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 .
This is a FINAL REJECTION in response to applicant’s claim amendments and arguments filed June 26, 2026. Claims 5 and 11 are currently amended. Claims 16-20 were previously withdrawn from consideration. Claims 1-15 are pending review in this correspondence.
Response to Amendment
Objection to claim 11 for various informalities is withdrawn in view of applicant’s claim amendments.
Rejection of claim 5 for being indefinite is withdrawn in view of applicant’s claim amendment.
Rejection of claims 1-4 as being unpatentable over Ingber et al (US 2015/0209783 A1) is maintained in view of applicant’s arguments to claim 1.
Rejection of claims 1, 4, 5, 9, and 10 as being unpatentable over Coppeta et al (US 2018/0142196 A1) in view of Ingber et al (US 2015/0209783 A1) is maintained in view of applicant’s arguments to claim 1.
Rejection of claims 6-8 as being unpatentable over Ingber et al (US 2015/0209783 A1) in view of Hoesl (US 2020/0386197 A1) is maintained in view of applicant’s arguments to claim 1.
Rejection of claims 11-13 as being unpatentable over Coppeta et al (US 2018/0142196 A1) and Ingber et al (US 2015/0209783 A1) in view of DeSilets et al (US 2002/0189374 A1) is maintained in view of applicant’s arguments to claim 1.
Rejection of claim 14 as being unpatentable over Coppeta et al (US 2018/0142196 A1) and Ingber et al (US 2015/0209783 A1) in view of John (US 2007/0063389 A1) is maintained in view of applicant’s arguments to claim 1.
Rejection of claim 15 as being unpatentable over Ingber et al (US 2015/0209783 A1) in view of Coppeta et al (US 2018/0142196 A1) is maintained in view of applicant’s arguments to claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al (US 2015/0209783 A1).
With respect to claim 1 Ingber discloses a bioreactor vessel (bubble trap 120, Para. 0045) comprising:
A base (first body portion 312, See Fig. 3A) having a plurality of through openings (inlet and outlet ports 342 and 344, See Fig. 3B) (See Para. 0046);
A lid (second body portion 316, See Fig. 3A) connected to the base via a plurality of threaded fasteners or a clamping mechanism (See Para. 0047); and
A gas-permeable, liquid impermeable membrane (membrane 320, See Fig. 3A and Para. 0046; See Paras. 0041 and 0050 for discussion of how the membrane is gas permeable but liquid impermeable; also see Para. 0009) sandwiched between the base and the lid and held in position by the plurality of fasteners (See Para. 0047).
The embodiment depicted in Fig. 3 of Ingber fails to disclose the use of heat stakes to hold the lid to the base and position the sandwiched membrane.
Fig. 2 and Para. 0038 of Ingber teach an alternative embodiment of the bubble trap 120, wherein the assembly of layers and body portions, can be held together by thread forming screws, nuts and bolts, clips, clamps, pins as well as or in addition to the use of heat staking, glue (e.g., biocompatible, low absorption adhesives), welding and various forms of bonding (e.g. thermal, solvent-activated, UV activated, ultrasonic).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of heat staking, as taught by Fig. 2 of Ingber, as a choice of fastening the plurality of layers together depicted in Fig. 3 of Ingber, such that various layers of device may be permanently bonded together in certain desired applications (See Para. 0038 of Ingber).
With respect to claim 2, Ingber discloses that the lid is devoid of sharp corners (See Figs. 3B/4B and Para. 0063 for discussion of how the bubble trap can be formed from a tubular structure).
With respect to claim 3, although there is no specific teaching that the corners of the lid have a specific shape and/or differing shapes, the courts held In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that a change in shape is matter of choice in which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus was significant. Thus, it would have been obvious to one of ordinary skill in the art at the time of filing to configure the corners of the lid to have any specific shape that is appropriate to the desired application and fabrication method of the bubble trap. Applicant should also note that Figs. 3B/4B depict the bubb le trap as having a cylindrical configuration, which would imply a round shape of the device.
With respect to claim 4 Ingber depicts a plurality of tubing connections (inlet port 342 and outlet port 344, See Fig, 3B and Para. 0046) configured to provide for vertical entry or exit of fluid to and from the bioreactor vessel. Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Ingber and the apparatus of Itoh is capable of the recitation of claim 4. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Itoh (see MPEP §2114). Furthermore, it should be noted that the inlet and outlet ports would be capable of connecting with tubing to enable vertical entry or exit of an applied fluid.
