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
Applicant’s election without traverse of Group I, claims 1-11, in the reply filed on 10/02/2025 is acknowledged.
Claim 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/02/2025.
Specification
The disclosure is objected to because of the following informalities: In the specification, paragraph [0057], “boned” should read “bonded”.
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:
“holding unit” in claim 1;
“detaching unit” in claim 1; and
“control unit” 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.
In this case, “holding unit” in claim 1 is being interpreted as a comprising a tub (specification, paragraph [0058]) or equivalents thereof;
“detaching unit” in claim 1 is being interpreted as a comprising a vibration plate with a piezoelectric element for producing an ultrasonic vibration (paragraph [0117]) and equivalents thereof; and
“control unit” in claim 1 is being interpreted as control circuitry (Fig. 4; paragraph [0163]) and equivalents thereof.
Claim Rejections - 35 USC § 112
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 2-8 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.
Regarding claim 2, claim 2 recites “a vibration tub configured to hold the acoustic matching liquid”. It is unclear if the vibration tub is the same or different from the “holding unit configured to hold the acoustic matching liquid” established in claim 1. Claims 3-8 are rejected by virtue of their dependency on claim 2.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 20210362145 A1; effectively filed 05/22/2020) in view of Ram et al. (US 20130084622 A1).
Regarding claim 1, Kim teaches a cell detaching apparatus (Fig. 1; abstract; paragraph [0013]) for detaching cells (Fig. 1; paragraphs [0013] and [0061] teaches detaching cells from a culture medium) placed on a base material (Fig. 1 and paragraphs [0051],[0061] teaches cells on a substrate 12 and container 18) floating on an acoustic matching liquid (Fig. 1 and paragraph [0052] teach substrate 12 and container 18 floating on water 40, i.e. acoustic matching liquid), from the base material (Fig. 1; paragraphs [0013] and [0061] teaches detaching cells from a culture medium), the cell detaching apparatus comprising:
a holding unit (Fig. 1, container 20, which reads on the 112(f) interpretation of a holding unit comprising a tub) configured to hold the acoustic matching liquid (Fig. 1 shows container 20 holding water 40);
a detaching unit (Fig. 1 and paragraph [0059] teaches a focused ultrasonic transducer 30 that has a plate and piezoelectric element, which reads on an equivalent of the 112(f) interpretation of the detaching unit) configured to detach the cells from the base material by applying an ultrasonic vibration to the cells through the acoustic matching liquid (Fig. 1 and paragraph [0013] teaches the transducer induces ultrasound to detach cells from the culture medium through the water 40); and
a control unit (paragraph [0059] teaches a controller that includes circuitry, which reads on the 112(f) interpretation of control unit).
Kim fails to teach the control unit configured to perform control to maintain a constant height of a fluid level of the acoustic matching liquid held by the holding unit with respect to the base material during application of the ultrasonic vibration.
Ram teaches devices and systems for continuous cell culture and other reactions, including chambers (abstract). Ram teaches in many reactor systems (including, for example, chemostats and other cell culture systems), it is desirable to maintain a constant liquid volume within the reactor (paragraphs [0022]-[0023]), where liquid can escape during operation via evaporation (paragraph [0022]). Ram teaches the amount of liquid within a chamber can be easily reset to a constant volume by flowing an inlet liquid into the chamber (paragraph [0024]). Ram teaches multiple liquid volume reset steps can be performed for operation (paragraph [0058]). Ram teaches flow rate can be controlled by a feed control and open loop by a software (paragraph [0125]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit of Kim to incorporate the teachings of known issues with liquid evaporation within a system and to ensure constant volume in a chamber of Ram (paragraphs [0022]-[0024],[0058],[0125]) to provide: the control unit configured to perform control to maintain a constant height of a fluid level of the acoustic matching liquid held by the holding unit with respect to the base material during application of the ultrasonic vibration. Doing so would have a reasonable expectation of successfully ensuring adequate amount of acoustic matching liquid throughout operation steps as taught by Ram.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Ram as applied to claim 1 above, and further in view of Yasuda et al. (US 20140370492 A1).
Regarding claim 9, modified Kim fails to teach: the cell detaching apparatus according to claim 1, further comprising a circulating pump, a temperature control tank, and a cooling fin for radiating heat larger than a heat quantity generated by driving power for driving the detaching unit.
