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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/220,224, filed on 04/01/2021.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8, drawn to a cell lysis device, classified in G01N2001/4904.
II. Claims 9-11, drawn to a method of lysing cells in a sample, classified in G01N29/02.
The inventions are independent or distinct, each from the other because:
Inventions Group I and Group II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the cell lysis device can be used to practice another and materially different process, such as echocardiography. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired separate status in the art in view of their different classification;
The inventions have acquired a separate status in the art due to their recognized divergent subject matter;
The inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Amadeo Ferraro on 02/20/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-11 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim(s) 7 and 9 is/are objected to because of the following informalities:
As to claim 7, the term “glycerine” should read “glycerin”.
As to claim 9, the term “maximise” in step C should read “maximize”.
Appropriate correction is required.
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 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dennis M. Connolly of US 2014/0024822 A1 (hereinafter, Connolly) in view of Shigeru Chiba of US 4,874,137 (hereinafter, Chiba).
As to claim 1, Connolly teaches to a cell lysis device (Connolly, paragraph [0075], Fig. 3B, teaches to an automated sample preparation device) comprising:
a housing (Connolly, paragraph [0080], Figs. 2 and 3B, teaches to a housing, as Connolly teaches to a periphery of the automated sample preparation device);
a sonication chamber provided within the housing (Connolly, paragraph [0079], Fig. 2, teaches to a sonication chamber provided within the housing, as Connolly teaches to a cartridge body 102), the sonication chamber being at least partly filled with an ultrasonic wave transfer medium (Connolly, paragraph [0079], Figs 2 and 3B, teaches to the sonication chamber being at least partly filled with an ultrasonic wave transfer medium, as Connolly teaches that the cartridge body 102 comprises a reservoir 103 containing a plurality of fluids), wherein the housing comprises an opening which is configured to receive a sample container (Connolly, paragraph [0081], Fig. 3B, teaches to wherein the housing comprises an opening which is configured to receive a sample container, as Connolly teaches that the automated sample preparation device comprises an opening which is configured to receive a disrupting chamber 113 for mixing fluids in a chamber distinct from the reservoirs);
an ultrasonic transducer which generates ultrasonic waves in the ultrasonic wav transfer medium within the sonication chamber (Connolly, paragraph [0081], Fig. 3B, teaches to an ultrasonic transducer which generates ultrasonic waves in the ultrasonic wave transfer medium within the sonication chamber, as Connolly teaches to a disrupter 112, wherein the disrupter 112 applies an ultrasonic force; Connolly teaches that the disrupter 112 is capable of breaking down the fluids), wherein the ultrasonic waves are transferred by the ultrasonic wave transfer medium from the ultrasonic transducer to the sample container to lyse cells when cells are contained within the sample container (Connolly, paragraphs [0022], [0084], Fig. 3B, teaches to wherein ultrasonic waves are transferred by the ultrasonic wave transfer medium from the ultrasonic transducer to the sample container to lyse cells when cells are contained within the sample container, as Connolly teaches to lysis of spores using ultrasonic bead beating using ultrasonic disruption for releasing nucleic acid molecules from cells).
Connolly does not explicitly teach such that a part of the sample container projects into the ultrasonic wave transfer medium.
In an analogous art, Chiba teaches to such that a part of the sample container projects into the ultrasonic wave transfer medium (Chiba, Fig. 1, teaches to such that a part of the sample container projects into the ultrasonic wave transfer medium, as Chiba teaches to bottom end 12d projecting into the ultrasonic wave transfer medium).
Both Connolly and Chiba relate to ultrasonic cell lysis (Chiba, abstract). Connolly does not explicitly teach a projection of a sample container into fluids. Connolly, Fig. 3B, does teach that a wall of the disrupting chamber 113 necessarily projects into the ultrasonic wave transfer medium as part of the disrupting chamber 113 makes contact with the fluids inside the reservoirs 103 for transmitting ultrasonic force. Chiba teaches to a configuration such that a part of the sample container projects into the ultrasonic wave transfer medium.
Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Connolly with the configuration of Chiba for radiating ultrasonic wave.
As to claim 8, Connolly in view of Chiba teaches to the device of claim 1, wherein the sample container is a microcentrifuge tube (Connolly, paragraph [0185], teaches wherein the sample container is a microcentrifuge tube, as Connolly teaches to using a microfuge tube placed in the socket of an ultrasonic sonicator for disrupting cells).
