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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/15/26 has been entered.
Claims 1-11, 13-15 remain pending.
The previous 35 USC 112 rejection of claim 12 is withdrawn due to the amendment cancelling the claim.
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 § 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, 5-10, is/are rejected under 35 U.S.C. 103 as being unpatentable over DOI (US 2004/0029265) in view of in view of WANTABE (JP 2005229843) as supplied by applicant on the IDS dated 4/18/22, rejections based on the translation document, further in view of BENJES (US 4311593) (newly cited).
Regarding claim 1, DOI discloses a cell culture case (cell culture device) comprising:
A vessel 7 (cell culture part) which includes cell proliferation space 8 (accommodation space) in which a plurality of cell substrates 1 (support bodies for cell culture) are disposed (Fig 1, 0053);
A cell culture circuit 9 (culture medium supply part) which has a culture liquid tank 14 with 10L of medium (configured to store a predetermined amount of culture medium for supply), and communicates with a filter 16 (gas supply port) that uses a gas exchanger for adjusting the concentration of a carbon dioxide gas to 5% (use carbon dioxide from outside) in the culture liquid in the circuit (keep carbon dioxide concentration of medium stored therein constant) (Fig 2, 0054, 0058);
a pump 13 that supplies the culture liquid and connects the circuit 9 and culture liquid tank 14 to circulate medium (0054, 0058, Fig 2).
DOI discloses the culture liquid tank includes a housing with an inner space that stores 10L of medium (store a predetermined amount of culture medium), recovery and discharge ports to supply and recover the culture medium in which one port is nearer the bottom surface of the culture liquid tank than the other (0053-54, 0058, fig 2), but does not explicitly disclose which port is used for recovery and which for discharge.
However, WANTABE discloses a culture apparatus comprising a culture chamber 8 (cell culture part), a culture solution tank 10 (medium supply part) that are connected by a pump 14, in which the culture solution tank 10 has recovery and discharge lines with openings (ports) (on lines with parts 12, 14 respectively) to supply and recover the culture medium, and the discharge part (line with pump 14) is formed at a position closer to the bottom surface of the culture liquid tank than the recovery port (line with 12) (0053-54, 0058, Fig 2).
It would have been obvious to one of ordinary skill in the art to modify the device of DOI to include the liquid tank port arrangement with the discharge line being nearer the bottom than the recovery port as taught by WANTABE because it allows for supply to the culture chamber to continue even when the medium level in the tank drops, thereby assuring the cells being cultured receive enough medium to survive. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to arrange the ports as claimed, since it has been held that rearranging parts of an invention involved only routine skill in the art. MPEP 2144.04.
DOI and WANTABE 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 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 creating a communication path, 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.
Regarding claim 5, DOI discloses the vessel 7 (culture part formed in shape of vessel), the plurality of cell substrates 1, are disposed in multiple stages at predetermined intervals in the vessel space and have the shape of a plate with a predetermined area (Fig 1, 0057), and connection ports 3a, 3b, 4a, 4b for allowing medium circulated to enter and exit (inlet, outlet) (0053-54, Fig 2).
Regarding claim 6, DOI discloses partitions 6a and 6b (two guide members) inserted into the space at either end so that they face each other and they have slot grooves as recesses in the longitudinal direction so that the ends of the substrates are fitted onto the partitions facing each other (Fig 1, 0053, 0057).
Regarding claim 7, DOI discloses the culture liquid tank as detailed in the rejection of claim 1 above, but does not explicitly disclose a gas supply port provided in the medium housing or the inner space of the tank being divided into two spaces.
However, WANTABE discloses a gas partial pressure regulator for a culture device comprising a culture solution tank or gas regulator with water (culture medium housing) with an inner space, a recovery port, and discharge port, and a conduit with filter (gas supply port) which is provided in the tank (housing) to allow carbon dioxide supplied from outside the tank to enter (Fig 2, 4, 0002-0003, 0011, 0028-29); in which the gas regulator is divided into a lower liquid containing portion (first space) and an upper gas, including carbon dioxide, portion (second space) and there is a port connected to the outside from the second space (Fig 4, 0034).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of DOI to include the medium supply with gas supply port and inner space divided as taught by WANTABE because it allow for improved efficiency of culture, the amount of gas consumed can be reduces and it improves the controllability of the culture environment and reliability of the culture (0022-24).
