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 .
Status of Claims
Claims 1-20 are pending and examined on the merits.
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 15 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.
Claim 15 recites the limitation "the exhaust port". There is insufficient antecedent basis for this limitation in the claim. It is assumed that Claim 15 should depend from Claim 11 instead of Claim 10.
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.
Claims 1, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa in view of Lampeter (US 2005/0084838).
Re Claim 1, Yoshikawa discloses a collection kit comprising:
an inlet tube (tube 18 that leads to cell injection port 15, e.g., Fig. 2) to which a medical bag accommodating an object to be collected is connected;
a collection bag (container 10) which is connected to a downstream side of the inlet tube, includes a plurality of accommodation chambers (storage chambers 14, 22, & 27) formed by overlapping and welding two flexible sheets (see translation page 2, paragraph that follows “[Container 10]”, “The container 10 is configured, for example, by laminating two resin sheets molded into a shape described later.”), and accommodates a predetermined amount of the object to be collected in each of the accommodation chambers; and
a plurality of outlet ports (cell recovery port 17 and sample collection ports 25 & 31) which are connected to the accommodation chambers, respectively, and allow the object to be collected to flow out from the accommodation chambers; wherein
the collection bag includes a connection flow path (linking paths 23 & 24 or paths 29 & 30) connecting the accommodation chambers adjacent to each other, and the connection flow path is integrally formed with the accommodation chambers by the two flexible sheets, and has a tubular portion formed in a tubular shape by cutting out (at linking units 21 & 26, see e.g., Fig. 2) the flexible sheets around the tubular portion between the accommodation chambers adjacent to each other.
Yoshikawa does not explicitly disclose adapters which are connected to downstream sides of the outlet ports, respectively, and connect culture bottles and the outlet ports by the culture bottles being attached to the adapters, respectively. Lampeter discloses a medical collection bag having multiple chambers (Fig. 2), wherein each chamber is equipped with an adapter (13, [0051] “Removal adapter 13 permits the sterile removal of the transported or stored liquid contents of the bag.”) at the outlet of each chamber. It would have been obvious to one skilled in the art at the time of filing to add the adapters taught in Lampeter into the outlets in Yoshikawa for improving the sterile removal of contents from the bag.
Re Claim 7, Yoshikawa discloses a collection method using the collection kit according to claim 1, the collection method comprising:
a step of connecting the medical bag to the inlet tube (translation page 2 last paragraph “A tube 18 is connected to the cell injection port 15 via a cylindrical member 33.”);
a step of introducing the object to be collected into the accommodation chambers of the collection bag through the inlet tube (translation page 2 last paragraph “The cell suspension 40 is circulated through the tube 18, and the cell suspension 40 is injected into the first storage chamber 14 through the cell injection 15.”);
a step of closing the tubular portion to prevent the object to be collected from moving between the plurality of accommodation chambers (implied by sealing portion 42, see Fig. 7); and
Yoshikawa does not explicitly disclose a step of separating the medical bag from the inlet tube. However, a person of ordinary skill has good reason to pursue the known options (disconnect the inlet tube or let it remain connected when the collection bag is completely filled) within his or her technical grasp. If this leads to the anticipated success (allowing the collection bag remain filled and optionally transported), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Yoshikawa also does not disclose a step of connecting the culture bottles to the adapters and injecting the object to be collected into the culture bottles. Lampeter discloses a medical fluid collection bag that has adapters for letting out the liquid inside the bag, thus implying the step of connecting bottles to the adapter to let out the liquid and into the bottle. It would have been obvious to one skilled in the art at the time of filing to modify with Lampeter for transferring liquid out of the collection bag in a sterile manner.
