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 .
Detailed Action
Summary
This is the Final Office Action based on application 18/043495 response filed 03/04/2026.
Claims 1-23 have been cancelled.
Claims 24-38 have been newly added, are pending, and have been fully considered.
Claim Objections
Claims 25-26 & 38 are objected to because of the following informalities:
With respect to Claims 25-26, in “the detecting step,” a “step,” was not referred to priorly in this claim, however it is clear that applicant means “the detecting,” from Claim 24. For simplicity’s sake, applicant should use the sample terminology throughout the claim set.
With respect to Claim 38, “the ACPP peptide,” “the CLU peptide,” “the ORM1 peptide,” “the CD97 peptide,” and “the SERPINA1,” peptide are all claimed, however these peptides were not referred to prior to this in the claim. Though it’s understood what is means here, it is possible they may want to delete, “the,”s for clarity sake.
Appropriate correction is required.
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 24-38 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.
With respect to Claim 24, the preamble is drawn towards “aggressive,” prostate cancer and the claim body is drawn towards only towards prostate cancer. This is confusing since it is not clear if applicant is concerned with prostate cancer or if instead just prostate cancer. Further, “aggressive,” is a relative term which is not defined by the claim and therefore unclear as one person would interpret differently from others. Examiner interprets it as meaning “prostate cancer,” as is in the claim body.
Further, with respect to Claim 24, step b) is drawn towards, “treating the subject with a prostate cancer,” however as subject was not identified earlier in the claim which has prostate cancer. Therefore, “the subject with prostate cancer,” fails to have proper antecedent basis as it is not clear what it refers back to.
Even further with respect to Claim 24, “SERPINA1,” which is claimed is a gene, but it is in parentheses for alpha-1anti trypsin, which is a protein. These are not the same thing though the gene encodes for the protein. Therefore, it is unclear which applicant intends to detect. The same is true for ACPP, which is claimed in parentheses which codes for prostatic acid phosphatase. PSA actually stands for prostate specific antigen, so that one is ok, but is it unclear when applicant is claiming all of the compounds if the compound in parentheses is an abbreviation, in the case of PSA, or a completely different compound as is in the other compounds listed above, so it is unclear which applicant intends to detect. Correction is required.
With respect to Claims 27-31, “the ACPP peptide,” “the CLU peptide,” “the ORM1 peptide,” “the CD97 peptide,” and “the SERPINA1,” peptide are unclear since “the,” generally refers back to something mentioned priorly in the claim. However, all of these Claims depend from Claim 24 through claims 26 and no “peptides,” are mentioned. Therefore, these terms are unclear as they fail to have proper antecedent basis.
With respect to Claim 32, “aggressive,” is a relative term which is not defined by the claim and therefore unclear as one person would interpret differently from others.
Further, with respect to Claim 32, it refers to “the detection step,” however the claim is written specifically to not include a detection step, but instead to have the biomarkers to be “has been determined,” meaning in the past, before the method starts. Therefore, “the detection step,” fails to have proper antecedent basis in the claim and it is unclear if applicant means to include a detection step or not. Therefore, it is also unclear in Claim 32, if applicant means that PRM is a required step in the claim or not, since it’s something that has already occurred.
With respect to Claims 33-37, “the ACPP peptide,” “the CLU peptide,” “the ORM1 peptide,” “the CD97 peptide,” and “the SERPINA1,” peptide are unclear since “the,” generally refers back to something mentioned priorly in the claim. However, all of these Claims depend from Claim 24 through claims 26 and no “peptides,” are mentioned. Therefore, these terms are unclear as they fail to have proper antecedent basis.
With respect to Claim 38, “aggressive,” is a relative term which is not defined by the claim and therefore unclear as one person would interpret differently from others.
Further, with respect to Claim 38, step iii) and step iv) list the same compound, “the ORM1 peptide shown in SEQ ID NO: 5.” It is unclear what applicant means here.
