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 .
Claim Status
Claims 1-18 are pending.
Claims 19-23 have been withdrawn.
Claims 1, 10, and 11 have been amended.
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, 4, 6, and 9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Branch et. al. (US 9096823 B1).
Regarding claim 1, Branch teaches “A lysis device,” (Fig. 1 and column 4 lines 28 and 29, 10 microfluidic lysing device); “comprising: a sample vessel having an outer surface, and a microchannel within confines of the outer surface,” (Fig 1 and column 4, lines 30 and 31, the microfluidic substrate 15 shows an outer surface and the channel 14).
The recitation “that is configured to receive a blood sample” is capability of the microchannel however taught within the ((111) Samples of DNA were extracted from a sample solution containing 250 fmol of DNA). Therefore the sample is configured to receive blood if its configured to receive a sample solution containing 250 fmol of DNA.
Further taught “and an acoustic transducer connected to the sample vessel to form a monolithic structure, (col. 4, lines 26-35, “FIG. 1 shows a perspective top-view schematic illustration of a device 10 that can be used for cell lysis by localized acoustic pressure. The acoustic-based microfluidic lysing device 10 comprises at least one acoustic transducer 12 disposed on a top lid 13 of a channel 14 that is formed in a microfluidic substrate 15. Whole cells can enter the channel 14 through an inlet 16 and are lysed by acoustic pressure in the channel generated by the array of acoustic transducers 12. The BAW transducer array can be monolithically integrated with the microfluidic channel on the same substrate.”)
The recitation “the acoustic transducer configured to expand and contract to generate ultrasonic acoustic standing waves inside the blood sample in the microchannel and to vibrate the sample vessel” is a capability of the acoustic transducer. Branch discloses the positively claimed structural elements of the acoustic transducer as claimed. Branch’s acoustic transducer is fully capable of the adaption in as much as it is recited and required by the claim (col. 7, lines 26-38); see e.g., Figs. 4 and 5)
The recitation “such that shear forces are induced within the microchannel, wherein a combination of the acoustic standing waves and the shear forces causes cavitation in the blood sample” merely refers to an expected result of operating the transducer and does not further structurally limit the acoustic transducer as claimed. See MPEP 2114.
Branch further teaches ultrasonic waves and an acoustic transducer disposed on a lysis portion of the channel, adapted to propagate an acoustic wave. (Column 1 lines 52 and 53, claim 1, and column 16 line 18, “Ultrasonic waves are known to induce significant pressure variation and induce cavitation within fluids. See G. Zhang et al., Jpn. J. Appl. Phys. 35, 3248 (1996). Thus, acoustic waves can provide a non-invasive lysing mechanism which is compatible with sealed microsystems.” “Positive controls were performed using a 20 kHz bench top ultrasonication system, using both acoustic finger and acoustic cup configurations.” “[A]t least one acoustic transducer disposed on a lysis portion of the channel, adapted to propagate an acoustic wave in the fluid and thereby generate sufficient localized acoustic pressure in the lysis portion to lyse the biological cells in the fluid by acoustic pressure.” Claim 1, one acoustic transducer disposed on a lysis portion of the channel, adapted to propagate an acoustic wave in the fluid.).
Regarding claim 2, Branch teaches all of claim 1 as above in addition to “wherein the sample vessel is constructed of glass.” (Column 4 line 59, Alternatively, a channel 14 can be formed in a glass, ceramic, or silicon-based substrate by bulk or surface micromachining.).
Regarding claim 4, Branch teaches all of claim 1 as above in addition to “wherein the outer surface is a first outer surface having a mounting area, the mounting area having a first shape, and wherein the acoustic transducer has a second outer surface having a second shape corresponding to the first shape, the second outer surface of the acoustic transducer bonded to the mounting area.” (Fig. 1, location and shape of the location of the outer surface and the acoustic transducer).
Regarding claim 6, Branch teaches all of claim 1 as above in addition to “wherein a height of the microchannel is about 100 micrometers.” (Column 6 line 18-21, The microfluidic cartridge comprises a 0.5 mm wide times 100 µm high channel formed in a 100 µm thick Mylar film sandwiched between a 0.2 mm thick fused silica substrate and a 2.38 mm thick acrylic layer.).
