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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, drawn to the method for constructing an idiopathic normal pressure hydrocephalus model based on a new/old brain-computing interface paradigm, in the reply filed on 6/22/26 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/26.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim Objections
Claims 1-7 are objected to because of the following informalities: the positive recitation of acronyms/abbreviations prior to their introduction, e.g. “iNPH” should apparently read “idiopathic normal pressure hydrocephalus (iNPH)” and “BCI” should apparently read “brain computer interface (BCI). Appropriate correction is required and Applicant’s attention is drawn to similar throughout the claims.
Claims 1-7 are objected to because of the following informalities: the positive recitation of improperly capitalized limitations, e.g. “Lumbar Tap Test” should apparently read “lumbar tap test”. Appropriate correction is required and Applicant’s attention is drawn to similar throughout the claims.
Claim 2 is objected to because of the following informalities: the positive recitation of “a new/old BCI paradigm” should apparently read “the new/old BCI paradigm” to avoid apparent antecedent or indefiniteness issue(s). Appropriate correction is required and Applicant’s attention is drawn to similar throughout the claims.
Claim 2 is objected to because of the following informalities: the positive recitation of “a target population” in lines 3 and 5 should apparently read “the target population” to avoid apparent antecedent or indefiniteness issue(s). Appropriate correction is required and Applicant’s attention is drawn to similar throughout the claims.
Claim 2 is objected to because of the following informalities: the positive recitation of “an image” should apparently read “the image” to avoid apparent antecedent or indefiniteness issue(s). Appropriate correction is required and Applicant’s attention is drawn to similar throughout the claims.
Claim 7 is objected to because of the following informalities: the positive recitation of improperly capitalized limitations, e.g. “The population” should apparently read “the population”. Appropriate correction is required and Applicant’s attention is drawn to similar throughout the claims.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the abstract idea is a mental process of training a model based on mathematically processed EEG signal data.
For independent claims 1, the claim(s) recite(s) a process constructing an iNPH model based on performing new/old stimulus BCI experiments before and after a spinal tap, processing P600 EEG signal data, and training a prediction model based on the signal data.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a neurological medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to determine a modeled relationship that may predict an output or diagnosis based on an input, thereby training themselves on the model and/or allowing it to be expressed via pen and paper.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of performing EEG signal data gathering, performing spinal tap, and processing EEG data to isolate p600 event-related potentials are well-known, routine and conventional in neurological data gathering and diagnosis amounting to insignificant data gathering as pre-solution activity.
Depending claims 2-7 inherit and do not remedy the non-statutory deficiency noted above. Despite further specifying steps relating to EEG signal gathering, EEG data processing, image display(s), and/or model training, the claims fail to integrate into a practical application or amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 112(a)
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 1-7 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 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.
Claim 1 positively recites “constructing an iNPH prediction model” and “training iNPH prediction model to obtain the iNPH prediction model”. The disclosure merely mentions a trained model, the trained model functionality, a model training module, and the claim language verbatim (see instant Specification [0055, 0077, 0107, 0109, 0111, 0116]). The disclosure does not appear to sufficiently describe any actual specific, corresponding step(s) or method(s) required for performing the “training” of the “iNPH prediction model” itself. Conversely, it is merely described as occurring while description thereof lacking and/or insufficient. Thus, in light of the lack of sufficient corresponding specificity regarding the training of the prediction model in the instant Specification one of ordinary skill in the art would not be apprised of demonstrated possession of the invention while it lacks written description.
Depending claims 2-7 inherit and do not remedy the lack of written description for failing to demonstrate possession with any sufficient, specific, and corresponding disclosure.
