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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 claims 1-18 in the reply filed on is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/01/2023, 01/24/2024, 07/02/2025, 02/20/2026 were filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1-18 are objected to because of the following informalities:
Claim 1 line 1 recites “Lysis apparatus” and should be amended to “A lysis apparatus”
Claims 2-28 line 1 recite “Lysis apparatus” and should be amended to “The lysis apparatus”
Appropriate correction is required.
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.
Claims 4, 5, 12, 14, 16, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 4 recites “the plane of rotation”. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “the plane of rotation”. There is insufficient antecedent basis for this limitation in the claim.
Claims 12 and 18 line 1 recite “tempering unit” and is unclear because the common definition of “tempering” is for changing the hardness and elasticity of metals. For prosecution, the limitation “tempering unit” will be interpreted to mean a heater or equivalent structure.
Claims 12 and 18 line 1 recite “tempering unit”. There is insufficient antecedent basis for this limitation in the claims.
Claim 14 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation “0.5 Hz to 40 Hz”, and the claim also recites “2 Hz to 30 Hz” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For prosecution, the narrower limitation will be interpreted as merely exemplary of the remainder of the claim, and therefore not required.
Claim 16 line 4 recites “the radial direction” and “the azimuthal direction”. There is insufficient antecedent basis for this limitation in the claim.
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 1-2, 6-11, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al (CN110938522A 03/31/2020; hereinafter Zhong).
Regarding claim 1, Zhong teaches lysis apparatus, comprising:
a chamber for receiving a sample (a bacterial lysis cell 9 – Figs. 1-2);
at least one magnetic actuator located within the chamber (a circular magnetic sheet 10 – Figs. 1-2);
at least two magnetic elements arranged outside the chamber (an upper circular magnet 2 and a lower circular magnet 4 – Figs. 1-2) and
a driving unit (a drive motor 6 – Figs. 1-2) for effecting a rotational relative movement between the chamber and the magnetic elements arranged outside the chamber (the drive motor 6 rotates the circular magnetic sheet 10 relative to the upper circular magnet 2 and the lower circular magnet 4 – Figs. 1-2 and paragraph 11), by which the chamber successively passes the magnetic elements located outside the chamber (the drive motor 6 rotates the bacterial lysis cell 9 successively pass the upper circular magnet 2 and the lower circular magnet 4 – Figs. 1-2 and paragraph 11), wherein the polarity of the magnetic elements is opposite with respect to the circular path of the rotational relative movement (the upper circular magnet 2 and the lower circular magnet 4 are capable of generating polarity opposite with respect to the circular path of the drive motor 6 – Figs. 1-2), such that the magnetic actuator arranged within the chamber is moved both translationally and rotationally around an own axis of the magnetic actuator to effect lysis of the sample (the circular magnetic sheet 10 moves both translationally and rotationally around an axis of the circular magnetic sheet 10 – Fig. 4 and paragraph 11),
wherein the chamber is configured to enable the at least one magnetic actuator located within the chamber to move both translationally and rotationally around an own axis of the magnetic actuator (the circular magnetic sheet 10 moves both translationally and rotationally around an axis of the circular magnetic sheet 10 – Fig. 4 and paragraph 11).
Regarding claim 2, Zhong teaches lysis apparatus according to claim 1, wherein the magnetic elements are magnetic poles or wherein each magnetic element is a magnet (the upper circular magnet 2 and the lower circular magnet 4 – Figs. 1-2).
Regarding claim 6, Zhong teaches lysis apparatus according to claim 1, wherein the at least two magnetic elements arranged outside the chamber are controllable (the upper circular magnet 2 and lower circular magnet 4 are capable of being controlled – Figs. 1-2) and/or variable electromagnets.
