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 .
Response to Amendment
The amendment filed June 20, 2026 has been entered.
Claims 1-13, 15-16, and 21-33 are pending, with claims 13, 15-16, and 21-22 being examined, and claims 1-12 and 23-33 deemed withdrawn.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed March 26, 2026.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 13 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suenaga et al. (WO Pub. No. 2018/230544; hereinafter Suenaga; already of record; US Pub. No. 2020/0199508 to Suenaga et al., already of record, used as an English translation).
Regarding claim 13, Suenaga discloses a cell culture jig for holding a bag-shaped cell culture vessel formed by mutually opposed planar substrates, at least one of the planar substrates being formed of a gas permeable film ([0048]-[0062], see Figs. 2A-2B. The jig is capable of holding the claimed bag-shaped cell culture vessel). The cell culture jig comprises:
a stage on which the cell culture vessel is placed ([0048]-[0062], see Figs. 2A-2B at stand 5).
A pressing member that presses the cell culture vessel to the stage ([0048]-[0062], [0067]-[0070], see Figs. 2A-2B at pressing member 6. See also Figs. 5A-5B at pressing member 60 having projections 62).
The stage is formed of a substrate having a surface that contacts the gas permeable film ([0048]-[0062], see Figs. 2A-2B at stand 5 having openings 5b).
A plurality of protruding portions are arranged in parallel on the surface of the substrate ([0048]-[0062], see Figs. 2A-2B at stand 5 having openings 5b, where the columns formed on the surface of the substrate of the stand that delineate the openings 5b are protruding portions).
A ventilation space is formed between the gas permeable film and the stage by spaces between the plurality of protruding portions ([0048]-[0062], see Figs. 2A-2B. the openings 5b of stand 5 will enable ventilation by allowing air to circulate in the space between the stand and a vessel placed on the stand).
Note: The instant Claims contain a large amount of functional language (ex: “on which the cell culture vessel is placed…”, “a ventilation space…”, “disposed to be movable”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Further Note: Regarding the cell culture jig being “for holding a bag-shaped cell culture vessel formed by mutually opposed planar substrates, at least one of the planar substrates being formed of a gas permeable film”, see MPEP 2111.02, which states that, “if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
Regarding claim 22, Suenaga discloses the cell culture jig according to claim 13. Suenaga further discloses a method for producing cells in which cells are cultured using the cell culture jig ([0048]-[0062]).
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.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Suenaga as applied to claims 13 and 22 above, and further in view of Reichmann (US Pub. No. 2016/0136333; already of record).
Regarding claim 15, Suenaga discloses the cell culture jig according to claim 13. Suenaga further discloses that guide pins are disposed upright, and the pressing member is disposed to be movable along the guide pins in a direction perpendicular to the stage ([0048]-[0062], especially at [0054], see Figs. 2A-2B at guide pins 72, and pressing member 6 moving along guide pins 72).
Suenaga fails to explicitly disclose that the guide pins are disposed upright on four corners of the stage, and the guide pins pass through guide bores provided to the pressing member.
Reichmann is in the field of compressing components (Reichmann [0001]), and is therefore reasonably pertinent to the problem faced by the inventor. Reichmann teaches guide pins that are disposed upright on four corners of a stage, where guide pins pass through guide bored provided to a pressing member (Reichmann; [0053], see Fig. 9, where second component 400 has bores 404 to accommodate guiding rods 104, and the second component 400 slides along guiding rods 104 to compress a hydrogel layer H). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the jig of Suenaga with the teachings of Reichmann so that the guide pins are disposed upright on four corners of the stage, and the guide pins pass through guide bores provided to the pressing member, as Reichmann teaches that this arrangement is suitable for compressing a component between a stage and a pressing member (Reichmann; [0053], see Fig. 9).
Regarding claim 16, Suenaga discloses the cell culture jig according to claim 13, wherein support pillars are disposed upright on four corners of the stage, a top panel is secured to the support pillars, the top panel includes guide pins, the guide pins pass through guide bores provided to the pressing member, and the pressing member is disposed to be movable along the guide pins in a direction perpendicular to the stage ([0048]-[0062], especially at [0054], see Figs. 2A-2B at frame 71, guide pins 72 extending from top of frame 71, and pressing member 6 moving along guide pins 72).
