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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/02/2026 has been entered.
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.
1. Claims 1-6, 8-10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over European Patent Application No. EP0718618 to Damen in view of Japanese Patent Application Publication No. 2017201969 to Tachibana et al. (cited by applicant), U.S. Patent Application Publication No. 2013/0323711 to Singh et al. and U.S. Patent No. 5,178,753 to Trabold.
Damen teaches an apparatus for filtering objects such as cells (Abstract) that holds an insert 64 (‘filter cup”) having a membrane filter 65 in an apparatus that includes a lower portion that covers a lower portion of the insert 64 and has at least one through-hole in a bottom surface portion, and an upper portion connected to the lower portion that covers an upper portion of the insert 64. (Fig. 4)
The “filter cup” in Damen includes a flange that supports the filter cup in the lower portion, which flange is away from the opening surface of the filter cup:
[AltContent: arrow][AltContent: textbox (Through-hole)][AltContent: arrow][AltContent: textbox (Filter cup)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Flange)][AltContent: textbox (Upper portion: Second filer cup attachment)][AltContent: textbox (Lower portion: First filter cup attachment)]
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As shown in an enlarged portion of Fig. 5, the flange is formed on an “upper portion” of the filter cup above the height mid-point:
[AltContent: textbox (Mid-point of height of cup)][AltContent: arrow]
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Damen teaches a tube 80c that extends into the lower portion and terminates at a through-hole that is located below the membrane filter as shown in Fig. 6.
Damen does not teach a filter cup with a filter for capturing microorganisms.
Tachibana et al. teaches an assembly that includes a housing 10 and a filter 20 within the housing that captures microorganisms 101. (Abstract, page 4, paragraph 6 English translation)
It would have been obvious to one of ordinary skill in the art to modify Damen to include a membrane filter on the bottom of insert 64 for capturing microorganisms as taught by Tachibana et al. Damen teaches that the membrane filter is used to separate or collect objects such as cells and particles.
Damen in view of Tachibana et al does not teach a lid on the upper portion of the assembly.
Singh et al. teaches a lid 215 for an upper portion 201 of a filtering apparatus. (Fig. 2B)
It would have been obvious to modify Damen in view of Tachibana et al. to include a lid on the upper portion of the assembly as taught by Singh et al. for purposes of being able to easily access the interior of the apparatus to place and replace the insert 64 (“filter cup”).
When such a lid is closed on the modified Damen device, an internal space would be enclosed which space would be sterile prior to use of the modified Damen device.
The upper and lower portions of the apparatus of Damen are connected by cooperating threaded areas as shown in Fig. 5.
Damen in view of Tachibana et al., Singh et al. does not teach attachment joint holes on an upper surface portion of the lower portion, wherein one of the attachment joint holes is on one side of an internal space of the lower portion filter cup attachment where the lower portion of the filter cup is located, or connectors projecting from a surface of the lower portion, the connectors being configured to be inserted into the attachment Joint holes of the lower portion to thereby connect the lower portion to the upper portion.
Trabold teaches attaching two cylindrical structures 21 using bolts 11 (“connectors”) that extend through holes (“joint holes”) that are aligned between the cylindrical structures.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Damen in view of Tachibana et al., Singh et al. to provide holes (“joint holes”) in an upper surface of the lower portion and in the lower surface of the upper portion through which bolts (“connectors”) can be used to secure the upper and lower portions together as taught by Trabold as a known means to connect cylindrical structures together.
I.) Regarding applicant’s claim 1, as noted above Damen in view of Tachibana et al., Singh et al. and Trabold teaches all the elements of claim 1.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that at least one through-hole is structurally configured to be fluidly connected to a suction filtration attachment having a connection structure portion connectable to a suction device.
The suction filtration attachment having a connection structure portion connectable to a suction device is not recited as a structural element in claim 2.
Rather, claim 2 recites that the at least one through-hole is “configured” to be fluidly connected to a suction filtration attachment having a connection structure portion connectable to a suction device.
Damen teaches a tube 80c that extends into the lower portion and terminates at a through-hole that is located below the membrane filter as shown in Fig. 6 and thereby teaches the at least one through-hole recited in claims 1 and 2.
The at least one though-hole of Damen is able, i.e., “configured” to be fluidly connected to a suction filtration attachment having a connection structure portion connectable to a suction device.
Therefore, claim 2 is rejected as being obvious over Damen in view of Tachibana et al., Singh et al. and Trabold as applied to claim 1.
III.) Regarding applicant’s claim 3, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 2 obvious from which claim 3 depends.
Claim 3 recites that the suction filtration attachment further includes a flow path that fluidly connects the at least one through-hole and the connection structure portion, and wherein the connection structure portion has a valve that controls opening and blocking of the flow path.
As noted above, the filtration attachment is recited in an intended use manner in claim 2 and is therefore not a claimed element of the filtration cartridge and not afforded any patentable weight.
Therefore, claim 3 is rejected as being obvious over Damen in view of Tachibana et al., Singh et al. and Trabold as applied to claim 1.
IV.) Regarding applicant’s claim 4, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the at least one through-hole is structurally configured to be fluidly connected to a centrifugal filtration attachment. As such the centrifugal filtration attachment is only recited in intended use language and is not a claimed structural element in claim 4.
Damen teaches a tube 80c that extends into the lower portion and terminates at a through-hole that is located below the membrane filter as shown in Fig. 6 and thereby teaches the at least one through-hole recited in claims 1 and 2.
The at least one though-hole of Damen is able, i.e., “configured” to be fluidly connected to a centrifugal filtration attachment.
Therefore, claim 4 is rejected as being obvious over Damen in view of Tachibana et al., Singh et al. and Trabold as applied to claim 1.
VI.) Regarding applicant’s claim 5, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 4 obvious from which claim 5 depends.
Claim 5 recites that the centrifugal filtration attachment has a container communicating with the through-hole.
Claim 5 depends on claim 4 which recites the centrifugal filtration attachment in an intended use recitation, so that the centrifugal filtration attachment is not a claimed element of applicant’s filtration cartridge.
Thus, the centrifugal filtration attachment recited in claim 5 is not given any patentable weight.
Nevertheless, as noted above, it would have been obvious to connect the through-hole in the lower portion of Damen in view of Tachibana et al., Singh et al. and Trabold to a centrifugal filtration attachment to perform centrifugal filtration as taught by Tachibana et al.
It would have further been obvious to include a container with the centrifugal filtration attachment that communicates with the through-hole to collect filtrate.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 5 obvious.
VII.) Regarding applicant’s claim 6, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that a closed state of the lid includes a first closed state in which the lid encloses the internal sterile space while maintaining a gap relative to the opening surface, and a second closed state in which the lid seals the internal sterile space.
In closing the lid of Damen in view of Tachibana et al., Singh et al. and Trabold when the cap is positioned over the upper portion of the assembly, before being fully pressed downward, a gap would exist before achieving a sealed state.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 6 obvious.
VIII.) Regarding applicant’s claim 8, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 8 depends.
Applicant’s claim 8 recites that the lid is opened and closed by a hinge mechanism while maintaining support of the filter cup by the flange.
In Damen in view of Tachibana et al., Singh et al. and Trabold the lid incorporated from Singh et al. has a hinged mechanism as shown in Fig. 2B.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 8 obvious.
IX.) Regarding applicant’s claim 9, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 9 depends.
Claim 9 recites that the through-hole is a filtration nozzle through which a liquid is able to pass from the upper portion to a lower portion of the filter cup attachment.
Applicant discloses that the filtration nozzle is a through-hole provided at the bottom portion of the first filter cup attachment. [0021]
Since applicant’s through-hole is below the filter 21, the “filtration nozzle” is interpreted as merely being the through-hole in the bottom of the lower portion of the filter cup attachment through which fluids having passed through filter 21 can pass.
Otherwise, a different “filtration nozzle” structure is not shown in the drawings as required under 37 CFR 1.83(a).
Therefore, the through-hole in Damen in view of Tachibana et al., Singh et al. and Trabold reads on applicant’s claimed filtration nozzle in claim 9.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 9 obvious.
X.) Regarding applicant’s claim 10, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 10 depends.
Claim 10 recites that an open portion of the through-hole is sealed with a sealing member.
In Damen in view of Tachibana et al., Singh et al. and Trabold it would have been obvious to seal the thorough-hole with sealing material such as tape before assembling the apparatus for purposes of keeping debris from entering the through-hole and apparatus housing.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 10 obvious.
XI.) Regarding applicant’s claim 12, as noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 12 depends.
