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 with traverse of Group I, claims 1-25, in the reply filed on December 22, 2025 is acknowledged. The traversal is on the ground(s) Group II claims expressly depend from claim 1, and so once claim 1 is in form for allowance, by default, so will the Group II claims. This is not found persuasive because as set forth in the restriction requirement, the inventions listed as Groups I-II do not relate to a single general inventive concept under PCT Rule 13.1 because they do not relate to one invention only, or to a group of inventions so linked so as to form a single inventive concept. Further, Applicants’ attention is drawn to the fact that the search for method claims requires the identification of processing steps, while the search for apparatus claims requires the identification of structural elements.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 5, 2023 and August 1, 2023 have been considered and made of record. Regarding the information disclosure statements filed on June 5, 2023, there is no requirement that applicants explain the materiality of English language references, however, is should be noted that it is desirable to avoid long lists of documents. If a long list is submitted, it is suggested to highlight those documents which have been specifically brought to applicant's attention and/or are known to be of most significance. In the case of lengthy documents, concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability. For further reference, see MPEP 609.04(a) III and MPEP 2004 (13).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “microcavity well is defined by sidewalls comprising grid segments that define each microcavity opening, and an individual microcavity centered within the microcavity opening” (claim 6), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities: In claim 1, the limitation “an opening of the bottom grid” in line 9 should read -- an opening of the plurality of openings of the bottom grid -- for consistency. In claim 20, the limitation “wherein the upper grid is formed from elastomeric materials selected from natural rubbers, styrene-butadiene block copolymers, styrene-ethylene-butylene-styrene polymers, polyisoprene, polybutadiene, ethylene propylene
rubber, ethylene propylene diene rubber, silicone elastomers, fluoroelastomers, polyurethane
elastomers, nitrile rubbers, or a combination thereof” should read -- wherein the upper grid is formed from elastomeric materials selected from natural rubbers, styrene-butadiene block copolymers, styrene-ethylene-butylene-styrene polymers, polyisoprene, polybutadiene, ethylene propylene rubber, ethylene propylene diene rubber, silicone elastomers, fluoroelastomers, polyurethane elastomers, nitrile rubbers, and a combination thereof --.
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.
Claim 6 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 6 recites the limitation "each microcavity opening" in line 2. There is insufficient antecedent basis for this limitation in the claim. A Plurality of microcavity openings was not previously recited in the claims.
Claim 6 recites the limitation "the microcavity opening" in line 3. It is unclear which microcavity opening the limitation is referring to.
Appropriate correction is required.
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)(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.
Claim(s) 1, 10, 16-17, 24 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Beurden (already or record, WO 2017/142410-A1; hereinafter ‘410).
Regarding claim 1, ‘410 discloses a microcavity plate comprising: a base comprising: a bottom grid comprising a plurality of grid segments arranged in ordered
rows and columns to form a plurality of openings (see FISG. 1A-1B: microplate (1) comprising a plurality of wells (2) arranged in ordered rows and columns to form a plurality of openings; page 15), and an open well comprising a plurality of sidewalls extending vertically from a
perimeter of the bottom grid (FIGS. 1A-1B: outer sidewalls surrounding wells (2)); and a microcavity substrate comprising a plurality of microcavities arranged in ordered rows and columns that align with the plurality of openings in the bottom grid (FIGS. 2B and 3: plate (7) having a plurality of tubes (9); page 16), each microcavity comprising a cavity disposed within an opening of the plurality of openings of the bottom grid (FIG. 3; page 16).
Regarding claim 10, ‘410 further discloses wherein each cavity in the plurality of microcavities comprises a top surface and a rounded bottom (see FIG. 3; pages 5-6).
Regarding claims 16-17, ‘410 further discloses wherein the microcavity substrate is formed from polystyrene (pages 8 and 18).
Regarding claim 24, the limitation “wherein the microcavity plate is used for cell culture of spheroids” is directed to the intended use of the claimed apparatus. Also see page 1 of ‘410.
Regarding claim 25, the limitation “wherein the microcavity plate is used for high-throughput screening” is directed to the intended use of the claimed apparatus. Also see page 14 of ‘410.