Re Claim 8, Yoshikawa and Lampeter combine to disclose claim 7. While they do not explicitly disclose wherein the tubular portion is closed by a clamp, ultrasonic sealing, or high frequency sealing in the step of closing the tubular portion to prevent the object to be collected from moving between the plurality of accommodation chambers, Yoshikawa discloses that the seal is a “thermal welding” (translation page 7 fifth paragraph “The thermal welding of the communication passages 23, 24”). Given that ultrasonic and thermal sealing are common methods in bonding flexible polymeric sheets, one skilled in the art would find it obvious to substitute thermal sealing with ultrasonic sealing because both achieve the same results and are widely known alternatives in the field of flexible medical containers.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa and Lampeter as applied to claim 1 above, and further in view of Wu (CN 108354830)
Re Claim 2, Yoshikawa and Lampeter combine to disclose claim 1, Yoshikawa also discloses wherein the plurality of accommodation chambers include a first accommodation chamber (14) having an upper portion to which the inlet tube (18) is connected, and a second accommodation chamber connected to the first accommodation chamber via the connection flow path (23 & 24). The references do not disclose an exhaust valve which is connected to an upper portion of the second accommodation chamber and exhausts air inside the first accommodation chamber and the second accommodation chamber. Wu discloses a medical fluid bag comprising multiple compartments and a venting valve/port (5) for one of the compartments (see Fig. 1). It would have been obvious to one skilled in the art at the time of filing to add the exhaust port/valve to any/each of the chambers of Yoshikawa so as to help fluid flow easily into the chambers while fluid is being delivered into the chamber(s) via the inlet.
Re Claim 3, Yoshikawa, Lampeter and Wu combine to disclose claim 2, and Yoshikawa further discloses wherein an upstream end of the connection flow path (23 & 24) is connected to the upper portion of the first accommodation chamber, and a downstream end of the connection flow path is connected to the second accommodation chamber. Yoshikawa does not explicitly disclose that the downstream end of the connection flow path fluidly interconnected to the lower portion of the second accommodation chamber. However, mere rearrangement requires only routine skills in the art. Given that Applicant has not presented criticality of the location of the downstream end being closer to the lower portion of the second chamber, said claimed location does not render the claimed invention patentably over prior art.
Re Claim 4, Yoshikawa, Lampeter and Wu combine to disclose claim 2, and Yoshikawa further discloses wherein the plurality of outlet ports include a first outlet port (17) connected to a lower portion of the first accommodation chamber and a second outlet port (25 or 31) connected to a lower portion of the second accommodation chamber.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa and Lampeter as applied to claim 1 above, and further in view of Sanchez (US 2021/0145695).
Re Claims 5-6, Yoshikawa and Lampeter combine to disclose claim 1 but neither discloses a frame member which holds peripheral edge portions of the flexible sheets and holds the flexible sheets in a planar shape, wherein the frame member includes: a frame body that holds the peripheral edge portions of the flexible sheets; and an abutment plate that abuts on the accommodation chambers in a thickness direction of the flexible sheets to prevent the accommodation chambers from expanding in the thickness direction.
Sanchez discloses a frame (10, Fig. 1) for holding a flexible medical fluid bag (flexible bag 2), wherein the frame would hold the peripheral edge portions of the bag (see Figs 4-5) and also have an abutment plate (8) that abuts on the bag in a thickness direction to prevent the bag from expanding in the thickness direction (see Fig. 1). It would have been obvious to one skilled in the art at the time of filing to glean from Sanchez so as to be able to safely transport a filled medical fluid bag.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa et al. (WO 2015/147077, English translation attached to this Office Action).
Re Claim 9, Yoshikawa discloses a collection kit, comprising:
a collection bag (10, e.g., Fig. 2) extending a width distance (in the left-right direction 52, Fig. 3) from a first side of the collection bag to a second side of the collection bag and extending a height distance (in the up-down direction 53) from an upper side of the collection bag to a lower side of the collection bag, the collection bag comprising:
a first flexible sheet (see translation page 2, paragraph that follows “[Container 10]”, “The container 10 is configured, for example, by laminating two resin sheets molded into a shape described later.”) comprising a first shape extending along the width distance and the height distance;
a second flexible sheet (implied in translation page 2) comprising a second shape extending along the width distance and the height distance, the second flexible sheet arranged overlapping and in contact with the first flexible sheet in a thickness direction,
a first accommodation chamber (storage chamber 14, e.g., Fig. 2) arranged between the first flexible sheet and the second flexible sheet, the first accommodation chamber disposed adjacent the first side of the collection bag;
a second accommodation chamber (storage chamber 27) arranged between the first flexible sheet and the second flexible sheet, the second accommodation chamber disposed adjacent the second side of the collection bag; and
a connection flow path (23, 24, 29, & 30) comprising an upstream end and a downstream end, the upstream end fluidly interconnected to the first accommodation chamber at an exit point of the first accommodation arranged closer to the upper side of the collection bag than the lower side of the collection bag, the downstream end fluidly interconnected to the second accommodation chamber, wherein the connection flow path fluidly interconnects the first accommodation chamber with the second accommodation chamber; and
an inlet tube (18) that is operatively connected to the first accommodation chamber, the inlet tube configured to attach to a medical bag comprising an object to be collected.
