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 .
Response to Arguments
2. Applicant’s argument received 08/21/2025 have been fully considered but they are not persuasive.
Regarding the rejection under 35 USC 101, Applicant argues (REMARKS, p.1-2):
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Examiner respectfully disagrees. Examiner reminds to the Applicant that during patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification. Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. See MPEP 2111.01. Moreover, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With these principles in mind, and focusing on what the inventor has invented exactly, Examiner maintains the position that step (a) of instant claim 1 encompasses a mental process, i.e., data analysis/evaluation/judgement that are performed in the human mind or with pen and paper. Under the BRI, the term "biomarker” may refer to an indicator of a biological state or condition, while the indicator could be a numerical value, a graphical marker, etc. The instant claim does not specify how said “one biomarker” or said “two biomarkers” is/are acquired. They could as easily relate to the values acquired from, e.g., look-up tables available from research laboratories as opposed to the generation of actual measurement data from biological fluids like synovial fluid and serum. Just for illustration purpose, considering the case of a family doctor interpreting blood work results to determine a patient's health condition, the process of interpretation may include comparing the specific readings of your lab results to established normal ranges for biomarkers like red blood cells, white blood cells, and platelets. In particular, the doctor can determine your blood sugar level by simply comparing the lab test readings to a standard in his office, without requiring you to use a blood glucose meter or get a blood test done on-site. The reading from your blood test is compared against standard reference ranges to determine if your level is normal, too high, or too low.
While arguing about the Examiner’s interpretation to the limitation of step (a), Applicant’s intention to monopolize the mental process across a wide range of applications is noted. However, according to MPEP, during patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification. The Examiner considers what a person of ordinary skill in the pertinent art would understand the term to mean, and the “broadest reasonable interpretation" is not the same as the "broadest possible interpretation.” Moreover, the Examiner’s interpretation of the phrase “determining a level of at least one biomarker and/or a ratio of two biomarkers in a serum sample …” is consistent with (but not opposed in character as to be incapable of existing together) how the term is used in the written description and drawings. As such, Applicant’s arguments in this regard are deemed unpersuasive.
Applicant further argues (REMARKS, p.2):
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Examiner respectfully disagrees. Examiner maintains the position that the pending claims must be given the broadest reasonable interpretation consistent with the specification. Examiner is required to start with the term's plain meaning as understood by a person of ordinary skill in the art at the time the invention was made. In the instant case, the claimed “biomarker” is not expressly limited to “substances whose presence in an organism is indicative of some phenomenon such as disease, infection, or environmental exposure.” Applicant’s reliance upon the specification in this regard is noted. However, the feature in the specification to which Applicant refers is not explicitly recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argues (REMARKS, p.3):
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Examiner respectfully disagrees. As set forth in the previous office action and the section 4 below in this office action, Examiner applied the two-step Alice/Mayo test to analyze if the claim is directed to a judicial exception. Under the 2019 PEG, the Examiner separates the claim limitations which constitute an abstract idea from “additional elements” that might be sufficient to amount to significantly more than the judicial exceptions to integrate the abstract idea into a practical application and/or to add an "inventive concept”. However, in all of these respects, the Examiner could not identify any additional elements that need to be analyzed under Step 2A - Prong 2 and Step 2B. Accordingly, Examiner asserts that, under the BRI, the pending claims 1-4 and 6-8 are directed to an abstract idea of quantifying lameness in a pig but without reciting any additional elements that amount to “significantly more” than the judicial exception.
The rest of the Applicant’s arguments with respect to the rejection under 35 USC 101 are reliant upon the issues discussed above or have been fully addressed by the analysis under the 2019 PEG as set forth below in the pending office action, thus are deemed non-persuasive as well.
Regarding the rejection under 35 USC 103, Applicant argues (REMARKS, p.4):
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Examiner respectfully disagrees. With the BRI to the claim, Examiner maintains the position that Chen does teaches method for quantifying lameness in a pig comprising the steps of: (a) determining a level of at least one biomarker and/or a ratio of two biomarkers in a serum sample from the pig, wherein the at least one biomarker is C2C, CTX1, CTX2, OC, or P2CP, and the ratio of two biomarkers is OC/CTX1, P2CP/C2C, or P2CP/CTX2 (para. 0012-0017); (b) generating a test score by standardizing the data from (a) (para. 0017-0018, 0053); and (c) using the test score to quantify lameness (para. 0018, 0048, 0064). Specifically, Chen mentions: “performing an analysis of the level of the at least one biomarker to determine whether the animal is healthy, is predisposed or likely to develop a joint ailment, or has a joint ailment” (para. 0028), wherein the “severity of the joint ailment” or lameness is quantified according to predetermined reference levels for healthy and lame animals (para. 0018). In particular, Chen explicitly teaches: “The severity of the joint ailment may be estimated based upon the level of the at least one biomarker” (para. 0028). Chen’s teaching of quantifying the severity of the lameness is further evidenced by the disclosed “Methods for Treating or Preventing Joint Ailments” (para. 0033). Undoubtedly, “administering an effective amount (emphasis added) of a metal chelate to the animal” requires or relies on quantifying the severity of the lameness as much accurately as possible. Applicant’s arguments in this regard are therefore unpersuasive.