Therefore, ‘410 meets and anticipates the limitations set forth in claim(s) 1, 10, 16-17, 24 and 25.
Claim Rejections - 35 USC § 103
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) 2-6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘410 as applied to claim 1 above, and further in view of Masuda (already of record, JP 2018-108032-A; with English machine translation).
Regarding claims 2-6, ‘410 discloses the microcavity plate according to claim 1. ‘410 does not explicitly disclose an upper grid comprising a plurality of well openings in ordered rows and columns that mirror the ordered rows and columns of the bottom grid, wherein the upper grid is configured for placement in the open well on top of the bottom grid delineating the ordered rows and columns of the base, wherein the plurality of well openings align with the plurality of microcavities in the microcavity substrate, and wherein a microcavity well is defined by sidewalls comprising grid segments that define each microcavity opening, and an individual microcavity centered within the microcavity opening. However, ‘410 does disclose wherein a seal, lid or cover plate is positioned over said plurality of microcavities (page 11, ll. 13-15). Masuda discloses a plate comprising a base comprising a bottom grid comprising a plurality of grid segments arranged in ordered rows and columns to form a plurality of openings (see, e.g., FIG. 3: container body (10) having a plurality of compartments; [0014]), and an upper grid comprising a plurality of well openings in ordered rows and columns that mirror the ordered rows and columns of the bottom grid, wherein the upper grid is configured for placement in the open well on top of the bottom grid delineating the ordered rows and columns of the base (see FIG. 3: partition member (20) includes side walls defining a plurality of open wells). In view of Masuda, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover of ‘410 with the upper grid of Masuda to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the benefit of preventing material transfer and contamination between the plurality of microcavities, as suggested by Masuda ([0035]). Regarding the limitation “wherein the plurality of well openings align with the plurality of microcavities in the microcavity substrate, and wherein a microcavity well is defined by sidewalls comprising grid segments that define each microcavity opening, and an individual microcavity centered within the microcavity opening,” the combination of ‘410 and Masuda intrinsically provide the configuration recited in said limitation. Furthermore, it is noted that the recitation of functional language "for placement in the open well on top of the bottom grid delineating the ordered rows and columns of the base" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed microcavity plate and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 14, modified ‘410 discloses wherein the upper grid comprises a plurality of protrusions extending from a perimeter of the upper grid (see FIG. 3 of Masuda).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘410 in view of Masuda as applied to claim 4 above, and further in view of Yu et al (US 2012/0107926; hereinafter “Yu”).
Regarding claims 7-8, modified ‘410 discloses the microcavity plate according to claim 4. Modified ‘410 does not explicitly disclose a gasket material integrated on a bottom of the upper grid, wherein when the upper grid is inserted in the open well, the gasket material is disposed between the bottom of the upper grid and a top of the microcavity substrate. Yu discloses a plate comprising a base (FIGS. 3B-3C: base plate (1); [0014]), a microcavity substrate (FIGS. 3B-3C: intermediate face (2); [0014]), and an upper grid (FIGS. 3B-3C: top plate (3); [0014]). Yu further discloses wherein a seal is arranged between the base, microcavity substrate and upper grid to achieve a right seal ([0065]). In view of Yu, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed a seal such as a gasket, as suggested by Yu, between the bottom of the upper grid and a top of the microcavity substrate of modified ‘410. One of ordinary skill in the art would have made said modification for the purpose of achieving a tight seal between the bottom of the upper grid and a top of the microcavity substrate and thereby prevent cross contamination between the microcavities.
Claim(s) 9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘410 as applied to claim 1 above.
Regarding claim 9, modified ‘410 discloses the microcavity plate according to claim 1. ‘410 does not explicitly disclose wherein the plurality of microcavities comprises 1536 individual microcavities. However, ‘410 does disclose wherein the number of the plurality of openings accommodating the plurality of microcavities can be varied (page 9, ll. 16-27; page 15, ll. 6-12). It would therefore have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the number of microcavities employed with the microcavity plate of ‘410 to comprise 1536 individual microcavities as claimed. One of ordinary skill in the art would have made said modification because ‘410 explicitly discloses that the number of microcavities can be varied (page 9, ll. 16-27; page 15, ll. 6-12). Further, one of ordinary skill in the art would have made said modification in order to increase cell culture throughput of the microcavity plate.