Claims 25-26 are rejected by virtue of their dependency on an unclear claim.
Even further with respect to Claim 38, the preamble of the claim states that the method is performed “to detect a decreased level of ACPP and PSA….” but it is not clear if one actually does in fact detect a decreased level or not.
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 ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title.
The claimed invention of Claims 24-38 are directed to non-statutory subject matter.
Through 101, inquiry:
Inquiry: Are the claims directed to a statutory category of invention?
Yes, independent Claims 24 & 32 and all claims depending therefrom are drawn towards a statutory category (a method).
Step 2A, Prong 1: Do the claims involve a Judicial Exception?
Yes, independent Claim 24 and those that depend therefrom are drawn towards “a method of treating,” however the claimed treating is done based on detection of the claimed biomarkers in a patient either suspected as having or having prostate cancer or having prostate cancer, in comparison to a control.
This comparison, “relative to,” is the judicial exception of an abstract idea/mental process or math, which is a judicial exception.
Further, though the term “diagnosis,” isn’t used, it is implicitly in the claim as the preamble is drawn towards a method for “treating aggressive prostate cancer,” and seemingly the only way to identify in the claim if there is aggressive prostate cancer or not is to diagnose it, based on the comparison of the claimed biomarkers to a control.
The diagnosis is a law of nature judicial exception which is the natural correlation of the level of measured biomarker and it’s correlation with the presence or absence of the disease prostate cancer or aggressive prostate cancer.
See USPTO subject matter eligibility example 29 & See MPEP 2106.04.
For independent Claim 32—as noted in the 112 (b) issues with the claim and with respect to whether a detection step is required or not and then therefore a comparison step. If the claim is only drawn towards treating, without other steps, a 101 rejection would not be made--- however as this is unclear, it carries the same analysis as for Claim 24 and therefore is rejected under 101, for the same reasons as Claim 24.
For independent Claim 38, it is drawn towards “identifying,” which is a mental process/abstract idea judicial exception. The identifying is done to determine “aggressive prostate cancer,” so this is also claiming a diagnosis, though the word is not used, it is still implicitly there and therefore this is a law of nature/natural correlation judicial exception. Further the determining is done by performing a PRM assay to level levels of ACPP and PSA, and CLU, ORM1, CD97, and SERPINA1, and the detected levels identify if the subject has cancer or not in comparison to a control. Therefore, it carries the same analysis as for Claim 24. The SEQ IDs claimed as just further specification on what the biomarker is for the natural correlation.
Step 2A, Prong 2: Has the natural correlation or abstract idea been integrated into a particular practical application?
In Claim 24, there is no particular practical application.
The claimed detecting of the biomarker is done to gather data to use the judicial exception. This is insignificant extra solution activity and therefore does not practically apply. See. MPEP 2106.05 (g).
Further—the claimed treating or treatment can be with, “a prostate cancer therapy comprising one or more of prostatectomy, radiation therapy, cryotherapy, hormone therapy, chemotherapy, and immunotherapy.” As the claimed level of generality, these treatments are not considered to be particular practical application or treatment.
The claimed treatment is akin to claiming, “administering a suitable medication,” since, “radiation therapy, cryotherapy, hormone therapy, chemotherapy, and immunotherapy,” are used in many instances, not specific to prostate cancer.” Further, things like at least, “cryotherapy,” and “prostatectomy,” are other procedures and not necessarily treatments. Therefore, this does not practically apply the judicial exceptions. As claimed, the treatments seem akin to “administering a suitable medication,” or treatment. See MPEP 2016.04 (d)(2):
“Consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way.”
For independent Claim 32—as noted in the 112 (b) issues with the claim and with respect to whether a detection step is required or not and then therefore a comparison step. If the claim is only drawn towards treating, without other steps, a 101 rejection would not be made--- however as this is unclear, it carries the same analysis as for Claim 32 and therefore is rejected under 101, for the same reasons as Claim 24.
