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 with traverse of Group I (claims 1-8); and species A2 (Fig. 9), and B4 (Equation 4) in the reply filed on 07/28/2026 is acknowledged. The traversal is on the ground(s) that “[...] no undue burden on the Examiner to consider all claims in the single application.” This is not found persuasive because: all the inventions are independent or distinct for the reasons given in the 06/09/2026 Restriction Requirement and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; and (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. There is a serious search and/or examination burden for the patentably distinct species as set forth in the 06/09/2026 Restriction Requirement, because at least the following reason(s) apply: (a) the species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification; (b) the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter; or (c) the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
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 1-8 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.
Claim 1 is unclear reciting “a culture vessel that contains one or more aggregates of cells and a culture medium; a suction tube that suctions a culture medium in the culture vessel” because it is unclear whether the “suction tube that suctions a culture medium in the culture vessel” is the same culture medium as recited in the “culture vessel that contains [...] a culture medium.”
Claims 3, 4, 7 and 8 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. It is unclear whether the applicant is claiming “an aggregate having a predetermined first particle size”, “a second particle size larger than the first particle size”, “an aggregate with a particle size corresponding to the tube diameter”. In addition, the “first particle size”, “second particle size”, “a particle size corresponding to the tube diameter” are undefined in the claims and the metes and bounds of the particle sizes and tube diameters are thereby indefinitely defined. The claimed “size” is unclear because it’s based upon prospective workpieces of the particles which are not positive elements of the claims.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 & 7 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Iwakami et al. (US 2021/0317394 A1).
Regarding claim 1, Iwakami teaches:
1. A culture device, comprising:
a culture vessel (e.g., first container) that contains one or more aggregates of cells and a culture medium (see Abstract & Claim 1 for example);
a suction tube (e.g., piping tube) that suctions the culture medium in the culture vessel (see ¶ 0038, 0062+ for example);
a suction unit (e.g., peristaltic pumps such as a tube pump, roller pump, syringe pump; liquid feed pump) that generates suction force in the suction tube (see ¶ 0122, 0139 for example); and
a control unit (e.g., mesh structure 22, 42), wherein the control unit is capable of controlling the suction unit (see ¶ 0072 & Table 1 for example).
With regard to limitations in claims 1-8 (e.g., [...] that controls the suction unit based on an antagonistic suction flow velocity of an aggregate, which is a velocity at which sedimentation of the aggregate is antagonistic to floating of the aggregate due to the suction of the culture medium, [...] controls the suction unit so as to suction the culture medium at a flow velocity equal to or lower than the antagonistic suction flow velocity of at least one of the aggregates, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 3-5 & 7, Iwakami teaches:
3. The culture device according to claim 1, wherein the control unit is capable of controlling the suction unit (see ¶ 0072 & Table 1 for example).
4. The culture device according to claim 3, wherein the control unit is capable of controlling the suction unit (see ¶ 0072 & Table 1 for example).
5. The culture device according to claim 1, further comprising a management unit (e.g., sensor) that is connected to the suction tube (see ¶ 0172 for example).
7. The culture device according to claim 1, further comprising a recovery unit (e.g., 40 collector for recovering cell aggregates with a predetermined size) including the suction tube, wherein the suction tube includes an inlet port (e.g., 43) and an outlet port (e.g., 44) disposed higher than the inlet port (see Fig. 15 for example), and the inlet port is connected to the culture vessel (see Fig. 19 for example).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5 & 7 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kitagawa (WO 2020/040041 A1 rejection referring to US equivalent US 2021/0171904 A1).
Regarding claim 1, Kitagawa teaches:
1. A culture device, comprising:
a culture vessel (e.g., 2) that contains one or more aggregates of cells (e.g., 8) and a culture medium (e.g., 10);
a suction tube (e.g., 22) that suctions the culture medium in the culture vessel (see ¶ 0058 for example);
a suction unit (e.g., 24) that generates suction force in the suction tube (see ¶ 0058 for example); and
a control unit (e.g., 16), wherein the control unit is capable of controlling the suction unit (see the controller 16 also controls drive of the drain pump 24 ¶ 0058).
