DETAILED ACTION
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 .
Election/Restrictions
Applicant's election without traverse of invention Group I, claims 1-18 and 21, and of ‘Staphylococcus aureus’ as species of bacteria, in the reply filed on 11/19/2025, is acknowledged. Claim 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Status
The amendment of 11/19/2025 has been entered. Claims 1-21 are pending (claim set as filed on 11/19/2025). Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-18 and 21 are currently under examination and were examined on their merits.
Priority
This application filed on 04/14/2023 claims priority to provisional application no. PRO 63/331,434, filed on 04/15/2022.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 07/14/2023 and 07/25/2023 have been received and considered.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites “(ESKAPE pathogens)” which renders the claim indefinite since it is unclear if “(ESKAPE pathogens)” is intended to further limit the claim, or if “(ESKAPE pathogens)” is used as an umbrella term to describe the bacterial strains listed in claim 12. One of ordinary skill in the art would not be able to determine the metes and bounds of the claim, and thus, could not clearly determine how to avoid infringement of claim 12.
In the interest of compact prosecution, claim 12 is interpreted to the broadest embodiment claimed.
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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 1-6, 8, 10-13, 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sorensen et al. (WO 2021/062042 A1, published on 04/01/2021), hereinafter ‘Sorensen’, in view of Fenyo et al. (“MALDI Sample Preparation: the Ultra Thin Layer Method”, published in 2007, Journal of Visualized Experiments (JoVE), (3), e192.3, pages 1-2), hereinafter ‘Fenyo’, and in view of Ishida et al. (“On-Probe Sample Pretreatment for Direct Analysis of Lipids in Gram-Positive Bacterial Cells by Matrix-Assisted Laser Desorption Ionization Mass Spectrometry”, published in Nov 2005, Applied and Environmental Microbiology, Vol. 71, No. 11, pages 7539–7541), hereinafter ‘Ishida’.
Sorensen’s general disclosure relates to “[m]ethods for processing and analyzing samples are presented, said methods useful for, among other uses, analysis of lipids and other analytes of a sample, said methods further useful for identification of microorganisms at the level of species, identification of microorganisms at a level other than species, detecting infections and other diseases, detecting and measuring growth of an organism, detecting and measuring an environmental response of an organism, determining and/or measuring antimicrobial resistance of a microorganism, and for other purposes” (see entire document, including abstract).
Regarding claim 1, pertaining to a method for determining antibiotic susceptibility, Sorensen discloses a method for determining antibiotic susceptibility (page 6, lines 27-28, line 31; page 7, lines 28-30; page 11, lines 28-30; page 17, lines 3-17; note, kanamycin is an antibiotic) comprising:
a) incubating an untreated mixture and a treated mixture (page 61, lines 18-21), wherein:
each mixture comprises a bacterial culture and deuterium oxide (D2O) (page 61, lines 18-21), wherein the bacterial culture comprises a D2O concentration of about 8% (page 17, lines 5-8);
the treated mixture comprises an antibiotic and the untreated mixture lacks an antibiotic (page 45, lines 10-15; page 61, lines 27-30; see multiple Kanamycin concentrations including 0 µg/mL in Fig. 1); and
the incubation is for a period of time sufficient for the untreated mixture to
produce deuterium-labeled membrane lipids (page 17, lines 3-8 ,12-17; page 46, lines 24-27; page 69, line 20; see claim 10, lines 1-2; see Fig. 1). It is noted that the incorporation of deuterium in membrane lipids extracted from P. fluorescens grown without kanamycin as shown in Fig. 1 indicates that incubation of P. fluorescens was for a period of time sufficient for the untreated mixture to produce deuterium-labeled membrane lipids;
Sorensen teaches
b) drying the untreated mixture and the treated mixture to provide a dry untreated mixture and a dry treated mixture, each comprising bacteria from the bacterial culture (page 21, lines 21-23; page 24, lines 24-27);
c) lysing the bacteria in each dry mixture to release deuterium-labeled membrane lipids
that comprise deuterium atoms bonded to carbon atoms of the membrane lipids, if present (page 25, lines 7-8 and 12-14). It is noted that the instant specification (page 20, lines 19-20) and instant claim 13 describe wherein ‘lysing’ comprises contacting the dry mixture with an alcohol and drying the resulting mixture.
