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 1-20 are currently pending and under exam herein.
Priority
The instant Application is a Continuation of US 15/717,777, filed 27 September 2017, now US Patent 11,646,098 which claims the benefit priority to US Provisional Application 62/401,843, filed 29 September 2016. Priority for each of claims 1-20 is acknowledged to the EFD of 29 September 2016.
Information Disclosure Statement
The Information Disclosure Statement filed 6 April 2023 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Drawings
The Drawings filed 29 March 2023 are accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US2023/0230653.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Please see, for example, paragraph [0044].
The use of the term Discern nCode™, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 8, and 19 recite, “receiving measurement values and their respective measurement time-date coordinates that are less recent than the date-time coordinates corresponding to the one or more laboratory or physiological measurements”. The claim is unclear with respect to the receipt of the “measurement values” because it is unclear as to whether the measurement values are different from the laboratory or physiological measurements or if the measurement values are just earlier gathered laboratory or physiological measurements representative of the same parameters. Clarification is requested.
Claims 1, 8 and 19 recite, “determining a probability of a macrophage activation syndrome for the subject by determining, for the time series, high-frequency components of a power spectrum or a surrogate measure of a high-frequency band of the power spectrum, the probability determined by using one or more predictive models; determining that the probability of the macrophage activation syndrome exceeds a threshold associated with a condition of the subject, with the one or more first laboratory or physiologic measurements, with the one or more second laboratory or physiologic measurements, or with other laboratory or physiologic measurements”, wherein the claim is indefinite with respect to the use of a predictive model as recited to determine a probability of MAS because there are no parameters recited that provide for the predictive model operation in the claim. As such, said determination is not clear. Further with respect to a probability exceeding a threshold for “a condition” the claim is not clear with respect to what condition is intended. In addition, it is not clear that as to what determination of a probability for only one of the recited parameters (a condition or first laboratory of physiological or second laboratory or physiological or other measurements) determines MAS in the claim. Clarification is requested through clearer claim language.
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 instant rejection reflects the Guidance as outlined in the MPEP at 2106:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With respect to step (1): yes, the claims are directed to a method, system and non-transitory computer-readable medium.
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular steps of determining) and mathematical concepts (in particular mathematical relationships and formulas textually recited as calculating or constructing).
The claim steps to abstract ideas are as follows:
Independent Claims 1, 8, and 19: “determining a probability of a macrophage activation syndrome for the subject by determining, for the time series, high-frequency components of a power spectrum or a surrogate measure of a high-frequency band of the power spectrum, the probability determined by using one or more predictive models; determining that the probability of the macrophage activation syndrome exceeds a threshold associated with a condition of the subject, with the one or more first laboratory or physiologic measurements, with the one or more second laboratory or physiologic measurements, or with other laboratory or physiologic measurements; in response to determining the probability of the macrophage activation syndrome exceeds the threshold, identifying a recommendation for a treatment or a therapy for the subject.
Dependent claims : recite additional steps that further limit the judicial exceptions in independent claims 1, 8 and 19 and as such, are further directed to abstract ideas. Such limitations are, for example, the RMSSD of claim 2; the thresholds or range of claim 3; time intervals of claim 4; “monitoring; determining and updating” of claim 5; “placing orders and modifying care plans of claim 6; “determining and updating in claim 7. Dependent claims 9-18 and 20 similarly limit the judicial exceptions of the instant claims. Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind and/or performance by mathematical operation because the steps, save for the recitation of a computer system and processor (claims 8-20) recite steps that could be performed mentally using pen and paper or by mathematical calculation doing the same. For example, there are no specifics as to the methodology involved in “constructing a time series” beyond simply taking obtained data and assessing the data by placing them in a series. Further steps of “determining that the length of the time series” could also be assessed by merely looking at the data from the time series and making that “determination”. The same logic applies to the remainder of the claimed steps. Thus, under the BRI, one could simply model with pen and paper using the appropriate mathematical techniques, including probability assessments and classification algorithms.
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim 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 is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the additional elements of the claims are as follows:
Claims 1, 8 and 19: “receiving one or more…measurements of the patient and corresponding date-time coordinates”; “receiving measurement values and their respective measurement date-time coordinates…”; “retrieving a time series…of measurements…”; “transmitting a notification to a caregiver…comprising a recommendation”
Claim 8: “processor”; “computer storage medium storing computer-usable instruction…”
Claim 19: “non-transitory computer storage media…on a processor”
Dependent claims 2-7, 9-18 and 20 recite steps that further limit the recited additional elements in the claims that further define types of data therein.