Claim Rejections - 35 USC § 112(b)
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 1-7 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 positively recites “constructing an iNPH prediction model” and “training iNPH prediction model to obtain the iNPH prediction model”. The disclosure merely mentions a trained model, the trained model functionality, a model training module, and the claim language verbatim (see instant Specification [0055, 0077, 0107, 0109, 0111, 0116]). The disclosure does not appear to sufficiently describe any actual specific, corresponding step(s) or method(s) required for performing the “training” of the “iNPH prediction model” itself. Conversely, it is merely described as occurring and any corresponding structure is a black-box. Thus, in light of the lack of sufficient corresponding specific structure(s) regarding the training of the prediction model in the instant Specification the scope of the claimed invention is indeterminate. It is ambiguous what may be expressly, implicitly, inherently, and/or inferentially required and/or excluded to be considered the claimed “prediction model”. One of ordinary skill in the art in light of the instant Specification would not be apprised of the metes and bounds of the claimed invention. Depending claims 2-7 inherit and do not remedy the indefiniteness.
Claim 1 recites the limitation "the new/old BCI paradigm" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Depending claims 2-7 inherit and do not remedy the indefiniteness.
The term “new/old BCI paradigm” in claim 1 is a relative term which renders the claim indefinite. The term “new/old BCI paradigm” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate as to what magnitude or degree of “new” and/or “old” may be expressly, implicitly, inherently, and/or inferentially required and/or excluded. One of ordinary skill in the art in light of the instant Specification would not be apprised of the metes and bounds of the claimed invention. Depending claims 2-7 inherit and do not remedy the indefiniteness.
Claim 1 recites the limitation "the target population" in line 3. There is insufficient antecedent basis for this limitation in the claim. Depending claims 2-7 inherit and do not remedy the indefiniteness.
Claim 1 recites the limitation "the event related potential features" in line 14. There is insufficient antecedent basis for this limitation in the claim. Depending claims 2-7 inherit and do not remedy the indefiniteness.
Claim 2 recites the limitation "the non-first presentation" in line 8. There is insufficient antecedent basis for this limitation in the claim. Depending claims 3-7 inherit and do not remedy the indefiniteness.
The term “specifically” in claim 4 is a relative term which renders the claim indefinite. The term “specifically” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate as to whether the limitation following specifically is required or not. Depending claims 5-7 inherit and do not remedy the indefiniteness.
Claim 4 positively recites the limitation "the international 10-20 system " in line 5. There is insufficient antecedent basis for this limitation in the claim. Depending claims 5-7 inherit and do not remedy the indefiniteness.
The term “the international 10-20 system” in claim 4 is a relative term which renders the claim indefinite. The term “the international 10-20 system” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate as to what “the international 10-20 system” expressly, implicitly, inherently, and/or inferentially requires and/or excludes, particularly while standards change over time. One of ordinary skill in the art in light of the instant Specification would not be apprised of the metes and bounds of the claimed invention. Depending claims 5-7 inherit and do not remedy the indefiniteness.
Claim 5 positively recites the limitation "the average of the left mastoid” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Depending claims 6-7 inherit and do not remedy the indefiniteness.
Claim 5 positively recites the limitation "the identification” in line 9. There is insufficient antecedent basis for this limitation in the claim. Depending claims 6-7 inherit and do not remedy the indefiniteness.
Claim 5 positively recites the limitation "the moment” in line 12. There is insufficient antecedent basis for this limitation in the claim. Depending claims 6-7 inherit and do not remedy the indefiniteness.
Claim 5 positively recites the limitation "the zero moment” in line 13. There is insufficient antecedent basis for this limitation in the claim. Depending claims 6-7 inherit and do not remedy the indefiniteness.
Claim 6 positively recites the limitation "the calculation” in line 13. There is insufficient antecedent basis for this limitation in the claim. Depending claim 7 inherits and does not remedy the indefiniteness.
The term “more positive potential” in claim 7 is a relative term which renders the claim indefinite. The term “more positive potential” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate as to what magnitude or degree of additional “positive potential” may be expressly, implicitly, inherently, and/or inferentially required and/or excluded. One of ordinary skill in the art in light of the instant Specification would not be apprised of the metes and bounds of the claimed invention.
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for modeling and associating EEG event related potentials with cognitive and/or neurological states including training machine learning prediction models thereon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights