CTNF 18/547,225 CTNF 77002 DETAILED CORRESPONDENCE Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. This action is in response to the papers filed March 11, 2026. Currently, claims 56-75 are pending. Claims 66, 75 have been withdrawn as drawn to non-elected subject matter. Election/Restrictions 08-25-02 Applicant's election of rs852810656 in the paper filed March 11, 2026 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 § 818.03(a)). Claims 66, 75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. The requirement is still deemed proper and is therefore made FINAL. Priority This application claims priority to PNG media_image1.png 64 608 media_image1.png Greyscale Drawings The drawings are acceptable. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 56-65, 67-68 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. 35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson , 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II. Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility. Question 1 The claimed invention is directed to a process that involves a natural principle and a judicial exception. Question 2A Prong I The claims are taken to be directed to an abstract idea, a law of nature and a natural phenomenon. Claim 56 is directed to “a method for treating bleeding in a canine” by “determining if a genetic mutation in SERPINF2 gene is present and treating the god with a veterinary composition” “if” the genetic mutation is present. Claim 63 is directed to “wherein the genetic mutation indicates that the canine is sensitive to experience delayed bleeding”. Claim 56 is directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of “determining if a genetic mutation in SERPINF2 gene is present”) and Claim 63 is directed to a law of nature/natural phenomenon (i.e. the natural correlation between the mutation and sensitivity to experience delayed bleeding). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow. Herein, claim 56 involves the patent-ineligible concept of an abstract process . Claim 56 requires performing the step of “determining if a genetic mutation in SERPINF2 gene is present”. Neither the specification nor the claims set forth a limiting definition for "determining" and the claims do not set forth how “determining” is accomplished. As broadly recited the determining step may be accomplished mentally by thinking about a subject’s genotype. Thus, the determining step constitutes an abstract process idea. A correlation that preexists in the human is an unpatentable phenomenon . The association between the mutation and sensitivity to experience delayed bleeding is a law of nature/natural phenomenon. The wherein clause tells users of the association and does not require more. The wherein clause does not require the process user to do anything in light of the correlation. Question 2A Prong II The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception. While the claim recites obtaining a sample and genotyping, this is not an integration of the exception into a practical application. Instead, these elements are data gathering required to perform the method. Thus, the claim is “directed to” the exception. Claim 56 recites a conditional treatment step with a general treatment. The treatment is not specification or particular and the treatment is not required. Accordingly, the claims are directed to judicial exceptions. Question 2B The second step of Alice involves determining whether the remaining elements, either in isolation or combination with the other non patent ineligible elements, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice , 134 S. Ct. at 2355 (quoting Mayo , 132 S. Ct. at 1297). The claims are not sufficiently defined to provide a method which is significantly more from a statement of a natural principle for at least these reasons: The claims do not include applying the judicial exception, or by use of, a particular machine. The claims do not tie the steps to a “particular machine" and therefore do not meet the machine or transformation test on these grounds. The use of machines generally does not impose a meaningful limit on claim scope. The claims also do not add a specific limitation other than what is well-understood, routine and conventional in the field. The steps are mere data gathering step that amounts to extra solution activity to the judicial exception. It merely tells the users of the method to determine the biomarkers of a sample without further specification as to how the sample should be analyzed. The claim does not recite a new, innovative method for such determination. The determining step essentially tells users to determine the markers through whatever known processes they wish to use. The step of determining the genotype was well known in the art at the time the invention was made. The prior art teaches that the SNP in SERPINF2 was known in the art as early as 2015 (see 102 rejection below). The steps are recited at a high level of generality. The claim merely instructs a scientist to use any genotyping analysis to determine the genotype. The claim does not require the use of any particular non- conventional reagents. 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. Additionally, the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements were well known. Specifically, the specification teaches the SNPs were in dbSNP v. 146 database (page 40, lines 23-25). 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. 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 these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter. Claim Rejections - 35 USC § 112-Description 07-30-01 The following is a quotation of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. 