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 examiner acknowledges the amendments set forth by the applicant dated 07/29/2026, wherein independent claims 1, 17, and 21 have been amended.
Response to Arguments
Applicant’s arguments and amendments with respect to the prior 112(b) rejection over claims 1, 17, 21, and their dependents regarding, wherein the lack of recitation of recovery of the biological fluid outside the preambles have been fully considered, and due to the amendments set forth by the applicant, the 112(b) rejection has been withdrawn.
Applicant’s arguments with respect to claims 1-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Given amendments entered by the applicant do not change the scope of the invention, the examiner has withdrawn the previous 103 rejections over the claims above and will proceed with a second non-final office action, per the remainder of this correspondence.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites the limitation "at least one pump" in lines 3-4. There is already antecedent basis for this limitation earlier in claim 17, thus it is unclear whether this limitation is in reference back to the prior basis, or if the Applicant intended on a separate, new limitation. The examiner believes the Applicant intended this limitation to be in reference back to the prior recitation of this limitation, and thus will interpret the claim as such.
Claim 20 is rejected due to its’ dependency on claim 19.
Claim Rejections - 35 USC § 103
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.
Claims 1-11 and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sasayama (US6129853A) in view of Karol (US20190316948A1).
Regarding claim 1, Sasayama teaches a system to recover residual biological fluid {Column 1 lines 6-7 re. filter set for blood components} from a soft sided {Column 4 lines 1-12, "material of the bag body 11 … includes a soft polyvinyl material"} fluid filter {Column 2 lines 11-12, "bag body … with a filter material"} having a fluid filter inlet and a fluid filter outlet and which is used by a biological fluid processing system, comprising: {Column 2 lines 11-12, "bag body having a blood flow inlet and a blood flow outlet"}
a fluid filter compression assembly; {Column 2 lines 18-21 re. rigid accommodation vessel}
the fluid filter compression assembly further comprising: a housing comprising an outer wall that defines a housing space that receives the fluid filter; {Column 2 lines 20-40 re. a vessel (housing), rectangular parallel piped portions (outer wall), wherein the rigid accommodation vessel has a space to accommodate the bag body (housing space)}
at least one bladder positioned within the housing space; {Column 2 lines 17-20 re. bag body inside rigid accommodation vessel}
at least one conduit; {Column 5 line 38 re. tube 21}
at least one pump; {Column 7 lines 65-67 re. pump}
wherein the at least one conduit is in fluid communication with the at least one bladder and the at least one pump; {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 7 lines 65-67 re. pump usage with stopcock 33}
and a clamp configured to selectively stop flow through the fluid filter inlet, {Column 6 lines 60-65 re. stopcock 33} wherein residual biological fluid expelled through the fluid filter outlet is recovered {Columns 2 line 59 - Column 3 line 4, "blood flow inlet and a blood flow outlet and has a filter material charged within … compressing the bag body … passing the blood through the bag body … and recovering the blood components} when the clamp is configured to stop flow through the fluid filter inlet. {Column 8 lines 1-14 re. the stopcock 33 being opened to allow the bag body to expand, then the addition of the blood components to follow}
While Sasayama is silent to the stopcock being closed when the biological fluid is being expelled of the bag body, Sasayama teaches opening the valve to expand the bag, then flowing blood through the bag, then expelling out of the bag. Thus, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to close the inlet stopcock of modified Sasayama, once the addition of blood has stopped, to allow for the release of blood in the direction of the outlet, as for the same reasons as the outlet stopcock would be closed during the addition of blood into the bag body. This reduces the chances of contamination, overflowing, and/or back/forward flowing during these liquid addition/removal steps.
Sasayama is silent to a reusable hardware unit .
Karol, drawn to a biological purification system, {Karol, abstract} teaches a reusable hardware unit. {[0292] re. this embodiment may be reusable in its entirety}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify Sasayama with Karol’s teachings of a reusable hardware unit as Karol teaches a biological purification system through a compressible device. {Karol, abstract} Doing so would create a more environmentally friendly system, reducing the waste of the device by not needing to replace each and every component between uses, which can additionally save the user costs.
