Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim status
Original claims 1-19 filed 6/8/3022 are pending.
Priority
This application filed 6/8/2022 is a continuation of 17/235575 filed 4/20/2021 now US Patent 11,384389, which is a continuation of 16/361753 filed 3/22/2019 now US Patent 11,098350, which is a continuation of 15/788549 filed 10/19/2017 (ABN), which is a continuation of 14/188455 filed now US Patent 9845497 which a continuation of 13/508318 filed (now US Patent 8703652) which was a National stage filing of PCT/US2010/055604 filed 11/5/2010 which claims benefit to US provisional application 61/280674 filed 11/6/2009; and
through parent application 16/361752 is related to 17/323917 filed 5/8/2021, 17/836671, 16/596509 and 16/669347; and
through parent application 15/788549 is related to 16/361741, 16/110682 and 16/110646
Information Disclosure Statement
The two information disclosure statements (IDS) submitted on 6/8/2022 and 9/5/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
It is noted that the listing of references in the specification is not a proper information disclosure statement. See for example citations 81-87 of 6/8/2022 IDS. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) 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.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 17/235575 parent application (now US Patent 11,384389). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being over the claims of application 17/323917, now US Patent 11,390918. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient uses the data obtained from processing a sample for cfDNA and is integral to the method of detecting differences where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient, and does provide for a step for comparing the data obtained (see claim 13 of ‘917). It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-34 of US Application No. 16/361741 filed 3/22/2019 (now US Patent 10988804). Although the conflicting claims are not identical, they are not patentably distinct from each because in the present case, claim 1 of the instant application is drawn to a computer implemented method for classification of SNPs present in a nucleic acid sequence from a sample of a transplant patient. In the present case, claim 1 encompasses all of the functional limitations of instructions of ‘741 set forth in claims 1 and 21 for any sample source and would have been obvious to combine all limitations taught in the referenced claims. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. 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).
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being over the claims of 16/110682 filed 8/23/208 (now US Patent 10329607). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being over the method claims of 16/110646 filed 8/23/2017 (now US Patent 10/494669). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 13/508318 (now US Patent 8703652). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 14/188455 (now US Patent 984497). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 16/361752 (now US Patent 11,098350). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 16/596509 (now US Patent 10982275). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 16/669347 (now US Patent 10968479). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 17/323917 (now US Patent 11390918). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of 17/836671(now US Patent 11597671). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant computer implemented method for classifying a sample based on SNPs in a transplant patient is integral to the method of detecting where the physical steps of obtaining the data are provided, specifically the step of determining the amount of donor specific cfDNA based on the SNP/polymorphism differences of the donor and patient. It is noted that the applications are related and provide the same disclosure with respect to practicing the methodology, and in review of the prosecution there does not appear to be a restriction requirement within the family history.
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.
Claim 8 is 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “SNP” in claim 16 is used by the claim to mean any type of polymorphism, while the accepted meaning is a nucleotide polymorphism including insertions, repeats and deletions. The term is indefinite because the specification does not clearly redefine the term. A review of the present specification provides:
“[0063] In some embodiments, the methods described herein are used to detect and/or quantify genomic DNA regions such as a region containing a DNA polymorphism. A polymorphism refers to the occurrence of two or more genetically determined alternative sequences or alleles in a population. A polymorphic marker or site is the locus at which divergence occurs. Preferred markers have at least two alleles, each occurring at a frequency of preferably greater than 1%, and more preferably greater than 10% or 20% of a selected population. A polymorphism may comprise one or more base changes, an insertion, a repeat, or a deletion. A polymorphic locus may be as small as one base pair. Polymorphic markers include single nucleotide polymorphisms (SNP's), restriction fragment length polymorphisms (RFLP's), short tandem repeats (STRs), variable number of tandem repeats (VNTR's), hypervariable regions, minisatellites, dinucleotide repeats, trinucleotide repeats, tetranucleotide repeats, simple sequence repeats, and insertion elements such as Alu.”
which support for the terms, but does not redefine SNP to be more than a single variation and provides only the guidance consistent with the art understood meaning of SNP. A review of the disclosure does not appear to provide for a definition where a SNP includes an insertion, a repeat or a deletion as set forth in the claim.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim analysis
Independent claim 1 is generally directed to a method for detecting donor-specific cell free nucleic acids in an organ transplant patient. Claim 1 requires 4 steps of generating a SNP profile of recipient which can be done from data previous obtained from a subject, providing a sample containing cfDNA from the recipient after the transplant, determining the amount of organ cfDNA that is present, and detecting whether there is a possible increase which might indicate rejection. The providing and determination of cfDNA in a sample from a transplant patient is based on polymorphic differences/SNPs between the donor and recipient and using the differences to quantify the donor derived sequences that are present. The first step of generating/genotyping profile can be interpreted as both a physical step (as set forth in dependent claims) and/or as a step where the sequence data is analyzed for example from a patient record. The final step of determining is based on at least one assay, but appears to be determined from the information obtained from the assay, not during the assay itself.
