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 .
Response to Arguments and Amendments
The claim amendments dated 7/21/2026 have overcome the rejection under 35 U.S.C. 112(b) presented in the prior Office Action.
Applicant's arguments filed 7/21/2026 have been fully considered but they are not persuasive.
Applicant has argued that the prior art of record does not anticipate claims 1 and 2.
In particular, Applicant asserts that Gubernator does not disclose the arrangement of the lid housing in claim 1. This is not found persuasive for the following reasons:
Examiner notes that claim element “lid housing” is broadly interpreted as any structure covering (or capable of covering) some other structure (MPEP § 2111). Therefore, Gubernator’s gasket reads on the claimed lid housing because it covers other structure in Gubernator’s apparatus.
Further, Applicant argues that Gubernator does not disclose the limitation “to create an air-tight seal when the sealing surface is pressed against the first layer” (p. 7-8 of the Remarks). However, Gubernator does teach the limitation in Fig. 3A and clearly in Fig. 11B (see annotated figures below). It has been held that drawings and pictures can anticipate claims if they clearly show the structure which is being claimed (MPEP § 2125). Examiner notes that the phrase “pressed against” is broadly interpreted as in contact with. Therefore, Gubernator’s perimeter edge and gas distribution layer meet the limitation of note, as shown below. Additionally, the limitation of note is directed toward the intended manner of operating the claimed system and does not differentiate the claimed system from the prior art system
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because all structural limitations are
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taught in the prior art (MPEP § 2114 II).
Even further, Applicant argues that Gubernator does not teach an air-tight seal between the sealing surface and first layer (p. 7-9 in the Remarks). However, claim 1 is silent to the location of the air-tight seal. 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 air-tight seal between the sealing surface and the first layer) 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). Additionally, the limitation “to create an air-tight seal” is contingent on the pressing of the sealing surface against the first layer and has been given appropriate patentable weight (MPEP § 2111.04 II).
Information Disclosure Statement
The information disclosure statement (IDS) filed on 4/17/2026 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gubernator et al. (US 2002/0176807 A1) (hereinafter Gubernator; present in IDS).
Regarding claim 1, Gubernator discloses a bioreactor system comprising (abstract, microtiter reaction system):
a lid assembly (Fig. 1A, gasket 24 and gas distribution plate 22 – see annotated figure below) including:
a lid housing having a top exterior surface and a bottom interior surface, the lid housing (Fig. 1B, gasket 24); and
a first layer disposed in the lid housing (Fig. 1B, gas distribution plate 22); and
wherein the bottom interior surface includes a sealing surface projecting toward the first layer to create an air-tight seal when the sealing surface is pressed against the first layer (Fig. 3A, perimeter edge 25 extends towards gas distribution plate 22; [0036], “Gasket 24 preferably has a perimeter edge 25 which forms a gas-tight seal around the outer perimeter of support rack 16”; [0037], “Top plate 26…is fastened into position by being pressed tightly downward upon gasket 24…Pressing top plate 26 tightly down upon gasket 24 to assemble the device causes gasket 24 to be compressed”).
The limitation “configured to cover a sample container” is directed toward the intended manner of operating the claimed apparatus and does not differentiate the claimed apparatus from the prior art apparatus because all structural limitations are taught in the prior art apparatus (MPEP § 2114 II). The gasket would be fully capable of achieving every claimed intended use because the gasket covers a support rack.
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Regarding claim 2, Gubernator discloses the bioreactor system of claim 1, wherein the first layer includes one or more first apertures configured for alignment with a respective guide element (Fig. 3A shows holes 23 (i.e., one or more first apertures) aligned with holes 27 (i.e., respective guide element) in top cover 26 – see annotated figure below),
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each first aperture being configured to open when a pipette tip is pushed through and to close when the pipette tip is removed ([0037], first aperture is opened when a needle (i.e., pipette tip) is pushed through the gasket and closed when removed).
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 3, 12, 14-18, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gubernator in view of Astle (US Patent 5,789,251) (see PTO-892; hereinafter Astle).
Regarding claim 3, Gubernator discloses the bioreactor system of claim 1, further comprising: one or more guide elements extending from the top exterior surface of the lid housing (Fig. 3A shows holes 27 extending from the top exterior surface of the gasket 24), each of the one or more guide elements having a hollow interior portion running from a top end to a bottom end (Fig. 3A shows guide elements are hollow from top to bottom), and each of the one or more guide elements being configured to receive and guide a pipette tip ([0037], “Holes 27 in top cover 26 permit easy access of injection needles”); and
wherein the first layer includes one or more first apertures each aligned with a respective guide element of the one or more guide elements (Fig. 3A shows holes 23 (i.e., one or more first apertures) aligned with holes 27 (i.e., respective guide element) in top cover 26).