Claim(s) 1, 4, 5, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coppeta et al (US 2018/0142196 A1) in view of Ingber et al (US 2015/0209783 A1).
With respect to claim 1, Coppeta discloses a bioreactor vessel (bi-layer multi-well cell culture platform 105, See Fig. 8), comprising:
A base (embossed plastic material 720b, See Fig. 8 and Para. 0088) for having a plurality of through openings (microchannel structures 125b);
A lid (first structural layer 550, See Fig. 8) connected to the base via adhesive films (See Para. 0090); and
A gas-permeable, liquid impermeable membrane (membrane 140, See Para. 088 for discussion of how the membrane is made of gas/oxygen permeable polymers such as fluorinated ethylene propylene (FEP)) sandwiched between the base and the lid and held in position by the adhesives (See Para. 0090).
Coppeta fails to disclose that the lid is connected to the base via a plurality of heat stakes and that the membrane is held in position between the lid and base by the plurality of heat stakes.
Ingber teaches a bubble trap 120, wherein an assembly of layers and body portions, can be held together by thread forming screws, nuts and bolts, clips, clamps, pins as well as or in addition to the use of heat staking, glue (e.g., biocompatible, low absorption adhesives), welding and various forms of bonding (e.g. thermal, solvent-activated, UV activated, ultrasonic) (See Fig. 2 and Para. 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of heat staking, as taught by Fig. 2 of Ingber, as a choice of fastening the plurality of layers together of the cell culture system of Coppeta, such that various layers of device may be permanently bonded together, which may desirable in certain desired applications (See Para. 0038 of Ingber).
With respect to claim 4 the combination of Coppeta and Ingber teaches a plurality of tubing connections (fluid reservoirs 110, See Fig. 8 and Para. 0090 of Coppeta; Para. 0041 discusses how the fluid reservoirs are configured to hold a vertical column of fluid) configured to provide for the vertical entry or exit of fluid to and/or from the bioreactor vessel. Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Ingber and the apparatus of Itoh is capable of the recitation of claim 4. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Itoh (see MPEP §2114). Furthermore, it should be noted that the fluid reservoirs would be capable of connecting with tubing to enable vertical entry or exit of an applied fluid.
With respect to claim 5 the combination of Coppeta and Ingber teaches a plurality of tubing connection that include a first tubing connection formed in one end of the lid and a second tubing connection formed in an opposite end of the lid (See Fig. 8 of Coppeta for depiction of the plurality of plurality of fluid reservoirs 110 spread in array across the entirety of the top surface of the first structural layer 550).
With respect to claim 9 the combination of Coppeta and Ingber teaches that the lid includes a plurality of vertically-oriented bolstering supports around a periphery of the lid (See Fig. 8 reproduced below).
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Fig. 8 (reproduction)
With respect to claim 10 the combination of Coppeta and Ingber teaches that the base includes a plurality of strengthening ribs extending generally perpendicularly with respect to a peripheral edge of the base (See Fig. 8 reproduced above).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al (US 2015/0209783 A1) in view of Hoesl (US 2020/0386197 A1).
Refer above for the teachings of Ingber.
With respect to claim 6 Ingber fails to teach that the membrane includes a plurality of apertures located along a peripheral edge of the membrane, the plurality of apertures being configured to receive the plurality of heat stakes therethrough to anchor the membrane to the lid and the base.
Hoesl teaches a housing assembly (100) that is provided with particulate filtration media 14 configured to remove entrained particulates from the air and an adsorbent material (200) extending about an entire internal circumference of the housing assembly between an inlet (12) and an outlet (16) such that all air passing between the inlet to the outlet must pass through the adsorbent material (See para. 0038). A frame is provided which is configured to contain the adsorbent material, this frame is illustrated particularly in FIGS. 2-10, the frame 300 is then configured to be permanently affixed to an interior of the housing 100, and in some instances between the inlet and the outlet. The placement of the frame and adsorbent material can then be provided in such a manner that any air or gasses escaping from the outlet in a reverse flow condition are configured to come into contact with the adsorbent material 200 contained within the frame 300 such that hydrocarbons contained in the air are adsorbed by the adsorbent material (See Para. 0039). The frame 300 can be provided with a plurality of corresponding apertures 316 provided about a perimeter edge, such as about a flange 314, or about an opposing edge of the first portion and an opposing edge of the second portion (See Para. 0045). These apertures provided on the first and second portions which are lined up provide a means by which the frame 300 can be permanently affixed to the housing 100. As illustrated in FIGS. 4-7, the housing 100 can then include one or more pins or posts 110 which are placed in such a manner and provided with sufficient length so as to extend through at least one of the one or more aligned apertures so as to secure the relative position between the frame 300 and the housing 100. Then a portion of each pin 110 can then be heat staked or otherwise deformed so as to mushroom a distal end of each pin and thus create an associated interfering lip 112 which cannot pass through the apertures or otherwise forms an interference fit with each associated one or more corresponding aperture through which the pin 110 extends (See Para. 0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the perimeter-placed apertures of Hoesl as the mechanism of connecting the various layers of the bubble trap of Ingber to create a lip that ensures a fluid-tight seal of the bubble trap (See Para. 0046 of Hoesl).
