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 Non-Final Office Action based on application 16/469337 RCE filed 10/21/2025.
Claims 1, 11, 14, 20, 27, & 30-39, 41 have been examined and fully considered.
Claims 2-10, 12-13, 21-26, 28-29 & 40 are cancelled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/21/2025 has been entered.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 11, 20, 27 & 32 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by STUART in AU 2007340265.
With respect to Claim 1, STUART teaches of a method for detection of biomarkers (abstract, Page 6, first-2nd paragraph), and further of detection of gene expression or of the expression of the proteins the genes encode for (Page 1, last paragraph, Page 8, last paragraph and page 9, first two paragraphs). STUART teaches that the gene detected can be MAP4(Page 82, line/row labeled 1163), and GDI1 (Page 71, row labeled 781). STUART further teaches that the detection can be by any appropriate method, including for example, detecting the quantity of mRNA transcribed from the gene or the quantity of cDNA produced from the reverse transcription of the mRNA transcribed from the gene or the quantity of the polypeptide or protein encoded by the gene (Page 298, last paragraph). STUART teaches of determining the gene expression or protein from a biological sample of a patient (Page 6, paragraph 1). Through broadest reasonable interpretation, this sample and patient is one which “may,” “suffer from Parkinson’s disease.”
With respect to Claim 11, STUART teaches of detecting NPM1 (Page 88, line/row marked as 1378), and ADAR (Page 50, line marked as 33) among other biomarkers.
With respect to Claims 20 & 32, STUART teaches of the sample being a blood sample (Page 296, paragraph 2).
With respect to Claim 27, STUART teaches that the gene detected can be MAP4(Page 82, line/row labeled 1163), and GDI1 (Page 71, row labeled 781). STUART teaches of detecting NPM1 (Page 88, line/row marked as 1378), and ADAR (Page 50, line marked as 33) among other biomarkers.
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.
Claims 33, 36-38 & 41 are rejected under 35 U.S.C. 103 as being obvious over STUART in AU 2007340265.
With respect to Claim 33, STUART teaches of a method for detection of biomarkers (abstract, Page 6, first-2nd paragraph), and further of detection of gene expression or of the expression of the proteins the genes encode for (Page 1, last paragraph, Page 8, last paragraph and page 9, first two paragraphs). STUART teaches that the gene detected can be MAP4(Page 82, line/row labeled 1163), and GDI1 (Page 71, row labeled 781). STUART further teaches that the detection can be by any appropriate method, including for example, detecting the quantity of mRNA transcribed from the gene or the quantity of cDNA produced from the reverse transcription of the mRNA transcribed from the gene or the quantity of the polypeptide or protein encoded by the gene (Page 298, last paragraph). STUART teaches of determining the gene expression or protein from a biological sample of a patient (Page 6, paragraph 1). Through broadest reasonable interpretation, this sample and patient is one which “may,” “suffer from Parkinson’s disease.”
STUART further teaches of comparing the expression signature of gene or protein to a normal (which means healthy) or control sample (Page 10, 3rd paragraph, halfway through starting with “A differentially expressed…” (Page 18, 2nd paragraph from bottom, halfway through, Page 19, last paragraph 5 & 4 lines from bottom).
STUART does not call out specifically finding decreased levels of MAP4, NPM1, or GDI1 though STUART does overall teach of monitoring for the biomarkers which are “differentially expressed,” meaning above or below, when compared to the reference. This teaching makes the claimed act of taking a sample and if the sample has a decreased level in comparison to a reference, detecting it obvious to one of ordinary skill in the art (Page 18, 2nd paragraph from bottom, halfway through, Page 19, last paragraph 5 & 4 lines from bottom). Further, detecting decreased levels of the biomarkers MAP4, NPM1, or GDI1 will depend on the sample taken.
With respect to Claim 36, STUART teaches of detecting NPM1 (Page 88, line/row marked as 1378), and ADAR (Page 50, line marked as 33) among other biomarkers.
With respect to Claims 37 & 38, STUART teaches of the sample being a blood sample (Page 296, paragraph 2).
With respect to Claim 41, STUART teaches that the gene detected can be MAP4(Page 82, line/row labeled 1163), and GDI1 (Page 71, row labeled 781). STUART teaches of detecting NPM1 (Page 88, line/row marked as 1378), and ADAR (Page 50, line marked as 33) among other biomarkers.
Claims 30-31 & 34-35 are rejected under 35 U.S.C. 103 as being obvious over STUART in AU 2007340265 in view of in view of POTASHKIN in US 20160244833.
