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 .
Status of the Claims
The amendment filed 11/25/2025 has been entered. Claims 1 and 133-152 are pending and under consideration.
Response to Arguments
In response to the applicant’s argument with respect 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 139 and 149 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 139 is added and recites “wherein the second internal diameter is larger than the first internal diameter”, and the first and second internal diameters are set forth in its precedent claim 136 as “said portion of the blood collection line arranged within said channel comprises a first tube having a first internal diameter, and said portion of the plasma delivery line arranged within said channel comprises a second tube having a second internal diameter”
However, the originally filed specification does not provide support for this relative sizing. Specifically, cited specification below discloses the opposite that the first internal diameter associated with the blood collection line as being larger than the second internal diameter associated with the plasma delivery line. Accordingly, the claim lacks written description support and constitutes new matter.
[0064] “an internal diameter of the tube of the blood collection line 102 can be larger than an internal diameter of the tube of the plasma delivery line 108”
[0069] “the blood collection line 102 (for example, a portion of the blood collection line 102 positioned within channel 252 of peristaltic pump 250) comprises a tube having an internal cross-sectional area (defining a flow area therethrough) that is larger than an internal cross-sectional area of a tube comprised by the plasma delivery line 108 (for example, a portion of the plasma delivery line 108 positioned within channel 252 of peristaltic pump 250)”
[0070] “the blood collection line 102 (for example, a portion of the blood collection line 102 positioned within channel 252 of peristaltic pump 250) comprises a tube having an internal diameter that is larger than an internal diameter of a tube comprised by the plasma delivery line 108 (for example, a portion of the plasma delivery line 108 positioned within channel 252 of peristaltic pump 250).”
Claim 149 line 2 recites “wherein the blood separation device comprises a centrifugal separator or at least one membrane and line”. However, the originally filed specification ([0013], [0025], [0044] and [0058]) does not provide support for discloses the blood separation device comprises at least one membrane but silent as to line. Accordingly, the claim lacks written description support and constitutes new matter
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 1, 133, 139 -144 and 150 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 1 recites the limitation "the first fraction of the blood" in line 7 and “the second fraction of the blood” in line 18. There is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution the limitations are “a first fraction of the blood” and “a second fraction of the blood” respectively.
Claim 133 line 2 recites “a channel”. There is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution the limitation is interpreted as “the channel”
Claim 139 recites “wherein the second internal diameter is larger than the first internal diameter” which renders the claim indefinite. As noted above in 112(a) rejection, it is not clear if the claim is intended to disclose the blood collection line and plasma delivery line as the originally disclosed specification [0064], [0069] and [0070], that is the first internal diameter of the blood collection line is larger than the second internal diameter of the plasma delivery line, or as claimed. In an effort to compact prosecution the limitation is being interpreted as the first and second diameters are different.
Claims 140-144 recite “approximately” which renders the claim indefinite. The term “approximately” is a subjective term, and since no objective standard is provided to allow the public to determine the scope of the claim, and, therefore, renders the claim indefinite. See MPEP 2173.05(b)(IV). Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005).
Claim 150 line 2 recite “ a first fraction”. There is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution the limitation is interpreted as “the first fraction”
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.
Claim 1, 133-146, 149, 150 and 152 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 5122112 A) in view of Vartia (US 20230025881 A1, foreign priority effectively filed 2019/12/13).
