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 .
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.
Priority
Receipt is acknowledged of certified copies of papers (JAPAN 2021-160264 09/30/2021) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements dated 1/2/2024; 4/10/2024; and 1/14/2026 have been considered and made of record.
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 limitation(s) is/are:
“a waste liquid accommodation unit” in claims 1 and 15 (corresponding structures ¶[0034] of the instant specification);
“a sampling unit” in claims 1 and 15 (corresponding structures ¶[0053] of the instant specification); and
“a cleaning solution accommodation unit” in claim 5 (corresponding structures ¶[0061] of the instant 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 § 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 9 and 13 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.
In claim 9, at line 2, “the sensor unit” lacks proper antecedent basis. Note: Claim 9 depends from claims 8 and 1 rather than claim 6. Clarification and/or correction is requested.
In claim 13, bridging lines 2 and 3, “the third waste liquid flow path” lacks proper antecedent basis. Note: Claim 13 depends from claim 6 rather than claim 12. Clarification and/or correction is requested.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8, 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Antwiler (US 2010/0042260) (Attached PTO-892) in view of Cannon et al. (US 2008/0032398) (Attached PTO-892).
With respect to claim 1, the reference of Antwiler discloses:
A cell culturing device (See annotated Fig. 2 below) comprising:
a circulation flow path ((first circulation path)(202) and (second fluid circulation path (206)) in fluid communication with a bioreactor (cell growth chamber)(100) and configured for flow of a liquid therein (¶[0017]);
a waste liquid flow path (waste line)(288) in fluid communication with the circulation flow path ((first circulation path)(202) and (second fluid circulation path (206)) and configured to receive a discard portion of the liquid from the circulation flow path (¶[0026]); and
a waste liquid accommodation unit (waste bag) (286) (Note: As discussed in the claim interpretation section above, the claim element “a waste liquid accommodation unit” is considered to invoke 35 USC 112(f). The instant specification at ¶[0034] discloses that the corresponding structure may include, for example, a medical bag, which is considered to be a corresponding structure described in the specification as performing the claimed function. As result, the waste bag of the reference of Antwiler is considered to meet this claim element.) in fluid communication with the waste liquid flow path and configured to receive and hold at least a portion of the discard portion of the liquid from the waste liquid flow path (¶[0026]).
PNG
media_image1.png
512
927
media_image1.png
Greyscale
Claim 1 differs by reciting that the culturing device includes a sampling unit in fluid communication with the waste liquid flow path between the circulation flow path and the waste liquid accommodation unit.
The reference of Antwiler discloses a sample port (216) in first circulation path (202) and a sample port (230) in second fluid circulation path (206). The reference also discloses that glucose and/or lactate measurements can be taken by any means on either the IC (202), EC (206) or in the waste line (288) (¶[0033]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide a sample port in fluid communication with the waste liquid flow path between the circulation flow path and the waste accommodation unit for the known and expected result of providing a sampling port for detection of glucose and/or lactate in the waste stream as suggested by the disclosure of Antwiler.
As discussed above, while the reference of Antwiler suggests providing a sample port in fluid communication with the waste liquid flow path between the circulation flow path and the waste accommodation unit, the reference does not specifically disclose that the sample port includes a sampling unit (Note: As discussed in the claim interpretation section above, the claim element “a sampling unit” is considered to invoke 35 USC 112(f). The instant specification at ¶[0053] identifies the corresponding structure could or may be any of a measurement circuit 88, a biosensor 90, a cleaning solution accommodation unit 92, a first standard solution accommodation unit 94, and a second standard solution accommodation unit 96).
The reference of Cannon et al. discloses that it is known in the art to provide a cell culture device with a sampling apparatus (¶[0052], [0053], [0072] and [0073]) that can include a measurement circuit (¶[0052]), an analyzer (¶[0053]) and a flushing system (¶[0052]) which is considered to be a structural and functional equivalent to the claimed sampling unit.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to communicate a sampling apparatus as suggested by the reference of Cannon et al. with the sampling port suggested by the reference of Antwiler for the known and expected result of providing an art recognized means for sampling and analyzing the sample in a sterile and automated manner.
With respect to claim 8, the structure resulting from the combination of the references as discussed above with respect to claim 1 would encompass a culturing device that includes a check valve configured to allow the liquid to move in a first direction toward the waste liquid accommodation unit and prevents movement of the liquid in a second direction toward the circulation flow path (see check valve (37) of Cannon et al.).
