FINAL ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is responsive to the Amendment and Response filed 13 November 2025. Claims 1-20 have been canceled and claims 21-37 have been added. All prior rejections of claims 1-20 are moot in view of the cancelation of those claims. Claims 21-37 are rejected for the reasons given below, which include new grounds of rejection necessitated by Applicant’s amendments. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Interpretation
With regard to claim 22 (which recites five possible alternatives regarding the subject’s condition corresponding to different possible patterns of scores/expression levels), it is noted that the language “the subject has ____ when the ___ score is…” is interpreted as further limiting of these possible outcomes of the “determining” of i) of claim 21 (although it is noted that the claims as written do not require any particular outcome).
Claim Objections
Claim 22 is objected to because of the following informalities: appropriate punctuation (specifically, a semicolon) is missing at the end of line 10. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)/second paragraph
THE FOLLOWING ARE NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS
Claims 24-29 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 24-29 are each indefinite over the recitation of the language “wherein the ____ score comprises inputting ____ into an algorithm…”, as this language appears to indicate that the “score” itself (which is a piece of information resulting from “determining” a score) is a process requiring “inputting…”. This rejection could be overcome by amending the claims to recite, e.g., “wherein the determining a ____ score comprises inputting….”.
Claim 28 is indefinite over the reference (in the second to last line) of expression levels “determined in step (a)”, because a) of claim 21 (from which claim 28 depends) does not include/recite such a step. Clarification is therefore required.
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.
THE FOLLOWING ARE NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claim 23 is 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.
Claim 23 recites the limitations “peramivir”, “zanamivir”, “oseltamivir”, and “baloxavir marboxil”. While it appears that Applicant’s intent may be to recite corresponding generic terminology for trademarked terms, the terms actually recited in claim 23 do not appear in the original disclosure. As Applicant has not provided any indication as to where support for these new limitations may be found, and has not provided evidence that the new claim limitations actually find basis in the original disclosure (such as by establishing that the new claim language corresponded to terminology appearing in the original disclosure as of Applicant’s effective filing date), Applicant’s amendment of 13 November 2025 adds new matter to the claims.
Claim Rejections - 35 USC § 112(d)/fourth paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
THE FOLLOWING ARE NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 24 and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 (from which claims 24 and 27 depend) requires “determining” viral and bacterial infection scores “based on the measured expression levels of” a group of six recited genes. As claims 24 and 27 recite the use of only five of this group of six genes in determining a score, these claims as written (while indefinite) appear to encompass at least some embodiments that are broadening of claim 21, such that the claims are not properly dependent from claim 21. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
THE FOLLOWING ARE NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS
Claims 21-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent claim 21 recites 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 nucleic acids and measuring the expression level of a biomarker in a nucleic acid-containing eluate, 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, constituted 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 24-29 recite further more 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 more 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. Claim 37 recites a more particular cartridge type that was well-known in the art (see again, e.g., Mauk et al and/or Niemz et al), such that nothing “significantly more” is added (with the use of the cartridge clearly corresponding to data gathering/extrasolution activity rather than any type of application of a JE).
Thus, none of claims 21-37 is presently directed to patent eligible subject matter.
Conclusion
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 DIANA B JOHANNSEN whose telephone number is (571)272-0744. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm EST.
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/DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682