DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed on 07/15/2026 has been entered. Claims 1, 3, 12, and 20 have been amended. Accordingly, claims 1-20 are pending and under consideration.
Response to Arguments
Applicant’s arguments with respect to claim(s) 20 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmadi in view of Treu et al. US 2023/0211059 A1 (previously cited) and Chapman et al. US 2019/0175814 A1 (newly cited), evidenced by Thayumanavan et al. US 2009/0184047 A1 (hereinafter Thayumanavan), as necessitated by amendment.
Applicant's arguments filed on 07/15/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “Yuds does not disclose a porous membrane. Therefore, there is no teaching or suggestion that it would be obvious to modify the clot neutralizer of Yuds and configure it to prevent condensation from forming on any alleged membrane of Boag. Furthermore, Boag does not disclose or suggest a desire to prevent condensation from forming on any alleged membrane on the vent of Boag. As such, the combination of features disclosed by Boag and Yuds does not render obvious the amended features "the controller configured to cause the one or more ultrasonic transducers to emit ultrasonic signals that displace particles in contents of the drip chamber away from the vent and the porous membrane such that condensation does not form on the porous membrane" of amended claim 1” on page 7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Yuds is not relied upon for any teaching of a porous membrane; rather, Boag is relied upon for said teaching. Furthermore, Examiner notes that the controller and the ultrasonic transducer of Yuds function to blast a mass before it reaches a critical size (Par. 21 of Yuds) at the taught frequencies of 50 MHz (Par. 40 of Yuds) and 65 MHz (Par. 40 of Yuds), which satisfied Applicant’s disclosed range of greater than 200 kHz (Par. 69 of Applicant’s PG-PUB). Therefore, the function of Yuds’ ultrasonic transducer and its operating frequency incorporated into Boag is reasonably understood by one of ordinary skill in the art to perform similarly to the claimed device, including the capable function of blasting masses before reaching a critical size; therefore, preventing condensation on the porous membrane because large particles cause condensation, as discussed by Par. 85 of Applicant’s PG-PUB (MPEP 2112.01- When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent). Also, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See rejection of claims below.
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 1-4, 6, 7, 9-15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Boag et al. US 3,964,479 A (previously cited, hereinafter Boag) in view of Yuds et al. US 2019/0358388 A1 (previously cited, hereinafter Yuds).
Regarding claim 1, Boag discloses a device 8 (Fig. 1 – device 8) for monitoring an extracorporeal circuit (Fig. 1 demonstrates an extracorporeal blood circulation) in which a blood pump 6 (Fig. 1 – pumping means 6) is disposed to convey blood (Col. 2, line 41-42 – “6 represents pumping means in the system for pumping the patient's blood therethrough”), the device 8 (Fig. 1) comprising:
vent 22 (Fig. 1 – air passage tube 22) of a drip chamber 12 (Fig. 3 – drip chamber 12) of the extracorporeal circuit (Fig. 1), the vent 22 (Fig. 1) comprising a porous membrane 60 (Fig. 1 – hydrophobic filter 60, and Col. 4, line 45-56 – “To assure against any flow of liquid into these parts of the system, a hydrophobic filter 60 is included in the tube 22. This filter allows the free passage of air therethrough but blocks the flow of liquid, and therefore the flow of blood or saline solution. Hydrophobic filter materials are well known and easily available in the market, an example being that currently being marketed under the trademark "Acropor" by the Gelman Instrument Company of Ann Arbor, Michigan, Acropor being a microporous hydrophobic organic polymer membrane filter of about 0.45 microns pore size”).
However, Boag does not disclose one or more ultrasonic transducer positioned in a predetermined vicinity of a vent; a controller coupled to the one or more ultrasonic transducers, the controller configured to cause the one or more ultrasonic transducers to emit ultrasonic signals that displace particles in contents of the drip chamber away from the vent and the porous membrane such that condensation does not form on the porous membrane.
Yuds, in the same field of endeavor of dialysis treatment (Abstract), teaches one ultrasonic transducer 702 (Fig. 7 – transducer/ultrasonic head 702).
Yuds, in another embodiment, teaches a controller 12 (Fig. 1 – hemodialysis system 12) coupled to the one ultrasonic transducer (Par. 48 – “the hemodialysis machine 12 may control an ultrasonic head”), the controller 12 (Fig. 1) configured to cause the one ultrasonic transducer to emit ultrasonic signals (Par. 48 – “the hemodialysis machine 12 may control an ultrasonic head, generating sounds waves…”) that displace particles in contents of the chamber (Par. 48 – “The hemodialysis machine 12 can provide signals to instruct the ultrasonic head to emit a series of brief ultrasonic bursts at an empirically determined frequency…”, and Par. 50 – “Breaking up clots using the ultrasonic head”) such that clot does not form (Par. 21 – “an ultrasonic head may be vibrated to blast the clotting mass before it reaches a critical size. The ultrasonic head produces sound waves at a frequency/wavelength to cause blood cells to vibrate more vigorously again, effectively breaking up the clot because the clot can no longer hold itself together”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Boag to further incorporate an ultrasonic transducer coupled to a controller as taught by Yuds, in order to break up clots in blood flowing through the chamber (Par. 41 of Yuds), in this instant case, through the drip chamber of Boag. Since the ultrasonic transducer of Yuds can be arranged below the drip chamber (Par. 30 and Par. 27 of Yuds), the incorporated ultrasonic transducer 702 of Boag in view of Yuds will also be below the drip chamber 12 of Boag, thus the transducer 702 will indeed be “positioned in a predetermined vicinity of the vent of drip chamber”. Furthermore, one of ordinary skill in the art would have had the technological capability to recognize that the broken-up blood clots within the drip chamber of Boag in view of Yuds should return to the patient as it is well-known in the field that extracorporeal blood treatment withdraws and return treated blood. Therefore, the “displaced particles” after the actuation of ultrasonic signals in the drip chamber 12 of Boag will be away from the vent 22 and the porous membrane 60 of Boag. Thus, the limitation of “away from the vent and the porous membrane” is met.
Examiner further notes that the controller and the ultrasonic transducer of Yuds function to blast a mass before it reaches a critical size (Par. 21 of Yuds) at the taught frequencies of 50 MHz (Par. 40 of Yuds) and 65 MHz (Par. 40 of Yuds), which satisfied Applicant’s disclosed range of greater than 200 kHz (Par. 69 of Applicant’s PG-PUB). Therefore, the function of Yuds’ ultrasonic transducer and its operating frequency incorporated into Boag is reasonably understood to perform similarly to the claimed device, including the capable function of blasting masses before reaching a critical size; therefore, preventing condensation on the porous membrane because large particles cause condensation (Par. 85 of Applicant’s PG-PUB). (MPEP 2112.01- When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent).
Regarding claim 2, Boag in view of Yuds discloses the invention of claim 1. The combination further discloses wherein the controller 12 (Fig. 1 of Yuds) causes the one ultrasonic transducer 702 (Fig. 7 of Yuds) to emit the ultrasonic signals of a predetermined frequency (Par. 48 of Yuds – “The hemodialysis machine 12 can provide signals to instruct the ultrasonic head to emit a series of brief ultrasonic bursts at an empirically determined frequency…”), the predetermine frequency configured to displace the particles (Par. 48 of Yuds – “The hemodialysis machine 12 can provide signals to instruct the ultrasonic head to emit a series of brief ultrasonic bursts at an empirically determined frequency…”, and Par. 50 – “Breaking up clots using the ultrasonic head”).
However, the combination does not currently disclose particles larger than a predetermined size.
Examiner notes that in Par. 39, Yuds discusses that an ultrasonic head is provided in some embodiments for breaking up clots or blasticing clotting masses before they reach a critical size; thus indicating that there are some level of monitoring the size of the clumps within a chamber. Par. 29 of Yuds also discusses that clotting causes the blood cells 304 (Fig. 3) to vibrate more slowly and will therefore have a higher amplitude of reflected light compared to blood cells 304 that are not clotting. For example, section 316 when illuminated by the light source 312 will have a lower amplitude of reflected light compared to section 318. On this basis, the clotting of section 318 will be blasted with ultrasonic energy, while the non-clotting section 316 will not because section 316 is monitored to not be at a predetermined size for ultrasonic treatment. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have had the technological capability to recognize that that the ultrasonic transducer of the combination will only perform ultrasonic treatment to particles larger than a predetermined size, also as taught by Yuds. 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 respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 3, Boag in view of Yuds discloses the invention of claim 2. The combination further discloses wherein the particles that are larger than the predetermined size (Par. 50 of Yuds – clots versus red blood cells) are capable of causing condensation (Par. 50 of Yuds - clots).
Examiner notes that once the modification is made as discussed in claim 1 and 2, the particles that are blood clots of Yuds will be displaced away from vent 22 of Boag since the blood clots will cause blockage on the vent 22 of Boag. Thus, the limitation is met.
Regarding claim 4, Boag in view of Yuds discloses the invention of claim 2. The combination further discloses wherein the particles (Par. 50 of Yuds – clots) that are displaced by the ultrasonic transducer 702 (Fig. 7 of Yuds) comprise red blood cells (Par. 50 of Yuds – “…red blood cells such that they cannot form clots…”; thus clots are formed of red blood cells).