Regarding claim 9, Branch teaches all of claim 1 as above in addition to “wherein the sample vessel comprises a first substrate, a second substrate and a third substrate between the first substrate and the second substrate, the first substrate, the second substrate and the third substrate being layered and bonded together to form a monolithic structure, the microchannel being a slot positioned through the third substrate.” (Column 4 line 18, In this example, the microfluidic cartridge comprises a 0.5 mm wide.times.100 .mu.m high channel formed in a 100 .mu.m thick Mylar film sandwiched between a 0.2 mm thick fused silica substrate and a 2.38 mm thick acrylic layer.) Therefore, the first and second substrates are the fused silica substrate and the acrylic layer and the third substrate in which the microchannel is within is the mylar film sandwiched.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Branch et. al. (US 9096823 B1).
Regarding claim 5, Branch teaches all of claim 1 as above but does not explicitly teach “wherein the microchannel is positioned in a transparent portion of the sample vessel, the transparent portion of the sample vessel being transparent to light.”.
However, within (Column 2 line 55 and column 18 line 38, Branch teaches that the microfluidic substrate preferably comprises a rigid material, such as plastic, glass, ceramic, or a silicon-based material. Microchannels were fabricated using wet etching of serpentine channels in borosilicate glass substrates). It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Branch to have a transparent portion of the sample vessel. A glass that is transparent to light would allow for optical analysis of the cells.
Claims 10, 12, 13, 15, 16, 18 is rejected under 35 U.S.C. 103 as being unpatentable over Branch et. al. (US 9096823 B1) in view of Schafer (US 20110166551 A1).
Regarding claim 10, Branch teaches “An assembly” (Column 4 line 39, Reversible coupling of a microfluidic cartridge to the BAW transducer array enables reuse of the transducer assembly while permitting disposal of the contaminated microfluidic cartridge.); “comprising: a controller;” (Column 5, line 22, FIG. 3 shows a schematic illustration of an RF circuit 30 that can be used to drive the BAW transducers 21. Computer control 31 can be used to tune the frequency of an RF source 32.); “and a lysis device,” Fig. 1 and column 4 lines 28 and 29, 10 microfluidic lysing device); “comprising: a sample vessel having an outer surface, a microchannel within confines of the outer surface,” (Fig 1 and column 30 and 31, the microfluidic substrate 15 shows an outer surface and the channel 14); “a first port extending through the outer surface to the microchannel,” (Fig. 1 and column 4 line 32, the microfluidic substrate 15 shows an outer surface and the channel 14); “and a second port extending through the outer surface to the microchannel,” (Fig. 1 and column 4 line 46, outlet 17). The recitation “such that a blood sample is insertable through the first port into the microchannel;” is capability of the second port and the microchannel. Branch discloses the positively claimed structural elements of the second port and the microchannel as claimed, such features are said to be fully capable of the recited adaption in as much as recited and required herein. However, Branch does teach (Column 4 line 31 and Columns 21 and 22 lines 7 and 1, summary of invention, pressure in the lysis portion and thereby lyse the biological cells in the fluid by acoustic pressure. Whole cells can enter the channel 14 through an inlet 16 and are lysed by acoustic pressure in the channel generated by the array of acoustic transducers 12. Lysate containing the acoustically lysed cells can exit the channel 14 through an outlet 17.) Therefore the biological cells in the fluid teach to a blood sample and the flow through the inlet, channel, and outlet teach to where the sample moves into and through.
Further taught “and an acoustic transducer connected the sample vessel to form a monolithic structure,” (Column 4 line 29 and Fig 1, acoustic transducer 12); “the acoustic transducer receiving electrical signals from the controller” (Column 5, line 22, FIG. 3 shows a schematic illustration of an RF circuit 30 that can be used to drive the BAW transducers 21. Computer control 31 can be used to tune the frequency of an RF source 32. Frequency tuning can be desirable to account for changes in the fabrication process due to variations in transducer mass loading and bonding. In this example, the RF drive circuit 30 comprises an RF source 32 that can be tuned from 48 to 58 MHz. The RF source 32 is connected to an RF power amplifier 33 (e.g., 2 W). The amplifier output can be split by power dividers 34 to drive each of the BAW (bulk acoustic wave) transducers 21 (e.g., four in this array). The power input can thereby be configured at deliver a maximum power (e.g., 200 mW) to each transducer.) Therefore, the computer control tunes the frequency from 48 to 59 MHz which is connected to the amplifier which is connected to the transducer which teaches the transducer receives its electrical signal from the controller.
