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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “stimulus mechanism” in claims 1-9, 16-24, “attachment mechanism” in claim 1, “logic mechanism” in claims 6, 21, “timing mechanism” in claims 7 and 22.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 4 and 19 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 4 recites the limitation "the at least one contact pad… such that the vibration". There is insufficient antecedent basis for this limitation in the claim. Claim 3 further defines the stimulus mechanism and sets forth that it produces a vibration, but claim 4 is not dependent upon claim 3 and therefore lacks antecedent basis for stimulus mechanism providing a vibration. Applicant is advised to amend claim 4 to positively set forth that the stimulus mechanism produces the vibration as in claim 3, or change the dependency of claim 4 accordingly. For examination purposes claim 4 will be interpreted as being dependent upon claim 3.
Similar arguments can be made for claim 19.
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.
(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.
Claims 1-4, 6-8, 10-13, 16-19, 21-23, 25-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franke (U.S 2018/0161579 A1).
Regarding claim 1, Franke discloses a therapeutic spectacles device for relieving symptoms of dry eye disease (Paragraph 0006, 0038), the therapeutic spectacles device comprising:
a protective housing configured to house a stimulus mechanism and an internal power source (see Figs. 3A-B and 4, Paragraph 0093 and 0095; The eyewear housing/frame includes electrodes 310 providing stimulus to the facial tissue controlled by a control system 330 mounted in the frame of the device; also see Paragraph 0083 wherein the glasses include a power supply to power the stimulation and controller, and see Paragraph 0098 which recites that the battery is mounted in/on the eyeglasses in earlier embodiments to Fig. 10);
at least one contact pad attached to the protective housing, the at least one contact pad configured to rest against a targeted area within a region selected from the group consisting of a patient's nasofrontal region, supraorbital region, suborbital region, temporal region, and any combination of the same (Paragraph 0095, the electrodes 310 can include conductive hydrogel electrode pads which are disposed on the bridge of the eyeglasses for contact with the nasofrontal region/nasal bridge); and
an attachment mechanism arranged on the protective housing, the attachment mechanism configured to fix the protective housing to the therapeutic spectacles device such that the at least one contact pad rests against the targeted area when the therapeutic spectacles device is fixed on spectacles worn by the patient (It is noted that ‘attachment mechanism’ is recited very broadly and thus applicant is advised to further define the mechanism; Fig. 3A/B, The temple tips/earpieces of the glasses frames secure the spectacles on the head and thus maintain the contact pads resting against the nasal bridge area; Alternatively see Fig. 5-6 and Paragraph 0105, wherein an eye mask 600 can include the stimulators and can include straps 602 for securement of the eye mask to the face; Paragraph 0096, sticky adhesive may also be used to stick a nasal strip holding the electrodes to the user),
wherein the internal power source has an energy capacity sufficient to provide uninterrupted power to operate the therapeutic spectacles device continuously for a period of time (Paragraph 0083, the stimulation system may include a battery to control the controller 130 and stimulators 110 and thus the battery must be able to provide power continuously for at least a certain duration; It is noted that the ‘period of time’ is extremely broad and accordingly a battery lasting only a few minutes would still meet the limitations as currently filed); and
wherein the stimulus mechanism is electrically connected to and powered by the internal power source (Paragraph 0083; also see Paragraph 0098 wherein the power supply is recited in previous embodiments to be on/in the eyeglasses), and is configured to deliver a stimulus through the at least one contact pad to the targeted area (Paragraph 0057, 0081-0082; The stimulators deliver electrical stimulus via the electrodes which are controlled/mediated by the control system 130).
Regarding claim 2, the device of Franke discloses the device of claim 1.
Franke further discloses wherein the stimulus mechanism and the at least one contact pad are positioned such that, when the therapeutic spectacles device is fixed on spectacles worn by the patient, the stimulus is delivered through a nasal bridge of the patient to an external branch of a patient's trigeminal cranial nerve to stimulate neuromodulation of the external branch of the patient's trigeminal cranial nerve (Paragraph 0044; The electrodes can provide stimulation to the nasal bridge or parts of the nose to stimulate various nerves of the face; The ophthalmic nerve is the first branch of the trigeminal nerve and thus neuromodulates those external nerves; The stimulation of those nerves can prompt tear production).
