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/Effective Filing Date
Acknowledgement is made that this application was filed as a divisional application of prior filed application 16/825,126, however it is an improper divisional filing, as there was no requirement for restriction in the parent application. Thus, the instant application is not afforded the exemption from double patenting rejection under 35 U.S.C. 121 over the parent. Applicants are required to correct the priority claim of the instant application by filing a new ADS, wherein under “domestic priority” the word “divisional” is lined through and the word “continuation” is written in and underlined.
The priority claim in the present application is acknowledged and reproduced here:
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Explicit support for the claim elements “displacing pins at a cartridge comprising the fluidic pathway” and “linearly displacing a cam card…” was not present in the priority documents prior to the January 19, 2016 amendment to the specification and drawings in the 14/168,760 application. Therefore, the effective filing date of claims 2 and 3, which recite these elements, is determined to be January 19, 2016 (the date of the amendment to include explicit support for these claim elements). Explicit support for “occluding a fluidic pathway at… a set of occlusion positions”, recited by claim 1, was not present in the priority documents prior to the 14/060,214 application, filed on October 22, 2013. Therefore, the effective filing date of claims 1 and 4-11 is determined to be October 22, 2013.
Claim Status
Claims 1-11 are pending in the present application.
Claims 1-11 are under examination.
Drawings
The drawings filed on September 12, 2022 are acceptable.
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 9 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 9 recites “(PAA)” and “(DABAM)”. Each of these terms are acronyms, the meanings of which may change over time. Furthermore, their inclusion in parentheses is an alternative limitation upon “Poly(allylamine)” and “Polypropyleneimine tetramine dendrimer Generation 1”, respectively, or merely a descriptor of the corresponding claim terms.
Based on the specification, PAA is interpreted to mean “Polyallylamine” and DABAM is interpreted to mean “polypropyleneimine tetramine dendrimer Generation 1”.
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 2 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams et al., US 20130210125 A1, published August 15, 2013.
Claim 1 is not rejected here because of the earlier effective filing date of claim 1, discussed in section 4 above. It is noted that the effective filing date of claims 2 and 3 has been determined to be January 19, 2016 (the date of the amendment to include explicit support for these claim elements in the priority documents). Therefore, the cited document, published on August 15, 2013 (more than one year prior to the effective filing date of the claims in question), is prior art under 102(a)(1).
Regarding claim 2, Williams et al. teaches a method for nucleic acid isolation comprising reversibly binding nucleic acids in a biological sample to magnetic beads (i.e. incubating affinity particles with a biological sample…) (Williams et al., paragraph 0022), occluding a fluidic pathway at a subset of occlusion positions, and separating the bead-bound nucleic acids from the biological sample within a fluidic pathway (Williams et al., paragraph 0058). Williams et al. further teach occluding the pathway comprises displacing pins at a cartridge comprising the pathway (Williams et al., paragraph 0042). Therefore, Williams et al. teaches each and every method step of the present claim 2.
Regarding claim 3, Williams teaches a “valving mechanism” for actuating the displacing pins at a cartridge (Williams et al., figure 10 A, see annotated figure below).
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Williams et al. further teach that the valving mechanism responsible for displacing the pins acts to apply a biasing force (i.e. displacing the pin) by a mechanical member that controllably occlude and open portions of a fluidic pathway at specific occlusion positions (Williams et al., paragraph 0076).
Therefore, Williams et al. teach all of the claimed method steps of the present claim 3.
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.
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 1-2, 4-6, 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Khripin et al., US 20110071031 A1, published March 24, 2011 (see citation US114 of IDS filed on September 12, 2022) in view of Chou et al., US 20040072278 A1, published April 15, 2004 (see citation US19 of IDS filed on September 12, 2022).
Regarding claim 1, Khripin et al. teach methods for isolating nucleic acids comprising incubating affinity coated particles with a biological sample wherein nucleic acids reversibly bind to the particles, are separated from the sample mixture, are washed, and are eluted (released) from the particles (Khripin et al., paragraphs 0003-0004 and 0061-0067).
Khripin et al. do not teach occluding a fluidic pathway.