Claim 38 also carries the same analysis as for Claim 24 for the reasons shown above.
Step 2B: Do the claims recite any elements which are significantly more than the natural correlation or abstract idea?
Claim 24 is not significantly more than the judicial exceptions.
The detecting is insignificant extra solution activity as shown above.
The claimed treating is well understood routine and conventional (WURC) in the art as shown below. This is evidenced by the prior art shown in the rejection below.
Therefore, as claimed, the independent claims is standard laboratory technique and is not sufficient to show an improvement in technology or add significantly more. See MPEP 2106.05 (a) & MPEP 2106.05 (d).
For independent Claim 32—as noted in the 112 (b) issues with the claim and with respect to whether a detection step is required or not and then therefore a comparison step. If the claim is only drawn towards treating, without other steps, a 101 rejection would not be made--- however as this is unclear, it carries the same analysis as for Claim 32 and therefore is rejected under 101, for the same reasons as Claim 24.
Claim 38 also carries the same analysis as for Claim 24 for the reasons shown above.
The dependent claims are reviewed for additional limitations dependent on the independent claim above.
Claims 25-26 make more specifications on the detection method used. At the level of generality claimed however in the claims, this still amounts to just performing a general data pull/data gathering to perform the judicial exceptions and therefore does not practically apply at step 2A, 2. Further, both mass spectrometry and PRM are WURC so do not add significantly more since all these techniques are WURC at step 2B.
Claims 27-31 & 33-37 specify biomarker/s that are detected. This (including the SEQ ID compounds) is still part of the judicial exception of a natural correlation/law of nature itself and part of the abstract idea comparison. Further- these SEQ IDS are naturally occurring compounds. Therefore, there is nothing additional claimed which practically applies at Step 2A, 2 or at Step 2B.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 24-25 are rejected under 35 U.S.C. 103 as being obvious by MATUSIK in US 20140308202 in view of MILLS in US 20180267044.
With respect to Claim 24, MATUSIK teaches of methods of assessing prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detection of ACPP (paragraph 0085, Table 1-2, 8-11), in a sample that can be urine (paragraph 0197) and of detecting PSA (paragraph 0040). MATUSIK also teaches of detecting SERPINA (Table 5). MATUSIK further teaches of detecting serum PSA (paragraph 0046), and of using the methods to distinguish severe or aggressive prostatic cancer (paragraph 0007, 0010, 0031, 0032). MATUSIK teaches of detecting elevated or decreased or increased expression or different levels of these compounds and associating them with the state or metastasis/aggressiveness of cancer (paragraph 0040, Claim 1), which reads on the instantly claimed detecting for levels of decrease levels of some biomarkers and increased levels of other biomarkers.
MATUSIK teaches of treating with chemotherapy which is one of the claimed treatments (paragraph 0010).
MATUSIK do not specifically teach of detecting ORM1, CD97, or clusterin however the instant claim only requires that the levels of ACPP and PSA and one of the other claims biomarkers of which SERPINA (which includes SERPINA1) is taught.
Though MATUSIK teaches of using controls (paragraph 0260), if explicit comparison to a control is not clear from this, MILLS is used to remedy this.
MILLS teaches of a method comprising measuring by method of immunoassay (ELISA) or mass spectrometry of biomarker levels in samples of urine, blood, serum with a patient with a risk of prostate gland cancer. It is disclosed that elevated levels of LRG1 correlate with risk of death due to prostate cancer, i.e., with aggressive prostate cancer. Further, the PSA level is estimated. MILLS also teaches of detecting levels above or below median being indicative of disease in comparison to a control (paragraph 0100, paragraph 0008, 0024, 0059, 0079). MILLS teaches of the treatment being chemotherapy or endocrine therapy or radiotherapy (paragraphs 0008, 0012,0032-0039, 0046, 0050, example 1, fig. 1). MILLS also teaches of correlating measured values with PSA detection (paragraph 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to compare all detected biomarkers to controls as is done in MILLS in the method of MATUSIK due to the advantage a panel of multiple biomarkers offers for being optimal for diagnostic abilities and due to the advantage controls have for indicating whether there is increased cancer risk (MILLS, paragraph 0005, Claim 43).