Regarding claim 3, the device of Franke discloses the device of claim 1.
Franke further discloses wherein the stimulus mechanism is configured to generate a vibration for stimulating the targeted area (see Paragraph 0009, 0013-0014, 0040, 0045; Instead of electrodes, the stimulus may be provided via ultrasound stimulation from an ultrasound transducer).
Regarding claim 4, the device of Franke discloses the device of claim 1.
Franke further discloses wherein the at least one contact pad and stimulus mechanism are positioned such that the vibration, when administered to the patient, has a wave direction that is perpendicular to a nasal bridge of the patient where it meets an external branch of a patient's trigeminal cranial nerve (see Figs. 3A/B and Fig. 10; The contact pads/electrodes are provided on either side of the bridge of the nose and thus deliver the vibration perpendicular to the axis of the nasal bridge; also see Paragraph 0044 regarding the stimulation of the ophthalmic branch of the trigeminal nerve).
Regarding claim 5, the device of Franke discloses the device of claim 1.
Franke further discloses wherein the stimulus mechanism is configured to generate electromagnetic radiation for stimulating the targeted area (Paragraph 0009; Electrical stimulation is provided to the user; Generation of an electrical current will induce an electromagnetic field at the locus of delivery).
Regarding claim 6, the device of Franke discloses the device of claim 1.
Franke further teaches a logic mechanism housed in the protective housing, the logic mechanism configured to automatically switch the stimulus mechanism on and off under given conditions (Paragraph 0093, the system includes control system 330 which receives signals from sensors to adjust stimulation to treat or reduce dry eye and thus controls the stimulation being on/off according to the status of the eyes/tear production; also see Paragraph 0048 regarding controlling of the stimulation waveforms, wherein stimulation can be provided as a step function with on/off conditions).
Regarding claim 7, the device of Franke discloses the device of claim 1.
Franke further discloses a timing mechanism housed in the protective housing, the timing mechanism configured to automatically switch the stimulus mechanism off after a given period of time (Paragraph 0040, the control system uses sensor data to determine treatment parameters and mode of stimulation, which includes duration parameters of the treatment; Thus, the control system sets a duration and stops the treatment after the duration has elapsed; also see Paragraph 0048 about on/off switching pattern of treatment, which is after a duration of 1-5 secs for example).
Regarding claim 8, the device of Franke discloses the device of claim 1.
Franke further discloses a controller housed in the protective housing, the controller being configured to control the stimulus mechanism using received input (Fig. 3A-B, controller 330; Paragraph 0040, 0082, 0093; The controller/control system adjusts the stimulus provided according to sensor data to treat dry eye).
Regarding claim 10, the device of Franke discloses the device of claim 1.
Franke further discloses at least one sensor, the sensor configured to observe a physical condition associated with a patient's tear meniscus (Paragraph 0010, 0063, 0070; A sensor may detect tear meniscus height which indicates a level of dry eye and thus adjusts the stimulus provided).
Regarding claim 11, the device of Franke discloses the device of claim 1.
Franke further discloses at least one sensor, the sensor configured to observe a physical condition associated with a patient's blink rate (Paragraph 0010, 0061, 0070; The sensor may detect blink rate as a metric for determining dry eye and to adjust the stimulus provided).
Regarding claim 12, the device of Franke discloses the device of claim 1.
Franke further discloses at least one sensor, the sensor configured to observe a physical condition associated with a patient's tear break-up time (Paragraph 0064; The image sensor can measure tear film breakup time as an indication of dry eye and to adjust the stimulus provided).
Regarding claim 13, the device of Franke discloses the device of claim 1.
