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) in the reply filed on June 3, 2026 is acknowledged.
Claims 11-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 3, 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 5-10 are objected to because of the following informalities:
Claim 5 recites, “determination part”, which after consultation with the specification is the “drive control function” component within the processing circuitry portion of the control apparatus (Specification; pg. 15 lines 15-25, drive control function (101); Fig. 2, Step 15 (ST15)). Claim 5 fails to make it understood that the determination part is a portion of the processing circuitry mentioned in the following claims (claims 6-10).
Claims 6-10 recite, “processing circuitry” as a controller of the greater system being claimed which is configured to do a variety of actions relating to the system’s function. Within the claims it is never stated that the processing circuitry is comprised of any other components. However, in the specification it clearly states that the drive control function is a portion of the processing circuitry which controls the drive mechanism in order to operate each part of the biosample processing apparatus (Specification; pg. 9 line 32 – pg. 10 line 32, processing circuitry (100), memory (110); pg. 15 lines 15-25, Fig. 1, drive control function (101) is the determination part). There is a disconnect between whether the processing circuitry is enacting all of the actions claimed in claims 6-10 or if the processing circuitry is communicating to another/other component(s) to complete the actions.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“first collection part” recited in claims 1, 2, 6, and 7. Claim 1 recites “first collection part” on lines 5, 9 and 12; claim 2 on line 4; claim 6 on lines 7 and 11; claim 7 on line 4.
For examination purposes “first collection part” will be interpreted as a filter (Specification; pg. 5 lines 16-25; Fig. 1, cell capturing part (14), target cells (T)), as recited in the specification.
“separation part” recited in claims 1-4 and 6-9. Claim 1 recites “separation part” on lines 9 and 16; claim 2 on lines 5, 8, and 10; claim 3 on lines 5, 7, 9, and 10; claim 4 on lines 6 and 9; claim 6 on line 9; claim 7 on lines 8 and 12; claim 8 on lines 6, 10, 11-12, and 15-16; claim 9 on lines 6 and 10.
For examination purposes “separation part” will be interpreted to be a filter (specification; pg. 2 line 33 to pg. 3 line 2; pg. 5 line 32 to pg. 6 line 8; Fig. 1, unnecessary component removal part (16), blood plasma component (P), biosample (S)), as recited in the specification.
“second collection part” recited in claims 1-4, and 6-9. Claim 1 recites “second collection part” on line 13; claim 2 on lines 8, 8-9, 10-11, and 11-12; claim 3 on lines 10-11; claim 4 on lines 6-7 and 7-8; claim 6 on line 9; claim 7 on lines 6, 8-9, 13, and 14; claim 8 on lines 9-10; claim 9 on line 5.
For examination purposes “second collection part” will be interpreted as a vessel for supplying the blood plasma that has been separated (Specification; pg. 6 lines 25-32; Fig. 1, blood plasma component supply part (18), syringe (18a), piston (18b), blood plasma component (P)), as recited in the specification.
“connection part” recited in claims 2, 3, 7, and 8. Claim 2 recites “connection part” on line 7; claim 3 on line 7; claim 7 on line 7; claim 8 on line 5.
For examination purposes “connection part” will be interpreted to be a location where any part connects to the flow paths established (Specification; pg. 4 lines 22-25), as recited in the specification.
“third collection part” recited in claims 4 and 9. Claim 4 recites “third collection part” on lines 2 and 9; claim 9 on lines 2, 7, and 10.
For examination purposes “third collection part” will be interpreted as the vessel which takes an amount of the blood plasma to be tested (Specification; pg. 6 lines 9-16, Fig.1, test sample collection port (17)), as recited in the specification.
“acquisition part” recited in claim 5 on line 3.
For examination purposes “acquisition part” will be interpreted as the “communication control function” portion of the control system which receives an analysis result (Specification; pg. 15 lines 4-14, communication control function (102); Fig. 2, Step 14 (ST14)), as recited in the specification.
“determination part” recited in claim 5 on line 5.
