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 .
This Office Action supercedes the Final Rejection mailed by the Office on 9/24/25.
Response to Arguments
Claim Rejections - 35 USC § 112
Applicant’s arguments, filed August 21, 2025, with respect to the 35 USC § 112 have been fully considered and are persuasive. The 35 USC § 112 rejections of February 21, 2025 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant's arguments filed August 21, 2025 have been fully considered but they are not persuasive.
As per independent claims 1 and 20, it is reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART. In the instant case, the cited references as taught by Beck (US 4664117 A) for claim 1, the combination of Beck (US 4664117 A) and Chowdhury (US 20060095108 A1) teaches the structural limitations of claims 1 and 20, respectively, as shown in the rejection below. Furthermore, the apparatuses of claims 1 and 20 are ultimately directed to systems comprising electrodes, waveform generators, and the system being connected to a power source, which are sufficiently taught and/or rendered obvious in view of the rejection to claims 1 and 20 below. The effect creating phosphenes that is argued by the Applicant is considered to be intended use under apparatus claims, and would not hold patentable weight in view of the structures of the prior art Beck (US 4664117 A) and Chowdhury (US 20060095108 A1) teaching the structural elements of the claim as stated in the rejection below. Similarly, claim 59 is further directed to activating electrodes, which is taught as per column 18, lines 12-17 – “The computer can further be programmed to use this information to construct a driving waveform for, say, the electrode pair EP1. Using the digital-to-analog converters DAC1 and DAC2 to form a bipolar source, the program can produce a phosphene spot or other pattern with the apparent bearing of the target object”, and therefore would be configured to teach any functional limitation of the claim.
Regarding method claim 32, the cited combination of Beck (US 4664117 A) in view of Agrama (US 8493286 B1) teaches the method as stated below, including activating electrodes in the left and right temples (Beck figure 1),
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And the left and right side of the person's head bilaterally across the nose bridge beneath the eyes and the left/right cheekbones (Beck figure 15).
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Beck does not teach activating the electrode pair at the right side medially on the person's head and the left side medially on the person's head to create a phosphene in the top of the visual field of the person; activating the electrode pair at the left side medially on the person's head and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge to create a phosphene in the middle left of the visual field of the person; activating the electrode pair at the right side medially on the person's head and the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge to create a phosphene in the middle right of the visual field of the person; and activating the electrode pair at the right side laterally on the person's head and the left side distally on the person's head to create a phosphene in the upper right and upper left of the visual field of the person, however Agrama teaches the deficient electrode positions of Beck as stated in the claim 32 rejection below. Since Beck teaches a method of inducing phosphenes, and Agrama teaches a similar facial stimulation system with electrodes placed around the eye areas, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode locations of Beck to try the electrode placements around the face (eye, cheek, forehead) as taught by Agrama since such modification would provide the predictable results of targeting a phosphene at a specific location in the eye/face.
Regarding the routine optimization, there are a fine number of locations on the face, particularly around the eye area. Finding the optimal locations would not require undue experimentation. Furthermore, stimulating different parts of the eye areas would result in predictable solutions, and there would be a reasonable expectation of success in finding the optimum location to induce a desired phosphene. Therefore, it would have been obvious to try stimulating different parts of the face/eye area using the device as described in Beck and Agrama in order to determine the optimum location. Nevertheless, the combined system of Beck and Agrama sufficiently teaches the required electrode placements as stated in the claim 32 rejection below.
Furthermore, the limitations of “to create phosphenes” or “creating phosphenes” at various locations around the eye is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04. I: “…the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003))”).
1.132 AFFIDAVIT
The declaration under 37 CFR 1.132 filed August 21, 2025 is insufficient to overcome the rejection of claims 1, 20, 32, and 59-74 based upon 35 USC 103 as set forth in the last Office action because: the facts presented are not germane to the rejection at issue. It refer(s) only to the system described in the above referenced application and not to the individual claims of the application. Thus, there is no showing that the objective evidence of non-obviousness is commensurate in scope with the claims. See MPEP § 716.