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Regarding Claim 1, Jones teaches substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including: a blood processing system comprising:
a blood collection line (annotated figure 2, blood collection line) configured to carry blood;
a blood separation device (figure 2, cell separator 40) connected to the blood collection line;
a plasma delivery line (annotated figure 2 and col 7 line 24 - col 8 line 2, plasma delivery line is configured to receive separated plasma from the cell separator 40 and delivery to column 11) connected to the blood separation device and configured to receive a first fraction of the blood (col 7 line 24 col 8 line 2, separated plasma);
a plasma processing device (figure 2, immunoaffinity column 11) connected to the plasma delivery line,
a pump (figure 2 col 7 line 24 - col 8 line 2, blood pump 42 causes the blood pass through the plasma separator 40), wherein a portion of the blood collection line and a portion of the plasma delivery line are positioned within the pump (figure 2, the blood collection line positioned within the pump 42), and wherein the pump (figure 2 col 7 line 24 – col 8 line 2, the pump is positioned within the circuit and conveys entire fluid within the circuit. Accordingly, the pump simultaneously conveys blood from the blood collection line to cell separator 40 and further conveying the separated plasma from the cell separator 40 to column 11 via the plasma delivery line) is configured to simultaneously cause the blood to flow through the blood collection line to the blood separation device and cause the first fraction of the blood to flow through the plasma delivery line to the plasma processing device;
a first return line (annotated figure 2, first return line) connected to the plasma processing device and configured to receive a processed first fraction (figure 2 col 7 line 24 – col 8 line 2, the first return line is configured to receive treated plasma from column 11) of the blood; and
a second return line (annotated figure 2, a second return line is configured to receive blood cell portion of the blood) connected to the blood separation device and configured to receive a second fraction of the blood (figure 2 col 7 line 24 – col 8 line 2, blood cell portion), wherein the second return line is connected to the first return line, thereby allowing the second fraction of the blood to be combined with the processed first fraction of the blood (annotated figure 2 and col 7 line 24 – col 8 line 2, the first and second line are connected and configured to mix the blood cells with the treated plasma);
wherein said pump comprises a channel, wherein said portion of the blood collection line and said portion of the plasma delivery line are arranged within the channel, and wherein the pump is configured to cause the received blood to flow through the blood collection line and cause the first portion of the blood to flow through the plasma delivery line.
Jones does not teach wherein and a portion of the plasma delivery line is positioned within the pump;
wherein said pump comprises a channel, wherein said portion of the blood collection line and said portion of the plasma delivery line are arranged within the channel, and wherein the pump is configured to cause the received blood to flow through the blood collection line and cause the first portion of the blood to flow through the plasma delivery line.
In the same field of endeavor, namely a blood ultrafiltration system, Verita teaches a peristaltic pump (figures 1-3, double-channel peristaltic pump 14) and wherein a portion of the blood collection line and a portion of the plasma delivery line (figure 2 and [0057-[0058] portion of lines 10a and 10c positioned within the pump 14).
wherein said pump comprises a channel (figure 2, channel defined by frame 141 and a rotational radius of a rotor comprising arms 143 and 145), wherein said portion of the blood collection line and said portion of the plasma delivery line are arranged within the channel (figure 2, the lines 10a and 10c are positioned within the channel and rotation of the rotor conveys fluid in the both fluid lines), and wherein the pump is configured to cause the received blood to flow through the blood collection line and cause the first portion of the blood to flow through the plasma delivery line.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones to incorporate the teachings of Vartia and provide the pump and fluid line arrangement as claimed above for the purpose of controlling both the incoming blood and effluent fluid simultaneously with fewer component, for example instead of using separate pumps for each fluid line, which potentially reduce cost and complexity of the device as taught by Vartia ([0051]).
Regarding claim 133, Jones, as modified by Vartia, teaches the blood processing system of claim 1.
The combination further teaches wherein the pump is a peristaltic pump (Vartia; double channel peristaltic pump 14) that comprises a channel and a rotor (Vartia; figure 2 and [0058] channel defined by frame 141 and a rotational radius of a rotor comprising arms 143 and 145), wherein the rotor is configured to cause the received blood to flow through the blood collection line and cause the first portion of the blood to flow through the plasma delivery line (Vartia; [0058] rotation of rotor conveys fluid in the both fluid lines 10a and 10c).
Regarding claim 134, Jones, as modified by Vartia, teaches the blood processing system of claim 1.
The combination further teaches wherein each of said portion of the blood collection line and said portion of the plasma delivery line is arranged in a generally U-shape within said channel (Vartia; figure 2, the fluid lines 10a and 10c are generally arranged in U-shape along with the channel).
Regarding claim 135, Jones, as modified by Vartia, teaches the blood processing system of claim 1.
The combination does not teach wherein said portion of the blood collection line and said portion of the plasma delivery line are arranged to contact one another within the channel.
In the same field of endeavor, namely a blood ultrafiltration system, Vartia teaches wherein said portion of the blood collection line and said portion of the plasma delivery line are arranged to contact one another within the channel (figure 3b, the fluid lines 10a and 10c and in contact one another through web 10d’).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones, as modified by Vartia, to incorporate the teachings of Vartia and provides the blood collection line and the plasma deliver line as claimed for the purpose of providing the line segments into a unitary component thereby facilitating installation of the line segment onto the pump head as taught by Vartia ([0061]).
Regarding claim 136, Jones, as modified by Vartia, teaches the blood processing system of claim 1.
The combination does not teach wherein:
said portion of the blood collection line arranged within said channel comprises a first tube having a first internal diameter;
said portion of the plasma delivery line arranged within said channel comprises a second tube having a second internal diameter; and
said first and second internal diameters are different.