With respect to claim 10, the bioreactor (cell growth chamber) (100) of the reference of Antwiler includes: a plurality of hollow fiber membranes (hollow fibers) (116); and a housing (cell growth chamber housing) (104) configured to receive the plurality of hollow fiber membranes; and the circulation flow path includes: a first circulation flow path (first circulation path)(202) in communication with a first region of the plurality of hollow fiber membranes; and a second circulation flow path (second fluid circulation path (206)) in communication with a second region of the plurality of hollow fiber membranes, the plurality of hollow fiber membranes being configured to allow the liquid to travel between the first region and the second region (Fig. 1 and ¶[0014]-[0016] of Antwiler).
With respect to claim 11, the reference of Antwiler discloses the first region is defined by interior surfaces of the plurality of hollow fiber membranes (intracapillary space), and the second region (extracapillary space) is defined by a space between the plurality of hollow fiber membranes and an interior-surface of the housing (Fig. 1 and ¶[0014]-[0016] of Antwiler).
With respect to claim 12, the reference of Antwiler discloses the waste liquid flow path includes: a first waste liquid flow path in fluid communication with the first circulation flow path; a second waste liquid flow path in fluid communication with the second circulation flow path; and a third waste liquid flow path in fluid communication with the first and second waste liquid flow paths and also the waste liquid accommodation unit (See annotated Fig. 2 above).
With respect to claim 14, the structure resulting from the combination of the references as discussed above with respect to claim 1 would encompass a culturing device wherein the sampling unit and the waste liquid flow path are aseptically joined (See the abstract of Cannon et al. which discusses “The integral flowpath cartridge aseptic sampling system”).
Claims 2, 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Antwiler (US 2010/0042260) (Attached PTO-892) in view of Cannon et al. (US 2008/0032398) (Attached PTO-892) taken further in view of Antwiler (US 2008/0220523) (Attached PTO-892).
With respect to claims 2 and 3, the combination of the references of Antwiler (’260) and Cannon et al. has been discussed above with respect to claim 1.
While the structure resulting from the combination of the references as discussed above with respect to claim 1 would encompass a sampling flow path in fluid communication with the waste liquid flow path communication with an analyzer, claims 2 and 3 differ by reciting that the sampling flow path includes a biosensor which can be a glucose sensor or a lactic acid sensor.
The reference of Antwiler (‘260) discloses that glucose and/or lactate measurements can be taken by any means on either the IC (202), EC (206) or in the waste line (288) (¶[0033]).
The reference of Antwiler (‘523) discloses that the use of commercially available glucose and lactate sensors (¶[0079]) can be used in a culture device as disclosed in the reference of Antwiler (‘260).
In view of these disclosures and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a commercially available glucose and/or lactate sensor within the sampling flow path for the known and expected result of providing an art recognized means for measuring glucose and/or lactate as suggested by the reference of Antwiler (‘260).
With respect to claim 15, the reference of Antwiler (‘260) discloses:
A cell culturing system comprising:
a cell culturing device (See annotated Fig. 2 above) comprising:
a circulation flow path ((first circulation path)(202) and (second fluid circulation path (206)) in fluid communication with a bioreactor (cell growth chamber)(100) and configured for flow of a liquid therein (¶[0017]);
a waste liquid flow path (waste line)(288) in fluid communication with the circulation flow path ((first circulation path)(202) and (second fluid circulation path (206)) and configured to receive a discard portion of the liquid from the circulation flow path (¶[0026]); and
a waste liquid accommodation unit (waste bag) (286) (Note: As discussed in the claim interpretation section above, the claim element “a waste liquid accommodation unit” is considered to invoke 35 USC 112(f). The instant specification at ¶[0034] discloses that the corresponding structure may include, for example, a medical bag, which is considered to be a corresponding structure described in the specification as performing the claimed function. As result, the waste bag of the reference of Antwiler (‘260) is considered to meet this claim element.) in fluid communication with the waste liquid flow path and configured to receive and hold at least a portion of the discard portion of the liquid from the waste liquid flow path (¶[0026]).
Claim 15 first differs by reciting that the culturing device includes a sampling unit in fluid communication with the waste liquid flow path between the circulation flow path and the waste liquid accommodation unit.
The reference of Antwiler (‘260) discloses a sample port (216) in first circulation path (202) and a sample port (230) in second fluid circulation path (206). The reference also discloses that glucose and/or lactate measurements can be taken by any means on either the IC (202), EC (206) or in the waste line (288) (¶[0033]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide a sample port in fluid communication with the waste liquid flow path between the circulation flow path and the waste accommodation unit for the known and expected result of providing a sampling port for detection of glucose and/or lactate as suggested by the disclosure of Antwiler (‘260).
