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 RCE filed 06/22/2026.
Claims 6 & 10 are pending and have fully been considered.
Claims 1-5, 7-9 & 11-17 have been 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/22/2026 has been entered.
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.
Claim 6 is rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by INGBER in US 20190077850.
With respect to Claim 6, INGBER teaches of a method for detecting a protein from E.Coli (which is a prokaryote) comprising:
eluting a protein from e.coli or s. aureus by adding 500 mM of NaCl to the sample comprising the E. Coli or S. Aureus (paragraph 0415, 0414, 498, 0646-0649 but mostly 0648-0649, 0609), and
performing MALDI-TOF on the eluted protein and thus detecting the amount of proteins in sample (paragraph 0230, 0243, 0253, 0256, 0693, 0694).
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.
Claim 10 is rejected under 35 U.S.C. 103 as being obvious by INGBER in US 20190077850 in view of WINGFIELD in Overview of the Purification of Recombinant Proteins Produced in Escherichia coli.
With respect to Claim 10, INGBER teaches of a method for detecting a protein from E.Coli (which is a prokaryote) comprising:
eluting a protein from e.coli or s. aureus by adding 500 mM of NaCl to the sample comprising the E. Coli or S. Aureus (paragraph 0415, 0414, 498, 0646-0649 but mostly 0648-0649, 0609), and
performing MALDI-TOF on the eluted protein and thus detecting the amount of proteins in sample (paragraph 0230, 0243, 0253, 0256, 0693, 0694)
INGBER further teaches of the e.coli being gram-negative(paragraph 0050, 0144, 0261, 0649, 0689).
INGBER does not teach of extracting or eluting the protein specifically from E.coli, which is the gram negative bacteria using NaCl of the claimed concentration.
WINGFIELD is used to remedy this and teaches of methods for purification of proteins in E.Coli (title), and further teaches of extracting/eluting proteins of the proteins in E.Coli using 1.0 M NaCl (Page 6.1.16, paragraph 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to extract/elute proteins from specifically E.Coli using the claimed high concentration of NaCl as is done in WINGFIELD in the method of INGBER due to the advantages these concentrations have extracting under non denaturing conditions and solving problems dealing with interactions involving folded protein(Page 6.1.16, paragraph 4).
Response to Arguments
Applicant's arguments filed 06/22/2026 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 the references or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner notes that she has reviewed exhibit A, and the Declaration of Saeyoung Lee filed 04/07/2026, however they is not convincing in overcoming the instantly cited prior art, especially at it is newly cited due amendments made with RCE filed 06/22/2026. 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.
SODEOKA in US 20150192590
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-propanol during liquid chromatography (paragraph 0075) and then it is detected by mass spectrometry with Raman Spectroscopy (paragraph 0023).
Further, SODEOKA teaches of using MALDI-TOF (paragraph 0094).
OLSON in US 4511503
OLSON is used to remedy this. OLSON teaches of a method for 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.
FENG in US 20170204448
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.
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
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