Regarding claim 11, modified ‘410 does not explicitly disclose wherein a diameter of each microcavity at the top surface of the microcavity is about 1500 μm. However, since the instant specification is silent to unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to modify the dimeter of the microcavities of ‘410 to have the claimed diameter, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 12, modified ‘410 discloses wherein an inner surface of the cavity is
coated with a coating non-adherent to cells (page 6, ll. 14-17).
Regarding claim 13, modified ‘410 discloses wherein the coating comprises an ultra low attachment (ULA) surface coating (‘410 at page 19).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘410 in view of Masuda as applied to claim 14 above, and further in view of Niggemann et al (US 2018/0127698; hereinafter “Niggemann”).
Regarding claim 15, modified ‘410 discloses the microcavity plate according to claim 14. Modified ‘410 discloses wherein the upper grid comprises a plurality of protrusions extending from a perimeter of the upper grid (see FIG. 3 of Masuda), but does not explicitly disclose wherein protrusions in the plurality of protrusions are configured to align and interlock with a plurality of through holes in the sidewalls of the open well. Niggemann discloses a plate comprising a base (FIG. 14: plate (310); [0148]) and a cover (320) having protrusions coupled corresponding grooves in sidewalls of the base (FIG. 14; [0148]). In view of Niggemann, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microcavity plate of modified ‘410 with the plate of Niggemann in order to secure the upper grid to the base, as disclosed by Niggemann (FIG. 14; [0148]). Modified ‘410 does not explicitly disclose wherein the sidewalls of the open well includes a plurality of through holes. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed through holes with the sidewalls of the open well in place of grooves in order to secure the upper grid to the base. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice which a person of ordinary skill in the art would have found obvious since the claimed microcavity plate would not perform differently than the prior art device of modified ‘410.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘410 as applied to claim 1 above, and further in view of Malito et al (US 2008/0044312; hereinafter “Malito”).
Regarding claims 18-19, modified ‘410 discloses the microcavity plate according to claim 1. Modified ‘410 does not explicitly disclose wherein the base is formed from polystyrene. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the base of modified ‘410 with a polystyrene to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known material for another. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 20, modified ‘410 does not explicitly disclose wherein the upper grid is formed from elastomeric materials selected from natural rubbers, styrene-butadiene block copolymers, styrene-ethylene-butylene-styrene polymers, polyisoprene, polybutadiene, ethylene propylene rubber, ethylene propylene diene rubber, silicone elastomers, fluoroelastomers, polyurethane elastomers, nitrile rubbers, and a combination thereof. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the upper grid of modified ‘410 with natural rubbers to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known material for another. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘410 in view of Masuda and Yu as applied to claim 7 above, and further in view of Malito et al (US 2008/0044312; hereinafter “Malito”).
Regarding claims 21-22, modified ‘410 discloses the microcavity plate according to claim 7. Modified ‘410 does not explicitly disclose wherein the gasket material is formed from an elastomer, wherein the elastomer comprises silicone. Malito discloses a base (FIG. 2a: substrate 70; [0026]) and a top plate (FIG. 2a: body (10); [0026]). Malito disclose wherein a silicone elastomer gasket is employed for sealing between the base and top plate (FIG. 2a: gasket (30); [0026]). In view of Malito, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the gasket of modified ‘410 with the silicone elastomer gasket of Malito to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known gasket for another for the predictable result of sealing between components. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 23, modified ‘410 does not explicitly disclose wherein the gasket material is formed from a pressure sensitive adhesive. Malito discloses a base (FIG. 2a: substrate 70; [0026]) and a top plate (FIG. 2a: body (10); [0026]). Malito disclose wherein a silicone elastomer gasket or a double-sided acrylic tape can be employed for sealing between the base and top plate (FIG. 2a: gasket (30); [0026]). In view of Malito, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the gasket of modified ‘410 with the double-sided acrylic tape of Malito to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known sealing means for another for the predictable result of sealing between components.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799