DETAILED ACTION
Claims 1, 9-11, and 13-19 are pending.
Status of Claims
Claims 1, 9-11, and 13-19 are pending. Claims 1, 9-11, and 13-19 have been amended. Claims 2-8, 12, and 20-24 have been cancelled. Claims 1, 9-11, and 13-19 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/21/2025 has been considered by the examiner.
Withdrawn Claim Objections and/or Rejections
The arguments filed on 11/13/2025 have been considered by the examiner.
The objection of claims 1-6, 8-11, and 13-24 for informalities as set forth on p. 2 of the previous office action (mailed on 05/19/2025) has been withdrawn in view of the amended and cancelled claims (filed on 11/13/2025).
The rejection of claim 9 under 35 USC 112(b) for being indefinite as set forth on p. 2 of the previous office action (mailed on 05/19/2025) has been withdrawn in view of the amended claim (filed on 11/13/2025).
The rejection of 1-6, 8-11, and 13-24 under 35 USC 112(a) for failing to comply with written description as set forth on pp. 5-11 of the previous office action (mailed on 05/19/2025) has been withdrawn in view of the amended and cancelled claims (filed on 11/13/2025).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1 recites “a means for reading a unique identification tag associated with the person or animal so as to associate a test with unique identification data of the particular person or animal in use”. Claim 1 recites “means for” language, but does not speak to any structure, material, or actions in support. The specification teaches that when the unique biomarker forms a sample under test (the analyte) comes into contact with an antibody on the test strip, it gives a visible signal which is measured by the test reading device (see page 7). The examiner is interpreting this “means for” language to be a test reading device, or a functional variant thereof.
Claim 1 recites “means to capture an indication of a result of the biomarker signature identification means test in a form of a photograph or a scan”. Claim 1 recites “means for” language, but does not speak to any structure, material, or actions in support. The specification teaches that the animal being tested has a unique identification tag which is read by the diagnostic reader such as optical character recognition/barcode or QR code and the data from the diagnostic test is captured by the portable apparatus (see page 10). The examiner is interpreting this “means for” language to be a diagnostic reader, such as optical character recognition/barcode or QR code, or a functional variant thereof.
Claim 1 recites “receiving and transmitting means”. Claim 1 recites “means for” language, but does not speak to any structure, material, or actions in support. The specification teaches that the test data from the apparatus is transmitted form the apparatus via a communication receiver” (see page 8). The examiner is interpreting this “means for” language to be a communication receiver, or a functional variant thereof.
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, 9-11, and 13-19 are rejected under 35 U.S.C. 101 because the claimed methods and devices are directed to a judicial exception of an abstract idea and laws of nature/natural phenomena without significantly more.
Step 2A prong 1: Does the claim recite a judicial exception?
The claims recite methods of observing the law of nature of naturally occurring antibodies and/or antigens and corelating them with the presence of at least one health condition. See preamble of claim 1, and the recitation of “analysis means” which encompasses specific types of antibodies (see claim 9), which implies that the device performs the correlation.
Step 2A prong 2: Does the claim recite additional elements that integrate the
exception into a practical application?
Regarding the method of using the judicial exception, the data gathering steps of relating the presence of levels of antibodies and/or antigens are required to use the law of nature and do not add a meaningful limitation to the methods as they are insignificant extra-solution activity or mere data gathering steps.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed elements when considered separately and in combination, do not add significantly more to the exceptions. The natural law/phenomenon is analogous to the correlation of biomarkers found ineligible by the courts, for example, in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012), Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) (Using well -known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015) (ineligible claims were directed to a method of detecting paternally inherited cell free fetal DNA, which is naturally occurring in maternal blood).