With respect to claim 7 the combination of Ingber and Hoesl teaches the inclusion of a gasket (gasket embossments 332,334, See Fig. 3A and Para. 0046 of Ingber) intermediate to the membrane and the lid.
With respect to claim 8, the combination of Ingber and Hoesl teaches that the gasket includes a plurality of apertures located along a peripheral edge of the gasket, the plurality of apertures being configured to receive the plurality of heat stakes therethrough to anchor the gasket to the lid and the base (See Paras. 0045-0046 of Hoesl for discussion of the incorporation of apertures to anchor the various layers, including the adsorbent material and filtration media to the frame and housing; Para. 0046 of Ingber discloses that the gasketing embossments extend around and define the shape of chambers 322 and Para. 0050 discloses that gasketing embossments can be incorporated onto each side of the membrane).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coppeta et al (US 2018/0142196 A1) and Ingber et al (US 2015/0209783 A1) in view of DeSilets et al (US 2002/0189374 A1).
Refer above for the combined teachings of Coppeta and Ingber.
With respect to claim 11, the combination of Coppeta (Fig. 8) and Ingber fails to teach that the base includes a plurality of wells configured to receive corresponding support posts of a rocking platform of a bioprocessing system. Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. Prior art that would be capable of performing the recited function suffice read upon the claimed subject matter. Additionally, applicant should note that the recited “rocking platform of a bioprocessing system” has not been positively recited as a feature of the currently claimed invention.
DeSilets teaches a multi-well test filter plate (10) that is provided with posts (48, 49) which fit, respectively, in holes (46, 47) of multi-well receiver plate (11) when multi-well receiver plate is positioned below the multi-well filter plate (See Para. 0034). Referring to FIGS. 3 and 3a, the posts 48 and 49 fit respectively into holes 46 and 47. Hole 46 is shaped with a three-sided perimeter so that post 48 contacts the walls of the hole 46 at three points 43a,b and c. This mode of contact prevents multi-well filter plate 10 from moving laterally with respect to the multi-well receiver plate 11. Post 49 contacts the walls of hole 47, in this embodiment shown in the form of a slot, at two points 45a and b so that part to part variations, or misalignment can only be accommodated in the direction shown by arrow 37. The lowermost ends of posts 48 and 49 are beveled to promote ease of insertion of the posts 48and 49 into holes 46 and 47 (See Para. 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the holes of the multi-well receiver plate of DeSilets into the base plate of combined Coppeta and Ingber to ensure a variable contact fit between the various layers of the device, when other layers are fitted with posts (See Paras. 0034-0035 of DeSilets).
With respect to claim 12, applicant has recited a limitation that is dependent upon a limitation that has not been positively recited (support posts). Thus, it should be noted that Para. 0035 of DeSilets teaches that hole 46 is shaped with a three sided perimeter and hole 47 is in the form of a slot.
With respect to claim 13, the combination of Coppeta, Ingber, and DeSilets teaches that one of the plurality of wells has an oblong shape (See para. 0035 for discussion of how hole 47 is in the form of a slot).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coppeta et al (US 2018/0142196 A1) and Ingber et al (US 2015/0209783 A1) in view of John (US 2007/0063389 A1).
Refer above for the combined teachings of Coppeta and Ingber.
With respect to claim 14 the combination of Coppeta and Ingber fails to teach that a membrane-facing surface of the base has a textured surface.
John teaches an apparatus and a method for the separation of a material layer (4) hardened on a flat plane (2) serving as a reference by means of a flexible, elastic separating layer (1) arranged between plane and material layer and designed in the form of a film or a gel-like material (See abstract). In order to prevent adhesion of the film to the bottom plate and ensuring supply of air, and hence, preventing the film from being sucked against the plane/bottom plate can be transposed by deliberately produced surface roughness or structuring [0042] a) on the lower side of the film (FIG. 5a) by micro/nano-structuring or [0043] b) on the side of the bottom plate oriented towards the film (FIG. 5b), e.g. by slight etching of the glass surface or suitably rough coatings (ITO coating) (See Para. 0041).
