DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
none
Pending:
1-18
Withdrawn:
none
Examined:
1-18
Independent:
1 and 17-18
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
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
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 3/17/2023 filing receipt, this application claims priority to no earlier than 8/18/2022. All claims have been interpreted as being accorded this priority date.
Objection to the specification: title
The title should be amended to more specifically reflect the claims, particularly the independent claims and referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example a title including terms such as: morbidity, probability and measuring. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim objections
Claims 1, 15 and 17-18 are objected to because of the following informalities. Appropriate correction is required. In each objection the claims are definite with respect to the issues cited here because interpretation would have been sufficiently clear to PHOSITA, but nonetheless the claims are objected to for consistency among the claims or as otherwise indicated. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate.
The following issues are objected to:
Claim
Recitation
Comment
1, 17-18
subject being
While "subject being" is clearly interpretable, simply "subject" would suffice and would be more readily readable. The poor readability here is compounded by "being" also occurring as a verb in the next line of the claim.
1, 15, 17-18
one or more hardware processors...
...on the basis of
In claim 1, a colon should follow "of" as beginning a list of claim elements.
Claims 17-18 are objected to similarly.
In claim 15, the same issue occurs with "...by using..."
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 1-18 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)
1
hardware processors configured to estimate morbidity
Claim 1 is to a 101 machine or manufacture, i.e. an "information processing device" in this instance, interpreted by statute according to its claimed physical structure, but it is not clear what is the structure associated with the recited "estimate morbidity..." and similar steps. Therefore, it is not clear whether the claim is limited according to these steps. MPEP 2106.03, 5th-6th paras. pertain. The recited "information processing device" and "hardware processors" are interpreted as not clearly requiring structure linking the "information processing device" to the recited process steps in a structural sense appropriate to a claim to a machine or manufacture. While the recited elements may comprise unrecited software storage in some embodiments, it is not clear that all embodiments of these elements must comprise software storage corresponding to the recited process steps. Structure should be recited specifically corresponding to stored software. The recited process steps are not properly claimed without corresponding structure. This rejection might be overcome by, for example, reciting a data storage device, comprised by the "information processing device," and instructions stored therein and configured according to the recited elements and steps. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
1, 17-18
morbidity
representing a probability of a subject being suffering from a specific disease
Interpretation of "morbidity" is unclear at least because in ordinary usage the term refers to a statistical property of a population, while the instant claim refers to a "subject being." It is unclear whether the "subject being" is representative of one subject in a population or is a particular singular person. Therefore, it is unclear whether "morbidity" must be estimated for one particular person, i.e. the "subject being," or for an unrecited population.
Depending on resolution of this rejection, a further 112/b rejection may apply if the term "morbidity" is being used with other than its ordinary definition but without adequate disclosure as to this lexicography (specification: [8, 24-27, etc.]). MPEP 2111.01.IV pertains.
1, 13, 17-18
specific disease
In claim 1, the recited "specific" is a term of relative or vague degree or form of association, neither defined in the specification ([3]) nor having a well-known and sufficiently particular definition in the art and in the instant context. For example, it is not clear what degree of specificity is required, e.g. as to cancer vs. autoimmune, breast cancer vs. liver cancer, triple-negative breast cancer vs. other forms of breast cancer, etc. (MPEP 2173.05(b) pertains.)
Claims 17-18 are rejected similarly.
Relatedly, in claim 13, the relationship is unclear between "specific" and "includes one or more of..." at least because it is unclear how a "specific" disease can "include one or more of" multiple diseases.
1, 3, 6, 9-10, 12, 17-18
the second physical quantity obtained by measuring the subject
In claim 1, it is unclear whether the step of obtaining (i.e. "...quantity obtained...") is required as part of the instantly recited "estimate morbidity" process or is a step previously performed and resulting in a product-by-process interpretation. Regarding product-by-process limitations within a claim, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential).
