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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 05/26/2026 has been entered.
A Note on Prosecution
This application 17/986,060 is a CON of patented application 16/407,026.
Information Disclosure Statement
The information disclosure statement(s) (IDS) were submitted on:
05/26/2026
Accordingly, the information disclosure statement(s) are being considered by the examiner.
Regarding the Information Disclosure Statement filed 05/26/2026, the Applicant was misnamed on the following citation:
Foreign Patent Document, Citation #2: WO 2024/076910 A3 (CZ Biohub SF, LLC)
Nevertheless, the document listed on the IDS has been considered.
Claim Objections
Claims 30 and 50 are objected to because of the following informalities:
Regarding claim 30, the phrase “smaller than each respective reservoir” should be “smaller than the volume of each respective reservoir”. This phrase fulfills grammatical parallelism to the prior phrase “wherein the volume of the receptacle is”.
Regarding claim 50, the phrase “when the fluid levels in the at least two reservoirs is different” should be “when the fluid levels in the at least two reservoirs are different”. This phrase fulfills the correct verb “are”, which agrees with the at least two “fluid levels”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a sealing member bonded or bondable to the body at an open side of the receptacle, to create a chamber for the organized multi-cellular structure” in claim 30.
“the sealing member is bonded to the body” in claim 41 (from claim 41’s dependence from claim 30).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 30 and 41 are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A review of the specification as filed shows that the following appears to be the corresponding structures, materials, or acts described in the specification as filed for the following 35 U.S.C. § 112(f) limitations:
“Sealing member 80 may be formed of glass or polymer, among others, and may be pre-formed or formed in situ, at least partially or completely inside receptacle 82.” – pg. 18 of 51
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
Regarding claim 49, the previous 35 U.S.C. § 112(b) rejection is withdrawn in light of the amendments. This is due to the use of the phrase “configured to” in claim 49. The claim is being interpreted to not claim substantially identical devices, but rather to have a configuration capable of supporting being connected to one or more substantially identical devices.
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.
Claims 30-33, 35-36, 40-41, 43, 45-46, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Gabridge (US 4952510) (previously cited); or, in the alternative, under 35 U.S.C. 103 as obvious over Gabridge (US 4952510) (previously cited) in view of Wilson (US 20080176318) (previously cited).
Regarding claim 30, Gabridge discloses a device (col. 1, lines 6-10) for culture of an organized multi-cellular structure (col. 1, lines 28-34), the device comprising:
(a) a body (col. 6, lines 8-10) defining a receptacle (Fig. 1, element 28 “lower portion”; col. 6, lines 27-38) and at least two reservoirs (Fig. 1, element 30 “compartmental volumes”; col. 6, lines 27-38), the at least two reservoirs overlying the receptacle (Fig. 1) and being in separate fluid communication with the receptacle via respective channels (Fig. 1, elements 32 “plurality of openings”; col. 7, lines 3-26), wherein the respective channels each extend through a top wall of the body adjacent to the at least two reservoirs (Fig. 1; col. 7, lines 3-26); and
(b) a sealing member (Fig. 1, element 16 “bottom surface”; col. 6, lines 7-26) bonded or bondable (col. 6, lines 5-15 “connect”) to the body at an open side of the receptacle (Fig. 1, element 28 “lower portion”; col. 6, lines 27-38), to create a chamber (Fig. 1) for the organized multi-cellular structure (col. 12, lines 6-13 “microorganisms in the liquid nutrient medium”), wherein at least one reservoir is in fluid communication with the chamber independently of each other reservoir via one of the respective channels (Fig. 1, elements 32 “plurality of openings”; col. 7, lines 3-26).
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Gabridge, Fig. 1
Gabridge does not disclose wherein the volume of the receptacle is smaller than each respective reservoir.
However, it would have been obvious to one skilled in the art before the effective filing date to modify the dimensions and/or volumes of the receptacle and those of each respective reservoir in order to have a larger amount of space to house reagents that feed the relatively smaller organoid compartment over a large period of time. Regarding the limitation, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). In addition, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”.
