DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
4-5, 8-11, 14-15, 18-22, 28, 32-34, 36-40, 45-86 and 88-129
Pending:
1-3, 6-7, 12-13, 16-17, 23-27, 29-31, 35, 41-44 and 87
Withdrawn:
24-26 and 41-42
Examined:
1-3, 6-7, 12-13, 16-17, 23, 27, 29-31, 35, 43-44 and 87
Independent:
1, 44 and 87
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"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
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
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 8/10/2021 filing receipt, this application claims priority to as early as 9/14/2018. At this point in examination, all claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The specification title objection is withdrawn.
The drawings objection is withdrawn.
The 112/b rejections are withdrawn, however new rejections are applied.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
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 1-3, 6-7, 12-13, 16-17, 23, 27, 29-31, 35, 43-44 and 87 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)
44, 87
wherein the plurality of quantitative measures is measured from a plurality of tumor-derived cell-free DNA (cfDNA) molecules from a blood sample of a subject...
In claim 44:
(i) It is unclear whether this recitation should be interpreted as product-by-process (PbP), the recited "plurality of measures" as product and the recited "is measured" as a previously performed process vs. whether the recitation requires that the "is measured" be performed as part of the instant claim.
Regarding product-by-process limitations in method claims, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential).
(ii) And, to the extent that the claim does require performance of the recited "is measured," then it is unclear how to interpret performance of this apparently wet laboratory step by the recited memory, processor and instructions. A corresponding 112/a rejection applies below. While the claim also recites "wherein the plurality of quantitative measures is measured from a set of sequencing reads," this does not clarify the above interpretation of the recited "is measured." If only analysis of sequence data is intended, then possibly the claim should explicitly recite input of the already-acquired sequence data, in which case a PbP interpretation would apply to any previous, not directly claimed sequencing step. Also, it is not clear that the claim is limited according to sample type, e.g. how structure of the recited software requires such a limitation.
Claim 87 , reciting similar "wherein" clauses, is rejected similarly.
87
comprising... code that... performs the steps of:...
Claim 87 is rejected as directly reciting a machine or manufacture and a process in the same claim. A claim to a manufacture, e.g. here a "medium," cannot directly recite a process step such as "performs." This is true whether the process step depends on a conditional phrase or not. MPEP 2173.05(p).II pertains.
To overcome this rejection, it would suffice to add "configured to" before the process step so as to properly focus on claimed structure. Any "configured to" probably should not be conditional on the recited "upon execution" so that it is clear what is the structure of the claimed manufacture.
MPEP 2173.05(p).II pertains regarding a claim directed to both product and process.
Claim rejections - 112/a
The following is a quotation of 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.
Regarding issues of written description support stemming even from the original claims and original disclosure, MPEP 2161.01.I (e.g. 6th para.), 2163.I and 2163.I.A pertain: "[O]riginal claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed" (MPEP 2161.01.I,6th para.).
Response to arguments regarding Claim Rejections - 35 USC 112/a -- written description
Applicant states (original emphasis removed, bold emphasis added, applicant remarks: p. 12):
that the quantitative measures to be obtained are measured from a set of sequencing reads (i.e., at each of the plurality of microsatellite repeat elements in the plurality of tumor-derived cfDNA molecules).
As further detailed in the revised 112/b and 112/a rejections and in contrast to Applicant's assertion above, the claim is not yet clearly limited to only computational analysis of sequence data and instead appears, at least in some embodiments, still to require physical measurement of cfDNA from a blood sample. As noted in the rejections, it may help to clearly recite input of the already-acquired sequence data and to avoid recitation open to interpretation as requiring performance of wet physical steps.
Written description
Claims 44 and 87 are rejected under 112/a as failing to comply with the written description requirement. The claims read on subject matter which is not described in the specification in such a way as to reasonably convey to PHOSITA that the inventors, at the time the application was filed, had possession of the claimed invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted. With regard to any suggested amendment(s) below to overcome a rejection, equivalent amendments also would be acceptable.