As discussed above, while the reference of Antwiler (‘260) suggests providing a sample port in fluid communication with the waste liquid flow path between the circulation flow path and the waste accommodation unit, the reference does not specifically disclose that the sample port includes a sampling unit (Note: As discussed in the claim interpretation section above, the claim element “a sampling unit” is considered to invoke 35 USC 112(f). The instant specification at ¶[0053] identifies the corresponding structure could or may be any of a measurement circuit 88, a biosensor 90, a cleaning solution accommodation unit 92, a first standard solution accommodation unit 94, and a second standard solution accommodation unit 96).
The reference of Cannon et al. discloses that it is known in the art to provide a cell culture device with a sampling apparatus (¶[0052], [0053], [0072] and [0073]) that can include a measurement circuit (¶[0052]), an analyzer (¶[0053]) and a flushing system (¶[0052]) which is considered to be a structural and functional equivalent to the claimed sampling unit.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to communicate a sampling apparatus as suggested by the reference of Cannon et al. with the sampling port suggested by the reference of Antwiler (‘260) for the known and expected result of providing an art recognized means for sampling and analyzing the sample in a sterile and automated manner.
Claim 15 further differs by reciting that the culture system includes:
a support device configured to receive the cell culturing device, the support device including a plurality of clamps configured to apply a pressure to one or more portions of the circulation flow path or the waste liquid flow path.
The reference of Antwiler (‘523) discloses that it is known in the art to provide the device components as disclosed in the reference of Antwiler (‘260) as a detachable flow circuit which can be configured to attach to fixed portions of a fluid flow controller (a support device) of the cell expansion system which can include pumps, valves and clamps (¶[0100]-[0106]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to mount the modified culture device of the combination of the references of Antwiler (‘260) and Cannon et al. on a fluid flow controller as suggested by the reference of Antwiler (‘523) for the known and expected result of allowing the fluid flow control components of the cell expansion system to be reused between different culture methods.
Claims 4, 5 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Antwiler (US 2010/0042260) (Attached PTO-892) in view of Cannon et al. (US 2008/0032398) (Attached PTO-892) and Antwiler (US 2008/0220523) (Attached PTO-892) taken further in view of Smith et al. (US 8,026,096) (Attached PTO-892).
The combination of the references of Antwiler (’260), Cannon et al. and Antwiler (‘523) has been discussed above with respect to claims 2 and 15.
Claim 4 differs by reciting that the sampling flow path includes : a first end in fluid communication with the waste liquid flow path; and a second end in fluid communication with the waste liquid flow path between the first end and the waste liquid accommodation unit, wherein the biosensor is disposed between the first end and the second end of the sampling flow path.
The reference of Smith et al. discloses that it is known in the art, when sampling media from a stream of fluid in a culture system, to provide an extraction loop (230) (Fig. 3) for diverting flow for analysis of metabolites within the culture media (Col. 23, line 65, to col. 24, line 59).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the sampling flow path as an extraction loop as suggested by the reference of Smith et al. for the known and expected result of providing an art recognized sampling structure for analysis of the culture medium while allowing the detected stream to be returned to the waste stream so as to avoid the need for the use of two separate waste containers in the system.
With respect to claim 5, the reference of Cannon et at. discloses that the use of a cleaning or flushing fluid is known in the art for cleaning the sample flow path between samples (¶[0052]). As a result, it would have been well within the purview of one having ordinary skill in the art to provide a cleaning solution accommodating unit (a container, such as a bag or a tank)(Note: As discussed in the claim interpretation section above, the claim element “a waste liquid accommodation unit” is considered to invoke 35 USC 112(f). The instant specification at ¶[0061] discloses that the corresponding structure may include, for example, a medical bag or a tank, which is considered to be a corresponding structure described in the specification as performing the claimed function.) to flush the biosensor within the sample stream to prevent contamination and/or reliable test results between samples.
Claim 16 first differs by reciting that the sampling flow path includes a biosensor.
The reference of Antwiler (‘260) discloses that glucose and/or lactate measurements can be taken by any means on either the IC (202), EC (206) or in the waste line (288) (¶[0033]).
The reference of Antwiler (‘523) discloses that the use of commercially available glucose and lactate sensors (¶[0079]) can be used in a culture device as disclosed in the reference of Antwiler (‘260).
In view of these disclosures and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a commercially available glucose and/or lactate sensor within the sampling flow path for the known and expected result of providing an art recognized means for measuring glucose and/or lactate as suggested by the reference of Antwiler (‘260).