Regarding claim 8-9, WANTABE discloses it was known to include a filter (0007) or a gas permeable tube (filter member is gas permeable film member) disposed in the second space and spaced apart from the culture medium (0029, Fig 2, 4).
Regarding claim 10, WANTABE discloses a carbon dioxide sensor to determine the CO2 concentration in the second space (0033-34, 0046).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over DOI (US 2004/0029265) in view of in view of WANTABE (JP 2005229843) and BENJES (US 4311593) (newly cited) as applied above, further in view of JOHNSON (US 2015/0056703).
Regarding claim 2-3, DOI discloses the plurality of cell substrates 1 (support bodies for cell culture) (Fig 1, 0053) are fiber bundles (0057) but does not disclose the support body includes a plate shaped nanofiber membrane coated with a protein motif or the nanofiber membrane with 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 at the time the invention was filed to modify the cell substrates of DOI to include the plate shaped coated nano-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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over DOI (US 2004/0029265) in view of in view of WANTABE (JP 2005229843) and BENJES (US 4311593) (newly cited) as applied above, further in view of in view of UBUKATA (US 20180201891).
Regarding claim 4, DOI discloses the plurality of cell substrates 1 (support bodies for cell culture) (Fig 1, 0053) are fiber bundles (0057) but does not disclose the support body 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 at the time the invention was filed to modify the cell substrates of DOI 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) 11, 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over DOI (US 2004/0029265) in view of in view of WANTABE (JP 2005229843) and BENJES (US 4311593) (newly cited) as applied above, and further in view of HUGH (US 6117687) as cited by applicant on the IDS dated 4/18/22.
Regarding claim 11, DOI and WANTABE do not explicitly disclose a circulation fan configured to circulate the carbon dioxide gas. However, HUGH discloses a control atmosphere incubator in which a fan is provided to circulate air within the incubator and control gas flow of carbon dioxide (Col. 10, lines 17-21, Col. 12, lines 46-59). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of DOI to include the fan for circulation as taught by HUGH because it would allow for better control over air flow and help maintain more even gas concentrations within the space. Further, it involves combining prior art elements according to known methods to yield predictable results.
Regarding claim 13-15, constant temperature maintenance means is interpreted under 35 USC 112f (see above) to be a heating jacket as recited in the Specification and dependent claim 15. DOI does not explicitly disclose a constant temperature maintenance means. However, HUGH discloses growing cell cultures in an incubator cabinet that operates at a specific temperature, the cabinet being heated by a surrounding water-jacket (constant temperature maintenance means is heating jacket) (Col. 1, lines 27-46, Col. 6, lines 66-Col. 7, line 20, Col. 10, lines 5-16, 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 device of DOI to include the constant temperature maintenance heating jacket surrounding the cell culture part of HUGH because it maintains all interior surfaces at a constant temperature to prevent undesirable cold spots or condensation (Col. 1, lines 28-46).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 (including base claims 1, 15) of copending Application No. 17/293741 (reference application). The culture medium supply part including a partition with an end that is spaced apart from the inner side that divides the culture medium housing into two spaces and the ports located above/below one another elements amended into claim 1 of the present application are found in claim 16 (including base claims 1, 15) of the reference application. The difference lies in the fact that the reference application claim includes many more elements of the cell culture part structure and is thus much more specific. Thus the invention of claim 16 of the reference application is in effect a "species" of the "generic" invention of claim # of the present application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Circ. 1993).
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims in this instant application are either anticipated by, or would have been obvious over the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11, 13-15 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. US 2308866 is cited as it represents the state of the art concerning media housing with partial dividers creating two compartments each connected to an inlet/outlet respectively.
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.
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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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