Claim 44 recites "A system..., comprising: ...programs... including... instructions for: obtaining a quantitative measure of each..., wherein the plurality of quantitative measures is measured from a plurality of tumor-derived cell-free DNA (cfDNA) molecules from a blood sample of a subject..." In some embodiments within a BRI, this recitation reads on physical analysis of a blood sample to obtain the recited data, even with the second "wherein" clause reciting "...measured from a set of sequencing reads..." A related 112/b rejection is applied above.
The specification discloses "Whole genome sequencing data is collected from about sets..." [sic] "...of blood samples obtained from subjects who are cancer patients" ([103]) and "For example, one or more computer servers may enable cloud computing over the network 530 ("the cloud") to perform various aspects of analysis, calculation, and generation of the present disclosure, such
as, for example, obtaining a quantitative measure of microsatellite repeat elements from a blood
sample of a subject..." ([107]), but the specification does not detail how a system comprising a computer and software instructions, let alone a manufacture comprising just the software instructions, would perform the recited "obtaining... from a blood sample..." The disclosure describes the desired inputs (e.g. "a blood sample") and outputs (e.g. "a quantitative measure of microsatellite repeat elements") but does not detail how to proceed from inputs to outputs in an automated manner. PHOSITA would have understood how a process claim allowing for actions by laboratory technicians would have accomplished claim 1 relying on knowledge of one of skill in the art to perform the recited laboratory steps, but it would not have been clear to PHOSITA how either the "system" of claim 44 or the "computer-readable medium" of claim 87 would have automatically performed the recited "obtaining... from a blood sample..." The written description provided is not clearly commensurate with the recited automated "obtaining..."
MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
Claim 87 similarly lacks adequate written description support.
As appropriate, these rejections may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations.
In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure.
MPEP 2163 generally pertains.
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.
Response to arguments regarding Claim Rejections - 35 USC 103
Applicant's argument (p. 13) is persuasive, and a new secondary reference has been applied, Chandrananda in place of Salvi.
Claims 1-3, 6-7, 12-13, 16-17, 23, 27, 29-31, 35, 43-44 and 87
Claims 1-3, 6-7, 12-13, 16-17, 23, 27, 29-31, 35, 43-44 and 87 are rejected under 35 USC 103 as unpatentable over Kautto (as cited on the 4/21/2022 IDS) in view of Chandrananda (as cited on the attached "Notice of References Cited" form 892).
Regarding claim 1, the recited obtaining a quantitative measure of microsatellite repeat elements reads on Kautto's "microsatellite length distributions" (Kautto: Fig. 1, caption; and entire document).
Kautto does not teach the recited sample from blood, but this recitation as well as cell-free DNA and microsatellite analysis are taught by Chandrananda's "...cell-free DNA fragments found in human plasma has been used to... investigate tumor DNA" (Chandrananda: abstract; and entire document), "More than 200,000 fragments are used to create the density curves for each micro-satellite..." (Chandrananda: p. 8, last para.; and entire document) and "useful in cancer research which uses cell-free DNA micro-satellite instability as a biomarker for presence of tumor DNA" (Chandrananda: p. 14, 2nd col.; and entire document).
The recited statistical measure of deviation of the plurality of quantitative measures reads on Kautto's "...repeat lengths for both the normal and tumor file are evaluated separately, with values too far from the mean (by default, beyond 3 standard deviations) discarded..." (Kautto: p. 7459, 1st col., last para.; and entire document).
The recited detecting instability when deviation satisfies a criterion reads on Kautto's "...identifying microsatellite instability in paired tumor-normal patient samples..." (Kautto: p. 7459, 1st col., 1st para.; and entire document).
Claim 2 recites mean length which reads on "...repeat lengths for both the normal and tumor file are evaluated separately, with values too far from the mean (by default, beyond 3 standard deviations) discarded..." (Kautto: p. 7459, 1st col., last para.; and entire document).
Claim 3 recites a subject diagnosed with cancer which reads on "...pan-cancer MSI analysis..." (Kautto: p. 7455, last col., last para.; and entire document).