In the same field of endeavor, namely a blood ultrafiltration system, Vartia teaches wherein:
said portion of the blood collection line arranged within said channel comprises a first tube having a first internal diameter (figure 3b and [0060] diameter of fluid line 10a);
said portion of the plasma delivery line arranged within said channel comprises a second tube having a second internal diameter (figure 3b and [0060] diameter of fluid line 10c); and
said first and second internal diameters are different (figure 3b and [0060] the fluid lines 10a and 10c having different diameter).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones, as modified by Vartia, to incorporate the teachings of Vartia and provides the blood collection line and the plasma delivery line as claimed for the purpose of providing distinct flow rates within the respective lines using a single pump head as taught by Vartia ([0023]-[0025])
Regarding claim 137, Jones, as modified by Vartia, teaches the blood processing system of claim 136.
The combination further teaches wherein the pump is configured to simultaneously cause the blood flowing through the blood collection line to flow at a first flow rate and cause the first fraction of the blood flowing through the plasma delivery line to flow at a second flow rate that is different than the first flow rate (Vartia; [0057] the pump is configured to generate distinct flow rates Qa within blood line 10a and Qb within 10b).
Regarding claim 138, Jones, as modified by Vartia, teaches the blood processing system of claim 137.
The combination further teaches wherein the second flow rate is less than the first flow rate (Vartia; [0057] Qa is less than the Qb).
Regarding claim 139, Jones, as modified by Vartia, teaches the blood processing system of claim 136.
The combination further teaches wherein the first and second internal diameter are different (Vartia; figure 3b and [0060] the fluid lines 10a and 10c having different diameter)
Regarding claim 140, Jones, as modified by Vartia, teaches the blood processing system of claim 136.
The combination does not teach wherein a ratio between the first internal diameter and the second internal diameter is between approximately 1 and approximately 3; though
Vartia teaches wherein a ratio between the first internal diameter and the second internal diameter is between 3-99.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones, as modified by Vartia and provides the ratio of the first and second internal diameter is between approximately 1 and approximately 3 since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0073]), and therefore the claimed device is not patentably distinct from the prior art.
Regarding claim 141, Jones, as modified by Vartia, teaches the blood processing system of claim 136.
The combination does not teach wherein the ratio between the first internal diameter and the second internal diameter is approximately 2; though
Vartia teaches wherein a ratio between the first internal diameter and the second internal diameter is between 3-99.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones, as modified by Vartia and provides the ratio of the first and second internal diameter is approximately 2 since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0073]), and therefore the claimed device is not patentably distinct from the prior art.
Regarding claim 142, Jones, as modified by Vartia, teaches the blood processing system of claim 137.
The combination does not teach wherein the second flow rate is between approximately 20% and approximately 30% of the first flow rate; though
Vartia teaches wherein the second flow rate is between 1% and 25% of the first flow rate (Vartia; [0064] fraction F =Qc/Qa in the range of 0.01-0.25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones, as modified by Vartia and provides wherein the second flow rate is between approximately 20% and approximately 30% of the first flow rate since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0057]), and therefore the claimed device is not patentably distinct from the prior art.
Regarding claim 143, Jones, as modified by Vartia, teaches the blood processing system of claim 137.
The combination further teaches wherein the second flow rate is no greater than approximately 100 mL/minute (Jones; col 7 lines 10-15, the second flow rate through the plasma delivery line is in rage from about 10 to 30 mL/min)
Regarding claim 144, Jones, as modified by Vartia, teaches the blood processing system of claim 137.
The combination does not teach wherein the first flow rate is at least approximately 50 mL/minute; though Jones teaches the first flow rate through the blood collection line is in range from 10 to 50 mL/min (col 7 line 40-45).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones, as modified by Vartia and provides the first flow rate is at least approximately 50 mL/minute since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0074]), and therefore the claimed device is not patentably distinct from the prior art.
Regarding claim 145, Jones, as modified by Vartia, teaches the blood processing system of claim 1.
The combination further teaches comprising a third return line connected to both of the first and second return lines (Jones; annotated figure 2, the third line).
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Regarding claim 146, Jones, as modified by Vartia, teaches the blood processing system of claim 145.
The combination further teaches wherein the third return line is configured to deliver a second fraction of the blood to the subject along with a processed first fraction of the blood (Jones; col 7 line 45-50 “The blood cells are then mixed with the treated plasma and the recombined blood returned to the patient.”).
