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 .
Response to Amendment
The amendment filed 18 June 2026 has been entered. Claim(s) 1-17, 19-27, and 38 are pending in the application. Applicant’s amendments to the claims have overcome each and every rejection under 35 U.S.C. 112(b) previously set forth in the Office Action mailed 08 April 2026.
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 one 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.
Claim(s) 1-3, 6, 8-9, 11-16, 27, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic (US 20190216380 A1) in view of Bartfeld (US 20120141341 A1), further in view of Fedoruk (US 20190307382 A2).
Regarding claim 1, Ivosevic discloses a sample collection container configured to be removably mounted to a blood collection device (collector portion 74 is removably mounted to portion 72 of a collection device 10, Fig 8; paragraph 0080-- a collection container 16 that is removably connectable to the port 26 of the holder 12. The collection container 16 defines a collection cavity 70 for receiving a blood sample 18, a container engagement portion 72, a blood collector portion 74, and a cap or septum 76), the collection container comprising:
a container body (body of collector portion 74, Fig 8) defining an interior configured to receive a sample provided from the blood collection device (collector portion 74 defines an interior 70 for receiving a blood sample, Fig 8; paragraph 0080), the container body comprising an upper portion comprising an open top (upper open top of collector portion 74 which is connected to 72, Fig 8) and a lower portion comprising a closed bottom (lower closed bottom of collector portion 74, Fig 8); and
a lid (lid 76, Fig 8) comprising:
a lid body (outer body of lid 76, Fig 8);
a flexible connection connected between the lid body and the upper portion of the container body (lid 76 is connected to the upper portion of 74, Fig 8; lid 76 pivots to cover the opening of 74 demonstrating that the connection is flexible, Fig 25-26) that moves the lid between a closed position, in which the lid covers the open top of the upper portion (closed position of the lid 76 which covers the open top of 74, Fig 26; paragraph 0080, 0110--the blood collector portion 74 is sealed by the cap 76 once removed from the collection device 10), and an open position, where the open top of the upper portion is uncovered (paragraph 0080-- The blood collector portion 74 is sealed via the cap or septum 76 once removed from the collection device 10 to protectively seal the blood sample 18 within the collection cavity 70 such that the cap 76 is in an open position with the top of 74 uncovered prior to sealing it with the cap);
Ivosevic teaches wherein the container body may comprise a pierceable septum to seal the opening (paragraph 0080-- The blood collector portion 74 is sealed via the cap or septum 76).
However, Ivosevic does not explicitly teach a pierceable septum mounted to the lid body that seals the upper portion open top when the lid is in the closed position; and a latch extending from the lid body that engages a catch on the upper portion of the container body to secure the lid in the closed position.
Bartfeld, in the same field of endeavor of a sample collection container to be removably mounted to a blood collection device, teaches a pierceable septum mounted to the lid body (septum 96 mounted to annular shoulder 92, Fig 3; paragraph 0053) that seals the upper portion open top when the lid is in the closed position (septum 96 seals the open top 46 in the closed position, Fig 9; paragraph 0056--septum 96 contacts and forms a barrier seal 122 with a portion of the interior 44 of the inner tube 32).
It would have been obvious to one having ordinary skill in the art to modify the device of Ivosevic, including a cap or a septum, to include a lid and a septum where the septum is connected to the lid as a pierceable septum in order to predictably improve the device by ensuring that a sample cannot be spilled or compromised by including a pierceable septum which enables secure collection of the sample in addition to a lid which prevents the septum from being contacted and thus contaminated or comprised unintentionally.
However, the combination fails to disclose the upper portion comprising a catch extending radially outwardly from a sidewall of the upper portion at a first radial position, the flexible connection at a second radial position opposite the first radial position, and a latch extending from the lid body comprising a frame comprising an opening configured to receive the catch on the upper portion of the container body with a portion of the catch protruding through the opening to secure the lid in the closed position.
