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 .
Election/Restrictions
Applicant’s election without traverse of the species of Figs 1A-3G in the reply filed on 6/17/26 is acknowledged.
Claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/17/26.
It is noted applicant states claims 1-2, 4-11, 13-17, 19-23 and 25 are elected in the above reply, however, claims 9 & 14 were cancelled. Therefore claims 1-2, 4-8, 10-11, 13, 15-17, 19-23 and 25 are the currently pending & elected claims.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119€ as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/976690, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application does not provide support for the subject matter in current application Figures 2-3 or 6-7 which corresponds to at least claims 8, 10-11.
Information Disclosure Statement
The information disclosure statement filed 5/16/25 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein that has been struck through has not been considered. Specifically, EP4103201 is a foreign patent document but no complete, legible copy has been provided, only a cover page citing another document has been supplied.
The information disclosure statement filed 7/17/24 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein that has been struck through has not been considered. Specifically, the NPL MACDONALD reference is listed as being pages 52-63, whereas only a truncated first page has been supplied.
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 21, 25 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 21 recites the limitations "the liquid cell culture medium source" in part a., and “the inoculum source container” in part b. There is insufficient antecedent basis for these limitations in the claim or claim 1 from which it depends.
Claim 25 recites the limitation "the medium source" in line 2. There is insufficient antecedent basis for this limitation in the claim or claim 1 from which it depends.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-6, 13, 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIM (US 2018/0100134) and CECCHI (US 20160312169) both as provided on the IDS dated 7/17/24.
Regarding claim 1, 2 LIM discloses a temperature controlled cell culture incubator with a housing connected to pump and regulator configured to provide a defined gas composition and internal atmospheric pressure (pressurizable gas mixing chamber) comprising a gas inlet connected to an oxygen tank, an inlet connected to a CO.sub.2 tank and a gas inlet connected to a nitrogen tank (multiple gas injection ports operably connected to multiple gas sources) [0074], an enclosed environmental chamber (cell culture compartment) (0075) for culturing the plate of cells in the incubator (cell culture vessel, holds liquid medium for cell culture), which would inherently have an interface at the surface of the medium and the gaseous environment inside the incubator [0063-65]; and a pump which dispenses defined gas mixtures to maintain chamber pressure and gas compositions using a flow meter (gas flow system) to control flow of gas & pressure to the enclosed environmental chamber (flow path portion comprising (a) a first gas flow path segment from the pressurizable chamber to the cell culture compartment) [0072-74], in which the gas composition can comprise an oxygen level between about 0.1-21% (gas flow system provides a hypoxic atmospheric condition in the culture compartment) and an atmospheric pressure of about 1 PSIG or greater (gas flow system provides a hyperbaric atmospheric condition) [0069-70].
LIM discloses the gas flow system as stated above, and that the gas inlet can be connected to a tank containing a custom gas mixture [0074] but does not explicitly disclose a separate gas mixing chamber connected to the cell culture compartment with a gas flow system comprising a circular flow path portion having a second flow path from the cell culture back to the mixing chamber.
However, CECCHI discloses a temperature and gas controlled incubator with a housing (Fig 6) comprising a gas system 216 contained in a separate lower portion of the device (gas mixing chamber), a chamber 240 (cell culture compartment) above, a dish 252 (cell culture vessel) inside the chamber 240 with an interface of the liquid containing specimens and the gaseous environment inside the chamber 240 (gas space between 209 and 201) and a gas recirculating system comprising a flow path from the mixing chamber 216 to the chamber 240 via inlet 217 and exits the chamber 240 through port 218 and connecting tubing 210 to return to the mixing chamber 216 (gas flow system comprising circular flow path with first and second flow path segments as claimed)[Fig 4-6, 0053-57].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of LIM to include the gas recirculating gas-mixing system as taught by CECCHI because CECCHI discloses this system overcomes the problem of traditional incubators that do not recirculate the gases and simply dump portions of gases into the environment where it may not properly blend and may not be homogenous throughout the incubator [0011] and can provide the proper best balance of gases, namely CO2, N2 and O2 and to be able to recirculate and adjust the concentration of the gases on a repeated basis [0063].
Regarding claim 4-6, these claims are directed toward functional limitations of the regulation system in use and do not positively recite any structural elements. The system as disclosed by the combination of LIM and CECCHI teaches all the positively recited structural components of claim 1 and as no further structures are claimed in claims 4-6 is therefore considered capable of maintaining the hyperbaric and hypoxic condition uniformly through the circular flow path, is capable of use with application of pneumatic pressure from the gas sources and is capable of flowing the gas continuously while the system is in operation.
Regarding claim 13, 15-17, CECCHI discloses the flow rate is regulatable and responsive in a feedback manner to sensed gas data originating from the flow path, the data relates to a composition of gas in the system [0059-60, Fig 8].
Claim(s) 7, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIM (US 2018/0100134) and CECCHI (US 20160312169) as applied above, further in view of NIAZI (US 20170198246) also as supplied by applicant on the IDS dated 7/17/24.
