DETAILED ACTION
Claims 1, 9-11, and 13-19 are pending.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 06/08/2026 has been entered.
Withdrawn Claim Objections and/or Rejections
The rejection of claims 1, 10-11, and 13-19 under 35 USC 102 as being anticipated by Pulitzer et al., as set forth on pp. 10-17 of the previous office action (mailed on 02/13/2026) has been withdrawn in view of the newly amended limitation of “identify the presence or otherwise of any of bovine or human tuberculosis, lung diseases including COPD and lung cancer, mycobacterial disease, such as Johne's disease (mycobacteria avium paratuberculosis (MAP) prostate and/or bladder cancer” (filed on 06/08/2026).
Claim Objections- New, Necessitated by Amendments.
1.Claim 1 is objected to because of the following informalities: Claim 1 recites “mycrobacterial disease”, which is misspelling of “mycobacterial disease”. Appropriate correction is required.
2.Claim1 is objected to because of the following informalities: Missing parenthesis after MAP, further “paratuberculosis” is misspelled. Examiner suggests the amendment “(mycobacteria avium paratuberculosis (MAP))”. Appropriate correction is required.
Claim Interpretation-Maintained.
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.
3.Claim 1 recites “a means for reading a unique identification tag of the test kit to be 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 Rejections - 35 USC § 112- New, Necessitated by Amendments.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4.Claims 1, 9-11, and 13-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation of “mycobacterial disease”, and the claim also recites “mycobacterial disease such as Johne’s disease” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 101-Maintained.
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.
5.Claims 1, 9-11, and 13-19 are rejected under 35 U.S.C. 101 because the claimed method is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1
This part of the eligibility analysis evaluates whether the claim falls within any statutory
category per MPEP 2106.03
Regarding instant claims 1, 9-11, and 13-19, Example 43 of “2019 PEG” is particularly enlightening
because the fact pattern of claim 1 of example 43 is most similar to the instant application
claims 1, 9-11, and 13-19.
Regarding claim 1 of example 43 of the “2019 PEG” and per Step 1, the claim is
directed to a process, which is one of the statutory categories of invention as the claim recites
“A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a
blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3)
to identify the patient as having a non-responder phenotype; (b) administering a treatment to the
patient having a non-responder phenotype.” (Step 1: YES).
Similarly, instant claims 1, 9-11, and 13-19 are directed to a statutory method that measures naturally occurring antibodies and/or antigens and corelating them with the presence of at least one health condition (STEP 1: YES).
Step 2A, Prong 1: Does the claim recite a judicial exception?
This part of the eligibility analysis evaluates whether the claim recites a judicial
exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a
judicial exception when the judicial exception is “set forth” or “described” in the claim.
Regarding instant claims 1, 9-11, and 13-19, Example 43 of the “2019 PEG” shows a similar fact pattern.
Regarding claim 1 in Example 43 of the “2019 PEG” and per Step 2A, prong 1, the
claim recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a
blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3)
to identify the patient as having a non-responder phenotype,” and according to broadest
reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the
ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent
phenotype.
Specifically, limitation (a) in claim 1 of Example 43 of the “2019 PEG” recites “calculating
a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic
Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder
phenotype,” which has a BRI that requires performing an arithmetic calculation (division) in
order to obtain the ratio of C11 to C13 levels, and then using this ratio to identify whether the
patient has the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or
greater and thus is not responding, or will not respond, to glucocorticoids). This limitation
therefore recites a mathematical calculation. The grouping of “mathematical concepts” in the
2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG
Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping
of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be
practically performed in the human mind, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Note that even if most
humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them
complete the recited calculation, the use of such physical aid does not negate the mental nature
of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract
ideas.
In addition, limitation (a) describes a naturally occurring relationship between the ratio
of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a
law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls
within the mathematical concept and mental process groupings in the “2019 PEG”, and a law of
nature), and the analysis must therefore proceed to Step 2A Prong Two.
