DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This Application has been transferred to Examiner Haney in Art Unit 1682.
3. Applicant’s election of Group 1 in the reply filed on October 20, 2025 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 § 818.01(a)).
Claims 1, 4, 6, 9, 12, 16, 18-19, 21-22, 29-31, 37-38, 40, 43-44, 46, and 51 are currently pending.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 20, 2025.
Claim Rejections - 35 USC § 101
4. 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 1, 4, 6, 12, 16, 18-19, 21-22, 29-31, 37-38, 40, 43-44, 46, and 51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims have been evaluated using the 2019 Revised Patent Subject Matter Eligibility Guidance (see Federal Register Vol. 84, No. 4 Monday, January 7, 2019).
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The instant claims recite abstract ideas.
The claims recite the following limitations:
-comparing the amount(s) of DS cf-DNA to a threshold value (clm 1 and 22);
-determining a treatment or monitoring regimen (clms 4, 30);
-making a treatment management decision (clms 4, 30);
-suggesting monitoring to the subject (clms 12, 37);
-suggesting the use of one or more additional tests (clms 12, 37);
-providing information about a treatment to the subject (clms 16, 40);
-determining that additional testing and/or monitoring is required (clm 18, 43);
-selecting or suggesting a treatment for the subject (clm 40);
- suggesting a treatment change (clm 40).
The broadest reasonable interpretation of these steps is that they fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgement, and opinion.
The claims recite a step of “comparing”. The broadest reasonable interpretation of the “comparing” step is that it may be accomplished by a mental processes. For example, one may “compare” the amount of DS-cfDNA and threshold value by reading both values and thinking about them.
The claims recite steps of “determining”, “making”, “suggesting”, “providing”, selecting”. Each of these steps could be performed by a human using mental steps or basic critical thinking.
The instant claims recite a law of nature.
The claims recite a correlation between the amount of DS cfDNA and risk such as transplant rejection, cardiac arrest, required mechanical circulatory support, and death (clms 1, 22, and 46). This type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses 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.
Claim 16 recites a method wherein determining a treatment regimen comprises treating the subject and/or providing information about a treatment to the subject. In view of the recitation of “and/or” the “treating” is optional. Since the “treating” step need not occur, claim 16 does not recite any steps or elements that integrate the judicial exception so as to practically apply the judicial exception. Further it is noted that a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or a medical condition. Herein, there is nothing particular about the treatment. Therefore even if the “treating” was a required step it is merely instructions to apply the exceptions in a generic way and does not provide a practical application of the judicial exceptions.
Claims 18 and 43 recite a method wherein making a treatment management decision comprises determining that additional testing and/or monitoring is required, initiating a treatment, changing the frequency of a treatment, changing the dosage of the treatment, changing the frequency and/or dosage of the treatment, changing the type of treatment to be performed, changing the timing of the treatment, or any combination of the foregoing. In view of the recitation of “any combination of the foregoing” the “treating” is optional. Since the “treating” step need not occur, claims 18 and 43 do not recite any steps or elements that integrate the judicial exception so as to practically apply the judicial exception. Further it is noted that a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or a medical condition. Herein, there is nothing particular about the treatment. Therefore even if the “treating” was a required step it is merely instructions to apply the exceptions in a generic way and does not provide a practical application of the judicial exceptions.
Claim 40 recites a method wherein determining a treatment regimen comprises selecting or suggesting a treatment for the subject, changing the treatment of the subject, suggesting such change, treating the subject, or providing information about a treatment to the subject. In view of the recitation of “or” the “treating” is optional. Since the “treating” step need not occur, claim 40 does not recite any steps or elements that integrate the judicial exception so as to practically apply the judicial exception. Further it is noted that a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or a medical condition. Herein, there is nothing particular about the treatment. Therefore even if the “treating” was a required step it is merely instructions to apply the exceptions in a generic way and does not provide a practical application of the judicial exceptions.
In addition to the judicial exceptions, the claims recite a step of determining an amount of DS cf-DNA in a sample taken from the subject. The additionally recited step is not considered to integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity (data gathering) to the judicial exceptions.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exceptions, the claims recite a step of determining an amount of DS cf-DNA in a sample taken from the subject. The additionally recited step does NOT amount to significantly more because it simply appends well understood, routine, and conventional activities previously known in the art to the judicial exceptions.
The step is recited at a high level of generality. The step of determining the amount of DS cf-DNA in a sample merely instructs a scientist to use any detection technique. 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.
