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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-3, in the reply filed on 4/12/2026 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/27/2023 and 3/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is less than 50 words in length and it contains the phrase “the present invention relates to” which is a phrase which can be implied. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities:
It is recommended that "comprising porous microwell" in line 2 read "comprising a porous microwell". Appropriate correction is required.
I. Appropriate correction is required.
Claim 3 is objected to because of the following informalities:
I. 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 1-3 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 1 recites the limitation "the upper part of the upper chamber" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the level of the culture medium in the culture medium reservoir is set to correspond to the level of the culture medium in the lower chamber” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (KR 1020200081853) (already of record) (machine translated).
Regarding claim 1, Lee et al. discloses a 3D cell culture device (para. 0001 “provides an environment capable of forming a three-dimensional cell spheroid”), comprising: an upper chamber (body 10), comprising a porous microwell comprising an opening (inlet 11), a porous membrane (membrane 20), and cell culture space for accommodating a culture medium (Figs. 1-2 space between inlet 11 and membrane 20 in body 10); a lower chamber (plate 30), comprising a space in which the upper chamber is disposed (Fig. 2); wherein fluid flowing into the upper part of the upper chamber passes through the porous microwell in the upper chamber and flows into the lower chamber (para. 0010), and wherein the fluid in the lower chamber is discharged and the fluid flows (para. 0061; Fig. 5).
Regarding claim 2, Lee et al. discloses a 3D cell culture device wherein the fluid in the lower chamber is discharged through a fluid outlet provided in the lower chamber, or is discharged through a gap region between the upper chamber and the lower chamber (para. 0061; Fig. 5).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR 1020200081853) (already of record) (machine translated) in view of Mohapatra et al. (US 11,198,842).
Regarding claim 3, Lee et al. discloses a 3D cell culture device, but does not disclose a culture medium reservoir disposed on the same plane as the lower chamber, and in fluid communication with the fluid outlet of the lower chamber, and wherein the level of the culture medium in the culture medium reservoir is set to correspond to the level of the culture medium in the lower chamber. However, Mohapatra et al. discloses an outlet well (16) disposed on the same plane as a center well (12) and in fluid communication with the center well (fluid conduits 19) which allows fluidic equilibrium to be achieved between the wells (Col. 4, lines 45-48). It would have been obvious to a person of ordinary skill in the art to use the Mohapatra et al. configuration of an outlet well disposed on the same plane as a center well and in fluid communication with the center well in Lee et al.’s device with a reasonable expectation that it would allow fluidic equilibrium to be achieved between the wells. This method for improving Lee et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Mohapatra 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 combine the teachings of Lee et al. and Mohapatra et al. to obtain the invention as specified in claim 3.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Isenberg et al. (US 2022/0340848 A1) discloses a well plate including an insert with a membrane for cell culture; Wikswo et al. (US 2021/0198607 A1) discloses a microfluidic bioreactor including chambers inserted inside other chambers, each including a membrane.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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