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 .
Claim Status
Claims 1-10, 12-14, 16-22 and 24-40 are pending in the current application. Claims 38-40 have been withdrawn.
Claim Interpretation
Regarding limitations recited in Claim 1 which are directed to a manner of operating disclosed reactor, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. In line 2, “bioprocess” is an intended use limitation. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.
With regard to Claim 25, MPEP 2111.02(II) states “the claim preamble must be read in the context of the entire claim. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” Therefore, the limitation of “in a chromatography system” in the preamble of Claim 25 is not given patentable weight.
In regard to the claim limitations “when locked” (claim 1, claim 16, claim 25) the Examiner notes that this is a conditional limitation and the preceding limitation is only required when the system is locked; in the situation where the system is unlocked this limitation is not required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 8, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718) in view of Maunder (US 2011/0089683).
With regard to Claims 1, 2, and 15, Blomberg discloses an automated fluid handling system comprising a housing and two or more fluid handling units arranged as interchangeable modular components with an external fluidics section (Abstract). Blomberg discloses a chromatography system comprising plural fluid handling components fluidically interconnected by fluid tubing to form a fluid flow path, said fluid handling components comprising one or more fluid ports (Figure 10, C8/L43-56, Figure 10 shows an embodiment of a fluidic interconnection arrangement with tubing arranged to interconnect the different component modules of the system).
However, Blomberg is silent to the one or more fluid ports comprising a spigot extending from a face and having an open end (capable of receiving a respective end of the fluid tubing) surrounded by a respective end of the fluid tubing such that the fluid tubing end sealingly embraces the spigot and a releasable locking clamp surrounding the respective end of the fluid tubing applying a radial locking force on an outer surface of the tubing end, locking the end of the fluid tubing on the spigot, wherein the radial locking force is generated by a movement of the releasable locking clamp along the fluid tubing towards the fluid handling component such that the releaseable locking clamp contacts the face of the fluid handling component when locked (Claim 1), wherein the spigot comprises a sealing ridge in close proximity to the open end such that the end of the fluid tubing having an inner wall creates a direct pocket-less seal between the tubing inner wall and the sealing ridge of the spigot, wherein at least two of said fluid handling component comprise respective spigots, said fluid tubing comprising releasable locking clamps respectively provided at each end thereof for attaching the fluid tubing to the spigots so as to fluidically interconnect the fluid handling components (Claim 15).
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Maunder discloses a retaining clamp for retaining a tube on a barbed connector (Abstract). As shown in Figure 5, tube 6 is connected to barbed connector 8 with barb 32 (spigot extending from a component face and for receiving a respective end of the fluid tubing such that the fluid tubing end sealingly embraces the spigot) ([0029]-[0034]). The barb has a sealing ridge such that the fluid tubing end creates a direct seal between the tubing inner wall and the sealing ridge (Figure 5); creates a direct pocket-less seal between the inner wall and sealing ridge (Figure 5). Fluid connections in the food, medical and pharmaceutical industries are commonly made with flanged connectors clamped to each other, and the connectors have hollow spigots to which the tube is connected ([0005]).
Maunder discloses a spigot for receiving a releasable locking clamp for applying a radial locking force on an outer surface of the tubing end for locking the end of the fluid tubing on the spigot, wherein the radial locking force is generated by a movement of the releasable locking clamp along the fluid tubing towards the fluid handling component such that the releaseable locking clamp contacts the face of the fluid handling component when locked (Figure 5, [0029]-[0036], retainer (locking clamp) comprises collet 2 and sleeve 4; the sleeve fits over the collet by movement along the fluid tubing). Maunder teaches the fluid handling component such that the releaseable locking clamp contacts the face of the fluid handling component when locked (Figure 5, [0029]-[0036], retainer (locking clamp) comprises collet 2 and sleeve 4); this limitation is only required in the condition when locked, when the system is not locked this limitation is not required. The object of the invention is to provide an improved retainer for retaining a tube on a barbed connector (Abstract, [0009]). It would be obvious to one of ordinary skill in the art to make the locking clamp releasable in order to remove the tubing from the spigot and reuse the locking clamp and the spigot, thus reducing costs and waste.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the one or more fluid ports of Blomberg to comprise a spigot extending from a component face and having an open end surrounded by a respective end of the fluid tubing such that the fluid tubing end sealingly embraces the spigot and a releasable locking clamp surrounding the respective end of the fluid tubing applying a radial locking force on an outer surface of the tubing end, locking the end of the fluid tubing on the spigot, wherein the radial locking force is generated by a movement of the releasable locking clamp along the fluid tubing towards the fluid handling component such that the releasable locking clamp contacts the face of the fluid handling component when locked (Claim 1), wherein the spigot comprises a sealing ridge (Claim 11), wherein at least two of said fluid handling component comprise respective spigots, said fluid tubing comprising releasable locking clamps respectively provided at each end thereof for attaching the fluid tubing to the spigots so as to fluidically interconnect the fluid handling components (Claim 15), as taught by Maunder, in order to seal fluid tubing to a spigot via a locking clamp, as is common in the art.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the locking clamp to be releasable, in order to remove the tubing from the spigot and reuse the locking clamp and the spigot, thus reducing costs and waste.
