DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 June 2026 has been entered.
Claims 21, 22, 25-26, and 28-29 have been amended and claims 24, 27, and 37 have been canceled. All prior rejections of claims 24, 27, and 37 are moot in view of the cancelation of those claims. Claims 21-23, 25-26, and 28-36 remain under consideration. Applicant’s amendments and arguments have been thoroughly reviewed, and have overcome the objection to claim 22 (in view of the amendment of the claim to correct a typographical error), and the prior rejections under 35 USC 112(b) (in view of Applicant’s clarifying amendments). Claims 21-23, 25-26, and 28-36 remain rejected for the reasons given below. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is non-final.
Claim Interpretation
With regard to the recitation of the limitation “the processing chamber” in c) of independent claim 21 (from which claims 22-23, 25-26, and 28-36 depend), it is noted that this is interpreted as referring to the “one of the processing chambers” recited in b) of the claim.
Also regarding claims 21-23, 25-26, and 28-36, it is noted that while claim 21 initially recites “measuring expression levels” (plural) of a biomarker, the body of the claim refers to “measuring the expression level” (singular, and the claim does not recite any other steps/activities corresponding to measurement of expression levels). Given what is actually recited in the body of the claim, the preamble recitation of a “method of measuring expression levels” is interpreted as referencing the type of activity specified in the body of the claim, i.e., the claim has not been interpreted as requiring multiple separate “measuring” of a biomarker.
Claim Rejections - 35 USC § 112(b)/second paragraph
The following is a quotation of 35 U.S.C. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-23, 25-26, and 28-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 21-23, 25-26, and 28-36 are indefinite over the recitation at h) and i) of claim 21 of the limitations “amplifying the nucleic acids” and “measuring the expression level of the biomarker in the eluate based on the amplification signals detected through the optical window”, respectively. First, it is noted that c), d), e), and f) reference processing of “nucleic acid”, not “nucleic acids”. The use of the plural “nucleic acids” in h) does not clearly relate back to the prior method steps, and raises a question as to whether h) is referencing the previously recited “nucleic acid”, or something else (as there are no other terms/actions/etc. in h) that necessarily link the “amplifying the nucleic acids” to the prior activities; clear antecedent basis is lacking). Second, the recitation “based on the amplification signals detected through the optical window” is confusing as the claim does not previously refer to such “amplification signals”, and further the recitation “based on” does not make clear what is actually required to achieve the “measuring the expression level” of the claim. Further clarification is therefore needed.
Claim Rejections - 35 USC § 112(a)/first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-23, 25-26, and 28-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection, and relates to two separate issues, as set forth below.
First, claim 23 remain rejected as a result of the addition of that claim by the amendment of 13 November 2025. The claim recites the limitations “peramivir”, “zanamivir”, “oseltamivir”, and “baloxavir marboxil”. While Applicant’s intent was to recite corresponding generic terminology for trademarked terms, these terms now recited in claim 23 do not appear in the original disclosure, nor has basis in the original disclosure been established for these terms (it is noted that MPEP 2173.05(u) states that examiners must determine whether there is sufficient support in the application for use of a generic term, and Applicant has yet to adequately establish that such support is present).
The reply of 29 June 2026 traverses the rejection on the grounds that corresponding brand names appear in the original disclosure, and that written description under 35 USC 112(a) is satisfied because an ordinary artisan “would recognize the limitations….as the generic drug names describing the same antiviral therapies…that were originally disclosed under their trademarked brand names”. However, this argument is non-persuasive, as such trademarks identify the source of goods, not the goods themselves (as was discussed in the prior rejection of the claim due to the original recitation therein of trademarks/tradenames). While Applicant could potentially provide evidence (in declaratory form, or by the citations of references) establishing that these terms were known to correspond to one another at the time the application was filed, Applicant’s assertions/arguments cannot take the place of actual evidence (see MPEP 716.01(c)). Accordingly, these arguments are not persuasive.
