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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the micromotors in figure 2. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 5, 7, and 16 are objected to because of the following informalities:
In claim 5, lines 1-2, “stress less” should be –stressless--.
In claim 7, line 2, “created” should be –create--.
In claim 16, line 2 “nerve hypstasis” should either be –hyperstasis-- or –hypostasis--.
Appropriate correction is required.
If the “hypstasis” in claim 16 is –hyperstasis--., claim 16 would be objected to under 37 CFR 1.75 as being a substantial duplicate of claim 15. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for nerve stimulators that perform sound, sight, smell, and motion stimulation, does not reasonably provide enablement for other stimulation types (ex. temperature, electric, or magnetic stimulation). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
A WANDS analysis of claim 1 is performed. First, the term “nerve stimulators” encompasses all potential stimulation types. While the specification clearly shows stimulation using sounds, sights, smells, and motions, it does not disclose how one would perform other nerve stimulation types. There are no examples in the specification, and there is no guidance in the specification how the non-sensory type stimulation is performed. In addition, the specification only gives guidance on how to perform the sight, sound, and tactile stimulation but not the smell stimulation. Thus, one would be required to undertake undue experimentation to determine the parameters to perform the claimed invention according to the scope of the claims.
Claims 2-16 inherit the deficiencies of claim 1 and are likewise rejected.
Claims 15 and 16 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 15 and 16 state that the system comprises a nerve frequency and amplitude stimulation that performs a specific function. However, there is no information in the specification as to what these frequencies and amplitudes are that can perform the claimed functions.
Claims 7, 8, 15-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 7-8 states that the plurality of nerve stimulators is configured to create a frequency of stimulation for a specific user condition. While the specification does state the concept of nerve frequencies and amplitude in stimulation, there is no guidance to obtain or examples given as to what the frequencies or amplitudes are or how to arrive at the claimed frequency. Thus, the claims require undue experimentation.
Claims 15 and 16 state that the system comprises a nerve frequency and amplitude stimulation that performs a specific function. While the specification does state the concept of nerve frequencies and amplitude in stimulation, there is no guidance to obtain or examples given as to what the frequencies or amplitudes are to arrive at the claimed function. Thus, the claims require undue experimentation.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the term “sense status” in line 1. It is not clear what this term is meant to encompass.
Claims 2-16 inherit the deficiencies of claim 1 and are likewise rejected.
Claim 2 recites the limitation “a user” in lines 1-2. It is not clear if this is a new instance or refers to the user mentioned in line 2 of claim 1.
Claim 5 recites the limitation “a user’s stress less baseline” in lines 1-2. It is not clear if this is a new instance or refers to the user mentioned in line 2 of claim 1.
Claim 6 recites the limitation "the nerve stimulation and the sensor monitors" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. This should probably be –the nerve stimulators and the sensors--.
Claims 7 recites the limitation “a user’s recorded hypostasis” in lines 1-2. It is not clear if this is a new instance or refers to the user mentioned in line 2 of claim 1.
Claims 8 recites the limitation “a user’s recorded hyperstasis” in lines 1-2. It is not clear if this is a new instance or refers to the user mentioned in line 2 of claim 1.
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, 2, 4, 6-10, 13, 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0008632 (Wetmore et al., hereinafter Wetmore).
In regards to claims 1, 6, and 13, Wetmore discloses a system used for neuromodulation (title, abstract; paragraphs 13-222).
a plurality of sensors configured to monitor sense status for a user via a wireless telemetry thereof (paragraphs 13-16, 20, 90, 96, 146-149, 160, and 195; components of the system can be wireless connected and controlled remotely and can have a wide variety of sensors including location sensors.);
a respective plurality of nerve stimulators disposed to increase or decrease a nerve response in reaction to the plurality of sensors (paragraphs 89-94, 96, 142-146; electrode or ultrasound transducers are used to modulate nerve/neural activity with one particular example changing the modulation parameters of the stimulation based on user location); and
a feedback circuit configured to process the wireless telemetry and drive the nerve stimulators to create a steady state relaxation in the user (paragraphs 44, 94, 100, 141-14, 188, 189, 195, 204; providing feedback to user requires the presence of a feedback circuit and a feedback loop which drives the modification of the stimulation parameters of the nerve stimulators (in one particular example changing the modulation parameters of the stimulation based on user location), thus making the loop connected to the stimulators and the sensors. This would also make the feedback circuit be in electrical communication with the sensors and nerve stimulators via a wireless transmission circuit, thus meeting the limitations of claim 13).
In regards to claim 2, Wetmore discloses the limitations of claim 1. In addition, Werner discloses in paragraph 157 an option that allows for a remote access code that is only temporarily functional and cannot be used for a later time (suggests one time access) for a user of the system.
In regards to claim 4, Wetmore discloses the limitations of claim 1. In addition, paragraphs 13, 19, 90, 93-99, 147 discloses the use of voice control for the system and remote control, which require the presence of remote access via user file voice activation limitation.
In regard to claims 7 and 8, Wetmore discloses the limitations of claim 1. In addition, due to the 112 issues of claims 7-8, the nerve stimulators of Wetmore can be considered as configured to create the frequency limitations of the claims.
