DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed July 2, 2026. Currently, claims 1-21 are pending. Claims 14, 16, 21, 22 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election of Group I, Claims 1-13, 15, 17-20 in the paper filed July 2, 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)).
Applicant elected the single SNP 45,616,738 on August 5, 2026. Applicant is requested to provide the AX number for the elected SNP.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
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Drawings
The drawings are acceptable.
Requirement for Information
Applicant and the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application.
The Rosengren (PO02393, 2020) reference used in this office action was authored, in part, by the inventor of this application, namely Maria Rosengren. The examiner requires further information in order to make further determinations about the patentability of the instant claims. In response to this requirement, please provide answers to each of the following interrogatories eliciting factual information:
The Rosengren (PO02393, 2020) reference teaches genome scan for back and croup conformation in the Icelandic horse. The IDS provides the date of publication as 2020. Applicant is required to provide the date of availability including the month, date and year, to allow the Examiner to determine if the reference qualifies as art under 102(a)(1) in the event any Declaration is filed. It is unclear whether this publication was filed more than a year before the priority date.
The applicant is reminded that the reply to this requirement must be made with candor and good faith under 37 CFR 1.56. Where the applicant does not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
This requirement is an attachment of the enclosed Office action. A complete reply to the enclosed Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the enclosed Office action.
Improper Markush Rejection
Claims 1-13, 15, 17-20 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
A Markush claim contains an “improper Markush grouping” if:
(1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. See MPEP § 2117.
Here each species is considered to each of the equine SNPs or haplotypes associated with predicting a phenotype such as conformation of back and croup.
The recited alternative species in the groups set forth here do not share a single structural similarity, as each different gene that could be detected is itself located in a separate region of the genome and has its own structure. The genes recited in the instant claims, do not share a single structural similarity since each consists of a different nucleotide sequences with different expression patterns. The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the markers comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of being correlated with equine SNPs or haplotypes associated with predicting a phenotype such as conformation of back and croup. Accordingly, while the different markers are asserted to have the property of being equine SNPs or haplotypes associated with predicting a phenotype such as conformation of back and croup, they do not share a single structural similarity.
MPEP 2117 (II)(A) provides the following guidance as to what constitutes a physical, chemical, or art recognized class:
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”
The recited genes do not belong to a recognized chemical class because there is no expectation from the knowledge in the art that the genes will behave in the same manner and can be substituted for one another with the same intended result achieved. In other words, there is no expectation from the knowledge in the art that each of the recited genes would function in the same way in the claimed method; it is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention. Further there is no evidence of record to establish that it is clear from their very nature that each of the recited genes possess the common property of being equine SNPs or haplotypes associated with predicting a phenotype such as conformation of back and croup.
MPEP 2117 (II) further states the following:
Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the compounds do not appear to be members of a recognized physical or chemical class or members of an art-recognized class, the members are considered to share a "single structural similarity" and common use when the alternatively usable compounds share a substantial structural feature that is essential to a common use. Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The recited alternative species do not share a substantial common structure just because they all have a sugar phosphate backbone. The sugar phosphate backbone of a nucleic acid chain is not considered to be a substantial common structural feature to the group of genes being claimed because it is shared by ALL nucleic acids. Further, the fact that the genes all have a sugar phosphate backbone does not support a conclusion that they have a common single structural similarity because the structure of comprising a sugar phosphate backbone alone is not essential to the asserted common use of being associated with breast cancer.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
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 1-13, 15, 17-20 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 1 is directed to “a method for predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse” using at least one biomarker.
Claim 17 is a method for selection of a horse for breeding.
Claim 18 is a method for selecting a training scheme for a horse.
Claim 1 is directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of” predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse”) and a law of nature/natural phenomenon (i.e. the natural correlation between the presence of biomarkers on ECA22 and conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse).
Selection of a horse and selecting a training scheme are mental steps and do not require anything more than mentally selecting or picking a horse or training scheme.
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 1 involves the patent-ineligible concept of an abstract process. Claim 1 requires performing the step of “predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse”. Neither the specification nor the claims set forth a limiting definition for " predicting” and the claims do not set forth how “predicting” is accomplished. As broadly recited the predicting may be accomplished mentally by thinking about a subject’s biomarkers and assessing conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse. Thus, the predicting constitutes an abstract process idea.
