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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 5-7 and, 13-15 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.
Claim 5 recites “each intersecting an inner wall” in line 3. The Examiner submits this phrase is unclear as it is unclear which element(s) is being referred to by the term “each”. Claim 5 also recites “the center of the base”. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation “the edge of the base" in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “wherein the reservoir has a teardrop shaped upper edge and the base is circular or teardrop shaped”. The Examiner submits the term “teardrop shaped” is unclear is it is unclear what exact shape is defined by the term “teardrop shaped”.
Claims 13 and 14 recite “a plate array comprising a plurality of assay plate according to claim 1. The Examiner submits this is unclear as the claim does not recite any structural features of the “plate array” for containing or locating the plurality of assay plate. For Examination purposes, the Examiner has given the claim a broad interpretation of a device simply having a plurality of assay plates.
Claim 15 recites “each configured for connection to a single plate”. The Examiner submits this phrase is unclear as it is unclear which element(s) is being referred to by the term “each”.
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 1-7 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berndt et al. (US 2005/0136546). Berndt teaches assay plate. The portions of the device most relevant to the instant claims are shown in Figures 2-6 and described in Paragraphs 0086-0102.
Regarding claims 1, 2, 3 and 4 – As shown in Figures 2-6, Berndt teaches an assay plate (plate 11) comprising a body (body 12) having a plurality of reservoirs (cavities 13), the reservoirs (cavities 13) shaped and aligned in the body (12) in an orientation to induce or control movement of fluid toward a single point in a frustoconical spout portion (well bottom 22).
Regarding claims 5 and 6 – Berndt further teaches a pair of opposed transition planes (18) intersecting an inner side wall (side walls of chambers 16, 17) having an angle different than the frustoconical portions of the well (bottom 22) in Figure 3.
Regarding claim 7 – Berndt shows a teardrop shaped well with a round bottom in Figure 9.
Regarding claim 9 – Berndt teaches a well that slopes downward in Figure 3. Regarding claims 10 and 11 – Berndt discloses a rectangular shape for the body and up to 384 cavities in Figure 1 and Paragraphs 0084-0085.
Claims 1-4, 7, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bennett et al. (US 2014/0322806).
Regarding claims 1, 2, 3 and 4 – As shown in Figures 4-8, Bennett teaches an assay plate comprising a body (article 400/600/700) having a plurality of reservoirs (chambers 410), the reservoirs (chamber 410) shaped and aligned in the body (article 400/600/700) in an orientation to induce or control movement of fluid toward a single point in a frustoconical spout portion (well bottom 460).
Regarding claim 7 – Figures 5 and 8 of Bennett show wells (chambers 410) having a tear drop shape.
Regarding claims 10 and 11 – Bennett teaches a rectangular shaped body having 96 wells in Figure 5 and Paragraph 0055.
Claims 1-4 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lichtenberg et al. (US 2018/0187136). Lichtenberg teaches a microplate device. The embodiments of the device most relevant to the instant claims are shown in Figures 1-4 and described in Paragraphs 0117-0131.
Regarding claims 1, 2, 3 and 4 – As shown in Figures 1-4, Lichtenberg teaches an assay device comprising a body (plate 1) having a plurality of reservoirs (wells 2), the reservoirs (wells 2 and 2.5) shaped and aligned in the body (plate 1) in an orientation to induce or control movement of fluid toward a single point (lower section 22) in a frustoconical spout portion (chute 26).
Regarding claims 10 and 11 – Lichtenberg shows a rectangular plate (1) in Figure 1 and recites up to 384 wells in a plate in Paragraph 0056.
Regarding claim 12 – Lichtenberg teaches a well volume of less than about 500 nanoliters in Paragraphs 0060-0065.
Claims 1, 2, 28, 29 and 33-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glezer et al. (2007/0202538). Glezer teaches a well plates having preloaded reagents on a shelf element in the wells above the well floor. The embodiments of the device most relevant to the instant claims are shown in Figures 1A-2J and described in Paragraphs 0075-0085.
Regarding claims 1, 2, 28 and 29– As shown in the cited Figures, Glezer teaches an assay plate comprising a body having a plurality of reservoirs (wells 200), the reservoirs shaped and aligned in the body in an orientation to induce or control movement of fluids to a single plane (well bottom 220). Glezer also teaches a plurality of ledges (shelves 115, 230, 230) at various locations in the well for retaining reagents in the figures and Paragraphs 0083-0085.
Regarding claims 32, 33, 34, 35 – Glezer teaches wells having a plurality of shelves extending from the sidewall at an angle that is parallel to the well bottom.
Regarding claims 36 – Figure 2i shows a shelf (260) that extends in a non-parallel direction from the well bottom.