Fedoruk, in the same field of endeavor of a collection container for securely collecting a bodily fluid such as blood, teaches a sample collection container (cup body 210, Fig 5; paragraphs 0067-0069) comprising an upper portion comprising an open top and a catch (locking hook 230) extending radially outwardly from a sidewall of the upper portion at a first radial position (Position of locking hook 230 at one side of the container open end, Fig. 5-7) and comprising a lid (lid 220, Fig 5) connected by a flexible connection (living hinge 230 connects lid 220 and body 210, Fig 5; paragraph 0068) at a second radial position opposite the first radial position (Living hinge 230 which connects the lid to the container at an opposite side of the open end from the locking hook 230, Figs. 5-7), further comprising a latch extending from the lid body (locking latch 240, Fig 5; paragraph 0071) comprising a frame (Locking latch 240 comprises a frame formed by side portions 250) comprising an opening (Center portion 253/hole 252) configured to receive the catch on the upper portion of the container body with a portion of the catch protruding through the opening (locking latch 240 engages locking hook 230 on the upper portion of container 210, Fig 5-7; paragraph 0071-- The center portion 253 of the latch 240 is open to allow for reception of the hook 230 when the lid 220 is closed) in order to secure the lid in the closed position (paragraph 0072-- Once the lid 220 is closed, the receptacle 200 is locked using a lock tag 260).
It would have been obvious to one having ordinary skill in the art to modify the lid of Ivosevic to further comprise a catch and latch as taught by Fedoruk in order to predictably improve the safety and security of the collected sample by locking the lid in the closed position and preventing spills or contamination.
Regarding claim 2, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 1. However, Ivosevic and Fedoruk are silent as to the frame of the latch being formed from a first material and the latch further comprising a cushion formed from a second material that is less rigid than the first material.
Bartfeld additionally teaches wherein a frame of a latch (strengthening member 140, Fig. 14) is formed from a first material (strengthening member 140 must be formed of a first material), the latch further comprising a cushion (sealing band 138, Fig. 14) formed from a second material (sealing band 138 must be formed of a second material; paragraph 0060—sealing band 138 is deformable…) that is less rigid than the first material (paragraph 0060--strengthening member 140 adjacent the sealing band 138 for providing additional rigidity NOTE: that the material of the sealing band 138 must be less rigid than the material of strengthening member 140 because of its description as deformable in contrast with the description of the strengthening member as providing rigidity).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the latch of the combined Ivosevic and Fedoruk to be formed of a first material and to additionally include a cushion as described by Bartfeld to predictably improve the device by allowing a more snug connection of the latch and catch as the cushion could be compressed, such that any open space in the fit of the latch and catch connection would instead by occupied by the cushion, thus preventing any jostling or other unwanted movement of the catch within the latch and improving the secure closure of the device.
Regarding claim 3, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 2. Bartfeld additionally teaches wherein the cushion is positioned proximate to a leading edge of the frame of the lid (sealing band 138 is positioned proximate to the bottom leading edge of strengthening member 140, Fig 14) and is configured to restrict the latch from being disengaged from the catch (paragraph 0062).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the latch of the combined Ivosevic and Fedoruk to be formed of a first material and to additionally include a cushion as described by Bartfeld to predictably improve the device by allowing a more snug connection of the latch and catch as the cushion could be compressed, such that any open space in the fit of the latch and catch connection would instead by occupied by the cushion, thus preventing any jostling or other unwanted movement of the catch within the latch and improving the secure closure of the device.
Regarding claim 6, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 2. Bartfeld additionally teaches wherein the first material is a semi rigid plastic (paragraph 0049--polypropylene), and the second material is a thermoplastic elastomer (paragraph 0053--thermoplastic elastomer).
Regarding claim 8, the combination of Ivosevic, Bartfeld and Fedoruk teaches the collection container of claim 1. Fedoruk additionally teaches wherein the catch on the upper portion of the container body comprises a sloped surface (hook 230 includes a downwardly sloped surface, Fig 5; paragraph 0069-- The cup body 210 further includes a locking hook 230 that can be in the form of a downwardly extending J-shaped hook with a slot or space 232 being defined therein) positioned such that, as the lid transitions between the open position and the closed position, the latch deflects over the catch prior to engaging the catch (the slope of hook 230 is positioned such that as the latch 240 pivots with the transition of the lid between the open position and the closed position it deflects over the slope surface of hook 230 prior to engaging the hook 230 in the center aperture 253, Fig 5; paragraph 0071).
