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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/30/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 27-47 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.
Regarding claim 27, the limitation: “maintaining the chamber oxygen level to the set hypoxic oxygen level and the total gas pressure to the set positive pressure level independently of each other, wherein maintaining the chamber oxygen level at the set hypoxic oxygen level comprises regulating the chamber oxygen level without altering the total gas pressure, and wherein maintaining the positive pressure level at the set positive pressure level comprises regulating the total gas pressure without altering the chamber oxygen level” is unclear. The hypoxic oxygen level and the total gas pressure are naturally different parameters. In addition, the oxygen pressure will naturally affect the total gas pressure. What does applicant mean by: set hypoxic oxygen level and the total gas pressure to the set positive pressure level independently of each other?
Regarding claim 27, the term “hypoxic” is a relative term which renders the claim indefinite. The term “hypoxic” is not defined by the claim, the specification as filed does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The word hypoxic generally means low oxygen level. However, the word hypoxic indicates different levels of low oxygen in different environments (anerobic/aerobic incubator, tissues, blood, water, etc.). The specification as filed discloses that hypoxic level may range from 0.1 to 21% oxygen depending on what microenvironment the system maybe simulating ( see paragraphs 14 and 72), 21% oxygen level is considered normal level in the atmosphere. Oxygen levels in incubators are important for cell growth and differentiation. Most cell culture laboratories maintain incubator environments with 20% oxygen and 5% carbon dioxide. What does applicant consider hypoxic condition for oxygen in a cell culture incubator? Thus, the specification as filed does not appear to provide a standard for ascertaining the requisite degree for the state of low oxygen.
Claims 28-47 depend on independent claim 27 and is therefore, rejected for the same reason.
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.
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.
Claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over Takagi US 2001/0021529 as cited in the IDS filed 08/11/2021 in view of West US 2005/0158701.
Regarding claim 27, Takagi discloses a method of regulating a gas flow system within an enclosed environmental chamber (culture chamber 20/culture box 42) that is within a cell culture incubator (culture apparatus 1) comprising: providing a gas flow system (gas mixture/concentration regulating apparatus 36) within the cell culture incubator comprising: a pressure sensor (a pressure sensor 112) to measure a total gas pressure within the enclosed environmental chamber and to convey a sensed pressured signal a nitrogen source [172] to provide nitrogen to the enclosed environmental chamber as discussed in at least paragraph 115; a vent to release gas from the enclosed environmental chamber (…pressure relief valve 26 by tubes 50A, 50B, 50C, 50D and 50E. The tubes 50A, 50D, 50E constituting gas absorption portion 41 (FIG. 1) are formed of a vent tube made of an elastomer material or the like capable of absorbing gas inside the culture box 42. Paragraph 103); and a control system (main control apparatus 230) to receive, and the sensed pressured signal from the pressure sensor as discussed in at least paragraph 119; regulating the total gas pressure within the enclosed environmental chamber as discussed in at least paragraphs 121-130; and the pressure level to the set positive pressure level independently of each other.
Takagi also discloses wherein external atmospheric air provide a source of oxygen discussed in at least paragraph 12.
Takagi does not explicitly disclose an oxygen sensor to measure a chamber oxygen level within the enclosed environmental chamber and to convey a sensed oxygen signal; an air injection pump to provide external atmospheric air to the enclosed environmental chamber; wherein the control system (main control apparatus 230) receives a sensed oxygen signal from an oxygen sensor; regulating the chamber oxygen level within the enclosed environmental chamber to a set hypoxic oxygen level that is less than 20.9% oxygen; and maintaining the chamber oxygen level to the set hypoxic oxygen level.
Takagi also does not explicitly disclose setting a set positive pressure level greater than 14.7 PSI.
West discloses an integrated bioreactor monitor and control system comprising: bioreactors [105, 110, 220 and 220’], a pressure sensor as discussed in at least paragraphs 49, 56 and 63, an oxygen sensor [205, 205’ and 180] to measure a chamber oxygen level within the enclosed environmental chamber and to convey a sensed oxygen signal as discussed in at least paragraphs 33, 45, 49 and 75; a control system (controller 120 and control system 221) receives a sensed pressured signal from the pressure sensor and a sensed oxygen signal from an oxygen sensor as discussed in at least paragraphs 49, 63, 78 and 103; regulating the chamber oxygen level within the enclosed environmental chamber as discussed in at least paragraphs 70-78; and an air injection pump (a pump control system 240/gas control system 235) to provide external atmospheric air to the enclosed environmental chamber as discussed in at least paragraphs 54, 69 and 90. Also see whole document.
The control system of West is capable of operating with any desired input values but does not explicitly disclose the set hypoxic oxygen level that is less than 20.9% oxygen and a set positive pressure level greater than 14.7 PSI. However, it would have been obvious to one of ordinary skill in the art to have the user input the desired hypoxic oxygen and positive pressure levels to provide the desired conditions for a specific organism cultured within the chambers.
It would have been obvious to one of ordinary skill in the art to modify Takagi with a pressure sensor and an oxygen sensor, a control system and an air injection pump as taught by West in order to implement a controlled process that benefits from monitoring conditions of the process and controlling factors affecting the process, which allows for appropriate growth conditions for the cells and/or tissue cultures. Further, the combination of Takagi and West is capable of maintaining the chamber oxygen level to the set hypoxic oxygen level and the total gas pressure to the set positive pressure level independently of each other, wherein maintaining the chamber oxygen level at the set hypoxic oxygen level comprises regulating the chamber oxygen level without altering the total gas pressure, and wherein maintaining the positive pressure level at the set positive pressure level comprises regulating the total gas pressure without altering the chamber oxygen level.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796