DETAILED ACTION
This action is in reply to papers filed 1/13/2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240301357A1, Published 9/12/2024.
Election/Restrictions
Applicant’s election with traverse of claims 22-25 in the reply filed on 1/13/20256 is acknowledged. The traversal is on the ground(s) that share unity of invention since the groups are linked by the unexpected finding of a method of preparation of a substrate material useful for the preparations of spheroids applicable to all types of cells forming spheroids and organoids which is simple and rapid and leads to pure, highly standardized and non-encapsulated cell spheroids. This is not found persuasive because none of the inventions cited by the Examiner recite the alleged unexpected finding. Moreover, note that inventions I-IV and VII do recite the technical feature of a substrate material, which is not found special in view of Hoehnel or Zurgil. And although inventions III-VIII recite ‘cell spheroids’ as a technical feature, said recitation is not a special technical feature in view of Hoehnel or Zurgil.
Accordingly, claims 26-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/13/2026.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 25 is 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 25 recites, inter alia, “….wherein the imprinted composite matrix comprises a hydrophilic polymer layer..” The metes and bounds of this limitation are unclear. This is because independent claim 22 step (c) does not recite the hydrophobic die is transferred onto the malleable layer of hydrophilic material of the composite matrix. Indeed, claim 22 only requires the hydrophobic die (comprising a plurality of tapered protuberances) to be pressed into the hydrophilic material of the composite matrix and step (d) of claim 22 requires the hydrophobic die to then be removed such that the hydrophilic material of the composite matrix now comprises a plurality of lasting well-shaped indents on its outer surface.
Therefore, no ‘residual’ hydrophobic material is transferred onto the hydrophilic material by the hydrophobic die. Thus, it is wholly unclear how the composite matrix in claim 25 would comprise a hydrophobic polymer layer with a plurality of lasting well shaped indents.
Clarification is requested.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 22-24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Deutsch et al. (WO2019145847A1, Published 8/1/2019; Ref. 3 in IDS filed 9/20/2023).
Deutsch et al. disclose a cell culturing device and method of using same (Abstract). Specifically, Deutsch teaches the device can be used to culture cells under conditions suitable for formation of 3D multicellular objects (e.g. spheroids) and to study cells/3D multicellular objects invasion capabilities, interactions between two or more cell populations and the effect of drugs on cells and 3D multicellular objects (Pg. 10, lines 30-34). Regarding claim 22(a), Deutsch discloses providing a semipermeable membrane supported by a support frame on its edges (see Fig. 4A, copied below). Deutsch discloses the ‘glued glass bottom’ is a plate having at least one well with a through-hole formed at a bottom. Deutsch discloses such plates are fabricated having optically transparent polymer or glass bottoms (Pg. 4, lines 6-9). In one embodiment, Deutsch discloses the transparent polymer is polypropylene (as in claim 23) (Pg. 8, lines 1-2). Continuing, Deutsch discloses forming a malleable layer of a hydrophilic and porous material on said semipermeable membrane to form a composite matrix (as in claim 22(b) (see Fig. 4B, copied below), wherein said hydrophilic and porous material is an agarose hydrogel (as in claim 24) (Pg. 14, lines 7-11). Deutsch discloses pressing a hydrophobic die (see Fig. 4C, copied below) comprising a plurality of tapered protuberances into an outer surface of the malleable layer of hydrophilic material of said composite matrix to form a plurality of well-shaped indents in said layer (as in claim 22(c); and d) removing the die from the layer of hydrophilic material to obtain an imprinted composite matrix comprising a hydrophilic material layer with a plurality of lasting well-shaped indents on its outer surface supported by a semipermeable membrane on its inner surface (as in claim 22(d) (see Fig. 4D-E, copied below).
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Accordingly, claims 22-24 are anticipated by Deutsch 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al. (WO2019145847A1, Published 8/1/2019; Ref. 3 in IDS filed 9/20/2023) as applied to claims 22-24 are above, and further in view of Apfel, C. (PgPub US20190382701A1, Published 12/19/2019).
Claim interpretation: In view of the 112 (b) rejection of claim 25 above, Examiner is interpreting the composite matrix to comprise the hydrophilic material
The teachings of Deutsch et al. are relied upon as detailed above. However, Deutsch et al. fails to teach well-shaped indents have an aperture from about 100 μm2 to 10 cm2, a depth from about 100 μm to 40 mm, and a bottom surface area from about 0 μm2 to 1 mm2 (as in claim 25).
Before the effective filing date of the claimed invention, Apfel taught systems and methods for obtaining a three-dimensional micro-tissue. For example, Apfel teaches the system includes at least one cell culture device that may include one or more wells, each well includes an opening at an upper surface of the cell culture device and a bottom located towards a lower surface of the cell culture device. The bottom may be characterized by a bottom surface area inside each well. Each well may include a wall extending from the opening to the bottom surface area to define a total volume (Abstract). Apfel teaches the wells provide an effective way for modeling tissue behavior under such concentration gradients, for example, to simulate the concentration gradients inside a tumor. Apfel teaches the opening cross-sectional area (aperture) 106′ has a surface area from about 0.75 to 325 mm2 (Pg. 5, para. 54). Apfel teaches the bottom surface area 110′ having a value from about 75 μm2 to about 800,000 μm2 (Pg. 6, para. 56). Apfel teaches the well 104 may be characterized by a well height (depth) 105 between opening 106 and bottom surface area 110′ along vertical well axis 122 of about 1 and about 25 mm (as in claim 25; see Fig. 1A, copied below) (Pg. 6, para. 66).
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When taken with the teachings of Deutsch et al., wherein Deutsch teaches a cell culture device for culturing cells under suitable conditions for the formation of spheroids, one of ordinary skill in the art would have found it prima facie obvious to modify the device of Deutsch to reflect the dimensions of Apfel. The skilled artisan would have found it prima facie obvious to make such a modification because Apfel teaches the parameters of the wells disclosed provide concentrating and aggregating cells effective space to form the three-dimensional micro-tissues.
Thus, the modification would have been prima facie obvious.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632