Specifically, claims 1, 59-60, 62-64, 20, and 65-70, are all directed to apparatus claims, in which the claims contain a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART. Ultimately, claims 1, 59-60, 62-64, 20, and 65-70 pertain to a system comprising electrode pairs, waveform generator, control device and power source. Any effect or usage of the system and its elements that is argued in the Affidavit concerning the creation and control of phosphenes, or for example creation of centroids (claims 60, 66) that is argued by the Applicant is considered to be mere intended use under apparatus claims, and would not hold patentable weight in view of the structures of the prior art Beck (US 4664117 A) and Chowdhury (US 20060095108 A1), within the fields of ocular stimulation systems for generating phosphenes, teaching the structural elements of the claims as stated in the rejection below.
Regarding method claim 32, specifically the reference of Agrama (US 8493286 B1) is merely relied upon to teach the deficient electrode positions of Beck as stated in the claim 32 rejection below. Since Beck teaches a method of inducing phosphenes, and Agrama teaches a similar facial stimulation system with electrodes placed around the eye areas (as analogous to the claimed invention which places electrodes around the eye area), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode locations of Beck to try the electrode placements around the face (eye, cheek, forehead) as taught by Agrama since such modification would provide the predictable results of targeting a phosphene at a specific location in the eye/face, thus rendering claim 32 obvious over the combined invention. Furthermore, any result including creating phosphenes and creating centroids to the method are considered to be intended results produced, and not to comprise positively recited steps of the method, see MPEP 2111.04.
The reference of Greenwald (US 20140200628 A1) is also used as an analogous art which similarly teaches generation of phosphenes, to teach the known technique of utilizing biphasic square wave pulses delivered to electrodes, and would therefore be obvious to one of ordinary skill in the art.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claim Rejections - 35 USC § 102
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, 59-60 and 63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beck (US 4664117 A), hereinafter Beck (cited previously).
Re. claim 1, Beck discloses a system for the generation of spatially resolved phosphenes in a person (abstract – “The invention produces visual sensations by applying low voltages through conductive electrodes to the outside of a person's head…As to information, the apparatus produces coded patterns or even rough analogs of normal visual scenes. As to aiding the blind, the apparatus responds to a sonar signal by placing phosphenes in the perceived visual field roughly where a normal person would see nearby objects”) comprising:
at least one pairs of electrodes for cutaneous connection to a person (column 14, lines 14-17: “Such two-dimensional effects may be developed by placement of three or more electrodes at particular positions on a person's head, and energization of the electrodes in pairs from independent (or coordinated) wavetrain generators”),
where each pairs of electrodes when connected to the person are located at a location selected from a group consisting of:
the right temple of the person's head and the left temple of the person's head (figures 1, 9, 13-16);
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or the left temple of the person's head and the left side of the person's head bilaterally across the nose bridge beneath the eyes; or the right temple of the person's head and the right side of the person's head bilaterally across the nose bridge beneath the eyes; or the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge; or the right side medially on the person's head and the left side medially on the person's head; or the left side medially on the person's head and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge; or the right side medially on the person's head and the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge; or the right side laterally on the person's head and the left side distally on the person's head;
Each of the at least one pairs of electrodes being connected to a waveform generator (FIG. 7 is an electrical block diagram of a preferred embodiment of a phosphene generator);
the waveform generators being connected to a first control device configured to activate a voltage waveform between each pairs of electrodes (microcomputer to DACs 1-6 in figure 7; column 16, lines 35-40: “Up to three electrode pairs (six electrodes in all) are driven by as many as six bipolar digital-to-analog converters, DAC1 through DAC6. The output voltage of each of these converters is controlled by the microprocessor and feeds (through a current-limiting resistance) an electrode pair”);
and the system being connected to a power source (figure 7, isolated power supply).