With respect to Claims 30 & 34, STUART teaches of the claimed invention as shown above for Claims 1 & 33. STUART does not teach of the sample being taken from a patient who is aged 52 to 69 years.
POTASHKIN is used to remedy this. POTASHKIN further teaches of a method of detecting Alzheimer’s (abstract and paragraph 0003) wherein the Parkinson’s disease patient is around an age of 60 years old (paragraph 0003, & 0058-0059), which falls into the claimed range. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a patient and sample from a patient who is in a range of years around 60 years of age since Parkinson’s disease is known to affect people over the age of 60 and there is a need in the art to better diagnose during the early stages of the disease (POTASHKIN, paragraph 0003).
With respect to Claim 31 & 35, STUART teaches of the claimed invention as shown above. STUART does not teach of the Parkinson’s being sporadic Parkinson’s disease.
POTASHKIN et al. teach of methods and kits for diagnosing, prognosing, and monitoring Parkinson’s disease (title). More specifically, POTASHKIN et al. teach of methods of diagnosing Parkinson’s Disease (PD), and also of diagnosing sporadic PD (paragraphs 0007-0009, & 0003). POTASHKIN et al. further teach of identifying a common transcriptional signature in blood of PD patients, four microarray studies (Table 1) were analyzed using INMEX, a web interface for the integrative meta-analysis.
POTASHKIN et al. further teach of determining the expression levels of all the markers on Table III which include MAP4 (paragraph 0035), and performing a meta-analysis on it (paragraph 0056), and of comparison of the samples to a control to see if they are above or below the control (paragraph 0008-0012, 0025). Further, POTASHKIN et al. teach of monitoring" refers to determining the regression, progression, course and/or onset of, and/or prognoses of PD before any treatment or during treatment in order to assess the PD patient's improvement or lack thereof over time (paragraph 0046). POTASHKIN et al. also teach of comparison of the samples to control thresholds (paragraph 0008-0012, 0025, 0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to diagnose sporadic Parkinson’s as is done in POTASHKIN in the method of PAWLOWSKI due to the need in the art for a method which can help diagnose sporadic Parkinson’s disease (POTASHKIN, paragraphs 0003-0006).
Claims 14 & 39 are rejected under 35 U.S.C. 103 as being obvious over STUART in AU 2007340265 in view of in view of PAWLOWSKI in US 20150152474.
With respect to Claims 14 & 39, STUART teaches of the invention as shown above. STUART does not teach of detection by mass spectrometry and of using antibodies.
PAWLOWSKI is used to remedy this. PAWLOWSKI teaches of a method of detecting diagnostic biomarkers and of identifying phenotypes for stage or progression of disease (abstract).
PAWLOWSKI teaches that the phenotype detected can be Parkinson’s disease (paragraph 0080, 0335).
PAWLOWSKI further teaches of taking a sample from the patient who can be suspected of having a disease including Parkinson’s (Table 0001). It is noted though through broadest reasonable interpretation (BRI) any sample from any patient can be considered a subject who “may suffer from Parkinson’s disease,” “with or without,” diagnosis.
PAWLOWSKI further teaches of detecting biomarkers NPM1 and GDI1 (Table 5), and of detecting biomarker MAP4(Table 5), of monitoring the protein expression level (paragraph 0459, 0479, 0333-0335). Table 5 identifies the biomarkers, and paragraph 0479 says that the protein expression of the biomarkers can be detected/analyzed. PAWLOWSKI further teaches of monitoring the phenotype by detecting the biomarkers relative to a reference level and of looking for decreased levels of the biomarkers (paragraph 0246). PAWLOWSKI further teaches that the reference value can be from the same subject who is assessed or from a representative or healthy population not suffering from the diseases (paragraph 0247).
PAWLOWSKI even further teaches of detecting the expression by mass spectrometry and also of using ELISA and antibodies (paragraph 0444, 0445).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use mass spectrometry and antibody detection for gene or protein expression as is done in PAWLOWSKI in the method of STUART due to the advantage it offers for both qualitatively and quantitatively detecting the level of the biomarker/s (PAWLOWSKI, paragraph 0444, 0452, 0458-0459, 0478).
Response to Arguments
Applicant's arguments filed 10/21/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of prior applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Particularly, due to amendments made 10/21/2025, a new 102 reference was used for Claim 1, STUART as shown above.
All claims remain rejected.
Conclusion
All prior art used in Final action dated 03/04/2024 is still considered relevant prior art, however it if not relied upon in the instant rejection due to the significantly amended claims.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758