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 .
Status of Claims
Claims 1-3, 5-16 and 18-21 are pending. Claims 18-20 remain withdrawn as drawn to a non-elected invention. Claims 1-3 and 5-16 and 21 have been examined.
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.
Claim(s) 1-2, 6-9 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2011/0311979, 12/22/2011) in view of Oldenburg et al. (US 6,027,695).
Regarding claim 1, Brown teaches throughout the publication a method (paragraph 0035) comprising: (a) distributing a fluid comprising nucleic acid material along a fluid pathway and into wells of an array of wells (paragraph 0110, plurality of wells) coupled to the fluid pathway (paragraph 0041, capillary action); and (b) distributing a liquid immiscible with the fluid, thereby displacing said fluid along the fluid pathway and into wells of the array of wells and preventing contents of each well from transferring to adjacent wells of the array of wells (paragraphs 0114).
While Brown fails to specifically teach that the array of wells is arranged in a hexagonal configuration and each well of the array of wells includes a hexagonal open surface and a hexagonal closed base surface opposing the hexagonal open surface and wherein each well has a substantially uniform hexagonal cross-section from the hexagonal open surface to the hexagonal closed base surface, Oldenburg teaches throughout the publication an apparatus such as a microtiter plate for holding liquid for optical measurement (abstract). More specifically, Oldenburg teaches at Figures 8-10, hexagonal microwells arranged in a honeycomb configuration with each well containing six side walls (column 6, lines 48-52), wherein Oldenburg clearly shows in Figure 8 that each well has a hexagonal top and bottom with the side walls following the hexagonal configuration to complete the uniform hexagonal cross-section from the top to base surface (see Figure 8 description at column 5, lines 16-20).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the shape of the wells of Brown to include a hexagonal shape and uniform hexagon cross-section configuration as taught by Oldenburg because Brown is generic regarding the well chamber cross-section and one skilled in the art would have been motivated to choose the appropriate shape based on the desired sample and test to be conducted on the sample within the well chambers. Additionally, Oldenburg teaches that the well configuration allows liquid to be prevented from collecting at the boundaries between adjacent wells and has optimal properties for optical screening applications (Oldenburg, column 4, lines 1-4).
Regarding claim 2, Brown teaches the method wherein a dead-volume of the fluid distributed along the fluid pathway is less than 10 microliters (paragraph 0076).
Regarding claim 6, Brown teaches the method wherein the liquid immiscible with the fluid comprises an oil (paragraph 0047).
Regarding claim 7, Brown teaches the method further comprising performing probe hybridization with a process reagent and said nucleic acid material (paragraph 0050).
Regarding claims 8-9, Brown teaches the method comprising transmitting heat to the array of wells, thereby processing said nucleic acid material, wherein the transmitting heat comprises thermocycling the fluid at the array of wells, wherein the fluid further comprises a process reagent (paragraphs 0013, 0146-0153, 0167).
Regarding claims 11 and 14, Brown teaches the method further comprising illuminating the array of wells and optically interrogating contents of one or more wells of the array of wells, wherein the optically interrogating comprises detecting fluorescence signals emitted from target objects in one or more wells of the array of wells (paragraph 0167, fluorescence microscopy).
Regarding claim 12, Brown teaches the method wherein said nucleic acid material comprises DNA (paragraphs 0050-0052).
Regarding claim 13, Brown teaches the method further comprising performing a quantitative analysis of said nucleic acid material (paragraph 0108).
Regarding claim 15, Brown teaches the method further comprising performing a polymerase chain reaction (PCR) assay (paragraphs 0165-0166).
Regarding claim 16, Brown teaches the method as described above including a plurality of wells (paragraph 0110) but fails to specifically teach that the array of wells comprises at least 100,000 wells. However, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 16 are for any particular purpose or solve any stated problem, and the prior art teaches that well quantity may be varied based on the desired test to be conducted. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the microfluidic art.
Claim(s) 3, 5, 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2011/0311979, 12/22/2011) in view of Oldenburg et al. (US 6,027,695), as applied to claim 1 above (hereinafter “Modified Brown”), and further in view of Handique et al. (US 2014/0212881, Pub Date: 07/31/2014, hereinafter “Handique”).
