DETAILED ACTION
1. Please note the Examiner of record has changed. Contact information is provided at the close of this Action.
Election/Restrictions
2. Applicant’s election of species, growth/differentiation factor 15 (GDF-15) in the reply filed on January 5, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Claims 1-28 are pending.
Claims 3, 4, 10, 12 and 15-19, drawn to non-elected species are withdrawn from examination.
Claims 21-28 have been added.
Claims 1, 2, 5-9, 11, 13, 14 and 20-28 are examined on the merits with the elected species, growth/differentiation factor 15 (GDF-15).
Claim Objections
4. Claims 1, 2, 9, 11, 13, 14, 24, 25 and 28 are objected to because of the following informality:
(a) the protein, matrix metalloproteinase-2 corresponding acronym is cited as MMP-2 and MMP2 in claims 1, 9, 24 and 28. Consistent with the specification is the former acronym, MMP-2. Applicant should cite this acronym within the claims, consistent with their disclosure.;
(b) the prostate health index (phi) is cited in claims 1, 2, 9, 11, 13 and 14 is art known to be italicized as noted in the Specification, see page 28, section 0117; Figures 2A, 2B, 3A and 3B on pages 9-12 of 20. However, the claims do not cite the non-italicized acronym of the said index. Applicant is requested to select one, italicized or non-italicized phi, consistent throughout the Specification and claims.; and
(c) in claim 25, between steps (b) and (c), the function word, “and” should be cited on line 5 after the semi-colon.
Correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 1, 2, 5-9, 11, 13, 14 and 20-28 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. Applicant’s claim 1 reads on identifying a patient as having aggressive prostate cancer with the measure of the concentration of total prostate specific antigen (PSA), free PSA, p2PSA in a patient’s serum sample, calculating phi, as well as fucosylated PSA (fuc-PSA) and GDF in the patient’s serum sample and using an algorithm to make the identification. Likewise, claim 25 reads on identifying a patient as having aggressive prostate cancer with the measure of the concentration of total PSA, free PSA and GDF in the patient’s sample to make the identification.
However, it is not clear what amount, what measure, what quantity of the concentration of these biomarkers within a panel definitively categorize an individual as having aggressive prostate cancer. Likewise, it is not clear what should the phi calculation together with the said measure of panel of biomarkers be to definitively categorize an individual as having aggressive prostate cancer. Moreover, it is not clear what algorithm or set of steps should be followed to identify a patient as having aggressive prostate cancer. Accordingly, the metes and bounds cannot be determined.
b. Applicant cites “…calculating phi based on the measured serum concentrations” and “…a panel of biomarkers comprising phi” in claim 1. Claims 2, 9, 11, 13 and 14 also cite the term, phi. The claim language cites the term as a formula, as well as a candidate prostate cancer biomarker. In the art, the acronym, phi is prostate health index, an FDA-approved blood test that combines three prostate specific antigen markers, total PSA, free PSA and p2PSA. It is not clear if phi is cited in the claims as “short hand” for the three said markers. Accordingly, the metes and bounds cannot be determined.
Claim Rejections - 35 USC § 101
7. 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.
8. The claimed invention (claims 1, 2, 5-9, 11, 13, 14 and 20-24) is directed to a judicial exception and/or natural phenomenon without significantly more. The claim(s) 1 recite(s) a method of identifying a patient as having aggressive prostate cancer comprising:
(a) measuring the concentration of total prostate specific antigen (PSA), free PSA, p2PSA in a patient’s serum sample, calculating phi based on the measured serum concentrations;
(b) measuring the concentration of fucosylated PSA (fuc-PSA) in the patient’s serum sample;
(c) measuring the concentration of the elected biomarker, GDF-15 along with those biomarkers cited with it; and
(d) using an algorithm to identify the patient as having aggressive prostate cancer based on a panel of biomarkers comprising total PSA, free PSA, p2PSA, fuc-PSA, the elected species, GDF-15, those cited in the panel with it and further comprising treating the patient with a prostate cancer therapy. Measuring the concentration of the said biomarker signature based on presence with the patient’s serum sample, calculating phi and using an algorithm is indicative of a patient having aggressive prostate cancer.
