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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Claims 1, 2 and 4-9 are pending in this application, Claim 2 is acknowledged as withdrawn, Claims 1 and 4-9 were examined on their merits.
The rejection of Claim(s) 1 and 4 under 35 U.S.C. § 103 as being unpatentable over Kyoto University (JP2017-006058A), translation, cited in the IDS, in view of Sanyo Electric Industries (JP2011-103832 A), translation, cited in the IDS, has been withdrawn due to the Applicant’s amendments to the claims filed 12/22/2025.
The rejection of Claim(s) 1, 4 and 5 under 35 U.S.C. § 103 as being unpatentable
over Kyoto University (JP2017-006058A), translation, cited in the IDS, in view of Sanyo
Electric Industries (JP2011-103832 A), translation, cited in the IDS, and further in view of Zhang et al. (US 2004/0058436 A1), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 12/22/2025.
The rejection of Claim(s) 1, 4, 5, 6, 7 and 8 under 35 U.S.C. § 103 as being
unpatentable over Kyoto University (JP2017-006058A), translation, cited in the IDS, in
view of Sanyo Electric Industries (JP2011-103832 A), translation, cited in the IDS, in
view of Zhang et al. (US 2004/0058436 A1), of record, and further in view of Collins et al. (WO 2014/093845 A1), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 12/22/2025.
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 7-9 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 7, now recites, “wherein the at least one moving step includes, after the concentration adjusting step”. However, Claim 7 depends from Claim 6 which recites, “after the first moving step, a concentration adjusting step” and Claim 6 depends from Claim 5 which recites, “at least one moving step”. Therefore, it is unclear when the limitations of Claim 6 occur as it cannot be determined if the moving step of Claims 5 and 6 are the only moving step(s). Claims 8 and 9 are rejected as being dependent upon rejected Claim 7. For purposes of examination, the Examiner has interpreted the Claims as referring to sequential limitations occurring after the “at least one moving step” of Claim 5.
Claim 6 recites the limitation "after the first moving step". There is insufficient antecedent basis for this limitation in the claim as Claim 6 depends from Claim 5 which recites “at least one moving step”.
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.
Claim(s) 1 and 4 are rejected under 35 U.S.C. § 103 as being unpatentable over Kyoto University (JP2017-006058A), translation, cited in the IDS, in view of Sanyo Electric Industries (JP2011-103832 A), translation, cited in the IDS, and Welch et al. (US 2014/0377739 A1).
Kyoto University teaches a method comprising:
a media emptying step of draining media from a culture vessel containing
adherent cultured human pluripotent stem cells (Pg. 10, Paragraph [0007], Lines 14-16);
a stripping solution supply step wherein stripping solution which acts on but does
not completely detach the adherent cells is introduced into the culture container for a
predetermined amount of time (Pg. 10, Paragraph [0007], Lines 16-20 and Pg. 28,
Paragraph 0073], Lines 6-15 and Paragraph [0074], Line 1);
a stripping liquid discharge step which drains the stripping liquid from the culture
vessel (Pg. 10, Paragraph [0007], Lines 20-21);
supplying a medium (recovery liquid) to the culture vessel to form a cell
suspension and recover the cells (Pg. 10, Paragraph [0007], Lines 21-25),
and a cell suspension transfer step which transfers the cell suspension from the
first to a second culture vessel via a connection path (Pg. 10, Paragraph [0007] and Pg. 11, Paragraph [0009], and reading on Claims 1 and 4.
Kyoto University further teaches that a tube pump moves the cell suspension from the first culture vessel to the second culture vessel and disrupts cell clumps (Pg. 11, Paragraph [0009].
Kyoto University does not teach that after the peeling/stripping liquid discharge a
portion of the peeling/stripping liquid remains as a residual adhering to the cells and
inner surface of the culture vessel (first container);
after the peeling/stripping liquid discharge a second waiting step for a second predetermined time period which is a time period until the cells are completely peeled by action of a residual peeling liquid;
or after the recovery liquid supply step is completed, at least one moving step of moving a cell suspension containing the cells from the first container to a second container, by feeding a gas to the first container, as required by Claim 1.
