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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 and 17-20 in the reply filed on October 27th, 2025 is acknowledged.
Claims 11-16 are withdrawn from consideration.
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 8-9 and 17-20 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 8 recites “obtain the image from the image sensor; derive a parameter of at least a portion of separated particles depicted in the image; determine whether the separated particles depicted in the image are part of the first portion or the second portion” wherein it is unclear if the “at least a portion of separated particles” refers to a larger portion that encompasses the first portion and the second portion.
Applicant may wish to amend the claim to utilize different terminology with respect to “at least a portion of separated particles” to both differentiate this “portion” language from that of the “first and second portion” while also providing that the derived-parameter-portion encompasses particles that may be found in either of the first and second portions. Claim 9 is further rejected for its dependence on Claim 8.
Similarly as above, Claim 17 recites “capture an image of the separated particles of the biological fluid containing cells” wherein “the separated particles” lacks antecedent basis and further lacks structural particularity for referencing the orientation of the imaging device. Claims 18-20 are further rejected for their dependence on Claim 17.
Thus, the imaging device of Claims 8 and 17 is indefinitely arranged with respect to the reagent container, outlet, inlet, and other elements of the apheretic system, thus rendering the imaging device indefinite.
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, 3, 7, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (US 2016/0325277 A1), hereinafter “Zhang”.
Regarding Claim 1, Zhang teaches a centrifugal apheretic system (Abstract) comprising:
an inlet configured to obtain a biological fluid containing cells (The opening sealed by butyl rubber plug 3 shown in Fig. 1 – see para. [0009].);
a collection container configured to collect the biological fluid containing cells from the inlet (Centrifuge tube 1 – see Fig. 1 and para. [0026].);
a centrifuge device connected to the collection container, wherein the centrifuge device is configured to rotate about an axis, causing particles in the biological fluid containing cells to separate in the collection container by a particle size and/or a particle flow rate (See para. [0026].);
an outlet configured to direct a first portion of the separated particles in the biological fluid containing cells from the collection container to a first channel of the outlet and direct a second portion of the separated particles in the biological fluid containing cells from the collection container to a second channel of the outlet (See para. [0024]: “the flow dividing mechanism includes a rotate-type flow divider valve 4, and a first flow guiding channel 4-1 and a second flow guiding channel 4-2”.),
as in Claim 1.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhang teaches the centrifugal apheretic system discussed above wherein the centrifuge device is a center axis centrifuge device configured to rotate about a central axis, and wherein the collection container is disposed at a periphery of the center axis centrifuge device (Para. [0026] discusses a centrifuge for centrifugation: centrifuges are generally configured to rotate about a center axis or rotational equivalent center of mass. Further, as the centrifuge tube of Zhang is configured to release blood components on its bottom end (Item A in Fig. 1.), the tube must necessarily be placed at a periphery of the centrifuge axis, as is common practice with apheretic centrifugal systems.), as in Claim 3.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhang teaches the centrifugal apheretic system discussed above further comprising: a motorized valve connected to the outlet, wherein the motorized valve is configured to open to either the first channel to direct the first portion of the separated particles to the first channel or the second channel to direct the second portion of the separated particles to the second channel (See para. [0036]: “Specifically, a flow dividing cabin is additionally disposed in the third example and is used together with the push-type flow divider valve, so as to automatically implement collection of the blood component divided out.” – See also paras. [0024-0026] regarding the first and second flow channels, and para. [0012] further discussing the flow dividing cabins.), as in Claim 7.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhang teaches the centrifugal apheretic system discussed above wherein the first channel is configured to direct the first portion of the separated particles to another container for further testing, and the second channel is configured to direct the second portion of the separated particles to a patient via a return line (As the device of Zhang comprises two outlet channels controllable by an automated push or rotable valve (as discussed in paras. [0024, 0036], the device is configured for and structurally capable of directing a first portion of the sedimented blood sample to a collection container, and a second portion returned to the patient.), as in Claim 10.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Fritchie (US 2012/0308435 A1), hereinafter “Fritchie”.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhang does not specifically teach the centrifugal apheretic system discussed above further comprising: a robotic arm connected to the inlet; and a dual needle connected to the robotic arm, wherein the robotic arm is configured to move the dual needle into the collection container, wherein a first needle of the dual needle is configured to provide the biological fluid containing cells to the collection container, and a second needle of the dual needle is configured to direct the separated particles from the collection container to the outlet, as in Claim 2.
