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, 12, 17, and 20 are objected to because of the following informalities: the term “bispecteral” in line 1 of claim 1 should be amended to read “bispectral”; the acronyms recited in claims 1, 12, and 20 should first be completely spelled out (e.g., electroencephalography (EEG), bispectral electroencephalography (BSEEG)); the phrase “display output” in claim 17 should be amended to read “display an output”; the term “and” should be added after the last comma in claim 17. 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.
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: “screening device” in claim 1.
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.
According to the specification, the screening device is a device comprising one or more computers.
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 7 and 12-19 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. Regarding claims 7 and 12, the originally filed specification fails to provide an adequate written description for how “an amount of neuroinflammation” is determined from comparing a BSEEG score to a clinical inflammation threshold. Regarding claims 7 and 18, the specification also fails to provide support for quantifying a level of brain wave abnormality. While the specification states that “BSEEG data was used to objectively quantify brain electrophysiological changes in response to LPS injection inducing a systemic inflammation reaction in C57B1/6 mice”, there is no description in the specification of quantifying/determining an amount of neuroinflammation or quantifying a level of brain wave abnormality. A quantification of brain electrophysiological changes is made, not a quantification of an amount of neuroinflammation or a level of brain wave abnormality.
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 1-20 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 1, it is unclear whether or not the claimed “platform tool” is a physical, tangible structure, or if it is intangible software. According to the specification (and claim 6), the claimed platform tool is intangible software. It is unclear how a physical element (the claimed system) would comprise an intangible element. For examination purposes, the claim is being interpreted such that the system comprises a non-transitory element upon which the platform tool is stored. The same indefiniteness issue and interpretation also apply to claim 12. Further regarding claim 1, the phrase “calculate a recorded BSEEG score” renders the claim indefinite. It is unclear what is meant by calculating a “recorded” BSEEG score. Is a BSEEG score previously recorded? If so, what would be the need to calculate an already recorded BSEEG score? For examination purposes, the phrase is being interpreted such that a BSEEG score is calculated and then recorded. The same indefiniteness issue and interpretation also apply to claim 20. Claims 2-4, 10, and 11 each recite that a system, a device claim, further comprises a step. This renders each of the claims indefinite in that it is unclear what further structural limitation reciting a step provides. Claims 2-4, 10, and 11 are being interpreted such that a structural element of the system is configured to perform the step recited in each respective claim. Regarding claim 7, the phrase “the level of brain wave abnormality” lacks proper antecedent basis, as does the phrase “the level of neuroinflammation”. The phrases are being interpreted as “a level of brain wave abnormality” and “a level of neuroinflammation”, respectively. Regarding claim 8, it is unclear if the “raw EEG data” recited in the claim is the same as or different than the “raw EEG data” of claim 1. For examination purposes, claim 8 is being interpreted such that the recorded BSEEG score is calculated from “the raw EEG data”. Regarding claim 9, as neither of claims 1, 8, or 9 previously recite recording or obtaining “EEG signals”, the phrase “EEG signals” lacks proper antecedent basis. Are the “EEG signals” of claim 9 the same as or different than the “EEG” and/or “raw EEG data” of claim 1? Furthermore, a ratio is a value determined between two numbers. As claim 9 is currently written, more than two values from more than two EEG signals could be used to determine “a ratio”. When more than two EEG signals/values are present, how is the ratio determined? Regarding claim 12, it is unclear how the claimed “tool” would itself “record EEG signals”. Clarification is requested. The phrase “the EEG signal” in line 7 of claim 12 lacks proper antecedent basis. For examination purposes, the phrase is being interpreted as “the EEG signals”. Regarding claim 15, it is unclear how a maximum BSEEG score is “calculated” over a given time period. Does Applicant intend for the claim to recite that a maximum BSEEG score is identified over a given time period? Clarification is requested. Regarding claim 19, it is unclear what further structural limitation the claim provides to claim 12 as the claim merely recites how long a given time period is; claim 12 makes no mention of a given time period. Furthermore, the phrase “the given time period” lacks proper antecedent basis. Further regarding claim 19, the term “about” is a relative term that renders the claim indefinite. The term “about” 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.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base 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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 20 follows.
Regarding claim 20, the claim recites a series of steps or acts, including comparing a recorded BSEEG score to a clinical inflammation threshold. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of comparing a recorded BSEEG score to a clinical inflammation threshold sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The claimed comparison does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the comparison, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of recording an EEG to obtain raw EEG data, and calculating a recorded BSEEG score. The recording and calculating steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes them from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the recording and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the system recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited at least one sensor is a generic sensor configured to perform routine data gathering activity, and the screening device/processor and platform tool make up a computer system configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The same rationale applies to claim 12.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and the display of data. The recording, calculating, and comparing steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Examiner’s Note
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dahaba et al. (Bispectral Index (BIS) monitoring…) teaches a system and method for using a BSEEG score to monitor encephalitis (neuroinflammation), but fails to teach or suggest comparing a BSEEG score to an inflammation threshold. Plaschke et al. (Early postoperative delirium…) discusses a relationship between BSEEG scores and delirium in patients, as well as a relationship between BSEEG scores and inflammation markers. Plaschke et al. fails to teach or suggest comparing a BSEEG score to an inflammation threshold. van den Boogaard et al. (Endotoxemia-induced inflammation…) discusses LPS-induced changes in cognitive function, and correlations between the LPS-induced changes and EEG parameters. Van den Boogaard et al. fails to teach or suggest comparing a BSEEG score to an inflammation threshold.
The following is a statement of reasons for the lack of prior art rejections:
Regarding claim 1, none of the prior art teaches or discloses, either alone or in combination, a bispectral EEG assessment system configured to compare a recorded BSEEG score to a clinical inflammation threshold, in combination with the other claimed elements.
Regarding claim 12, none of the prior art teaches or suggests, either alone or in combination, a system comprising a tool configured to compare a BSEEG score to a clinical inflammation threshold, in combination with the other claimed elements.
Regarding claim 20, none of the prior art teaches or suggests, either alone or in combination, a method comprising comparing a recorded BSEEG score to a clinical inflammation threshold, in combination with the other claimed steps.
Conclusion
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791