Re. claim 59, Beck further teaches where the first control device is configured to receive input data (Beck figure 7, ROM1 and ROM2 to microcomputer)
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and convert the input data to a pattern of activation for the at least one pairs of electrodes (Beck figures 7 shows phosphene generator for generating phosphenes; column 16, lines 35-40: “Up to three electrode pairs (six electrodes in all) are driven by as many as six bipolar digital-to-analog converters, DAC1 through DAC6. The output voltage of each of these converters is controlled by the microprocessor and feeds (through a current-limiting resistance) an electrode pair“)
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using the following pattern:
activating the electrode pair at the right temple of the person's head and the left temple of the person's head to create a phosphene in in left and right sides of the visual field of the person; activating the electrode pair at the left temple of the person's head and the left side of the person's head bilaterally across the nose bridge beneath the eyes to create a phosphene in the lower left of the visual field of the person; activating the electrode pair at the right temple of the person's head and the right side of the person's head bilaterally across the nose bridge beneath the eyes to create a phosphene in the lower right of the visual field of the person; activating the electrode pair at the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge to create a phosphene in the bottom of the visual field of the person; activating the electrode pair at the right side medially on the person's head and the left side medially on the person's head to create a phosphene in the top of the visual field of the person; activating the electrode pair at the left side medially on the person's head and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge to create a phosphene in the middle left of the visual field of the person; activating the electrode pair at the right side medially on the person's head and the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge to create a phosphene in the middle right of the visual field of the person; activating the electrode pair at the right side laterally on the person's head and the left side distally on the person's head to create a phosphene in the upper right and upper left of the visual field of the person (Beck teaches the system is used to deliver stimulation, or driving waveforms, to the electrode pairs, as per column 18, lines 12-17 – “The computer can further be programmed to use this information to construct a driving waveform for, say, the electrode pair EP1. Using the digital-to-analog converters DAC1 and DAC2 to form a bipolar source, the program can produce a phosphene spot or other pattern with the apparent bearing of the target object”).
Furthermore, it is reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART. In the instant case, it is taught as stated above, that the system of Beck is configured to activate electrode pairs based on input data, and can be delivered at any electrode positioned at any part of the face.
Re. claim 60, Beck further teaches where the pattern further comprises activating two pairs of electrodes simultaneously to create centroids (Beck figure 7, voltages V1 for electrode pair EP1, V2 for EP2 and V3 for EP3).
Re. claim 63, Beck further teaches a sensor, the sensor being configured to send input data to the first control device (figure 7, receiver sensor R), where the sensor is a spatial sensor and the input data is spatial data and the first control device converts the spatial data into a phosphene pattern that, when the at least one electrodes is connected to the person, communicates information about the person's spatial surroundings to the person (Beck column 17, lines 36-45: “The user wears a version of the headset equipped with two ultrasonic transmitters XMIT1 and XMIT2 and with an ultrasonic receiver R. Although these units can be chest mounted, placing them on the user's head is preferred so that the user can obtain additional information in natural ways by tilting or turning of the head without necessarily moving the torso. All the necessary transmitter, receiver and other phosphene-generator electronics may be mounted within the headset cover 101.”; column 17 lines 53-63: “The computer generates a sonar "chirp" pattern at one transmitter XMIT1 and "listens" for the echo with the receiver R. The computer can time the propagation of the wave from one transmitter XMIT1 (at, say, the left-hand side) to a reflecting object in the field of the transmitter-sensor system and back to the receiver sensor R. Then by "chirping" the other transmitter XMIT2 (at, say, the right-hand side), again listening for the echo, and timing the propagation, the computer collects enough information to calculate the range and bearing of the reflecting object.”).
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.
Claim(s) 20, 65-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 4664117 A), hereinafter Beck, in view of Chowdhury (US 20060095108 A1), hereinafter Chowdhury (cited previously).
Re. claim 20, Beck teaches a system comprising:
at least one electrode (column 14, lines 14-17: “Such two-dimensional effects may be developed by placement of three or more electrodes at particular positions on a person's head, and energization of the electrodes in pairs from independent (or coordinated) wavetrain generators.”; figure 7 shows three electrode pairs EP1-EP3, or six total electrodes), where each electrodes when connected to a person is located at a location selected from a group consisting of:
the left temple of the head (figures 1, 9, 13-16);
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or the right temple of the head; or under the left eye at an interior position; or under the left eye at a middle position; or under the left eye at an exterior position; or under the right eye at an interior position; or under the right eye at a middle position; or under the right eye at an exterior position; or above the left eye at an interior position; or above the left eye at a middle position; or above the left eye at an exterior position; or above the right eye at an interior position; or above the right eye at a middle position; or above the right eye at an exterior position; or above the nose to the right side; or above the nose to the left side;
each electrode pairs being connected to a waveform generator (FIG. 7 is an electrical block diagram of a preferred embodiment of a phosphene generator);
and the system being connected to a power source (figure 7, isolated power supply).
Beck does not explicitly teach where each electrodes forms a unipolar pair with a ground electrode, where the ground electrode can be cutaneously connected to the person; and the waveform generators being connected to a first control device configured to activate a voltage waveform between each electrodes and the ground electrode
Chowdhury discloses an extraocular device which produces phosphenes (Chowdhury paragraphs 0055, 0090) and further discloses in figure 8, a stimulating electrode (13, 14) can be stimulated with respect to a distant ground electrode 3 (monopolar), to create monopolar electrode pairs, where each electrodes forms a unipolar pair with a ground electrode (Chowdhury paragraph 0116 – “FIG. 8 shows examples of certain methods for electrical stimulation of the eye with an extraocular device of the invention. A stimulating electrode can be stimulated with respect to a distant ground electrode 3 (monopolar)”). Chowdhury further teaches where the ground electrode can be cutaneously connected to the person (Chowdhury paragraph 0116 – “FIG. 8 shows examples of certain methods for electrical stimulation of the eye with an extraocular device of the invention”).
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Chowdhury further teaches the waveform generators being connected to a first control device configured to activate a voltage waveform between each electrodes and the ground electrode (Chowdhury figure 1 shows the stimulator 5 in connection to the electrodes 3; paragraph 0103 – “In a further form, the function of the electrical stimulator is replaced with a means for electrically stimulating the one or more electrodes of the device”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode configuration of Beck, incorporate the ground electrode 3 of Chowdhury into the electrode configuration of the Beck in order to create monopolar stimulation pulses and induce phosphenes.
Re. claim 65, the combined invention of Beck and Chowdhury (hereinafter the combined invention) further teaches further teaches where the first control device is configured to receive input data (Beck figure 7, ROM1 and ROM2 to microcomputer)
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and convert the input data to a pattern of activation for the at least one pairs of electrodes (Beck figures 7 shows phosphene generator for generating phosphenes; column 16, lines 35-40: “Up to three electrode pairs (six electrodes in all) are driven by as many as six bipolar digital-to-analog converters, DAC1 through DAC6. The output voltage of each of these converters is controlled by the microprocessor and feeds (through a current-limiting resistance) an electrode pair“)
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using the following pattern:
activating the electrode pair at the right temple of the person's head and the left temple of the person's head to create a phosphene in in left and right sides of the visual field of the person; activating the electrode pair at the left temple of the person's head and the left side of the person's head bilaterally across the nose bridge beneath the eyes to create a phosphene in the lower left of the visual field of the person; activating the electrode pair at the right temple of the person's head and the right side of the person's head bilaterally across the nose bridge beneath the eyes to create a phosphene in the lower right of the visual field of the person; activating the electrode pair at the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge to create a phosphene in the bottom of the visual field of the person; activating the electrode pair at the right side medially on the person's head and the left side medially on the person's head to create a phosphene in the top of the visual field of the person; activating the electrode pair at the left side medially on the person's head and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge to create a phosphene in the middle left of the visual field of the person; activating the electrode pair at the right side medially on the person's head and the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge to create a phosphene in the middle right of the visual field of the person; activating the electrode pair at the right side laterally on the person's head and the left side distally on the person's head to create a phosphene in the upper right and upper left of the visual field of the person (Beck teaches the system is used to deliver stimulation, or driving waveforms, to the electrode pairs, as per column 18, lines 12-17 – “The computer can further be programmed to use this information to construct a driving waveform for, say, the electrode pair EP1. Using the digital-to-analog converters DAC1 and DAC2 to form a bipolar source, the program can produce a phosphene spot or other pattern with the apparent bearing of the target object”).
