DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
The Amendment and Response filed December 23, 2025 is acknowledged.
Claims 1, 6-8, 12, 14-15, 17-22, 28-29, 33, 35 and 47 were pending. Claims 20-22, 28-29, 33, 35 and 47 are being examined on the merits. Claims 1, 6-8, 12, 14-15 and 17-19 remain withdrawn.
Response to Arguments
Applicant’s arguments filed December 23, 2025 have been fully considered.
The following rejections are MODIFIED in view of the amendments to the claims:
Rejection of claims 20-22, 28-29, 33, 35 and 47 under 35 USC § 101
Response to arguments regarding 35 USC § 101 rejections
The rejections are modified in view of the instant amendments. However, to the extent that Applicant’s arguments relate to the instantly amended claims, the Examiner notes the following.
Applicant argues that the 35 USC § 101 rejections should be withdrawn for various reasons, discussed in turn below.
Step 2A, Prong 1
First, regarding Step 2A, Prong 1, Applicant makes the following arguments:
Applicant states that while the Office Action cites “computer logic” as an abstract idea, the Office Action does not “discuss[] any of the control actions the processor recited in the claims is configured to control … [including] control of the fluidics and thermal interface to flow various substances, perform thermal cycles and timing thereof, and receipt of an analysis of signals from specific portions of the instrument” (Remarks, pp. 9-10).
Applicant argues that the Office’s assertion as to the recited “‘logic’ and ‘processor’ and their interaction and configuration within the system are not merely mathematical or arithmetic operations” and that the Office’s position is “overly broad and inaccurate”. Applicant further argues that the “claims do not just recite ‘computer logic’ that carries out mathematical calculation; rather the computer logic and one or more processors are operably coupled to other system components and provide specific interaction and control …” (Remarks, pp. 9-10).
Applicant argues that the office incorrectly “conflate[s] claims that are directed to algorithms with claims that involve the use of algorithms to perform claim limitations” and further that “[u]nder this interpretation by the Office, any claims that include a computing device as part of a system would fall within the mathematical calculations exception …” (Remarks, p. 10).
The Examiner disagrees. In each of these arguments, Applicant misunderstands and
misapplies the Step 2A, Prong 1 analysis. The only inquiry in Step 2A, Prong 1 is whether the claim recites an abstract idea (or other judicial exception (JE)), which Applicant concedes that it does. For example, see the flowchart in MPEP 2106.04(II)(A), which shows in part …
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Notice that the word used is “recite” not “directed to”, as Applicant repeatedly misstates. The additional elements Applicant refers to are analyzed in Step 2A, Prong 2 and in Step 2B. The fact that additional elements are recited in the claim does not somehow negate the fact that an abstract idea is recited, or change the Step 2A, Prong 1 analysis in any way.
Finally, for clarity of record, Applicant states that the prior Office Action refers to “(b) computer logic” and comments that there is no “(b)” in the claims. The Examiner notes that “(b) [computer] logic” appeared in the first 3 versions of claims 20 and 47, but the claims were amended to remove “(b)” in the last claim set. The “(b)” was inadvertently not removed from the Office Action mailed October 22, 2025, but has been removed below.
Step 2A, Prong 2
As to this prong, Applicant reiterates their arguments provided in the July 9, 2025 response that the instant claims provide the technological improvements of “increased efficiency and accuracy in nucleic acid sample processing and analysis that can be utilized for applications where time is of the essence”, and “biological sample preparation and analysis workflows, including in forensic analysis applications, that control the fluidics and thermal interface to perform one or more thermal cycles corresponding to … qPCR on a first portion of DNA, [] and to perform … additional thermal cycles corresponding to … STR PCR on a second portion of DNA, and determine … a target number of thermal cycles” (Remarks, pp. 12-13). Applicant concludes “[t]hese in addition to other aspects recited in the claims are clearly above and beyond instructing a generic computer to carry[] out a well-known method” (Remarks, p. 13).