However, modified Blomberg is silent to wherein a resulting interconnection withstands at least 10 bar.
Blomberg discloses that the maximum operating pressure of the system pumps is about 20 mPa, which is about 200 bar (C3/L5-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the resulting interconnection of modified Blomberg withstands at least 10 bar, as taught by Blomberg, in order for the spigot and tubing interconnection to be pressurizable up to 30 bar while the interconnection seal is maintained, since the system of Blomberg operates within this range.
With regard to Claims 3 and 8, modified Blomberg is silent to wherein the releasable locking clamp comprises a cylindrical inner component configured to accept fluid tubing therein, said inner component including a resiliently deflectable portion arranged to urge the outer surface of the respective end of the fluid tubing around the respective spigot (Claim 3), wherein the resiliently deflectable portion of the cylindrical inner component includes plural circumferentially arranged fingers which are deflectable inwardly in use (Claim 8); and a cylindrical collar element having an internal through-aperture configured to accept the inner component, the internal through-aperture and resiliently deflectable portion having complementary surface formations which in a first position of the cylindrical collar element mounted to the inner component provide said resilient deflection in use, and which in a second different position do not cause said deflection, wherein in the first position, the cylindrical collar element is on the end of the fluid tubing.
Maunder discloses the releasable locking clamp comprises a cylindrical inner component for accepting fluid tubing, said inner component comprising a resiliently deflectable portion arranged to urge an outer surface of the fluid tubing toward a respective spigot (Claim 3), wherein the resiliently deflectable portion of the inner component includes plural circumferentially arranged fingers which are deflectable inwardly in use (Claim 8) (Figure 5, [0034], Abstract, collet 2 (cylindrical inner component) comprises fingers with inward projections 18 (resiliently deflectable portion) which urge the tube against the connector behind the barb (arranged to urge an outer surface of the fluid tubing toward the spigot)).
Maunder discloses a cylindrical collar element having an internal through-aperture for slideably accepting the inner component, the aperture and resiliently deflectable portion having complementary surface formations which in a first position of the collar element mounted to the inner component provide for said resilient deflection in use, and which in a second different position do not cause said deflection (Figure 5, [0029]-[0034], sleeve 4 (cylindrical collar element) has an internal through-aperture for slideably accepting the collet 2 (cylindrical inner component), the sleeve 4 comprising inward projections 28 which are designed to mate with the projections 19 of the collet 2 and lock the collet and sleeve together, urging the fingers of the collet inwards and together (the aperture and resiliently deflectable portion having complementary surface formations which in a first position of the collar element mounted to the inner component provide for said resilient deflection in use; wherein the radial locking force is generated by a movement of the releasable locking clamp along the fluid tubing towards the fluid handling component); when the projections of the sleeve and collet are not locked together, the sleeve and collet are in the second position (and which in a second different position do not cause said deflection)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the releasable locking clamp of modified Blomberg comprises a cylindrical inner component configured to accept fluid tubing therein, said inner component including a resiliently deflectable portion arranged to urge the outer surface of the respective end of the fluid tubing around the respective spigot (Claim 3), wherein the resiliently deflectable portion of the cylindrical inner component includes plural circumferentially arranged fingers which are deflectable inwardly in use (Claim 8) and a cylindrical collar element having an internal through-aperture configured to accept the inner component, the internal through-aperture and resiliently deflectable portion having complementary surface formations which in a first position of the cylindrical collar element mounted to the inner component provide said resilient deflection in use, and which in a second different position do not cause said deflection, wherein in the first position, the cylindrical collar element is on the end of the fluid tubing, as taught by Maunder, in order to retain a fluid tubing on a spigot.