Claim 6 recites sequencing cfDNA which reads on Chandrananda's §"Results" and §"Sequencing coverage statistics" (Chandrananda: p. 6-13; and entire document).
Claim 7 recites whole genome sequencing which reads on "...whole-genome coverage..." (Chandrananda: p. 3, 1st para.; and entire document).
Claim 12 recites identifying a treatment which reads on "...Reliable detection of MSI is clinically useful as MSI-positive tumors appear more susceptible to immune-enhancing therapies..." (Kautto: p. 7452, 2nd col., 1st para.; and entire document) and "...incorporating MANTIS into clinical NGS pipelines may permit MSI testing on a large scale, and improve access to emerging therapies that exploit microsatellite instability in cancer" (Kautto: p. 7458, last para.; and entire document).
Claim 13 recites immunotherapy which reads on "...immune-enhancing therapies..." (Kautto: p. 7452, 2nd col., 1st para.; and entire document).
Claims 23 and 27 recite a z-score and an absolute value of a mean z-score which read on "...Z-score..." and the various statistical methods disclosed (Kautto: p. 7453, Table 1; and entire document).
Claims 29-30 recite mononucleotides and/or dinucleotides which read on "...mononucleotide..." and "...other repeats..." (Kautto: p. 7460, 1st col., 4th para.; and entire document).
Claim 31 recites 1 million distinct microsatellite repeat elements, and repetition of the identification of repeat elements would have been prima facie obvious (MPEP 2143 E., Example 9 pertains).
Claim 35 recites sensitivity of at least about 90% which reads on "...sensitivity (MANTIS 97.18%, MSISensor 96.48%, mSINGS 76.06%)..." (Kautto: abstract; and entire document).
Claim 43 recites presence of a microsatellite stability which would have been a prima facie obvious to try choice from a finite number of identified, predictable solutions, i.e. stability vs. instability, with a reasonable expectation of success.
Claims 44 and 87 recite a "system" and a "medium" which read on the art as described for claim 1. The computational elements of claims 44 and 87 are obvious over the computational environment of Kautto (Kautto: abstract; and entire document).
Combining Kautto and Chandrananda
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the Zzz teaching of Kautto using the related teaching of Chandrananda. As motivation to combine, an advantage taught by Chandrananda of modifying methods such as those of Kautto would have been the teaching of Chandrananda that "High-throughput sequencing of cell-free DNA fragments found in human plasma has been used to... investigate tumor DNA" (Chandrananda: abstract). Thus, PHOSITA would have been motivated to modify Kautto using the above techniques of Chandrananda in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Kautto and Chandrananda are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Chandrananda to the related teaching of Kautto.
Claims 16-17
Claims 16-17 are rejected under 35 USC 103 as unpatentable over Kautto in view of Chandrananda as applied to claim 1 above and further in view of Salvi (as cited on the 10/1/2025 "Notice of References Cited" form 892).
Claims 16-17 recite amplifying and enriching which reads on "...restriction-enriched PCR..." (Salvi: p. 6555, 2nd col., 1st para.; and entire document).
Combining Kautto, Chandrananda and Salvi
Previously cited references are combined as described above.
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the Zzz teaching of Kautto using the related teaching of Salvi. As motivation to combine, an advantage taught by Salvi of modifying methods such as those of Kautto would have been the teaching of Salvi that "Blood-based test could improve sensitivity and specificity of current screening..." (Salvi: p. 6553, 2nd col., 3rd para.). Thus, PHOSITA would have been motivated to modify Kautto using the above techniques of Salvi in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Kautto and Salvi are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Salvi to the related teaching of Kautto.
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.
Response to arguments regarding Claim Rejections - 35 USC 101
Applicant states (original emphasis removed, bold emphasis added, applicant remarks: p. 15):
...the claimed methods only involve a mathematical concept, and are not directed to a mathematical concept per se.
Addressing 101 analysis as organized at MPEP 2106, Applicant's Step 2A, 1st prong remarks are not yet persuasive and are further addressed in the rejection.