Regarding claim 6, Boag in view of Yuds discloses the invention of claim 1. The combination further discloses further comprising a pore size (Fig. 1 of Boag depicts a filter 60, wherein Col. 4, line 47-56 of Boag discusses a pore size of said filter – “a hydrophobic filter 60 is included... Hydrophobic filter materials are well known and easily available in the market, an example being that currently being marketed under the trademark "Acropor" by the Gelman Instrument Company of Ann Arbor, Michigan, Acropor being a microporous hydrophobic organic polymer membrane filter of about 0.45 microns pore size”; Examiner does note that that this pore size is not positively claimed within claim 6 and is currently interpreted to be a functional language limitation) of the drip chamber 12 (Fig. 1 of Boag).
However, the combination currently does not disclose further comprising one or more sensors to monitor a pore size of the drip chamber.
Yuds, in the same field of endeavor of dialysis treatment (Abstract) and in another embodiment, teaches one sensor 602 (Fig. 6 – optical sensor assembly 602) to monitor clots or masses of red blood cells of a certain size (Par. 40 – “the ultrasonic head can be used to locally detect clots or masses of red blood cells between 20 μm and 100 μm at a lower frequency, e.g., at 50 MHz,”, wherein an ultrasonic head is a part of the optical sensor assembly 602 as discussed in Par. 38).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include a sensor, also as taught by Yuds, in order to monitor the particles size (Par. 40 of Yuds). Examiner contends that since said sensor of Yuds is capable of monitoring particle sizes of the drip chamber shown in Fig. 6 of Yuds (consistent system layout of Applicant’s Fig. 2), the sensor 602 of Yuds is highly capable of monitoring the pore size of Boag’s drip chamber 12. Thus, the limitation is met.
Regarding claim 7, Boag in view of Yuds discloses the invention of claim 6. The combination further discloses wherein the one sensor 602 (Fig. 6 of Yuds) comprise a second set of ultrasonic transducers (Par. 38 of Yuds – “an optical sensor assembly 602 with a fiber-optic sensor and an ultrasonic or piezoelectric head… Ultrasonic heads that can be used include high frequency transducers”), the second set of ultrasonic transducers (Par. 38 of Yuds) to emit ultrasonic signals of a second predetermined frequency (Par. 40 of Yuds – “the ultrasonic head can be used to locally detect clots or masses of red blood cells between 20 μm and 100 μm at a lower frequency, e.g., at 50 MHz”).
Examiner notes that once the modification is made as discussed in claim 6, the optical sensor assembly of Yuds will be incorporated into the device of Boag in view of Yuds, including the second operating frequency. Thus, the limitation is met.
However, the combination does not currently disclose wherein the controller is coupled with the second set of ultrasonic transducers, the controller configured to cause the second set of ultrasonic transducers to emit ultrasonic signals.
Since it has been established in the modification of claim 1 that the controller 12 of Yuds will be coupled to the ultrasonic transducer, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Boag in view of Yuds to further have the second set of ultrasonic transducer coupled to the controller of Boag in view of Yuds, as Yuds already demonstrates that the controller 12 provides signals to instruct ultrasonic transducer to emit signals. Thus, the limitation is met.
Regarding claim 9, Boag in view of Yuds discloses the invention of claim 2. The combination further discloses wherein the one ultrasonic transducer 702 (Fig. 7 of Yuds) is a first set of ultrasonic transducers 702 (Fig. 7 of Yuds), the predetermined frequency (Par. 48 of Yuds – “The hemodialysis machine 12 can provide signals to instruct the ultrasonic head to emit a series of brief ultrasonic bursts at an empirically determined frequency…”) is a first predetermined frequency (Par. 40 of Yuds and Par. 38 of Yuds discuss breaking up clots, wherein “the ultrasonic head can produce sound waves at 65 MHz to break up clots”).
However, the combination currently does not disclose the device comprises a second set of ultrasonic transducers that are coupled with the controller, which causes the second set of ultrasonic transducers to emit ultrasonic signals of a second predetermined frequency, different from the first predetermined frequency, the ultrasonic signals of the second predetermined frequency prevent blood clots in the contents of the drip chamber.
Yuds, in another embodiment, teaches a second predetermined frequency (Par. 50 – “20 Hz”), the ultrasonic signals of the second predetermined frequency prevent blood clots in the contents of the drip chamber (Par. 50 – “the ultrasonic head can emit a constant low frequency in the range of 20 Hz that “stirs” red blood cells such that they cannot form clots”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of the combination and duplicate the ultrasonic transducer to include another set of ultrasonic transducer, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. Furthermore, Yuds discusses that the ultrasonic head/transducer can also emit at another range such as 20 Hz to constantly stir red blood cells, as opposed to 65 MHz to break up blood clots as established above; therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second set of ultrasonic transducer to emit at a different frequency, as Yuds teaches both embodiments. 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 respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 10, Boag in view of Yuds discloses the invention of claim 9. The combination further discloses wherein the second set of ultrasonic transducers emits ultrasonic signals continuously that prevents red blood cells from clotting (Par. 50 of Yuds – “the ultrasonic head can emit a constant low frequency in the range of 20 Hz that “stirs” red blood cells such that they cannot form clots”).
