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 18/272868 filed 07/18/2023.
This application was examined as part of the PBA program.
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 1-13 are rejected under 35 U.S.C. 103 as being obvious over FENG in US 20170204448 in view of SHORT in US 20050124010.
With respect to Claim 1, FENG teaches of methods to identify sepsis-causing bacteria. The methods described herein employ plating microorganisms directly on to a MALDI-MS plate, adding concentrated formic acid, and identifying the microorganism by mass spectrometry. FENG further teaches of adding organic solvent to the formic acid and that the instant methods enable direct extraction of proteins from microorganisms without the need for liquid protein extraction methods and yields positive identification results for gram-positive bacteria, gram-negative bacteria and yeast in minutes (abstract).
More specifically with respect to what is claimed, FENG teaches of a method of extracting a protein from Escherichia coli or another gram-negative bacteria (paragraph 0018) by adding, to Escherichia coli, an organic solvent such as methanol, ethanol, and acetonitrile (which is and R-CN) (abstract, paragraph 0017). Gram-negative bacteria’s are prokaryotes, which are single-celled microorganisms.
FENG teaches of extraction but does not call out elution.
SHORT is used to remedy this and teaches of methods of investigating samples by eluting proteins and polypeptides from the sample and analysis of them by mass spectrometry (paragraph 0565-0569). SHORT further teaches that the sample can be gram negative bacteria (paragraph 1955).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to elute proteins and polypeptides as is done in SHORT in the method of FENG due to the advantage separation/elution of proteins allows for comparison or relative protein concentrations in the samples and simultaneous identification of proteins (SHORT, paragraph 0563-0564).
With respect to Claim 2, FENG teaches of using an organic solvent such as methanol, ethanol, and acetonitrile (which is and R-CN) (abstract, paragraph 0017).
With respect to Claim 3, FENG teaches of using acetonitrile (which is and R-CN) (abstract, paragraph 0017).
With respect to Claim 4, FENG teaches of a method of extracting a protein from Escherichia coli or another gram-negative bacteria (paragraph 0018). Gram-negative bacteria’s are prokaryotes, which are single-celled microorganisms.
With respect to Claim 5, FENG teaches of a method of extracting a protein from Escherichia coli or another gram-negative bacteria (paragraph 0018).
With respect to Claim 6, FENG teaches of the instant method as shown above including a prokaryote but does not call out addition of a hypertonic solution.
SHORT is used to remedy this and teaches of methods of investigating samples by eluting proteins and polypeptides from the sample and analysis of them by mass spectrometry (paragraph 0565-0569). SHORT further teaches that the sample can be gram negative bacteria (paragraph 1955) which is a prokaryote.
Even further, SHORT teaches that the solutions can be hypertonic (paragraph 2626) and that NaCl is added in a concentration of from 10-250 mM or 50mM to 200mM (paragraph 0233) making a hypertonic solution.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use a hypertonic solution of NaCl in the claimed range as is done in SHORT in the method of FENG due to the advantage controlling the salt/NaCl concentration allows for simulating physiological conditions and also for buffering solutions (SHORT, paragraph 0233).
With respect to Claim 7, FENG teaches of the instant method as shown above including a prokaryote but does not call out addition of a hypertonic solution.
SHORT is used to remedy this and teaches of methods of investigating samples by eluting proteins and polypeptides from the sample and analysis of them by mass spectrometry (paragraph 0565-0569). SHORT further teaches that the sample can be gram negative bacteria (paragraph 1955) which is a prokaryote.
Even further, SHORT teaches that the solutions can be hypertonic (paragraph 2626) and that NaCl is added in a concentration of from 10-250 mM or 50mM to 200mM (paragraph 0233) making a hypertonic solution.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use a hypertonic solution of NaCl in the claimed range as is done in SHORT in the method of FENG due to the advantage controlling the salt/NaCl concentration allows for simulating physiological conditions and also for buffering solutions (SHORT, paragraph 0233).
With respect to Claim 8, FENG teaches of the instant method as shown above including a prokaryote but does not call out addition of a hypertonic solution.
SHORT is used to remedy this and teaches of methods of investigating samples by eluting proteins and polypeptides from the sample and analysis of them by mass spectrometry (paragraph 0565-0569). SHORT further teaches that the sample can be gram negative bacteria (paragraph 1955) which is a prokaryote.
Even further, SHORT teaches that the solutions can be hypertonic (paragraph 2626) and that NaCl is added in a concentration of from 10-250 mM or 50mM to 200mM (paragraph 0233) making a hypertonic solution.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use a hypertonic solution of NaCl in the claimed range as is done in SHORT in the method of FENG due to the advantage controlling the salt/NaCl concentration allows for simulating physiological conditions and also for buffering solutions (SHORT, paragraph 0233).
With respect to Claim 9, FENG teaches of the instant method as shown above including a prokaryote but does not call out addition of a hypertonic solution.
SHORT is used to remedy this and teaches of methods of investigating samples by eluting proteins and polypeptides from the sample and analysis of them by mass spectrometry (paragraph 0565-0569). SHORT further teaches that the sample can be gram negative bacteria (paragraph 1955) which is a prokaryote.
Even further, SHORT teaches that the solutions can be hypertonic (paragraph 2626) and that NaCl is added in a concentration of from 10-250 mM or 50mM to 200mM (paragraph 0233) making a hypertonic solution.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use a hypertonic solution of NaCl in the claimed range as is done in SHORT in the method of FENG due to the advantage controlling the salt/NaCl concentration allows for simulating physiological conditions and also for buffering solutions (SHORT, paragraph 0233).
With respect to Claim 10, FENG teaches of a method of extracting a protein from Escherichia coli or another gram-negative bacteria (paragraph 0018). Gram-negative bacteria’s are prokaryotes, which are single-celled microorganisms.
With respect to Claim 11, FENG teaches of methods to identify sepsis-causing bacteria. The methods described herein employ plating microorganisms directly on to a MALDI-MS plate, adding concentrated formic acid, and identifying the microorganism by mass spectrometry. FENG further teaches of adding organic solvent to the formic acid and that the instant methods enable direct extraction of proteins from microorganisms without the need for liquid protein extraction methods and yields positive identification results for gram-positive bacteria, gram-negative bacteria and yeast in minutes (abstract).
More specifically with respect to what is claimed, FENG teaches of a method of extracting a protein from Escherichia coli or another gram-negative bacteria (paragraph 0018) by adding, to Escherichia coli, an organic solvent such as methanol, ethanol, and acetonitrile (which is and R-CN) (abstract, paragraph 0017). Gram-negative bacteria’s are prokaryotes, which are single-celled microorganisms.
FENG further teaches of performing mass spectrometry on the extracted protein (paragraph 0013).
FENG teaches of extraction but does not call out elution.
SHORT is used to remedy this and teaches of methods of investigating samples by eluting proteins and polypeptides from the sample and analysis of them by mass spectrometry (paragraph 0565-0569). SHORT further teaches that the sample can be gram negative bacteria (paragraph 1955).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to elute proteins and polypeptides as is done in SHORT in the method of FENG due to the advantage separation/elution of proteins allows for comparison or relative protein concentrations in the samples and simultaneous identification of proteins (SHORT, paragraph 0563-0564).
With respect to Claim 12, FENG teaches of using MALDI-TOF (paragraph 0003, 0039, 0042).
With respect to Claim 13, FENG teaches of using MALDI-TOF (paragraph 0003, 0039, 0042).
Conclusion
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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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758