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 Final Action for application 18/272868 filed 04/07/2026.
Claims 1, 4-6, 10, 12-13 & 16-17 are pending and have fully been considered.
Claims 16-17 are newly added.
Claims 2-3, 7-9, 11 & 14-15 are newly added.
Claim Rejections - 35 USC §102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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 & 12-13 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated SODEOKA in US 20150192590.
With respect to Claim 1, SODEOKA teaches of a method for detecting a biomolecule by mass spectrometry (abstract), wherein the biomolecule can be proteins in a prokaryote (paragraph 0101).
SODEOKA further teaches that the protein is eluted by using n-propanol, which is the same thing as 1-propanaol during liquid chromatography (paragraph 0075) and then it is detected by mass spectrometry with raman spectroscopy (paragraph 0023).
With respect to Claim 12, SODEOKA teaches of using MALDI-TOF (paragraph 0094). SODEOKA also teaches of detection with mass spectrometry with raman spectroscopy and liquid chromatography (paragraph 0023).
With respect to Claim 13, SODEOKA teaches of using MALDI-TOF (paragraph 0094).
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 non-obviousness.
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 4-5 are rejected under 35 U.S.C. 103 as being obvious over SODEOKA in US 20150192590 in view of FENG in US 20170204448
With respect to Claim 4, SODEOKA teaches of a method for detecting a biomolecule by mass spectrometry (abstract), wherein the biomolecule can be proteins in a prokaryote (paragraph 0101).
SODEOKA further teaches that the protein is eluted by using n-propanol, which is the same thing as 1-propanaol during liquid chromatography (paragraph 0075) and then it is detected by mass spectrometry with raman spectroscopy (paragraph 0023).
SODEOKA does not teach of the prokaryote being a gram-negative bacteria.
FENG is used to remedy this. FENG more specifically teaches of methods to identify sepsis-causing bacteria. FENG teaches of 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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to detect gram negative bacteria as is done in FENG in the method of SODEOKA due to the need in the art for better methods for identification and detection of bacteria such as gram negative bacteria due to the havoc bacteria can cause on the body such as inflammation, sepsis, and organ damage and failure (FENG, paragraph 0002-0003).
With respect to Claim 5, FENG teaches of a method of extracting a protein from Escherichia coli or another gram-negative bacteria (paragraph 0018).
Claims 6 & 16-17 are rejected under 35 U.S.C. 103 as being obvious over SODEOKA in US 20150192590 in view of OLSON in US 4511503.
With respect to Claim 6, SODEOKA teaches of a method for detecting a biomolecule by mass spectrometry (abstract), wherein the biomolecule can be proteins in a prokaryote (paragraph 0101).
SODEOKA further teaches that the protein is eluted by using n-propanol, which is the same thing as 1-propanaol during liquid chromatography (paragraph 0075) and then it is detected by mass spectrometry with raman spectroscopy (paragraph 0023).
SODEOKA does not teach of elution using NaCl in the claimed concentration.
OLSON is used to remedy this. OLSON teaches of a method for A dissolving and eluting refractile proteins (abstract). OLSON further teaches that these refractile proteins can be the heterologous proteins in bacteria (of which the E.coli taught by SODEOKA is one of) (column 1, lines 9-16, column 2, lines 39-56). OLSON further teaches that the refractile bodies can be recovered/eluted using any suitable salt, such as NaCl, and that it is used in the range of 0.01M to 2M (proteins (OLSON, Column 9, line 59-column 10 line 15)--- which includes the claimed range of 400mM-1.5 M NaCl.
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 NaCl in the concentration in the range taught in OLSON in the method of SODEOKA due to the advantage it shows for suspending and disrupting cellular debris to enable recovery of the refractile bodies/proteins (OLSON, Column 9, line 59-column 10 line 15).
With respect to Claim 16, SODEOKA teaches of using MALDI-TOF (paragraph 0094). SODEOKA also teaches of detection with mass spectrometry with raman spectroscopy and liquid chromatography (paragraph 0023).
With respect to Claim 17, SODEOKA teaches of using MALDI-TOF (paragraph 0094).
Claim 10 is rejected under 35 U.S.C. 103 as being obvious over SODEOKA in US 20150192590 in view of OLSON in US 4511503 and further in view of FENG in US 20170204448
With respect to Claim 10, SODEOKA teaches of a method for detecting a biomolecule by mass spectrometry (abstract), wherein the biomolecule can be proteins in a prokaryote (paragraph 0101).
SODEOKA further teaches that the protein is eluted by using n-propanol, which is the same thing as 1-propanaol during liquid chromatography (paragraph 0075) and then it is detected by mass spectrometry with raman spectroscopy (paragraph 0023).
SODEOKA does not teach of elution using NaCl in the claimed concentration.
OLSON is used to remedy this. OLSON teaches of a method for A dissolving and eluting refractile proteins (abstract). OLSON further teaches that these refractile proteins can be the heterologous proteins in bacteria (of which the E.coli taught by SODEOKA is one of) (column 1, lines 9-16, column 2, lines 39-56). OLSON further teaches that the refractile bodies can be recovered/eluted using any suitable salt, such as NaCl, and that it is used in the range of 0.01M to 2M (proteins (OLSON, Column 9, line 59-column 10 line 15)--- which includes the claimed range of 400mM-1.5 M NaCl.
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 NaCl in the concentration in the range taught in OLSON in the method of SODEOKA due to the advantage it shows for suspending and disrupting cellular debris to enable recovery of the refractile bodies/proteins (OLSON, Column 9, line 59-column 10 line 15).
FENG is used to remedy this. FENG more specifically teaches of methods to identify sepsis-causing bacteria. FENG teaches of 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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to detect gram negative bacteria as is done in FENG in the method of SODEOKA due to the need in the art for better methods for identification and detection of bacteria such as gram negative bacteria due to the havoc bacteria can cause on the body such as inflammation, sepsis, and organ damage and failure (FENG, paragraph 0002-0003).
Response to Arguments
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) the instant claims have been considered but are moot because the new ground of rejection does not rely on e combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically the new references SODEOKA in US 20150192590 and OLSON in US 4511503 are used due to amendments dated 04/07/2026 which significantly change the scope of the instant claims. The SHORT reference priorly used, is no longer used, and the FENG reference is only used to support the other two references instead of as a primary reference.
The examiner notes that she has reviewed exhibit A briefly, however it seems it be focused on something applicant reported post-filing the instant application. It was informative, but especially since new prior art was used due to the instantly made amendments, is not convincing in overcoming the prior art, nor would it be an accepted showing of any supposed unexpected results as it was not filed with the instant specification.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
SHORT in US 20050124010
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).
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.
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
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