Gubernator is silent to the hollow interior portion having a larger cross-sectional area at the top end than at the bottom end.
However, Gubernator teaches a funnel (Fig. 7, funnel portion 36 – see figure below) for receiving needles (i.e., pipette tips) (Fig. 7 shows needle 44 inserted into funnel 36). The funnel having a larger cross-sectional area at the top end than at the bottom.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the guide element of Gubernator to have a larger cross-sectional area at the top end than at the bottom because it has been held that changes in shape are considered a matter of choice which a person of ordinary skill in the art would find prima facie obvious absent persuasive evidence that the particular shape configuration is significant (MPEP §2144.04).
Gubernator does not teach wherein each first aperture is configured to open when the pipette tip is pushed through and to close when the pipette tip is removed.
However, Astle teaches a microplate comprising a plurality of wells and a layer of film (i.e., the first layer). The layer of film having a plurality of slits (i.e., apertures) configured to open when pipette tip is pushed through and to close when a pipette tip is removed (Col. 3, lines 23-30; Figs. 4 and 5).
Astle teaches that the slits prevents evaporation of reagents in the microplate (Col. 2, lines 61-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form each first aperture of Gubernator as the slits of Astle in order to prevent evaporation in the sample container.
Regarding claim 12, the prior art combination teaches the bioreactor system of claim 3.
The prior art combination is silent to a second layer.
However, it would have been obvious to one of ordinary skill in the art to further modify the bioreactor system of Gubernator to include a second layer, as such a modification represents mere duplication of the first layer made obvious in claim 3. It has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). The duplication of the first layer would merely provide further protection against evaporation or contamination of the sample container contents.
Regarding the limitation “disposed between the bottom end of each of the one or more guide elements and the top exterior surface of the lid housing” modifying the device taught by the prior art combination such that the second layer is between the bottom of each of the one or more guide elements and the top exterior surface of the lid housing would amount to merely rearrangement of parts. Such a modification would predictably result in further protection against evaporation or contamination of the sample container contents. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the bioreactor system taught by Gubernator to include a second layer disposed between the bottom end of each of the one or more guide elements and the top exterior surface of the lid housing to provide redundant protection against sample or reagent evaporation and contamination.
The limitations “the second layer having one or more second apertures aligned with a respective guide element of the one or more guide elements and a respective first aperture of the one or more first apertures, and providing access to a through-hole in the lid housing, each of the one or more second apertures being configured to open when the pipette tip is pushed through the second aperture and to close when the pipette tip is removed” are met by the prior art combination as the second layer would have the same structure and capabilities as the first layer made obvious in the rejection for claim 3.
Regarding claim 14, the prior art combination teaches the bioreactor system of claim 3.
The prior art combination is silent to the one or more guide elements being an integral part of the lid housing.
However, modifying the bioreactor system taught by the prior art combination such that the one or more guide elements are an integral part of the lid housing instead of separate would have been obvious to one of ordinary skill in the art before the effective filing date of the invention. It has been held that the use of a one-piece construction instead of structures disclosed in the prior art would be merely a matter of obvious engineering choice (MPEP § 2144.04 V).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bioreactor system taught by the prior art combination to integrate the one or more guide elements and the lid housing with a reasonable expectation that it would guide a pipette tip.
Regarding claim 15, the prior art combination teaches the bioreactor system of claim 3.
Gubernator further discloses wherein the one or more guide elements are removably coupled to the top exterior surface of the lid housing (Fig. 1A and 1B show that guide elements are removably coupled using clips 28; [0031]).
Regarding claim 16, the prior art combination teaches bioreactor system of claim 3, wherein the hollow interior portion has a frustoconical shape (hollow interior portion with a funnel shape (i.e., frustoconical shape) was made obvious in the rejection for claim 3).
Regarding claim 17, the prior art combination teaches the bioreactor system of claim 3, wherein the one or more first apertures are slits (slits are made obvious in the rejection for claim 3).
Regarding claim 18, the prior art combination teaches the bioreactor system of claim 3. Astle further teaches wherein the slits (i.e., the one or more first apertures) are self-healing (Col. 3, para. 2, “As pipette tip 50 enters crossed slits 20, it opens them…As pipette tip 50 is withdrawn…causes slits 20 to resume the original, or closed, position, essentially resealing well 12”). Therefore, the one or more first apertures of the prior art combination are self-healing.
Regarding claim 21, the prior art combination teaches the bioreactor system of claim 3.
Gubernator of the prior art combination discloses a sample container, wherein the sample container includes a plurality of wells (Col. 3, line 51, “a support rack 16, having an array of reaction wells 18”; Fig. 1A, support rack 16).