Sorensen teaches
f) analyzing the untreated sample and the treated sample for deuterium incorporation by
mass spectrometry, thereby determining the amount of deuterium incorporation in the samples (page 17, lines 3-5; page 61, lines 1-2; see Fig. 1);
and comparing the deuterium incorporation in the untreated sample to the deuterium
incorporation in the treated sample (page 45, lines 10-15; page 46, lines 3-15; see Fig. 1);
thereby determining the antibiotic susceptibility of the bacterial culture (page 7, line 28 - page 8, line 2; page 8, lines 15-18; page 46, lines 3-15).
Regarding claim 4, pertaining to the deuterium-labeled membrane lipids, Sorensen teaches wherein the deuterium-labeled membrane lipids comprise deuterium-labeled phosphatidylethanolamines (PE), phosphatidylglycerols (PG), or cardiolipin (CL) (page 70, lines 1-9; page 77, lines 29 – page 78, line 5; see claim 11). It is noted that ‘PG34:1’ (page 70, line 9; page 78, line 5; claim 11) reads on phosphatidylglycerol (PG).
Regarding claim 5, pertaining to the deuterium-labeled membrane lipids, Sorensen teaches wherein the deuterium-labeled membrane lipids comprise deuterium-labeled PE 32: 1, PE 33: 1, PE 34: 1, or PG 34: 1 (page 70, lines 1-9; page 77, lines 29 – page 78, line 5; see claim 11).
Regarding claim 6, pertaining to the deuterium-labeled membrane lipids, Sorensen teaches wherein the deuterium-labeled membrane lipids comprise deuterium-labeled PE 32: 1 (page 70, line 6; page 78, line 2; see claim 11).
Regarding claim 8, pertaining to the incubation period, Sorensen teaches wherein the untreated mixture and treated mixture are incubated for about 30 minutes, between 30 minutes and 1 hour, about 1 hour, about 1 hour, between 1 and 2 hours, about 2 hours, between 2 and 3 hours, about 3 hours, between 3 and 4 hours, about 4 hours (page 69, lines 25-27; page 77, lines 22-24; see claim 10 on page 87, lines 4-6).
Regarding claim 10, based on Sorensen’s teachings that incorporation of deuterium in membrane lipids indicates growth (page 4, lines 1-2; page 7, lines 22-25), it is considered within the skill of an ordinary artisan, to determine that the bacteria are resistant to the antibiotic when the amount of deuterium incorporated in the untreated sample is about the same as the treated sample.
Regarding claim 11, based on Sorensen’s teachings that incorporation of deuterium in membrane lipids indicates growth (page 4, lines 1-2; page 7, lines 22-25; page 57, lines 18-19), and that deuterium incorporation in an antibiotic treated sample is reduced in an antibiotic susceptible culture (page 17, lines 3-17; page 45, lines 9-15; see Fig. 1), it is considered within the skill of an ordinary artisan to determine that the bacteria are susceptible to the antibiotic when the amount of deuterium incorporated in the untreated sample is more than the treated sample.
Regarding claim 12, pertaining to the bacteria, please see above under Election/Restrictions. Sorensen teaches wherein the bacteria comprise the elected Staphylococcus aureus (page 21, lines 2-3).
Regarding claim 13, pertaining to lysing, Sorensen teaches wherein lysing comprises contacting the dry mixture with an alcohol and drying the mixture (page 25, lines 7-8 and 12).
Regarding claim 16, pertaining to a MALDI matrix, Sorensen teaches wherein the untreated sample and treated sample are contacted with a MALDI matrix compound prior to analysis by mass spectrometry (page 25, lines 22).
Regarding claims 17 and 18, pertaining to the antibiotic concentration, Sorensen teaches wherein the wherein the method comprises incubating more than one treated mixture with the antibiotic at a plurality of different concentrations (page 17, lines 21-23; page 46, lines 7-15; see different kanamycin concentrations in Fig. 1) (instant claim 17), the method further comprising determining the minimum inhibitory concentration (MIC) of the antibiotic (page 8, lines 15-18; page 20, lines 27-29) (instant claim 18).
