DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of group I, WFDC2(HE) and total PSA; %free PSA and DRE HE4, total PSA, %Free PSA, DRE, logarithmic function, (iii) increasing specificity to discriminate between subjects having aggressive CaP and control subjects., selecting a suitable positive rate, claim 16, from claims 14-17, serum in the reply filed on 12/5/2025 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)).
Claims 3, 14-15, 17is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/5/2025.
Priority
The instant application was filed 12/13/2022 and is a national stage entry of PCT/AU2021/050705 with an international filing date: 06/30/2021 and claims foreign priority to AU2020902212, filed 06/30/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/16/2023 is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The 80 page specification filled 3/16/2023 has hyperlink on page 12. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Applicant should review the entire specification and remove hyperlinks.
The 80 page specification filled 3/16/2023 has flowcharts or diagrams on pages 26, 28, 39, 50, 52, 68. However, 37 CFR 1.58 Chemical and mathematical formulas and tables states: (a) The specification, including the claims, may contain chemical and mathematical formulae, but shall not contain drawings or flow diagrams.
Claim Objections
Claims 5-34 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim 4. See MPEP § 608.01(n). Accordingly, the claims 5-34 not been further treated on the merits.
Claim Rejections - 35 USC § 112
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.
Claims 1-2 and 4 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.
Claim 1 recites, “in the test subject's biological sample.” The claim does not previously recite, “test subject's biological sample.” Thus the metes and bounds are unclear what in the test subject's biological sample is referring to. The claim should be amended to provide antecedent basis for this limitation.
Claim 1 recites, “applying a suitable algorithm and/or transformation to a combination of the clinical variable measurements and analyte level/s of the test subject to thereby generate a test subject score value for comparison to a threshold value.” The recitation of suitable algorithm and/or transformation suggests there are non-suitable algorithm and/or transformation. The specification fails to provide a standard or definition to differentiate suitable algorithm and/or transformation from non-suitable algorithm and/or transformation. Further the claims is vague, unclear and appears to be incomplete as to how analyte levels and clinical variables are applied to algorithm and/or transformation to provide a test subject score value.
Claim 1 recites, “determining whether the test subject has aggressive CaP by comparison of the subject test score value and the threshold value.” However, the specification states, “As used herein the abbreviation "AgCaP" refers to aggressive prostate cancer defined as prostate cancer with a Gleason score of 3+4 or greater.” The specification later states,” Aggressive prostate cancer may be characterized by a minimum Gleason grade or score/sum (e.g. at least 7 (e.g. 3 + 4 or 4 + 3, 5+2), or at least 8 (e.g. 4+4, 5 + 3 or 3 + 5).” The specification in the examples states, “Samples from patients diagnosed with biopsy-confirmed prostate cancer from Arm 2 of the clinical trial were used for development of models differentiating aggressive (Gleason >3+4) from non-aggressive prostate cancer patients” and “NonAgCaP: patients with non-aggressive prostate cancer defined as Gleason Score equal to 3+3 8. NOT AgCaP = No CaP + NonAgCaP 9. AgCaP: patients with aggressive prostate cancer defined as biopsy Gleason Score equal to 3+4 or higher 10” Thus the metes and bounds are unclear what is required of aggressive prostate cancer in the claim in view of the specification. The specification appears to provide multiple different interpretations of aggressive prostate cancer and non-aggressive prostate cancer based on Gleason scores, but the claim appears a comparison to the subject test score value, which does not specifically require A Gleason score. Further it is unclear from the determining step how comparison of the test subject score value to a threshold value identifies a subject as having aggressive prostate cancer. Further step c) recites, “the subject test score value.” However step b) recites “test subject score value.” Thus it is unclear if recitation in step c) is intended to find antecedent basis in step b0 or is referencing something else.
Further claim 1 recites, “the one or more analyte/s comprise or consist of.” The recitation is confusing as it provides open language of one or more then closed language. Thus the metes and bounds are confusing and unclear.
Claim 1 also recites, “in a manner that allows discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value.” The recitation suggests there is also in a manner that does not allow discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value.” The specification and claims provide no standard to differentiate in a manner that allows discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value and in a manner that does not allow discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value.” Further this is unclear due to the different standards in the specification of aggressive and non-aggressive prostate cancer.
