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 .
It is noted that Examiner for the present application has been changed. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Examiner Masudur Rahman.
It is noted that this new office action that the previous action (mailed on 08/20/2026) is replaced/superseded.
Claim Status
In the reply filed on 20 February 2026, claim 1 is amended, claims 10-12 are withdrawn. Therefore, claims 1-12 are herein pending.
Election/Restrictions
Applicant previously elected without traverse of Group 1 claim(s) 1-9, drawn to a cell culture device/apparatus comprising a base that has ridges, the troughs of the ridges being more hydrophilic than the peaks or surrounding area, and an upper piece comprising wells or walls that retain a suspension/culture of cells and a storage vessel of a buffer, wherein, somehow, the cells are exposed to a gas.
Applicants did not indicate explicitly whether the election was with or without traverse. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, non-elected Groups, there being no allowable generic or linking claim.
Claims 1-9 are currently under consideration.
Withdrawn Rejections
The Applicant has amended the claim 1 and Claim I recite "a groove formed in the base body and retaining the cell together with the buffer solution, wherein the groove is configured such that the buffer solution retained therein is exposed to a gas phase in an outside. In the cited prior art Park et al. (Biotechnology and Bioengineering 90(5):632-644, 2005) describes a microfabricated grooved substrate used in a closed perfusion circuit. As shown in Figure IA on page 634 and described in the "Flat-Plate Bioreactor" section on pages 634-635, the device has a glass substrate covered by a polycarbonate upper plate with a silicone gasket to provide a "water-tight seal". Consequently, in Park, the liquid in the grooves is physically isolated from the outside atmosphere (gas phase). The oxygen is supplied to the cells in an "oxygenator" as shown in Fig. IB, which is separated from the grooves. Thus, Park does not teach or render obvious at least the features of "a groove formed in the base body and retaining the cell together with the buffer solution, wherein the groove is configured such that the buffer solution retained therein is exposed to a gas phase in an outside," as recited in amended claim 1. Therefore, the prior rejection of claim(s) 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (Biotechnology and Bioengineering 90(5):632-644, 2005) is hereby withdrawn.
New Claim Rejections - 35 USC § 102
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.
Claims 1, 4-5, 7-9 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (Langmuir 2018, 34, 5358−5366; cited in PTO892, hereinafter “Lee”). This new rejection is maintained for reasons of record and current applicants’ amendments.
Claim Interpretation: Claim 1 describes a unit for exposing cells to a gas-phase substance while keeping the cells in a thin layer of buffer solution. According to SPEC, the solution is to confine cells and buffer solutions in a defined cell-holding structure, such as a groove or hydrophilic region, whose geometry and surface properties set the buffer layer thickness. A connected storage portion continuously supplies buffer to the cell-holding area, helping prevent drying while preserving a thin liquid film. This lets gas-phase substance reach the cells through the buffer layer. The same structure can also support optical observation of cell response. [0006]-[0007], [0017], [0045], [0069]. Accordingly, the claimed unit is understood to facilitate contact between a gas-phase substance and cells while the cells remail in buffer solution.
Examiner interprets the claim 1 is a designed unit configured to expose a gas-phase substance to a cell in a buffer solution comprising "a groove formed in the base body and retaining the cell together with the buffer solution, wherein the groove is configured such that the buffer solution retained therein is exposed to a gas phase in an outside."
MEPE 2173.05(p) states “A product-by-process claim, which is a product claim that defines the claimed product in terms of the process by which it is made, is proper. Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 1354, 117 USPQ2d 1733, 1739 (Fed. Cir. 2016); In re Luck, 476 F.2d 650, 177 USPQ 523 (CCPA 1973); In re Pilkington, 411 F.2d 1345, 162 USPQ 145 (CCPA 1969); and In re Steppan, 394 F.2d 1013, 156 USPQ 143 (CCPA 1967). A claim to a device, apparatus, manufacture, or composition of matter may contain a reference to the process in which it is intended to be used without being objectionable under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, so long as it is clear that the claim is directed to the product and not the process. In here, examiner interpreted that the groove is configured such that the buffer solution retained therein is exposed to a gas phase in an outside is a process of intended use of the groove within exposure device.