Further, even if Suenaga is not considered to teach that the support pillars are disposed upright on four corners of the stage, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the support pillars be disposed upright on four corners of the stage, in order to provide support for the top panel from all corners of the stage, therefore improving the structural integrity of the jig.
Still further, even if Suenaga is not considered to teach that the pressing member is disposed to be movable along the guide pins in a direction perpendicular to a stage, Reichmann teaches a pressing member that is disposed to be movable along guide pins in a direction perpendicular to a stage (Reichmann; [0053], see Fig. 9, where second component 400 has bores 404 to accommodate guiding rods 104, and the second component 400 slides along guiding rods 104 to compress a hydrogel layer H). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the jig of Suenaga with the teachings of Reichmann so that the pressing member is disposed to be movable in a perpendicular direction along the guide pins, as Reichmann teaches that this arrangement is suitable for compressing a component between a stage and a pressing member (Reichmann; [0053], see Fig. 9).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Suenaga.
Regarding claim 21, Suenaga discloses the cell culture jig according to claim 13, and all limitations recited therein. Suenaga further discloses that a plurality of ridges are formed to be arranged in parallel as the protruding portion (see Figs. 2A-2B at stand 5 having openings 5b, which will enable ventilation, where the space between columns on the stand 5 form the opening).
Suenaga fails to explicitly disclose that a plurality of approximately triangular prisms are formed to be arranged in parallel in a mountain range pattern as the protruding portion.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the protruding portion be a plurality of approximately triangular prisms formed to be arranged in parallel in a mountain range portion, since the configuration of the protruding portion is a matter of design choice which a person having ordinary skill in the art before the effective filing date of the invention would have found obvious absent persuasive evidence that the particular configuration of the protruding portion was significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), and MPEP 2144.04(IV)(B). The motivation for providing the protruding portion as a plurality of approximately triangular prisms formed in parallel in a mountain range portion would have been that such a configuration would still provide for openings to receive recess portions of a bag, as in Suenaga ([0048]-[0062], see Figs. 2A-2B), and would therefore still be suitable for use like in Suenaga.
Response to Arguments
Applicant's arguments filed June 20, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 10-11 of their Remarks that Suenaga does not disclose protruding portions formed on the surface of the stage. Applicant argues that Fig. 2 of Suenaga clearly shows that the “protrusions” are merely walls of through-holes, i.e. openings 5b. However, the Examiner respectfully disagrees. The Applicant’s assertion that the protrusions are merely walls of through-holes is conclusory, and Fig. 2 of Suenaga, as best understood by the Examiner, clearly shows columnal features, which protrude out from the bottom of the substrate where the bag is being held. Under broadest reasonable interpretation, these features are protrusions, absent persuasive evidence to the contrary.
Applicant further argues on Pg. 11 of their Remarks that Suenaga does not disclose, “a ventilation space is formed between the gas permeable film and the stage by spaces between the plurality of protruding portions”, as claimed in the instant amended claim set. The Examiner respectfully disagrees. The limitation “a ventilation space” is functional language. However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. In this case, the openings 5b between the columnal features (i.e., the protruding portions) is a void space where air can circulate between the stage and a bag vessel placed on the stage, particularly as the bag itself is not positively recited within claim 13.
Applicant further argues on Pgs. 11-14 of their Remarks that the claimed invention provides numerous advantages over Suenaga, such as decreased manufacturing complexity, decreased cost, and superior performance. These advantages are secondary considerations. However, secondary considerations are not considered under rejections of 35 U.S.C. 102, only 35 U.S.C. 103. See MPEP 2131.04 and In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). As the claims in question have been rejected under 35 U.S.C. 102, such secondary considerations are moot.
Applicant’s arguments on Pgs. 14-15 of their Remarks regarding the unsuitability of the applied secondary references to reject the features of independent claim 13 are not persuasive, as the features of independent claim 13 have been rejected using Suenaga over 35 U.S.C. 102.
Conclusion
THIS ACTION IS MADE FINAL. 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 John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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/JOHN MCGUIRK/Primary Examiner, Art Unit 1798
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