Regarding claim 7, Zhong teaches lysis apparatus according to claim 6, which is configured to at least reduce the magnetic field acting on the magnetic actuator arranged within the chamber from the at least two magnetic elements arranged outside the chamber, independent of the relative rotational motion (the upper circular magnet 2 and lower circular magnet 4 are mounted off center relative to the shaft 5 and least reduce the magnetic field acting on the circular magnetic sheet 10 independent of the rotation velocity of the circular magnetic sheet 10 around the shaft – Figs. 1-2).
Regarding claim 8, Zhong teaches lysis apparatus according to claim 1, wherein the lysis apparatus comprises at least one lysis particle located within the chamber (bacterial cells – paragraph 11).
Regarding claim 9, Zhong teaches lysis apparatus according to claim 8, wherein the at least one lysis particle comprises maximum dimensions of less than 0.5 mm (bacterial cells are smaller than 0.5 mm – paragraph 11).
Regarding claim 10, Zhong teaches lysis apparatus according to claim 1, wherein the at least two magnetic elements arranged outside the chamber are configured to be stationary at the time of the lysis (the upper circular magnet 2 and the lower circular magnet 4 are stationary because they are on circular plates that do not contact the rotating shaft – Figs. 1-2 and paragraph 11) and the driving unit is configured to rotate the chamber with respect to an axis of rotation relative to the magnetic elements located outside the chamber (the drive motor 6 rotates the circular magnetic sheet 10 relative to the upper circular magnet 2 and the lower circular magnet 4 – Figs. 1-2 and paragraph 11).
Regarding claim 11, Zhong teaches lysis apparatus according to claim 1, wherein the chamber comprises a diaphragm (a breathable membrane – paragraph 14).
Regarding claim 13, Zhong teaches lysis apparatus according to claim 1, wherein the at least two magnetic elements outside the chamber are arranged at an angle in the plane of rotation of 20° to 180° to each other (the upper circular magnet 2 and lower circular magnet 4 are at an angle of 20° to 180° – Figs. 1-2).
Regarding claim 14, Zhong teaches lysis apparatus according to claim 1, wherein the driving unit is configured to provide the rotational relative movement with a rotational frequency of 0.5 Hz to 40 Hz, advantageously of 2 Hz to 30 Hz (the drive motor 6 is capable of a rotational frequency of 0.5 Hz to 40 Hz – Figs. 1-2).
Regarding claim 15, Zhong teaches lysis apparatus according to claim 1, wherein the chamber comprises at least the length of the longest diagonal of the magnetic actuator located within the chamber (the bacterial lysis cell 9 is at least the length of the longest diagonal of the circular magnetic sheet 10 – Figs. 1-2), within two of three spatial directions that are perpendicular to each other, and comprises at least the length of the longest diagonal of the magnetic actuator located within the chamber minus 20% in a third of the three spatial directions perpendicular to each other (the bacterial lysis cell 9 is at least the length of the longest diagonal of the circular magnetic sheet 10 minus 20% in a third of the three spatial directions – Figs. 1-4) .
Regarding claim 16, Zhong teaches lysis apparatus according to claim 1, wherein the chamber comprises at least the size of the length of the magnetic actuator located within the chamber in at least two directions of three directions that are formed by the direction of the axis of rotation, the radial direction with respect to the rotation and the azimuthal direction with respect to the rotation (the bacterial lysis cell 9 is at least the length of the circular magnetic sheet 10 in at least two directions – Figs. 1-2).
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 3-5, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong in view of Yoo (US20090253130A1 published 10/08/2009).
Regarding claim 3, Zhong teaches lysis apparatus according to claim 1, which is configured to at least reduce the magnetic field acting on the magnetic actuator arranged within the chamber from the at least two magnetic elements arranged outside the chamber, independent of the rotational relative movement (the drive motor 6 reduces the magnetic field acting on the circular magnetic sheet 10 by moving the towards and away from the upper circular magnet 2 and the lower circular magnet 4, independent of the rotational velocity of the magnetic actuator – Figs. 1-2).
However, Zhong does not teach an actuator to change the distance between the chamber and the at least two magnetic elements arranged outside the chamber, independent of the rotational relative movement.