Regarding the phrase “the organized multi-cellular structure”, this term is a manner of operating the claimed invention. The material or article worked upon by the apparatus does not limit the apparatus claims. MPEP § 2115. This limitation is a manner of operating or intended use of a claimed apparatus and does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Gabridge would be fully capable of operating in this manner given its reservoirs, channels, receptacle, chamber, and sealing member.
If it is deemed that Gabridge does not teach that their invention is “for culture of an organized multi-cellular structure” as stated in the claimed preamble, a preamble merely indicates the intended use of the apparatus and does not add structural limitations to the claims. MPEP § 2111.02(II). Because the apparatus taught by Gabridge teaches all the structural limitations claimed, it would be capable of being used in this manner. Applicant is also reminded that the intended use of or manner of operating a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II).
Regarding the phrase “bonded or bondable”, these terms are claimed in the alternative. Because the bonded parts of Gabridge inherently describe both these terms, no further rejections are required at this time.
If it is deemed that the terms “a sealing member [that is] bonded or bondable” are not fulfilled by Gabridge as above, Wilson discloses a sealing member (paragraph [0054] “cap 30 covers access port 70”) that is bonded or bondable (paragraph [0088] “bond dimethyl silicone to a rigid plastic”).
In the analogous art of culture flasks, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the bonded or bondable sealing member of Wilson in order to have a liquid-tight bond that is biocompatible (Wilson, paragraph [0088]).
Regarding claim 31, Gabridge discloses further comprising a scaffold (col. 9, lines 62-68; and col. 10, lines 1-7 “solid nutrient media”) attached to a wall of the reservoirs (Fig. 1, element 30 “compartmental volumes”; col. 6, lines 27-38).
Gabridge does not disclose a scaffold attached to a wall of the receptacle.
However, this is an obvious re-arrangement of parts, where the solid nutrient medium of Gabridge could be located in the receptacle rather than in the reservoirs. Regarding this limitation, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). It would have been obvious to one skilled in the art before the effective filing date to modify the location of the scaffold of Gabridge with the location in the receptacle in order to allow for a single solid medium in the receptacle to be exposed to liquid media from the reservoirs.
Regarding claim 32, Gabridge discloses wherein the scaffold is included in a hydrogel (col. 1, lines 14-19 “agar”).
Regarding claim 33, Gabridge discloses wherein the receptacle and the at least two reservoirs are formed integrally with one another (col. 10, lines 15-20 “integral part”).
If it is deemed that Gabridge does not disclose “wherein the receptacle and the at least two reservoirs are formed integrally with one another”, integration of parts is obvious. Integration of parts would have been obvious to one of ordinary skill in the art as a matter of obvious engineering choice. MPEP § 2144.04(V)(B). It would have been obvious to one skilled in the art before the effective filing date to modify Gabridge’s invention to be integrally formed among the receptacle and the at least two reservoirs in order to have fewer possible leak points for the medium and microbes.
The limitation “formed integrally” is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
Regarding claim 35, Gabridge discloses wherein each reservoir of the at least two reservoirs shares a wall with the receptacle (Fig. 1; col. 4, lines 11-16).
Regarding claim 36, Gabridge discloses two channels (Fig. 1; col. 7, lines 3-26).
Gabridge does not disclose wherein at least one of the respective channels functions as an inlet of the chamber and at least one of the respective channels functions as an outlet of the chamber.
However, regarding the limitation, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Gabridge or modified Gabridge would be fully capable of operating in this manner given the structures of the two channels.
Regarding claim 40, Gabridge discloses wherein the device is in a sterilized condition (col. 3, lines 52-58).
Additionally, regarding the limitation, the phrase “a sterilized condition” is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
Additionally, regarding the limitation “a sterilized condition” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Gabridge would be fully capable of operating in this manner given the structure of the device.
Regarding claim 41, Gabridge discloses wherein the sealing member (Fig. 1, element 16 “bottom surface”; col. 6, lines 7-26) is bonded (col. 6, lines 5-15 “connect”) to the body (Fig. 1, element 28 “lower portion”; col. 6, lines 27-38).