It would have been obvious to one having ordinary skill in the art to modify the lid of Ivosevic to further comprise a catch as taught by Fedoruk in order to predictably improve the safety and security of the collected sample by locking the lid in the closed position and preventing spills or contamination.
Regarding claim 9, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 1. Bartfeld additionally teaches wherein the septum comprises an inwardly facing surface that faces the interior of the container body (bottom surface of 96 faces the interior of container 34, Fig 9) and an outwardly facing surface opposite the inwardly facing surface (opposite top surface of 96 faces the exterior of container 34, Fig 9), the outwardly facing surface comprising a recess or well (the top surface comprises a well 100, Fig 3) positioned to collect any fluid that escapes from the interior of the container body during retraction of a needle through the septum (paragraph 0053--100 is a concave receiving surface for directing a needle hence also is configured to collect any fluid that escapes from the interior during retraction of the needle).
Regarding claim 11, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 1, with Bartfeld specifically relied upon to disclose a septum. Bartfeld additionally teaches wherein the septum comprises an inwardly facing surface that faces the interior of the container body when the lid is in the closed position (bottom surface of 96 faces the interior of container 34 when the lid is closed, Fig 9), the inwardly facing surface of the septum comprising a chamfered peripheral edge (tapered peripheral edge of the bottom of 96, Fig 9).
Regarding claim 12, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 11. Bartfeld additionally teaches wherein the inwardly facing surface of the septum defines a central cavity (the bottom surface of 96 defines a centrally located cavity, Fig 9; cavity 106, Fig 3), which enhances radial deformation of the septum during centrifugation (paragraph 0053--the septum 96 is a thermoplastic elastomer hence configured to radially deform during centrifugation; the tapered bottom cavity of 96 is shaped to enhance deformation radially outward towards the wall of the inner tube 32 during centrifugation, Fig 9).
Regarding claim 13, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 12. Bartfeld additionally teaches wherein the central cavity comprises a tapered annular surface (the bottom central cavity of 96 comprises a tapered outer annular surface, Fig 9).
Regarding claim 14, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 12. Bartfeld additionally teaches wherein the upper portion open top comprises an annular chamfered edge (see an annular tapered portion of the upper sidewall of 32 near the bottom of septum 96, Fig 9) positioned to contact a chamfered peripheral edge of the septum (tapered peripheral edge of the bottom of 96, Fig 9) as the lid moves to the closed position (the tapered portions of 32 and 96 are configured to mate as the lid moves to the closed position, Fig 9).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the upper portion open top to comprise an annular chamfered edge as described by Bartfeld in order to predictably improve the secure containment of sampled liquid in the container by providing a tight seal of the septum with the container.
Regarding claim 15, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 14. Bartfeld additionally teaches wherein the annular chamfered edge of the upper portion deforms the septum when the lid is in the closed position, thereby sealing the interior of the container body (paragraph 0054--the annular interior wall hence including the tapered portion contacts the pierceable septum; paragraph 0056--the septum 96 contacts and forms a barrier seal with the interior of the inner tube 32; paragraph 0053--the pierceable septum 96 is formed from a thermoplastic elastomer such that deforms as it contacts the interior wall of the container).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the upper portion open top to comprise an annular chamfered edge as described by Bartfeld in order to predictably improve the secure containment of sampled liquid in the container by providing a tight seal of the septum with the container.
Regarding claim 16, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 15. Bartfeld additionally teaches wherein the septum is configured to radially expand during centrifugation (paragraph 0053--the septum 96 is a thermoplastic elastomer hence configured to radially expand during centrifugation), thereby enhancing the sealing of the interior of the container body (paragraph 0056--the septum 96 contacts the inner wall to form a barrier seal hence radially expanding during centrifugation enhances the seal).
Regarding claim 27, the combination of Ivosevic, Bartfeld and Fedoruk teaches the collection container of claim 14. Fedoruk additionally teaches wherein the flexible connection comprises a hinge (living hinge 230).
Regarding claim 38, the combination of Ivosevic, Bartfeld and Fedoruk teaches the collection container of claim 14. Fedoruk additionally teaches wherein the catch comprises opposing axial walls extending from the sidewall of the upper portion (each side of locking hook 230 may be considered an axial wall of the hook which are on opposing sides of the hook and extend from the sidewall of the upper portion, Fig. 5-7) and wherein the opening of the frame is a square or rectangular shaped opening sized to receive the opposing axial walls of the catch (Shape of the opening/hole 252/253 is rectangular or square, see Fig. 5 and 7).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Bartfeld, further in view of Fedoruk, further in view of Frei (US 20110119859 A1).
