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 .
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed steps, the process steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 1, the Examiner notes that the claim does not recite a step of passing a metabolite and mobile phase through a column, thus it is readily apparent what the phrase “that has passed through the column” references. Applicant should amend the claims so that it is clear that a metabolite and mobile phase are passed through a column.
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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoang et al., (Analytical and Bioanalytical Chemistry, 2020, 41:2261-2276).
For claim 1, Hoang et al., teach quantitation of N-acyl homoserine lactones comprising a mobile phase including carbon dioxide in a supercritical state (page 2263, Supercritical-fluid (page 2263, chromatography), placing a microorganism cultured in agar in the mobile phase (page 2263, Bacterial strains, fermentation, extraction, and sample preparation), and performing mass spectrometry on the sample (pages 2263-2264, SFC-HRMS analysis).
For claim 2, Hoang et al., teach cutting a bacterial strain with an agar medium (page 2263, Bacterial strains, fermentation, extraction, and sample preparation) wherein the bacterial strain and agar are placed in the mobile phase (page 2263, Bacterial strains, fermentation, extraction, and sample preparation).
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(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoang et al., (Analytical and Bioanalytical Chemistry, 2020, 41:2261-2276) in view of Singamaneni et al., (US 2020/0305416) .
Regarding claim 3, Hoang et al., the metabolite being hydrophobic (N-acyl homoserine lactone), but do not teach the mobile phase comprising carbon dioxide and ammonium formate methanol.
Singamaneni et al., teach a method of preparing and preserving a biological sample wherein a mobile phase for HPLC comprises ammonium formate in methanol (paragraph 0107). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Singamaneni et al., clearly teach that ammonium formate in methanol is a suitable mobile phase for liquid chromatography, thus one of ordinary skill in the art at the time the invention was made would have found it obvious to include ammonium formate in methanol as a solid phase for liquid chromatography. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Hoang et al., wherein the mobile phase includes ammonium formate methanol as combining prior art elements according to know methods to yield predictable results requires only routine skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAN A GERIDO/ Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797