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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/2025 has been entered.
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 41-60 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation with no practical application and without significantly more.
Claims 41-49 recite a method of placing a subject with prostate cancer under active surveillance by detecting a pattern APPL1, SORT1, and SDC1 in a prostate tissue sample from the subject.
Claims 50-50 recite a method for selecting a subject to be treated for prostate cancer by detecting a pattern APPL1, SORT1, and SDC1 in a prostate tissue sample from the subject.
The claimed manner of detecting prostate cancer based on the biomarkers APPL1, SORT1, and SDC1 (and the Gleason scores in claims 47 and 58 using antibodies for detection in claims 59 and 60) is directed to the natural correlation discussed above.
The claimed scope of placing a subject under active surveillance and the claimed treatment steps are not significantly more than routine and conventional activity specified at a high level of generality and fail to amount to significantly more than the judicial exception.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because: the additional steps of using a reference that is a normal or benign prostate tissue (claim 42, 43, 51 and 52); and correlating with the Gleason scores (claims 47 and 58) and using antibodies for detection in claims (59 and 60) are nothing more than routine and conventional data gathering and comparison steps, i.e. insignificant extra-solution activity, and routine and conventional activity specified at a high level of generality.
Likewise, the surveillance and treatment steps are nothing more than conventional methods used to monitor for prostate cancer (even before detection) and treat prostate cancer, because they do not even require any particular application of the recited detecting step.
Accordingly, the treatment limitation does not integrate the recited judicial exception into a practical application and the claims and is therefore directed to the judicial exception.
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 54-56 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.
Each of claims 54-56 recite “the selection” in line 1. There is insufficient antecedent basis for this limitation in these claims since claim 50 from which each of claims 54-56 depend recites “the subject is selected for treatment” and does not recite a treatment selection.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 41-49 are rejected under 35 U.S.C. 103 as being unpatentable over Brooks et al. (cited by applicant) in view of Song et al. (cited by applicant), Contreras et al. (cited by applicant) and Tanimoto et al. (“The perlecan-interacting growth factor progranulin regulates ubiquitination, sorting, and lysosomal degradation of sortilin,” Matrix Biol. (2017) 64, 27–39).
Brooks et al. is directed to “METHODS FOR DETECTING PROSTATE CANCER” as set forth in the title.
Brooks et al. teaches methods of detecting prostate cancer by assessing the levels of endosomal and/or lysosomal markers Specifically in paragraph [0121] Brooks et al. teaches:
“In certain embodiments, the selected marker comprises one or more of CATHEPSIN B, CAPTHESIN D, α-GALACTOSIDASE, RAB7, LIMP-1, LIMP-2, TFR1, TFR2, STAMP2, SORT1 (SORTILIN), APPL1, EEA-1, LAMP-1, RAB4, APPL2, RAB5, RAB11, MPR, PAP, ACTIN, M6PR, IGFR2, MYO1B, PDCD6IP, SDCBP, SDC1, STX7, STX12, FGF1, FGF2, FGF3, FGFR1, FGFR2, FGFR3, NOX2, NOX4, and/or a mRNA encoding one of the aforementioned, a fragment of one of the aforementioned, a derivative of one of the aforementioned, and a processed form of one of the aforementioned.”
In paragraph [0531] Brooks et al. teaches that:
“Examples of selected markers that may be used include one or more of the following proteins or their mRNAs: CATHEPSIN B, CAPTHESIN D, α-GALACTOSIDASE, RAB7, LIMP-1, LIMP-2, TFR1, TFR2, STAMP2, SORT1 (SORTILIN), APPL1, EEA-1, LAMP-1, RAB4, APPL2, RAB5, RAB11, MPR, PAP, ACTIN, M6PR, IGFR2, MYO1B, PDCD6IP, SDCBP, SDC1, STX7, STX12, FGF1, FGF2, FGF3, FGFR1, FGFR2, FGFR3, NOX2, and NOX4.”
