteroaromatic ring having the nitrogen atom in the general formula (3) in the ring ([0022]: the structure stated above is disclosed).
Regarding claim 6, the Hatakeyama/Voros combination discloses the bio-electrode according to claim 1, further comprising a resin other than the component (A) as a component (B) contained in the material of the living-body contact layer ([0091]: the bio-electrode composition has a component A mixed with a resin).
Regarding claim 7, the Hatakeyama/Voros combination discloses the bio-electrode according to claim 6, wherein the component (B) is one or more selected from a silicone resin, a (meth)acrylate resin, and a urethane resin ([0091]: the resin is selected from a silicone base, acrylic base, or urethane base resins).
Regarding claim 8, the Hatakeyama/Voros combination discloses a method for manufacturing the bio-electrode according to claim 1. Voros further teaches the method comprising a step of manufacturing the micropillar by inserting a resin containing the component (A) into a mold to be a template (Voros [0033]: the sensor device is manufactured by providing a mold with an array of recesses etched into the substrate where the conductive material is deposited into the recesses of the array), and releasing the resin from the mold (Voros [0033]-[0034]: the sensor device is released from the mold by dissolution). It would be obvious to utilize the manufacturing method of Voros by including a sacrificial layer as doing so would provide for a strain-free release of the sensor which avoids the formation of micro-cracks.
Regarding claim 9, the Hatakeyama/Voros combination discloses a method for manufacturing the bio-electrode according to claim 1. Voros further teaches the method comprising a step of manufacturing the micropillar by inserting a resin containing the component (A) into a pattern of a resin to be a template (Voros [0033]-[0034]: the sensor device is manufactured by providing a mold with an array of recesses etched into a substrate which is made of a sacrificial material where the conductive material is deposited into the recesses of the array; [0076]: the sacrificial layer is made of PMGI derivative which is a type of resin), and dissolving a pattern of the resin with water or an alkaline aqueous solution to release the resin containing the component (A) (Voros [0033]-[0034]: the sacrificial layer of the mold is dissolved in the developer solution to release the conductive component; [0083]: a single developer solution can be used for the steps; [0084]: the developer is a basic buffered KOH solution – KOH is an aqueous alkaline solution). It would be obvious to utilize the manufacturing method of Voros by including a sacrificial layer as doing so would provide for a strain-free release of the sensor which avoids the formation of micro-cracks.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Hatakeyama/Voros combination as applied to claim 1 and described above, in view of Gupta et al. (hereinafter ‘Gupta’, Introduction to Polyurethane Chemistry).
Regarding claim 4, the Hatakeyama/Voros combination discloses the bio-electrode according to claim 1 as described above. The combination also discloses that unit-a has the following repeating units:
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wherein the R, X, and M+ variables represent options that are the same as the claimed options ([0018], [0020]).
However, Hatakeyama does not disclose these repeating units having urethane groups in the main chain, since that is the only difference between units a5 and A6 and that is the main difference between the remaining groups.
Gupta teaches the chemistry of polyurethanes, their benefits, and their structure ([Abstract]). Gupta further teaches that polyurethanes are specifically used in medical devices, like that of Hatakeyama ([Abstract]). While not specifically directed to sensing electrodes, it is analogous to both the instant application and Hatakeyama because it discusses how to modify the main chain of a polymer to modify the properties of the polymer, which is the same focus of both Hatakeyama and the instant application as they are both modifying the polymeric structure in order to modify the properties of the polymer. Polyurethanes are characterized by the presence of a urethane linkage and are formed by a reaction between hydroxyl and isocyanate groups, similar to how the instant application forms the repeating units A5-A7 (Page 3). Creating a polymer with a high number of urethane linkages in the main can increase the interactions among the chains through hydrogen bonding and modifying polyols further aids in the physical properties of the polymer (Pages 6 and 9). Modifying the hydrogen bonding between chains is an obvious way to modify a materials physical properties since the interactions between the polymeric chains is increased. Furthermore, as evidenced by Gupta, modifying a polymer’s main chain to utilize urethane linkages is of routine skill in the art. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the urethane linkages taught by Gupta in the repeating units of Hatakeyama in order to increase the interactions between the polymeric chains in the living body contact layer in order to modify the physical properties of that layer to have the desired strength.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794