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 submits that claim 33 should be included in Group I. Examiner agrees.
Applicant’s election without traverse of Group I, claims 1-21 and 33 in the reply filed on 7/9/2026 is acknowledged.
Claims 22-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/9/2026.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 12/15/2023, 1/18/2024, and 4/3/2025 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The use of the terms ANSI ([0027] and [0069]), DVD ([0061]), Gibco ([0078]), Invitrogen ([0078] and [0079]), Sigma ([0078] and [0079]), BD ([0078]), Lonza ([0078]), R&D Systems ([0079]), and Accutase ([0079]) which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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, 4, 12, 15, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US 20190316068 A1, hereinafter referred to as Chen – presented in IDS dated 4/3/2025).
Regarding claim 1, Chen discloses a microwell array ([0381], “2×3 array of microwells”; Fig. 13A-13D – see figure below) comprising:
a substrate ([0021], solid support base reads on a substrate);
a plurality of wells in the substrate (Fig. 13B), each well having an opening, a sidewall surface and a bottom surface (Fig. 13B);
at least one longitudinal recess arranged in the bottom surface of each of the plurality of wells (Figs. 13B-13D); and
at least one micropillar arranged within the longitudinal recess at each end of the longitudinal recess ([0137], two pillars; Fig. 13D).
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The limitation “configured for high-throughput screening of micro-tissue” is merely a recitation of a purpose or intended use of the invention and has been given an appropriate patentable weight (MPEP § 2111.02 II).
Regarding claim 4, Chen discloses the microwell array of claim 1.
Chen discloses the microwell array further comprising a set of electrodes electrically connected to at least one of the plurality of wells ([0133], “a set of electrodes 122 that are inserted in the wells 112 to provide electrical signals to stimulate tissue generation”).
Regarding claim 12, Chen discloses he microwell array of claim 1, wherein the micropillars are confined to the ends of the longitudinal recess (see Chen Fig. 13C above).
Regarding claim 15, Chen discloses the microwell array of claim 1, wherein a distance between the micropillars at each end of the longitudinal recess is 1000 to 2000 µm ([0099], “the distance is within the range of…1.0-4.0 mm”).
Regarding claim 20, Chen discloses the microwell array of claim 1, wherein the substrate is composed of cyclic olefin copolymer ([0098] discloses COC-polymers usable for the support base, i.e., the substrate).
Regarding claim 21, Chen discloses the microwell array of claim 1, wherein a portion of the bottom surface of the well connecting to a recess side wall of the longitudinal recess is provided with a sloped portion having an angle of incline such that a depth of the bottom surface of the well in the sloped portion increases with closer proximity to the longitudinal recess ([0144] disclose that the lower chamber, i.e., longitudinal recesses, can be tapered; Figs. 15A-15E).
Claim Rejections - 35 USC § 103
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 2-3, 6, 14, 16-19, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Huebsch et al. (US 20170211044 A1, hereinafter referred to as Huebsch – presented in IDS dated 4/3/2025).
Regarding claim 2, Chen discloses the microwell array of claim 1.
Chen is silent to an expanded depression arranged at each end of the at least one longitudinal recess.
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However, Huebsch in the art of micro-tissue culturing teaches it is known in the art to form a tissue culturing plate ([0030], culture plate) comprising microwells with a dogbone shape ([0044]), the dogbone shape having two holes, i.e., expanded depressions, joined by a canal, i.e., a longitudinal recess ([0044]). See annotated Huebsch Fig. 1B below.
Huebsch teaches that the holes anchor micro-tissues and that the canals force cellular alignment and three dimensional self-assembly ([0044]) and produces accurate organ and tissue models ([0042]).
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 device of Chen to form expanded depressions arranged at each end of the longitudinal recess because Huebsch teaches that such a structure would force cellular alignment and three dimensional self-assembly to produce accurate organ and tissue models.
Regarding claim 3, the prior art combination teaches the microwell array of claim 2.
Huebsch of the prior art combination discloses that the expanded depression is circular, oval, rectangular, square, V-shaped, or triangular ([0010], [0044], Fig. 1B as shown above).