Franke further discloses at least one sensor, the sensor configured to observe a physical condition associated with a patient's head movement (Paragraph 0079; The sensor may include an accelerometer or IMU may detect the acceleration or velocity of the user’s head, indicating travel in a vehicle that is indicative of drier air or likely to cause dry eye symptoms; It is noted that ‘physical condition’ as recited is highly broad and applicant is advised to further define the condition and movement detected).
Regarding claim 16, Franke discloses therapeutic spectacles for relieving symptoms of dry eye disease (Paragraph 0006, 0038), the therapeutic spectacles comprising:
a pair of unobstructed lenses set in a frame (Fig. 3A-B and Paragraph 0073, the device includes a lens frame with unobstructed lenses in the frame), the frame comprising a protective housing configured to house a stimulus mechanism and an internal power source (see Figs. 3A-B and 4, Paragraph 0093 and 0095; The eyewear housing/frame includes electrodes 310 providing stimulus to the facial tissue controlled by a control system 330 mounted in the frame of the device; also see Paragraph 0083 wherein the glasses include a power supply to power the stimulation and controller, and see Paragraph 0098 which recites that the battery is mounted in/on the eyeglasses in earlier embodiments to Fig. 10); and
at least one contact pad attached to the frame, the at least one contact pad configured to rest against at least one targeted area in a region selected from the group consisting of a patient's nasofrontal region, supraorbital region, suborbital region, temporal region, or any combination of the same when the therapeutic spectacles are worn by the patient (Paragraph 0095, the electrodes 310 can include conductive hydrogel electrode pads which are disposed on the bridge of the eyeglasses for contact with the nasofrontal region/nasal bridge),
wherein the internal power source has an energy capacity sufficient to provide uninterrupted power to operate the therapeutic spectacles continuously for a period of time (Paragraph 0083, the stimulation system may include a battery to control the controller 130 and stimulators 110 and thus the battery must be able to provide power continuously for at least a certain duration; It is noted that the ‘period of time’ is extremely broad and accordingly a battery lasting only a few minutes would still meet the limitations as currently filed), and
wherein the stimulus mechanism is electrically connected to and powered by the internal power source (Paragraph 0083; also see Paragraph 0098 wherein the power supply is recited in previous embodiments to be on/in the eyeglasses), and is configured to deliver a stimulus through the at least one contact pad to the at least one targeted area (Paragraph 0057, 0081-0082; The stimulators deliver electrical stimulus via the electrodes which are controlled/mediated by the control system 130).
Regarding claim 17, the device of Franke discloses the device of claim 16.
Franke further discloses wherein the stimulus mechanism and contact pad are positioned such that, when the therapeutic spectacles are worn by the patient, the stimulus is delivered through a nasal bridge of the patient to an external branch of a patient's trigeminal cranial nerve to stimulate neuromodulation of the external branch of the patient's trigeminal cranial nerve (Paragraph 0044; The electrodes can provide stimulation to the nasal bridge or parts of the nose to stimulate various nerves of the face; The ophthalmic nerve is the first branch of the trigeminal nerve and thus neuromodulates those external nerves; The stimulation of those nerves can prompt tear production).
Regarding claim 18, the device of Franke discloses the device of claim 16.
Franke further discloses wherein the stimulus mechanism is configured to generate a vibration for stimulating the nasofrontal region (see Paragraph 0009, 0013-0014, 0040, 0045; Instead of electrodes, the stimulus may be provided via ultrasound stimulation from an ultrasound transducer).
Regarding claim 19, the device of Franke discloses the device of claim 16.
Franke further discloses wherein the position of the at least one contact pad and stimulus mechanism are positioned such that the vibration, when administered to the patient, has a wave direction that is perpendicular to a nasal bridge of the patient where it meets an external branch of a patient's trigeminal cranial nerve (see Figs. 3A/B and Fig. 10; The contact pads/electrodes are provided on either side of the bridge of the nose and thus deliver the vibration perpendicular to the axis of the nasal bridge; also see Paragraph 0044 regarding the stimulation of the ophthalmic branch of the trigeminal nerve).
Regarding claim 21, the device of Franke discloses the device of claim 16.
