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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12 May 2026 and 01 July 2026 were filed after the mailing date of the first Office Action on 07 April 2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings were received on 01 July 2026. These drawings are acceptable.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 01 July 2026, with respect to the rejections of claims 1-9 under US 2013/0037485 (Wilt) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2013/0037485 (Wilt) in view of US 10,240,117 (Dahlberg et al.).
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0037485 (Wilt) in view of US 10,240,117 (Dahlberg et al.).
With respect to the limitations of claim 1, Wilt et al. disclose a method for assessing the integrity of a system (leak testing a blood treatment system), comprising the steps of:
utilizing a pump of a system, pressurizing a plurality of flow lines (various integrity tests are performed to verify the devices and flow lines in the system are leak-proof by placing the components of the system under positive pressure through some means of pressurization - paragraphs [0897-0914]); and
measuring a decay of a pressure within the plurality of flow lines for a predetermined duration (a pressure decay test is performed to ensure that the system components are leak-proof - paragraphs [0897-0914]). Wilt fails to expressly disclose that the system is a single-use bioprocessing kit.
Dahlberg et al. disclose a bioreactor container and an integrity check method for bioreactor containers, whereby the bioreactor container (1) is a flexible container with at least one container opening/exit (9a-9d – Figure 1). An integrity check of the container (1) can be performed by connecting the at least one container opening (9a) to a fluid source (27). The container (1) is filled with fluid from the source (27) at a time T1 with a predetermined positive pressure P1. A pressure difference P2-P1 between a second pressure P2 at a second time T1 is compared with the first pressure P1 to determine if a leak is present in the container (col. 12, lines 14-42 and Figure 9). Modifying the method of Wilt to test the integrity of a bioprocessing kit would have been obvious to one of ordinary skill in the art at the time of filing the invention as it is known in the art to test structures with a pressure decay method; and it is not inventive to take a known process and apply it to new structure. Moreover, the Examiner argues that a bioreactor is utilized in a bioprocessing system for processing or for storage; and its use as a culture vessel is a choice of design that would be obvious to one of ordinary skill in the art at the time of filing the invention.
With respect to the limitation of claim 2, the combination (Wilt et al.) discloses utilizing a pump for effecting a flow of liquid through the plurality of flow lines during operation of the system. The combination fails to expressly disclose that the pump is a peristaltic pump; however, the Examiner argues that the type of pump being used is a choice of design that would be obvious to one of ordinary skill in the art at the time of filing the application. Moreover, the type of pump used does not provide novelty to the method of assessing the integrity of a system. One of ordinary skill in the art would have the requisite knowledge of which type of pump is advantageous for the process being performed and would use a particular pump over another pump based on said advantages.
With respect to the limitation of claim 3, the combination (Wilt et al.) further discloses the step of actuating at least one valve to isolate a subset of the plurality of flow lines prior to pressurizing the subset of the plurality of flow lines. It is notoriously well-known to manipulate valves to isolate specific components within a system. Wilt et al. also disclose verifying that the valves within the system open and close properly (paragraphs [0907-0910]).
With respect to the limitation of claim 4, the combination (Wilt et al.) further discloses the step of isolating the plurality of flow lines by actuating at least one valve to leak test the components of the system. This isolation includes tubing and connections to bagged dialysate and other components of the blood treatment system. The particular type of product attached at the end of a tubing line does not provide novelty to the method of assessing the integrity of a system or a tube connection within the system. One of ordinary skill in the art would have the requisite knowledge to attach any number of products to a tubing line and would want to ensure that the connection is leak free.
With respect to the limitation of claim 5, the combination (Wilt et al.) discloses isolating the subset of the plurality of flow lines by the actuation of the at least one valve includes a waste line configured for connection to a waste bag. The combination (Wilt et al.) discloses that it is well-known to utilize a waste valve (18) (Figure 1). Additionally, Wilt et al. disclose a procedure whereby the system is purged of fluid and disinfected/rinsed, the fluid of which needs to be contained to ensure that hazardous fluids do not come into contact with people. Providing a waste bag to collect hazardous fluid would have been well within the purview of one of ordinary skill in the art as a means of keeping people safe by disposing of blood products.
With respect to the limitation of claim 6, the combination (Wilt et al.) discloses isolating the subset of the plurality of flow lines by the actuation of at least one valve includes a flow line connected to a hollow fiber filter. It is notoriously well-known to manipulate valves to isolate specific components within a system, such as a filter (paragraph [0911]). The Examiner argues that the type of filter being used is a choice of design that would be obvious to one of ordinary skill in the art at the time of filing the application. Moreover, the type of filter used does not provide novelty to the method of assessing the integrity of a system. One of ordinary skill in the art would have the requisite knowledge of which type of filter is advantageous for the process being performed and would use a particular filter over another filter.
With respect to the limitation of claim 7, the combination (Wilt et al.) further discloses the step of actuating at least one valve to isolate a bioreactor vessel of the bioprocessing system from the pressure in the plurality of flow lines prior to pressurizing the plurality of flow lines. It is notoriously well-known to manipulate valves to isolate specific components within a system to test for leakage, such as a cartridge or cassette (paragraphs [0898-0899]). The Examiner argues that the cartridge used to make the dialysate is equivalent to a bioreactor and one of ordinary skill in the art at the time of filing the application would want to make sure connections were leak free.
With respect to the limitation of claim 8, the combination (Wilt et al.) further discloses the step of measuring a pressure decay within the plurality of flow lines utilizing a pressure sensor intermediate a first pneumatic interface and a second pneumatic interfaces (a pressure decay is utilized to leak test the various components of the system, whereby the components of the system are tested by gas under pressure – paragraphs [0897-0914]).
With respect to the limitation of claim 9, the combination (Wilt et al.) discloses a plurality of components leak tested by a gas under pressure, including a plurality of filters. The filters since operating in a dialysis system need to be sterile to prevent the spread of disease within the blood product.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art to US 9,534,980 discloses a method for testing the integrity of a bioreactor container by measuring a change in pressure over time of the positive pressure of the container.
The prior art to US 2016/0272931 discloses equipment utilized to manufacture chemical agents using disposable containers and means of testing the integrity of the disposable containers.
The prior art to JP 4907038 discloses a method for regulating and controlling one bioreactor installation and means of testing the integrity of the bioreactors.
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 DANIEL SEAN LARKIN whose telephone number is 571-272-2198. The examiner can normally be reached M-F 9:00 AM - 5:30 PM.
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, Laura Sweeney can be reached at 571-272-2160. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL S LARKIN/Primary Examiner, Art Unit 2855
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