Regarding claim 149, Jones, as modified by Vartia, teaches the blood processing system of claim 1.
The combination further teaches wherein the blood separation device comprises a centrifugal separator (Jones; col 7 lines 1-23, withdrawn blood is separated into its cellular components and plasma by centrifugation) or at least one membrane and line and is configured to separate the blood into a first fraction and a second fraction, said first fraction comprising plasma and said second fraction comprising one or more cellular components of the blood.
Regarding claim 150, Jones, as modified by Vartia, teaches the blood processing system of claim 1.
The combination further teaches wherein said plasma processing device is an adsorption device (Jones; col 7 line 24- col 7 line 2, the immunoaffinity column 11 packed with immunoadsorbent) configured to adsorb at least a portion of the plasma of the first fraction of the blood to remove one or more substances from the first fraction of the blood (Jones; col 3 lines 5-15, the immunoadsorbent absorbs and removes free antigen and circulating immune complexes containing the antigen from the plasma).
Regarding claim 151, Jones, as modified by Vartia, teaches the blood processing system of claim 1.
The combination further teaches wherein the pump is the only pump in the blood processing system (Vartia; figure 1, pump 14)
Claim 147 and 148 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 5122112 A) in view of Vartia (US 20230025881 A1, foreign priority effectively filed 2019/12/13), and in further view of Maginot et al (US 20050096609 A1)
Regarding claim 147, Jones, as modified by Vartia, teaches the blood processing system of claim 145.
The combination does not teach comprising a blood source access device configured to connect to the third return line and deliver a second fraction of the blood to the subject along with a processed first fraction of the blood.
In the same field of endeavor, namely a catheter system for hemodialysis, Maginot teaches a blood source access device (figures 1 and 3 and [0127] dual catheter system 12 comprising ingress line 47 and egress line 47, and they are configured to be connected to inlet and outlet line of the hemodialysis machine 10 respectively. Examiner’s note: the blood source access device is interpreted as dual lumen catheter as set forth in claim 148) configured to connect to the third return line and deliver a second fraction of the blood to the subject along with a processed first fraction of the blood.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones, as modified by Vartia, to incorporate the teachings of Maginot and provide the blood source access device as claimed substituting venous and artery access of Jones as shown figure 2 for the purpose of effectively performing hemodialysis, as taught by Maginot ([0210]). Specifically, utilizing a dual lumen catheter in the hemodialysis procedure allows simultaneous withdrawal and return of blood through a single access point, while traditional catheter system requires multiple punctures for placement of separate withdrawal and return catheter. The modification simplifies the procedure, improves patient comfort, and reduces the likelihood of complications associated with multiple catheter placements.
Regarding claim 148, Jones, as modified by Vartia and Maginot, teaches the blood processing system of claim 147.
The combination further teaches wherein said blood source access device comprises a dual lumen catheter (Maginot; figure 1 and 3 and [0127] dual catheter system 12 comprising ingress line 47 and egress line 47), wherein the blood collection line is configured to connect to a first port (Maginot; [0127] egress line connected to the inlet line 16) of the dual lumen catheter and wherein the third return line is configured to connect to a second port (Maginot; [0127] ingress line 45 is connected to the outlet line 18) of the dual lumen catheter.
Claim 151 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 5122112 A) in view of Vartia (US 20230025881 A1, foreign priority effectively filed 2019/12/13), and in further view Roberts et al (US 20070181499 A1).
Regarding claim 151, Jones, as modified by Vartia, teaches the blood processing system of claim 150.
The combination does not expressly teach wherein the adsorption device comprises one or more absorptive materials selected from the group consisting of thermally expanded graphite (TEG), graphene nanoplatelets (GNPs), polymer derived ceramic carbide-derived carbon (PDC-CDC), an ion exchange resin, and a non-ion exchange resin.
In the same field of endeavor, namely a plasma detoxification and volume control system, Roberts teaches wherein the adsorption device comprises one or more absorptive materials selected from the group consisting of thermally expanded graphite (TEG), graphene nanoplatelets (GNPs), polymer derived ceramic carbide-derived carbon (PDC-CDC), an ion exchange resin, and a non-ion exchange resin ([abstract, 0044, 0064 and 0065] the toxin removal device comprises absorbent material for example ion exchange resins.)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jones, as modified by Vartia, to incorporate the teachings of Roberts and provides the absorption device as claimed for the purpose of removing free and protein-bound toxins associated with sepsis and renal failure from plasma as taught by Roberts (abstract).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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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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/S.H./Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781