Franke further discloses a logic mechanism housed in the protective housing, the logic mechanism configured to automatically switch the stimulus mechanism on and off under given conditions (Paragraph 0093, the system includes control system 330 which receives signals from sensors to adjust stimulation to treat or reduce dry eye and thus controls the stimulation being on/off according to the status of the eyes/tear production; also see Paragraph 0048 regarding controlling of the stimulation waveforms, wherein stimulation can be provided as a step function with on/off conditions).
Regarding claim 22, the device of Franke discloses the device of claim 16.
Franke further discloses a timing mechanism housed in the protective housing, the timing mechanism configured to automatically switch the stimulus mechanism off after a given period of time (Paragraph 0040, the control system uses sensor data to determine treatment parameters and mode of stimulation, which includes duration parameters of the treatment; Thus, the control system sets a duration and stops the treatment after the duration has elapsed; also see Paragraph 0048 about on/off switching pattern of treatment, which is after a duration of 1-5 secs for example)..
Regarding claim 23, the device of Franke discloses the device of claim 16.
Franke further discloses a controller housed in the protective housing, the controller being configured to control the stimulus mechanism using received input (Fig. 3A-B, controller 330; Paragraph 0040, 0082, 0093; The controller/control system adjusts the stimulus provided according to sensor data to treat dry eye).
Regarding claim 25, the device of Franke discloses the device of claim 16.
Franke further discloses at least one sensor, the sensor configured to observe a physical condition associated with a patient's tear meniscus (Paragraph 0010, 0063, 0070; A sensor may detect tear meniscus height which indicates a level of dry eye and thus adjusts the stimulus provided).
Regarding claim 26, the device of Franke discloses the device of claim 16.
Franke further discloses at least one sensor, the sensor configured to observe a physical condition associated with a patient's blink rate (Paragraph 0010, 0061, 0070; The sensor may detect blink rate as a metric for determining dry eye and to adjust the stimulus provided).
Regarding claim 27, the device of Franke discloses the device of claim 16.
Franke further discloses at least one sensor, the sensor configured to observe a physical condition associated with a patient's tear break-up time (Paragraph 0064; The image sensor can measure tear film breakup time as an indication of dry eye and to adjust the stimulus provided).
Regarding claim 28, the device of Franke discloses the device of claim 16.
Franke further discloses at least one sensor, the sensor configured to observe a physical condition associated with a patient's head movement (Paragraph 0079; The sensor may include an accelerometer or IMU may detect the acceleration or velocity of the user’s head, indicating travel in a vehicle that is indicative of drier air or likely to cause dry eye symptoms; It is noted that ‘physical condition’ as recited is highly broad and applicant is advised to further define the condition and movement detected).
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 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Franke (U.S 2018/0161579 A1), as applied to claims 1 and 16, in view of De Toni (U.S 2017/0354818 A1).
Regarding claim 5, the device of Franke discloses the device of claim 1.
Franke is silent regarding specifically wherein the stimulus mechanism is configured to generate electromagnetic radiation for stimulating the targeted area.
However, De Toni teaches wherein electromagnetic radiation is useful in stimulation and treatment of dry eye conditions (Paragraph 0027-0032; Electromagnetic radiation/waves of various forms/frequencies can be used to stimulate the eyes and surrounding area for the treatment of dry eye; also see Paragraph 0017 regarding radiating element transmitting the EM waves).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Franke to include the stimulus mechanism delivering electromagnetic radiation, such as that taught by De Toni, in order to provide a known alternative modality for treatment of dry eye in the patient (Paragraph 0017; also see Paragraph 0007, 0013).
Regarding claim 20, the device of Franke discloses the device of claim 16.
Franke is silent regarding specifically wherein the stimulus mechanism is configured to generate electromagnetic radiation for stimulating the targeted area.
