DETAILED ACTION
This action is pursuant to claims filed on 3/13/2024. Claims 1-13 are pending. A first action on the merits of claims 1-13 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 .
Specification
The abstract of the disclosure is objected to because the length exceeds 150 words and because the final sentence states “here, K is set to the following value according to the pyramidal shape. Expression (2)” which does not make sense. It does not state the value of K or what “Expression (2)” is. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities:
The limitations defining K are not formatted consistently with the rest of the claim. It could cause confusion whether that limitation is part of the claim or not.
Appropriate corrections are required.
Claim Interpretation
Regarding claim 1, the metes and bounds of the claim are interpreted to be the structure of the electrode itself. The equation is interpreted functionally as it is simply the method by which the height of the protrusions is determined, essentially becoming a product-by-process limitation. This interpretation is applied because the height of the protrusions is fixed upon construction and is not adjustable during use based on the disclosure of the instant application. Determining the height of the protrusions is done during the manufacturing process, during which time the equation is applied to ensure the proper height is achieved. Therefore, “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Similarly, claims 2-4 do not define structural parameters of the device itself. Rather, they are simply parameters of the functional equation – defining anatomical structure of the user of the load and pressure applied during use. Therefore, the structure of the prior art is found to disclose the limitation if the equation is satisfied when the claim limitation is applied to the equation.
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 1-13 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 1 is rejected because it recites “in a case where a number of the protrusions is indicated as N.” This limitation is indefinite. It is unclear if the “number of the protrusions” is all of the plurality of protrusions or a subset of the plurality of protrusions. It is also unclear if this N is a specific number of protrusions from the range of the plurality of protrusions or if it can be any arbitrary number of protrusions of the plurality of protrusions, thus meaning the equation is satisfied regardless of the number of protrusions selected. Furthermore, “in a case” implies the limitation is conditional upon a number of protrusions being indicated as N. Since it is indefinite as to what number of the protrusions is intended to be set as N, it is indefinite whether the limitation is applied. Therefore, claim 1 is rejected because it is unclear what number of protrusions N represents and whether the limitation is even applied to the claim.
Claim 1 is further rejected because it states “the protrusion portions” and “the protrusion portion.” These statements lack proper antecedent basis. Prior to this statement, “a plurality of protrusion portions” has been introduced and subsequently “the plurality of protrusion portions” is utilized. It is indefinite whether “the protrusion portions” is the same plurality of protrusion portions and if “the protrusion portion” is a specific protrusion or an arbitrary protrusion or whether it applies to only a single protrusion portion of all of the protrusion portions. Therefore, the claim is rejected.
Claims 2-13 are rejected due to their dependance on claim 1.
Claims 6, 7, 8, 10, and 11 are rejected for reciting “the protrusion portion.” This statement lacks antecedent basis and is rejected for the same reasons described in claim 1.
Claim 9 is rejected for reciting “the protrusion portions.” This statement lacks antecedent basis and is rejected for the same reasons described in claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 12 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Specifically, claim 12 recites “the being mounted on the head of the subject.” This limitation positively recites the human head as a requirement for the device to be mounted on. Thus, the claim is attempting to include the human head in the scope of the patentable subject matter. Therefore, the claim is rejected. The examiner recommends amending to state --configured to be mounted […]-- or --adapted to be mounted […]--.
Claim Rejections - 35 USC § 102/35 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1-5, 7, 9, 12, and 13 are rejected under 35 USC § 102 as being anticipated by Gevins et al. (hereinafter ‘Gevins’, US 4967038 A) or alternatively, under 35 U.S.C. 103 as being unpatentable over Gevins.