Yoo teaches a bio memory disc drive apparatus for sample processing comprising an actuator (a slider on which the movable permanent magnet 5a – Fig. 2B and paragraph 384) to change the distance between the chamber and the at least two magnetic elements arranged outside the chamber, independent of the rotational relative movement (the central controller 101 controls the movement of the permanent magnet 5a to open and close the valve of the bio memory disc – paragraph 442). Yoo also teaches the central controller 101 controls the spindle motor 120 and remotely transmits the diagnosis result (paragraphs 315 and 442).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Zhong, with the movable permanent magnet 5a and central controller 101, taught by Yoo, to control the spindle motor 120 and remotely transmits the diagnosis result. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Zhong and Yoo teach discs for processing biological samples.
Regarding claim 4, Zhong, modified by Yoo, teaches lysis apparatus according to claim 3, wherein the actuator is configured to move the at least two magnetic elements arranged outside the chamber perpendicular to the plane of rotation (the slider is capable of moving the upper circular magnet 2 and the lower circular magnet 4 perpendicular to the plane of rotation – Yoo Fig. 2B and paragraph 384).
Regarding claim 5, Zhong, modified by Yoo, teaches lysis apparatus according to claim 3, wherein the actuator is configured to move the at least two magnetic elements arranged outside the chamber parallel to the plane of rotation, independent of the rotational relative movement (the slider is capable of moving the upper circular magnet 2 and the lower circular magnet 4 parallel to the plane of rotation – Yoo Fig. 2B and paragraph 384).
Regarding claim 12, Zhong teaches lysis apparatus according to claim.
However Zhong does not teach wherein the lysis apparatus comprises tempering unit configured to change the temperature of the chamber.
Yoo teaches a bio memory disc drive apparatus for sample processing comprising tempering unit configured to change the temperature of the chamber (a heating means or a laser generating unit for heating the chamber and capable of deactivating the at least one magnetic actuator – paragraph 106). Yoo teaches to use the laser beam to move the sample by heating the rear portion of the sample and causing air expansion (paragraph 121).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, taught by Zhong, with the laser, taught by Yoo, to gain the ability to move the sample. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Zhong and Yoo teach discs for processing biological samples.
Regarding claim 18, Zhong teaches lysis apparatus according to claim 1.
However, Zhong does not teach wherein the lysis apparatus comprises tempering unit configured to heat the at least one magnetic actuator located within the chamber above the Curie temperature to deactivate the at least one magnetic actuator.
Yoo teaches a bio memory disc drive apparatus for sample processing wherein the lysis apparatus comprises tempering unit configured to heat the at least one magnetic actuator located within the chamber above the Curie temperature to deactivate the at least one magnetic actuator (a heating means or a laser generating unit for heating the chamber and capable of deactivating the at least one magnetic actuator – paragraph 106). Yoo teaches to use the laser beam to move the sample by heating the rear portion of the sample and causing air expansion (paragraph 121).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, taught by Zhong, with the laser, taught by Yoo, to gain the ability to move the sample. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Zhong and Yoo teach discs for processing biological samples.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong.
Regarding claim 17, Zhong teaches lysis apparatus according to claim 1.
Although Zhong does not teach wherein the at least two magnetic elements outside the chamber are configured to comprise, at the time of the lysis, a maximum perpendicular distance with respect to the plane of the rotational relative movement to the chamber that is 5 cm maximum, Zhong teaches a maximum perpendicular distance between the bacterial lysis cell 9 and the upper circular magnet 2 and the lower circular magnet 4 (Figs. 1-4).
The only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and the device having the claimed relative dimensions would not perform differently than the prior art device (i.e. making the Zhong device bigger or smaller would read on the 5 cm maximum limitation). Therefore, per MPEP 2144.04 IV the claimed device is not patentably distinct from the Zhong device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20110111987A1 – a microfluidic rotor with stationary and rotating magnets
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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