Regarding claim 21, pertaining to a method for determining antibiotic susceptibility, Sorensen teaches a method for determining antibiotic susceptibility (page 6, lines 27-28, line 31; page 7, lines 28-30; page 11, lines 28-30; page 17, lines 3-17; note, kanamycin is an antibiotic) comprising:
a) incubating an untreated mixture comprising deuterium oxide (D2O) and a
bacterial culture, wherein the untreated mixture lacks an antibiotic (page 45, lines 10-15; page 61, lines 27-30; see kanamycin concentrations including 0 µg/mL in Fig. 1);
b) incubating a treated mixture comprising an antibiotic, D2O, and a bacterial
culture (page 45, lines 10-15; page 61, lines 27-30; see Kanamycin concentrations in Fig. 1);
wherein the bacterial cultures comprise a D2O concentration of about 8% (page 17, lines 5-8);
c) drying the untreated mixture to provide a dry untreated mixture, and drying the
treated mixture to provide a dry treated mixture (page 21, lines 21-23; page 24, lines 24-27);
d) lysing bacteria of the bacterial culture in the dry untreated mixture and dry
treated mixture to provide lysed mixtures of membrane lipids (page 25, lines 7-8 and 12-14). It is noted that the instant specification (page 20, lines 19-20) and instant claim 13 describe wherein ‘lysing’ comprises contacting the dry mixture with an alcohol and drying the resulting mixture.
Sorensen further teaches
g) analyzing for an amount of deuterium incorporation in the untreated and treated
sample by mass spectrometry (page 17, lines 3-5; page 61, lines 1-2; see Fig. 1); and
h) comparing the amount of deuterium incorporation in the untreated sample to
the amount of deuterium incorporation in the treated sample (page 45, lines 10-15; page 46, lines 3-15; see Fig. 1);
wherein the susceptibility of the antibiotic is thereby determined (page 7, line 28 - page 8, line 2; page 8, lines 15-18; page 46, lines 3-15).
In addition, pertaining to D2O concentrations, Sorenson teaches wherein the D2O concentration is less than 30% (page 52, line 17), and that “concentrations greater than 30% can cause alterations in the growth behavior of microorganisms” (page 52, lines 19-21).
Sorensen does not teach d) contacting the lysed untreated mixture and the lysed treated mixture with a protic solvent, thereby exchanging deuterium atoms bonded to heteroatoms of the deuterium-labeled membrane lipids with hydrogen atoms from the protic solvent; e) removing the protic solvent from the lysed untreated mixture and the lysed treated mixture to provide an untreated sample and a treated sample for analysis (instant claim 1), wherein the D2O concentration in the bacterial culture is about 10% v/v to about 40% v/v (instant claim 2), wherein the D2O concentration in the bacterial culture is about 20% v/v (instant claim 3), wherein the protic solvent comprises an aqueous acid (instant claim 15), wherein the treated and untreated mixture have a fixed concentration of bacteria (instant claim 21), and e) contacting the lysed untreated mixture and a protic solvent, and contacting the lysed treated mixture and a protic solvent; f) removing the protic solvent from the lysed untreated mixture and lysed treated mixture to provide an untreated and a treated sample for analysis, wherein soluble contaminants are removed with the protic solvent (instant claim 21).
Fenyo’s general disclosure relates to the preparation of an ultra-thin matrix/analyte layer for analyzing peptides and proteins by Matrix-Assisted Laser Desorption Ionization Mass Spectrometry (MALDI-MS) (see entire document, including abstract).
Regarding claims 1 and 21, pertaining to contacting and removal of a protic solvent, Fenyo teaches a wash step using a protic solvent to prepare a sample for mass spectrum analysis (“0.1% aqueous TFA solution”; see Washing step and Acquisition of mass spectra on page 2, paragraphs 3-4).
Regarding claim 15, Fenyo teaches wherein the protic solvent comprises an aqueous acid (“0.1% aqueous TFA solution”; see Washing step 1 on page 2, paragraph 3; note, TFA, trifluoroacetic acid).
Ishida’s general disclosure relates to on-probe sample pretreatment using trifluoroacetic acid as an additional reagent for detection of phospholipids by means of matrix-assisted laser desorption ionization mass spectrometry (see entire document, including abstract).
Regarding claims 1 and claim 21, pertaining to a protic solvent, Ishida teaches wherein “[o]n-probe sample pretreatment using trifluoroacetic acid as an additional reagent enabled the direct detection of phospholipids in whole bacteria by means of matrix-assisted laser desorption ionization mass spectrometry for not only gram-negative organisms but also gram-positive ones with a thicker peptidoglycan layer” (see abstract). Ishida further discloses that TFA enhances the ion formation of phospholipids (page 7539, right column, paragraph 1), and that additional TFA can cause hydrolysis of phospholipids in gram-negative bacteria (page 7540, right column, paragraph 2).