Ram teaches devices and systems for continuous cell culture and other reactions, including chambers (abstract). Ram teaches in many reactor systems (including, for example, chemostats and other cell culture systems), it is desirable to maintain a constant liquid volume within the reactor (paragraphs [0022]-[0023]), where liquid can escape during operation via evaporation (paragraph [0022]). Ram teaches the amount of liquid within a chamber can be easily reset to a constant volume by flowing an inlet liquid into the chamber (paragraph [0024]). Ram teaches multiple liquid volume reset steps can be performed for operation (paragraph [0058]). Ram teaches a pumping mechanism allows for addition of a constant volume of a liquid (paragraph [0060]). Ram teaches flow rate can be controlled by a feed control and open loop by a software (paragraph [0125]). Ram teaches the device can include sensors that monitors gas and/or liquid in the chamber, where the sensors can determine temperature (paragraph [0067]). Ram teaches the temperature of component can be controlled using heat exchangers (paragraph [0068]).
Yasuda teaches a reaction control device (abstract; Fig. 1). Yasuda teaches the device comprises a reaction vessel (Fig. 1, element 1), a circulating pump (Fig. 1, pumps 7) and a temperature control tank (liquid reservoir tanks 4), where circulating liquid is controlled to reflux such that the temperature thereof is fine-tuned to the temperature of the liquid in the corresponding reservoir tank 4 by the auxiliary temperature control mechanism 10 before the liquid returns to the reservoir tank 4 (paragraph [0140]). Yasuda further teaches the temperature control mechanisms can include an air-cooling fin type cooling mechanism (paragraph [0140]). Yasuda teaches mechanisms that maintains each of the liquids of different temperatures (paragraph [0013]). Yasuda teaches delicate control of temperature of liquid to be circulated to ensure temperature fluctuation is suppressed (paragraph [0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Kim to incorporate the teachings of monitoring and controlling temperature of Ram (paragraphs [0067]-[0068]) and the teachings of controlling temperature via pumps, liquid reservoir tanks, and temperature mechanisms such as fins of Yasuda (Fig. 1; paragraphs [0013], [0140], [0143]) to provide: the cell detaching apparatus according to claim 1, further comprising a circulating pump, a temperature control tank, and a cooling fin for radiating heat larger than a heat quantity generated by driving power for driving the detaching unit. Doing so would have a reasonable expectation of successfully improving control of temperature fluctuations in the apparatus as taught by Yasuda (paragraph [0143]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Ram as applied to claim 1 above, and further in view of Takimoto et al. (US 20190218500 A1).
Regarding claim 10, modified Kim fails to teach the cell detaching apparatus according to claim 1, further comprising a housing, wherein an observation window including a transparent member is provided at a bottom portion of the housing.
Takimoto teaches a culture observation system (abstract) comprising a housing (Fig. 1, cell culture flask 2), wherein an observation window including a transparent member is provided at a bottom portion of the housing (Fig. 1 and paragraph [0100] teaches element 2 is optically transparent and comprises a bottom transparent member, i.e. bottom plate 2b). Takimoto teaches observation of a sample by illuminating a sample from below and acquiring an image (paragraph [0008]). Takimoto teaches monitoring cells in a culture container disposed in an incubator (paragraph [0037]). Takimoto teaches the system includes LED light sources (paragraph [0043]). Takimoto teaches simultaneously lighting up LED light sources at different positions allows for a less uneven image of the sample to be acquired (paragraph [0113]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Kim to incorporate the teachings of a culture observation system including an observation window including a transparent member at a bottom of a housing of Takimoto (Fig. 1; paragraphs [0008],[0037],[0100]) to provide: the cell detaching apparatus according to claim 1, further comprising a housing, wherein an observation window including a transparent member is provided at a bottom portion of the housing. Doing so would have a reasonable expectation of successfully improving observation of the cells within the apparatus as taught by Takimoto (paragraphs [0037],[0113]), therefore improving characterization of the cells over time.
Regarding claim 11, modified Kim fails to teach the cell detaching apparatus according to claim 1, further comprising a light-emitting element disposed inside a vibration tub or inside a housing.