For step 1 of the 101 analysis, the claims are found to be directed to a statutory category of a method of analyzing cell free nucleic acids in a urine sample.
For step 2A of the 101 analysis, the judicial exception of the claims are the steps of determining the amount donor specific nucleic acid which is a process of analyzing the data from the one or more assay. In determining the amount cell free nucleic acid from the organ, in view of the guidance of the specification the step involves counting the relative number of reads for a given genotype based on SNPs. When sequencing is used, the step of aligning and comparing sequence to arrive at the identification of genotypes in sequences are considered instructional steps to compare the reads; when digital PCR is used the process itself can be used to provide a value relative to the amount of a sequence present in a sample tested. The judicial exception is a set of instructions for analysis of sequence data from a urine sample, and appear to be directed to the category of Mental Processes, that is concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Here providing sequence reads for comparison and counting them or obtaining a relative quantitative value using dPCR do not appear to be complex steps and can be performed in one’s mind or evaluating the data on paper. Dependent claims set forth the number of reads as 1000 or SNPs as 10, but this does not appear to be a size or complexity that cannot be performed without the aid of a computer.
Recent guidance from the office requires that the judicial exception be evaluated under a second prong to determine whether the judicial exception is practically applied. In the instant case, the claims do not have an additional element to which the judicial exception is applied, and results only in the observation of amount of cell free nucleic acid present in the sample. This judicial exception requires steps recited at high level of generality and are only stored on a non-transitory, and is not found to be a practical application of the judicial exception as broadly set forth.
For step 2B of the 101 analysis, each of the independent claims recites additional elements and are found to be the steps of obtaining sequence data from a urine sample. At the time of filing the art recognizes that urine contains cell free DNA representing both the donor and recipient, for example Zhang et al. provide evidence for the presence of donor and recipient derived DNA in cell-free urine samples of solid organ transplants such as renal transplantation recipients: and demonstrate the presence of urinary DNA chimerism as evidence of the presence of both donor and patient cfDNA. Additionally, analysis by Zhong et al. provide evidence for changes in cell-free DNA in urine as a marker for kidney graft rejection. With respect to claim 1, it appears that the two additional elements were known steps for obtaining sequence read data, and more specifically practiced with urine samples from transplant recipients. Given the evidence and art of record, these steps as broadly set forth do not appear to provide for significantly more when analyzed with the claim as a whole. To the extent that the ‘determining’ step for comparing or quantitating the read data in the urine sample can be facilitated using a computer program, it is noted that in explaining the Alice framework, the Court wrote that "[i]n cases involving software innovations, [the step one] inquiry often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool." The Court further noted that "[s]ince Alice, we have found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology." Moreover, these improvements must be specific -- "[a]n improved result, without more stated in the claim, is not enough to confer eligibility to an otherwise abstract idea . . . [t]o be patent-eligible, the claims must recite a specific means or method that solves a problem in an existing technological process." Here, the claims provide evaluating 1000 reads or ten SNPs which appear to be practically evaluated in one’s mind, and while a computer could facilitate the analysis it does not appear to affect the function of a computer or require unique or special system for the evaluation to tie it to a technical field.
As indicated in the summary of the judicial exception above and in view of the teachings of the specification, the steps are drawn to analysis of sequence data that is present in a urine sample. For analysis on a computer to ‘determine’ an amount, while the instruction are stored on a medium and could be implemented on a computer, together the steps do not appear to result in significantly more than a means to compare sequences. The judicial exception of the method as claimed can be performed by hand and in light of the previous claims to a computer medium and in light of the teaching of the specification on a computer. In review of the instant specification the methods do not appear to require a special type of processor and can be performed on a general purpose computer.
Based upon an analysis with respect to the claim as a whole, claims 1-5, 7-20 do not recite something significantly different than a judicial exception. Claims 1-5, 7-20 are directed towards a method of receiving sequence data and comparing the data to identify ‘malicious’ sequences. Dependent claims set forth additional steps which are more specifically define the source or type of nucleic acid present in the sample, the considerations and steps of calculating, and comparing, and do not add additional elements which result in significantly more to the claimed method for the analysis. No additional steps are recited in the instantly claimed invention that would amount to significantly more than the judicial exception. Without additional limitations, a process that employs mathematical algorithms (aligning sequences) to manipulate existing information (quantitate reads or PCR products) to generate additional information is not patent eligible. Furthermore, if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is non-statutory. In other words, patenting abstract idea cannot be circumvented by attempting to limit the use to a particular technological environment or purpose and desired result.
