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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on July 30, 2026 is acknowledged.
Claims 3-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 July 30, 2026.
Information Disclosure Statement
No IDS has been filed to date of the instant Office communication.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because some of the Figures are poor in quality with illegible figure texts (see Figs. 2, 7, and 15-17, for example). Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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 and 2 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.
Primary reason for claim 1 being held indefinite is that the multiple usage of the “and/or” after virtually all of the recited limitations render indefinite just exactly what the claimed invention is and what the metes and bounds resulting from the multiple such combinations encompassed by limitations that are imposed by “and/or” are.
For example, claim 1 recites that a group of target regions in the cfDNA are enriched, and proceeds to recite that the group comprises “from about 24 to about 384 target regions and/or from about 24 to about 100 target regions and/or from about 24 to about 96 target regions …” It is not distinguish what difference is between a cfDNA that has group of targets from cfDNA that are both 100 and 384. This is because a range that covers both “about 24 to about 100 targets” and “about 24 to about 384 targets” is 24 to about 384 targets. There is no other range.
Applicants may want to employ “or” instead of “and/or” in this case.
Then claim recites that each target region comprise a single nucleotide polymorphism (SNP) and/or wherein the group is predetermined for the patient without a priori knowledge of the genotype of the patient, then later requires the step (c) of detecting a sequence encoding the SNP. However, the “and/or” recitation results in the step of target comprising SNP an optional step, resulting in the confusion as to whether step (c) is now an optional step.
The claim then recites the limitation, “Nsnp is the number of sequences encoding a unique SNP” and recites and “and/or” followed by reciting the Nsnp is equal to or greater than the number of color channels on the detection instruments.” However, the “and/or” conjunction discussed above regarding “SNP” and the NsnP renders the limitation of the Nsnp being equal to or greater than the number of color channels not required.
The claims are replete with the usage of “and/or” and this results in an incomprehensible claim.
Claim 2 is also replete with such usage of “and/or” limitations which renders the claims incomprehensible.
While MPEP 2143.03 stats that a claim limitation which is considered indefinite cannot be disregarded, the court in, In re Steele, 305 F.2d 859,134 USPQ 292 (CCPA 1962) stated that, “it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions”.
As discussed above, the claims are incomprehensible and as such no meaningful assumption could be made and therefore, no prior art rejection could be made.
Applicants are advised to redraft the claims to clearly define the actual invention, and recite alternative limitations (embodiments) in a dependent claim instead of using the conjunction, “and/or” after every limitation in a single claim as presently presented.
Conclusion
No claims are allowed.
Although no prior art rejection could be made due to the incomprehensive nature of the claims, the Office provides the following documents which may be relevant to patentability inquiry.
Vlaminck et al. (Science Translational Medicine, June 2014, vol. 6, no. 241, pages 1-9) generally teach that circulating cell-free DNA allows noninvasive diagnosis of heart transplant rejection, wherein the artisans teach that donor-derived cell-free DNA was purified from plasma and sequenced (see Abstract, and page 1st column):
“we present the results of a prospective cohort study that evaluated the performance of donor-derived cfdDNA to measure allograft rejection after heart transplantation. We analyzed 565 plasma samples collected longitudinally from 65 adult and pediatric transplant recipients … Our findings indicate that cfdDNA measurements have the potential to replace the endomyocardial biopsy and that these measurements can possibly be used for other aspects of patient management, such as predicting rejection events and managing immunosuppressant dosing”
Beck et al. (Transplantation Proceedings, 2015, vol. 47, pages 2400-2403) generally teach the method of predicting transplantation rejection in a subject by use of a cell-free DNA from plasma sample with determination involving multiple SNPs:
“Cell-free DNA (cfDNA) circulating in the blood plasma … Droplet digital PCR (ddPCR) was used to quantify GcfDNA [graft-derived cell-free DNA] in plasma of HTx and KTx recipients … cfDNA is extracted from a 2-mL specimen and subjected to the parallel quantification of recipient and graft derived cfDNA, b the use of ddPCRs for single nucleotide polymorphisms (SNPs) differences between those 2 genomes. These SNPs have been selected using a population genomics approach in a manner to ensure the highest probability of being different between 2 individuals, which are SNPs, where the alternative alleles have a similar frequency in the population. To increase the precision, several such SNP assays are combined into 1 patient-specific assay and then used for every sampling point.” (page 2402, 1st column)
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YOUNG J KIM/Primary Examiner
Art Unit 1637 October 3, 2026
/YJK/