With regard to Claims 4 and 5, modified Blomberg is silent to wherein the cylindrical inner component further includes a stop portion co-operable with the cylindrical collar element to prevent or inhibit the movement of the cylindrical collar element off the inner component in at least one direction (Claim 4), wherein said cylindrical collar element is slideable on the cylindrical inner component from said first position where said deflection is provided, to the second position where said cylindrical collar element abuts the stop portion (Claim 5).
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Maunder discloses in a separate embodiment that an additional projection 140 (stop portion) is provided on the outside of the annular ring of the collet 102, which can be used to hold the collet and sleeve together (Figure 6, [0043]). As shown on Figure 6 the sleeve is slideable between a first position where the projections 119 are located to a second position where the sleeve abuts the stop portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the cylindrical inner component of modified Blomberg further includes a stop portion co-operable with the cylindrical collar element to prevent or inhibit the movement of the cylindrical collar element off the inner component in at least one direction (Claim 4), wherein said cylindrical collar element is slideable on the cylindrical inner component from said first position where said deflection is provided, to the second position where said cylindrical collar element abuts the stop portion (Claim 5), as taught by Maunder, in order to hold the collar element and cylindrical inner component together.
With regard to Claim 10, modified Blomberg is silent to wherein the fluid tubing has a resting size of an inner diameter that is less than +/- 10% of an outer diameter of the spigot.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the fluid tubing has a resting size of an inner diameter that is less than +/- 10% of an outer diameter of the spigot, so that the fluid tubing can form a seal on the spigot.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718) in view of Maunder (US 2011/0089683), as applied to the claims above, and in further view of Lombardi, III et al (US 2015/0076815).
With regard to Claim 6, modified Blomberg discloses all the limitations in the claims as set forth above. However, modified Blomberg is silent to the releasable locking clamp being characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions.
Maunder discloses that the sleeve 4 (cylindrical collar element) is essentially cylindrical in shape ([0031], Figure 4) (i.e., with no sudden changes in direction).
Furthermore, Lombardi, III et al (Lombardi) discloses a quick connect fluid conduit connector including male and female connector components that releasably engage with each other to fluidically connect two fluid conduits (Abstract). Lombardi teaches that a user may readily grasp the male connector component at a grip flange (projection) in order to move the male connector component towards and away from engagement with the female connector component ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the releasable locking clamp of modified Blomberg to be characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions, as taught by Maunder and Lombardi, in order for a user to be able to move the sleeve (cylindrical collar element) towards and away from the collet (cylindrical inner component).
However, modified Blomberg is silent to wherein the projection is formed at one end of the cylindrical collar element, wherein the stop portion is formed at one end of the cylindrical inner component, wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the cylindrical collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion.
The projection of modified Blomberg can be placed on the sleeve (cylindrical collar element) in any position and still be used to manually manipulate the cylindrical collar element between the first and second position. Therefore, the placement of the projection is not critical and can be placed wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the projection of modified Blomberg is formed at one end of the cylindrical collar element, wherein the stop portion is formed at one end of the cylindrical inner component, wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the cylindrical collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion, since the projection can be placed on the sleeve (cylindrical collar element) in any position and still be used to manually manipulate the cylindrical collar element between the first and second position.
With regard to Claim 7, modified Blomberg discloses all the limitations in the claims as set forth above. However, modified Blomberg is silent to wherein the releasable locking clamp is characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions, wherein the projection and an outer surface of the cylindrical collar element on which the projection is formed has a continuously curved profile with no sudden changes in direction.
Maunder discloses that the sleeve 4 (cylindrical collar element) is essentially cylindrical in shape ([0031], Figure 4) (i.e., with no sudden changes in direction).