Regarding claim 1, a system for testing for presence of at least one health condition with regard to an animal or person on which the system is used, said system comprising: an apparatus comprising a body located at a first geographical location in use including: a means for reading a unique identification tag associated with the person or animal so as to associate a test with unique identification data of the particular person or animal in use, a portion with which a sample of tissue and/or fluid from the person or animal is brought into contact, biomarker signature identification means including an immunochromatography strip to test the sample, means to capture an indication of a result of the biomarker signature identification means test in a form of a photograph or scan, data receiving and transmitting means, wherein the captured indication of the result of the biomarker signature test and the unique identification data of the particular person or animal are wirelessly transmitted to a second geographical location remote from a first geographical location in use; and receiving and transmitting means and a database located at the second geographical location, whereby the captured indication for the test and associated unique identification data is received by the receiving means at the second geographical location and communicated to the database to be compared to validate database control parameters to determine a status of a condition in use, and wherein the status of the condition and an action or range of actions which are required to be performed for the identified status of the condition, are transmitted by the transmitting means at the second geographical location to a user at the first geographical location is merely a data gathering step and is directed towards the judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Moreover, the claimed apparatus is recited at a high level of generality, and encompasses well-known, conventional, and routine means for performing such identification, including, for example a processor, detector, or well-known device that is capable of performing an identification or correlation. Such device is well known, conventional, and routine in the art and therefore does not amount to "significantly more" than the judicial exception. See also prior art cited in the section below under 35 USC 103.
Regarding claim 9, wherein the one or more analysis means includes a series of biomarker antibodies in a form so as to identify a presence, or otherwise of any of bovine or human tuberculosis, lung diseases including COPD and lung cancer, mycrobacterial disease, Johne's disease (mycobacteria avium paratubercolosis (MAP)) prostate and/or bladder cancer is directed towards the judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 9 recites the presence of biomarkers to a naturally occurring illness.
Regarding claim 10, wherein the body portion which contacts with said sample is formed so as to allow a lateral flow test to be performed on the apparatus is an insignificant extra-solution activity. Pulitzer et al., teaches the body portion which contacts with said sample is formed so as to allow a lateral flow test to be performed on the apparatus is routine and conventional in the art.
Regarding claim 11, wherein the test apparatus includes a further point of use analytical apparatus with a different test and analysis mechanism and so allow the apparatus to include or be adapted to provide a range of differing on site analysis options is an insignificant extra-solution activity. Pulitzer et al., teaches the test apparatus including a further point of use analytical apparatus with a different test and analysis mechanism and so allow the apparatus to include or be adapted to provide a range of differing on site analysis options is routine and conventional in the art.
Regarding claim 13, wherein the said on-site analysis options are provided on the body portion and are available to be selectively used is an insignificant extra-solution activity. Pulitzer et al., teaches on-site analysis options are provided on the body portion and are available to be selectively is routine and conventional in the art.
Regarding claim 14, wherein at least the part of the body which includes the portion for contact with the sample is releasable from the remainder of the body and thereby allows a part with an appropriate analysis option for the test which is to be performed, to be fitted to the remainder of the body and thereby adapt the apparatus used is an insignificant extra-solution activity. Pulitzer et al., teaches part of the body which includes the portion for contact with the sample is releasable from the remainder of the body and thereby allows a part with an appropriate analysis option for the test which is to be performed, to be fitted to the remainder of the body and thereby adapt the apparatus used is routine and conventional in the art.
Regarding claim 15, wherein the indication generated by the apparatus is a visual indication means is an insignificant extra-solution activity. Pulitzer et al., teaches the indication that is generated by the apparatus is a visual indication means is routine and conventional in the art.
Regarding claim 16, wherein a first colour equates to a clear test result and a second or number of further colours equate to a particular health problem and/or type of health problem is an insignificant extra-solution activity. Pulitzer et al., teaches the first color equates to a clear test result and the second equates to a particular health problem is routine and conventional in the art.
