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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 25 August 2025 June 2025.
Claims 1-2 and 4-12 are pending.
Claim 1 is amended.
Claims 3 and 13-14 are cancelled.
No claims are withdrawn.
No claims are newly added.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-8, and 11-12 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Nozaki et al. (US 2017/0145365 A1), referred to hereinafter as “Nozaki”.
Regarding Claim 1, Nozaki teaches a system for defined adjustment of the level of a flowable medium in a hollow body, the system comprising:
a tank 201 (Fig. 2A and [0028]: The cells and the culture mediums are maintained on the inside of the culture vessels 201 and 202, and it is possible to culture the cells.”) containing at least a predefined minimum volume of a flowable medium ([0032]: “the culture medium in the culture vessels 201 and 202”);
a hollow body 202/205 disposed within the tank, the hollow body having one or more openings (Fig. 2A and [0030]: “Further, the culture vessel 202 is an insertion-type culture vessel, so that the regenerative tissues are present on the inside thereof…The bottom surface of the cell culture insertion container 202 is of a porous membrane 213, and has a plurality of holes with a diameter of, for example, about 0.4 μm.” – The insert container thus has one or more openings through its bottom surface via the porous membrane 213. – Additionally, the lid 205 provides the upper wall of the hollow body, forming the “hollow” space within.);
each opening is located entirely below a surface of the flowable medium (As Fig. 2A shows the port 216 (configured to remove culture media as discussed in para. [0036]) as above the membrane containing the one or more openings (as further discussed in para. [0038]), the culture media must thereby extend above the membrane 206 such that the one or more openings (of the membrane) are located completely below the surface of the culture media.);
and one or more channels 215, each including a channel inlet and a channel outlet (Fig. 2A and [0030]: “In the connector part 214, the first port 215 is placed so that in the culture vessel 202, the opening ends thereof comes slightly below the upper end of the culture vessel 202.”),
wherein each channel inlet is positioned in a region of the hollow body configured to contain a volume of gas enclosed between a wall of the hollow body and the flowable medium (Fig. 2A shows pockets of imprisoned gas between the insert container 202 and the flowable medium – see also para. [0056].),
wherein each channel outlet is located outside the hollow body and outside a volume of the flowable medium in the tank (Fig. 2A shows the lower inlet of flow channel 215 the upper outlet of the flow channel 215 is arranged outside the insert container 202 and outside the culture medium.),
and wherein the one or more channels are each configured to allow the gas enclosed between the wall of the hollow body and the flowable medium to be discharged from the hollow body through the respective channel inlets to the channel outlets ([0052]: “the other stream is connected to a first exhaust gas opening/closing valve 303” – Fig. 3 shows the channel 215 as connected to the gas exhaust valve 303, thereby allowing gas enclosed between the wall of the hollow body 202 and the flowable medium to be discharged from the hollow body 202 through the channel 215. Examiner further notes that while Nozaki teaches the channel 215 as a feed supply channel, the apparatus is appropriately structured such that that the channel 215 is fully capable of removing gas from the system. And wherein it is further noted that the channel 217 as seen through Fig. 3 is also configured with an exhaust valve for removing gas from the system. – See also paras. [0052-0056 and 0060-0062].);
as in Claim 1.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki teaches the system discussed above wherein, when the system includes a plurality of channels, all of the channel inlets of the one or more channels are disposed on one plane that is orientated orthogonally to the direction of gravitational force (Fig. 2A shows the channel inlet (the end immersed in the culture solution) as disposed on one plane that is orientated orthogonally to the direction of gravitational force, as in wherein the inlet opening is coplanar with the bottom floor of the tank 201. – Examiner further notes that Applicant has amended the claim to be recited by way of a conditional that is not positively not necessitated by the claim and is thereby not required in the prior art.), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki teaches the system discussed above wherein the tank is configured such that the tank permits an input of mechanical oscillations or resonant mechanical oscillations into a flowable medium disposed within the tank ([0042]: “By having a semi-open cavity 221, cushioning is possible when impacts and oscillations are applied to the closed-system culture vessel 101 from the side surface direction.”) and the tank is at least partially produced from metal or plastic ([0030]: “The materials are plastics having plasticity and rigidity, such as PC, PS, and polyethylene terephthalate.”), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki teaches the system discussed above wherein the tank has a plurality of connections 217/218 which are respectively suitable for feeding the flowable medium into the tank 201 and/or for discharging the flowable medium from the tank 201 ([0036]: “…a third port 217 for supplying the culture medium and the like to the culture vessel 201, and a fourth port 218 for discharging the culture medium and the like from the culture vessel 201.”), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki teaches the system discussed above wherein the hollow body 202/205 is a sample holder (Further, the culture vessel 202 is an insertion-type culture