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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12-17 of U.S. Patent No. 11007367 hereafter known as Pat ‘367 in view of Paul Jr et al (US 20040176820) hereafter known as Paul for being obvious as outlined in the table below.
Claim in AP 18440673
Where the limitation(s) is in the claims of Pat ‘367
Modification (if any used) and/or further explanation (if needed)
Claims 1 and 10
See Claim 1
However, Pat ‘367 is silent as to the exact type of waveform and therefore, fails to disclose specifically a “generating a hybrid waveform” and only discloses varying one of the claimed varied waveform parameters. Thus, Pat ‘367 fails to fully disclose “generating a hybrid waveform comprising a series of current pulses having a peak current amplitude between 1 microamp and 450 microamps, wherein three or more waveform parameters of the hybrid waveform are varied in accordance with a visual disease treatment protocol, wherein the varied waveform parameters are selected from the group consisting of pulse width, pulse period, pulse position, pulse coding, peak current amplitude, duty cycle, and pulse shape”.
Paul discloses in the analogous art of microcurrent stimulation for ophthalmic conditions [see abstract… “A method and apparatus for providing microcurrent stimulation (MSC) therapy. In accordance with the present invention, it has been determined that the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases.”] known treatments that produce excellent results in treating ophthalmic conditions include using hybrid waveforms with different pulse widths, pulse periods and pulse amplitudes [see para 44… “One particular sequence that has produced excellent results is as follows. A first microcurrent signal having a first modulation frequency more than 200 Hz but less than or equal to 300 Hz is applied for a period from 1 second up to 120 seconds. A second microcurrent signal having a second modulation frequency more than 10 Hz but less than or equal to 200 Hz is then applied for a period from 1 second up to 240 seconds. A third microcurrent signal having a third modulation frequency more than 1 Hz but less than or equal to 10 Hz is then applied for a period from 10 seconds up to 800 seconds.”]
Since Paul discloses the use of hybrid waveforms with different pulse widths, pulse periods and pulse amplitudes are known to produce excellent results in treating ophthalmic conditions, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Pat ‘367 to use hybrid waveforms with different pulse widths, pulse periods and pulse amplitudes similar to that disclosed by Paul (i.e. thereby reciting generating a hybrid waveform as claimed) because this this a known technique to provide a known improved result in the field of the ophthalmology.
Claims 2, 11
See claim 12
Claims 3, 12
See claim 13
Claims 4, 13
See claim 14
Claims 5 and 14
See claim 15
Claims 6-7 and 15-16
See rejection to claims 1 and 10 for claims 6-7 and 15-16, respectfully.
As outlined in the rejection to claims 1 and 10 above in this table, Pat ‘367 in view of Paul disclose the waveform parameters of pulse width, pulse period and pulse amplitude as being varied. This is also interpreted as different parameters of pulse width, pulse period and pulse position (in seconds) as recited by claims 6 and 15 and also interpreted as different parameters of pulse width, pulse period and pulse coding (in Hz) as recited by claims 7 and 16.
Claims 8 and 17
See claim 16
Claim 9
See claim 17
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paul.