One way to overcome a rejection for non-patent-eligible subject matter is to persuasively argue that the claimed subject matter is not directed to a judicial exception. Another way for the applicants to overcome the rejection is to persuasively argue that the claims contain elements in addition to the judicial exception that either individually or as an ordered combination are not well understood, routine, or conventional. Another way for the applicants to overcome the rejection is to persuasively argue that the claims as a whole result in an improvement to a technology. Persuasive evidence for an improvement to a technology could be a comparison of results of the claimed subject matter with results of the prior art, or arguments based on scientific reasoning that the claimed subject matter inherently results an improvement over the prior art. The applicants should show why the claims require the improvement in all embodiments.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zhang et al. (Presence of donor- and recipient-derived DNA in cell-free urine samples of renal transplantation recipients: urinary DNA chimerism. Clin Chem. 1999;45:1741–1746), Zhong et al. (Cell-free DNA in urine: a marker for kidney graft rejection, but not for prenatal diagnosis? Ann N Y Acad Sci. 2001;945:250–257), and Gadi et al. (Soluble donor DNA concentrations
in recipient serum correlate with pancreas-kidney rejection, Clin Chem. 2006;52:379–382).
Claim 1 is directed to a method for detecting donor-specific cell free nucleic acids in an organ transplant patient. The method requires providing a SNP profile of recipient, providing a sample after transplant of cfDNA from the recipient, determining an amount of cfDNA from the transplanted organ, and determining possible rejection when the amount increases over a threshold. Dependent claims provide for various known sources of cfDNA such as plasma, blood or urine as a sample from a transplant patient, and screening is based on polymorphic differences/SNPs between the donor and recipient and using the differences to quantify the donor derived sequences that are present. The first step of ‘generating’ for SNP genotyping can be interpreted as both a physical step (as set forth in dependent claims) and/or as a step where the sequence data is analyzed for example from a patient record. The final step of determining is based on at least one assay for determination, but appears to be determined from the information obtained from the assay, not during the assay itself. Dependent claims set forth and describe the nature of the cfDNA nucleic acid in the sample being analyzed, type of transplant (anything, solid organ,..), state of the SNP being homozygous or heterozygous, and possible frequency of the SNP allele.
A review of the relevant art of record demonstrates that the presence of cfDNA in urine and in blood was well known, and more specifically for the claims the ability to distinguish sequences of cfDNA in a transplant patient and the recognition that the cfDNA represented both the patient and the donor organ was in the prior art. For example, Zhang et al. provide evidence for the presence of donor and recipient derived DNA in cell-free urine samples of solid organ transplants such as renal transplantation recipients: and demonstrate the presence of urinary DNA chimerism, that is the presence of both donor and patient cfDNA. Zhong et al. provide evidence for cell-free DNA in urine as a marker for kidney graft rejection. Similarly for the kidney, Gadi et al. teach soluble donor DNA concentrations in recipient serum. It is noted that the amount correlates with pancreas-kidney rejection, and provides for a classification related to the quantity of cfDNA that can be detected. Gadi et al. use a panel of HLA specific makers and derive quantitative read data. While each of the references clearly teach that donor and patient specific markers are necessary to discern the difference of the source of the cfDNA being analyzed, none of the references specifically state to use SNPs that may be present. However, at the time the presence of SNPs and their use in distinguishing genome sources was known.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to substitute the use of SNPs associated uniquely with a donor and uniquely with a recipient in the analysis of cell free nucleic acids to provide a broader overview of the variety of genotypes present in the sample of a chimeric patient. One having ordinary skill in the art would have been motivated to substitute SNPs in addition to those disclosed, one for the other, in order to obtain a broader image of the nucleic acids that are present in the sample. Given the evidence the transplant donors represent chimeric individuals, and that the presence of cfDNA represented both sources of donor organ and patient, there would be an expectation to detect other variants like SNPs that were known to exist in a genome. Further, in view of the success of all, Zhong et al., Gadi et al. and Zhang et al. there would have been a reasonable expectation of success to use and detect SNPs in the differentiations and quantitation of cfDNA in a transplant patient.
Thus, the claimed invention as a whole was clearly prima facie obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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/Joseph Woitach/Primary Examiner, Art Unit 1687
Prosecution Insights