Claims 1, 2, 3, 13, 15-19, and 38-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kinney et al. (US 8,602,958). Kinney teaches a method and assembly for pooling liquid from the wells of a microplate after performing PCR with the microplate. The embodiments of the device most relevant to the instant claims are shown in Figures 1-3, and described in Paragraphs YYY. Kinney teaches a method of pooling sample comprising placing the tray (50/70) on top of the multiwell plate (30) to form an assembly (60), inverting the assembly (60) of the multiwell plate (30) and tray (50/70) and centrifuging the assembly (60) in column 5, line 43 – column 6, line 16.
Regarding claims 1, 2, and 3 – As shown in Figures 2-3, Kinney teaches an assay plate comprising a body (plate 30) having a plurality of reservoirs (wells 34), the reservoirs (wells 34) shaped and aligned in the body (plate 30) in an orientation to induce or control movement of fluid toward a single point in a frustoconical spout portion (bottom of well 34).
Regarding claims 13 and 15 – Figures 21 and 22 of Kinney show an assembly having array comprised of a plurality of assay plates (plates 30) the plurality of assay plates rests on a rectangular funnel array comprising a plurality of rectangular funnel elements (tray 50/70).
Regarding claims 16 and 17 – Kinney teaches a lip (surface 32) and shoulder (ridge 36) on the multiwell plate (30) that mate with a lip (frame 42) and shoulder (stop 44) of the tray (50/70) to align and connect the plate and tray. See Figures 2, 3, 6 and 8. The tray (50) includes collection vessel (walls 58A-58C) located closer to one corner of the funnel (tray 50).
Regarding claims 18 and 19 – Kinney shows a housing for coupling the assemblies to a rotor having a plurality of channels for containing the plates in Figures 21 and 22.
Regarding claim 38 – Kinney teaches a system for centrifugation comprising at least one assay plate (plate 30), an adapter (unlabeled centrifuge rotor adapter in Figures 21-22), and a centrifuge wedge (frame 40) having thin corner portions (42) and thick corner portions (44) opposite each other. The adapter (unlabeled centrifuge rotor adapter in Figures 21-22) secures both the plate (30) and wedge (frame 40) as part of the assembly (30).
Regarding claims 39, 40 and 41 – Kinney further discloses a plurality of funnel trays (50) reversibly connected to the plurality of plates (30) and positioned in the adapter in Figures 21-22.
Inventorship
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 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Berndt et al. (US 2005/0136546) in view of Glezer et al. (2007/0202538). Berndt teaches every element of claims 8 and 30-32 except for the ledge portion in the reservoir. Glezer teaches a well plate having preloaded reagents on a shelf element in the wells above the well floor. The embodiments of the device most relevant to the instant claims are shown in Figures 1A-2J and described in Paragraphs 0075-0085. As shown in the cited Figures, Glezer teaches an assay plate comprising a body having a plurality of reservoirs (wells 200), the reservoirs shaped and aligned in the body in an orientation to induce or control movement of fluids to a single plane (well bottom 220). Glezer further teaches a plurality of ledges (shelves 115, 230, 230) at various locations in the well for retaining reagents in the figures and Paragraphs 0083-0085. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the shelf elements from Glezer with the device of Berndt. One of ordinary skill in the art at the time would add the shelf elements to Berndt in order to provide preloaded reagents above the bottom of the well as taught by Glezer.
Claims 28-36 are rejected under 35 U.S.C. 103 as being unpatentable over Berndt et al. (US 2005/0136546) in view of Glezer et al. (2007/0202538). Berndt teaches assay plate. The portions of the device most relevant to the instant claims are shown in Figures 2-6 and described in Paragraphs 0086-0102.
Regarding claims 28-31 – As shown in Figures 2-6, Berndt teaches an assay plate (plate 11) comprising a body (body 12) having a plurality of reservoirs (cavities 13), the reservoirs (cavities 13) shaped and aligned in the body (12) in an orientation to induce or control movement of fluid toward a single point in a frustoconical spout portion (well bottom 22). Berndt teaches every element of claims except for the ledge portion in the reservoir. Glezer teaches a well plate having preloaded reagents on a shelf element in the wells above the well floor. The embodiments of the device most relevant to the instant claims are shown in Figures 1A-2J and described in Paragraphs 0075-0085. As shown in the cited Figures, Glezer teaches an assay plate comprising a body having a plurality of reservoirs (wells 200), the reservoirs shaped and aligned in the body in an orientation to induce or control movement of fluids to a single plane (well bottom 220). Glezer further teaches a plurality of ledges (shelves 115, 230, 230) at various locations in the well for retaining reagents in the figures and Paragraphs 0083-0085. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the shelf elements from Glezer with the device of Berndt. One of ordinary skill in the art at the time would add the shelf elements to Berndt in order to provide preloaded reagents above the bottom of the well as taught by Glezer.
Regarding claims 32, 33, 34, 35 – Glezer teaches wells having a plurality of shelves extending from the sidewall at an angle that is parallel to the well bottom in Figures 2A-2J.
Regarding claims 36 – Figure 2i of Glezer shows a shelf (260) that extends in a non-parallel direction from the well bottom.