Second, as a result of Applicant’s amendments to independent claim 21 (amendment of 29 June 2026), claims 21-23, 25-26, and 28-36 now encompass new matter. In particular, while the application as filed provides basis for a cartridge as recited in amended claim 21, as well as some activities employing such a cartridge (primarily discussed at paragraphs 183-186 of the disclosure, as noted by Applicant at the top of page 7 of the Reply), the claim now recites several specific actions that do not find basis in the application as filed, including the “actuating a valve” as set forth in d), the ”transporting the eluate to the reaction tube” of g), and the “measuring the expression level….based on the amplification signals detected through the optical window” of i). While the specification discloses that a “valve enables fluid transfer from chamber to chamber and contains nucleic acids lysis and filtration components” (specification paragraph 184), this is not equivalent to an “actuating the valve” as set forth in the claim, and there is no other disclosure of the use of a valve in the application. Similarly, the specification states that a “reaction tube enables very rapid thermal cycling”, which does not constitute a disclosure of “transporting eluate” to this specific tube. Finally, while the specification teaches that an “optimal window enables real-time optical detection”, this does not support the claim activity of measuring expression “in the eluate based on the amplification signals detected through the optical window” (which is more specific/particular than what was originally disclosed). It is noted that discussion of these specific cartridge components and their uses is limited to this particular portion of the specification, and that the application does not otherwise disclose what is now claimed. Further, while the specification does incorporate by reference in their entirety several prior US patents related to “laboratory in a cartridge” technology (see paragraph 183), this general disclosure of several entire documents does not support the amendment of the claims to now recite the noted specific method steps/activities. Accordingly, Applicant’s amendment of 29 June 2026 adds new matter to the claims.
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.
Claims 21-23, 25-26, and 28-36 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent claim 21 as amended continues to recite multiple abstract ideas, including:
i) ”determining” scores for viral and bacterial infection based on measured expression levels, which potentially encompasses both thought and mathematical concepts/calculations;
ii) ”comparing” scores to cutoff values, which is an activity that may be performed entirely in the human mind;
iii) ”determining” a subject’s status with regard to a viral infection, bacterial infection, or non-infectious cause of fever, which encompasses drawing conclusions from previously recited “determining” and “comparing” (i.e., a further entirely mental activity); and
iv) “selecting” a therapy “for administration”, which again – given that no actual treating/administering is required – encompasses, e.g., forming a conclusion regarding a planned/future action, which may be achieved by thought.
It is also noted that this series of steps, considered together, is also abstract in nature, as it may be performed by thought, potentially encompassing calculations/mathematical concepts.
These judicial exceptions (JEs) are not integrated into a practical application because there are no activities required by the claims that constitute an application/ implementation of a JE. While the claims recite use of a cartridge in steps of extracting and analyzing nucleic acids to accomplish measuring the expression level of a biomarker “based on” amplification signals, such data gathering required to obtain information to use a JE does not add a meaningful limitation to the method, as it is insignificant extrasolution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these data gathering activities, whether considered alone or in combination, constitute well-understood routine and conventional activities as of Applicant’s effective filing date. For example, Mauk et al (Microarrays 4:474-489 [2015]; cited herein; see entire reference, particularly Fig. 1) and/or Niemz et al (Trends in Biotechnology 29(5):240 [2011]; cited herein; see entire reference, particularly Fig. 1) teach cartridges/cassettes that may be employed in extraction/isolation of nucleic acids from samples as well as further processing/ amplification/detection of target nucleic acids therein, and which include structural elements meeting the requirements of the claims (see in particular Fig. 1A of Niemz et al). With further regard to the measurement of gene expression levels in biological samples, including with regard to the particular genes of the claims, this also encompasses well-understood, routine, and conventional activity as of the effective filing date of the claimed invention (see, e.g., any of Tsalik et al, Eden et al, Storch, and Liu et al, previously cited). Further, the levels of gene expression that occur in association with a disease/condition are themselves natural phenomena (rather than something “more” than a JE), and the broad/general activities set forth in the claims (e.g., “measuring the expression level of the biomarker”) correspond to the types of laboratory techniques recognized by the courts as well-understood, routine, and conventional in the life science arts when claimed at a high level of generality (as is the case here) (see MPEP 2106.05(d)(II)). Additionally, while the claims recites activities involving a particular group of genes, these activities are abstract ideas – e.g., thinking about relative “scores” via comparisons with other scores/values – rather than something “more” than a JE. An inventive concept cannot be furnished by a JE itself (see MPEP 2106.05(I)).
