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 Group II, claims 10-16 in the reply filed on August 22, 2025 is acknowledged.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Arguments
Applicant's arguments filed December 11, 2025 have been fully considered but they are not persuasive.
The claims have not been amended to overcome all 112 issues. See rejections herein.
Applicant’s arguments, see remarks/amendments, filed December , 2025, with respect to the rejection(s) of the claim(s) under 102, 103, and double patenting have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Suenaga et al., US 2020/0199508 and Koseki et al., WO2020100567.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 10-11 and 16 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.
As to claim 10, it is unclear if the cell culture bag is intended to be comprised of a gas permeable flexible film material or if such is just used during the forming of the bag. The phrase “formed using” indicates the latter. If applicant intends for the bag to be comprised of a gas-permeable, flexible film material, then the claim should clearly recite such.
Furthermore it is unclear what the “having…and comprising” clauses modify, the film material or the bag. If the bag, then the claim should clearly recite such. For example, the cell culture bag comprises a lower face including on an inner surface of the lower face; and an upper face opposite the lower face….
Furthermore, it appears as if the last line of the claim should read as “before adding cells to the cell culture bag.”
Claims 11 and 16 are rejected via dependency upon a rejected claim.
As to claim 11, it is noted that the phrase “the lower face of the cell culture bag comprises the plurality of recesses is redundant in view of claim 10. Only the clause “wherein the plurality of recess comprises 10 to 1,000,000 recesses” is further limiting of claim 10.
Claim 16 recites the limitation "the application of a pressure to the cell culture bag". There is insufficient antecedent basis for this limitation in the claim. It appears as if the phrase should read as “wherein the applying of the pressure to the cell culture bag…” to be consistent with claim 10. “Furthermore the term “un” appears to be a misspelling of “an”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 10-11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suenaga et al., US 2020/0199508 and further in view of Koseki et al., WO2020100567.
Suenaga discloses a culturing method employing a cell culture bag (2) comprising upper film 21 and the lower film 22 which form the bag body 2 are formed of a (flexible) plastic film having gas transmission (gas permeable). (paragraph 0044; Figures 2A-2B and corresponding descriptions). The bag further comprises plurality of recess portions 4 (more than 10, Figure 1C) formed in the lower film 22 of the cell culturing bag. (paragraph 0050, Figures 2A-B corresponding descriptions).
The bag is placed on a stand and sandwiched between a pressing member (6) having a bottom surface (6a) substantially parallel to the placement surface (5a) is used to press the upper film (21) from above such that contents of the bag are discharged from the bag. (Abstract, Figures 2A-B corresponding descriptions).
Suenaga does not disclose that air is removed from the bag before adding cells to the bag.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Koseki discloses a culturing method comprising placing a culture medium in a culture vessel 2 (flexible bag) and removing bubbles (air) which cause problems during cell culturing from the vessel before adding cells because ( paragraphs 0003, 10-14, 17, etc.; claims 11-12, Figures 4, 6).
It would have been obvious to, and within common sense, knowledge, and skill of ordinary skill in the art before the effective filing date of the invention to modify the teachings Suenaga to provide for removing bubbles from the cell culture bag before adding cells to the bag to avoid problems caused by the presence of bubbles during culturing as taught by Koseki and because such does not require any special skills nor knowledge beyond that of one of ordinary skill in the art and such modifications would yield predictable results.
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 BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798