Examiner notes that once the combination is made as discussed in claim 9, the emitted frequency by the second set of ultrasonic transducers will continuously prevents clotting as taught by Yuds. Thus, the limitation is met.
Regarding claim 11, Boag in view of Yuds discloses the invention of claim 9. However, the combination does not currently disclose wherein the second set of ultrasonic transducers emits ultrasonic signals of a third predetermined frequency, different from the first and second predetermined frequencies, the ultrasonic signals of the third predetermined frequency sever chains of red blood cells.
Yuds, in another embodiment, teaches wherein the set of ultrasonic transducers emits ultrasonic signals of a third predetermined frequency (Par. 50 – “50 MHz”), the ultrasonic signals of the third predetermined frequency sever chains of red blood cells (Par. 50 – “the ultrasonic head can emit a series of brief bursts at 50 MHz to sever long chains of red blood cells”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second set of ultrasonic transducer of the combination to further emit a third frequency, also as taught by Yuds, in order to sever long chains of red blood cells (Par. 50 of Yuds) and because as Yuds teaches both embodiments. 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 respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.). Examiner notes that once the modification is made as discussed, the third frequency at 50 MHz is indeed different from the first frequency of 65 MHz and the second frequency 20 Hz (see claims 9 -10 above). Thus, the limitation of “different from the first and second predetermined frequencies” is met.
Regarding claim 12, Boag discloses a dialysis system (Fig. 1 depicts an extracorporeal blood circulation system with an artificial kidney 4), comprising:
a venous drip chamber 12 (Fig. 3 – drip chamber 12; Examiner notes that drip chamber 12 is located on the return line of the system, which is consistent with Applicant’s venous drip chamber 132; thus, the limitation is met) comprising a vent 22 (Fig. 1 – air passage tube 22), the vent 22 (Fig. 1) comprising a porous membrane 60 (Fig. 1 – hydrophobic filter 60, and Col. 4, line 45-56 – “To assure against any flow of liquid into these parts of the system, a hydrophobic filter 60 is included in the tube 22. This filter allows the free passage of air therethrough but blocks the flow of liquid, and therefore the flow of blood or saline solution. Hydrophobic filter materials are well known and easily available in the market, an example being that currently being marketed under the trademark "Acropor" by the Gelman Instrument Company of Ann Arbor, Michigan, Acropor being a microporous hydrophobic organic polymer membrane filter of about 0.45 microns pore size”).
However, Boag does not disclose one or more ultrasonic transducers positioned in a predetermined vicinity of the vent; a controller coupled with the one or more ultrasonic transducers, the controller configured to cause the one or more ultrasonic transducers to emit ultrasonic signals that displace particles in contents of the venous drip chamber away from the vent and the porous membrane such that condensation does not form on the porous membrane.
Yuds, in the same field of endeavor of dialysis treatment (Abstract), teaches one ultrasonic transducer 702 (Fig. 7 – transducer/ultrasonic head 702).
Yuds, in another embodiment, teaches a controller 12 (Fig. 1 – hemodialysis system 12) coupled with the one ultrasonic transducer (Par. 48 – “the hemodialysis machine 12 may control an ultrasonic head”), the controller 12 (Fig. 1) configured to cause the one ultrasonic transducer to emit ultrasonic signals (Par. 48 – “the hemodialysis machine 12 may control an ultrasonic head, generating sounds waves…”) that displace particles in contents of the venous drip chamber (Par. 48 – “The hemodialysis machine 12 can provide signals to instruct the ultrasonic head to emit a series of brief ultrasonic bursts at an empirically determined frequency…”, and Par. 50 – “Breaking up clots using the ultrasonic head”) such that clot does not form (Par. 21 – “an ultrasonic head may be vibrated to blast the clotting mass before it reaches a critical size. The ultrasonic head produces sound waves at a frequency/wavelength to cause blood cells to vibrate more vigorously again, effectively breaking up the clot because the clot can no longer hold itself together”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transducer of Boag to be ultrasonic and coupled to a controller as taught by Yud, in order to break up clots in blood flowing through the chamber (Par. 41 of Yud), in this instant case, through the drip chamber of Boag. Since the ultrasonic transducer of Yuds can be arranged below the drip chamber (Par. 30 of Yuds), the incorporated ultrasonic transducer 702 of Boag in view of Yuds will also be below the drip chamber 12 of Boag, thus the transducer 702 will indeed be “positioned in a predetermined vicinity of the vent”. Furthermore, one of ordinary skill in the art would have had the technological capability to recognize that the broken-up blood clots within the drip chamber of Boag in view of Yud should return to the patient as it is well-known in the field that extracorporeal blood treatment withdraws and return treated blood. Therefore, the “displaced particles” after the actuation of ultrasonic signals in the drip chamber 12 of Boag will be away from the vent 22 and the porous membrane 60 of Boag. Thus, the limitation of “away from the vent and the porous membrane” is met.
