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 .
Election/Restrictions
Applicants’ election of Group I, claims 1-11 in the reply filed on 06/16/26, is acknowledged. Claims 12-14 are withdrawn from further consideration pursuant of 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic of linking claim. This election was made without traverse in the reply filed on 06/16/26.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 05/06/2024 has been certified and made of record.
Claim Objections
Claims 4 and 7 are objected to because of the following informalities:
Regarding claim 4, “The cell culture supply apparatus supplies first culture media to one of two types of cells of the culture chip, and supplies second culture media to the other one” (p. 2, Lines 6-8) should read “The cell culture supply apparatus supplies a first culture media to one of two types of cells of the culture chip, and supplies a second culture media to the other one”.
Regarding claim 7, “and having a driving pressure transmission unit forming a channel through which the cell culture media move” (p. 2, Lines 25-26 and p. 3, Line 1) should read “and having a driving pressure transmission unit forming a channel through which the cell culture media moves”.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
Rotational driving unit in claim 1 and 8 – The specification teaches the rotational driving unit as one of various types of motors (AC motor, a DC motor, a step motor) (p. 13, Lines 22-23)
Driving pressure unit in claim 1, 7, and 10.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claims 1-7 and 10-11 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. Specifically, although the disclosure teaches driving pressure unit (element 335) as protruding upwards along a periphery of the ring gear (element 333), the specific structure of what comprises a driving pressure unit is never disclosed or provided. Claims 1, 7, and 10 are therefore rejected under 112(a). Claims 2-6 and 11 are included in the rejection for depending on rejected claims 1 and 10, respectively.
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 1-7 and 10-11 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.
Claims 1, 7, and 10 recites the limitation "the base" in line 7 (claim 1), line 3 (claim 7), and line 10 (claim 10). There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the base will be interpreted as a base or support element provided for the culture device.
Claims 3 and 6 recites the limitation "the driving pressure transmission unit" in line 25-26 (claim 3) and line 17 (claim 6). There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the driving pressure transmission unit will be interpreted as channel or tubing provided.
Furthermore, claim 3 recites the limitation “the driving pressure transmission unit connects two channels among a plurality of channels formed on the channel plate to one”. It is unclear regarding the structure of this connection, specifically whether the connection is to one culture chip or another structural feature. Furthermore, it is unclear regarding the structural difference between the driving pressure transmission unit and driving transmission unit. For examination purposes, if two channels are connected to a culture chip or container – this will be seen as meeting the claim limitation.
Claim 4 recites the limitation “the cell culture supply apparatus”. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, if an element or structural feature provides culture media for a co-culture, this will be seen as meeting this limitation.
Claim limitation “Driving pressure unit “ in claim 1, 7, and 10 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. As stated above, although the specification teaches “driving pressure unit” as protruding upwards along a periphery of the ring gear (element 333), the specific structure of what comprises a driving pressure unit is never disclosed or provided. The structure performing the function of pumping, supplying, and recovering the cell culture media (p. 15, 1st paragraph) is unclear. Claims 2-6 and 11 are included in the rejection for depending on rejected claims 1 and 10, respectively
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.
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.
For examination purposes, if a claim element performs a pumping operation through supplying and recovering the cell culture media, this will be seen as meeting this claim limitation (driving pressure unit).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR 101770337 B1 – with provided machine translation) (referenced in 892) in view of Zeng (CN 113832009 A – with provided machine translation) (referenced in 892).
Regarding claim 1, Lee et al. teaches a cell culture media supply apparatus for cell culture chips (abstract, See annotated FIG. 1), comprising:
a channel plate (See annotated FIG. 2, base plate - element 110) accommodating a cell culture chip (FIG. 2, culture container - element 120) and having a channel-shaped driving transmission unit (FIG. 2, element 140 – medium supply unit) provided at a lower portion thereof;
a top cover provided at an upper portion of the base (FIG. 2, element 170 – cover), and to which the channel plate is coupled to a periphery thereof (FIG. 2, element 170 – cover);
a base unit (FIG. 1, element 30 – support portion);
a driving pressure unit protruding upwards, and pressing the driving transmission unit by the rotation of the gear unit to allow the driving transmission unit to perform a pump operation (FIG. 1, element 300 – fluid transfer unit, which includes a drive pump so that cells, media, etc. can be moved between the cell culture module 100 and the storage unit 200. – structurally a driving pressure unit by performing a pumping operation (p. 5 – 10th paragraph of attached Machine Translation).
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Lee et al. fails to teach:
A rotational driving unit generating a rotation driving for generating a rotational driving force and gear unit.