Sanyo Electric Industries teaches that a release agent is supplied to decompose
protein which adheres cells to an inner wall to peel cells off and the waiting time is
determined by the cell type and release agent, but is usually 3 to 8 minutes (Pg. 18,
Paragraph [0034]).
Welch et al. teaches removing cell culture media from a cell culture device by pumping (Column 5, Paragraph [0046]), and by introducing a gas into the cell culture device to displace the media (Column 5, Paragraph [0047]).
It would have been obvious to those of ordinary skill in the art to modify the
method of Kyoto University to include a second predetermined waiting period after
removal of the stripping/peeling solution to ensure the cells are completely detached
because this would allow time for the stripping/peeling solution to have a maximal effect
on detaching the adherent cells from the culture vessel. As Sanyo Electric Industries
teaches a typical time period to affect such a stripping/peeling step, it therefore would
have been obvious to the ordinary artisan that the time period to effect cell detachment
from a culture vessel with a stripping/peeling/release agent is known in the art as a
optimizable variable depending on the types of the cells and the peeling agent, which
could be determined by routine experimentation and optimization and used again as a
"predetermined" time period. Those of ordinary skill in the art would have been motivated to make this modification in order to assure optimal removal of adherent cells.
There would have been a reasonable expectation of success in making this modification
because both references are drawn to the same field of endeavor, that is, use of
chemical agents to remove adherent cultured cells from a container.
With regard to the limitation of Claim 1, that "after the peeling/stripping liquid
discharge a portion of the peeling/stripping liquid remains as a residual adhering to the
cells and inner surface of the culture vessel (first container)", this would be an inherent
feature of the method of Kyoto University whom teaches the same container and
method steps as claimed, therefore the same results would also be expected.
The Examiner notes that Pg. 9, Paragraph [0031] of the Specification as filed
indicates that:
"In step S14, the entire amount of the peeling liquid L is basically discharged from the closed container 50. However, in reality, as shown in FIG. 5D, the residual peeling liquid L adhere to the inner surface of the closed container 50 and the cells C due to surface tension."
As the prior art performs the same peeling/stripping liquid discharge from a
culture vessel and the surface tension of liquids is a universal physical property, the
same effect of residual peeling/stripping liquid adhering to both the inner surface of the
culture vessel and cells therein would also be expected in the prior art.
It would have been further obvious to those of ordinary skill in the art to modify the method of Kyoto University and Sanyo Electronic Industries comprising a cell suspension transfer step using a tube pump which transfers the cell suspension from the first to a second culture vessel via a connection path to introduce a gas into the first container to move the cell suspension to the second container as taught by Welch et al. because Welch teaches that both pumps and gas displacement may be used to move cell culture media from one container to another. Those of ordinary skill in the art would have been motivated to make this modification based on artisan preference and the availability of cell culture media removal apparatus. There would have been a reasonable expectation of success in making this modification because Kyoto University teaches removing cells suspended in a liquid media from one container to another using a pump and Welch teaches that liquid media may be removed from a container using either a pump or gas displacement.
Claim(s) 1, 4 and 5-8 are rejected under 35 U.S.C. § 103 as being unpatentable over Kyoto University (JP2017-006058A), translation, cited in the IDS, in view of Sanyo Electric Industries (JP2011-103832 A), translation, cited in the IDS, and Welch et al. (US 2014/0377739 A1), as applied to Claims 1 and 4 above, and further in view of Takayama et al. (US 2019/0322977 A1).
The teachings of Kyoto University, Sanyo Electric Industries and Welch et al. were discussed above.