However, Fritchie teaches a robotic sample handling system fort automated clinical sample analyzers wherein biological patent sample is injected into sample tube holders via a robotic sample handler ([0118-0121]) comprising a dual needle wherein a first needle is configured for injecting sample and the second needle is configured for venting so as to maintain neutral pressure within the sample container ([0112]) thereby preventing/reducing risk of pressure buildup in the sample tube upon injection while maintaining an aseptic/closed tube injection process ([0085]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the centrifugal apheretic system of Zhang further comprising: a robotic arm connected to the inlet; and a dual needle connected to the robotic arm, wherein a first needle of the dual needle is configured to provide the biological fluid containing cells to the collection container, such as suggested by Fritchie, so as to prevent/reduce risk of pressure buildup in the sample tube upon injection while maintaining an aseptic/closed tube injection process.
Further, while Zhang does not specifically teach the second needle as “configured to direct the separated particles from the collection container to the outlet”, the needle of Zhang is structurally capable of directing the separated particles via fluid/air actuation. See also MPEP 21454 IV: "Rationale different from applicant's is permissible". Further, see Zhang paras. [0009, 0026] discussing use of a needle probe.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Conway (US PAT 4,342,419 A), hereinafter “Conway”.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhang teaches the centrifugal apheretic system discussed above wherein the centrifuge device is a spinning centrifuge device and rotates the collection container about the central axis ([0026]), as in Claim 4.
Further regarding Claim 4, Zhang does not specifically teach the centrifugal apheretic system discussed above as configured to surround the collection container, as in Claim 4.
However, Conway teaches a centrifuge device wherein the container-receiving bucket of the device (Fig. 2) is configured to surround the container so as to provide a secondary container for preventing contamination due to leaks (col. 1, lines 29-40).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the centrifugal apheretic system of Zhang as configured to surround the collection container, such as suggested by Conway, so as to prevent/contain contamination due to unforeseen leaks in the specimen container.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Howell (Howell, Gary; "How Self-Balancing Centrifuge Rotor Technology Works", Lab Manager: How it Works, Apr 6, 2011.), hereinafter “Howell”.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhang does not specifically teach the centrifugal apheretic system discussed above wherein the centrifuge device is an off-center axis centrifuge device configured to rotate offset relative to the central axis, as in Claim 5.
However, Howell discusses the benefits of off-center axis rotor (also called eccentric or self-balancing rotor) as achieving balance around the centrifugal periphery containing samples by adjusting the axis of rotation away from the central axis so as to avoid eccentric rotor unbalancing which poses risk of dangerous vibrations/oscillations leading to dangerous failure at high speed (page 2).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the centrifugal apheretic system of Zhang wherein the centrifuge device is an off-center axis centrifuge device configured to rotate offset relative to the central axis, such as suggested by Howell, so as to reduce the risk of rotor failure due to an unbalanced sample load.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Howell, as applied to Claim 5 above, and in further view of Fell et al. (US PAT 10,906,049 B2), hereinafter “Fell”.
Regarding Claim 6, the prior art meets the limitations of Claim 5 as discussed above. Further, Zhang/Howell does not specifically teach the centrifugal apheretic system discussed above further comprising: at least two off-center axis centrifuge devices connected to the inlet in parallel, wherein each of the at least two off-center axis centrifuge devices comprise collection containers and each collection container is configured to receive part of the biological fluid containing cells, as in Claim 6.
