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 .
Information Disclosure Statement
The information disclosure statements (03/06/2024, 03/06/2024, 07/09/2025, and 04/17/2026) have been certified and made of record.
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:
“Cell culture process module” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
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
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "light-based manipulation" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the one or more pumps” in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim limitation “cell culture process module” (claim 1) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Specifically, although the disclosure provides cell culture process modules (para. [0551] – element 7710 and FIG. 80 – element 8002), the disclosure fails to provide specific structure of what entails a process module, such as specific features or elements comprising a module. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 2-16 are included in this rejection because they depend from rejected claim 1 and fail to cure the deficiencies of claim 1.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure above does not provide adequate structure to perform the claimed function of managing the cell culture process (cell culture process module – claim 1). The specification does not demonstrate the applicant has made an invention that achieves the claimed function because the invention is not described in sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention. Claims 2-16 are included in this rejection because they depend from rejected claim 1 and fail to cure the deficiencies of claim 1.
It should be further noted that in light of the specification, it is unclear what structure is the cell culture process module. Therefore, for examination purposes, if a process or element manages the cell culture process, this will be interpreted as meeting this claim limitation.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 6, 8, 11, 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyd et al. (US 20170014824 A1) (referenced in IDS).
Regarding claim 1, Boyd et al. teaches a cell culture container (See annotated FIG. 2), comprising:
a closed fluidic cell culture chamber comprising a first surface (gasket element 58);
a transparent substrate (FIG. 2, slide - element 56, structurally performs the same function as the semi-transparent surface in the claim) attached to the first surface (FIG. 2), wherein the transparent surface is configured to:
support a cell culture process (cell sorting – para. [0007]) performed on a cell culture adhered to the semi-transparent surface (element 56); and
one or more inlets (FIG. 1, element 68 – inlet opening) for introducing fluid media into the cell culture chamber (para. [0069]);
one or more outlets (FIG. 1, element 70 – outlet opening) for flushing fluid media and cells from the cell culture chamber (para. [0069]);
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one or more pluggable connectors (FIG. 1, Luer fitting - element 72) configured to provide fluid and/or electrical communication between the cell culture container and a cell culture process module configured to manage the cell culture process. (Note: This element was invoked by 112f: cassette members (element 52 and 54) house and manage cell sorting in the device). Cell culture process module here connects the cell container with the module elements.
Regarding the limitation “enable light-based cell imaging and light-based cell manipulation of the cell culture”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitation of the claim (MPEP § 2114 II). Therefore, the transparent substrate employed in Boyd et al.’s apparatus would be fully capable of achieving every claimed intended use because Boyd et al. discloses that slide (element 56) provides a window into the flow chamber of the cassette (element 50) for optical observation through the bottom member (element 54) (para. [0066]) and would be structurally capable of enabling light-based cell imaging and light-based cell manipulation of the cell culture, absent clear evidence otherwise.
Regarding claim 2, Boyd et al. teaches the cell container of claim 1. Regarding the limitation “semi-transparent surface is configured to enable light-based cell imaging when illuminated with light within a first wavelength range and enable light-based cell manipulation when illuminated with light within a second wavelength”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitation of the claim (MPEP § 2114 II).
Therefore, the transparent substrate employed in Boyd et al.’s apparatus would be fully capable of achieving every claimed intended use because Boyd et al. discloses that slide (element 56) provides a window into the flow chamber of the cassette (element 50) for optical observation through the bottom member (element 54) (para. [0066]) and would be structurally capable of enabling light-based cell imaging when illuminated with light within a first wavelength range and enable light-based cell manipulation when illuminated with light within a second wavelength, absent clear evidence otherwise.
Regarding claim 6, Boyd et al. teaches the cell container of claim 1. Boyd et al. teaches that the apparatus is used for cell sorting (cell process) (para. [0002]). Thus, the claim is anticipated.
