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
This is the Non-Final Action for application 18/277424 filed 08/16/2023 and is examined as part of the PBA program.
Claims 1-15 are pending and have been fully considered.
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 1-15 are rejected under 35 U.S.C. 103 as being obvious over ROSENQUIST in US 20030148272 in view of SHUBER in US 20120309010.
With respect to Claim 1, ROSENQUIST teaches of a method for measuring type I collagen using a sandwich immunoassay in which a single antibody specific for a particular amino acid sequence is used for detection (abstract).
ROSENQUIST further teaches that the antibody can also be used which is reactive with a peptide sequence of for collagen type I-III, but preferably for type I (paragraph 0025, 0066), and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP, so anticipating instant Claim 1.
ROSENQUIST further teaches that the type I collagen is forming in an organism as C-terminal propetide sequences and that after removal of the propeptide molecules the remaining molecules a terminal telopeptides (C-terminal) (paragraph 0053, 0032, 0068-0069).
ROSENQUIST does not teach of specifically detecting/contacting the C-terminal telopeptides with a monocloncal antibody.
SHUBER teaches of a method for detecting a target nucleic acid and/ or a target protein in a single assay (abstract). SHUBER further teaches that the biomarker which is detected can be collagen I c-terminal teleopeptide (paragraph 0030), and that monoclonal antibodies are used to bind to the sequence for the target biomarker molecules (paragraphs 0063, 0065).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect specifically the C-terminal telopeptides using monocloncal antibodies as is done in SHUBER in the method of ROSENQUIST due to the fact that C-terminal telopeptides of collagen I are known to be associated with diseases and due to the advantage that since slightly different biomarkers provide slightly different results it would be advantageous to one to screen for multiple types of the same biomarker to increase the accuracy of diagnosis (SHUBER, paragraph 0030, 0003-0005).
With respect to Claim 2, ROSENQUIST further teaches that the antibody can also be used which is reactive with a peptide sequence of for collagen type I-III, but preferably for type I (paragraph 0025, 0066), and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP. ROSENQUIST does not teach of “not,” recognizing FDFSFLP.
SHUBER is used to remedy this. SHUBER teaches of the instant claims as shown above for Claim 1. SHUBER does not teach of not recognizing FDFSFLP, but only teaches of SHUBER teaches that the biomarker which is detected can be collagen I c-terminal teleopeptide (paragraph 0030), and that monoclonal antibodies are used to bind to the sequence for the target biomarker molecules (paragraphs 0063, 0065).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect specifically the C-terminal telopeptides (not recognizing FDFSFLP) using monocloncal antibodies as is done in SHUBER in the method of ROSENQUIST due to the fact that C-terminal telopeptides of collagen I are known to be associated with diseases and due to the advantage that since slightly different biomarkers provide slightly different results it would be advantageous to one to screen for multiple types of the same biomarker to increase the accuracy of diagnosis (SHUBER, paragraph 0030, 0003-0005).
With respect to Claim 3, ROSENQUIST teaches of the antibodies being bound directly or indirectly to a label (paragraph 0068, 0080, 0082).
With respect to Claim 4, ROSENQUIST teaches of the antibodies being bound directly or indirectly to a label can be bound or conjugated to an enzyme (paragraph 0080, 0082).
With respect to Claim 5, ROSENQUIST teaches of the antibodies being bound directly or indirectly to a label can be bound or conjugated to an enzyme and of detecting (meaning there is a signal) from the label (paragraph 0080, 0082, 0084).
With respect to Claim 6, ROSENQUIST teaches of measuring a body fluid sample (paragraph 0057) such as a serum or plasma sample (paragraph 0105, 0112).
With respect to Claim 7, ROSENQUIST teaches of the sample being from a subject with cancer (paragraph 0074), but does not teach of one of the claims cancers nor of metastasis to the bones.
SHUBER is used to remedy this and teaches of the claims as shown above for Claim 1. SHUBER further teaches of detecting cancer with the invention (paragraph 0014, 0025, 0027), and that the cancer can be associated with breast or bone cancer (meaning metastasis if in multiple areas) (paragraph 0030, 0093).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect cancer with the invention/biomarkers as is done in SHUBER in the method of ROSENQUIST due to the fact that the techniques/biomarkers of SHUBER have been found to be especially useful in screening for cancer (SHUBER, paragraph 0014).
With respect to Claim 8, ROSENQUIST teaches of the assay being ELISA (paragraph 0080).
With respect to Claim 9, ROSENQUIST teaches of a kit and method for using kit to measure type I collagen using a sandwich immunoassay in which a single antibody specific for a particular amino acid sequence is used for detection (abstract).
ROSENQUIST further teaches that the antibody can also be used which is reactive with a peptide sequence of for collagen type I-III, but preferably for type I (paragraph 0025, 0066), and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP.