The prior art also demonstrates the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known. For example see the prior art of Mitchell (WO 2018/237078 Pub 12/27/2018) discussed in detail in the 102 rejection set forth below.
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.
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
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 the reasons set forth above the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112
5. 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 1, 4, 6, 12, 16, 18-19, 21-22, 29-31, 37-38, 40, 43-44, 46, and 51 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 1, 4, 6, 12, 16, 18-19, 21-22, 29-31, 37-38, 40, 43-44, 46, and 51 are rejected as being indefinite. The claims encompass comparing the amounts to a threshold, wherein the threshold is any one of the values of the table, wherein when the amount is greater than or equal to the threshold value, risk is indicated or increased. The claims are indefinite because it is unclear how a comparison to the values in the “N”, “Std Dev” columns could be used to determined that a risk is indicated or increased. Further the claims are indefinite because they encompass many overlapping ranges. For example the min-max on Day 0 for no event is -3.59-1.09 and this overlaps with the min-max on Day 0 for an event which is 0.51-2.65. Therefore it would be unclear if a subject with 1.0 on Day 0 would have an event or no event.
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Claims 1, 4, 6, 12, 16, 18-19, 21-22, 29-31, 37-38, 40, 43-44, 46, and 51 are rejected over the recitations of “e.g., day 0”; “e.g., day 14”; “e.g., for day 0 and/or day 14” in claims 1 and 22. “e.g” is an abbreviation for the Latin phrase exempli gratia, meaning “for example” and the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 1, 4, 6, 12, 16, 18-19, 21-22, 29-31, 37-38, 40, 43-44, 46, and 51 are rejected over the recitations of “(e.g., day 0)” and “(e.g., day 14)” in claims 1 and 22. The claims are considered indefinite because they contain information in parentheses. Parentheticals make the claims indefinite because it is unclear whether the information in the parentheses has the same, less, or more weight as the rest of the claim language. This rejection may be overcome by deleting the information in parentheses.
Claims 1, 4, 6, 12, 16, 18-19, 21-22, 29-31, 37-38, 40, 43-44, 46, and 51 are rejected over the recitation of “such as 013, 0.14, 0.23, or 0.43 or any one of the values of the below table” in claims 1 and 22. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 1, 4, 6, 12, 16, 18-19, 21-22, 29-31, 37-38, 40, 43-44, 46, and 51 are rejected over the recitation of “such as the mean, median, lower quartile, etc. of the table” in claims 1 and 22. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Further the recitation of “etc.” is indefinite. “etc.” is used at the end of a list to indicate that further, similar items are included. Because it is unclear what similar items would be included and what similar items would not be included, the claims do not clearly define the boundaries of patent protection desired.
Claims 1, 4, 6, 12, 16, 18-19, 21 are rejected over the recitation of “such as rejection” in claim 1. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 21 and 46 are rejected over the recitation of “such as an adult or a pediatric heart transplant subject”. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 29 is rejected over the recitation of “such as a different point in time during the treatment”. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
6. 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, 4, 6, 12, 16, 18, 19, 21, 22, 29, 30, 31, 37, 38, 40, 43, 44, 46, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitchell (WO 2018/237078 Pub 12/27/2018).
Regarding Claims 1 and 22 Mitchell teaches a method comprising determining an amount of donor-specific cell-free DNA (DS cf-DNA) in at least two samples taken from a subject each at a different time, wherein at least one sample is taken prior to rejection treatment and the other taken post treatment (page 75, clm 54). Mitchell teaches the method further comprises comparing the amounts of DS cf-DNA to threshold values and/or amounts from one or more prior time points (page 76, claim 62). Mitchell teaches the method wherein an amount of DS cf-DNA that is greater than a threshold value and/or is increased or increasing relative to amount(s) from earlier time point(s) represents an increased or increasing risk (page 78, claim 78). Thus Mitchell teaches method of assessing a sample from a transplant subject, the method comprising: (a) determining an amount of donor-specific cell-free DNA (DS cf-DNA) in a sample taken from the subject before, during, and after treatment for transplant rejection and (b) comparing the amount(s) of DS cf-DNA to a threshold value, wherein when the amount(s) is greater than or equal to the threshold value, risk, is indicated or increased.
Regarding Claims 4 and 30 Mitchell determining a treatment or monitoring regimen for the subject based on the amounts of DS cf-DNA compared to the threshold values and/or amounts from one or more time points (page 76, claim 63). Thus Mitchell teaches a method further comprising determining a treatment or monitoring regimen for the subject based on the comparisons.