If it is deemed that Gabridge does not disclose wherein the sealing member is bonded to the body, Wilson discloses wherein the sealing member (paragraph [0054] “cap 30 covers access port 70” and paragraph [0121] “Septum can be present in molded silicone”) is bonded to (paragraph [0088] “bond dimethyl silicone to a rigid plastic”) the body (paragraph [0053], “multi-shelved device”).
In the analogous art of culture flasks, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the sealing member of Wilson in order to have a liquid-tight and biocompatible seal (Wilson, paragraph [0088]).
Regarding claim 43, Gabridge discloses wherein the body defines two or more reservoirs each disposed in fluid communication with the receptacle (Fig. 5; col. 6, lines 46-51; col. 13, lines 9-12).
Gabridge does not disclose at least four reservoirs.
However, this limitation is obvious under duplication of parts. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with at least four reservoirs in order to create further partitions for at least four different substances to interact with the substance in the receptacle.
Regarding claim 45, Gabridge discloses wherein the body comprises a pair of lateral windows to permit illumination of an interior of the chamber via either lateral window of the pair of the lateral windows (col. 6, lines 38-46).
If it is deemed that Gabridge does not disclose the limitation above, Wilson discloses wherein the body (paragraph [0053], “multi-shelved device”) comprises a pair of lateral windows (annotated Fig. 1A and paragraph [0076] “Optically clear materials are preferred” and paragraph [0090] “sidewall support is a rigid, clear material”) to permit illumination (paragraph [0076]) of an interior of the chamber (paragraph [0054], chamber created by sealing the “manifold 60”) via either of the lateral window of the pair of lateral windows (annotated Fig. 1A and paragraph [0076] “Optically clear materials are preferred” and paragraph [0090] “sidewall support is a rigid, clear material”).
In the analogous art of culture vessels, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the pair of lateral windows of Wilson in order to provide optical transparency for visual detection of contamination and pH (Wilson, paragraph [0083]).
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Regarding claim 46, Gabridge discloses wherein the pair of lateral windows are disposed opposite each other (Fig. 1).
If it is deemed that Gabridge does not disclose the limitation above, Wilson discloses wherein the pair of lateral windows (annotated Fig. 1A and paragraph [0076] “Optically clear materials are preferred” and paragraph [0090] “sidewall support is a rigid, clear material”) are disposed opposite each other (annotated Fig. 1A and Figs. 5A-5C and paragraphs [0057], [0062], and [0066]).
In the analogous art of culture vessels, it would have been obvious to one skilled in the art before the effective filing date to modify the pair of lateral windows of Gabridge with those of Wilson in order to in order to provide optical transparency for visual detection of contamination and pH (Wilson, paragraph [0083]).
Regarding claim 50, Gabridge discloses wherein the device is arranged such that gravity drives flow of a medium into the receptacle via a first respective channel and out of the receptacle via a second respective channel (col. 7, first and second full paragraphs).
Regarding the terms “simultaneously” and “when the fluid levels in the at least two reservoirs is different”, this is an intended use or manner of operation of the device, due to the differences in fluid levels in the receptacle and the at least two reservoirs. Regarding the limitation, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Gabridge would be fully capable of operating in this manner given the openings, receptacle, and at least two reservoirs.
Claims 34, 42, 44, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Gabridge (US 4952510) (previously cited) in view of Wilson (US 20080176318) (previously cited) as applied to claims 30 and 41.
Regarding claim 34, Gabridge discloses wherein the body is molded (col. 9, lines 27-32) as a single piece (col. 3, lines 18-20).
Gabridge does not disclose wherein the body is injection-molded as a single piece.
Wilson discloses wherein the body (paragraph [0053], “multi-shelved device”) is injection-molded as a single piece (paragraphs [0088]-[0090]).
In the analogous art of culture flasks, it would have been obvious to one skilled in the art before the effective filing date to modify the culture apparatus of Gabridge with the injection molding of Wilson in order to create a liquid tight bond that is biocompatible (Wilson, paragraph [0088]).
Additionally, the limitation is a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP § 2113.
Regarding claim 42, Gabridge does not disclose wherein the sealing member comprises a polymer.
Wilson discloses wherein the sealing member comprises a polymer (paragraph [0054] “cap 30 covers access port 70” and paragraph [0121] “Septum can be present in molded silicone”).