Applicant further argues (REMARKS, p.5):
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Examiner respectfully disagrees. Chen teaches: establishing reference biomarker levels for healthy and lame animals (para. 0017-0018), determining the level of at least one biomarker present in the blood sample collected from a target animal (para. 0004), and quantifying the “severity of the lameness of the target animal based on comparisons between the instantly determined biomarker level and the pre-established reference biomarker levels (para. 0004); wherein the reference biomarker levels are established by correlating biomarker levels with visual lames/joint ailments standards (para. 0017-0018). Put it differently, Chen teaches: (a) determining a level of at least one biomarker and/or a ratio of two biomarkers in a serum sample from the pig (para. 0019: “collecting a blood sample from the animal, (b) determining the level of at least one of the biomarkers disclosed herein that is present in the blood sample”); (b) generating a test score by comparing the level of at least one biomarker and/or the ratio of two biomarkers determined in (a) to the pre-established reference levels (para. 0017-0019: “wherein the analysis includes comparing the levels of the at least one biomarker in the blood sample to joint ailment-positive and/or joint ailment-negative reference levels of the at least one biomarker in order to determine”, see also 0053), wherein said generating a test score includes or is based on standardizing the data from (a) (para. 0023: “Accessing the blood may also involve the use of a fluid pathway, a capillary channel (e.g., a capillary tube), a fluid transfer medium (e.g., a hydrophilic porous material), or some kind of mechanical or vacuum means in conjunction with the skin-piercing element. … the sample collection method preferably maintains the integrity of the sample such that abundance values for each molecular feature can be accurately measured”; see also para. 0025-0026); and (c) using the test score to quantify lameness (para. 0018-0019, 0048, 0064).
It is well-known that data standardization is the process of transforming raw data into a consistent, uniform format by applying predefined rules to ensure conformity. It involves making data from different sources compatible, which improves its quality, making it easier to integrate, analyze, and understand. For example, it can involve converting dates into a single format or ensuring that all values for a specific category are consistent. As such, Chen’s teaching of para. 0022-0028) indeed encompasses the limitation of “standardizing the data from (a)” argued by the Applicant.
Applicant further argues (REMARKS, p.5):
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Examiner respectfully disagrees. Examiner recognizes that obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). Examiner further recognizes that the test for obviousness is not whether the features of a second reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the instant case, Examiner considers that Chen discloses a technique of quantitatively determining health conditions of a target animal by comparing the level of at least one biomarker present in the blood sample of the target animal with pre-established reference biomarker levels. Chen is silent on: said comparing comprises statistical analyses such as generating the test score by standardizing the data collected from the target animal to have a mean of 0 and a standard deviation of 1, wherein increasing deviation of the test score from the mean correlates with increased lameness. However, Sun teaches a long-duroc blood routine data analyzing method which ensures the correctness and integrality of data analysis. As set forth in section 6 below in this Office action, the modification of Chen in view of Sun’s teaching arrives the features in question. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Sun’s biomarker data analyses technique into Chen to remedy the above-noted deficiencies of Chen. One of ordinary skill in the art would have recognized that the results of such a combination were predictable since the use of that known technique provides the rationale to arrive at a conclusion of obviousness. In particular, it is obvious that the modification of Chen in view of Sun would provide a robust algorithm for statistically quantifying animal lameness based on biomarker data (Sun, Abstract).
The rejection of pending claims under 35 USC 103 is therefore maintained.
Claim Rejections - 35 USC § 101
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 101 that form the basis for the rejections under this section made in this Office action:
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.
4. Claims 1-4 and 6-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Under the 2019 PEG (now been incorporated into MPEP 2106), the revised procedure for determining whether a claim is "directed to" a judicial exception requires a two-prong inquiry into whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human interactions such as a fundamental economic practice, or mental processes); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim: (3) adds a specific limitation beyond the judicial exception that is not "well-understood, routine, conventional" in the field (see MPEP § 2106.0S(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Claims 1-4 and 6-8 are directed to an abstract idea of quantifying lameness in a pig.