Independent claim
Regarding claim 1:
Paul discloses:
A method of using microcurrent stimulation for the treatment of a visual disease [see abstract… “A method and apparatus for providing microcurrent stimulation (MSC) therapy. In accordance with the present invention, it has been determined that the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases.”], comprising:
generating a hybrid waveform comprising a series of current pulses [see para 28… “current will be provided in a square waveform at a frequency of 292 Hz for 60 seconds. During those 60 seconds the program indicator light (50) is lit, which advises the user that the program is underway. When the current applied at 292 Hz for 60 seconds stops, an audible tone will sound and the next step in the therapy program will begin. Here, program indicator light (51) will light, current will be provided at 30 Hz for 120 seconds. At the conclusion of this step in the therapy program, a tone will sound again. The program indicator light (51) will dim and program indicator light (52) will light. This indicates that current will be provided at 9.1 Hz for 180 seconds. A third tone will sound indicating that step in the therapy program is over.”] having current amplitude between 1 microamp and 1000 microamps [see para 35… “the current can be present at a constant dc current of between, for example, 1.0 and 1,000.00 .mu.A.”],
wherein three or more waveform parameters of the hybrid waveform are varied in accordance with a visual disease treatment protocol, wherein the varied waveform parameters are selected from the group consisting of pulse width, pulse period, pulse position, pulse coding, peak current amplitude, duty cycle, and pulse shape [see para 44… “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal. In accordance with this embodiment, each signal is applied for a longer period of time than the previously applied signal. One particular sequence that has produced excellent results is as follows. A first microcurrent signal having a first modulation frequency more than 200 Hz but less than or equal to 300 Hz is applied for a period from 1 second up to 120 seconds. A second microcurrent signal having a second modulation frequency more than 10 Hz but less than or equal to 200 Hz is then applied for a period from 1 second up to 240 seconds. A third microcurrent signal having a third modulation frequency more than 1 Hz but less than or equal to 10 Hz is then applied for a period from 10 seconds up to 800 seconds.” Discloses at least three waveforms with different pulse width, pulse period and pulse amplitude] and
applying the hybrid waveform to at least one stimulation point within an eye region [see para 44… “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal.”].
However, Paul only discloses current amplitude between 1- 1000 microamps and therefore fails to disclose the hybrid wave as specifically “having a peak current amplitude between 1 microamp and 450 microamps”.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a peak current amplitude of 1-450 microamps because this is a subset of the taught current amplitude of 1-1000 microamps.
Independent claim
Regarding claim 10:
Paul discloses:
A method of generating a microcurrent waveform for use in the treatment of a visual disease [see abstract… “A method and apparatus for providing microcurrent stimulation (MSC) therapy. In accordance with the present invention, it has been determined that the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases.”], comprising:
generating a hybrid waveform comprising a series of current pulses [see para 28… “current will be provided in a square waveform at a frequency of 292 Hz for 60 seconds. During those 60 seconds the program indicator light (50) is lit, which advises the user that the program is underway. When the current applied at 292 Hz for 60 seconds stops, an audible tone will sound and the next step in the therapy program will begin. Here, program indicator light (51) will light, current will be provided at 30 Hz for 120 seconds. At the conclusion of this step in the therapy program, a tone will sound again. The program indicator light (51) will dim and program indicator light (52) will light. This indicates that current will be provided at 9.1 Hz for 180 seconds. A third tone will sound indicating that step in the therapy program is over.”] having current amplitude between 1 microamp and 1000 microamps [see para 35… “the current can be present at a constant dc current of between, for example, 1.0 and 1,000.00 mu.A.”], wherein three or more waveform parameters of the hybrid waveform are varied in accordance with a visual disease treatment protocol, wherein the varied waveform parameters are selected from the group consisting of pulse width, pulse period, pulse position, pulse coding, peak amplitude, duty cycle, and pulse shape [see para 44… “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal. In accordance with this embodiment, each signal is applied for a longer period of time than the previously applied signal. One particular sequence that has produced excellent results is as follows. A first microcurrent signal having a first modulation frequency more than 200 Hz but less than or equal to 300 Hz is applied for a period from 1 second up to 120 seconds. A second microcurrent signal having a second modulation frequency more than 10 Hz but less than or equal to 200 Hz is then applied for a period from 1 second up to 240 seconds. A third microcurrent signal having a third modulation frequency more than 1 Hz but less than or equal to 10 Hz is then applied for a period from 10 seconds up to 800 seconds.” Discloses at least three waveforms with different pulse width, pulse period and pulse amplitude].
However, Paul only discloses current amplitude between 1- 1000 microamps and therefore fails to disclose the hybrid wave as specifically “having a peak current amplitude between 1 microamp and 450 microamps”.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a peak current amplitude of 1-450 microamps because this is a subset of the taught current amplitude of 1-1000 microamps.
Dependent claims:
Regarding claims 2 and 11, see para 44 of Paul [see “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal. “] with two of the four microcurrent signals being at least a first and second pulse sequence as claimed.