This judicial exception is not integrated into a practical application because gathering information and observing levels of candidate cancer biomarkers in a patient’s serum sample from a subject required to use the correlation does not add a meaningful limitation to the method as they are insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it does not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The analysis as set forth in the 2019 Guidance is as follows:
Step 1: Yes, claims are drawn to a method which is one of the four statutory categories, a process.
Step 2A, prong 1: Yes, the claims recite/describe/set forth a judicial exception. The claims describe the relationship between the presence/measure of the concentration of biomarkers, total PSA, free PSA, p2PSA, fuc-PSA (% fuc-PSA), GDF-15 and additional biomarkers within a patient’s serum sample and said patient having aggressive prostate cancer.
Step 2A, prong 2: No, the judicial exception is not integrated into a practical application. The claims do not rely on or use the exception here. Once the presence of the serum biomarker(s) is detected and measured by conventional means and implementing an algorithm to identify the patient as having aggressive prostate cancer based on said biomarker signature comprising phi, there are no additional elements or combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Step 2B: No, there is no inventive concept present in the clams. The steps of analyzing the presence of candidate cancer biomarker(s) in a biological sample is established by well understood, routine conventional methods, and in addition they are pre-solution activity, i.e. data gathering necessary to perform the correlation. The following claims and steps inform one of ordinary skilled in the art the comparison and the presence of biomarker(s) identifies an individual as having aggressive prostate cancer. The claims do not recite additional elements that amount to significantly more than the judicial exception.
Moreover, the claims describe the said relationship utilizing an algorithm, not set forth in the claims and regarded as an abstract idea. Consequently, setting forth a natural law. Notwithstanding, even if mathematical equations and/or mathematical calculations were noted in the claims these are regarded as limitations in the mind. The claims contain mental processes and mathematical concepts, which are abstract ideas and a series of data gathering steps required to collect necessary input for the scoring algorithm and may be performed in the mind. The algorithm requires variables, numbers and mathematical relationships for a
computer-implemented system. This system is a tool to perform the mathematical concepts. While a process is not unpatentable simply because it contains a mathematical algorithm, the claims as a whole have been analyzed and determined to not contain additional elements or provide significantly more than the natural laws. Accordingly, these claims are not be eligible under step 2A or step 2B.
Claims 1, 2, 5-9, 11, 13, 14 and 20-24 are drawn to a non-statutory method having a "natural principle" as a limiting element or step without reciting additional elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself. In the instant case, the "natural principle" is: detecting a panel of particular prostate cancer biomarkers in an individual’s sample, which is indicative of prostate cancer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because assaying for candidate prostate cancer biomarkers does not add significantly more and is not an inventive concept. Because methods for making such determinations were well known in the art, these steps simply tell researchers to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activities are normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such law. Detection of candidate prostate cancer biomarkers and agents has been observed by applicant but not engineered by applicant. The claims do not add significantly more to the natural phenomenon because the claims do not require a novel reagent, apparatus of incorporate a novel treatment based on the correlation.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Recited elements such as “identifying”, “measuring”, and “calculating” based on the natural principle impose no meaningful limit on the performance of the claimed invention. As set forth the claims do not impose meaningful limits on the performance of the claimed invention. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas). Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the recited natural principle. The claims do not "practically apply" the natural principle; rather, the claims "simply inform" the natural principle to one performing routine active method steps and do not amount to significantly more than the natural principle itself. Thus, the technology used by the instant claims is well-known in the art and does not contribute significantly more to the judicial exception. See the 2019 Revised Patent Subject Matter Eligibility Guidance and Federal Register https://www.federalregister.gov/documents/2019/10/18/2019-22782/october-2019-patent-eligibility-guidance-update; and FDsys.gov.
