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 .
Preliminary Remarks
The arguments submitted by applicant on 05/21/2026 have been entered. No claims have been amended, canceled, or added. Claims 6-9 and 13-20 were not elected and therefore, are withdrawn from consideration. Furthermore, claims 1-20 remain pending in the application.
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.
Claims 1-3, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 4789,601 A-Banes and further in view of US 10,101,336 B2-Bergo.
Regarding claim 1, Banes discloses a multiwell plate (culture plate 10, col. 5, line 3, Fig. 1) for a cell population in a liquid medium (col. 5, lines 1-2), the multiwell plate (culture plate 10, Fig. 1) comprising: a frame having a frame surface (rectangularly shaped structure--frame including a flat upper surface 12—frame surface, col. 5, lines 5-7, Fig. 1) and frame sides extending from the frame surface (side walls 13,14, and end walls 15,16, col. 5, line 8, Fig. 1);
Banes discloses a plurality of wells (wells, 18, col. 5, lines 10-11, Fig. 1), each well (well 18, Fig. 1) having an open end (well 18 is shown in Fig. 1 as having an open end, col. 5, lines 10-11, Fig. 1) a closed end opposite the open end (bottom surface of well bases 22, col. 5, line 36, Fig. 1) and at least one wall (wall 20, col. 5, lines 16-18, Fig. 1); between the open end and the closed end;
Banes discloses wherein the open end of each of the wells (wells 18 is shown in Fig. 1 as having an open end, col. 5, lines 10-11, Fig. 1) is surrounded by the frame surface (frame surface 12, col. 5, lines 5-7, Fig. 1);
Banes discloses wherein the closed end (bottom surface of well bases 22, col. 5, line 36, Fig. 1) comprises a well surface between and contacting the at least one wall (well surface—wall 20, col. 5, lines 16-18, Fig. 1);
Regarding claim 1, Banes teaches the invention discussed above. Further, Banes teaches a continuous anchor ring (anchor ring 24, col. 5, lines 18-19, Figs. 1-2) on the well surface of the closed end of one or more of the wells (bottom surface of well bases 22, Figs. 1-2, col. 5, lines 18-19). However, Banes does not explicitly teach a raised height of the continuous ring from the well surface forming a continuous boundary on the well surface, the raised height forming a microchamber volume.
For claim 1, Bergo teaches an invention relating to the field of high throughput biological assays and more specifically to the field of microarrays and analysis of microarrays by spectrographic methods. The embodiments disclosed herein also relate to the field of live cell microarrays (col. 1, lines 17-21) and Bergo teaches various shapes and dimensions of microwells (col. 15, lines 20-21), specifically, Fig. 4A of Bergo shows a cross-section of a microwell having a raised height of the continuous ring from the well surface, shown below in annotated Fig. 4A), further, the raised height forms a microchamber volume, which reads on the instant claim limitation of a raised height of the continuous ring from the well surface forming a continuous boundary on the well surface.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the plate 10 of Banes and further include a raised height of the continuous ring from the well surface, the raised height forming a microchamber volume as taught by Bergo, because Bergo suggest the shape and dimension of the microwell allow for securing a sample or bead of an assay (col. 15, lines 20-23).
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Regarding claim 2, Banes discloses wherein the at least one continuous ring (anchor ring 24, col. 5, lines 18-19, Figs. 1-2; that is, ring 24 is oriented on the bottom well surface 22 of well 18, where cell culture occurs) is configured to define at least one cell seeding area on the well surface.
Regarding claim 3, Banes discloses wherein the multiwell plate (plate 10, Fig. 1) comprises more than one continuous ring (anchor ring 24, col. 5, lines 18-19, Figs. 1-2, where the plate 10 comprises a plurality of wells 18, each well 18 comprises anchor rings 24, shown in Figs. 1-2) configured to define more than one cell seeding area.
Regarding claim 10, Banes discloses a method of seeding cells (col. 3, lines 20-21) in a central portion of a culture well (well 18, Figs. 1-2), the method comprising: a liquid medium (col. 9, lines 44-49) comprising cells into the at least one cell seeding area on the well surface (well base 22, col. 5, line 18, Fig. 1) of claim 2.
Regarding claim 11, Banes discloses further comprising incubating the culture well after seeding with cells (col. 7, lines 66-68, and col. 8, lines 1-2; col. 9, lines 50-51).
