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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 2, 2026 has been entered.
Claims 1-15 and 18-21 remain pending wherein claim 21 remains withdrawn but subject to rejoinder. Applicant amended claims 1, 2 and 9.
Response to Arguments
Applicant's arguments with respect to the patentability of claim 18 have been fully considered but they are not persuasive.
Applicant argues that claim 18 is patentable over the disclosure of Sage because Sage does not disclose the method steps recited in claim 1. Remarks 6-9. The argument is not persuasive because claim 18 is directed to a system, not a method. The patentability of claim 18 is based on its structure, not how it is used. Consequently, Applicant’s argument that claim 18 is patentable because Sage does not disclose the step of “removing the separated biologically relevant biomolecules…” recited in claim 1 is not persuasive. Because Sage teaches an apparatus/device comprising all of the structural features recited in claim 18, the rejection of claim 18 is maintained.
Regarding the method claims, Applicant’s arguments are moot. The amendment necessitated the new grounds of rejection set forth below.
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, the limitation “and being configured to” should be changed to “the measuring instrument being configured to”. Currently, “being configured to” modifies the method (i.e. the method is configured to carry out a measurement), which does not make sense.
Appropriate correction is required.
Claim Interpretation
As indicated in previous Office actions, this application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitations use generic placeholders that are coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholders are not preceded by a structural modifier.
Such claim limitations are: “closing mechanism” in claim 2.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f), it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If Applicant does not intend to have the limitation interpreted under 35 U.S.C. 112(f), Applicant may:
(1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or
(2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
In this instance, the limitation “closing mechanism” is being interpreted as devices/substances/structures disclosed in [0030]-[0031] of the specification, and their equivalents.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sage (WO 2010/075199).
With respect to claim 18, Sage discloses a device comprising a container 10a comprising an opening (slit 1040) and a valve 1020 configured to be opened and closed to enable controllable drainage of a liquid in the container 10a (see Fig. 1a), and a magnet (see step 8, p. 15),
wherein the magnet is arranged at the container (see step 12, p. 15), and
the valve 1020 is configured to be opened and closed by a closing mechanism (vacuum, see abstract) to enable controllable drainage of the liquid.
Claim Rejections - 35 USC § 103
Claims 1-8, 10, 11, 15, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dumitrescu (US 2008/0138251 A1) in view of Sage.
With respect to claim 1, Dumitrescu discloses a device for isolating and purifying nucleic acid (see [0001]), the device comprising a container 10 comprising an opening 116, and a valve 54 configured to be opened (see [0038]) and closed (see [0041]) to enable controllable drainage of a liquid in the container 10a (see Fig. 1).
While Dumitrescu further discloses a conventional method of isolating and purifying nucleic acid (see [0002]-[0003]), the disclosure of Dumitrescu is directed to the device, and hence it does not explicitly disclose a method of using the device to isolate and purify nucleic acid. However, based on the disclosure of the conventional method and how the device is intended to improve upon said method, a method of using the device to isolate and purify nucleic acid would comprise the steps of:
arranging magnetic particles and a liquid containing biologically relevant biomolecules (nucleic acid) and impurities (other components of “biological sample”) in the container (see [0002]);
reversibly bonding the biologically relevant biomolecules to the magnetic particles (see [0002]);
removing liquid containing the impurities (see [0002]) through the opening 116 of the container 10 by opening the valve 54 (see [0006]-[0007] and [0042] disclosing the purpose of valve 54); and
removing the biologically relevant biomolecules from the container 10 through the opening 116 in an open state of the valve 54 by opening the valve 54 (see [0002]).
However, Dumitrescu does not disclose or suggest the following claimed steps:
fixing the magnetic particles in the container with the magnet; and
separating the biologically relevant biomolecules from the magnetic particles such that the biologically relevant biomolecules are removed through the opening 116 without the magnetic particles.
Sage discloses an analogous device for isolating and purifying nucleic acid (see Fig. 1a and lines 1-2, p. 4), and Sage further discloses a method of using the device to isolate and purify nucleic acid, the method comprising the steps of:
arranging magnetic particles and a liquid containing biologically relevant biomolecules in the container (step b, penultimate para., p. 4);
reversibly bonding biologically relevant biomolecules to the magnetic particles (step b, and step f disclosing that the bonding is reversible);
fixing the magnetic particles in the container with the magnet (step c);
removing the liquid containing impurities through the opening of the container by opening the valve (step d); and
separating the biologically relevant biomolecules from the magnetic particles before removing the biologically relevant biomolecules from the container (step f).