While Sorensen does not teach step d) contacting the lysed untreated mixture and the lysed treated mixture with a protic solvent (instant claim 1), step e) contacting the lysed untreated mixture and a protic solvent, and contacting the lysed treated mixture and a protic solvent (instant claim 21), removing the protic solvent TFA from the lysed untreated mixture and the lysed treated mixture to provide an untreated sample and a treated sample for analysis (step e in instant claim 1, step f in instant claim 21), and wherein the protic solvent comprises an aqueous acid (instant claim 15), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Sorensen’s method with Fenyo’s TFA wash step for preparing a sample for mass spectrometry and with Ishida’s teaching on improved phospholipid detection using TFA comprising solution in sample preparation for mass spectrometry, to have created a method comprising d) contacting the lysed untreated mixture and the lysed treated mixture with a trifluoroacetic acid comprising solution (instant claim 1), e) contacting the lysed untreated mixture and a trifluoroacetic acid comprising solution, and contacting the lysed treated mixture and a trifluoroacetic acid comprising solution (instant claim 21), comprising removing the protic solvent TFA from the lysed untreated mixture and the lysed treated mixture to provide an untreated sample and a treated sample for analysis (step e in instant claim 1, step f in instant claim 21), and wherein the protic solvent comprises aqueous TFA (instant claim 15). One would have been motivated to do so in order to develop a superior method for detecting antibiotic susceptibility by using an aqueous TFA wash step that allows for improved detection of phospholipids in the treated and untreated mixtures (Ishida, page 7539, right column, paragraph 1; see abstract), but avoids prolonged exposure to TFA that could cause phospholipid degradation (Ishida, page 7540, right column, paragraph 2).
A skilled artisan would have reasonably expected success in combining Sorensen’s, Fenyo’s, and Ishida’s teachings, since all references are directed to the analysis of biological samples using mass spectrometry (Sorensen, page 28, lines 18-20; Fenyo, see abstract; Ishida, see abstract).
While modified Sorensen does not expressly teach wherein the treated and untreated mixture have a fixed concentration of bacteria, wherein the fixed concentration of bacteria in the treated mixture is the same as in the untreated mixture (instant claim 21), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified Sorenson’s method wherein the treated and untreated mixture have a fixed concentration of bacteria, wherein the fixed concentration of bacteria in the treated mixture is the same as in the untreated mixture. It would have been within the skill of an ordinary artisan to have recognized to use the same fixed bacterial concentration in the treated and untreated mixtures, in order to establish the same experimental conditions except the addition of antibiotic, thereby allowing to examine the impact of antibiotic treatment on bacterial growth.
While modified Sorensen does not teach wherein the D2O concentration in the bacterial culture is about 10% v/v to about 40% v/v (instant claim 2), wherein the D2O concentration in the bacterial culture is about 20% v/v (instant claim 3), the instantly recited concentrations would be would be within the realm of routine experimentation since Sorensen teaches a wherein the D2O concentration in a bacterial culture is less than 30% (page 52, line 17), and that “concentrations greater than 30% can cause alterations in the growth behavior of microorganisms” (page 52, lines 19-21). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the optimal D2O concentrations in the bacterial culture to allow for sufficient incorporation of deuterium without altering the growth of the bacterial culture. Further one would expect success since Sorensen’s teachings are directed to multiple bacterial strains (see page 21, lines 2-19), and therefore, manipulation of the D2O concentration based on the teachings of the reference would be within the purview of an artisan. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the
prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955). See
MPEP § 2144.05 part II A.
Regarding claim 1, pertaining to the thereby clause in step d, the combination of Sorensen’s, Fenyo’s and Ishida’s teachings would implicitly result in exchanging deuterium atoms bonded to heteroatoms of the deuterium-labeled membrane lipids with hydrogen atoms from the protic solvent. Since Sorensen teaches mixtures comprising deuterated membrane lipids and Fenyo teaches a wash step comprising a protic solvent, it is highly expected and thus obvious that the method taught by Sorensen in view of Fenyo and Ishida, would result in the exchange of deuterium atoms bonded to heteroatoms of the deuterium-labeled membrane lipids with hydrogen atoms from the protic solvent.
Regarding claim 21, pertaining to the wherein clause in step f, the combination of the combination of Sorensen’s, Fenyo’s, and Ishida’s teachings would implicitly result in wherein soluble contaminants are removed with the protic solvent. Since Sorensen teaches preparing samples for mass spectrum analysis and Fenyo teaches a washing samples for mass spectrum analysis with a protic solvent, it is highly expected and therefore obvious, that the method taught by Sorensen in view of Fenyo and Ishida, would result in removal of soluble contaminants with the protic solvent.
