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 Objections
Claims 1 and 14 are objected to because of the following informalities:
Regarding claim 1, in line 3, “user’s” should be rewritten as “user”. Regarding claim 14, in line 4, “the sensor” should be rewritten as “the at least one sensor”.
Appropriate correction is required.
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: “extending reality (XR) system” defined as a headset (see paragraph [010]) in claim 1; “stimulation system” defined as implanted electrodes (see paragraph [038]) in claim 1; “controller configured to allow the user…” in claim 13 and “controller configured to generate…” in claim 18 defined as a handheld unit with one or more buttons (see paragraph [036]).
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.
Claims 3, 8, 12-23 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.
Regarding claim 3, the limitation “the stimulation” is unclear if it is referring back to “stimulation” recited in line 6 of claim 1 or “perceptual stimulation” recited in claim 2, as claim 3 depends on both.
Regarding claim 8, it is not further defining claim 1, as claim 1 requires the steps of “generating the stimulation pattern” and “applying stimulation” and claim 8 is recited in such a manner to suggest those two steps are not to be performed. Claim 8 describes the method of “not generating the stimulation pattern or applying the stimulation response”, which makes it indefinite.
Regarding claim 12, it recites the limitation "the at least one electrode”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, it recites the limitation “the XR system”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 16, 21, and 22 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claims 16, 21, and 22, as per MPEP 2105 III, notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Under broadest reasonable interpretation, currently, claim 16, 21, and 22 are directed towards at least one electrode being implanted in a user and is therefore non-statutory subject matter.
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.
Claims 1-3, 5, 9-15, 17-20, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malchano (US 20220008746 A1).
Regarding claim 1, Malchano teaches a method comprising:
Presenting a virtual environment to a user with an extended reality (XR) system (“method can include a peripheral stimulation system…to generate a nerve stimulus”, paragraph [0015], “the virtual reality headset can provide an augmented reality experience”, paragraph [0282]);
Determining an interaction of the user with the virtual environment (“the nerve stimulation system can receive or determine feedback associated with neural activity, physiological activity, environmental parameters, or device parameters”, paragraph [0015]);
Generating a stimulation pattern responsive to the user’s interaction with the virtual environment (“the nerve stimulation system can manage, control, or modify stimulus parameters based on the feedback”, paragraph [0015]); and
Applying stimulation to the user’s nervous system with a stimulation system based on the stimulation pattern (“electrical currents applied to or across the peripheral nervous system…based on feedback”, paragraph [0013]).
Regarding claim 2, Malchano teaches applying a perceptual stimulation to the user’s nervous system with the stimulation system (“the brain can observe or perceive auditory (or audio) signals…brain also can observe or perceive various other forms of stimulation (e.g., deep-brain, olfactory, touch, etc.)”, paragraph [0024]).
Regarding claim 3, Malchano teaches applying the stimulation to a sensory region of the user’s brain (“stimulation signals to induce synchronized neural oscillations in the brain of a subject…visual, auditory, among others”, paragraph [0022]).
Regarding claim 5, Malchano teaches selecting the stimulation pattern based on a type of the interaction, a type of virtual object being interacted with, or combinations thereof (“the visual stimulation can include overlaying content on the display device and modulating the overlaid content…virtual reality headset 401…captures the real, physical world”, paragraph [0362]).
Regarding claim 9, Malchano teaches training the user’s nervous system to associate the stimulation with the interaction performed by the user in the virtual environment (“after having applied the external stimuli to the nervous system of the subject, additional cognitive and physiological assessments may be repeatedly performed over time to determine whether the external stimuli were effective in entraining the brain of the subject to the particular frequency…improving the cognitive states or functions of the brain”, paragraph [0032]).
Regarding claim 10, Malchano teaches applying the stimulation including modulating an amplitude of a sequence of stimulation pulses over time based on the stimulation pattern (“can adjust, manage, or control the frequency of neural oscillations…modulation frequency at which can amplitude of the current is modulated”, paragraph [0013]).
Regarding claim 11, Malchano teaches the method further comprising:
Receiving information from sensors which measure activity in the user’s nervous system (“feedback component 160 can include…a feedback sensor such as…brain wave sensor, EEG probe”, paragraph [0298]);
Decoding the information (“synchronized activity of a group of neurons…can be observed by electroencephalography….signal properties can be observed from neural recordings using time-frequency analysis”, paragraph [0240]); and
Determining the interaction with the virtual environment based on the decoded information (“nerve stimulus generator component 1650 can be configured to…detect the nerve stimulus (or resulting nervous system activity caused by the nerve stimulus generator component 1650) caused by the nerve stimulus generator”, paragraph [0543]).