Claim Rejections - 35 USC § 103
9. 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.
10. Claim(s) 1, 2, 5-9, 11, 13, 14 and 20-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al., US 2016/0069884 A1 (published March 10, 2016/ IDS reference #1, U.S. Patent Application Publications, submitted March 29, 2023), and further in view of Schettini et al., WO 2014/082083 A1 (published 30 May 2014/ IDS reference #1, Foreign Patent Documents submitted March 29, 2023) and Wang et al., (Scientific Reports 4 (5012): 1-8 (published 23 May 2014). Zhang teaches “…a method for diagnosing aggressive prostate cancer in a patient comprising the steps of (a) collecting a serum sample from the patient; (b) detecting the levels of a panel of biomarkers in the sample collected from the patient, wherein the panel of biomarkers comprises fucosylated PSA [fuc-PSA]; and (c) comparing the levels of the panel of biomarkers with predefined levels of the same panel of biomarkers that correlate to a patient having aggressive prostate cancer and predefined levels of the same panel of biomarkers that correlate to a patient not having aggressive prostate cancer, wherein a correlation to one of the predefined levels provides the diagnosis.
In another aspect, the present invention provides methods for treating prostate cancer in a patient. In a specific embodiment, the method comprises the steps of (a) collecting a serum sample from the patient; (b) detecting the levels of a panel of biomarkers in the sample collected from the patient, wherein the panel of biomarkers comprises fucosylated PSA; (c) comparing the levels of the panel of biomarkers with predefined levels of the same panel of biomarkers that correlate to a patient having aggressive prostate cancer and predefined levels of the same panel of biomarkers that correlate to a patient not having aggressive prostate cancer, wherein a correlation to one of the predefined levels provides the diagnosis; and (d) treating the patient with an appropriate therapeutic regimen for aggressive prostate cancer if the diagnosis of the patient correlates to aggressive prostate cancer or treating the patient with an appropriate therapeutic regimen for non-aggressive prostate cancer if the diagnosis of the patient correlates to non-aggressive prostate cancer. The appropriate therapeutic regimen (for aggressive prostate cancer or for non-aggressive prostate cancer) can be determined by one of ordinary skill in the art using the methods described herein and other patient and diagnostic information.
In yet another aspect, the present invention provides methods for determining the aggressive prostate cancer status in a patient. In a specific embodiment, the method comprises the steps of (a) collecting a sample from the patient; (b) measuring the levels of a panel of biomarkers in the sample collected from the patient, wherein the panel of biomarkers comprises fucosylated PSA; and (c) comparing the levels of the panel of biomarkers with predefined levels of the same panel of biomarkers that correlate to one or more aggressive prostate cancer statuses selected from the group consisting of having aggressive prostate cancer, not having aggressive prostate cancer, progressing aggressive prostate cancer, and regressing aggressive prostate cancer, wherein a correlation to one of the predefined levels determines the aggressive prostate cancer status of the patient.”, see page 3, sections 0018-0020.
“In one embodiment, a method comprises (a) isolating glycoproteins from a serum sample obtained from the patient using a lectin affinity capture assay; and (b) quantitating the amount of fucosylated PSA from the isolated glycoproteins of step (a) using an immunoassay. In another embodiment, the method further comprises the step of generating a report showing the quantitated amount of fucosylated PSA. In yet another embodiment, the method further comprises a display of control levels of fucosylated PSA that correlate to aggressive prostate cancer and non-aggressive prostate cancer. In alternative embodiments, the method can further comprise the step of identifying the patient as having aggressive prostate cancer based on a statistically significant increase in fucosylated PSA present in the patient sample relative to reference levels that correlate to non-aggressive prostate cancer. In certain embodiments, the method further comprises the step of recommending, prescribing or treating the patient with, an appropriate therapeutic regimen for aggressive prostate cancer if the quantitated amount of fucosylated PSA correlates to aggressive prostate cancer or recommending, prescribing or treating the patient with, an appropriate therapeutic regimen for non-aggressive prostate cancer if the quantitated amount of fucosylated PSA correlates to non-aggressive prostate cancer. It is also contemplated that the methods comprise a recommendation, prescription, treatment or administration of a cancer therapy to a patient identified or diagnosed as having aggressive prostate cancer or non-aggressive prostate cancer using a method described herein.”, see section 0009 bridging pages 1 and 2.
