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 .
Status of the Claims
The amendment filed 4/21/2026 has been entered. Claims 1, 6-9, and 12-14 remain pending in the application; claims 13-14 remain withdrawn; and claims 2-5 and 10-11 have been cancelled. Applicant’s amendments to the claims have overcome the objection to claim 6 and the 112(b) rejection to claim 9 previously set forth in the Non-Final Office Action mailed 1/23/2026.
Response to Arguments
Applicant's arguments filed 4/21/2026 have been fully considered but they are not persuasive.
The applicant argues on pp. 11-13 of Remarks that Kwon et al. does not disclose a continuous circumferential first stepped portion along the inner wall of the well unit; first and second sub-wells each smaller than the bottom portion; and a second stepped portion formed between the bottom portion and each of the first and second sub-wells. This is not persuasive, as Kwon et al. discloses two sub-wells and two stepped portions with a continuous circumference (see annotated Fig. 3 below). The applicant also argues that it would not have been obvious to select the claimed numerical values and structural relationship among features of the claimed invention as Kwon et al. does not teach or suggest the specific arrangement of a first circumferential stepped portion, two reduced-diameter sub-wells, a second stepped portion associated with both sub-wells, and curved inner edges of both sub-wells. This is not persuasive, as Kwon et al. does disclose these features, as shown in the annotated Fig. 3 below and in the 35 USC § 103 section below.
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Annotated Fig. 3 of Kwon et al. (KR 10-1711105)
The applicant argues on pp. 13-14 of Remarks that “whereby the second fluid introduced through the inlet portion fills the lower portion by being redirected laterally at the first stepped portion and is brought into contact with a solid thin film of the first fluid in the first sub-well without formation of bubbles at the inner edges” is not an intended use of the apparatus, but rather a physical consequence of the specifically recited structural configuration which is not recited in Kwon et al. This is not persuasive, as Kwon et al. does recite the required features (as will be discussed in the 35 USC § 103 section below) which house the two liquids being used in the device. Though Kwon et al. does not explicitly disclose the second fluid coming into contact with the first fluid “without the formation of bubbles”, Kwon et al.’s device would be fully capable because the prior art apparatus is disclosed to hold the second fluid injected on a solidified first fluid (p. 5) and would be structurally capable of uniformly distributing the second fluid and ensuring stable contact between the second fluid and a solid thin film of the first fluid while preventing bubble formation absent clear evidence otherwise (see MPEP § 2114).
The applicant argues on p. 14 of Remarks that the previously submitted affidavit supports the non-obviousness of the claimed structural combination as amended claim 1 further aligns with the experimentally demonstrated structure. This is not persuasive, as an affidavit must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness (MPEP § 716.02(e)). As explained in the Non-Final Office Action dated 1/23/2026, the comparative examples do not describe Kwon et al.’s device as each comparative example is missing structure that is present in Kwon et al.’s device, and newly amended claim 1 does not render the affidavit sufficient to overcome the obviousness rejections to the claims based on Kwon et al.
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.
Claims 1, 6-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon et al. (KR 10-1711105) (already of record) (machine translated).
Regarding claim 1, Kwon et al. teaches a cell culture test device (abstract) comprising a plurality of well units (abstract; Fig. 1 100 multi-well-based cell-culture-inspection apparatus) comprising: an inlet portion (Fig. 1 110 well unit) through which a first fluid and a second fluid are introduced (abstract), and a bottom portion (Fig. 2 220 first sub-well; Fig. 2(b) at “n2” line) having an inner edge formed by the bottom portion and an inner wall of the well unit (Fig. 2), the bottom portion comprising: a first sub-well (Fig. 2 220 first sub-well) in which the first fluid is accommodated (abstract), and a second sub-well (Fig. 2 230 second sub-well) in which the second fluid is accommodated (abstract) and in which an antibiotic is loaded at a specific location (p. 6 “solution containing a physiological-active material may be provided to the second sub-well… antibiotic”), wherein, a first stepped portion protrudes toward a center of the well unit along a circumference of the inner wall of the well unit such that the well unit has a lower portion whose inner width is smaller than that of an upper portion at an inlet portion side (Fig. 2(b) 221 concave portion; p. 4 “width w1 of the concave portion 221 may be 0.5 or more and less than 1 with respect to the width w2”), the first stepped portion has a continuous edge shape along the circumference of the inner wall (Fig. 2(a) 221 concave portion), and an inner edge of the second sub-well has a curved shape (p. 4 “concave… may have a circular or elliptical shape”).