Regarding claim 12, Malchano teaches a system comprising:
An extended reality (XR) system configured to present virtual environment to a user (“the virtual reality headset can provide an augmented reality experience”, paragraph [0282]);
A neural interface (“neural stimulation system can include, interface”, paragraph [0006]) configured to deliver stimulation to a nervous system of the user based on a stimulation pattern (“electrical currents applied to or across the peripheral nervous system…based on feedback”, paragraph [0013]); and
A computing system (computing device 700) configured to generate the stimulation pattern responsive to an interaction of the user with the virtual environment and provide the stimulation pattern to the neural interface (“the nerve stimulation system can manage, control, or modify stimulus parameters based on the feedback”, paragraph [0015]), wherein the neural interface is configured to apply the stimulation pattern through the at least one electrode (“system may include an electrode. The electrode may provide peripheral nerve stimulation to the subject”, paragraph [0092]) to the nervous system of the user.
Regarding claim 13, Malchano teaches the XR system including at least one controller (“computing device 700 can include…an I/O controller”, paragraph [0314]) configured to allow the user to interact with the virtual environment.
Regarding claim 14, Malchano teaches at least one sensor configured to measure activity in the nervous system of the user (“feedback component 160 can include…a feedback sensor such as…brain wave sensor, EEG probe”, paragraph [0298]),
Wherein the computing system includes a decoder (“feedback monitor 135”, paragraph [0305]) configured to determine an interaction with the virtual environment based on decoding the measured activity from the sensor (“the feedback monitor 135…can detect and record eye movement of the person and analyze the recorded eye movement to determine an attention span or level of attention”, paragraph [0305]).
Regarding claim 15, Malchano teaches the XR system including a headset configured to be worn by the user (“virtual reality headset 401”, paragraph [0282]).
Regarding claim 17, Malchano teaches a system including:
An extended reality (XR) headset (“the virtual reality headset can provide an augmented reality experience”, paragraph [0282]);
A neural interface (“neural stimulation system can include, interface”, paragraph [0006]) including at least one stimulation electrode (“system may include an electrode. The electrode may provide peripheral nerve stimulation to the subject”, paragraph [0092]);
At least one processor (“neural stimulation system comprising a processor”, paragraph [0047]); and
Computer readable non-transitory media loaded with instructions (“computer readable medium for evaluating neural responses”, paragraph [0117]), which when executed by the at least one processor cause the system to (“system may include one or more processors…execute one or more programs to treat a subject”, paragraph [0060]):
Generate a virtual environment and provide information related to the virtual environment to the XR system (“NSS 105 can operate in conjunction with the virtual reality headset 401…and a feedback sensor”, paragraph [0355]);
Receive input information from the XR system (“feedback sensor 605”, paragraph [0355]);
Determine an interaction with the virtual environment based on the input information (“the feedback monitor 135…can detect and record eye movement of the person and analyze the recorded eye movement to determine an attention span or level of attention”, paragraph [0305]); and
Provide a stimulation pattern to the neural interface responsive to the interaction (“the nerve stimulation system can manage, control, or modify stimulus parameters based on the feedback”, paragraph [0015]), wherein the neural interface is configured to apply voltage to the at least one stimulation electrode based on the stimulation pattern (“nerve stimulus generation module 1610…to provide electricity or power having certain voltage and current characteristics to drive the electrodes to output or discharge an electric current”, paragraph [0519]).
Regarding claim 18, Malchano teaches at least one controller configured to generate at least part of the input information (“control unit 2104 is configured to control operation of the electrodes…can include or can be coupled to the nerve stimulus generation module 1610”, paragraph [0593]).
Regarding claim 19, Malchano teaches the input information including motion tracking information (“NSS 105 can receive motion data”, paragraph [0338]).
Regarding claim 20, Malchano teaches at least one sensor configured to measure activity in a user’s nervous system (“feedback component 160 can include…a feedback sensor such as…brain wave sensor, EEG probe”, paragraph [0298]), wherein the instructions, when executed by the at least one processor further cause the system to decode the measured activity, wherein the decoded activity is at least part of the input information (“the system may include a feedback monitor executed by at least one processor of a neural stimulation system”, paragraph [0066]).
Regarding claim 23, Malchano teaches the instructions when executed by the at least one processor (“system may include one or more processors…execute one or more programs to treat a subject”, paragraph [0060]), further cause the system to select the stimulation pattern from a plurality of stimulation patterns, wherein the selection is based on a type of the interaction, a type of virtual object the interaction is with, or combinations thereof (“the visual stimulation can include overlaying content on the display device and modulating the overlaid content…virtual reality headset 401…captures the real, physical world”, paragraph [0362]).
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.