The Examiner disagrees, at least, for the reasons discussed below in conjunction with the 35 USC § 101 rejections. Briefly, MPEP 2106.05(a)(II) states that “the claim must include more than mere instructions to perform the method on a generic component … to qualify as an improvement to existing technology”. Here, all of the non-JE components are generic components, including the fluidic cartridges, the fluidics and thermal interface, the control module, the processors1.
Applicant also argues that the claimed subject matter is eligible because the instant claims are similar to Enfish, LLC v. Microsoft Corp., 882 F.3d 1327 (Fed. Cir. May 12, 2016), because they offer technological improvements in the functionality and use of the of a biological assay system configured to carry out specific tasks.
However, as to Enfish, the MPEP states that it should be determined “whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool” to determine whether there is an improvement to computer functionality. MPEP 2106.05(a)(I). Here, the limitation in claims 20 and 47 that is analogous to the Enfish “computer” is the instant “control module comprising computer logic”. Applicant has not even argued that there is an improvement in the functioning of the “control module” itself, as would seemingly be required if analogizing to Enfish. Further, to the extent that Applicant is arguing that the instant claims provide an improvement to “any other technology or technical field”, as discussed in MPEP 2106.05(a)(II), it should be noted that the MPEP does not cite Enfish as being any way relevant to that inquiry.
Step 2B
Finally, as to Step 2B, Applicant reiterates their arguments provided in the January 29, 2025 and July 9, 2025 response that the instant claims are patent eligible because the instant systems are analogous to a non-conventional and non-generic arrangement of a generic computer network, and cites the BASCOM case (Remarks, pp. 14-15).
The Examiner disagrees, and emphasizes the following point - the “computer logic” that relates to how the cycles of the STR PCR are determined based on an ongoing PCR is a JE itself. The “additional element” consideration only relates to non-JE claim limitations. A JE itself cannot be an “additional element that amounts to an inventive concept”. MPEP 2106.05 states …
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Further, specifically in reference to BASCOM, MPEP 2106.05(I)(B) recites …
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Regarding Applicant’s statement that “the arrangement of hardware and control logic can itself be non-conventional” (Remarks, p. 14), the Examiner can find no support for such a statement in the MPEP, nor has Applicant provided any. Rather, here, the arrangement of hardware alone (i.e., the “additional elements”) would have to be sufficient to integrate the judicial exception into a practical application for the claim to eligible at Step 2B. Applicant has not even presented such an argument, but the Examiner notes that a system configured to carry out multiple PCR reactions in parallel, per se, is not unconventional.
These arguments are not persuasive. The rejection is modified in view of the instant claim amendments.
Claim Interpretation
Independent claims 20 and 47 each recite “[a] system … comprising … fluidic cartridge(s) …; a[n] interface …; a control module …; and computer logic … to cause … operations” to be performed. The instant specification teaches that the term “logic” is synonymous with the term “programming” (p. 32, ll. 27-33), and that the programming/logic may reside locally, e.g., on the instrument, or remotely, e.g., as a cloud-based computational resource, or both (p. 32, ll. 27-33 through p. 33, ll. 1-2). Thus, for purposes of examination, the term “logic” in each of claims 20 and 47 is interpreted as a set of instructions or algorithms that cause a computer instrument/system to execute a specific operation.
Further, the specification teaches various embodiments of the claims 20 and 47 system
comprising an interface and logic, including embodiments where the interface and logic are comprised within a system that also includes hardware components (e.g., a cartridge) for carrying out the operations (e.g., qPCR, STR PCR) encoded by the claimed logic (e.g., p. 32, ll. 12-16). Claims 20 or 47 have now been amended to recite additional hardware components (e.g., a control module) for carrying out the operations (e.g., qPCR, STR PCR) and thus, the broadest reasonable interpretation of claims 20 and 47 does include hardware components, i.e., cartridges, for carrying out the molecular biology steps that are encoded within the logic. However, the recited hardware components are generic components in the art of nucleic acid amplification.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted.
Claims 20-22, 28-29, 33, 35 and 47 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to non-statutory subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more judicially-recognized exceptions to patentability (JEs), i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature, as identified below. Below, it is not clear that any element or combination of elements in addition to the JE(s), i.e. and "additional elements," either integrate the identified JE(s) into a practical application and/or are non-conventional additional elements. Therefore, it is not clear that any claim is directed to significantly more than the identified JE(s).
