Prosecution Insights
Last updated: April 19, 2026
Application No. 17/806,238

METHODS AND COMPOSITIONS FOR CANCER DETECTION, CHARACTERIZATION OR MANAGEMENT IN COMPANION ANIMALS

Non-Final OA §101§103§112
Filed
Jun 09, 2022
Examiner
VANN-OJUEKAIYE, KENDRA RAYCHELL
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Zoetis Services LLC
OA Round
1 (Non-Final)
0%
Grant Probability
At Risk
1-2
OA Rounds
3y 2m
To Grant
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 8 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
61 currently pending
Career history
69
Total Applications
across all art units

Statute-Specific Performance

§101
13.1%
-26.9% vs TC avg
§103
41.9%
+1.9% vs TC avg
§102
8.9%
-31.1% vs TC avg
§112
20.2%
-19.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 8 resolved cases

Office Action

§101 §103 §112
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 of Group I, claims 1-18, drawn to a method of determining if a companion animal is likely to have cancer in the reply filed on 10/30/2025 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 Claims 19-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025. Applicant’s election of the species: SEQ ID NO: 1 and genomic sequence of a healthy animal as the reference sequence in the reply filed on 10/30/2025 is acknowledged. Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. 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 Status Claims 1-24 are pending. Claims 16-24 are withdrawn. Claims 1-15 are currently under examination Priority This application is a CON of PCT Application No. PCT/US2020/065337, filed on 12/16/2020, which claims benefit of U.S. Provisional Application No. 62/949,920, filed on 12/18/2019. The priority date of claim set filed on 06/09/2022, is determined to be 12/18/2019. Claim Rejections - 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. Claim 1 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. Claim 1 is indefinite over the limitation “statistically significant difference”. It is unclear as to what measure of significance is needed to be considered significant in the instant claims. Claims 2-11 depend on claim 1. Claim 4 is indefinite over the limitation “wherein the sequence specific primer has a nucleotide sequence of any one of SEQ ID NOs: 1”. It is unclear if cfDNA from any companion animal could be amplified using SEQ ID NO:1, which appears to be a sequence of the canine genome. Claim 5 is indefinite over the limitation “the sequence specific primer has a nucleotide sequence of SEQ ID NO: 1”. It is unclear if cfDNA from any companion animal could be amplified using SEQ ID NO:1, which appears to be a sequence of the canine genome. Claim 8 is indefinite over the limitation “performing a single primer extension using any one or more of SEQ ID NOs: 1”. It is unclear if cfDNA from any companion animal could be amplified using SEQ ID NO:1, which appears to be a sequence of the canine genome. Claim 9 is indefinite over the limitation “performing a single primer extension using SEQ ID NO: 1 as a portion of the primer”. It is unclear if cfDNA from any companion animal could be amplified using SEQ ID NO:1, which appears to be a sequence of the canine genome. 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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas of obtaining and comparing, routine and conventional step of amplifying and determining the number and distribution of the copies, without significantly more. The claim(s) recite(s) abstract ideas and routine and conventional methods. This judicial exception is not integrated into a practical application because no additional elements integrate the judicial exceptions into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are considered significantly more than the judicial exceptions. Claim analysis The instant claim 1 is directed towards: A method of determining if a companion animal is likely to have cancer, comprising: obtaining circulating cell free DNA (cfDNA) in a biological sample from a companion animal; amplifying the cfDNA using a sequence specific primer that is derived from repeat elements present throughout the genome of the companion animal to obtain copies of the repeat element and adjacent genomic sequences; determining the number and distribution of the copies of amplified regions in the cfDNA; and comparing the number and distribution of copies of the amplified regions, including the adjacent genomic sequences, to one or more healthy animals to determine if the number and distribution of copies in the companion animal suspected of having cancer differs from the number of copies of the amplified regions in the one or more healthy animals, wherein a statistically significant difference