Components of the panel of biomarkers include total PSA (tPSA), free PSA (fPSA), fucosylated PSA (fuc-PSA) (as well as a percentage of fuc-PSA) and soluble form of the TIE-2 receptor (sTIE-2), see page 1, section 0008; section 0022 spanning pages 3 and 4; and page 10, sections 0094 and 0095.
The taught assays “…can also use lectins to enrich, isolate or otherwise select for the biomarker proteins of interest followed by subsequent analysis using antibodies. In certain embodiments, the assay utilizes both antibodies and lectins to detect and measure biomarker proteins of interest. In certain embodiments, the assay utilizes lectins or antibodies to enrich target proteins and followed by mass spectrometric analysis. In certain embodiments, the assay utilizes mass spectrometry to quantify the proteins or modified glycoproteins with [fucosylated] glycans.”, see page 1, section 0007; page 2, section 0010. The assay may be a lectin affinity capture assay, see page 1, section 0009.
Zhang teaches “the values measured for markers of a biomarker panel are mathematically combined and the combined value is correlated to the underlying diagnostic question”, wherein a classification algorithm can be implemented utilizing the measures of the biomarkers to address aggressive prostate cancer status.”, see sections 0101-0105 and 0112-0121 spanning pages 11-13.
Zhang does not teach biomarkers, phi, growth differentiation factor 15 (GDF-15), syndecan 1 (SDC1), IL-6 R alpha, matrix metalloproteinase-2 (MMP-2), cancer antigen 15-3 (CA15-3), TIE-2, vascular cell adhesion molecule 1 (VCAM-1), p2PSA and B7 homolog 3 (B7H3) are measured in the assays. Nor does, Zhang teach the prostate cancer therapy comprises prostatectomy, radiation therapy, cryotherapy, hormone therapy, chemotherapy, immunotherapy and combinations thereof.
However, Schettini teaches “[b]iomarkers can be assessed for diagnostic therapy-related or prognostic methods to identify…a condition or disease, or the state or progression of a disease, select candidate treatment regimens for diseases, conditions, disease stages, and stages of a condition,”, see Abstract. The biomarkers are comprised within biological samples including peripheral blood, serum or plasma, see page 4, section 0021. Biomarkers include B7H3 (line 3 from bottom) and GDF-15 (line 4) in section 0048 spanning pages 12 and 13, respectively and page 111, 4th Prostate…segment; B7H3 on page 92, section 00371 and page 104, section 00419; syndecan (SDC1) also art known as CD138 on page 5, line 3 from bottom of page; Tie2 is found on page 105, section 00421; on page 135, epithelial membrane antigen (EMA/CA15-3/MUC-1) on line 13 and MMP-2 (72kDA CoUagenase IV) on line 10 up from bottom of page; page 138, VCAM-1 in Cytokine…segment and IL-6R in Membrane…segment and page 140; and IL6R on page 111, 4th Prostate…segment. IL6R is also art known as IL-6R alpha.
Schettini also teaches prostate cancer therapies, prostatectomy, radiation therapy, hormone therapy, cryosurgery/cryotherapy, chemotherapy, and immunotherapy, see page 98, section 00402; page 202; “Prostate Cancer Treatments” spanning pages 203 and 204; and page 206, section 00666.
