DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on December 30, 2025, February 2, 2026, and February 4, 2026 have been entered. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any rejections or objections not reiterated herein have been withdrawn.
Claims 1 and 6-9 are currently pending.
Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 11, 2025.
Declaration Under 37 CFR 1.132- Subject Matter Eligibility
3. The declarations under 37 CFR 1.132 filed February 2, 2026 and February 4, 2026 are insufficient to overcome the rejection made under 35 U.S.C. 101 as set forth in the last Office action. For a detailed explanation see paragraph 5 below.
Claim Rejections - 35 USC § 101
4. 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 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims have been evaluated using the 2019 Revised Patent Subject Matter Eligibility Guidance (see Federal Register Vol. 84, No. 4 Monday, January 7, 2019).
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The instant claims recite a law of nature. The claims recite a correlation between rs1815739, rs12722, rs1049434, rs2010963, and rs1799945 and muscular and/or ligament injuries. This type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
The instant claims recite abstract ideas.
The claims recite a step of “determining a regression function associated to the polymorphism profile, wherein the regression function is a logistic regression function in the form of
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It is noted that mathematical concepts, including performing mathematical calculations, are considered to be abstract ideas.
Additionally the claims recite a step of “classifying” the individuals predisposition to muscular and/or ligament injuries on the basis of the value of said regression function. The classifying step broadly encompasses a mental process. For example, one may “classify” the predisposition by thinking about the value. Concepts that can be performed in the human mind (including observation, evaluation, judgment, opinions) are considered to be abstract ideas.
Finally the claims recite a step of “applying” the classification of the individual as having a predisposition to muscle and/or ligament injuries from step (c) to develop personalized nutrition and training for the individual to reduce the individual’s predisposition to muscle and/or ligament injury. This step broadly encompasses a mental process. For example, one may develop the personalized nutrition and training plan by thinking about what exercises an individual should do and/or not do and what foods an individual should have and/or not have when they are predisposed to muscular and/or ligament injuries. Concepts that can be performed in the human mind (including observation, evaluation, judgment, opinions) are considered to be abstract ideas.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
In addition to the judicial exceptions the claims recite assaying a genetic sample for the presence of genetic variations (rs1815739, rs12722, rs1049434, rs2010963, and rs1799945). This step does not integrate the judicial exceptions into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exceptions the claims recite assaying a genetic sample for the presence of genetic variations (rs1815739, rs12722, rs1049434, rs2010963, and rs1799945). This step does not amount to significantly more because it simply appends well understood, routine, and conventional activities previously known in the art, specified at a high level of generality, to the judicial exceptions.
The steps are recited at a high level of generality. Assaying a genetic sample for the presence of genetic variations merely instructs a scientist to use any genotyping technique. 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 applicants 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 are well known or commercially available. For example the specification teaches the following:
[0040] The screening for the genetic polymorphisms in the 5 genes was carried out by standard techniques such as PCR amplification of genomic DNA followed by sequencing or real-time PCR.
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.
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
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 the reasons set forth above the claims are not directed to patent eligible subject matter.
Response To Arguments
5. In the responses filed on December 30, 2025, February 2, 2026, and February 4, 2026 the Applicants traversed the rejection under 35 USC 101.
Response Filed December 30, 2025
The response (pages 3-5) traverses the examiners finding under Step 2A Prong 1. The Applicants assert that the claims do not recite judicial expectations.
This argument has been fully considered but is not persuasive. Under Step 2A Prong 1, we evaluate whether the claim recites a judicial exception, i.e., an abstract idea, a law of nature, or a natural phenomenon. In this case claim 1 recites at least two judicial exceptions identified in the guidance. First, claim 1 recites a natural correlation between the SNPs recited in the claim and the predisposition to muscular and/or ligament injuries. Second, claim 1 recites at least two types of abstract ideas identified in the guidance: mathematical concepts and mental processes. Claim 1 recites a mathematical equation and requires performing a mathematical calculation to obtain a regression function. Claim 1 also recites “classifying” the individuals predisposition to muscular and/or ligament injuries on the basis of the value of regression function. The “classifying” step broadly encompasses a mental process because in can be performed in the human mind by thinking about the regression value. Additionally the claims require the user of the method to develop personalized nutrition and training for the individual based on their predisposition to muscle and/or ligament injuries. This broadly encompasses a mental process because in can be performed in the human mind by thinking about what exercises an individual should do and/or not do and what foods an individual should have and/or not have when they are predisposed to muscular and/or ligament injuries. It is maintained that claim 1 recites the judicial exceptions of a law of nature and the abstract subject matter of mathematical concepts and abstract ideas (Step 2A, Prong One: Yes).