Further taught “that cause the acoustic transducer to expand and contract to generate ultrasonic acoustic standing waves inside the blood sample in the microchannel” (Claim 1, Column 2 line 44 and Column 9 lines 36-39, one acoustic transducer disposed on a lysis portion of the channel, adapted to propagate an acoustic wave in the fluid. Positive controls were performed using a 20 kHz bench top ultrasonication system, using both acoustic finger and acoustic cup configurations. At least one acoustic transducer disposed on a lysis portion of the channel, adapted to generate localized acoustic pressure in the lysis portion and thereby lyse the biological cells in the fluid by acoustic pressure. In the microchannel, the pressure field results from the superposition of standing waves in the z-direction and waves in the x-direction that are inherently weaker due to lateral coupling.);
Branch does not teach “and to vibrate the sample vessel such that shear forces are induced within the microchannel”.
Schafer teaches a selective lysing of cells using ultrasound in addition to “and to vibrate the sample vessel such that shear forces are induced within the microchannel”. (Claim and Paras [0037], and [0022], the apparatus comprising: a transducer that vibrates to generate an acoustic wave. Thus there will be a differential force applied to the different cells. This is in addition to the shear forces that would be induced because the large cells would span the nodal location. Excessive pressure levels can lead to the onset of cavitation within the fluid, which may act to lyse all the cells within the exposure region irrespective of size.)
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 Branch to incorporate the teachings of Schafer wherein the vibrate the sample vessel such that shear forces are induced within the microchannel. Doing so allows the breaking of the sample at an increased rate within the microchannel without using harsh chemicals.
The recitation “wherein a combination of the acoustic standing waves and the shear forces cause cavitation in the blood sample,” is capability of the acoustic standing waves and shear forces. Modified Branch discloses the positively claimed structural elements of the acoustic standing waves and shear forces as claimed, such acoustic standing waves and shear forces are said to be fully capable of the recited adaption in as much as recited and required herein. In addition, Branch teaches cavitation and acoustic waves within (Column 3, line 52, Ultrasonic waves are known to induce significant pressure variation and induce cavitation within fluids. See G. Zhang et al., Jpn. J. Appl. Phys. 35, 3248 (1996). Thus, acoustic waves can provide a non-invasive lysing mechanism which is compatible with sealed microsystems.).
Regarding claim 12, Branch teaches all of claim 10 as above in addition to “wherein the outer surface of the sample vessel has a first side, and a second side opposite the first side, the first side and the second side being planar.” (Fig. 1, lysis device 10).
Regarding claim 13, Branch teaches all of claim 10 as above in addition to “wherein the sample vessel is constructed of glass.” (Column 4 line 59, Alternatively, a channel 14 can be formed in a glass, ceramic, or silicon-based substrate by bulk or surface micromachining..).
Regarding claim 15, Branch teaches all of claim 10 as above in addition to, ”wherein the outer surface of the sample vessel is a first outer surface having a mounting area, the mounting area having a first shape, and wherein the acoustic transducer has a second outer surface having a second shape corresponding to the first shape, the second outer surface of the acoustic transducer bonded to the mounting area.” (Fig. 1, location and shape of the location of the outer surface and the acoustic transducer).
Regarding claim 16, Branch teaches all of claim 10 as above but does not explicitly teach “wherein the microchannel is positioned in a transparent portion of the sample vessel, the transparent portion of the sample vessel being transparent to light.”. However, within (Column 2 line 55 and column 18 line 38), Branch teaches the microfluidic substrate preferably comprises a rigid material, such as plastic, glass, ceramic, or a silicon-based material. Microchannels were fabricated using wet etching of serpentine channels in borosilicate glass substrates). It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Branch to have a transparent portion of the sample vessel. A glass that is transparent to light would allow for optical analysis of the cells.