Regarding the limitation “the first stepped portion has a height between 0.2 mm and 4 mm”, Kwon et al. discloses a stepped portion in the range of 1 µm to 5 mm (p. 6). Kwon et al. teaches that the depth of the concave portion allows biological material to be easily observed in units of a single cell or a single cell colony (p. 6). It would have been obvious to one of ordinary skill in the art to use the range taught in Kwon et al. with a reasonable expectation that this size range would allow biological material to be easily observed in units of a single cell or a single cell colony. Furthermore, it has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range is obvious in view of Kwon et al. because Kwon et al. discloses a range of 1 µm to 5 mm, which overlaps the claimed range of 0.2 mm to 4 mm. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the broader prior art range because the prior art teaches the same utility over the entire range.
Regarding the limitation “the first stepped portion… has a height… that is smaller than a distance from the inner edge of the bottom portion to a center of the bottom portion”, Kwon et al. teaches wherein the height of the first stepped portion (p. 6 “depth of the recess is between 100 µm and 500 µm”) is smaller than the distance from the inner edge of the first sub-well to the center of the bottom portion (p. 6 “width… 100 µm to 5 mm”) in the embodiment of Fig. 3. Kwon et al. teaches that that the depth of the concave portion allows biological material to be easily observed in units of a single cell or a single cell colony and the width of the concave portion provides a space to fix cells to a desired area not larger than the size of an imaging device, allowing observation of the entire area of the concave portion (p. 6). It would have been obvious to one of ordinary skill in the art to use the width and height of the concave/first stepped portion in the embodiment of Fig. 3 with reasonable expectation that it would allow biological material to be easily observed in units of a single cell or a single cell colony and the provides a space to fix cells to a desired area not larger than the size of an imaging device, allowing observation of the entire area of the first stepped portion. This method for improving the embodiment shown in Fig. 2 was within the ability of one of ordinary skill in the art based on the teachings of Kwon et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment shown in Fig. 2 with the embodiment shown in Fig. 3 to obtain the invention as specified in claim 1.
Regarding the limitation “an angle of 90° or more with respect to an advancing direction of the second fluid” Kwon et al. clearly shows in Fig. 2(b) that the first stepped portion is such that it is perpendicular to the bottom portion of the well. Furthermore, Kwon et al. discloses that the first sub-well has a height such that the first fluid does not pass to the second sub-well (p. 3). One of ordinary skill in the art would understand that this would arrive at the first stepped portion having an angle of 90° or more with respect to the advancing direction of the second fluid such that the introduced second fluid is prevented from advancing vertically from the bottom portion. It has been held that “the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art” (MPEP § 2125). One of ordinary skill in the art would understand from the description of the first sub-well in combination with the drawings that Kwon et al. discloses a sub-well having a height and shape such that the first fluid does not advance vertically into the second sub-well.
However, Kwon et al. does not expressly teach the first stepped portion having an angle of 90° or more with respect to the advancing direction of the second fluid such that the introduced second fluid is prevented from advancing vertically from the bottom portion. Nonetheless, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP § 2144.05). Kwon et al. discloses general conditions for the angle of the stepped portion as compared to the bottom portion of the well, as set forth above, and the skilled artisan would recognize that adjusting the angle of the stepped portion would adjust the volume of fluid able to be held in the second sub-well before spilling into the first sub-well and mixing the fluids in the two sub-wells. Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to discover an optimum range for the angle of the stepped portion relative to the bottom portion of the well.
Regarding the limitation “the first sub-well and the second sub-well are each made smaller than a diameter of the bottom portion such that a second stepped portion is formed between the bottom portion and each of the first and second sub-wells”, Kwon et al. teaches a cell culture test device wherein the first sub-well is smaller than the diameter of the bottom portion of the well unit such that a second stepped portion is formed (Fig. 3(b) 322 micro-patterned groove -p.5). Kwon et al. teaches that the micro-patterned groove fixes the first fluid to the bottom surface of the concave portion, and allows the first fluid to spread uniformly in the first sub-well (p. 5). It would have been obvious to one of ordinary skill in the art to use the embodiment shown in Fig. 3 including a second stepped portion with reasonable expectation that it would fix the first fluid to the bottom surface of the first stepped portion, and allow the first fluid to spread uniformly in the first sub-well. This method for improving the embodiment shown in Fig. 2 was within the ability of one of ordinary skill in the art based on the teachings of Kwon et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment shown in Fig. 2 with the embodiment shown in Fig. 3 to obtain the invention as specified in claim 1.