However, Chou et al. teach methods wherein a fluidic pathway inside a microfluidic chip is used to carry particles and reagents/waste to and from reservoirs/wells (abstract and paragraphs 0139-0144). Chou et al. teach the particles (i.e. beads) are associated with nucleic acids (Chou et al., paragraph 0172), and that the microfluidic chip further comprises regulators “mechanisms for generating and/or regulating movement of materials” including valves (Chou et al., paragraph 0147) or movable posts that constitute physical barrier-based retention mechanisms for retaining materials within a particular reservoir within a plurality of reservoirs in a network (Chou et al., paragraph 0211-0214). Chou et al. teach microfluidic manipulation of materials and particles advantageously provide for improved control of input particles, analytes, and reagents, and reduce the amount of sample required for biological assays (Chou et al., paragraph 0119).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the methods for nucleic acid isolation comprising reversible nucleic acid binding to affinity particles, taught by Khripin et al., with the teachings of Chou et al., comprising microfluidic manipulation of particles to arrive at the claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to modify the molecular techniques taught by Khripin et al. with the microfluidic techniques taught by Chou et al. because of the teachings of Chou et al. that microfluidic systems advantageously “scale down” cell and particle assays with the predictable benefit of reducing the quantities of consumable materials (i.e. (clinical) samples, reagents, etc.) required for biological and chemical assays (Chou et al., paragraph 0119). The ordinary artisan would therefore have been reasonably confident that the microfluidic methods and devices taught by Chou et al. would have beneficially improved the methods of Khripin et al. comprising purification of nucleic acids using affinity particles, especially in the context of biological or chemical assays requiring expensive materials or rare/precious samples by reducing the quantity of materials and sample required for a given assay.
Regarding claim 2, Chou et al. teach that occluding the fluidic pathway comprises displacing pins (i.e. physical barriers, movable posts) at a cartridge comprising the fluidic pathway (Chu et al., paragraphs 0211-0214).
Regarding claims 4-6, Chou et al. teach that particles can be sequentially treated at a set of retention sites (i.e. first, second, and third occlusion positions) comprising washing the particles between exposure to reagents (Chou et al., paragraph 0440 and 0471-0473) (i.e. performing the binding/capture, washing, and elution steps taught by Khripin et al. at each of a sequence of retention sites). Khripin et al. teach that nucleic acids can be released from affinity particles by raising the pH (Khripin et al., paragraph 0004) and that a person having ordinary skill in the art can readily optimize the precise ionic and pH conditions necessary to cause complex formation and elution (Khripin et al., paragraphs 0073-0075).
Regarding claim 8, Chou et al. teaches that the microfluidic device may comprise internal detection sites including channels, chambers, traps, etc. (i.e. defining a fluidic path to a diagnostic chamber and delivering an analyte to the detection chamber) (Chou et al., paragraph 0255-0257)
Regarding claim 10, Chou et al. teach that the nucleic acid capturing affinity particles are magnetic and are positioned (i.e. captured) in the fluidic pathway using a magnetic field (Chou et al., paragraph 0191).
Regarding claim 11, Chou et al. teach that detection sites may be internal or external to the microfluidic system, and transport to a detection site can comprise recovery of particles or particle components (i.e. eluted DNA) from the microfluidic system, external manipulation, and detection (Chou et al., paragraphs 0255-0257).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Khripin et al., US 20110071031 A1 in view of Chou et al., US 20040072278 A1 as applied to claims 1-2, 4-6, 8, and 10-11 above, and further in view of Webster et al., US 20050180891 A1, published August 18, 2005 (see citation US29 on IDS filed on September 12, 2022).
Regarding claim 3, Khripin et al. in view of Chou et al. teaches methods of nucleic acid isolation from a biological sample comprising binding nucleic acids to magnetic affinity particles, occluding a fluidic pathway in a microfluidic cartridge by displacing pins at a set of occlusion positions, capturing the affinity particles using a magnetic field, separating the captured, nucleic acid bound particles from the sample, and sequentially washing the particles and eluting the nucleic acids from the magnetic particles at sequential retention sites (i.e. occlusion positions). Specifically, Chou et al. teach retention sites may be formed by physical barriers comprising movable columns or posts (i.e. displacing pins) (Chou et al., paragraph 0214).