Regarding claim 8, Boyd et al. teaches the cell container of claim 1. Regarding the limitation “one or more pluggable connectors are configured to enable the cell culture container to be removably coupled to the cell culture process module”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitation of the claim (MPEP § 2114 II).
Therefore, the pluggable connectors (Luer Fittings - element 72) employed in Boyd et al.’s apparatus would be fully capable of achieving every claimed intended use because Boyd et al. teaches that “each of the bores 68, 70 is internally threaded for receiving a luer fitting 72” (para. [0064]), with bores (element 68 and 70) part of top cassette member 52 (para. [0064]) would be structurally capable of enabling the cell culture container to be removably coupled to the cell culture process module
Regarding claim 11, Boyd et al. teaches the cell container of claim 1. Boyd et al. teaches “The Luer fittings 72 may be provided to attach tubing from the cassette 50 device to a pump (not shown), such as a precision syringe pump” – para. [0069], as the pump described allows fluid media in and out of the cassette (element 50). Thus, the claim is anticipated.
Regarding claim 16, Boyd et al. teaches the cell container of claim 1. Regarding the limitation “the cell culture container is configured for insertion into the cell culture process module in at least one of a first orientation and a second, inverted orientation”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitation of the claim (MPEP § 2114 II).
Therefore, the cell culture container employed in Boyd et al.’s apparatus would be fully capable of achieving every claimed intended use because Boyd et al. teaches that slide (element 56) may rest on ledge 76, which is configured to receive the slide 56 such that the surface of the slide is flush with the inner surface 64 of the bottom cassette member 54 forming a floor for the interior flow chamber. This configuration would be structurally capable of enabling the cell culture to be inserted into the cell culture process module in at least one of a first orientation and a second, inverted orientation
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Albritton et al. (WO 03093791 A2) (referenced in 892).
Regarding claim 3, Boyd et al. teaches the cell container of claim 1. Boyd et al., however, fails to teach that light-based cell manipulation comprises lysing one or more cells of the cell culture from the semi-transparent surface. Albritton et al. teaches the usage of a laser-based cell lysis system for rapid cellular lysis and collection of the contents of cells (para. [0005]). Albritton et al. teaches that this laser-based cell lysis system allows rapid lysing of a single cell (or cells) with rapid subsequent collection of the contents for the analysis of enzymatic activity (para. [0005]).
It would have been prima facie obvious to one of ordinary skill in the art to use Albritton et al.’s teaching of a laser-based cell lysis system in Boyd et al.’s cell container because laser-based cell lysis enables rapid lysing of a single cell (or cells), which allows subsequent collection of the contents for analysis. The optical window provided in Boyd et al.’s cell container would allow laser-based cell lysis to be performed in the container. This method of improving Boyd et al.’s cell container was within the ability of one of ordinary skill in the art based on the teachings of Albritton et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Boyd et al. and Albritton et al. to obtain the invention as specified in claim 3.
Regarding claim 4, modified Boyd et al. teaches the device of claim 3. Boyd et al. teaches an outlet (element 70) in the cell culture container. Regarding the limitation “configured to enable removal of the one or more lysed cells from the cell culture chamber”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitation of the claim (MPEP § 2114 II). Therefore, outlet employed in Boyd et al. device would be fully capable of achieving every claimed intended use because Boyd et al. discloses that outlets (FIG. 1, element 70 – outlet opening) can allow introduction and discharging a fluid into and from the channel (para. [0069]), and would be structurally capable of removing lysed cells from the cell culture chamber, absent clear evidence otherwise.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Nolan Boyd et al. (doi: 10.1089/ten.tea.2008.0351) (herein referred to as N. Boyd et al.) (referenced in 892).
