DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/994,935, filed on 01/15/2025.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 8, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Connor (US 20220233124 A1).
Regarding claim 1, Connor teaches bioelectrode ([abstract] This invention is a dry EEG electrode) comprising: an electrode member made of elastic material with conductivity ([0118] an EEG electrode can be made from conductive elastomeric material which is created by doping, impregnating, or embedding conductive material into an otherwise non-conductive elastomeric polymer or hydrogel. In another example, an EEG electrode can be made from elastomeric material (such as an elastomeric polymer) which is doped, impregnated, or embedded with conductive particles or microstructures (such as metal particles or microstructures)), the electrode member including a base having a shape of a sheet or a shape of a plate (Fig 16; 1601) and including a first surface and a second surface facing in a direction opposite to a direction in which the first surface faces ([0260] In an example, an electrode which is worn on a portion of a person's head which is covered with hair can comprise a base which is configured to have an orientation which is generally parallel to the surface of a person's head and 2 to 4 hair-penetrating and/or hair-engaging protrusions which extend inward from the base toward the surface of the person's head), and a plurality of protrusions protruding from the second surface ([0361] FIG. 16 shows a side cross-sectional view of an EEG electrode for use on a hair-covered portion of a person's head comprising: a distal portion 1601; and a plurality of protrusions which extend out from the distal portion toward the person's head); and a plurality of cores made of a material having a Young's modulus greater than that of the elastic material ([0361] a inner core 1602 made from a first material and an outer layer 1603 made from a second material) ([0363] the Young's modulus of the first material is greater than that of the second material), the plurality of cores being provided corresponding to two or more protrusions among the plurality of protrusions (Fig 16), wherein a distal end of each of the plurality of cores is disposed within a middle of a corresponding protrusion in a direction of protrusion ([0362] an inner core spans between 50% and 95% of the longitudinal axis of a protrusion).
Regarding claim 2, Connor teaches the bioelectrode according to Claim 1, wherein each of the plurality of cores has a shape of a rod extending in the direction of protrusion of the corresponding protrusion (Fig 16).
Regarding claim 3, Connor teaches the bioelectrode according to Claim 1, wherein each of the plurality of cores is made of metal or resin ([0364] In an example, an inner core of a protrusion can be stiffer and/or more resilient than an outer layer of a protrusion. In an example, an outer layer of a protrusion can more compliant or compressible than an inner core of a protrusion. In an example, an inner core can be made with metal and an outer layer can be made with a conductive polymer).
Regarding claim 4, Connor teaches the bioelectrode according to Claim 3, wherein the elastic material includes a rubber material and a conductive particle ([0118] an EEG electrode can be made from conductive elastomeric material which is created by doping, impregnating, or embedding conductive material into an otherwise non-conductive elastomeric polymer or hydrogel. In another example, an EEG electrode can be made from elastomeric material (such as an elastomeric polymer) which is doped, impregnated, or embedded with conductive particles or microstructures (such as metal particles or microstructures)) ([0120] an EEG electrode can be made from rubber which has been impregnated, doped, or embedded with gold or gold alloy particles or pieces).
Regarding claim 6, Connor teaches the bioelectrode according to Claim 1, wherein a distal surface of each of the plurality of cores is a convex curved surface (Fig 16).
Regarding claim 8, Connor teaches the bioelectrode according to Claim 1, wherein two or more cores among the plurality of cores are in a single body (Fig 16; Inner core) (Fig 59; [0522] a first (distal) electrode portion 5901 which further comprises a plurality of first proximal protrusions extending out from the first electrode portion toward the surface of a person's head).
Regarding claim 13, Connor teaches the bioelectrode according to Claim 1, wherein each of the plurality of protrusions extends in a direction at an angle ([0462] an electrode base 4101; and a ring of electroconductive proximal protrusions (e.g. pins, prongs, teeth, spikes, fingers, and/or protrusions), including protrusion 4102, which extend out in a non-perpendicular manner from the electrode base toward the person's head in order to penetrate between hairs and come into contact with the surface of the person's head) relative to a direction of thickness of the base ([0463] all of the protrusions extend out from the electrode base at the same, non-perpendicular angle, but they extend in different directions. In this example, all of the protrusions in the ring extend out from the electrode base at the same, non-perpendicular angle, but the directions in which they extend vary and are substantially-aligned with the circle of the ring).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20220233124 A1).
Regarding claim 5, Connor teaches the bioelectrode according to Claim 1, wherein a distance between the distal end of each of the plurality of cores and a distal end of the corresponding protrusion is within a range of 2.0 mm or more and 3.0 mm or less ([0362] an inner core spans between 50% and 95% of the longitudinal axis of a protrusion).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Connor to include wherein a distance between the distal end of each of the plurality of cores and a distal end of the corresponding protrusion is within a range of 2.0 mm or more and 3.0 mm or less. Doing so optimizes the longitudinal length of the core to obtain a desired balance of flexibility in the protrusion and rigidity of the core. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a distance between the distal end of each of the plurality of cores and a distal end of the corresponding protrusion is within a range of 2.0 mm or more and 3.0 mm or less, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20220233124 A1) in view of Dalke (US 9060703 B2).
Regarding claim 7, Connor teaches the bioelectrode according to Claim 1, but fails to teach wherein a core that is any one of the plurality of cores has a head portion at a proximal end, a width of the head portion being greater than a width of a middle of the core in a direction of length of the core.
