DETAILED ACTION
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. However, the Figures do not appear to show multiple filters of decreasing pore size in the direction of flow. Therefore, this feature must be shown or canceled from the claims. No new matter should be entered.
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.
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.
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.
Claims 1, 2, 4, 7 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 8802361) in view of Wang (US 20130131423) and Nakaguma (WO 2014014089)1.
With respect to claims 1 and 7, Lee discloses an organ preservation apparatus comprising a perfusion pump circuit having a cassette (Figure 1:12) configured to contain an organ (Figure 1:14) and a perfusion fluid for preservation of the organ. A first pump (Figure 1:20) and a first tubing (Figure 1:16) are fluidly coupled and configured to circulate the perfusion fluid through the organ via a first recirculation loop. Lee teaches that a second pump 20 and a second tubing (Figure 1:18) are also fluidly coupled to the cassette and are configured to circulate the perfusion fluid through a second recirculation loop. This is described in column 7, lines 6-17. Lee teaches that both the first and second recirculation loops may include a filter (Figure 1:28) configured to screen the perfusion fluid. Lee, however, does not expressly teach that this second recirculation loop is configured as a perfusion solution filtering device, such that the filter 28 is designed to remove virus and bacteria.
Wang discloses a perfusion solution filtering device comprising a filter (Figure 1:3) configured to separate a fluid containing a virus and/or bacteria. This is taught in paragraph [0061]. Cleaned perfusion fluid (Figure 1:7) is sent back to a source using a pump (Figure 1:2). In at least some embodiments, multiple filters are provided, wherein the filters have a decreasing pore size in the direction of flow. See, for example, Figure 7 showing multiple filters 19 of decreasing size. Paragraph [0061] teaches a pore size of about 60 nm designed specifically to capture a virus.
Nakaguma discloses a perfusion solution filtering device comprising a filter (Figure 1:3) configured to separate a virus and/or bacteria from a circulating fluid (“The polymer substrate for virus removal according to (5) or (6), wherein the polymer substrate is a porous hollow fiber, a nonwoven fabric, or a dialysis membrane,
(8) The polymer substrate for virus removal according to (7), wherein the polymer substrate is a porous hollow fiber, (9) The polymer substrate for virus removal according to (8) above, wherein the average flow pore size of the porous hollow fiber is in the range of 50 to 500 nm”). Nakaguma teaches a filter pore size as low as 50 nm and discusses filter pore sizes as low as 20 nm appearing in the prior art.
Before the effective filing date of the claimed invention, it would have been obvious to configure the filter in communication with Lee’s second pump and second tubing as a filter designed to remove virus and bacteria. Wang and Nakaguma each teach that there is a need in the art to eliminate pathogens and contaminants from medical fluid, and that a possible solution is through filtration. Wang and Nakaguma show how the properties of a filter may be adjusted to determine what viral and bacterial contaminants are selectively removed. Wang, in particular, indicates that multiple filters of decreasing pore size are especially effective in removing differently sized contaminants or particles in a stepwise manner.
With respect to the limitation “consisting essentially of”, it is noted that although Lee shows in Fig. 1 that the organ perfusion system may include additional structures such as an air trap 30 and a heat exchanger 32, those of ordinary skill would have recognized that each of these features may be removed when not necessary or to reduce the cost of assembly and operation. In other words, it would have been obvious to arrange the modified Lee system to consist essentially of a perfusion pump circuit having a cassette and a first pump, a perfusion solution filtering device having a filter and a second pump, input tubing and output tubing. It is entirely within the ability of one of ordinary skill to choose not to use optional elements (e.g., oxygenator, bubble trap, heat exchanger) based on the organ to be perfused, the goals of the perfusion operation, to reduce costs, to simplify the construction of the system, or for essentially any other reason or for no reason. Furthermore, it is well established that the phrase “consisting essentially of” occupies a middle ground between closed claims that are written in a “consisting of” format and fully open claims that are drafted in a “comprising” format. Unlike the narrow limitation “consisting of”, the term “consisting essentially of” does not exclude features that do not materially affect the basic and novel characteristics of the claimed invention. Here, the novel feature of the organ preservation device involves the use of a filter to identify a virus positive organ, and does not preclude auxiliary elements (e.g., oxygenator, bubble trap, heat exchanger) that operate according to well known principles.
With respect to claim 2, Lee, Wang and Nakaguma disclose the combination as described above. Lee further states the pump may be a peristaltic pump (“The system 10 also includes one or more pumps 20, such as a peristaltic pump”).
With respect to claim 4, Lee, Wang and Nakaguma disclose the combination as described above. Lee shows in Fig. 1 the required input and output tubing to connect the perfusion pump circuit and the modified perfusion solution filtering device.
With respect to claims 10, 14 and 18, Lee, Wang and Nakaguma disclose the combination as described above. Lee discloses a corresponding method in which an organ is placed into the cassette, and the perfusion pump is operated to pass fluid through the first and second recirculation loops 16,18 in order to restore and preserve an organ for transplantation. Wang and Nakaguma teach methods in which in which a perfusion solution filtering device is used to filter a perfusion fluid in order to remove a virus. Wang specifically states that the purpose is to remove a virus to produce a cleaned perfusion fluid. Wang teaches in paragraphs [0072] and [0073] that a fluid is first tested to identify a virus position condition and that the filter is operated until a cleaned fluid is produced.
With respect to claims 11-13, 15-17, 19 and 20, Lee, Wang and Nakaguma disclose the combination as described above. Lee states in column 1, lines 26-39 that the organ to be transplanted may be a kidney. Wang teaches in paragraphs [0026], [0045] and [0062] that the virus to be removed in a hepatitis virus.
Claims 3, 5, 6, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 8802361) in view of Wang (US 20130131423) and Nakaguma (WO 2014014089) as applied to claims 1, 4 and 7, and further in view of Wright (US 20040248281).
Lee, Wang and Nakaguma disclose the combination as described above. Lee, however, does not teach sampling ports or a housing to contain the filter, pump and second tubing.
Wright discloses an organ preservation apparatus comprising a cassette for holding an organ (Figure 2:60). The cassette (Figure 2:65) is serviced by at least first and second tubings and first and second pumps. Paragraphs [0065]-[0069] teach that a housing (Figure 11:200) is provided for supporting a pump, a portion of tubing, and at least one filter. Wright further states in paragraphs [0049] and [0066] that sample ports (Figure 11:295) are provided to draw a liquid in or out of the tubing.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Lee system with a housing and sample ports to facilitate transport and maintenance of the organ. Wright teaches that these are common features in the tissue preservation art, and that enable improved handling and diagnostics. It is prima facie obvious to apply a known technique to a known device ready for improvement to yield predictable results. See MPEP 2143.
Response to Arguments
In response to Applicant’s amendment, a new ground of rejection is made in view of the combination of Lee with Wang and Nakaguma.
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 NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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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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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
1 See provided English translation
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