It would have been obvious to one of ordinary skill in the art before ethe effective filing date of the claimed invention to incorporate the etching of suitably rough coatings taught by John in membrane-facing surface of the base of combined Coppeta and Ingber such that the membrane is prevented from being adhered to the surface of the base (See Para. 0041 of John).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al (US 2015/0209783 A1) in view of Coppeta et al (US 2018/0142196 A1).
Refer above for the teachings of Ingber.
With respect to claim 15 Ingber fails to teach that the membrane is formed from fluorinated ethylene propylene.
Coppeta teaches a multi-well cell culture platform (105), wherein a membrane (140) is sandwiched between second and third structural layers, respectively (560 and 570, See Fig. 4A and Para. 0079). The membrane may be a non-permeable membrane. In some implementations, the membrane may be a tensioned membrane. In some implementations, the membrane may be a non-tensioned membrane that includes fluorinated ethylene propylene (FEP) (See Para. 0048). FEP is a gas/oxygen permeable polymer that may allow fluid flow to be decoupled from oxygen requirements or enables static cell cultures where there is no flow in either microchannel (See Para. 0092).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the membrane of Ingber of FEP, as taught by Coppeta, such that fluid flow may be decoupled from oxygen requirements when static cell cultures are present (See Para. 0092 of Coppeta).
Response to Arguments
Applicant's arguments filed June 26, 2026 have been fully considered but they are not persuasive:
APPLICANT ARGUES: “Ingber's Bubble Trap Is Not a Bioreactor Vessel - Cells Are Cultured in the Separate Microfluidic Device 110, Not in the Bubble Trap
The Office reads claim l's preamble ("a bioreactor vessel") to Ingber's bubble trap 120 (Para. [0045]). This is incorrect. Ingber's bubble trap 120 is not a vessel in which cells are cultured or in which any biological reaction takes place. It is a fluid-conditioning component upstream of the microfluidic device 110 where cells actually reside.
Ingber's specification is explicit on this point. Para. [0031] states: "a bubble trap device or component can be used to remove air or gas bubbles from the fluid before it enters the microfluidic device." Para. [0035] further confirms: the bubble trap devices 120A, 120B receive fluid "possibly containing gas bubbles" and remove the gas "before it exits the bubble trap" and "flows through fluid connections 132, 134 to the microfluidic device 110."
Cell culture occurs exclusively in the microfluidic device 110. Para. [0034] describes the membrane 113 of microfluidic device 110 as being "treated or coated to support or promote cell attachment or adhesion" and identifies a broad range of cell types, including immune system cells, that adhere to membrane 113. Para. [0034] further describes cell culture media, stem cell differentiation, and tissue formation as occurring in device 110. No such cell culture activity occurs in Ingber's bubble trap 120.
Ingber's own claims confirm the structural relationship. For example, claim 1 of Ingber claims a microfluidic system in which the bubble trap's separation chamber is "connected to a fluid channel and the fluid channel being connected to the inlet of the microfluidic device." Cells are claimed as a feature of the microfluidic device, not the bubble trap. The bubble trap appears in the claims as an ancillary sub-component whose purpose is to deliver bubble-free fluid to the device where cells reside.
Given that Ingber's bubble trap 120 is not a "bioreactor vessel" in the sense of a vessel used for cell culture or biological reaction, the Office's reading of claim 1 to this component is a fundamental mischaracterization of ingber' s disclosure. Applicant respectfully submits that all rejections grounded on Ingber's bubble trap 120 as a bioreactor vessel should be withdrawn on this basis alone” (See Pgs. 6-8 of applicant’s remarks/arguments filed 6/26/2026).
EXAMINER’S RESPONSE: The examiner respectfully disagrees with the applicant’s assertions above. More specifically, the applicant recites in the pre-amble a “bioreactor vessel” and then continues to provide for the specific structures required to quality as a “bioreactor vessel”. Applicant states that they are intending for the bioreactor vessel to be used for cell culture or a biological reaction, but there is no additional structure provided in the claims that would eliminate Ingber’s bubble trap from qualifying as a bioreactor vessel as claimed by applicant. The bubble trap of Ingber is intended to separate bubbles from a fluid that can contain cells (See Paras. 0008-0009) and has the claimed structural features. Applicant should consider incorporating language that more clearly structurally distinguishes the bioreactor vessel of the current invention from the bubble trap of Ingber.
