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 Status
Claims 1-15 are currently pending and examined on the merits.
Priority
The instant application is a 371 of PCT/US22/17489 filed on 2/23/2022, which claims priority to U.S. Provisional Application 63/152,750 filed on 2/23/2021, and claims foreign priority under U.S.C. 119 to Application US63152750 filed on 2/23/2021. At this point in examination, the effective filing date of claims 1-15 is 2/23/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/23/2023 are in compliance with the provisions of 37 CFR 1.97. A signed copy of the corresponding 1449 form has been included with this Office Action.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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, 3-4, 6, 8-9, 11, and 13-14 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.
The term “modeling” in claim 1, lines 2, 5, and 9-11; claims 3, 8, and 13, lines 2-3; claims 4, 9, and 14, line 2; claim 6, lines 4, 7, and 11-13; and claim 11, lines 4, 7, and 11-13 is a relative term which renders the claim indefinite. The term “modeling” 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. It is unclear if the modeling is being performed or if the model is generated from “modeling”. The specification is also silent as to which definition the term “modeling” takes. Therefore, claims 1, 3-4, 6, 8-9, 11, and 13-14 are rendered indefinite and rejected under 35 U.S.C. 112(b).
The term “within a predetermined proximity” in claim 1, line 5, claim 6, line 7, and claim 11, line 7 is a relative term which renders the claim indefinite. It is unclear how values of physiological variables can be “within” a predetermined proximity as this could mean being within a range of values or above/below/equal to a specific value, rather than inside a predetermined value that indicates proximity. The specification is also silent as to which definition the term “within” takes. Therefore, claims 1, 6, and 11 are rendered indefinite and rejected under 35 U.S.C. 112(b).
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106:
Eligibility Step 1: Claims 1-5 are directed to a method (process) for predicting one or more subtypes of glucose dysregulation. Claims 6-10 are directed to a system (machine). Claims 11-15 are directed to a non-transient computer-readable medium (machine). Therefore, these claims are encompassed by the categories of statutory subject matter, and thus satisfy the subject matter eligibility requirements under Step 1.
[Step 1: YES]
Eligibility Step 2A: First, it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A, Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth described in the claim.
Claims 1, 6, and 11 recite the following steps which fall within the mental processes and/or mathematical concepts groups of abstract ideas, as noted below.
Independent claims 1, 6, and 11 further recite:
generating, for an in silico population of subjects, modeling for one or more physiological variables which are respectively indicative of the one or more subtypes (i.e., mental processes, mathematical concepts);
determining whether one or more values of the one or more physiological variables according to the modeling are within a predetermined proximity of one or more respectively corresponding subtype variable values corresponding to the one or more subtypes when the one or more physiological variables are observed in vivo (i.e., mental processes);
in response to the one or more values of the one or more physiological variables according to the modeling being determined to be within the predetermined proximity, fixing one or more parameters defining the modeling (i.e., mental processes);
applying the modeling, according to the fixed one or more parameters, for a real subject to determine correspondence for the real subject to the one or more subtypes (i.e., mental processes, mathematical concepts).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pencil and paper, and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind. Dependent claims 2-5, 7-10, and 12-15 recite information further limiting the judicial exceptions indicated above.
Therefore, claims 1, 6, and 11 recite an abstract idea.
[Step 2A, Prong One: YES]
Eligibility Step 2A, Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that, when examined as a whole, integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A, Prong One are not integrated into a practical application because of the reasons noted below.
Claims 6 and 11 recite the additional non-abstract element (EIA) of a general-purpose computer system or parts thereof:
a system comprising a processor and a processor-readable memory (claim 6);
a non-transient computer-readable medium (claim 11).
The EIA do not provide any details of how specific structures of the computer elements are used to implement the JE. The claims require nothing more than a general-purpose computer to perform the functions that constitute the judicial exceptions. The computer elements of the claims do not provide improvements to the functioning of the computer itself (as in DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (as in Diamond v. Diehr); nor do they utilize a particular machine (as in Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the JE using a computer, and therefore the claim does not recite integrate that JE into a practical application.
Thus, the additionally recited elements merely invoke a computer as a tool, and/or amount to insignificant extra-solution data gathering activity, and as such, when all limitations in claims 1-15 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application. Claims 6 and 11 contain additional elements that would not integrate a judicial exception into a practical application and are further probed for inventive concept in Step 2B.
[Step 2A, Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
With respect to claims 6 and 11: The limitations identified above as non-abstract elements (EIA) related to general-purpose computer systems do not rise to the level of significantly more than the judicial exception. These elements do not improve the functioning of the computer itself, or comprise an improvement to any other technical field (Trading Technologies Int’l v. IBG, TLI Communications). They do not require or set forth a particular machine (Ultramercial v. Hulu, LLC., Alice Corp. Pty. Ltd v. CLS Bank Int’l), they do not affect a transformation of matter, nor do they provide an unconventional step. Simply appending well understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception are insufficient to provide significantly more (as discussed in Alice Corp., CyberSource v. Retail Decisions, Parker v. Flook, Versata Development Group v. SAP America).