Specifically, representative claim 1 recites:
A method for quantifying lameness in a pig, the method comprising:
(a) determining a level of at least one biomarker and/or a ratio of two biomarkers in a serum sample from the pig, wherein the at least one biomarker is C2C, CTX1, CTX2, OC, or P2CP, and the ratio of two biomarkers is OC/CTX1,P2CP/C2C, or P2CP/CTX2;
(b) generating a test score by standardizing the data from (a) to have a mean of 0 and a standard deviation of 1; and
(c) using the test score to quantify lameness, wherein increasing deviation of the test score from the mean correlates with increased lameness.
The claim limitations in the abstract idea have been highlighted in bold above; the remaining limitations are “additional elements”.
The highlighted portion of the claim constitutes an abstract idea under the 2019 Revised Patent Subject Matter Eligibility Guidance and the additional elements are NOT sufficient to amount to significantly more than the judicial exceptions, as analyzed below:
Step
Analysis
1. Statutory Category ?
Yes.
Method
2A - Prong 1: Judicial Exception Recited?
Yes.
Under its broadest reasonable interpretation (BRI), the step of “(a) determining a level of at least one biomarker and/or a ratio of two biomarkers in a serum sample from the pig, wherein the at least one biomarker is C2C,CTX1, CTX2, OC, or P2CP, and the ratio of two biomarkers is OC/CTX1,P2CP/C2C, or P2CP/CTX2” encompasses a mental process, namely concepts performed in the human mind or with pen and paper. Under its BRI, the term "biomarker” may refer to an indicator of a biological state or condition, while the indicator could be a numerical value, a graphical marker, etc. The instant claim does not specify how said “one biomarker” or said “two biomarkers” is/are acquired. They could just as easily relate to the values acquired from, e.g., look-up tables available at research laboratories as opposed to the generation of actual measurement data from biological fluids like synovial fluid and serum. Thus claim 1 would monopolize the abstract idea across a wide range of applications.
Under the BRI, the steps of “(b) generating a test score by standardizing the data from (a) to have a mean of 0 and a standard deviation of 1” encompass mathematical concepts (and also a mental process, i.e. data manipulation/evaluation), namely a series of calculations leading to one or more numerical results or answers, which can be performed in the human mind or with pen and paper.
Under the BRI, the steps of “(c) using the test score to quantify lameness, wherein increasing deviation of the test score from the mean correlates with increased lameness” encompasses a mental process, namely concepts performed in the human mind or with pen and paper.
Nothing in the claimed limitations precludes these steps recited in the bolded portion from practically being performed in the mind and/or using a pen and paper.
These steps recited in the bolded portion therefore amount to a series of mental or mathematical steps, making these limitations amount to an abstract idea. Nothing in the claimed limitations precludes these steps from practically being performed in the mind and/or using a pen and paper.
As such, the bolded portion of instant claim 1 amounts to an abstract idea falling within a combination of the “Mathematical Concepts” and “Mental Process” Groupings of Abstract Ideas defined by the 2019 PEG.
2A - Prong 2: Integrated into a Practical Application?
No.
The claim as a whole does not meet any of the following criteria to integrate the abstract idea 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.
Various considerations are used to determine whether the additional elements are sufficient to integrate the abstract idea into a practical application. However, in all of these respects, the claim fails to recite additional elements which might possibly integrate the claim into a particular practical application. Instead, based on the above considerations, the claim would tend to monopolize the algorithm across a wide range of applications.
2B: Claim provides an Inventive Concept?
No.
See analysis given in 2A - Prong 2 above.
The claim is therefore ineligible under 35 USC 101.
The dependent claims 2-4 and 6-8 inherit attributes of the independent claim 1, but do not add anything which would render the claimed invention a patent eligible application of the abstract idea. These claims merely extend (or narrow) the abstract idea which do not amount for "significant more" because they merely add details to the algorithm which forms the abstract idea as discussed above.
In particular, claim 8 recites the limitation “wherein the lameness is due to natural causes or due to fast body weight gain”. Under the BRI, this limitation encompasses merely data characterization which can be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of diagnosing/quantitating lameness in animals.
Hence the claims 1-4 and 6-8 are treated as ineligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
5. 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 of this title, 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.
6. Claims 1-4 and 6-8 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 20200289555 A1) in view of Sun (CN 110441505 A, machine translation).