Claim 16 further differs by reciting that the sampling flow path includes : a first end in fluid communication with the waste liquid flow path; and a second end in fluid communication with the waste liquid flow path between the first end and the waste liquid accommodation unit, wherein the biosensor is disposed between the first end and the second end of the sampling flow path.
The reference of Smith et al. discloses that it is known in the art, when sampling media from a stream of fluid in a culture system, to provide an extraction loop (230) (Fig. 3) for diverting flow for analysis of metabolites within the culture media (Col. 23, line 65, to col. 24, line 59).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the sampling flow path as an extraction loop as suggested by the reference of Smith et al. for the known and expected result of providing an art recognized sampling structure for analysis of the culture medium while allowing the detected stream to be returned to the waste stream so as to avoid the need for the use of two separate waste containers in the system.
With respect to the clamps required of claims 17 and 18, the reference of Antwiler (‘523) discloses that it is known in the art to provide the device components as disclosed in the reference of Antwiler (‘260) as a detachable flow circuit which can be configured to attach to fixed portions of a fluid flow controller (a support device) of the cell expansion system which can include pumps, valves and clamps (¶[0100]-[0106]). As a result, the use of clamps to control the flow of the fluid within the waste liquid flow path and sampling fluid flow path would have been well within the purview of one having ordinary skill in the art since the clamping of tubes within the disposable fluid circuit would simplify the structure of the system by avoiding the use of more complex valves.
Claims 6, 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Antwiler (US 2010/0042260) (Attached PTO-892) in view of Cannon et al. (US 2008/0032398) (Attached PTO-892) taken further in view of Marx et al. (US 2013/2095598) (Attached PTO-892).
The combination of the references of Antwiler (’260) and Cannon et al. has been discussed above with respect to claim 1.
With respect to claims 6 and 7, the structure resulting from the combination of the references of Antwiler (‘260) and Cannon et al. fails to disclose a sensor unit for measuring pH in fluid communication with the waste liquid flow path between the circulation flow path and the sampling unit.
The reference of Marx et al. discloses that it is known in the art to monitor the status of the conditions within a culture system using sensors, including pH sensors, wherein the sensors are positioned in the intracapillary fluid, the extracapillary fluid and/or waste collector (¶[0055]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide a pH sensor in the waste liquid flow path for the known and expected result of providing a means recognized in the art to monitor the pH within the culture device. Placement of the sensor in the flow path prior to the sampling unit would ensure that the detected pH is not influenced by the analyzers or biosensors of the sampling unit.
With respect to claim 13, the reference of Antwiler discloses the waste liquid flow path includes: a first waste liquid flow path in fluid communication with the first circulation flow path; a second waste liquid flow path in fluid communication with the second circulation flow path; and a third waste liquid flow path in fluid communication with the first and second waste liquid flow paths and also the waste liquid accommodation unit (See annotated Fig. 2 above). Positioning of the sampling unit in communication with the third waste liquid flow path would have been obvious such that a single sampling unit can be used to sample from with the first or second flow path.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Antwiler (US 2010/0042260) (Attached PTO-892) in view of Cannon et al. (US 2008/0032398) (Attached PTO-892) and Antwiler (US 2008/0220523) (Attached PTO-892) taken further in view of Marx et al. (US 2013/2095598) (Attached PTO-892).
The combination of the references of Antwiler (’260), Cannon et al. and Antwiler (‘523) has been discussed above with respect to claim 15.
With respect to claim 19, the structure resulting from the combination of the references of Antwiler (‘260), Cannon et al. and Antwiler (‘523) fails to disclose a sensor unit for measuring pH in fluid communication with the waste liquid flow path between the circulation flow path and the sampling unit.
The reference of Marx et al. discloses that it is known in the art to monitor the status of the conditions within a culture system using sensors, including pH sensors, wherein the sensors are positioned in the intracapillary fluid, the extracapillary fluid and/or waste collector (¶[0055]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide a pH sensor in the waste liquid flow path for the known and expected result of providing a means recognized in the art to monitor the pH within the culture device. Placement of the sensor in the flow path prior to the sampling unit would ensure that the detected pH is not influenced by the biosensors of the sampling unit.
With respect to claim 20, the structure resulting from the combination of the references as discussed above with respect to claims 15 and 19 would encompass a culturing device that includes a check valve configured to allow the liquid to move in a first direction toward the waste liquid accommodation unit and prevents movement of the liquid in a second direction toward the circulation flow path (see check valve (37) of Cannon et al.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The reference of Wolfe et al. (US 4,999,298) (Attached PTO-892) is cited as prior art which pertains to a culture system that includes circulation flow path with a bioreactor, a waste line in communication with the flow path and a pH probe in communication with the flow path.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights