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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 1, 3-4, 6 are rejected under applicant-cited Arai (JP2016159274, references are made to the English translation provided by applicant) in view of Kozlenko (US9566579) further in view of Kohara (US9814792).
Claim 1: Arai teaches a disposable pipette used in a medical field or a biochemical field, the disposable pipette comprising: a resin-made pipette main body (see annotated Fig. 1, below) having a connection portion (cartridge 1) connected to a suction device (pipettor 3); and a resin filter (resin-sintered filter 15) in which, the resin filter is inserted into the connection portion and is subjected to radiation exposure (radiation sterilization [0017, 0028]).
Arai fails to teach wherein the pipette main body is made of resin.
However, Kozlenko teaches a pipette 410 (Fig. 4) including a main body (shaft 430) made of resin (col. 6, lines 28-29).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to make a pipette main body from resin in order to be able to see the contents therein by using a clear pipette material (Kozlenko, col. 6, lines 28-29).
Arai in view of Kozlenko fails to teach in a case where the resin filter is inserted into the connection portion and is subjected to radiation exposure such that an absorbed dose is 20 kGy or more, an elution amount measured in accordance with a plastic drug container test method eluate test of Pharmacopoeia of Japan is equivalent to a maximum absorbance of 0.08 or less in a wavelength range of 220 nm to 241 nm and is equivalent to a maximum absorbance of 0.05 or less in a wavelength range of 241 nm to 350 nm.
However, Kohara teaches a sterilized medical formed article including a medical formed article formed form resin (claim 1) wherein an elution test and UV absorption are assessed (Col. 9, lines 33-end). The UV absorption results were assessed as follows: A case where the difference in absorbance at 220 to 241 nm with respect to the blank sample was 0.08 or less was evaluated as “Good”, and a case where the difference in absorbance at 220 to 241 nm with respect to the blank sample was more than 0.08 was evaluated as “Bad”. A case where the difference in absorbance at 241 to 350 nm with respect to the blank sample was 0.05 or less was evaluated as “Good”, and a case where the difference in absorbance at 241 to 350 nm with respect to the blank sample was more than 0.05 was evaluated as “Bad”.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the teaching of Kohara with the device of Arai in view of Kozlenko in order to suppress changes to the medical formed article when subject to high-energy rays for sterilization (Kohara, col. 7, lines 17-29).
Claim 3: Arai in view of Kozlenko further in view of Kohara teaches the pipette of claim 1. Arai teaches wherein the resin filter is a porous resin sintered filter ([0018 porous resin sintered filter 15).
Claim 4: Arai in view of Kozlenko teaches the device of claim 1. Arai teaches wherein the resin filter is formed of a polyethylene-based resin or a polypropylene-based resin ([0020] polyethylene or polypropylene).
Claim 6: Arai in view of Kozlenko teaches the device of claim 3. Arai teaches wherein the resin filter is formed of a polyethylene-based resin or a polypropylene-based resin ([0020] polyethylene or polypropylene).
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Arai in view of Kozlenko further in view of Kohara further in view of Kulshrestha et al. (US2013/0116628).
Claim 2: Arai in view of Kozlenko further in view of Kohara teaches the pipette of claim 1, but fails to teach wherein the elution amount, in a case where the resin filter is subjected to radiation exposure such that an absorbed dose is 70 kGy or more, is equivalent to a maximum absorbance of 0.08 or less in the wavelength range of 220 nm to 241 nm and is equivalent to a maximum absorbance of 0.05 or less in the wavelength range of 241 nm to 350 nm.
However, Kulshrestha teaches the use of resins for disposable medical devices (title) including resin material which is radiation stable and capable of withstanding exposure to gamma rays in the range from about 5 kGys to about 75 kGys [0083]. Therefore, it is known to expose devices to radiation in the range including 70kgy or more.
Based on the teachings of Kohara, a person having ordinary skill in the art before the effective filing date of the invention would want the maximum absorbance to remain 0.08 or less in the wavelength range of 220 nm to 241 nm and 0.05 or less in the wavelength range of 241 nm to 350 nm when the exposure is increased from 20kGy to 70 (or more) kGy. The exposure of 70+ kGy is known in the art when sterilizing resin, as taught by Kulshrestha.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use a resin which exhibits the desired maximum absorbance taught by Kohara when exposed to anticipated radiation in the range of 70 kGy, as taught by Kulshrestha in order to use a material that is capable of withstanding increased radiation to obtain sufficient sterilization (Kulshrestha [0012]).
Claim 5: Arai in view of Kozlenko further in view of Kohara teaches the device of claim 2. Arai teaches wherein the resin filter is formed of a polyethylene-based resin or a polypropylene-based resin ([0020] polyethylene or polypropylene).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEAN MORELLO whose telephone number is (313)446-6583. The examiner can normally be reached M-F 9-4.
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/JEAN F MORELLO/Examiner, Art Unit 2855 6/22/26
/KRISTINA M DEHERRERA/Supervisory Patent Examiner, Art Unit 2855
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