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 with traverse of Group, I, claims 1-9, in the reply filed on 17 February 2026 is acknowledged. The traversal is on the ground(s) that the technical features of showing a measurement of pressure decay within a plurality of flow lines in special technical features not disclosed in Oppegard et al. This is not found persuasive because Oppegard et al. disclose a medical fluid delivery system comprising a plurality of flow lines leading to various components of the delivery system and performing a pressure decay test on each of the components to determine if the components leak, including the filter, the pumps, the valves, the dialysis fluid circuit (paragraphs [0018], [0020-0022], [0031-0032], [0047-0048], [0086], [0089], [0094], [0114], [0119] and [0132]) is not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 17 February 2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 25 May 2023, 31 July 2023, 05 February 2024, 03 July 2024, 11 June 2025, 15 November 2025, and 06 March 2026 1-2are compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because of the following:
Figures 1-2: Blank reference boxes 110, 210, 210a, 210b, 210c, and 310 should also be labeled with their representative structure in order to more easily identify the structure quickly that is utilized in the invention without having to read through the specification.
Reference box (110) should also be labeled -- Controller --. See 37 C.F.R. 1.83(a) below.
1.83 Content of drawing.
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(a) The drawing in a nonprovisional application must show every feature of the invention specified in the claims. However, conventional features disclosed in the description and claims, where their detailed illustration is not essential for a proper understanding of the invention, should be illustrated in the drawing in the form of a graphical drawing symbol or a labeled representation (e.g., a labeled rectangular box). In addition, tables that are included in the specification and sequences that are included in sequence listings should not be duplicated in the drawings.
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(b) When the invention consists of an improvement on an old machine the drawing must when possible exhibit, in one or more views, the improved portion itself, disconnected from the old structure, and also in another view, so much only of the old structure as will suffice to show the connection of the invention therewith.
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(c) Where the drawings in a nonprovisional application do not comply with the requirements of paragraphs (a) and (b) of this section, the examiner shall require such additional illustration within a time period of not less than two months from the date of the sending of a notice thereof. Such corrections are subject to the requirements of § 1.81(d).
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[31 FR 12923, Oct. 4, 1966; 43 FR 4015, Jan. 31, 1978; paras. (a) and (c) revised, 60 FR 20195, Apr. 25, 1995, effective June 8, 1995; para. (a) revised, 69 FR 56481, Sept. 21, 2004, effective Oct. 21, 2004; para. (a) revised, 78 FR 62368, Oct. 21, 2013, effective Dec. 18, 2013]
PLEASE NOTE THAT A REFERENCE NUMERAL IS NOT A LABEL.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 8 is objected to because of the following informalities:
Re claim 8, claim line 4: The term – interface – should replace the term “interfaces.”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0037485 (Wilt et al.).
With respect to the limitations of claim 1, Wilt et al. disclose a method for assessing the integrity of a bioprocessing system (leak testing a blood treatment system), comprising the steps of:
utilizing a pump of a bioprocessing 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]).
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 2-9 are rejected under 35 U.S.C. 103 as being unpatentable over US (Wilt et al.).
With respect to the limitation of claim 2, Wilt et al. disclose utilizing a pump for effecting a flow of liquid through the plurality of flow lines during operation of the bioprocessing system. Wilt et al. fail to 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, Wilt et al. further disclose 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, Wilt et al. further disclose 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, Wilt et al. disclose 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. Wilt et al. disclose 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, Wilt et al. disclose isolating the subset of the plurality of flow lines by the actuation of the 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, Wilt et al. further disclose 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, Wilt et al. further disclose 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, Wilt et al. disclose a plurality of components that are 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 disclose means for testing the integrity of various bioprocessing components or testing the integrity of fluid lines.
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 Martin 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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