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 4/28/26 has been entered and fully considered.
Claims 1-5, 8, 11-19 remain pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/6/26 and on 4/28/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
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.
Claim 8 is 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. The amendment to claim 8 recites that “each of the multiple supporters is slidably inserted into the slot grooves on the upper and lower surfaces facing each other”. The specification and drawings do not provide support for slot grooves on the upper and lower surfaces of the inner space that allows for a supporter end to be slidably inserted. While the specification does recite mounting grooves 422a [Figs 13-14] on the culture housing top and bottom (upper and lower surface of the inner space), these grooves are for receiving supporting bars and not for the ends of the supporters. The specification does recite that the guide members are inserted in the inner space so that one surface faces each other and that the surfaces with slot grooves may face each other [0100-101] but there is no support for the slot grooves on the upper and lower surfaces of the inner space as currently claimed.
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.
Claim 8 is 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 8, the amendment to the claim reciting “at least two guide members are inserted in the inner space so that the upper surface faces the lower surface of the inner space”, renders the claim unclear. It is not clear from the claim how the insertion of guide members causes the upper and lower surfaces of the inner space to face each other. Therefore the limitation renders the claim indefinite as the meets and bounds of the invention cannot be determined.
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, 4-5, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over WANG (US 2018/0057784) in view of HU (US 5605835) as cited by applicant on the IDS dated 4/6/26.
With respect to claim 1, WANG discloses a bioreactor (cell culture system) comprising:
an incubator 950 that includes an inner space to provide a culture environment in which a cell is stably cultured (Fig 9, 0106-108);
a culture chamber (cell culture part) that is disposed in the inner space (Fig 9) and includes multiple screens 300 (supporters) to which cells to be cultured are attached (Fig 1b, 0055);
the multiple screens are provided in a plate shape having a predetermined area (Fig 3d) disposed in the accommodation space so that the multiple screens are stacked to be spaced apart from each other (Fig 3e);
a media reservoir 60 (medium supply part) disposed in the inner space and stores a predetermined amount of medium supplied to the cell culture part (Fig 9, 1b);
a pump 140 that may be disposed in the inner space (0107-108), and connected to the cell culture part and the medium supply part through a connection pipe (Fig, 10a, 12) respectively,
wherein the medium supply part is configured such that the medium stored in the medium supply part is supplied to the cell culture part during cell culture and then is repeatedly circulated through driving of the pump so that the medium can be recovered to the medium supply part (Fig 10a, 12, 0112).
WANG discloses a series of slots and grooves (separated member) that separates between two screens (supporters) facing each other so that the multiple screens are separated apart from each other along a height direction of the culture housing (0072, 0088, Fig 3E) but does not explicitly disclose the separated member comprises multiple supporting bars that penetrate the multiple supporters, each supporting bar is extended between an upper and lower surface of the inner space and spacers surrounding and fastening between the multiple supporters, wherein the multiple supports are stacked to be spaced apart by the spacers.
However, HU discloses a bioreactor device comprising a cell culture part having cell growth plates 138 (multiple supporters) to which cells to be cultured are attached that are in a plate shape and stacked to be spaced apart from one another (Fig 5), and securing means 156 such as bolts, screws or the like (multiple supporting bars of separated member) penetrate the growth plates 138 (multiple supporters) and fix the growth plates in an inner space, wherein each of the securing means 156 is extended between an upper surface 112 and lower surface 114 of the inner space (Fig 5), and membranes 142 that serve as gaskets such that each membrane 142 separates each plate from each other plate and from the interior faces of the end plates (spacers, supporters are stacked to be spaced apart by the spacers), the membranes 142 surround and fasten the securing means 156 between the growth plates 138 (Col. 15, lines 13-36 and Fig 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the separation of screens of WANG as WANG discloses it is desirable the screens do not touch each other (0098), by using the system of bolts/screws penetrating the supporters and spacers surrounding and fastening the bolts/screws between the supporters to provide spacing apart from one another as taught by HU because such a system can be used to hold the assembled sandwich of plates together to function as a bioreactor (Col. 15, line 13-36).
With respect to claim 4-5, WANG discloses the inner space of the incubator is formed as one inner space (Fig 9, 11) in which a temperature is maintained at a constant temperature in a chamber while a carbon dioxide concentration is maintained at a certain level inside the temperature chamber (0052, 0106-108), and the cell culture part and the medium supply part are disposed together in the one inner space(Fig 9, 11, 0107-108).
With respect to claim 18, WANG discloses a rotor (driving part) that rotates the scaffold chamber (Fig 15, 0127-135).