Regarding claim 17, wherein the analysis means include a number of biomarkers, with the number, type and/or specific configuration of the biomarkers selected to suit the particular test which is to be performed is an insignificant extra-solution activity. Pulitzer et al., teaches a number of biomarkers, with number, type and/or specific configuration of the biomarkers selected to suit the particular test to be performed is routine and conventional in the art.
Regarding claim 18, wherein the biomarkers which are detected, rely on any or any combination of contact with the sample from a person or animal in the form of saliva, urine and/or blood problem is an insignificant extra-solution activity. Pulitzer et al., teaches biomarkers being detected in samples in the form of saliva, urine, and/or blood is routine and conventional in the art.
Regarding claim 19, wherein the analysis of the data received from the apparatus uses "omics" research is an insignificant extra-solution activity. Pulitzer et al., teaches the analysis of the data received from the apparatus uses “omics” research is routine and conventional in the art.
Thus claims 1, 9-11, and 13-19 are rejected under 35 USC 101.
Claim Rejections - 35 USC § 101-Response to Arguments
The arguments filed on 11/21/2025 have been considered by the examiner.
On pp. 6-7 applicant argues that the near instantaneous testing and response and performing of any necessary actions at the first geological location such that the vet or doctor can perform the test and the actions at the same location during a single visit overcomes the 35 USC 101 rejection. However, the near instantaneous testing and response and performing of any necessary actions at the first geological location such that the vet or doctor can perform the test and the actions at the same location during a single visit are not claimed limitations. Further, the claims are still directed towards a judicial exception without significantly more. The time of testing is not significantly more. Pulitzer teaches that the diagnostics test can be used for immediate, cost-effective test results that can be provided by and used by hospitals and clinics to provide rapid, on-site test results that are required to prescribe certain medications (see [0049]).
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1, 10-11, and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pulitzer et al., (WO2018/075557A1) (IDS filed on 02/08/2022).
Regarding claim 1, Pulitzer teaches a system for testing for presence of at least one health condition with regard to an animal or person on which the system is used (see claim 1 of ‘557), said system comprising:
an apparatus comprising a body located at a first geographical location in use including (see figure 1, see [0005]):
means for reading a unique identification tag associated with the person or animal so as to associate a test with unique identification data of the particular person or animal in use (see [0005] “In one aspect thereof, an immediate health assessment response system is provided. The system comprises a testing device having thereon an alignment target and having a plurality of immunoassay test strips, the plurality of immunoassay test strips each including a sample pad capable of receiving a biologic sample, a conjugate pad containing particles for conjugating with antibodies or antigens present in the biologic sample, and a membrane strip having a test line and a control line, wherein the test line and the control line are viewable, and a server configured to receive information from a mobile device regarding test results from a test performed using the testing device, receive an image from a mobile device, process the image to determine results based on pixel count and line intensity of the test line of each of the plurality of immunoassay test strips, compare the results of processing the image to a control for each test line of each of the plurality of immunoassay test strips, and provide a risk indicator, wherein the risk indicator alerts a user to seek medical attention immediately.”),
a portion with which a sample of tissue and/or fluid from the person or animal is brought into contact (see figure 1, see figure 3, see [0005]),
biomarker signature identification means including an immunochromatography strip to test the sample (see figure 1, see figure 3),
means to capture an indication of a result of the biomarker signature identification means test in a form of a photograph or scan (see figure 8A, see [0055]),
data receiving and transmitting means, wherein the captured indication of the result of the biomarker signature test and the unique identification data of the particular person or animal are wirelessly transmitted to a second geographical location remote from a first geographical location in use (see figure 1, see figure 8A-B, see [0068] “The table 1300 is illustrative of the type of data stored in association with data for a biologic transmitted by the plurality of mobile devices 1202 for storage on the database 1204”); and
receiving and transmitting means and a database located at the second geographical location (see figure 1, see figure 8A-B, see [0068] “The table 1300 is illustrative of the type of data stored in association with data for a biologic transmitted by the plurality of mobile devices 1202 for storage on the database 1204”),
whereby the captured indication for the test and associated unique identification data is received by the receiving means at the second geographical location and communicated to the database to be compared to validate database control parameters to determine a status of a condition in use (see figures 8A-B, see [0015] “FIG. 8A illustrates a diagrammatic representation of one embodiment of a process for a mobile device application for testing device image capture and image processing, wherein an image alignment indicator is not aligned with the subject of the image”, see [0016] “FIG. 8B illustrates a diagrammatic representation of one embodiment of a process for a mobile device application for testing device image capture and image processing, wherein an image alignment indicator is aligned with the subject of the image”, see [0055]), and
wherein the status of the condition and an action or range of actions which are required to be performed for the identified status of the condition (see claim 1 of ‘557 teaching a risk indicator that alerts a user to seek medical attention immediately if needed), are transmitted by the transmitting means at the second geographical location to a user at the first geographical location (see claim 1 of ‘557).
