DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 13 July 2026 has been entered.
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, 3-6 and 8-17 are rejected under 35 U.S.C. 103 as being unpatentable over Fricking (US 20130316396) in view of Faldt (US 20180346864) and Bleile (US 20140166653).
With respect to claims 1, 3, 8, 9 and 11-14, Fricking discloses a bioreactor comprising a chamber (Figure 2:100) and a filter (Figure 2:200) disposed within the bioreactor chamber. The filter is fluidically connected to an exterior of the bioreactor chamber through at least one fluid conduit (Figure 2:220). Paragraph [0026] notes that the filter is at least partially submerged. Another fluid conduit (Figure 2:300) functions as a tether that loosely tethers the filter to the bioreactor chamber while allowing the filter to move within a predefined constrained volume. The two conduits 220, 300 allow movement of the filter but are configured to prevent the filter from touching an inner surface of the bioreactor chamber in use. This is described in paragraph [0029] (“The flexible tubes 220, 300 are coupled through the wall of the bioreactor bag 100. The flexible tubes 220, 300 are flexible enough to permit the filter assembly 200 to move freely on the liquid surface 170. If necessary, the length and the position of the flexible tubes 220, 300 in relation to the bioreactor wall may be arranged such that the movement of the perfusion filter assembly 200 is somewhat limited, e.g. to prevent the filter assembly 200 from colliding with the walls of the bioreactor 100. In such a way, the operational durability of the perfusion filter may be further increased”).
Accordingly, it is believed that the fluid conduit 220 reads on the claimed “at least one fluid conduit”, and that the additional fluid conduit 300 reads on the claimed “at least one tether”. Although Fricking teaches that the filter moves laterally across a predefined constrained volume of the bioreactor chamber in a controllable manner (i.e., due to the properties of features 220, 300), it is unclear if the tether 300 also allows for vertical movement.
Faldt discloses a bioreactor comprising a chamber (Figure 1:3) having a filter (Figure 1:7) disposed therein. The filter is suspended in a culture medium by a plurality of flexible tethers (Figure 1:15, 21a-d) that allow the filter to move but prevent the filter from touching an inner surface of the chamber. Tethers 21a-d are provided at the four corners of the filter (see Fig. 2) and are configured as flexible plastic strips. Faldt further describes in paragraph [0031] that heat-sealed seams are utilized to attach features to the bioreactor.
Bleile discloses a reactor comprising a chamber (Figure 1B:10) and a cover (Figure 1B:20) suspended within a fluid medium disposed inside the container. Paragraph [0044] teaches that the cover may be configured as a membrane. At least one tether (Figure 3A:50) loosely tethers the membrane to the reactor chamber, thereby allowing the membrane to move laterally and vertically within a predefined constrained volume spaced from an inner surface of the chamber. This is taught in paragraphs [0022]-[0036] and in the abstract (“By adjusting the length of the restraining tether 50, an operator can ensure that the cover is relaxed or is pulled taut” and “two or more guide assemblies spaced about the peripheral wall for securing the cover to the peripheral wall and for permitting the cover to freely travel substantially vertically up and down within the interior space. Each assembly has a vertical guide, a clamping member, and an upper and a lower delimiting stop”). Paragraph [0029], in particular, states that lateral extensions (Figure 3B:70) are provided in communication with the tethers in order to adjust the extent to which the membrane is permitted to move laterally. Bleile teaches in paragraphs [0029] and [0030] that the tethers 50 may be constructed from flexible materials (e.g., chain, cable, rope) and may have varying lengths to permit a loose and relaxed membrane orientation that allows limited vertical and lateral movement through a predefined space.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Fricking bioreactor with multiple tethers that controllably permit vertical and lateral movement of the filter throughout a predefined constrained volume. Bleile and Faldt show how this provides additional mechanical strength to the filter while not compromising the ability of the filter to move within a restricted space. Faldt, in particular, states that orienting the filter a set distance away from a bioreactor sidewall produces a crossflow filtration effect that reduces clogging and fouling, and thereby allows the filter to be used for a longer time. Bleile shows how the length of the tether and the provision of vertical/lateral guides enables one to control the movement and activity of a membrane (“filter”) within a reactor volume.
With respect to claim 4, Fricking, Faldt and Bleile disclose the combination as described above. Fricking further shows that the filter includes an upper layer (Figure 1a:26) and a filtration membrane (Figure 1a:21) coupled to the upper layer. The tether is attached to a surface of the filter via a barb port (Figure 1a:27).
With respect to claim 5, Fricking, Faldt and Bleile disclose the combination as described above. Fricking states in paragraph [0025] that the filter is constructed using buoyant material, such that the filter floats on the culture media surface.
With respect to claim 6, Fricking, Faldt and Bleile disclose the combination as described above. Fricking teaches in paragraph [0026] that a distribution mesh (Figure 1a:24) is disposed between the upper layer 26 and the filtration membrane 21.
With respect to claim 10, Fricking, Faldt and Bleile disclose the combination as described above. Fricking teaches in paragraph [0012] that the tether 300 is flexible. As previously discussed, Bleile also teaches flexible tethers.
With respect to claim 15, Fricking, Faldt and Bleile disclose the combination as described above. Fricking indicates in paragraph [0004] that the movement of the filter across the surface of the culture media induces de-clogging of the filter (“As the bioreactor is rocked, the filter moves rapidly back and forth in the culture media. This back and forth motion serves to clean the filter and allows it to operate without severe clogging”).
With respect to claims 16 and 17, Fricking, Faldt and Bleile disclose the combination as described above. Fricking shows in Figs. 1 and 2 and teaches in paragraph [0014] that the chamber is a flexible bag that is configured to operate as a perfusion bioreactor.
Conclusion
This is a non-final rejection.
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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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
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