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 .
Response to Amendment
The Amendment filed on 1/20/2026 has been entered. Claims 1-11 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “a plurality of microgroove,” however, the specification as filed doesn’t provide support for the term “microgrooves.” The specification discusses a microstructure but doesn’t specify that the microstructure is a plurality of microgrooves. Additionally, the drawings do not show that the microstructures can be considered to be “microgrooves.” Claims 2-11 are rejected by virtue of their dependence on a rejected base claim.
Claims 6-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “A cassette type of culture device for biochemical testing,” however, the specification as filed doesn’t provide support for a cassette type of culture device. The specification only discusses the term “cassette” in regarding to the incubation cassette which is equivalent to the edge recess in the current claims. Claims 7 and 8 are rejected by virtue of their dependence on a rejected base claim.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “the target cells entering the top second opening of the incubation cassette settle by gravity onto the layer of hydrogel,” however, the specification as filed doesn’t provide support for how the target cells settle in the device. The specification makes no mention as to the settling of the cells nor anything about gravity.
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 6-8 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.
The term “type” in claim 6 is a relative term which renders the claim indefinite. The term “type” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, being a “cassette type” is unclear as it is not known how “type” is changing the term cassette.
Claim 7 recites “The culture device of claim 6,” however, the preamble of claim 6 is “A cassette type of culture device for biochemical testing.” Claim 7 is therefore unclear if the claim is directed to only the culture device (and not the cassette type) or if the claim is directed to the cassette type.
Claim 8 recites “The culture device of claim 6,” however, the preamble of claim 6 is “A cassette type of culture device for biochemical testing.” Claim 7 is therefore unclear if the claim is directed to only the culture device (and not the cassette type) or if the claim is directed to the cassette type.
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(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/227772, hereinafter Nordon in view of United States Application Publication No. 2016/030631, hereinafter Wang.
Regarding claim 1, Nordon teaches a culture device (figures 6 and 7) for biochemical testing (abstract), comprising: a first plate (items 500 and 700 and paragraph [0112]) as a substrate (figures 6 and 7); and a second plate (items 200, 300 and 400 and paragraph [0112]) as a fluid channel layer (figures 6 and 7), having a bottom surface (the upper side of item 200) and being bonded to the first plate (paragraph [0112]), wherein the bottom surface of the second plate comprising: an edged recess (the recess formed in item 200 right about item 312), extending from a first edge of the second plate toward a center of the second plate (figure 6), the edged recess and the first plate to form an incubation cassette (figure 7), so that the incubation cassette has a second opening (items 210 and 220) directly for receiving target cells (intended use MPEP § 2114 (II)); and a U-shaped recess (item 410 and the portions of items 430 and 440 in side of items 200 and 300), surrounding the edged recess (figure 7), the U-shaped recess and the first plate to form a supply channel (items 410, 430 and 440) for transporting and storing nutrient solution (intended use MPEP § 2114 (II)); a plurality of microgrooves (item 312), connecting the edged recess and the U-shaped recess (figure 7 and paragraph [0113]), thereby forming a microstructure to connect the incubation cassette and the U-shape channel (paragraph [0113]).
Nordon fails to teach a layer of hydrogel, disposed on a side of the microstructure near the incubation cassette and wherein the first plate and the second plate are transparent material.
Wang teaches a cell culturing device which has a layer of hydrogel filing the cell culture channels to provide a porous environment for growing cells (Wang paragraph [0027]) and the device is made from an optically transparent material to facilitate viewing of the cellular samples (Wang, paragraph [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a layer of hydrogel disposed on a side of the microstructure near the incubation cassette because it would provide a porous environment for growing cells (Wang paragraph [0027]) and further to have made the first and second plate a transparent material because it would facilitate viewing of the cellular samples (Wang, paragraph [0033]).
Regarding claim 2, Nordon teaches the incubation cassette is a flat-pocket shaped space (figures 6 and 7)
Nordon fails to teach the range of a depth of the edged recess is 0.5 to 3.0 mm, so the incubation cassette is flat pocket-shaped space.
Wang further teaches altering the thickness of each plate can provide the diffusion rate required, the amount of three-dimensional volume required and the required microfluidics of the device (Wang, paragraph [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum depth of the edged recess to a range of 0.5 to 3.0 mm which would allow for the diffusion rate required, the amount of three-dimensional volume required and the required microfluidics of the device (Wang, paragraph [0036]) (MPEP § 2144.05 (II)).
Regarding claim 3, Nordon teaches wherein the U-shape channel comprises a chamber (item 410) disposed at the bottom of the U-shape channel (figure 7) and the chamber connects the incubation cassette via the microstructure (figure 7).
Regarding claim 4, Nordon teaches wherein two ends, defined as two first openings (items 430 and 440), of the U-shape channel are opened at the first edge of the second plate (figure 7).
Regarding claim 5, Nordon teaches wherein the microgrooves are parallel to each other (figure 6).
Regarding claim 6, Nordon teaches a cassette type of culture device for biochemical testing culture device of claim 2 (see supra), wherein the first plate and the second plate are vertical to a horizontal surface if used (the if makes every after optional), so the second opening of the incubation cassette is positioned toward the top (if the device is turned on its side, one of item 481 or 483 would be positioned towards the top), and a z-axis of cell structure are directly observed and side views of multi-layered cellular samples for real-time monitoring are provided (intended use MPEP § 2114 (II) and the device would be able to be viewed in the z-axis).
Regarding claim 7, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Nordon and Wang and the apparatus of modified Nordon is capable of having the target cells entering the top second opening of the incubation cassette settle by gravity onto the layer of hydrogel disposed above the microstructure, and a three-dimensional layered multicellular structures are cultivated by sequentially adding target cells over time. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Nordon (see MPEP §2114).
Regarding claim 8, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Nordon and Wang and the apparatus of modified Nordon is capable of having the top second opening of the incubation cassette is directly accessed with a micropipette for air-liquid interface (ALI) culture. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Nordon (see MPEP §2114).
Regarding claim 9, Nordon teaches wherein the width of each of the microgrooves is 100 to 900 µm (paragraph [0210]).
Regarding claim 10, the method of micro-machining is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by Nordon and Wang (MPEP § 2113). The burden is on applicants to show product differences in product by process claims. Here, the limitations as to the micro-machining is given minimal patentable weight.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nordon and Wang as applied to claim 1 above, and further in view of United States Application Publication No. 2004/0227200, hereinafter Fukuyama.
Regarding claim 11, Nordon teaches the first and second plate polydimethylsiloxane (paragraph [0112]).
Fukuyama teaches a microchemical chip which is made from a transparent material which is polydimethylsiloxane, polyethylenetelephthalate or polycarbonate (Fukuyama, paragraph [0086]).
Examiner further finds that the prior art contained a device/method/product (i.e., made from polyethylenetelephthalate or polycarbonate) which differed from the claimed device by the substitution of component(s) (i.e., polydimethylsiloxane) with other component(s) (i.e., polyethylenetelephthalate or polycarbonate), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., polydimethylsiloxane with polyethylenetelephthalate or polycarbonate), and the results of the substitution (i.e., being a transparent substrate) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute polydimethylsiloxane of reference Nordon with polyethylenetelephthalate or polycarbonate of reference Fukuyama, since the result would have been predictable.
Response to Arguments
Applicant’s arguments, see pages 11-14, filed 1/20/2026, with respect to the rejection(s) of claim(s) 1, 3-8 and 10 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nordon and Wang.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796