A correlation that preexists in the horse is an unpatentable phenomenon. The association between the presence of biomarkers on ECA22 and conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse is a law of nature/natural phenomenon. The "predicting” tells users of the process to predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse in the sample, amounts to no more than an "instruction to apply the natural law". This predicting is no more than a mental step. Even if the step requires something more such as to verbalize the discovery of the natural law, this mere verbalization is not an application of the law of nature to a new and useful end. The predicting does not require the process user to do anything in light of the correlation. The "predicting” fails to provide the “practical assurance” sought by the Prometheus Court that the “process is more than a drafting effort designed to monopolize the law of nature itself.”
Question 2A Prong II
The exception is not integrated into a practical application of the exception. The claims does not recite any additional elements that integrate the exception into a practical application of the exception. While the claim recites determining in a sample the presence or absence of at least one biomarker, 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.
Claims 17-18 are is directed to a method for selection a horse for breeding and selecting a training scheme. The selection of a horse or a training scheme is merely a mental step and is not an integration of the judicial exception. In the event the claim required breeding a particular horse or training a horse with a particular scheme, this may overcome the rejection.
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 measuring determining the presence or absence of at least one biomarker is 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 presence of absence of at least one biomarker was well known in the art at the time the invention was made. The prior art teaches that analysis of equine SNPs was routinely performed on the 670K equine chip from Affymetrix (see Schaefer, for example). Table 1 is a summary of the SNPs on ECA22 using the Affymetrix numbering systems. This is a commercially available biochips and arrays that comprise the claimed biomarkers. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any expression analysis assay, mutation and promoter methylation analysis to determine the expression and mutation and methylation status. 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.
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
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.
Claims 1-13, 15, 17-20 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 determining any structurally undefined biomarker in a 3 million region from ECA22 which possess the functionality of being associated with predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse.
Relevant to the lack of particular structural limitations in the rejected claims drawn to nucleic acids, MPEP 2163 states:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.
Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ 2d 1161 (Fed. Cir. 2010) recently re-affirmed the written description requirement. Ariad reiterates that “the hallmark of written description is disclosure" and “possession as shown in the disclosure” is a more complete formulation of the test for written description. Ariad considers situations of genus claims and states that the written description requirement ensure that "when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function."
Vas-Cath Inc. V. Mahurkar, 19 USPQ2b 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed”. In The Regents of the University of California v. Eli Lilly (43 USPQ2b 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(1), the court states that “An adequate written description of a DNA…’ required a precise definition, such as by structure, formula, chemical name, or physical properties’, not a mere wish or plan for obtaining the claimed chemical invention”.
In the case of the instant claims, the functionality of identifying biomarkers diagnostic of predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse is a critical feature of the claimed methods.
The specification teaches identifying several SNPs in the 45,347,000-45,662,000 region that are associated with score of back and croup. The specification teaches is it not, however clear that all polymorphisms within 44,000,000 to 47,000,000 on ECA22 are associated with predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse. The specification teaches a vast number of SNPs were not found to be associated.
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As seen in Figure 1B, a handful of SNPs are significantly associated with back and croup but the majority of SNPs on chromosome 22 are lack association, as they are below the line of significance. 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 ECA22, position 44,000,000 to 47,000,000 to predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse, simply based on their existence. The specification is silent with respect to which biomarkers within the claim region are associated with gait quality or type. Applicant has not described a representative number within the genus. Accordingly, Applicants have not adequately disclosed the relevant identifying characteristics of a representative number of species within the claimed genus.
With respect to claims which encompass biomarkers, no common structural attributes identify the members of the genus. The current claims encompass a large genus of nucleic acids which comprise biomarkers in the ECA22, position 44,000,000 to 47,000,000. 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 16 SNPs for which data is provided. The specification does not define biomarkers. However, the state of the art teaches biomarkers encompasses 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 ECA22, position 44,000,000 to 47,000,000. 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 diagnosing conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse 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 conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse because it is not clear which polymorphisms or mutations within ECA22 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 polynucleotides 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
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.
Claims 1-13, 15, 17-20 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 methods of detecting biomarkers in the ECA22, position 44,000,000 to 47,000,000, does not reasonably provide enablement for a method for predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse by detecting biomarkers in the ECA22, position 44,000,000 to 47,000,000. 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 a method for predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse by detecting biomarkers in the ECA22, position 44,000,000 to 47,000,000.
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).
Guidance in the Specification.
