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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/07/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities: the phrase “and” in line 4 should be amended to read –or--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “predicted future glucose levels” in line 3 should be amended to read –the predicted future glucose levels--. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the phrase “the predicted future glucose level” in lines 3 and 4 should be amended to read -- the predicted future glucose levels--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the phrase “and” in line 2 should be amended to read –or--. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the phrase “and” in line 4 should be amended to read –or--. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: the phrase “predicted future glucose levels” in line 2 should be amended to read –the predicted future glucose levels--. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: the phrase “the predicted future glucose level” in lines 2 and 3 should be amended to read -- the predicted future glucose levels--. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: the phrase “and” in line 2 should be amended to read –or--. 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:
Limitation “brain signal recorder” in claims 1 and 11, the claims does not recite enough structure that corresponds to the claimed “recorder” to perform the function of record brain activity signal. However, the specification disclose (the brain signal recorder is selected from the group consisting of: an electroencephalography (EEG) device; a functional near-infrared spectroscopy (fNIRS) device; an electrocorticography (ECoG) device; a deep-brain stimulation device; and a magnetoencephalography (MEG) device, par.0009) which can be interpreted as the structure that corresponds to the claimed “brain signal recorder”.
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 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.
Claim 1 recites the limitation "the patient" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the patient" in line 3. 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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1: claims 1 and 11, recites a device and series of steps or acts, respectively, to manage glucose. Thus, the claims are directed to a process and a product. which are ones of the statutory categories of invention.
STEP 2A PRONG ONE: The claim(s) recite(s) specific limitations/method steps of: record a brain activity signal of a user's brain using the brain signal recorder, and decode the brain activity signal to predict future glucose levels of the patient. This limitation recites a mental process, because the claimed limitation 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.
STEP 2A PRONG TWO: This judicial exception is not integrated into a practical application because the claim(s) recite the combination of additional elements/method steps of: brain signal recorder and a controller/processor. Accordingly, this additional element/step does not integrate the abstract idea into a practical application because the claim limitations fail 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.
STEP 2B: The claim(s) does/do not include additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements, such as, brain signal recorder and a controller/processor, but do(es) not include additional elements that are sufficient to amount to significantly more than the judicial exception because these structural elements are generically claimed to enable the collection of data by performing the basic functions of: (i) receiving, processing, and providing/displaying data, and (ii) automating mental tasks. The courts have recognized these functions to be well‐understood, routine, and conventional functions when claimed in a merely generic manner. Merely adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC). As such, the recitation of these additional limitations in claims 2-10 and 12-20 does not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment and represent insignificant extra-solution activity. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as a sensor and use of a processor does 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)). Thus, the claimed invention does not amount to significantly more than the Abstract Idea.
When viewed alone or in combination, the limitations of claims 1-20 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Houben et al (US 6,572,542).
As to claims 1 and 11, Houben teaches a glucose management device and method (device shown in fig.6-8 that detectes glucose level and/or changes in blood insulin, abstract, col.5, lines 8-20), comprising:
a brain signal recorder (EEG electrodes 20 providing EEG signals input 21, col.11, lines 30-33 and lines 45-65, fig.7-8); and
a controller (processor 34 and memory in processor 34, col.12, fig.7-8), comprising:
a processor (processor 34, col.12, fig.7-8); and a memory (multi-dimensional data field defining acceptable and unacceptable EEG-derived parameters and ECG-derived parameters may be loaded into the memory of processor 34, col.18, lines 40-55), the memory containing a glucose monitoring application (inherently the application in the memory that stores all measured data and analysis data to determine glucose level, col.18, lines 40-55, and many of the steps illustrated in FIG. 9, for example, are carried out under microprocessor control, and as such are steps executed by software loaded into or present in the hardware of the system, col.14, lines 25-40 and lines 50-55) configured to direct the processor to:
record a brain activity signal of a user's brain using the brain signal recorder (record and receive EEG signals input 21 from user’s brain, col.11-col.12, and col.15, lines 15-30 and col.18, fig.7-8, 11 and 14-16); and
decode the brain activity signal to predict future glucose levels of the patient (signals/inputs derived from ECG signals and EEG signals may be employed in combination to reliably predict the onset, or to indicate the presence of, hypoglycemia in a human patient, abstract, col.5, lines 45-50, EEG signals provide a means of confirming or improving the accuracy of predicting the onset and/or presence of a hypoglycemic state, col.17, lines 20-25 and prediction of glucose level is based on derived data from EEG signals, col.22, lines 1-25).