Regarding independent claim 1, Gevins discloses a brain wave detection electrode which is brought into contact with a head of a subject to detect brain waves ([Abstract]: electrode for contacting scalp for EEG detection), the brain wave detection electrode comprising:
a base portion ([Col 4, lines 57-60]: pure rubber block that is formed below the fingers 18 as seen in Fig. 3A);
a plurality of protrusion portions protruding from the base portion (protrusions 18 in Fig. 3A which extend from the rubber block); and
an electrode portion provided in the protrusion portion (conductive metal tips 17 provided on the fingers 18 as seen in Fig. 3A),
wherein the protrusion portion is an elastic body ([Col 5, lines 29-45]: the protrusions are flexible rubber) and has a pyramidal shape (protrusions 18 have a pyramidal shape as seen in Fig. 3A), and
in a case where a number of the protrusion portions is indicated as N (number of protrusions in Fig. 3A), a height of a pyramid of the protrusion portion is indicated as H (height of the protrusions in Fig. 3A), a width of the pyramid of the protrusion portion is indicated as D (width of the pyramid protrusions as seen in Fig. 3A), a load acting on the plurality of protrusion portions is indicated as F (simply based on a use case which is shown in Fig. 1), a pressure acting on a region where a tip of the protrusion portion is in contact with the head when the load F has acted is indicated as P (another result of a use case as shown in Fig. 1), and a thickness of hair of the head of the subject is indicated as h (thickness of hair of patient as shown in Fig. 1), the following expression (1) is satisfied ([Col 4, lines 57-60]: the lengths of the fingers are 0.5 to 1.0cm; in the most simple case, when the patient is bald, h is 0, and thus the equation equals 0 which means that the inequality is satisfied since H is 0.5 to 1 which is greater than 0; the equation is interpreted functionally as it is the process by which the height of the protrusions is determined and since the structure is disclosed and satisfies the equation in one of the many scenarios, the limitation is disclosed)
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Alternatively, determining the height of the protrusions based upon the use case and anatomical constraints involves only routine skill in the art. The structure H, D, and N are all disclosed by Gevins since H is simply the height of the protrusions, D is the width of the pyramid (and as seen in Fig. 3A, all of the protrusions have a width), and N is simply the number of protrusions. The claim does not limit the values of these variables. Furthermore, the variables F and P are simply based on the use of the device, namely how tightly it is pressed against the head of the user, not structures of the electrode protrusions. Lastly, h is simply the thickness of the hair of the user, which is an anatomical constraint of the user and not a structure of the device. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the use case and anatomical features of the user such that the equation is satisfied given that the structure of the device is disclosed and anticipated by Gevins.
Regarding claim 2, Gevins discloses the brain wave detection electrode according to claim 1, wherein the thickness h is 0.5 mm or more and 5.0 mm or less (the thickness of the hair of the user is not a structural limitation of the device but rather an anatomical feature of the user used in the equation of claim 1; in a case where the thickness, h, is 0.5mm and the force is 0, the result is 0.75mm; the equation is still satisfied since H is 0.5cm to 1cm which is greater than 0.75mm; the only variable assigned a value by the claim is h, thus F can be any number).
Alternatively, determining the height of the protrusions, which is the purpose of the equation presented in claim 1 and what the variable h is in relation to, based upon the use case and anatomical constraints involves only routine skill in the art. The structure H, D, and N are all disclosed by Gevins since H is simply the height of the protrusions, D is the width of the pyramid, and N is simply the number of protrusions. The claim does not limit the values of these variables. Furthermore, the variables F and P are simply based on the use of the device, namely how tightly it is pressed against the head of the user, not structures of the electrode protrusions, and are also not limited by the claim. Similarly, the thickness of the user’s hair is not a structural constraint of the device. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the anatomical features of the user, namely the thickness of the user’s hair, such that the equation is satisfied given that the structure of the device is disclosed and anticipated by Gevins.
Regarding claim 3, Gevins discloses the brain wave detection electrode according to claim 1, wherein the load F is 0.5 N or more and 4.0 N or less (the load F is not a structural limitation of the device but rather a use case variable of the equation in claim 1; in a case where the thickness, h, is 0 and the force is 0.5N, the result is 0; the equation is satisfied since H is 0.5cm to 1cm which is greater than 0; the only variable assigned a value by the claim is F, thus h can be any number).