Regarding claim 2, Sasayama teaches wherein the at least one pump is configured to pump fluid media into the at least one bladder. {Column 7 lines 60-67 re. compressed gas (liquid media, see claim 5 for interpretation of liquid media) being pump into bag body by a pump}
Regarding claim 3, Sasayama teaches wherein when the fluid filter is disposed in the housing space {Column 4 lines 17-20 re. filter material within bag body & Column 2 lines 15-30 re. rigid accommodation vessel containing the blood bag} and the at least one pump pumps fluid media into the at least one bladder, the fluid filter is compressed. {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump}
Regarding claim 4, Sasayama teaches wherein when the fluid filter contains residual biological fluid from fluid processing {Column 2 lines 60-67 re. adherence of blood components to the filter material} the clamp is used to selectively stop flow through the fluid filter inlet and the at least one pump pumps fluid media into the at least one bladder, {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump} at least a portion of the residual biological fluid is expelled through the fluid filter outlet when the fluid filter is compressed. {Column 7 lines 57-62 re. blood passed through bag body and to outlet 112}
Regarding claim 5, Sasayama teaches wherein the fluid media is air and the at least one pump is an air pump configured to inflate the at least one bladder. {Column 7 lines 10-11 re. compressed gas being air & Column 8 lines 1-5 re. compressed gas entering and expanding the bag body when stopcock 33 is opened}
Regarding claim 6, Sasayama teaches wherein when the fluid filter is disposed in the housing space and the at least one pump pumps air into the at least one bladder, the fluid filter is compressed. {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas}
Regarding claim 7, Sasayama teaches wherein the outer wall of the filter housing further comprises opposed front and rear walls and opposed side walls connected to the front and rear walls, respectively. {Figure 4 & V Column 6 lines 10-20 filter set 10 and vessel body 42}
Regarding claim 8, Sasayama teaches wherein the outer wall of the filter housing further comprises at least one slot to accommodate the fluid filter inlet or outlet. {Figure 4 & Column 7 lines 5-15 re. groove 43 for the tubes connected to bag body, allowing the lid to be closed without crushing the tubes}
Regarding claim 9, Sasayama teaches wherein the outer wall of the filter housing further comprises respective slots through the opposed front and rear walls. {Figure 4 & Column 6 lines 5-10 re. groove 43}
The examiner would like to note for the following rejection of claims 10-11, 16, and 19; the applicant has claimed a plurality of multiple components of the invention such as: conduits, pumps, bladders; while claiming the same function of the individually claimed components earlier in the instant application. MPEP 2144.04 recites, “mere duplication of parts has no patentable significance unless a new of unexpected result is produced;” and given the applicant claims the same functions as the individually claimed components, it is clear to one of ordinary skill in the art that there are no unexpected results from the plurality of each component. The above listed claims will be mapped to the singular forms of the claimed components within the references as the plurality of components do not hold patentable significance.
Regarding claim 10, Sasayama teaches wherein: the at least one bladder further comprises first and second bladders being spaced apart and positioned within the housing space; {Column 2 lines 17-20 re. bag body inside rigid accommodation vessel}
the at least one conduit further comprises first and second conduits; {Column 5 line 38 re. tube 21}
at least one pump further comprises first and second pumps; {Column 7 lines 65-67 re. pump}
and the first conduit is in fluid communication with the first bladder and the first pump, and the second conduit is in fluid communication with the second bladder and the second pump. {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 7 lines 65-67 re. pump usage with stopcock 33}
Regarding claim 11, Sasayama teaches wherein the first and second pumps are configured to pump fluid media into the first and second bladders, respectively. {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas}
