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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 5/1/26. Claims 1-10 are pending. Claims 8-10 are withdrawn. Claims 1-7 are considered on the merits.
Election/Restriction Requirement
Applicant’s election without traverse of Group I, claims 1-7 in the reply filed on 5/1/26 is acknowledged. Claims 8-10 are withdrawn as non-elected inventions.
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 1-7 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.
Claims 1-7 are confusing because the describe two inventions without sufficient connection between them. Initially the 1st two indented clauses of claim 1 describe a cell culture device with a culture vessel that comprises a supply port and an discharge port. Initially this device is confusing because of the phrase “the medium supply vessel serves as a mixing vessel”. The claims appear to use mixing vessel as a synonym for medium supply vessel. This makes the final structure of the medium supply vessel unclear if it is simply an equivalent term or something more.
The method steps of claim 1 do not fully integrate with the device. The “used medium” is transferred to a mixing vessel, with no guidance if the ports of the culture vessel are used.
Claim 2 is confusing because its steps are disjointed. The amounts discussed at the end of the claim are not clearly integrated into the prior steps. The claim uses the phrase “remaining used medium” and “portion of the used medium”. It is not entirely clear if these are the same amounts or even the same media. This entire phrase at the end of claim 2:
and the concentration-adjusted medium in an amount corresponding to the portion of the used medium is transferred from the mixing vessel to the culture vessel
is not completely integrated into the prior limitations of claims 2 or 1. It seems there is a verb missing after ‘concentration-adjusted medium’ and ‘in an amount corresponding’.
It appears the Applicant wishes to claim the same amount of concentrated-adjusted media is added to the culture vessel as the amount of discharged media removed to ensure the amount of media inside the culture vessel remains unchanged during the method. However this concept is not clear in either claim 1 or 2.
In claim 3, the term “liquid thickness” of the medium is indefinite. It is unclear if this refers to the viscosity of the liquid or the geometrical dimensions of the liquid as if fills the container. [0051] of the Specification states:
Here, when the closed-type culture bag is used as the culture vessel 10, since the top surface of the culture bag follows changes in an amount of filled liquid (liquid thickness), it is easier to control the liquid thickness compared with a case of using a rigid open-type vessel.
This appears to indicate that liquid thickness is synonymous with filled liquid. [0062] of the Specification states:
In the cell culture system of the embodiment, as the detection unit 70 that
measures changes in the liquid thickness of the medium, for example, a length measurement sensor can be suitably used.
This appears to measure the length of the liquid in the culture chamber, indicating that it might be the liquid level in the culture chamber. Since this term has several different interpretations in light of the Specification, it is indefinite how claim 3 is limited with this phrase “liquid thickness”.
Also claim 3 has these confusing steps:
discharging a portion of the remaining used medium in the culture vessel from the culture vessel before the remaining used medium is discharged from the culture vessel while the concentration-adjusted medium is transferred from the mixing vessel to the culture vessel
the phrase “discharging a portion of the remaining used medium in the culture vessel… before the remaining used medium is discharged from the culture vessel” seem circular since the used medium must be in the culture vessel prior to being discharged. It seems like the Applicant wishes to replace the discharged medium with conc.-adjusted medium to maintain the volume of media in the culture vessel, however this concept does not seem apparent with this phrase.
The 2nd portion of claim 3 is equally confusing. It contains the phrase “the culture vessel is filled with concentration adjusted medium by discharging all the rest of the remaining medium”. This phrase removes all the remaining medium but does not describe how the conc.-adjusted medium is filled into the culture vessel. And the phrase “while the state where the liquid thickness of the medium is decrease in the culture vessel is maintained” also seems contradictory. Since the liquid thickness is both decreased and maintained.
Claim 4 depends from claim 3 and limits:
discharging from the culture vessel is stopped after all the rest of the remaining used medium inside the culture vessel is replaced with the concentration-adjusted medium,
However claim 3 never clearly provides a step of replacing the used media with conc. adjusted medium, so it is unclear how this step can be completely executed. Claim 4 also has a similar problematic phrase seen in claim 2:
the concentration-adjusted medium in an amount corresponding to the portion of the used medium and the portion of the remaining used medium is transferred from the mixing vessel to the culture vessel.
It seems there is a verb missing after ‘concentration-adjusted medium’ and ‘in an amount corresponding’
Claim 5 includes the term “medium exchange rate” but does not include a step that involves time so it is unclear what ‘rate’ is being adjusted. It is unclear how “adjusting the mixture ratio” of the new medium and used medium alters any rate of this method.
Claim 6 is confusing because the phrase:
before the mixture ratio of the amount of new medium in the mixing vessel to the amount of used medium transferred from the culture vessel to the mixing vessel is adjusted,
appears to be missing some kind of verb to accurately identify what steps are occurring in this step. The second half of claim 6 is also confusing because it adds new medium to the culture vessel, which does not occur in the previous steps. Previously, new medium was added to the mixing vessel which produced conc.-adjusted medium that was added to the culture vessel. The lack of conc.adjusted medium in this claim makes all the steps limited in claim 6 confusing.
Claim 7 is confusing because the phrase “medium exchange rate…from 50% or more to less than 100%” does not denote a time factor necessary for ‘a rate’.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102b or under 35 U.S.C. 103 as being anticipated by or obvious over Matsuda et al. ( EP 0431464, published 1991).
As detailed below, Matsuda et al. teach a method whose steps are substantially identical to the claims but the significant 35 USC 112(b) issues detailed above make it difficult to completely compare to the prior art. Therefore a dual rejection under 102/103 is made since Matsuda et al. either inherently meets the claimed method (M.P.E.P 2112 III and V) or is prima facie obvious.
Matsuda et al. teach the following device for culturing cells in Fig. 1. Arrows have been added to show the flow of media in the device. This device executes the following method (col 7, lines 5-40):
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#10 is a culture vessel and #11 is a medium supply vessel which are part of a fluidly connected circuit of culture media.
The culture vessel #10 has two ports #34 and #30 for the addition or removal of media line #19 and #20 respectively.
When filling the culture media in #10, media stored in the medium supply vessel #11 is pumped #16 through the circulation switching device #18 into line #19 and port #24 to the culture vessel.
The spent media in #10 culture vessel is then recirculated to the #11 medium supply vessel by leaving the culture vessel at outlet #25 and return line #20.
The switching device #18 directs the spent media to recovery line #22 through the dissolved oxygen (DO) sensor #21 to measure the oxygen content of the spend media.
A quantity of the recirculating spent media is removed via line #26 before returning to the medium circulation tank #11.
A quantity of fresh media corresponding to the amount of removed media is added via line #13 to make a mixture ratio which maintain the same volume in this media circuit.
The fresh media is mixed with the spent media (e.g. mixture ratio) by stirring blade #23 to make concentration-adjusted media which is then recirculated to culture vessel #10 into either port #25 or #24 based on the direction selected for the switching device #18 to maintain the volume of media in the culture vessel.
Experiment 1 (col 9, lines 15-35) teach this circulation process occurs continuously, meaning the amount of media in this circuit is the same as the process executes so the rate of media entering the culture vessel is the same as that discharging.
Therefore the invention as a whole is anticipated by the reference.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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