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 (method) is defined by the positively claimed steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that the term “plurality” and nouns ending in “s” only requires 2.
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 1-6 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.
As to claim 1, it is unclear what steps are required to be performed to define the method because such steps are not clearly listed. Instead the claim recites… a fractionating process for…; a treating process for….; a mixing process; and an analyzing process for…. It is unclear what steps are required to define each of the processes because the claim does not recite such. It appears if such phases should be deleted such that claim provides for a list of steps (actions). However, it is noted that the claim does not specify who and/or what (structure and/or structures) is required to perform each of the such.
As to claim 1, it is unclear if the sample is intended to be a liquid sample because the claim does not clearly recite such. If so, then the claim should clearly recite such. It presumed so because the fractions are labeled as “liquid fractions”. However, this not preclude the fractions of the initial one sample from being a solid and subsequently combined with liquid fractions. (Also applicable to claims 3-4).
It is unclear if each of the plurality of liquid fractions are required to include some amount of the steroid compound because the claim does not require such.
It is unclear what is considered as “treatment” because the claim does not specify such. Any action done to the plurality (two) liquid fractions can be considered as “treatment”.
It is unclear if by “mixing” it is intended for each of the plurality (two) liquid fractions to be mixed with each other and/or mixed with some other substance, material, liquid, etc. because the claim does not recite such. In view of above, it is presumed that the term “solution” means liquid. It is further presumed that the phrase, “the mixed sample solution” is intended to be the same as the prior recited “a single mixed sample solution (liquid)”. If so, the claim should clear recite such. Also applicable to claim 6.
Claims 2-6 are rejected via dependency upon a rejected claim.
As to claim 2, it is unclear what is required of a steroid compound to be considered as having a “specific” structure because the claim does not define such. All compounds have a “specific” structure.
As to claims 2-3, it is unclear what is required to be done and by who/what to define “a derivatization treatment” and “derivatization treatment of estradiol” because such are not defined in the claims. Furthermore, in claim 3, it is unclear how “estradiol” is related to any of the one sample and the two liquid fractions because the claim does not provide for such.
Claim 6 recites the limitation "the solvent of the mixed sample solution". There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of any solvent.
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.
(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.
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.
(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.
Claim(s) 1-2 and 4-6 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Holmquist; Brett et al., US 2013/0137185.
Holmquist discloses methods for measuring steroidal compounds in a plurality of samples by mass spectrometry. (abstract; paragraph 0008).
The method includes the multiplex sample is subjected to an extraction column (fractionating a sample). The extraction column is a solid-phase extraction (SPE) column. In other related embodiments, the extraction column is a turbulent flow liquid chromatography (TFLC) column. (paragraph 0016-17).
A plurality of samples (fractions of sample) are each processed (treated) differently to form a plurality of processed samples, wherein as a result of the processing, the steroidal compound in each processed sample is distinguishable by mass spectrometry from the steroidal compound in other processed samples; combining (mixing the fractions) the processed samples to form a multiplex sample; and the multiplexed sample is analyzed via mass spectrometry. (paragraph 0008).
As to claim 2 the sample fractions can be treated/processed via different derivatization treatments. (paragraphs 0007, 09-10, 24-27, 30, 72, 94-96, and more).
As to claim 6, the samples can include formic acid. (paragraph 0170).
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 Holmquist; Brett et al., US 2013/0137185 as applied above, and further in view of Goldman et al., US 2009/0134325.
Holmquist does not disclose derivatization treatment of estradiol.
Goldman discloses method for determining the amount of estradiol in a test sample where estradiol can be or not be derivatized estradiol prior to detection by mass spectrometry.
It would have been obvious to one of ordinary skill in the art before the effective filing date to recognize that one can choose to derivatize estradiol in a sample prior to performing mass spectrometry to measure the amount of estradiol in a sample as taught by Goldman.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PONTHIER; Jérôme et al.; Fraefel; Marius et al.; Hoffmann; Thomas et al.; Hoffmann; Thomas et al.; MANTZOROS; Christos et al.; HOBOU; Yoshitaka et al.; Griffiths; William et al.; Holmquist; Brett et al.; Holmquist; Brett et al.; Holmquist; Brett et al.; Holmquist; Brett et al.; Grant; Russell Philip et al.; Hyde; Roderick A. et al.; Goldman; Mildred M. et al.; and Yoshihama; Makoto et al. disclose steroidal analysis methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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