Furthermore, it is reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART. In the instant case, it is taught as stated above, that the system of Beck is configured to activate electrode pairs based on input data, and can be delivered at any electrode positioned at any part of the face.
Re. claim 66, the combined invention further teaches where the pattern further comprises activating two electrodes simultaneously to create centroids (Beck figure 7, voltages V1 for electrode pair EP1, V2 for EP2 and V3 for EP3).
Re. claim 67-68, the combined invention teaches the claimed invention except where the activated two electrodes have identical electrical stimulation intensities, and where the activated two electrodes have different electrical stimulation intensities.
The combined invention however teaches amplitude modulation to the electrode pairs (Beck column 5, lines 15-17: “…means for generating voltage wavetrains, and these wavetrains (by definition) have parameters that include frequency, amplitude, and dc bias”; column 16, lines 50-58: “The control program can also maintain the software equivalent of twenty low-frequency waveform generators. By virtue of its "multiply" instructions, it can also effect amplitude or frequency modulation on any given output channel”; column 18, lines 22-23: “The pulse duration or the voltage amplitude, or both, can be used to control the brightness of the phosphene”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modulating the electrodes of the combined invention to include identical stimulation intensities and different stimulation intensities, since such modification would provide the predictable results of inducing phosphenes.
Re. claim 69, the combined invention further discloses a sensor (Beck figure 7, receiver sensor R), the sensor being configured to send input data to the first control device (Beck figure 7), where the sensor is a spatial sensor and the input data is spatial data and the first control device converts the spatial data into a phosphene pattern that, when the at least one electrodes is connected to the person, communicates information about the person's spatial surroundings to the person (Beck column 17, lines 36-45: “The user wears a version of the headset equipped with two ultrasonic transmitters XMIT1 and XMIT2 and with an ultrasonic receiver R. Although these units can be chest mounted, placing them on the user's head is preferred so that the user can obtain additional information in natural ways by tilting or turning of the head without necessarily moving the torso. All the necessary transmitter, receiver and other phosphene-generator electronics may be mounted within the headset cover 101.”; column 17 lines 53-63: “The computer generates a sonar "chirp" pattern at one transmitter XMIT1 and "listens" for the echo with the receiver R. The computer can time the propagation of the wave from one transmitter XMIT1 (at, say, the left-hand side) to a reflecting object in the field of the transmitter-sensor system and back to the receiver sensor R. Then by "chirping" the other transmitter XMIT2 (at, say, the right-hand side), again listening for the echo, and timing the propagation, the computer collects enough information to calculate the range and bearing of the reflecting object.”).
Claim(s) 61-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 4664117 A), hereinafter Beck.
Re. claims 61-62, Beck teaches claimed invention as stated above in claim 1, but does not explicitly teach where the activated two pairs of electrodes have identical electrical stimulation intensities, and where the activated two pairs of electrodes have different electrical stimulation intensities.