Claim 2 recites, “non-aggressive prostate cancer.” However, the specification states, “As used herein the abbreviation "AgCaP" refers to aggressive prostate cancer defined as prostate cancer with a Gleason score of 3+4 or greater.” The specification later states,” Aggressive prostate cancer may be characterized by a minimum Gleason grade or score/sum (e.g. at least 7 (e.g. 3 + 4 or 4 + 3, 5+2), or at least 8 (e.g. 4+4, 5 + 3 or 3 + 5).” The specification in the examples states, “Samples from patients diagnosed with biopsy-confirmed prostate cancer from Arm 2 of the clinical trial were used for development of models differentiating aggressive (Gleason >3+4) from non-aggressive prostate cancer patients” and “NonAgCaP: patients with non-aggressive prostate cancer defined as Gleason Score equal to 3+3 8. NOT AgCaP = No CaP + NonAgCaP 9. AgCaP: patients with aggressive prostate cancer defined as biopsy Gleason Score equal to 3+4 or higher 10” Thus the metes and bounds are unclear what is required of aggressive prostate cancer in the claim in view of the specification. The specification appears to provide multiple different interpretations of aggressive prostate cancer and non-aggressive prostate cancer based on Gleason scores. Thus the metes and bounds are unclear.
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 1-2 and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental step or abstract and natural correlation or phenomenon. The claim(s) recite(s) the abstract idea or mental steps of applying and determining. .The applying step use data from naturally occurring analytes or clinical variables to generate a test subject score value. The determining step is a mental step which requires a comparison. This judicial exception is not integrated into a practical application because there are no steps which depend from or otherwise integrate the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as the claim provides no specific reagents.
Claim analysis
The instant claim 1 is directed towards a method for diagnosing aggressive prostate cancer (CaP) in a test subject, comprising: (a) obtaining an analyte level for one or more analytes in the test subject's biological sample, and obtaining a measurement of one or more clinical variables from the test subject; and (b) applying a suitable algorithm and/or transformation to a combination of the clinical variable measurements and analyte level/s of the test subject to thereby generate a test subject score value for comparison to a threshold value; and (c) determining whether the test subject has aggressive CaP by comparison of the subject test score value and the threshold value, wherein: the one or more analyte/s comprise or consist of WAP four-disulfide core domain protein 2 (WFDC2 (HE4)), and optionally total prostate specific antigen (PSA), the one or more clinical variables comprise at least one of: %Free PSA, DRE, Prostate Volume (PV) and the threshold value was determined by: measuring said one or more analyte/s in a series of biological samples obtained from a population of subjects having aggressive CaP and from a population of control subjects not having aggressive CaP, to thereby obtain an analyte level for each said analyte in each said biological sample of the series; combining each said analyte level of the series with measurements of said one or more clinical variables obtained from each said subject of the populations, in a manner that allows discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value...
The applying step is taking naturally occurring phenomenon of clinical values and analytes. The applying step uses an algorithm or transformation which is a mental step, abstract idea. The comparing in the determining step is a mental step or abstract idea. Further the obtaining analyte level and obtaining analyte levels broadly encompass getting data from a lab report.
.
Dependent claims set forth further limitations to about control groups.
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, abstract idea and law of nature or natural phenomena.
With regards to claim 1, the claim recites, “a) obtaining an analyte level for one or more analytes in the test subject's biological sample, and obtaining a measurement of one or more clinical variables from the test subject; and (b) applying a suitable algorithm and/or transformation to a combination of the clinical variable measurements and analyte level/s of the test subject to thereby generate a test subject score value for comparison to a threshold value; and (c) determining whether the test subject has aggressive CaP by comparison of the subject test score value and the threshold value, wherein: the one or more analyte/s comprise or consist of WAP four-disulfide core domain protein 2 (WFDC2 (HE4)), and optionally total prostate specific antigen (PSA), the one or more clinical variables comprise at least one of: %Free PSA, DRE, Prostate Volume (PV) and the threshold value was determined by: measuring said one or more analyte/s in a series of biological samples obtained from a population of subjects having aggressive CaP and from a population of control subjects not having aggressive CaP, to thereby obtain an analyte level for each said analyte in each said biological sample of the series; combining each said analyte level of the series with measurements of said one or more clinical variables obtained from each said subject of the populations, in a manner that allows discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value.” All of these can be considered mental steps or abstract ideas. The claim are drawn to the natural correlation of analytes and clinical values with aggressive prostate cancer.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the claims provide no limitations which depend or otherwise integrate the judicial exception..
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No, the claim has no active step which explicitly require analysis of a sample.