Alternatively, determining the height of the protrusions, which is the purpose of the equation presented in claim 1 and what the variable F is in relation to, based upon the use case and anatomical constraints involves only routine skill in the art. The structure H, D, and N are all disclosed by Gevins since H is simply the height of the protrusions, D is the width of the pyramid, and N is simply the number of protrusions. The claim does not limit the values of these variables. Furthermore, the variables F and P are simply based on the use of the device, namely how tightly it is pressed against the head of the user, not structures of the electrode protrusions. Similarly, the thickness of the user’s hair, h, is not a structural constraint of the device and is also not limited by the claim. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the use case of the device, namely the load applied to the protrusions, such that the equation is satisfied given that the structure of the device is disclosed and anticipated by Gevins.
Regarding claim 4, Gevins discloses the brain wave detection electrode according to claim 1, wherein the pressure P is 10 kPa or more and 1,000 kPa (the pressure P is not a structural limitation of the device but rather a use case variable of the equation in claim 1; in a case where the thickness, h, is 0 and the pressure is 10kPa, the result is 0; the equation is satisfied since H is 0.5cm to 1cm which is greater than 0; the only variable assigned a value by the claim is P, thus h can be any number).
Alternatively, determining the height of the protrusions, which is the purpose of the equation presented in claim 1 and what the variable P is in relation to, based upon the use case and anatomical constraints involves only routine skill in the art. The structure H, D, and N are all disclosed by Gevins since H is simply the height of the protrusions, D is the width of the pyramid, and N is simply the number of protrusions. The claim does not limit the values of these variables. Furthermore, the variables F and P are simply based on the use of the device, namely how tightly it is pressed against the head of the user, not structures of the electrode protrusions. Similarly, the thickness of the user’s hair, h, is not a structural constraint of the device and is also not limited by the claim. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the use case of the device, namely the pressure applied to the protrusions, such that the equation is satisfied given that the structure of the device is disclosed and anticipated by Gevins.
Regarding claim 5, Gevins discloses the brain wave detection electrode according to claim 1, wherein the height H of the pyramid is 20 mm or less ([Col 4, lines 57-60]: the lengths of the fingers are 0.5 to 1.0cm; 5 to 10 mm is less than 20mm).
Regarding claim 7, Gevins discloses the brain wave detection electrode according to claim 1, wherein the pyramid of the protrusion portion is an angular pyramid (the pyramid of the protrusion is an angular pyramid as seen in Fig. 3A).
Regarding claim 9, Gevins discloses the brain wave detection electrode according to claim 7, wherein the protrusion portions are arranged such that sides of bottom surfaces of adjacent protrusion portions are in contact with each other (the sides of the bottoms of adjacent protrusions contact each other as seen in Figs. 3A-3E).
Regarding claim 12, Gevins discloses a brain wave measuring device (device shown in Fig. 1) comprising: the brain wave detection electrode according to claim 1 (device in Fig. 1 comprises electrodes 12a); and a frame to which the brain wave detection electrode is attached (body 11 to which the electrodes 12a are attached as seen in Fig. 1), the frame being mounted on the head of the subject (the body 11 is mounted on the head of the subject).
Regarding claim 13, Gevins discloses a brain wave measuring method comprising: mounting the brain wave measuring device according to claim 12 on the head of the subject ([Col 4, lines 20-21]: the EEG device is placed on the patient’s head) and measuring brain waves ([Col 4, lines 20-22]: the device detects the patient’s brain waves).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code can be found under 35 U.S.C. 102/35 U.S.C. Claim Rejection above.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gevins as applied to claim 1 and described above.
Regarding claim 6, Gevins discloses the brain wave detection electrode according to claim 1 as described above. Gevins further discloses that the rubber fingers may be made of natural or synthetic rubber foam or other suitable elastomeric rubber-like polymers ([Col 7, lines 38-50]).
However, Gevins is silent to the compression rate of the rubber material.
The compression rate of rubber typically resides between 10-30% for solid rubber materials like silicone, neoprene, or nitrile, and 30-50% for foam materials like cellular silicone, urethane, and neoprene as evidenced by Abrare (“Compression Rates in Rubber Gaskets: Solid vs. Foam/Sponge for Air and Water Sealing”). Modifying the compression rate of the rubber of Gevins to lie between 0.1% and 50% is of routine skill in the art since the typical compressive rate of various types of rubber is between 10% and 50%. Additionally, the instant application states the material is a TPE or rubber, similar to that disclosed in Gevins ([0042] Instant App). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to ensure that the compression rate of the rubber in the protrusions of Gevins is between 10% and 50%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and the material disclosed by Gevins should inherently have a compression rate that resides in the claimed range as evidenced by Abrare. In re Aller, 105 USPQ 233.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gevins as applied to claims 1 and 7/1 respectively and described above, in view of Connor (US 20210137455 A1).
