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 .
Summary
This is the initial Office action on the 17/997711 application filed on 11/1/22.
Claims 1-9 are pending and have been fully considered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63,003706, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application only provides support for instant application Figure 8. There is no disclosure of a method as currently claimed. Accordingly, claims 1-9 are not entitled to the benefit of the prior application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/3/23 and 11/1/22 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: control device in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-9 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 1 recites “a control device” which falls under 35 USC 112f interpretation as stated above, but the current specification as filed does not disclose what structure is constituted by the term "control device".
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.
Claim limitation “control device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification as filed does not disclose what structure is constituted by the term "control device". Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over GUINN (US 4889812) as cited on both IDS, in view of WEST (US 2005/01858701).
Regarding claim 1-2, 6-7, GUINN discloses controlling operation of a bioreaction process comprising:
A microprocessor based circuit as a system control device that is programmed to monitor and regulate all aspects of cell culture in a bioreactor automatically (sending computer-readable instructions from a control device to a bioreactor, automatically adjusting fluid circuit) (Col 7, lines 3-34), the system control 76 being located remotely distanced at a separate location than the bioreactor system 16 (Fig 1);
Wherein the bioreactor system comprises: a bioreactor chamber 16, a reservoir 12, (Fig 1), level detecting devices 94, 96 (volume of fluid) and a probe manifold 154 for pH, oxygen and glucose (sensors) (Col. 9, lines 14-43), two fluid circuits (first and second section of fluid circuit) comprising a first for nutrient fluid to a bioreactor 28 from reservoir (Col. 3, line 54-60, fig 1) and second for harvest fluid from the bioreactor to the reservoir 30 (Col. 5, lines 43-65, Fig 1),
The microprocessor can also be used to automate harvesting of the cell by-products, as by withdrawing a predetermined volume of harvest fluid from the bioreactor 16 periodically according to a predetermined schedule, (Col 7, lines 9-12) (receiving the computer-readable instructions to the bioreactor system; operating the bioreactor system based on the computer-readable instructions);
wherein the operating the bioreactor system comprises the steps of:
obtaining sensor measured values for at least three parameters via the plurality of sensors the probes are able to monitor the pH, oxygen, glucose, liquid level and specifically providing a set point via the placement of the level sensors, receiving indication from the level detectors of the fluid level compared to the set points, and controlling the fluid circuit to add or removed fluid until the level is at the specified level (automatically adjusting one of the parameters) (Col. 4, line 55-Col 5, line 42, col 9, lines 41-43).
Guinn does not explicitly disclose providing a predetermined setpoint; comparing the sensor measured values to the predetermined setpoint; and controlling the fluid circuit to: remove some of the first fluid from the bioreactor chamber, add some of the second fluid to the bioreactor chamber, or a combination thereof, until each of the sensor measured values substantially matches the predetermined setpoint for all three parameters.
However, WEST discloses an integrated bioreactor monitor and control system and method of use comprising a controller/computer with computer readable instructions (0105) located at a remote location from a bioreactor (Fig 1), the bioreactor system comprising a bioreactor chamber 105, a media vessel (reservoir) (0055), a fluid circuit between the bioreactor and the gas/liquid control in the utility tower (Fig 2) and a plurality of sensors e.g. temperature pH dissolved oxygen and level/foam communicating the controller (0033), in which specified set points can be programmed into the control system (providing predetermined setpoint), the system compares a monitored condition relative to the specified set point, and controls the fluid circuit to add fluid to the bioreactor until the difference between the monitored and desired values decreases (until sensor measured values match predetermined set point), in which the process can be done for pH, oxygen and temperature conditions (all three parameters) (0097-104) with automated control (automatically adjusting fluid circuit to all of the parameters) (0088).
It would have been obvious to one of ordinary skill in the art to modify the method of GUINN to include the providing a predetermined setpoint; comparing the sensor measured values to the predetermined setpoint; and controlling the fluid circuit to: remove some of the first fluid from the bioreactor chamber, add some of the second fluid to the bioreactor chamber, or a combination thereof, until each of the sensor measured values substantially matches the predetermined setpoint steps for three parameters rather than only the liquid level as taught by WEST because it facilitates reproduction of the process in a more precise manner when all parameters are adjusted by an electronic control and allows for easy incorporation of regulations governing control procedures (0006-7).
Regarding claim 3, GUINN discloses cells and cellular by-products are in the bioreactor (Col 3, lines 1-15) and growth factors (Col 6, lines 1-10) (plurality of biological factors).
Regarding claim 4, GUINN discloses the first fluid is a nutrient fluid (Col. 4, lines 1-10).
Regarding claim 5, GUINN discloses the second fluid is a nutrient fluid in combination with a gas (Col 3, lines 42-60).
Regarding claim 8, WEST discloses the adjusting of cell growth conditions form a plurality of data signals form the sensor system can occur simultaneously (0088).
Regarding claim 9, WEST discloses the system is configured to operate in a batch process or continuous (recirculation or perfusion culturing mode) and is capable of controlling changing from one to another (0088).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional references on the attached PTO 892 represent the state of the art of applicant’s invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799