The response (page 5) traverses the examiners finding under Step 2A Prong 2. The Applicants assert that the claims do not recite judicial expectations. The Applicants argue that even if individual limitations implicate judicial exceptions, the claim as a whole integrates such concepts into a specific practical application. The ordered combination of laboratory assaying, constrained computational modeling, classification, and mandatory application to personalized nutrition and training constitutes a specific injury-reduction workflow involving structured technical steps and real-world physical intervention.
This argument has been fully considered but is not persuasive. Having determined that claim 1 recites judicial exceptions, Step 2A Prong 2 of the Guidance requires that we evaluate whether the claim as a whole integrates the recited judicial exceptions into a practical application of the exception. The Guidance specifies that first we identify whether there are any additional elements recited in the claim beyond the judicial exceptions, then evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. As discussed above, steps (b), (c), and (d) are judicial exceptions. That leaves step (a) as a step recited in addition to the judicial exceptions. Step (a) recites data gathering to obtain a polymorphism profile. This step is recited at a high level of generality because the assaying can be done by any method known in the art to detect genetic variations. This step does not integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity to the judicial exception. (Step 2A, Prong 2: NO). It is maintained that the claims are directed to the judicial exceptions (Step 2A: YES).
The response (pages 5-7) asserts that even if the claim is ineligible at Step 2A, the subject matter is nonetheless eligible at Step 2B because the claim recites an inventive concept. The Applicants argue that the Examiner has provided no evidentiary support to demonstrate that the elements are well-understood, routine, and conventional.
This argument has been fully considered but is not persuasive. Step 2B requires that we look to whether the claim adds a specific limitation beyond the judicial exceptions that was not well understood, routine, or conventional in the field. MPEP 2106.05(d) states that one or more of the following should be provided when determining if a element or combination of elements is well understood, routine, and conventional:
(a) A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s);
(b) A citation to one or more of the court decisions discussed in Subsection II below as noting the well-understood, routine, conventional nature of the additional element(s);
(d) A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s).
In addition to the judicial exceptions the claim recite a step of assaying a genetic sample for the presence of genetic variations (rs1815739, rs12722, rs1049434, rs2010963, and rs1799945). This step is recited at a high level of generality because it merely instructs a scientist to use any genotyping technique. 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 applicants invention and at the time the application was filed.
Regarding (a) the rejection cites an express statement in the specification that demonstrates the well understood, routine, and conventional nature of the assaying.
[0040] The screening for the genetic polymorphisms in the 5 genes was carried out by standard techniques such as PCR amplification of genomic DNA followed by sequencing or real-time PCR.
Regarding (b) the rejection cites the following court decisions that show that nucleic acid genotyping is well-understood, routine, and conventional 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)
Regarding (d) the Examiner is taking Official notice that genotyping SNPs is unquestionably well-known, routine, and conventional.
It is maintained that step (a) does not provide an inventive concept (Step 2B: NO). In conclusion claim 1 is directed to a judicial exception without significantly more, and therefore, is not eligible for patent protection.
