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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/04/2019 is incompliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
The claims are objected to because the lines are crowded too closely together, making reading difficult. Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b).
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: in plate-shaped member; porous member; spacing member; blocking member; claims 1-4, 7, and 9 respectively.
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 § 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 2-3 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 3 recites the limitation "the support" in lines 1 of said claims. There is insufficient antecedent basis for this limitation in the claim. Moreover, independent claim 1 recites “a support assembly” and “a plurality of supports”. Therefore, it is unclear as to which “support” applicant is referring to and attempting to claim.
Claims 2 and 3 recites the limitation “the support member” in line 2 of said claims. There is insufficient antecedent basis for this limitation in the claim. Moreover, independent claim 1 recites “a plate-shaped member”, a support assembly” and “a plurality of supports”. Therefore, it is unclear as to which “support member” applicant is referring to and attempting to claim.
Claim 2 recites the limitation “the nanofiber membrane” in line 3. There is insufficient antecedent basis for this limitation in the claim. Moreover, the claim previously recites “a pair of nanofiber membranes”. Therefore, it is unclear as to which nanofiber applicant is referring to and attempting to claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kenney et al. (US2008/0206857 A1; hereafter “Kenney”).
Regarding claim 1, Kenney discloses a bioreactor for suspended cells (abstract; and para. [0011])
“comprising: a housing formed in a box shape having a culture space with a predetermined volume and including a seeding port for seeding suspended cells into the culture space through a medium containing the suspended cells on one side;”: Kenney discloses apparatus 100, para. [0029], Fig. 1 comprises an outer vessel body 101 having a box shape, as shown in Fig. 1; predetermined volume, para. [0011]; further, Kenney discloses a seeding port (opening 121, para. [0029], Fig. 1).
“a support assembly formed of a plate-shaped member having a predetermined area and including a plurality of supports disposed in multiple stages at intervals along one direction of the housing;”: Kenney discloses supports 119 provide structural arrangements to integrally incorporate the surfaces 113 and 115 in forming growth chambers 111 of apparatus 100, para. [0029], Fig. 1).
“gas inlet formed through the housing by a predetermined area to allow gas to flow into the culture space from the outside,”: Kenney discloses a manifold directs and separates the in-flow of liquid and out-flow of gas through a cell culture vessel (para. [0010]).
“a porous member covering the gas inlet to allow the gas to enter the culture space from the outside while preventing the medium from leaking to the outside,”: Kenney discloses the necked opening may be covered by a cap (not shown) and the cap may incorporate filters to allow for the exchange of gas and prevent leakage of media (para. [0030], Fig. 1; the cap provides an entry to the manifold and the interior of apparatus 100).
“wherein the culture space includes a medium storage space filled with a certain amount of medium so that all of the plurality of supports are submerged and a gas storage space located above the medium storage space and filled with gas,”: Kenney discloses providing a cell growth apparatus of the present invention, introducing cells and/or media into said cell growth apparatus in a tilted filling position, filling the internal volume (para. [0011]). Also, Kenney discloses tracheal air spaces 118 through the apparatus 100 provide gaseous communication, para. [0031], where Fig. 1 shows air spaces 118 are disposed above the media 127, Fig 1).
“the medium storage space includes a plurality of cell growth spaces separated from each other by the plurality of supports disposed in multiple stages at intervals.”: Kenney discloses a plurality of growth chamber 111 (para. [0029], Fig. 1; growth chambers 111 are shown in Fig. 1 also separated by support 119 disposed at multiple intervals.
Regarding claim 2, Kenney discloses supports 119, also discussed above in claim 1; Kenney discloses various sizes and shapes of the supports 119 may be incorporated to facilitate positioning of the membranous layers 113 for cell culture 117 within the cell culture vessel 100 (para. [0036]). Also, Kenney discloses 113 membranes 113 may be made of one or more membranes known in the art (para. [0033]). Kenney also discloses membrane 113 can be affixed to supports 119 and side walls 112 by any number of methods including but not limited to adhesive (para. [0036]). Further, Kenney discloses the membrane layer, may be treated to enable cell growth. Treatment may be accomplished by any number of methods known in the art (para. [0039]).