Regarding claim 7, 19 LIM and CECCHI do not explicitly disclose the gas mixing chamber comprises a vent to an external atmospheric space. However, NIAZI discloses a container (mixing chamber) with a gas flow controller connected to multiple input sources of gas, the container having a valve (regulatable vent) with a vent fan [0012] that is triggered by a predetermined pressure in the container to exhaust gas to the outside of the room (vents to external atmospheric space) [0049]. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of LIM and CECCHI to include the mixing chamber having a vent to an atmospheric space that is external to the system as taught by NIAZI because it allows the release of any overpressure from the container while allowing it to be operated in an ISO 9 environment, without any risk of contamination of the content of the container [0049].
Claim(s) 8, 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIM (US 2018/0100134) and CECCHI (US 20160312169) as applied above, further in view of LIM (WO 2019/152920) also as supplied by applicant on the IDS dated 7/17/24.
Regarding claims 8, LIM’920 discloses the gas flow and liquid flow regulation system of claim 1, wherein the cell culture compartment comprises a cartridge, the cartridge comprising: a. a gas entry port and a liquid medium entry port, wherein the gas entry port is connected to the pressurizable gas-mixing chamber, and wherein the liquid medium entry port is connected to a liquid medium source container; b. a gas exit port that directs gas flow to return to the pressurizable gas-mixing chamber; and C. a liquid medium exit port, wherein the liquid medium exit port directs liquid flow to a downstream culture container (Para. [0157], A cell culture vessel may be any conventional cell culture accommodation, of any scale, including merely by way of example, a cell culture plate, a cell culture dish, a cell culture well, a cell culture cartridge, a cell culture flask, or a cell culture bag; (Claim 8, wherein the single integrated controller system being configured to operate each of the individual incubators individually of the one or more other individual incubators comprises being configured to be able to operate two or more of the individual incubators in parallel with respect to the atmospheric conditions within the individual incubators (i.e. individual incubators with each its own atmosphere)). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of LIM and CECCHI with the cartridge of LIM ‘920 because it allows for easy use and reuse of the main system components to allow greater flexibility.
Regarding claim 10-11, LIM’920 discloses wherein the cartridge hosts a gas-permeable cell culture bag that accommodates the liquid medium and a population of cultured cells within the liquid medium (Para. [0027], In some embodiments of the multi-incubator cell culture system, at least one of the individual incubators is sized and configured to accommodate a cell culture bag rocker device and a cell culture bag of at least 1-liter volume disposed thereon; Para. [0085], Master controllers 42 are in control of the operation of air injection valves 61, pressure release vents 64, nitrogen intake from source 72, carbon dioxide intake from source 71, and operation of gas recirculation path 65 of each individual incubator 20 (gas permeates in and out of each bag, gas permeable cell culture bag surface at interface); Para. [0100], A method of culturing cells in a cell culture incubator includes aseptically transferring a first volume of cell culture medium containing a cell population from a reservoir external to the cell culture incubator into the cell culture vessel disposed within the cell culture incubator, to establish a seed cell population, and then culturing the seed cell population within the cell culture vessel for a culture duration to allow growth of the seed population to an expanded cell population. The method further includes aseptically transferring a second volume of cell culture medium containing the expanded cell population from the cell culture vessel into a cell sampling or cell harvesting container). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of LIM and CECCHI with the gas permeable cartridge of LIM ‘920 because it allows for easy use and reuse of the main system components to allow greater flexibility and allows for exchange of gases while keeping the cells enclosed to avoid contamination.
Claim(s) 20-23, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIM (US 2018/0100134) and CECCHI (US 20160312169) as applied above, further in view of WOJCIECHOWSKI (US 2009/0269841) also as supplied by applicant on the IDS dated 7/17/24.
Regarding claim 20, LIM and CECCHI disclose the system of claim 1 but don’t explicitly disclose a culture inoculum source container operably connected to the cell culture vessel. However, WOJCIECHOWSKI discloses a system for the production of cells comprising an enclosed bioreactor (culture vessel) that is supplied with inoculate sample, inherently from a source container that is operably connected to the bioreactor [0129]. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of LIM and CECCHI with the inoculum source as taught by WOJCIECHOWSKI because it allows for sterilization of the system before adding the cells [0128-129].
Regarding claim 21, LIM and CECCHI disclose the system of claim 1 but don’t explicitly disclose a liquid flow path as claimed.
However, WOJCIECHOWSKI discloses a system for the production of cells comprising a flow path 210 from a user provided container of fresh media to the cell culture (liquid cell culture medium source container into cell culture compartment); a flow path 220 or 216 from a source of inoculate and sample respectively (inoculum source container into cell culture) and a flow path 126, 218 for harvesting (from cell culture compartment into downstream cell culture collection container) [0129]. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of LIM and CECCHI with the liquid flow path as taught by WOJCIECHOWSKI because it allows for maintaining or expanding cell lines for a duration of any time needed [0141] while allowing for sealed culture ware [0041].
Regarding claim 22, WOJCIECHOWSKI discloses the perfusion medium flow rate is adjustable [0018] and is independent of the gas [0074, 0088].
Regarding claim 23, WOJCIECHOWSKI discloses the liquid flow regulation system further comprises a peristaltic pump (hydraulic flow rate mechanism) in the flow path [0076].
Regarding claim 25, WOJCIECHOWSKI discloses the flow rate of liquid through from the media source and cell culture compartment is regulatable and responsive in a feedback manner to sensed dissolved analyte data from a pH sensor and a CO.sub.2 sensor that determines lactate concentration (dissolved gas levels, liquid medium components)[0124-125].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See additional references listed on the attached PTO 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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