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 .
Response to Amendment
The amendment filed 12/23/25 has been entered and fully considered.
Claims 1-14 remain pending, of which claims 8-14 were previously withdrawn.
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: illumination unit in claim 1 and 2.
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 § 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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over by SUZUKI (US 2017/0369830) in view of CUIFFI (US 2014/0030752) as cited on the PTO-892 dated 12/19/24 as previously applied, further in view of ZHENG (US 2014/0133702) (newly cited).
The limitation “illumination unit” has been interpreted under 35 USC 112f as stated above to be an LED illumination system (Spec 0031) and functional equivalents thereof.
Regarding claim 2, SUZUKI discloses: a cell culture device (cell production device) comprising:
A substrate 2 (cell production plate) having liquid feeding and discharging portions 10, 20 (fluid circuit) in which tanks 11, 21 are provided in each portion along with a culture dish 3 (plurality of functional sites are integrated); the tanks 11, 21 being reservoirs capable of storing a plurality of types of fluids (plurality of fluid reservoirs, cell induction and culture tank); a culture dish 3 that is capable of performing induction and culture of cells based on the stored fluids (cell induction and culture); and the reservoir tank 11 stores culture liquid (culture medium for initialization or induction) (0048-53, fig 1).
SUZUKI discloses a fluid circuit from reservoir 11 to waste tank 21 (fig 2) and the culture medium must have an optimum pH for tissues and cells (0100) but does not explicitly disclose a culture medium circulation path configured to circulate medium nor a sensor for pH as claimed.
However, CUIFFI discloses a cell culture system with a fluid circuit comprising a plurality of fluid reservoirs 118 or 1118 and 120 or 1120, a cell culture platform (induction and culture tank) 102 or 1102, in which the fluid is recirculated through the cell culture platform (culture medium circulation path in communication with the cell induction and culture tank, configured to circulate medium) (0044, 0113-0116, Fig 1, 11), and a sensor 106 for sensing pH value of a medium in the cell culture platform 102 or in the fluid circuit (0039, 0117).
It would have been obvious to one of ordinary skill in the art to modify the fluid circuit of SUZUKI to include a culture medium circulation path and sensor for pH as taught by CUIFFI because the circulation path recirculation would allow the device to operate with a lower overall media volume required and therefore would not require large storage tanks the pH sensor allows for a user monitoring the parameter and making adjustments (0039, 0117) would allow for maintaining the optimum pH of the cells as desired by SUZUKI.
SUZUKI discloses the plate has a transparent area through which the cells can be observed by a microscope optical system (provided outside plate) in the area of the culture dish 3 (cell induction and culture tank) (0025, 0059-60, Fig 3-4), but does not explicitly disclose the optical microscope includes an illumination unit.
However, ZHENG discloses a microscopy methodology comprising specimen surface 140 (cell induction and culture tank) for receiving a specimen of cells (0059) having a transparent layer (0066) and an optical system with a light detector 160 for capturing images in which an illumination source 110 with a light element 117 e.g. an LED display (illumination unit) is provided outside of the surface 140 (plate) and is configured to illuminate the specimen from in front or in rear (Fig 1, 3, 10, 0060-62, 0066, 0072, 0171).
It would have been obvious to one of ordinary skill in the art to modify the optical microscope system of SUZUKI to include the illumination unit in the arrangement as taught by ZHENG because this method may provide an autonomous, cost effective, high resolution microscopic solution for high resolution imaging of confluent specimens and other specimens in which objects in the specimen may be contiguously connected over a sizable length. One advantage is that the systems and devices may be made compact (e.g., on the chip-scale) and at lower cost than convention microscopy (0055).
Regarding the contents of the container, the examiner has given the limitation its appropriate weight. This limitation does not afford patentability to the apparatus because they are not defining any structural features of said apparatus but merely defining the contents used in the claimed apparatus during its use.
It has been well established that it is fundamental that an apparatus claim defines the structure
of the invention and not how the structure is used in a process, or what materials the structure houses in carry out the process. For apparatus claims, if the prior art structure is capable of performing the intended use, then it meets the claim. Apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 &§ 2173.05(g)).
Claim(s) 1, 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over SUZUKI (US 2017/0369830) in view of NANKERVIS (US 2015/0275170) in view of CUIFFI (US 2014/0030752) as cited on the PTO-892 dated 12/19/24 as previously applied, further in view of ZHENG (US 2014/0133702) (newly cited).
Regarding claim 1, The limitation “illumination unit” has been interpreted under 35 USC 112f as stated above to be an LED illumination system (Spec 0031) and functional equivalents thereof.
SUZUKI discloses: a cell culture device (cell production device) comprising:
A substrate 2 (cell production plate) having liquid feeding and discharging portions 10, 20 (fluid circuit) in which tanks 11, 21 are provided in each portion along with a culture dish 3 (plurality of functional sites are integrated); the tanks 11, 21 being reservoirs capable of storing a plurality of types of fluids (plurality of fluid reservoirs); a culture dish 3 that is capable of performing induction and culture of cells based on the stored fluids (cell induction and culture); and the reservoir tank 11 stores culture liquid (culture tank with medium for initialization or induction) (0048-53, fig 1) in which flexible tubes connect the supply and discharge ports to the fluid network (0050, 0019) and that there is a closed perfusion system flow path to prevent contamination to the culture liquid (Fig 18 0090-91) but does not explicitly disclose a plurality of closed connectors that connect the fluid circuit to an external space in a closed manner.
