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 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.
Claims 1-10 and 12-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 12-13 recite, at least in part the following step(s): “monitor(ing), by the computing device and EEG headset, current extrinsic network activity and current intrinsic network activity of a patient; generate/generating, by the computing device, a current depression index based on the relationship between the current extrinsic network activity and the current intrinsic network activity.”
Under the first of the two-prong inquiry of step 2A for evaluating 101, this limitation is considered a mental process because these step(s), when given its/their broadest reasonable interpretation(s), describe(s) carrying out said step(s) mentally (i.e. a mental task in the human mind) but for the recitation of generic computer components. In other words, absent the recitation of a computing device, EEG headset, memory, processor, and display, nothing precludes the claimed step from practically being performed mentally (i.e. a mental task in the human mind), especially in light the 112 rejections below. In view of the foregoing, claim(s) 1 and 12 recite(s) an abstract idea.
The claim(s) further recite(s) the relationship between extrinsic network activity, current intrinsic network activity, and depression. Therefore, the claim(s) also contain(s) a law of nature.
Under the second of the two-prong inquiry of step 2A, this judicial exception is not integrated into a practical application because there are no limitations that indicate improvements to the functioning of a computer or to the technology/technical field; effecting a particular treatment or prophylaxis for a disease/condition; applying the judicial exception with a particular machine (the control unit and sensor are recited with such generality that they are not considered a particular machine); effecting a transformation or reduction of a particular article to a different state/thing; applying the judicial exception in a meaningful way beyond generally linking to a particular technological environment. There are no limitations referring to any practical output or application in the claims.
Since the second of the two-prong inquiry of step 2A is not satisfied, the claim is then evaluated under step 2B.
Under step 2B for evaluating 101, the claim(s) does not include additional elements that are sufficient to amount to significantly more than the judicial exception because
the following additional element(s): "memory, processor, display device, mobile device, speaker, electrodes” are recited with a high level of generality (i.e. as a generic computing device performing generic computer function) such that it amounts to no more than instructions to apply the exception using a generic computer component. Therefore, the additional element(s) do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea and/or law of nature.
The claim(s) include(s) the additional step(s)/element(s): “displaying a representation of the relationship between the current depression index and a baseline depression index previously generated for the patient.” The additional step(s)/element(s) are not sufficient to amount to significantly more than the judicial exception(s) since such additional step(s)/element(s) are well-understood, routine and conventional in the art or are mere insignificant extra-solution activities. The comparing to a baseline is also routine and conventional manner of analysis. In other words, the additional step(s)/element(s) amount(s) to no more than mere instructions to apply the exception(s) using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Accordingly, Claim(s) 1 and 12-13 do(es) not amount to significantly more than the abstract idea itself.
Claims 2-10 and 13-16 do not add more to the abstract idea or law of nature and thus are also rejected. It is noted that claims 11, 17-20 recite that the extrinsic network activity and intrinsic network activity are measured by electrodes.
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: “headset“ of Claim 1, 12, 19.
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 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 1-20 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 1, 12, and 19, the recitation of monitoring “current extrinsic network activity and current intrinsic network activity of a patient” is broader than what is disclosed in most of applicant’s specification, which is drawn to a particular method of monitoring said extrinsic and intrinsic network activity of a patient brain, i.e. using separable spectral content (0007). Since the claim recites any and all manner or mechanisms of monitoring extrinsic and intrinsic network activity of a patient brain, these other manner or mechanisms other than the one drawn to in the disclosure therefore fail to meet the written description requirement because the specification does not convent to one of ordinary skill in the art that the inventor had possession of said other manner or mechanisms of monitoring extrinsic and intrinsic network activity of a patient brain as included in the scope of the claims.
Claims 2-11, 13-18 and 20 are rejected because they do not sufficiently clarify the scope of the claimed invention to an embodiment that is adequately supported by the specification.
Claims 1-20 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.
Regarding Claims 1, 12, and 19, the recited claims while enabling for embodiments of monitoring extrinsic and intrinsic network activity of a patient brain described in the specification of the invention, does not reasonably provide enablement for all possible combinations of manner or mechanisms of monitoring extrinsic and intrinsic network activity of a patient brain, as recited in the broad language of Claims 1, 12, and 19. Therefore, 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 the claims. This is because the scope of the claim language is more broad than what the disclosure and invention appear enabled for since it does not adequately enable one of ordinary skill in the art to practice all manner or mechanisms (past and future) for monitoring extrinsic and intrinsic network activity of a patient brain without undue experimentation based on the content of the disclosure, the existence of working examples, and the breadth of the claims.