However, De Toni teaches wherein electromagnetic radiation is useful in stimulation and treatment of dry eye conditions (Paragraph 0027-0032; Electromagnetic radiation/waves of various forms/frequencies can be used to stimulate the eyes and surrounding area for the treatment of dry eye; also see Paragraph 0017 regarding radiating element transmitting the EM waves).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Franke to include the stimulus mechanism delivering electromagnetic radiation, such as that taught by De Toni, in order to provide a known alternative modality for treatment of dry eye in the patient (Paragraph 0017; also see Paragraph 0007, 0013).
Claims 9, 14, 24 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Franke (U.S 2018/0161579 A1), as applied to claims 1 and 16, in view of Mowery (U.S 2019/0143116 A1).
Regarding claim 9, the device of Franke discloses the device of claim 1.
Franke further discloses wherein the at least one contact pad comprises at least two contact pads (see Fig. 3A-3B, Fig. 10; There are two electrodes 310 on either side of the nose bridge).
Franke is silent regarding wherein the at least one contact pad comprises at least two contact pads and in which the at least two contact pads are positioned to stimulate at least two targeted areas within the region selected from the group consisting of the patient's nasofrontal region, supraorbital region, suborbital region, temporal region, and any combination of the same.
However, Franke also teaches that multiple alternative locations of the stimulators may be used in any suitable location for stimulation of the facial nerves (Paragraph 0046) and further wherein the electrodes can be placed to target the nasofrontal region, supraorbital region, suborbital region (see Fig. 3A/B, nasofrontal region about the bridge, Fig. 5-6, the stimulators 510/610 are spaced about the eye and thus at supraorbital and suborbital regions; also see Paragraph 0106 and Fig. 7A regarding the stimulators surrounding the orbits).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the spectacles of Franke to include stimulators positioned to stimulate about the orbits, such as that taught by Franke, in order to provide known alternative arrangements and positions for stimulation of various facial nerves (Paragraph 0044, 0046, 0007).
Franke is silent regarding wherein the controller is specifically configured to control the stimulus mechanism such that the at least two targeted areas can be targeted for stimulus independently.
However, Mowery teaches an array of electrodes about the eye for treatment of ocular diseases wherein the therapy includes independent activation of each of the electrodes (Paragraph 0086; also see Paragraph 0029 regarding electrodes being wired individually and separately to the stimulation controller and Paragraph 0064 regarding driving the electrodes independently or in phase; also see Figs. 1-4 wherein the electrodes are spaced from one another to target different areas).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Franke to include controlling the electrodes on different areas independently, such as that taught by Mowery, in order to allow for more control of the delivered therapy (Paragraph 0086) and to test and evaluate the particular electrodes/sets of electrodes best suited for relieving particular symptoms (Paragraph 0064).
Regarding claim 14, the device of Franke discloses the device of claim 1.
Franke is silent regarding a radio transmitter and receiver housed in the protective housing, the radio transmitter and receiver configured to wirelessly transmit and receive data from the therapeutic spectacles device to an external computing device, the external computing device having an interface for controlling the therapeutic spectacles device.
However, Mowery teaches a radio transmitter and receiver housed in the protective housing (Paragraph 0080, the eyewear may include an RF transceiver which communicates with an external PC or other device; also see Paragraph 0068 regarding transmission of measurements from the skin/nerves for adjustment of therapy), the radio transmitter and receiver configured to wirelessly transmit and receive data from the therapeutic spectacles device to an external computing device (Paragraph 0080, the RF transceiver communicates with a remote PC and conducts signals between the external controller and the electrodes), the external computing device having an interface for controlling the therapeutic spectacles device (Paragraph 0080; The external device may be a PC, tablet, laptop, etc. and the transceiver can receive signals to operate the electrodes; also see Paragraph 0068 regarding adjustment of therapy).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Franke to have included an RF transceiver to transmit and receive data from an external device, such as that taught by Mowery, in order to collect patient data externally and to determine and adjust the applied therapy to the user (Paragraph 0068 and 0080).
Regarding claim 24, the device of Franke discloses the device of claim 16.
Franke further discloses wherein the at least one contact pad comprises at least two contact pads (see Fig. 3A-3B, Fig. 10; There are two electrodes 310 on either side of the nose bridge).