As to claims 2 and 12, Houben teaches the glucose management device and method, wherein the glucose monitoring application further directs the processor to provide a warning when estimated glucose levels rise above a threshold value (triggering an alarm 25, if measured glucose level below and/or above a predetermined threshold value, col.13, lines 35-50, col.17, lines 60-67, and col.18, lines 43-55, fig.7-8).
As to claims 3 and 13, Houben teaches the glucose management device and method, wherein the brain signal recorder is selected from the group consisting of: an electroencephalography (EEG) device (EEG electrodes 20 providing EEG signals input 21, col.11, lines 30-33 and lines 45-65, fig.7-8); a functional near-infrared spectroscopy (fNIRS) device; an electrocorticography (ECoG) device; a deep-brain stimulation device; and a magnetoencephalography (MEG) device.
As to claims 4 and 14, Houben teaches the glucose management device and method, wherein to decode the brain activity signal, the glucose monitoring application further directs the processor to provide the brain activity signal to a multivariate decoder trained on spectral profiles of intracranial activity (a multi-dimensional data field defining acceptable and unacceptable EEG-derived parameters and ECG-derived parameters may be loaded into the memory of processor 34, col.18, lines 40-55, and analyzing measure EEG signals using artificial neural network, col.19, lines 55-65 and col.23-24, fig.11 and 14-16).
As to claims 5 and 15, Houben teaches the glucose management device and method, wherein the brain activity signal describes the spectral profile of the broadband brain activity (measuring EEG signals using various frequency range, col.17, lines 1-10).
As to claims 6 and 16, Houben teaches the glucose management device and method, wherein the glucose monitoring application further directs the processor to deliver a therapy to the user based on predicted future glucose levels in order to manage glucose levels in a desired therapeutic range (delivering insulin using delivery device 35 and/or 47, col.12, lines 5-25, col.13, lines 1-10, fig.7-8).
As to claims 7 and 17, Houben teaches the glucose management device and method, wherein the therapy is insulin provided via an insulin pump to the user (delivering insulin using delivery device 35 and/or 47, col.12, lines 5-25, col.13, lines 1-10, fig.7-8).
As to claims 8 and 18, Houben teaches the glucose management device and method, wherein the therapy is brain stimulation (Cranial Nerve Stimulation Treatments Using Neurocyberetic Prostheses") which is incorporated here by reference, col.3, lines 11-14 and col.14, lines 50-55).
As to claims 9 and 19, Houben teaches the glucose management device and method, wherein the glucose monitoring application further directs the processor to: store the predicted future glucose level in the memory (all measured data and predicted and determined glucose levels are loaded in the memory in processor 34, col.13, lines 35-45, col.14, lines 25-55, col.15, lines 55-60, and col.18); and
validate the predicted future glucose level based on a measured glucose level received from a glucose monitor (validating/comparing measured glucose level from EEG signals from sensor 20/23 with measured glucose sensor 33 before initiating an alarm or activating insulin delivery device 35, col.12, lines 1-30, and col.15, lines 15-60, fig.8 and fig.9).
As to claims 10 and 20, Houben teaches the glucose management device and method, wherein the glucose level is selected from the group consisting of: blood glucose level (determining blood glucose level, abstract, col.5, lines 5-15, col.7-8, see whole document); and interstitial glucose level.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 5712725596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791