With respect to Claim 25, MATUSIK teaches of detection by mass spectrometry (paragraph 0010).
Claims 32, 26-27, 31, 33, 37-38 are rejected under 35 U.S.C. 103 as being obvious by MATUSIK in US 20140308202 in view of MILLS in US 20180267044 and further in view of BOUTROS in WO 2017/190218.
With respect to Claim 32, MATUSIK teaches of methods of assessing and treating prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detection of ACPP (paragraph 0085, Table 1-2, 8-11), in a sample that can be urine (paragraph 0197) and of detecting PSA (paragraph 0040). MATUSIK also teaches of detecting SERPINA (Table 5). MATUSIK further teaches of detecting serum PSA (paragraph 0046), and of using the methods to distinguish severe or aggressive prostatic cancer (paragraph 0007, 0010, 0031, 0032). MATUSIK teaches of detecting elevated or decreased or increased expression or different levels of these compounds and associating them with the state or metastasis/aggressiveness of cancer (paragraph 0040, Claim 1), which reads on the instantly claimed detecting for levels of decrease levels of some biomarkers and increased levels of other biomarkers.
MATUSIK teaches of treating with chemotherapy which is one of the claimed treatments (paragraph 0010).
MATUSIK do not specifically teach of detecting ORM1, CD97, or clusterin however the instant claim only requires that the levels of ACPP and PSA and one of the other claims biomarkers of which SERPINA (which includes SERPINA1) is taught.
Though MATUSIK teaches of using controls (paragraph 0260), if explicit comparison to a control is not clear from this, MILLS is used to remedy this.
MILLS teaches of a method comprising measuring by method of immunoassay (ELISA) or mass spectrometry of biomarker levels in samples of urine, blood, serum with a patient with a risk of prostate gland cancer. It is disclosed that elevated levels of LRG1 correlate with risk of death due to prostate cancer, i.e., with aggressive prostate cancer. Further, the PSA level is estimated. MILLS also teaches of detecting levels above or below median being indicative of disease in comparison to a control (paragraph 0100, paragraph 0008, 0024, 0059, 0079). MILLS teaches of the treatment being chemotherapy or endocrine therapy or radiotherapy (paragraphs 0008, 0012,0032-0039, 0046, 0050, example 1, fig. 1). MILLS also teaches of correlating measured values with PSA detection (paragraph 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to compare all detected biomarkers to controls as is done in MILLS in the method of MATUSIK due to the advantage a panel of multiple biomarkers offers for being optimal for diagnostic abilities and due to the advantage controls have for indicating whether there is increased cancer risk (MILLS, paragraph 0005, Claim 43).
MATUSIK and MILLS do not teach of detection by a PRM/parallel reaction monitoring assay.
BOUTROS is used to remedy this and teaches of a method for diagnosis of prostate cancer (abstract). BOUTROS further teaches of detection of biomarkers using a parallel reaction monitoring (PRM) assay mass spectrometry ( Page 19, last paragraph and Page 20, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to perform parallel reaction monitoring as is done in BOUTROS in the methods of MATUSIK and MILLS due to the advantage it offers for targeted quantification (Page 20, first paragraph).
With respect to Claim 26, MATUSIK and MILLS teach of the invention as shown above for Claim 25. They do not teach of the use of PRM.
BOUTROS is used to remedy this and teaches of a method for diagnosis of prostate cancer (abstract). BOUTROS further teaches of detection of biomarkers using a parallel reaction monitoring (PRM) assay mass spectrometry (Page 19, last paragraph and Page 20, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to perform parallel reaction monitoring as is done in BOUTROS in the methods of MATUSIK and MILLS due to the advantage it offers for targeted quantification (Page 20, first paragraph).