Beck however teaches amplitude modulation to the electrode pairs (Beck column 5, lines 15-17: “…means for generating voltage wavetrains, and these wavetrains (by definition) have parameters that include frequency, amplitude, and dc bias.”; column 16, lines 50-58: “The control program can also maintain the software equivalent of twenty low-frequency waveform generators. By virtue of its "multiply" instructions, it can also effect amplitude or frequency modulation on any given output channel”; column 18, lines 22-23: “The pulse duration or the voltage amplitude, or both, can be used to control the brightness of the phosphene”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modulating the electrode pairs of the combined invention to try identical stimulation intensities and different stimulation intensities, since such modification would provide the predictable results of inducing phosphenes.
Claim(s) 32, 71-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 4664117 A), hereinafter Beck, in view of Agrama (US 8493286 B1), hereinafter Agrama (cited previously).
Re. claim 32, Beck discloses a method of generating spatially resolved phosphenes in a person, comprising: cutaneously attaching at least one pairs of electrodes to a person (column 14, lines 14-17: “Such two-dimensional effects may be developed by placement of three or more electrodes at particular positions on a person's head, and energization of the electrodes in pairs from independent (or coordinated) wavetrain generators.”), where the at least one pairs of electrodes whose locations are selected from a group consisting of:
the right temple of the person's head and the left temple of the person's head (figures 1, 9, 13-16);
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or the left temple of the person's head and the left side of the person's head bilaterally across the nose bridge beneath the eyes; or the right temple of the person's head and the right side of the person's head bilaterally across the nose bridge beneath the eyes; or the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge; or the right side medially on the person's head and the left side medially on the person's head; or the left side medially on the person's head and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge; or the right side medially on the person's head and the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge; or the right side laterally on the person's head and the left side distally on the person's head;
where each of the at least one pairs of electrodes is connected to a waveform generator (FIG. 7 is an electrical block diagram of a preferred embodiment of a phosphene generator);
and the waveform generators are connected to a first control device configured to activate at least one voltage waveform between the at least one pairs of electrodes (microcomputer to DACs 1-6 in figure 7; column 16, lines 35-40: “Up to three electrode pairs (six electrodes in all) are driven by as many as six bipolar digital-to-analog converters, DAC1 through DAC6. The output voltage of each of these converters is controlled by the microprocessor and feeds (through a current-limiting resistance) an electrode pair“);
sending input data to the first control device, the first control device converting the input data to a pattern of activation for the at least one pairs of electrodes (Beck figure 7 shows phosphene generator for generating phosphenes; column 16, lines 35-40: “Up to three electrode pairs (six electrodes in all) are driven by as many as six bipolar digital-to-analog converters, DAC1 through DAC6. The output voltage of each of these converters is controlled by the microprocessor and feeds (through a current-limiting resistance) an electrode pair“),
and so activating the at least one pairs of electrodes to generate a phosphene pattern in the person using the following pattern:
activating the electrode pair at the right temple of the person's head and the left temple of the person's head to create a phosphene in left and right sides of the visual field of the person (figure 1);
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activating the electrode pair at the left temple of the person's head and the left side of the person's head bilaterally across the nose bridge beneath the eyes to create a phosphene in the lower left of the visual field of the person (figure 15);
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activating the electrode pair at the right temple of the person's head and the right side of the person's head bilaterally across the nose bridge beneath the eyes to create a phosphene in the lower right of the visual field of the person (figure 15);
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activating the electrode pair at the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge (figure 15);
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and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge to create a phosphene in the bottom of the visual field of the person (figure 15);
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Beck does not explicitly teach activating the electrode pair at the right side medially on the person's head and the left side medially on the person's head to create a phosphene in the top of the visual field of the person; activating the electrode pair at the left side medially on the person's head and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge to create a phosphene in the middle left of the visual field of the person; activating the electrode pair at the right side medially on the person's head and the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge to create a phosphene in the middle right of the visual field of the person; and activating the electrode pair at the right side laterally on the person's head and the left side distally on the person's head to create a phosphene in the upper right and upper left of the visual field of the person.