None of the above references taught wherein the cell suspension in the first container is
moved to a stirring part, as required by Claim 5;
wherein after the at least one moving step, a concentration adjusting step of adjusting a concentration of the cell suspension in the stirring part, as required by Claim 6;
after the concentration adjusting step, a second moving step of moving the
concentration-adjusted cell suspension from the stirring part to a second container by
feeding a gas to the stirring part, as required by Claim 7;
or wherein a volume of the second container is larger than a volume of the first
container, as required by Claim 8.
Takayama et al. teaches moving a cell suspension from a first container (Storage container, #20) to a stirring part (Stirring unit, #30) and from the stirring part to a second container (#s 61-43) (Fig, 1 and Pg. 3, Paragraphs [0053]-[0054])
It would have been further obvious to those of ordinary skill in the art to modify the method of Kyoto University, Sanyo Electronic Industries and Welch et al. comprising a cell suspension transfer step using gas displacement which transfers the cell suspension from the first to a second culture vessel via a connection path to transfer the cell suspension by gas displacement from a first container to a stirring part and from the stirring part to a second container as taught by Takayama et al. because this would prevent settlement of the cells out of suspension and move the cell suspension to the desired container. Those of ordinary skill in the art would have been motivated to make this modification in order to keep the cells being transferred in suspension and move the cell suspension to the desired location. There would have been a reasonable expectation of success in making this modification because all the references are reasonably drawn to the same field of endeavor, that is, cell culture techniques.
With regard to Claim 8, it would have been further obvious to those of ordinary skill in the art to modify the method of Kyoto University such that the second culture vessel has a larger volume than the first culture vessel because a difference in size between limitations taught in the prior art and those claimed would not create a patentable distinction. See the MPEP at 2144.04, IV, A.
Those of ordinary skill in the art would have been motivated to make this modification in order to have a larger volume vessel in which to culture the passaged cells, if so desired. There would have been a reasonable expectation of success in making this modification because Kyoto University already teaches a dual culture vessel system and a difference in the size/proportion between the culture vessels does not establish patentability.
Claim(s) 1, 4-8 and 9 are rejected under 35 U.S.C. § 103 as being unpatentable over Kyoto University (JP2017-006058A), translation, cited in the IDS, in view of Sanyo Electric Industries (JP2011-103832 A), translation, cited in the IDS, and Welch et al. (US 2014/0377739 A1) and Takayama et al. (US 2019/0322977 A1), as applied to Claims 1 and 4-8 above, and further in view of Nie et al. (US 2014/0212966 A1).
The teachings of Kyoto University, Sanyo Electric Industries, Welch et al. and Takayama et al. were discussed above.
None of the above references taught wherein the first container is a multi-layer container, as required by Claim 9.
Nie et al. teaches a method wherein adherent cells are contacted with a liquid medium which causes release of the cells from the surface of the culture vessel for harvesting and passaging (Pgs. 2-3, Paragraph [0025]) wherein the cell culture plate or vessel may be a stacked cell culture apparatus or a multilayer cell apparatus (Pg. 3, Paragraph [0027]).
It would have been obvious to those of ordinary skill in the art to modify the method of Kyoto University, Sanyo Electronic Industries, Welch et al. and Takayama et al. comprising a cell culture and recovery method using a cell culture vessel to use a multi-layer cell culture vessel as taught by Nie et al. because Kyoto University does not specify the type of cell culture vessel used in the method and Nie et al. teaches specific vessels suitable for cell culturing. Those of ordinary skill in the art would have been motivated to make this modification in order to culture cells on multiple layers of the cell culture vessel thereby increasing the number of cells which could be recovered from a single vessel. There would have been a reasonable expectation of success in making this modification because all the references are reasonably drawn to the same field of endeavor, that is, cell culture techniques.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 4-9 have been considered but are moot because the new ground of rejection set forth above do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. For example, the arguments note that Kyoto University does not teach the new limitations of Claim 1 of using gas displacement to move a cell suspension from a first container to a second container (see Remarks, Pg. 7, Lines 1-11 and Pg. 8, Lines 1-3), however these are met by the combination of Kyoto University and the newly cited Welch et al. reference as set forth above.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653 01/16/2026