With respect to Claim 27, MATUSIK teaches of methods of assessing prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detection expression of ACPP (paragraph 0085, Table 1-2, 8-11), and that the expression can include assessing protein expression (paragraph 0010) (which would inherently include the expression of SEQ ID NO: 1 claimed, as it is a natural compound. See Claim 32 and 26 rejection for the teaching of PRM.
With respect to Claim 31, MATUSIK teaches of methods of assessing prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detecting SERPINA expression (Table 5), and that the expression can include assessing protein expression (paragraph 0010) (which would inherently include the expression of SEQ ID NO: 26 claimed, as it is a natural compound. See Claim 32 and 26 for rejection for the teaching of PRM.
With respect to Claim 33, MATUSIK teaches of methods of assessing prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detection expression of ACPP (paragraph 0085, Table 1-2, 8-11), and that the expression can include assessing protein expression (paragraph 0010) (which would inherently include the expression of SEQ ID NO: 1 claimed, as it is a natural compound. See Claim 32 rejection for the teaching of PRM.
With respect to Claim 37, MATUSIK teaches of methods of assessing prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detecting SERPINA expression (Table 5), and that the expression can include assessing protein expression (paragraph 0010) (which would inherently include the expression of SEQ ID NO: 26 claimed, as it is a natural compound. See Claim 32 rejection for the teaching of PRM.
With respect to Claim 38, MATUSIK teaches of methods of assessing and treating prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detection of ACPP (paragraph 0085, Table 1-2, 8-11), in a sample that can be urine (paragraph 0197) and of detecting PSA (paragraph 0040). MATUSIK also teaches of detecting SERPINA (Table 5). MATUSIK further teaches of detecting serum PSA (paragraph 0046), and of using the methods to distinguish severe or aggressive prostatic cancer (paragraph 0007, 0010, 0031, 0032). MATUSIK teaches of detecting elevated or decreased or increased expression or different levels of these compounds and associating them with the state or metastasis/aggressiveness of cancer (paragraph 0040, Claim 1), which reads on the instantly claimed detecting for levels of decrease levels of some biomarkers and increased levels of other biomarkers.
MATUSIK teaches of treating with chemotherapy which is one of the claimed treatments (paragraph 0010).
MATUSIK do not specifically teach of detecting ORM1, CD97, or clusterin however the instant claim only requires that the levels of ACPP and PSA and one of the other claims biomarkers of which SERPINA (which includes SERPINA1) is taught.
Though MATUSIK teaches of using controls (paragraph 0260), if explicit comparison to a control is not clear from this, MILLS is used to remedy this.
MILLS teaches of a method comprising measuring by method of immunoassay (ELISA) or mass spectrometry of biomarker levels in samples of urine, blood, serum with a patient with a risk of prostate gland cancer. It is disclosed that elevated levels of LRG1 correlate with risk of death due to prostate cancer, i.e., with aggressive prostate cancer. Further, the PSA level is estimated. MILLS also teaches of detecting levels above or below median being indicative of disease in comparison to a control (paragraph 0100, paragraph 0008, 0024, 0059, 0079). MILLS teaches of the treatment being chemotherapy or endocrine therapy or radiotherapy (paragraphs 0008, 0012,0032-0039, 0046, 0050, example 1, fig. 1). MILLS also teaches of correlating measured values with PSA detection (paragraph 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to compare all detected biomarkers to controls as is done in MILLS in the method of MATUSIK due to the advantage a panel of multiple biomarkers offers for being optimal for diagnostic abilities and due to the advantage controls have for indicating whether there is increased cancer risk (MILLS, paragraph 0005, Claim 43).
MATUSIK and MILLS do not teach of detection by a PRM/parallel reaction monitoring assay.