Furthermore, Lombardi, III et al (Lombardi) discloses a quick connect fluid conduit connector including male and female connector components that releasably engage with each other to fluidically connect two fluid conduits (Abstract). Lombardi teaches that a user may readily grasp the male connector component at a grip flange in order to move the male connector component towards and away from engagement with the female connector component ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the releasable locking clamp is characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions, wherein the projection and an outer surface of the cylindrical collar element on which the projection is formed has a continuously curved profile with no sudden changes in direction, as taught by Maunder and Lombardi, in order for a user to be able to move the sleeve (cylindrical collar element) towards and away from the collet (cylindrical inner component).
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718) in view of Maunder (US 2011/0089683), as applied to the claims above, and in further view of Roose et al (US 2015/0290610), Zacharias (US 2008/0319451), or Yoo (US 2008/0183156).
With regard to Claim 9, modified Blomberg discloses all the limitations in the claims as set forth above. However, modified Blomberg is silent to wherein the fluid tubing has an outside diameter of around 3 to 10 mm.
Such fluid tubing is well known across arts. Roose discloses flexible PVC tubing with an internal diameter of 3.2 mm and outer diameter of 4.8 mm ([0151]). Zacharias discloses silicone tubing having 3.2 mm ID and 4.8 mm OD ([0081]). Yoo discloses that drainage tubes can have an outer diameter of 4.8 mm and an inner diameter of 3.2 mm ([0024]).
Furthermore, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the fluid tubing has an outside diameter of around 3 to 10 mm, as taught by Roose, Zacharias, or Yoo, since where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
With regard to Claim 12, modified Blomberg discloses all the limitations in the claims as set forth above.
However, modified Blomberg is silent to wherein the fluid tubing has an inner diameter of 3.2 mm and an outer diameter of 4.8 mm, and the spigot has a base diameter of 3.25 mm and the sealing ridge a diameter of 3.45 mm.
Such fluid tubing is well known across arts. Roose discloses flexible PVC tubing with an internal diameter of 3.2 mm and outer diameter of 4.8 mm ([0151]). Zacharias discloses silicone tubing having 3.2 mm ID and 4.8 mm OD ([0081]). Yoo discloses that drainage tubes can have an outer diameter of 4.8 mm and an inner diameter of 3.2 mm ([0024]).
Furthermore, with regard to both the fluid tubing and spigot dimensions, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
Finally, it would be obvious for the sealing ridge of the spigot to be wide enough for the fluid tubing to form a seal around the sealing ridge, but not too wide such that the fluid tubing would not be able to fit over the sealing ridge.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the fluid tubing has an inner diameter of 3.2 mm and an outer diameter of 4.8 mm, and the spigot has a base diameter of 3.25 mm and the sealing ridge a diameter of 3.45 mm, as taught by Roose, Zacharias, or Yoo, in order for the fluid tubing to form a seal with the sealing ridge of the spigot, and since where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718) in view of Maunder (US 2011/0089683), as applied to the claims above, and in further view of Graham et al (US 2016/0305586).
With regard to Claims 13 and 14, modified Blomberg discloses all the limitations in the claims as set forth above. However, modified Blomberg is silent to wherein the fluid tubing is formed of a substantially rigid material (Claim 13), wherein the substantially rigid material comprises Fluorinated EtenPropen (FEP) plastic (Claim 14).
Graham et al (Graham) discloses a manifold assembly has a manifold and can be located between a block and a plate, and serve as a stator for a valve or other component (Abstract). Graham discloses that the stator for a valve may be part of a liquid chromatography system ([0034]), and that associated tubing may be made from fluorinated ethylene propylene (FEP), among other choices, which are biocompatible ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the fluid tubing is formed of a substantially rigid material (Claim 13), wherein the substantially rigid material comprises Fluorinated EtenPropen (FEP) plastic (Claim 14), as taught by Graham, for biocompatible applications in the chromatography system of modified Blomberg.
Claims 16-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kronholm et al (US 2015/0158736) in view of Maunder (US 2011/0089683) and Blomberg (US 8,821,718).