07-31-01 AIA Claim s 56-64, 67-73 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims are broadly drawn to methods which comprise identifying any structurally undefined variant or polymorphism in the gene encoding SERPINF2 gene in a canine and which possess the functionality of being associated with bleeding (Claim 63). In the case of the instant claims, the specification and the art teach two mutations in SERPINF2 gene in canine. The disclosure of two mutations in SERPINF2 is not representative of the genus of mutations in SERPINF2 that would require treatment for bleeding. With respect to Claim 63, the functionality of identifying polymorphisms or variants indicative of bleeding is a critical feature of the claimed methods. The specification teaches identifying two variants and polymorphisms in the SERPINF2 gene that are associated with bleeding. However, it is not clear that all polymorphisms in SERPINF2 are associated with bleeding. Given the guidance in the specification and what was taught in the art prior to the invention, the skilled artisan would be unable to predictably correlate structural changes in the gene encoding SERPINF2 and bleeding, simply based on their existence. In analyzing whether the written description requirement is met for a genus claim, it is first determined whether a representative number of species have been described by their complete structure. The specification discloses two mutations in SERPINF2 that would be associated with bleeding or require treatment. With respect to claims which encompass mutations, no common structural attributes identify the members of the genus. The current claims encompass a large genus of nucleic acids which comprise variants in any region of canine SERPINF2 nucleic acid. The genus includes an enormous number of variants, polymorphisms and mutations for which no written description is provided in the specification. This large genus is represented in the specification by only the particularly named 2 polymorphisms for which data is provided. The genus of mutations may encompass SNPs, deletions, insertions, translocations, microsatellites, for example. The claims encompass a genus of structurally undefined polymorphisms which require a specific functionality. The genus includes a large number of polymorphisms and mutations for which no written description is provided in the specification. This large genus is represented in the specification by a few mutations; however this disclosure does not provide for a predictable association with any polymorphism or variant in the SERPINF2 gene as is broadly claimed. Here, no common element or attributes of the sequences are disclosed which would permit selection of sequences as polymorphisms. No structural limitations or requirements which provide guidance on the identification of sequences which meet the functional limitations of being associated with bleeding is provided. The specification provides no correlation between the structure of the recited polymorphisms and the claimed function of such polymorphisms. Therefore, the polymorphisms are not representative of the genus of any polymorphism associated with bleeding because it is not clear which polymorphisms or mutations within the coding or non-coding region of the SERPINF2 gene would have the same affect. Therefore, the specification fails to teach how to distinguish members of the claimed genus of polymorphisms and variants which possess the claimed functionality from non members. Thus, considering the breadth of the mutations required by the claimed methods, their specific required functionalities, and the teachings of the instant specification, it is the conclusion that the specification does not provide an adequate written description of the broadly claimed subject matter. Claim Rejections - 35 USC § 112-Scope of Enablement 07-30-01 The following is a quotation of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. 07-31-03 AIA Claim s 56-65, 67-74 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for detecting rs852810656 in Scottish deer hounds and making treatment decisions , does not reasonably provide enablement for determining any genetic mutation in SERPINF2 gene is associated with any bleeding in any breed of canines . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands , 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404, “Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” The nature of the invention and breadth of claims The claims are drawn to methods of treating bleeding in any canine by determining any genetic mutation in SERPINF2 gene. The invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). The unpredictability of the art and the state of the prior art The art teaches delayed postoperative hemorrhage (DEPOH) is breed specific. The after teaches performing whole genome sequencing of genes associated with DEPOH in Scottish deerhounds. Court et al. (J. of Veterinary Internal Medicine, Vol. 37, pages 6510-517, 2023)(applicant’s own work) teaches SERPINF2 variant c.605C>T is associated with DEPOH in Scottish deerhounds. Court teaches DEPOH is a health problem in certain sighthound dog breeds. Court teaches anecdotal evidence indicates that Scottish deerhounds are susceptible to DEPOH with clinical signs that are similar to those described for DEPOH for retired racing greyhounds. Court states the marker might only be useful for predicting the risk for DEPOH in Scottish deerhounds and not other breeds such as greyhounds (page 516, col. 2). Court-2025 (Frontiers in Veterinary Science, Vol. 12, No. 1609780, November 2025) teaches analysis of DEPOH across dog breeds with the SERPINF2 c.605T/T genotype. Court teaches it is unclear whether other breeds are affected. Court concludes that “further research is needed to obtain better estimates of the susceptibility of different breeds to DEPOH, especially in those breeds with a relatively high prevalence of the SERPINF2 c.605C>T variant. Guidance in the