Regarding claims 3 and 12, wherein a polarity of each of the first and second pulse sequences is varied to generate a bipolar waveform [see para 28 of Paul…. “During the therapy program the polarity of the electrodes (22) and (22A) will reverse every two seconds. At this point, a user will remove the electrodes (22) and (22A), turn the on/off switch (40) to off, and the microcurrent nerve stimulation apparatus (10) is ready to begin another treatment program or maybe stored until required for further use” which discloses a bipolar waveform as claimed.]
Regarding claims 4 and 13, see para 28 of Paul [see “current will be provided in a square waveform at a frequency of 292 Hz for 60 seconds. During those 60 seconds the program indicator light (50) is lit, which advises the user that the program is underway. When the current applied at 292 Hz for 60 seconds stops, an audible tone will sound and the next step in the therapy program will begin. Here, program indicator light (51) will light, current will be provided at 30 Hz for 120 seconds. At the conclusion of this step in the therapy program, a tone will sound again. “] which disclose an audible tone sounding each step where the parameters are the same.
Regarding claims 5-7 and 14-16, see para 44 of Paul [see… “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal. In accordance with this embodiment, each signal is applied for a longer period of time than the previously applied signal. One particular sequence that has produced excellent results is as follows. A first microcurrent signal having a first modulation frequency more than 200 Hz but less than or equal to 300 Hz is applied for a period from 1 second up to 120 seconds. A second microcurrent signal having a second modulation frequency more than 10 Hz but less than or equal to 200 Hz is then applied for a period from 1 second up to 240 seconds. A third microcurrent signal having a third modulation frequency more than 1 Hz but less than or equal to 10 Hz is then applied for a period from 10 seconds up to 800 seconds.”] which disclose different parameters of pulse width, pulse period and pulse amplitude as recited by claims 5 and 14; also interpreted as different parameters of pulse width, pulse period and pulse position (in seconds) as recited by claims 6 and 15; also interpreted as different parameters of pulse width, pulse period and pulse coding (in Hz) as recited by claims 7 and 16.
Regarding claims 8 and 17, see abstract of Paul [see “the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases.”] and see para 38 of Paul [see “the present invention is not only directed toward stabilizing or improving conditions of macular degeneration, but also to stabilizing or improving other ocular diseases or problems, including, for example, Dry Macular Degeneration, Wet Macular Degeneration Stargardt's, Retinitis Pigmentosa, Glaucoma, CMV-Retinitis, Best's Disease Macular Dystrophy, Optic Neuritis, Diabetic Retinopathy, Ischemic Anterior Optic, Neuritis, Usher's Syndrome, Leber's Congenital Amaurosis, Cone-Rod Dystrophy, Cone Dystrophy, Choroideremia and Gyrate Atrophy, Central Retinal Artery Occlusion, Central Retinal Vein Occlusion, Branch Retinal Artery Occlusion, Branch Retinal Vein Occlusion, Central Serous Chorioretinopathy, Cystoid Macular Edema, Ocular Histoplasmosis, Ocular Toxoplasmosis and Retinopathy of Prematurity”] which discloses treating one or more of the claimed visual diseases
Regarding claim 9:
wherein the applying step comprising using a probe to apply the hybrid waveform to the stimulation point [see Fig. 1 elements 15, 15A and 22, 22A (i.e. probe to apply waveform) and see para 25… “If the polarity of the current is reversed as part of a therapy method, then more than two electrodes may be employed. Electrodes (22) and (22A) connect by means of dual-lead wires (20) and (20A) and probes (15) and (15A) to electrode jacks (14) and (14A) in the front of the box (11). Electrodes (22) and (22A) will be applied to a user completing an electrical circuit, which allows a microcurrent to pass from one electrode through the body of the user to the other electrode to complete the circuit.”]
and further comprising the step of attaching a counter electrode to a body part [see Fig. 3B element 44 (i.e. counter electrode) and para 34… “Ends of the electrodes (44) come into contact with the user's skin at a location in the periorbital region of the face. The electrodes (44) are surrounded by a plastic dielectric material (47) that insulates the electrodes (44). FIG. 3C shows a front view of the goggles (40). The regions (45) and (46) are seen in the front views as groups of very small openings formed in the goggles (40). The electrical circuitry housed in casing (42) may be the same as those contained in housing (11) shown in FIG. 1”]
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796