Prosecution Insights
Last updated: August 15, 2026
Application No. 18/286,685

PROFILING CELL TYPES IN CIRCULATING NUCLEIC ACID LIQUID BIOPSY

Non-Final OA §101§102§103§112
Filed
Oct 12, 2023
Priority
Apr 13, 2021 — provisional 63/174,447 +2 more
Examiner
GOLDBERG, JEANINE ANNE
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
CZ Biohub SF LLC
OA Round
1 (Non-Final)
46%
Grant Probability
Moderate
1-2
OA Rounds
7m
Est. Remaining
87%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allowance Rate
377 granted / 822 resolved
-14.1% vs TC avg
Strong +41% interview lift
Without
With
+40.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
85 currently pending
Career history
907
Total Applications
across all art units

Statute-Specific Performance

§101
22.9%
-17.1% vs TC avg
§103
19.6%
-20.4% vs TC avg
§102
17.4%
-22.6% vs TC avg
§112
29.8%
-10.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 822 resolved cases

Office Action

§101 §102 §103 §112
DETAILED CORRESPONDENCE 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 . This action is in response to the papers filed July 1, 2026. Currently, claims 1-7, 10, 12, 20, 22, 30, 32, 40 are pending. Claims 1-7, 20, 22, 30, 32, 40 have been withdrawn as drawn to non-elected subject matter. Election/Restrictions Applicant's election of Group II, claims 10 and 12 and ATP6V0D2, ATP6V1G3 and CLNK in the paper filed July 1, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is still deemed proper and is therefore made FINAL. Priority This application claims priority to PNG media_image1.png 88 816 media_image1.png Greyscale The provisional application does not provide support for the claimed invention. The provisional does not include the genes associated with kidney function or any of the elected genes, ATP6V0D2, ATP6V1G3 and CLNK. Thus, the instant claims are entitled to the benefit of April 12, 2022. Drawings The drawings are acceptable. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The list on pages 74-85 have not been considered unless they are also provided on an IDS. Improper Markush Rejection Claims 10, 12 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117. A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. See MPEP § 2117. Here each species is considered to each of the kidney function biomarker genes listed in Table 1-5 and Table 11. The recited alternative species in the groups set forth here do not share a single structural similarity, as each different gene that could be detected is itself located in a separate region of the genome and has its own structure. The genes recited in the instant claims, do not share a single structural similarity since each consists of a different nucleotide sequence with different expression patterns. The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the markers comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of being correlated with colorectal cancer. Accordingly, while the different markers are asserted to have the property of being kidney function biomarker genes, they do not share a single structural similarity. MPEP 2117 (II)(A) provides the following guidance as to what constitutes a physical, chemical, or art recognized class: A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved” The recited genes do not belong to a recognized chemical class because there is no expectation from the knowledge in the art that the genes will behave in the same manner and can be substituted for one another with the same intended result achieved. In other words, there is no expectation from the knowledge in the art that each of the recited genes would function in the same way in the claimed method; it is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention. Further there is no evidence of record to establish that it is clear from their very nature that each of the recited genes possess the common property of being kidney function biomarker genes. MPEP 2117 (II) further states the following: Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the compounds do not appear to be members of a recognized physical or chemical class or members of an art-recognized class, the members are considered to share a "single structural similarity" and common use when the alternatively usable compounds share a substantial structural feature that is essential to a common use. Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The recited alternative species do not share a substantial common structure just because they all have a sugar phosphate backbone. The sugar phosphate backbone of a nucleic acid chain is not considered to be a substantial common structural feature to the group of genes being claimed because it is shared by ALL nucleic acids. Further, the fact that the genes all have a sugar phosphate backbone does not support a conclusion that they have a common single structural similarity because the structure of comprising a sugar phosphate backbone alone is not essential to the asserted common use of being kidney function biomarker genes. To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. Following this analysis, the claims are rejected as containing an improper Markush grouping. 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 10, 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. 35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II. Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility. Question 1 The claimed invention is directed to a process that involves a natural principle and a judicial exception. Question 2A Prong I The claims are taken to be directed to an abstract idea, a law of nature and a natural phenomenon. Claims 10, 12 are directed to “a method of evaluating kidney function in a human” by detecting the presence or absence of quantity of cell-free RNA, generating a score and comparing the score to a control to evaluate kidney function in the human. Claims 10, 12 are directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of “generating a score” and “comparing the score to a control” “thereby evaluating kidney function”) and a law of nature/natural phenomenon (i.e. the natural correlation between the expression of ATP6V0D2, ATP6V1G3 and CLNK and kidney function). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow. Herein, claims 10, 12 each involves the patent-ineligible concept of an abstract process. Claim 10 requires performing the step of “generating a score” and “comparing the score to a control” “thereby evaluating kidney function”. Neither the specification nor the claims set forth a limiting definition for "generating a score" and the claims do not set forth how “generating a score” is accomplished. As broadly recited the generating a score step may be accomplished mentally by thinking about a subject’s expression of genes and assessing whether the subject has good kidney function, CKD, AKI or minimal change disease. Thus, the determining step constitutes an abstract process idea. Additionally generating a score is a mathematical concept that requires math relationships in the form of functions and equations. The generation of a score may be extremely simple in nature such that the calculation could be performed mentally. The scores may logistic regression models, decision tree classifiers or nearest neighbors’ model, for example. These are mathematical concepts, i.e. abstract ideas. The specification teaches the bioinformatic processing was performed using known computer programs (see para 161). Claim 10 further recites a comparison between the expression level and a normal control that is deemed an abstract idea (see MPEP 2106.04(a)(2)(III)(A); • claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014)). A correlation that preexists in the human is an unpatentable phenomenon. The association between the presence, absence or quantity of cell-free RNA and kidney function is a law of nature/natural phenomenon. The “thereby” clause which tells users of the process to predict kidney function in the sample, amounts to no more than an "instruction to apply the natural law". This conclusion is no more than a mental step. Even if the step requires something more such as to verbalize the discovery of the natural law, this mere verbalization is not an application of the law of nature to a new and useful end. The thereby does not require the process user to do anything in light of the correlation. The thereby clause fails to provide the “practical assurance” sought by the Prometheus Court that the “process is more than a drafting effort designed to monopolize the law of nature itself.” Question 2A Prong II The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception. While the claim recites providing a sample and detecting from the biological sample the presence, absence or quantity of cell-free RNA, this is not an integration of the exception into a practical application. Instead, these elements are data gathering required to perform the method. Thus, the claim is “directed to” the exception. Accordingly, the claims are directed to judicial exceptions. Question 2B The second step of Alice involves determining whether the remaining elements, either in isolation or combination with the other non patent ineligible elements, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297). The claims are not sufficiently defined to provide a method which is significantly more from a statement of a natural principle for at least these reasons: The claims do not include applying the judicial exception, or by use of, a particular machine. The claims do not tie the steps to a “particular machine" and therefore do not meet the machine or transformation test on these grounds. The use of machines generally does not impose a meaningful limit on claim scope. The claims also do not add a specific limitation other than what is well-understood, routine and conventional in the field. The measuring expression is mere data gathering step that amounts to extra solution activity to the judicial exception. It merely tells the users of the method to determine the presence, absence or quantity of cell-free RNA biomarkers of a sample without further specification as to how the sample should be analyzed. The claim does not recite a new, innovative method for such determination. The determining step essentially tells users to determine the markers through whatever known processes they wish to use. The step of determining the expression was well known in the art at the time the invention was made. The prior art teaches that expression analysis using commercially available biochips and arrays that comprise the claimed genes. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any expression analysis assay, mutation and promoter methylation analysis to determine the expression and mutation and methylation status. The claim does not require the use of any particular non-conventional reagents. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine and conventional activities engaged in by scientists prior to applicant’s invention and at the time the application was filed. Each of these genes is found on the Affymetrix U133 array. Thus, analysis of the U133 array would detect the presence, absence or quantity of the claimed genes. Additionally, the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements were well known. Specifically, the specification teaches the cfRNA samples were obtained from previously available data sets (para 159). Thus, the art teaches how the data was previously obtained. Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546; Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014) For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter. Claim Rejections - 35 USC § 112-Scope of Enablement The following is a quotation 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. Claims 10, 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods for determining the presence, absence or quantity of ATP6V0D2, ATP6V1G3 and CLNK, does not reasonably provide enablement for evaluating any kidney function using ATP6V0D2, ATP6V1G3 and CLNK. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404, “Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” The nature of the invention and breadth of claims The claims are drawn to methods of evaluating kidney function by analyzing three elected genes, namely ATP6V0D2, ATP6V1G3 and CLNK. The invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). The unpredictability of the art and the state of the prior art The art teaches the broad scope of kidney function encompasses chronic kidney disease, acute kidney injury, minimal change disease, glomerulonephritis, good pasture syndrome, Iga nephropathy, interstitial nephritis, polycystic kidney disease, primary hyperoxaluria , vasculitis. Sharifian et al. (Sci. Rep. Vol. 8, No. 17870, December 14, 2018) teaches distinct patterns of transcriptional alterations characterize acute and chronic kidney injury. Figure 7 and 8 illustrate different transcriptional genes for the AKI and CKD models. The different genes have different expression patterns in the different conditions. The instant specification does not teach which pattern is associated with which kidney function. Guidance in the Specification. The specification provides no evidence that the elected genes ATP6V0D2, ATP6V1G3 and CLNK are differentially expressed to be indicative of prognosis or diagnosis of chronic kidney disease, acute kidney injury, minimal change disease or any other kidney function metric. The specification is limited to a list of genes indicative of cell types associated with kidney. The elected ATP6V0D2, ATP6V1G3 and CLNK are the first three genes listed in the “kidney cell type gene profiles” (para 54). The genes are listed as intercalated cell. There is no analysis that intercalated cells express higher or lower versions of the claimed genes or that higher or lower expression in these intercalated cells is indicative of a kidney function, such as chronic kidney disease, acute kidney injury or minimal change disease. The guidance provided by the specification amounts to an invitation for the skilled artisan to try and follow the disclosed instructions to make and use the claimed invention. Quantity of Experimentation The quantity of experimentation in this area is extremely large since there is significant number of parameters which would have to be studied to enable the skilled artisan to practice the broad scope of the claimed invention. The claims are directed to evaluating any kidney function and indicating a prognosis or diagnosis of CKD, AKI and/or minimal change disease. The art teaches kidney function encompasses a very wide range of kidney diseases and conditions. The specification is limited to teaching kidney cell type gene profiles. The elected ATP6V0D2, ATP6V1G3 and CLNK are the first three genes listed in the “kidney cell type gene profiles” (para 54). The genes are listed as intercalated cell. It would require further unpredictable and undue experimentation to determine if and how these genes are associated with each kidney function. It is unpredictable if the genes are overexpressed in CKD, AKI or both. It is unpredictable whether both genes must be overexpressed to diagnose or prognose a chronic kidney disease or whether neither gene is overexpressed in minimal change disease. The specification is silent how the presence, absence or quantity of elected ATP6V0D2, ATP6V1G3 and CLNK is associated with kidney function. This would require significant inventive effort, with each of the many intervening steps, upon effective reduction to practice, not providing any guarantee of success in the succeeding steps. Level of Skill in the Art The level of skill in the art is deemed to be high. Conclusion Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of a working example and the negative teachings in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written. Claim Rejections - 35 USC § 112- 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. Claims 10, 12 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 pre-AIA the applicant regards as the invention. A) The claim refers to tables. MPEP 2173.05(s) states: Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Claim 10 recites Tables 1-5, 11. Appropriate correction is required. B) Claim 10 requires “wherein cell type and indicative genes are provided in Table 11”. It is unclear what “where in cell type” encompasses. It is unclear whether the claim requires obtaining a biological sample of a particular cell type or whether the cell type plays into the score in some manner. It is unclear how cell type is used to generate a score. Clarification is required. C) Claim 12 does not appear to require an active method step but merely states a property of the kidney function. It is unclear whether the claim is intended to require a prognosis or diagnosis active method step. Clarification is required. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 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. Claim(s) 10, 12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nerenberg et al. (WO2017156310, September 14, 2017). Nerenberg teaches methods for analyzing RNA from kidney for expression of genes including ATP6V1G3, ATP6V0D2 and SLC4A9 among additional genes (para 5)(three genes listed in Table 11). Nerenberg teaches the sample may be plasma or serum, i.e. cell free RNA (para 16, 21 for example). Nerenberg teaches comparing the levels or identifies of marker to reference values may categorize the patient or sample as being indicative of a particular disease. Nerenberg teaches the data may be predicted from models, i.e. calculations that provide a score (para 13). Nerenberg teaches the quantity of the polynucleotides are compared in two samples to make a determination of health state of a subject (para 26). Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 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, 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 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 10, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nerenberg et al. (WO2017156310, September 14, 2017) in view of Hamidi et al. (US 2024/0410013, priority November 5, 2021). Nerenberg teaches methods for analyzing RNA from kidney for expression of genes including ATP6V1G3, ATP6V0D2 and SLC4A9 among additional genes (para 5). Nerenberg teaches the sample may be plasma or serum, i.e. cell free RNA (para 16, 21 for example). Nerenberg teaches comparing the levels or identifies of marker to reference values may categorize the patient or sample as being indicative of a particular disease. Nerenberg teaches the data may be predicted from models, i.e. calculations that provide a score (para 13). Nerenberg teaches the quantity of the polynucleotides are compared in two samples to make a determination of health state of a subject (para 26). Nerenberg does not teach analysis of CLNK, the third elected gene. Hamidi teaches CLNK is a transcript found in kidney cancer. Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have combined the references of Nerenberg and Hamidi. The combination of references would suggest validating any number of kidney disease genes that were found to be associated. The art teaches ATP6V1G3, ATP6V0D2 and SLC4A9 and CLNK are associated with kidney conditions. It would have been obvious to choose from the finite number of identified, predictable solutions, with a reasonable expectation of success (see MPEP 2143(e)). Here, the selection of at least 3 markers including at least ATP6V1G3, ATP6V0D2 and CLNK would be obvious to try. This is not a situation of picking and choosing or a laundry list. The mere fact that the references disclose a multitude of effective combinations does not render any particular combination of genes less obvious. Picking and choosing may be entirely proper in the making of a 103, obviousness rejection (see In re Arkley, 455 F.2d 586,587 (CCPA 1972). The specification does not identify a secondary consideration demonstrating criticality or anything unexpected about the combination of three known biomarkers in a method of detecting kidney function. Instead, this is a situation of obvious to try. The diagnosis of kidney function was an art recognized problem that many skilled artisans were studying, including studying gene profiles of ATP6V1G3, ATP6V0D2 and CLNK. Thus, there was an art recognized problem. The art teaches a finite number of markers. The cited art here specifically identifies ATP6V1G3, ATP6V0D2 and CLNK as associated with kidney function. Given these references, it would have been obvious to validate these gene expression markers as suggested by the art. Applicant does not identify a secondary consideration demonstrating criticality or anything unexpected about the combination of three known prior art gene markers. Conclusion No claims allowable over the art. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Luxon et al. (US2005/0130193, June 16, 2005) teaches methods for detecting an diagnosing human renal cell carcinoma by analyzing total RNA from tissue and gene expression profiling on a HG-133 array. Luxon does not teach analysis of serum or cell-free RNA for analysis. Each of the elected genes are on the U133 array. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm. 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, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682 August 4, 2026
Read full office action

Prosecution Timeline

Oct 12, 2023
Application Filed
Apr 22, 2026
Response after Non-Final Action
Apr 30, 2026
Examiner Interview (Telephonic)
Aug 06, 2026
Non-Final Rejection mailed — §101, §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
46%
Grant Probability
87%
With Interview (+40.9%)
3y 5m (~7m remaining)
Median Time to Grant
Low
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