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 Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
actuating means in claim 6 (does not meet prong B of the 3-prong analysis, see MPEP 2181);
connector means for interconnecting the smart tank with a further smart tank in claim 7 (“connector” is sufficient structure);
“at least one assembly-connecting means” in claim 9 (does not meet prong B of the 3-prong analysis, see MPEP 2181);
at least one channel-connecting means in claim 10 (does not meet prong B of the 3-prong analysis, see MPEP 2181);
at least one corresponding channel-connecting means in claim 10 (does not meet prong B of the 3-prong analysis, see MPEP 2181); and
pumping means, stirring means, blending means, cell-harvest means, resin means, hollow-fibre means, spectroscopy means, UV spectroscopy means in claim 11 (does not meet prong B of the 3-prong analysis, see MPEP 2181, in any of the cases).
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 , 6, and 10-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “wherein the at least one integrated channel is chosen from a group of channel-types consisting of the following channel types:… a bypass-channel, for guiding a biochemical medium and/or an operating medium, wherein the bypass-channel is not connected to the reservoir of the smart tank, or wherein the bypass- channel is adapted to be fluidically separated from or connected to the reservoir of the smart tank” (emphasis added). However, claim 1, from which claim 3 depends, recites that “the at least one integrated channel…is fluidly connected to the at least one reservoir”. Therefore, it is unclear how the at least one integrated channel could be not connected to the reservoir as recited in claim 3, as this would contradict claim 1. Meanwhile, the phrase “connected to the reservoir of the smart tank” in the noted portion of claim 3 would appear to be redundant as this is already recited in claim 1.
Regarding claim 6, the phrase “may be” (line 3) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation "the at least one sidewall element" in lines 5-6, in line 15, and in line 19. There is insufficient antecedent basis for this limitation in the claim. The prior lines of the claim specify that the smart tank comprises “multiple sidewall elements” rather than “at least one sidewall element”.
Regarding claim 11, the phrase "such as" (last line) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-4, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US Patent Application Publication 2010/0029000) in view of Modena et al. (Smart Cell Culture Systems: Integration of Sensors and Actuators into Microphysiological Systems).
Regarding claim 1, Zhong et al. discloses a tank for a bio-pharma process line (the disclosed assembly is configured to hold fluid for a bio-pharma process, see para. 28-31, 41, and thus reads on a tank for a bio-pharma process line), the tank comprising:
a top plate element (10), at least one sidewall (14), and a bottom plate element (18) (para. 28-29) (Fig. 1, sheet 1 of 5), wherein
the top plate element, the at least one sidewall element and the bottom plate element are arranged to from at least one reservoir (interior of the assembly) for receiving at least one biochemical medium (Abstract, para. 28-29) (Figs. 1-7, sheets 1-4 of 5); and
the tank further comprises
at least one integrated channel (para. 37) (Figs. 1-7, sheets 1-4 of 5), for guiding the at least one biochemical medium (Abstract, para. 37), wherein the at least one integrated channel extends within the top plate element and the at least one sidewall element (para. 37) (Figs. 1-7, sheets 1-4 of 5), wherein the integrated channel is fluidly connected to the at least one reservoir and is configured to guide at least one process medium from or to the reservoir (para. 37) (Figs. 1-7, sheets 1-4 of 5), wherein the length of the at least one integrated channel is longer than the thickness of the respective top plate element and sidewall element (Figs. 1-7, sheets 1-4 of 5).
Zhong et al. is silent as to the tank being a smart tank.
Modena et al. discloses that it was known in the art to use a “smart” cell culture system (Abstract), e.g., by inserting a real-time monitoring sensor into a vessel such as a cell culture flask (p. 1770 col. 2 para. 2).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the tank disclosed by Zhong et al. to comprise a smart tank, e.g., by equipping the tank with a sensor for real-time monitoring of processes therein, based on the teachings of Modena et al., in order to improve the analysis of biological processes being conducted within the tank.
Regarding claim 3, Zhong et al. discloses wherein the at least one integrated channel comprises an outlet channel for removing a biochemical medium and/or an operating medium from the reservoir of the smart tank (para. 37) (Figs. 1-7, sheets 1-4 of 5) and wherein the tank comprises multiple channels of different channel-types (para. 37) (Figs. 1-7, sheets 1-4 of 5).
Regarding claim 4, Zhong et al. discloses a fluid outlet port associated with a respective integrated channel (para. 28, 37) (Figs. 1-7, sheets 1-4 of 5).
Regarding claim 9, Zhong et al. discloses wherein the top plate element comprises a skirt (reads on at least one assembly-connecting means) configured to secure an assembly of the top plate element and the at least one sidewall element which is adjacent thereto (para. 34) (Figs. 1-7, sheets 1-4 of 5). As to the limitations regarding the at least one corresponding assembly-connecting means, this feature is an optional limitation as it is listed in the alternative (“and/or at least one corresponding assembly-connecting means”) and therefore these limitations do not introduce a patentable distinction over the prior art.