Regarding the limitation “an inner edge of the first sub-well has a radius of curvature of 0.1 to 1 mm (p. 6 “width… 100 µm to 5 mm”) and a height of 0.1 to 1 mm (p. 6 “depth… 100 µm to 1 mm”). Kwon et al. teaches that the width of the concave portion provides a space to fix cells to a desired area not larger than the size of an imaging device, allowing observation of the entire area of the concave portion (p. 6). It would have been obvious to one of ordinary skill in the art to use the range taught in Kwon et al. with a reasonable expectation that this size range would allow biological material to be easily observed in the concave portion. Furthermore, it has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range is obvious in view of Kwon et al. because Kwon et al. discloses a range of 100 µm to 5 mm, which overlaps the claimed range of 0.1 to 1 mm. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the broader prior art range because the prior art teaches the same utility over the entire range.
Regarding the limitations “the second fluid introduced through the inlet portion fills the lower portion by being redirected laterally at the first stepped portion and is brought into contact with a solid thin film of the first fluid in the first sub-well without formation of bubbles at the inner edges”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Kwon et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to hold the second fluid injected on a solidified first fluid (p. 5) and would be structurally capable of uniformly distributing the second fluid and ensuring stable contact between the second fluid and a solid thin film of the first fluid while preventing bubble formation absent clear evidence otherwise.
Regarding claim 6, Kwon et al. teaches a cell culture test device wherein the inner edge of the bottom portion formed by the bottom portion and the inner wall of the well unit has a continuous edge shape along the circumference of the inner wall (Fig. 2).
Regarding claim 7, Kwon et al. clearly shows in Fig. 2(b) that the inner edge of the bottom portion formed by the bottom portion and the inner wall of the well unit is perpendicular relative to the bottom portion. Furthermore, Kwon et al. discloses that the first sub-well has a height such that the first fluid does not pass to the second sub-well (p. 3). One of ordinary skill in the art would understand that this would arrive at the inner edge of the bottom portion formed by the bottom portion and the inner wall of the well unit having an angle of 70 to 120° with respect to the bottom portion. It has been held that “the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art” (MPEP § 2125). One of ordinary skill in the art would understand from the description of the first sub-well in combination with the drawings that Kwon et al. discloses a sub-well having a height and shape such that the first fluid does not advance vertically into the second sub-well.
However, Kwon et al. does not expressly teach wherein the inner edge of the bottom portion formed by the bottom portion and the inner wall of the well unit has an angle of 70 to 120° with respect to the bottom portion. Nonetheless, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP § 2144.05). Kwon et al. discloses general conditions for the angle of the inner edge of the bottom portion as compared to the bottom portion of the well, as set forth above, and the skilled artisan would recognize that adjusting the angle of the inner edge of the bottom portion would adjust the volume of fluid able to be held in each sub-well before spilling into the other sub-well and mixing the fluids in the two sub-wells. Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to discover an optimum range for the angle of the inner edge of the bottom portion relative to the bottom portion of the well.
Regarding claim 8, Kwon et al. teaches a cell culture test device wherein the second stepped portion has a continuous edge shape along circumferences of respective upper ends of the first and second sub-wells (Fig. 3(a) 322 micro-patterned groove – p.5).
Regarding claim 9, Kwon et al. teaches a cell culture test device wherein at least a portion of a bottom face of the well unit is made of an optically transparent material such that a biological agent in the first sub-well is observable through the bottom face (p. 5 “at least a portion of the bottom surface of the concave portion 221 may be made of an optically transparent material to observe an object in the first fluid through the bottom surface of the concave portion 221. For example, the body of the cell-culture-inspection apparatus may be formed of a transparent material”).
Regarding claim 12, Kwon et al. teaches a cell culture test device wherein the first fluid is a mixture solution of a gelling agent-containing liquid medium and a biological agent (p. 3 “the first fluid may be a mixed solution of a liquid medium containing a solidifying agent and a biological material”, p. 5 “the first fluid may be gelled”) and the second fluid is a solvent (p. 3 “the second fluid may be a solvent”) selected from water, cell culture media, dimethylformamide (DMF), and dimethyl sulfoxide (DMSO) (p. 6 “as a solvent that dissolves the freeze-dried bioactive-material, water, a medium for cell culture, dimethylformamide (DMF), dimethyl sulfoxide (DMSO) may be used”).
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 ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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