In paragraph [0151] Brookes et al. teaches that:
“Certain embodiments of the present disclosure comprise detecting three or more of the following selected markers: CATHEPSIN B, CAPTHESIN D, α-GALACTOSIDASE, RAB7, LIMP-1, LIMP-2, TFR1, TFR2, STAMP2, SORT1 (SORTILIN), APPL1, EEA-1, LAMP-1, RAB4, APPL2, RAB5, RAB11, MPR, PAP, ACTIN, M6PR, IGFR2, MYO1B, PDCD6IP, SDCBP, SDC1, STX7, STX12, FGF1, FGF2, FGF3, FGFR1, FGFR2, FGFR3, NOX2, NOX4 and/or a mRNA encoding one of the aforementioned, a fragment of one of the aforementioned, a derivative of one of the aforementioned, and a processed form of one of the aforementioned.”
Brooks et al. does not specifically teach using APPL1, SORT1 and SDC1 together as biomarkers.
Song et al. teaches that it is known to use APPL1 as a biomarker in detection of prostate cancer.
Contreras et al. teaches that it is known to use SDC1 as a biomarker in detection of prostate cancer.
Tanimoto et al. teaches that sortilin loss may contribute to prostate cancer progression. (page 27)
It would have been obvious to one of ordinary skill in the art to conduct routine optimization experimentation using APPL1 and SDC1 as taught by Song et al., Contreras et al. and Tanimoto et al. together with others of the biomarkers taught by Brooks et al. including SORT1 and use SORT1 together with APPL1 and SDC1 as a biomarker set for detecting prostate cancer based on the amounts of APPL1, SOFT1, and SDC1.
As for placing a subject under active surveillance after diagnosing prostate cancer, it is conventional to monitor cancer patients as taught by Books et al. in paragraph [0367]
I.) As noted above, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. teach all the elements of claim 41.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 41 obvious.
II.) Regarding applicant’s claim 42, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 41 obvious from which claim 42 depends.
Claim 42 recites that the pattern of APPL1 protein, Sortilin protein, and Syndecan-1 protein in the prostate tissue sample is determined as compared to a reference.
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have further been obvious to compare the amounts of APPL1, SORT1 and SDC1 to a reference for purposes of comparing and determining differences in the amounts of APPL1, SORT1 and SDC1 to a known baseline reference.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 42 obvious
III.) Regarding applicant’s claim 43, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 42 obvious from which claim 43 depends.
Claim 43 recites that the reference is a normal prostate tissue sample or benign prostate tissue sample.
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to compare the amounts of APPL1, SORT1 and SDC1 to a normal prostate tissue sample or benign prostate tissue sample for purposes of comparing and determining differences in the amounts of APPL1, SORT1 and SDC1 to a normal or benign reference.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 42 obvious
IV.) Regarding applicant’s claim 44, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 41 obvious from which claim 44 depends.
Claim 44 recites that the active surveillance comprises periodic prostate specific antigen testing and/or repeat biopsy.
Brooks et al. teaches that the prostate-specific antigen (PSA) test is currently used for prostate cancer screening. [0004]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al., upon detecting a subject has prostate cancer, it would have been obvious to periodically monitor the subject’s cancer using periodic prostate specific antigen testing to track progression of the cancer.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 44 obvious.
V.) Regarding applicant’s claim 45, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 41 obvious from which claim 45 depends.
Claim 45 recites that the active surveillance comprises periodic prostate specific antigen testing.
As noted above, Brooks et al. teaches that the prostate-specific antigen (PSA) test is currently used for prostate cancer screening. [0004]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al., upon detecting a subject has prostate cancer, it would have been obvious to periodically monitor the subject’s cancer using periodic prostate specific antigen testing to track progression of the cancer.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 45 obvious.
VI.) Regarding applicant’s claim 46, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 41 obvious from which claim 46 depends.
Claim 46 recites that the active surveillance comprises periodic repeat biopsy.
Brooks et al. teaches that biological samples that are examined for prostate cancer can comprises a biopsy or a tissue sample.
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. upon detecting a subject has prostate cancer, it would have been obvious to periodically monitor the subject’s cancer using periodic prostate biopsy tissue sample testing to track progression of the cancer.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 46 obvious.
V.) Regarding applicant’s claim 47, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 41 obvious from which claim 47 depends.
Claim 47 recites that the subject has a Gleason score of 2 to 6 or an ISUP grade group 1.