Regarding claim 4, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 2.
However, the combination fails to explicitly teach wherein the cushion is positioned on the frame between the opening and the leading edge of the frame.
Frei, in analogous art of a latch arrangement for connecting a lid to a container (Abstract), teaches a latch element for securing a lid to a container (paragraph 0029-- latch arrangement 1 for releasably securing a lid 2 to a container 3), wherein the latch comprises a cushion member positioned on the frame between the opening and the leading edge of the frame (flange 35 between magnetic element 6 and a bottom leading edge of latch 4, Fig 6; paragraph 0041--the latch element 4 is composed of a flexible thermoplastic elastomer… allows the latch 4 to comply with distortions… hence portion 35 is a cushioning member; paragraph 0039--flange 35 acts to retain the latch element 4 against movement).
It would have been obvious to one having ordinary skill in the art to modify the latch of the combination such that the cushion member is positioned on the frame between the opening and the leading edge of the rigid frame as taught by Frei in order to use the cushioning member to predictably improve the seal of the lid against the container by providing a cushion which can prevent distortions of jostling of the lid from dislodging the lid (see paragraph 0041 of Frei) and can predictably use the cushioning member to better retain the latch against movement (see Paragraph 0039 of Frei).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic (US 20190216380 A1) in view of Bartfeld (US 20120141341 A1), further in view of Fedoruk (US 20190307382 A2), further in view of Belfance (US 20130256329 A1).
Regarding claim 5, the combination of Ivosevic, Bartfeld and Fedoruk teach the collection container of claim 2. However, Ivosevic is silent as to wherein the lid body, the flexible connection, and the container body comprise the first material, and wherein the septum comprises the second material. Bartfeld additionally teaches wherein the container body comprises a first material (paragraph 0049-- inner tube 32 and the outer tube 34 may be formed of the same material, such as polypropylene and/or polyethylene), and wherein the septum comprises the second material (paragraph 0053--septum 96 is formed from a thermoplastic elastomer).
However, Bartfeld is silent as to the material of the lid body and the flexible connection.
Belfance further teaches wherein the lid body, flexible connection, and container body are all formed of a first material (paragraph 0051--lid 102 and container body 104 formed from polypropylene; body 104 and lid 102 are integral hence the hinge 128 is also polypropylene, paragraph 0053).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the container of the combined Ivosevic, Bartfeld, and Fedoruk to use the same first material of polypropylene for lid body, flexible connection and container body in order to simplify the manufacturing process and provide rigidity and strength to the structural components of the container.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic (US 20190216380 A1) in view of Bartfeld (US 20120141341 A1), further in view of Fedoruk (US 20190307382 A2) , further in view of Aljefri (US 20200305781 A1).
Regarding claim 7, the combination of Ivosevic, Bartfeld, Fedoruk and Belfance teach the collection container of claim 6. Bartfeld additionally teaches wherein the first material is polypropylene (paragraph 0049--polypropylene), and the second material is a flexible (paragraph 0053--thermoplastic elastomer).
However, Bartfeld does not explicitly disclose the second material is at least one of liquid silicone rubber, urethane rubber, and latex rubber.
Aljefri, in the same field of endeavor of a blood collection tube, teaches a septum may be made of an elastomer material such as liquid silicone rubber, urethane rubber, and latex rubber (Paragraph 0075, 0082-- The sealing member or septum may be made of a rubber material such as natural rubber, isoprene rubber, chloroprene rubber and silicone rubber, and a resin such as a thermoplastic elastomer, for instance, styrene-butadiene-styrene (SBS) block copolymer. Other materials described for the elastomeric sleeve 14 may also be used for the sealing member or septum).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the container via a simple substitution for a different elastomer material as described in Aljefri as it is known in the art (see Aljefri, paragraph 0075, 0082) that these materials include similar properties and would be capable of functioning similarly as the septum to seal the opening.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic in view of Bartfeld, further in view of Fedoruk, further in view of Burns (US 5494170 A).