Regarding claim 10, Pulitzer teaches the body portion which contacts with said sample is formed so as to allow a lateral flow test to be performed on the apparatus.
Pulitzer teaches these claimed limitations in the following disclosures:
• See figure 3.
• See [0073]: “Referring now to FIG. 17, there is illustrated one embodiment of a vertical flow immunoassay device 1700. It will be understood that testing device 300 and other embodiments herein illustrate a lateral flow immunoassay device”.
Regarding claim 11, Pulitzer teaches the test apparatus includes a further point of use analytical apparatus with a different test and analysis mechanism and so allow the apparatus to include or be adapted to provide a range of differing on site analysis options.
Pulitzer teaches these claimed limitations in the following disclosures:
• See [0073]: “Referring now to FIG. 17, there is illustrated one embodiment of a vertical flow immunoassay device 1700. It will be understood that testing device 300 and other embodiments herein illustrate a lateral flow immunoassay device. However, other types of immunoassay devices may be used. For example, vertical flow immunoassay devices may be used, a two-sided flow through assay, or even a sandwich ELISA test may be run.”.
Regarding claim 13, Pulitzer teaches on site analysis options are provided on the body portion and are available to be selectively used.
Pulitzer teaches these claimed limitations in the following disclosures:
• See claim 15: “The method of Claim 11, wherein the test results include a qualitative result.”.
• See claim 16: “The method of Claim 11, wherein the test results include a quantitative result.”.
• See claim 17: “The method of Claim 16, wherein the quantitative result is a reaction rating.”.
Regarding claim 14, Pulitzer teaches at least the part of the body which includes the portion for contact with the sample is releasable from the remainder of the body and thereby allows a part with an appropriate analysis option for the test which is to be performed, to be fitted to the remainder of the body and thereby adapt the apparatus.
Pulitzer teaches these claimed limitations in the following disclosures:
• See [0073]: “Referring now to FIG. 17, there is illustrated one embodiment of a vertical flow immunoassay device 1700. It will be understood that testing device 300 and other embodiments herein illustrate a lateral flow immunoassay device. However, other types of immunoassay devices may be used. For example, vertical flow immunoassay devices may be used, a two-sided flow through assay, or even a sandwich ELISA test may be run.”.
Regarding claim 15, Pulitzer teaches the indication generated by the apparatus is a visual indication means.
Pulitzer teaches these claimed limitations in the following disclosures:
• See [0041]: “The test results in various embodiments may be in the form of a visual qualitative reading test, a visual semiquantitative format, a reader quantitative assay format, and/or combinations thereof. Additionally, an electronic implementation may be used where the result is displayed digitally on a screen disposed within the apparatus, and visible to the user.”.
Regarding claim 16, Pulitzer teaches wherein a first color equates to a clear test result and a second or number of further colors equate to a particular health problem and/or type of health problem.