In regard to claim 9, Wetmore discloses the limitations of claim 1. Applicant has not given any guidance as to what is considered as “near the nerve stimulators”, thus the feedback circuit of Wetmore would be considered as disposed near the nerve stimulators as part of the circuit would be on the near the user and the stimulator device when stimulation is occurring.
In regards to claim 10, Wetmore discloses the limitations of claim 1. Additionally, Wetmore shows the manipulation of the system using a graphical user interface on a cell phone in figures 10-31 and paragraphs 13, 32, 35, 95, 108, 113, 121, 145-148, 183, 201-222.
In regards to claims 15-16, Wetmore discloses the limitations of claim 1. In addition, the system of Wetmore would naturally have a nerve frequency and amplitude of stimulation as any stimulation would have one. Due to the 112 issues of the claims, Wetmore would meet the limitations of the claims.
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0015468 (Aarts et al., hereinafter Aarts).
In regards to claim 1, Aarts discloses a method and system for maintain states in a subject (see title and abstract). Aart discloses in paragraphs 23-74 the following system components:
a plurality of sensors configured to monitor sense status for a user via a wireless telemetry thereof (some of the sensors are wirelessly connected – paragraphs 23 and 59-62);
a respective plurality of nerve stimulators disposed to increase or decrease a nerve response in reaction to the plurality of sensors (paragraphs 59-68; feedback applies stimulation ranging from audio, visual, and electrical stimulation, which requires the presence of stimulators such as speakers, screens, and electrodes to stimulate nerves respectively); and
a feedback circuit configured to process the wireless telemetry and to drive the nerve stimulators to create a steady state relaxation in the user (paragraphs 59-68 disclose a feedback mechanism which suggests the presence of feedback circuit that controls and modulates the stimulation by processing data from the sensors to output a feedback stimulation and paragraphs 24-26 disclose maintaining the subject at a particular state of relaxation between two thresholds).
In regards to claim 11, Aarts discloses the limitations of claim 1. It is noted that Aarts mentions using visual stimulation using a television screen which meets the limitations of claim 11. Note that applicant has not defined what encompassed by the term “large screen” (what being defined as “large” can vary depending on the type of device that has the screen as well as a person’s perception) thus allowing the screen of Aarts to meet the limitations of the claim.
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.
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over 2011/0015468 (Aarts et al., hereinafter Aarts) as applied to claim 1 above, and further in view of US 2016/0262608 (Krueger).
In regards to claim 3, Aarts discloses the limitations of claim 1 including the presence of a screen but does not disclose the presence of a holograph. In a related area, Krueger discloses systems that use virtual or augmented reality to improve human performance (title and abstract). Of note is paragraphs 282 which discloses the use of holograms/holograph to provide a more immersive environment and to provide ways to teach, train, learn, explore, and collaborate. Thus, it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the system of Aarts to use holographs with the screen to provide a more immersive environment and to provide ways to teach, train, learn, explore, and collaborate.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0008632 (Wetmore et al., hereinafter Wetmore) as applied to claim 1 above, and further in view of US 2015/0360030 (Cartledge et al., hereinafter Cartledge) and US 2014/0058189 (Stubbeman).
In regards to claim 5, Wetmore discloses the limitations of claim 1 but does not state that the feedback circuit is calibrated to a user’s stress less baseline. In a related area, Cartledge discloses an electrostimulator and methods of stimulation (title and abstract). Of particular note are paragraphs 366-375 which discloses calibration in order to maximize stimulation potential). Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of Wetmore to calibrate the feedback circuit as taught by Cartledge in order to maximize stimulation potential.
In a related area, Stubbeman discloses systems and methods for brain stimulation. As noted in paragraphs 106-115 baseline measurements are taken during a resting eyes closed period (user stress less baseline) where the baseline is used as a reference point to compare against treatments. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the system of Wetmore and Cartledge to take a user’s stress less baseline in order to provide a point of reference to compare treatment efficacy.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0008632 (Wetmore et al., hereinafter Wetmore) as applied to claim 1 above, and further in view of US 2009/0132018 (DiUbaldi et al., hereinafter DiUbaldi).
In regards to claim 12, Wetmore discloses the limitations of claim 1 but does not state that one of the stimulators is a small dermal patch. In a related area, DiUbaldi discloses nerve stimulation patches for stimulating nerves (title and abstract; paragraphs 14-109). These patches can be considered as small dermal patches. DiUbaldi states in paragraph 23 that the patch has a lower overall profile and a smaller footprint over a surface such as a patient’s skin surface. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the system of Wetmore to substitute the nerve stimulator with the nerve stimulator patch of DiUbaldi in order to have a smaller footprint on a patient’s skin surface.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0008632 (Wetmore et al., hereinafter Wetmore) as applied to claim 1 above, and further in view of US 2014/0179986 (Kelley)
In regards to claim 14, Wetmore discloses the limitations of claim 1 but does not state the presence of micromotors. In a related area, Kelly discloses a system and method for treating insomnia (title and abstract). Figures 1 and 7 and paragraphs 61-74 and 160 show stimulator modules (110 and 712) that contain vibration motors. Because there are at least two modules present, it would be configured to create three-dimensional vibratory stimulation. Kelley states in paragraph 62 and 160 that vibration and electrical stimulation are some known ways of stimulating nerves and can be combined for synergistic effects. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the system of Wetmore to use include a plurality of micromotors for vibration stimulation as taught by Kelley in order to provide additive effects of combined therapy stimulations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791