Wang teaches utilizing the phi test with additional tests in order to determine, diagnose and distinguish between aggressive prostate cancer and non-aggressive prostate cancer, see entire reference. The phi “…is calculated using the formula (p2PSA/fPSA × √tPSA).”, see page 1, 2nd paragraph (para.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references to assay several candidate prostate cancer biomarkers and perform analysis to arrive at a high diagnostic accuracy rate and improve specificity in categorizing the prostate cancer. Designating the prostate cancer as aggressive or not, yields information regarding cancer prognosis, progression and arriving upon best treatment options, see all references in their entirety.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in all references, there are several art known methods and analyses in the art that can be efficiently and reproducibly implemented to analyze several candidate prostate cancer biomarkers allowing those in the art to discern their impact on the prostate cancer patient’s diagnosis and clinical outcome, see all references in their entirety.
11. Claim(s) 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al., US 2016/0069884 A1 (published March 10, 2016/ IDS reference #1, U.S. Patent Application Publications, submitted March 29, 2023), and further in view of Schettini et al., WO 2014/082083 A1 (published 30 May 2014/ IDS reference #1, Foreign Patent Documents submitted March 29, 2023) and Wang et al., (Scientific Reports 4 (5012): 1-8 (published 23 May 2014). Zhang teaches several methods of identifying aggressive prostate cancer, see the entire document. “[T]he method comprises the steps of (a) collecting a serum sample from the patient; (b) detecting the levels of a panel of biomarkers in the sample collected from the patient, wherein the panel of biomarkers comprises fucosylated PSA; (c) comparing the levels of the panel of biomarkers with predefined levels of the same panel of biomarkers that correlate to a patient having aggressive prostate cancer and predefined levels of the same panel of biomarkers that correlate to a patient not having aggressive prostate cancer, wherein a correlation to one of the predefined levels provides the diagnosis; and (d) treating the patient with an appropriate therapeutic regimen for aggressive prostate cancer if the diagnosis of the patient correlates to aggressive prostate cancer or treating the patient with an appropriate therapeutic regimen for non-aggressive prostate cancer if the diagnosis of the patient correlates to non-aggressive prostate cancer. The appropriate therapeutic regimen (for aggressive prostate cancer or for non-aggressive prostate cancer) can be determined by one of ordinary skill in the art using the methods described herein and other patient and diagnostic information.
In yet another aspect, the present invention provides methods for determining the aggressive prostate cancer status in a patient. In a specific embodiment, the method comprises the steps of (a) collecting a sample from the patient; (b) measuring the levels of a panel of biomarkers in the sample collected from the patient, wherein the panel of biomarkers comprises fucosylated PSA; and (c) comparing the levels of the panel of biomarkers with predefined levels of the same panel of biomarkers that correlate to one or more aggressive prostate cancer statuses selected from the group consisting of having aggressive prostate cancer, not having aggressive prostate cancer, progressing aggressive prostate cancer, and regressing aggressive prostate cancer, wherein a correlation to one of the predefined levels determines the aggressive prostate cancer status of the patient.”, see page 3, sections 0019 and 0020.
“In one embodiment,… the method further comprises a display of control levels of fucosylated PSA [fuc-PSA] that correlate to aggressive prostate cancer and non-aggressive prostate cancer. In alternative embodiments, the method can further comprise the step of identifying the patient as having aggressive prostate cancer based on a statistically significant increase in fucosylated PSA present in the patient sample relative to reference levels that correlate to non-aggressive prostate cancer. In certain embodiments, the method further comprises the step of recommending, prescribing or treating the patient with, an appropriate therapeutic regimen for aggressive prostate cancer if the quantitated amount of fucosylated PSA correlates to aggressive prostate cancer or recommending, prescribing or treating the patient with, an appropriate therapeutic regimen for non-aggressive prostate cancer if the quantitated amount of fucosylated PSA correlates to non-aggressive prostate cancer. It is also contemplated that the methods comprise a recommendation, prescription, treatment or administration of a cancer therapy to a patient identified or diagnosed as having aggressive prostate cancer or non-aggressive prostate cancer using a method described herein.”, see section 0009 bridging pages 1 and 2.
