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
In response to the amendment received on 05/26/2026:
-currently, claim(s) 1-16 is/are pending, with claims 9-11 withdrawn from consideration
claim objections are withdrawn for claim 7
- a new ground(s) of rejection is made for at least claims 1, 8, and 12-16 over Dennis M. Connolly of US 2014/0024822 A1 (hereinafter, Connolly) in view of Shigeru Chiba of US 4,874,137 (hereinafter, Chiba) and Vladimir Bashkirov of US 2009/0233814A1 (hereinafter, Bashikirov)
Claim Rejections - 35 USC § 103
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(s) 1, 8, and 12-16 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) and Vladimir Bashkirov of US 2009/0233814A1 (hereinafter, Bashikirov).
As to claim 1, Connolly teaches a cell lysis device (Connolly, paragraph [0075], Fig. 3B, teaches an automated sample preparation device).
In an analogous art, Chiba teaches a sample container having a tube with an interior space containing a sample of cells in a liquid solution within the interior space of the sample container (Chiba, Fig. 1, teaches to container 12 having a tube for containing cells in solution to be lysed by radiation of ultrasonic wave; see below).
Connolly does not explicitly teach a sample container having a tube with an interior space containing a sample of cells in a liquid solution within the interior space of the sample container. Connolly, paragraph [0075], Fig. 3B, does teach to an automated sample preparation device. Accordingly, Chiba teaches that it was well known in the cell lysis art to have used a sample container. The cell lysis device can comprise of the sample container. Because Chiba teaches that such materials were operable, it would have been obvious to one of ordinary skill in the art at the time of invention to have used the cell lysis device of Connolly with a reasonable expectation of success.
The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their perspective functions, and the combinations yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.)
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Fig. 1 of Chiba
Connolly in view of Chiba teaches to a housing (Chiba, Fig. 1, teaches to the space comprising the vessel 4 in the casing 5 as a housing) having a side wall, a base and a cover opposite to the base, the cover including an opening which receives at least a part of the tube of the sample container, the at least a part of the tube of the sample container closing and sealing the opening in the cover (Chiba, Fig. 1, teaches to a closure plate 21 as a cover for the space comprising the vessel 4 in the casing 5; therefore, the space comprising the vessel 4 has a side wall, a base, and a cover opposite to the base; the closure plate 21 receives the tube of containers 12, which closes and seals the opening in the closure plate 21);
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), the ultrasonic wave transfer medium being a liquid having an acoustic impedance (Chiba, Fig. 1, teaches to liquid bath W in vessel 4; any liquid necessarily has an acoustic impedance), wherein 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) and the ultrasonic wave transfer medium is retained within the sonication chamber by the part of the tube of the sample container which closes and seals the opening in the cover of the housing (Chiba, Fig. 1, teaches to a closure plate 21 as a cover for the space comprising the vessel 4 in the casing 5; therefore, the space comprising the vessel 4 has a side wall, a base, and a cover opposite to the base; the closure plate 21 receives the tube of containers 12, which closes and seals the opening in the closure plate 21), the sample container containing the sample of cells in the liquid solution within the interior space of the sample container separate from the ultrasonic wave transfer medium present in the sonication chamber (Chiba, Fig. 1, teaches to containers 12 for containing samples for cell lysis that are separate from the liquid bath W);
an ultrasonic transducer within the sonication chamber positioned proximate to the lower end of the sample container (Chiba, Fig, 1, teaches to ultrasonic generator 2 positioned next to the lower end of the sample container).
In an analogous art, Bashikirov teaches to the ultrasonic transducer being in contact with the ultrasonic wave transfer medium in the sonication chamber and outside of the sample container (Bashikirov, paragraph [0004], Fig. 4, teaches that transducer is in water bath contacting the ultrasonic wave transfer medium).
Connolly in view of Chiba does not explicitly teach the ultrasonic transducer being in contact with the ultrasonic wave transfer medium in the sonication chamber and outside of the sample container. Connolly in view of Chiba does teach to ultrasonic generator 2 positioned next to the lower end of the sample container. Accordingly, Bashikirov, Fig. 4, teaches that it was well known in the cell lysis art to have used an ultrasonic transducer being in contact in water bath. The transducer can contact water in the bath. Because Bashikirov teaches that such structures were operable, it would have been obvious to one of ordinary skill in the art at the time of invention to have used ultrasonic transducer in water of Connolly in view of Chiba with a reasonable expectation of success.
