DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-2, 4, 7, 9-10, 12-15, 17, 19-20, 22-24, 28, 31, 35, and 38 pending and examined herein.
Claims 3, 5-6, 8, 11, 16, 18, 21, 25-27, 29-30, 32-34, 36-37, and 39-40 are canceled.
Priority
As detailed on the 10 July 2025 filing receipt, the application claims priority as early as 09 November 2020. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Information Disclosure Statement
An information disclosure statement (IDS) was filed on 16 December 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the references are being considered by the examiner.
Claim Interpretation
Claim 1 recites, in its preamble, the method is for assessing risk in a subject. However, the claim recites only obtaining total cf-DNA and reporting and/or recording the amount of said cfDNA, making its application to assessing risk a statement of intended use. MPEP 2111.02(II) pertains.
Claim Objection - 35 USC § 112(b)
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 2, 7, 10, 13 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 2, 7 and 10 are objected to for unclear antecedence. Claim 1 instantiates a risk and a subject while claims 2, 7, and 10 recite either a risk or a subject as well. While the risk and the subject in the independent claim are interpreted as directed to an intended use as discussed in the Claim Interpretation section above, they still instantiate a risk and subject and make it unclear whether later occurrences of a risk and a subject refer to the same risk and subject. For compact examination, it is assumed later occurrences of a risk and a subject will be amended to “the risk” and “the subject” or a similar amendment will be entered. Claim 13 is similarly rejected as it is dependent on claim 7.
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 20 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 20 is directed to a report comprising information and claim 22 is directed to a database comprising information. Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations are not directed to any of the statutory categories (MPEP 2106). Furthermore, where a claim as a whole is directed to conveying a message or meaning to a human reader independent of the intended computer system, and/or a computer-readable medium merely serves as a support for information or data, no functional relationship exists. This is therefore non-functional descriptive material with no patentable weight (MPEP 2111.05).
Claims 2, 4, 7, 9-10, 12-15, 17, 19-20, 22-23, 28, 31, 35, and 38 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). The claims as a whole, considering all claim elements individually and in combination, are directed to a judicial exception at Step 2A, Prong 2, and the additional elements of the claims, considered individually and in combination, do not provide significantly more at Step 2B than the abstract idea of "assessing a risk in a subject."
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of
nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The claims are directed to a method (claims 2, 4, 7, 9-10, 12-15, 17, 19, 23, 28, 31, 35, and 38), which falls within one of the categories of statutory subject matter. Claims 20 and 22 are not directed to a statutory category because they are directed to data per se and conveying a message or meaning to a human reader independent of the medium, and thus are non-functional descriptive material lacking patentable weight. [Step 1: claims 2, 4, 7, 9-10, 12-15, 17, 19, 23, 28, 31, 35, and 38: yes; claims 20 and 22: no]
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Claim 2 recites at least comparing amounts of total cf-DNA to a threshold value, where comparing values may be interpreted as a mental step of data evaluation or as a mathematical concept wherein numerical values are related.
Claim 4 recites comparing the amount(s) of cfDNA to a threshold, where comparing values may be interpreted as a mental step of data evaluation or as a mathematical concept wherein numerical values are related.
Claim 7 recites determining a risk based on comparison, where a risk determination is evaluation of the data and thus a mental concept.
Claim 10 recites comparing data and determining risk, where comparing values may be interpreted as a mental step of data evaluation or as a mathematical concept wherein numerical values are related and where a risk determination is evaluation of the data and thus a mental concept.
Claim 12 recites determining a treatment or monitoring regimen and providing values, both of which are data organization or evaluation that the human mind is practically equipped to perform.
Claim 17 recites additional information about the threshold, which is data for comparison, and data is abstract.
Claim 23 recites determining a regimen, suggesting tests, determining or suggesting assessment frequency, and changing or suggesting the change of assessment, all of which are mental steps as the human mind can making determinations, make suggestions, and suggest changes. Accessing the subject is interpreted as at least two people interacting and thus organization of human activity.
Claim 28 recites determining a treatment regimen, selecting a regimen, suggesting a treatment, and providing information, all of which are mental steps of data selection and evaluation.
Claim 35 recites additional information about the risk, interpreted as evaluation of the risk and thus a mental concept.
