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 .
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:
At least one pulling mechanism…so as to clamp an end of a culture bag as in claim 6.
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.
Those structures as disclosed in par.[0041] of Applicant’s pre-grant publication US 2025/0059488, 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 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 2-5 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 2 and 5 recites the limitation "the face of the cover". There is insufficient antecedent basis for this limitation in the claim.
It appears that Applicant intends to initially establish a face of the cover.
With regard to claim 5, the recitation to the heating glass is said heater is not clearly understood. Does Applicant intend to recite something on the order of “wherein the heater comprises a heating glass” in further defining this element of the temperature module?
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.
Claim(s) 1 and 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 113736615A (as seen through English Translation provided through Google Translate as filed by Applicant on 6/24/24), hereafter CN-113, in view of TWI745196B (See attached English translation cited by Application on IDS filed 6/24/24), hereafter TW.
CN-113 discloses an automated cell culture device for holding a cell culture bag performing cell culturing comprising: a main body 10 enclosing a culture room 14 (i.e. a culture chamber and for receiving a culture bag), and the main body having an opening (see fig. 1 and the open space afforded by the opened top in fluid communication with the culture room) on a top thereof that communicates with the culture room, and the main body further having a receiving groove 16 (‘infusion hole’) at a lateral side thereof (see at the plug seat 17 on the left, lateral side as in fig. 1) which communicates the culture room, and a bottom of the culture room being adapted for a culture bag to place thereon (see fig. 1 in which a culture bag 90 is placed thereon).
CN-113 further discloses a connection seat 172 (infusion hole connector) adapted for insertion into the receiving groove, the connection seat being formed with at least one through hole (see fig. 2 with close-up of the plug seat 17 and the opening coincident with the line to the numerical identifier ‘175’) adapted for at least one pipeline (see pipeline 53; though it is noted that the pipeline itself is not a positively claimed element of the device and is drawn to a prospective workpiece) to insert through so that the at least one pipeline connects the culture room and the exterior, an end of the at least one pipeline toward the culture room being adapted connecting to the culture bag (as discussed above, such pipeline is not a positively claimed element of the claim and is drawn to an prospective workpiece; as above, CN-113 provides such and at least provides the commensurate, positively recited connection seat formed with a through hole and fully capable thereof (i.e. adapted to).
CN-113 further discloses a cover 13 detachably disposed on the main body to cover the opening in order to selectively close the culture room.
CN-113 further disclose a temperature control module (not particularly provided with a numerical identifier to the drawings) disposed on at least one of the main body and the cover, including a heater and a temperature sensor (temperature detecting member) being electrically connected to the heater (the main body has a first connector, wherein the heater and the temperature sensor are electrically connected to the first connector) and the temperature sensor being adapted to (as in capable of) detecting a temperature in the culture room and driving the heater to heat up the culture room. CN-113 further discloses a gas module (‘carbon dioxide source supply’), comprising a carbon dioxide sensor and a gas source connecting member wherein the carbon dioxide sensor is located in the culture chamber, the body is provided with a second connector and a gas delivery hole, the carbon dioxide sensor is electrically connected to the second connector, the second connector is exposed from the surface of the body, the gas delivery hole is communicated with the culture chamber and the external space so as to be connected to a carbon dioxide supply source 91 outside the body and so as to provide gas to the culture chamber/culture room. See claims 1-10 of CN-113, pars.[0020-0033], figs. 1-4, for example). With regard to claim 5, CN-113 discloses the cover is formed with an observation opening at an intermediate portion of the cover (i.e. a portion of the cover coincident with the observation plate 15), a heating glass 15 arranged on the observation window, wherein pivotable cover covering the heating glass(in which the observation plate 15 is provided with a pivot as seen at least through fig. 1 and likewise to that of the pivotable top cover 13), the heating glass is said heater and the temperature detecting member (see above in cl. 1 with respect to the temperature module) is disposed on the face of the cover facing the culture room. (claims 1-10 of CN-113, pars.[0020-0033], figs. 1-4). With regard to claim 7, the gas module and the connection seat are arranged at two opposite ends of the culture room (with respect to the seat 17 and in which the gas module extends to the line and source 91 at the opposite end of the culture room; fig. 1
CN-113 does not specifically disclose at least one slide track and a clamping member as recited in claim 1.
CN-113 does not specifically disclose at least one pulling mechanism arranged at an end of the culture room to clamp an end of a culture bag as in cl. 6.
CN-113 does not specifically disclose a ventilation rack placed on the bottom of the culture room as in cls. 8 and 9.