The specification does not give working examples or embodiments in terms of structure of how to monitor extrinsic and intrinsic network activity of a patient brain without using separable spectral content, which is the one manner disclosed (0007 applicant’s disclosure). For all other manner or mechanisms of monitoring extrinsic and intrinsic network activity of a patient brain, one of ordinary skill in the art at the time of the invention would have to perform undue experimentation based on the lack of content of the specification showing the algorithm, structure and methodology to make and perform said other manner or mechanisms of monitoring extrinsic and intrinsic network activity of a patient brain for at least the following reasons: lack of working examples for said other manner or mechanisms for monitoring, the lack of direction provided by the inventor, the high level of unpredictability in the art of neuroscience since such mechanisms may be currently unknown and undiscovered in the art since there is limited known, agreed upon, and concrete knowledge in the art available to a skilled artisan regarding the mechanisms for monitoring extrinsic and intrinsic network activity of a patient brain, the nature of the invention, which relies upon only one hypothesis of a manner to evaluate depression and mechanisms of monitoring extrinsic and intrinsic network activity of a patient brain, the state of the prior art which is highly divergent from current and future knowledge in the art.
Claims 2-11, 13-18 and 20 are rejected because they do not sufficiently clarify the scope of the claimed invention to an embodiment that is enabled, as elaborated above
To overcome the 112 first paragraph rejections, applicant is encouraged to amend the claims to more specifically define the scope of the invention as it is most drawn to the submitted specification to conform to written description and enablement requirements.
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 8, 10-11, and 13-18 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 pre-AIA the applicant regards as the invention.
Claims 8 and 10 lack proper antecedent basis for the recitation of “the 10-20 EEG system.”
Regarding Claim 11, it is unclear if the recitation of “extrinsic network activity” and “intrinsic network activity” are the same or different from that recited in Claim 1.
Claims 13-18 depend from claim 11 but are directed to a method, whereas claim 11 recites in the preamble a “BCI system”. It appears claims 13-18 should instead depend from claim 12.
Regarding Claim 15, it is unclear if the recitation of “extrinsic network activity” and “intrinsic network activity” are the same or different from that recited in Claim 12.
Regarding Claim 15, it is unclear if the recitation of “baseline extrinsic network activity” and “baseline intrinsic network activity” are the same or different from that recited in Claim 14.
Regarding Claim 17-18, it is unclear if the recitation of “current extrinsic network activity” and “current intrinsic network activity” are the same or different from that recited in Claim 1.
Clarification and proper use of articles to provide proper antecedent basis is suggested.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 1-6, 12-14, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinrikus et al (US Pat No. 8244341 – cited by applicant) in view of Barnehama et al (US Pub No. 20130177883 – cited by applicant) and Lo et al (US Pub No. 20150332020).
In regard to Claims 1, 12-14, and 19, Hinrikus et al disclose a brain computer interface (BCI) system comprising: an electroencephalogram (EEG) electrodes (plurality) 2, best seen in Figure 5; and a computing device (analyzing device) communicatively coupled to the EEG electrodes, the computing device comprising necessarily comprising a memory, a processor and a display device 6 (Col.3: 25-Col.4: 7), the memory storing instructions, i.e. algorithms 5 (Figure 5) that, when executed by the processor, cause the processor to: monitor, using the EEG electrodes, current extrinsic network activity and current intrinsic network activity of a patient when measured by the EEG, also see 112 rejection above, seen in Figure 2-4 (Col.3; 6-Col.4: 6, 42-67; Col.5-7: 30);
generate a current depression index – index value -- based on the relationship between the current extrinsic network activity and the current intrinsic network activity, which is included in the manner of analysis using SASI and cSASI, seen in Figures 2-4 (Col.3; 6-Col.4: 6, 42-67; Col.5-7: 30); and display, on the display device between the current depression index, best seen in Figure 6-7.
However, Hinrikus et al do not expressly disclose the electrodes are part of a headset and the display displays a representation of the relationship between the current depression index and a baseline depression index previously generated for the patient. Barnehama et al teach that it is well-known in the art to provide EEG electrodes 56 on a headset 50, a band configured to be positioned adjacent a head of a patient, the headset defined as any structure that can worn on a part of the head of the patient, the headset removably attached to a mobile communication device, best seen in Figure 5 (0051). It is noted that Barnehama et al disclose that it is also well known to provide a memory for storing algorithms of a computing device for the desired function of the device (0070).
Regarding Claims 3-4, Barnehama et al disclose the analogous BCI interface with computing device 64 which comprises a mobile device (0051).
Regarding Claim 5, Barnehama et al disclose EEG headset comprises at least one speaker 54 operable to output audio from the computing device 64, best seen in Figure 5 (0051-0060).
Lo et al teach that it is well-known in the art to display chronic condition symptoms against a baseline that was previously generated to effectively enable comparison for change (0045).