BOUTROS is used to remedy this and teaches of a method for diagnosis of prostate cancer (abstract). BOUTROS further teaches of detection of biomarkers using a parallel reaction monitoring (PRM) assay mass spectrometry ( Page 19, last paragraph and Page 20, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to perform parallel reaction monitoring as is done in BOUTROS in the methods of MATUSIK and MILLS due to the advantage it offers for targeted quantification (Page 20, first paragraph).
Claims 30 & 36 are rejected under 35 U.S.C. 103 as being obvious by MATUSIK in US 20140308202 in view of MILLS in US 20180267044 in further in view of BOUTROS in WO 2017/190218 and further in view of DAVIS in WO 2010080702.
With respect to Claims 30 & 36, MATUSIK teaches of methods of assessing prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detection of ACPP (paragraph 0085, Table 1-2, 8-11), in a sample that can be urine (paragraph 0197) and of detecting PSA (paragraph 0040). MATUSIK also teaches of detecting SERPINA (Table 5). MATUSIK further teaches of detecting serum PSA (paragraph 0046), and of using the methods to distinguish severe or aggressive prostatic cancer (paragraph 0007, 0010, 0031, 0032). MATUSIK teaches of detecting elevated or decreased or increased expression or different levels of these compounds and associating them with the state or metastasis/aggressiveness of cancer (paragraph 0040, Claim 1), which reads on the instantly claimed detecting for levels of decrease levels of some biomarkers and increased levels of other biomarkers.
MATUSIK teaches of treating with chemotherapy which is one of the claimed treatments (paragraph 0010).
Though MATUSIK teaches of using controls (paragraph 0260), if explicit comparison to a control is not clear from this, MILLS is used to remedy this.
MILLS teaches of a method comprising measuring by method of immunoassay (ELISA) or mass spectrometry of biomarker levels in samples of urine, blood, serum with a patient with a risk of prostate gland cancer. It is disclosed that elevated levels of LRG1 correlate with risk of death due to prostate cancer, i.e., with aggressive prostate cancer. Further, the PSA level is estimated. MILLS also teaches of detecting levels above or below median being indicative of disease in comparison to a control (paragraph 0100, paragraph 0008, 0024, 0059, 0079). MILLS teaches of the treatment being chemotherapy or endocrine therapy or radiotherapy (paragraphs 0008, 0012,0032-0039, 0046, 0050, example 1, fig. 1). MILLS also teaches of correlating measured values with PSA detection (paragraph 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to compare all detected biomarkers to controls as is done in MILLS in the method of MATUSIK due to the advantage a panel of multiple biomarkers offers for being optimal for diagnostic abilities and due to the advantage controls have for indicating whether there is increased cancer risk (MILLS, paragraph 0005, Claim 43).
MATUSIK and MILLS do not teach of using PRM.
MATUSIK and MILLS do not teach of detection by a PRM/parallel reaction monitoring assay.
BOUTROS is used to remedy this and teaches of a method for diagnosis of prostate cancer (abstract). BOUTROS further teaches of detection of biomarkers using a parallel reaction monitoring (PRM) assay mass spectrometry ( Page 19, last paragraph and Page 20, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to perform parallel reaction monitoring as is done in BOUTROS in the methods of MATUSIK and MILLS due to the advantage it offers for targeted quantification (Page 20, first paragraph).
MATUSIK, MILLS, and BOUTROS do not specifically teach of detecting CD97.
DAVIS is used to remedy this. DAVIS further teaches of a method of profiling for a patient that has prostate cancer (abstract). DAVIS further teaches of detecting CD97 in comparison to a control (Table 1, Table 8) (which would inherently include the expression of SEQ ID NO: 42 claimed, as it is a natural compound. See Claim 32 rejection for the teaching of PRM.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect CD97 as is done in DAVIS in the methods of MATUSIK, MILLS, and BOUTROS due to the need in the art for biomarkers to diagnose aggressive from benign disease in prostate cancer and the advantage the biomarkers in DAVIS shown to this affect (Table 1, Table 8, Page 2, last paragraph, Page 3, first paragraph 1-2).