Examiner further notes that the controller and the ultrasonic transducer of Yuds function to blast a mass before it reaches a critical size (Par. 21 of Yuds) at the taught frequencies of 50 MHz (Par. 40 of Yuds) and 65 MHz (Par. 40 of Yuds), which satisfied Applicant’s disclosed range of greater than 200 kHz (Par. 69 of Applicant’s PG-PUB). Therefore, the function of Yuds’ ultrasonic transducer and its operating frequency incorporated into Boag is reasonably understood to perform similarly to the claimed device, including the capable function of blasting masses before reaching a critical size; therefore, preventing condensation on the porous membrane because large particles cause condensation (Par. 85 of Applicant’s PG-PUB). (MPEP 2112.01- When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent).
Regarding claim 13, Boag in view of Yuds discloses the invention of claim 12. The combination further discloses wherein the venous drip chamber 12 (Fig. 3 of Boag) is top-vented (Fig. 3 of Boag – air passage tube 22 is disposed on the top of chamber 12).
Regarding claim 14, Boag in view of Yuds discloses the invention of claim 12. The combination further discloses wherein the controller 12 (Fig. 1 of Yuds) causes the one ultrasonic transducer 702 (Fig. 7 of Yuds) to emit the ultrasonic signals of a predetermined frequency (Par. 48 of Yuds – “The hemodialysis machine 12 can provide signals to instruct the ultrasonic head to emit a series of brief ultrasonic bursts at an empirically determined frequency…”), the predetermined frequency selected to displace the particles (Par. 48 of Yuds – “The hemodialysis machine 12 can provide signals to instruct the ultrasonic head to emit a series of brief ultrasonic bursts at an empirically determined frequency…”, and Par. 50 – “Breaking up clots using the ultrasonic head”)
However, the combination does not currently disclose particles larger than a predetermined size.
Examiner notes that in Par. 39, Yuds discusses that an ultrasonic head is provided in some embodiments for breaking up clots or blasticing clotting masses before they reach a critical size; thus indicating that there are some level of monitoring the size of the clumps within a chamber. Par. 29 of Yuds also discusses that clotting causes the blood cells 304 (Fig. 3) to vibrate more slowly and will therefore have a higher amplitude of reflected light compared to blood cells 304 that are not clotting. For example, section 316 when illuminated by the light source 312 will have a lower amplitude of reflected light compared to section 318. On this basis, the clotting of section 318 will be blasted with ultrasonic energy, while the non-clotting section 316 will not because section 316 is monitored to not be at a predetermined size for ultrasonic treatment. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have had the technological capability to recognize that that the ultrasonic transducer of Boag in view of Yuds will only perform ultrasonic treatment to particles larger than a predetermined size, also as taught by Yuds. 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 respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 15, Boag in view of Yuds discloses the invention of claim 14. The combination further discloses further comprising a pore size (Fig. 1 of Boag depicts a filter 60, wherein Col. 4, line 47-56 of Boag discusses a pore size of said filter – “a hydrophobic filter 60 is included... Hydrophobic filter materials are well known and easily available in the market, an example being that currently being marketed under the trademark "Acropor" by the Gelman Instrument Company of Ann Arbor, Michigan, Acropor being a microporous hydrophobic organic polymer membrane filter of about 0.45 microns pore size”; Examiner does note that that this pore size is not positively claimed within claim 6 and is currently interpreted to be a functional language limitation) of the drip chamber 12 (Fig. 1 of Boag).
However, the combination currently does not disclose further comprising one or more sensors to monitor a pore size of the drip chamber.
Yuds, in the same field of endeavor of dialysis treatment (Abstract) and in another embodiment, teaches one sensor 602 (Fig. 6 – optical sensor assembly 602) to monitor clots or masses of red blood cells of a certain size (Par. 40 – “the ultrasonic head can be used to locally detect clots or masses of red blood cells between 20 μm and 100 μm at a lower frequency, e.g., at 50 MHz,”, wherein an ultrasonic head is a part of the optical sensor assembly 602 as discussed in Par. 38).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Boag in view of Yuds to further include a sensor, also as taught by Yuds, in order to monitor the particles size (Par. 40 of Yuds). Examiner contends that since said sensor of Yuds is capable of monitoring particle sizes of the drip chamber shown in Fig. 6 of Yuds (consistent system layout of Applicant’s Fig. 2), the sensor 602 of Yuds is highly capable of monitoring the pore size of Boag’s drip chamber 12. Thus, the limitation is met.