Applicant’s claim 12 recites that the filtration cartridge is disposable.
The assembly of Damen in view of Tachibana et al., Singh et al. and Trabold can be disposed of.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 12 obvious.
XII.) Regarding applicant’s claim 13, as noted above, Damen in view of Tachibana et al. Singh et al. and Trabold renders claim 1 obvious from which claim 13 depends.
Applicant’ claim 13 recite that the filtration cartridge is at least doubly packaged.
Damen in view of Tachibana et al. Singh et al. and Trabold does not teach that the filtration cartridge is at least doubly packaged.
When packaging for shipping or storage, it would have been obvious to package any number of the assemblies of Damen in view of Tachibana et al., Singh et al. and Trabold, including double packaging for reducing the number of packaging container used.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 13 obvious.
2. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Damen in view of Tachibana et al., Singh et al. and Trabold as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2016/0067710 to Larsen et al.
I.) As noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the lid moves in a direction parallel to the opening surface during opening and closing.
Singh et al. teaches a hinged lid.
Damen in view of Tachibana et al., Singh et al. and Trabold does not teach a lid that moves parallel to the opening of the insert 64.
Larsen et al. teaches that sliding, hinged or a removable lids are functionally equivalent. [0081].
It would have been obvious to one of ordinary skill in the art to modify Damen in view of Tachibana et al., Singh et al. and Trabold to include a sliding lid as a matter of design choice based on Larsen et al teaching that sliding, hinged or a removable lids are functionally equivalent.
Therefore, Damen in view of Tachibana et al. Singh et al., Trabold and Larsen et al. renders claim 7 obvious.
3. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Damen in view of Tachibana et al., Singh et al. and Trabold as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2010/0255484 to Halverson et al. (cited by applicant)
I.) As noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 1 obvious from which claim 11 depends.
Claim 11 recites that the filter cup include a support plate that fixes the filter and the support plate has a through-hole through which the liquid having passed through the filter.
Damen in view of Tachibana et al., Singh et al. and Trabold does not teach a support plate.
Halverson et al. teaches a filter support plate that can have a plurality of apertures.
It would have been obvious to modify Damen in view of Tachibana et al., Singh et al. and Trabold to include a filter support plate in the insert 64 having through-holes as taught by Halverson et al. for purposes of supporting the filter.
Therefore Damen in view of Tachibana et al. Singh et al., Trabold and Halveron et al. renders claim 11 obvious.
4. Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Damen in view of Tachibana et al., Singh et al. and Trabold.
I.) Regarding applicant’s claim 14, claim 14 recites a microbial test method that uses the filtration cartridge of claim 1 and the steps of: connecting the filtration cartridge to a suction filtration attachment in a sterile operation zone; connecting the suction filtration attachment to a suction device; opening the lid of the second filter cap attachment (upper portion of the assembly) to add a sample into the filter cup (insert 64); closing the lid to enclose the internal sterile space above the opening surface; and driving the suction device to filter the sample so that microorganisms are captured by the filter.
As noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders obvious the structure of the filtration cartridge.
Damen teaches applying a vacuum to the lower portion of the assembly (column 3, lines 48-50) and providing a negative pressure to draw fluid through the filter (column 4, line 13-17)
Tachibana et al. teaches both suction filtration (page 5, paragraph 4 of English translation) and centrifugal filtration (page 4, paragraph 1 of English translation)
When using the assembly of Damen in view of Tachibana et al., Singh et al. and Tarbold to test microorganisms as taught by Tachibana et al., it would have been obvious to attach a suction device to the lower portion of the assembly to draw fluid through the filter of the insert 64.
It would have further been obvious to open the lid to add sample to the insert 64 and close the lid before applying suction to the lower portion. Performing the test in sterile environment would have been obvious to avoid contamination and renders obvious a sterile space between the lid and opening.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 14 obvious.
II.) Regarding applicant’s claim 16, claim 16 recites a microbial test method that uses the filtration cartridge of claim 1 and the steps of: connecting the filtration cartridge and a centrifugal filtration attachment in a sterile operation zone; opening the lid of the second filter cap attachment (upper portion of the assembly) to add a sample into the filter cup (insert 64); closing the lid and driving the suction device; and performing centrifugal filtration of the sample so that microorganisms are captured by the filter.
As noted above, Damen in view of Tachibana et al., Singh et al. and Trabold renders obvious the structure of the filtration cartridge.