For examination purposes “determination part” will be interpreted as the “drive control function” portion of the control system which receives the analysis result from the acquisition part (Specification; pg. 15 lines 15-25, drive control function (101); Fig. 2, Step 15 (ST15)), as recited in the specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawakura (US5314624A).
Regarding claim 1, Kawakura teaches:
A biosample processing apparatus (Kawakura; Abstract, Col. 2 line 52 - Col. 3 line 24) comprising:
a sample supply part (Kawakura; Col. 1 lines 49 - 56; Figs. 1 and 4, blood supply line (2), blood pump (1)) connected to one end of a tubular flow path (Kawakura; Col. 1 lines 49 - 56; Figs. 1 and 4, blood supply line (2), blood pump (1)) and configured to supply a first sample containing components extracted from a subject to the flow path (Kawakura; Abstract; The nature of blood being filtered it is inherent that the blood is extracted from a subject.);
a first collection part (Kawakura; Col. 1 lines 49 - 56; Figs. 1 and 4, blood pump (1), blood supply line (2), primary filter (3), blood cell return line (4)) provided on the flow path and configured to collect target cells (Kawakura; Col. 1 lines 49 - 56; Figs. 1 and 4, blood pump (1), blood supply line (2), primary filter (3), blood cell return line (4); Target cells are the blood cells being sent into the blood cell return line (4)) to be cultured from the first sample supplied to the flow path (A recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus. See MPEP 2114(II));
a separation part (Kawakura; Col. 1 line 57 to Col. 2 line 4; Figs. 1 and 2, plasma pump (5), secondary filter (8)) provided downstream of the first collection part (Kawakura; Kawakura; Col. 1 line 57 to Col. 2 line 4; Figs. 1 and 4, plasma pump (5), secondary filter (8); The secondary filter (8) read to the separation part is shown to be downstream of the primary filter (3) read to the first collection part in figures 1-4) on the flow path and configured to separate a blood plasma component or a blood serum component as a second sample (Kawakura; Col. 1 line 57 to Col. 2 line 4; Figs. 1 and 2, plasma pump (5), secondary filter (8), purified plasma return line (9)) from the first sample from which the target cells have been collected by the first collection part; and
a second collection part (Kawakura; Col. 1 line 57 to Col. 2 line 4; Figs. 1 and 4, plasma pump (5), secondary filter (8), purified plasma return line (9), heating bag (10)) connected to another end of the flow path and configured to collect the second sample separated by the separation part (Kawakura; The purified plasma return line (9) and heating bag (10) are being read to the second collection part which receives the filtered plasma which is read to the second sample referenced in the claim).
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okazaki (US8758603B2).
Regarding claim 1, Okazaki teaches:
A biosample processing apparatus (Okazaki; Abstract) comprising:
a sample supply part (Okazaki; Col. 1 line 42 - Col. 2 line 4, Fig. 1, collected blood circuit (1), blood pump (7)) connected to one end of a tubular flow path (Okazaki; Col. 1 line 42 - Col. 2 line 4, Fig. 1, blood circuit (1), plasma circuit (4), blood pump (7)) and configured to supply a first sample containing components extracted from a subject to the flow path (Okazaki; Abstract; The nature of blood being filtered it is inherent that the blood is extracted from a subject.);
a first collection part (Okazaki; Col. 1 lines 42-63, Fig. 1, plasma separator (5)) provided on the flow path and configured to collect target cells (Okazaki; Col. 1 lines 42-63, return blood circuit (2); The collected blood circuit (1) blood is separated in the plasma separator yielding blood plasma and the "target cells" the blood cells in return blood circuit (2)) to be cultured from the first sample supplied to the flow path (A recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus. See MPEP 2114(II));
a separation part provided downstream of the first collection part (Okazaki; Col. 5 line 66 - Col. 6 line 34, Fig. 1, plasma circuit (4), plasma component separator (6a), plasma pump (8)) on the flow path and configured to separate a blood plasma component or a blood serum component as a second sample (Okazaki; Col. 5 line 66 - Col. 6 line 34, Fig. 1, return plasma circuit (15), plasma component separator (6a), return plasma pump (16)) from the first sample from which the target cells have been collected by the first collection part; and
a second collection part (Okazaki; Col. 5 line 66 - Col. 6 line 34, Fig. 1, return plasma circuit (15), plasma component separator (6a), return plasma pump (16)) connected to another end of the flow path and configured to collect the second sample separated by the separation part (Okazaki; Col. 5 line 66 - Col. 6 line 34, Fig. 1, return plasma circuit (15), plasma component separator (6a), return plasma pump (16); The return plasma circuit collects and transports the filtered plasma component).