Regarding claim 18, Branch teaches all of claim 10 as above in addition to “wherein the sample vessel comprises a first substrate, a second substrate and a third substrate between the first substrate and the second substrate, the first substrate, the second substrate and the third substrate being layered and bonded together to form a monolithic structure, the microchannel being a slot positioned through the third substrate.” (Column 4 line 18, In this example, the microfluidic cartridge comprises a 0.5 mm wide.times.100 .mu.m high channel formed in a 100 .mu.m thick Mylar film sandwiched between a 0.2 mm thick fused silica substrate and a 2.38 mm thick acrylic layer.) Therefore, the first and second substrates are the fused silica substrate and the acrylic layer and the third substrate in which the microchannel is within is the mylar film sandwiched.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Branch et. al. (US 9096823 B1) and further in view of Su et. al. (JP 2008508876 A), machine translation.
Regarding claim 3, Branch teaches all of claim 1 as above in addition to “wherein the sample vessel is constructed of a non-glass material” (Para 10, The microfluidic substrate preferably comprises a rigid material, such as plastic, glass, ceramic, or a silicon-based material.). Therefore the silicon-based material teaches to the non-glass material. However, Branch does not teach “having a Young's modulus within a range from about 50 Gpa to 90 Gpa”.
Su teaches sample tissue destruction and / or cell lysis device in addition to “having a Young's modulus within a range from about 50 Gpa to 90 Gpa” (Page 3 and 4, The coupling and mixing chamber may further include a piezoelectric material and a second material in contact with the piezoelectric material. The second material may be any suitable material. In particular, the second material has a Young's modulus of 50-220 GPa. The second material may be formed of a metal or polymer material. A step of operating the piezoelectric material in contact with the second material (where the second material has an uneven surface on the side opposite to the side in contact with the piezoelectric material, and the uneven surface is in contact with the sample.)) Therefore, the coupling and mixing chamber teaches to the claimed sample vessel and the second material which is on the coupling and mixing chamber teaches to the Young’s modulus as it is within the range.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Branch to incorporate the teachings of Su wherein the non-glass material has a Young’s modulus of about 50 Gpa to 90 Gpa. Doing so allows a stiffness of the sample vessel which does not allow absorbing of a mechanical energy such as vibrations so the energy can be used on the sample.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Branch et. al. (US 9096823 B1) and Schafer (US 20110166551 A1) as applied to claim 10 and further in view of Su et. al. (JP 2008508876 A), machine translation.
Regarding claim 14, Branch teaches all of claim 10 as above in addition to “wherein the sample vessel is constructed of a non-glass material” (Para 10, The microfluidic substrate preferably comprises a rigid material, such as plastic, glass, ceramic, or a silicon-based material.). Therefore the silicon-based material teaches to the non-glass material. However, Branch does not teach “having a Young's modulus within a range from about 50 Gpa to 90 Gpa”.
Su teaches sample tissue destruction and / or cell lysis device in addition to “having a Young's modulus within a range from about 50 Gpa to 90 Gpa” (Page 3 and 4, The coupling and mixing chamber may further include a piezoelectric material and a second material in contact with the piezoelectric material. The second material may be any suitable material. In particular, the second material has a Young's modulus of 50-220 GPa. The second material may be formed of a metal or polymer material. A step of operating the piezoelectric material in contact with the second material (where the second material has an uneven surface on the side opposite to the side in contact with the piezoelectric material, and the uneven surface is in contact with the sample.)) Therefore, the coupling and mixing chamber teaches to the claimed sample vessel and the second material which is on the coupling and mixing chamber teaches to the Young’s modulus as it is within the range.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Branch to incorporate the teachings of Su wherein the non-glass material has a Young’s modulus of about 50 Gpa to 90 Gpa. Doing so allows a stiffness of the sample vessel which does not allow absorbing of a mechanical energy such as vibrations so the energy can be used on the sample.
Claim 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Branch et. al. (US 9096823 B1) in view of Hwang et. al. (US 8859272 B2 ).
Regarding claim 7, Branch teaches all of claim 1 as above but does not teach “wherein a width of the microchannel is about two millimeters.”.
Hwang teaches a micro-device for disrupting cells in addition to “wherein a width of the microchannel is about two millimeters.”. (Column 7, lines 26-30, The inlet 30 and the outlet 32 may be in fluid-communication with the first chamber 22, for example, through a microchannel (not shown). The microchannel may have a width in a range of about 1 um to about 10,000 um, for example about 1 um to about 5,000 um.). Therefore, 2 millimeters is within the range of 1 µm to 10,000 µm.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Branch to incorporate the teachings of Hwang wherein the non-glass material has a width of the microchannel is about two millimeters. Doing so reduces the chance of clogging but still staying on the relatively small scale.
Regarding claim 8, Branch teaches all of claim 1 as above but does not explicitly teach “wherein a microchannel aspect ratio of a width to a height of the microchannel is about 0.05.”. However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Branch by having the width to height ratio of the microchannel to be about 0.05, since Branch teaches a microchannel with a length of 100 micrometers (Column 6 line 18-21, The microfluidic cartridge comprises a 0.5 mm wide times 100 µm high channel) and Hwang teach a width of 5 micrometers that is within the taught range in (Para [28], width in a range of about 1 um to about 10,000 um). These height and widths would provide a width to height ratio of 0.05. In addition, having such ratio would allow for a secondary flow which assists in the cell manipulation and separation.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Branch et. al. (US 9096823 B1) and Schafer (US 20110166551 A1) as applied to claim 10 and further view of Burdon et. al. (ES 2197681 T3) and Talebour et. al. (ES 2658169 T3).
Regarding claim 11, Branch teaches all of claim 10 as above in addition to “wherein the outer surface of the sample vessel has a first side, and a second side opposite the first side the assembly further comprising” (Fig. 1).
Branch does not teach “ a transmitter being positioned on the first side of the sample vessel, the transmitter positioned to emit a light medium through the microchannel; and a receiver being positioned on the second side of the sample vessel.” It appears, from a review of the specification, that applicant is referring to an optical transmitter and optical receiver for viewing the microchannel.
Burdon teaches Obtaining biological changes in the product it is also important in certain devices to multi-layer microfluids of the present invention. One of The most important changes is the process of cell lysis. In addition to “the transmitter being positioned on the first side of the sample vessel , the transmitter positioned to emit a light medium through the microchannel;” (Page 23 and 24, The aforementioned optical detection it requires materials, located between the channel and the cavity that It contains the fluid, and the outside of the device, which are optically transparent. As used herein document, `` optically transparent '' and `` optically transmitter '' means that are capable of transmitting light visible and / or ultraviolet. As shown in Figure 29, the tracks Fillers can also be combined with optically layered transmitters In the device for layer microfluids multiple 950, an opaque layer 951 separates a layer optically 952 single channel transmitter 952. Tracks 954-956 they form in layer 951 and are filled with a material optically transmitter This provision allows to carry out optical measurements of the fluid at different points of channel 953.)
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 Branch to incorporate the teachings of Burdon wherein the non-glass material has the transmitter being positioned on the first side of the sample vessel, the transmitter positioned to emit a light medium through the microchannel. Doing allows for a more inclusive assembly which allows for a transmitter within the assembly which can allow for automation and also remote analysis if needed. In addition, to providing localized control and increased operation time.
Talebour teaches capture and lysis devices in addition to “and the receiver being positioned on the second side of the sample vessel,” (Page 4, on the first electrode to prevent the flow of a pharaic current into the microfluidic channel under the application of a voltage between the first and second electrodes, where the adjacent material and the secondary receivers are arranged in the dielectric layer).
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 Branch to incorporate the teachings of Talebour wherein the non-glass material has and the receiver being positioned on the second side of the sample vessel. Doing allows the sample to be processed within one assembly and reduces the need to use addition devices to complete the process.
Branch does not explicitly teach “ the sample vessel being constructed of a material transparent to the light medium.” However, does teach glass substrates within (Column 2 line 55 and column 18 line 38, Branch teaches that The microfluidic substrate preferably comprises a rigid material, such as plastic, glass, ceramic, or a silicon-based material. Microchannels were fabricated using wet etching of serpentine channels in borosilicate glass substrates).
Burdon teaches “ the sample vessel being constructed of a material transparent to the light medium” (Page 23 and 24, Th/e aforementioned optical detection it requires materials, located between the channel and the cavity that It contains the fluid, and the outside of the device, which are optically transparent.).