Regarding claim 5, Boyd et al. teaches the cell culture container of claim 1, but fails to teach that the cell culture process is performed for at least 30 days. N. Boyd et al. teaches of that differentiation prior to subculturing of human embryonic stem cells takes a period of 20-30 days (p. 2 - Differentiation procedure and culture). It has been established in the case where the claimed ranges (“the cell process is performed for at least 30 days”) overlap or lie inside ranges disclosed by the prior art (cell differentiation: 20-30 days), a prima facie case of obviousness exists (MPEP § 2144.05 I). Thus, it would have been prima facie obvious to use the claimed range of 30 days since this range overlaps with the prior art’s range (N. Boyd et al. - 20-30 days), which is used for stem cell differentiation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Singh et al. (US 20140357506 A1) (referenced in 892).
Regarding claim 7, Boyd et al. teaches the device of claim 1, but fails to specifically teach that the cell culture comprises one or more (induced pluripotent stem cell (iPSC) colonies. Singh et al. teaches a methodology for adhesive force-based stem cell sorting (para. [0133]). Specifically, iPSC cells are selectively detached and isolated (cell sorting) from a mixture of cells adhered to a substrate relative to parental cells and partially reprogrammed cells that have a higher adhesion strength than the iPS cells do for the substrate (para. [0133]).
It would have been prima facie obvious to one of ordinary skill in the art to use Singh et al.’s teaching of induced pluripotent stem cell (iPSC) colonies in Boyd et al.’s cell container because iPSC cells are selectively detached and isolated from a mixture of cells due to their specific adhesion strength. The cell sorting provided in Boyd et al.’s cell container would enable iPSC colonies to be sorted from a mixture. This method of improving Boyd et al.’s cell container was within the ability of one of ordinary skill in the art based on the teachings of Singh et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Boyd et al. and Singh et al. to obtain the invention as specified in claim 7.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Gebauer (US 20150247114 A1) (referenced in 892).
Regarding claim 9, Boyd et al. teaches the cell culture container of claim 1, but fails to teach that the pluggable connectors comprises an aseptic fluid connector. Gebauer teaches a perfusion system with aseptic connectors (element 65), which may pre-sterilized to reduce and avoid infection of the cell culture (para. [0032]).
It would have been prima facie obvious to one of ordinary skill in the art to use Gebauer’s teaching of aseptic connections in Boyd et al.’s cell container because aseptic connections allow pre-sterilization to be performed to reduce and avoid infection of the cell culture. This method of improving Boyd et al.’s cell container was within the ability of one of ordinary skill in the art based on the teachings of Gebauer. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Boyd et al. and Gebauer. to obtain the invention as specified in claim 9.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Hinojosa (US 20200181555 A1) (referenced in 892).
Regarding claim 10, Boyd et al. teaches the cell culture container of claim 1, but fails to specifically teach that the cell culture container further comprises one or more rails configured to allow the cell culture container to be mechanically transported. Hinojosa teaches a microfluidic device (element 16) that can be detachably linked with a perfusion manifold assembly to temporarily lock the microfluidic device in place (para. [0111]). Specifically, through using guide rail, side slot, internal or external track (element 25), a stable guide path for the device is conveyed by machine or by hand into position (para. [0111]).
It would have been prima facie obvious to one of ordinary skill in the art to use Hinojosa’s teaching of a guide rail in Boyd et al.’s cell container because guide rails enable detachable linking with an assembly in a stable guide path. This method of improving Boyd et al.’s cell container was within the ability of one of ordinary skill in the art based on the teachings of Hinojosa. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Boyd et al. and Hinojosa to obtain the invention as specified in claim 10.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Charest et al. (US 20120318726 A1) (referenced in 892).
Regarding claim 12, Boyd et al. teaches the cell culture container of claim 1, but fails to specifically teach that pumps are controllable to vary fluid flow dynamics within the closed fluidic cell culture chamber. Charest et al. teaches a device (element 200) for culturing cells in a biomimetic environment (para. [0054]) with a fluid injection system (element 250) and syringe pump (element 254) (para. [0062]). Charest et al. specifically teaches that syringe pump controls syringe (element 252) to control the amount of fluid flowed, the flow rate, and the length of time that fluid is flowed.
