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 of Group I, claims 21-36, in the reply filed on February 17, 2026 is acknowledged. Because applicant 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)).
Claim 37 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings were received on June 1, 2023. These drawings are acceptable.
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 21-37 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.
With respect to claim 21 it is unclear what is intended to be encompassed by the phrase “inhibiting cell detachment” in line 7. The limitation states that inhibiting cell detachment is provided over the entire circumference of a cell culture surface, but it is unclear what part of the kit is intended to be the cell culture surface. Does the cell culture surface include the cell detachment inhibition region and the stimulus-responsive region, and or is it intended to only be the cell detachment inhibition region? Additionally, is the clause of “inhibiting cell detachment” intended to convey an intended use of the device, or does this limitation convey some intrinsic property specific to the cell detachment inhibition region, that meets the requires of inhibiting cell detachment? Clarification is requested.
Additionally, with regard to the recitation of lines 10-11 of claim 21, does the recitation “which is varied by an external stimulus” convey an intended use of the stimulus-responsive region, or is the adhesiveness varying dependent upon the application of an external stimulus intended to convey an intrinsic property of either the stimulus-responsive region or a material of the stimulus-responsive region? Clarification is requested.
Additionally, what is the metric by which cell adhesiveness is being measured such that a determination can be made that the taught cell detachment inhibition region is 3-15 times stronger than that of the stimulus-responsive region? Clarification is requested.
Claims 22-36 are ultimately dependent upon claim 21 and thus, inherit the same deficiencies.
Claim 22 recites the limitation "the container shape" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
With respect to claim 24 it is unclear if the recitation of the cell detachment inhibition region being a cell adhesive surface in a temperature range is intended to convey how the kit is utilized (i.e. the kit is used in the specified temperature range), if the temperature range is intended to convey a temperature in which the cell adhesive surface is manufactured, or if the recitation conveys that the cell detachment inhibition region only has a degree of adhesiveness within the specified temperature range. Clarification is requested. Claim 25 is dependent upon claim 24, and thus, inherits the same deficiencies.
With respect to claim 25 it is unclear if the recitation is intended to convey an intended use of the kit, such as the not exposing the cell adhesive surface to external stimulus, or if the recitation is intended to convey a property of the cell adhesive surface (i.e. the cell adhesive surface does not respond to external stimulus). Clarification is requested.
With respect to claim 31 it is unclear if this limitation is drawn to a specific property of the cell culture device or if this intended to be interpreted as a method of manufacture of the cell sheet of the cell culture device, which would be interpreted as intended use of the device. Clarification is requested.
Citation of Pertinent Prior Art
The prior art made of record is considered pertinent to applicant's disclosure:
JP 2019/024350 A (provided by applicant) provides a cell culture vessel comprising a sheet formation region that includes a stimulus responsive region in which the degree of cell adhesiveness changes in response to a stimulus and at least one cell adhesiveness region having cell adhesiveness arranged so as to surround and be contiguous with the stimulus responsive region. There is at least one adhesion boundary at the boundary where the stimulus responsive region is contiguous with the cell adhesion region, and the stimulus responsive region is a region that is in continuous contact with each adhesion boundary (See abstract); and
Killic et al (US 2018/0171276 A1) provides a chip platform that mimics important aspects of human tissues or organs and is easy to manufacture and convenient to use. The platform allows faster drug or treatment development for human diseases, such as airway related conditions, and makes the initial testing on drugs and compounds safer, as it does not involve human subjects (See Para. 0005). The device includes a body having a top compartment and a bottom compartment separated by a porous membrane that is at least partially optically transparent. The membrane is coated with at least one attachment molecule that supports the attachment of a plurality of living cells (See Para. 0006).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 May 30, 2026
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