DETAILED ACTION
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, 9, 10, 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lobedann (US 20160375159) in view of Runyon (US 7682823) and Fischer (US 5312011).
With respect to claims 1, 9, 10 and 13, Lobedann discloses an incubation device comprising a helical coil (Figure 2:1) comprising an inlet port (Figure 2:4) for receiving fluid and an outlet port (Figure 2:5) for dispensing the fluid. The helical coil is supported by an incubation housing comprising at least one frame (Figure 2:3) that allow multiple helical coils to be vertically stacked (see also Figs. 5 and 7). Lobedann, however, does not appear to teach that the incubation housing is configured as an incubation chamber having an internal cavity for receiving the helical coil, or that the incubation housing has a top exterior surface having a recessed edge configured to releasably mate with a bottom perimeter flange of another incubation chamber.
Runyon discloses an incubation chamber (Figure 6:230) comprising an inlet port for receiving fluid and an outlet port for dispensing fluid via a plurality of conduits (Figure 4:170, 180, 190, 200). The incubation chamber includes a base and an internal cavity for receiving a liquid container (Figure 2:105). Runyon shows in Fig. 6 and describes in column 19, lines 27-39 that the incubation chamber has a top exterior surface having a first contour and a bottom exterior surface having a second contour, such that the top exterior surface is configured to releasably mate with the bottom exterior surface of another incubation chamber.
Fischer discloses a container chamber (Figure 1:10) comprising an internal cavity for receiving a liquid. Column 3, line 59 to column 5, line 49 teaches that the incubation chamber has a cover (Figure 1:14) characterized by a first contour and a perimeter edge that is lower in height than a top exterior surface so as to form a recess (Figure 4:46). The chamber includes a base (Figure 1:12) having a second contour and a perimeter flange (Figure 4:54) that extends downwardly and sits in the recess to thereby allow two chambers to mate or interlock in a stacking relation. This is shown in Fig. 5.
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The cover is connected to the base using a hinge (Figure 5:16) that allows the cover to be reconfigurable between an open position and a closed position with respect to the base.
Before the effective filing date of the claimed invention, it would have been obvious to modify the Lobedann incubation system so that the helical coil is positioned in an incubation chamber having an internal cavity and top and bottom surfaces that releasably mate with each other to facilitate stacking. Runyon teaches this would serve to conserve space and allow one to organize fluidic components in an orderly manner. Runyon further teaches that the provision of an incubation chamber having an internal cavity offers improved physical support and temperature control over a fluidic component. Fischer describes how incubation chamber stacking is useful for storage and space conservation, and that this stacking is effectively enabled when a top surface of the chamber is defined by a recess along a perimeter edge that interfaces with a perimeter flange extending from a bottom surface of another chamber. Fischer shows that this mating/interlocking interaction is easy to manipulate using manual and/or automated handling means and offers improved structural stability to the stacked chamber elements.
With respect to claims 3, 12 and 15, Lobedann, Runyon and Fischer disclose the combination as described above. Lobedann further shows in Fig. 2 that the helical coil has at least first and second coiled regions that are orthogonally oriented relative to each other.
Claims 2, 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lobedann (US 20160375159) in view of Runyon (US 7682823) and Fischer (US 5312011) as applied to claims 1, 10 and 13, and further in view of Ando (US 20190157788) and/or Nishimura (US 20070261907).
Lobedann, Runyon and Fischer disclose the combination as described above. Lobedann appears to show that the helical coil is skewed in Fig. 2, but does not expressly state that the skew angle ranges from 30° to 60°.
Ando discloses a helical coil (Figure 3:40) characterized by an adjustable skew angle that may be modified to affect the height of the coil. This is taught in paragraph [0016] (“each of the winding surfaces of the coils is tilted to be in a state in which each of the winding surfaces of the coils is further inclined with respect to the coil axis L to reduce the height of the spring (a size in a direction perpendicular to an axis direction of the spring”).
Nishimura discloses a helical coil (Figure 11:39) characterized by an adjustable skew angle that may be modified to affect the height of the coil. This is taught in paragraph [0031] (“the coils of the annular member are inclined at a first angle with respect to an axis of the coils and in the second state, the coils are inclined at a second angle to reduce a height of the annular member”).