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gubernator and Astle as applied to claim 3 above, and in further view of Stevens (US Patent 5,484,731) (see PTO-892; hereinafter Stevens).
Regarding claim 4, the prior art combination teaches the bioreactor system of claim 3.
The prior art combination does not teach wherein the sealing surface includes a partition dividing a first recessed area on the bottom interior surface of the lid housing from a second recessed area on the bottom interior surface of the lid housing.
However, Stevens teaches a sealing surface (Fig. 3, lip of lid – see annotated figure below) including a partition dividing a first recessed area on a bottom interior surface of a lid from a second recessed area on the bottom interior surface of a lid (Fig. 3, sections 22 and 23) for a multi-well culture plate (title).
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Stevens shows that different sections isolate different sets of wells (Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the bioreactor system taught by the prior art combination to partition the sealing surface to isolate sets of wells for the purpose of controlling the environment of each set of wells.
Regarding claim 5, the prior art combination teaches the bioreactor system of claim 4.
The prior art combination does not teach the sealing surface and the partition being continuous with one another.
However, further modifying the bioreactor system taught by the prior art combination such that the sealing surface and the partition being continuous with one another would have been obvious to one of ordinary skill in the art before the effective filing date of the invention. It has been held that the use of a one-piece construction instead of structures disclosed in the prior art would be merely a matter of obvious engineering choice (MPEP § 2144.04 V).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the sealing surface and the partition such that they are continuous with one another with a reasonable expectation that the partitions would isolate different sets of wells.
Regarding claim 6, the prior art combination teaches the bioreactor system of claim 4.
Gubernator further discloses a first gas port connected to lid housing (Fig. 3A, gas port 40 as part of gasket 24).
The prior art combination is silent to the precise location of the first gas port.
However, further modifying the bioreactor system taught by the prior art combination such that the first gas port is connected to the first recessed area of the lid housing would amount to merely rearrangement of parts, as such a modification would predictably result in providing a gas interface for a first section enclosed by the first recessed area of the lid housing. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI).
The limitation “configured to receive pressurizing gas” is directed toward the intended manner of operating the claimed apparatus and does not differentiate the claimed apparatus from the prior art apparatus because all structural limitations are taught in the prior art apparatus (MPEP § 2114 II). The gas port taught by Gubernator would be fully capable of achieving every claimed intended use because the gas port can introduce gas, creating pressure ([0038]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination bioreactor system to incorporate a first gas port connected to the first recessed area of the lid housing to control the environment of a section of wells.
Regarding claim 7, the prior art combination teaches the bioreactor system of claim 6.
The prior art combination does not teach a second gas port and a third gas port, wherein the second and third gas ports are configured to receive and/or remove one or more gases from the second recessed area.
However, further modifying the bioreactor system taught by the prior art combination to include a second and third gas port represents mere duplication of the first gas port. It has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). That is, a skilled artisan would reasonably expect a duplication of the first gas port would function the same, e.g., provide an interface for gas.
The limitation “configured to receive and/or remove one or more gases from the second recessed area” is directed toward the intended manner of operating the claimed apparatus and does not differentiate the claimed apparatus from the prior art apparatus because all structural limitations are taught in the prior art apparatus (MPEP § 2114 II). The gas ports taught by Gubernator would be fully capable of achieving every claimed intended use because the gas ports can introduce or evacuate gas ([0038]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination bioreactor system to include a second and third gas port because the extra ports would allow a user to control the environment in extra sections of wells.
Regarding claim 8, the prior art combination teaches the bioreactor system of claim 4.
The prior art combination is silent to one or more additional partitions configured to separate additional recessed areas between the bottom interior surface of the lid housing and the first layer.
However, further modifying the bioreactor system taught by the prior art combination to include one or more additional partitions would amount to mere duplication of parts. It has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). An ordinarily skilled artisan would reasonably expect that a one or more additional partitions would simply create additional recessed areas.
The limitation “configured to separate additional recessed areas between the bottom interior surface of the lid and the first layer” is directed toward the intended manner of operating the claimed apparatus and does not differentiate the claimed apparatus from the prior art apparatus because all structural limitations are taught in the prior art apparatus (MPEP § 2114 II). The bioreactor system taught by the prior art combination would be fully capable of achieving every claimed intended use because each partition creates recessed areas (see claim 4 rejection).
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gubernator and Astle as applied to claim 3 above, and in further view of Kelly-Greene et al. (US 2020/0017817 A1) (see PTO-892; hereinafter Kelly-Greene).
Regarding claim 11, the prior art combination teaches the bioreactor system of claim 3.
The prior art combination does not teach a sterile layer disposed on a bottom side of the first layer, wherein the sterile layer is configured to be pierced by the pipette tip.