[AltContent: textbox ([img-media_image1.png]
Fig. 2 of Lee)]Regarding claims 1 and 7, Lee discloses an open microfluidic devices fabricated in a step with methods such as micromilling and injection molding because they do not require bonding of multiple layers, wherein the groove includes a meanderingly extending part (Fig. 2Ai top view). Lee teaches in Fig. 1 that the open microfluidic systems are reliable as air bubbles, and bonding defects are alleviated, therefore, such platforms, pico-liter to microliter droplets are generated and manipulated in an immiscible phase, enabling applications such as high-throughput cell screening, DNA sequencing, directed evolution, and chemical reactions (abstract, Fig. 2 and 7; p. 5358 left hand col. 1st ¶; p. 5359 left hand col. 1st ¶). MPEP 2125 states Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). In here, Lee clearly discloses an exposure unit in order to expose a gas-phase substance to a cell in a buffer solution, the exposure unit comprising a base body (i.e., microchannel). Therefore, POSITA would anticipate the groove is configured such that the buffer solution retained therein is exposed to a gas phase in an outside.
Regarding claims 4 and 9, Lee teaches that the top view channel (Figure 2Ai) was optimized to image a long section of the open channel, whereas the side-view channel (Figure 2Aii) was designed to have a thin transparent 2 mm wall allowing side-view imaging (p. 5360 left hand col. 2nd ¶). Therefore, POSITA would anticipate the part of the base body where the groove is formed is configured to be transparent with respect to light from the cell retained in the groove and the device is configured for observation device.
Regarding claim 5, Lee teaches that the base body further includes a second storage portion connected to the other end of the groove and storing the buffer solution discharged from the groove (Fig. 2Ai).
Regarding claim 8, Lee teaches a device with a circular inlet reservoir had a diameter of 30 mm and a depth of 1.0 mm. The channel for side-view imaging (Figures 2Aii, 3B, and 4B) was 60 mm long; the circular inlet reservoir had a diameter of 10 mm and a depth of 1.0 mm (p. 5364 “Channel Dimensions” ¶ and Fig. 2Ai). Therefore, POSITA would anticipate the device of Lee having an inlet reservoir with a first storage portion configured by a recess formed in the base body.
Accordingly, Lee anticipates instant claims 1, 4-5, 7-9.
Response To Arguments
Applicant's arguments filed on 20 February 2026 are acknowledged.
Applicant argues that Park does not teach or render obvious at least the features of "a groove formed in the base body and retaining the cell together with the buffer solution, wherein the groove is configured such that the buffer solution retained therein is exposed to a gas phase in an outside," as recited in claim 1. See remark p. 5 last ¶.
The Applicant's arguments have been fully considered but is not persuasive because the new ground of rejection addresses the new limitations. In the new rejection, Lee discloses an open microfluidic devices fabricated in a step with methods such as micromilling and injection molding because they do not require bonding of multiple layers, wherein the groove includes a meanderingly extending part (Fig. 2Ai top view). MPEP 2125 states Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). Lee clearly discloses an exposure unit in order to expose a gas-phase substance to a cell in a buffer solution, the exposure unit comprising a base body (i.e., microchannel). Therefore, POSITA would anticipate the groove is configured such that the buffer solution retained therein is exposed to a gas phase in an outside.
Subject Matter Free of Art
Claims 2-3, 6 are objected because art does not teach or reasonably suggest the base body includes a first member having a surface where the groove is formed and a second member disposed on the surface, the groove is exposed to the outside via the first opening and at least a part of the first storage portion is configured by the second opening. Since claims 2-3, 6 depend on rejected base independent claim 1. Claims 2-3, 6 would be free of the art, if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic, can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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