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
Claims 1 – 8, 13 and 14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9/19/2025.
Response to Arguments
Applicant's arguments, filed 6/18/2026, regarding the rejection of claims 9, 10 and 15 – 17 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Smith et al. (US 2017/0175063 A1; hereinafter “Smith”), have been fully considered but they are not persuasive. Regarding claim 9, applicant alleges that Smith does not anticipate the claimed method. Examiner respectfully disagrees. Regarding claim 9, Smith teaches a method of controlling a plurality of automated process control stations via a central control station (a plurality of automated tissue engineering systems comprising one or more tissue engineering modules (tissue engineering modules 118; paragraph 175; figure 5), each comprising a bioreactor, can be operated and networked under the control of a remote computer; Abstract; paragraphs 38, 173, 174 and 240; figure 2), the method comprising: establishing network connections with a plurality of computer systems corresponding to a plurality of automated process control stations (the tissue engineering system of the present invention in various embodiments is under the control of one or more microprocessors (paragraph 138); the tissue engineering system is provided with a communications link 114 (paragraph 174; figure 2); it is also within the scope of the invention to have a plurality of automated tissue engineering systems operating and networked under the control of a remote computer; paragraphs 138 and 240), each configured to control a plurality of automated cell engineering systems (tissue engineering modules 118; paragraph 175) configured for production of cell cultures (paragraphs 8 and 240); accessing, by the central control station, control information history of a first computer system from the plurality of computer systems (a tissue engineering module comprising at least one bioreactor comprises a linked microprocessor (paragraph 79) comprises a first computer system; the tissue engineering system includes a central microprocessor which can keep track of processing events that would include process control information (e.g., for various tissue engineering protocols; paragraph 183) and quality control records; paragraphs 27, 29, 69, 138, 173 and 174); and providing to the first computer system at least one of a cell culture growth protocol update and a cell engineering software update (a computer/communications link 114 provides the capability to upload new software, modify control parameters using an external computer, download data as well as troubleshoot and test the device; paragraphs 27 and 174). See also the comments and annotations in the revised rejection below.
Claim Objections
The previous object to claim 19 has been withdrawn.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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(s) 9, 10, 15 – 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Smith et al. (US 2017/0175063 A1; hereinafter “Smith”).
Regarding claim 9, Smith teaches a method of controlling a plurality of automated process control stations via a central control station (a plurality of automated tissue engineering systems comprising one or more tissue engineering modules (tissue engineering modules 118; paragraph 175; figure 5), each comprising a bioreactor, can be operated and networked under the control of a remote computer; Abstract; paragraphs 38, 173, 174 and 240; figure 2), the method comprising:
establishing network connections with a plurality of computer systems corresponding to a plurality of automated process control stations (the tissue engineering system of the present invention in various embodiments is under the control of one or more microprocessors (paragraph 138); the tissue engineering system is provided with a communications link 114 (paragraph 174; figure 2); it is also within the scope of the invention to have a plurality of automated tissue engineering systems operating and networked under the control of a remote computer; paragraphs 138 and 240), each configured to control a plurality of automated cell engineering systems (tissue engineering modules 118; paragraph 175) configured for production of cell cultures (paragraphs 8 and 240);
accessing, by the central control station, control information history of a first computer system from the plurality of computer systems (a tissue engineering module comprising at least one bioreactor comprises a linked microprocessor (paragraph 79) comprises a first computer system; the tissue engineering system includes a central microprocessor which can keep track of processing events that would include process control information (e.g., for various tissue engineering protocols; paragraph 183) and quality control records; paragraphs 27, 29, 69, 138, 173 and 174); and
providing to the first computer system at least one of a cell culture growth protocol update and a cell engineering software update (a computer/communications link 114 provides the capability to upload new software, modify control parameters using an external computer, download data as well as troubleshoot and test the device; paragraphs 27 and 174).
Regarding claim 10, Smith teaches the method of claim 9, further comprising providing the cell engineering software update to the plurality of computer systems (a computer/communications link 114 provides the capability to upload new software, modify control parameters using an external computer, download data as well as troubleshoot and test the device (i.e., tissue engineering modules 118; paragraph 175); paragraphs 27, 174, 183 and 240).
Regarding claim 15, Smith teaches the method of claim 9, wherein each of the plurality of computer systems is configured to control a corresponding plurality of automated cell engineering systems (tissue engineering modules 118) by:
initiating a cell engineering process according to a cell culture growth protocol in the corresponding plurality of automated cell engineering systems (the central processor unit (CPU) 128 controls the operational sequence, the transport of fluids and gases, the management of process data, the monitoring of system status, the user interface, and the external data communications port (paragraph 176); paragraphs 8, 24, 27, 44, 66, 79, 138 and 240);
receiving, at the automated process control system via the plurality of network connections (a computer/communications link 114 provides the capability to upload new software, modify control parameters using an external computer, download data as well as troubleshoot and test the device (i.e., tissue engineering modules 118; paragraph 175); paragraphs 27, 174, 183 and 240), process information (tracking of processing events (i.e., process information) can be performed by the central microprocessor and/or module-based microprocessor for incorporation into quality control records; paragraph 29) from the corresponding plurality of automated cell engineering systems (paragraphs 27, 29 and 174), and
providing a plurality of control signals to cause the corresponding plurality of automated cell engineering systems to adjust one or more process parameters of the corresponding plurality of automated cell engineering systems in accordance with the cell culture growth protocol based on the process information (a computer/communications link 114 provides the capability to upload new software, modify control parameters using an external computer, download data as well as troubleshoot and test the device (i.e., tissue engineering modules 118; paragraph 175); paragraphs 27, 174, 183 and 240).
