DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
This application has been re-docketed to a different art unit and a different examiner.
Cancellation of restriction requirements
After further consideration, previous restriction requirements are cancelled, rendering moot the 6/9/2026 election. No claims are withdrawn.
Status of claims
Canceled:
none
Pending:
1-9
Withdrawn:
NONE
Examined:
1-9
Independent:
1, 6 and 9
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"
x
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 or column:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 4/18/2024 filing receipt, this application claims priority to no earlier than 9/28/2021. 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: spectral measurement, machine learning model, metabolic model, etc. 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 2 and 9 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
2, 9
comprise
In claim 2, a colon is needed after "comprise" before subsequent list of units.
Claim 9 is objected to similarly regarding the list beginning with "calculate the actually..."
Contrast claim 6.
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 1-9 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
a microorganism production amount prediction unit that is configured to calculate...
Claim 1 is to a 101 machine or manufacture, i.e. a "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 "configured to calculate..." 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 "device" is interpreted as not clearly requiring structure linking the "device" to the recited 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 "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.
9
spectrum acquisition unit
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "spectrum acquisition") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. [9]), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
9
a control unit configured to calculate...
...
the control unit is configured to
calculate...
Claim 9 is to a 101 machine or manufacture, i.e. a "system" 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 "configured to calculate..." 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 "system" is interpreted as not clearly requiring structure linking the "system" to the recited 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 "system," 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.
The later recited "...the control unit is configured to..." similarly renders the claim indefinite.
Claim interpretations
The following claim interpretations apply to all instances of the following terms throughout all claims:
Claim
Recitation
Comment
1
spectral measurement unit
Definite under 112/b after properly invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "spectral measurement") without reciting steps or structure to prevent invoking. However, clearly linked portion of the specification do disclose sufficient structure, material, or acts and not just desired results, as exemplified at [33]. MPEP 2181.III-IV pertain.
1
microorganism production amount prediction unit
Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "microorganism production amount prediction"), but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure (in this instance in the form of subsequent algorithmic steps) not to invoke. MPEP 2181.I.C pertains.
1, 6, 9
concentration actual-measurement model
Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "concentration actual-measurement"), but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure (in this instance in the form of subsequent algorithmic steps) not to invoke. MPEP 2181.I.C pertains.
1
machine-learning model
Recites means (or an equivalent, nonce term, here "model") and function and/or result (here "machine-learning"), but the recitation does not invoke 112/f because it is interpreted as a well-known process. MPEP 2181.I.A,3rd para. pertains with analogy to structures having "sufficiently definite meaning," such as "filters" and "brakes."
2
substrate concentration actual-measurement unit
Definite under 112/b after properly invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "substrate concentration actual-measurement") without reciting steps or structure to prevent invoking. However, clearly linked portion of the specification do disclose sufficient structure, material, or acts and not just desired results, as exemplified at [10-11]. MPEP 2181.III-IV pertain.
2
metabolic model unit
Definite under 112/b after properly invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "metabolic model") without reciting steps or structure to prevent invoking. However, clearly linked portion of the specification do disclose sufficient structure, material, or acts and not just desired results, as exemplified at [10, 27, 38-39, 46, 55-58, 61]. MPEP 2181.III-IV pertain.
2
parameter update unit
Definite under 112/b after properly invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "parameter update") without reciting steps or structure to prevent invoking. However, clearly linked portion of the specification do disclose sufficient structure, material, or acts and not just desired results, as exemplified at [27, 42]. MPEP 2181.III-IV pertain.
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 1-9
Claims 1-9 are rejected under 35 USC 103 as unpatentable over Peng (as cited on the attached "Notice of References Cited" form 892).
Regarding claim 1, the recited spectroscopy is taught as "spectroscopy " (Peng: §2.4).
The recited concentration is taught as "predicting growth" (Peng: p. 1024, 2nd col.), "morphogen concentration" (Peng: Fig. 1 caption) and "in vitro culture" (Peng: p. 1024, 2nd col.).
The recited machine learning is taught as "Machine Learning" (Peng: title).
The recited metabolic model including differential equations is taught as "finding the metabolic dynamics represented by coupled nonlinear ordinary differential equations..." (Peng: §2.2).
The recited update is taught as "creation of mathematical models of dynamical systems from measured experimental data" and "...training data and iterative model refinement or progressive model reduction" (Peng: §2.4).
The art is applied to claim 2-4 as described above for claim 1.
Regarding claim 5, application to E. coli is taught as the title of Peng's citation #10 "Absolute metabolite concentrations and implied enzyme active site occupancy in Escherichia coli."
To the extent that the limitations within the claims are taught individually but are not explicitly taught with the recited relationships and sequencing among limitations, then in the absence of a secondary consideration to the contrary, it would have been prima facie obvious to PHOSITA to try the recited combination of limitations as those limitations are taught individually as described above. Trying the recited combinations would have been examples of combining prior art elements, elements taught within the same reference, according to known methods to yield predictable results and choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (MPEP 2143.I pertains).
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.
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 1-9 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 1-9: 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 predicting culture concentration including the JE elements of "...calculate an actually measured substrate concentration...," "predict a mircoorganism culture concentration... by updating...," "wherein...," "wherein..." and "wherein...," 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 6 and 9 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 calculating a concentration, updating a parameter, using an equation, etc., 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, 6 and 9: 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: [7]).
[Step 2A, 2nd prong: claims 1, 6 and 9: 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 1, 6 and 9 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 "spectral measurement unit" (claim 1 and similarly in claim 9) and "spectrum data acquisition" 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 disclosed ([33]).
Data gathering does not impose any meaningful limitation on the judicial exceptions or on how the judicial exceptions are performed. Data gathering is insufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
The recited "incubator" is a conventional element 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 disclosed ([29]).
The recited "memory" and "control unit" is a conventional element 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)).
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, 6 and 9: NO]
Summary and conclusion regarding claims 1, 6 and 9
Summing up the above analysis of claims 1, 6 and 9, 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 2-5 and 7-8 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.
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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