Similarly, instant claims 1, 9-11, and 13-19 recite a method that measures naturally occurring antibodies and/or antigens and corelating them with the presence of at least one health condition selected from any of bovine or human tuberculosis, lung diseases, mycobacterial disease, prostate cancer, and/or bladder cancer, which describes a naturally occurring relationship between biomarkers and a disease, and is thus considered a law of nature. Consequently, instant claims 1, 9-11, and 13-19 recite the judicial exception of applying and using a law of nature and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong 2: Does the claim recite additional elements that integrate the exception into a practical application?
Regarding instant claims 1, 9-11, and 13-19, Example 43 of “2019 PEG” shows a similar fact pattern.
In claim 1 of example 43 of the “2019 PEG” and per Step 2A, prong 2, the claim as a
whole does not integrate the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any additional
elements recited in the claim beyond the judicial exception, and (b) evaluating those additional
elements individually and in combination to determine whether the claim as a whole integrates
the exception into a practical application. Besides the abstract idea, the claim 1 of example 43
of the “2019 PEG” recites the additional element of “(b) administering a treatment to the patient
having a non-responder phenotype”. Although this limitation indicates that a treatment is to be
administered, it does not provide any information as to how the patient is to be treated, or what
the treatment is, but instead covers any possible treatment that a doctor decides to administer
to the patient. In fact, this limitation is recited at such a high level of generality that it does not
even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into
account when deciding which treatment to administer, making the limitation’s inclusion in this
claim at best nominal. Thus, limitation (b) of example 43 of the “2019 PEG” fails to
meaningfully limit the claim because it does not require any particular application of the recited
calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial
exception. Accordingly, limitation (b) of example 43 of the “2019 PEG” does not integrate the
recited judicial exception into a practical application and the claim is therefore directed to the
judicial exception.
Similarly, instant claims 1, 9-11, and 13-19 do not have additional elements that would integrate the judicial exception cited above into a practical application. Instant claim 1 recites the additional elements of (a) a means for reading a unique identification tag of the test kit to be 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; (b) a mobile phone device operable with an app to capture an indication of a result of the biomarker signature identification means test in a form of a photograph or scan, said mobile phone device operable as a data receiving and transmitting means, wherein the captured indication of the result of the biomarker signature test and the unique identification data of the test kit, particular person or animal are wirelessly transmitted to a second geographical location remote from a first geographical location in use; (c) 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 (d) 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 and received by to a user at the first geographical location via the mobile phone device and app so as to result in the system providing for the near instantaneous testing and response and performing of necessary action or range of actions at the first geographical location such that a person treating the person or animal can perform both the test and the action or range of actions at the same location during a single visit and once completed, the data which has been transmitted and received by the mobile phone device is not required to be retained on the mobile phone. The additional elements of (a) – (d) does not integrate the recited judicial exception into a practical application of the exception, as it is merely a form of display of the results of the law of nature. Showing a representation of the data received from the natural correlation is not sufficient to show practical application.
Further, in comparison to claim 1, example 43, did not pass step 2A prong 2 with step of general treatment. Instant claims 1, 9-11, and 13-19 do not even recite a treatment step. Example 43 failed with a step of a general treatment, instant claims 1, 9-11, and 13-16 do not recite a further active step, let alone a treatment.
Therefore, instant claims 1, 9-11, and 13-19 do not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
Regarding instant claims 1, 9-11, and 13-19, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claim does not recite any active steps. Instant claim 1 recites the additional elements (a) a means for reading a unique identification tag of the test kit to be 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; (b) a mobile phone device operable with an app to capture an indication of a result of the biomarker signature identification means test in a form of a photograph or scan, said mobile phone device operable as a data receiving and transmitting means, wherein the captured indication of the result of the biomarker signature test and the unique identification data of the test kit, particular person or animal are wirelessly transmitted to a second geographical location remote from a first geographical location in use; (c) 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 (d) 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 and received by to a user at the first geographical location via the mobile phone device and app so as to result in the system providing for the near instantaneous testing and response and performing of necessary action or range of actions at the first geographical location such that a person treating the person or animal can perform both the test and the action or range of actions at the same location during a single visit and once completed, the data which has been transmitted and received by the mobile phone device is not required to be retained on the mobile phone. The additional elements of (a) – (d) do not amount to significantly more than the judicial exception because the limitations they are merely data gathering steps that are directed towards the judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Accordingly, instant claims 1, 9-11, and 13-19 are not eligible (STEP 2B: NO).