The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their perspective functions, and the combinations yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.)
Connolly in view of Chiba and Bashikirov teaches to the ultrasonic transducer not contacting the liquid solution with the sample of cells contained within the sample container, the ultrasonic transducer generating (Chiba, Fig. 1, teaches that the ultrasonic generator 2 is not contacting the samples in the containers 12) 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).
As to claim 8, Connolly in view of Chiba and Bashikirov 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).
As to claim 12, Connolly in view of Chiba, Bashikirov teaches to the device of claim 1, wherein the cell lysis device further comprises a transducer holder which is coupled to the base of the housing, the transducer holder carrying and at last partly surrounding the ultrasonic transducer (Chiba, Fig. 1, teaches to coil 3 that surround and hold the ultrasonic generator 2).
As to claim 13, Connolly in view of Chiba, Bashikirov teaches to the device of claim 1, wherein the ultrasonic wave transfer medium is a liquid which has a higher acoustic impedance than water (Bashikirov, paragraph [0006], teaches that high concentration glycerol solutions are normally used to increase the viscosity of the liquid medium by several orders of magnitude compared to pure water; glycerol has a higher acoustic impedance than pure water).
As to claim 14, Connolly in view of Chiba, Bashikirov teaches to the device of claim 1, wherein the housing of the sonication capsule is generally cylindrical (Connolly, Fig. 2, teaches to cartridge body 102 and reservoir insert 101 in cylindrical shape).
Connolly in view of Chiba, Bashikirov does not explicitly teach the base of the sonication capsule is generally circular and positioned at a first end of the sonication capsule and the cover of the sonication capsule is generally circular and positioned at a second end of the sonication capsule opposite to the first end of the sonication capsule.
However, where the only difference between the prior art and the instant claim is a recitation of relative dimension of the claimed structure and a structure having the claimed relative dimensions would not perform differently than the prior art structure, the claimed structure is not patentably distinct from the prior art structure. In addition, the configuration/shape of the claimed structure is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. Please see MPEP § 2144.04(IV)(B)
As to claim 15, Connolly in view of Chiba, Bashikirov teaches to the device of claim 1, wherein the sonication capsule is a disposable, single-use capsule (Chiba, Fig. 1, teaches to containers 12 in the form of eppendorf tube; the tubes are operable to be disposable, single-use capsule).
As to claim 16, Connolly in view of Chiba, Bashikirov teaches to the device of claim 1, wherein the sonication chamber is pre-filled with the ultrasonic wave transfer medium (Chiba, Fig. 1, teaches to liquid bath W in vessel 4 for transferring ultrasonic wave to the containers 12 to be operable; the liquid bath W is necessarily prefilled prior to the operation of the cell lysis device).
Claim(s) 2-3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connolly in view of Chiba and Bashikirov, 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 and Bashikirov 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 Bashikirov 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 and Bashikirov 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 and Bashikirov 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 Bashikirov 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 and Bashikirov 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 and Bashikirov 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 Bashikirov 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 and Bashikirov 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 Connolly in view of Chiba and Bashikirov, 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 and Bashikirov 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 Bashikirov 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 and Bashikirov 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 Connolly in view of Chiba and Bashikirov, 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 and Bashikirov 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 Bashikirov 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 and Bashikirov 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 Connolly in view of Chiba and Bashikirov, 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) as applied to claim 4 above, and in further view of He Long CN 201629350 U (hereinafter, Long).
As to claim 5, Connolly in view of Chiba, Bashikirov 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, Bashikirov 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, Bashikirov 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, Bashikirov and Hanzhou with the glass coating of Long for improving reliability of the ultrasonic transducer.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant’s arguments, see pg. 9, filed 05/26/2026, with respect to the rejection(s) of claim(s) 1-8 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made.
Claim(s) 1, 8, and 12-16 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) and Vladimir Bashkirov of US 2009/0233814A1 (hereinafter, Bashikirov).
Please refer to the rejection above.
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.
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/JOHN LEE/Examiner, Art Unit 1794
/BRYAN D. RIPA/Primary Patent Examiner, Art Unit 1794
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