Hence, the claims explicitly recite numerous elements that, individually and in combination,
constitute abstract ideas. The claims must therefore be examined further to determine whether they
integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A: Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Elements in addition to the abstract ideas recited in the claims are: obtaining additional pre-operative total cf-DNA samples (claim 4), obtaining post-operative total-cf DNA samples (claim 7 and 9), obtaining samples from the subject (claim 12), where the samples are taken 1-3 times daily (claim 13), the subject is a non-transplant or cardiac surgery subject (claim 14), who is assessed for up to a week before surgery (claim 15), providing a report (claims 19-20) or storing in a database (claims 19 and 22), obtaining total-cfDNA at different time points (claim 23), the sample is a blood, plasma, or serum sample (claim 31), and the subject is monitored, treated, or treated over time (claim 38).
Obtaining information, whether about the subject, data being collected before or after surgery, the type of data, and sampling type/frequency are data gathering elements. Data gathering is insignificant extra solution activity and does not integrate the abstract idea into a practical application. MPEP 2106.05(g) pertains.
Recording data in a database is interpreted as storing information on a general purpose computer, and applying the abstract ideas on a general purpose computer does not integrate the abstract ideas into a practical application. MPEP 2106.05(f) pertains.
Reporting data is interpreted as generic data outputting, and data outputting is insignificant extra solution activity and does not integrate the abstract idea into a practical application. MPEP 2106.05(g) pertains. [Step 2A Prong Two: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05). Elements in addition to the abstract ideas recited in the claims are: obtaining additional pre-operative total cf-DNA samples (claim 4), obtaining post-operative total-cf DNA samples (claim 7 and 9), obtaining samples from the subject (claim 12), where the samples are taken 1-3 times daily (claim 13), the subject is a non-transplant subject or cardiac surgery subject (claim 14), who is assessed for up to a week before surgery (claim 15), providing a report (claims 19-20) or storing in a database (claims 19 and 22), obtaining total-cfDNA at different time points (claim 23), the sample is a blood, plasma, or serum sample (claim 31), and the subject is monitored, treated, or treated over time (claim 38).
Gögenur (Critical Care 21(14): 10 pgs., 2017; newly cited) teaches a review of cell-free DNA as a predictive biomarker, including cfDNA as a means of predicting medical complications (abstract), including multiple time points during the admission period (pg. 3, col. 2, first paragraph) and up to seven days after surgery (Table 1) and every 20 minutes for 180 minutes (Table 1), suggesting multiple times daily, data being stored in databases (pg. 8, col. 1, last paragraph) or reports (pg. 1, col. 2, second paragraph), wherein the sample is collected from blood (pg. 1, col. 1, first paragraph), and observation over time amounts to monitoring. General surgery is taught (pg. 2, col. 1, fifth paragraph). It is also noted that the cfDNA obtaining steps are disclosed as commercially available (specification: pg. 13, last paragraph) and thus conventional.
Therefore, the recited additional elements, alone or in combination with the judicial exceptions, do not appear to provide an inventive concept. [Step 2B: No]
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole,
are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not
constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as
being directed to non-statutory subject matter.
It is noted that claim 1 is not rejected under 35 USC 101 because it does not recite abstract ideas: obtaining an amount of pre-operative total cell-free DNA in a sample from a subject is a physical, data collecting step, and reporting and/or recording that amount is not a mental or mathematical step. Additionally, changing sampling frequency in view of cfDNA amount (claim 24) is not considered a conventional step in the prior art.
Claim Rejections - 35 USC § 102(a)(1)
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-2, 4, 7, 9-10, 12-14, 19-20, 22-23, 28, 31, 35, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stoppelkamp (Plos One 10(8): 20 pgs., 2015; newly cited).
Claim 1 recites obtaining an amount of pre-operative total cell-free DNA (cf-DNA) in a sample from the subject and reporting and/or recording the amount of pre-operative total cf-DNA.
Stoppelkamp teaches determining amount of circulating cell-free DNA as a marker for neutrophil activation (pg. 9, first paragraph) and thus a predictor for immune response from the subject. The amount of cfDNA is reported and/or recorded in Fig. S3C.
Claim 2 recites comparing the amount of pre-operative total cf-DNA to a threshold total cf-DNA
value or other amount from a different point in time or determining a risk in the subject based on the obtained amount of pre-operative total cfDNA or comparing the amount of pre-operative total cf-DNA to a threshold total cf-DNA value or other amount from a different point in time and determining a risk in the subject based on the comparison of the amount of pre-operative total cf-DNA to the threshold or other total cf-DNA value.
Stoppelkamp teaches comparison of cfDNA across different time points (Fig. S3C).