Regarding claim 6, Okazaki teaches all of the elements of the current invention as stated with respect to claim 1. Okazaki teaches:
The biosample processing apparatus according to claim 1, further comprising
processing circuitry (Okazaki; Col. 6 line 25 - Col. 7 line 15; Fig. 1, processing unit (30), first pressure measuring means (10), second pressure measuring means (11), third pressure measuring means (12), fourth pressure measuring means (13), control unit (31), blood pump (7), plasma pump (8), air pump (9), return plasma pump (16); Table 1, The measurement of the pressure differences across the decides how the control unit uses the pumps which it is able to control pump blood through the filters and collection parts) configured to:
supply the first sample containing the components extracted from the subject from the sample supply part to the flow path (Okazaki; Col. 6 lines 26-34, Fig. 1, control unit (31), blood pump (7), collected blood circuit (1)),
collect the target cells to be cultured from the first sample supplied to the flow path to the first collection part (Okazaki; Col. 6 line 35 - Col. 7 line 15; Table 1; Fig. 1, control unit (31) blood pump (7), plasma separator (5), air pump (9)),
separate the blood plasma component or the blood serum component as the second sample by the separation part from the first sample from which the target cells have been collected by the first collection part (Okazaki; Col. 6 line 35 - Col. 7 line 15; Table 1; Fig. 1, plasma pump (8), return plasma pump (16), plasma component separator (6a), control unit (31)),
and collect the separated second sample to the second collection part (Okazaki; Col. 6 line 35 - Col. 7 line 15; Table 1; Fig. 1, plasma pump (8), air pump (9), return plasma pump (16), return plasma circuit (15), plasma component separator (6a), control unit (31); the return plasma circuit collects and transports the filtered plasma component).
Allowable Subject Matter
Claims 2-5 and 7-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the limitations that are neither taught nor rendered obvious by the prior art are as follows:
“a culture part connected to a location between the sample supply part and the first collection part and”
“[the culture part]…connected to a location between the separation part and the second collection part;”
“and a first switch part provided at a connection part of the culture part between the separation part and the second collection part and
“configured to selectively switch between a direction of flow from the separation part to the second collection part and a direction of flow from the second collection part to the culture part.”
Regarding claim 3, the limitations that are neither taught nor rendered obvious by the prior art are as follows:
“a second switch part provided at a connection part of the separation part between the flow path and the discharge path and”
“configured to selectively switch between a direction of flow from the separation part to the second collection part and a direction of flow from the separation part to the discharge path.”
Regarding claims 2 and 3, the closest prior art to the claimed invention are those which refer to hemodialysis and other apparatuses involving the filtering of blood. The prior art found closest to read on the claim was Kawakura (US5314624A).
Kawakura teaches a blood filtering apparatus (Kawakura; Abstract, Col. 2 line 52 - Col. 3 line 24). The apparatus includes a filter which separates out the blood cells (Kawakura; Col. 1 lines 49 - 56; Figs. 1 and 4, blood pump (1), blood supply line (2), primary filter (3), blood cell return line (4); Target cells are the blood cells being sent into the blood cell return line (4)) and another filter downstream which separates off impurities to achieve filtered blood plasma (Kawakura; Col. 1 line 57 to Col. 2 line 4; Figs. 1 and 4, plasma pump (5), secondary filter (8); The secondary filter (8) read to the separation part is shown to be downstream of the primary filter (3) read to the first collection part in figures 1-4). These two filtered components are mixed in a heater bag to be reinfused into the originator of the blood (Kawakura; Col. 1 line 57 to Col. 2 line 4; Figs. 1 and 4, blood cell return line (4), plasma pump (5), secondary filter (8), purified plasma return line (9), heating bag (10)). Kawakura also includes a discharge path (Kawakura; Col. 5 line 57 – Col. 6 line 31, Fig. 2, waste line (14), valve (14a)) for the unnecessary components following the second filter which purifies the blood plasma component.
