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 .
Response to Amendment
The Amendment filed 08/19/2025 has been entered. Claims 5 and 7-10 remain pending in the application. Claims 8-9 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 7, and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 recites new matter of “the programmable logic controller, the microcomputer, or the computer continuously calculates the liquid thickness of the medium filled in the culture bag based on the signal outputted by the analog length measurement sensor; and the target value of the calculated liquid thickness is predetermined based on sizes of the cells or the spheres trapped in the culture portion, such that the cells or the spheres are kept being trapped in the culture portion; and with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly, the calculated liquid thickness is adjusted to the target value through continuous vertical movements” (emphasis added). The specification discloses an analog type sensor performing continuous measurement” (paragraph [0036]); a desired liquid thickness (paragraph [0060]); maintaining a liquid thickness size that prevents relocation of the spheres (paragraphs [0064],[0069]-[0070]); and the pressing member moving vertically up and down (paragraph [0048]). However, the disclosure does not provide support for the specific limitations of “the programmable logic controller, the microcomputer, or the computer continuously calculates the liquid thickness of the medium filled in the culture bag based on the signal outputted by the analog length measurement sensor; and the target value of the calculated liquid thickness is predetermined based on sizes of the cells or the spheres trapped in the culture portion, such that the cells or the spheres are kept being trapped in the culture portion; and with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly, the calculated liquid thickness is adjusted to the target value through continuous vertical movements” (emphasis added)”. Additionally, the paragraphs [0023],[0028],[0043],[0048]-[0049], and [0054] provided by the applicant (Remarks filed 08/19/2025, page 7) does not provide support for the above limitations. Thus, the claim was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 7 and 10 are rejected by virtue of their dependency on claim 5, since they require all of the limitations and written description issue of claim 5.
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 5, 7, and 10 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 5, claim 5 recites “a guide hole…a guide pin” in lines 35-36. It is unclear if the guide hole and guide pin of lines 35-36 are the same or different from the guide hole and guide pin established previously in lines 22-23. Note that the limitations of lines 35-38 appears to repeat the same limitations as lines 22-25. Claims 7 and 10 are rejected by virtue of their dependency on claim 5.
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.
Claims 5, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Suenaga et al. (WO 2018230544 A1, cited in the IDS filed 02/01/2023; see machine translation) in view of Takeuchi et al. (WO 2016190312 A1, cited in the IDS filed 08/10/2021; corresponding document US 20180127696 A1, also cited in the IDS filed 08/10/2021, is used for referencing herein), and Suenaga et al. (US 20150191262 A1; herein, “Pub ‘262”).
Regarding claim 5, Suenaga teaches a culture device (Fig. 2; paragraph [0001]) comprising:
a culture bag (Fig. 2, cell culture bag 1) provided with at least one port (port 3) and formed of a soft packing material (Fig. 2 and paragraph [0032] teaches the culture bag is flexible, thus is a soft packing material);
a medium (Fig. 2, medium S within the cell culture bag);
a frame (Fig. 2, stand 5) on which the culture bag is placed (Fig. 2);
a pressing member (Fig. 2, pressing member 6) that causes the liquid thickness in the culture bag to be uniform by pressing the culture bag against the frame (interpreted as a functional limitation of the pressing member, see MPEP 2114; Fig. 2 shows pressing member 6 causing the thickness of the culture bag 1 to be uniform by pressing the culture bag against frame 5; paragraph [0038]);
a top plate portion (Fig. 2, frame 71) disposed so as to face the pressing member (Fig. 2);
a supporting structure (Fig. 2, guide pins 72) movably supporting the pressing member in a vertical direction with respect to the top plate portion (Fig. 2 shows guide pins 72 movably supporting pressing member 6 with respect to frame 71);
a pump (paragraph [0034] teaches a pump connected to port 3) disposed in a tubular member (paragraph [0034] teaches a pump connected to port 3 and paragraph [0046] teaches the pump is a peristaltic pump connected to port 3 via a tube; the instant specification paragraph [0055] teaches an example of a liquid delivery means disposed in a tube is a peristaltic pump; therefore Suenaga’s pump, which is a peristaltic pump connected to port 3 via a tube, is interpreted as a pump disposed in a tubular member) connecting the culture bag (paragraphs [0034]] teaches a pump connected to port 3), to perform liquid delivery between the culture bag and a medium bag (interpreted as an intended use of the pump, see MPEP 2114; paragraph [0053] teaches sucking or delivering liquid with the pump, thus, the pump is capable of performing liquid delivery as claimed at a later time);
cells or spheres (Fig. 2, cells or spheres C) to be cultured (interpreted as an intended use, see MPEP 2114; Fig. 2, cells or spheres C are capable of being cultured at a later time);
a plurality of concave parts for housing the cells or spheres (Fig. 2, concave recesses 4 that houses the cells or spheres C) in a culture portion of the culture bag (Fig. 2, interpreted as a portion of cell culture bag 1 capable of culturing, which includes the recesses 4); and
wherein:
the supporting structure (Fig. 2, guide pins 72) comprises a guide pin (72) disposed between the top plate portion (71) and the frame (5) (Fig. 2), such that the pressing member is movable in a vertical direction (Fig. 2),
the supporting structure (Fig. 2, guide pins 72) comprises a guide pin (72) disposed between the top plate portion (71) and the frame (5) (Fig. 2), such that the pressing member is movable in a vertical direction (Fig. 2).
Suenaga further teaches: a flow rate control means and injecting and discharging medium from the port and the pump delivers fluid at a low speed with high accuracy (paragraph [0046]) and controlling flow rate of medium passing through the port relative to the liquid thickness or height to reduce the time required for medium replacement while suppressing the outflow of cells (paragraphs [0051]-[0052]), thereby controlling the liquid thickness of the medium filled in the culture bag, to control the gap between the upper surface film and the lower surface film of the culture bag (Figs. 2(a)-2(b) and paragraphs [0051]-[0052]) teaches controlling the thickness of the medium and gap between the upper surface film 21a and lower surface film 22 of the cell culture bag 1); and the top plate comprises a guide hole (Fig. 2) configured to allow the guide pin 71 to pass through, such that the pressing member is movable in a vertical direction with the guide pin. Suenaga teaches the liquid thickness plus the thickness of the upper and lower films correspond to the height from the support surface to the bottom surface of the pressing member (paragraph [0049]). Suenaga teaches in order to prevent cells from peeling off, it is preferable that the pressing member stops descending to maintain a predetermined distance between the upper and lower films, i.e. liquid thickness (paragraph [0058]). Suenaga teaches the pressing member is at a position such that cells or the spheres are kept being trapped in the culture portion (Figs. 2(b), 4(b), 5(b)).
Suenaga fails to teach: a medium bag; the pump connecting the culture bag and the medium bag; an analog length measurement sensor that continuously outputs signals corresponding to the liquid thickness of the medium filled in the culture bag; and a programmable logic controller, a microcomputer, or a computer that controls operation of the pump based on detection information inputted from the analog length measurement sensor so as to control delivery of the medium between the culture bag and the medium bag; the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin; the programmable logic controller, the microcomputer, or the computer continuously calculates the liquid thickness of the medium filled in the culture bag based on the signal outputted by the analog length measurement sensor; the programmable logic controller, the microcomputer, or the computer controls performance of the pump to adjust the calculated liquid thickness to a target value, based on the calculated liquid thickness feedback from the signal outputted by the analog length measurement sensor; and the target value of the calculated liquid thickness is predetermined based on sizes of the cells or the spheres trapped in the culture portion, such that the cells or the spheres are kept being trapped in the culture portion; the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin; and with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly, the calculated liquid thickness is adjusted to the target value through continuous vertical movements.
Takeuchi teaches a culture device comprising a culture bag (abstract). Takeuchi teaches vessels can reserve a culture medium, such as a bag (paragraph [0058]). Takeuchi teaches a pump that connects a culture bag and a medium bag (Fig. 3 and paragraph [0038], teach pump 91 fluidically connects culture bag 90 with one of server bags 39 and 40 that reserve a culture medium). Takeuchi teaches an analog type length measurement sensor (Fig. 4 and paragraph [0065] teaches distance sensor 67 and magnet 68; Figs. 5A-5C and paragraphs [0065],[0069] teach the distance sensor 67 that outputs a voltage according to a magnetic fluid density from the magnet based on distance, thus the distance sensor is an analog type length measurement sensor) that continuously measures a change caused by a change in the liquid thickness of the medium filled in the culture bag (Figs. 5B-5C and paragraphs [0065],[0069] teach the distance sensor 67 detects distance changes between the distance sensor 67 and magnet 68 caused from the amount of liquid flowing into the culture bag, i.e. change in liquid thickness; thus, the distance sensor is capable of continuously measuring distance changes); and a programmable logic controller, a microcomputer, or a computer (Figs. 1-3 and paragraphs [0054]-[0056], control portion 11 that includes a display and data input portion and supply/discharge control portion) that controls operation of the pump (paragraph [0076] teaches the supply/discharge control portion drives, i.e. controls operation, of the supply pump 91) based on detection information inputted from the analog type length measurement sensor so as to control delivery of the medium between the culture bag and the medium bag (paragraph [0096] teaches the control portion stops the supply pump when an output value of the distance sensor exceeds a threshold value, thus, controlling delivery of the medium between culture bag 90 and bags 39 or 40). Takeuchi teaches the programmable logic controller, the microcomputer, or the computer (Figs. 1-3 and paragraphs [0054]-[0056], control portion 11 that includes a display and data input portion and supply/discharge control portion) controls performance of the pump (paragraph [0076] teaches the supply/discharge control portion drives, i.e. controls operation, of the supply pump 91), thereby controlling the liquid thickness of the medium filled in the culture bag, to control the gap between the upper surface film and the lower surface film of the culture bag (paragraph [0096] teaches the control portion stops the supply pump when an output value of the distance sensor exceeds a threshold value, thus, controlling delivery of the medium between culture bag 90 and bags 39 or 40, thereby controls the liquid thickness and the gap between an upper surface film and lower surface film of the culture bag; Figs. 5B-5C shows as the liquid thickness increases, the gap between the upper surface film and lower surface film of the culture bag increases).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the culture device of Suenaga to incorporate the teachings of a pump connecting a bag comprising medium and a culture bag of Takeuchi (Fig. 3 and paragraph [0038]) to provide: a medium bag; and the pump connecting the culture bag and the medium bag. Doing so would have a reasonable expectation of successfully connecting the culture bag to a vessel for medium, such as a medium bag, for proper delivery injection and discharging of medium.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the culture device of modified Suenaga to incorporate the Takeuchi’s teachings of an analog type length measurement sensor that continuously measures the thickness of a culture bag and a control portion to control delivery of a medium based on the sensor (Figs. 4, 5B-5C; paragraphs [0054]-[0056], [0065], [0069], [0096]) and Suenaga’s teachings of controlling flow rate of medium passing through the port relative to the liquid thickness to reduce the time required for medium replacement while suppressing the outflow of cells, which allows for control of the liquid thickness and the gap between the upper surface film and lower surface film of the culture bag (paragraphs [0051]-[0052]; Figs. 2(a)-2(b)) and Suenaga’s teachings of providing the pressing member at an appropriate vertical direction to maintain a predetermined liquid thickness to prevent cells from peeling off (paragraph [0058]) and keeping cells trapped in the culture portion due to the liquid thickness and pressing member (Figs. 2(b), 4(b), 5(b)) to provide: an analog length measurement sensor that continuously outputs signals corresponding to the liquid thickness of the medium filled in the culture bag; and a programmable logic controller, a microcomputer, or a computer that controls operation of the pump based on detection information inputted from the analog length measurement sensor so as to control delivery of the medium between the culture bag and the medium bag; the programmable logic controller, the microcomputer, or the computer continuously calculates the liquid thickness of the medium filled in the culture bag based on the signal outputted by the analog length measurement sensor; the programmable logic controller, the microcomputer, or the computer controls performance of the pump to adjust the calculated liquid thickness to a target value, based on the calculated liquid thickness feedback from the signal outputted by the analog length measurement sensor; and the target value of the calculated liquid thickness is predetermined based on sizes of the cells or the spheres trapped in the culture portion, such that the cells or the spheres are kept being trapped in the culture portion; and with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly, the calculated liquid thickness is adjusted to the target value through continuous vertical movements. Doing so would have a reasonable expectation of successfully improving automation of controlling fluid flow as taught by Takeuchi (Figs. 4, 5B-5C; paragraphs [0065],[0069],[0096]), and thus improve accuracy and control of fluid flow based on thickness or height of a culture bag as desired by Suenaga (paragraphs [0046], [0051]-[0052]), which would prevent cells from peeling off and keep cells within the culture portion based on adjustment of the liquid thickness and pressing member as taught by Suenaga (paragraph [0058]; Figs. 2(b), 4(b), 5(b)).
While Suenaga teaches the top plate comprises a guide hole (Fig. 2) configured to allow the guide pin 71 to pass through, such that the pressing member is movable in a vertical direction with the guide pin, modified Suenaga fails to teach: the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin; and the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin.
Pub ‘262 teaches system (Fig. 7) comprising a culture bag (Fig. 7, container 3); and a pressing member (Fig. 7, interpreted as element plate-like pressing member 6-3 and the structure that is adjacent to the screw element of driving unit 7-3) comprising a guide hole (Fig. 7, interpreted as the hole of the horizontal structure coupled to pressing member 6-3 through which the screw element of driving unit 7-3 passes through), and a guide pin (Fig. 7, the screw element of driving unit 7-3) is configured to pass through the guide hole (Fig. 7), such that the pressing member is movable in a vertical direction along the guide pin (Fig. 7(a) and 7(b) shows the pressing element 6-3 and the structure coupled to the pressing element is movable vertically along the screw element of driving unit 7-3). Pub ‘262 teaches the driving unit 7-3 is connected to the plate-like pressing member 6-3, and serves to allow this plate-like pressing member 6-3 to move reciprocally in the vertical direction, and is a plate-like up-and-down movement means (paragraph [0093]). Pub ‘262 teaches an alternative embodiment where it is possible to use a unit that drives a supporting part 7-3b connected to the plate-like pressing member 6-3 by means of an electrically-operated cylinder (an actuator for the movement in the vertical direction) (paragraph [0093]).
Since Pub ‘262 teaches an arrangement for a pressing member to press a culture bag, similar to Suenaga, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the top plate, pressing member, and guide pin of Suenaga to incorporate a known alternative arrangement for a pressing member where the pressing member is movable in a vertical direction along a guide pin that passes through a guide hole of the pressing member of Pub ‘262 (Fig. 7; paragraph [0093]) to provide: the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin; and the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin. Doing so would have been an obvious substitution of one known element (Suenaga’s top plate, pressing member, and support structure) for another (Pub ‘262’s pressing member and support member), and the result of the substitution would have been predictable (e.g. allowing for vertical control of the pressing member) (See MPEP 2143(I)(B)).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the top plate, pressing member, and guide pin of Suenaga to incorporate a known alternative arrangement for a pressing member where the pressing member is movable in a vertical direction along a guide pin that passes through a guide hole of the pressing member of Pub ‘262 (Fig. 7; paragraph [0093]) to provide the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin; and the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin. Doing so would be a mere reversal of parts, where modifying Suenaga’s pressing member and guide pins to move through guide holes of the pressing member (as taught by Pub ‘262) rather than the guide pins moving with the pressing member and through guide holes of the top plate (Suenaga, Fig. 2) would be an obvious matter of choice amounting to mere reversal of the movable parts of Suenaga which would result in an equivalent vertical movement of the pressing member (In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955)).
Regarding claim 7, modified Suenaga fails to explicitly teach wherein the programmable logic controller, the microcomputer, or the computer calculates the liquid thickness of the medium and controls the operation of the pump based on the liquid thickness.
Suenaga further teaches: injecting and discharging medium from the port and the pump delivers fluid at a low speed with high accuracy (paragraph [0046]) and controlling flow rate of medium passing through the port relative to the liquid thickness or height to reduce the time required for medium replacement while suppressing the outflow of cells (paragraphs [0051]-[0052]). Suenaga teaches controlling the flow rate such that as the height, i.e. thickness, decreases, the flow rate is decreased and vice versa (paragraph [0051]).
Takeuchi teaches measuring magnetic flux by a distance sensor to detect distance increases and decreases (Figs. 5B-5C; paragraphs [0065]-[0066]); the control portion judging if a distance between supporting surfaces exceeds a distance D2 (paragraph [0069]); and the control portion stops the supply pump when an output value of the distance sensor exceeds a threshold value (paragraph [0096]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control portion of Suenaga to incorporate the teachings of controlling flow rate based on height or thickness of Suenaga (paragraph [0051]) and the teachings of detecting distance increases and decreases using a distance sensor of Takeuchi (paragraphs [0065]-[0066]) to provide: the programmable logic controller, the microcomputer, or the computer calculates the liquid thickness of the medium and controls the operation of the pump based on the liquid thickness. Doing so would have a reasonable expectation of successfully determining the thickness or height of the medium of the culture bag to improve automation of controlling fluid flow as taught by Takeuchi (paragraphs [0065],[0069],[0096]), and thus improve accuracy and control of fluid flow based on the thickness as desired by Suenaga (paragraphs [0046], [0051]-[0052]).