Thus, instant claims 1, 9-11, and 13-19 are rejected under 35 USC 101.
Response to Arguments
Applicant's arguments filed 06/08/2026 have been fully considered but they are not persuasive.
On p. 5-6 applicant argues that the amendments to claim 1 to include the feature “the near instantaneous testing and response and performing the necessary action or range of actions at the first geographical location such that a person treating the person or animal can perform both the test and the action or range of actions at the same location during a single visit” overcomes the 35 USC 101 rejection.
However, these newly added limitations do not integrate the judicial exception into a practical application, as they are merely just data gathering steps that rely on the natural correlation. The steps recite performing data gathering steps to determine the natural correlation, regardless of the location. The newly added limitations do not amount to significantly more than the judicial exception as the limitations are directed to steps of determining the natural correlation and nothing more.
Claim Rejections - 35 USC § 103- New, Necessitated by Amendments.
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.
6.Claims 1, 9-11, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pulitzer et al., (WO2018/075557A1) (IDS filed on 02/08/2022), in view of Parekh et al., (WO2015128681A1) (IDS filed on 02/08/2022).
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 test kit comprising a body located at a first geographical location in use including: a means for reading a unique identification tag of the test kit to be 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 figure 1, 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]),
one or more biomarker signature identification means including an immunochromatography strip to test the sample so as to identify the presence of antibodies (see figure 1, see figure 3, see [0005] “a conjugate pad containing particles for conjugating with antibodies or antigens present in the biologic sample”, see claim 2 of ‘557) (instant claim 9),
a mobile phone device operable with an app to capture an indication of a result of the biomarker signature identification means test in a form of a photograph or scan (see [0005] “the method comprises receiving at a server information from a mobile device regarding test results from a test performed using a testing device, a testing device having thereon an alignment target and having a plurality of immunoassay test strips”, see claim 1 of ‘557, see figure 8, see [0015]),
said mobile phone device operable as a data receiving and transmitting means, wherein the captured indication of the result of the biomarker signature test and the unique identification data of the test kit, 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…”, [0068] teaching the first geographical location being the mobile phone and the second geographical location being the data base that the physician, disease researchers, and others have access to); and
receiving and transmitting means and a database located at the second geographical location (see [0065] “data and results from the tests may be stored on the database 1204 at the remote server 1206. As described herein, this data may be used as a control for testing analysis for users of the plurality of mobile devices 1202. This data may also be used to provide data sets for biologies to a medical organization 1210. The medical organization 1210 may be doctor's offices, researchers, hospitals, testing labs, and other individuals or organizations that have an interest in the health and analysis of users taking the test and of their biologic samples. In this way, data can be gathered from a variety of biologies tested for a variety of different medical conditions and characteristics”, see figure 12),
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 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”, see figure 12), 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 and received by to a user at the first geographical location via the mobile phone device and app so as to result in the system providing for the near instantaneous testing and response and performing of necessary action or range of actions at the first geographical location such that a person treating the person or animal can perform both the test and the action or range of actions at the same location during a single visit and once completed, the data which has been transmitted and received by the mobile phone device is not required to be retained on the mobile phone (see figure 12, see claim 1 of ‘557, see [0034] “ As further described herein, the present detecting apparatus and method use human (patient/consumer- derived) antibodies from the sample and the test zone that contains a humanized antibody directed against the protein of interest that is preconjugated to a detecting substance that results in a visual change.”, see [0050] “The diagnostic test can be provided to and used by hospitals and clinics to provide rapid, on-site test results that are required to prescribe certain medications, such as omaluzimab, by their FDA labels”) (instant claim 1).