Brooks et al. teaches that the Gleason Grading system is used to evaluate a prostate cancer. A “score” is assigned to a prostate cancer on the basis of the combination of a “Gleason” pattern associated with various features of a tumor specimen and a subsequent grade assigned to the patterns of the tumour specimen. A Gleason score of 2-4 is considered to be a cancer of low aggressiveness. [0106]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to evaluate subjects that have Gleason scores of 2-4 or above to confirm the cancer diagnosis.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 47 obvious.
VI.) Regarding applicant’s claim 48, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 48 obvious from which claim 48 depends.
Claim 48 recites that step (i) comprises contacting the sample with an antibody that binds the APPL1 protein, an antibody that binds the Sortilin protein and an antibody that binds the Syndecan-1 protein.
Brooks et al. teaches using antibody, or an antigen binding fragment thereof, raised to a polypeptide comprising an amino acid sequence of one or more of ASNDHDAAINRYSRLSKKRENDKVKYEVTEDVYT (SED ID NO. 1), DEVASDPLYVPDPDPTKFPVNRNLTRKAGYLNARNKT (SEQ ID NO. 2), and SEGQFVVLSS SQSEESDLGE GGKKRESEA (SEQ ID NO. 3), and one or more of PNTFKTLDSWRDEFLIQASPRDPENFPFVVLGNKI (SED ID NO. 4), DPENFPFVVLGNKIDLENRQVATKRAQAWCYSKNN (SEQ ID NO. 5), ALKQETEVELYNEFPEPIKLDKNDRAKASAESCSC (SEQ ID NO. 6). [0270]. [0285]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to contact the sample with an antibody that binds the APPL1 protein, an antibody that binds the Sortilin protein and an antibody that binds the Syndecan-1 protein, in view of Brooks et al. teaching the use of such antibodies for detecting for prostate cancer.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 48 obvious.
VII.) Regarding applicant’s claim 49, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 48 obvious from which claim 49 depends.
Claim 49 recites that the antibody that binds the APPL1 protein binds to an epitope within the amino acid sequence ASSRPNQASSEG (SEQ ID NO: 1),the antibody that binds the Sortilin protein binds to an epitope within the amino acid sequence WVSKNFGGKWEEIHK (SEQ ID NO: 4), and the antibody that binds the Syndecan-1 protein binds to an epitope within the amino acid sequence EPKQANGGAYQKPTK (SEQ ID NO: 6).
As noted above, Brooks et al. teaches using antibody, or an antigen binding fragment thereof, raised to a polypeptide comprising an amino acid sequence of one or more of ASNDHDAAINRYSRLSKKRENDKVKYEVTEDVYT (SED ID NO. 1), DEVASDPLYVPDPDPTKFPVNRNLTRKAGYLNARNKT (SEQ ID NO. 2), and SEGQFVVLSS SQSEESDLGE GGKKRESEA (SEQ ID NO. 3), and one or more of PNTFKTLDSWRDEFLIQASPRDPENFPFVVLGNKI (SED ID NO. 4), DPENFPFVVLGNKIDLENRQVATKRAQAWCYSKNN (SEQ ID NO. 5), ALKQETEVELYNEFPEPIKLDKNDRAKASAESCSC (SEQ ID NO. 6). [0270]. [0285]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to contact the sample with an antibody that binds the APPL1 protein binds to an epitope within the amino acid sequence ASSRPNQASSEG (SEQ ID NO: 1),the antibody that binds the Sortilin protein binds to an epitope within the amino acid sequence WVSKNFGGKWEEIHK (SEQ ID NO: 4), and the antibody that binds the Syndecan-1 protein binds to an epitope within the amino acid sequence EPKQANGGAYQKPTK (SEQ ID NO: 6) for detecting for prostate cancer.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 49 obvious.
2. Claims 50-61 are rejected under 35 U.S.C. 103 as being unpatentable over Brooks et al. (cited by applicant) in view of Song et al. (cited by applicant) and Contreras et al. (cited by applicant).
Brooks et al. is directed to “METHODS FOR DETECTING PROSTATE CANCER” as set forth in the title.