Response Filed February 2, 2026
This Supplementary response was submitted with a declaration under 37 CFR 1.132 by Dr. Enrico Bucci in support of the patentability of claims under 35 USC 101. The response asserts that the declaration provides evidentiary support that:
1. The claims under examination are not directed to a natural law, natural phenomenon,
or abstract idea. Rather, the claimed invention is directed to a specific, multi-step, human-
engineered process for predicting and reducing the risk of muscular and/or ligament injuries in a
human individual. Dr. Bucci declaration paragraphs 3, 16-17;
2. The claimed method recites additional steps that integrate the identified specific,
predefined single nucleotide polymorphisms (SNPs) in a defined set of genes - ACTN3,
COL5A1, MCT1, VEGF, and HFE- into a practical application, including physical assay of an
individual's genetic sample, generation of a polymorphism profile, application of a defined
logistic regression model, and classification of injury predisposition. The classification is
actively applied to develop personalized nutrition and training protocols, constituting a concrete
preventive or prophylactic intervention that produces a real-world benefit. Dr. Bucci declaration
paragraphs 4-12;
3. Even if certain genetic associations were asserted to be known individually, it was not
well-understood, routine, or conventional to combine the claimed SNPs across these genes into a
single predictive model, apply a weighted regression function to classify injury predisposition,
and use that classification to drive personalized injury-reduction strategies; the claimed invention
recites an inventive concept. Dr. Bucci declaration paragraphs 13-14; and
4. The claimed method steps meaningfully limit the use of the identified genetic
polymorphisms, and the claims do not preempt all uses of the identified genetic polymorphisms.
The declaration has been fully considered but is insufficient to overcome the rejections. Regarding argument 1, the Examiner has considered paragraphs 3, 16, and 17 of the declaration but does not agree that the claims are not directed to judicial exceptions. Claim 1 recites at least two judicial exceptions identified in the guidance. First, claim 1 recites a natural correlation between the SNPs recited in the claim and the predisposition to muscular and/or ligament injuries. Second, claim 1 recites at least two types of abstract ideas identified in the guidance: mathematical concepts and mental processes. Claim 1 recites a mathematical equation and requires performing a mathematical calculation to obtain a regression function. Claim 1 also recites “classifying” the individuals predisposition to muscular and/or ligament injuries on the basis of the value of regression function. The “classifying” step broadly encompasses a mental process because in can be performed in the human mind by thinking about the regression value. Additionally the claims require the user of the method to develop personalized nutrition and training for the individual based on their predisposition to muscle and/or ligament injuries. This broadly encompasses a mental process because in can be performed in the human mind by thinking about what exercises an individual should do and/or not do and what foods an individual should have and/or not have when they are predisposed to muscular and/or ligament injuries. It is maintained that claim 1 recites the judicial exceptions of a law of nature and the abstract subject matter of mathematical concepts and abstract ideas (Step 2A, Prong One: Yes). In addition to the judicial exceptions (steps (b), (c), and (d)), the claims recite step (a). Step (a) recites data gathering to obtain a polymorphism profile. This step is recited at a high level of generality because the assaying can be done by any method known in the art to detect genetic variations. This step does not integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity to the judicial exception. (Step 2A, Prong 2: NO). It is maintained that the claims are directed to the judicial exceptions (Step 2A: YES).
Regarding argument 2, the Examiner has considered paragraphs 4-12 of the declaration. The only step that is recited in addition to the judicial exception is step (a). Step (a) recites assaying a genetic sample obtained from the human individual for the presence of a genetic variation. It is maintained that this step is recited at a high level of generality because the assaying can be done by any method known in the art to detect genetic variations. This step does not integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity (data gathering) to the judicial exception.
Regarding argument 3, the Examiner has considered paragraphs 13-14 of the declaration. The examiner acknowledges that specific SNPs in specific genes are recited. The claims recite a correlation between rs1815739, rs12722, rs1049434, rs2010963, and rs1799945 and muscular and/or ligament injuries. This type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
Since the correlation between the SNPs and predisposition to muscular and/or ligament injuries is one the judicial exceptions, the SNPs (or combination of SNPs) cannot therefore be the claim element that confers patent eligibility.
Regarding argument 4, it is noted that while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
In conclusion the response and declaration filed on January 2, 2026 are insufficient to overcome the rejection under 35 USC 101.
