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 .
Response to Amendment
The Amendment filed on 9/8/2025 has been entered. Claims 1, 3, 4, 7-20, 22, 25 and 27 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejection previously set forth in the non-final Office Action mailed 5/8/2025.
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.
Claim(s) 1, 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2013/0244241, hereinafter Carrera in view of WO 2015/084458, hereinafter Ismagilov.
Regarding claim 1, Carrera teaches a device (item 100) for isolating a biological material from a sample (abstract), the device comprising: a housing (item 102) defining a plurality of compartments (item 116) and a plurality of fluid channels (paragraph [0038] and item 226), wherein each compartment is configured to be fluidically connected to a respective fluid channel (paragraph [0038]), and wherein each fluid channel comprises a respective end terminating at a track disposed on the housing (paragraph [0037]); a slider (item 104) movable along the track (paragraph [0037]), the slider comprising a plurality of connecting channels extending therethrough (paragraph [0037]), wherein a selected one of the connecting channels is configured to connect ends of selected ones of the fluid channels based on a position of the slider along the track (paragraph [0037]); and a dry reagent capsule (item 216, paragraph [0046]), the dry reagent capsule comprising at least one dry reagent for mixing with the sample (paragraph [0046]), and to fluidically connect the dry reagent to a respective fluid channel in-situ (paragraph [0046]).
Carrera fails to teach the dry reagent capsule is configured to be mounted to the housing and comprising at least one chamber configured to contain the at least one dry reagent, wherein the housing further comprises a hollow post configured to break a seal covering the at least one chamber connects the at least one chamber to a fluid channel.
Ismagilov teaches a device for the controlling of one or more fluids and/or reagents in which a blister pack comprising at least one chamber is inserted into the device which can become fluidically connected when the blister pack is ruptured which allow for mixing in the blister pack (Ismagilov, paragraphs [0217] and [0222]-[0226]) and the housing comprises a hollow post (Ismagilov, item 2620) configured to break a seal covering the at least one chamber and connect the at least one chamber to a fluid channel (Ismagilov, paragraph [0282]) so as to pierce the blister/blister pack (Ismagilov, paragraph [0282]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the dry reagent a capsule with at least one chamber which is mounted to the housing because it would allow for the mixing of the contents in the blister pack (Ismagilov, paragraph [0217]) and to have added a hollow post because it would assist in piercing the blister/blister pack (Ismagilov, paragraph [0282]).
Regarding claim 3, Carrera teaches wherein the plurality of compartments comprises a sample compartment (item 114) configured to receive the sample (paragraph [0042]), a plurality of liquid reagent compartments (item 116 and paragraph [0038]) and a waste compartment (item 124A and paragraph [0038]), and wherein the plurality of liquid reagent compartments are preloaded with respective liquid reagents (paragraph [0038]).
Regarding claim 4, Carrera teaches wherein each of the sample and liquid reagent compartments comprises a respective inlet configured to be connected to pneumatic source for controlling a fluid flow to or from said compartment (paragraph [0048]), the device further comprising a first pneumatic vent (item 212) disposed in one of the liquid reagent compartments (paragraph [0048]) and a second pneumatic vent (item 212) disposed in the waste compartment (paragraph [0048]).
Claim(s) 7-20 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrera and Ismagilov as applied to claim 3 above, and further in view of Shin, Y., et al., “Dimethyl adipimidate/Thin film Sample processing (DTS); A simple, low-cost and versatile nucleic acid extraction assay for downstream analysis,” Sci Rep 5, 14127 (2015), hereinafter Shin and United States Application Publication No. 2014/0332098, hereinafter Juncker.
Regarding claims 7 and 8, Carrera and Ismagilov teach all limitation of claim 3; however, Carrera and Ismagilov fail to teach in a first position, the slider is configured to connect a first liquid reagent compartment, of the plurality of liquid reagent compartments, containing a hydration buffer of the liquid reagents with a first chamber of the at least one chamber of the dry reagent capsule, the first chamber containing a first dry reagent of the at least one dry reagent, for mixing the hydration buffer with the first dry reagent to form a first solution and in a second position, the slider is configured to connect the first liquid reagent compartment with a second liquid reagent compartment of the plurality of liquid reagent compartments containing a lysis buffer of the liquid reagents, for mixing the first solution with the lysis buffer to form a second solution.
Shin teaches a DNA extraction assay in which a lysis buffer and dimethyl adipimidate (DMA) are mixed together before adding the sample to the mixture (Shin, page 7, paragraph 1) as a combination of DMA and lysis buffer allows for a recovery of more the 95% of the DNA while a lysis buffer alone allows for a recovery of less than 50% of the DNA (Shin, page 3, paragraph 2).