Claims 1, 7, 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sorensen et al. (WO 2021/062042 A1, published on 04/01/2021), hereinafter ‘Sorensen’, in view of Fenyo et al. (“MALDI Sample Preparation: the Ultra Thin Layer Method”, published in 2007, Journal of Visualized Experiments (JoVE), (3), e192.3, pages 1-2), hereinafter ‘Fenyo’, in view of Ishida et al. (“On-Probe Sample Pretreatment for Direct Analysis of Lipids in Gram-Positive Bacterial Cells by Matrix-Assisted Laser Desorption Ionization Mass Spectrometry”, published in Nov 2005, Applied and Environmental Microbiology, Vol. 71, No. 11, pages 7539–7541), hereinafter ‘Ishida’, and in view of Idelevich et al. (“Rapid Direct Susceptibility Testing from Positive Blood Cultures by the Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry-Based Direct-on-Target Microdroplet Growth Assay”, published on 08/09/2018, Journal of Clinical Microbiology, Vol. 56, Issue 10, e00913-18, pages 1-8), hereinafter ‘Idelevich’.
Modified Sorensen’s teachings have been set forth above.
Modified Sorenson does not teach wherein the untreated mixture and the treated mixture are incubated in a chamber comprising a solution that has about the same concentration of D2O as the concentration of D2O in the untreated mixture and the treated mixture (instant claim 7), wherein the bacterial culture has a concentration of about 0.1 x 108 CFU/mL to about 10 x 108 CFU/mL (instant claim 9), and wherein removing the protic solvent comprises wicking or blotting the protic solvent (instant claim 14).
Idelevich’s general disclosure relates to a recently developed direct-on-target microdroplet growth assay (DOT-MGA) that allows rapid universal antimicrobial susceptibility testing (AST) using matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDITOF MS), and its application on positive blood cultures (BCs) for the acceleration of sepsis diagnostics (see entire document, including abstract).
Regarding claim 7, pertaining to incubation, Idelevich teaches wherein microbial cultures are incubated in a chamber, wherein the chamber comprises water at the bottom so that the chamber is used as a humidity chamber to avoid evaporation of the culture (page 3, paragraph 3, lines 12-18; see left photograph in Fig. 1).
Regarding claim 9, pertaining to the bacterial culture, Idelevich teaches a bacterial culture comprising 1x108 CFU/ml (page 2, paragraph 7).
Regarding claim 14, pertaining to removing a solvent, Idelevich teaches removing a liquid from samples by blotting the liquid (page 3, paragraph 3, lines 20-23; see center photograph in Fig. 1).
While modified Sorensen does not teach wherein the untreated mixture and the treated mixture are incubated in a chamber comprising a solution (instant claim 7), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Sorensen’s method with Idelevich’s teachings on a humidity chamber for bacterial cultures, in order to have created a method for antibiotic susceptibility testing wherein the untreated mixture and the treated mixture are incubated in a chamber comprising a solution. One would have been motivated to do so to avoid evaporation from the mixtures (Idelevich, page 3, paragraph 3, lines 12-18).
While modified Sorensen does not teach wherein the solution in the chamber has about the same concentration of D2O as the concentration of D2O in the untreated mixture and the treated mixture (instant claim 7), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Sorensen’s method with Sorensen’s teachings on incorporation D2O in lipids, to have created a method wherein the solution in the chamber has about the same concentration of D2O as the concentration of D2O in the untreated mixture and the treated mixture in the humidity chamber. One would have been motivated to do so in order to ensure that the solution in the chamber does not affect incorporation of deuterium in the membrane lipids during growth of the bacterial cultures.
While modified Sorenson does not teach wherein the bacterial culture has a concentration of about 0.1 x 108 CFU/mL to about 10 x 108 CFU/mL (instant claim 9), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Sorensen’s method with Idelevich’s teachings on bacterial culture CFU/mL, to have developed a method wherein the bacterial culture has a concentration of about 1 x 108 CFU/mL. One would have been motivated to do so to ensure sufficient growth and therefore deuterium incorporation in the culture.
While modified Sorensen does not teach wherein removing the protic solvent comprises wicking or blotting the protic solvent (instant claim 14), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Sorensen’s method with Idelevich’s teachings on removing a liquid by blotting, in order to have created a method wherein removing the protic solvent comprises blotting the protic solvent. One would have been motivated to do so to quickly and efficiently remove the protic solvent from the mixtures.
A skilled artisan would have reasonably expected success in combining modified Sorensen’s and Idelevich’s teachings since both teachings are directed to the preparation of biological samples for mass spectrum analysis (Sorensen, page 28, lines 18-20; Idelevich, see abstract and Fig. 1).
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SANDRA ZINGARELLI/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653