With regard to Claims 16, Kronholm et al (Kronholm) discloses methods, techniques, and processes for enhancing the purity of a mixed rare earth solution (Abstract). Kronholm discloses a chromatography column comprising at least one spigot (Figure 3, [0104], two columns were used in the experiments performed, the columns including ground glass joints on both ends with ground glass adapters with 7 mm barbed hose fittings attached to these). Kronholm discloses that the spigot is a barbed hose fitting ([0104]). The barbs on the hose fitting are inherently sealing ridges.
However, Kronholm is silent to the chromatography column comprising at least one releasable coupling, said spigot having an open end surrounded by a respective end of a fluid tubing such that the fluid tubing end sealingly embraces the spigot, and said releasable coupling comprising a releasable locking clamp applying a radial locking force on an outer surface of the fluid tubing end, locking the end of the fluid tubing on the spigot, resulting in an interconnection, wherein the radial locking force is generated by a movement of the releasable locking clamp along the fluid tubing towards the fluid handling component such that the releasable locking clamp contacts the face of the fluid handling component when locked, a direct pocket-less seal between the tubing inner wall and the sealing ridge of the spigot.
Maunder discloses a retaining clamp for retaining a tube on a barbed connector (Abstract). As shown in Figure 5, tube 6 is connected to barbed connector 8 with barb 32 (spigot extending from a component face and for receiving a respective end of the fluid tubing such that the fluid tubing end sealingly embraces the spigot) ([0029]-[0034]). The barb has a sealing ridge such that the fluid tubing end creates a direct seal between the tubing inner wall and the sealing ridge (Figure 5); such that the end of the fluid tubing having an inner wall creates a direct pocket-less seal between the inner tubing wall and the sealing ridge of the spigot (Figure 5). Fluid connections in the food, medical and pharmaceutical industries are commonly made with flanged connectors clamped to each other, and the connectors have hollow spigots to which the tube is connected ([0005]).
Maunder discloses a spigot, extending from at least one face of the chromatography column, for receiving a releasable locking clamp for applying a radial locking force on an outer surface of the tubing end for locking the end of the fluid tubing on the spigot, wherein the radial locking force is generated by a movement of the releasable locking clamp along the fluid tubing towards the face of the fluid handling component (Figure 5, [0029]-[0036], retainer (locking clamp) comprises collet 2 and sleeve 4). Maunder teaches the fluid handling component such that the releaseable locking clamp contacts the face of the fluid handling component when locked (Figure 5, [0029]-[0036], retainer (locking clamp) comprises collet 2 and sleeve 4); this limitation is only required in the condition when locked, when the system is not locked this limitation is not required. The object of the invention is to provide an improved retainer for retaining a tube on a barbed connector (Abstract, [0009]). It would be obvious to one of ordinary skill in the art to make the locking clamp releasable in order to remove the tubing from the spigot and reuse the locking clamp and the spigot, thus reducing costs and waste.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the chromatography column of Kronholm to comprise at least one releasable coupling, said spigot having an open end surrounded by a respective end of a fluid tubing such that the fluid tubing end sealingly embraces the spigot, and said releasable coupling comprising a releasable locking clamp applying a radial locking force on an outer surface of the fluid tubing end, locking the end of the fluid tubing on the spigot, resulting in an interconnection, wherein the radial locking force is generated by a movement of the releasable locking clamp along the fluid tubing towards the face of the fluid handling component, as taught by Maunder, in order to seal fluid tubing to a spigot via a locking clamp, as is common in the art.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the locking clamp to be releasable, in order to remove the tubing from the spigot and reuse the locking clamp and the spigot, thus reducing costs and waste.
However, modified Kronholm is silent to wherein the interconnection withstands at least 10 bar.
Blomberg discloses an automated fluid handling system comprising a housing and two or more fluid handling units arranged as interchangeable modular components with an external fluidics section (Abstract). Blomberg discloses that the maximum operating pressure of the system pumps is about 20 mPa, which is about 200 bar (C3/L5-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the interconnection of modified Kronholm withstands at least 10 bar, as taught by Blomberg, in order for the spigot and tubing interconnection to be pressurizable up to at least 10 bar while the interconnection seal is maintained, since the chromatography systems typically operate within this range.
