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 .
Summary
This is the initial Office action on the 17/922703 application filed on 12/23/25.
Claims 1-23 are pending of which claims 14-23 are new.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 11-13 plus new claims 14-23 in the reply filed on 12/23/25 is acknowledged.
Claims 1-10 were withdrawn by applicant in the above response.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/1/22 and 2/28/24 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: medium adding device, medium collection device, detection device in claim 14, selection mechanism in claim 18 and member covering a surface in claim 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-15, 17-18, 20, 22-23 is/are rejected under 35 U.S.C. 102a1 as being anticipated by MIYASHITA (US 2016/0348146).
Regarding claim 11, 15, 22-23 MIYASHITA discloses a microorganism measuring method (cell detection method) comprising:
dispensing a liquid/reagent (adding part of prepared culture medium) from a reagent tube (medium container) to a collection container 30 (culture 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 culture medium from the culture 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 (culture medium moves from medium container to culture container to collection container) (0082-104, Fig 1).
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, claim limitations interpreted under 35 USC 112f as stated above are: medium adding device is a syringe and functional equivalents thereof [0035 of PGPub]; medium collection device is a centrifuge, pressure pump or other device and functional equivalents thereof [0042 of PGPub] and detection device is a luminescence measurement device is a device that detects light generated by a luminescence reaction including a sensor such as CCD, CMOS, or photomultiplier tube [0056 of PG Pub].
MIYASHITA discloses the method is performed with a reagent dispenser 4 including nozzle and pump which are functional equivalents of syringe and pressure pump (medium adding device, medium collection device) (0077- 0081) and a photon counting unit 52 including a photomultiplier tube (detection device) (0082).
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, claim limitations interpreted under 35 USC 112f as stated above are: selection mechanism: flow path 1008 [0257 of PGPub] or switching valve [0189 of PGPub] and functional equivalents thereof.
MIYASHITA discloses the reagent dispenser includes a pump to make the nozzle suck or discharge liquid (functional equivalent of switching valve) that connects the culture container with a collection container (0077).
Regarding claim 20, claim limitations interpreted under 35 USC 112f as stated above are: member covering a surface is an adapter with valve and capillary and functional equivalents thereof [0158-160 of PGPub].
MIYASHITA discloses the collection container filter 30a has a suction head 32a covering a surface of the filter that has a pathway for fluid flow (functional equivalent of adapter with capillary) (0071-75, Fig 1).
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) 16, 19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over MIYASHITA (US 2016/0348146).
Regarding claim 16, MIYASHITA discloses the nozzle (medium adding device) 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 19, MIYASHITA does not explicitly disclose the medium adding device 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 21, MIYASHITA discloses controlling the amount of aliquot is achieved by predetermined control by a controller (0081) but does not explicitly disclose 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5217875 was cited as a reference in the rejection of related claims in App. No. 17/056454.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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