Claims 28 & 34 are rejected under 35 U.S.C. 103 as being obvious by MATUSIK in US 20140308202 in view of MILLS in US 20180267044 and further in view of BOUTROS in WO 2017/190218 and further in view of AEBERSOLD in US 20070269895.
With respect to Claim 28 & 34, MATUSIK teaches of methods of assessing and treating prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detection of ACPP (paragraph 0085, Table 1-2, 8-11), in a sample that can be urine (paragraph 0197) and of detecting PSA (paragraph 0040). MATUSIK also teaches of detecting SERPINA (Table 5). MATUSIK further teaches of detecting serum PSA (paragraph 0046), and of using the methods to distinguish severe or aggressive prostatic cancer (paragraph 0007, 0010, 0031, 0032). MATUSIK teaches of detecting elevated or decreased or increased expression or different levels of these compounds and associating them with the state or metastasis/aggressiveness of cancer (paragraph 0040, Claim 1), which reads on the instantly claimed detecting for levels of decrease levels of some biomarkers and increased levels of other biomarkers.
MATUSIK teaches of treating with chemotherapy which is one of the claimed treatments (paragraph 0010).
MATUSIK do not specifically teach of detecting ORM1, CD97, or clusterin however the instant claim only requires that the levels of ACPP and PSA and one of the other claims biomarkers of which SERPINA (which includes SERPINA1) is taught.
Though MATUSIK teaches of using controls (paragraph 0260), if explicit comparison to a control is not clear from this, MILLS is used to remedy this.
MILLS teaches of a method comprising measuring by method of immunoassay (ELISA) or mass spectrometry of biomarker levels in samples of urine, blood, serum with a patient with a risk of prostate gland cancer. It is disclosed that elevated levels of LRG1 correlate with risk of death due to prostate cancer, i.e., with aggressive prostate cancer. Further, the PSA level is estimated. MILLS also teaches of detecting levels above or below median being indicative of disease in comparison to a control (paragraph 0100, paragraph 0008, 0024, 0059, 0079). MILLS teaches of the treatment being chemotherapy or endocrine therapy or radiotherapy (paragraphs 0008, 0012,0032-0039, 0046, 0050, example 1, fig. 1). MILLS also teaches of correlating measured values with PSA detection (paragraph 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to compare all detected biomarkers to controls as is done in MILLS in the method of MATUSIK due to the advantage a panel of multiple biomarkers offers for being optimal for diagnostic abilities and due to the advantage controls have for indicating whether there is increased cancer risk (MILLS, paragraph 0005, Claim 43).
MATUSIK and MILLS do not teach of detection by a PRM/parallel reaction monitoring assay.
BOUTROS is used to remedy this and teaches of a method for diagnosis of prostate cancer (abstract). BOUTROS further teaches of detection of biomarkers using a parallel reaction monitoring (PRM) assay mass spectrometry ( Page 19, last paragraph and Page 20, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to perform parallel reaction monitoring as is done in BOUTROS in the methods of MATUSIK and MILLS due to the advantage it offers for targeted quantification (Page 20, first paragraph).
MATUSIK, MILLS, and BOUTROS do not teach of detecting CLU (clusterin).
AEBERSOLD is used to remedy this and teaches of detecting glycoproteins in a sample (abstract) and further teaches of detection for prostate cancer (paragraph 0011). They further teach of detecting clusterin (paragraph 0208) which would inherently include the expression of SEQ ID NO: 3 claimed, as it is a natural compound.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect clusterin as is done in AEBERSOLD in the methods of MATUSIK, MILLS, and BOUTROS and AEBERSOLD due to the advantage analysis of complex and complete protein samples offers for quantitative proteomics (paragraph 0012).
