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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/28/2026 has been entered.
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.
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) and U.S. Patent Application Publication No. 2013/0323711 to Singh et al.
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.
I.) Regarding applicant’s claim 1, as noted above Damen in view of Tachibana et al. and Singh et al. teaches all the elements of claim 1.
Therefore, Damen in view of Tachibana et al. and Singh et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. as applied to claim 1.
III.) Regarding applicant’s claim 3, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. as applied to claim 1.
IV.) Regarding applicant’s claim 4, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. as applied to claim 1.
VI.) Regarding applicant’s claim 5, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. 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. and Singh et al. renders claim 5 obvious.
VII.) Regarding applicant’s claim 6, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. 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. and Singh et al. renders claim 6 obvious.
VIII.) Regarding applicant’s claim 8, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. the lid incorporated from Singh et al. has a hinged mechanism as shown in Fig. 2B.
Therefore, Damen in view of Tachibana et al. and Singh et al. renders claim 8 obvious.
IX.) Regarding applicant’s claim 9, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. reads on applicant’s claimed filtration nozzle in claim 9.
Therefore, Damen in view of Tachibana et al. and Singh et al. renders claim 9 obvious.
X.) Regarding applicant’s claim 10, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. 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. and Singh et al. renders claim 10 obvious.
XI.) Regarding applicant’s claim 12, as noted above, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. can be disposed of.
Therefore, Damen in view of Tachibana et al. and Singh et al. renders claim 12 obvious.
XII.) Regarding applicant’s claim 13, as noted above, Damen in view of Tachibana et al. and Singh et al. renders claim 1 obvious from which claim 13 depends.
Applicant’ claim 13 recite 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. and Singh et al., including double packaging for reducing the number of packaging container used.
Therefore, Damen in view of Tachibana et al. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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, 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. 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. and Singh et al.
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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. 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. and Singh et al. do 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. and Singh et al. 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., 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. and Singh et al. 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. and Singh et al. do 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. and Singh et al. 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., Okanojo et al. and Noda et al. renders claim 17 obvious.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive.
On page 8 of applicant’s response filed 02/18/2026 applicant argues that when the upper portion of Damen is opened, the insert is no longer maintained in a supported configuration and is accessible for removal or replacement.
Applicant’s argument overlooks that Damen has been amended above to include a lid as taught by Singh et al. which would allow the insert to maintained in a supported configuration and accessible for removal or replacement when the lid is open.
On page 8 of applicant’s response filed 02/18/2026 applicant argues that Tachibana et al. likewise does not disclose a filter cup that remains supported by a flange while a lid is opened or closed, nor does it describe a suspended configuration maintained by cooperation between a flange and an upper attachment.
As noted above, Tachibana et al. as been relied upon as teaching an assembly that includes a housing 10 and a filter 20 within the housing that captures microorganisms rending it obvious to modify Damen to include a membrane filter on the bottom of insert 64 for capturing microorganisms as taught by Tachibana et al.
On pages 8-9 of applicant’s response filed 02/28/2026 applicant argues that Singh et al. does not disclose a lid that is positioned away from an opening surface to enclose an internal sterile space while maintaining continuous support of a suspended filter cup and that Singh et al. also does not disclose or suggest a structural arrangement in which a filter cup remains supported by a flange engaged with an upper attachment during lid opening and closing.
As noted above, Singh et al. teaches a lid 215 for an upper portion 201 of a filtering apparatus, rendering it 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.
Applicant argues concerning the internal sterile space are not persuasive since it would have been obvious to initially began using the apparatus of Damen as modified by Tachibana et al, and Singh et al. in a sterile condition to avoid contamination.
While applicant has argued the individual references it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. (MPEP (IV)).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798