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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-6, in the reply filed 6/18/2026 is acknowledged.
Claims 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/18/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/7/2023 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-6 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.
Regarding claim 1, the phrase “a discharging pipe connected to the lid portion” renders the claim indefinite in light of the specification. This limitation appears inconsistent with the specification disclosure ([0023] and [0024] each disclose the discharging pipe connected to the lid portion when the rotation of the culture container is stopped) (MPEP § 2173.03). The instant claim language alludes that the discharging pipe is permanently connected to the lid portion. Examiner suggests amending the claims to be consistent with the written disclosure.
Claims 2-6 are similarly rejected as they depend upon rejected claim 1.
Regarding claim 2, the phrase “the lid portion is formed on a portion of the side surface farther from the rotation axis” renders the claim indefinite. The phrase is silent as to the element the lid portion is farther from the rotation axis than. For examination on the merits, the limitation will be interpreted as the lid portion is formed on a portion of the side surface farthest from the rotation axis as this appears consistent with the specification, e.g., in Figs. 2, 4, 6, and 10.
Further, the phrase “so as to include both ends of the spiral” renders the claim indefinite. It is unclear if the both ends of the spiral refers to the ends of the spiral length-wise (of the culture container) or within the same plane (as shown in Figs. 2, 4, 6, and 10). I.e., it is unclear if the spiral spans the length of the culture container.
Claim 3 is similarly rejected as it depends upon rejected claim 2.
Regarding claim 5, the phrase “the ejecting pipe ejects the supplied cells with a predetermined pressure” renders the claim indefinite. It is unclear if the supplied cells are the same as the cells suspended in the liquid. For examination on the merits, the limitation will be interpreted as the supplied cells suspended in liquid as this appears consistent with the written disclosure. Examiner suggests amending the limitation to clarify the limitation of note. Additionally, it is unclear if the ejecting pipe provides the predetermined pressure or if an unclaimed element provides the predetermined pressure. For examination on the merits, it will be interpreted that an unclaimed element provides the predetermined pressure as this appears to be consistent with the written disclosure ([0029] describes a pump and control apparatus providing fluid and setting the predetermined pressure, respectively). See MPEP § 2172.01 in regards to unclaimed essential subject matter.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kabaha et al. (US 2015/0017714 A1) (hereinafter referred to as Kabaha – see PTO-892) in view of Honda et al. (US Patent 5,139,953) (hereinafter referred to as Honda – see PTO-892).
Regarding claim 1, Kabaha discloses a cell culture apparatus (title) comprising:
a culture container ([0018], cells cultured in centrifuge chamber) having a transverse hollow tubular shape (Fig. 3 shows transverse hollow tubular shape), having an opening formed in a center of a bottom surface of the culture container (Fig. 3 shows opening – see annotated figure below), and;
an ejecting pipe inserted from the opening into the culture container (Fig. 2, one of ports 17 and associated tubing); and
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a discharging pipe (Fig. 2, one of ports 17 and associated tubing).
Kabaha is silent to an inner surface of the culture chamber having a shape of a single spiral when viewed from a direction of the rotation axis. Nonetheless, modifying the device of Kabaha such that the inner surface of the culture chamber is shaped as claimed would be obvious to one of ordinary skill in the art. It has been held that changes in shape are considered a matter of choice which a person of ordinary skill in the art would find prima facie obvious absent persuasive evidence that the particular shape configuration is significant (MPEP § 2144.04 IV B).
Kabaha does not disclose the culture chamber having an openable and closable lid portion formed on a side of the culture chamber and a motor configured to rotate the culture chamber around a rotation axis perpendicular to the bottom surface.
However, Honda in the art of rotary reactors teaches it is known in the art to use a drain valve, i.e., an openable and closable lid portion, formed on the side of a rotary column (Fig. 1, drain valve 27), i.e., a culture chamber, for draining (col. 4, lines 36-48), and a variable speed motor, i.e., a motor, configured to rotate the rotary column around a rotation axis perpendicular to the surface (Fig. 1 – see annotated figure below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Kabaha to incorporate an openable and closable lid portion formed on a side of the culture chamber as it would predictably control flow out of the culture chamber. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Kabaha to incorporate a motor to drive rotation of the culture chamber, as this method for improving the apparatus of Kabaha would have been known in the art.