Claim(s) 2-3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dennis M. Connolly of US 2014/0024822 A1 (hereinafter, Connolly) in view of Shigeru Chiba of US 4,874,137 (hereinafter, Chiba), as applied to claim 1 above, and in view further view of Lim, H. J., et al. "Portable lysis apparatus for rapid single‐step DNA extraction of Bacillus subtilis." Journal of Applied Microbiology 120.2 (2016): 379-387 (hereinafter, Lim).
As to claim 2, Connolly in view of Chiba does not explicitly teach wherein the ultrasonic transducer is at least partly of a compound comprising lead, zirconium, and titanium.
In an analogous art, Lim teaches to wherein the ultrasonic transducer is at least partly of a compound comprising lead, zirconium, and titanium (Lim, pg. 380, teaches to wherein the ultrasonic transducer is at least partly of a compound comprising lead, zirconium, and titanium, as Lim teaches to an annular piezoelectric disc made of lead zirconia titanate; Lim teaches herein that the PZT is a very well-known piezoelectric material and has been used extensively for mechanical actuator, especially in liquid ejection, in both research and commercial applications)
Both Connolly in view of Chiba and Lim relate to a cell lysis apparatus (Lim, abstract). Connolly does not explicitly teach to a cell lysis apparatus comprising a PZT material. Connolly, paragraph [0101], does teach to comprising an ultrasonic transducer. Lim teaches to a cell lysis apparatus comprising a PZT material, which at least partly comprises lead, zirconium, and titanium.
Therefore, 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 Connolly in view of Chiba with the PZT material of Lim for improving performance of the cell lysis apparatus by forcing the diaphragm into an out-of-plane vibration.
As to claim 3, Connolly in view of Chiba does not explicitly teach wherein the ultrasonic transducer is a circular disc shape and has a diameter of 16 mm and a thickness of 0.7 mm.
In an analogous art, Lim teaches to the device of claim 1, wherein the ultrasonic transducer is a circular disc shape and has a diameter of 16 mm and a thickness of 0.7 mm (Lim, pg. 380, teaches to wherein the ultrasonic transducer is a circular disc shape and has a diameter of 16 mm and a thickness of 0.7 mm, as Lim teaches to an annular piezoelectric disc made of lead zirconia titanate, with a diameter of 16 mm and a thickness of 0.65; for examination purposes, 0.65 mm of Lim reads into 0.7 mm of the claimed invention; where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device; see MPEP §2144.04.IV.A.).
Both Connolly in view of Chiba and Lim relate to a cell lysis apparatus (Lim, abstract). Connolly does not explicitly teach to a cell lysis apparatus comprising a circular disc shape of ultrasonic transducer. Connolly, paragraph [0101], does teach to comprising an ultrasonic transducer. Lim teaches to a cell lysis apparatus comprising a PZT material in a circular disc shape, which at least partly comprises lead, zirconium, and titanium.
Therefore, 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 Connolly in view of Chiba with the circular disc shape of Lim for improving performance of the cell lysis apparatus by forcing the diaphragm into an out-of-plane vibration.
As to claim 6, Connolly in view of Chiba does not explicitly teach wherein the ultrasonic transducer is carried by a transducer holder which is of silicone rubber.
In analogous art, Lim teaches to the device of claim 1, wherein the ultrasonic transducer is carried by a transducer holder which is of silicone rubber (Lim, pg. 380, teaches to wherein the ultrasonic transducer is carried by a transducer holder which is of silicone rubber, as Lim teaches to a silicone ring seal).
Both Connolly in view of Chiba and Lim relate to a cell lysis apparatus (Lim, abstract). Connolly does not explicitly teach to using a silicone ring seal. Connolly, paragraph [0101], does teach to comprising an ultrasonic transducer. Lim teaches to a cell lysis apparatus comprising a silicone ring seal for holding or connecting an ultrasonic transducer assembly to the cell lysis apparatus.
Therefore, 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 Connolly in view of Chiba with the silicone ring seal of Lim for improving performance of the cell lysis apparatus by integrating ultrasonic transducer to the cell lysis apparatus.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dennis M. Connolly of US 2014/0024822 A1 (hereinafter, Connolly) in view of Shigeru Chiba of US 4,874,137 (hereinafter, Chiba), as applied to claim 1 above, and in view further view of Cintas, P., et al. "Glycerol: a solvent and a building block of choice for microwave and ultrasound irradiation procedures." Green Chemistry 16.3 (2014): 1056-1065 (hereinafter, Cintas).
As to claim 7, Connolly in view of Chiba does not explicitly teach wherein the ultrasonic wave transfer medium comprises vegetable glycerin.