Khripin et al. in view of Chou et al. do not teach that displacing the pins comprises a cam card that displaces to a position where at least one pin transitions to a position that occludes the fluidic pathway.
However, Webster et al. teaches a microfluidic cartridge comprising multiple reservoirs and reaction chambers in fluidic communication that further comprises fluid flow controlling structures comprising a linear actuator (Webster et al., abstract). Webster et al. further teach that the control structure comprising a linear actuator (i.e. pin) can be actuated (i.e. displaced) by several different devices comprising a motor/cam/piston configuration (i.e. a pin actuated by the displacement of a cam card) (Webster et al., paragraph 0045).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the method of nucleic acid purification using magnetic affinity microparticles in a microfluidic device in which the fluidic pathway is occluded by physical barriers comprising displacing pins, taught by Khripin et al. in view of Chou et al. with the teachings of Webster to arrive at the claimed invention. The ordinary artisan would have been motivated to modify the displacing pin barrier system taught by Khripin et al. in view of Chou et al. with the motor/cam/piston configuration to actuate a linear actuator controlling flow of materials through a microfluidic device, taught by Webster et al., because of the teaching of Webster et al. that a motor/cam/piston configuration is a suitable mechanical means linearly actuating a piston (i.e. a pin) for the purpose of controlling the flow of materials through a microfluidic cartridge. The ordinary artisan would therefore have been reasonably confident that such a modification would have successfully controlled the flow of materials between the retention sites of the microfluidic device taught by Khripin et al in view of Chou et al.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Khripin et al., US 20110071031 A1 in view of Chou et al., US 20040072278 A1 as applied to claims 1-2, 4-6, 8, and 10-11 above, and further in view of Chinnaiyan et al., US 20090239221 A1, published September 24, 2009 (see citation US72 on IDS filed on September 12, 2022).
Regarding claim 7, Khripin et al. in view of Chou et al. teaches methods of nucleic acid isolation from a biological sample comprising binding nucleic acids to magnetic affinity particles, occluding a fluidic pathway in a microfluidic cartridge by displacing pins at a set of occlusion positions, capturing the affinity particles using a magnetic field, separating the captured, nucleic acid bound particles from the sample, and sequentially washing the particles and eluting the nucleic acids from the magnetic particles at sequential retention sites (i.e. occlusion positions). Khripin et al. in view of Chou et al. further teach eluting the nucleic acids from the particles by raising the pH (Khripin et al., paragraph 0004) and that a person having ordinary skill in the art can readily optimize the precise ionic and pH conditions necessary to cause complex formation and elution (Khripin et al., paragraphs 0073-0075). Khripin et al. in view of Chou et al. teach using controls for nucleic acid purification with the affinity particles (Khripin et al., paragraph 0038), however, Khripin et al. in view of Chou et al. do not teach spiking the sample with a process control comprising a set of primers and probes selected based on the nucleic acid material.
It is noted that the claims do not state how the probes and primers are used as a control, other than by “spiking the sample” with them.
However, Chinnaiyan et al. teach a method wherein a sample is spiked with primers and probes (Chinnaiyan et al., paragraph 0386), which has the added advantage of allowing determination of whether detection of a target analyte will be reliable (paragraph 0475).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the method taught by Khripin et al. in view of Chou et al. comprising separating nucleic acids from a biological sample using affinity particles in a microfluidic device by spiking in primers and probes of a process control, as taught by Chinnaiyan et al. The ordinary artisan would have been motivated to make such a modification because the modification would have had the predictable benefit of allowing determination of whether or not the detection of a target analyte is reliable as explicitly taught by Chinnaiyan et al., (Chinnaiyan et al., paragraph 0475). In addition, it would have been obvious to the ordinary artisan that the known techniques of Chinnaiyan (comprising a spike-in control) could have been applied to the nucleic acid purification methods taught by Khripin et al. in view of Chinnaiyan et al. with predictable results because the known techniques taught by Chinnaiyan comprising providing process controls predictably result in reagents useful for determining whether a nucleic acid assay is reliable.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Khripin et al., US 20110071031 A1 in view of Chou et al., US 20040072278 A1 as applied to claims 1-2, 4-6, 8, and 10-11 above, and further in view of Caruso et al., US 20080241242 A1, published October 2, 2008 (see citation US67 on IDS filed on September 12, 2022).