Regarding claim 3, Kenney discloses supports 119, also discussed above. Further, supports 119 are shown in Fig. 2 having multiple through holes formed in the support member (supports 119, also shown in the cross section of one of the supports 119.
Regarding claim 4, Kenney discloses support 119 includes an upper plate and a lower plate (show below in annotated Fig. 2);
“a plurality of supports disposed between the upper plate and the lower plate so that one surfaces face each other (shown below in annotated Fig. 2);
“a spacing member disposed between two supports facing each other so as to separate the two supports (sidewall 112, are disposed between the upper and lower plates, shown below in annotated Fig. 2);
“a plurality of fastening bars that fasten and integrate the upper plate, the lower plate, the plurality of supports, and the spacing member (the top of supports 119, comprises a device to secure the several layers/compartments of apparatus 100, Fig. 2).”
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Regarding claim 5, Kenney discloses a housing body in a box shape (apparatus 100 comprises an outer vessel body 101, para. [0029], Fig. 1 shows the vessel body 101 having a box shape, including a culture space—cell growth chambers 111, para. [0029], Fig. 1); further, a top plate 110 is shown disposed on the upper portion of apparatus 100, Fig. 1. Kenney discloses a fastening bar (discussed above in claim 4 and shown disposed on the top of upper plate 110 on support 119, Fig. 2, where the entire support is disposed through culture chambers 111 and from the top plate 110 through the bottom tray 120 of apparatus 100.
Regarding claim 6, Kenney discloses fixing grooves (shown below in annotated Fig. 2 below).
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Regarding claim 7, Kenney discloses a blocking member (barrier plate 106 and sidewalls 112 surround the apparatus 100, Fig. 2, para. [0030], which is attached to the sides of supports 119.
Regarding claim 8, Kenney discloses the support assembly (supports 119, Fig. 2) are disposed in the medium storage area (supports 119 are positioned in apparatus 100, where the supports 119 are shown disposed through the growth chambers 111, which comprise the media, and spaced at a distance from the inner surface housing where the seeding port (opening 121, Fig. 2). Also, Fig. 2 shows a plurality of cel growth spaces (growth chambers 111) divided by supports 119 of apparatus 100.
Regarding claim 9, Kenney discloses the apparatus 100 of the present invention may be made by any number of acceptable manufacturing methods well known to those of skill in the art (para. [0037]) and Kenney discloses the apparatus 100 is assembled from a collection of separately injection molded parts. Although any polymer (such as polystyrene, polycarbonate, acrylic, polystyrene, or polyester) suitable for molding and commonly utilized in the manufacture of laboratory ware may be used, polystyrene (para. [0037]; polystyrene is known in the art to be naturally hydrophobic).
Regarding claim 10, Kenney discloses apparatus 100 comprises an air vent (air in via opening 121, Fig. 7). Also, Kenney discloses the apparatus may include any unitary structure, vessel, device or flask that would benefit from a directional inflow and outflow of liquid and air into and from an internal volume (para. [0064]). It is noted that that the term “or” in the claim is being interpreted to indicate only one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Therefore, the reference of Kenney meets the limitations of claims 1-10.
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kenney et al. (US2008/0206857 A1; hereafter “Kenney”) as applied to claim 10 above, and further in view of US2020/0131461 A1; hereafter “Martin”, has an effective filing date as of the provisional application).
Regarding claim 11, Kenney teaches the invention discussed above in claim. 10.
Kenney does not explicitly teach an extension tube connected to a port in the culture space and having a predetermined length.
For claim 11, Martin teaches a cell culture vessel includes a wall including an inner surface defining a cell culture chamber of the vessel (Abstract) and Martin teaches a vessel including an extension tube (conduit 232 connecting the first aperture 205 to the second region 103b, Fig. 13, para. [0052]), where a lower end of conduit 232 is also disposed in the culture space 103b of vessel 200).
It would have been obvious to on of ordinary skill in the art at the time of the effective filing date of the invention to incorporate the conduit of Martin with the device of Kenney, in order to provide path for passing fluid through the conduit connecting the first opening to the second region of vessel for culturing cells in the vessel (para. [0052]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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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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/LENORA A ABEL/Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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