With further regard to dependent claim 22, this claim recites a series of alternative contingent/conditional limitations without requiring that any of the alternatives actually be met; thus, the analysis above that applies to claim 21 also applies to claim 22 (see MPEP 2111.04(II): “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”). Claim 23 recites various more particular therapies that may be “selected” as part of the claimed method; however, the “selecting” of the claims is abstract (as discussed above), and claim 23 does not require any type of application/implementation of the claimed method, or any active steps in which the recited therapies are actually employed (such that nothing “more” than a JE is added by the claim). Claims 25-26 and 28-29 recite further particular abstract ideas, encompassing more specific thoughts and/or calculations; nothing “significantly more” than a JE, and nothing constituting an application/implementation of a JE, is added (and even to the extent that “inputting” could be considered manipulative in nature, such inputting to provide information for scoring/calculations constituted routine and conventional activity as of Applicant’s effective filing date). Claims 30-32 recite further specific types of bacterial infection, non-infectious cause of fever, and viral infection, respectively, but these are further limitations on the abstract “determining” of the claimed method (i.e., more specific types of JEs), rather than something “more” than a JE, or an application of a JE. Claim 33 recites more particular types of samples from which data may be gathered, which amounts to insignificant extrasolution activity (even in the case where some type of physical/active sample testing might be required); further, nothing “significantly more” is added by limiting the claims to information gathered from standard types of biological samples known in the prior art. Claims 34-35 recite broad categories of well-known techniques for the gathering of data (i.e., related to insignificant extra solution activity, rather than an application of a JE), and such testing was clearly well-known in the art as of Applicant’s effective filing date (see again, e.g., Tsalik et al, cited above). Claim 36 requires testing of a more particular type of subject, which is further limiting of a data gathering, rather than an application/implementation of a JE. Further, the testing of a subject with a fever/a postoperative subject for infection was clearly well-understood, routine and conventional as of Applicant’s effective filing date, such that nothing significantly more than a JE is added.
Thus, none of claims 21-23, 25-26, and 28-36 is presently directed to patent eligible subject matter
The Reply of 29 June 2026 traverses the prior rejection under 35 USC 101 on the following grounds.
Applicant summarizes the amendment of claim 21 (Reply page 9 bridging to page 10), and urges that claim 21 “integrates the recited exception into a practical application using a ‘particular machine or manufacture that is integral to the claim’” (citing to MPEP 2106.04(d) and 2106.05(b))(Reply page 10). More particularly, Applicant argues that the method steps now recited in the claim use the physical features of the cartridge in a defined order, and that the “ordered sequence transforms the biological sample into purified and amplified products, and optical signals representing quantified expression, using the specific cartridge architecture, and thus constitutes a practical, technological application rather than mere ‘observation’ of a correlation” (Reply page 10 bridging to page 11).
These arguments have been thoroughly considered but are not persuasive. Initially, it is noted that the rejection does not assert that the claims recite an observation of a correlation; rather, the focus of the rejection is the recitation in the claims, following the gathering of data via use of the recited cartridge, of several abstract ideas (with the measured gene expression levels also constituting a natural phenomenon, a further judicial exception (JE)). With regard to the argument that the cartridge constitutes a “particular machine or manufacture”, it is noted that cartridges of the type in question were known in the art as of Applicant’s effective date (as discussed in the rejection, with Applicant’s specification also referencing/acknowledging prior disclosures of such a cartridge [see, e.g., specification paragraph 183]). Further, the activities set forth in the claim recite use of the cartridge in a standard manner for purposes of “measuring the expression level of the biomarker” (i.e., gathering data), and claim 21 then subsequently recites a series of abstract steps/activities (again, as discussed in the rejection). Thus, in the instant case, the preponderance of the evidence weighs in favor of concluding that the use of the cartridge corresponding to routine data gathering, a type of extra solution activity (it is noted that the claims do not set forth the inclusion in the cartridge of any reagents/materials, e.g., specific probes/primers, that target the particular genes of the recited biomarker; rather, the use of the cartridge concludes with “measuring the expression level….based on the amplification signals…”, with the biomarker subsequently recited). Nothing in the claim following this data gathering constitutes a practical application (for example, the claims do not recite an actual treatment, but rather conclude with ‘selecting” a therapy); rather, a series of mental/abstract activities are recited. With regard to MPEP 2106.05(b), it is noted that while it is stated that use of a particular machine “may integrate the recited judicial exception into a practical application or provide significantly more”, involvement of a “particular machine” in data gathering/extra-solution activity – which appears to be the case here - does not do so (see in particular MPEP 2106.05(b) at (II) and (III)). Thus, Applicant’s arguments are not found persuasive given the manner in which the cartridge and its use are recited in the claims.
Conclusion
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/DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682
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