DETAILED ACTION
Status of the Claims
Claims 1-6 and 8-17 are pending.
Allowable Subject Matter
The indicated allowability of claim 7 is withdrawn in view of the newly discovered reference(s) to Qian et al. Rejections based on the newly cited reference(s) follow.
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.
3. Claim(s) 1-2 and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qian et al. (US 2003/0211564).
Claim 1. Qian et al. teach a fluid device for measuring glycated protein (multilayer reagent test strip 10 for measuring glycated protein; see abstract and Fig 1), the device comprising:
a protease container portion containing a protease immobilized therein (protease 15 absorbed on nylon mesh; [0083][0107] and Fig 1);
a first ketoamine oxidase container portion arranged separate from and fluidly connected to the protease container portion (signal producing layer 16 comprising ketoamine oxidase arranged separately and fluidly connected to protease nylon mesh; [0061][0083] and Fig 1), the first ketoamine oxidase container portion containing a hydrogen peroxide detection portion and a first ketoamine oxidase immobilized on the hydrogen peroxide detection portion (the signal producing layer 16 comprises ketoamine oxidase covalently bonded to detection region to detect hydrogen peroxide; [0061]); and
a second ketoamine oxidase disposed upstream of the protease (number of distinct layer could be disposed on the test strip including second layer of protease layer and second ketomaine oxidase layer disposed on the first protease and first ketoamine oxidase layer [0025], thus stacked layers comprising second set disposed on first set of layers would comprise second ketoamine oxidase disposed upstream of the protease/first protease.
Claim 2. Qian et al. teach the first ketoamine oxidase container portion is arranged downstream of the protease container portion (signal producing layer 16 is arranged downstream of protease 15; see Fig 1).
Claim 11, Qian et al. teach glycated protein comprises glycated albumin [0005].
Claim 12. Qian et al. teach device further comprises an albumin sensor (glycated albumin is detected by the device; [0005], thus the device is an albumin sensor).
Claim 13. Qian et al. teach fluid device comprising substrate (support element 18; see Fig 1 and [0084]).
Claim 14. Qian et al. teach comprising a protective layer covering the first ketoamine oxidase, the second ketoamine oxidase and/or the protease (mesh layer 12 is disposed over the ketoamine oxidase and protease layer; see Fig 1).
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.
3. Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al. as applied to claim 1 above, and further in view of Hughes et al. (US 2018/0251811).
Claims 15-17. Qian et al. do not teach a heater for heating the protease, the first ketoamine oxidase, and/or the second ketoamine oxidase, a temperature sensor for measuring a temperature of the protease container portion and/or the first ketoamine oxidase container portion and the temperature sensor is configured to output a signal for controlling a temperature of the protease container portion
However, Hughes et al. teach test strip comprised of protease disposed on a track for digestion of Hb [0041]. Hughes et al. further teaches track could be optionally heated to enhance protease digestion activity and a temperature sensor is also included to regulate the temperature level [0041].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Hughes et al. teaching to add heater and temperature sensor to the Qian et al. device to enhance protease digestion activity and regulate temperature level.
Allowable Subject Matter
Claims 3-6 and 8-10 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.
Conclusion
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
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