Regarding claim 11, Zhong et al. discloses an outlet for transmitting cell culture fluid (reads on a cell-harvest-means) (para. 37).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US Patent Application Publication 2010/0029000) in view of Modena et al. (Smart Cell Culture Systems: Integration of Sensors and Actuators into Microphysiological Systems), as applied to claim 1, above, and in further view of Lei (US Patent Application Publication 2019/0376016).
Regarding claim 5, Zhong et al. discloses an inlet port for delivering medium into the tank (para. 37) (Figs. 1-7, sheets 1-4 of 5) for the culture of cells therein (Abstract, para. 4).
Zhong et al. is silent as to at least one filter wherein the port is covered by the at least one filter, wherein the filter is chosen from a group of filter-types as specified in claim 5.
Lei discloses a cell culture system (Abstract) comprising an inlet for delivering medium into the system and a filter for the inlet for preventing the entry of virus and bacteria (para. 27-28).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the inlet port disclosed by Zhong et al. to include a viral filter and/or bacterial filter covering the port, based on the teachings of Lei, in order to prevent viral and/or bacterial contamination of cell cultures.
As to the limitation of the filter being heated and/or cooled, this is a recitation of intended use of the filter and has therefore been given appropriate patentable weight. The filter taught by the prior art combination is fully capable of achieving the claimed intended use as the entire tank including the filter could be positioned within a heated or cooled laboratory room.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US Patent Application Publication 2010/0029000) in view of Modena et al. (Smart Cell Culture Systems: Integration of Sensors and Actuators into Microphysiological Systems), as applied to claim 1, above, and in further view of Veraitch et al. (US Patent Application Publication 2020/0255790).
Regarding claim 6, Zhong et al. discloses wherein the at least one integrated channel is configured to allow fluid transfer (para. 37).
Zhong et al. is silent as to at least one valve associated with the at least one integrated channel, wherein the valve may be a flow control valve, a cutoff valve, a pressure relief valve or a non return valve, wherein the valve is a mechanical valve that is configured to be actuatable from the outside of the smart tank by means of an actuating means.
Veraitch et al. discloses a cell processing system (Abstract) comprising a cell processing container including a valve (27) for fluid transfer (para. 168), wherein the valve controls flow (para. 168) and is a mechanical valve configured to be actuatable from outside the container by means of an actuating means (para. 168) (Figs. 1-6, sheets 1-6 of 19).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the at least one integrated channel disclosed by Zhong et al. to have at least one flow control mechanical valve associated therewith wherein the valve is configured to be actuatable from outside the smart tank by means of an actuating means, based on the teachings of Veraitch et al., as the skilled artisan would have been motivated to adopt a known configuration for gaining control of fluid transfer through the tank.
Regarding claim 7, Zhong et al. in view of Modena et al. teaches the smart tank, as set forth above. Zhong et al. discloses flowing medium out of the tank (para. 37).
The prior art combination is silent as to the smart tank further comprising at least one connector means for interconnecting the smart tank with a further smart tank wherein the connector means provides a fluidical connection and is further adapted for interconnecting the smart tank fluidically with a further smart tank without using a hose.
Veraitch et al. discloses a cell processing system (Abstract) comprising a cell processing container comprising at least one connector means for fluidically interconnecting the container with a further container without using a hose, e.g., to allow for fluid transfer to an auxiliary container (para. 196-200) (Figs. 12-13, sheet 9 of 19).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the smart tank taught by Zhong et al. in view of Modena et al. to comprise at least one connector (reads on the claimed at least one connector means) for interconnecting the smart tank with a further smart tank wherein the connector means provides a fluidical connection and is further adapted for interconnecting the smart tank fluidically with a further smart tank without using a hose, based on the teachings of Veraitch et al., to allow transfer to an auxiliary container for further cell processing, storage, and/or analysis.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US Patent Application Publication 2010/0029000) in view of Modena et al. (Smart Cell Culture Systems: Integration of Sensors and Actuators into Microphysiological Systems), as applied to claim 1, above, and in further view of Nuber et al. (US Patent Application Publication 2021/0355422).
Regarding claim 8, Zhong et al. discloses wherein the tank is made of a polymeric material (para. 36).
Zhong et al. is does not expressly teach wherein the smart tank is sterilizable by means of autoclaving, ETO gas, and/or gamma radiation, prior, during, or after being assembled.
Nuber et al. discloses a cell processing device (Abstract) made of a polymeric material and sterilizable by means of autoclavable such that the device is capable of being reused (para. 41).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the tank taught by modified Zhong et al. to be sterilizable by means of autoclaving, based on the teachings of Nuber et al., to improve the utility of the device by allowing it to be reused.
Allowable Subject Matter
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799