Regarding claim 12, Banes discloses wherein the incubated cells are substantially free of incubator induced edge effects (col. 7, lines 66-68, and col. 8, lines 1-2; col. 9, lines 50-51). Further, Banes discloses the base of well 18 includes an anchor ring 24, Fig. 1, col. 5, lines 60-63).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over US4789601A-Banes.
Regarding claim 4, Banes teaches the invention discussed above in claim 1. Further, Banes teaches at least one continuous ring (ring 24), also discussed above. However, Banes does not explicitly teach wherein the at least one continuous ring has a height of about 0.01 mm to about 2 mm.
For claim 4, Banes discloses the claimed invention except for wherein the at least one continuous ring has a height of about 0.01 mm to about 2 mm. It would have been an obvious matter of design choice to include at least one continuous ring has a height of about 0.01 mm to about 2 mm, since applicant has not disclosed that having the dimensions of a continuous ring of the well surface solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the ring disclosed above in Banes.
Regarding claim 5, discloses the claimed invention except for wherein the at least one continuous ring has an inner diameter of about 0.5 mm to about 6.0 mm. Further, Banes teaches at least one continuous ring (ring 24), also discussed above. However, Banes does not explicitly teach at least one continuous ring has an inner diameter of about 0.5 mm to about 6.0 mm. It would have been an obvious matter of design choice to include at least one continuous ring has an inner diameter of about 0.5 mm to about 6.0 mm, since applicant has not disclosed that having the dimensions of a continuous ring of the well surface solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the ring disclosed above in Banes.
Response to Arguments
Applicant's arguments filed 05/21/2026 have been fully considered but they are not persuasive. On the top of page 5 of applicant’s remarks, applicant cites the relied upon art from the Office Action mailed on 03/02/2026. Also, applicant recites claim 1 of the instant application, which is recited as follows: “at least one continuous ring on the well surface of the closed end of one or more of the wells, the at least one continuous ring having a raised height from the well surface for forming a continuous boundary on the well surface, the raised height forming a microchamber volume when interfaced with an assay analysis instrument.”
On the middle and bottom of page 5 and the top of page 6 of applicant’s remarks, applicant asserts “Figure 4A of Bergo as allegedly teaching the continuous ring on the well surface as claimed. However, a careful review of Bergo reveals that the structure depicted in Figure 4A does not meet the limitation of ‘the raised height forming a microchamber volume when interfaced with an assay analysis instrument’.” Also, applicant asserts “in Bergo, to the extent that any transient microenvironment is formed, it is created by the downward movement of the instrument's sensor probe coming into proximity with the well bottom, or by features located entirely on the sensor probe itself. If Figure 4A shows any raised features on the bottom of a well, these features do not physically or functionally interface with the assay instrument to enclose and isolate a volume. Instead, fluid would either flow freely over these features, or the probe relies on its own geometry to restrict diffusion.” In response, a raised height of a continuous ring from a well surface is shown and depicted in a cross-sectional view of Fig. 4A of Bergo, which is very similar to the figures depicted in the instant application. Also, as discussed above in the rejection and shown in annotated Fig. 4A of Bergo above in the rejection, the raised portion of the cell culture device is shown and is as continuous ring of the well surface of the device.
Moreover, applicant’s assertion that “if Figure 4A shows any raised features on the bottom of a well, these features do not physically or functionally interface with the assay instrument to enclose and isolate a volume. Instead, fluid would either flow freely over these features, or the probe relies on its own geometry to restrict diffusion” is not found persuasive for the following reasons. Firstly, Bergo teaches the microwell plates may be obtained from commercial suppliers either as a pre-fabricated item or as a custom-manufactured product. Suitable microwell plates may be also produced by a skilled person using methods and devices that are known in the art (col. 11, lines 1-5). Secondly, Bergo teaches identification of an active agent performed by measuring optical properties of its corresponding carrier bead is a particularly useful approach that may be readily implemented using the devices and methods disclosed in the instant specification, as well as the analytical instruments and protocols known in the field (col. 18, lines 48-53). Additionally, Bergo teaches devices, methods and compositions related to the fields of biological cell culture, high-throughput cell screening, cell microarrays, bead-based cell assays, live cell screening, intact cell analysis, fluorescence microscopy and whole cell mass spectrometry. Various devices suitable for cell culture are known in the art (col. 46, lines 8-13).
