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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/9/2025 has been entered.
Status of the Claims
The amendment filed 12/9/2025 has been entered. Claims 1, 3-4, 6-9, and 12-14 remain pending in the application; claims 13-14 remain withdrawn; and claims 2, 5, and 10-11 remain cancelled.
Response to Arguments
Applicant's arguments and affidavit filed 12/9/2025 have been fully considered but they are not persuasive. The affidavit (it is to be noted that the applicants arguments follow the affidavit) under 37 CFR 1.132 filed 12/9/2025 is insufficient to overcome the obviousness rejections of claims 1, 3-4, 6-9, and 12 based upon Kwon et al. (KR 10-1711105) (already of record) (machine translated) as set forth in the previous Office action dated 9/16/2025.
The affidavit alleges unexpected results; however, 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)). The Applicant points to Example 1 and Comparative Examples 1-3 (explained on p. 22 of the instant specification as well as pp. 3-5 of the affidavit) which are experiments performed comparing the claimed invention (Example 1) to similar devices with different dimensions of a stepped portion height, stepped portion angle, and curved inner edge, respectively (Comparative Examples 1-3, respectively).
The Applicant alleges that Comparative Example 1 describes Kwon et al.’s device (the closest prior art). This is not true, as Comparative Example 1 specifically lacks a stepped portion (p. 4 of the affidavit; p. 22 of the specification). Kwon et al.’s device discloses a stepped portion (Figs. 2(b) 221 concave portion, 3(b) 322 concave portion) and therefore, Comparative Example 1 does not describe Kwon et al.’s device. Thus, the affidavit does not compare the claimed invention with the closest prior art to be effective to rebut a prima facie case of obviousness.
The Applicant also alleges that Comparative Example 2 describes Kwon et al.’s device (the closest prior art). This is not true, as Comparative Example 2 describes a side wall of the sub-well that lays in the same plane as the lower portion of the corresponding well unit. Kwon et al.’s device clearly shows a side wall of the sub-well which is higher than a lower portion of the well unit (Figs. 2(b), 3(b) topmost step of the steps of the sub-well) and therefore, Comparative Example 2 does not describe Kwon et al.’s device. Thus, the affidavit does not compare the claimed invention with the closest prior art to be effective to rebut a prima facie case of obviousness.
The Applicant also alleges that Comparative Example 3 describes Kwon et al.’s device (the closest prior art). This is not true, as Comparative Example 3 specifically describes edges of the wells that are right-angled (p. 22 of the specification). Kwon et al.’s device discloses a sub-well with a curved shape (p. 4 “concave… may have a circular or elliptical shape”), not right-angled. Therefore, Comparative Example 3 does not describe Kwon et al.’s device and thus, the affidavit does not compare the claimed invention with the closest prior art to be effective to rebut a prima facie case of obviousness.
Further regarding Comparative Example 3, the affidavit alleges that Comparative Example 3 uses a well structure in which the junction between the bottom portion of the well and the wall is sharp/right-angled. However, objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support (MPEP 716.02(d)). Comparative Example 3 is not commensurate in scope with the claims as claim 1 only describes “an inner edge of the first sub-well has a curved shape with a radius of curvature of 0.1 to 1 mm and a height of 0.1 to 1 mm”. The claims do not purport to having a sharp/right-angled junction between the bottom portion of the well and the wall, and thus, this comparative experiment is not effective to rebut a prima facie case of obviousness as it is not commensurate in scope with the claims.
The affidavit also argues that the claimed ranges of the stepped portion height, stepped portion angle, and curved inner edge are all critical for eliminating interface bubbles and significantly improving uniform lateral distribution and reproducibility of fluid height over a solid thin film (p. 5 of the affidavit). This is not persuasive because to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (MPEP 716.02(d)). The experiments performed comparing Example 1 and Comparative Examples 1-3 only test two possible values: a device which has the noted feature (Example 1) and a device which does not have the noted feature (Comparative Examples 1-3). These experiments do not appear to compare a sufficient number of tests both inside and outside the claimed range to demonstrate the criticality of the claimed range, and are thus not persuasive to rebut a prima facie case of obviousness.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claim Objections
Claim objected to because of the following informalities: it is recommended that "the unit" should read "the . Appropriate correction is required.
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 4 and 9 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.
Claim 4 recites the limitation "the distance from the inner edge" in line 2 and “the center of the bottom portion” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 9 is directed to an apparatus, but contains method step limitations: “an antibiotic is loaded at a specific location”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite (MPEP § 2173.05(p)).
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, 3-4, 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), each of the plurality of well units 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 comprising a first sub-well (Fig. 1 120 first sub-well) in which the first fluid is accommodated (abstract), wherein a first stepped portion protrudes toward the center of the well unit along the 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”), and an inner edge of the first 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 “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 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 limitations “the second fluid is redirected laterally and uniformly distributed while preventing vertical creep and bubble formation” and “the curved shape thereby preventing formation of air bubbles during fluid introduction and ensures stable contact between the second fluid and a solid thin film of the first fluid”, 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 3, Kwon et al. teaches a cell culture test device wherein the first stepped portion has a continuous edge shape along the circumference of the inner wall (Fig. 2(a) 221 concave portion).
Regarding claim 4, Kwon et al. is silent to the height of the first stepped portion of the embodiment of Fig. 2. However, 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 4.
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 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 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 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 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 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). 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 8.
Regarding claim 9, Kwon et al. teaches a cell culture test device wherein the bottom portion comprises a second sub-well (Fig. 2 230 second sub-well) in which the second fluid is accommodated (abstract) and 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”).
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”).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kwon et al. (WO 2017/183875 A1) discloses a multi-well cell culture test device comprising a plurality of well units each comprising first and second sub-wells.
Conclusion
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799