vessel, so that the regenerative tissues [the sample] are present on the inside thereof.), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki teaches the system discussed above wherein, for each channel of the one or more channels, the channel inlet situated in the hollow body 202/205 has an opening which is configured such that surface tension of the flowable medium prevents penetration of the flowable medium into each channel (As in Fig. 2A, when any of the channels of the connector part 214 (when attached to a feed/waste tube sealed at the other end) are submerged in the culture medium, the surface tension at the inlet/outlet and air contained within the channel prevent the culture medium from entering the channel. – Examiner further notes the recitation “when the tank is filled with the flowable medium and a minimum fill volume of flowable medium is disposed within the tank” is drawn to a conditional that is not necessitated by the claim. Further, the recitation “penetration of the flowable medium into each channel” is drawn to a process limitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight. – Further, the channels of Nozaki are fully capable of use with a flowable medium having a surface tension that prevents intrusion of the flowable medium into the one or more channels.), as in Claim 8.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki teaches the system discussed above wherein the one or more channels are attachable to the hollow body (Fig. 2A shows the channel 215 as attached to the hollow body 202 via the lid 205.), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki teaches the system discussed above wherein a volume of the flowable medium in the tank 201 corresponds to at least the minimum fill volume or is larger than the minimum fill volume (While Nozaki does not specifically discuss a minimum or maximum fill volume of the tank 201, a minimum and maximum fill volume inherently and necessarily exist within the system given that the fill volume must be at least enough to contact the lower membrane of the inner container 202 to provide basal nutrient feed, and that the fill volume must not exceed the upper opening of the tank 201 as this would cause spillage. As such, the volume of the flowable medium must be greater than the minimum fill volume and less than the maximum fill volume so as to ensure the functionality of the culture device and to prevent hazardous contamination to a user from spillage.), as in Claim 12.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Nozaki. Nozaki has been discussed above.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki does not specifically teach the system discussed above wherein at least one channel of the one or more channels has an at least partially V-shaped configuration or an at least partially U-shaped configuration, as in Claim 2.
However, mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B). Herein, Nozaki discloses commensurate linear channels which similarly serve the purpose of adjusting the level of a flowable medium in a hollow body and cycling cell growth media as the claimed V-shaped channels.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the channels of Nozaki as having an at least partially V-shaped configuration as this configuration is merely an alternative configuration to the linear configuration taught by Nozaki, wherein both configurations serve the same or a similar purpose; and would have a reasonable expectation of success therein.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki does not specifically teach the system discussed above wherein at least some of the channels function as spacers between a lower edge of the hollow body and a bottom of the tank and are configured for spacing the hollow body at a predefined distance from the tank bottom when the hollow body has been placed in the tank, as in Claim 10.
However, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of at least some of the channels arranged between a lower edge of the hollow body and a bottom of the tank to act as spacers between the floor of the insert container and the floor of the tank would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the at least some of the channels.
It is further noted that Nozaki is similarly interested in spacing the bottom of the insert container 202 at a defined distance from the bottom of the tank 201, wherein Fig. 2A shows that the inner container 202 is restricted to a predefined position by the pressing part 204, specifically the joint portion 208 which forms an inverse truncated conical through-hole 209 that receives the culture vessel 202 – see para. [0033].
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the channels of the system of Nozaki as arranged between a lower edge of the hollow body and a bottom of the tank to act as spacers between the floor of the insert container and the floor of the tank as this arrangement represents a mere alternative to the spacers/joint portions 208 of Nozaki which achieve the same purpose of the claimed channel spacers; and would have a reasonable expectation of success therein.
Examiner further notes the recitation “when the hollow body has been placed in the tank” is drawn to a conditional that is not necessitated by the claim.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nozaki in view of Tay et al. (US 2019/0376013 A1), referred to hereinafter as “Tay”. Nozaki has been discussed above.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, Nozaki does not specifically teach the system discussed above wherein the hollow body has a plurality of internal segments which, when placing the hollow body in the tank or when filling the tank, allow a plurality of mutually separated imprisoned volumes of gas to be formed in the hollow body and each of the internal segments is associated with at least one channel inlet when the hollow body is placed in the tank, as in Claim 9.
