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 II comprising claims 9 – 12 and new claims 15 – 19 in the reply filed on 9/19/2025 is acknowledged.
Claims 1 – 8, 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Claim Objections
Claim 19 is objected to because of the following informalities: Claim 19 does not end in a period. Appropriate correction is required.
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 and 15 – 17 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 can be operated and networked under the control of a remote computer; Abstract; paragraphs 174 and 240), the method comprising:
establishing network connections with a plurality of computer systems corresponding to a plurality of automated process control stations, each configured to control a plurality of automated cell engineering systems 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 (paragraphs 27 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 (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 (paragraphs 174 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 by:
initiating a cell engineering process according to a cell culture growth protocol in the corresponding plurality of automated cell engineering systems (paragraphs 8 and 240);
receiving, at the automated process control system via the plurality of network connections, process information from the corresponding plurality of automated cell engineering systems (paragraphs 27 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 (paragraphs 27 and 174).
Regarding claim 16, Smith teaches the method of claim 9, further comprising providing to the first computer system the cell culture growth protocol update (paragraphs 174 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 (paragraphs 174, 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.
However, Seiver teaches systems for analyzing information history and modifying local user access based on the information history (paragraphs 23, 49 and 72). These steps would enable process and product information to remain secure and accessible to appropriate personal. 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.
However, Zalewski teaches analyzing control information history to determine local user compliance with best practices such as accepted community standards (paragraphs 18, 58 and 103). 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 (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 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
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, Elizabeth A Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796