Claims 29 & 35 are rejected under 35 U.S.C. 103 as being obvious by MATUSIK in US 20140308202 in view of MILLS in US 20180267044 and further in view of BOUTROS in WO 2017/190218 and further in view of JOOSS in US 20080279831.
With respect to Claim 29 & 35, MATUSIK teaches of methods of assessing and treating prostate cancer in subjects suspected of having prostate cancer(abstract), which includes detection of ACPP (paragraph 0085, Table 1-2, 8-11), in a sample that can be urine (paragraph 0197) and of detecting PSA (paragraph 0040). MATUSIK also teaches of detecting SERPINA (Table 5). MATUSIK further teaches of detecting serum PSA (paragraph 0046), and of using the methods to distinguish severe or aggressive prostatic cancer (paragraph 0007, 0010, 0031, 0032). MATUSIK teaches of detecting elevated or decreased or increased expression or different levels of these compounds and associating them with the state or metastasis/aggressiveness of cancer (paragraph 0040, Claim 1), which reads on the instantly claimed detecting for levels of decrease levels of some biomarkers and increased levels of other biomarkers.
MATUSIK teaches of treating with chemotherapy which is one of the claimed treatments (paragraph 0010).
MATUSIK do not specifically teach of detecting ORM1, CD97, or clusterin however the instant claim only requires that the levels of ACPP and PSA and one of the other claims biomarkers of which SERPINA (which includes SERPINA1) is taught.
Though MATUSIK teaches of using controls (paragraph 0260), if explicit comparison to a control is not clear from this, MILLS is used to remedy this.
MILLS teaches of a method comprising measuring by method of immunoassay (ELISA) or mass spectrometry of biomarker levels in samples of urine, blood, serum with a patient with a risk of prostate gland cancer. It is disclosed that elevated levels of LRG1 correlate with risk of death due to prostate cancer, i.e., with aggressive prostate cancer. Further, the PSA level is estimated. MILLS also teaches of detecting levels above or below median being indicative of disease in comparison to a control (paragraph 0100, paragraph 0008, 0024, 0059, 0079). MILLS teaches of the treatment being chemotherapy or endocrine therapy or radiotherapy (paragraphs 0008, 0012,0032-0039, 0046, 0050, example 1, fig. 1). MILLS also teaches of correlating measured values with PSA detection (paragraph 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to compare all detected biomarkers to controls as is done in MILLS in the method of MATUSIK due to the advantage a panel of multiple biomarkers offers for being optimal for diagnostic abilities and due to the advantage controls have for indicating whether there is increased cancer risk (MILLS, paragraph 0005, Claim 43).
MATUSIK and MILLS do not teach of detection by a PRM/parallel reaction monitoring assay.
BOUTROS is used to remedy this and teaches of a method for diagnosis of prostate cancer (abstract). BOUTROS further teaches of detection of biomarkers using a parallel reaction monitoring (PRM) assay mass spectrometry ( Page 19, last paragraph and Page 20, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to perform parallel reaction monitoring as is done in BOUTROS in the methods of MATUSIK and MILLS due to the advantage it offers for targeted quantification (Page 20, first paragraph).
MATUSIK, MILLS, and BOUTROS do not teach of detecting ORM1.
JOOSS is used to remedy this and teaches of detecting prostate cancer (abstract) and further teaches of detection of ORM1 (paragraph 0168, 0176), which would inherently include the expression of SEQ ID NO: 5 claimed, as it is a natural compound.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect ORM1 as is done in JOOSS in the methods of MATUSIK, MILLS, and BOUTROS due to the advantage the biomarkers in JOOS offer in providing an immune response indication (paragraphs 0009-0014).
Response to Arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive.
In response dated 03/04/2026, applicant cancelled all of the prior pending claims and submitted a completely new set of claims. Therefore, the rejections are made for the reasons shown above. Applicant’s instant arguments do not apply to the current grounds of rejection, since completely new claims were filed 03/04/2026.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758