Agrama teaches the known method of facial stimulation in figures 1-5 where a plurality of electrodes are placed around the eyes, cheeks and forehead, including:
activating the electrode pair at the right side medially on the person's head and the left side medially on the person's head to create a phosphene in the top of the visual field of the person (Agrama figure 1);
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activating the electrode pair at the left side medially on the person's head and the left side of the person's head on the left cheekbone beneath the eyes to the left side of the nose bridge to create a phosphene in the middle left of the visual field of the person (Agrama figure 1);
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activating the electrode pair at the right side medially on the person's head and the right side of the person's head on the right cheekbone beneath the eyes to the right side of the nose bridge to create a phosphene in the middle right of the visual field of the person (Agrama figure 1);
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activating the electrode pair at the right side laterally on the person's head and the left side distally on the person's head to create a phosphene in the upper right and upper left of the visual field of the person (Agrama figure 1);
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Agrama teaches a similar method of facial stimulation in figures 1-5 where a plurality of electrodes are placed around the eyes, cheeks and forehead as shown above. Since Agrama and Beck teach facial stimulation systems, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode locations of Beck to try the electrode placements around the face (eye, cheek, forehead) as taught by Agrama above, since such modification would provide the predictable results of targeting a phosphene at a specific location in the eye/face. Furthermore, the limitations of “to create phosphenes” at various locations around the eye is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04. I).
Re. claim 71, the combined invention of Beck and Agrama (hereinafter the combined invention) further teaches where the pattern further comprises activating two electrodes simultaneously to create centroids (Beck figure 7, voltages V1 for electrode pair EP1, V2 for EP2 and V3 for EP3). Furthermore, the limitations of “to create centroids” is considered to comprise an intended result of the stimulation and not to comprise a positively recited step of the method (see MPEP 2111.04. I).
Re. claim 72-73, the combined invention teaches the claimed invention except where the activated two electrodes have identical electrical stimulation intensities, and where the activated two electrodes have different electrical stimulation intensities.
The combined invention however teaches amplitude modulation to the electrode pairs (Beck column 5, lines 15-17: “…means for generating voltage wavetrains, and these wavetrains (by definition) have parameters that include frequency, amplitude, and dc bias”; column 16, lines 50-58: “The control program can also maintain the software equivalent of twenty low-frequency waveform generators. By virtue of its "multiply" instructions, it can also effect amplitude or frequency modulation on any given output channel”; column 18, lines 22-23: “The pulse duration or the voltage amplitude, or both, can be used to control the brightness of the phosphene”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modulating the electrodes of the combined invention to include identical stimulation intensities and different stimulation intensities, since such modification would provide the predictable results of inducing phosphenes.
Re. claim 74, the combined invention further discloses a sensor (Beck figure 7, receiver sensor R), the sensor being configured to send input data to the first control device (Beck figure 7), where the sensor is a spatial sensor and the input data is spatial data and the first control device converts the spatial data into a phosphene pattern that, when the at least one electrodes are connected to the person, communicates information about the person's spatial surroundings to the person (Beck column 17, lines 36-45: “The user wears a version of the headset equipped with two ultrasonic transmitters XMIT1 and XMIT2 and with an ultrasonic receiver R. Although these units can be chest mounted, placing them on the user's head is preferred so that the user can obtain additional information in natural ways by tilting or turning of the head without necessarily moving the torso. All the necessary transmitter, receiver and other phosphene-generator electronics may be mounted within the headset cover 101.”; column 17 lines 53-63: “The computer generates a sonar "chirp" pattern at one transmitter XMIT1 and "listens" for the echo with the receiver R. The computer can time the propagation of the wave from one transmitter XMIT1 (at, say, the left-hand side) to a reflecting object in the field of the transmitter-sensor system and back to the receiver sensor R. Then by "chirping" the other transmitter XMIT2 (at, say, the right-hand side), again listening for the echo, and timing the propagation, the computer collects enough information to calculate the range and bearing of the reflecting object.”).