The specification provides no evidence that the broad scope of the claims are enabled. The specification analyzed genome wide analysis of equine SNPs associated with back and croup (see Figure 1B). The specification fails to provide any analysis of gait quality or gait type and associations.
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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 invention as broadly as claimed.
The claims are directed to analysis of any biomarker in the ECA22, position 44,000,000 to 47,000,000 and predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse. The specification teaches 16 particular SNPs associated with back and croup. The claims encompass any biomarker, including deletions, insertions and SNPs, for example. The specification has not enabled the analysis of any deletions or insertions. It is unpredictable whether any insertions or deletions are present in the extremely large region on ECA22 and if there are, whether they are associated with conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse.
Furthermore, the specification provides analysis of back and croup over a genome wide study to identify 16 SNPs that have a significant association. The specification fails to analyze any gait quality and/or gait performance type trot or pace of a horse and each individual biomarker. The specification teaches the biomarkers predict trotter vs pacer but provide no analysis. According to the claims the first haplotype is a pacer and the 2nd haplotype is a pacer but the specification provides no discussion or analysis. Table 5 illustrate haplotype analysis and there are three haplotypes with AT and two with GC, with some being associated with back and croup and others not. It is unpredictable whether the disclosed SNPs are associated with any gait quality and/or gait performance type trot or pace of a horse. The skilled artisan would be required to perform significant additional unpredictable and undue experimentation to determine whether any biomarker in the claimed region are associated with alternative phenotypes. 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 § 112- Second Paragraph
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.
Claims 1-13, 15, 17-20 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 pre-AIA the applicant regards as the invention.
A) The claims are indefinite. It is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of Claim 1 is directed to a method for predicting conformation of back and croup, and/or gait quality and/or gait performance type trot or pace of a horse. However, the claim only provides for determining in a sample the presence or absence of a biomarker. Thus, it is not clear if applicant intends to cover any method determining in a sample the presence or absence of a biomarker, or if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If the claim requires something
more, it is unclear what additional active process step the method requires and it appears that the claims are incomplete. The claims fail to provide any active steps that clearly accomplish the goal set for the by the preamble of the claims. Claims 17 and 18 and the claims depending from each of the claims are similarly indefinite. Correction is required.
B) Claims 3-7 recited “of from nucleotides position”. It is unclear what “of from” encompasses. It is unclear whether the position is located within the region or in a region of the nucleotide positions. It is possible “of from” is a typographical error. Correction is required.
C) Regarding claim18, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosengren et al. (PO0293: Equine, 2020, from the IDS).
It is noted that the authorship of the Rosengren et al. reference is distinct from the inventorship of the instant application and that this rejection may be overcome by the filing of a 132 Katz-type declaration or a declaration under 37 CFR 1.130(a) (see MPEP 717.01(a)(1)(B) “Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an "unequivocal" statement from the inventor or a joint inventor that he/she (or some specific combination of named joint inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary.”)
Rosengren teaches genome scan for back and Croup conformation in the Icelandic horse. Rosengren teaches horses were genotyped using the 670K Axiom Equine Genotyping Array. Rosengren teaches twelve SNPS on ECA22 reached significance and haplotype analysis revealed two opposite haplotypes that resulted in higher and lower scores for the back and croup.
Claims 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Fergraeus et al. (Physiological Reports, ISSN 2051-817X, Vol. 6, No. 10, e13700, 2018).
Fergraeus teaches a region in the horse genome that is associated with harness racing performance. Fergraeus teaches a method for studying a large number of SNPs (abstract). DNA was extracted from blood and genotypes on Illumina SNP50 BeadChips comprising large numbers of SNPs, namely 54,602 and 57,165 SNPs (page 2, col. 2). Figure 1 illustrates analysis of SNPs in different horses. Figure 1 illustrates the association of a handful of SNPs on Chromosome 22. Table 2 teaches allele frequency for SNPs including 22:45,748,491 which is within the scope of the instant claims. Fergraeus teaches g22:45748491C>T was significantly associated with racing performance results in Coldblooded trotters (page 10). The CC genotype was negatively influencing performance results and the TT genotype was at a high frequency in athletic breeds.
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rosengren et al. (BMC Genomics, Vol. 22, No. 267, Online April 14, 2021) teaches a QTL for conformation of back and croup influences lateral gait quality in Icelandic horses. This is Applicant post filing date reference.
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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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
August 7, 2026
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