However, Fell teaches an apheretic system having a plurality of centrifuges arranged and operating in simultaneously to be able “to process several cord blood units in parallel in order to be competitive and reduce operating costs, by making it possible for one technician to simultaneously process several units in parallel” (col. 2, line 29), wherein each centrifuge comprises collection containers configured to receive part of the biological fluid containing cells having individual inlets as seen through Fig. 5 and discussed in col. 2, line 42.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the centrifugal apheretic system of Zhang/Howell further comprising: at least two off-center axis centrifuge devices connected to the inlet in parallel, wherein each of the at least two off-center axis centrifuge devices comprise collection containers and each collection container is configured to receive part of the biological fluid containing cells, such as suggested by Fell, so as to achieve the discussed benefits of reduced operating costs.
Claims 8-9, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Stacey et al. (US PAT 10,564,145 B2), hereinafter “Stacey”. Zhang has been discussed above.
Regarding Claim 8, the prior art meets the limitations of Claim 7 as discussed above. Further, Zhang does not specifically teach the centrifugal apheretic system discussed above further comprising: an image sensor connected to the motorized valve and configured to capture an image of the separated particles of the biological fluid containing cells; and a computing node electrically connected to the sensor, wherein the computing node comprises a processor and a memory, wherein the memory comprises instructions that are configured to cause the processor to: obtain the image from the image sensor; derive a parameter of at least a portion of separated particles depicted in the image; determine whether the separated particles depicted in the image are part of the first portion or the second portion of the biological fluid containing cells based on the derived parameter; and cause the motorized valve connected to the outlet to open either the first channel or the second channel based on whether the separated particles included in the image are part of the first portion or the second portion of the biological fluid containing cells, as in Claim 8.
However, Stacey teaches a respective centrifugal apheretic system comprising: an image sensor connected to a motorized valve and configured to capture an image of separated particles of a biological fluid containing cells (col. 12, lines 27-61); and a computing node electrically connected to the sensor, wherein the computing node comprises a processor and a memory (col. 2, line 25), wherein the memory comprises instructions that are configured to cause the processor to: obtain the image from the image sensor; derive a parameter of at least a portion of separated particles depicted in the image; determine whether the separated particles depicted in the image are part of the first portion or the second portion of the biological fluid containing cells based on the derived parameter; and cause the motorized valve connected to the outlet to open either the first channel or the second channel based on whether the separated particles included in the image are part of the first portion or the second portion of the biological fluid containing cells (col. 12, lines 32-34). Therein, this arrangement allows for precise detection of the component interfaces of the separated biological sample and precisely separate each component based on the image stream from the image sensor.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the centrifugal apheretic system of Zhang further comprising: an image sensor connected to the motorized valve and configured to capture an image of the separated particles of the biological fluid containing cells; and a computing node electrically connected to the sensor, wherein the computing node comprises a processor and a memory, wherein the memory comprises instructions that are configured to cause the processor to: obtain the image from the image sensor; derive a parameter of at least a portion of separated particles depicted in the image; determine whether the separated particles depicted in the image are part of the first portion or the second portion of the biological fluid containing cells based on the derived parameter; and cause the motorized valve connected to the outlet to open either the first channel or the second channel based on whether the separated particles included in the image are part of the first portion or the second portion of the biological fluid containing cells, such as suggested by Stacey, so as to achieve precise separation of the fluid components of the sedimented patient sample.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, as discussed above regarding Claim 8, one skilled in the art would find it obvious to provide the centrifugal apheretic system of Zhang with the imaging sensor of Stacey. Therein, Stacey additionally teaches the imaging sensor wherein the biological fluid containing cells comprises a stream of blood cells (See col. 10, lines 3-22 discussing fluid flow within the system.), and wherein the memory of the computing node comprises instructions that are further configured to cause the processor to: determine a color of at least the portion of the separated particles depicted in the image; and derive a hematocrit level of the at least the portion of the separated particles depicted in the image based on the determined color (col. 14, line 27: “the algorithm may be dependent upon the color of the light generated by the light source 320, the fluid within the separation device (e.g., whole blood, red cells, plasma, etc.), and/or the characteristics of the blood being processed and its individual components (e.g., hematocrit, platelet count, etc.)”), as in Claim 9.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying the centrifugal apheretic system of Zhang with the imaging sensor of Stacey, to provide the biological fluid containing cells comprising a stream of blood cells, and wherein the memory of the computing node comprises instructions that are further configured to cause the processor to: determine a color of at least the portion of the separated particles depicted in the image; and derive a hematocrit level of the at least the portion of the separated particles depicted in the image based on the determined color, such as suggested by Stacey, so as to enable hematocrit detection, an important parameter of blood samples.