In claims 3, 6, 9-10, 12 and 17-18, forms of "obtain" similarly render those claims indefinite.
2
estimate distribution
A grammatical article should precede "distribution," e.g. "a distribution."
3, 6
the first physical quantity obtained in advance and the second physical quantity obtained in advance
In claim 3, each instance of "quantity" requires but lacks antecedent at least because the previous recitations of these elements did not include "obtained in advance." Possibly "obtained in advance" should be recited as "wherein the... was obtained in advance."
In claim 6, a similar issue renders the claim indefinite regarding the recited "obtained..."
9
statistical information
The relationship is unclear between this instance of "information" and the instance in the "second probability model" of claim 1.
10
the time being associated with reaction using the sample
Not interpretable at least due to the recited "...reaction..." The relationship is unclear between "reaction" and the rest of the claim. Possibly "reaction" requires a grammatical article.
11
...a function including a product of the first probability model, the second
probability model, and the prior probability of morbidity.
Not interpretable. It is not clear whether "product" refers to the result of multiplication or to any output of the model. It is not clear what is the relationship between "product" and the later recited "second... model" and "prior probability." If "product" refers to multiplication, then it is not clear what is being multiplied, e.g. a "model" not clearly being a math quantity ready for multiplication, such as a scalar value, a vector, a metric, etc.
12
the first physical quantity includes protein, ...
The relationship is unclear between "quantity" and "protein..." at least because "quantity" is interpreted as a value, i.e. an instance of information, and it is not clear how information can "include" a physical element such as a "protein," etc.
13
brain tumor
At least this element should be preceded by a grammatical article. The same applies to "sarcoma."
15
the morbidity converted by using Bayes' theorem
Requires but lacks clear antecedent
18
the computer program instructing the computer to
Claim 18 is rejected as directly reciting a machine and a process in the same claim. A claim to a machine, e.g. here a "computer program product," cannot directly recite a process step such as "instructing." MPEP 2173.05(p).II pertains. It may suffice to add "configured to" before the process step so as properly focus on claimed structure. MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
No prior art has been applied to the following claims
No prior art is applied to claims 1-18. Close art, for example Charlson (as cited on the attached "Notice of References Cited" form 892), as well as other art found in the search histories and on the IDSs, while addressing population morbidity in its ordinary usage, does not teach the instant combination of morbidity of a single "subject being" along with the recited combination of particularly recited models and "prior probability," and it is not clear that any combinable art of record would have rendered the claims obvious.
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 1-18 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 1-18: 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 estimating morbidity including the JE elements of "estimate morbidity...," "a first probability model...," "a second probability model...," "a prior probability...," 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 17-18 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 the recited models and prior probability, 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 and 17-18: 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 a physical quantity to morbidity, including the JE element of "estimate morbidity..."
Claims 17-18 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 1 and 17-18: 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: [27]).
[Step 2A, 2nd prong: claims 1 and 17-18: 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
All elements of claims 1 and 17-18 are part of a JE as identified above such that no element is recited which is additional to the identified JE(s). Therefore, no claim recites significantly more than the identified JE(s), and it is not clear that any claim is otherwise sufficiently analogous to controlling case law identifying an example of an eligible claim.
The recited computer hardware is interpreted as conventional as exemplified by the software environment taught by Charlson (p. 708, 2nd para.; as cited on the attached "Notice of References Cited" form 892) and as exemplified at MPEP 2106.05(d).II and 2106.05(f-g).
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 1 and 17-18: NO]
Summary and conclusion regarding claims 1 and 17-18
Summing up the above analysis of claims 1 and 17-18, 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 2-16 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.
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.
Prior art made of record but not relied upon
Additional art is listed on the attached form 892, made of record but not relied upon, and also is considered pertinent to applicant's disclosure.
Examiner comment
Applicant is encouraged to request an interview for clarification or discussion regarding the rejection(s). The examiner's phone number is provided below.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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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
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