APPLICANT ARGUES: “Ingber's Bubble Trap Is an Open System That Vents Gas to Ambient Atmosphere - It Is Incompatible with the Claimed Closed, Sterile Bioprocessing Environment
Separately and independently, Ingber's bubble trap 120 operates as an open system that actively vents gas to the ambient atmosphere. This is an inherent and essential feature of Ingber's design and further distinguishes it from the claimed bioreactor vessel, which is specifically configured for use in sterile, closed bioprocessing systems.
Para. [0036] of Ingber states expressly: "as shown in FIGS. 2 and 2A, the exhaust chamber 224 can be open and the gas from the bubbles can be released in to the ambient atmosphere."
Para. [0043] confirms that the pressure differential driving bubble separation requires that "the air pressure in the exhaust chamber 224 should be sufficient to enable the gas bubble to pass through the membrane," which is achieved by connecting the exhaust side to ambient atmospheric pressure. Para. [0052] further confirms that exhaust channels 562A, 562B "enable the air pressure in the exhaust chamber 524 to equalize to the ambient pressure and enable gas bubbles to pass through the membrane."
Applicant's bioreactor vessel, by contrast, is specifically designed for use as part of a functionally-closed sterile bioprocessing system, as described in the application as filed. In such a system, the vessel must maintain sterile containment integrity throughout the bioprocessing operation; any venting to ambient atmosphere would introduce contamination and defeat the purpose of the closed system.
Ingber's open-to-atmosphere exhaust architecture is therefore architecturally and functionally incompatible with the claimed bioreactor vessel. A person of ordinary skill in the art designing sterile bioreactor vessels for cell culture would not look to Ingber's open-system bubble trap as a design reference, because Ingber's fundamental operating principle, venting gas to ambient atmosphere through a porous hydrophobic membrane, is incompatible with the sterility requirements of closed bioprocessing” (See Pgs. 8-10 of applicant’s remarks/arguments filed 6/26/2026).
EXAMINER’S RESPONSE: The examiner respectfully disagrees with applicant’s assertions above. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the bioreactor vessel system being sterile and closed) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
APPLICANT ARGUES: “Claims 1-4 stand rejected under 35 U.S.C. § 103 as allegedly unpatentable over Ingber alone. Applicant respectfully traverses this rejection.
In addition to the threshold deficiencies of Ingber discussed in Section I above, the Office concedes that Ingber's Fig. 3 embodiment "fails to disclose the use of heat stakes to hold the lid to the base and position the sandwiched membrane." The Office then turns to Para. [0038] of Ingber, which lists heat staking as one option among a "laundry list" of fastening alternatives, to supply this limitation.
Paragraph [0038] does not establish a prima facie case of obviousness, however. Paragraph [0038] recites: "the bubble trap 120, as an assembly of layers and body portions, can be held together by thread forming screws, nuts and bolts, clips, clamps, pins as well as or in addition to the use of heat staking, glue (e.g., biocompatible, low absorption adhesives), welding and various forms of bonding (e.g. thermal, solvent-activated, UV activated, ultrasonic)." This passage presents heat staking as one among at least ten listed alternatives. There is no teaching, suggestion, or motivation in Ingber to specifically select heat staking over the other listed methods, let alone to configure heat stakes to perform the specific dual function required by claim 1.
Claim 1 requires not merely that a heat stake connects the lid to the base, but that the same heat stakes also hold the membrane in position between the lid and the base. This is a structural arrangement in which a single element performs two simultaneous functions: (1) mechanically joining the lid to the base, and (2) anchoring the membrane by passing through or engaging with peripheral features of the membrane. No embodiment of Ingber teaches or suggests this dual- function heat stake arrangement. Simply substituting heat staking for screws in Ingber's Fig. 3 fastening arrangement would not inherently result in those stakes also holding the membrane in position, because Ingber's membrane is described as being compressed between the body portions by the fasteners (Para. [0047]), the fasteners act on the body portions, not directly on the membrane itself.
The Office's obviousness reasoning thus impermissibly relies on hindsight to select heat staking from Ingber's list and apply it in a specific way not disclosed or suggested by Ingber. KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007) (rejecting "an expansive and flexible approach" to obviousness that "can take the form of an invitation to an improper hindsight analysis")” (See Pgs. 10-11 of applicant’s remarks/arguments filed 6/26/2026).
EXAMINER’S RESPONSE: In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning as it pertains to the incorporation of heat stakes into the primary embodiment of the prior art, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Additionally, with regard to applicant’s assertion that Ingber fails to disclose or teach the membrane being held in position by the plurality of heat stakes, applicant has not provided specific language that further defines what it means for the membrane to be “held in position.” The membrane is described as being layered between the base the lid, and as such, any fastening mechanism that would maintain the position of the membrane between the base and the lid would qualify as holding the membrane in position.
APPLICANT ARGUES: “Claims 1, 4, 5, 9, and 10 stand rejected under 35 U.S.C. § 103 as allegedly unpatentable over Coppeta in view of Ingber. Applicant respectfully traverses this rejection.
The Office reads claim l's elements on Coppeta's bi-layer multi-well cell culture platform 105 (Fig. 8): base = embossed plastic material 720b; lid = first structural layer 550; membrane = membrane 140. However, all layers in Coppeta's Fig. 8 assembly are joined by adhesive films 730a-730d (Para. 0090-91), not by heat stakes. The Office then relies on Ingber's Para. [0038] to supply the motivation to use heat staking. This combination fails for multiple reasons.
First, as discussed above, all rejections that incorporate Ingber as a reference rely on Ingber's bubble trap 120. Ingber's bubble trap, however, is not a bioreactor vessel, its sole function is to remove gas bubbles from fluid before that fluid reaches the microfluidic device where cells reside. Accordingly, Ingber provides no relevant teaching of how a bioreactor vessel should be constructed. Ingber's Para. [0038] is a description of how the bubble trap body portions (not a bioreactor vessel) may be fastened together, and there is no motivation for one of ordinary skill to apply those fastening alternatives to Coppeta's cell culture platform.
Second, again discussed above, Ingber's bubble trap 120 is an open-to-atmosphere device. Coppeta's cell culture platform is similarly an open well-plate format device: its fluid reservoirs 110 are open wells on the upper surface of first structural layer 550, exposed to the incubator environment. Paras. [0090]-[0092] of Coppeta generally describe assembly by adhesive bonding with no reference to any closed or sterile architecture. Neither Ingber nor Coppeta teaches or suggests a bioreactor vessel configured for a functionally-closed sterile bioprocessing system, and there is no motivation in either reference to configure such a vessel using heat staking to maintain sterile integrity.
Third, and most fundamentally, for the sake of argument, even if one or ordinary skill were motivated to combine Coppeta and Ingber, the combination would not yield claim 1's structure. Coppeta's membrane 140 is held in place by adhesive films (Para. [0090]: "the first side of the membrane 140 attaches to portions of the second layer of adhesive film 730b and to portions of the third layer of adhesive film 730c"). Ingber Para. [0038] teaches heat staking as a fastening option for Ingber's bubble trap body. Nowhere in either reference is there a teaching or suggestion that heat stakes should be configured to both connect a lid to a base and simultaneously hold a membrane in position, i.e., the dual-function arrangement recited by claim 1. Simply substituting heat stakes for adhesive films in Coppeta would require fundamentally redesigning Coppeta's precision adhesive-layer architecture (which is specifically engineered to align microchannels 125a/125b with micron-level precision) and would not inherently result in heat stakes that anchor the membrane” (See Pgs. 11-12 of applicant’s arguments/remarks filed 6/26/2026).
EXAMINER’S REPSONSE: The examiner respectfully disagrees with applicant’s assertions above.
First, applicant recites in the pre-amble a “bioreactor vessel” and then continues to provide for the specific structures required to quality as a “bioreactor vessel”. Applicant states that they are intending for the bioreactor vessel to be used for cell culture or a biological reaction, but there is no additional structure provided in the claims that would eliminate Ingber’s bubble trap from qualifying as a bioreactor vessel as claimed by applicant. The bubble trap of Ingber is intended to separate bubbles from a fluid that can contain cells (See Paras. 0008-0009) and has the claimed structural features. Applicant should consider incorporating language that more clearly structurally distinguishes the bioreactor vessel of the current invention from the bubble trap of Ingber.
Second, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the bioreactor vessel system being sterile and closed) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Third, it is unclear how applicant’s current claim language supports two different configurations, one being the lid and base held together and the second being the membrane being held in position. Currently, the current recitation merely requires that the membrane is positioned between the base the lid, and as such, any fastening mechanism that would maintain the position of the membrane between the base and the lid would qualify as “holding the membrane in position”. The incorporation (not substitution) of heat stakes would merely provide an additional means to hold the various layers of the device in the desired arrangement.
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.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 September 3, 2026
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