In light of the disclosure of Sage, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a magnet to fix the magnetic particles in the container 10 when conducting the method taught by Dumitrescu, and also separate the biologically relevant biomolecules from the magnetic particles before eluting the biomolecules via the opening 116. The former modification would ensure that the magnetic particles (and the biologically relevant biomolecules bound thereto) are not eluted during the washing step (i.e. removing liquid containing the impurities step). The latter modification would facilitate recovery of the magnetic particles for subsequent use by retaining them in the container 10 using the magnet (the biologically relevant biomolecules have to be separated from the magnetic particles at some point before analysis via PCR anyway).
With respect to claim 2, the container 10 taught by Dumitrescu is configured to be filled with the liquid (see Fig. 1);
the magnetic particles would be freely movable in the container 10 in the absence of the magnet,
the magnet would be arranged at the container during the fixing step (e.g. on the outer wall of the container); and
the valve 54 is configured to be opened and closed by a closing mechanism (pressure from tube 168, see Fig. 1 and [0041]) to enable controllable drainage of the liquid.
With respect to claims 3 and 5, the valve 54 is configured to be opened and closed by a closing mechanism in the form of a pressure changer (tube 168) configured to change the air pressure above the liquid such that a retention force of the valve 54 is overcome, thus opening the valve (see [0041]).
With respect to claim 4, the closing mechanism is not a part of the device and the method does not explicitly recite a step of opening the valve using the claimed pressure changer. That said, given that the valve 54 is configured to be opened based on pressure change, it is configured to be (i.e. capable of being) opened and closed by a closing mechanism in the form of a hydrostatic pressure changer that adds liquid to the container such that a retention force of the valve 54 is overcome.
With respect to claim 6, the valve 54 is arranged at opening 116 (see Fig. 1b).
With respect to claim 7, the valve 54 is a collecting container (see Fig. 6 and [0025] illustrating/disclosing a cup-shaped structure 56 of the valve 54 that can hold fluid).
With respect to claim 8, the opening 116 is configured to be closed with a bead* which is floatable on the liquid.
*The bead is not a part of the claimed device and the claim provides no context for the bead. Consequently, it encompasses any hypothetical bead, including a bead having a size that corresponds to the size of the opening 116 (see Fig. 6). Such a bead would have the ability to close the opening 116.
With respect to claims 10 and 11, Sage further discloses the use of a mixer in the form of magnetic bars inside its device (see last paragraph of page 10). In light of the disclosure of Sage, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a magnetic stirring bar inside the container 10 taught by Dumitrescu to facilitate binding of the biologically relevant biomolecules to the magnetic particles.
With respect to claim 15, given that the scope of the claimed invention is limited to the use of one device, the recitation of additional devices connected in series does not further limit the claimed method. Nevertheless, Sage discloses a plurality of devices serially with one another (see Fig. 2). In light of the disclosure of Sage, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have serially connected a plurality of containers 10 taught by Dumitrescu to improve efficiency.
With respect to claim 18, the combination of Dumistrescu and Sage discloses an apparatus/device having the claimed features (see rejection of claim 2).
With respect to claim 19, the biologically relevant biomolecules (nucleic acid) would be capable of being reversibly immobilized by the magnetic particles (see rejection of claim 1).
Claims 12-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dumitrescu (US 2008/0138251 A1) in view of Sage as applied to claims 1-8, 10, 11, 15, 18 and 19 above, and further in view of Klimecki et al. (WO 01/00875, hereby referred to as “Klimecki”).
Regarding claims 12 and 20, neither Dumistrescu nor Sage disclose a container in the form of a plate with wells (e.g. a microtiter plate).
Klimecki teaches a fluidic system for performing magnetic separations, wherein the separations occur within the wells of a microplate system (see page 6). Klimecki teaches that each individual well is separately addressable, enabling high throughput and parallel processing of samples (see lines 17-19, page 3; lines 5-30, page 23; lines 14-15, page 25; Fig. 3). In light of the disclosure of Klimecki, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Dumistrescu such that a multiwell plate is used as the containers, wherein the bottom of each well comprises a valve.
Regarding claim 13, if Dumistrescu is modified pursuant to the teachings of Klimecki, then each well would comprise a plurality of openings (one at the top and one at the bottom).
With respect to claim 14, as discussed above, the closing mechanism is not a part of the claimed device, and the method does not recite a step of using the closing mechanism. Nevertheless, given that the valve 54 taught by Dumistrescu is configured to be opened based on pressure change, it is configured to be (i.e. capable of being) opened and closed by a pressure changer that applies pressure to each well.
Allowable Subject Matter
Claim 9 would be allowable if it is amended to overcome the claim objection set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Dumitrescu and Sage both disclose a method of reversibly immobilizing biomolecules (nucleic acid) using magnet particles, as discussed above. However, neither Dumitrescu nor Sage disclose arranging a measuring instrument at the opening or in the container, and carrying out a measurement on a drop hanging at the opening or in the container, respectively. Based on the intended use of the containers (purify a sample for further processing), there is no motivation to perform detection within the containers or on a drop hanging at the openings of the containers, as recited in claim 9.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796