However, Tay teaches a respective device for cell culture wherein the body on which cells grow has a plurality of internal segments/rows of wells 58 (Fig. 1A) and each of the internal segments is associated with at least one channel inlet so as to direct fluids to and/or away from each segment ([0010]: “The present devices can include of an array of wells and channels passing over respective subsets of the wells such that each channel can direct fluids to and/or away from a corresponding subset of the wells. Each well can serve as a culture chamber for growing cells.”). Wherein this arrangement thereby allows for more fine-tuned control over the culture of cells, wherein the conditions of certain segments can be adjusted depending on parameters relating to the cells contained therein.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the system of Nozaki such that the hollow body has a plurality of internal segments and each of the internal segments is associated with at least one channel inlet when the hollow body is placed in the tank, such as suggested by Tay, so as to provide an arrangement that allows for more fine-tuned control over the culture of cells, wherein the conditions of certain segments can be adjusted depending on parameters relating to the cells contained therein; and would have a reasonable expectation of success therein.
Examiner further notes the recitation “when placing the hollow body in the tank or when filling the tank” is drawn to a conditional that is not necessitated by the claim. Further, the recitations “placing the hollow body in the tank” and “filling the tank” are drawn to process limitations. As the claims are drawn to a device, such process recitations are not afforded patentable weight.
Further regarding Claim 9, while Nozaki/Tay does not specifically discuss a plurality of mutually separated imprisoned volumes of gas being formed in the hollow body when placing the hollow body in the tank or when filling the tank, the commensurately structured hollow body of Nozaki/Tay would similarly trap separately imprisoned volumes of gas when the internal segments of the modified insert container 202 of Nozaki are sealed with the lid 205 of Nozaki.
Response to Arguments
35 USC 112
Applicant’s cancellation of Claim 3 renders moot the rejection thereto under 35 USC 112(b) set forth in the previous office action. As such, the rejection of Claim 3 under 35 USC 112(b) is hereby withdrawn.
35 USC 102 and 103
Applicant’s arguments are on the grounds that allegedly the pocket of gas in Nozaki is not situated between a wall of the hollow body 202 and the flowable medium, as required by Claim 1, but rather between the lid member attached to the hollow body 202 and the flowable medium. Applicant asserts that the lid member is not part of the hollow body and thereby does not meet the claim limitation.
Applicant’s arguments are not persuasive because the Claim 1 recitations to the trapped volume of air “enclosed between a wall of the hollow body and the flowable medium” merely serve to provide for the positioning of the inlet to provide gaseous communication with the headspace culture gas above the liquid culture media. As such, the inlet of Nozaki shown in Fig. 2A as in fluid communication with such a headspace culture gas above the flowable medium is commensurately provided “in a region of the hollow body configured to contain a volume of gas enclosed between the walls of the hollow body and the flowable medium” as the inlet identically provides for such gaseous communication with the headspace culture gas as required and enabled by its placement in the region containing the gas.
Further, even if the lid portion 205 is taken as a separate element of the hollow body 202, the device remains as providing a pocket of gas between the side walls of the hollow body and the flowable medium as the diagonals between the side walls and the flowable medium remain as having gas volume “enclosed” (surrounded) therebetween, the inlet of channel 215 therein remaining commensurately positioned as in the instant claims. Additionally herein, the lid portion 205 is interpreted as a part of the hollow body 202 as it forms an upper wall of the hollow body (Applicant’s claims permit this interpretation given that the instant recitations do not specify the hollow body must be formed as one continuous piece.), thereby providing the hollow body as sealed from contamination. As such, the gas volume trapped between the lid 205 and the flowable medium, and the inlet of the channel 215 being positioned in said gas volume, satisfies the claim limitations thereto.
Applicant further argues that the device of Nozaki allegedly does not provide for the Claim 1 recitation requiring the one or more openings of the hollow body be located entirely below a surface of the flowable medium, again asserting that the openings of the lid portion 205 are not a part of the hollow body.
Applicant’s arguments are not persuasive because, as discussed in the body of the action, the one or more openings are interpreted as the openings/pores in the membrane allowing fluid communication through the membrane. The prior office actions do not rely on the lid member 205 for providing the one or more openings. As the membrane is located entirely below the flowable medium, the one or more openings are also located entirely below the flowable medium.
Applicant further argues that the additional prior art of Chen and Tay do not cure the alleged deficiencies in Nozaki. However, Applicant’s argument is moot because, as discussed above, no such deficiencies exist in Nozaki.
Applicant further argues that the devices of Nozaki and Chen are structurally incompatible. However, Applicant’s argument is moot because Chen is not relied upon for teaching any aspect of the instant claims, Applicant having cancelled Claim 3 (the only claim previously rejected utilizing Chen) in their reply.
Thus, Examiner respectfully maintains the rejection of Claims 1, 4-8, and 11-12 under 35 USC 102 as anticipated by Nozaki, and the rejection of Claims 2 and 10 under 35 USC 103 as unpatentable over Nozaki, and the rejection of Claim 9 under 35 USC 103 as unpatentable over Nozaki in view of Tay.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798