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 § 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) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shibuya (US 2020/0063106) in view of Ganan (WO 99/30835).
Regarding claims 1 and 10, Shibuya teaches a cell culture apparatus comprising a sampling channel (P4) extracting a culture liquid in a culture tank (2) to be tested in an analysis device; and a pressure applying device (20 a,b,c) applying pressure to the sampling channel. Applicants recite “the pressure applying device controls a fluid in the sampling channel so that a pressure gradient toward an open-end nozzle on an outlet side of the sampling channel is 1 kPa/m or more.” Applicants do not further recite structural elements in the claim in order to achieve the recited pressure gradient. Shibuya teaches a pump and a tube and it is capable of having a pressure gradient toward an open-end nozzle on an outlet side of the sampling channel is 1 kPa/m or more
Notwithstanding, It would have been obvious to one having ordinary skill in the art such that the pressure applying device of Shibuya controls a fluid in the sampling channel so that a pressure gradient toward an open-end nozzle on an outlet side of the sampling channel is 1 kPa/m or more in order to precisely obtain the droplets required for analysis.
Regarding claim 2, Shibuya fails to teach an inner diameter of a tube arranged in the sampling channel is 1.5 mm or less.
Ganan teaches a molecular assembly comprising a capillary needle with an open microchannel arranged in the sampling channel is 1.5 mm or less in order to produce the desired droplet size. (Refer to page 26)
It would have been obvious to on having ordinary skill in the art to provide the device of Shibuya with an inner diameter of a tube arranged in the sampling channel is 1.5 mm or less in order to produce the desired droplet size.
Regarding claims 3 and 11, the sampling channel is provided with a switching mechanism (32) switching between at least one of an aseptic liquid, aseptic water, buffer solution, and aseptic air and the culture liquid.
Regarding claim 4, a measurement device (Refer to paragraph [0049]) measuring a flow pressure or a liquid flow speed in the sampling channel. Applicants further recite “wherein the pressure applying device is controlled based on a measured value measured by the measurement device, and the flow pressure or the liquid flow speed is controlled so as to achieve the pressure gradient.” This limitation is considered a process and/or intended use limitation, which do 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. are 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. The pressure applying device of Shibuya is capable of being controlled by the pressure regulating valve based on a measured value measured by the measurement device, and the flow pressure or the liquid flow speed is controlled so as to achieve the pressure gradient.
Regarding claim 5, the sampling channel includes a check valve. (Refer to paragraph [074])
Regarding claim 6, Applicants recite “a flow speed when extracting the culture liquid is in a laminar flow region with a Reynolds number of less than 2,000.” This limitation is considered a process and/or intended use limitation, which do 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. are 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. The pressure applying device of Shibuya is capable of a flow speed when extracting the culture liquid is in a laminar flow region with a Reynolds number of less than 2,000.
Regarding claim 7, the pressure applying device is at least one of a tube pump, a diaphragm pump, an air pump for feeding aseptic air, and an air compressor for feeding aseptic air. (Refer to paragraph [0118])
Regarding claim 8, a material of the tube (p4) is fluororesin, polytetrafluoroethylene, tetrafluoroethylene/ethylene copolymer, tetrafluoroethylene/perfluoroalky. vinyl ether copolymer, polyetheretherketone, or polyetheretherketone ketone. (Refer to paragraph [0074])
Regarding claim 9, the tube (P4) is arranged immediately before the analysis device. (Refer to Figure 1)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI NAGPAUL whose telephone number is (571)272-1273. The examiner can normally be reached M-F 9am to 5pm, EST.
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/JYOTI NAGPAUL/Primary Examiner, Art Unit 1798