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 Amendment
The Preliminary amendment filed 10/21/2024 has been entered.
Applicant amended claims 1 and 3, and canceled claim 2.
Drawings
The drawings are objected to because Figures 1-3 . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 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 and 3-6 are rejected under 35 USC § 102(a)(1) as being anticipated by Liao et al. ("Determination of pseudoprotodioscin in rat plasma by UPLC–MS/MS: Assay development and application to pharmacokinetic study") herein known as Liao.
Regarding claim 1, Liao is directed to sensitive ultraperformance liquid chromatography–tandem mass spectrometric (UPLC–MS/MS) method for the determination of pseudoprotodioscin (PPD) in rat plasma (Abstract).
Liao discloses a mass spectrometry method (Abstract, (ultraperformance liquid chromatography–tandem mass spectrometric (UPLC–MS/MS) method)) comprising: a preparation step of adding a predetermined alkali metal ion to a liquid sample (Abstract, (The mobile phase was comprised of acetonitrile and0.1 mmol L−1aqueous lithium acetate); (Section 3.1, (In order to enhance the sensitivity of the method, [M + Li]+was chosen for the precursor ions of PPD and IS by appending 0.1 mM lithium acetate and 0.03% FA in the mobile phase.)), in which the predetermined alkali metal ion is added to an organic solvent (acetonitrile), a mobile phase containing the organic solvent to which the predetermined alkali metal ion has been added is adjusted (Section 2.2, (The gradient elution composed of acetonitrile (mobile phase A) and ultrapure water contained 0.03% formic acid and 0.1 mM lithium acetate (mobile phase B), Multiple-reaction monitoring (MRM) mode was selected for quantification using the [M + Li]+ ion as the precursor.)) and the liquid sample is introduced into a column of a liquid chromatograph on a flow of the mobile phase (Abstract, (Plasma samples were processed byacetonitrile-mediated plasma protein precipitation and chromatographed using a step gradient pro-gram on a C18 column (2.1 × 50 mm i.d., 1.7 μm). The mobile phase was comprised of acetonitrile and0.1 mmol L−1aqueous lithium acetate mixed with 0.03% formic acid at the flow rate of 0.2 mL min−1)), an ionization step of ionizing a target compound contained in the liquid sample flowing out of the column to which the alkali metal ion has been added (Abstract, (Multiple reaction monitoring (MRM) transitions were performed for detection and lithium adduct ions were employed with a significant improvement of the response of the analytes in electrospray positive ionization mode.)), and a measurement step of measuring an intensity of an adduct ion formed in the ionization step by adding the predetermined alkali metal ion to the target compound, or an intensity of an ion derived from the adduct ion (Section 3.1, ( In order to enhance the sensitivity of the method, [M + Li]+was chosen for the precursor ions of PPD and IS by appending 0.1 mM lithium acetate and 0.03% FA in the mobile phase. As is shown in Fig. 1, the intensity of [M +Li] ++peak was more than 10-fold higher than [M + Na] +. Daughter scan of the three adduct ions was also investigated in their corresponding conditions, the fragment ions of [M + Li] +were much higher than the others as well).
Regarding Claim 3, Liao discloses the mass spectrometry method wherein in the preparation step, a pH adjusting agent (Formic acid) for adjusting pH is further added to the mobile phase (Abstract, (The mobile phase was comprised of acetonitrile and 0.1 mmol L−1aqueous lithium acetate mixed with 0.03% formic acid)).
Regarding claim 4, Liao discloses the mass spectrometry method wherein in the preparation step, a volatile salt of a predetermined alkali metal (lithium acetate) is added to the liquid sample. (Abstract, (The mobile phase was comprised of acetonitrile and 0.1 mmol L−1aqueous lithium acetate mixed with 0.03% formic acid)).
Regarding claim 5, Liao discloses the mass spectrometry method, wherein the predetermined alkali metal ion is a lithium ion or a sodium ion (Section 3.1, ( In order to enhance the sensitivity of the method, [M + Li]+was chosen for the precursor ions of PPD and IS by appending 0.1 mM lithium acetate and 0.03% FA in the mobile phase. As is shown in Fig. 1, the intensity of [M +Li] ++peak was more than 10-fold higher than [M + Na] +. Daughter scan of the three adduct ions was also investigated in their corresponding conditions, the fragment ions of [M + Li] +were much higher than the others as well).
Regarding claim 6, Liao discloses the mass spectrometry method wherein in the measurement step, among ions generated in the ionization step, an adduct ion formed by an addition of the predetermined alkali metal ion to the target compound is selected as a precursor ion, the precursor ion is subjected to a dissociation treatment, and then an intensity of an ion not dissociated by the dissociation treatment is measured. (Section 3.1, ( In order to enhance the sensitivity of the method, [M + Li]+was chosen for the precursor ions of PPD and IS by appending 0.1 mM lithium acetate and 0.03% FA in the mobile phase); (Section 2.2, (The gradient elution composed of acetonitrile (mobile phase A) and ultrapure water contained 0.03% formic acid and 0.1 mM lithium acetate (mobile phase B), Multiple-reaction monitoring (MRM) mode was selected for quantification using the [M + Li]+ ion as the precursor.))
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOUD MOTAZ ABDEL LATIF whose telephone number is (571)272-6535. The examiner can normally be reached Monday-Friday 8:30-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin L Lebron can be reached at 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAHMOUD MOTAZ ABDEL LATIF/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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