Juncker teaches that storage of reagents in a dried form is a common way to preserve reagents (Juncker, paragraph [0178]) and a buffer solution which rehydrates dehydrated reagents stored within the reservoirs (Juncker, paragraph [0125]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to made the first position of the slider to connect a first liquid reagent containing a hydration buffer and a first chamber having a first dry reagent (DMA) to form a first solution and in a second position connect the first solution with the lysis buffer to mix the first solution and lysis buffer because a combination of DMA and lysis buffer allows for a recovery of more the 95% of the DNA while a lysis buffer alone allows for a recovery of less than 50% of the DNA (Shin, page 3, paragraph 2) and storing reagents (DMA) in dried form would preserve the reagents (Juncker, paragraph [0178]).
Regarding claim 9, Carrera teaches wherein, in a third position (paragraph [0131]), the slider is configured to: connect the second liquid reagent compartment with a second reagent (paragraph [0131]), the second chamber containing a second reagent (paragraph [0131]), for mixing the second solution with the second dry reagent to form a third solution (paragraph [0131]); and connect the second chamber of the dry reagent capsule with the sample compartment for mixing the third solution with the sample to form a fourth solution (paragraph [0132]).
Carrera fails to teach second reagent is a dry reagent in the second chamber of the dry reagent capsule.
Juncker teaches that storage of reagents in a dried form is a common way to preserve reagents (Juncker, paragraph [0178]) and a buffer solution which rehydrates dehydrated reagents stored within the reservoirs (Juncker, paragraph [0125]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have dried the lysis buffer (second reagent) of Carrera and added it to the dry reagent capsule because storing reagents (lysis buffer) in dried form would preserve the reagents (Juncker, paragraph [0178]).
Regarding claim 10, Carrera teaches wherein the fluid channels comprise a binding channel (item 226), and wherein, in a fourth position, the slider is configured to connect the sample compartment with the binding channel (paragraphs [0141]-[0142]) to store the fourth solution in the binding channel for a predetermined period for extracting the biological material from the fourth solution and binding the extracted biological material to a surface of the binding channel (intended use MPEP § 2114 (II)).
Regarding claim 11, Carrera teaches wherein, in a fifth position, the slider is configured to: connect a third liquid reagent compartment of the plurality of liquid reagent compartments containing a first wash buffer of the liquid reagents (paragraph [0143]) with the binding channel to wash the biological material bound to the surface of the binding channel (paragraph [0143]); and connect the binding channel with the waste compartment for discarding a first waste solution without the biological material to the waste compartment (paragraph [0143]).
Regarding claim 12, Carrera teaches wherein, in a sixth position, the slider is configured to: connect a fourth liquid reagent compartment of the plurality of liquid reagent compartments containing a second wash buffer of the liquid reagents with the binding channel (paragraph [0144]) to wash the biological material bound to the surface of the binding channel (paragraph [0144]); and connect the binding channel with the waste compartment for discarding a second waste solution without the biological material to the waste compartment (paragraph [0144]).
Regarding claim 13, modified Carrera, as described above, teaches all limitations of claim 12; however, modified Carrera, as described above, fails to teach wherein, in a seventh position, the slider is configured to: connect a fifth liquid reagent compartment of the plurality of liquid reagent compartments containing an elution buffer of the liquid reagents with the binding channel to elute the biological material from the surface of the binding channel; and connect the binding channel with an outlet for collecting the eluted biological material.
Ismagilov further teaches rotating a cap with an elution buffer to driving the elution buffer through a binding matrix to elute the sample so that the sample can be collected from a collection well. (Ismagilov, paragraph [0278]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made a seventh position for the slider which connects the reagent compartment containing an elution buffer with the binding channel which connects to an outlet because it would allow for the elution buffer to elute the sample so that the sample can be collected from a collection well. (Ismagilov, paragraph [0278]).
Regarding claim 14, Carrera and Ismagilov teach all limitation of claim 3; however, Carrera and Ismagilov fail to teach in a first position, the slider is configured to: connect a first liquid reagent compartment of the plurality of liquid reagent compartments containing a lysis buffer of the liquid reagents with one chamber of the at least one chamber of the dry reagent capsule, the chamber containing the at least one dry reagent, for mixing the lysis buffer with the at least one dry reagent to form a reagent solution.
Shin teaches a DNA extraction assay in which a lysis buffer and dimethyl adipimidate (DMA) are mixed together before adding the sample to the mixture (Shin, page 7, paragraph 1) as a combination of DMA and lysis buffer allows for a recovery of more the 95% of the DNA while a lysis buffer alone allows for a recovery of less than 50% of the DNA (Shin, page 3, paragraph 2).
Juncker teaches that storage of reagents in a dried form is a common way to preserve reagents (Juncker, paragraph [0178]) and a buffer solution which rehydrates dehydrated reagents stored within the reservoirs (Juncker, paragraph [0125]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to made the first position of the slider to connect a first liquid reagent containing a lysis buffer and a first chamber having a first dry reagent (DMA) because a combination of DMA and lysis buffer allows for a recovery of more the 95% of the DNA while a lysis buffer alone allows for a recovery of less than 50% of the DNA (Shin, page 3, paragraph 2) and storing reagents (DMA) in dried form would preserve the reagents (Juncker, paragraph [0178]).