Regarding Claim 17, Zhang teaches a system comprising:
an inlet configured to obtain a biological fluid containing cells (The opening sealed by butyl rubber plug 3 shown in Fig. 1 – see para. [0009].);
a collection container configured to collect the biological fluid containing cells from the inlet (Centrifuge tube 1 – see Fig. 1 and para. [0026].);
a centrifuge device connected to the collection container, wherein the centrifuge device is configured to rotate about an axis, causing particles in the biological fluid containing cells to separate in the collection container; an outlet comprising a first channel and a second channel (See para. [0026]. See para. [0024]: “the flow dividing mechanism includes a rotate-type flow divider valve 4, and a first flow guiding channel 4-1 and a second flow guiding channel 4-2”);
a motorized valve configured to open the first channel and the second channel (See para. [0036]: “Specifically, a flow dividing cabin is additionally disposed in the third example and is used together with the push-type flow divider valve, so as to automatically implement collection of the blood component divided out.” – See also paras. [0024-0026] regarding the first and second flow channels, and para. [0012] further discussing the flow dividing cabins.);
as in Claim 17.
Further regarding Claim 17, Zhang does not specifically teach the centrifugal apheretic system discussed above further comprising an image sensor connected to the motorized valve and configured to capture an image of the separated particles of the biological fluid containing cells; and a computing node electrically connected to the sensor, wherein the computing node comprises a processor and a memory, wherein the memory comprises instructions that are configured to cause the processor to: obtain the image from the image sensor; derive a particle size of at least a portion of separated particles depicted in the image; determine whether the separated particles depicted in the image are part of the first portion or the second portion of the biological fluid containing cells based on the derived particle sizes; and cause the motorized valve connected to the outlet to open either the first channel or the second channel based on whether the separated particles included in the image are part of the first portion or the second portion of the biological fluid containing cells, as in Claim 17.
However, Stacey teaches a respective centrifugal apheretic system comprising: an image sensor connected to the motorized valve and configured to capture an image of the separated particles of the biological fluid containing cells (col. 12, lines 27-61); and a computing node electrically connected to the sensor, wherein the computing node comprises a processor and a memory (col. 2, line 25), wherein the memory comprises instructions that are configured to cause the processor to: obtain the image from the image sensor; derive a particle size of at least a portion of separated particles depicted in the image (col. 4, line 67 discusses the controller determining the level of blood agglutination wherein this parameter is known in the art to be drawn to the particle size of clumps of blood: 0 is clear, 1+ is small clumps, 2+ is small to medium clumps, 3+ is large clumps, and 4+ is a solid clot); determine whether the separated particles depicted in the image are part of the first portion or the second portion of the biological fluid containing cells based on the derived particle sizes; and cause the motorized valve connected to the outlet to open either the first channel or the second channel based on whether the separated particles included in the image are part of the first portion or the second portion of the biological fluid containing cells (col. 12, lines 32-34). Therein, this arrangement allows for the determination of agglutination level, an important factor in transfusion safety for avoiding injecting clots into a patient.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the centrifugal apheretic system of Zhang further comprising an image sensor connected to the motorized valve and configured to capture an image of the separated particles of the biological fluid containing cells; and a computing node electrically connected to the sensor, wherein the computing node comprises a processor and a memory, wherein the memory comprises instructions that are configured to cause the processor to: obtain the image from the image sensor; derive a particle size of at least a portion of separated particles depicted in the image; determine whether the separated particles depicted in the image are part of the first portion or the second portion of the biological fluid containing cells based on the derived particle sizes; and cause the motorized valve connected to the outlet to open either the first channel or the second channel based on whether the separated particles included in the image are part of the first portion or the second portion of the biological fluid containing cells, such as suggested by Stacey, so as to monitor the agglutination level, an important factor in transfusion safety for avoiding injecting clots into a patient.