Regarding claim 16, Sasayama teaches wherein the fluid media is air and the first and second pumps are air pumps configured to inflate the respective first and second bladders. {Column 7 lines 10-11 re. compressed gas being air & Column 8 lines 1-5 re. compressed gas entering and expanding the bag body when stopcock 33 is opened}
Regarding claim 17, Sasayama teaches a method of recovering residual biological fluid {Column 1 lines 5-10 re. method for recovering blood components} from a soft sided {Column 4 lines 1-12, "material of the bag body 11 … includes a soft polyvinyl material"} fluid filter {Column 2 lines 11-12, "bag body … with a filter material"} having a fluid filter inlet and a fluid filter outlet and which is used by a biological fluid processing system, the method comprising: {Column 2 lines 11-12, "bag body having a blood flow inlet and a blood flow outlet"}
a fluid filter compressions assembly {Column 2 lines 18-21 re. rigid accommodation vessel} having a housing comprising an outer wall that defines a housing space that receives the fluid filter, {Column 2 lines 20-40 re. a vessel (housing), rectangular parallel piped portions (outer wall), wherein the rigid accommodation vessel has a space to accommodate the bag body (housing space)}
at least one bladder positioned within the housing space; {Column 2 lines 17-20 re. bag body inside rigid accommodation vessel}
at least one conduit; {Column 5 line 38 re. tube 21}
at least one pump, {Column 7 lines 65-67 re. pump} wherein the at least one conduit is in fluid communication with the at least one bladder and the at least one pump; {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 7 lines 65-67 re. pump usage with stopcock 33}
and a clamp configured to selectively stop flow through the fluid filter inlet. {Column 8 lines 1-14 re. the stopcock 33 being opened to allow the bag body to expand, then the addition of the blood components to follow}
While Sasayama is silent to the stopcock being closed when the biological fluid is being expelled of the bag body, Sasayama teaches opening the valve to expand the bag, then flowing blood through the bag, then expelling out of the bag. Thus, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to close the inlet stopcock of modified Sasayama, once the addition of blood has stopped, to allow for the release of blood in the direction of the outlet, as for the same reasons as the outlet stopcock would be closed during the addition of blood into the bag body. This reduces the chances of contamination, overflowing, and/or back/forward flowing during these liquid addition/removal steps.
Sasayama further teaches passing fluid through the fluid filter inlet, the fluid filter, and the fluid filter outlet; {Columns 2-3 lines 59-4, "blood flow inlet and a blood flow outlet and has a filter material charged within … compressing the bag body … passing the blood through the bag body … and recovering the blood components}
engaging the clamp to selectively stop flow through the fluid filter inlet; {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump}
engaging the at least one pump to pump fluid media into the at least one bladder, {Column 7 lines 10-11 re. compressed gas being air & Column 8 lines 1-5 re. compressed gas entering and expanding the bag body when stopcock 33 is opened} causing the fluid filter to be compressed {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump} and to expel residual biological fluid through the fluid filter outlet; {Column 7 lines 57-62 re. blood passed through bag body and to outlet 112}
and recovering the residual biological fluid expelled through the fluid filter outlet when the clamp is configured to stop flow through the fluid filter inlet. {Columns 2-3 lines 59-4, "blood flow inlet and a blood flow outlet and has a filter material charged within … compressing the bag body … passing the blood through the bag body … and recovering the blood components}
Sasayama is silent to a reusable hardware unit .
Karol, drawn to a biological purification system, {Karol, abstract} teaches a reusable hardware unit. {[0292] re. this embodiment may be reusable in its entirety}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify Sasayama with Karol’s teachings of a reusable hardware unit as Karol teaches a biological purification system through a compressible device. {Karol, abstract} Doing so would create a more environmentally friendly system, reducing the waste of the device by not needing to replace each and every component between uses, which can additionally save the user costs.
