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 § 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 7, 16 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.
Claims 7 and 16 recite the limitation "the most recently predicted time point". 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. The claims recite the collection and analyzing of data. More specifically, independent claims 1, 10 and 19 and their dependent claims are directed to the mental process (i.e. abstract idea) of collecting and processing health data.
Concerning Revised Step 2A, Prong One (whether the claim recites a judicial exception), please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016);
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology
Concerning Revised Step 2A, Prong Two (if the claim recites a judicial exception, evaluate whether the judicial exception is integrated into a practical application) the claims here do not integrate the abstract idea into a practical application because the claims merely uses a sensor to collect data with already well-known technology. The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). The fundamental data collection and processing steps performed by Applicant's claimed invention could theoretically be carried out manually by a person. Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Concerning Step 2B, in addition to the relevant discussion in Step 2A, prong two above, please note, as explained in MPEP § 2106.05(I) (A), limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include those listed therein.
The claims does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements are well- known, routinely-used generic devices/technologies.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 9-13, 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenfeld (US 20060271407 A1; 11/30/2006).
Regarding claim 1, Rosenfeld teaches a severity calculator system ([0008]; [0102]-[0103]), comprising:
a processor ([0078] “computer”); and
a non-transitory processor readable storage medium containing instructions executable by the processor ([0078] “computer”) to:
determine a patient state machine by collecting and transforming one or more of patient static measurements and patient dynamic measurements (note: instant claim recitation interpreted in light of instant specification [0035]; Rosenfeld Fig. 6A-6D; [0027]; [0081]; [0098]; [0102]),
determine a patient avatar, the patient avatar being substantially derived from at least one of a patient archetype model and a patient model (note: instant claim recitation interpreted in light of instant specification [0034]; Rosenfeld [0015]; [0021]; [0066] “predictive model”; [0086]-[0087]; [0089] the thresholds of the reference are patient-specific and disease-specific),
collect information from at least one user or device that performs at least one test associated with a disease state ([0018]; [0098]; [0105]; [0139]),
determine the trajectory of a patient ([0020]-[0021] “predictive of a change in a patient’s condition”), wherein:
the trajectory of the patient is one or more of towards a healthy state, towards organ failure, and towards the disease state ([0102]-[0103]), and
the trajectory of the patient is computed by a patient trajectory predictor ([0008]; [0103]), and
determine and output at least one patient intervention that, when the patient intervention is performed, leads to homeostasis of a patient ([0015] “treatment plan”; [0038]; [0086] “whether a patient’s condition is deteriorating … an intervention order”; Table 1; it is inherent that any treatment/intervention of a disease/disorder’s goal is to achieve homeostasis of the patient).
Claim 10 is rejected under substantially the same basis as claim 1 above.
Claim 19 is rejected under substantially the same basis as claim 1 above.
Regarding claim 2, Rosenfeld teaches wherein the disease state is acute pancreatitis (Table 1 “Acute pancreatitis diagnosis and treatment”).
Claim 11 is rejected under substantially the same basis as claim 2 above.
Claim 20 is rejected under substantially the same basis as claim 2 above.
Regarding claim 3, Rosenfeld teaches wherein the at least one patient intervention includes one or more of taking no action with respect to the patient ([0103] “withhold or discontinue the application of resources”), administering normal saline solution, administering dextrose solution, administering Ringer's lactate solution, administering albumin, administering plasma, or administering a solution of electrolytes.
Claim 12 is rejected under substantially the same basis as claim 3 above.
Regarding claim 4, Rosenfeld teaches wherein the instructions further cause the processor to choose an intervention and communicate with an infusion device (Table 1 “Infusion pump administration treatment”).
Claim 13 is rejected under substantially the same basis as claim 4 above.
Regarding claim 9, Rosenfeld teaches wherein the at least one test associated with a disease state is one or more of a measurement of blood pressure ([0128] “hypotension”; [0130]), respiratory rate ([0101] “respiratory measures”), heart rate, serum electrolyte levels, blood urea nitrogen levels, blood creatinine levels, arterial blood gas levels, pH, pulse oximetry, imaging, blood cell count, urine output, fecal output, body temperature, blood sugar measurements, liver injury test, lipid profiles, serum protein levels, albumin levels, hormone levels, metabolome levels, and secretion levels.
Claim 18 is rejected under substantially the same basis as claim 9 above.
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.
Claims 5-6, 8, 14-15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenfeld as applied to claims 1, 10 above, in view of Tamano (US 20210042700 A1; Filed 11/29/2018).
Regarding claim 5, Rosenfeld does not teach wherein the instructions further cause the processor to compute a prediction error. Note that Rosenfeld teaches validating the system to actual outcome vs predicted outcome ([0008]; [0103]). However, Tamano teaches in the same field of endeavor ([0002]) wherein the instructions further cause the processor to compute a prediction error (Fig. 1-2B; [0023]; [0094]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Rosenfeld to include this feature as taught by Tamano because this enables improvement of the predictive model ([0094]; Fig. 7).
Claim 14 is rejected under substantially the same basis as claim 5 above.
Regarding claim 6, the combination of Rosenfeld and Tamano teaches wherein the prediction error includes one or more of a mean square error, a sum of squared errors, a t-statistic, or a rule-based output (Tamano [0045]-[0050]; [0088]; [0094]).
Claim 15 is rejected under substantially the same basis as claim 6 above.
Regarding claim 8, in the combination of Rosenfeld and Tamano, Tamano teaches wherein the instructions further cause the processor to change the patient avatar based on the computed prediction error (Fig. 7; [0088]).
Claim 17 is rejected under substantially the same basis as claim 8 above.
Claims 7, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenfeld and Tamano as applied to claims 5, 14 above, and further in view of Nakano (US 20180350069 A1; Filed 11/3/2017).
Regarding claim 7, the combination of Rosenfeld and Tamano does not teach wherein the prediction error is only based on the most recently predicted time point. Note that Tamano does teach using only data indicating the predicted value for error calculation ([0060]). However, Nakano teaches in the same field of endeavor ([0001]-[0002]) wherein the prediction error is only based on the most recently predicted time point ([0003] “error of the last prediction”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Rosenfeld and Tamano to include this feature as taught by Nakano because this enables improvement of the model ([0003]).
Claim 16 is rejected under substantially the same basis as claim 7 above.
Conclusion
This is a continuation of applicant's earlier Application No. 16/700014. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application; note that claims are identical to original claims of 16/700014 of which a non-final had been sent which is identical to the claim rejection(s) above with respect to grounds of rejection. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792