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 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 7, 12, 14, 17 and 19 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.
Claim 7 depends from itself.
Claim 12 recites the limitation "said partition coefficient" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 depends from itself.
Claim 17 depends from itself.
Claim 19 recites the limitation "the partition coefficient" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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) 1-6, 9-11, 13, 15 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olechno, et al (U.S. Patent Application Publication 2019/0301986 A1).
Regarding claim 1, Olechno discloses a method of assessing hydrophobicity of a target analyte (paragraphs 0234, 0241-0247), comprising:
Preparing a single-phase system (paragraph 0244) and a phase-separated system (paragraph 0241) containing substantially the same quantity of a target analyte;
Introducing at least a portion of the single-phase system into a mass spectrometer to acquire a first measurement of at least one mass signal associated with said target analyte (paragraphs 0245, 0246, 0227);
Introducing at least a portion of a phase of the phase-separated system in which miscibility of said target analyte is different than its miscibility in said single-phase system into the mass spectrometer to acquire a second measurement of said at least one mass signal associated with said target analyte (paragraphs 0242, 0243, 0227), and
Utilizing said first and second measurements of said mass signal to assess hydrophobicity of said target analyte (paragraph 0247).
Regarding claim 2, Olechno discloses wherein any of said steps of introducing any of said single-phase system and said phase-separated system into the respective mass spectrometer comprises applying one or more acoustic pulses to any of said single-phase system and said phase-separated system so as to eject a plurality of droplets thereof into the respective mass spectrometer (paragraphs 0241, 0242, 0245, 0227).
Regarding claim 3, Olechno discloses wherein said one or more acoustic pulses are applied to an exposed surface of any of said single-phase and phase-separated system (paragraph 0250).
Regarding claim 4, Olechno discloses wherein said single-phase system comprises an aqueous solution of said target analyte (paragraph 0234).
Regarding claim 5, Olechno discloses wherein said phase-separated system comprises a mixture of said target with water and an organic solvent, wherein said organic solvent includes any of pentanol and octanol (paragraph 0234, 0139, 0140).
Regarding claim 6, Olechno discloses wherein said step of utilizing said first and second measurements for assessing hydrophobicity of the target analyte comprises obtaining a ratio of said second and said first mass measurements and determining whether said ratio lies within a predefined range (paragraph 0247).
Regarding claim 9, Olechno discloses a method of assessing hydrophobicity of a target analyte, comprising:
Acquiring a first measurement of a mass signal of a target analyte from a single-phase system containing a quantity of said target analyte (paragraph 0244);
Acquiring a second measurement of said mass signal of the target analyte from a phase of a phase-separated system, which contains substantially the same quantity of said target analyte, wherein said target analyte exhibits a miscibility in said phase of the phase-separated system that is different than its miscibility in the single-phase system (paragraphs 0241-0243); and
Utilizing said second and first measurements of the mass signal to assess hydrophobicity of said target analyte (paragraph 0247).
Regarding claim 10, Olechno discloses wherein the step of utilizing said second and first measurements of the mass signal comprises computing a ratio of an intensity of said second measurement of the mass signal relative to said first measurement of the mass signal (paragraph 0247).
Regarding claim 11, Olechno discloses calculating a hydrophobicity parameter (distribution coefficient D) for said target analyte based on said ratio.
Regarding claim 13, Olechno discloses determining whether said hydrophobicity parameter lies within a predefined range for assessing hydrophobicity of said target analyte (paragraph 0247).
Claim 15 is drawn to the apparatus for performing the method of claim 1, and the same rejection applies mutatis mutandis.
Regarding claim 16, Olechno discloses wherein the analysis module is configured to compute said measure of hydrophobicity based on a partition coefficient (distribution coefficient D) of said target analyte.
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.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olechno in view of Danielsson, et al (“Methods for determining n-octanol-water partition constants” Trac Trends in Analytical Chemistry, Elsevier, Amsterdam, NL, vol 15, no. 4, April 1 1996, pp. 188-196; cited in IDS, copy in IFW).
Regarding claim 18, Olechno teaches the system of claim 18, but fails to teach wherein said analysis module is configured to assess an oral bioavailability of said target analyte based on said computed measure of hydrophobicity; however, Danielsson teaches that the relevance of the partition constant to the bioavailability is well known; see, e.g. section 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the computed measure of hydrophobicity to assess an oral bioavailability of the analyte in Olechno’s system, because such an assessment was a well known use of a measure of hydrophobicity.
Allowable Subject Matter
Claims 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 8, the prior art fails to teach wherein the ratio increases as hydrophobicity of said target analyte increases.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P MASKELL whose telephone number is (571)270-3210. The examiner can normally be reached M-F 10A-6P.
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/MICHAEL MASKELL/ Primary Examiner, Art Unit 2878 22 August 2026
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