Yoshikawa does not explicitly disclose that the downstream end of the connection flow path fluidly interconnected to the second accommodation chamber at an inflow point of the second accommodation arranged closer to the lower side of the collection bag than the upper side of the collection bag. However, mere rearrangement requires only routine skills in the art. Given that Applicant has not presented criticality of the location of the downstream end being closer to the lower side of the collection bag, said claimed location does not render the claimed invention patentably over prior art.
Re Claim 10, Yoshikawa discloses claim 9, and also discloses further comprising:
an inlet port (15) fluidly interconnected with the first accommodation chamber and arranged adjacent the upper side of the collection bag, wherein inlet port is fluidly interconnected with the inlet tube (see e.g., Fig. 3);
a first outlet port (17) fluidly interconnected with the first accommodation chamber and arranged adjacent the lower side of the collection bag (Fig. 3); and
a second outlet port (31) fluidly interconnected with the second accommodation chamber and arranged adjacent the lower side of the collection bag (Fig. 3).
Claims 11 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa in view of Wu.
Re Claims 11 & 15, Yoshikawa discloses disclaim 10 but does not disclose an exhaust port fluidly interconnected to the second accommodation chamber and arranged adjacent the upper side of the collection bag or an exhaust valve operatively connected to the exhaust port, the exhaust valve configured to allow passage of gas from the collection bag and prevent passage of liquid from the collection bag. Wu discloses a medical fluid bag comprising multiple compartments and a venting valve/port (5) for one of the compartments (see Fig. 1). It would have been obvious to one skilled in the art at the time of filing to add the exhaust port/valve to any/each of the chambers of Yoshikawa so as to help fluid flow easily into the chambers and to prevent gas build up for any contents that may generate gas. One skilled in the art would likely want to add such a port/valve at the upper side of the collection bag because gas/air is lighter than liquid and would rise to the top of each chamber as the chamber is being filled with liquid.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa in view of Sanchez (US 2021/0145695).
Re Claims 16-18, Yoshikawa discloses claim 10 but neither discloses a frame member which holds peripheral edge portions of the collection bag and holds the collection bag in a planar shape, wherein the frame member includes: a first frame body portion; and a second frame body portion attached to the first frame body portion, wherein the first frame body portion and the second frame body portion comprise recesses that accommodate the first accommodation chamber and the second accommodation chamber of the collection bag in the thickness direction, wherein the peripheral edge portions of the collection bag are held and disposed between abutment surfaces of the first frame body portion and the second frame body portion.
Sanchez discloses a frame (10) for holding a flexible medical fluid bag (flexible bag 2), wherein the frame would hold the peripheral edge portions of the bag (see Figs. 4-5) and have upper and lower portions that define recesses (see Fig. 1 where a recess is implied because it accommodates a filled fluid bag) also have abutment surfaces (8) that abuts on the bag in a thickness direction to prevent the bag from expanding in the thickness direction. It would have been obvious to one skilled in the art at the time of filing to glean from Sanchez so as to be able to safely transport a filled medical fluid bag.
Allowable Subject Matter
Claims 12-14 & 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Re Claim 12, no prior art is found to disclose the upper and lower recesses in the connection region.
Claims 13-14 are allowable for being dependent from Claim 12.
Re Claims 19-20, the frame taught by Sanchez does not comprise the claimed features.
Conclusion
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
24 July 2026
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