Brooks et al. teaches methods of detecting prostate cancer by assessing the levels of endosomal and/or lysosomal markers Specifically in paragraph [0121] Brooks et al. teaches:
“In certain embodiments, the selected marker comprises one or more of CATHEPSIN B, CAPTHESIN D, α-GALACTOSIDASE, RAB7, LIMP-1, LIMP-2, TFR1, TFR2, STAMP2, SORT1 (SORTILIN), APPL1, EEA-1, LAMP-1, RAB4, APPL2, RAB5, RAB11, MPR, PAP, ACTIN, M6PR, IGFR2, MYO1B, PDCD6IP, SDCBP, SDC1, STX7, STX12, FGF1, FGF2, FGF3, FGFR1, FGFR2, FGFR3, NOX2, NOX4, and/or a mRNA encoding one of the aforementioned, a fragment of one of the aforementioned, a derivative of one of the aforementioned, and a processed form of one of the aforementioned.”
In paragraph [0531] Brooks et al. teaches that:
“Examples of selected markers that may be used include one or more of the following proteins or their mRNAs: CATHEPSIN B, CAPTHESIN D, α-GALACTOSIDASE, RAB7, LIMP-1, LIMP-2, TFR1, TFR2, STAMP2, SORT1 (SORTILIN), APPL1, EEA-1, LAMP-1, RAB4, APPL2, RAB5, RAB11, MPR, PAP, ACTIN, M6PR, IGFR2, MYO1B, PDCD6IP, SDCBP, SDC1, STX7, STX12, FGF1, FGF2, FGF3, FGFR1, FGFR2, FGFR3, NOX2, and NOX4.”
In paragraph [0151] Brookes et al. teaches that:
“Certain embodiments of the present disclosure comprise detecting three or more of the following selected markers: CATHEPSIN B, CAPTHESIN D, α-GALACTOSIDASE, RAB7, LIMP-1, LIMP-2, TFR1, TFR2, STAMP2, SORT1 (SORTILIN), APPL1, EEA-1, LAMP-1, RAB4, APPL2, RAB5, RAB11, MPR, PAP, ACTIN, M6PR, IGFR2, MYO1B, PDCD6IP, SDCBP, SDC1, STX7, STX12, FGF1, FGF2, FGF3, FGFR1, FGFR2, FGFR3, NOX2, NOX4 and/or a mRNA encoding one of the aforementioned, a fragment of one of the aforementioned, a derivative of one of the aforementioned, and a processed form of one of the aforementioned.”
Brooks et al. does not specifically teach using APPL1, SORT1 and SDC1 together as biomarkers.
Song et al. teaches that it is known to use APPL1 as a biomarker in detection of prostate cancer.
Contreras et al. teaches that it is known to use SDC1 as a biomarker in detection of prostate cancer.
It would have been obvious to one of ordinary skill in the art to conduct routine optimization experimentation using APPL1 and SDC1 as taught by Song et al., Contreras et al. and Tanimoto et al. together with others of the biomarkers taught by Brooks et al. including SORT1 and use SORT1 together with APPL1 and SDC1 as a biomarker set for detecting prostate cancer based on the amounts of APPL1, SOFT1, and SDC1.
As for selecting a subject to be treated for prostate cancer, it is conventional to treat prostate cancer upon detection as taught by Books et al. in paragraph [0002]
I.) As noted above, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. teach all the elements of claim 50.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious.
II.) Regarding applicant’s claim 51, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious from which claim 51 depends.
Claim 51 recites that the pattern of APPL1 protein, Sortilin protein, and Syndecan-1 protein in the prostate tissue sample is determined as compared to a reference.
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to compare the amounts of APPL1, SORT1 and SDC1 to a reference for purposes of comparing and determining differences in the amounts of APPL1, SORT1 and SDC1 to a known baseline reference.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 51 obvious
III.) Regarding applicant’s claim 52, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious from which claim 52 depends.
Claim 52 recites that the reference is a normal prostate tissue sample or benign prostate tissue sample.
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to compare the amounts of APPL1, SORT1 and SDC1 to a normal prostate tissue sample or benign prostate tissue sample for purposes of comparing and determining differences in the amounts of APPL1, SORT1 and SDC1 to a normal or benign reference.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 52 obvious
IV) Regarding applicant’s claim 53, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious from which claim 53 depends.
Claim 53 recites that the selection for treatment comprises initiating one or more of surgical intervention, radiation therapy and a therapeutic agent.
Brooks et al. teaches prostate cancer treatment comprising one or more of surgical intervention, radiation therapy and administration of a therapeutic agent. [0224]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. upon detecting a subject has prostate cancer, it would have been obvious to treat the subject with surgical intervention, radiation therapy and administration of a therapeutic agent as taught by Brooks et al.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 53 obvious.