Regarding Claims 6 and 29 Mitchell teaches a method wherein at least one sample is taken prior to rejection treatment and the other taken post treatment (page 75, claim 54). Thus Mitchell teaches a method wherein one or more further amounts of DS cf-DNA are obtained from a sample taken from the subject at a different point in time.
Regarding Claims 12 and 37 Mitchell teaches a method wherein at least one sample is taken prior to rejection treatment and the other taken post treatment (page 75, claim 54). Thus Mitchell teaches a monitoring regimen the comprises determining the amount of DS cf-DNA in the subject over time.
Regarding Claim 16 Mitchell teaches a method wherein determining a treatment regimen comprises treating the subject (page 75, claim 49).
Regarding Claims 18 and 43 Mitchell teaches a method wherein determining a treatment regimen comprises selecting or suggesting a treatment for the subject or changing the treatment of the subject or suggesting such change (page 79, claim 83).
Regarding Claims 19 and 44 Mitchell teaches the analysis of plasma samples (page 79, claim 87).
Regarding Claims 21 and 46 Mitchell teaches a method wherein the transplant subject is a pediatric heart transplant subject (page 79, claim 88).
Regarding Claim 31 Mitchell teaches a method comprising reporting and/or recording the amounts of DS cfDNA (page 75, claim 56).
Regarding Claim 38 Mitchell teaches that the time between samples is decreased if the amount of DS cf-DNA is increased relative to the threshold or an amount from an earlier time point (page 79, claim 81).
Regarding Claim 40 Mitchell teaches determining a treatment regimen comprises selecting or suggesting a treatment for the subject or changing the treatment of the subject or suggesting such change (page 79, claim 83).
Regarding Claim 51 Mitchell teaches a method wherein the risk is risk of transplant rejection (page 20, lines 8-10).
Double Patenting
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
8a. Claims 1, 19, 21, 22, 44, 46, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,385,396. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1 and 22 both sets of claims require determining an amount of DS cf-DNA in a sample and comparing the amount of DS cf-DNA to a threshold, wherein when the amount is greater than or equal to the threshold value risk is indicated or increased (clm 1 of the patent). Regarding Claims 19 and 44 both sets of claims state that the sample is plasma (clm 11 of the patent). Regarding Claims 21 and 46 both sets of claims state that the subject is a pediatric heart transplant subject (clms 8 and 9 of the patent). Regarding Claim 51 both sets of claims state that the risk is risk of transplant rejection (clm 2 of the patent).
8b. Claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,385,396 in view of Mitchell (WO 2018/237078 Pub 12/27/2018). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the Patent are discussed above. The instant claims are different from those of the Patent because they further require the limitations set forth in claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, and 43. However as discussed above in the 102 rejections, Mitchell teaches each of these limitations and it would have been obvious to modify the claims of the Patent in view of the teachings of Mitchell for the benefit of being able to monitor transplant patients at risk.
9a. Claims 1, 19, 21, 22, 44, 46, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,472,680. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1 and 22 both sets of claims require determining an amount of DS cf-DNA in a sample and comparing the amount of DS cf-DNA to a threshold, wherein when the amount is greater than or equal to the threshold value risk is indicated or increased (clm 1 of the patent). Regarding Claims 19 and 44 both sets of claims state that the sample is plasma (clm 11 of the patent). Regarding Claims 21 and 46 both sets of claims state that the subject is a pediatric heart transplant subject (clms 8 and 9 of the patent). Regarding Claim 51 both sets of claims state that the risk is risk of transplant rejection (clm 2 of the patent).
9b. Claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,472,680 in view of Mitchell (WO 2018/237078 Pub 12/27/2018). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the Patent are discussed above. The instant claims are different from those of the Patent because they further require the limitations set forth in claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, and 43. However as discussed above in the 102 rejections, Mitchell teaches each of these limitations and it would have been obvious to modify the claims of the Patent in view of the teachings of Mitchell for the benefit of being able to monitor transplant patients at risk.
10a. Claims 1, 22, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 48, 82, 104, 118, 158 of Application 16/504,469. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1 and 22 both sets of claims require determining an amount of DS cf-DNA in a sample and comparing the amount of DS cf-DNA to a threshold, wherein when the amount is greater than or equal to the threshold value risk is indicated or increased (clm 1 of the copending application). Regarding Claim 51 both sets of claims state that the risk is risk of transplant rejection (clm 3 of the copending application).