Regarding claim 18, Boag in view of Yuds discloses the invention of claim 14. The combination further discloses wherein the one ultrasonic transducer 702 (Fig. 7 of Yuds) is a first set of ultrasonic transducers 702 (Fig. 7 of Yuds), the predetermined frequency (Par. 48 of Yuds – “The hemodialysis machine 12 can provide signals to instruct the ultrasonic head to emit a series of brief ultrasonic bursts at an empirically determined frequency…”) is a first predetermined frequency (Par. 40 of Yuds and Par. 38 of Yuds discuss breaking up clots, wherein “the ultrasonic head can produce sound waves at 65 MHz to break up clots”).
However, the combination currently does not disclose the dialysis system comprises a second set of ultrasonic transducers that are coupled with the controller, which causes the second set of ultrasonic transducers to emit ultrasonic signals of a second predetermined frequency, different from the first predetermined frequency, the ultrasonic signals of the second predetermined frequency prevent blood clots in the contents of the venous drip chamber.
Yuds, in another embodiment, teaches a second predetermined frequency (Par. 50 – “20 Hz”), the ultrasonic signals of the second predetermined frequency prevent blood clots in the contents of the drip chamber (Par. 50 – “the ultrasonic head can emit a constant low frequency in the range of 20 Hz that “stirs” red blood cells such that they cannot form clots”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of the combination and duplicate the ultrasonic transducer to include another set of ultrasonic transducer, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. Furthermore, Yuds discusses that the ultrasonic head/transducer can also emit at another range such as 20 Hz to constantly stir red blood cells, as opposed to 65 MHz to break up blood clots as established above; therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second set of ultrasonic transducer to emit at a different frequency, as Yuds teaches both embodiments. 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 respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 19, Boag in view of Yuds discloses the invention of claim 18. The combination further discloses wherein the controller 12 (Fig. 1 of Yuds) causes the second set of ultrasonic transducers to perform:
emit ultrasonic signals continuously to prevent red blood cells from clotting (Par. 50 of Yuds – “the ultrasonic head can emit a constant low frequency in the range of 20 Hz that “stirs” red blood cells such that they cannot form clots”).
Examiner notes that once the combination is made as discussed in claim 18, the emitted frequency by the second set of ultrasonic transducers will continuously prevents clotting as taught by Yuds. Thus, the limitation is met.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Boag in view of Yuds aver as applied to claim 2 above, and further in view of Van Driel et al. US 5,811,658 A (previously cited, hereinafter Van Driel).
Regarding claim 5, Boag in view of Yuds discloses the invention of claim 2. However, the combination does not disclose wherein the ultrasonic signals of the predetermined frequency allow the particles that are smaller than the predetermined size to pass through the vent.
Van Driel, in the same field of endeavor of ultrasonic diversion of microair in blood (Title), teaches wherein the ultrasonic signals 24 (Fig. 2 – acoustic radiation 24) of the predetermined frequency (Claim 6 – “said frequency is substantially 1 MHz”) allow the particles 26 (Fig. 2 – small bubbles 26) that are smaller than the predetermined size (Col. 3, line 12-15 – “the system 10 can measure bubble sizes and counts more accurately because small bubbles will not be masked by large ones, and the detectors 30 and 46 can each be more finely tuned within a smaller range of bubble sizes”) to pass through the vent 33 (Fig. 2 – vent 33).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further have the ultrasonic signals allow smaller particles to pass through the vent as taught by Van Driel, in order to combat the problem of air emboli (Col. 1, line 28 of Van Driel) as microair bubbles have been suspected to cause memory loss, strokes, and other undesirable effects in the patient (Col. 1, line 16-18 of Van Driel).
Claims 8, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Boag in view of Yuds as applied to claim 6 and claim 15 above, and further in view of Ahmadi et al. US 2022/0126010 A1 (previously cited, hereinafter Ahmadi), evidenced by Thayumanavan et al. US 2009/0184047 A1 (previously cited, hereinafter Thayumanavan)
Regarding claim 8, Boag in view of Yuds discloses the invention of claim 6. However, the combination does not disclose wherein, in response to the pore size being detected to be less than a predetermined threshold, the controller performs at least one from a group of operations, the group of operations comprises, stopping the blood pump, closing a venous clamp, and alerting a user.