Components of the panel of biomarkers can include total PSA (tPSA), free PSA (fPSA), fucosylated PSA (fuc-PSA), see page 1, section 0008; section 0022 spanning pages 3 and 4; and page 10, sections 0094 and 0095.
The biomarkers can be differentially present in UI (NC or non-aggressive prostate cancer) and aggressive prostate cancer, and, therefore, are useful in aiding in the determination of aggressive prostate cancer status. In certain embodiments, the biomarkers are measured in a patient sample using the methods described herein and compared, for example, to predefined biomarker levels/ratios and correlated to aggressive prostate cancer status. In particular embodiments, the measurement(s) may then be compared with a relevant diagnostic amount(s), cut-off(s), or multivariate model scores that distinguish a positive aggressive prostate cancer status from a negative aggressive prostate cancer status. The diagnostic amount(s) represents a measured amount of a biomarker(s) above which or below which a patient is classified as having a particular aggressive prostate cancer status. For example, if the biomarker(s) is/are up-regulated compared to normal (e.g., no cancer or non-aggressive prostate cancer) during aggressive prostate cancer, then a measured amount(s) above the diagnostic cutoff(s) provides a diagnosis of aggressive prostate cancer. Alternatively, if the biomarker(s) is/are down-regulated during aggressive prostate cancer, then a measured amount(s) at or below the diagnostic cutoff(s) provides a diagnosis of non-aggressive prostate cancer. The opposite may hold true as well (i.e., expression of the biomarker is lower/downregulated in aggressive prostate cancer vs. no cancer or non-aggressive prostate cancer) As is well understood in the art, by adjusting the particular diagnostic cut-off(s) used in an assay, one can increase sensitivity or specificity of the diagnostic assay depending on the preference of the diagnostician. In particular embodiments, the particular diagnostic cut-off can be determined, for example, by measuring the amount of biomarkers in a statistically significant number of samples from patients with the different aggressive prostate cancer statuses, and drawing the cut-off to suit the desired levels of specificity and sensitivity.”, see page 11, section 0098.
Zhang does not teach additional biomarkers, growth differentiation factor 15 (GDF-15), matrix metalloproteinase-2 (MMP-2), p2PSA and B7 homolog 3 (B7H3) were measured.
However, Schettini teaches “[b]iomarkers can be assessed for diagnostic therapy-related or prognostic methods to identify…a condition or disease, or the state or progression of a disease, select candidate treatment regimens for diseases, conditions, disease stages, and stages of a condition,”, see Abstract. The biomarkers are comprised within biological samples including peripheral blood, serum or plasma, see page 4, section 0021. Biomarkers include B7H3 (line 3 from bottom) and GDF-15 (line 4) in section 0048 spanning pages 12 and 13, respectively and page 111, 4th Prostate…segment; B7H3 on page 92, section 00371 and page 104, section 00419; and MMP-2 (72kDA CoUagenase IV) on line 10 up from bottom of page.
Wang teaches utilizing the phi test with additional tests in order to determine, diagnose and distinguish between aggressive prostate cancer and non-aggressive prostate cancer, see entire reference. The phi “…is calculated using the formula (p2PSA/fPSA × √tPSA).”, see page 1, 2nd paragraph (para.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references to assay several candidate prostate cancer biomarkers and perform analysis to arrive at a high diagnostic accuracy rate and improve specificity in categorizing the prostate cancer. Designating the prostate cancer as aggressive or not, yields information regarding cancer prognosis, progression and arriving upon best treatment options, see all references in their entirety.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in all references, there are several art known methods and analyses in the art that can be efficiently and reproducibly implemented to analyze several different candidate prostate cancer biomarkers allowing those in the art to discern their impact on the prostate cancer patient’s diagnosis and clinical outcome, see all references in their entirety.
Conclusion
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- Song et al. A panel of selected serum protein biomarkers for the detection of aggressive prostate cancer. (Theranostics, 11(13): 6214-6224, published 2021 May 15).
13. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-6PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
March 3, 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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