DETAILED ACTION
Status of the Claims
Claims 1-16 and 19-22 are currently pending and are the subject of this Office Action.
The following Office Action is in response to Applicant’s communication dated 08/17/2026. Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. Applicant’s arguments with respect to claims 1-9 and 17-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The following rejection(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Restriction Requirement
Applicant's election with traverse of invention I, drawn to claims 1-16, 19-20, and 22 in the reply filed on 08/17/2026 is acknowledged. The traversal is on the ground(s) that “[t]he limitations of claim 21 are the same as or similar to the limitations in claim 1. Consequently, the Applicants respectfully submit that it would not present a serious search and/or examination burden to also examine claim 21.”
This is not found persuasive because a search of each of these inventions would require different key word and/or sequence searches in different patent, non-patent literature and structure databases and require, at least, specific searches for particular steps concerning invention I (e.g. the actual method steps rather than merely non-transitory computer readable medium comprising computer readable instructions), not required for the apparatus centered search of invention II. These searches would then require subsequent in-depth analysis of all relevant prior art literature and method references, placing a serious and undue burden on the Office in terms of both search and examination if Groups I & II are examined together.
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/17/2026.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(e) to U.S. provisional application 63/229,385 filed on 08/04/2021. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(e), which papers have been placed of record in the file.
Modified Claim Rejections - 35 USC § 101
Necessitated by Amendments
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 1-16, 19-20, and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
As per MPEP § 2106, the subject matter eligibility analysis begins at Step 1: Is the claim to a process, machine, manufacture, or composition of matter? Here, the claims are drawn to a process, so the answer is yes.
Next, Step 2A asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? Step 2A is a two prong inquiry, wherein Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon?
In the present case, independent claim 1 recites a step of “determining” and a step of “identifying”, with the full text of each being:
“determining, using the processing system, an estimate of activity percentages of the compounds, wherein the estimate of the activity percentages of the compounds is based on a noise distribution and the noise distribution is based on the first controls”
“identifying, using the processing system, one or more active compounds of the first assay that present or exceed the selected level of activity based on the first reference, the second reference, the measured activity, and the estimate of activity percentages”
Both steps can reasonably be considered to each belong to one or more categories of judicial exceptions. The “determining” step can reasonably be considered to be a mathematical calculation and/or a mental process, while the “identifying” step can reasonably be considered to be a mental process.
Regarding mathematical calculations, MPEP § 2106.04(a)(2)(I) states:
A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.
Regarding mental processes, MPEP § 2106.04(a)(2)(III) states:
The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).
Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675.
Note that the guidance is clear that a claim can recite a mental process even if it is claimed as being performed on a computing device. Such is the case here, where both steps are claimed to be performed “using a processing system”. The term “processing system” is not defined in the disclosure as originally filed, however, as per MPEP 2111, the USPTO “applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant’s specification.” In the present case, this reasonably includes a generic computer. Therefore, the claim recites one or more judicial exceptions.
The Guidance in MPEP 2106 states that if the identified limitation(s) falls within at least one of the groupings of abstract ideas, it is reasonable to conclude that the claim recites an abstract idea in Step 2A Prong One and that the claim them requires further analysis in Step 2A Prong Two, which is whether the claim recites additional elements that integrate the exception(s) into a practical application of that exception(s). See MPEP § 2106.04(d), which states that a claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, and MPEP § 2106.05(e), which states that other considerations for Step 2A Prong Two and Step 2B are the presence of “meaningful limitations”, which are limitations when they amount to significantly more than the judicial exception, or when they integrate a judicial exception into a practical application.
In the instant case, for claim 1, additional steps include three steps of receiving, using a processing system, measured activity and a first and second reference. These “receiving” steps can reasonably be considered mere data gathering steps, which have been consistently identified by the courts are insignificant extra-solution activities that do not represent integrating the judicial exception(s) into a practical application, as required by Prong Two of Step 2A. For detailed discussion of insignificant extra-solution activities and how they relate to subject matter eligibility analysis, please see MPEP § 2106.05(g).
Claim 1 further comprises a step of “(i) synthesizing the one or more compounds based on the identified one or more active compounds or (ii) performing further testing on the identified one or more active compounds to further identify one or more compounds from the further testing for the synthesizing.” Although this is a physical step, effecting a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)), it amounts to simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which does not integrate the judicial exception into a practical application, nor does it amount to significantly more than the judicial exception. See MPEP § 2106.05(I).
Therefore, the claim must further be analyzed to identify additional elements to determine whether the claim as a whole amounts to significantly more than the judicial exception (i.e. Step 2B of the analysis).
Step 2B of the analysis asks: does the claim recite additional elements that amount to “significantly more” than the judicial exception(s)? This is often referred to as a search for an inventive concept and is detailed in MPEP § 2106.05.