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 4664117 A), hereinafter Beck, in view of Greenwald (US 20140200628 A1), hereinafter Greenwald (cited previously).
Re. claim 64, Beck teaches square wave signals (Beck column 9, lines 36-38: “At the heart of the wavetrain-producing apparatus is an oscillator 31 (FIG. 3), which generates basic square, triangle and pulse waveforms…”; column 16, lines 43-49: “The digital-to-analog converter can produce complex waveforms under control of a program. Since phosphene frequencies are relatively low, the digital-to-analog converter "update rate" is relatively slow, and the sixteen-bit computer can easily compute output data for sine, square, pulse, triangle, ramp or other waveforms at each converter.”). The combined invention does not explicitly teach the square signals to be biphasic.
Greenwald teaches a method of performing a brightness fitting that normalizes brightness across electrodes (Greenwald paragraph 0008), and teaches in paragraph 0051 a brightness matching technique in which subjects reported phosphene brightness from stimuli directed at electrodes containing biphasic, cathodic-first, charge-balanced square wave pulses (Greenwald paragraph 0051 – “In Experiment 2 we used a brightness matching technique, where subjects were asked to report which of two phosphenes appeared brighter. As well as comparing brightness matching performance within a single electrode, we also compared brightness across pairs of electrodes. Both reference and test stimuli consisted of 200 ms, 15 Hz pulse trains that contained biphasic, cathodic-first, charge-balanced square wave pulses.”).
Since the combined invention and Greenwald are all electrical stimulation systems which produce phosphenes, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the biphasic square wave pulses as taught by Greenwald into the electrodes/electrode pairs of the combined invention, since such modification would provide the predictable results of inducing phosphenes to gain insight into the apparent brightness of the percept (Greenwald paragraph 0050).
Claim(s) 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 4664117 A), hereinafter Beck, in view of Chowdhury (US 20060095108 A1), hereinafter Chowdhury, and in further view of Greenwald (US 20140200628 A1), hereinafter Greenwald.
Re. claim 70, the combined invention of Beck and Chowdhury (hereinafter the combined invention) teaches square wave signals (Beck column 9, lines 36-38: “At the heart of the wavetrain-producing apparatus is an oscillator 31 (FIG. 3), which generates basic square, triangle and pulse waveforms…”; column 16, lines 43-49: “The digital-to-analog converter can produce complex waveforms under control of a program. Since phosphene frequencies are relatively low, the digital-to-analog converter "update rate" is relatively slow, and the sixteen-bit computer can easily compute output data for sine, square, pulse, triangle, ramp or other waveforms at each converter.”).
The combined invention does not explicitly teach the square signals to be biphasic.
Greenwald teaches a method of performing a brightness fitting that normalizes brightness across electrodes (Greenwald paragraph 0008), and teaches in paragraph 0051 a brightness matching technique in which subjects reported phosphene brightness from stimuli directed at electrodes containing biphasic, cathodic-first, charge-balanced square wave pulses (Greenwald paragraph 0051 – “In Experiment 2 we used a brightness matching technique, where subjects were asked to report which of two phosphenes appeared brighter. As well as comparing brightness matching performance within a single electrode, we also compared brightness across pairs of electrodes. Both reference and test stimuli consisted of 200 ms, 15 Hz pulse trains that contained biphasic, cathodic-first, charge-balanced square wave pulses.”).
Since the combined invention and Greenwald are all electrical stimulation systems which produce phosphenes, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the biphasic square wave pulses as taught by Greenwald into the electrodes/electrode pairs of the combined invention, since such modification would provide the predictable results of inducing phosphenes and gain insight into the apparent brightness of the percept (Greenwald paragraph 0050).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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