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 1 – 15 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. With regard to claims 1 – 8, 11 – 13, and 15, through use of the phrases “preferably”, “more preferably”, “in particular”, “optionally”, and/or “even more preferably” the claims include both narrower and broader ranges within the same claim, rendering the metes and bounds unclear (see MPEP 2173.05(c)). With regard to claim 13, the claim appears to define “the electrolyte” in both lines 4 - 5 and lines 16 – 26; it is unclear which iteration Applicant intends to limit the claim scope. With regard to claim 15, the claim is generally drawn to a “use” without reciting any positively claimed steps to perform the corresponding ‘use’.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is drawn to a “use” which is not within one of the statutory categories of invention (see MPEP 2173.05(q)).
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 – 10 and 15 (as best understood in light of the rejections under 35 USC 112, as set forth above) is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Offenbacher et al. (USPN 8,163,165 – cited by Applicant). Offenbacher et al. teach an electrochemical sensor (Figures 2 – 4 and the descriptions thereof in column 4) that may be used for sensing analytes in body fluids, particularly oxygen or carbon dioxide (column 10, lines 4 – 15; column 11, lines 34 - 52). The sensor including a composition that comprises glycerin/glycerol (a hygroscopic compound) and polyethylene glycol (a hydrophilic/evaporation inhibiting compound), in particular as discussed in Example 4 (column 13), which provides elements consistent with the requirements of the claims. Further, recognize use of a pH buffer and/or alkali metal chloride (column 7, lines 28 – column 8, line 14) and mention that the composition may include polyvinylpyrrolidone (column 7, line 55 – column 8, line 2). Offenbacher et al. provide details regarding selection of materials and overall configuration of the sensor in the Detailed Description section.
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) 11 – 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Offenbacher et al. Offenbacher et al. teach all of the features of the claimed invention as discussed above. While Offenbacher et al. discuss details regarding selection of materials, they do not provide the particular composition percentages as set forth in claims 11 and 12. However, without a showing of unexpected results or criticality it would have been within the skill level of the art before the effective filing date of the claimed invention to have performed routine experimentation to determine results-effective variable based parameters of the composition. Additionally, although Offenbacher et al. recognize that their electrochemical sensor may be used to analyze a variety of biological fluids, they do not particularly teach the sensor configuration includes a means for attaching to a living body, as set forth in claim 13. However, a variety of manners to attach/connect an electrochemical sensor to a living subject were well known in the art before the effective filing date of the claimed invention, and thus it would have been within the skill level of the art to modify Offenbacher et al. to include a means for attachment, to permit the sensor to be held in a desired position during the measurement of the body fluid of interest.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chuck Marmor, II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
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