ROSENQUIST further teaches of the assay being for C-terminal (teleopeptides) (paragraph 0053, 0032) and that the antibodies and monocloncal antibodies for type I collagen (paragraphs 0068-0069).
Specifically, ROSENQUIST teaches that the kit can contain the monoclonal antibody with sequence CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP (paragraph 0080).
With respect to Claim 10, ROSENQUIST teaches that the kit can contain the monoclonal antibody with sequence CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP (paragraph 0080). ROSENQUIST does not teach of “not,” recognizing FDFSFLP.
SHUBER is used to remedy this. SHUBER teaches of the instant claims as shown above for Claim 1. SHUBER does not teach of not recognizing FDFSFLP, but only teaches of SHUBER teaches that the biomarker which is detected can be collagen I c-terminal teleopeptide (paragraph 0030), and that monoclonal antibodies are used to bind to the sequence for the target biomarker molecules (paragraphs 0063, 0065).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect specifically the C-terminal telopeptides (not recognizing FDFSFLP) using monocloncal antibodies as is done in SHUBER in the method of ROSENQUIST due to the fact that C-terminal telopeptides of collagen I are known to be associated with diseases and due to the advantage that since slightly different biomarkers provide slightly different results it would be advantageous to one to screen for multiple types of the same biomarker to increase the accuracy of diagnosis (SHUBER, paragraph 0030, 0003-0005).
With respect to Claim 11, ROSENQUIST teaches of measuring a body fluid sample (paragraph 0057) such as a serum or plasma sample (paragraph 0105, 0112).
With respect to Claim 12, ROSENQUIST teaches of the sample being from a subject with cancer (paragraph 0074), but does not teach of one of the claims cancers nor of metastasis to the bones.
SHUBER is used to remedy this and teaches of the claims as shown above for Claim 1. SHUBER further teaches of detecting cancer with the invention (paragraph 0014, 0025, 0027), and that the cancer can be associated with breast or bone cancer (meaning metastasis if in multiple areas) (paragraph 0030, 0093).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect cancer with the invention/biomarkers as is done in SHUBER in the method of ROSENQUIST due to the fact that the techniques/biomarkers of SHUBER have been found to be especially useful in screening for cancer (SHUBER, paragraph 0014).
With respect to Claim 13, ROSENQUIST teaches of the assay being ELISA (paragraph 0080).
With respect to Claim 14, ROSENQUIST teaches of a monoclonal antibody used in a kit and method for measuring type I collagen using a sandwich immunoassay in which a single antibody specific for a particular amino acid sequence is used for detection (abstract).
ROSENQUIST further teaches that the antibody can also be used which is reactive with a peptide sequence of for collagen type I-III, but preferably for type I (paragraph 0025, 0066), and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP.
ROSENQUIST further teaches of the assay being for C-terminal (teleopeptides) (paragraph 0053, 0032) and that the antibodies and monocloncal antibodies for type I collagen (paragraphs 0068-0069).
Specifically, ROSENQUIST teaches that the kit can contain the monoclonal antibody with sequence CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP (paragraph 0080).
With respect to Claim 15, ROSENQUIST teaches that the kit can contain the monoclonal antibody with sequence CSAGFDFSFLPQPPQE (paragraph 0069), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP (paragraph 0080). ROSENQUIST does not teach of “not,” recognizing FDFSFLP.
SHUBER is used to remedy this. SHUBER teaches of the instant claims as shown above for Claim 1. SHUBER does not teach of not recognizing FDFSFLP, but only teaches of SHUBER teaches that the biomarker which is detected can be collagen I c-terminal teleopeptide (paragraph 0030), and that monoclonal antibodies are used to bind to the sequence for the target biomarker molecules (paragraphs 0063, 0065).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to detect specifically the C-terminal telopeptides (not recognizing FDFSFLP) using monocloncal antibodies as is done in SHUBER in the method of ROSENQUIST due to the fact that C-terminal telopeptides of collagen I are known to be associated with diseases and due to the advantage that since slightly different biomarkers provide slightly different results it would be advantageous to one to screen for multiple types of the same biomarker to increase the accuracy of diagnosis (SHUBER, paragraph 0030, 0003-0005).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
ROSENQUIST2 in US 20040224375
With respect to Claim 1, ROSENQUIST2 teaches of a method for measuring type II collagen using a sandwich immunoassay in which a single antibody specific for a particular amino acid sequence is used for detection (abstract).
ROSENQUIST2 further teaches that the antibody can also be used which is reactive with a peptide sequence of the collagen molecule upstream, and that the peptide sequence the antibody is reactive with can be CSAGFDFSFLPQPPQE (paragraph 0070), which includes the claimed amino acid/peptide sequence ID NO: 1 GFDFSFLP and sequence ID NO: 2, FDFSFLP.
ROSENQUIST2 further teaches of the assay being for C-telopeptides and that the monocloncal antibodies to C-telopeptides can be monoclonal antibodies prepared for type I collagen (paragraphs 0117-0118).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel, can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758