In the analogous art of culture flasks, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the sealing membrane comprising a polymer of Wilson in order to create a liquid-tight and biocompatible seal (Wilson, paragraph [0088]).
Regarding the limitation “at least one of a glass or a polymer”, the limitation has been claimed in the alternative. Because modified Gabridge discloses a polymer, no further rejections are required at this time.
Regarding claim 44, Gabridge discloses the sealing member (Fig. 1, element 16 “bottom surface”; col. 6, lines 7-26); and a portion of the receptacle comprises a bottom window for imaging a contents of an interior of the chamber (col. 4, lines 19-21).
Gabridge does not disclose wherein the sealing member comprises a bottom window for imaging a contents of an interior of the chamber.
Wilson discloses the sealing member (paragraph [0054] “cap 30 covers access port 70” and paragraph [0121] “Septum can be present in molded silicone”) comprises a bottom window (paragraph [0054] “cap 30 covers access port 70” and paragraph [0083] “optical transparency” can be used in any of the materials throughout the cell culture device) for imaging a contents (paragraphs [0076] “microscopically observe cells in culture” and [0083]) of an interior of the chamber (paragraph [0054], chamber created by sealing the “manifold 60”).
In the analogous art of culture flasks, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the bottom window of Wilson in order to use the optical transparency for visual detection of contamination and pH (Wilson, paragraph [0083]).
Regarding the limitation “for imaging a contents of an interior of the chamber” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Gabridge would be fully capable of operating in this manner given the transparent bottom window of the sealing member of modified Gabridge.
Regarding claim 49, Gabridge does not disclose further configured to be connected to one or more substantially identical devices.
Wilson discloses further configured to be connected (paragraphs [0087]-[0088] and Figs. 18A-18E) to one or more (paragraphs [0090] and Figs. 18A-18E) substantially identical devices (Figs. 18A-18E).
In the analogous art of culture flasks, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the embodiments of Wilson in order to obtain a flask that has multiple culture compartments for the expansion of the cell culture, allows culture compartments to be partially filled with medium, and/or minimizes the volume of trypsin, PBS, or any other liquid that is involved in removing cells from the cell compartments (Wilson, paragraph [0090]).
Regarding the limitation “substantially identical units”, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the substantially identical units in order to have more replicates of the same conditions for the cell culture, or to expose different cell cultures to the same environmental conditions in a single trial.
Regarding the limitation “connected to one another”, integration of parts would have been obvious to one of ordinary skill in the art as a matter of obvious engineering choice. MPEP § 2144.04(V)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the integral connections to one another in order to employ one device rather than multiple devices at the same time, which is useful for mass production and robotic handling.
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Gabridge (US 4952510) (previously cited) as applied to claim 30, further in view of Jung (KR 20150069113) (machine translation) (previously cited); or, in the alternative, under 35 U.S.C. 103 as obvious over Gabridge (US 4952510) (previously cited) in view of Wilson (US 20080176318) (previously cited) as applied to claim 30, further in view of Jung (KR 20150069113) (machine translation) (previously cited).
Regarding claim 37, Gabridge does not disclose further comprising a removable lid configured to cover an open top of each reservoir of the at least two reservoirs.
Jung discloses a removable lid (Fig. 2, element 300 and paragraphs [0050]-[0055]) configured to cover an open top of a reservoir (Fig. 2, element 100 and paragraphs [0055]-[0056]).
In the analogous art of laboratory vessels for animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Gabridge with the removable lid of Jung in order to cover the insertion hole to the reservoir (Jung, abstract). This removable lid would promote aseptic handling of a sterile container.
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Regarding claim 38, Gabridge does not disclose wherein the removable lid comprises a flange configured to restrict a lateral movement of the removable lid.
Jung discloses wherein the removable lid (Fig. 2, element 300 and paragraphs [0050]-[0055]) comprises a flange (Fig. 2, element 311 “support grooves” and element 312 “opening groove”; paragraphs [0053]-[0054]; Figs. 4A and 4B, element 120 “insertion pin”; paragraphs [0048]-[0050]) configured to restrict a lateral movement (paragraph [0050] “the container body (100) and the cover (300) can be firmly connected to each other”) of the removable lid (Fig. 2, element 300 and paragraphs [0050]-[0055]).