V.) Regarding applicant’s claim 54, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious from which claim 54 depends.
Claim 54 recites that the selection for treatment comprises initiating surgical intervention.
As noted above, Brooks et al. teaches prostate cancer treatment comprising one or more of surgical intervention, radiation therapy and administration of a therapeutic agent. [0224]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. upon detecting a subject has prostate cancer, it would have been obvious to treat the subject with surgical intervention, radiation therapy and administration of a therapeutic agent as taught by Brooks et al.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 54 obvious.
VI.) Regarding applicant’s claim 55, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious from which claim 55 depends.
Claim 55 recites that the selection for treatment comprises initiating radiation therapy.
As noted above, Brooks et al. teaches prostate cancer treatment comprising one or more of surgical intervention, radiation therapy and administration of a therapeutic agent. [0224]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. upon detecting a subject has prostate cancer, it would have been obvious to treat the subject with surgical intervention, radiation therapy and administration of a therapeutic agent as taught by Brooks et al.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 55 obvious.
VII.) Regarding applicant’s claim 56, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious from which claim 56 depends.
Claim 56 recites that the selection for treatment comprises initiating a therapeutic agent.
As noted above, Brooks et al. teaches prostate cancer treatment comprising one or more of surgical intervention, radiation therapy and administration of a therapeutic agent. [0224]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. upon detecting a subject has prostate cancer, it would be obvious to treat the subject with surgical intervention, radiation therapy and administration of a therapeutic agent as taught by Brooks et al.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 56 obvious.
VIII.) Regarding applicant’s claim 57, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 56 obvious from which claim 56 depends.
Claim 56 recites that the therapeutic agent is selected from the group of androgen deprivation therapy (ADT), androgen receptor (AR) antagonists and chemotherapeutics.
Brooks et al. teaches that patients with low-risk cancer are typically not candidates for pelvic lymph node irradiation or androgen deprivation therapy (ADT). [0540]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. upon detecting a subject has prostate cancer, it would be obvious to treat the subject with androgen deprivation therapy as taught by Brooks et al.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 57 obvious.
IX.) Regarding applicant’s claim 58, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious from which claim 58 depends.
Claim 58 recites that the subject has a Gleason score of 7 to 10 or an ISUP grade group 2 to 5.
Brooks et al. teaches that the Gleason Grading system is used to evaluate a prostate cancer. A “score” is assigned to a prostate cancer on the basis of the combination of a “Gleason” pattern associated with various features of a tumor specimen and a subsequent grade assigned to the patterns of the tumour specimen and that a score of 7 is considered to be a score of intermediate aggressiveness and a score of 8-10 is considered to be a cancer of high aggressiveness.
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to evaluate subjects that have Gleason scores of 7-10 to confirm the cancer diagnosis.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 58 obvious.
X.) Regarding applicant’s claim 59, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 50 obvious from which claim 59 depends.
Claim 59 recites step (i) comprises contacting the sample with an antibody that binds the APPL1 protein, an antibody that binds the Sortilin protein and an antibody that binds the Syndecan-1 protein.
As noted above, Brooks et al. teaches using antibody, or an antigen binding fragment thereof, raised to a polypeptide comprising an amino acid sequence of one or more of ASNDHDAAINRYSRLSKKRENDKVKYEVTEDVYT (SED ID NO. 1), DEVASDPLYVPDPDPTKFPVNRNLTRKAGYLNARNKT (SEQ ID NO. 2), and SEGQFVVLSS SQSEESDLGE GGKKRESEA (SEQ ID NO. 3), and one or more of PNTFKTLDSWRDEFLIQASPRDPENFPFVVLGNKI (SED ID NO. 4), DPENFPFVVLGNKIDLENRQVATKRAQAWCYSKNN (SEQ ID NO. 5), ALKQETEVELYNEFPEPIKLDKNDRAKASAESCSC (SEQ ID NO. 6). [0270]. [0285]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to contact the sample with an antibody that binds the APPL1 protein, an antibody that binds the Sortilin protein and an antibody that binds the Syndecan-1 protein, in view of Brooks et al. teaching the use of such antibodies for detecting for prostate cancer.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 59 obvious.