Claim 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over WANG (US 2018/0057784) in view of HU (US 5605835) as applied above and further in view of JOHNSON (US 2015/0056703) as submitted by applicant on the IDS dated 11/27/23.
With respect to claim 2, WANG discloses the screens (supporters) as stated above are used as scaffolds (0054) and made of fibers (0081) but does not disclose it includes a plate shaped nanofiber membrane coated with a protein motif and a support member attached to one surface through an adhesive layer.
However, JOHNSON discloses fiber scaffolds (nanofiber membrane) coated with at least one compound to promote cellular attachment including proteins (coated with protein motif) (0024), the scaffolds can be various shapes such as a sheet (plate shaped) (Fig 2), that can be placed in a bioreactor (supporter) for cell culture, the fiber structure attached to the bioreactor (supporter) walls (support member) on one side using an adhesive (0025).
It would have been obvious to one of ordinary skill in the art to modify the screens of WANG to include the added fiber scaffolds adhered to a wall as taught by JOHNSON because it provides an improved substrate that allows for the desired growth of large numbers of usable adherent cells while allowing the cells to be harvested efficiently (0002-3, 0024, 0027-29).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over WANG (US 2018/0057784) in view of HU (US 5605835) as applied above and further in view of in view of UBUKATA (US 20180201891) as submitted by applicant on the IDS dated 11/27/23.
d. With respect to claim 3, WANG discloses the screens (supporters) as stated above are used as scaffolds (0054) but does not explicitly disclose it is a plasma treated plate shaped film member.
However, UBUKATA discloses a cell holding container (supporter) with a sheet or plate shaped elastic body capable of stretch (plate shaped film member) with a cell contacting face (Fig 1, 6, 0053, 0076) that is adherent to cells due to a plasma treatment (0091).
It would have been obvious to one of ordinary skill in the art to modify the screens of WANG to include the plasma treated cell holding plate shaped film member as taught by UBUKATA because it allows for observation of the cells, is thin enough to reversibly deform into a predetermined shape to improve visibility of cells as need and no air bubbles are mixed into the cells (0030-32).
Claim(s) 8, 11-14, is/are rejected under 35 U.S.C. 103 as being unpatentable over WANG (US 2018/0057784) in view of in view of HU (US 5605835) as applied above and further in view of in view of KIM (US 2010/0304472).
With respect to claim 8, 11, 13-14, WANG discloses the holder with grooves and slots to support the screens as stated above (separated member) (0072) but does not explicitly disclose the further features of the separated member being formed of two guide members having the grooves that are slidably inserted in the inner space with the grooves facing each other.
However, KIM discloses the culture flask receiving part has frames on the right and left 32, 34 (guide members) inserted to face each other, the frames include multiple slot grooves 36 recessed in a length direction so the flasks (supporters) can be slidably inserted and also a push unit with a plurality of supports 132 fastened on to multiple robot arms 134, the arms having a predetermined length and are separated apart from each other and positioned between the two frame sides (guide members), in which the flasks (supporters) inserted into the spaces (grooves) (Fig 4, 9, 10 ).
It would have been obvious to one of ordinary skill in the art to modify the screen holder of WANG to include the separated member features as disclosed by KIM because they would provide stronger reinforcement of the screens to support a heavy culture mass without allowing the screens to sag and touch as WANG discloses it is desirable the screens do not touch each other (0098).
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to form the grooves of WANG on separate guide members that are then inserted into the space, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. MPEP 2144.04.
f. With respect to claim 11, WANG discloses a medium inlet on the culture housing (Fig 10a, 12) but does not explicitly disclose a concave on the culture housing. KIM discloses the culture device include at least one medium inlet 50 that is provided on the surface of the culture flask to allow medium from the medium supply bottle to be injected into the culture space, the housing surrounding the inlet is concave in a direction opposite to the inflow direction (Fig 11).
It would have been obvious to one of ordinary skill in the art to modify the shape of the housing at the medium inlet of WANG to include the concavity of KIM in order to easily find and insert the tubing to connect the pump to the housing.
g. With respect to claims 12-14, interrupting means is defined under 35 USC 112f as stated above to be the protrusion as stated in claim 14 or functional equivalents thereof.
Regarding claims 12-14, WANG discloses a showerhead to distribute the liquid medium (0110) but does not explicitly disclose a distributing plate nor its additional features as claimed. KIM discloses an injection unit 50 (distributing plate) disposed between the medium inlet and the culture flask (supporter), the injection unit having a detachable plate shaped body with multiple through holes and a syringe 51 (interrupting means) positioned corresponding to the inlet to prevent flow of medium, the syringe formed with a piston (protrusion) that protrudes a predetermined length from the medium inlet (Fig 5, 0092-100).