Regarding claim 10, Suenaga further teaches wherein the pressing member (Fig. 2, pressing member 6) includes a pressing portion having a horizontal surface in a shape (Fig. 2, interpreted as the lower surface of the pressing member 6 which is horizontal in shape), the pressing portion presses the culture bag (Fig. 2), the shape is the same as a shape of a horizontal surface of a culture portion of the culture bag (Fig. 2), and the pressing portion presses only an inside of a region of the culture portion (Fig. 2, the lower surface of pressing member 6 is capable of pressing only an inside region of a culture portion of culture bag 1).
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 08/19/2025, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(b) of 04/24/2025 have been withdrawn.
Applicant's arguments, see pages 8-15, filed 08/19/2025, with respect to the rejections of claims 5, 7, and 10-11 under 35 U.S.C. 103, have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Remarks, page 10, “delicate and fine control of the liquid thickness of the medium filled in the culture bag”; Remarks, page 11, “improved tracking performance…accurately and consistently follow a target value over time…enhanced responsiveness and stability…”; Remarks, page 11, “the pressing member applying a pressure…within a specified range set…”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that Takeuchi, Suenaga, and Pub ‘262 individually fails to teach “with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly, the calculated liquid thickness is adjusted to the target value through continuous vertical movements,” contributed by “the pressing member movable in vertical directions along the guide pin,” and “the pressing member comprises a guide hole, and the supporting structure comprises a guide pin disposed between the top plate portion and the frame, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in vertical directions along the guide pin” (Remarks, pages 12-13) one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As discussed in the rejection of claim 5 under 35 U.S.C. 103, Suenaga teaches: the supporting structure (Fig. 2, guide pins 72) comprises a guide pin (72) disposed between the top plate portion (71) and the frame (5) (Fig. 2), such that the pressing member is movable in a vertical direction (Fig. 2), the supporting structure (Fig. 2, guide pins 72) comprises a guide pin (72) disposed between the top plate portion (71) and the frame (5) (Fig. 2), such that the pressing member is movable in a vertical direction (Fig. 2); Suenaga in view of Takeuchi are used to arrive at the claimed “with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly, the calculated liquid thickness is adjusted to the target value through continuous vertical movements”; and Suenaga in view of Pub ‘262 are used to arrive at the claimed “the pressing member comprises a guide hole, and the guide pin is configured to pass through the guide hole, such that the pressing member is movable in a vertical direction along the guide pin”.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (Remarks, pages 13-14), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As discussed above in the rejection under 35 U.S.C. 103 of claim 5, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed limitations of the analog type length measurement sensor and limitations of the programmable logic controller, a microcomputer, or a computer; i.e., one of ordinary skill in the art would recognize that including a distance sensor of Takeuchi would allow for measurement of the culture bag thickness to therefore allow for improved accuracy and control of fluid within the culture bag in relation to the pump and pressing plate.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references to arrive at the claimed “a feedback control of the liquid thickness to a target value, based on the calculated liquid thickness feedback from the signals [continuously] outputted by the analog length measurement sensor,” particularly, “for keeping the cells or the spheres trapped in the culture portion (the target value of the calculated liquid thickness is predetermined based on sizes of the cells or the spheres trapped in the culture portion), ... with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly” (Remarks, pages 13-15), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, note that “feedback control” is not claimed.
In this case, Suenaga in view of Takeuchi is used to arrive at the claimed limitations argued by applicant: an analog length measurement sensor that continuously outputs signals corresponding to the liquid thickness of the medium filled in the culture bag; and a programmable logic controller, a microcomputer, or a computer that controls operation of the pump based on detection information inputted from the analog length measurement sensor so as to control delivery of the medium between the culture bag and the medium bag; the programmable logic controller, the microcomputer, or the computer continuously calculates the liquid thickness of the medium filled in the culture bag based on the signal outputted by the analog length measurement sensor; the programmable logic controller, the microcomputer, or the computer controls performance of the pump to adjust the calculated liquid thickness to a target value, based on the calculated liquid thickness feedback from the signal outputted by the analog length measurement sensor; and the target value of the calculated liquid thickness is predetermined based on sizes of the cells or the spheres trapped in the culture portion, such that the cells or the spheres are kept being trapped in the culture portion; and with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly, the calculated liquid thickness is adjusted to the target value through continuous vertical movements.