If the obtain step of claim 1 is considered an active step. The specification teaches:
Data from 22 of the 32 analytes measured using the 3-Plex and 29-Plex Luminex panels was used for analysis. - 22 analytes: VEGF, G-CSF, Glypican-1, NT-proANP, Kallikrein 3, HGF, VEGF-C, Tie- 2, VEGF R2/KDR/Flk-1, ErbB2/Her2, CXCL13.BLC.BCA-1, IL-7, WFDC2 (HE4), MADCAM-1, Leptin, CD40L, IL-18, IL.6.R.Alpha, uPA.Urokinase, PDGF.AB, osteopontin, mesothelin. Thus the claim does not provide additional steps which are significantly more.
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.
Claim(s) 1-2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fuksenko (US 20190027249), Walz (Cancer (2018) volume 113, pages 2695-), . T Fox Chase cancer center (Prostate Cancer: The Gleason Score Explained July 26, 2018)
Fuksenko teaches, “The present invention relates to systems and methods for improving the accuracy of disease diagnosis and to associated diagnostic tests involving the correlation of measured analytes with binary outcomes (e.g., not-disease or disease), as well as higher-order outcomes (e.g., one of several phases of a disease). Methods of the present invention use biomarker sets, preferably those with orthogonal functionality, to obtain concentration and proximity score values for disease and non-disease states. The biomarker a set's proximity scores are graphed on an orthogonal grid, with one dimension for each biomarker. The proximity scores and orthogonal gridding is then used to calculate a disease state or non-disease state diagnosis for the patient.” Fukensko teaches,” [0003] The present invention relates to systems and methods for improving the accuracy of disease diagnosis and to associated diagnostic tests involving the correlation of measured analytes with binary outcomes (e.g., not-disease or disease), as well as higher-order outcomes (e.g., one of several phases of a disease).” Fuksenko teaches, “[0078] “Training Set Model” is an algorithm or group of algorithms constructed from the training set that allows assessment of blind samples regarding the predictive outcome as to the probability that a subject (or patient) has a disease or does not have the disease. The “training set model” is then used to compute the scores for blind samples for clinical and diagnostic purposes. For this purpose, a score is provided over an arbitrary range that indicates percent likelihood of disease or not-disease or some other predetermined indicator readout preferred by a healthcare provider who is developing a diagnosis for a patient.” Fuksenko teaches, “HE 4 is far better than PSA for prostate cancer in men. Yet they are not good enough for regulatory approval for screening. Even the combination of the two is not effective. Note that the single biomarker is relatively good for both. CA 125 will achieve about 50% specificity at 90% sensitivity. HE 4 will achieve about 45% specificity at 90% sensitivity. “ (0162) Fuksenko teaches, “he second case has been used where the population distribution is closer to the training set distribution (e.g., aggressive/non-aggressive prostate cancer).” (0208)
Fuksenko does not specifically the use of %free PSA.
However, Walz teaches , “Of all, 23% had prostate cancer on biopsy, 16.5% of patients treated with radical prostatectomy had pT3 stage, and 35.6% had a pathological Gleason score of 3 1 4 or higher. The most accurate predictor of prostate cancer on biopsy was percent free PSA (0.68) versus age (0.50), total PSA (0.57), or rectal ex-amination findings (0.58). Of patients with percent free PSA below 14%, 59% had prostate cancer. In multivariate models, percent free PSA (P < .001) and rectal ex-amination findings (P 5 .001) were the only independent predictors of prostate cancer. The combined AUC of all predictors (0.69) was no” t significantly (P 5 .7)higher than that of percentage of free PSA alone (0.68) (abstract) Walz teaches, “The novelty of our findings resides in the identification of a biomarker, which can accurately stratify the risk of prostate cancer at prostate biopsy in men with PSA values 2.5 ng/mL. The %free PSA cutoffs of 14%, 15% to 27%, and 28% can discriminate between men with probabilities of prostate cancer that differ drastically between 59% (%free PSA 14%) and 9% (%free PSA 28%, Table 4).”
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to include %free PSA in the algorithm and methods of Fuksenko to identify risk of prostate cancer using HE4 and total PSA . The artisan would be motivated as Walz teaches, “The novelty of our findings resides in the identification of a biomarker, which can accurately stratify the risk of prostate cancer at prostate biopsy in men with PSA values 2.5 ng/mL. The %free PSA cutoffs of 14%, 15% to 27%, and 28% can discriminate between men with probabilities of prostate cancer that differ drastically between 59% (%free PSA 14%) and 9% (%free PSA 28%, Table 4).” The artisan would have a reasonable expectation of success is merely using known clinical values and analytes.
With regards to claim 2, Fuksenko teaches aggressive/non-aggressive prostate cancer).” (0208)
Fuksenko and Walz do not specially teach non aggressive prostate cancer is Gleason score of 3+3.