Response Filed February 4, 2026
This Supplementary response was submitted with a declaration under 37 CFR 1.132 by Dr. Canio Martinelli in support of the patentability of claims under 35 USC 101. The response asserts the following:
(i) Dr. Martinelli Declaration provides objective evidence as to how the claimed invention improved upon the state of the art and factual basis for determining that one of ordinary skill in the art would have concluded that the claimed invention improved the underlying technical field.
(ii). Dr. Martinelli Declaration also explains where the improvement is reflected in claim 1. See, for example, Dr. Martinelli Declaration paragraphs 10-19.
(iii). Dr. Martinelli Declaration establishes that the claim does not recite law of nature, abstract ideas or mental processes. See, for example, Dr. Martinelli Declaration paragraphs 16, 21-23 and 28.
(iv). Dr. Martinelli Declaration establishes that the claim recites the additional element (clam 1 (d)) such that the claimed invention applies information from the analysis in clam 1 (a) -(c) to effect a particular outcome. Applicant respectfully points out that the additional element has more than a nominal relationship to the alleged judicial exceptions because it applies the recited law of nature and abstract ideas from clam 1 steps (a) -(c) in claim 1 step (d) in a manner that imposes a meaningful limit on the recited law of nature and abstract ideas. Namely, information from clam 1 steps (a) -(c) is used to develop personalized nutrition and training protocols for an individual to reduce the individual's predisposition to muscle and/or ligament injuries. In this way, Applicant respectfully submits that claim 1 step (d) integrates the recited law of nature and abstract ideas into a practical application under Step 2A, Prong Two. See, for example, Dr. Martinelli Declaration paragraphs 17-20 and 28.
The declaration has been fully considered but is insufficient to overcome the rejections. Regarding (i-ii), the Examiner has considered paragraphs 10-19 of the declaration. When the judicial exception itself is the purported improvement, such as the recognition of an association between a set of SNPs and predisposition to muscular and/or ligament injury, the claim is directed to the judicial exception, not an eligible improvement to a technology or technical field through integration of the judicial exception into a system or process.
Regarding (iii), the Examiner has considered paragraphs 16, 21-23 and 28 of the declaration but does not agree that the claims are not directed to judicial exceptions. Claim 1 recites at least two judicial exceptions identified in the guidance. First, claim 1 recites a natural correlation between the SNPs recited in the claim and the predisposition to muscular and/or ligament injuries. Second, claim 1 recites at least two types of abstract ideas identified in the guidance: mathematical concepts and mental processes. Claim 1 recites a mathematical equation and requires performing a mathematical calculation to obtain a regression function. Claim 1 also recites “classifying” the individuals predisposition to muscular and/or ligament injuries on the basis of the value of regression function. The “classifying” step broadly encompasses a mental process because in can be performed in the human mind by thinking about the regression value. Additionally the claims require the user of the method to develop personalized nutrition and training for the individual based on their predisposition to muscle and/or ligament injuries. This broadly encompasses a mental process because in can be performed in the human mind by thinking about what exercises an individual should do and/or not do and what foods an individual should have and/or not have when they are predisposed to muscular and/or ligament injuries. It is maintained that claim 1 recites the judicial exceptions of a law of nature and the abstract subject matter of mathematical concepts and abstract ideas (Step 2A, Prong One: Yes). In addition to the judicial exceptions (steps (b), (c), and (d)), the claims recite step (a). Step (a) recites data gathering to obtain a polymorphism profile. This step is recited at a high level of generality because the assaying can be done by any method known in the art to detect genetic variations. This step does not integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity to the judicial exception. (Step 2A, Prong 2: NO). It is maintained that the claims are directed to the judicial exceptions (Step 2A: YES).
Regarding (iv), the Examiner has considered paragraphs 17-20 and 28 of the declaration. The examiner does not agree that step (d) is an element recited in addition to the judicial exception. As explained above, step (d) is another judicial exception that is recited in the claims. Judicial exceptions cannot be relied upon to provide integration because they are not elements/steps that are recited in addition to the judicial exceptions.
In conclusion the response and declaration filed on January 4, 2026 are insufficient to overcome the rejection under 35 USC 101.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682