Regarding Claim 20, Lo et al disclose the memory further stores instructions that, when executed by the processor, cause the processor to display an interactive environment on a display device due to it being a smart mobile device (0015).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the invention of Hinrikus et al such that the electrodes are part of a headset, the headset removably attached to the mobile communications device, the headset comprising: at least one speaker to output audio from the mobile communications device and a band configured to be positioned adjacent a head of a patient, a plurality of EEG electrodes coupled to the band as taught by Barnehama et al, to effectively provide a configuration for the BCI interface that can be used with common place mobile devices as well as provide an audio output for desired feedback.
Therefore, it would have also been obvious to one of ordinary skill in the art at the time of filing to modify the invention of Hinrikus et al such that the display displays a representation of the relationship between the current depression index and a baseline depression index previously generated for the patient as suggested by Lo et al, such that there is generating the baseline depression index based on the relationship between the monitored baseline extrinsic network activity and the monitored baseline intrinsic network activity, and the interactive environment being responsive to at least one of the current depression index and the current extrinsic and intrinsic network activity, to effectively provide a visual measure of change in the depression index.
Claim 2: Hinrikus et al disclose the memory further stores instruction that, when executed by the processor, cause the processor to: monitor, using the EEG headset, baseline extrinsic network activity and baseline intrinsic network activity of the patient to generate the baseline depression index and store the baseline depression index in the memory (Col.3; 6-Col.4: 6, 42-67; Col.5-7: 30), wherein it would have been obvious to store the index in the memory as known in the art or suggested by Barnehama et al for later comparison, such as taught by Lo et al.
Claim 6: Hinrikus et al disclose the EEG headset comprises a plurality of electrodes 2, best seen in Figure 5.
Claims 7-11 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinrikus et al in view of Barnehama et al and Lo et al, further in view of Hagedorn et al (US Pat No. 8838247 – cited by applicant).
Regarding Claims 7-10 and 17-18, Hinrikus et al in combination with Barnehama et al and Lo et al disclose the invention above but do not expressly disclose the position of the electrodes on the EEG headset. Hagedorn et al teach that it is well-known in the art to provide an analogous EEG headset wherein a first electrode of the plurality of electrodes is disposed on the EEG headset to be positioned to monitor a lateral temporal lobe location of the patient when the EEG headset is worn by the patient at position T3 on the 10-20 EEG system, best seen in Figure 5, a second electrode of the plurality of electrodes is disposed on the EEG headset to be positioned to monitor a posterior lateral frontal lobe location of the patient when the EEG headset is worn by the patient, the posterior lateral frontal lobe location is one of C3 and CZ on the 10-20 EEG system as an effective configuration for EEG testing. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the invention of Hinrikus et al as modified by Barnehama et al and Lo et al such that the first and second electrodes are positioned in the above manner as taught by Hagedorn et al, as an effective configuration for the EEG testing, wherein in combination, the monitoring current extrinsic network activity of the patient comprises monitoring a lateral temporal lobe location using the EEG headset and the monitoring current intrinsic network activity of the patient comprises monitoring a posterior lateral frontal lobe location using the EEG headset as an obvious manner of doing so in light of the 112 rejections above.
Claim 11: Hinrikus et al disclose the memory stores instructions that, when executed by the processor, cause the processor to: monitor extrinsic network activity by monitoring the second electrode of the plurality of electrodes; and monitor intrinsic network activity by monitoring the first electrode of the plurality of electrodes, wherein due to the position of electrodes in Figure 5, it is submitted that a first electrode is capable of being used to monitor intrinsic network activity as it occurs in one brain hemisphere, and to a second electrode positioned on the second hemisphere of the brain to monitor extrinsic network activity, wherein the memory is taught above. Also see the 112 rejections above.
Claims 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinrikus et al in view of Barnehama et al and Lo et al, further in view of Picard et al (US Pub No. 20140081090).
Hinrikus et al in combination with Barnehama et al and Lo et al disclose the invention above but do not expressly disclose performing a mood intervention. Picard et al teach that it is well-known in the art to provide a mood intervention in response to atypical brain activity (0026). It is also submitted that it is common sense in the art that comparison between before and after an intervention to evaluation the effect of the intervention. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the invention of Hinrikus et al as modified by Barnehama et al and Lo et al such that there is monitoring extrinsic monitoring baseline extrinsic network activity and baseline intrinsic network activity of the patient and generating the baseline depression index are performed before and after a mood intervention is attempted for the patient as taught by Picard et al to effectively evaluate the effect of said intervention in response to the atypical brain activity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached on 10 am - 6 pm.
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H.Q. NGUYEN
Examiner
Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791