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 .
DETAILED ACTION
Summary
This is the initial Office action on the 18/692853 application filed on 3/18/24.
Claims 1-9 are pending and have been fully considered.
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 3/21/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is 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.
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: frame part, driving part, cell culture part in claim 1; porous member in claim 3, and spacing member in claim 8.
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.
Claim 5 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 5, the limitations recite “the scaffold”, however, claim 1 from which it depends recites “a plurality of scaffolds”. It is unclear which of the plurality of scaffolds is “the” scaffold referred to in claim 5, or if applicant intended the limitation to apply to each or all of the claimed scaffolds.
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, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZHANG (US 20150093819) as cited by applicant on the IDS filed 3/21/24 in view of HO (US 2018/0371394).
Regarding claim 1, frame part, driving part and cell culture part are is interpreted under 35 USC 112f (see statute above) to be: frame part – base plate + mounting plate [Spec 38], driving part – known driving motors [Spec 40] and cell culture part – housing and plurality of scaffolds [Spec 45] and functional equivalents thereof for each.
ZHANG discloses a bioreactor system 10, for suspension cells, comprising a cell culture chamber 15 (cell culture part) including remaining parts 5, 8 (frame part) on which a rotation motor 65 (driving part) is mounted; the cell culture chamber 15 (housing) having an interior 35 (inner space)in which cell culture media including suspension cells are disposed, wherein one side of the chamber 15 is axially coupled to the rotation motor (0028-40, Fig 1-2f).
ZHANG discloses the cell culture chamber, but does not explicitly disclose the plurality of scaffolds disposed in multiple stages and spaced predetermined intervals in the inner space.
However, HO discloses a bioreactor system comprising a culture vessel 1 (culture part) in a supporting vessel 7 which is connected to a coupling shaft to a motor 14 (driving part) on a platform 18 (frame part), in which the culture vessel 1 is a multi-tray culture vessel comprising at least two rectangular cell culture compartments (plurality of scaffolds) arranged in a stacked orientation with respect to each other (disposed in multiple stages and spaced predetermined intervals) (Fig 1, 0057-62).
It would have been obvious to one of ordinary skill in the art to modify the culture chamber of ZHANG to include the multi-tray stacked culture compartments as taught by HO because it allow for forming separated compartments that remain connected to others via a manifold (0061) and allows for automated cell culture in a scaled up fashion using commonly used systems (0003).
Regarding claim 2, ZHANG discloses the culture chamber is rotated by the motor so that the medium is maintained in a suspension state between the two ends of the culture chamber (0030-36, 0039, Fig 2a-2f) and HO discloses the culture vessel is rotated to a position to allow a given amount of medium to sufficiently fill each tray such that the fluid is equilibrated among all trays (0061-62).
Regarding claim 3-4, porous member is interpreted under 35 USC 112f (see statute above) to be a water repellent membrane as recited in claim 4 and functional equivalents thereof.
ZHANG discloses the culture container has one or more ports serving as entrances for materials required for cell growth, such as CO2 (gas inlet), the port inherently having a predetermined area to allow the gas to be introduce to the inner space; and discloses the housing can include a wall (predetermined area of gas inlet formed to pass through housing) made with gas permeable materials (porous member covering a gas inlet), in which gas permeable membranes are known to be impermeable to liquid (water-repellent) (0022, 0029).
Regarding claim 5, HO discloses cell culture trays are plate shaped members having a predetermined area, that divide the inner space into a plurality of culture compartments (Fig 6, 0070), and the medium including cells is stored in the inner space to fill each of the plurality of the culture spaces (Fig 1, 0057-62).
Regarding claim 8, spacing member is interpreted under 35 USC 112f (see statute above) to be ring shaped members or bar shaped members [Spec 88] and functional equivalents thereof. HO discloses the plurality of trays (scaffolds) remains spaced at predetermined interval via a manifold post (spacing member) disposed between two trays (0061, Fig 6).
Regarding claim 9, ZHANG discloses the medium can further include magnetic particles (0030), which shows the bioreactor is capable of use with medium including magnetic particles that are peptide motif-coated.
Regarding the contents of the container, the examiner has given the limitation its appropriate weight. This limitation does not afford patentability to the apparatus or system 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 carrying out the process. It is noted the material/fluid handled by an apparatus is accorded no weight in apparatus claims, MPEP 2115.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZHANG (US 20150093819) as cited by applicant on the IDS filed 3/21/24 in view of HO (US 2018/0371394) and further in view of JOHNSON (US 2015/0056703).
Regarding claim 6-7, modified ZHANG does not disclose the scaffolds include plate shaped supports having a pair of nanofiber membranes attached that are motif coated with through holes.
However, JOHNSON discloses fiber scaffolds (nanofiber membrane, inherently includes plurality of through holes) 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 scaffold of ZHANG and HO to include the added fiber scaffolds 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).
The prior art does not explicitly disclose a pair of nanofiber surfaces attached to both surfaces of the support, however, The pair merely represents either a duplication of parts already known in the art or a rearrangement of parts without substantially affecting functionality or operation, and therefore is prima facie obvious. See MPEP 2144.04.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional references cited were cited in related applications.
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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