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Lobedann helical coil is skewed at a coil skew angle ranging from 30° to 60°. Ando and Nishimura show how inclining a coil will reduce the height of that coil, which would allow for the conservation of space and the ability to stack greater numbers of coils and incubation chambers when using the Lobedann system. In view of this teaching, coil skew angle is understood to be a result effective variable optimized through routine experimentation, and it would have been within the ability of one of ordinary skill to choose a coil skew angle between 30° to 60° in order to adjust the height of the Lobedann coils by a desired amount.
Response to Arguments
Applicant's arguments filed 25 June 2026 have been fully considered but they are not persuasive.
Applicant argues that Fischer is directed to an entirely different field and problem, and that one of ordinary skill would not be motivated to consider Fischer. However, Fischer is reasonably pertinent to the problem faced by the inventor and therefore is analogous art. More specifically, Fischer offers solutions to the problem of incubator stacking and shows that releasably interlocking cover and base features are well known and operate in a predictable manner. Applicant’s invention, Lobedann and Runyon all discuss incubator stacking, and those of ordinary skill would have looked to Fischer to further improve on this concept.
Applicant states that Fischer is interested in reducing contamination in a mundane consumer product-usability environment, which is very different than the highly specialized biopharmaceutical field of continuous virus inactivation. In response, it is noted that Lobedann and Runyon each show that incubator stacking is something that is done during specialized biopharmaceutical operations. Fischer is merely provided as evidence that such stacking would be further improved by using interlocking top/bottom surfaces having corresponding flange and recess interfaces. The fundamental motivation to stack comes from Lobedann and Runyon, while Fischer shows a specific mechanism for stabilizing incubation chambers interlocked in a stacking relation.
Applicant argues that Fischer teaches away from the proposed combination because Fischer cautions against allowing anything to enter or exit the container, except through a deliberate opening and reclosing of the lid. This appears to be conflating two entirely different concepts: 1) keeping a container sealed to prevent material loss and/or contamination, and 2) using interlocking features (e.g., flanges, recesses) to improve stacking. Those of ordinary skill would be interested in Fischer’s recommendations to keep the incubator chambers securely stacked together (“the bottom of container "A" snaps to the top of container "B" by a male/female pressure fit. In a similar fashion, the bottom of container "B" snaps to the top of container "C". With such a novel pressure fit design, the plurality of interconnected individual containers 10 forms the stackable system wherein the containers are secured together”) without being bound to any additional alleged requirement that the incubator containers should never include ports for fluid transfer.
Applicant argues that Fischer does not properly disclose the claimed cover/base stacking structure. In response, it is noted that the claims require:
“said cover of said incubation chamber has a top exterior surface having a first contour and a perimeter edge that is lower in height than the top exterior surface so as to form a recess”
This is shown by Fischer as the flat region 46 that surrounds the male section 50. The flat region 46 is a recess having a height that is lower than the height to the top exterior surface 50.
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The claims further require:
“said base of the incubation chamber has a bottom exterior surface having a second contour and a perimeter flange extending downward”
This is shown by Fischer as the lower sidewall 54 of the base that extends past the chamber bottom 53.
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The claims further require:
“the perimeter flange can sit in the recess allowing two incubation chambers to mate or interlock in a stacking relation”
As discussed in the rejections above, this is clearly shown in Fig. 5 of Fischer.
Applicant lastly argues that Runyon teaches away from limitations in claim 10 that require a series connection by instead showing chambers arranged in parallel. However, all the claims, including claim 10, are directed to a singular incubation chamber. Any possible fluidic connection between stacked incubation chambers relates to an intended use – for example, claim 10 states that the incubation chamber is “allow[ed]…to mate or interlock in a stacking relation and arranged in series” with another incubation chamber. The chambers disclosed by Lobedann and Runyon are fully capable of doing exactly this regardless of whether or not Runyon shows a parallel fluidic connection in other embodiments. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
THIS ACTION IS MADE FINAL. 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
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