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 test kit (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”) (instant claim 10) and the apparatus test kit 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 (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) (instant claim 11). Pulitzer teaches on site analysis options are provided on the body portion and are available to be selectively used (see claims 15-17 of ‘557) (instant claim 13) and 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 test kit (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.”) (instant claim 14). Pulitzer teaches the indication generated by the apparatus test kit is a visual indication means (see [0041]) (instant claim 15).
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 (see [0057], see [0031]) (instant claim 16). 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 (see [0044]) (instant claim 17). 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 (see [0028]) (instant claim 18). Pulitzer teaches wherein the analysis of the data received from the apparatus uses "omics" research (see [0062], see [0065]) (instant claim 19).
Pulitzer does not teach identifying the presence or otherwise of any of bovine or human tuberculosis, lung diseases including COPD and lung cancer, mycobacterial disease, such as Johne's disease (mycobacteria avium patatubercolosis (MAP) prostate and/or bladder cancer.
Parekh teaches the one or more analysis means includes a series of biomarker antibodies in a form so as to identify a presence of lung diseases (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 claims 1 and 16 of ‘681) (instant claim 1).
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 been motivated to optimize the biomarkers being tested, depending on the disease being tested. Pulitzer explicitly teaches that the methods and device can be used for different applications (by selecting the test strips) (see [0039], see [0067]). Parekh teaches that chronic infections or inflammation of the lungs (such as COPD) have inflammatory components that are detectable (see page 1 lines 13-21). Parekh teaches that monitoring and measuring biomarkers for lung inflammation is useful because it accurately predicts pulmonary exacerbation events before they happen, or identify the events earlier, allowing for treatment sooner (see page 1 lines 13-31). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
Response to Arguments
Applicant's arguments filed 06/08/25026 have been fully considered but they are not persuasive.
On p. 6 applicant argues that Pulitzer does not teach the use of biomarkers for diseases like cancer or autoimmune diseases as measuring specific metabolite or proteomic biomarkers.
While that is true, Pulitzer does teach that the methods and device can be used with different applications (see [0039], see [0067]). Parekh teaches measuring biomarkers for the diseases listed in instant claim 1. Further, it is routine in the art to optimize the biomarkers being used in an assay depending on what disease/illness is being detected.
On pp. 6-7 applicant argues that the device of Pulitzer used for measurement is very specifically a hardware reader which has to be connected to a computer at the point of use. Applicant further argues that while Pulitzer suggests the device can be mobile, it is submitted that that isn’t entirely correct as the device requires connecting cables, power, and if the database is located in the actual computer, then it will have a very limited capability.
However, Pulitzer explicitly teaches the device being a mobile device (see abstract). Pulitzer teaches that the mobile device is a home health test device (see [0004]). Pulitzer does not teach that the mobile device needs to be connected to a computer at the point of use, Pulitzer actually teaches the opposite (see [0058]). At [0005] and [0006] Pulitzer teaches that the mobile testing device receives an image of the test strip, the image is then processed to determined based on the pixel count and line intensity of the test line of each of the plurality of immunoassay test strips, and provide a risk indicator.
If applicant is referring to figures 15-16 and [0071] – [0072] of Pulitzer, it is understood that Pulitzer teaches a device that uses a PC for scanning a test strip, but that is not the mobile device being referred to. Pulitzer simply shows an alternative to the mobile device.
On p. 7 applicant argues that Pulitzer contains a database that is located within the set of apparatus device. However, Pulitzer explicitly states that the database is a remote server over a network (see figure 12, see [0067]) that can be accessed by a physician, medical team, disease researchers (see [0068]).
Conclusion
No claim is allowed.
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
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