Regarding claim 6, Chen discloses the microwell array of claim 1.
Chen is silent to the at least one longitudinal recess comprising a groove portion.
However, Huebsch teaches it is known in the art to form a tissue culturing plate ([0030], culture plate) comprising microwells with a dogbone shape ([0044]), i.e., at least one longitudinal recess, the dogbone shape having two holes joined by a canal, i.e., a groove portion ([0044]). See annotated Huebsch Fig. 1B above.
Huebsch teaches that the such a structure forces cellular alignment and three dimensional self-assembly ([0044]) and produces accurate organ and tissue models ([0042]).
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 longitudinal recess of Chen to comprise a groove portion because Huebsch teaches that such a structure would force cellular alignment and three dimensional self-assembly to produce accurate organ and tissue models.
Regarding claim 14, Chen discloses the microwell array of claim 1, but is silent to a depth of at least one longitudinal recess.
However, Huebsch teaches a microwell for culturing microtissues wherein a depth of at least one longitudinal recess is 500 µm or less ([0050], “the microwell depth is at least about 200 µm”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify at least one longitudinal recess of Chen to have a depth of 500 µm or less because Huebsch shows that the claimed depth is suitable for culturing microtissues.
Regarding claim 16, the prior art combination teaches the microwell array of claim 6.
Huebsch of the prior art combination teaches that the width of the canal, i.e., groove portion, of at least one longitudinal recess is less than 200 µm ([0030], “The canal region…with a width of 100 μm”).
Although Huebsch does not explicitly disclose or teach the width claimed, it has been held that the prior art anticipates the claimed range when a specific example in the prior art is within a claimed range (MPEP § 2131.03).
Regarding claim 17, the prior art combination teaches the microwell array of claim 2.
Huebsch does not explicitly disclose the claimed width of the expanded depression.
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Huebsch teaches that the width of the expanded depression is ~500 µm, which falls within the claimed range of more than 200 µm and less than 600 µm (see Fig. 1B shown above and Huebsch Fig. 3F1 shown below).
It has been held that the prior art anticipates the claimed range when a specific example in the prior art is within a claimed range (MPEP § 2131.03).
Regarding claim 18, Chen discloses the microwell array of claim 1, but is silent to at least a portion of a bottom surface of at least one longitudinal recess being provided with a non-fouling coating.
However, Huebsch teaches that it is known in the art to use a blocking agent, i.e., a non-fouling coating, to inhibit cell adhesion ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide at least a portion of a bottom surface of at least one longitudinal recess of Chen with a non-fouling coating to inhibit cell adhesion, as taught by Huebsch. Such a modification would predictably inhibit cell adhesion to at least a portion of a bottom surface of the at least one longitudinal recess, and one of ordinary skill in the art would be motivated to promote cell movement in the longitudinal recess for testing.
Regarding claim 19, Chen discloses the microwell array of claim 1.
Chen teaches it is known in the art to use a cell adhesion coating to selectively promote cell adhesion ([0152] teaches that certain parts of the device can be treated with a sticky coating).
Although Chen does not expressly disclose wherein a cell adhesion coating is provided on the bottom surface at least at each end of the at least one longitudinal recess in an area adjacent the at least one micropillar, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chen to meet the claim of note as Chen shows that such a modification is known in the art. Such a modification would predictably promote cell adhesion near the micropillar, and one of ordinary skill in the art would be motivated to promote growth of a dogbone-shaped tissue structure.
Regarding claim 33, Chen discloses the microwell array of claim 1, but is silent to at least a bottom surface and sidewall of the at least one longitudinal recess being provided with a non-fouling coating.
However, Huebsch teaches that it is known in the art to use a blocking agent, i.e., a non-fouling coating, to inhibit cell adhesion ([0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide at least a bottom surface and sidewall of the at least one longitudinal recess of Chen with a non-fouling coating to inhibit cell adhesion, as taught by Huebsch. Such a modification would predictably inhibit cell adhesion to at least a bottom surface and sidewall of the at least one longitudinal recess, and one of ordinary skill in the art would be motivated to promote cell movement in the longitudinal recess for testing.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Austin et al. (US Patent 5,427,663, hereinafter referred to as Austin – see PTO-892).