Regarding claim 18, Sasayama teaches wherein the fluid media is air and the at least one pump is an air pump that when engaged inflates the at least one bladder. {Column 7 lines 10-11 re. compressed gas being air & Column 8 lines 1-5 re. compressed gas entering and expanding the bag body when stopcock 33 is opened}
Regarding claim 19, Sasayama teaches wherein the at least one bladder further comprises first and second bladders being spaced apart and positioned within the housing space, {Column 2 lines 17-20 re. bag body inside rigid accommodation vessel}
the at least one conduit further comprises first and second conduits, {Column 5 line 38 re. tube 21}
at least one pump further comprises first and second pumps, {Column 7 lines 65-67 re. pump}
and the first conduit is in fluid communication with the first bladder and the first pump, and the second conduit is in fluid communication with the second bladder and the second pump, {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 7 lines 65-67 re. pump usage with stopcock 33}
the method further comprising: engaging the clamp to selectively stop flow through the fluid filter inlet; {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body)}
and engaging the first and second pumps to pump fluid media into the respective first and second bladders, {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas} causing the fluid filter to be compressed {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump} and to expel residual biological fluid through the fluid filter outlet. {Column 7 lines 57-62 re. blood passed through bag body and to outlet 112}
Regarding claim 20, Sasayama teaches wherein the fluid media is air and the first and second pumps are air pumps that when engaged inflate the respective first and second bladders. {Column 7 lines 10-11 re. compressed gas being air & Column 8 lines 1-5 re. compressed gas entering and expanding the bag body when stopcock 33 is opened}
Regarding claim 21, Sasayama teaches a system to recover residual biological fluid {Column 1 lines 6-7 re. filter set for blood components} from a soft sided {Column 4 lines 1-12, "material of the bag body 11 … includes a soft polyvinyl material"} fluid filter {Column 2 lines 11-12, "bag body … with a filter material"} having a fluid filter inlet and a fluid filter outlet and which is used by a biological fluid processing system, comprising: {Column 2 lines 11-12, "bag body having a blood flow inlet and a blood flow outlet"}
a fluid filter compression assembly; {Column 2 lines 18-21 re. rigid accommodation vessel}
the fluid filter compression assembly further comprising: a housing comprising an outer wall that defines a housing; {Column 2 lines 20-40 re. a vessel (housing), rectangular parallel piped portions (outer wall), wherein the rigid accommodation vessel has a space to accommodate the bag body (housing space)}
at least one bladder positioned within the housing space; {Column 2 lines 17-20 re. bag body inside rigid accommodation vessel}
at least one conduit; {Column 5 line 38 re. tube 21}
at least one pump; {Column 7 lines 65-67 re. pump}
wherein the at least one conduit is in fluid communication with the at least one bladder and the at least one pump; {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 7 lines 65-67 re. pump usage with stopcock 33}
and a clamp configured to selectively stop flow through the fluid filter inlet, {Column 6 lines 60-65 re. stopcock 33} and residual biological fluid expelled through the fluid filter outlet is recovered {Columns 2 line 59 - Column 3 line 4, "blood flow inlet and a blood flow outlet and has a filter material charged within … compressing the bag body … passing the blood through the bag body … and recovering the blood components} when the clamp is configured to stop flow through the fluid filter inlet. {Column 8 lines 1-14 re. the stopcock 33 being opened to allow the bag body to expand, then the addition of the blood components to follow}
While Sasayama is silent to the stopcock being closed when the biological fluid is being expelled of the bag body, Sasayama teaches opening the valve to expand the bag, then flowing blood through the bag, then expelling out of the bag. Thus, it would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to close the inlet stopcock of modified Sasayama, once the addition of blood has stopped, to allow for the release of blood in the direction of the outlet, as for the same reasons as the outlet stopcock would be closed during the addition of blood into the bag body. This reduces the chances of contamination, overflowing, and/or back/forward flowing during these liquid addition/removal steps.
Sasayama is silent to a reusable hardware unit .
Karol, drawn to a biological purification system, {Karol, abstract} teaches a reusable hardware unit. {[0292] re. this embodiment may be reusable in its entirety}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify Sasayama with Karol’s teachings of a reusable hardware unit as Karol teaches a biological purification system through a compressible device. {Karol, abstract} Doing so would create a more environmentally friendly system, reducing the waste of the device by not needing to replace each and every component between uses, which can additionally save the user costs.
Regarding claim 22, Sasayama teaches wherein when the fluid filter is disposed in the housing space and the at least one pump pumps fluid media into the at least one bladder, the fluid filter is compressed. {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas}
Regarding claim 23, Sasayama teaches wherein when the fluid filter contains residual biological fluid from fluid processing, {Column 2 lines 60-67 re. adherence of blood components to the filter material}
the clamp is used to selectively stop flow through the fluid filter inlet {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump} and the at least one pump pumps fluid media into the at least one bladder, {Column 7 lines 60-67 re. compressed gas}
at least a portion of the residual biological fluid is expelled through the fluid filter outlet when the fluid filter is compressed. {Column 7 lines 57-62 re. blood passed through bag body and to outlet 112 & Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump}
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sasayama (US6129853A) modified by Karol (US20190316948A1), as applied to the claims above, in view of Weasler (US20140066281A1).