Regarding claim 1, Chen discloses a method for quantifying lameness in a pig (Abstract; para. 0018, 0048-0049), the method comprising: (a) determining a level of at least one biomarker and/or a ratio of two biomarkers in a serum sample from the pig, wherein the at least one biomarker is C2C, CTX1, CTX2, OC, or P2CP, and the ratio of two biomarkers is OC/CTX1, P2CP/C2C, or P2CP/CTX2 (para. 0012-0017); (b) generating a test score by standardizing the data from (a) (para. 0017-0018: by inherency, in order to correlate biomarker levels with standard indicators of lameness or joint ailments, the data from (a) must be standardized so that it can be comparable with the standard indicators; see also para. 0053); and (c) using the test score to quantify lameness (para. 0018, 0048, 0064).
Chen does not mention explicitly: generating the test score by standardizing the data from (a) to have a mean of 0 and a standard deviation of 1, wherein increasing deviation of the test score from the mean correlates with increased lameness.
Sun teaches a technique of analyzing biomarker data (Abstract) comprising: generating a test score by standardizing the biomarker data to have a mean of 0 and a standard deviation of 1 (para. 0018-0019), wherein increasing deviation of the test score from the mean correlates with increased lameness (para. 0004, 0066: “ … the health level is determined according to the comprehensive score and whether there is disease at the blood collection point. A comprehensive score of 0-2 is judged as healthy, 2-10 is judged as sub-healthy, and above 10 points or individuals with diseases at the blood collection point are judged as having diseases, which are represented by HH, Hh, and hh respectively”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Sun’s teaching of biomarker data analyses technique into Chen to arrive the claimed invention. Doing so would provide a robust algorithm for statistically quantifying animal lameness based on biomarker data (Sun, Abstract).
Regarding claims 2-4, Chen teaches using lameness gait scores to identify lameness in production animals (para. 0003), wherein gait may be scored on a 5-point scale, ranging from “0” for animals with a normal gait to “4” for animals that are reluctant to walk and bear weight on one or more legs (para. 0018).
Chen does not but Sun teaches: wherein an increase or decrease of the test score from the mean correlates with a health level score (para. 0004, 0066: “ … the health level is determined according to the comprehensive score and whether there is disease at the blood collection point. A comprehensive score of 0-2 is judged as healthy, 2-10 is judged as sub-healthy, and above 10 points or individuals with diseases at the blood collection point are judged as having diseases, which are represented by HH, Hh, and hh respectively”. Note, it is well-known that a z-score analysis is a statistical method used to determine how many standard deviations a data point is away from the mean of a distribution thus identify outliers or unusual values, wherein positive z-score indicates the data point is above the mean, negative z-score indicates the data point is below the mean, and z-score of 0 represents the data point is equal to the mean).
The combination of Chen and Sun is silent on: wherein an increase or decrease from about 0.1 to about 0.2 units from the mean correlates with a lameness gait score of about 2.0; wherein an increase or decrease of about 0.3 to about 0.5 units from the mean correlates with a lameness gait score of about 3.0; wherein an increase or decrease of about 0.5 units from the mean or greater correlates with a lameness gait score of about 4.0.
However, it is deemed that the limitations in question relate merely to a matter of design options for the correlation between the test score and the lameness gait score, which does not affect the functionality of the intended use of the invention in view of the combined teachings of Chen and Sun, and the skilled person in the art would conceive and apply such design options without needing inventive skill but depending on practical considerations and according to the dictates of the circumstances. It has been held that an obvious matter of engineering design choice is not patentably advanced.
Regarding claim 6, Chen teaches: wherein increasingly positive test scores for P2CP, P2CP/C2C, and P2CP/CTX2 correlate with increased lameness (para. 0017-0018, 0029, 0048, 0053, 0064).
Regarding claim 7, Chen teaches: wherein increasingly negative test scores for C2C, CTX1, and OC correlate with increased lameness (para. 0019: “the analysis includes comparing the levels of the at least one biomarker in the blood sample to joint ailment-positive and/or joint ailment-negative reference levels of the at least one biomarker in order to determine …”; see also para. 0028, 0055).
Regarding claim 8, Chen teaches: wherein the lameness is due to natural causes or due to fast body weight gain (para. 0003, 0053).
Conclusion
7. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIUQIN SUN whose telephone number is (571)272-2280. The examiner can normally be reached 9:30am-6:00pm.
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, Shelby A. Turner can be reached on (571) 272-6334. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/X.S/Examiner, Art Unit 2857
/SHELBY A TURNER/Supervisory Patent Examiner, Art Unit 2857