Regarding Claim 18, the prior art meets the limitations of Claim 17 as discussed above. Further, Zhang teaches the centrifugal apheretic system discussed above wherein the outlet is configured to direct a first portion of the separated particles in the biological fluid containing cells from the collection container to the first channel of the outlet and direct a second portion of the separated particles in the biological fluid containing cells from the collection container to the second channel of the outlet (See para. [0026] discussing first and second channels.), as in Claim 18.
Regarding Claim 20, the prior art meets the limitations of Claim 17 as discussed above. Further, Zhang teaches the centrifugal apheretic system discussed above wherein the centrifuge device is a center axis centrifuge device configured to rotate about a central axis, and wherein the collection container is disposed at a periphery of the center axis centrifuge device (Para. [0026] discusses a centrifuge for centrifugation: centrifuges are generally configured to rotate about a center axis or rotational equivalent center of mass. Further, as the centrifuge tube of Zhang is configured to release blood components on its bottom end (Item A in Fig. 1.), the tube must necessarily be placed at a periphery of the centrifuge axis, as is common practice with apheretic centrifugal systems.), as in Claim 20.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Stacey, as applied to Claims 8-9, 17-18, and 20 above, and in further view of Fritchie. Zhang, Stacey, and Fritchie have been discussed above.
Regarding Claim 19, the prior art meets the limitations of Claim 17 as discussed above. Further, Zhang/Stacey does not specifically teach the centrifugal apheretic system discussed above further comprising: a robotic arm connected to the inlet; and a dual needle connected to the robotic arm, wherein the robotic arm is configured to move the dual needle into the collection container, wherein a first needle of the dual needle is configured to provide the biological fluid containing cells to the collection container, and a second needle of the dual needle is configured to direct the separated particles from the collection container to the outlet, as in Claim 19.
However, Fritchie teaches a robotic sample handling system fort automated clinical sample analyzers wherein biological patent sample is injected into sample tube holders via a robotic sample handler ([0118-0121]) comprising a dual needle wherein a first needle is configured for injecting sample and the second needle is configured for venting so as to maintain neutral pressure within the sample container ([0112]) thereby preventing/reducing risk of pressure buildup in the sample tube upon injection while maintaining an aseptic/closed tube injection process ([0085]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the centrifugal apheretic system of Zhang further comprising: a robotic arm connected to the inlet; and a dual needle connected to the robotic arm, wherein a first needle of the dual needle is configured to provide the biological fluid containing cells to the collection container, such as suggested by Fritchie, so as to prevent/reduce risk of pressure buildup in the sample tube upon injection while maintaining an aseptic/closed tube injection process.
Further, while Zhang does not specifically teach the second needle as “configured to direct the separated particles from the collection container to the outlet”, the needle of Zhang is structurally capable of directing the separated particles via fluid/air actuation. See also MPEP 21454 IV: "Rationale different from applicant's is permissible". Further, see Zhang paras. [0009, 0026] discussing use of a needle probe.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/
Primary Examiner, Art Unit 1798