[Step 2B: NO]
Therefore, claims 1-15 are patent ineligible under 35 U.S.C. § 101.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-3, 5-8, 10-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ahlqvist et al. (bioRxiv, 2017, 1-43), as provided in the IDS filed 8/23/2023.
With respect to claims 1, 6, and 11:
Claim 6 recites a system comprising a processor and a processor-readable memory. Claim 11 recites a non-transient computer-readable medium.
Broadly claiming an automated means to replace a manual function to accomplish the same result does not distinguish over the prior art. See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F .3d 1157, 1161, 82 USPQ2d 1687, 1691 (Fed. Cir. 2007) (“Accommodating a prior art mechanical device that accomplishes [a desired] goal to modern electronics would have been reasonably obvious to one of ordinary skill in designing children’s learning devices. Applying modern electronics to older mechanical devices has been commonplace in recent years.”); In re Venner, 262 F. 2d 91, 95, 120 USPQ 193, 194 (CCPA 1958); see also MPEP § 2144.04. Furthermore, implementing a known function on a computer has been deemed obvious to one of ordinary skill in the art if the automation of the known function on a general purpose computer is nothing more than the predictable use of prior art elements according to their established functions. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007); see also MPEP § 2143, Exemplary Rationales D and F. Likewise, it has been found to be obvious to adapt an existing process to incorporate Internet and Web browser technologies for communicating and displaying information because these technologies had become commonplace for those functions. Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1326-27, 87 USPQ2d 1350, 1357 (Fed. Cir. 2008).
Regarding the recited generating, for an in silico population of subjects, modeling for one or more physiological variables which are respectively indicative of the one or more subtypes, Ahlqvist et al. discloses performing cluster analysis in newly diagnosed diabetic patients from the Swedish ANDIS (All New Diabetics in Scania) cohort using five variables (GAD-antibodies, BMI, HbA1c, HOMA2-B, and HOMA2-IR) (pg. 3, Methods, lines 1-3; pg. 10, para. 1, lines 3-6). Also, further teaches clusters of patients assigned to respective disease subtypes characterized by the five variables (pg. 10, para. 3; pg. 20, Figure 1B). This teaches modeling physiological variables indicative of disease subtypes.
Regarding the recited determining whether one or more values of the one or more physiological variables according to the modeling are within a predetermined proximity of one or more respectively corresponding subtype variable values corresponding to the one or more subtypes when the one or more physiological variables are observed in vivo, Ahlqvist et al. discloses using three independent cohorts (SDR, ANDIU, and DIREVA) to replicate the clustering analysis performed for the ANDIS cohort and assigning patients in the replication cohorts to clusters based on which cluster they were most similar to, calculated as their Euclidean distance from the nearest cluster center derived from ANDIS coordinates and found similar distributions (pg. 11, para. 2-3; pg. 28, Figures S3 (C) and (E) and S4 (B) and (D)). This teaches comparing clusters of physiological variable values corresponding to disease subtypes between cohorts of patients to determine whether they are within proximity or similar to each other.
Regarding the recited in response to the one or more values of the one or more physiological variables according to the modeling being determined to be within the predetermined proximity, fixing one or more parameters defining the modeling, Ahlqvist et al. discloses using three independent cohorts (SDR, ANDIU, and DIREVA) to replicate the clustering analysis performed for the ANDIS cohort and assigning patients in the replication cohorts to clusters based on which cluster they were most similar to, calculated as their Euclidean distance from the nearest cluster center derived from ANDIS coordinates and found similar distributions (pg. 11, para. 2-3; pg. 28, Figures S3 (C) and (E) and S4 (B) and (D)). This teaches that similar distributions of patients and their physiological variable values were found from determining their proximity, which are fixed in Figures S3 (C) and (E) and S4 (B) and (D).
Regarding the recited applying the modeling, according to the fixed one or more parameters, for a real subject to determine correspondence for the real subject to the one or more subtypes, Ahlqvist et al. discloses using three independent cohorts (SDR, ANDIU, and DIREVA) to replicate the clustering analysis performed for the ANDIS cohort and assigned patients in the replication cohorts to clusters based on which cluster they were most similar to, calculated as their Euclidean distance from the nearest cluster center derived from ANDIS coordinates and found similar distributions (pg. 11, para. 2-3; pg. 28, Figures S3 (C) and (E) and S4 (B) and (D)). This teaches patients assigned to clusters based on the ANDIS cohort clusters they were determined to be most similar to, which determines correspondence of the patients to one or more disease subtypes.
With respect to claims 2, 7, and 12:
Regarding the recited wherein: the one or more physiological variables comprise one or more of (a) fasting glucose, (b) fasting C-peptide, (c) HOMA2-B, (d) HOMA2-IR, or (e) any combination thereof, Ahlqvist et al. discloses performing cluster analysis in newly diagnosed diabetic patients from the Swedish ANDIS (All New Diabetics in Scania) cohort using five variables (GAD-antibodies, BMI, HbA1c, HOMA2-B, and HOMA2-IR) (pg. 3, Methods, lines 1-3; pg. 10, para. 1, lines 3-6). This teaches physiological variables comprising HOMA2-B and HOMA2-IR.