Regarding claims 3 and 21, Modified Brown teaches the method as described above and further teaches that pressurized loading techniques can also be utilized in the system (paragraph 0046). However, Modified Brown fails to explicitly teach that the method comprises applying pressure to the array of wells by a pressure system or alternatively, applying positive pressure via a pump of a flow control system in flow control system in communication with an inlet to the fluid pathway to distribute the liquid. Handique teaches throughout the publication a system and method for capturing and analyzing a set of cells on an array of parallel chambers (abstract). More specifically, Handique teaches that the device receives a biological sample including the set of cells under positive pressure through the sample inlet, which can be coupled to a fluid channel coupled to a pump configured to provide the positive pressure (paragraph 0026).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the method of Modified Brown, a pump to provide positive pressure for fluid flow as taught by Handique because Brown is generic regarding the pressurized loading techniques that can be utilized and one skilled in the art would have been motivated to choose the appropriate pressure source based on desired methodology.
Regarding claim 5, Modified Brown teaches the method as described above and further teaches that the sample is subjected to PCR and the sample can contain PCR solutions and primers (Brown, paragraph 0052). While Brown fails to specifically teach that the PCR reactions include dNTPs, Handique teaches that the chambers can be used to perform PCR including reagents such as PCR master mix, primers, dNTPs, and detection buffers (paragraph 0072). It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the method of Brown, PCR reagents such as dNTPs as taught by Handique because it would have been desirable to include the necessary reagents to properly analyze the supplied samples, such as enable detection of mutations, and to incorporate the necessary reagents to conduct the desired PCR reagents.
Regarding claim 10, while Modified Brown does not specifically teach that the nucleic acid material is derived from blood, a cell culture or a cancer cell, Handique teaches that analyses can be conducted on cells carried in a volume of blood or other digested tissue or for example, from a breast cancer cell line (paragraphs 0060-0061). It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to provide the nucleic acid analyses in the method of Brown on blood, cell or cancer cell samples as taught by Handique because Brown is generic regarding the origins of the samples that are analyzed with the method and one skilled in the art would have been motivated to choose the appropriate sample source based on the analysis to be conducted.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 8-9, 13-14 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8, 11, 15 and 17 of U.S. Patent No. 11,865,542.
Although the claims at issue are not identical, they are not patentably distinct from each other because, regarding instant claim 1, Patent 542 recites a method for capturing and processing nucleic acid material comprising: within an array of wells defined within a substrate, isolating genetic material from a sample, wherein each well in the array of wells extends into a planar surface of the substrate, the substrate further comprising a fluid pathway in fluid communication with and passing across the array of wells, the fluid pathway at least partially defined at the planar surface, and wherein the array of wells comprises at least 10,000 wells within an area of the substrate, wherein isolating genetic material from the sample comprises isolating genetic material with a population of probe-coupled particles at the array of wells, at greater than 80% capture efficiency of the population of probe-coupled particles, within the array of wells, upon flow of the sample with the population of probe-coupled particles to the array of wells; delivering one or more process reagents into the fluid pathway and to the array of wells; distributing a layer of oil across open surfaces of the array of wells, thereby preventing contents of each well from transferring to adjacent wells of the array of wells; transmitting heat to the substrate and to the array of wells, thereby processing said genetic material; illuminating the substrate and the array of wells; and optically interrogating contents of each well of the array of wells (patent claim 1).
Additionally, patent claim 2 reads on instant claim 16, patent claim 8 reads on instant claims 8-9, patent claim 11 reads on instant claim 6, patent claim 15 reads on instant claim 13 and patent claim 17 reads on instant claim 14.
Response to Arguments
Applicant’s arguments filed 03/09/2026 have been considered but are not found to be persuasive. Applicant argues on pages 6-7 that Oldenburg does not teach or suggest wells having a substantially unform hexagonal cross-section since the wells of Oldenburg have six inclined walls and thus the cross-sectional dimension of the wells decreases from the hexagonal opening at the top to the hexagonal footprint at the bottom. This argument is not persuasive because as currently recited, the claim states that each well has a hexagonal open surface and a hexagonal closed base surface opposing the hexagonal open surface, wherein each well has a substantially uniform hexagonal cross-section from the hexagonal open surface to the hexagonal closed base surface. Oldenberg clearly shows at Figures 8-10, a hexagonal open surface and a hexagonal closed surface. Regarding the limitation “substantially uniform hexagonal cross-section” and giving the claim it’s broadest reasonable interpretation, the uniform hexagonal cross-section is not limited to uniform dimensions from the open surface to the base surface and thus a well having a uniform hexagonal shape at the cross-section from the open surface to the base surface still reads on the claimed limitation. While the presence of inclined walls do create a decreased dimension of the footprint of the wells, the inclined walls still present a uniform hexagonal shape throughout the entirety of the well. To further distinguish from the prior art, Examiner recommends providing more information regarding the uniform cross-section and what properties of the cross-section remain uniform from the top of the well to the bottom.
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 REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677