10b. Claims 4, 6, 12, 16, 18, 19, 21, 29, 30, 31, 37, 38, 40, 43, 44, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 48, 82, 104, 118, 158 of Application 16/504,469 in view of Mitchell (WO 2018/237078 Pub 12/27/2018). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the Patent are discussed above. The instant claims are different from those of the Patent because they further require the limitations set forth in claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, and 43. However as discussed above in the 102 rejections, Mitchell teaches each of these limitations and it would have been obvious to modify the claims of the Patent in view of the teachings of Mitchell for the benefit of being able to monitor transplant patients at risk.
11a. Claims 1, 19, 21, 22, 44, 46, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 50, 57, 60, 66, 70, 74, 78, 89, 92 of Application 16/623,719. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1 and 22 both sets of claims require determining an amount of DS cf-DNA in a sample and comparing the amount of DS cf-DNA to a threshold, wherein when the amount is greater than or equal to the threshold value risk is indicated or increased (clms 1 and 2 of the copending application). Regarding Claims 19 and 44 both sets of claims state that the sample is plasma (clm 1 of the copending application). Regarding Claims 21 and 46 both sets of claims state that the subject is a heart transplant subject (clm 89 of the copending application). Regarding Claim 51 both sets of claims state that the risk is risk of transplant rejection (clm 1 of the copending application).
11b. Claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 50, 57, 60, 66, 70, 74, 78, 89, 92 of Application 16/623,719 in view of Mitchell (WO 2018/237078 Pub 12/27/2018). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the Patent are discussed above. The instant claims are different from those of the Patent because they further require the limitations set forth in claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, and 43. However as discussed above in the 102 rejections, Mitchell teaches each of these limitations and it would have been obvious to modify the claims of the Patent in view of the teachings of Mitchell for the benefit of being able to monitor transplant patients at risk.
12a. Claims 1, 19, 21, 22, 44, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-9, 13, 17-26, 29 of Application 17/493,293. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1 and 22 both sets of claims require determining an amount of DS cf-DNA in a sample and comparing the amount of DS cf-DNA to a threshold, wherein when the amount is greater than or equal to the threshold value risk is indicated or increased (clms 1 and 5 of the copending application). Regarding Claims 19 and 44 both sets of claims state that the sample is plasma (clm 26 of the copending application). Regarding Claims 21 and 46 both sets of claims state that the subject is a heart transplant subject (clm 29 of the copending application).
12b. Claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, and 43, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-9, 13, 17-26, 29 of Application 17/493,293 in view of Mitchell (WO 2018/237078 Pub 12/27/2018). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the Patent are discussed above. The instant claims are different from those of the Patent because they further require the limitations set forth in claims 4, 6, 12, 16, 18, 29, 30, 31, 37, 38, 40, 43, and 51. However as discussed above in the 102 rejections, Mitchell teaches each of these limitations and it would have been obvious to modify the claims of the Patent in view of the teachings of Mitchell for the benefit of being able to monitor transplant patients at risk.
13a. Claims 1, 21, 22, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10, 13, 17, 20, 22, 26, 28, 29-31, 35, 39, 43-46, 51, 85 of Application 17/493,230. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1 and 22 both sets of claims require determining an amount of DS cf-DNA in a sample and comparing the amount of DS cf-DNA to a threshold, wherein when the amount is greater than or equal to the threshold value risk is indicated or increased (clms 1 and 2 of the copending application). Regarding Claims 21 and 46 both sets of claims state that the subject is a heart transplant subject (clm 22 of the copending application).
13b. Claims 4, 6, 12, 16, 18, 19, 29, 30, 31, 37, 38, 40, 43, 44, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10, 13, 17, 20, 22, 26, 28, 29-31, 35, 39, 43-46, 51, 85 of Application 17/493,230 in view of Mitchell (WO 2018/237078 Pub 12/27/2018). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the Patent are discussed above. The instant claims are different from those of the Patent because they further require the limitations set forth in claims 4, 6, 12, 16, 18, 19, 29, 30, 31, 37, 38, 40, 43, 44, and 51. However as discussed above in the 102 rejections, Mitchell teaches each of these limitations and it would have been obvious to modify the claims of the Patent in view of the teachings of Mitchell for the benefit of being able to monitor transplant patients at risk.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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/AMANDA HANEY/Primary Examiner, Art Unit 1634