Pulitzer teaches these claimed limitations in the following disclosures:
• See [0057]: “The results indicator 814 may be a qualitative result or a quantitative result. For example, and as shown in FIG. 8B, a qualitative result for the results indicator 814 may indicate, in the case of a testing device for testing pregnancy as well as an infection, a plus sign next to a line reading "pregnant:" and a plus sign next to a line reading "infection:" to indicate that the user is both pregnant and infected with the bacteria or virus being tested, such as the Zika virus. For a quantitative result, the results might provide a numeric rating. For instance, a rating system between 1-100 may be used. If the results provide a low rating to the user, such as a rating of 10, this indicates a low risk of infection, although medical attention may be sought by the user anyway. For example, if the user is pregnant, and also receives a 10 rating for Zika, this may indicate that Zika was detected in low amounts. However, the user may still seek medical attention or further testing from her doctor because Zika has been known to cause birth defects. If the rating is a high rating, such as 95, this indicates that an infection has most likely occurred and medical attention should be sought immediately.”.
• See [0031]: “For example, the control line 112, in embodiments where a colored qualitative response is provided, may appear as an overly saturated color, such as a dark or bright saturated red, once the sample reaches the control line 112. This saturated color may be used as a comparison against the qualitative response shown on the test line 1 10.”.
Regarding claim 17, Pulitzer teaches the analysis means include a number of biomarkers, with the number, type and/or specific configuration of the biomarkers selected to suit the particular test which is to be performed.
Pulitzer teaches these claimed limitations in the following disclosures:
• See [0044]: “In the embodiment shown in FIG. 3, a single sample well 308 is included for collection of a single type of biologic for testing, with each of the plurality of strips 304 being
suited for testing for antigens using that particular biologic sample type. For example, if the
testing device 300 is a combined pregnancy and Zika test, having both a pregnancy strip and a
Zika strip, a urine sample may be deposited into the sample well 308, causing the urine sample
to come into contact with the sample pad 104 on both the pregnancy strip and the Zika strip. It
will be understood that both of these tests may also be performed with a blood sample.”.
Regarding claim 18, Pulitzer teaches the biomarkers which are detected, rely on any or any combination of contact with the sample from a person or animal in the form of saliva, urine and/or blood.
Pulitzer teaches these claimed limitations in the following disclosures:
• See [0028]: “The biologic analyte 106 may be any biologic needed for use in the immunoassay, such as urine, blood, saliva, stool, sweat, or other biologies to be used as an analyte.”.
Regarding claim 19, Pulitzer teaches wherein the analysis of the data received from the apparatus uses "omics" research.
Pulitzer teaches these claimed limitations in the following disclosures:
• See [0062]: “Similarly, if blood is detected in urine, it could be a sign of a problem with the kidneys or the bladder. Blood, for example, allows for the detection of glucose, inflammation,
hormones, genetic defect risks, and metabolic endocrine disorders.”.
• See [0065]: “These medical conditions may be high blood pressure, diabetes, bacterial or viral infections, inflammation, an increase in hormone levels, genetic disease markers, and/or
metabolic disorders.”.
Claim Rejections - 35 USC § 102-Response to Arguments
The arguments filed on 11/21/2025 have been considered by the examiner.
On p. 7 applicant argues that Pulitzer only makes the patient aware of the need for medical attention, it does not disclose the generation of a particular action or range of actions which are required to be performed on the person. However, the device alerting the patient to seek immediate medical attention is the generation of a particular action that needs to be performed (seek medical attention).
On p. 7 applicant argues that in contrast, the applicant’s current invention, the range of actions which are actually required to be performed on the person or animal is sent back to the user who has performed the test and allows the user, which is typically a doctor or a vet, to undertake these actions and therefore ensure the actions are performed on the specific person or animal. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the doctor or vet undertaking actions to ensure the actions are performed) are not 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). Further, Pulitzer teaches that their device can share information from the patients test to a healthcare provider via the healthcare provider using the database (see [0069]).