MPEP 2106 organizes JE analysis into Steps 1, 2A (1st prong & 2nd prong) and 2B as analyzed 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.
Analysis of claims 20-22, 28-29, 33, 35 and 47
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Independent claim 20 is directed to a 101 machine or manufacture, here a "system," with non-transitory elements such as "(a) a[n] interface ..."
Independent claim 47 is directed to a 101 machine or manufacture, here a "system," with non-transitory elements such as "(a) a[n] interface ..."
[Step 1: claims 20 and 47: YES]
Step 2A, 1st prong: Do the claims recite a judicially-recognized exception (JE), e.g. a law of nature, a natural phenomenon or product, or an abstract idea (MPEP 2106.04.II.A.1 & .04(a))?
MPEP 2106.I, 2nd para. identifies four court-recognized types of JEs: abstract ideas, laws of nature, natural phenomena and natural products.
MPEP § 2106.04(a)(2) further explains that abstract ideas may be grouped as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
• certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
• mental processes (procedures for observing, evaluating, analyzing/ judging and
organizing information).
The instant claims at Step 2A, 1st prong, at least preliminarily are interpreted as reciting JEs in the form of abstract ideas (claims 20 and 47), as follows.
At this step of the analysis, elements of independent claim 20 are interpreted as directed to the abstract idea of mathematical concepts, including the particularly recited JE steps/elements of "computer logic” which, when executed, “cause[s] … the system to perform … operations”, including all recitation within each listed element. The above-identified steps/elements are interpreted as directed to the abstract ideas identified below.
Claim 47 is analyzed similarly at this step.
BRIs of the claims are analogous to the JE of an abstract idea in the form of a mathematical concept, including mathematical relationships and calculations. Instant examples of math concepts that cause the claim(s) to be directed to the above-identified JE(s) include the "computer logic” which, when executed, “cause[s] … the system to perform … operations”, as recited in claim 20, in which “logic” is interpreted as a particular set of instructions or algorithms that cause a computer instrument/system to execute a specific operation. Case law, establishing the mathematical concept JE and to which the instant claims are analogized, is presented in MPEP 2106.04(a)(2).I, including examples of analogous mathematical concept JEs.
Claim 47 is analyzed similarly at this step.
[Step 2A, 1st prong: claims 20 and 47: YES]
Step 2A, 2nd prong: Are the above-identified JEs integrated into a practical application (MPEP 2106.04.II.A.2 & .04(d))?
Generally regarding Step 2A, 2nd prong
MPEP 2106.04(d).I lists the following considerations for evaluating whether additional elements integrate a judicial exception into a practical application:
An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to affect 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).
Additionally, the courts have also identified limitations that did not integrate a judicial exception into a practical application:
Merely reciting a phrase such as "apply it" (or an equivalent) along with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP 2106.05(f);
Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP 2106.05(g); and
Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP 2106.05(h).
At this point in examination, it is not clear that the identified JEs are integrated into a practical application according to any of the "considerations" exemplified in MPEP 2106.04(d).
For example, relating to the first consideration at MPEP 2106.04(d)(1), it is not yet clear in the record that application of the above-identified JEs in all claimed embodiments must result in an improvement to the technology field in the form of, for example, improved detection and discrimination of nucleic acid targets (specification: p. 9, ll. 30-34 through p. 10, ll. 1-22). In addition, claims 20 and 47 incorporate hardware components; specifically, “one or more fluidic cartridges each comprising one or more chambers” and “a control module … operably coupled to the … interface”. However, the instant specification does not define the limitation “fluidic cartridges comprising chambers” in any way that would exclude generic hardware components in the field of nucleic acid amplification (p. 3, ll. 4-13), nor does it define “a control module” in any way that would exclude a generic computer (p. 32, l. 11, et seq.). Thus, at least some embodiments of the instantly claimed system comprises generic hardware components/computers. Further, MPEP 2106.05(a)(II) states that “the claim must include more than mere instructions to perform the method on a generic component … to qualify as an improvement to existing technology”. In addition, see Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017), where the Federal Circuit held that using well-known standard laboratory techniques, specifically using ELISA kits and techniques, to detect enzyme levels in a bodily sample was not sufficient to show an improvement to technology. Therefore, while there are non-JE components in the claims 20 and 47 systems, they are not sufficient to result in an improvement in a technology or technical field for the reasons set forth in MPEP 2106.05(a)(II).
