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 .
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 3 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.
Regarding claim 3, Claim 3 recites the limitations ”the anion exchange resin”, “the chelate resin layer”, “the cation exchange resin layer”. There is insufficient antecedent basis for these limitations in the claim. It appears that applicant intended to recite “The nucleic acid isolation device of claim 2” instead of “The nucleic acid isolation device of claim 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1-2 and 5 are rejected under 35 USC § 102(a)(1) and/or 102(a)(2) as being anticipated by Nakamura et al. ( US 20140197107 A1) herein known as Nakamura.
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(Nakamura, Figs.4)
Regarding Claim 1 , Nakamura is directed to a method of purifying nucleic acids, a method of extracting nucleic acids and a kit for purifying nucleic acids, and more particularly to a method of purifying nucleic acids by adsorbing foreign substances with an ion exchange resin [0001].
Nakamura discloses a nucleic acid isolation device (nucleic acid purifying instrument 3) comprising: a main body formed to allow a biological sample to pass through from top to bottom; and an absorption layer (ion exchange resin 10) provided inside the main body to absorb an inhibitor (foreign substances contain protein and a metal salt) that inhibits a polymerase chain reaction and is included in the sample, wherein, when the sample passes through the main body, the inhibitor is absorbed into the absorption layer and nucleic acids are discharged through a lower portion of the main body (Fig.1 and 4; Abstract; [0002], [0009], [0018], [0021], [0038], [0136] ,[0178], [0039] (Alternatively, the nucleic acid purifying instrument 3 may have a tube having opening at upper and lower sections. In this case, after the sample is distributed through the nucleic acid purifying instrument 3 and the sample is adsorbed by the ion exchange resin 10, a separate chip or the like can be used to recover the sample flowed from the lower section)).
Regarding Claim 2, Nakamura discloses the nucleic acid isolation device (nucleic acid purifying instrument 3) wherein the absorption layer (ion exchange resin 10) comprises at least one resin layer selected from a cation exchange resin layer that is positively charged, an anion exchange resin layer that is negatively charged, or a chelate resin layer (Fig.4 (A); Abstract ; [0009]- [0011], [0045]).
Regarding Claim 5, claim 5 recites the nucleic acid isolation device of claim 1, wherein a flow rate at which the sample passes through the inside of the main body [[(10)]] is 15 u/sec or less.
The limitations recited in claims 5 which is directed to a manner of operating disclosed nucleic acid isolation device, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd.Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.
The nucleic acid isolation device of Nakamura is capable of being operated at a flow rate at which the sample passes through the inside of the main body [[(10)]] is 15 u/sec or less as recited above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al. ( US 20140197107 A1) herein known as Nakamura, as applied to the claim 1 above, in view of Singer et al. (US 20130237699 A1) herein known as Singer.
Regarding Claims 3, Nakamura teaches all the limitations in claim 1 as set forth above.
Nakamura discloses the nucleic acid isolation device (nucleic acid purifying instrument 3) wherein the cation exchange resin layer (20), the anion exchange resin layer (30), and cation exchange resin layer (40), are arranged sequentially in the absorption layer (ion exchange resin 10)) from top to bottom of the main body ([0089]-[0091] ; Fig.4 (A)). Nakamura also discloses the nucleic acid isolation device (nucleic acid purifying instrument 3) may contain a chelate additive such as EDTA [0045].
However, Nakamura is silent to the nucleic acid isolation device wherein the anion exchange resin layer, the chelate resin layer, and the cation exchange resin layer are arranged sequentially in the absorption layer from top to bottom of the main body.
Singer is directed to the invention relates to a chromatographic device for isolating and/or purifying double-stranded nucleic acids (Abstract).
Singer discloses the ion exchange resins are arranged substantially separately from one another, preferably in the form of two successive layers in the flow direction of the mobile phase from the inlet to the outlet [0053]. Singer also discloses the combination of different metal ions can be immobilized together on exactly one further material (ion exchange resin layer) or else can each be immobilized on different materials (ion exchange resin layers) which are arranged in individual layers or in mixtures [0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura ‘s nucleic acid isolation device wherein the anion exchange resin layer, the chelate resin layer, and the cation exchange resin layer are arranged sequentially in the absorption layer from top to bottom of the main body as taught by Singer, such that the combination of different metal ions can be immobilized together on exactly one further material (resin layer) or else can each be immobilized on different materials, which are arranged in individual layers (see Singer, [0052]- [0053]). In this case, according to Singer, one of ordinary skill in the art could substitute individual layers of anion exchange resin layer, chelate resin layer, and cation exchange resin layer for the anion exchange resin layer and cation exchange resin layer containing chelate additive of Nakamura, yielding nothing more than predictable results ( see MPEP 2144.06 II. Substituting Equivalents Known for the Same Purpose).
Regarding Claim 4, Nakamura teaches all the limitations in claim 1 as set forth above.
Nakamura discloses the nucleic acid isolation device (nucleic acid purifying instrument 3) , wherein the absorption layer (ion exchange resin 10) comprises an anion exchange resin layer (30), chelate resin (chelate additive such as EDTA), and a cation exchange resin layer (20, 40) ([0045], [0089]-[0091] ; Fig.4 (A)). The percent amount of the anion exchange resin layer (30) and the cation exchange resin (40) is 50% to 150% ([0077]).
However, Nakamura is silent to the absorption layer comprises an anion exchange resin layer and a volume ratio of the anion exchange resin layer, the chelate resin layer (122), and the cation exchange resin layer (123) is 1:1:1.
