DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
1-3, 10, 12-14, 19-22, 29, 31-36, 38-41 and 43
Pending:
4-9, 11, 15-18, 23-28, 30, 37 and 42
Withdrawn:
none
Examined:
4-9, 11, 15-18, 23-28, 30, 37 and 42
Independent:
4, 37 and 42
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line or column:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 11/7/2023 filing receipt, this application claims priority to no earlier than 12/18/2020. All claims have been interpreted as being accorded this priority date.
Claim rejections - 112/b
The following is a quotation of 35 USC 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 5, 9 and 25 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
5
...the plurality of dynamic and static clinical parameters differs between at two of the reference subjects.
Not interpretable at least due to the recited "...between at two..." Possibly "...between at least two..."
9, 25
substantially real-time
In claim 9, the recited "substantially real-time" is a term of relative or vague degree or form of association, neither defined in the specification ([11]) nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.) Claim 25 is rejected similarly.
Claim rejections - 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 USC 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 USC 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention.
Claims 4-5, 7-9, 11, 15-18, 23-25, 26-28, 30, 37 and 42
Claims 4-5, 7-9, 11, 15-18, 23-25, 26-28, 30, 37 and 42 are rejected under 35 USC 103 as unpatentable over Newberry (US20200253562 as cited on the 6/16/2023 IDS).
Regarding claim 4, Newberry discloses a method of generating a model for prognosing a CV outcome for a monitored subject ([0111], [0113], [0117], [0156], [0258]) infected with an etiologic agent ([0281], [0285]) at using a system ([0362]), comprising at least one controller that comprises, or is capable of accessing, computer readable media comprising non-transitory computer executable instructions ([0362]) which, when executed by at least one electronic processor, perform at least: generating a first set of data values of a first plurality of dynamic clinical parameters ([0038], [0297], [0318]) associated with at least a first plurality of monitored reference subjects infected with the etiologic agent, wherein at least a subset of the first set of data values comprises one or more time-series data values ([0111], [0117], [0156]); processing at least some of the first set of data values for at least some of the first plurality of monitored reference subjects infected with the etiologic agent using one or more sliding time windows that comprise one or more feature time windows associated with one or more outcome time windows, wherein the feature time windows comprise one or more time series features selected from the group consisting of: a short feature, a long feature, and an exponentially weighted decaying feature to produce at least a first set of processed dynamic features ([0038], [0111], [0117], [0156], [0297], [0318]); combining at least some of the first set of processed dynamic features with a second set of data values of a first plurality of static clinical parameters ([0318], [0322]) associated with at least some of the first plurality of monitored reference subjects infected with the etiologic agent for one or more of the time windows to produce at least a first set of combined features ([0318], [0322]); and, training at least one classifier using at least some of the first set of combined features ([0318], [0322]), thereby generating the model for prognosing the CV outcome for the monitored subject infected with the etiologic agent ([0111-0117], [0156], FIGs. 26 and 41).
Newberry teaches each of the limitations as described above, however Newberry does not teach the limitations in a single embodiment in the same, consecutive sequence as recited. It would have been prima facie obvious to try the recited sequence as an example of combining prior art elements taught within the same reference according to known methods to yield predictable results.
Claim 5 specifies a difference among the reference subjects which reads on Newberry at [326].
Regarding claims 7-8 and 26, Newberry teaches updating with additional data ([336]). Also, repetition of previously recited steps, such as the initial iteration of data processing, would have been prima facie obvious (MPEP 2143 E., Example 9 pertains).
Regarding claims 9 and 25, Newberry teaches various embodiments of time-sensitive analysis ([39, 211]).
Regarding claims 11 and 15-18, Newberry teaches time-series data ([136] and FIG. 6).
Regarding claim 23, Newberry teaches prognosis as described for claim 4.
Regarding claim 24, Newberry teaches risk calculation ([28-41, 117-129, 235-239, 337]).
Regarding claim 27, Newberry teaches storing data in an electronic health record ([361]).
Regarding claim 28, Newberry teaches "treatment for infection or perform additional treatments and intervention" ([239]).
Regarding claim 30, Newberry teaches at least one of the recited algorithms ([295-297]).
The art is applied to claims 37 and 42 similarly to as described above.
Claim 6
Claim 6 is rejected under 35 USC 103 as unpatentable over Newberry (US20200253562 as cited on the 6/16/2023 IDS) as applied above and further in view of Kotsiantis (as cited on the attached Form 892).
Newberry does not teach but Kotsiantis does teach analysis of data with absent values (§2).
Combining Newberry and Kotsiantis
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the Zzz teaching of Newberry using the related teaching of Kotsiantis. As motivation to combine, an advantage taught by Kotsiantis of modifying methods such as those of Newberry would have been the teaching of Kotsiantis that "Depending on the circumstances, researchers have a number of methods to choose from to handle missing data..." (§2). Thus, PHOSITA would have been motivated to modify Newberry using the above techniques of Kotsiantis in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Newberry and Kotsiantis are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Kotsiantis to the related teaching of Newberry.
Claim rejections - 101
35 USC 101 reads:
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.
For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted.
Judicial exceptions (JE) to 101 patentability
Claims 4-9, 11, 15-18, 23-28, 30, 37 and 42 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below.
In Alice, citing Mayo and Bilski, two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE?
MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below.
MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03
[Step 1: claims 4-9, 11, 15-18, 23-28, 30, 37 and 42: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04
Preliminarily, in a 1st prong of Step 2A, elements of independent claim 1 are interpreted as directed to the abstract idea of generating a model including the JE elements of "generating...," "processing...," "combining..." and "training...," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below.