Regarding claim 12, Sasayama teaches fluid media is pumped into at least one of the first and second bladders by the respective first or second pump, the fluid filter is compressed. {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump}
Modified Sasayama fails to teach wherein when the fluid filter is disposed in the housing space between the spaced apart first and second bladders.
Weasler, drawn to a blood purification system, {Weasler, abstract} teaches wherein when the fluid filter is disposed in the housing space between the spaced apart first and second bladders. {Figure 6 references (12, 30, 50, and 54) "blood container, holder, first bladder, second bladder" respectively and paragraph 53, "blood packs include additional components such as red cell … filters. Although not shown in the figures, these components can also be included"}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify modified Sasayama with Weasler’s teachings wherein when the fluid filter is disposed in the housing space between the spaced apart first and second bladders as Weasler, similar to modified Sasayama, teaches a compressible blood bag system for the separation of blood components. {Weasler, abstract} Doing so would create a filtration system with greater separation, as it is well known in the art, that additional, different filtration steps, will remove a greater amount of target components.
Regarding claim 13, Sasayama teaches wherein when the fluid filter contains residual biological fluid from fluid processing, {Column 2 lines 60-67 re. adherence of blood components to the filter material}
the clamp is used to selectively stop flow through the fluid filter inlet and the at least the first or second pump pumps fluid media into the respective first or second bladder, {Column 7 lines 4-8 re. stopcock 33 inserted between port 31 and tube 21 (which leads to bag body) & Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump}
at least a portion of the residual biological fluid is expelled through the fluid filter outlet when the fluid filter is compressed. {Column 7 lines 57-62 re. blood passed through bag body and to outlet 112}
Regarding claim 14, Sasayama teaches fluid media is pumped into the first and second bladders by the respective first and second pumps, the fluid filter is compressed. {Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump}
Modified Sasayama fails to teach wherein when the fluid filter is disposed in the housing space between the spaced apart first and second bladders.
Weasler, drawn to a blood purification system, {Weasler, abstract} teaches wherein when the fluid filter is disposed in the housing space between the spaced apart first and second bladders. {Figure 6 references (12, 30, 50, and 54) "blood container, holder, first bladder, second bladder" respectively and paragraph 53, "blood packs include additional components such as red cell … filters. Although not shown in the figures, these components can also be included"}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify modified Sasayama with Weasler’s teachings wherein when the fluid filter is disposed in the housing space between the spaced apart first and second bladders as Weasler, similar to modified Sasayama, teaches a compressible blood bag system for the separation of blood components. {Weasler, abstract} Doing so would create a filtration system with greater separation, as it is well known in the art, that additional, different filtration steps, will remove a greater amount of target components.
Regarding claim 15, Sasayama teaches wherein when the fluid filter contains residual biological fluid from fluid processing, {Column 2 lines 60-67 re. adherence of blood components to the filter material}
the clamp is used to selectively stop flow through the fluid filter inlet {Column 6 lines 60-65 re. stopcock 33} and the first and second pumps pump fluid media into the respective first and second bladders, {Column 7 lines 60-67 re. compressed gas (liquid media, see claim 5 for interpretation of liquid media) being pump into bag body by a pump}
at least a portion of the residual biological fluid is expelled through the fluid filter outlet when the fluid filter is compressed. {Column 7 lines 57-62 re. blood passed through bag body and to outlet 112 & Column 8 lines 6-10 re. the compression of the filter material during the addition of the compressed gas through the pump}
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR J ROTONDI whose telephone number is (571)272-2058. The examiner can normally be reached M-F 8:00am-4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Lebron can be reached at (571)272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CONNOR J ROTONDI/ Examiner, Art Unit 1773
/BENJAMIN L LEBRON/ Supervisory Patent Examiner, Art Unit 1773
