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 13-22 in the reply filed on 2/16/2026 is acknowledged. Claims 1-12 and 23-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/16/2026.
Claim Status
Claims 1-33 are pending, with claims 13-22 being examined, and claims 1-12 and 23-33 deemed withdrawn.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) received on 12/29/2022, 6/3/2024, 9/27/2024, 1/21/2025, 3/6/2025, 7/28/2025, and 9/4/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are 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 15-16 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.
Regarding claim 15, Lns. 3-4 recite, “the pressing member is disposed to be movable in a perpendicular direction along the guide pins”. However, it is unclear what the direction of movement of the pressing member is supposed to be perpendicular to. Is the movement supposed to be perpendicular to a length of the guide pins? A width of the guide pins? Or something else? Further clarification is needed. For purposes of compact prosecution, the above limitation has been examined as meaning that the pressing member is disposed to be movable in a perpendicular direction relative to any dimension of the guide pins, along the guide pins.
Claim 16 contains similar issues regarding the recitation of, “the pressing member is disposed to be movable in a perpendicular direction along the guide pins”, and is similarly rejected and examined.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-14, 19-20, 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 on the IDS received 12/29/2022; US Pub. No. 2020/0199508 to Suenaga et al., already of record on the IDS received 12/29/2022, used as an English translation).
Regarding claim 13, Suenaga discloses a cell culture jig for holding a bag-shaped cell culture vessel of a closed system, the cell culture vessel including 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 claims 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 enabling ventilation between the gas permeable film and the stage ([0048]-[0062], see Figs. 2A-2B at stand 5 having openings 5b, which will enable ventilation). and the gas permeable film side of the cell culture vessel is placed on the stage (the cell culture vessel is not positively recited, and the gas permeable film side of a cell culture vessel is capable of being placed on the stage).
Note: The instant Claims contain a large amount of functional language (ex: “on which the cell culture vessel is placed…”, “enabling ventilation…”, “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 of a closed system, the cell culture vessel including 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 14, Suenaga discloses the cell culture jig according to claim 13, wherein the pressing member is formed of a substrate enabling ventilation between the gas permeable film and the pressing member, and the gas permeable film side of the cell culture vessel is pressed by the pressing member ([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 space between the projections enable ventilation).
Regarding claim 19, Suenaga discloses the cell culture jig according to claim 13.
With regards to the substrate enabling ventilation being formed by uneven processing of a surface of the substrate, the substrate of Suenaga is identical to a substrate that is formed by uneven processing of a surface of the substrate. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 20, Suenaga discloses the cell culture jig according to claim 19, wherein a protruding portion is formed on the surface of the substrate enabling ventilation (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).
With regards to the protruding portion being formed by the uneven processing, the substrate of Suenaga is identical to a substrate that is formed by uneven processing of a surface of the substrate. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Suenaga as applied to claims 13-14, 19-20, and 22 above, and further in view of Reichmann (US Pub. No. 2016/0136333).
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 in a perpendicular direction along the guide pins ([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 in a perpendicular direction along the guide pins ([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 in a perpendicular direction along the guide pins, Reichmann teaches a pressing member that is disposed to be movable in a perpendicular direction along guide pins (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).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Suenaga as applied to claims 13-14, 19-20, and 22 above, and further in view of Heike et al. (Translation of JP Pub. No. 2006-325437; hereinafter Heike).
Regarding claim 17, Suenaga discloses the cell culture jig according to claim 13.
Suenaga fails to explicitly disclose that the substrate enabling ventilation is a porous material.
Heike is in the analogous field of culture trays (Heike Pg. 1 1st Para.). Heike teaches a substrate enabling ventilation that is a porous material (Heike; Pg. 6 Last Para.-Pg. 7 1st Para., see Fig. 2). 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 Heike so that the substrate enabling ventilation is a porous material, as Heike teaches that such a substrate will allow gas exchange for discarding carbon dioxide generated during cell culture, thereby promoting cell growth, proliferation, differentiation, and/or selection (Heike Pg. 3 3rd-5th Paras.).
Regarding claim 18, Suenaga discloses the cell culture jig according to claim 13.
Suenaga fails to explicitly disclose that the substrate enabling ventilation is a perforated plate.
Heike teaches a substrate enabling ventilation that is a perforated plate (Heike; Pg. 6 Last Para.-Pg. 7 1st Para., see Fig. 2). 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 Heike so that the substrate enabling ventilation is a perforated plate, as Heike teaches that such a substrate will allow gas exchange for discarding carbon dioxide generated during cell culture, thereby promoting cell growth, proliferation, differentiation, and/or selection (Heike Pg. 3 3rd-5th Paras.).
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 20, 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.
Conclusion
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/Examiner, Art Unit 1798