In the present case, this analysis closely mirrors that of Prong Two, above, in considering the additional elements of the claims. As outlined above, independent claim 1 recites three steps of “receiving”, which were determined to be mere data gathering steps and thus can be considered as insignificant extra-solution activities that do not amount to “significantly more” than the judicial exceptions. The only other additional element is the final step of synthesizing one or more compounds or performing further testing. As was determined above, these additional elements each amount to simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which does not amount to significantly more than the judicial exception(s).
Therefore, the claim is not patent eligible.
In some cases, limitations of dependent claims may result in a claimed invention that is patent eligible, and therefore must be thoroughly considered.
Claims 2-3 recite “preparing a second assay based on the identified one or more active compounds of the first assay, wherein the second assay comprises second controls” and “conducting an experiment on the second assay using the experiment system”, respectively, however, these steps amount to simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception so as to essentially represent instructions to merely “apply” the judicial exceptions, which does not integrate the judicial exception into a practical application, nor do they amount to significantly more than the judicial exception(s).
Claim 4 recites “identifying one or more active compounds of the second assay for the synthesizing based on the first reference and the second reference, based on the measured activity of the experiment on the second assay”, which itself reasonably can be considered a mental process, being an abstract idea, and is a judicial exception. Therefore, it cannot transform claim 1 into patent eligible subject matter.
Claims 5-9 and 11-16 merely further define or limit the noise distribution, first and second references, estimation of activity percentages, and therefore cannot be considered as additional elements that integrate the judicial exceptions into practical applications, nor can they amount to “significantly more” than the judicial exceptions and therefore are similarly patent ineligible. Claim 10 recites a step of “adjusting error assumptions”, which reasonably encompasses embodiments wherein this step is purely a mental step, which is itself a judicial exception.
Independent claim 19 is essentially the same as claim 1 but requires in the final step “conducting an experiment on a second assay comprising the identified active compounds to further identify active compounds from the second assay; and synthesizing the one or more compounds based on the further identified active compounds.” The analysis here is analogous to claim 1, wherein although the final steps are physical steps, effecting a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)), such steps amount to simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which does not integrate the judicial exception into a practical application, nor do they amount to significantly more than the judicial exception. See MPEP § 2106.05(I). Claim 20 merely further defines or limits the noise distribution and therefore cannot be considered an additional element that integrate the judicial exceptions into practical applications, nor can it amount to “significantly more” than the judicial exceptions and therefore is similarly patent ineligible. Claim 22 depends from claim 19, further comprising iterating the conducting an experiment on a second assay until an additional testing criteria is satisfied to provide one or more compounds satisfying the additional testing criteria and synthesizing the one or more compounds satisfying the additional testing criteria. This amounts to simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which does not integrate the judicial exception into a practical application, nor does it amount to significantly more than the judicial exception. See MPEP § 2106.05(I).
For further information, please see the latest revision of MPEP § 2104-2106 {Patent Subject Matter Eligibility Under 35 U.S.C. 101}, including MPEP § 2106.04 {Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception} and 2106.05 {Eligibility Step 2B: Whether a Claim Amounts to Significantly More}, as well as any additional guidance on Subject Matter Eligibility, provided on the USPTO website at
https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility.
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Response to Arguments
The 04/13/2026 remarks argue: claims are eligible subject matter.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
The remarks at pages 10-11 assert that the method claimed in amended claim 1 requires the experiment system, the measurement instrumentation, the wells, and the processing system all as claimed, and therefore is not directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea as related to the Step 2A analysis.
In response, as noted in the amended rejection, above, MPEP 2106 is clear that “[c]laims can recite a mental process even if they are claimed as being performed on a computer.” That is, the mere inclusion of physical apparatuses cannot alone rescue a claim from rejection under 35 U.S.C. 101. Regarding the processing system, the measurement instrumentation, and the wells, MPEP 2106.05(b) is helpful and particularly relevant. Here, the Guidance states that “[i]t is noted that while the application of a judicial exception by or with a particular machine is an important clue, it is not a stand-alone test for eligibility” (emphasis in original). Regarding the newly added “processing system” in the claims, MPEP 2106.05(b) states that “[i]t is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine.” As detailed in the rejection, above, the “processing system” of the claims lacks a limiting definition in the specification and therefore the broadest reasonable interpretation of the term in light of the specification includes a system capable of receiving, determining, and identifying the details of the claims and reasonably includes a generic computer. As for the measurement instrumentation and the wells, the “[u]se of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more.” The term “measurement instrumentation” is stated at a very high level of generality as necessary for data gathering steps, and the use of wells (e.g., in multi-well plates) is incredibly routine, conventional, and well-understood in the field of assay compound screening.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST.
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/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