In short, Suenaga provides teachings and suggestions of controlling flow rate of medium passing through the port relative to the liquid thickness to reduce the time required for medium replacement while suppressing the outflow of cells, which allows for control of the liquid thickness and the gap between the upper surface film and lower surface film of the culture bag (paragraphs [0051]-[0052]; Figs. 2(a)-2(b)). Suenaga also provides teachings that in order to prevent cells from peeling off, it is preferable that the pressing member stops descending to maintain a predetermined distance between the upper and lower films, i.e. liquid thickness (paragraph [0058]); and the pressing member is at a position such that cells or the spheres are kept being trapped in the culture portion (Figs. 2(b), 4(b), 5(b)). Takeuchi provides teachings and suggestions of: an analog type length measurement sensor that continuously measures the thickness of a culture bag and a control portion to control delivery of a medium based on the sensor (Figs. 4, 5B-5C; paragraphs [0054]-[0056],[0065],[0069],[0096]).
It would have been obvious to one of ordinary skill in the art to have modified the culture device of modified Suenaga to incorporate the Takeuchi’s teachings of an analog type length measurement sensor that continuously measures the thickness of a culture bag and a control portion to control delivery of a medium based on the sensor (Figs. 4, 5B-5C; paragraphs [0054]-[0056], [0065], [0069], [0096]) and Suenaga’s teachings of controlling flow rate of medium passing through the port relative to the liquid thickness to reduce the time required for medium replacement while suppressing the outflow of cells, which allows for control of the liquid thickness and the gap between the upper surface film and lower surface film of the culture bag (paragraphs [0051]-[0052]; Figs. 2(a)-2(b)) and Suenaga’s teachings of providing the pressing member at an appropriate vertical direction to maintain a predetermined liquid thickness to prevent cells from peeling off (paragraph [0058]) and keeping cells trapped in the culture portion due to the liquid thickness and pressing member (Figs. 2(b), 4(b), 5(b)) to provide: an analog length measurement sensor that continuously outputs signals corresponding to the liquid thickness of the medium filled in the culture bag; and a programmable logic controller, a microcomputer, or a computer that controls operation of the pump based on detection information inputted from the analog length measurement sensor so as to control delivery of the medium between the culture bag and the medium bag; the programmable logic controller, the microcomputer, or the computer continuously calculates the liquid thickness of the medium filled in the culture bag based on the signal outputted by the analog length measurement sensor; the programmable logic controller, the microcomputer, or the computer controls performance of the pump to adjust the calculated liquid thickness to a target value, based on the calculated liquid thickness feedback from the signal outputted by the analog length measurement sensor; and the target value of the calculated liquid thickness is predetermined based on sizes of the cells or the spheres trapped in the culture portion, such that the cells or the spheres are kept being trapped in the culture portion; and with corporation of the pressing member, within a movable range of the pressing member in the vertical directions downwardly and upwardly, the calculated liquid thickness is adjusted to the target value through continuous vertical movements. Doing so would have a reasonable expectation of successfully improving automation of controlling fluid flow as taught by Takeuchi (Figs. 4, 5B-5C; paragraphs [0065],[0069],[0096]), and thus improve accuracy and control of fluid flow based on thickness or height of a culture bag as desired by Suenaga (paragraphs [0046], [0051]-[0052]), which would prevent cells from peeling off and keeps cells within the culture portion based on the liquid thickness and pressing member as taught by Suenaga (paragraph [0058]; Figs. 2(b), 4(b), 5(b)).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed limitations of the analog type length measurement sensor and the programmable logic controller, a microcomputer, or a computer; i.e., one of ordinary skill in the art would recognize that including a distance sensor of Takeuchi would allow for continuous measurement of the culture bag thickness to therefore allow for improved accuracy and control of fluid within the culture bag in relation to the pump and pressing plate, thus preventing cells from peeling off and keeping cells within the culture portion based on adjustment of the liquid thickness and pressing member as taught by Suenaga (paragraph [0058]; Figs. 2(b), 4(b), 5(b)).
In response to applicant’s argument that “one skilled in the art having a common sense would not be even motivated to combine the cited references to arrive at the claimed invention” (Remarks, page 14) is conclusory and amounts to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references or why it would not be obvious to combine the references.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758