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 .
Response to Amendment
The amendment filed 7/6/26 has been entered and fully considered.
Claims 1-23 remain pending, of which claims 1-10 were previously withdrawn.
The previous 35 USC 112f interpretation has been withdrawn due to the amendments.
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) 11-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over MIYASHITA (US 2016/0348146) in view of ISHIMARU (US 2021/0207072) (newly cited) as supplied by applicant on the IDS dated 11/1/22.
Regarding claim 11, 15, 22-23 MIYASHITA discloses a microorganism measuring method (cell detection method) comprising:
dispensing a liquid/reagent (adding medium) from a reagent tube (medium container) to a collection container 30 (container) holding sample microorganisms (holding cells to be detected) on a filter surface 30a (filter inherently has pore diameter smaller than size of cells being tested in order to hold the cells);
taking an aliquot of the reaction liquid 110a in the collection container 30 and dispensing it into a measurement tube 50 (collecting the medium from the container)(0071);
and measuring the luminescence intensity based on the single photon method (detecting light from) from the tube 50 having a luminescence reagent 110d mixed with the reaction liquid 110a (medium moves from starting container to cell container to collection container) (0082-104, Fig 1).
MIYASHITA discloses the above method but does not explicitly disclose the medium added to the container holding cells to culture cells held in the container nor the collecting step in which the medium contains a secretion from cultured cells.
However, ISHIMARU discloses a cell detection method comprising adding a liquid medium and specimen (cells to be detected) to prepare a culture medium to a culture portion of a container 200 for culturing the microbes in the container (adding part of prepared culture medium to culture container to culture cells held in culture container) and dripping the culture medium into the lower container (collecting the culture medium in collection container), the medium containing ATP produced by the microbes (containing a secretion from the cultured cells) and detecting light from a luminescent reagent mixed with the collected culture medium (0012, 0058-73).
It would have been obvious to one of ordinary skill in the art to modify the method of MIYASHITA to include the steps of adding a prepared culture medium to a container with cells to culture the cells held in the culture container and collecting the culture medium containing a secretion form the cultured cells as taught by ISHIMARU because it allows for the detection of cell proliferation over time during a cell culturing process while decreasing the possibility of contaminating the culture medium which produces false positives (0009-12).
Regarding claim 12, MIYASHITA discloses repeating the above steps a plurality of times (Fig 3A, 0157, 0161), and compares the results (0162-191, Fig 6).
Regarding claim 13, MIYASHITA discloses using a different measurement tube 50 (collection container) each time when repeating measurements (0108, 0113).
Regarding claim 14, MIYASHITA discloses the method is performed with a reagent dispenser 4 including nozzle and pump (syringe and pressure pump) configured to add or collect medium (0077- 0081) and a photon counting unit 52 (configured to detect light) including a photomultiplier tube (luminescence measurement device) (0082).
Regarding claim 16, MIYASHITA discloses the nozzle (syringe) is configured to discharge a predetermined amount of liquid (0077-78) but does not explicitly disclose the volume is 0.5-5 times a value obtained by multiplying an area and thickness of the filter. However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to choose the predetermined amount to be within the claimed range in order to provide the right amount of liquid to adequately flush the filter as desired by MIYASHITA (0090-93) without using any more than necessary of the expensive reagents. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to choose the volume of liquid to use based on the filter area and thickness, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05.
Regarding claim 17, MIYASHITA discloses the luminescent reagent is a luciferase-luciferin reagent as the ATP luminescence reagent (0101), such that luminescence is caused by ATP in the reaction liquid and the ATP luminescence reagent reacting on each other (0102).
Regarding claim 18, MIYASHITA discloses the reagent dispenser includes a pressure pump to make the nozzle suck or discharge liquid (switching) that connects the culture container with a collection container (0077), but does not explicitly disclose a switching valve configured to connect to an arbitrary collection container among a plurality.
However, ISHIMARU discloses using valves 24 to control introduction into each chamber (0154). It would have been obvious to one of ordinary skill in the art to modify the dispenser system of MIYASHITA to include valves as taught by ISHIMARU for controlling which chamber input fluids are directed to because it allows for automating a filling procedure to reduce the risk of human error and increase productivity of the system.
Regarding claim 19, MIYASHITA does not explicitly disclose the nozzle (syringe) adds the medium substantially parallel to the filter surface. However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to change the orientation of the nozzle of MIYASHITA to be parallel in order to allow for a more even spread of the culture microorganisms over the surface of the filter. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to change the orientation of the nozzle, since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04.
Regarding claim 20, MIYASHITA discloses the collection container filter 30a has a suction head 32a (adapter) covering a surface of the filter that has a pathway for fluid flow (adapter with capillary) and filtration controller to control the pump (valve) (0071-75, Fig 1).
Regarding claim 21, MIYASHITA discloses controlling the amount of aliquot is achieved by predetermined control by a controller (0081) but does not explicitly disclose the nozzle adding an entire amount of culture medium from a reagent tube (medium container). However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to add the entirety of the reagent tube contents as the predetermined aliquot if the reagents were supplied in said tubes in the volume necessary for the detection method being used. Additionally, It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the reagent dispenser add an entire amount of medium from a medium container, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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