On the top of page 6, applicant’s assertion that “Bergo fails to teach or suggest an assay analysis instrument descending and physically cooperating with a raised ring on the well surface to define the boundary of a microchamber volume. Because the structure in Bergo's Figure 4A does not structurally or functionally form a microchamber volume upon interfacing with an instrument, it falls short of the claimed limitations. Furthermore, attempting to combine the microplate of Banes with the assay system of Bergo lacks a valid motivation to combine and would result in an inoperable system.” In response, this argument is not found persuasive because Bergo teaches the microwell plates may be obtained from commercial suppliers either as a pre-fabricated item or as a custom-manufactured product. Suitable microwell plates may be also produced by a skilled person using methods and devices that are known in the art (col. 11, lines 1-5). Secondly, Bergo teaches identification of an active agent performed by measuring optical properties of its corresponding carrier bead is a particularly useful approach that may be readily implemented using the devices and methods disclosed in the instant specification, as well as the analytical instruments and protocols known in the field (col. 18, lines 48-53). Also, Bergo teaches devices, methods and compositions related to the fields of biological cell culture, high-throughput cell screening, cell microarrays, bead-based cell assays, live cell screening, intact cell analysis, fluorescence microscopy and whole cell mass spectrometry. Various devices suitable for cell culture are known in the art (col. 46, lines 8-13). For the reasons previously discussed, applicant’s assertion that the combination of the relied upon references would render them inoperable for the intended purpose, is not found persuasive, because Bergo teaches the device can be customized and further, Bergo teaches various suitable devices known in the art.
On the middle of page 6 of applicant’s remarks, applicant asserts “the primary teaching of Banes is the provision of a multiwell plate having flexible, stretchable bottoms designed to subject cells to mechanical strain. Conversely, the purpose of forming a "microchamber volume" in an assay analysis instrument requires a highly precise, fixed, and static volume to accurately measure changes in minute analyte concentrations (e.g., oxygen or pH over time). If a POSITA were to attempt to interface an assay analysis probe (from Bergo) against a ring on the flexible-bottom plate of Banes to form a microchamber volume, the physical downward pressure of the instrument may inherently push against the flexible bottom. This would cause the bottom to stretch, bow, or deform, completely destroying the fixed, precise microchamber volume required for the assay analysis to function. A POSITA would recognize that Banes' flexible plate teaches away from, and is structurally incompatible with, the strict volumetric requirements of forming a transient microchamber with an instrument.” In response, applicant’s argument is not found persuasive because it appears applicant has mischaracterized the reference of Banes. Banes teaches a culture well plate comprised of a polyorganosiloxane composition (col. 2,line 66-67 and col. 3, lines 1-2). That is, polyorganosiloxane cell culture plates are well known in the art and a PHOSITA knows the latter typically entail a rigid structure via molding into a fixed shape. The latter is disclosed in Banes: “For specific applications which do not require flexing of the cells but for which adherence of the cells to the cell substrate is desired, a surface-modified polyorganosiloxane composition according to the present invention may alternatively be deposited in a six-well culture plate without first excising the well bases, col. 8, lines 3-8). Banes discloses system may thus be used for the in vitro flexing of cell culture substrates (col. 7, lines 65-66). That is, the term “may” as disclosed in Banes indicates a possibility or option. Further, Banes teaches an alternative to applicant’s assertion, as noted above in this section (col. 8, lines 3-8).
Regarding the bottom of page 6, applicant’s assertion that “Because Bergo's Figure 4A does not teach the raised height of a well-surface ring forming a microchamber volume when interfaced with an instrument, and because Banes' flexible bottom is structurally incompatible with forming a precise microchamber, the rejection of Claim 1 under 35 U.S.C. § 103 is improper. The Applicant respectfully requests the withdrawal of this rejection.” Applicant’s latter argument is not found persuasive for the reasons discussed above in this section. As discussed above, Bergo teaches a raised height of a continuous ring from a well surface is shown and depicted in a cross-sectional view of Fig. 4A of Bergo (shown above in annotated Fig. 4A of Bergos). Also, Banes teaches a polyorganosiloxane cell culture plate, which is known to be of rigid structure. Moreover, Banes teaches an alternative to applicant’s assertion of a “multiwell plate having flexible bottoms”, also discussed directly above in this section. For the reasons discussed above, claims 1-5 and 10-12 stand rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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