TW discloses an automated cell culture device, comprising: a body, the body defining an accommodating space and a platform being formed on the top surface of the body, the platform being provided with at least one sliding rail part, the at least one sliding rail part extending in a sliding direction, and the platform allowing a culture bag to be flatly placed thereon; and a bag clamping member (slidably provided on the at least one sliding part, wherein the bag clamping member is for pressing against the culture bag to prevent liquid in the culture bag from flowing to the side of the culture bag close to a second end of the platform, and the bag clamping member can slide on the culture bag in the sliding direction; TW discloses that such arrangement affords a cell culture device that can maintain the concentration of the culture medium regardless of the amount of culture medium in the culture bag, so as to ensure the stable quality of cell culture and facilitate automated culture production. TW further discloses a clip bag 21 as a clip member equivalent to the at least one pulling mechanism as in cl. 6. TW additionally discloses a ventilation rack 60 so that the bottom of the culture bag can be breathable that may be a metal mesh or a hole plate or other similar objects (see description, paragraphs [0011]-[0022], and figures 1-7).
It would have been obvious to one of ordinary skill in the art to modify CN-113 to provide at least one slide track and a clamping member as recited in claim 1 such as suggested by the analogous art of TW to that of an automated cell culture device to provide cell culture device that can maintain the concentration of the culture medium regardless of the amount of culture medium in the culture bag, so as to ensure the stable quality of cell culture and facilitate automated culture production that would be likewise appreciated by CN-113.
It would have also been obvious to one of ordinary skill in the art to modify CN-113 to provide a ventilation rack rack placed on the bottom of the culture room such as suggested by the analogous prior art of TW in order to afford breathability to the culture bag and maximize permeability and oxygenation.
Further, while TW does not explicitly disclose that the ventilation rack is formed of a plurality of hollow portions to facilitate ventilation of a bottom of the culture bag, TW discloses various embodiments of such a ventilation member and asserts that other suitable forms are appreciated.
Thus, it would have been obvious through routine engineering design to optimize for permeability and oxygenation in affording a breathable supported culture bag to one of ordinary skill in the art in view of the teachings thereto as in TW and in which such a modification would have a reasonable expectation of success in CN-113 for the likewise desired purpose afford breathability to the culture bag and maximize permeability and oxygenation to the culture bag. This is further seen as an obvious engineering design choice through routine engineering for the reasons discussed above and absent a showing of a criticality or unexpected results arising otherwise.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN-113 in view TW, as applied to claim 1 and 5-9 above, and further in view of CN110358684A (See attached English translation cited by Application on IDS filed 6/24/24), hereafter CN-684.
CN-113/TW does not particularly disclose an illumination counting module as recited in claim 2 and claim 4.
With regard to claim 3, CN-113 discloses the included culture bag as claimed (see claims 1-10 of CN-113, pars.[0020-0033], figs. 1-4).
CN-684 discloses an automated cell culture apparatus that includes an illumination counting module (i.e. spectral measurement system) including a light source, light receiving (i.e. spectrometer), the light source on one side of the culture room and such that the culture bag (which is drawn to a prospective workpiece not necessitated by the claim) is between the light source and the light receiver, and the light source adapted to emit light of 400-600nm (and as in 400nm to the visible spectrum) as recited therein to provide real-time optical density measurements to assess cell density, cell volume, and the like (abstract, pars.[0022-0028], fig. 1).
It would have been obvious to one of ordinary skill in the art to modify CN-113/TW to provide an illumination counting module as recited in claim 2 such as suggested by the analogous art of CN-684 to an automated cell culture device in which such an illumination counting module affords a fast and non-invasive optical mechanism for assessing cell density and monitoring the sought cell culture growth over time.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN-113 in view TW, as applied to claim 1 and 5-9 above, and in further view of Kobayashi et al. (US 2014/0087455), hereafter Kobayashi.
CN-113 and TW does not specifically disclose further comprising a cooling box and a pump as recited in claim 10.
Kobayashi discloses an automated cell culture device and transport device comprising a closed flow channel with three modules, wherein the three modules are a culture medium module containing cell liquid, culture medium, cleaning liquid, or waste liquid, which needs to be refrigerated (any one of those fluids being contained constituting a “cooling box” holding such liquid(s)), and a pump that feeds these liquids into the culture chamber (par.[0041], for example).
It would have been obvious to one of ordinary skill in the art to modify CN-113/TW to provide a cooling box and a pump as recited in claim 10 such as taught by the analogous prior art of Kobayashi to an automated cell culture device in which such provides for fluid supply modules to properly deliver the desired fluid and states thereof for carrying out the sought automated cell culture assay in a controlled and automated fashion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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