However, Kelly-Greene teaches it is known in the art of multi-well plates to use a film (i.e., sterile layer) that can be pierced by an import/export tip (i.e., pipette tip).
Kelly-Greene teaches that the film protects samples against contamination and evaporation as well as maintaining an internal atmosphere (Col. 27, lines 30-37). The film can also be pierced by an import/export tip (i.e., pipette tip) (Col. 27, lines 20-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the prior art combination bioreactor system to incorporate the film of Kelly to improve protection against contamination and evaporation.
Regarding claim 13, the prior art combination teaches the bioreactor system of claim 3.
The prior art combination does not teach one or more posts extending from the bottom interior surface of the lid housing toward the first layer.
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However, Kelly-Greene in the art of multi-well plates shows one or more posts extending from a bottom interior surface of a lid housing toward a sealing element (i.e., first layer) (Fig. 4A, one or more posts shown extending from bottom side 106b of the lid 106 – see annotated figure below; Fig. 1B shows exploded view of overall device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the prior art combination bioreactor system to incorporate the posts of Kelly as the posts would improve the seal between the first layer and the lid housing.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gubernator and Astle as applied to claim 21 above, and further in view of Stevens and Martin et al. (WO 2020/013851 A1) (hereinafter Martin, see PTO-892).
Regarding claim 22, the prior art combination teaches the bioreactor system of claim 21.
The prior art combination does not disclose or teach a first portion or second portion of the sample container, or wherein one or more of the first wells are fluidically coupled to one or more of the second wells via one or more fluidic channels.
However, Stevens in the analogous art of multiwell culturing plates teaches it is known in the art to form a first portion of a sample container including one or more first wells and a second portion of a sample container including one or more second wells (Fig. 2).
Additionally, Martin in the analogous art of microplates teaches it is known in the art to use fluidic channels to fluidically couple one or more wells ([0050]; Figs. 1 and 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination sample container such that it further comprises a first portion including one or more first wells and a second portion including one or more second wells, wherein one or more of the first wells are fluidically coupled to one or more of the second wells via one or more fluidic channels as Stevens and Martin teach that such features were known in the art. An ordinarily skilled artisan would be motivated to use a design known in the art.
The limitations “configured to contain fluid reagents” and “configured to contain a fluid sample comprising one or more cells” are directed toward the intended manner of operating the claimed first wells and second wells, respectively, and do not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art one or more first wells and one or more second wells would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
The limitation “wherein the lid assembly provides an air-tight seal around the sample container” is contingent on the compression of the lid assembly against the sample container and has been given appropriate patentable weight (MPEP § 2111.04 II). No further prior art rejections are required as all structure necessary to meet the claim is taught and/or anticipated by the prior art of record.
Regarding claim 23, the claim as written is directed to a contingent limitation, i.e., the air-tight seal in claim 22. No further prior art rejections are required as all structure necessary to meet the claim is taught and/or anticipated by the prior art of record.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Gubernator and Astle as applied to claim 22 above, and in further view of Grimberg et al. (US 2017/0285047 A1) (see PTO-892; hereinafter Grimberg) and Ziegler (EP 2221135 A2) (see PTO-892 – English machine translation provided; hereinafter Ziegler).
Regarding claim 24, the prior art combination teaches the bioreactor system of claim 22,
The prior art combination does not teach an eccentric lever and a ball sleeve comprising radially guided balls configured to compress the lid assembly against the sample container.
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However, Grimberg teaches it is known in the art to use a clamping member in the form of an eccentric cam lever (i.e., eccentric lever) to securely clamp an upper and lower plate together to assemble the device ([0200]; Fig. 4A – see annotated figure below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the prior art combination bioreactor system to incorporate an eccentric lever, as taught by Grimberg, to secure the lid assembly to a sample container.
Grimberg does not teach the eccentric lever and a ball sleeve comprising radially guided balls.
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However, Ziegler in the art of locking mechanisms discloses an eccentric lever (15) and a ball sleeve comprising radially guided balls (8, 9) (Fig. 1 – see annotated figure below) for fixing a first element to a second element ([0001]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the eccentric cam lever of Grimberg for the design of Ziegler. It has been held that a claim has no patentable significance when substitution of one known element for another yields predictable results to one of ordinary skill in the art (MPEP §2143 B). Ziegler’s eccentric lever design would predictably secure the lid assembly against a sample container.
The limitation “configured to compress the lid assembly against the sample container” is directed toward the intended manner of operating the claimed apparatus and does not differentiate the claimed apparatus from the prior art apparatus because all structural limitations are taught in the prior art apparatus (MPEP § 2114 II). The eccentric lever design taught by the prior art combination would be fully capable of achieving every claimed intended use because the lever can fix two elements together.
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 ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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/A.J.C./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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