Takimoto teaches a culture observation system (abstract) comprising a cell culture flask (Fig. 1, cell culture flask 2) and a housing (Fig. 1, see element 3 surrounding at least elements 6, 4, and 22), and LEDs disposed in the housing (Fig. 1 shows LED light sources 7 within the housing). Takimoto teaches observation of a sample by illuminating a sample from below and acquiring an image (paragraph [0008]). Takimoto teaches monitoring cells in a culture container disposed in an incubator (paragraph [0037]). Takimoto teaches the system includes LED light sources (paragraph [0043]). Takimoto teaches simultaneously lighting up LED light sources at different positions allows for a less uneven image of the sample to be acquired (paragraph [0113]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Kim to incorporate the teachings of a culture observation system including LEDs within a housing of Takimoto (Fig. 1; paragraphs [0008],[0037],[0100]) to provide: the cell detaching apparatus according to claim 1, further comprising a light-emitting element disposed inside a vibration tub or inside a housing. Doing so would have a reasonable expectation of successfully improving observation and imaging of the cells within the apparatus with less uneven images as taught by Takimoto (paragraphs [0037],[0113]), therefore improving characterization of the cells over time.
Allowable Subject Matter
Claim 2-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the closest prior art of Kim et al. (US 20210362145 A1; effectively filed 05/22/2020) further teaches the cell detaching apparatus according to claim 1, further comprising a vibration tub (Fig. 1, container 20) configured to hold the acoustic matching liquid (Fig. 1 shows container 20 holding water 40). Kim fails to teach: a storage tub configured to store the acoustic matching liquid separately from the vibration tub, wherein the acoustic matching liquid is flowably connected with the storage tub via a fluid path, and the storage tub including a sinking member is configured to control the height of the fluid level of the acoustic matching liquid.
A reference Ram et al. (US 20130084622 A1) teaches devices and systems for continuous cell culture and other reactions, including chambers (abstract). Ram teaches in many reactor systems (including, for example, chemostats and other cell culture systems), it is desirable to maintain a constant liquid volume within the reactor (paragraphs [0022]-[0023]), where liquid can escape during operation via evaporation (paragraph [0022]). Ram teaches the amount of liquid within a chamber can be easily reset to a constant volume by flowing an inlet liquid into the chamber (paragraph [0024]). Ram teaches multiple liquid volume reset steps can be performed for operation (paragraph [0058]). Ram teaches flow rate can be controlled by a feed control and open loop by a software (paragraph [0125]). However, Ram fails to teach or suggest all of the limitations of claim 2, specifically the storage tub including a sinking member is configured to control the height of the fluid level of the acoustic matching liquid.
A reference Parks (US 3365945 A) teaches a metering apparatus for accurately determining volume of components in a liquid mixture (abstract). Parks teaches a float that is actuated by liquid level and a counter or indicator is responsive to liquid level (column 5, lines 46-69). However, Parks fails to teach or suggest all of the limitations of claim 2, such as a storage tub including a sinking member is configured to control the height of the fluid level of the acoustic matching liquid.
None of the prior art teaches or fairly suggests, alone or in combination, all of the limitations of claim 2, specifically the combination of the cell detaching apparatus further comprising a sinking member is configured to control the height of the fluid level of the acoustic matching liquid. Thus, claim 2 is deemed allowable. Claims 3-8 are deemed allowable based on their dependency on claim 2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ott (US 20170015963 A1) teaches a bioreactor apparatus (abstract) and methods of standard cell culture methods (paragraph [0092]). Ott teaches a drainage pump maintains a constant fluid level in the chamber while the negative pressure during inspiration and the positive pressure during expiration are accomplished by the PPC module 700; wherein by replacing the source of negative and positive ventilation with the PPC module, foaming of media, graph damage due to turbulence and equipment breakdown throughout the culture is prevented and/or reduced (paragraph [0128]). Ott teaches maintaining appropriate pressure and/or fluid levels in the chamber (paragraphs [0005],[0121]).
Kurashina et al. (Kurashina et al., “Effective cell collection method using collagenase and ultrasonic vibration”, Biomicrofluidics 8, 054118 (2014)) teaches a cell collection method based on ultrasonic vibration (abstract; Fig. 7), where cells are detached from a substrate via ultrasonic vibration (Fig. 1).
Imashiro et al. (Imashiro et al., “Detachment of cell sheets from clinically ubiquitous cell culture vessels by ultrasonic vibration”, Nature Scientific Reports, 10, 9468 (2020)) teaches a system and method of detaching cells from a culture dish with ultrasonic vibration (abstract; Fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758