Ahmadi, in the same field of endeavor of dialysis system preventing air bubbles (Par. 3), teaches wherein, in response to the measured pressure being detected to be more than a predetermined threshold (Par. 62 – “An increase in the value of subsequent pressure measurements at pressure transducer 13 may indicate clotting of the gas removal filter 2,”), the controller 112 (Fig. 3 – application 112) performs at least one from a group of operations, the group of operations comprises alerting a user (Par. 62 – “If clotting of air removal filter 2 or excess unremoved air is detected, application 112 may include an operation to signal an alarm 16”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Boag in view of Yuds to alert a user upon detection of the sensor as taught by Ahmaid, in order to notify of clotting in the filter (Par. 62 of Ahmadi), and as it is well-known in the field of extracorporeal blood treatment to provide cautionary message to the operators and inform them of improper air venting. Examiner further notes that the clogging detection method of Ahmadi is operated based on pressure measurement (Par. 62 of Ahmadi – “An increase in the value of subsequent pressure measurements at pressure transducer 13 may indicate clotting of the gas removal filter 2, or excess unremoved air in gas removal filter 2 and/or vent tubing 10”). According to evidentiary reference Thayumanavan, it is known in the art that “the movement of water from one side to the other side of the membrane causes change in pressure, compared to the atmospheric pressure, inversely proportional to membrane dimension. As pore size decreases, increased pressure change can be observed” as discussed in Par. 61; therefore, one of ordinary skill in the art would have had the technological capability to reasonably deduce a membrane dimension and pore size from the measured increase pressure at the membrane/filter, and compare said value to a new predetermined threshold due to the established inverse relationship. Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of the combination to utilize the pore size parameter derived from the monitored pressure change for detecting air/clogging, as Thayumanavan evidently discusses the inverse relationship between increased pressure and pore size.
Regarding claim 16, Boag in view of Yuds discloses the invention of claim 15. However, the combination does not disclose wherein, in response to the pore size being detected to be less than a predetermined threshold, the controller performs at least one from a group of operations, the group of operations comprises, stopping a blood pump, closing a venous clamp, and alerting a user.
Ahmadi, in the same field of endeavor of dialysis system preventing air bubbles (Par. 3), teaches wherein, in response to the measured pressure being detected to be more than a predetermined threshold (Par. 62 – “An increase in the value of subsequent pressure measurements at pressure transducer 13 may indicate clotting of the gas removal filter 2,”), the controller 112 (Fig. 3 – application 112) performs at least one from a group of operations, the group of operations comprises alerting a user (Par. 62 – “If clotting of air removal filter 2 or excess unremoved air is detected, application 112 may include an operation to signal an alarm 16”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of the combination to alert a user upon detection of the sensor as taught by Ahmaid, in order to notify of clotting in the filter (Par. 62 of Ahmadi), and as it is well-known in the field of extracorporeal blood treatment to provide cautionary message to the operators and inform them of improper air venting. Examiner further notes that the clogging detection method of Ahmadi is operated based on pressure measurement (Par. 62 of Ahmadi – “An increase in the value of subsequent pressure measurements at pressure transducer 13 may indicate clotting of the gas removal filter 2, or excess unremoved air in gas removal filter 2 and/or vent tubing 10”). According to evidentiary reference Thayumanavan, it is known in the art that “the movement of water from one side to the other side of the membrane causes change in pressure, compared to the atmospheric pressure, inversely proportional to membrane dimension. As pore size decreases, increased pressure change can be observed” as discussed in Par. 61; therefore, one of ordinary skill in the art would have had the technological capability to reasonably deduce a membrane dimension and pore size from the measured increase pressure at the membrane/filter, and compare said value to a new predetermined threshold due to the established inverse relationship. Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of the combination to utilize the pore size parameter derived from the monitored pressure change for detecting air/clogging, as Thayumanavan evidently discusses the inverse relationship between increased pressure and pore size.
Regarding claim 17, Boag in view of Yuds in view of Ahmadi discloses the invention of claim 16. The combination further discloses wherein the one sensor 602 (Fig. 6 of Yuds) comprise a second set of ultrasonic transducers (Par. 38 of Yuds – “an optical sensor assembly 602 with a fiber-optic sensor and an ultrasonic or piezoelectric head… Ultrasonic heads that can be used include high frequency transducers”), the second set of ultrasonic transducers (Par. 38 of Yuds) to emit ultrasonic signals of a second predetermined frequency (Par. 40 of Yuds – “the ultrasonic head can be used to locally detect clots or masses of red blood cells between 20 μm and 100 μm at a lower frequency, e.g., at 50 MHz”).
Examiner notes that once the modification is made as discussed in claim 15, the optical sensor assembly of Yuds will be incorporated into the device of Boag in view of Yuds, including the second operating frequency. Thus, the limitation is met.
However, the combination does not currently disclose wherein the controller is coupled with the second set of ultrasonic transducers, the controller configured to cause the second set of ultrasonic transducers to emit ultrasonic signals.
Since it has been established in the modification of claim 12 that the controller 12 of Yuds will be coupled to the ultrasonic transducer, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further have the second set of ultrasonic transducer coupled to the controller of Boag in view of Yuds, as Yuds already demonstrates that the controller 12 provides signals to instruct ultrasonic transducer to emit signals. Thus, the limitation is met.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmadi in view of Treu et al. US 2023/0211059 A1 (previously cited, hereinafter Treu) and Chapman et al. US 2019/0175814 A1 (newly cited, hereinafter Chapman), evidenced by Thayumanavan et al. US 2009/0184047 A1 (previously cited, hereinafter Thayumanavan).