Regarding claim 10, the combination of Ivosevic, Bartfeld, and Fedoruk teaches the collection container of claim 1.
However, the combination fails to disclose wherein the lid body comprises an annular flange defining an opening and wherein the septum is inserted through the opening with the annular flange received within an annular notch of the septum.
Burns, in the same field of endeavor of a body fluid collection tube, teaches a lid (closure 110 including body 111, Fig 11) comprising a pierceable septum (sealing element 112 of closure 110, Fig 11; Col. 6, line 33--sealing element 112; Col. 8, line 1-3--sealing elements of thermoplastic elastomer material to be pierced by a needle) for sealing a collection tube (closure 110 with sealing member 112 is used to seal tube 1, Fig 11; Col. 7, line 51-52--sealing member seals the open end of the tube), wherein the lid body comprises an annular flange defining an opening (body 111 includes an annular flange with an opening for the septum 112, Fig 11) and wherein the septum is inserted through the opening with the annular flange received within an annular notch of the septum (septum 112 is inserted through the opening and a notch between portions 114 and 118 of the septum receives the annular flange, Fig 11) in order to secure the septum to the lid body (Col. 6, line 35-38--the lower flange 114 and upper portion 118 securely hold the sealing element 112 within shield 111).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the lid body of Ivosevic to comprise an annular flange defining an opening and the septum to include an annular notch as taught by Burns in order to predictably improve safety and security of the device by allowing for a secure placement of the septum in the lid body which would enable the device to be sealed to prevent spills immediately upon withdrawal of a needle from the container.
Claim(s) 1, 9-15, 27, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furrer (US 20150224497 A1) in view of Fedoruk.
Regarding claim 1, Furrer discloses a sample collection container (sample collection tube 100) configured to be removably mounted to a blood collection device (Paragraph 0006, 0042, 0048, 0050), the collection container comprising:
a container body (Body formed by closed end 12, sidewall 20, and open end 11 with closure base portion 31; Fig. 1) defining an interior (Inner space 40, Fig. 2c-d) configured to receive a sample provided from the blood collection device (paragraph 0051, 0055—for collecting a body fluid sample), the container body comprising an upper portion (portion of the tube closest to the open end 11, Fig. 1) comprising an open top (open end 11, Fig. 2d) and a lower portion (Portion closest to closed end 12, Fig. 1) comprising a closed bottom (closed end 12, Fig. 1); and
a lid (Cap portion 32, elastomeric material 33, hinges 34, stop element 35, counter element 36, Figs. 2a-2d) comprising:
a lid body (Cap portion 32, Figs. 2a-2d);
a flexible connection connected between the lid body and the upper portion of the container body at a second radial position opposite the first radial position (Hinges 34) that moves the lid between a closed position (Paragraphs 0052-0056), in which the lid covers the open top of the upper portion (Fig. 2a and 2c demonstrate the closed position), and an open position, where the open top of the upper portion is uncovered (Fig. 2a and 2d demonstrate the open position of the lid);
a pierceable septum mounted to the lid body (elastomeric material 33) that seals the upper portion open top when the lid is in the closed position (Paragraph 0052, 0055-- The upper part of the elastomeric material 33 is accessible from the outside through an opening of the cap portion 32 such that a needle (not shown) can pierce the elastomeric material 33 while the tube 100 is still closed…enables piercing with minimal force for collecting a body fluid sample through the cap portion 32 when the tube 100 is closed); and
However, Furrer fails to disclose the upper portion comprising a catch extending radially outwardly from a sidewall of the upper portion at a first radial position, the flexible connection at a second radial position opposite the first radial position, and a latch extending from the lid body comprising a frame comprising an opening configured to receive the catch on the upper portion of the container body with a portion of the catch protruding through the opening to secure the lid in the closed position.