Applicant states (original emphasis removed, bold emphasis added, applicant remarks: p. 16 and 18):
... The specification notes that MSI can be a good marker... ... However, analysis of tissue samples for determination of MSI (e.g., as disclosed in Kautto) can be problematic because it necessitates the availability of tumor tissue. ...
...
The specification also...identifies technical improvements realized by the claims...
Applicant's Step 2A, 2nd prong remarks regarding improvement are not yet persuasive at least because it is not yet clear how the claim differs from the previous state of the technology field. A difference is necessary but not sufficient to demonstrate improvement. Also, the remarks appear to rely on avoidance of a tumor sample in favor of a blood sample, but, at least due to the above 112 rejections, it is not yet clear that at least claims 44 and 87 are so limited.
Aspects of Applicant's asserted improvement appear in both the 2A/2nd prong and 2B portions of Applicant's remarks and are addressed immediately above.
It does appear that a Step 2A, 2nd prong, 1st consideration explanation of improvement may become a persuasive path to demonstrating patent eligibility.
As to what may be unconventional, such an interpretation only applies to steps and elements of the claim interpreted as being in addition to the identified judicial exceptions.
Judicial exceptions (JE) to 101 patentability
Claims 1-3, 6-7, 12-13, 16-17, 23, 27, 29-31, 35, 43-44 and 87 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 1-3, 6-7, 12-13, 16-17, 23, 27, 29-31, 35, 43-44 and 87: 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 analyzing data to assess microsatellite instability including the JE elements of "processing..." and "detecting...," 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 44 and 87 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 at least the recited use of "a statistical measure of deviation," with four instances recited throughout all steps of claim 1, which instances are interpreted as causing the claim to be directed to at least one math concept.
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.
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, 44 and 87: 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: [2-4, 62-66]).
And for example, regarding the second consideration at MPEP 2106.04(d)(2), claims 12-13 recite "treatment" and "therapy," but it is not yet clear that the required "treatment" or "therapy" is: (i) definitely required in physical form, e.g. may instead simply be identification of treatment, (ii) informed by the identified judicial exceptions and (iii) sufficiently particular. The treatments recited in claim 13 appear to read on all possible treatment types.
[Step 2A, 2nd prong: claims 1, 44 and 87: 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, 44 and 87 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 "obtaining...," while reading on some embodiments requiring physical analysis, also reads on embodiments which merely import data from previous analysis. Obtaining data from previous analysis, e.g. inputting data, is a conventional element of a laboratory and/or computing environment and/or conventional data gathering/input 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, 44 and 87: NO]
Summary and conclusion regarding claims 1, 44 and 87
Summing up the above analysis of claims 1, 44 and 87, 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 2-3, 6-7, 12-13, 16-17, 23, 27, 29-31, 35 and 43 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.
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, as in the following specific examples which also are understood to be well-known and routine:
claim 6-7: "sequencing..." and "whole genome sequencing" are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by Kautto (as cited on the 4/21/2022 IDS), Chandrananda (as cited on the attached "Notice of References Cited" form 892) and Salvi (as cited on the 10/1/2025 "Notice of References Cited" form 892), and generally it is understood that the examples in the reference are well-known and routine.
claims 12-13: "administering...," are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by Kautto, Chandrananda and Salvi, and generally it is understood that the examples in the reference are well-known and routine.
claims 16-17: "enriching...," are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified by Kautto, Chandrananda and Salvi, and generally it is understood that the examples in the reference are well-known and routine.
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.
Applicant's amendments necessitated the new grounds for rejection in this 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.
Inquiries
Information regarding the filing, management and status of patent applications which are published (available to all users) or unpublished (available to registered users) may be obtained from the Patent Center: https://patentcenter.uspto.gov. Further is available at https://www.uspto.gov/patents/apply/patent-center, and information about filing in DOCX format is available at https://www.uspto.gov/patents/docx.
The Electronic Business Center (EBC) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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
Prosecution Insights