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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended claim 1 to recite supplying a mobile phase including carbon dioxide to a container in which a microorganism is cultured on a solid medium and discharging the mobile phase including a component of a metabolite to a column, and argued that the cited prior art requires extraction steps not required in the instant claims. In light of the amendments, claim 1 is no longer rejected under 35 U.S.C. 102 as detailed in the previous Office Action. However, as detailed below, claim 1 now stands rejected under 35 U.S.C. 103 as being obvious over the combination of Hoang et al., (previously cited) in view of Fujito et al., (US 2021/0116425). Because reference to Ishii et al., is newly cited, the Examiner will not argue the merits of its teachings here, but will instead rely on the rejection detailed below. Therefore, in light of the teachings of the prior art, the Examiner contends that the limitations of the instant claims are taught by the combination of Hoang et al., in view of Fujito et al., thus the claims are not in condition for allowance.
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 phrase “fluidly connected” does not require a direct structural connection between the column and the container. For the purposes of examination, the Examiner will read any fluid connection between a column and a container as being fluidly connected.
For claim 4, the phrase “previously cultured” is indefinite as the Examiner is unable to determine what the term “previously” references. Specifically, is unclear if “previously” means before the extraction, or if “previously” references some other point in the process that is not explicitly recited in claim 4.
For claim 9, the phrase “that flows the container” is oddly phrased, or a typographical error. For the purposes of examination, the Examiner will read claim 9 as being indefinite because the Examiner is unable to determine the metes and bounds of the phrase “that flows the container.”
For claim 13, the term “analyzed” is sufficiently broad so as to read on any type of analysis, including visual analysis of the colonies. As such, the term “analysis” will be broadly interpreted with respect to the prior art.
Claim Rejections - 35 USC § 112
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.
Claims 4, 9, 10, and 13 are 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.
For claim 4, the phrase “previously cultured” is indefinite as the Examiner is unable to determine what the term “previously” references. Specifically, is unclear if “previously” means before the extraction, or if “previously” references some other point in the process that is not explicitly recited in claim 4. Claim 13 depends from claim 4 and is also indefinite.
For claim 9, the phrase “flows the container” is unclear as the Examiner is unable to determine if the container is flowing with the mobile phase, or if the contents of the container is flowing with the mobile phase. For the purposes of examination, the Examiner will read any mobile phase that flows to or into a container as meeting the limitation in question.
For claim 10, the phrase “the mobile phase flows through the solid medium” is unclear as the Examiner is unable to determine the metes and bounds of “flows through.” Specifically, the Examiner is unable to determine if the claim intends to recite a mobile phase penetrating and flowing through a solid medium, or if Applicant considers a mobile phase flowing through the container in contact with the solid medium constitutes a mobile phase flowing through a solid medium. For the purposes of examination, the Examiner will read any mobile phase that flows through a container as meeting the claim limitation.
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) 1-?? 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 Fujito et al., (US 2021/0116425).
Regarding claims 1 and 10, 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 chromatography), placing a microorganism cultured in agar in the mobile phase (page 2263, Bacterial strains, fermentation, extraction, and sample preparation), separating the components of the mobile phase on a column (page 2265, Recovery of analytes from the medium), and performing mass spectrometry on the sample (pages 2263-2264, SFC-HRMS analysis). Hoang et al., do not teach introducing the mobile phase into a container, and discharging the mobile phase to a column fluidly connected to the container.
Fujito et al., teach an extraction, recovery, and analysis method wherein a supercritical fluid including carbon dioxide (paragraph 0025) is introduced to an extraction container that stores a sample (paragraphs 0023, 0025), discharged to a trap column (paragraph 0030), and analyzing the extracted components by mass spectrometry (paragraphs 0012, 0061). With respect to claim 10, the Examiner notes that the claim is being read in light of the rejection under 35 U.S.C. 112(b), and interpreted as set forth in the 112(b) rejection. Fujito et al., teach their extraction method provides the advantage of extracting many components under different extraction conditions from a single fraction (paragraph 0006).
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., with the extraction and analysis method of Fujito et al., in order to extract multiple components under different extraction conditions from a single fraction as taught by Fujito et al.
For claims 2 and 4, 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).
Regarding claims 5 and 6, Hoang et al., teach quantitation of N-acyl homoserine lactones which comprises a hydrocarbon, amino acid, and an alicyclic hydrocarbon (Abstract).
Regarding claims 8 and 9, Hoang et al., do not teach discharging a component and/or metabolite from a container with the mobile phase.
Fujito et al., teach an extraction, recovery, and analysis method wherein the extracted components are discharged from a container to a trap column (paragraph 0029). 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 Fujito et al., teach that target components are dissolved in supercritical carbon dioxide, thus one of ordinary skill in the art would have found it obvious to discharge extracted components dissolved in a mobile phase to a trap column as taught by Fujito et al. 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 extracted components in a mobile phase are discharged from a container to a trap column as taught by Fujito et al., as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 11, Hoang et al., teach supercritical carbon dioxide as the mobile phase (page 2263, Supercritical-fluid chromatography).
Regarding claim 12, Hoang et al., teach the mobile phase comprising methanol (organic modifier, page 2263 Supercritical-fluid chromatography).
Regarding claim 13, Hoang et al., teach cultivating bacteria in Petri dishes for 1 week (page 2263, Bacterial strains, fermentation, extraction, and sample preparation) which reads on analyzing colonies without separation from a solid medium (agar). The Examiner notes that claim 13 is being read in light of the claim interpretation detailed above in which the term “analyzed” is sufficiently broad so as to be read on by the teachings of Hoang et al.
Regarding claim 14, Hoang et al., teach supplying a mobile phase at a pressure sufficient to maintain carbon dioxide in a supercritical state (page 2263, Supercritical-fluid chromatography).
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 Fujito et al., (US 2021/0116425) as applied to claim 1 above, and further in view of Singamaneni et al., (US 2020/0305416).
Regarding claim 3, Hoang et al., in view of Fujito et al., 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.
Claim(s) 7 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 Fujito et al., (US 2021/0116425) as applied to claim 5 above, and further in view of Robertson (US 2018/0344785).
Regarding claim 7, Hoang et al., in view of Fujito et al., do not teach extraction of isoprenoid.
Robertson teaches a method for extraction and isolation of isoprenoid comprising placing flower material into an extraction chamber (paragraph 0027) and introducing a subcritical mobile phase into the extraction chamber (paragraph 0027). Robertson teaches that the taught process provides the advantage of a rapid and cost effective means of extracting isoprenoids (paragraph 0012).
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., in view of Fujito et al., further in view of Robertson to extract isoprenoids in order to provide a rapid and cost effective method of extracting isoprenoids as taught by Robertson.
Conclusion
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 DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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