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. It is noted for the record that this Application has been transferred to Examiner Haney in Art Unit 1682.
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 24, 2026 has been entered. Any rejections or objections not reiterated herein have been withdrawn.
Claims 22, 24-25, and 30 are currently pending and have been examined herein.
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 22, 24, 25, and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a judicial exception that is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim analysis is set forth below.
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 claims recite the following:
determining kidney transplant status;
wherein if the measured dd-cfDNA value exceeds a selected dd-cfDNA active rejection threshold value, the recipient is deemed to be undergoing active rejection;
if the measured measure dd-cfDNA value is less than the selected dd-cfDNA active rejection threshold value; and if the measure of kidney function is indicative of normal kidney function, the recipient is deemed to be stable; and
if the measured dd-cfDNA value is less than the selected dd-cfDNA active rejection threshold value; and if the measure of kidney function is indicative of impaired kidney function, the recipient is deemed to be undergoing borderline rejection.
The instant claims recite an abstract idea.
The “determining” step broadly encompasses a mental processes. For example, one may “determine” kidney transplant status by (i) thinking about the dd-cfDNA value and whether it is greater than or less than a threshold and (ii) thinking about the kidney function. Mental processes, which are concepts performed in the human mind, (including observation, evaluation, judgment, opinions) are considered to be abstract ideas.
The instant claims recite a law of nature.
The claims recite a correlation between (i) dd-cfDNA and transplant status and (ii) kidney function and transplant status. These types of correlations are 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 30 recites the following:
if the kidney recipient is deemed to be undergoing active rejection, the method comprises the additional step of administering to the kidney recipient a suitable intervention for active rejection; and
if the kidney recipient is deemed to be undergoing borderline rejection, the method comprises the additional step of administering to the kidney recipient a suitable intervention for borderline rejection.
Here the administering steps are conditional and only occur when the kidney recipient is deemed to be undergoing active rejection or borderline rejection. The claims broadly encompasses situations where the kidney recipient is deemed to be stable and in those situations the treatment is not administered. Since the administering step need not occur, claim 30 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 any treatment or prophylaxis limitation must be “particular”, i.e., specifically identified so that it does not encompass all applications of the judicial exceptions. Herein the recitations of “a suitable intervention for active rejection” and “a suitable intervention for borderline rejection” are not particular and are merely instructions to “apply” the exception in a generic way.
In addition to the judicial exceptions, the claims recite steps of measuring dd-cfDNA in the kidney recipient and measuring kidney function (eGFR or creatinine) in the kidney recipient. These steps are NOT considered to integrate the judicial exceptions into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exceptions, the claims recite steps of measuring dd-cfDNA in the kidney recipient and measuring kidney function (eGFR or creatinine) in the kidney recipient. These steps do NOT amount to significantly more because they simply append well understood, routine, and conventional activities previously known in the art, specified at a high level of generality, to the judicial exceptions.
The prior art demonstrates the well understood, routine, conventional nature of additional elements. For example Moshkevich (US 2023/0287497 Filed 12/14/2020 with priority back to 62/715,178 Filed 8/6/2018) teaches measurement of dd-cfDNA, creatinine, and eGFR in samples from kidney transplant patients (see Example 2, paras 0625, 0631, 0633, 0634, 0641, 0643).
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);
Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
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 § 102
5. 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 22, 24, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moshkevich (US 2023/0287497 Filed 12/14/2020 with priority back to 62/715,178 Filed 8/6/2018).
Regarding Claims 22, 24, and 25 Moshkevich teaches measuring the dd-cfDNA level in plasma samples obtained from kidney transplant recipients. Moshkevich teaches that the median level of dd-cfDNA in active rejection (2.76%) is significantly higher in comparison to the medial level of dd-cfDNA in borderline rejection (0.59%) and stable (0.19%). Moshkevich teaches using a cut off of >1% for dd-cfDNA to separate active rejection from non-rejection (including borderline and stable) (paras 0631, 0633, and 0641). Additionally Moshkevich teaches measuring creatinine and eGFR. Moshkevich teaches that the median creatinine level in active rejection (1.5 mg/dl) is higher in comparison to the medial creatinine levels in borderline rejection (1.4 mg/dl%) and stable (0.9 mg/dl). Moshkevich teaches using a cut off of >1.8 mg/dl for creatinine to separate active rejection from non-rejection (including borderline and stable) (paras 0633, 0644, and 0643). Moshkevich teaches that the median eGFR score in active rejection is (52.5), in borderline rejection (51.8) and stable (69.3). Moshkevich teaches using a cut off of <40.0 for eGFR to separate active rejection from non-rejection (including borderline and stable) (paras 0633, 0634, 0643, and 0644). Thus Moshkevich teaches a method of assessing graft rejection status in a kidney recipient, comprising the steps of: measuring donor-derived cell-free DNA (dd-cfDNA) in the kidney recipient by assessment of a blood sample obtained from the kidney recipient; obtaining a measurement of kidney function by assessment of eGFR or creatinine in a blood sample obtained from the kidney recipient; and determining kidney transplant status. Moshkevich teaches a method wherein if the measured dd-cfDNA value exceeds a selected dd-cfDNA active rejection threshold value, the recipient is deemed to be undergoing active rejection. Moshkevich teaches the dd-cfDNA active rejection threshold value is >1%. This open interval anticipates values that are between 0.75% and 2%, a value that is 1%, and a value that is 1.5%.
Claim Rejections - 35 USC § 103
6. 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.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Moshkevich (US 2023/0287497 Filed 12/14/2020 with priority back to 62/715,178 Filed 8/6/2018) in view of Bamoulid (Expert Opin Pharmacother 2015 16(11):1627-1648).
The teachings of Moshkevich are presented above.
Moshkevich does not teach a method wherein if the kidney recipient is deemed to be undergoing active rejection, the method comprises the additional step of administering to the kidney recipient a suitable intervention for active rejection.
However Bamoulid is a review article discussing treatment options for kidney transplant rejection (see Table 1 and 2).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Moshkevich by further administering a suitable intervention for active rejection to a subject with kidney rejection as suggested by Bamoulid. One of skill in the art would have been motivated to administer one of the treatments taught by Bamoulid for the benefit of being able to stop the recipients immune system from destroying the new kidney and to keep the kidney working.
6. 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.
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 Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682
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