In the analogous art of laboratory vessels for animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Gabridge with the removable lid and flange of Jung in order to cover the insertion hole to the reservoir with a seal (Jung, abstract and paragraph [0037]). This removable lid would promote aseptic handling of a sterile container.
Regarding the phrase “configured to restrict a lateral movement of the removable lid”, this is an intended use of the flange recited. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Gabridge would be fully capable of operating in this manner given the removable lid and its flange.
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Regarding claim 39, Gabridge does not disclose wherein the removable lid comprises a fluid-tight seal with the at least two reservoirs.
Jung discloses wherein the removable lid (Fig. 2, element 300 and paragraphs [0050]-[0055]) comprises a seal (paragraph [0037]) with a reservoir (Fig. 2, element 100 and paragraphs [0055]-[0056]).
In the analogous art of laboratory vessels for animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Gabridge with the removable lid and seal of Jung in order to cover the insertion hole to the reservoir with a seal (Jung, abstract and paragraph [0037]). This removable lid would promote aseptic handling of a sterile container.
If it is deemed that the seal of Jung is not a fluid-tight seal, Jung’s background section discloses a fluid-tight seal (paragraph [0013]).
In the analogous art of laboratory vessels for animal cells, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Gabridge with the removable lid and seal of Jung in order to cover the insertion hole to the reservoir with a fluid-tight seal (Jung, abstract and paragraph [0037]). This removable lid would promote aseptic handling of a sterile container, orienting the container in order to place reagents inside or allow cells to be cultured; and rotating the container for ease of use without fluid leaks.
Claims 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Gabridge (US 4952510) (previously cited) as applied to claim 30, in view of Baumfalk (US 20120097557) (previously cited); or, in the alternative, under 35 U.S.C. 103 as obvious over Gabridge (US 4952510) (previously cited) in view of Wilson (US 20080176318) (previously cited) as applied to claim 30, further in view of Baumfalk (US 20120097557) (previously cited).
Regarding claim 47, Gabridge discloses the body (col. 6, lines 8-10) and the chamber (Fig. 1).
Gabridge does not disclose wherein the body defines an access tube having an open top end and a closed bottom end, and wherein a shared wall separates the chamber from the closed bottom end of the access tube.
Baumfalk discloses an access tube (Fig. 4 and abstract, “adapter”) having an open top end (Fig. 4 and abstract, “receiving opening”) and a closed bottom end (Fig. 4 and abstract, “boundary surface”; claim 1), and wherein a shared wall (Fig. 4, elements 5`` and 13``` and paragraph [0038]) separates the chamber (Fig. 4, container interior; paragraph [0020]) from the closed bottom end of the access tube (Fig. 4 and abstract, “boundary surface”; claim 1).
In the analogous art of systems for analyte sensing and monitoring, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the access tube of Baumfalk in order to detect analytes or probe the interior of the chamber (Baumfalk, paragraph [0010]).
Regarding claim 48, Gabridge does not disclose wherein the access tube comprises a barrier at one end of the access tube.
Baumfalk discloses wherein the access tube (Fig. 4 and abstract, “adapter”) comprises a barrier (Fig. 4, elements 5`` and 13``` and paragraph [0038]) at one end (Fig. 4 and abstract, “boundary surface”; claim 1) of the access tube (Fig. 4 and abstract, “adapter”).
In the analogous art of systems for analyte sensing and monitoring, it would have been obvious to one skilled in the art before the effective filing date to modify the apparatus of Gabridge with the closed-ended access tube of Baumfalk in order to detect analytes or probe the interior of the chamber (Baumfalk, paragraph [0010]) while keeping the interior of the container sterile (Baumfalk, paragraphs [0013]-[0014]).
Response to Arguments
Applicant’s arguments filed 05/26/2026 have been fully considered but they are not persuasive.