It would have been prima facie obvious to one of ordinary skill in the art to use Charest et al.’s teaching of a controllable syringe pump in Boyd et al.’s cell container because the controllable syringe enables the amount of fluid flowed, flow rate, and the length of time that fluid is flowed to be controlled in the device. This method of improving Boyd et al.’s cell container was within the ability of one of ordinary skill in the art based on the teachings of Charest et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Boyd et al. and Charest et al. to obtain the invention as specified in claim 12.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Szita et al. (US 20110306081 A1) (referenced in 892).
Regarding claim 13, Boyd et al. teaches the cell culture container of claim 1, but fails to teach that the internal height of the closed fluidic cell culture chamber is less than 1 millimeter. Szita et al. teaches a microfluidic device including a chamber (abstract) specifically for culturing human embryonic stem cells (hESC) (para. [0052]). Szita et al. further teaches that the preferred chamber has a height of about 0.5 mm, as this size is particularly useful for culturing the stem cells on a bed of feeder cells (para. [0052]). It has been established in the case where the claimed ranges (“the closed fluidic cell culture chamber internal height of less than 1 millimeter”) overlaps or lie inside ranges disclosed by the prior art (chamber height of about 0.5 mm), a prima facie case of obviousness exists (MPEP § 2144.05 I). Thus, it would have been prima facie obvious to use the claimed range of a closed fluidic cell culture chamber internal height of less than 1 millimeter, since it overlaps with the prior art’s range (chamber height of about 0.5 mm), which is used for culturing stem cells.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Zhang et al. (US 20060199260 A1) (referenced in 892).
Regarding claim 13, Boyd et al. teaches the cell culture container of claim 1, but fails to teach that the first surface has an area of at least 25 square centimeters. Zhang et al. teaches a microbioreactor for culturing cells (abstract). Zhang et al. further teaches “the interior of the chamber had an area of 11.5 cm by 6.5 cm, and a height of 2.5 cm. This volume was large compared to the volume of the microbioreactor to ensure that gaseous oxygen was in large excess compared to the oxygen consumed by the cells during a fermentation.” (para. [0321]). It has been established in the case where the claimed ranges (“first surface has an area of at least 25 square centimeters”) overlaps or lie inside ranges disclosed by the prior art (area of 11.5 cm by 6.5 cm), a prima facie case of obviousness exists (MPEP § 2144.05 I). Thus, it would have been prima facie obvious to use the claimed range of a “first surface has an area of at least 25 square centimeters, since it overlaps with the prior art’s range (area of 11.5 cm by 6.5 cm), which is used for ensuring gaseous oxygen was in large excess.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd et al. (already referenced) in view of Sun et al. (CN107192475A with provided MT) (referenced in 892).
Regarding claim 15, Boyd et al. teaches the cell culture container of claim 1, but fails to specifically teach that the cell culture container further comprises one or more sensors to obtain environmental data in the closed fluidic cell culture chamber. Sun et al. teaches a microfluidic chip (element 8) with a temperature sensor electrode (element 5) and temperature sensor (element 6) present in temperature sensor chamber (element 4). Sun et al. teaches that temperature sensors enable real-time and accurate temperature detection on the chip (para, [0026] of MT), as temperature is a crucial factor in affecting microreactions in microfluidic chips, directly impacting the quality of biological experiments such as cell culture. (para. [0008] of MT).
It would have been prima facie obvious to one of ordinary skill in the art to use Sun et al.’s teaching of a temperature sensor in Boyd et al.’s cell container because temperature sensors enable real-time and accurate tracking of temperature in a microfluidic chip, a factor that directly impacts quality of cell culture. This method of improving Boyd et al.’s cell container was within the ability of one of ordinary skill in the art based on the teachings of Sun et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Boyd et al. and Sun et al. to obtain the invention as specified in claim 15.
Conclusion
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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
Prosecution Insights