indicates that the companion animal is highly likely to have cancer. The obtaining circulating cell free DNA (cfDNA) in a biological sample from a companion animal is considered to be an abstract idea. See MPEP 2106.04 (a)(2). The comparing the number and distribution of copies of the amplified regions, including the adjacent genomic sequences, to one or more healthy animals to determine if the number and distribution of copies in the companion animal suspected of having cancer differs from the number of copies of the amplified regions in the one or more healthy animals is considered to be an abstract idea. See MPEP 2106.04 (a)(2). The amplifying the cfDNA using a sequence specific primer and the determining the number and distribution of the copies of amplified regions in the cfDNA are considered to be active steps requiring the analysis of a sample. The active step is routine and conventional as demonstrated by the 35 USC § 103 rejections stated below. Dependent claims set forth further limitations about the companion animal, sequence specific primer, sample, determination of the number and distribution of copies of amplified regions, and amplification of SINE sequence. The instant claim 12 is directed towards: A method of determining if a canine animal is likely to have cancer, comprising: obtaining circulating cell free DNA (cfDNA) in a biological sample from a canine containing canine genomic sequences; amplifying short interspersed nuclear element (SINE) sequences and adjacent sequences from the canine genomic sequences to determine the number and distribution of SINE sequences in the canine genomic sequences; and determining whether the companion animal is likely to have cancer based on the number and distribution of the SINE sequences. The obtaining circulating cell free DNA (cfDNA) in a biological sample from a canine animal is considered to be an abstract idea. See MPEP 2106.04 (a)(2). The determining whether the companion animal is likely to have cancer based on the number and distribution of the SINE sequences is considered to be an abstract idea. See MPEP 2106.04 (a)(2). The amplifying short interspersed nuclear element (SINE) sequences and adjacent sequences from the canine genomic sequences is considered to be an active step requiring the analysis of a sample. The active step is routine and conventional as demonstrated by the 35 USC § 103 rejections stated below. Dependent claims set forth further limitations about the sequence specific primer, sample and amplification of SINE sequence. According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility. Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case, the Step 1 requirement is satisfied as the claims are directed towards a process. Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, abstract ideas. With regard to claim 1, the claim recites “A method of determining if a companion animal is likely to have cancer, comprising: obtaining circulating cell free DNA (cfDNA) in a biological sample from a companion animal; amplifying the cfDNA using a sequence specific primer that is derived from repeat elements present throughout the genome of the companion animal to obtain copies of the repeat element and adjacent genomic sequences; determining the number and distribution of the copies of amplified regions in the cfDNA; and comparing the number and distribution of copies of the amplified regions, including the adjacent genomic sequences, to one or more healthy animals to determine if the number and distribution of copies in the companion animal suspected of having cancer differs from the number of copies of the amplified regions in the one or more healthy animals, wherein a statistically significant difference indicates that the companion animal is highly likely to have cancer.” The obtaining circulating cell free DNA and the comparing the number and distribution of copies of the amplified regions are abstract ideas. The amplifying the cfDNA using a sequence specific primer and the determining the number and distribution of the copies of amplified regions in the cfDNA are considered to be routine and conventional active steps. With regard to claim 12, the claim recites “A method of determining if a canine animal is likely to have cancer, comprising: obtaining circulating cell free DNA (cfDNA) in a biological sample from a canine containing canine genomic sequences; amplifying short interspersed nuclear element (SINE) sequences and adjacent sequences from the canine genomic sequences to determine the number and distribution of SINE sequences in the canine genomic sequences; and determining whether the companion animal is likely to have cancer based on the number and distribution of the SINE sequences.” The obtaining circulating cell free DNA and determining whether the companion animal is likely to have cancer based on the number and distribution of the SINE sequences are considered to be an abstract ideas. The amplifying short interspersed nuclear element (SINE) sequences and adjacent sequences from the canine genomic sequences is considered to be routine and conventional active steps. Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? No, there are no additional steps that integrate the claims into a practical application. Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No, there are no additional elements that are significantly more than the judicial exceptions. Regarding claims 1 and 12, the claim require the routine and conventional active steps of amplifying the cfDNA using a sequence specific primer and determining the number and distribution of the copies of amplified regions in the cfDNA similar to that of Buis et al. (“Buis”; Patent App. Pub. US 20190309352 A1, Oct. 10, 2019, filed on Nov. 16, 2017). Buis discloses “The invention provides methods for determining whether a subject is predisposed to the disease or condition, or for diagnosing a disease or condition, or for detecting the state of a disease or condition, by detecting nucleic acid fragment size patterns, copy number variations, mutational landscape, genomic instability, methylation status, and combinations thereof in a subject. The invention further provides methods for selecting nucleic acid molecules for use in the methods of the invention.” (Abstract).Thus, the claim does not provide additional steps which are significantly more. Dependent claims require limitations about the companion animal, sequence specific primer, sample, determination of the number and distribution of copies of amplified regions, and/or amplification of SINE sequence. which are all routine and conventional based on Buis et al. (“Buis”; Patent App. Pub. US 20190309352 A1, Oct. 10, 2019, filed on Nov. 16, 2017) in view of Mounts et al. (“Mounts”; Patent App. Pub. US 20070009899 A1, Jan. 11, 2007). Claim Rejections - 35 USC § 103 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(s) 1-3, 6-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Buis et al. (“Buis”; Patent App. Pub. US 20190309352 A1, Oct. 10, 2019, filed on Nov. 16, 2017). Buis discloses “The invention provides methods for determining whether a subject is predisposed to the disease or condition, or for diagnosing a disease or condition, or for detecting the state of a disease or condition, by detecting nucleic acid fragment size patterns, copy number variations, mutational landscape, genomic instability, methylation status, and combinations thereof in a subject. The invention further provides methods for selecting nucleic acid molecules for use in the methods of the invention.” (Abstract). Regarding claim 1, Buis teaches “The methods and compositions disclosed herein may be useful for the detection, diagnosis, or prognosis of a wide range of diseases and conditions including, but not limited to, cancer” (Para. 86). Buis teaches a method comprising “A method for determining the nucleotide sequence of one or more target nucleic acids in a subject” (Para. 7). Buis teaches a method comprising “The terms “subject” and “patient”, as used herein, refer to any animal, such as a dog, a cat, a bird, livestock, and particularly a mammal, and preferably a human.” (Para. 116). Thus, Buis teaches a method of determining if a companion animal is likely to have cancer. Buis teaches a method comprising obtaining circulating cell free DNA (cfDNA) in a biological sample from a companion animal; (Para. 8; Para. 117). Buis teaches a method comprising “ c) hybridizing an anchor primer ... and hybridizing a genome-informed primer, which is substantially complementary to a repeat sequence in the nucleic acid, to produce a plurality of replicons, wherein the anchor sequence and the repeat sequence flank a gap region in the plurality of target nucleic acid sequences of interest; d) … amplicons that are amplified from the replicons in step c)” (Para. 10-11). Thus, Buis teaches a method comprising amplifying the cfDNA using a sequence specific primer that is derived from repeat elements present throughout the genome of the companion animal to obtain copies of the repeat element and adjacent genomic sequences. Buis teaches a method comprising “further comprising determining the number of the unique amplicons sequenced at step d); determining a read density based at least in part on the number of unique amplicon sequences” (Para. 12). Thus, Buis teaches a method comprising determining the number and distribution of the copies of amplified regions in the cfDNA. Buis teaches