Singer discloses the ion exchange resins are arranged substantially separately from one another, preferably in the form of two successive layers in the flow direction of the mobile phase from the inlet to the outlet [0053]. Singer also discloses the combination of different metal ions can be immobilized together on exactly one further material (ion exchange resin layer) or else can each be immobilized on different materials (ion exchange resin layers) which are arranged in individual layers or in mixtures [0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura ‘s nucleic acid isolation device, wherein the absorption layer comprises an anion exchange resin layer, a chelate resin layer, and a cation exchange resin layer, and a volume ratio of the anion exchange resin layer, the chelate resin layer, and the cation exchange resin layer is 1:1:1 as taught by Singer, such that the combination of different metal ions can be immobilized together on exactly one further material (resin layer) or else can each be immobilized on different materials, which are arranged in individual layers (see Singer, [0052]- [0053]). In this case, according to Singer, one of ordinary skill in the art could substitute individual layers of anion exchange resin layer, chelate resin layer, and cation exchange resin layer for the anion exchange resin layer and cation exchange resin layer containing chelate additive of Nakamura, yielding nothing more than predictable results ( see MPEP 2144.06 II. Substituting Equivalents Known for the Same Purpose).
Regarding Claim 7, Nakamura teaches all the limitations in claim 1 as set forth above.
Nakamura discloses the nucleic acid isolation device (nucleic acid purifying instrument 3) of claim 1, wherein the main body comprises an accommodation part in which the input sample is accommodated, an adsorption part in which the absorption layer (ion exchange resin 10) is provided ([0009], [0021], [0038]- [0039]; [0136], Fig.1 (A)).
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( Nakamura, Fig. 1 (A))
However, Nakamura does not explicitly disclose a discharge part formed below the adsorption part.
Singer discloses a discharge part (3) formed below the adsorption part (4) (Fig.1; [0032]). Singer also discloses the chromatographic can additionally comprise at least one collection vessel for collecting the mobile phase (eluate) emerging from the outlet after elution has occurred ([0033]).
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(Singer Fig. 1)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura ‘s nucleic acid isolation device wherein a discharge part formed below the adsorption part as taught by Singer, in order to collect nucleic acids discharged from the lower portion of the main body (see Singer [0033]), yielding nothing more than predictable results.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al. ( US 20140197107 A1) herein known as Nakamura, as applied to the claim 1 above, in view of Perry (US 20140018529 A1) herein known as Perry.
Regarding Claim 6, Nakamura teaches all the limitations in claim 1 as set forth above.
However, Nakamura is silent to the nucleic acid isolation device, further comprising: an input chamber having a space formed therein for inputting the sample into an upper portion of the main body ; and a collection chamber having a space formed therein for collecting the nucleic acids discharged from the lower portion of the main body.
Perry is directed to a chromatographic device for isolating and/or purifying double-stranded nucleic acids ([0001]).
Perry discloses the nucleic acid isolation device, further comprising: an input chamber (upper chamber 30) having a space formed therein for inputting the sample into an upper portion of the main body (32); and a collection chamber (41) having a space formed therein for collecting the nucleic acids discharged from the lower portion of the main body. Perry also discloses the device may be used in a rapid nucleic acid isolation process without clogging while accommodating complex samples (Abstract; [0041], [0066] , [0074]; Fig. 3).
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(Perry ,Fig. 3)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura ‘s nucleic acid isolation device to further comprise: an input chamber having a space formed therein for inputting the sample into an upper portion of the main body ; and a collection chamber having a space formed therein for collecting the nucleic acids discharged from the lower portion of the main body as taught by Perry, in order to input the sample into an upper portion of the main body and to collect the nucleic acids discharged from the lower portion of the main body for rapid nucleic acid isolation process without clogging while accommodating complex samples (see Perry Abstract), yielding nothing more than predictable results.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al. ( US 20140197107 A1) herein known as Nakamura, as applied to the claim1 above, and further in view of Kenrick et al. (US 20080300397 A1) herein known as Kenrick.
Regarding Claim 8, Nakamura teach all the limitations in the claim 1 as set forth above.
However, Nakamura is silent to the nucleic acid isolation device wherein an upper filter and a lower filter both formed in a mesh structure to filter foreign substances contained in the biological sample are provided on an upper portion and a lower portion of the absorption layer, respectively.
Kenrick is directed to an improved system and method for nucleic acid purification. More specifically, it relates to a simple and rapid system and method for the extraction and purification of plasmid DNA from cells [0002].
Kenrick discloses the nucleic acid isolation device wherein an upper filter (pre-filter) and a lower filter (support frit) both formed in a mesh structure (porous sintered polyethylene) to filter foreign substances (residual contaminant ) contained in the biological sample are provided on an upper portion and a lower portion of the absorption layer (pDNA binding Membrane/matix) respectively. Kenrick also discloses a combination of both a pre-filter and a depth filter further reduces residual contaminant flow-through from the pre-filter,(Fig.1; [0011], [0023]).
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( Kenrick; Fig. 1)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura ‘s nucleic acid isolation device, wherein an upper filter and a lower filter both formed in a mesh structure to filter foreign substances contained in the biological sample are provided on an upper portion and a lower portion of the absorption layer, respectively as taught by Kenrick, in order to reduces residual contaminant (see Kenrick, [0023]) ]), yielding nothing more than predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOUD MOTAZ ABDEL LATIF whose telephone number is (571)272-6535. The examiner can normally be reached Monday-Friday 8:30-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin L Lebron can be reached at 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAHMOUD MOTAZ ABDEL LATIF/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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