Claims 4, 16, 21, and 22 are rejected under 35 U.S.C. 103 as being obvious over Malchano in view of Poltorak (US 20200368491 A1).
Regarding claim 4, Malchano teaches all the limitations of claim 1, but does not teach applying the stimulation through implanted electrodes.
However, Poltorak teaches a method of applying stimulation through implanted electrodes (“sensory stimulation…for the brain region associated with the stimulation electrode”, paragraph [0390], “neuron firing patterns…detected by implanted electrodes”, paragraph [0232]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of presenting a virtual environment and applying stimulation to a user’s nervous system of Malchano with the method of applying stimulation through implanted electrodes of Poltorak in order to send electrical signals to induce activity in the user’s nervous system (“method relies on influencing…neural physiology via the mechanical treatment of neural tissues…surrounding the nervous system”, paragraph [0139]).
Regarding claim 16, Malchano teaches all the limitations of claim 12, but does not teach at least one electrode being implanted in the user.
However, Poltorak teaches at least one electrode being implanted in the user (“neuron firing patterns…detected by implanted electrodes”, paragraph [0232]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Malchano with the at least one implanted electrode of Poltorak in order to send electrical signals to induce activity in the user’s nervous system (“method relies on influencing…neural physiology via the mechanical treatment of neural tissues…surrounding the nervous system”, paragraph [0139]).
Regarding claim 21, Malchano teaches all the limitations of claim 17, but does not teach at least one stimulation electrode being implanted in a user.
However, Poltorak teaches at least one electrode being implanted in the user (“neuron firing patterns…detected by implanted electrodes”, paragraph [0232]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Malchano with the at least one implanted electrode of Poltorak in order to send electrical signals to induce activity in the user’s nervous system (“method relies on influencing…neural physiology via the mechanical treatment of neural tissues…surrounding the nervous system”, paragraph [0139]).
Regarding claim 22, Malchano in view of Poltorak teaches all the limitations of claim 21.
Furthermore, Poltorak teaches the at least one stimulation electrode being implanted in a sensory region of the user’s brain (“EEG electrode…in the brain region just beneath it”, paragraph [0043]).
Claims 6-8 are rejected under 35 U.S.C. 103 as being obvious over Malchano in view of Simon (CA 3132042 A1).
Regarding claim 6, Malchano teaches all the limitations of claim 1, but does not teach generating the stimulation pattern responsive to the user grasping a virtual object in the virtual environment.
However, Simon teaches a method of generating a stimulation pattern (“VR therapy that deliver therapeutic stimulation, which is constantly and dynamically adapted to the subject’s abilities in that exact moment”, paragraph [13], page 9; Simon) responsive to the user grasping a virtual object in the virtual environment (“a subject…to pick up and grasp an object can be given that ability in VR”, paragraph [11], page 8; Simon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of presenting a virtual environment and applying stimulation to a user’s nervous system of Malchano with the method of generating the stimulation pattern based on the user grasping a virtual object in the virtual environment of Simon in order to receive neuroperceptual feedback.
Regarding claim 7, Malchano in view of Simon teaches all the limitations of claim 6.
Furthermore, Malchano teaches generating a first stimulation pattern responsive to a first type of virtual object and generating a second stimulation pattern responsive to a second type of object (“neural stimulation sensing system can include a stimulus generator module…a first measurement device, a second measurement device, a subject attentiveness monitor, a stimulus control module…stimulus control module can determine an adjustment to the external stimulus”, paragraph [0041]; Malchano). Malchano teaches the method of generating a first and second stimulation pattern responsive to a type of virtual object, but does not teach the stimulation pattern being responsive to grasping a virtual object.
However, Simon teaches a stimulation pattern being responsive to grasping a virtual object (“a subject…to pick up and grasp an object can be given that ability in VR”, paragraph [11], page 8; Simon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Malchano in view of Simon in order to receive neuroperceptual feedback from more than one object and determine the state of the user’s nervous system from multiple objects.
Regarding claim 8, Malchano in view of Simon teaches all the limitations of claim 7.
Furthermore, Malchano teaches not generating the stimulation pattern or applying the stimulation responsive to a third type of virtual object (“other stimulation output device corresponding to other stimulation modalities…may be configured to not generate an output”, paragraph [0853]; Malchano). Malchano teaches not generating the stimulation pattern responsive to a third type of virtual object, but does not teach the stimulation pattern being responsive to grasping a virtual object.
However, Simon teaches a stimulation pattern being responsive to grasping a virtual object (“a subject…to pick up and grasp an object can be given that ability in VR”, paragraph [11], page 8; Simon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Malchano in view of Simon in order to have the user interact with an object without generating stimulation in order to determine what type of stimulation to apply.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