Regarding claim 20, Ahmadi discloses a method (Par. 2 – “methods for detecting air in a fluid return line and automatically purging the air therefrom”), comprising:
using one or more sensors 6, 13 (Fig. 4 – gas detector 6 and pressure transducer 13), a pore size of a drip chamber 19 (Fig. 5 – drip chamber 19 and an opening such as vent port 4)
However, Ahmadi does not currently disclose detecting a pore size of a drip chamber coupled to a pump that causes a fluid to flow through the drip chamber; and in response to the pore size of the drip chamber being below a predetermined size, causing the pump to stop the flow of fluid and closing a venous clamp.
Ahmadi, in another embodiment, teaches detecting clotting of a chamber 2 (Fig. 1 – gas removal filter 2, and Par. 62 – “If clotting of air removal filter 2… is detected”, this detection is done via transducer 13 and indicate “clotting of the gas removal filter 2… in gas removal filter 2 and/or vent tubing 10”) coupled to a pump (Par. 62 – blood pump) that causes a fluid to flow through the chamber 2 (Fig. 1, and Par. 62 – “ (i.e. blood) flow rate through inlet 1 and outlet 5”, which indicates that the blood pump has to be coupled to the chamber 2 to deliver blood to and from said chamber).
Treu, in the same field of endeavor of detecting possible clotting in filters (Par. 74 and Par. 361), teaches in response to the arterial outlet pressure exceeds a predetermined threshold (Fig. 48A, and Par. 362 – “a check of the arterial pressure blood pump outlet pressure sensor 564… The blood pump outlet pressure sensor 564 can be continuously monitored… If the blood pump outlet pressure sensor 564 exceeds a predetermined threshold value”), causing the pump to stop the flow of fluid (Par. 364 – “the system stops all pumps S4807 for a period of time”).
Chapman, in the same field of endeavor of drip chambers in dialysis system (Abstract), teaches in response to low pressure in the venous line 122/126 (Fig. 1) downstream of the venous drip chamber 125 (Fig. 1), closing a venous clamp 137 (Fig. 1 – venous line clamp 137, and Par. 92 – “Low pressure in the fluid line 122 will cause the venous line clamp 137 to close, blocking fluid flow through the venous line 126”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ahmadi to further include detection of filter clogging via sensors, also as taught by Ahmadi, since as Ahmadi teaches both embodiments. 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 respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.). Examiner further notes that the clogging detection method of Ahmadi is operated based on pressure measurement (Par. 62 of Ahmadi – “An increase in the value of subsequent pressure measurements at pressure transducer 13 may indicate clotting of the gas removal filter 2, or excess unremoved air in gas removal filter 2 and/or vent tubing 10”). According to evidentiary reference Thayumanavan, it is known in the art that “the movement of water from one side to the other side of the membrane causes change in pressure, compared to the atmospheric pressure, inversely proportional to membrane dimension. As pore size decreases, increased pressure change can be observed” as discussed in Par. 61; therefore, one of ordinary skill in the art would have had the technological capability to reasonably deduce a membrane dimension and pore size from the measured increase pressure at the membrane/filter. Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ahmadi to utilize the pore size parameter derived from the monitored pressure change for detecting air/clogging, as Thayumanavan evidently discusses the inverse relationship between increased pressure and pore size.
Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ahamdi to further stop the pump in response to an exceeding of a threshold value as taught by Treu, in order to detect possible clotting in filters (Par. 361 of Treu). Treu discusses that “clotting building up in a filter (e.g., a blood filter) will obstruct blood flow, and thus increase resistance of flow thorough the filter, which will be observable as an increase in the pressure…” and “It is expected that if the filter(s) are not clogged, the pressure reading will be at a normal level”. Therefore, one of ordinary skill in the art would have had the technological capability to recognize the relationship between the increased pressure and pore/opening size of the combined drip chamber, such that increased upstream pressure inversely correlates to pore size as clots causes pressure build up as evidenced by Thayumanavan above, and apply said known technique to a similar method (Both Ahamdi and Treu’s method teaches detecting and purging air). Thus, the limitation “in response to the pore size of the drip chamber being below a predetermined size” is met.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further close a venous clamp in response to low pressure downstream of the venous drip chamber as taught by Chapman, in order to block fluid flow through the venous line (Par. 92 of Chapman). One of ordinary skill in the art would have had the technological capability to reasonably deduce that low pressure in the venous line may be caused by a clog in the venous drip chamber 125 of Chapman, particularly a reduction in the pore size of the drip chamber, resulting in less fluid flow towards the venous line returning to patient. Therefore, one of ordinary skill in the art would have been motivated to close the venous clamp in response to a low pressure in the venous line, or in other words, a clog in the venous drip chamber.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weaver et al. US 2009/0320684 A1 teaches a hydrophobic membrane that prevents condensation.
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