XI.) Regarding applicant’s claim 60, as noted above Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 59 obvious from which claim 60 depends.
Claim 60 recites the antibody that binds the APPL1 protein binds to an epitope within the amino acid sequence ASSRPNQASSEG (SEQ ID NO: 1),the antibody that binds the Sortilin protein binds to an epitope within the amino acid sequence WVSKNFGGKWEEIHK (SEQ ID NO: 4), and the antibody that binds the Syndecan-1 protein binds to an epitope within the amino acid sequence EPKQANGGAYQKPTK (SEQ ID NO: 6)
As noted above, Brooks et al. teaches using antibody, or an antigen binding fragment thereof, raised to a polypeptide comprising an amino acid sequence of one or more of ASNDHDAAINRYSRLSKKRENDKVKYEVTEDVYT (SED ID NO. 1), DEVASDPLYVPDPDPTKFPVNRNLTRKAGYLNARNKT (SEQ ID NO. 2), and SEGQFVVLSS SQSEESDLGE GGKKRESEA (SEQ ID NO. 3), and one or more of PNTFKTLDSWRDEFLIQASPRDPENFPFVVLGNKI (SED ID NO. 4), DPENFPFVVLGNKIDLENRQVATKRAQAWCYSKNN (SEQ ID NO. 5), ALKQETEVELYNEFPEPIKLDKNDRAKASAESCSC (SEQ ID NO. 6). [0270]. [0285]
In Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. it would have been obvious to contact the sample with an antibody that binds the APPL1 protein binds to an epitope within the amino acid sequence ASSRPNQASSEG (SEQ ID NO: 1),the antibody that binds the Sortilin protein binds to an epitope within the amino acid sequence WVSKNFGGKWEEIHK (SEQ ID NO: 4), and the antibody that binds the Syndecan-1 protein binds to an epitope within the amino acid sequence EPKQANGGAYQKPTK (SEQ ID NO: 6) for detecting for prostate cancer.
Therefore, Brooks et al. in view of Song et al., Contreras et al. and Tanimoto et al. renders claim 60 obvious.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
The Coley Declaration under 47 CFR 1.132 promotes that using a pattern of APPL1, Sortilin and SDC1 provides technological improvements over conventional H&E-stained tissue and traditional Gleason/ISUP grading.
However, as noted above Song et al. teaches that it is known to use APPL1 as a biomarker in detection of prostate cancer, and Contreras et al. teaches that it is known to use SDC1 as a biomarker in detection of prostate cancer, and Tanimoto et al. teaches that sortilin loss may contribute to prostate cancer progression, and Brooks et al. teaches three or more biomarkers selected from a group that includes APPL1, SORT1 and SDC1.
It follows that the state of the art of prostate cancer detection has progressed to focusing on biomarkers rather than H&E-stained tissue and Gleason/ISUP grading, and the Coley Declaration does not address how the combination of APPL1 and SORT1 (with or without SDC1) is an improvement over the state of the art of prostate cancer detection using the biomarkers exemplified by Song et al, Contreras et al., Tanimoto et al. and Brooks et al.
In response to Step 2B of applicant’s arguments concerning the 35 USC 101 determination on page 11 of applicant’s remarks, the examiner notes that claim do not recite significantly more than the judicial exception, because determining prostate cancer using the biomarkers including APPL1 and SORT1 (with or without SDC1) is not unknown in the current state of the art and the surveillance and treatment protocols claimed are conventional.
Applicant has not shown that combination of APPL1 and SORT1 (with or without SDC1) is a significant improvement over other combinations of the biomarkers that are known to be useful for detecting prostate cancer.
In reference to the obviousness rejection under 35 USC 103 applicant argues that “No reference or combination thereof, teaches or suggests the specific combination od APPL1 + Sortilin + SDC1 as a preferred or promising combination for active clinical management, nor the conditional clinical decision rules.”
This argument requires SDC1 which is optionally claimed.
Further, the record does not establish that the combination of APPL1 and SORT1 (with or without SDC1) is a significant improvement over other combinations of the biomarkers that are known to be useful for detecting prostate cancer.
Further, as noted above the claimed the surveillance and treatment protocols claimed are conventional and it has not been demonstrated how their application can be improved by using the combination of APPL1 and SORT1 (with or without SDC1) to detect prostate cancer.
Conclusion
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798