In an analogous art, Cintas teaches to the device of claim 1, wherein the ultrasonic wave transfer medium comprises vegetable glycerin (Cintas, pg. 1060, teaches to wherein the ultrasonic wave transfer medium comprises vegetable glycerin, as Cintas teaches to using glycerol, or glycerin, as an ultrasonic wave transfer medium).
Both Connolly in view of Chiba and Cintas relate to applying ultrasonic wave (Cintas, pg. 1060). Connolly does not explicitly teach that the fluid used for transferring ultrasonic wave comprises vegetable glycerin. Connolly, paragraph [0086], does teach using water. Cintas teaches using glycerin for transferring ultrasonic wave. Cintas teaches that using glycerin improves wave transfer efficiency due to high acoustic impedance and viscosity of glycerin.
Therefore, 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 Connolly in view of Chiba with the glycerin of Cintas for improving wave transfer efficiency in transferring ultrasonic waves.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dennis M. Connolly of US 2014/0024822 A1 (hereinafter, Connolly) in view of Shigeru Chiba of US 4,874,137 (hereinafter, Chiba), as applied to claim 1 above, in view further view of Hanzhou Ultrasonic (accessed at https://piezo-ultrasonic.com/piezo-ceramic-discs.html on February 19, 2026, available as of February 16, 2020; hereinafter, Hanzhou).
As to claim 4, Connolly in view of Chiba does not explicitly teach wherein the ultrasonic transducer comprises a first electrode and a second electrode which are provided on opposing sides of the ultrasonic transducer, wherein the first electrode and the second electrode comprise silver and the capacitance between the first electrode and the second electrode is 800pF to 1300pF.
In analogous art, Hanzhou teaches to the device of claim 1, wherein the ultrasonic transducer comprises a first electrode and a second electrode which are provided on opposing sides of the ultrasonic transducer (Hanzhou, YT-5NM Piezo Ceramic Discs, teaches to wherein the ultrasonic transducer comprises a first electrode and a second electrode which are provided on opposing sides of the ultrasonic transducer, as Hanzhou teaches to having silver electrodes on each side), wherein the first electrode and the second electrode comprise silver and the capacitance between the first electrode and the second electrode is 800pF to 1300pF (Hanzhou, YT-5NM Piezo Ceramic Discs, teaches to wherein the first electrode and the second electrode comprise silver and the capacitance between the first electrode and the second electrode is 800 pF to 1300pF, as Hanzhou teaches to having 980± 20 % pF).
Both Connolly in view of Chiba and Hanzhou relate to ultrasonic transducers (Hanzhou, YT-5NM Piezo Ceramic Discs). Connolly in view of Chiba does not explicitly teach using a piezo ceramic discs, wherein each disc has silver electrodes on each side, and wherein the piezo ceramic discs have capacitance that is between 800 pF to 1300 pF. Connolly in view of Chiba does teach to using an ultrasonic transducer for lysing cells. Hanzhou teaches to a piezo ceramic discs in ultrasonic transducers for transducing ultrasonic waves.
Therefore, 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 Connolly in view of Chiba with the piezo ceramic discs of Hanzhou for transducing ultrasonic waves.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dennis M. Connolly of US 2014/0024822 A1 (hereinafter, Connolly) in view of Shigeru Chiba of US 4,874,137 (hereinafter, Chiba), as applied to claim 1 above, in view of Hanzhou Ultrasonic (accessed at https://piezo-ultrasonic.com/piezo-ceramic-discs.html on February 19, 2026; hereinafter, Hanzhou), and in further view of He Long CN 201629350 U (hereinafter, Long).
As to claim 5, Connolly in view of Chiba and Hanzhou does not explicitly teach wherein the first electrode is at least partly covered with a glass coating.
In an analogous art, Long teaches to wherein the first electrode is at least partly covered with a glass coating (Long, paragraph [0010], Fig. 1, teaches to wherein the first electrode is at least partly covered with a glass coating, as Long teaches to glass protective layer 3 on metallic silver electrode layer 2).
Both Connolly in view of Chiba and Hanzhou and Long relate to ultrasonic transducer (Long, paragraph [0001]). Connolly in view of Chiba and Hanzhou does not explicitly teach a glass coating. Connolly in view of Chiba and Hanzhou does teach to ultrasonic transducer comprising a piezoelectric transducer of discs that have silver electrodes. Long teaches to glass coating on silver electrodes for protecting and improving reliability of the ultrasonic transducer.
Therefore, 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 Connolly in view of Chiba and Hanzhou with the glass coating of Long for improving reliability of the ultrasonic transducer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN LEE whose telephone number is (703)756-1254. The examiner can normally be reached M-F, 7:00-16:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN LEE/Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794