Regarding claim 9, Khripin et al. in view of Chou et al. teaches methods of nucleic acid isolation from a biological sample comprising binding nucleic acids to magnetic affinity particles, occluding a fluidic pathway in a microfluidic cartridge by displacing pins at a set of occlusion positions, capturing the affinity particles using a magnetic field, separating the captured, nucleic acid bound particles from the sample, and sequentially washing the particles and eluting the nucleic acids from the magnetic particles at sequential retention sites (i.e. occlusion positions). Khripin et al. in view of Chou et al. further teaches that the affinity particles comprise microparticles that are amide bonded to capture moieties comprising polyallylamine (Chou et al., paragraphs 0066-0067).
Khripin et al. in view of Chou et al. does not teach the molecular weight of the polyallylamine capture moieties.
However, Caruso et al. teach methods of capturing nucleic acids from samples comprising beads having polyelectrolyte capture moieties (Caruso et al., paragraph 0055 and 0062), wherein the polyelectrolyte comprises poly(allylamine) having a molecular weight of 15,000 Da (paragraph 0104).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the method taught by Khripin et al. in view of Chou et al. with the teachings of Caruso et al. to arrive at the claimed invention with a reasonable expectation of success. The ordinary artisan would have been motivated to modify the methods taught by Khripin et al. in view of Chou et al. that teach capturing nucleic acids on affinity particles comprising polyallylamine with the polyallylamines of specific molecular weights (15,000 Da i.e. <40,000 Da), because of the teaching of Caruso et al. that polyallylamines of this molecular weight are compatible with nucleic acid capture (Caruso et al., paragraph 0055). The ordinary artisan would have been reasonably confident that the modification would have predictably resulted in nucleic acid binding particles because of the explicit teachings of Caruso et al. that 15,000 Da polyallylamines successfully capture nucleic acids from biological samples (Caruso et al., paragraph 0055).
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..
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,382,532 (herein referred to as ‘532) (See citation US261 on IDS filed on September 12, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘532 clearly anticipate the present claims.
Regarding claim 1, the claims of ‘532 recite: A method for nucleic acid isolation comprising: incubating a binding moiety solution (comprising affinity moiety-coated microparticles comprising polypropylenimine tetramine dendrimer Generation 1 amide-bonded to a set of microparticles) (i.e. affinity particles) with a biological sample (i.e. incubating affinity particles with a biological sample, occluding a fluidic pathway at a first subset of occlusion positions, and separating the set of moiety-bound nucleic acid particles from the sample mixture within the fluidic pathway.
Therefore, claim 1 of ‘532 recites all of the method steps of the present claim 1.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,540,636 (herein referred to as ‘636) (See citation US262 on IDS filed on September 12, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘636 clearly anticipate the present claims.
Regarding claim 1, the claims of ‘636 recite: A method for nucleic acid isolation comprising: incubating a binding moiety solution (comprising affinity moiety-coated microparticles) (i.e. affinity particles) with a biological sample (i.e. incubating affinity particles with a biological sample, occluding a fluidic pathway at a first subset of occlusion positions, and separating the set of moiety-bound nucleic acid particles from the sample mixture within the fluidic pathway.
Therefore, claim 1 of ‘636 recites all of the method steps of the present claim 1.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,633,647 (herein referred to as ‘647) (see citation US272 on IDS filed on September 12, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘647 clearly anticipate the present claims.
Regarding claim 1, the claims of ‘647 recite: A method for nucleic acid isolation comprising incubating affinity moiety-coated microparticles with a biological sample for reversibly binding nucleic acid material of the biological sample, occluding a fluidic pathway at a first set of occlusion positions…, and separating the affinity-bound nucleic acid particles from the sample mixture.