Fedoruk, in the same field of endeavor of a collection container for securely collecting a bodily fluid such as blood, teaches a sample collection container (cup body 210, Fig 5; paragraphs 0067-0069) comprising an upper portion comprising an open top and a catch (locking hook 230) extending radially outwardly from a sidewall of the upper portion at a first radial position (Position of locking hook 230 at one side of the container open end, Fig. 5-7) and comprising a lid (lid 220, Fig 5) connected by a flexible connection (living hinge 230 connects lid 220 and body 210, Fig 5; paragraph 0068) at a second radial position opposite the first radial position (Living hinge 230 which connects the lid to the container at an opposite side of the open end from the locking hook 230, Figs. 5-7), further comprising a latch extending from the lid body (locking latch 240, Fig 5; paragraph 0071) comprising a frame (Locking latch 240 comprises a frame formed by side portions 250) comprising an opening (Center portion 253/hole 252) configured to receive the catch on the upper portion of the container body with a portion of the catch protruding through the opening (locking latch 240 engages locking hook 230 on the upper portion of container 210, Fig 5-7; paragraph 0071-- The center portion 253 of the latch 240 is open to allow for reception of the hook 230 when the lid 220 is closed) in order to secure the lid in the closed position (paragraph 0072-- Once the lid 220 is closed, the receptacle 200 is locked using a lock tag 260).
It would have been obvious to one having ordinary skill in the art to modify the lid of Furrer to further comprise a catch and latch as taught by Fedoruk in order to predictably improve the safety and security of the collected sample by locking the lid in the closed position and preventing spills or contamination.
Regarding claim 9, the combination of Furrer and Fedoruk teaches the collection container of claim 1. Furrer additionally teaches wherein the septum comprises an inwardly facing surface that faces the interior of the container body (See lower face of the elastomeric material 33 in Fig. 2c) and an outwardly facing surface opposite the inwardly facing surface (See upper face of elastomeric material 33 in Fig. 2c), the outwardly facing surface comprising a recess or well (The upper/outwardly facing surface is shaped like a well, Fig. 2c) positioned to collect any fluid that escapes from the interior of the container body during retraction of a needle through the septum (Paragraph 0055—bi-concave shape with a thinner region in the center and a thicker region at the edges).
Regarding claim 10, the combination of Furrer and Fedoruk teaches the collection container of claim 1. Furrer additionally discloses wherein the lid body comprises an annular flange defining an opening and wherein the septum is inserted through the opening with the annular flange received within an annular notch of the septum (See Fig. 2c-2d which shows an annular flange of the lid 32 received within an annular notch of the septum, indicated by the shaded area of the lid 32 which appears to fit beneath the ‘rim’ of the elastomeric material 33).
Regarding claim 11, the combination of Furrer and Fedoruk teaches the collection container of claim 1. Furrer additionally teaches wherein the septum comprises an inwardly facing surface that faces the interior of the container body when the lid is in the closed position (see Fig. 2c for the inwardly facing surface of elastomeric material 33 facing the interior of the container body), the inwardly facing surface of the septum comprising a chamfered peripheral edge (see Fig. 2b the inwardly facing surface of the elastomeric material 33 includes a chamfered peripheral edge).
Regarding claim 12, the combination of Furrer and Fedoruk teaches the collection container of claim 11. Furrer additionally teaches wherein the inwardly facing surface of the septum defines a central cavity, which enhances radial deformation of the septum during centrifugation (see central cavity of inwardly facing surface of elastomeric material 33 in Figs.23c-d).
Regarding claim 13, the combination of Furrer and Fedoruk teaches the collection container of claim 12. Furrer additionally teaches wherein the central cavity comprises a tapered annular surface (Tapered annular surface of the cavity formed by inwardly facing surface of elastomeric material 33 in Figs. 2c-d).
Regarding claim 14, the combination of Furrer and Fedoruk teaches the collection container of claim 12. Furrer additionally teaches wherein the upper portion open top comprises an annular chamfered edge (see annular chamfered edge of open top in Fig. 2b) positioned to contact a chamfered peripheral edge of the septum as the lid moves to the closed position (see transition between open and closed positions, Figs. 2b-2c).
Regarding claim 15, the combination of Furrer and Fedoruk teaches the collection container of claim 14. Furrer additionally teaches wherein the annular chamfered edge of the upper portion deforms the septum when the lid is in the closed position, thereby sealing the interior of the container body (paragraph 0055--the elastomeric material 33 is shaped as a disc with circular shape and having a diameter, which is slightly larger than the diameter of the inner wall 21, and that can be squeezed such as to form-fit in a gas-tight manner into the open end 11; Fig. 2c).