Regarding claim 5, Chen discloses the microwell array of claim 4.
Chen is silent to the electrodes being composed of evaporated gold.
However, Austin in the art of studying microstructures teaches that forming electrodes using evaporated gold is known in the art (col. 10, lines 35-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the electrodes of Chen such that the electrodes are composed of evaporated gold because Austin teaches it is a suitable material for electrodes.
Claims 7-8, 10, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Chen.
Regarding claim 7, Chen discloses the microwell array of claim 1.
Chen is silent to a plurality of micropillars arranged within the at least one longitudinal recess at each end of the longitudinal recess.
Nonetheless, 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 microwell array of Chen to comprise a plurality of micropillars as such a modification represents mere duplication of the pillars discussed above. It has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). Such a modification would predictably enhance cell adhesion to each end of the longitudinal recess.
Regarding claim 8, Chen teaches the array of claim 7.
Chen is silent to the plurality of micropillars is arranged in a triagonal pattern.
Nonetheless, 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 arrangement of the plurality of micropillars as such a modification would amount to mere rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI C).
Regarding claim 10, Chen discloses the microwell array of claim 1.
Chen is silent to at least one well of the microwell array comprising a plurality of discontinuous longitudinal recesses.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify at least one well of the microwell array such that it comprises a plurality of discontinuous longitudinal recesses as such a modification represents mere duplication and rearrangement of the longitudinal recesses discussed above. It has been held that the duplication of parts or rearrangement of parts has no patentable significance unless a new and unexpected result is produced (MPEP § 2144.04 VI B, MPEP § 2144.04 VI C). Such a modification would predictably provide more space for culturing cells.
Regarding claim 11, Chen discloses the microwell array of claim 1.
Chen discloses wherein a ratio of a length to a width of the at least one longitudinal recess is 3.05 to 1.85 (Fig. 3C).
Although Chen does not expressly disclose the claimed ratio, 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 ratio of Chen such that it is 2 to 15 as such a modification would amount to mere changes in proportion or size. It has been held that changes in proportion or size do not patentably distinguish from the prior art (MPEP § 2144.04 IV A).
Regarding claim 13, Chen discloses the microwell array of claim 1, wherein a diameter of the at least one micropillar is 400 µm ([0139], width reads on diameter because the pillar is cylindrical). Chen further discloses that the width of the pillar affects tissue stability and maturation ([0189]).
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 , when the particular parameter is recognized as a result-effective variable (MPEP § 2144.05). Chen discloses the general conditions for the diameter of the at least one micropillar and further teaches that it is a result-effective variable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to discover an optimum or workable range for a diameter of the at least one micropillar.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Rodgers, John W. An Investigation of Micro and Nanomanufactured Polymer Substrates to Direct Stem Cell Response for Biomedical Applications. Lehigh University, 2014 (hereinafter referred to as Rodgers – see PTO-892).
Regarding claim 9, Chen teaches the microwell array of claim 1.
Chen is silent to the elastic modulus of a material of the at least one micropillar is 30 to 70 MPa, but suggests that polymers having a tunable elastic moduli may be suitable for preparing a solid support base, i.e., the at least one micropillar ([0018], support base comprises a pillar; [0021] discloses a list of polymers, including polyurethane).
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Rodgers in the art of micro and nanostructures for cell culturing teaches that polyurethane (PU) based polymers have an elastic modulus encompassing the claimed range (Fig. 1-4 – see figure below).
Rodgers teaches that elastic modulus is a critical parameter associated with pillar bending mechanics (3.3 Micropillar bending mechanics) and the ideal polymer must match the appropriate stiffness to mimic the compliance of a desired tissue type (5.1 Polymers).
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, when the particular parameter is recognized as a result-effective variable (MPEP § 2144.05). Rodgers discloses the general conditions for the elastic modulus of a material and further teaches that the parameter is a result-effective variable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to discover an optimum or workable range for the elastic modulus of the material by routine optimization.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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/A.J.C./ Examiner, Art Unit 1799
/William H. Beisner/ Primary Examiner, Art Unit 1799
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