However, Fox Chase cancer center teaches, “he pathologist who examines the cells—taken during your biopsy—will look at their patterning in the samples. Each area is graded on a scale of 1 to 5, and the two numbers are added together to get the Gleason score. If a Gleason score is written in your pathology report as 3+4=7, this means most of your tumor is grade 3 and less of it is grade 4. These numbers are then added together for a total Gleason score of 7. Grades 1 and 2 are not usually used to describe cancer —these grades are for tissue that almost looks normal and isn't considered cancerous. The lowest possible Gleason score of a cancer found in a prostate biopsy is 6—cancer with the least risk of spreading quickly. “
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to use patients with Gleason scores of 3+3 as non-aggressive. The artisan would be motivated as Fox Chase cancer center specifically teaches a Gleason score of 6 or 3+3 is not aggressive. The artisan would have a reasonable expectation of success as the artisan is merely using art recognized standard for non-aggressive prostate cancer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim1-2 and 4 rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12618843. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Instant claims are drawn to A method for diagnosing aggressive prostate cancer (CaP) in a test subject, comprising: (a) obtaining an analyte level for one or more analytes in the test subject's biological sample, and obtaining a measurement of one or more clinical variables from the test subject; and (b) applying a suitable algorithm and/or transformation to a combination of the clinical variable measurements and analyte level/s of the test subject to thereby generate a test subject score value for comparison to a threshold value; and (c) determining whether the test subject has aggressive CaP by comparison of the subject test score value and the threshold value, wherein: the one or more analyte/s comprise or consist of WAP four-disulfide core domain protein 2 (WFDC2 (HE4)), and optionally total prostate specific antigen (PSA), the one or more clinical variables comprise at least one of: %Free PSA, DRE, Prostate Volume (PV) and the threshold value was determined by: measuring said one or more analyte/s in a series of biological samples obtained from a population of subjects having aggressive CaP and from a population of control subjects not having aggressive CaP, to thereby obtain an analyte level for each said analyte in each said biological sample of the series; combining each said analyte level of the series with measurements of said one or more clinical variables obtained from each said subject of the populations, in a manner that allows discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value.
The claims of 843 are drawn to . A method for diagnosing aggressive prostate cancer (CaP) in a test subject, comprising: (a) detecting one or more analyte/s in a biological sample from the test subject to thereby obtain an analyte level for each said analyte in the test subject's biological sample, and obtaining a measurement of two or more clinical variables from the test subject; and (b) applying a suitable algorithm and/or transformation to a combination of the clinical variable measurements and analyte level/s of the test subject to thereby generate a test subject score value for comparison to a threshold value; (c) determining that the test subject has aggressive CaP when the subject test score value is above the threshold value; and (d) treating the subject diagnosed with aggressive CaP with one or more of surgery, radiation, or drugs, wherein: the one or more analyte/s comprise or consist of leptin, the two or more clinical variables comprise at least two of: total prostate-specific antigen (PSA), digital rectal examination (DRE), subject age, prostate volume, and the threshold value is determined by: detecting said one or more analyte/s in a series of biological samples obtained from a population of subjects having aggressive CaP and from a population of control subjects not having aggressive CaP, to thereby obtain an analyte level for each said analyte in each said biological sample of the series; combining each of said one or more analyte levels of the series with measurements of said two or more clinical variables obtained from each said subject from the population of subjects having aggressive CaP and from each subject from the population of control subjects, in a manner that allows discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value; and wherein the two or more clinical variables and the one or more analyte/s comprise any one of the following: total PSA, prostate volume, leptin, subject age, IL-7 and VEGF; total PSA, prostate volume, leptin, subject age, IL-7, VEGF, osteopontin and CD40L; total PSA, % free PSA, prostate volume, leptin, osteopontin and HE4.WFDC2; total PSA, DRE, leptin, subject age, VEGF and IL-7; total PSA, DRE, leptin, subject age, VEGF, osteopontin; total PSA, DRE, leptin, subject age, VEGF, IL-7, GPC-1; total PSA, DRE, leptin, subject age, VEGF, osteopontin, GPC-1; total PSA, DRE, leptin, subject age, VEGF, IL-7, GPC-1, % free PSA; total PSA, DRE, leptin, subject age, VEGF, osteopontin, GPC-1, % free PSA; total PSA, DRE, leptin, subject age, prior negative biopsy, VEGF-C, osteopontin, GPC-1, CD40L, proPSA, % free PSA.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims the claims of 843 encompass the instant claims.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/Primary Examiner, Art Unit 1683
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