Claims 14 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kinney et al. (US 8,602,958) in view of Lebl (US 6,121,054).
Claim 14 – Kinney as discussed above teaches every element of claims 14 and 20-23 except for the plurality of assay plates being four plates. Kinney only teaches two plates in the embodiment disclosed in Figures 21-22 and column 7, lines 52-64. Lebl teaches a method and device for centrifuging microlplates. The portions of the device most relevant to the instant claims are shown in Figures 3A-3F and described in column 3, line 65 – column 4, line 20. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine 4 microplates and the centrifuge adapter having 4 slots for retaining microplates from Lebl with the device of Kinney. One of ordinary skill in the art at the time would add the additional microplates and adapter slots to Kinney in order to process more samples as taught by Lebl.
Regarding claims 20-23 – Kinney further discloses a plurality of funnel trays (50) reversibly connected to the plurality of plates (30) and positioned in the adapter in a centrifuge housing in Figures 21-22.
Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kinney et al. (US 8,602,958) in view of Lebl (US 6,121,054) and further in view of Nam et al. (US 2008/0268450). Kinney and Lebl as combined above teach every element of claim 14 except for the use of an identifier in processing the PCR products. Kinney does not each an identifier in the wells for identifying compounds. Kinney teaches a method of pooling samples from PCR procedure comprising placing the tray (50/70) on top of the multiwell plate (30) to form an assembly (60) and then inverting the assembly (60) of the multiwell plate (30) and tray (50/70) in column 5, line 43 – column 6, line 16. Kinney further teaches loading each well with the same volume and liquid in column 2, lines 31-44. Nam teaches an amplification method and a method for detecting an analyte of interest via bio-barcode assay. Nam discloses the method for detecting an analyte in Paragraphs 0048-0055 and 0138-0153. The method includes providing a multiwell plate, splitting an equal volume and concentration of sample into the wells, binding an oligonucleotide analyte to the barcode oligonucleotide, and then processing the analytes by detecting the barcode oligonucleotide. See Paragraphs 0050-0055 and 0143-0145. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the oligonucleotide barcode from Nam with the combined teachings of Kinney and Lebl. One of ordinary skill in the art at the time would add the barcode oligonucleotide to Kinney and Lebl in order detect nucleotides as taught by Nam.
Claims 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Kinney et al. (US 8,602,958) in view of Glezer et al. (2007/0202538). Kinney as described above teaches every element of claims 42-44 except for the shelves in the reservoirs. Glezer teaches a well plates having preloaded reagents on a shelf element in the wells above the well floor. The embodiments of the device most relevant to the instant claims are shown in Figures 1A-2J and described in Paragraphs 0075-0085. As shown in the cited Figures, Glezer teaches an assay plate comprising a body having a plurality of reservoirs (wells 200), the reservoirs shaped and aligned in the body in an orientation to induce or control movement of fluids to a single plane (well bottom 220). Glezer also teaches a plurality of ledges (shelves 115, 230, 230) at various locations in the well for retaining reagents in the figures and Paragraphs 0083-0085. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the shelf elements from Glezer with the device of Kinney. One of ordinary skill in the art at the time would add the shelf elements to Kinney in order to provide preloaded reagents above the bottom of the well as taught by Glezer.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Glezer et al. (2007/0202538) in view of Lichtenberg et al. (US 2018/0187136). Glezer teaches a well plates having preloaded reagents on a shelf element in the wells above the well floor. The embodiments of the device most relevant to the instant claims are shown in Figures 1A-2J and described in Paragraphs 0075-0085. As shown in the cited Figures, Glezer teaches an assay plate comprising a body having a plurality of reservoirs (wells 200), the reservoirs shaped and aligned in the body in an orientation to induce or control movement of fluids to a single plane (well bottom 220). Glezer also teaches a plurality of ledges (shelves 115, 230, 230) at various locations in the well for retaining reagents in the figures and Paragraphs 0083-0085. Glezer does not teach the volume recited in the claim of less than 500 nanoliter.
Lichtenberg teaches a microplate device. The embodiments of the device most relevant to the instant claims are shown in Figures 1-4 and described in Paragraphs 0117-0131. As shown in Figures 1-4, Lichtenberg teaches an assay device comprising a body (plate 1) having a plurality of reservoirs (wells 2), the reservoirs (wells 2 and 2.5) shaped and aligned in the body (plate 1) in an orientation to induce or control movement of fluid toward a single point (lower section 22) in a frustoconical spout portion (chute 26). Lichtenberg shows a rectangular plate (1) in Figure 1 and recites up to 384 wells in a plate in Paragraph 0056. In Paragraph 0065, Lichtenberg teaches a well volume of less than 500 nanoliters. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the well volume from Lichtenberg with the device of Glezer. One of ordinary skill in the art at the time would add the well volume to Glezer in order to provide an increased number of wells in the plate as taught by Lichtenberg.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 September 30, 2025
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798