Regarding claim 27, the combination of Furrer and Fedoruk teaches the collection container of claim 14. Furrer additionally teaches wherein the flexible connection comprises a hinge (Hinges 34; paragraph 0052-0054).
Regarding claim 38, the combination of Furrer and Fedoruk teaches the collection container of claim 14. Fedoruk additionally teaches wherein the catch comprises opposing axial walls extending from the sidewall of the upper portion (each side of locking hook 230 may be considered an axial wall of the hook which are on opposing sides of the hook and extend from the sidewall of the upper portion, Fig. 5-7) and wherein the opening of the frame is a square or rectangular shaped opening sized to receive the opposing axial walls of the catch (Shape of the opening/hole 252/253 is rectangular or square, see Fig. 5 and 7).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 17, the prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “wherein the upper portion is configured to be press fit over the axial retention protrusion of the lower portion thereby attaching the upper portion to the lower portion and, when fully seated together, rotation of the upper portion relative to the lower portion pushes the upper portion axially away from the lower portion and beyond the axial retention protrusion thereby facilitating release of the upper portion from the lower portion; and a lid comprising: a lid body”.
While Smith (US 20030034323 A1) teaches a collection container (container comprising closure 20 and container 22, Fig 5), wherein the lower portion (container 22) comprising an axial retention protrusion (Neck 26), and wherein the lower portion of the container body and the upper portion of the container body are separable and removably attached together (paragraph 0036-- the dispensing system 20 (NOTE: comprising the upper portion, closure body 30) is a separate one-piece or multi-piece unit (e.g., a closure) which is adapted to be removably or non-removably mounted to a previously manufactured container 20 (equivalent to a lower portion) which has an opening 28 to the container interior), Smith teaches that the upper portion may be either press fit or configured such that rotation of the upper portion relative to the lower portion pushes the upper portion axially away from the lower portion (e.g., by unscrewing of threaded portions). Furthermore, Smith teaches away from the configuration facilitating release of the upper and lower portion and instead discloses that the configuration of the elements should serve to discourage separation of the components (Paragraph 0051--If the user attempts to unscrew the closure body 30 with a sufficient amount of torque, then the tamper-evident band 100 will separate from the bottom of the closure body skirt 90. This will serve as an indication that the closure body 30 has been unscrewed, at least partially, from the fully assembled configuration).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the container of Ivosevic to include separable upper and lower portions such that the container includes a lower portion open top, and a lower portion annular sidewall extending therebetween, and wherein the upper portion of the container body comprises an upper portion open bottom inserted over the lower portion open top of the container body, the upper portion open top, and an upper portion annular sidewall extending therebetween as taught by Smith in order to predictably improve the versatility of the container by permitting, for instance, the connection of differently sized lower portions in order to enable the upper portion including the lid and flexible connection to be utilized for different volumes of collection.
The other pertinent prior art of the record, Ivosevic, Furrer, Fedoruk, and Bartfeld fail to disclose or suggest any configuration of a lower portion of the container body and the upper portion of the container body are separable and removably attached together.
For this reason, claims 17 and 19-26 are indicated as allowable.
Response to Arguments
Applicant’s arguments, see pages of applicant’s remarks, filed 18 June 2026, with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered and are partially persuasive.
Regarding the arguments with respect to the rejection of independent claim 1, the rejection of the claim in view of Ivosevic and Fedoruk (acknowledged on page 8 of the remarks) has been updated and maintained and a new rejection in view of Furrer has additionally been provided. As no particular argument has been presented beyond generally asserting that the rejection is traversed for failing to disclose all of the elements of the claims, it is simply noted that each limitation of the claim is disclosed by Ivosevic, Fedoruk, and Bartfeld in combination as described above in this action. The examiner finds the arguments that Bartfeld and Belfance do not sufficiently disclose the claimed features of the latch and catch as amended persuasive and as such Bartfeld and Belfance are no longer relied upon to disclose the argued elements.
Regarding the arguments with respect to the rejection of independent claim 17, the arguments are found persuasive and the rejection of the claim and its dependents is withdrawn.
Regarding the arguments with respect to new claim 38, the arguments are moot as Fedoruk has been used to teach the limitations of the claim rather than Bartfeld, which the applicant has argued against.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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