It would have been obvious to one of ordinary skill in the art to modify the showerhead of WANG to include the distribution plate of KIM in order to provide better control of the distribution of the liquid medium drops as taught by WANG are desirable (0110).
Claim(s) 15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over WANG (US 2018/0057784) in view of in view of HU (US 5605835) as applied above, in view of MATSUDA (UA 5260211).
e. With respect to claim 15, WANG discloses the medium supply includes a reservoir (storage space) that is an enclosed shape 60 with an open upper portion (closed by lid 62) an inlet and outlet through the medium flows (Fig 1a, 1b), but does not explicitly disclose that the inlet is formed in the medium housing at a position relatively higher than the outlet.
However, MATSUDA discloses a process for cultivating adherent cells comprising a culture tank 10 and medium recirculating tank 11 (medium housing), the tank 11 having an enclosed shape with an open upper portion and a storage space in which a certain amount of the medium is stored (Fig 1), and an embodiment in which the medium recirculating tank 102 is connected to the culture tank 101 by connector pipes 103, 104 (inlet and outlet) such that medium is recovered from the culture tank via upper pipe 103 (inlet) and supplied to culture tank through lower connector pipe 104 (outlet, inlet is located higher than outlet) (Fig 7).
It would have been obvious to one of ordinary skill in the art to modify the culture solution storing part of WANG to include the inlet/outlet arrangement as taught by MATSUDA because it helps uniformalize concentrations of nutrient, pH and DO supplied into a culture tank filled with cell matrix so as to improve a proliferating efficiency for adhesive animal cells (Col. 2, lines 45-52).
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to choose the claimed inlet/outlet arrangement, since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04
f. With respect to claim 17, MATSUDA discloses a filter 15 on a gas pipe on an upper portion of the tank 11 (Fig 1), the gas pipe capable of receiving or emitting gas through the filter to the medium in the storage space.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WANG (US 2018/0057784) in view of in view of HU (US 5605835), further in view of MATSUDA (US 5260211) as applied above, and further in view of BENJES (US 4311593).
g. With respect to claim 16, WANG and MATSUDA do not explicitly disclose the medium housing having a partition wall that protrudes from the bottom surface to divide the storage space as claimed.
However, BENJES discloses a process for treating waste water comprising a digester 2 (culture system) having multiple recirculation loops including an outflow device 70(medium housing) having an enclosed shape with an open upper portion and including a liquid trap 71 (at least one partition wall) protruding from a bottom surface such that one end is connected to an inner surface of the device while the other end is separated apart from the inner surface, and the device (storage space) is divided into a recovery space connected to the inlet 72 and supply space connected to the outlet 75 which leads to a recirculation loop or waste (Fig 1, 5, 6, Col. 6, lines 42-56).
It would have been obvious to one of ordinary skill in the art to modify the culture solution storing part of KIM and MATSUDA to include the partition wall as taught by BENJES because it would allow for separation of the fluids withdrawn from the culture device based on gravity such that the desired portion can be recirculated while the undesired portion is sent to waste.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WANG (US 2018/0057784) in view of in view of HU (US 5605835) as applied above, in view of LEUTHAEUSER (US 2013/0157366) as submitted by applicant on the IDS dated 5/13/21.
h. With respect to claim 19, WANG discloses the rotor may have a horizontal axis of rotation, but does not explicitly disclose a rotation also around a Z-axis.
However, LEUTHAEUSER discloses a rotation system for cell growth chamber that rotates the chamber about a first rotational axis and also about a second rotational axis (0009) wherein the first is a longitudinal axis (x-axis) and the second is a substantially perpendicular axis (z-axis) (0026).
It would have been obvious to one of ordinary skill in the art to modify the driving part with one axis of rotation of WANG to enable both a rotation around the x-axis and the z-axis as taught by LEUTHAEUSER because adjusting the orientation of the cell growth chamber during a priming sequence allows the air or gas bubbles or pockets residing within the cell growth chamber to be driven from the cell growth chamber as the cell growth chamber is primed with a priming fluid. In addition, it is also advantageous to adjust the orientation of the cell growth chamber while cells are growing within the cell growth chamber to mitigate problems associated with cells settling within the cell growth chamber under the influence of gravity (0006).
Response to Arguments
12. Applicant’s arguments with respect to claim(s) 1-5, 8, 11-19 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 references on the attached PTO 892 are cited as they also disclose cell culture systems having supporting bars similar to those recited in claim 1.
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
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