Franke is silent regarding wherein the at least one contact pad comprises at least two contact pads and in which the at least two contact pads are positioned to stimulate at least two targeted areas within the region selected from the group consisting of the patient's nasofrontal region, supraorbital region, suborbital region, temporal region, and any combination of the same.
However, Franke also teaches that multiple alternative locations of the stimulators may be used in any suitable location for stimulation of the facial nerves (Paragraph 0046) and further wherein the electrodes can be placed to target the nasofrontal region, supraorbital region, suborbital region (see Fig. 3A/B, nasofrontal region about the bridge, Fig. 5-6, the stimulators 510/610 are spaced about the eye and thus at supraorbital and suborbital regions; also see Paragraph 0106 and Fig. 7A regarding the stimulators surrounding the orbits).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the spectacles of Franke to include stimulators positioned to stimulate about the orbits, such as that taught by Franke, in order to provide known alternative arrangements and positions for stimulation of various facial nerves (Paragraph 0044, 0046, 0007).
Franke is silent regarding wherein the controller is specifically configured to control the stimulus mechanism such that the at least two targeted areas can be targeted for stimulus independently.
However, Mowery teaches an array of electrodes about the eye for treatment of ocular diseases wherein the therapy includes independent activation of each of the electrodes (Paragraph 0086; also see Paragraph 0029 regarding electrodes being wired individually and separately to the stimulation controller and Paragraph 0064 regarding driving the electrodes independently or in phase; also see Figs. 1-4 wherein the electrodes are spaced from one another to target different areas).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Franke to include controlling the electrodes on different areas independently, such as that taught by Mowery, in order to allow for more control of the delivered therapy (Paragraph 0086) and to test and evaluate the particular electrodes/sets of electrodes best suited for relieving particular symptoms (Paragraph 0064).
Regarding claim 29, the device of Franke discloses the device of claim 16.
Franke is silent regarding a radio transmitter and receiver housed in the protective housing, the radio transmitter and receiver configured to wirelessly transmit and receive data from the therapeutic spectacles device to an external computing device, the external computing device having an interface for controlling the therapeutic spectacles device.
However, Mowery teaches a radio transmitter and receiver housed in the protective housing (Paragraph 0080, the eyewear may include an RF transceiver which communicates with an external PC or other device; also see Paragraph 0068 regarding transmission of measurements from the skin/nerves for adjustment of therapy), the radio transmitter and receiver configured to wirelessly transmit and receive data from the therapeutic spectacles device to an external computing device (Paragraph 0080, the RF transceiver communicates with a remote PC and conducts signals between the external controller and the electrodes), the external computing device having an interface for controlling the therapeutic spectacles device (Paragraph 0080; The external device may be a PC, tablet, laptop, etc. and the transceiver can receive signals to operate the electrodes; also see Paragraph 0068 regarding adjustment of therapy).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Franke to have included an RF transceiver to transmit and receive data from an external device, such as that taught by Mowery, in order to collect patient data externally and to determine and adjust the applied therapy to the user (Paragraph 0068 and 0080).
Claim 15 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Franke (U.S 2018/0161579 A1).
Regarding claim 15, the device of Franke discloses the device of claim 1.
Franke is silent regarding wherein the spectacles internal power source comprises a rechargeable battery.
However, Franke teaches a handheld electrical stimulator for the eyes wherein the power source may be rechargeable (Paragraph 0111, the power source can be recharged via contracts or wireless power transfer).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Franke to make the battery rechargeable, such as that taught by Franke, in order to prolong use of the device and allow easy of re-use (Paragraph 0111).
Regarding claim 30, the device of Franke discloses the device of claim 16.
Franke is silent regarding wherein the spectacles internal power source comprises a rechargeable battery.
However, Franke teaches a handheld electrical stimulator for the eyes wherein the power source may be rechargeable (Paragraph 0111, the power source can be recharged via contracts or wireless power transfer).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Franke to make the battery rechargeable, such as that taught by Franke, in order to prolong use of the device and allow easy of re-use (Paragraph 0111).
Conclusion
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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