However, Dalke teaches wherein a core that is any one of the plurality of cores has a head portion at a proximal end, a width of the head portion being greater than a width of a middle of the core in a direction of length of the core ([31] FIG. 2, include at least a head portion 16, a tip portion 18, and a body portion 20 disposed between the head portion 16 and the tip portion 18…Preferably, the head portion 16 has a diameter greater than the diameter of the body portion 20). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Connor to include wherein a core that is any one of the plurality of cores has a head portion at a proximal end, a width of the head portion being greater than a width of a middle of the core in a direction of length of the core. Doing so allows for the core members to be held at the proximal end within the support member.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20220233124 A1) in view of Li (CN 112754486 A).
Regarding claim 9, Connor teaches the bioelectrode according to Claim 8, but fails to teach further comprising: an annular member integrated with the plurality of cores.
However, Li teaches further comprising: an annular member integrated with the plurality of cores ([Pg 7, Para 1] As shown in FIG. 1 and FIG. 5, in some embodiments, the micro-needle 12 and the annular substrate 10 are integrally formed, namely, when producing, the annular substrate 10 and the micro-needle 12 are integrally formed by the same mould, micro-needle 12 and annular substrate 10 can be made of the same material). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Connor to include further comprising: an annular member integrated with the plurality of cores. Doing so allows for support of the cores as they are integrally formed with the annular member.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20220233124 A1) in view of Li (CN 112754486 A), further in view of Futashima (WO 2018230445 A1).
Regarding claim 10, Connor teaches the bioelectrode according to Claim 9, but fails to teach further comprising: a support member having a shape of a plate and being in contact with the first surface, wherein the annular member is interposed between the base and the support member.
However, Futashima teaches further comprising: a support member having a shape of a plate and being in contact with the first surface (Fig 14; support member 2), wherein the annular member is interposed between the base (Fig 14; base 32) and the support member (Fig 18; annular projection 35) ([Pg 11, Para 1] A portion 35 is formed to protrude. On the other hand, as shown in FIGS. 19 and 20, an annular recess 25 into which the annular projection 35 can be fitted is formed on the end surface (the bottom surface in FIG. 19) of the support member 2). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Connor to include further comprising: a support member having a shape of a plate and being in contact with the first surface, wherein the annular member is interposed between the base and the support member. Doing so allows for the annular member to be held in place by the support and base to reduce shifting of the cores.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20220233124 A1) in view of Li (CN 112754486 A), further in view of Futashima (WO 2018230445 A1) and Putz (US 7425142 B1).
Regarding claim 11, Connor teaches the bioelectrode according to Claim 9, but fails to teach further comprising: a support member having a shape of a plate, being in contact with the first surface and being interposed between the base and the annular member, wherein the support member has a plurality of notches through which the plurality of cores passes.
However, Futashima teaches further comprising: a support member having a shape of a plate, being in contact with the first surface (Fig 14; support member 2), and being interposed between the base (Fig 14; base 32) and the annular member (Fig 18; annular projection 35) ([Pg 11, Para 1] A portion 35 is formed to protrude. On the other hand, as shown in FIGS. 19 and 20, an annular recess 25 into which the annular projection 35 can be fitted is formed on the end surface (the bottom surface in FIG. 19) of the support member 2). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Connor to include further comprising: a support member having a shape of a plate, being in contact with the first surface and being interposed between the base and the annular member, wherein the support member has a plurality of notches through which the plurality of cores passes. Doing so allows for the annular member to be held in place by the support and base to reduce shifting of the cores.
Further, Putz teaches wherein the support member has a plurality of notches through which the plurality of cores passes ([14] notches 28 along presentation face 26. The notches 28 intersect with void 24 to expose contacts 14 of tail 12 at presentation face 26 in alignment with and intersecting, the pin 23 of spring-loaded pin plunger devices 22) ([19] As shown best in FIG. 3, presentation face 26 has a lead edge 44. Notches 28 are located on lead edge 44 of presentation face 26). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Connor to include wherein the support member has a plurality of notches through which the plurality of cores passes. Doing so allows for the annular member to be held in place by the support member notches and base to reduce shifting of the cores.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20220233124 A1) in view of Futashima (WO 2018230445 A1) and Putz (US 7425142 B1).
Regarding claim 12, Connor teaches the bioelectrode according to Claim 1, but fails to teach further comprising: a support member having a shape of a plate and being in contact with the first surface, wherein the support member has a plurality of notches through which the plurality of cores passes.
However, Futashima teaches further comprising: a support member having a shape of a plate and being in contact with the first surface (Fig 14; support member 2). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Connor to include further comprising: a support member having a shape of a plate and being in contact with the first surface. Doing so allows for the support member to support the base.
Further, Putz teaches wherein the support member has a plurality of notches through which the plurality of cores passes ([14] notches 28 along presentation face 26. The notches 28 intersect with void 24 to expose contacts 14 of tail 12 at presentation face 26 in alignment with and intersecting, the pin 23 of spring-loaded pin plunger devices 22) ([19] As shown best in FIG. 3, presentation face 26 has a lead edge 44. Notches 28 are located on lead edge 44 of presentation face 26). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Connor to include wherein the support member has a plurality of notches through which the plurality of cores passes. Doing so allows for the annular member to be held in place by the support member notches and base to reduce shifting of the cores.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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