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 April 24, 2026 is acknowledged. Claims 1, 9-11, 13-15 and 18-24 are pending wherein claim 21 remains withdrawn but subject to rejoinder. Notwithstanding the status identifiers, Applicant amended claims 1, 9-11, 13-15 and 18-21 (as acknowledged in the Remarks), and added new claims 22-24.
Response to Arguments
The amendment necessitated the new grounds of rejection set forth below. Regarding Applicant’s arguments directed to prior art, while the arguments are directed to the prior art cited in the new ground of rejection (Dumitrescu, Sage and Klimecki), the arguments are not directed to the specific teachings of the references relied upon in the rejections. Consequently, the arguments are moot.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, the recitation “wherein the openings at which the valves are arranged” should be changed to “the opening at which the valve is arranged”. The recitation is referring to “each well”.
Likewise, the limitation “the openings at which the valve is arranged” should be changed to “the opening at which the valve is arranged”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 9-11, 13-15, 18-20 and 22-24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites “the closing mechanism”. There is no antecedent basis for the limitation.
In addition, in claim 1, the recitation “each well of the container through the openings in an open state of the valves” (see page 3) is indefinite. First, because the recitation is referring to “each well”, the limitation “valves” should be changed to “valve”. Second, given that the claim has been amended to recite a second opening associated with each well, it is unclear whether the limitation “openings” refers to both “openings” in each well, or whether it is a typographical error and intends to just refer to the opening at which the valve is arranged. In addition to correcting the indefiniteness, the limitation “an opening” and subsequent references to the “opening” should be changed to “ a/the first opening”.
The number of pressure changers in the claimed invention is unclear. The claim introduces a single closing mechanism comprising a pressure changer, yet the end of the claim specifies that “the pressure changer” (i.e. the singular pressure changer introduced earlier) is arranged at “the second opening”, which is associated with one well. It is unclear whether the claimed invention comprises a plurality of pressure changers (i.e. one for each well), or just one pressure changer that services all of the wells.
Claim 9 recites “the opening”. Due to the amendment to claim 1, it is unclear to which opening the limitation refers.
Claim 14 is grammatically incorrect, and it renders the claim indefinite.
Claim 18 is directed to an apparatus comprising the device of claim 1. Yet, claim 18 does not recite any additional element(s) of the apparatus. Consequently, the scope of the claimed apparatus is unclear. The limitation “apparatus” does not inherently convey subject matter, so it is unclear what claim 18 intends to additionally claim such that claim 18 is considered patentably distinct from claim 1.
Claim 23 recites “the opening of the capillary”. There is no antecedent basis for the limitation.
Claims not explicitly rejected are rejected due to dependency.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
As discussed above, the scope of claims 1 and 18 is identical despite claim 18 referring to the invention as an apparatus.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 recites that the “biomolecules…are capable of being reversibly attached to the magnetic particles”, which anticipates claim 19.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
Claims 1, 9-11, 13-15, 18-20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dumitrescu (US 2008/0138251 A1) in view of Klimecki et al. (“Klimecki”) (WO 01/00875) and Sage (WO 2010/075199 A2).
With respect to claim 1, Dumitrescu discloses a device for isolating and purifying nucleic acid (see [0001]), the device comprising (see Fig. 1):
a container 10 comprising a first opening 116 arranged at the bottom of the container, a valve 54 arranged at the first opening 116 (see Fig. 4), and a second opening 16 arranged at the top of the container, wherein the second opening 16 is configured to be filled with liquid, wherein the valve is configured to be opened (see [0038]) and closed (see [0041]) to enable controllable drainage of the liquid; and
a closing mechanism in the form of a pressure changer 160 arranged at the second opening 16, wherein the pressure changer is configured to change air pressure above the liquid such that a retention force of the valve is overcome by the pressure, thus opening the valve and allowing the liquid to be drained from the container through the first opening 116 in an open state of the valve (see [0038]).