However, NANKERVIS discloses a closed cell expansion machine in which the system has a bioreactor (cell induction and culture unit), fluid conveyance assembly (fluid circuit) having tubing (injection discharge units) to provide the fluid paths, in which the tubing extends to the exterior of the machine (external space) where welded connections (plurality of closed connectors) to tubing associated with media bags are (plurality of fluid reservoir units, channels capable of injecting or discharging fluid to/from the fluid circuit via the plurality of closed connectors) (0044, 0048).
It would have been obvious to one of ordinary skill in the art to modify the cell culture device substrate of SUZUKI to include the welded connections in the tubing between the fluid path and external media bags as taught by NANKERVIS because the connections maintain the closed cell expansion (production) system (0003) while allowing access to the media bags to visually inspect quantity or quality or to swap the bags with other types of replacement fluids as disclosed by NANKERVIS (0022).
SUZUKI discloses a fluid circuit from reservoir 11 to waste tank 21 (fig 2) and the culture medium must have an optimum pH for tissues and cells (0100) but does not explicitly disclose a culture medium circulation path configured to circulate medium nor a sensor for pH as claimed.
However, CUIFFI discloses a cell culture system with a fluid circuit comprising a plurality of fluid reservoirs 118 or 1118 and 120 or 1120, a cell culture platform (induction and culture tank) 102 or 1102, in which the fluid is recirculated through the cell culture platform (culture medium circulation path in communication with the cell induction and culture tank, configured to circulate medium) (0044, 0113-0116, Fig 1, 11), and a sensor 106 for sensing pH value of a medium in the cell culture platform 102 or in the fluid circuit (0039, 0117).
It would have been obvious to one of ordinary skill in the art to modify the fluid circuit of SUZUKI to include a culture medium circulation path and sensor for pH as taught by CUIFFI because the circulation path recirculation would allow the device to operate with a lower overall media volume required and therefore would not require large storage tanks the pH sensor allows for a user monitoring the parameter and making adjustments (0039, 0117) would allow for maintaining the optimum pH of the cells as desired by SUZUKI.
SUZUKI discloses the plate has a transparent area through which the cells can be observed by a microscope optical system (provided outside plate) in the area of the culture dish 3 (cell induction and culture tank) (0025, 0059-60, Fig 3-4), but does not explicitly disclose the optical microscope includes an illumination unit.
However, ZHENG discloses a microscopy methodology comprising specimen surface 140 (cell induction and culture tank) for receiving a specimen of cells (0059) having a transparent layer (0066) and an optical system with a light detector 160 for capturing images in which an illumination source 110 with a light element 117 e.g. an LED display (illumination unit) is provided outside of the surface 140 (plate) and is configured to illuminate the specimen from in front or in rear (Fig 1, 3, 10, 0060-62, 0066, 0072, 0171).
It would have been obvious to one of ordinary skill in the art to modify the optical microscope system of SUZUKI to include the illumination unit in the arrangement as taught by ZHENG because this method may provide an autonomous, cost effective, high resolution microscopic solution for high resolution imaging of confluent specimens and other specimens in which objects in the specimen may be contiguously connected over a sizable length. One advantage is that the systems and devices may be made compact (e.g., on the chip-scale) and at lower cost than convention microscopy (0055).
Regarding the contents of the container, the examiner has given the limitation its appropriate weight. This limitation does not afford patentability to the apparatus because they are not defining any structural features of said apparatus but merely defining the contents used in the claimed apparatus during its use. It has been well established that it is fundamental that an apparatus claim defines the structure of the invention and not how the structure is used in a process, or what materials the structure houses in carry out the process. For apparatus claims, if the prior art structure is capable of performing the intended use, then it meets the claim. Apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 &§ 2173.05(g)).
Regarding claim 3-5, SUZUKI does not explicitly disclose a variable volume unit for storing fluid. However, NANKERVIS discloses use of media, waste or outlet bags for holding fluids (variable volume unit, physical variable volume material is a flexible bag) (0022, 0029). It would have been obvious to modify the device of SUZUKI to additionally comprise flexible bags as taught by NANKERVIS because they provide an inexpensive container for fluid storage that can be disposed of after use to prevent contamination and enables welded connections to tubing from the bags (0048).
Regarding claim 6, SUZUKI discloses micro flow rate pumps 12, 22 in the fluid circuit that transfer the fluid stored in the reservoir tanks 11, 21 (0051, 53).
Regarding claim 7, NANKERVIS discloses there are tubing guide slots 214 mounted on the top of the machine face through which tubing is welded (connectors mounted on one face) to external media bags (fluid reservoirs connectable to the closed system connectors) (0044) which can be a single bag (0039) with a valve or other type of mechanism that controls the flow of fluid from the bag (plurality of dispense and suction units).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional reference on the PTO 892 relates to LED illumination units for cell culture plates and is therefore a relevant to the instant application as providing the state of the art.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799