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 Branch to incorporate the teachings of Burdon wherein the sample vessel being constructed of a material transparent to the light medium. Doing allows for the transmitter to transmit through the sample vessel increasing the operation time and localized control of the device.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Branch et. al. (US 9096823 B1) and Schafer (US 20110166551 A1) as applied to claim 10 and further view of Hwang et. al. (US 8859272 B2).
Regarding claim 17, Branch teaches all of claim 10 as above in addition to, “wherein the height of the microchannel is about 100 micrometers” (Column 6 line 18-21, The microfluidic cartridge comprises a 0.5 mm wide times 100 µm high channel formed in a 100 µm thick Mylar film sandwiched between a 0.2 mm thick fused silica substrate and a 2.38 mm thick acrylic layer.).
However, Branch does not teach “and the width of the microchannel is about two millimeters.”.
Hwang teaches “and the width of the microchannel is about two millimeters.”. (Column 7, lines 26-30, The inlet 30 and the outlet 32 may be in fluid-communication with the first chamber 22, for example, through a microchannel (not shown). The microchannel may have a width in a range of about 1 um to about 10,000 um, for example about 1 um to about 5,000 um.). Therefore, 2 millimeters is within the range of 1 µm to 10,000 µm.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Branch to incorporate the teachings of Hwang wherein the non-glass material has a width of the microchannel is about two millimeters. Doing so reduces the chance of clogging but still staying on the relatively small scale.
Response to Amendments
Claim Amendments
Applicants’ amendments to claim 11 have overcome the 112 rejections in the non-final office action. Applicants amendments to independent claim 1 have not overcome the prior rejection set forth within the non-final dated 9/10/2025. Applicants appendments to independent clam 10 have overcome the 102 rejection set forth in the non-final rejection and a new 103 rejection has been made.
Response to Arguments
Applicant's arguments filed 12/9/2025 have been fully considered.
Applicant argues that Branch cannot anticipate amended independent claims 1 and 10 as it fails to disclose a device having an acoustic transducer that is “configured to” or may be “caused to” expand and contract to generate ultrasonic acoustic standing waves inside the blood sample in the microchannel and to vibrate the sample vessel such that shear forces are induced within the microchannel, wherein a combination of the acoustic standing waves and the shear forces causes cavitation in the blood sample.
Examiner maintains the rejection for claim 1. The recitations “configured to” or “caused to” without the controller performing such configuration or cause is capability of the device and the positively claimed limitations are taught within the rejection. Regarding claim 10, the examiner has withdrawn the previous 102 rejection and applied a 103 rejection based on claim amendments.
Applicant argues that the Branch device is configured to lyse certain cells without causing cavitation so it cannot be used to anticipate the present claims. Applicant states that Branch references a couple of instances of cavitation but they are separate devices and the structure is not disclosed.
Examiner points out that the cavitation within independent claim 1 is capability of the device and the rejection points to all of the positively claimed feature of the device.
Applicant argues that Branch has no teachings of combination of acoustic standing waves and shear forces causing cavitation. Examiner points out that cavitation is a capability within the device and not positively claimed. The rejections set forth teach all of the positively claimed features.
Applicant argues there is no reason or suggestion to select Branch as a starting point as Branch teaches away from the fundamental principles of the claimed invention.
Examiner disagrees in that Branch teaches the capability of cavitation within the background of the invention in addition to teaching all of the positively claimed features of the present invention.
Applicant argues the Branch does not have an optical component and no motivation to have a transparent portion of the sample vessel.
Examiner agrees that branch does not have an optical component however has made a rejection using addition prior art and provided reason to combine with Branch.
Applicant argues a person would not be motivated to combine Branch and Su as Branch teaches to a non-cavitation device and Su is to a high frequency and that would have the device be inoperable.
Examiner disagrees that Branch teaches to a non-cavitation device and highlights that the cavitation within the present claims is capability of the device and the rejections set forth have the positive claimed features and is therefore capable of the cavitation.
Applicant argues that there is no motivation to combine Hwang with Branch as they operate on different principles of cell disruption. Examiner disagrees and maintains that Hwang teaches disrupting cells which is what a lysis device does and therefore there is motivation to combine.
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 VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798