With regard to limitations in claims 1-8 (e.g., [...] that controls the suction unit based on an antagonistic suction flow velocity of an aggregate, which is a velocity at which sedimentation of the aggregate is antagonistic to floating of the aggregate due to the suction of the culture medium, [...] controls the suction unit so as to suction the culture medium at a flow velocity equal to or lower than the antagonistic suction flow velocity of at least one of the aggregates, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 3-5 & 7, Kitagawa teaches:
3. The culture device according to claim 1, wherein the control unit is capable of controlling the suction unit (see the controller 16 also controls drive of the drain pump 24 ¶ 0058).
4. The culture device according to claim 3, wherein the control unit is capable of controlling the suction unit (see the controller 16 also controls drive of the drain pump 24 ¶ 0058).
5. The culture device according to claim 1, further comprising a management unit that is connected to the suction tube (e.g., concentration sensor, computer elements, circuits, CPU, memory, and software configuration is embodied by computer program product, ¶ 0046-0051+).
7. The culture device according to claim 1, further comprising a recovery unit (e.g., 26) including the suction tube, wherein the suction tube includes an inlet port (e.g., 34a) and an outlet port (e.g., 34b) disposed higher than the inlet port, and the inlet port is connected to the culture vessel (see Fig. 3 for example).
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.
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) 6 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwakami et al. (US 2021/0317394 A1).
Regarding claims 6 & 8, Iwakami teaches:
6. The culture device according to claim 1, comprising a plurality of combinations of the culture vessel and the suction tube, wherein the plurality of combinations are connected with each other (see Fig. 19 for example).
8. The culture device according to claim 7, wherein the recovery unit (40) comprises a plurality of the suction tubes (see Fig. 19 for example), wherein the outlet port (44) of one of adjacent two of the suction tubes is connected to the inlet port (43) of the other of the adjacent two suction tubes (see Fig. 15 for example), so that the plurality of the suction tubes are connected with each other, and the inlet port of the most upstream suction tube is connected to the culture vessel (see Fig. 19 for example).
Iwakami further teaches different experimental setup using various culture tubes for different sphere diameters providing different proliferation rates, see Table 11. Although Iwakami does not explicitly teach the tube diameters of the suction tubes are different from each other, it would have been obvious to one of ordinary skill in the art at the time the invention was made to select appropriate diameter for the design of the device for the purpose of providing desired proliferation rates (Iwakami Table 11+).
Claim Rejections - 35 USC § 103
Claim(s) 6 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa (WO 2020/040041 A1 rejection referring to US equivalent US 2021/0171904 A1) in view of Iwakami et al. (US 2021/0317394 A1).
Regarding claims 6 & 8, Kitagawa teaches:
6. The culture device according to claim 1, comprising a plurality of combinations of the culture vessel and the suction tube, wherein the plurality of combinations are connected with each other (see Figs. 2-3 for example).
8. The culture device according to claim 7, wherein the recovery unit (e.g., 26) comprises a plurality of the suction tubes (see Fig. 3 for example), wherein the outlet port (e.g., 34b) of one of adjacent two of the suction tubes is connected to the inlet port (e.g., 34a) of the other of the adjacent two suction tubes (see Fig. 3 for example), so that the plurality of the suction tubes are connected with each other, and the inlet port of the most upstream suction tube is connected to the culture vessel (see Fig. 3 for example).
However, Kitagawa does not explicitly teach: wherein the tube diameters of the suction tubes are different from each other, and wherein the recovery unit comprises a plurality of the suction tubes having different tube diameters.
See Iwakami above.
Although Iwakami does not explicitly teach the tube diameters of the suction tubes are different from each other, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Kitagawa by selecting appropriate diameter for the design of the device for the purpose of providing desired proliferation rates (Iwakami Table 11+).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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