[Step 2A, 2nd prong: claims 20 and 47: NO]
Step 2B: Do the claims recite a non-conventional arrangement of additional elements (i.e. elements in addition to any identified JE) (MPEP 2106.05)?
All elements of claims 20 and 47 are part of the identified JEs (as described above), except for elements identified here as conventional elements in addition to the above JEs:
The recited "(a) a[n] interface ..." steps/elements, interpreted as requiring a hardware component for receiving and operating one or more cartridges (specification, p. 4, ll. 16-18), is a conventional element of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by Wunderle2 (WO 2016/205428 A1: paras. 17, 126, 128, 132, 136, 140-141), as are fluidic cartridge(s) comprising chamber(s) and control modules, e.g., generic computers, as also exemplified by Wunderle (WO 2016/205428 A1: paras. 3, 117, 125-126; Fig. 1).
[Step 2B: claims 20 and 47: NO]
Summary and conclusion regarding claims 20 and 47
Summing up the above 101 JE analysis of claims 20 and 47, 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 above-identified JE(s), into patent eligible subject matter.
Remaining claims 21-22, 28-29, 33 and 35
Claims 28-29 and 35 add elements which also are part of the identified JEs for the same reasons described above 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:
Claims 21-22: the recited “one or more actuators”, and “a thermocycler” step/element, as evidenced by Wunderle (WO 2016/205428 A1: paras. 10, 63, 121, 128, 141, 169, 174, 183).
Claim 33: the recited “capillary electrophoresis …” step/element as evidenced by Wunderle (WO 2016/205428 A1: paras. 116, 122-124, 128).
Prior Art
Claims 20-22, 28-29, 33, 35 and 47 are free of the art.
The closest prior art is Wunderle (WO 2016/205428 A1). Wunderle is directed to a valved cartridge and system than can be used to perform nucleic acid amplification reactions, including STR amplification of forensic samples The cartridge and system comprises an “interface”, “logic” and various hardware components (abstract; paras. 13-14, 17, 111, 126). Wunderle teaches a method of qPCR where the reaction volume comprises a multiplex reaction of STR amplification and a human specific probe. The human specific probe is used to quantify the amount of DNA in the reaction volume. That information can then be used to adjust the number of amplification cycles to achieve optimal amplification of the STR reaction (para. 174).
However, Wunderle does not teach the following combination of limitations in instant
claims 20 and 47: (1) requiring that the system is configured to permit two reactions to occur in parallel in two separate reaction volumes; specifically, a qPCR in a first reaction volume and an STR PCR in a second reaction volume; (2) that the system is configured to start the STR PCR before the qPCR is complete; and (3) that the system is configured to adjust the number of cycles of the STR PCR based on the information from the qPCR. Further, there does not seem to be any motivation for the ordinary artisan to modify Wunderle to incorporate these limitations because Wunderle teaches that forensic samples are often limited in volume, and thus there is a concern about not having a sufficient sample to perform both qPCR to quantify the amount of the sample and also perform the actual STR PCR (para. 174). In the instant claims, the ordinary artisan would understand that STR PCR may be overamplified by the time the sample is quantified with the qPCR. Thus, the ordinary artisan would not be motivated to modify Wunderle to arrive at the instant claims because of the risk of wasting forensic samples.
Conclusion
Claims 20-22, 28-29, 33, 35 and 47 are being examined and are rejected. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 For example, a search of US and international patent databases using the search string “((fluid$3 ADJ5 cartridge$3) OR (interface) OR (control ADJ module$3) OR processor$3)” produces 39,686,585 hits. Even if the search is limited to CPC C12Q 1/6806, the search still produces 16,163 hits.
2 Wunderle was cited in the Information Disclosure Statement submitted June 4, 2021.