Regarding limitation I, Zeng teaches a rotatable cell culture dish device (para. [0001] of Machine Translation), which uses a motor for rotating device (element 103) (para. [0020] of Machine Translation) and internal gear ring (FIG. 2, element 203) fixedly installed in the mounting tray (FIG. 2, element 101), which threads with internal gear (FIG. 2, element 202). Zeng specifically teaches that this rotation ensures the individual culture dishes are evenly and uniformly irritated when placed in an incubator (para. [0012] of Machine Translation).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Zeng’s teaching of a motor and gear unit (gear ring) in Lee et al.’s device because the motor and gear ring allows even and uniform irritation when placed in an incubator. This method of improving Lee et al.’s was within the ability of one of ordinary skill in the art based on the teachings of Zeng. 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 Lee et al. and Zeng to obtain the invention specified in claim 1.
Regarding claim 2, modified Lee et al. teaches the cell culture media supply apparatus for cell culture chips of claim 1. Modified Lee et al. specifically reaches a gear unit including a ring gear. Furthermore, the combination of references of claim 1 would encompass a structure of a driving pressure unit moving integrally with the ring gear. Thus, the claim is prima facie obvious.
Regarding claim 3, modified Lee et al. teaches the cell culture media supply apparatus for cell culture chips of claim 1. Furthermore, Lee et al. teaches at least two channels connected the culture container (See FIG. 3). Thus, the claim is prima facie obvious.
Regarding claim 6, modified Lee et al. teaches the cell culture media supply apparatus for cell culture chips of claim 1. Furthermore, Lee et al.’s teaching of a driving pressure unit of claim 1 would encompass the structure wherein a progress direction of the driving pressure unit and a longitudinal direction of the driving pressure transmission unit coincide with each other. Therefore, the claim is prima facie obvious.
Regarding claim 7, Lee et al. teaches a cell culture media supply apparatus for cell culture chips (abstract, See annotated FIG. 1 – claim 1 rejection), comprising:
a base unit (FIG. 1, element 30 – support portion);
a channel plate (FIG. 2, base plate – element 110) having a reservoir accommodating a cell culture chip and reserving cell culture media (FIG. 2, culture container - element 120), and having a driving pressure transmission unit forming a channel through which the cell culture media moves, which is provided at a lower portion thereof (FIG. 2, element 140 – medium supply unit);
a top cover provided at an upper portion of the base , and to which the channel plate is coupled to a periphery thereof (FIG. 2, element 170 – cover);
a driving pressure unit pressing and transforming the driving pressure transmission unit (FIG. 1, element 300 – fluid transfer unit, which includes a drive pump so that cells, media, etc. can be moved between the cell culture module 100 and the storage unit 200. – structurally a driving pressure unit by performing a pumping operation (p. 5 – 10th paragraph of attached Machine Translation).
Lee et al. fails to teach:
A gear unit which is rotatable in the base unit
Regarding limitation I, Zeng teaches a rotatable cell culture dish device (para. [0001] of Machine Translation), which uses a motor for rotating device (element 103) (para. [0020] of Machine Translation) and internal gear ring (FIG. 2, element 203) fixedly installed in the mounting tray (FIG. 2, element 101), which threads with internal gear (FIG. 2, element 202). Zeng specifically teaches that this rotation ensures the individual culture dishes are evenly and uniformly irritated when placed in an incubator (para. [0012] of Machine Translation).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Zeng’s teaching of a motor and gear unit (gear ring) in Lee et al.’s device because the motor and gear ring allows even and uniform irritation when placed in an incubator. This method of improving Lee et al.’s was within the ability of one of ordinary skill in the art based on the teachings of Zeng. 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 Lee et al. and Zeng to obtain the invention specified in claim 7.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (already referenced), Zeng (already referenced) as applied to claim 1 above, and further in view of Nakamura et al. (US 20210348097 A1) (referenced in 892).
Regarding claim 4, modified Lee et al. teaches the cell culture media supply apparatus for cell culture chips of claim 1. Modified Lee et al. fails to teach that the cell culture chip is a chip for co-culturing two types of cells, and a cell culture supply apparatus for providing media for two types of cells. Nakamura et al. teaches a cell culture chip (abstract) for co-culture (element 9 -scaffold – para. [0019])), where medium is provided in first main flow path (element 3-1) and second main flow path (element 4-1). Nakamura et al. specifically teaches that co-culture chips allow increased accuracy of evaluation of cells/cell sheet possessing a function closer to an organ (para. [0024]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Nakamura et al.’s teaching of a co-cultured chip in Lee et al.’s device because co-culturing allows increased accuracy of evaluation of cells/cell sheet possessing a function closer to an organ. This method of improving Lee et al.’s was within the ability of one of ordinary skill in the art based on the teachings of Nakamura 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 Lee et al. and Nakamura et al. to obtain the invention specified in claim 4.
Regarding claim 5, modified Lee et al. teaches the apparatus of claim 4. Furthermore, the cell culture apparatus would be structurally capable of providing a first culture media and second culture media at different speeds. Thus, the claim is prima facie obvious.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (already referenced) in view of Lai et al. (CN210065798U – with provided machine translation) (referenced in 892).
Regarding claim 8, Lee et al. teaches a cell culture media supply apparatus for cell culture chips (abstract, See annotated FIG. 1 – claim 1 rejection) comprising:
a cell culture media equipped with a cell culture chip, and supply cell culture media to the cell culture chip (FIG. 2, element 140 – medium supply unit (medium supply unit provides cell culture medium to the container, so this claim limitation is met);
a case unit accommodating the cell culture media supply unit (See annotated FIG. 1 in claim 1 rejection – internal space (element 20)).;
wherein a plurality of supply units are stacked and provided in the case unit (Annotated FIG. 1).
Lee et al. fails to teach:
A rotational driving unit coupled to the cell culture media supply unit and driving the cell culture media supply unit to supply the cell culture media.
Lai et al. teaches a cell culture chip device (para. [0008]), with a base containing a peristaltic pump, and peristaltic pump drive mechanism (para. [0033]). Lai et al. teaches that peristaltic pump drive mechanism is configured to drive the peristaltic pump to rotate, thereby pumping the drug to be tested into the media circulation pipeline (para. [0033]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Lai et al.’s teaching of rotational pumping and driving mechanism in Lee et al.’s device a rotational pumping and driving mechanism would enable pumping of a liquid to occur in the system. In this present case, one of ordinary skill in the art would understand using a rotational pumping and driving mechanism to pump fluids – such as fluid media in a cell culture chip device. This method of improving Lee et al.’s was within the ability of one of ordinary skill in the art based on the teachings of Lai 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 Lee et al. and Lai et al. to obtain the invention specified in claim 8.
Regarding claim 9, modified Lee et al. teaches the cell culture media supply apparatus of claim 8. Furthermore, Lee et al. teaches through-holes at a location corresponding to the cell culture media supply unit in the case unit through containers (element 120). Thus, the claim is prima facie obvious.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (already referenced), Lai et al. (already referenced) as applied to claim 8 above, and further in view of Zeng (already referenced).
Regarding claim 10, modified Lee et al. teaches the apparatus of claim 8. Lee et al. further teaches the channel plate (FIG. 2, base plate – element 110) having a reservoir accommodating a cell culture chip and reserving cell culture media (FIG. 2, culture container - element 120), and having a driving pressure transmission unit forming a channel through which the cell culture media moves, which is provided at a lower portion thereof (FIG. 2, element 140 – medium supply unit);
a top cover provided at an upper portion of the base , and to which the channel plate is coupled to a periphery thereof (FIG. 2, element 170 – cover);
a driving pressure unit pressing and transforming the driving pressure transmission unit (FIG. 1, element 300 – fluid transfer unit, which includes a drive pump so that cells, media, etc. can be moved between the cell culture module 100 and the storage unit 200. – structurally a driving pressure unit by performing a pumping operation (p. 5 – 10th paragraph of attached Machine Translation).
Furthermore, the combination of references of claim 8 would encompass a structure of a base unit including a rotational driving unit (Lai et al.’s teaching of rotational pumping).
However, modified Lee et al. fails to teach a gear unit rotated by the rotational driving unit. Zeng teaches a rotatable cell culture dish device (para. [0001] of Machine Translation), which uses a motor for rotating device (element 103) (para. [0020] of Machine Translation) and internal gear ring (FIG. 2, element 203) fixedly installed in the mounting tray (FIG. 2, element 101), which threads with internal gear (FIG. 2, element 202). Zeng specifically teaches that this rotation ensures the individual culture dishes are evenly and uniformly irritated when placed in an incubator (para. [0012] of Machine Translation).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Zeng’s teaching of a motor and gear unit (gear ring) in modified Lee et al.’s device because the motor and gear ring allows even and uniform irritation when placed in an incubator. This method of improving modified Lee et al.’s was within the ability of one of ordinary skill in the art based on the teachings of Zeng. 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 modified Lee et al. and Zeng to obtain the invention specified in claim 10.
Regarding claim 11, modified Lee et al. teaches the apparatus of claim 10. Furthermore, modified Lee et al.’s apparatus would be structurally capable of handling different types of cell culture chips equipped at different layers, as the stacked configuration of base plates (element 110), as seen in FIG. 1, would enable different types of cell culture chips to be placed. Furthermore, the combination of references of claim 10 would be structurally capable of having differing cell culture media movement speed through the gear unit. Thus, claim 11 is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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