Regarding claim 16, Smith teaches the method of claim 9, further comprising providing to the first computer system the cell culture growth protocol update (a computer/communications link 114 provides the capability to upload new software, modify control parameters using an external computer, download data as well as troubleshoot and test the device (i.e., tissue engineering modules 118; paragraph 175); paragraphs 27, 174, 183 and 240).
Regarding claim 17, Smith teaches the method of claim 16, further comprising
providing an updated plurality of control signals to cause the plurality of automated cell engineering systems to adjust one or more process parameters of the plurality of automated cell engineering systems in accordance with the cell culture growth protocol update during the cell engineering process (a computer/communications link 114 provides the capability to upload new software, modify control parameters using an external computer, download data as well as troubleshoot and test the device (i.e., tissue engineering modules 118; paragraph 175); paragraphs 27, 174, 183, 194 and 240).
Regarding claim 20, Smith teaches the method of claim 9, wherein the control information history includes at least one of records of control signals sent to one or more automated cell engineering systems, process parameters, process information, or production information recorded over time (a computer/communications link 114 provides the capability to modify control parameters using an external computer, download data as well as troubleshoot and test the device (i.e., tissue engineering modules 118; paragraph 175); tracking of processing events (which implicitly includes process information and or production information) can be performed by the central microprocessor and/or the module-based microprocessor for incorporation into quality control records (paragraph 29); paragraphs 27, 174, 183, 194 and 240).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2017/0175063 A1; hereinafter “Smith”) in view of Seiver et al. (US 2018/0241768 A1; hereinafter “Seiver”).
Regarding claim 11, Smith does not specifically teach the method of claim 9, further comprising analyzing the control information history; and modifying local user access to the first computer system based on the analysis of the control information history. Smith does teach tracking of processing events (e.g., process control information) can be performed by the central microprocessor and/or module-based microprocessor for incorporation into quality control records; paragraph 29).
However, Seiver teaches systems for analyzing information history and modifying local user access based on the information history (e.g., paragraphs 23, 49 and 72). These steps would enable process and product information to remain secure and accessible to appropriate personal. The same concept and methodology taught by Seiver can be readily applied and adapted to the operation of the Smith tissue engineering system. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the steps of analyzing the control information history; and modifying local user access to the first computer system based on the analysis of the control information history.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2017/0175063 A1; hereinafter “Smith”) in view of Zalewski et al. (WO 2009/055342 A1; hereinafter “Zalewski”).
Regarding claim 12, Smith does not specifically teach the method of claim 9, further comprising analyzing the control information history to determine local user compliance with best practices. Smith does teach tracking of processing events (e.g., process control information) can be performed by the central microprocessor and/or module-based microprocessor for incorporation into quality control records; paragraph 29).
However, Zalewski teaches analyzing control information history to determine local user compliance with best practices such as accepted community standards (e.g., paragraphs 18, 58 and 103). The same concept and methodology taught by Zalewski can be readily applied and adapted to the operation of the Smith tissue engineering system. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the step of analyzing the control information history to determine local user compliance with best practices.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2017/0175063 A1; hereinafter “Smith”) in view of Tamura et al. (US 7,487,117 B1; hereinafter “Tamura”).
Regarding claim 18, Smith does not specifically teach the method of claim 9, wherein the cell culture growth protocol update corresponds to an updated cell culture delivery requirement.
Regarding claim 19, Smith teaches the method of claim 9, further comprising monitoring one or more parameters of the cell culture growth protocol associated with an automated cell engineering system of the plurality of automated cell engineering systems (e.g., paragraphs 27, 174 and 240), but does not specifically teach the steps of: projecting, according to the monitoring, a cell culture delivery date; and alerting an authorized user in advance of the cell culture delivery date.
However, Tamura teaches a sales support system incorporating delivery projection and delivery updates of products or services (Abstract; col. 12, lines 3 – 5; col. 20, lines 33 – 36) and alerting an authorized user in advance of the delivery date (col. 9, lines 52 – 55). The same concept and methodology taught by Tamura can be readily applied and adapted to the operation of the Smith tissue engineering system. The rationale to support an obviousness rejection under 35 U.S.C. 103 may rely on logic and sound scientific principle (see MPEP § 2144.02). The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success (see MPEP § 2143.02). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the cell culture growth protocol update corresponds to an updated cell culture delivery requirement and the steps of: projecting, according to the monitoring, a cell culture delivery date; and alerting an authorized user in advance of the cell culture delivery date to facilitate effective product delivery.
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 BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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