Claim 4 recites obtaining an amount of pre-operative total cf-DNA in one or more additional
samples from the subject, each taken at a different point in time or obtaining an amount of pre-operative total cf-DNA in one or more additional sample from the subject, each taken at a different point in time, and comparing the amount(s) of preoperative total cf-DNA to threshold values or amounts from one or more different time points.
Stoppelkamp teaches multiple pre-operative time points, including at admission and surgery start, where the start is interpreted as pre-operative (Fig. S3C).
Claim 7 recites determining a risk in the subject based on a comparison(s), or determining a risk in the subject based on a comparison(s) of and obtaining an amount of post-operative total cf-DNA in one or more additional samples from the subject, each taken at a different time point, or (g) obtaining an amount of post-operative total cf-DNA in one or more additional samples from the subject, each taken at a different time point.
Stoppelkamp teaches time points before and after surgery (pg. 3, second paragraph).
Claim 9 recites the post-operative different point(s) in time are one or more of the following post-operative times: immediately following surgery, 12 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 10 days, 14 days, 21 days, or 28 days.
Stoppelkamp teaches post-operative assessments at 1, 2, 3, 5, and 8 days post-surgery (Fig. S3C).
Claim 10 recites comparing the amount(s) of post-operative total cf-DNA to threshold values or
amounts from one or more prior points in time, or comparing the amount(s) of post-operative total cf-DNA to threshold values or amounts from one or more prior points in time and determining a risk in the subject based on the comparison(s).
Stoppelkamp teaches a plot of cfDNA amounts before and after surgery, with significance testing for comparison (pg. 9, first paragraph).
Claim 12 recites at least one of: determining a treatment or monitoring regimen for the subject based on the amount(s) of pre-operative total cf-DNA, post-operative total cf-DNA, or pre-operative total cf-DNA and post-operative total cf-DNA, or the comparison(s), or providing or obtaining one or more threshold values or amount(s) from one or more different points in time, or (e) obtaining the sample(s) from the subject.
Stoppelkamp teaches biomarkers as an indicator for systemic inflammatory response syndrome (abstract) and these predictive markers as indicators for early therapeutic interventions (abstract), interpreted as determining a treatment.
Claim 13 recites pre-operative total cf-DNA, post-operative total cf-DNA, or pre-operative total cf-DNA and post-operative total cf-DNA is obtained from samples taken from the subject once, twice, or thrice daily.
Stoppelkamp teaches sampling at least once per day over multiple days (pg. 4, first paragraph).
Claim 14 recites the subject is a non-transplant subject or a cardiac surgery subject.
Stoppelkamp teaches subjects related to cardiovascular surgery (abstract).
Claim 19 recites the amount(s), threshold value(s), or amount(s) and threshold value(s) are provided in a report or are recorded in a database.
Stoppelkamp teaches the amounts in Fig. S3C, where the figure is interpreted as evidence of being recorded and as a report.
Claim 20 recites a report that comprises the amount(s) and/or threshold value(s) of claim 1.
Stoppelkamp teaches the amounts in Fig. S3C, where the figure is interpreted as a report.
Claim 22 recites a database that comprises the amount(s) and/or threshold value(s) of claim l.
Stoppelkamp teaches a figure with cfDNA amounts (Fig. S3C), where the values are interpreted as necessarily being recorded, such as in a database, to prepare the figure.
Claim 23 recites the determining a monitoring regimen comprises obtaining amount(s) of total cf-DNA in the subject over time or at a subsequent point in time, or suggesting such monitoring to the subject, using or suggesting the use of one or more additional test(s) to assess the subject, assessing or suggesting the assessment of the subject at one or more points in time, determining or suggesting the frequency or timing of the assessment, or changing the frequency or timing of the assessment or suggesting such change.
Stoppelkamp teaches using “eight consecutive time points before and after surgery, we sought to establish a combination of biomarkers predicting the development of SIRS available for clinical decision in the early post-operative period or at early hours in the ICU in order to timely counteract the dysregulation of the immune system” (pg. 3, second paragraph).
Claim 28 recites the determining a treatment regimen comprises selecting or suggesting a treatment for the subject, changing the treatment of the subject or suggesting such change, changing the timing or frequency of the treatment of the subject or suggesting such change, treating the subject, or
providing information about a treatment to the subject.
Stoppelkamp teaches using the taught biomarkers are early indicators for sepsis or septic shock and thus diagnosis for treatment (pg. 3, first paragraph) and timely intervention (pg. 11, second to last paragraph) and a common treatment is an antibiotic (pg. 13, first paragraph).
Claim 31 recites the sample is a blood, plasma, or serum sample.
Stoppelkamp teaches blood samples collected from all patients (pg. 4, first paragraph).
Claim 35 recites the risk is a risk of cardiac arrest, need for mechanical ventilation, or death following surgery.
Stoppelkamp teaches the risk for SIRS including sepsis (pg. 2, first paragraph), where sepsis may be fatal.
Claim 38 recites the subject is monitored over time, treated, or treated over time.
Stoppelkamp teaches a method in which the subject is “monitored for signs of SIRS and blood samples were taken to investigate biomarkers at pre-assigned time points” (abstract).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 15
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stoppelkamp in view of the rejection under 35 USC 102(a)(1) as applied to claims 1-2, 4, 7, 9-10, 12-14, 19-20, 22-23, 28, 31, 35, and 38 as found above and further in view of Henriksen (Molecular Oncology 14: 1670-1679, 2020; newly cited).
Claim 15 recites the subject is assessed for at least 1, 2, 3, 4, 5, 6, or 7 days prior to surgery.
Stoppelkamp does not teach the day of admission and start of surgery as different days.
Henriksen teaches pre-operative blood collections up to 287 prior to surgery for cfDNA characterization (pg. 1672, col. 2, third paragraph).
Combining Stoppelkamp and Henriksen
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to samples more than a day ahead of surgery as taught by Henriksen because more pre-operative samples would be able to generate a more reliable baseline for comparison to post-operative levels. Both Stoppelkamp and Henriksen are directed to the shared field of endeavor of using cell-free DNA as a predictive biomarker, and their combination would be expected to succeed. Therefore, the invention is prima facie obvious.
Claim 17
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Stoppelkamp in view of the rejection under 35 USC 102(a)(1) as applied to claims 1-2, 4, 7, 9-10, 12-14, 19-20, 22-23, 28, 31, 35, and 38 as found above and further in view of Grömminger (US 20170314073 A1; newly cited).
Claim 17 recites a threshold value is provided for each time point an amount of pre-operative total cf-DNA, post-operative total cf-DNA, or pre-operative total cf-DNA and post-operative total cf-DNA is obtained.
Stoppelkamp teaches early systemic inflammatory response syndrome with cfDNA amount based on pre-operative and post-operative levels, and their comparison based on significance testing (pg. 9, first paragraph), but not a threshold independent of said test.
Grömminger teaches thresholds as total cfDNA exceeding a threshold indicating a risk (paragraph [105]).
Combining Stoppelkamp and Grömminger
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to use a threshold as taught by Grömminger in cfDNA sampling regarding surgery as taught by Stoppelkamp because the threshold may represent a reference level in published literature (paragraph [105]), where the reference is considered typical and thus exceeding it would suggest risk. Both Stoppelkamp and Grömminger are directed to the shared field of endeavor of using cell-free DNA as a predictive biomarker, and their combination would be expected to succeed. Therefore, the invention is prima facie obvious.
Claim 24
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Stoppelkamp in view of the rejection under 35 USC 102(a)(1) as applied to claims 1-2, 4, 7, 9-10, 12-14, 19-20, 22-23, 28, 31, 35, and 38 as found above and further in view of Avanzini (bioRxiv 946228: 16 pgs., 2020; newly cited).
Claim 24 recites the time between samples is decreased if the amount(s) of pre-operative total cf-DNA or postoperative total cf-DNA is increased relative to threshold(s) or amount(s) from earlier time point(s), or wherein the time between samples is increased if the amount of pre-operative total cf-DNA or
post-operative total cf-DNA is decreased relative to threshold(s) or amount(s) from earlier time point(s).
Stoppelkamp does not teach adjustment of sampling rate based on cfDNA amount.
Avanzini teaches increasing sampling rate to increase performance when performing cfDNA sampling (pg. 10, second paragraph).
Combining Stoppelkamp and Avanzini
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to increase sampling rate as taught by Avanzini in cfDNA sampling regarding surgery as taught by Stoppelkamp because increasing cell-free DNA in the bloodstream indicates shedding and/or cell death (Avanzini: pg. 4, fourth paragraph), and increasing sampling rate in situations with problematic indication of cell death increases the performance of screening (pg. 10, second paragraph). Both Stoppelkamp and Avanzini are directed to the shared field of endeavor of using cell-free DNA as a predictive biomarker, and their combination would be expected to succeed. Therefore, the invention is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert J Kallal whose telephone number is (571)272-6252. The examiner can normally be reached Monday through Friday 8 AM - 4 PM EST.
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/Robert J. Kallal/Examiner, Art Unit 1685
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