a method comprising “detecting copy number variation by comparing the read density to a plurality of reference read densities that are computed based on reference nucleic acid samples isolated from reference subjects” (Para.12). Buis also teaches a method comprising “wherein reference value is from one or more cancer-free subjects” (Para. 16) and “the sample comprises at least one nucleic acid sequence whose genome is suspected of having undergone variation… used to detect a disease or condition, or detect the state of a disease or condition, or determine whether a subject has a predisposition to a disease or condition, in samples from any mammal” (Para. 118). Buis teaches a method comprising “b) calculating a first value of a first parameter based on the amounts of nucleic acids at the plurality of sizes, the first parameter providing a statistical measure of a size profile of nucleic acids in the sample; c) comparing the first value to a reference value” (Para. 14-15). Thus, Buis teaches a method comprising comparing the number and distribution of copies of the amplified regions, including the adjacent genomic sequences, to one or more healthy animals to determine if the number and distribution of copies in the companion animal suspected of having cancer differs from the number of copies of the amplified regions in the one or more healthy animals, wherein a statistically significant difference indicates that the companion animal is highly likely to have cancer. The teachings of Buis are documented above in the rejection of claims xx under 35 U.S.C. 103. Claim 2-3, 6-7 and 10-11 depend on claim 1. Claim 7 depends on claim 6, which depends on claim 1. Claim 11 depends on claim 10, which depends on claim 1. Regarding claim 2, Buis teaches a method wherein “The terms “subject” and “patient”, as used herein, refer to any animal, such as a dog” (Para. 116). Regarding claim 3, Buis teaches a method wherein “a genome-informed primer, which is substantially complementary to a repeat sequence in the nucleic acid” and “wherein the repeat sequence is selected from the group consisting of Alu repeats” (Para. 12).”Alu repeats” read on SINE sequences. Regarding claim 6, Buis teaches a method wherein “sample is a blood sample” (Para. 118). Regarding claim 7, Buis teaches a method wherein “circulating tumor DNA (ctDNA) in blood” (Para. 140). Regarding claim 10, Buis teaches a method wherein “multiple layers of unique molecular tags and/or barcodes can be used within the methods to identify specific primer species” (Para. 140). Regarding claim 11, Buis teaches a method wherein “The term “MIP,” as used herein, refers to a molecular inversion probe (also known as a circular capture probe). As used herein, the terms “primer”, “probe”, or “capture probe” also may refer to a MIP” and “the polynucleotide linker (or the backbone linker) in the MIPs are universal” (Para. 119). Therefore, the invention as recited in claims 1-3, 6-7 and 10-11 are prima facie obvious over the prior art Buis et al. One of ordinary skill in the art would have had a reasonable expectation of success given the lack of novelty. It would have been obvious to determine if a companion animal is likely to have cancer according to the limitations of the instant application claims 1-3, 6-7 and 10-11 based on Buis et al. (Patent App. Pub. No. US 20190309352 A1). Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Buis et al. (“Buis”; Patent App. Pub. US 20190309352 A1, Oct. 10, 2019, filed on Nov. 16, 2017). Regarding claim 12, Buis teaches “a method for determining the nucleotide sequence of one or more target nucleic acids in a subject” (Para. 7). Buis teaches methods comprising “a method of determining whether a subject has a predisposition to a disease or condition that is associated with ... CNV [copy number variation] status ... Particular diseases and conditions include, for example, cancers” (Para. (150). Buis teaches a method comprising “The terms “subject” and “patient”, as used herein, refer to any animal, such as a dog” (Para. 116). Buis teaches a method comprising “a) obtaining a nucleic acid sample isolated from a subject” (Para. 8). Buis teaches a method wherein “sample comprises at least one nucleic acid sequence whose genome is suspected of having undergone variation ... samples from any mammal, including, but not limited to dogs ... cell-free DNA may be isolated from the sample prior to further analysis)” (Para. 118). Buis teaches a method comprising “] c) hybridizing an anchor primer ... and hybridizing a genome-informed primer, which is substantially complementary to a repeat sequence in the nucleic acid, to produce a plurality of replicons, wherein the anchor sequence and the repeat sequence flank a