As further noted above, Tachibana et al. teaches both suction filtration (page 5, paragraph 4 of English translation) and centrifugal filtration (page 4, paragraph 1 of English translation)
When using the assembly of Damen in view of Tachibana et al., Singh et al. and Trabold to test microorganisms as taught by Tachibana et al., it would have been obvious connect the assembly and a centrifugal filtration attachment in a sterile operation zone.
It would have further been obvious to open the lid to add sample to the insert 64 and close the lid before applying performing centrifugal filtration. Performing the test in sterile environment would have been obvious to avoid contamination.
Therefore, Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 16 obvious.
5. Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Damen in view of Tachibana et al., Singh et al. and Trabold as applied to claims 14 and 16 above, and further in view of U.S. Patent Application Publication No. 2015/0192505 to Okanojo et al. (cited by applicant) and U.S. Patent No. 10,323,266 to Noda et al.
I.) Regarding applicant’s claim 15, as noted above Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 14 obvious from which claim 15 depends.
Claim 15 recites opening the lid in the sterile operation zone after the capturing of the microorganisms, adding a first reagent to the filter cup, closing the lid, and then performing reaction;
filtering, after the reaction, the first reagent by driving the suction device; opening the lid in the sterile operation zone to add a second reagent to the filter cup; closing the lid to perform reaction; and
opening the lid in the sterile operation zone to distribute a reaction liquid of the second reagent and the microorganisms from above the filter of the filter cup.
Damen in view of Tachibana et al., Singh et al. and Trabold does not teach adding first and second reagents to the insert 64.
Okanojo et al. teaches filtering microorganisms, removing ATP (adenosine triphosphate) and adding a luminous reagent (e.g., luciferase and luciferin) and measurement of the luminescence. [0013]
Noda at al. teaches using a reagent to extract ATP. (column 2, lines 28-30)
In performing the test method using the assembly of Damen in view of Tachibana et al. Singh et al. and Trabold above, it would have been obvious, after filtering microorganisms to include a first reagent to extract ATP as taught by Noda et al. and then a second luminous reagent as taught by Okanojo et al. to conduct analysis of the microorganisms.
Therefore, Damen in view of Tachibana et al., Singh et al., Trabold, Okanojo et al. and Noda et al. renders claim 15 obvious.
II.) Regarding applicant’s claim 17, as noted above Damen in view of Tachibana et al., Singh et al. and Trabold renders claim 16 obvious from which claim 17 depends.
Claim 17 recites opening the lid in the sterile operation zone after the capturing of the microorganisms, adding a first reagent to the filter cup, closing the lid to perform reaction, setting the filtration cartridge in the centrifuge after reaction; performing centrifugal filtration of a first reaction liquid of the first reagent and the microorganisms; removing the first centrifugal filtration attachment in the sterile operation zone; connecting the second centrifugal filtration attachment to the filtration cartridge; opening the lid to add a second sample to the filter cup; closing the lid; performing reaction; setting the filtration cartridge to which the second centrifugal attachment is connected in the centrifuge after reaction to filter the second reaction liquid of the second reagent and the microorganisms by centrifugal filtration; and collecting the filtrate in a container provided in the second centrifugal filtration attachment.
Damen in view of Tachibana et al., Singh et al. and Trabold does not teach adding first and second reagents to the insert 64.
Okanojo et al. teaches filtering microorganisms, removing ATP (adenosine triphosphate) and adding a luminous reagent (e.g., luciferase and luciferin) and measurement of the luminescence. [0013]
Noda at al. teaches using a reagent to extract ATP. (column 2, lines 28-30)
In performing the test method using the assembly of Damen in view of Tachibana et al., Singh et al. and Trabold above, it would have been obvious, after filtering microorganisms to include a first reagent to extract ATP as taught by Noda et al. using a first centrifugal attachment to the assembly and then adding a second luminous reagent as taught by Okanojo et al. and using a second centrifugal attachment to the assembly, and collect the filtrate after the second reaction for analysis purposes
Therefore, Damen in view of Tachibana et al., Singh et al., Trabold, Okanojo et al. and Noda et al. renders claim 17 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 1-13 have been considered but are moot because the new ground of rejection relies upon Trabold as teaching using holes and connectors to connect cylindrical elements together as necessitated by applicant’s amendments to the claims.
Conclusion
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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