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 § 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.
Regarding claims 4-6 and 13, the claimed invention is directed to mathematical concepts and mental steps without significantly more. The claim(s) recite(s) “forming droplet dots of the reagent for the (N+1)th layer on the dried droplet dots of the Nth layer, wherein "N" is a natural number of 1 or greater”, “the formation of droplet dots of the reagent for the (N+1)th layer is performed so that the center of each of the droplet dots is positioned at a point of intersection of lines extended between the centers of adjacent ones of droplet dots in the Nth layer” and “the formation of droplet dots of the reagent for the (N+1)th layer is performed so that the droplet dots at least partially cover the dried droplet dots in the Nth layer.” Claim 2 teaches nothing more than a manufacturing method of depositing droplets which is routine, conventional activity to those in the relevant field as disclosed in Pei (2013/0098775). This judicial exception is not integrated into a practical application because ink jets as disclosed in Pei teaches are used for precision droplets and the mathematical equations are just part of gathering information from the ink jet. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as disclosed in Pei.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-3 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pei US (2013/0098775).
Regarding claim 1, Pei teaches a biosensor comprising a base material (20); a conductive part (21) including two or more electrodes (W and S) provided on a surface of the base material (20); and a reagent layer (40, refer to paragraph [0057]) provided on at least a part of the conductive part (21). Applicants further recite “wherein the reagent layer is a reagent layer with the reagent stacked three- dimensionally”, Pei teaches where drops or droplets of the reagent layer compositions are dispensed in the channel and then solidified which is equivalent to a reagent stacked three-dimensionally. (Refer to paragraph [0057]) Applicants further recite “obtained by repeatedly forming droplet dots of the reagent on the conductive part.” This limitation is considered a process and/or intended use limitation, which does not further delineate the structure of the claimed apparatus (i.e. from apparatus claim 1) from that of the prior art. Since claim 1, etc. is drawn to an apparatus statutory class of invention, it is the structural limitations of the apparatus, as recited in the claims, which are considered in determining the patentability of the apparatus itself. This recited process or intended use limitation is accorded no patentable weight to an apparatus. Process limitations are not germane to patentability to a structure, which is not distinguished from the prior art. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As discussed above, the apparatus of Pei teaches where drops or droplets of the reagent layer compositions are dispensed in the channel formed by the channel forming layer containing electrically-conductive paths and then solidified. (Refer to Figure 4)
Regarding claim 2, Pei teaches biosensor comprising a base material (20); a conductive part (21) including two or more electrodes (W and S) provided on a surface of the base material (20); and a reagent layer (40) provided on at least a part of the conductive part, wherein the method comprises repeatedly forming droplet dots of a reagent on the conductive part to form the reagent layer in which the reagent is stacked three- dimensionally. Pei teaches where drops or droplets of the reagent layer compositions are dispensed in the channel by the channel forming layer containing electrically-conductive paths and then solidified. (Refer to paragraph [0057])
Regarding claim 3, drying the droplet dots of the reagent. (Refer to paragraph [0057])
Regarding claim 14, wherein the reagent contains an oxidoreductase and an electron transfer substance. (Refer to paragraph [0007])
Regarding claim 15, a base material (20); a conductive part (21) including two or more electrodes provided on a surface of the base material; and a reagent layer provided on at least a part of the conductive part. (Refer to claim 1 rejection)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pei in view of Deeg (US 5378638).
Refer above for the teachings of Deeg.
Deeg fails to teach the formation of droplet dots of the reagent for the first layer is performed so that adjacent ones of the droplet dots do not overlap and the formation of droplet dots of the reagent for the second or subsequent layers is performed so that adjacent ones of the droplet dots abut one another. Deeg further fails to teach the formation of droplet dots of the reagent is performed repeatedly until droplet dots of at least the fourth layer are formed.
Deeg teacjes an analysis element comprising a carrier layer containing a reagent domain. Deeg teaches several different reagent domain patterns including the formation of droplet dots of the reagent for the first layer is performed so that adjacent ones of the droplet dots do not overlap (refer to Col. 4, Lines 59-65) and the formation of droplet dots of the reagent for the second or subsequent layers is performed so that adjacent ones of the droplet dots abut one another. (Refer to Figure 1) Deeg further fails to teach the formation of droplet dots of the reagent is performed repeatedly until droplet dots of at least the fourth layer are formed. (Refer to Col. 1, Lines 43-49)
It would have been obvious to one having ordinary skill in the art to provide the device of Pei with the different formations of reagent droplets in order to maximize diffusion of the sample during analyisis.
Pei fails to teach the amount of a reagent is 10 ng to 30 ng per one droplet dot and the formation of droplet dots of the reagent is performed until the mean thickness of the reagent layer is 5 um to 10 um.
It would have been obvious to one having ordinary skill in the art to modify Pei such that the amount of a reagent is 10 ng to 30 ng per one droplet dot and the formation of droplet dots of the reagent is performed until the mean thickness of the reagent layer is 5 um to 10 um in order to obtain minimal amount of sample for analysis.
Conclusion
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/JYOTI NAGPAUL/Primary Examiner, Art Unit 1798