With respect to claims 3, 8, and 13:
Regarding the recited wherein: the one or more values of the physiological variables according to the modeling are respectively determined based on one or more of modeling for (l) insulin secretion, (m) C-peptide secretion, (n) β-cell function, (o) insulin resistance, or (p) any combination thereof, Ahlqvist et al. discloses performing cluster analysis in newly diagnosed diabetic patients from the Swedish ANDIS (All New Diabetics in Scania) cohort using five variables (GAD-antibodies, BMI, HbA1c, HOMA2-B, and HOMA2-IR) (pg. 3, Methods, lines 1-3; pg. 10, para. 1, lines 3-6). Also, further teaches clusters of patients assigned to respective disease subtypes characterized by the five variables (pg. 10, para. 3; pg. 20, Figure 1B). For instance, Cluster 2 labeled Severe Insulin Deficient Diabetes (SIDD) encompasses patients with low insulin secretion (low HOMA2-B) and Cluster 3 labeled Severe Insulin Resistant Diabetes (SIRD) encompasses patients with insulin resistance (high HOMA2-IR). This teaches physiological variables determined corresponding to modeling for insulin secretion and insulin resistance.
With respect to claims 5, 10, and 15:
Regarding the recited wherein: the one or more subtypes comprise one or more of (q) SIDD (severe insulin-deficient diabetes), (r) SIRD (severe insulin-resistant diabetes), (s) MOD (mild obesity-related diabetes), (t) MARD (mild age-related diabetes), or (u) any combination thereof, Ahlqvist et al. discloses performing cluster analysis in newly diagnosed diabetic patients from the Swedish ANDIS (All New Diabetics in Scania) cohort using five variables (GAD-antibodies, BMI, HbA1c, HOMA2-B, and HOMA2-IR) (pg. 3, Methods, lines 1-3; pg. 10, para. 1, lines 3-6). Also, further teaches clusters of patients assigned to respective disease subtypes such as Severe Insulin Deficient Diabetes (SIDD), Severe Insulin Resistant Diabetes (SIRD), Mild Obese Diabetes (MOD), and Mild Age-Related Diabetes (MIRD), characterized by the five variables (pg. 10, para. 3; pg. 20, Figure 1B). This teaches disease subtypes comprising SIDD, SIRD, MOD, and MIRD.
Therefore, the differences in the prior art were encompassed in known variations or in principle known in the prior art. The rationale would have been the predictable use of prior art elements according to their established functions. KSR 550 U.S. at 417.
For these reasons, the instant claims do not recite any new element or new function or unpredictable result, and the examiner invites the applicant to provide evidence demonstrating the novel or unobvious difference between the claimed limitations and those used in the prior art, as mere argument cannot take the place of evidence lacking in the record. Estee Lauder Inc. v. L’Oreal, S.A., 129 F .3d 588, 595 (Fed. Cir. 1997).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ahlqvist et al. (bioRxiv, 2017, 1-43) as applied to claims 1-3, 5-8, 10-13, and 15 above, in view of Barker et al. (Diabetes, Obesity and Metabolism, 2013, 16(3), 262-267) and Lachin et al. (Diabetes, 2014, 63(2), 739-748).
Ahlqvist et al. is applied to claims 1-3, 5-8, 10-13, and 15 above.
With respect to claims 4, 9, 14:
Ahlqvist et al. does not disclose wherein: the one or more values of the physiological variables according to the modeling are determined based on β-cell function in dependence on at least a value comprising
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However, Barker et al. discloses using mixed models with natural log transformed fasting C-peptide as an outcome variable and time fitted with a random slope with inclusion of an age at onset
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time interaction variable to investigate if the decline of fasting C-peptide (FCP) over 5 years differed between age at onset groups (pg. 263, col. 2, para. 3, lines 4-8). Also, further discloses a correlation between age at diagnosis of type 1 diabetes and fasting C-peptide with rapid decline of β-cell function in young patients (pg. 262, Aims, line 1; pg. 262, Conclusions). This teaches performing a natural logarithm transformation on fasting C-peptide levels, and discusses correlation between fasting C-peptide levels and β-cell function, therefore β-cell function dependence on fasting C-peptide is relational.
It would have been prima facie obvious to one of ordinary skill in the art to modify the clustering analysis disclosed by Ahlqvist et al. to incorporate logarithm transformation of C-peptide levels disclosed by Barker et al. One would be motivated to incorporate this transformation of C-peptide levels in the clustering analysis method because Lachin et al. discloses that a logarithm of C-peptide improved linearity of associations and better satisfied the assumptions of approximately normally distributed and homoscedastic residuals (pg. 740, col. 2, para. 3, lines 1-9). This means a logarithm transformation would improve the fit of models used to assess C-peptide effects. There is a likelihood of success, since clustering analyses of diabetes subjects and C-peptide analysis are well known techniques in the field of health sciences.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jammy Luo whose telephone number is (571)272-2358. The examiner can normally be reached Monday - Friday, 9:00 AM - 5:00 PM EST.
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/J.N.L./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686
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