Kawakura includes no mention or concept of cell culture and cell collection beyond that which is meant to purify a person’s blood and return it to their body. As a result, Kawakura includes no need or mention of switches which enable flow directions to be changed to allow for the washing of the target blood cells and the disposal of the wash as well as the disposal of unneeded filtered plasma. Therefore, Kawakura is unable to read on:
the culture part which is connected to a point between the sample supply part and first collection part and connected to a point between the separation part and the second collection part
switches configured to enable the discharge of the wash used on the target cells collection in the first collection part and configured to discharge the unneeded/excess filtered blood plasma
Regarding claim 7, the limitations that are neither taught nor rendered obvious by the prior art are as follows:
“a culture part connected to a location between the sample supply part and the first collection part and connected to a location between the separation part and the second collection part”
“a first switch part provided at a connection part of the culture part between the separation part and the second collection part and configured to switch a direction of the flow path,”
“wherein the processing circuitry selectively switches the first switch part to a direction of flow from the separation part to the second collection part or a direction of flow from the second collection part to the culture part.”
Regarding claim 7, the closest prior art to the claimed invention is those which refer to a control apparatus for hemodialysis and other apparatuses involving the filtering of blood. The prior art found closest to read on the claim was Okazaki (US8758603B2).
Okazaki teaches all of the elements of the current invention as stated with respect to claim 6.
Okazaki includes no mention or concept of cell culture and cell collection beyond that which is meant to purify a person’s blood and return it to their body. As a result, Okazaki includes no need or mention of switches which enable flow directions to be changed to selectively collect or dispose of the filtered plasma components. This also means that the processing circuitry or control unit of Okazaki does not have control of switches for these purposes. Therefore, Okazaki is unable to read on:
“a culture part connected to a location between the sample supply part and the first collection part and connected to a location between the separation part and the second collection part”
“a first switch part provided at a connection part of the culture part between the separation part and the second collection part and configured to switch a direction of the flow path,”
“wherein the processing circuitry selectively switches the first switch part to a direction of flow from the separation part to the second collection part or a direction of flow from the second collection part to the culture part.”
Regarding claim 8, the limitations that are neither taught nor rendered obvious by the prior art are as follows:
“a second switch part provided at a connection part of the separation part between the flow path and the discharge path,”
“wherein the processing circuitry selectively switches the second switch part to a direction of flow from the separation part to the second collection part or a direction of flow from the separation part to the discharge path and”
“discharges the first sample after the second sample is separated from the discharge path when the second switch part is switched to the direction of flow from the separation part to the discharge path.”
Regarding claim 8, the closest prior art to the claimed invention is those which refer to a control apparatus for hemodialysis and other apparatuses involving the filtering of blood. The prior art found closest to read on the claim was Okazaki (US8758603B2).
Okazaki teaches all of the elements of the current invention as stated with respect to claim 6.
Okazaki includes no mention or concept of a discharge path or a switch that allows for the flow out of said discharge path. As a result, the processing circuitry or control unit of Okazaki does not have control of switches for these purposes. Therefore, Okazaki is unable to read on:
“a second switch part provided at a connection part of the separation part between the flow path and the discharge path,”
“wherein the processing circuitry selectively switches the second switch part to a direction of flow from the separation part to the second collection part or a direction of flow from the separation part to the discharge path and”
“discharges the first sample after the second sample is separated from the discharge path when the second switch part is switched to the direction of flow from the separation part to the discharge path.”
Regarding claims 4 and 5, both claims 4 and 5 are dependent on claim 2 and are thus allowable as a result of the allowance of claim 2.
Regarding claims 9 and 10, both claims 9 and 10 are dependent on claim 7 and are thus allowable as a result of the allowance of claim 7.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONAVAN L BRIDGES whose telephone number is (571)272-9636. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/DONAVAN L. BRIDGES/Examiner, Art Unit 1758
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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