The prior art combination is silent to the discharging pipe connected to the lid portion. Nonetheless, modifying the prior art combination apparatus such that the discharging pipe is connected to the lid portion would amount to merely rearrangement of parts, as such a modification would predictably result in the discharge of liquid occurring at the position of the lid portion. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI).
The limitation “an inner wall surface of the culture container is a surface for culturing cells” is directed toward the intended manner of operating the claimed inner wall surface of the culture chamber and does not differentiate the claimed inner wall surface of the culture chamber from the corresponding prior art element because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art inner wall surface of the culture chamber would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
The limitations “ejects a liquid onto the inner wall surface” and “discharges the ejected liquid from the lid portion to an outside of the culture container” are directed toward the intended manner of operating the claimed ejecting pipe and the discharging pipe, respectively, and do not differentiate the claimed ejecting pipe and the discharging pipe from the corresponding prior art elements because all structural limitations are taught in the prior art (MPEP § 2114 II). The ports, i.e., the ejecting pipe and the discharging pipe, would be fully capable of achieving every claimed intended use because they can facilitate flowing fluid.
Regarding claim 4, the prior art combination teaches the cell culture apparatus according to claim 1,
The limitation “wherein the ejecting pipe ejects the liquid onto the cells cultured on the inner wall surface during rotation of the culture container” is directed toward the intended manner of operating the claimed ejecting pipe and does not differentiate the claimed ejecting pipe from the prior art because all structural limitations are taught in the prior art (MPEP § 2114 II).
The limitation “thereby peeling the cells from the inner wall surface” is a limitation contingent on the ejecting pipe ejecting liquid onto cells cultured on the inner wall surface during rotation of the culture container and has been given appropriate patentable weight (MPEP § 2111.04 II). No further prior art rejections are required as all structure necessary to meet the claim is taught by the prior art of record.
Regarding claim 5, the prior art combination teaches the cell culture apparatus according to claim 1.
The limitation “wherein the discharging pipe supplies the cells suspended in the liquid to the ejecting pipe” is directed toward the intended manner of operating the claimed discharging pipe and does not differentiate the claimed discharging pipe from the prior art discharging pipe because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art discharging pipe would be fully capable of achieving every claimed intended use because the prior art discharging pipe can facilitate liquid with suspended cells.
The limitation “the ejecting pipe ejects the supplied cells with a predetermined pressure” is directed toward the intended manner of operating the claimed ejecting pipe and does not differentiate the claimed ejecting pipe from the prior art ejecting pipe because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art ejecting pipe would be fully capable of achieving every claimed intended use because the prior art ejecting pipe can facilitate liquid with suspended cells.
The limitation “thereby separating the cells from each other” is a limitation contingent on the ejecting pipe ejecting the supplied cells with a predetermined pressure and has been given appropriate patentable weight (MPEP § 2111.04 II). No further prior art rejections are required as all structure necessary to meet the claim is taught by the prior art of record.
Regarding claim 6, the prior art combination teaches the cell culture apparatus according to claim 1.
The limitation “wherein the discharging pipe is connected to the lid portion” is a limitation contingent on controlling the rotation of the culture container and has been given appropriate patentable weight (MPEP § 2111.04 II). No further prior art rejections are required as all structure necessary to meet the claim is taught by the prior art of record.
Allowable Subject Matter
Claims 2 and 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claims and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, Kabaha in view of Honda provides the closest prior art, as discussed above.
The prior art combination teaches cell culture apparatus of claim 1. Honda of the prior art combination discloses that the lid portion formed on a portion of the side surface farther from the rotation axis (Fig. 1, drain valve 27).
However, the prior art combination fails to fairly disclose, teach or suggest wherein the lid portion is formed near a protrusion, and the protrusion is formed on the inner wall surface so as to include both ends of the spiral within the claimed environment.
Claim 3 contains allowable subject matter as it depends upon claim 2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kessler et al. (US 2019/0283042 A1) discloses a centrifuge system for separating cells in suspension.
Tao et al. (CN 1131302 C) (English machine translation provided) discloses a rotating cell culture device.
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/A.J.C./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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