Regarding claim 8, Gevins discloses the brain wave detection electrode according to claim 7/1 as described above. Gevins further discloses that the protrusions are pyramidal as seen in Fig. 3A.
However, Gevins is silent to the pyramid portions being hexagonal pyramids.
Connor teaches a mobile EEG monitoring device ([Abstract]). Connor further teaches that the sensors of the device include hair-penetrating protrusions with a hexagonal cross-sectional shape, a square cross-sectional shape, a polygonal cross-sectional shape, an annular cross-sectional shape, an oval cross-sectional shape, or an elliptical cross-sectional shape ([0356]). The protrusions also taper from a larger base to a smaller tip, thus forming a pyramidal shape similar to Gevins ([0512]). Since Connor teaches a variety of pyramidal shapes for the protrusions on an EEG sensor, it would be obvious to utilize one of many known protrusion shapes in the electrode of Gevins. Furthermore, the instant application does not provide criticality to the hexagonal shape as the instant application contemplates alternate shapes such as a conical shape, a triangular pyramid, or a quadrangular pyramid (Fig. 8 of the instant application). Therefore, it would have been an obvious matter of design choice to make the protrusions into hexagonal pyramids as taught by Connor. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 10, Gevins discloses the brain wave detection electrode according to claim 1 as described above. Gevins further discloses that the protrusions are pyramidal as seen in Fig. 3A.
However, Gevins is silent to the pyramid portions being cones.
Connor teaches a mobile EEG monitoring device ([Abstract]). Connor further teaches that the sensors of the device include hair-penetrating protrusions with a circular cross-sectional shape, a hexagonal cross-sectional shape, a square cross-sectional shape, a polygonal cross-sectional shape, an annular cross-sectional shape, an oval cross-sectional shape, or an elliptical cross-sectional shape ([0356]). The protrusions also taper from a larger base to a smaller tip, thus forming a pyramidal shapes similar to Gevins ([0512]). A round cross section that tapers to a tip inherently forms a cone. Since Connor teaches a variety of pyramidal shapes for the protrusions on an EEG sensor, it would be obvious to utilize one of many known protrusion shapes in the electrode of Gevins. Furthermore, the instant application does not provide criticality to the cone shape as the instant application contemplates alternate shapes such as a conical shape, a triangular pyramid, or a quadrangular pyramid (Fig. 8 of the instant application). Therefore, it would have been an obvious matter of design choice to make the protrusions into conical pyramids or cones as taught by Connor. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gevins as applied to claim 1 and described above, in view of Yoshitomi et al. (hereinafter ‘Yoshitomi’, US 20210000371 A1).
Regarding claim 11, Gevins discloses the brain wave detection electrode according to claim 1 as described above. Gevins further discloses that the protrusions are made of natural or synthetic rubber foam or other suitable elastomeric rubber-like polymers ([Col 7, lines 38-50]).
However, Gevins is silent to the protrusions being made of cured silicone rubber.
Yoshitomi teaches a bioelectrode which includes an electrode member with multiple protrusions as seen in Fig. 1, similar to the device of Gevins. The electrode protrusions 3, as seen in Figs. 1 and 2, are formed by curing a silicone rubber ([0050]). The cured silicone rubber provides for a degree of flexibility and elasticity, has satisfactory adhesion to the body of the subject, has a soft skin feel, is unlikely to cause discomfort when used for a long period of time, and can maintain stable contact to the body ([0050]). It would be routine for one of ordinary skill in the art to utilize a cured silicone rubber for the protrusions of Gevins since Gevins discloses the ability to utilize a variety of rubbers for the protrusions. 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 cured silicone rubber taught by Yoshitomi for the protrusions of Gevins since doing so would provide for enhanced patient comfort and allow for stable long-term use.
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