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 Objections
Claims 1, 5, 9, and 10 are objected to because of the following informalities: The term “selected” (claim 1, line 10; claim 5, line 9; claim 9, line 3) should recite “selected to” for proper grammatical construction of the phrase. Claim 10 includes two periods at the end of the sentence. Appropriate correction is required.
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.
Claim 15 is 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. It is unclear what Applicant intends by indicating “of any one of claim 5”, as only a single claim number is referred to by the phrase.
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 – 8, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoon et al. (USPN 11,045,119 – cited by Applicant). Yoon et al. discloses an analyte sensor, method of use, and method of manufacture including (references shown in brackets) an analyte sensor apparatus comprising:
a base layer [Fig. 2: "Polyester substrate"];
a conductive layer disposed on the base layer [Column 5, Lines 51-54: "The electrode may be a gold (Au), silver (Ag) or copper (Cu) electrode. Specifically, a gold electrode may be used for accuracy of the electrical signal, although not being limited thereto"], wherein the conductive layer includes a working electrode [Column 5, Lines 35-37: "The intensity of the generated electrical signal is measured as the reduced enzymes encounter an electrode"];
an analyte sensing layer disposed on the working electrode [Fig. 1: "Glucose dehydrogenase (GDH)" – covering details as set forth in Claims 2, 6], wherein the analyte sensing layer comprises an enzyme selected to react with an analyte [Column 5, Lines 23-37: "the 'sensor unit' refers to a unit recognizing the glucose in the biological sample that has been permeated by the filter unit. Specifically, the sensor unit may contain an enzyme such as glucose oxidase, glucose dehydrogenase (GDH), glucose hexokinase, cholesterol oxidase, glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), etc. In addition, it may further contain pyrroloquinoline quinone (PQQ) as a coenzyme. Any enzyme that uses glucose as a substrate may be contained without limitation. When the enzymes contained in the sensor unit encounter the glucose in blood, an electrical signal is generated as the glucose is oxidized and the enzymes are reduced"]; and
an analyte transporting layer disposed over the analyte sensing layer [Column 4, Lines: 43-45: "In the present disclosure, the 'filter unit' refers to a unit which purifies the biological sample and serves to allow selective permeation of glucose in the biological sample"], wherein:
the analyte transporting layer comprises materials that form a phospholipid bilayer [Fig. 1 and Column 4, Lines 63-64: "The filter unit may be formed by coating a cytoplasmic membrane on a biosensor"]; and
the analyte transporting layer comprises at least one protein selected facilitate transport of the analyte from an environment in which the sensor is disposed to the enzyme [Column 4, Lines 53-58: "The glucose transporter protein is a protein that introduces glucose into a cell through the cytoplasmic membrane. It is a transporter that facilitated diffusion-type transporter driven by the difference in glucose concentration inside and outside the cell. It may be GLUT1, GLUT2, GLUT3, GLUT4, etc., specifically GLUT1, although not being limited thereto" – covering details as set forth in claims 3, 4, 7, 8]; and
the analyte transporting layer inhibits the diffusion of at least one of acetaminophen, ascorbate, m-cresol, phenol, glycerol and urate therethrough [column 10, lines 23-29: "In order to investigate the glucose detection specificity of the red blood cell membrane-coated biosensor according to the present disclosure, 5 mM glucose (corresponding to average glucose concentration in human) and the signal-interfering substance ascorbic acid (AA), uric acid (UA) or galactose (GA) at different concentrations were added to a sample and the change in current was measured", Figs. 9A and 98 (top row shows a schematic diagram illustrating the transport layer inhibiting the diffusion of ascorbic acid and uric acid), column 2, lines 50-53: "the present disclosure provides a biosensor for measuring glucose, containing a filter unit formed of a cytoplasmic membrane, wherein the filter unit allows selective permeation of glucose", and column 10, lines 44-56: "As seen from FIGS. 9A-9D, whereas the control group showed increased difference from the normal value as the concentration of the signal-interfering substance was increased, the biosensor coated with the cytoplasmic membrane of the present disclosure could specifically detect glucose only without being significantly affected by the addition of the signal-interfering substance. That is to say, when the red blood cell membrane containing the membrane protein is used as a filter according to the present disclosure, glucose present in the sample can be detected with high sensitivity because not only monosaccharides or disaccharides but also polysaccharides other than glucose present in the sample cannot pass through the filter"].
Additionally, one using the sensor of claim 1 in its intended manner would necessarily perform the steps of claim 15.
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) 9 - 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. as applied to claims 5 - 8 above. Yoon et al. teach an analyte sensor and manufacture thereof, as discussed above but do not provide details of the steps as set forth in claims 9 – 14. However, in implementing Yoon et al. one would be aware of known manufacturing techniques, and the claims generally encompass such known techniques for creating the different layers present in the sensor of Yoon et al. Thus, without a showing of criticality or unexpected results it would have been within the skill level of the art to utilize known manufacturing techniques for manipulation of the phospholipids (claims 9, 10) and creation of certain layers (claim 12), and to optimize properties of the molecules (claim 11, 13, 14) consistent with the intended result/properties as discussed in Yoon et al., since it has generally been held to be within the skill level of the art to rely on known techniques used in their intended manner to provide predicable results.
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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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791