On p. 7 applicant argues that Pulitzer’s device cannot be used in regard to an animal. However, the instant claim 1 recites “animal or person”.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pulitzer et al., as applied to claims 1, 10-11, and 13-19 above, and in further view of Parekh et al., (WO2015128681A1) (IDS filed on 02/08/2022).
The teachings of Pulitzer as it pertains to claims 1, 10-11, and 13-19 are discussed in the 35 USC 102 rejection above. Pulitzer does not teach the one or more analysis means includes a series of biomarker antibodies in a form so as to identify a presence, or otherwise of any of bovine or human tuberculosis, lung diseases including COPD and lung cancer, mycrobacterial disease, Johne's disease (mycobacteria avium paratubercolosis (MAP)) prostate and/or bladder cancer.
Regarding claim 9, Parekh teaches the one or more analysis means includes a series of biomarker antibodies in a form so as to identify a presence, or otherwise of any of bovine or human tuberculosis, lung diseases including COPD and lung cancer.
Parekh teaches these claimed limitations in the following disclosures:
• See page 4 lines 12-20: “The subject is a mammalian subject, typically a human. In certain embodiments, the subject is suffering from a respiratory disorder. More specifically, the
respiratory disorder may be chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF). The inventors have accumulated data showing the effectiveness of this approach in these
specific disease conditions. COPD represents a collection of lung diseases including chronic
bronchitis, emphysema and chronic obstructive airways disease and thus any of these lung
diseases may be monitored according to the invention. The invention may also be applicable to monitoring of asthma and interstitial lung disease (ILD). The invention may also be applied to
bronchiectasis.”.
• See claim 1: “A method for monitoring inflammation status of a subject, the method comprising determining levels of at least one neutrophil activation marker in urine samples taken from the subject at multiple time points, wherein increased levels of the at least one neutrophil activation marker in a urine sample are indicative of or predictive of an exacerbation of inflammation and/or wherein decreased levels of the at least one neutrophil activation marker in a urine sample following an increase are indicative or predictive of recovery from, or successful treatment of, an exacerbation of inflammation.”.
• See claim 16: “The method according to any preceding claim wherein the subject is suffering from a respiratory disorder, optionally wherein the respiratory disorder is chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF).”.
It would have been obvious to one of ordinary skill in the art at the time of the instant application modify the system taught by Pulitzer with the detection of COPD taught by Parekh. One of ordinary skill in the art would have reasonable expectation of success because they both teach systems for testing/monitoring of a health condition. Pulitzer provides motivation by teaching that the methods and device can be used for different applications (by selecting the test strips) (see [0039], see [0067]). Pulitzer provides motivation by teaching that the device taught allows for medical attention to be sought much more quickly (see [0061]). Parekh provides motivation by teaching that chronic infection or inflammation of lung diseases (such as COPD) have inflammatory components that can be detected (see page 1 lines 13-21). Parekh teaches biomarkers that can be used to detect airway inflammation found in COPD (see page 41 lines 9-15). One of ordinary skill in the art would have had reasonable expectation of success because they both teach systems for testing/monitoring of a health condition.
Claim Rejections - 35 USC § 103-Response to Arguments
The arguments filed on 11/21/2025 have been considered by the examiner.
On p. 8 applicant argues that Parekh only suggests specific types of diseases which may be tested for but does not add anything further to render Pulitzer any more relevant. Pulitzer teaches a system and method for immediate health assessment response system with the claimed limitations of instant claim 1. Parekh teaches a device that is used to monitor biomarker antibodies in those with bovine or human tuberculosis (TB), lung diseases such as COPD and lung cancer. Parekh provides motivation for monitoring biomarkers for the conditions of bovine or human TB, COPD, and lung cancer because the following diseases cause chronic inflammation (see page 1 lines 13-21).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MCKENZIE A DUNN whose telephone number is (571)270-0490. The examiner can normally be reached Monday-Tuesday 730 am -530pm, Wednesday-Friday 730 am-430 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678