gap region in the plurality of target nucleic acid sequences of interest; d) sequencing a plurality of amplicons that are amplified from the replicons in step c)” (Para. 10-11) and “wherein the repeat sequence is selected from the group consisting of Alu repeats” (Para. 12). Buis teaches a method comprising “further comprising determining the number of the unique amplicons sequenced at step d); determining a read density based at least in part on the number of unique amplicon sequences; and detecting copy number variation by comparing the read density to a plurality of reference read densities that are computed based on reference nucleic acid samples isolated from reference subjects” (Para. 12). Buis teach a method comprising “a subject has a predisposition to a disease or condition that is associated with ... CNV [copy number variation] status ... Particular diseases and conditions include, for example, cancers” (Para. 150). Buis also teaches a method comprising “wherein reference value is from one or more cancer-free subjects” (Para. 16) and “the sample comprises at least one nucleic acid sequence whose genome is suspected of having undergone variation… used to detect a disease or condition, or detect the state of a disease or condition, or determine whether a subject has a predisposition to a disease or condition, in samples from any mammal” (Para. 118). The teachings of Buis are documented above in the rejection of claim 12under 35 U.S.C. 103. Claim 13 depends on claim 12. Regarding claim 13, Buis teaches a method wherein “sample is a blood sample” (Para. 118). Therefore, the invention as recited in claims 12-13 are prima facie obvious over the prior art Buis et al. One of ordinary skill in the art would have had a reasonable expectation of success given the lack of novelty. It would have been obvious to determine if a canine animal is likely to have cancer according to the limitations of the instant application claim 12-13 based on Buis et al. (Patent App. Pub. No. US 20190309352 A1). Claim(s) 1, 3-5 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Buis et al. (“Buis”; Patent App. Pub. US 20190309352 A1, Oct. 10, 2019, filed on Nov. 16, 2017) in view of Mounts et al. (“Mounts”; Patent App. Pub. US 20070009899 A1, Jan. 11, 2007) The teachings of Buis are documented above in the rejection of claims 1 under 35 U.S.C. 103. Claims 3-5 and 8-9 depend on claim 1. Claims 4 and 5 depend on claim 3, which depends on claim 1. Buis does not explicitly teach the limitations of claims 4-5 and 8-9. Mounts discloses “The present invention provides nucleic acid arrays and methods of using the same for detecting gene expression in animal models of osteoarthritis or other inflammatory diseases. The nucleic acid arrays of the present invention comprise polynucleotide probes for genes that are differentially expressed in osteoarthritis-affected cartilage tissues as compared to non-osteoarthritic cartilage tissues. In one embodiment, a nucleic acid array of the present invention comprises a plurality of polynucleotide probe sets, each of which is capable of hybridizing under stringent or nucleic acid array hybridization conditions to a different respective tiling sequence selected from Table C, or the complement thereof.” (Abstract). Regarding claims 4-5, Mounts teaches a method wherein “The probes in Table I are perfect match probes and correspond to SEQ ID NOs: 12,312-210,107” (Para. 130) and SEQ ID NO: 219902 of sequence listing comprises a nucleic acid of 100% identity to SEQ ID NO: 1 of the instant application”, where “S” is a “G” (see alignment below). Thus, Buis and Mounts teach a method wherein the sequence specific primer has a nucleotide sequence of any one of SEQ ID NOs: 1-10, or a sequence having at least 90% sequence identity thereof; and wherein the PNG media_image1.png 173 626 media_image1.png Greyscale sequence specific primer has a nucleotide sequence of SEQ ID NO: 1 Regarding claims 8 and 9, Buis teaches a method wherein “Following hybridization, a polymerase and a ligase are added under extension/ligation conditions” (Para. 67). Mounts teaches a method wherein “The probes in Table I are perfect match probes and correspond to SEQ ID NOs: 12,312-210,107” (Para. 130) and SEQ ID NO: 219902 of sequence listing comprises a nucleic acid of 100% identity to SEQ ID NO: 1 of the instant application”, where “S” is a “G” (see alignment above). Thus, Buis and Mounts teach a method wherein determining the number and distribution of the copies of amplified regions comprises performing a single primer extension using any one or more of SEQ ID NOs: 1-10, or a sequence having at least 90% sequence identity thereof, as a portion of the primer being extended; and wherein determining the number and distribution of the copies of amplified regions comprises performing a single primer extension using SEQ ID NO: 1 as a portion of the primer being extended. Buis and Mounts are both considered to be analogous to the claimed invention because they are in the same field of determining whether a subject is predisposed to the disease or condition. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of obtaining CfDNA, amplifying the cfDNA, comparing the copies of amplified regions to a healthy animal and determining the difference which indicates the companion animal is likely to have cancer as taught by Buis to incorporate the method wherein the primer sequence is SEQ ID NO: 1 of the instant application as taught by Mounts and provide a method of determining if a companion animal is likely to have cancer. Doing so would allow for the diagnosis of cancer in a companion animal using a specific canine sequence. Claims 12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Buis et al. (“Buis”; Patent App. Pub. US 20190309352 A1, Oct. 10, 2019, filed on Nov. 16, 2017) in view of Mounts et al. (“Mounts”; Patent App. Pub. US 20070009899 A1, Jan. 11, 2007) The teachings of Buis are documented above in the rejection of claims 12-13 under 35 U.S.C. 103. Claim 14-15 depend on claim 12. Buis does not explicitly teach the limitations of claims 14-15. Mounts discloses “The present invention provides nucleic acid arrays and methods of using the same for detecting gene expression in animal models of osteoarthritis or other inflammatory diseases. The nucleic acid arrays of the present invention comprise polynucleotide probes for genes that are differentially expressed in osteoarthritis-affected cartilage tissues as compared to non-osteoarthritic cartilage tissues. In one embodiment, a nucleic acid array of the present invention comprises a plurality of polynucleotide probe sets, each of which is capable of hybridizing under stringent or nucleic acid array hybridization conditions to a different respective tiling sequence selected from Table C, or the complement thereof.” (Abstract). Regarding claim 14, Mounts teaches a method wherein “The probes in Table I are perfect match probes and correspond to SEQ ID NOs: 12,312-210,107” (Para. 130) and SEQ ID NO: 219902 of sequence listing comprises a nucleic acid of 100% identity to SEQ ID NO: 1 of the instant application”, where “S” is a “G” (see alignment below). Thus, Buis and Mounts teach a method wherein the sequence specific primer has a nucleotide sequence of any one of SEQ ID NOs: 1-10, or a sequence having at least 90% sequence identity thereof. PNG media_image1.png 173 626 media_image1.png Greyscale Regarding claim 15, Mounts teaches a method wherein “The probes in Table I are perfect match probes and correspond to SEQ ID NOs: 12,312-210,107” (Para. 130) and SEQ ID NO: 219902 of sequence listing comprises a nucleic acid of 100% identity to SEQ ID NO: 1 of the instant application”, where “S” is a “G” (see alignment above).Thus, Buis and Mounts teach a method wherein the sequence specific primer has a nucleotide sequence of SEQ ID NO: 1 Buis and Mounts are both considered to be analogous to the claimed invention because they are in the same field of determining whether a subject is predisposed to the disease or condition. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of obtaining CfDNA, amplifying the cfDNA, comparing the copies of amplified regions to a healthy animal and determining the difference which indicates the companion animal is likely to have cancer as taught by Buis to incorporate the method wherein the primer sequence is SEQ ID NO: 1 of the instant application as taught by Mounts and provide a method of determining if a companion animal is likely to have cancer. Doing so would allow for the diagnosis of cancer in a companion animal using a specific canine sequence. Conclusion No claims are in condition for allowance. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENDRA R VANN-OJUEKAIYE whose telephone number is (571)270-7529. The examiner can normally be reached M-F 9:00 AM- 5:00 PM. 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, Winston 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KENDRA R VANN-OJUEKAIYE/Examiner, Art Unit 1682 /WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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Prosecution Timeline

Jun 09, 2022
Application Filed
Nov 13, 2025
Non-Final Rejection — §101, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
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Grant Probability
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3y 2m
Median Time to Grant
Low
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