Claims 37 and 42 are analyzed similarly.
BRIs of the claims are analogous to an abstract idea in the form of at least a mental process, at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource, Synopsys and Electric Power Group). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process.
BRIs of the claims also are analogous to an abstract idea in the form of a mathematical concept, including mathematical relationships and calculations, as found in the following case law, as cited and discussed above: collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group) and/or obtaining and comparing intangible data (e.g. Cybersource, Ambry and Myriad CAFC) and/or execution of an algorithm to implement mathematical relationships and/or formulas, including image processing (e.g. TLI, Digitech, Benson, Flook, Diehr, FuzzySharp, In re Grams and In re Abele all as cited in MPEP 2106).
Instant examples of math concepts include at least the recited produce processed dynamic features, as well as relationships inherent in recitations as the only supported embodiments.
The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field.
Regarding inherency of abstract ideas, MPEP 2106.04.II.A.1 includes: "the claims in Alice Corp. v. CLS Bank, 'described' the concept of intermediated settlement without ever explicitly using the words 'intermediated' or 'settlement'" (emphasis added, p. 1). Similarly, inherency can effectively be recitation, as in, for example, "By claiming simply 'crystalline paroxetine hydrochloride hemihydrate' with no reference to how it was produced, SKB effectively claimed 'crystalline paroxetine hydrochloride hemihydrate whether non-naturally occurring or arising through natural conversion.' Claim 1, as issued, therefore combines patentable and unpatentable subject matter, and is invalid under Section 101." (capitalization added, SmithKline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, 1321-33, Fed. Cir. 2004).
In the instant type of data processing claims, the specification is not merely adding background explanation as to how a claimed process works, e.g. a physical process based on, involving or further explained by abstract ideas and natural laws. Rather, the specification is detailing the only disclosed way that a programmer may proceed from the recited inputs to the recited outputs, e.g. through actual performance of the disclosed judicial exceptions (JEs).
Regarding the "Meaning of 'Recites,'" MPEP 2106.04.II.A.1 states:
In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims "set forth" an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words "intermediated" or "settlement."
While the "set forth" language approximates explicit recitation, it also is fundamental that all recitation must be interpreted and that to be patent eligible a claim must satisfy 101 according to its properly interpreted scope, e.g. for all embodiments on which the claim reads, e.g. according to any inherency pertinent to a given claim and disclosure accompanying that claim, i.e. consistent with the "described" meaning of "recites" as in the MPEP. Thus, within a BRI, the identified abstract idea elements read on one or more embodiments which only involve manipulation of data. It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim.
As in Alice (at 306, as cited in the MPEP above) and Bilski (as cited in Alice, id), an abstract idea may comprise multiple abstract elements or steps (i.e. from Alice: "a series of steps" at 306) and need not be a single equation, relationship or principle.
It is not clear that the identified elements must represent other than an abstract idea according to any relevant analysis or case law.
[Step 2A, 1st prong, abstract idea: claims 1: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- law of nature -- MPEP 2106.I and 2106.04
Preliminarily, at this 1st step of the analysis, elements of independent claim 1 are directed to a law relating data values to prognosis, including the JE element of "training" a "classifier."
Claims 37 and 42 are analyzed similarly.
A BRI of the instant claims is analogous to a law of nature as found, for example, in Mayo (as cited in the MPEP above). It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim. It is not clear that the above identified law of nature including the identified elements, taken together and within a BRI, must in all embodiments represent other than a law of nature according to any relevant analysis or case law. Therefore, in answer to the 1st Mayo/Alice question, the above elements are directed to a law of nature.
[Step 2A, 1st prong, natural law: claims 4, 37 and 42: YES]
Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d)
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B.
Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: [87]).
[Step 2A, 2nd prong: claims 4, 37 and 42: NO]
Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs? -- MPEP 2106.I and 2106.05
Addressing the second Mayo/Alice question, all elements of claims 4, 37 and 42 are part of one or more identified JEs (as described above), except for elements identified here as conventional elements in addition to the above judicial exceptions:
The recited "controller" and "computer readable media" are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input/output elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g), and as exemplified by Newberry (US20200253562 as cited on the 6/16/2023 IDS), and generally it is understood that the examples in the reference are well-known and routine.
It is emphasized that, outside of an improvement argument, analysis of what is conventional generally pertains to the above-identified additional elements and not to elements identified as part of a JE.
[Step 2B: claims 4, 37 and 42: NO]
Summary and conclusion regarding claims 4, 37 and 42
Summing up the above analysis of claims 4, 37 and 42, each viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim.
Remaining claims
Claims 5-9, 11, 15-18, 23-27 and 30 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101.
Elements of the following claims are additional elements but nonetheless are conventional elements of a laboratory or computing environment, conventional data gathering elements or conventional post-processing elements, as in the following specific examples which also are understood to be well-known and routine:
claim 28: "administering... therapies...," are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input/output elements, as exemplified by Newberry, and generally it is understood that the examples in the reference are well-known and routine.
None of the dependent claim elements provides the something significantly more than the identified JE(s) necessary to satisfy 101.
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
Inquiries
Information regarding the filing, management and status of patent applications which are published (available to all users) or unpublished (available to registered users) may be obtained from the Patent Center: https://patentcenter.uspto.gov. Further information is available at https://www.uspto.gov/patents/apply/patent-center, and information about filing in DOCX format is available at https://www.uspto.gov/patents/docx.
The Electronic Business Center (EBC) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
Prosecution Insights