Specification. The specification provides no evidence that the broad scope of the claimed invention is enabled for the full scope of the claims. The specification teaches 10 single nucleotide variants (SNVs) were identified in 6 genes (page 40, lines 23-25). A SNV in SERPINF2 (c.605 C>T, p.A202V) is nonsynonymous (page 40, line 25). The specification analyzes the presence of c.605 C>T allele in a range of different dog breeds. The specification finds the allele in breeds not expected to have bleeding issues. The specification compares the proportion of dogs with at least one variant allele between case and control groups and find the SNV is statistically different. The specification specifically analyzes association of genotype with delayed postoperative bleeding in Scottish deerhounds. The data demonstrates that none of the cases had the C/C 605 genotype while none of the control dogs had the homozygous variant genotype. PNG media_image2.png 196 700 media_image2.png Greyscale The guidance provided by the specification amounts to an invitation for the skilled artisan to try and follow the disclosed instructions to make and use the claimed invention. Quantity of Experimentation The quantity of experimentation in this area is extremely large since there is significant number of parameters which would have to be studied to enable the skilled artisan to practice the claimed inventions as broadly as claimed. The claims are directed to any variant in SERPINF2. The specification teaches 2 variants in SERPINF2. The specification teaches a significant association with c.605C>T. The dbSNP database teaches there are over 200 variants on chromosome 9 from 45,000,000-46,000,000. The specification does not teach which of these variants are associated with bleeding or bleeding treatments. It is unpredictable for the skilled artisan to analyze additional variants and mutations in the SERPINF2 gene of canines to determine which variants are predictably associated with bleeding or bleeding treatments. Further, the claims are directed to any canine breed. The specification results are limited to Scottish deerhounds. Applicant’s own post filing date work repeatedly states that further research is needed to obtain better estimates of different breeds to DEPOH. Court specifically says that it is unclear whether other breeds are affected. Therefore, it would require further unpredictable and undue experimentation to perform the experimentation necessary to determine whether other breeds are affected by DEPOH and whether they may be treated. This would require significant inventive effort, with each of the many intervening steps, upon effective reduction to practice, not providing any guarantee of success in the succeeding steps. Level of Skill in the Art The level of skill in the art is deemed to be high . Conclusion Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of a working example and the negative teachings in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-06 AIA 15-10-15 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. 07-15-aia AIA Claim(s) 69, 72-74 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by European Variation Archive (Variant Summary for ss190830599, October 9, 2015) . European Variation Archive rs852810656 teaching detecting a genetic mutation in a SERPINF2 gene, namely a variant in dog assembly GCA_000002285.2 (CanFam3.1). The first entry of the SNP as ss190830599 was created October 9, 2015. Ss190830599 is an entry under rs852810656. The canis lupus familiaris was whole genome sequences for 590 samples using Illumina NovaSeq 6000, Illumina HiSeq 2500 and variant data was obtained. HiSeq 2500 uses bridge PCR within a flow cell to generate clusters of clonal DNA strands before sequencing. The instant specification states that the c.605C>T variant is rs852810656 and causes A202V . 07-15-aia AIA Claim(s) 69, 71-74 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Genomia Genetic Laboratory (Result Certificate #012345, January 2, 2021) . Genomia teaches detection of c.605C>T mutation in SERPINF2 gene causing DOPOH in Scottish deerhounds (limitations of Claim 67, 73-74). Genomia teaches the mutation was not detected, therefore, the conditional step of treating “if” the genetic mutation is present does not need to be performed. With respect to Claims 57-59, 68, the treatment is not required by the claims “if” the genetic mutation is not present. With respect to Claim 60-62, the bleeding is delayed postoperative hemorrhage (DEPOH). With respect to Claim 63-65, the c.605C>T mutation inherently indicates that the canine is sensitive to experience delayed bleeding. With respect to Claim 69, the c.605C>T mutation was detected whether it was present in the genetic sample. With respect to Claim 71, the sample type was blood . Conclusion No claims allowable. 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. DEPOHGEN Bleeding Disorder testing for dogs (College of Veterinary Medicine Washington Animal Disease Diagnostic Laboratory, August 2025). A WSU veterinarian discovered a genetic mutation associated with the condition and developed a diagnostic test. The diagnostic test is being sold. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm. 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 Winston Shen can be reached on (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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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682 March 31, 2026 Application/Control Number: 18/547,225 Page 2 Art Unit: 1682 Application/Control Number: 18/547,225 Page 3 Art Unit: 1682 Application/Control Number: 18/547,225 Page 4 Art Unit: 1682 Application/Control Number: 18/547,225 Page 5 Art Unit: 1682 Application/Control Number: 18/547,225 Page 6 Art Unit: 1682 Application/Control Number: 18/547,225 Page 7 Art Unit: 1682