Carrera further teaches connecting the chamber of the dry reagent capsule with the sample compartment for mixing the reagent solution with the sample to form a sample solution (paragraph [0132]).
Regarding claim 15, Carrera teaches wherein the fluid channels comprise a binding channel (item 226), and wherein, in a second position, the slider is configured to connect the sample compartment with the binding channel to store the sample solution in the binding channel (paragraphs [0141]-[0142]) for a predetermined period for extracting the biological material from the sample solution and binding the extracted biological material to a surface of the binding channel (intended use MPEP § 2114 (II)).
Regarding claim 16, Carrera teaches wherein, in a third position, the slider is configured to: connect a second liquid reagent compartment of the plurality of liquid reagent compartments containing a first wash buffer of the liquid reagents (paragraph [0143]) with the binding channel to wash the biological material bound to the surface of the binding channel (paragraph [0143]); and connect the binding channel with the waste compartment for discarding a first waste solution without the biological material to the waste compartment (paragraph [0143]).
Regarding claim 17, Carrera teaches wherein, in a fourth position, the slider is configured to: connect a third liquid reagent compartment of the plurality of liquid reagent compartments containing a second wash buffer of the liquid reagents with the binding channel (paragraph [0144]) to wash the biological material bound to the surface of the binding channel (paragraph [0144]); and connect the binding channel with the waste compartment for discarding a second waste solution without the biological material to the waste compartment (paragraph [0144]).
Regarding claim 18, Carrera teaches wherein, in a fifth position, the slider is configured to: connect a fourth liquid reagent compartment of the plurality of liquid reagent compartments containing a third wash buffer of the liquid reagents with the binding channel (paragraph [0130]) to wash the biological material bound to the surface of the binding channel (intended use MPEP § 2114 (II)); and connect the binding channel with the waste compartment for discarding a third waste solution without the biological material to the waste compartment (paragraph [0130]).
Regarding claim 19, modified Carrera, as described above, teaches all limitations of claim 18; however, modified Carrera, as described above, fails to teach wherein, in a sixth position, the slider is configured to: connect a fifth liquid reagent compartment of the plurality of liquid reagent compartments containing an elution buffer of the liquid reagents with the binding channel to elute the biological material from the surface of the binding channel; and connect the binding channel with an outlet for collecting the eluted biological material.
Ismagilov further teaches rotating a cap with an elution buffer to driving the elution buffer through a binding matrix to elute the sample so that the sample can be collected from a collection well. (Ismagilov, paragraph [0278]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made a seventh position for the slider which connects the reagent compartment containing an elution buffer with the binding channel which connects to an outlet because it would allow for the elution buffer to elute the sample so that the sample can be collected from a collection well. (Ismagilov, paragraph [0278]).
Regarding claim 20, modified Carrera teaches wherein the at least one dry reagent comprises lyophilized beads containing a crosslinker (DMA) selected to attach to the biological material (see supra), and wherein the surface of the binding channel is coated with a functional group selected to attach to the crosslinker (see supra).
Regarding claim 27, modified Carrera teaches wherein the at least one dry reagent comprises lvophilized beads containing a crosslinker (DMA) selected to attach to the biological material (see supra), and wherein the surface of the binding channel is coated with a functional group selected to attach to the crosslinker (see supra).
Response to Arguments
Applicant's arguments filed 9/8/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding applicant’s argument regarding the reference of Carrera and that it doesn’t teach the dry reagent capsule and that the seal is broken by a hollow post of the housing is not found persuasive. The reference of Carrera is not utilized for this teaching and rather the reference of Ismagilov is utilized for this teaching.
Regarding applicant’s argument that the various pushing units described in Ismagilov are movable and not part of the housing is not found persuasive. The pushing units of Ismagilov are interpreted to be part of the housing as the pushing units are within the overall device and are therefore considered to be part of the housing. There is no structure present in Ismagilov which would prevent the pushing units from being considered part of the housing. Additionally, the claim only states that the dry reagent capsule is configured to be mounted to the housing and the claim makes no mention as to what would be considered the “pushing member” of Ismagilov as part of the claim. So even if the pushing members are not considered part of the housing, the prior art would still read on the claim. The blisters themselves are connected to the housing of Ismagilov and therefore read on the claim of the dry reagent capsule configured to be mounted to the housing.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the hollow post forms a duct to fluidically connect the chamber to a respective fluid channel) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim only states that the “hollow post configured to … fluidically connect the at least one chamber…” This recitation doesn’t specify that the fluid actually flow through the hollow needle, but just rather that the hollow post is part of a structure which connects the one chamber to a fluid channel.
Regarding applicant’s argument that Ismagilov fails to teach any hollow post that can break the seal not found persuasive. Ismagilov teaches a hollow post that can break the seal as shown in figure 26, specifically item 2620 which is a piercing structure which pierces the blister and let the fluid flow through the piercing structure as claimed which is added to the device of Carrera as described above.
In response to applicant's argument that dry reagent capsule and the hollow post are added for a different reason, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See MPEP § 2145 (II).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796