Therefore, claim 1 of ‘647 recites all of the method steps of the present claim 1.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 9,339,812 (herein referred to as ‘812) (See citation US260 on IDS filed on September 12, 2022). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘812 clearly anticipate the present claims.
Regarding claim 1, the claims of ‘812 recite: A method for processing and detecting (i.e. isolating) nucleic acids from a biological sample comprising: combining biological samples with magnetic beads (i.e. affinity particles) to produce nucleic acid-magnetic bead samples, occluding a subset of fluidic pathways, and detecting nucleic acids using a set of detection chambers… (i.e. separating the particles from the sample mixture).
Therefore, claim 15 of ‘812 recites all of the method steps of the present claim 1.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 9,441,219 (herein referred to as ‘219) in view of Khripin et al., US 20110071031 A1.
Regarding claim 1, the claims of ‘219 recite a method for processing a biological sample and separating a nucleic acid volume from the biological sample comprising: displacing a subset of pins to occlude a fluidic pathway of a cartridge, and separating the nucleic acid volume from the sample within the pathway (Claim 16 of ‘219).
The claims of ‘219 do not recite incubating affinity particles with the biological sample to reversibly bind nucleic acid material of the biological sample. The claims of ‘219 do not describe any particular means of separating the nucleic acid volume from the sample within the pathway. However, Khripin et al. teach methods for isolating nucleic acids comprising incubating affinity coated particles with a biological sample wherein nucleic acids reversibly bind to the particles, are separated from the sample mixture, are washed, and are eluted (released) from the particles (Khripin et al., paragraphs 0003-0004 and 0061-0067).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to have modified the method steps recited by the claim 16 of ‘219 with the affinity coated particles taught by Khripin et al. for separation of nucleic acids from a biological sample.
The ordinary artisan would have been motivated to modify the microfluidic methods taught by ‘219 with the affinity particles taught by Khripin to arrive at the presently claimed method because Khripin teaches the particles are compatible with separation of nucleic acids from biological samples and would have provided the predictable advantages in facilitating nucleic acid purification from a biological sample by solid-phase ion-exchange capture, rather than by other techniques known in the art such as phenol:chloroform extraction or salt:ethanol precipitation which are more labor-intensive, less amenable to automation, and require the use of volatile organic solvents, which would present health hazards during manufacture, operation, and disposal of the microfluidic apparatus required by the claims of ‘219.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 10,041,062 (herein referred to as ‘062) in view of Khripin et al., US 20110071031 A1.
Regarding claim 1, the claims of ‘062 recite a method of separating a nucleic acid volume from a biological sample comprising: displacing a subset of pins to occlude a fluidic pathway of a cartridge, and separating the nucleic acid volume from the sample within the pathway.
The claims of ‘062 do not recite incubating affinity particles with the biological sample to reversibly bind nucleic acid material of the biological sample. The claims of ‘062 do not describe any particular means of separating the nucleic acid volume from the sample within the pathway. However, Khripin et al. teach methods for isolating nucleic acids comprising incubating affinity coated particles with a biological sample wherein nucleic acids reversibly bind to the particles, are separated from the sample mixture, are washed, and are eluted (released) from the particles (Khripin et al., paragraphs 0003-0004 and 0061-0067).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to have modified the method steps recited by the claim 15 of ‘062 with the affinity coated particles taught by Khripin et al. for separation of nucleic acids from a biological sample.
The ordinary artisan would have been motivated to modify the microfluidic methods taught by ‘062 with the affinity particles taught by Khripin to arrive at the presently claimed method because Khripin teaches the particles are compatible with separation of nucleic acids from biological samples and would have provided the predictable advantages in facilitating nucleic acid purification from a biological sample by solid-phase ion-exchange capture, rather than by other techniques known in the art such as phenol:chloroform extraction or salt:ethanol precipitation which are more labor-intensive, less amenable to automation, and require the use of volatile organic solvents, which would present health hazards during manufacture, operation, and disposal of the microfluidic apparatus required by the claims of ‘062.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY MARK TURPIN whose telephone number is (703)756-5917. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/Z.M.T./Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682