With respect to the additional elements in the instant claims, those steps directed to data gathering, such as “receiving” data perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further steps herein directed to additional non-abstract elements of “processor; computer; storage medium etc…” do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
Steps of performing an “action” that includes recommendations, notifications, new orders, altering care plans, modifying plans are steps that are considered steps that do not integrate the recited judicial exception into any practical application beyond merely informing the relative audience as to what to do with the generated data, i.e. extra-solution activity.
None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
As such, the claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the data gathering elements of the instant claims, the prior art to Lavrac (Artificial Intelligence in Medicine (1999) Vol. 16:3-23-IDS reference) at least discloses that data gathering for medical information is an element that is routine, well-understood and conventional in the art. Said portions of the prior art are, for example, page 3 (abstract); page 4 (description of knowledge discovery databases (KDD) that house medical information and page 5 (disclosure of modeling techniques for medical data). As such, activities such as data gathering do not improve the functioning of a computer or comprise an improvement to any other technical field; they do not require or set forth a particular machine; they do not effect a transformation of matter; nor do they provide a non-conventional or unconventional step. Rather, the data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to the instant claims, the additional limitations of “emitting a notification” or “performing an action” such as notifying a caregiver fails to rise to significantly more than the judicial exception. The prior art to Lavrac, for example, recognizes that these are extra-solution steps whereby analysis leads to information for decision support (see abstract). Thus, the steps providing steps that routinely are practiced by healthcare providers, such as analyzing data to make recommendations or care plans etc. do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not effect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such these limitations fail to rise to the level of significantly more.
With respect to claims 8-20, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. Further exemplified prior art to, for example, Lavrac teaches that computing elements are routine, well-understood and conventional in the art. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,646,098. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims herein are directed to the limitations that are directed to a method (system and non-transitory computer-readable medium) comprising operative steps that include the following:
receiving one or more measurements of a subject, the one or more measurements comprising:
one or more first laboratory or physiologic measurements and one or more corresponding date-time coordinates; and
one or more second laboratory or physiologic measurements and a respective date-time coordinate, the one or more second laboratory or physiologic measurements being less recent than the one or more date-time coordinates corresponding to the one or more first laboratory or physiologic measurements;
retrieving a time series including at least the one or more first laboratory or physiologic measurements and the one or more second laboratory or physiologic measurements, the time series constructed based on the one or more corresponding date-time coordinates of the one or more first laboratory or physiologic measurements and the respective date-time coordinate of the one or more second laboratory or physiologic measurements;
determining a probability of a macrophage activation syndrome for the subject by determining, for the time series, high-frequency components of a power spectrum or a surrogate measure of a high-frequency band of the power spectrum, the probability determined by using one or more predictive models;
determining that the probability of the macrophage activation syndrome exceeds a threshold associated with a condition of the subject, with the one or more first laboratory or physiologic measurements, with the one or more second laboratory or physiologic measurements, or with other laboratory or physiologic measurements;
in response to determining the probability of the macrophage activation syndrome exceeds the threshold, identifying a recommendation for a treatment or a therapy for the subject; and
transmitting a notification to a caregiver indicating that the subject has the probability, corresponding to a future time interval, of the macrophage activation syndrome exceeding the threshold, the notification comprising the recommendation.
The instant claims include steps that further provide for identification of a recommendation for treatment or therapy for the subject (a subject can be a patient as claimed in the ‘098 patent) wherein dependent claims in the ‘098 patent further include modification to care plans and of increase in testing, for example that fairly read on “recommendations for a treatment of a subject”. As such, the claims are obvious variants ones of the other and are subject to non-statutory double patenting herein.
Prior Art
With respect to the prior art, the closest prior art to Lehmberg et al. (British Journal of Haematology (2010) Vol. 160:275-287-IDS reference) and to Janka et al. (Blood Reviews (2014) Vol. 28:135-142-IDS reference) fail to teach or fairly suggest the method for predicting an occurrence of a macrophage activation syndrome in a patient over a future time interval by assessing time series data, as instantly claimed. Specifically, the instant claims include assessment of at least three values in each of the time series of the first and second laboratory or physiological measurements and determining probability of MAS by calculation high frequency components of a power spectrum or a surrogate measure of high frequency band of the power spectrum and wherein determining that probability of MAS exceeds the associated threshold provides for indication of a future event of MAS.
Conclusion
No claims are allowed.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439. Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 12:00PM to 10:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/Lori A. Clow/Primary Examiner, Art Unit 1687
Prosecution Insights