The device differs from the claimed invention in that the container 10 is not a well of a multiwell plate. In addition, Dumitrescu does not disclose that the valve is a capillary. Lastly, Dumitrescu does not explicitly disclose at least one permanent magnet movably arranged on the container.
Regarding the multiwell plate and the capillary valve, like Dumitrescu, Klimecki teaches a fluidic system for performing magnetic purification, wherein the purification occurs 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 modified the device of Dumitrescu such that a multiwell plate is used as the container, wherein each well is analogous to container 10 taught by Dumitrescu. The modification would increase throughout and hence efficiency. Regarding the capillary valve, if the container is modified as a microplate, then the valves would naturally be in the form of microvalves as the wells of microplates comprise millimeter dimensions.
Regarding the permanent magnet, Dumitrescu discloses that nucleic acid isolation/purification (the process that the device of Dumitrescu is intended to perform) typically involves the use of magnetic particles (see [0002]-[0003]). Moreover, Sage discloses an analogous device for isolating and purifying nucleic acid (see Fig. 1a and lines 1-2, p. 4), the device comprising a container 10a (see Fig. 1a) for receiving magnetic particles bound to nucleic acid (see step b, penultimate para., p. 4) and a permanent magnet 540 outside the container 10a (see Fig. 4) for manipulating the magnetic particles. In light of the disclosure of Dumitrescu and 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 provided the device taught by Dumitrescu with a permanent magnet movably arranged on the container between a first position in which the magnet affixes the magnetic particles to a wall of the container, and a second position in which the magnet enables the magnetic particles to freely move in the container. The modification would enable the device to perform nucleic acid purification using magnetic particles as suggested by Dumitrescu and explicitly taught by Sage.
With respect to claims 10 and 11, Sage further discloses the use of a mixer in the form of magnetic bars inside individual containers (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 provided a magnetic stirring bar inside each container (well) of the modified Dumitrescu device to facilitate magnetically-induced mixing.
With respect to claim 13, as discussed above (see rejection of claim 1), each well would comprise a plurality of openings, one at the top and one at the bottom.
With respect to claims 14 and 22, the pressure changer is a pressure chamber arrangement (see Fig. 1 of Dumitrescu) connected to the upper part of each container such that each container is configured to be individually applied with pressure from above. The modification of the container suggested in the rejection of claim 1 would comprise individual wells fitted with said pressure chamber arrangement.
With respect to claim 15, given that the scope of the claimed invention is limited to a single device, the recitation of additional devices connected in series does not further limit the claimed invention. 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 microplates to improve efficiency.
With respect to claim 18, as discussed above (see rejection of claim 1), the combination of Dumitrescu, Klimecki and Sage discloses an apparatus/device having the claimed features.
With respect to claim 19, the biomolecules are not part of the claimed device. Hence, the claim is directed to subject matter unrelated to the claimed device. Consequently, the claim is rejected by virtue of claim 1 being rejected.
With respect to claim 20, as discussed above (see rejection of claim 1), the container would be a microplate.
With respect to claim 23, as discussed above (see rejection of claim 1), the first opening (opening at which the capillary valve is situated) is an opening for draining, and thus discharging, the liquid from the container.
With respect to claim 24, the device further comprises a collection container beneath the device for collecting liquid drained from the first openings (see abstract of Dumitrescu).
Allowable Subject Matter
Claim 9 would be allowable if it is amended to overcome the applicable claim objection(s) and 35 U.S.C. 112(b) rejection(s) 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:
The combination of Dumitrescu, Klimecki and Sage discloses a device for reversibly immobilizing biomolecules (nucleic acid), as discussed above. However, the combination does not disclose or suggest a measuring instrument arranged at a first opening or in the container, wherein the measuring instrument is configured to carry out a measurement on a drop hanging at the first opening or in the container, respectively. Based on the intended use of the device (purify a sample for further processing), there is no motivation to perform detection within the container or on a drop hanging at the openings of the container so as to arrive at the claimed invention.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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