Regarding pg. 5 of 11 of Applicant remarks, regarding claim interpretations under 35 U.S.C. § 112(f), the term “sealing member” merits a 112(f) interpretation. The sealing member: “… may be formed of glass or polymer, among others, and may be pre-formed or formed in situ, at least partially or completely inside receptacle 82” (from the instant specification, pg. 18 of 51). Applicant has not recited sufficient structure to describe the nonce term “sealing member”, other than it is to be used for bonded or bondable sealing.
Regarding pg. 6 of 11 of Applicant remarks, regarding the previous 35 U.S.C. § 112(b) rejecting claim 49, the rejection is withdrawn in light of the amendments.
Regarding pg. 7 of 11 of Applicant remarks, regarding the size of the volume of the receptacle in comparison to that of each respective reservoir, these arguments are considered unpersuasive. Although this amendment has written description support (instant specification, pg. 18, lines 13-19), the rejection is maintained because changes in the relative size and/or dimensions of a component of the prior art are obvious modifications. Specifically, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify the volumes of the apparatus of modified Gabridge with the smaller receptacle volume than each respective reservoir in order to have a larger amount of space to house reagents that feed the relatively smaller organoid compartment over a large period of time.
Regarding pgs. 8-9 of 11 of Applicant remarks, in general, the drawings of an invention are not to be taken to scale. However, for the reasons already stated above, it would have been obvious to modify the volumes of Gabridge. Applicant’s arguments are considered unsubstantiated, as no evidence is provided that the prior art cannot function in the manner claimed. Therefore, it is presumed that modified Gabridge is enabled. Furthermore, the openings are configured so that when the vessel is tipped at an angle with respect to the upright position, liquid located in the lower container volume flows through openings and into the compartmental volumes (Fig. 1; col. 7, first full paragraph). Contrarily, the reverse fluid movement can also occur, wherein the liquid in the compartmental volumes flows through openings and into the lower container volume (Fig. 1; col. 7, second full paragraph).
Additionally, the way that the apparatus of Gabridge is tilted according to gravity is also a form of intended use or a manner of operating the apparatus. For instance, one could start from an upright position (or even a tilt in the reverse direction if need be) and begin to forwardly tilt the apparatus at a small angle, and then increase to a larger forward angle over the course of a period of time and still fulfill fluid flow via gravity. Therefore, at least modified Gabridge is enabled for the same purposes as that of the claimed invention. Regarding the arguments about fluid flow due to gravity, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Gabridge would be fully capable of operating in this manner given the receptacle, openings, and at least two reservoirs.
In addition, to directly address the presumption that Gabridge cannot operate in the intended way claimed, according to the citation provided by Applicant (Gabridge, col. 7, lines 3-26), the following argument is provided:
Gabridge recites the prevention of accidental fluid entrance into the compartmental volumes 30:
With openings 32 so configured, culture vessels 10 and 13 may be placed in a generally horizontal position, with transparent section 20 facing upwardly, without liquid located in lower container portion 28 accidentally entering compartmental volumes 30.
Gabridge, col 7, lines 17-22
However, this accident prevention feature does not preclude the flow of fluid from compartmental volume to lower container volume and back as already described above (Gabridge, col. 7, first and second full paragraphs), as the fluid flow is dependent on the tilting and orientation of the apparatus with respect to gravity – an intended use or manner of operation of the apparatus.
Regarding pgs. 9-10 of 11, new claim 50 is to be examined on its merits. However, the claim is rejected for the reasons stated above, under Gabridge. Additionally, the volume of the compartments of Gabridge implicitly describes a height of the compartments. This height can be modified for the purpose of the effect claimed – simultaneous emptying of one reservoir and filling of another reservoir at two different liquid levels. This height dependence is because the volume of the lower container volume of Gabridge may or may not be large enough to hold the entire volume of one of the reservoirs without further modification. It is unknown exactly what the dimensions of Gabridge’s device are, but the claimed feature is obvious in light of the stated intended use in Gabridge for allowing liquid flow back and forth among the compartments and the lower container volume; modifications to Gabridge’s dimensions are also obvious with regards to the MPEP, as stated above about the relative size and dimensions of parts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is 571-272-9807, and whose fax number is 571-273-8464. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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