With regard to Claims 17 and 22, modified Kronholm is silent to wherein the releasable coupling comprises a cylindrical inner component configured to accept a fluid tube therein, said inner component including a resiliently deflectable portion arranged to urge the outer surface of the respective end of the fluid tube around the respective spigot (Claim 17), wherein the resiliently deflectable portion of the cylindrical inner component includes plural circumferentially arranged fingers which are deflectable inwardly in use (Claim 22); and a cylindrical collar element having an internal through-aperture configured to accept the inner component, the internal through-aperture and the resiliently-deflectable portion having complementary surface formations which in a first position of the cylindrical collar element mounted to the inner component provide said resilient deflection in use, and which in a second different position do not cause said deflection, wherein in the first position, the cylindrical collar element is on the end of the fluid tubing.
Maunder discloses the releasable locking clamp comprises a cylindrical inner component for accepting fluid tubing, said inner component comprising a resiliently deflectable portion arranged to urge an outer surface of the fluid tubing toward a respective spigot (Claim 17), wherein the resiliently deflectable portion of the inner component includes plural circumferentially arranged fingers which are deflectable inwardly in use (Claim 22) (Figure 5, [0034], Abstract, collet 2 (cylindrical inner component) comprises fingers with inward projections 18 (resiliently deflectable portion) which urge the tube against the connector behind the barb (arranged to urge an outer surface of the fluid tubing toward the spigot)).
Maunder discloses a cylindrical collar element having an internal through-aperture for slideably accepting the inner component, the aperture and resiliently deflectable portion having complementary surface formations which in a first position of the collar element mounted to the inner component provide for said resilient deflection in use, and which in a second different position do not cause said deflection (Figure 5, [0029]-[0034], sleeve 4 (cylindrical collar element) has an internal through-aperture for slideably accepting the collet 2 (cylindrical inner component), the sleeve 4 comprising inward projections 28 which are designed to mate with the projections 19 of the collet 2 and lock the collet and sleeve together, urging the fingers of the collet inwards and together (the aperture and resiliently deflectable portion having complementary surface formations which in a first position of the collar element mounted to the inner component provide for said resilient deflection in use, wherein in the first position, the cylindrical collar element is on the end of the fluid tubing); when the projections of the sleeve and collet are not locked together, the sleeve and collet are in the second position (and which in a second different position do not cause said deflection)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for to wherein the releasable coupling of modified Kronholm comprises a cylindrical inner component configured to accept a fluid tube therein, said inner component including a resiliently deflectable portion arranged to urge the outer surface of the respective end of the fluid tube around the respective spigot (Claim 17), wherein the resiliently deflectable portion of the cylindrical inner component includes plural circumferentially arranged fingers which are deflectable inwardly in use (Claim 22); and a cylindrical collar element having an internal through-aperture configured to accept the inner component, the internal through-aperture and the resiliently-deflectable portion having complementary surface formations which in a first position of the cylindrical collar element mounted to the inner component provide said resilient deflection in use, and which in a second different position do not cause said deflection, wherein in the first position, the cylindrical collar element is on the end of the fluid tubing, as taught by Maunder, in order to retain a fluid tubing on a spigot.
With regard to Claims 18 and 19, modified Kronholm is silent to wherein the cylindrical inner component further includes a stop portion co-operable with the collar element to prevent or inhibit the movement of the cylindrical collar element off the cylindrical inner component in at least one direction (Claim 18), wherein said cylindrical collar element is slideable on the cylindrical inner component from said first position where said deflection is provided, to the second position where said cylindrical collar element abuts the stop portion (Claim 19).
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Maunder discloses in a separate embodiment that an additional projection 140 (stop portion) is provided on the outside of the annular ring of the collet 102, which can be used to hold the collet and sleeve together (Figure 6, [0043]). As shown on Figure 6 the sleeve is slideable between a first position where the projections 119 are located to a second position where the sleeve abuts the stop portion.
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention for wherein the cylindrical inner component of modified Kronholm further includes a stop portion co-operable with the collar element to prevent or inhibit the movement of the cylindrical collar element off the cylindrical inner component in at least one direction (Claim 18), wherein said cylindrical collar element is slideable on the cylindrical inner component from said first position where said deflection is provided, to the second position where said cylindrical collar element abuts the stop portion (Claim 19), as taught by Maunder, in order to hold the collar element and cylindrical inner component together.
With regard to Claim 24, Kronholm discloses that the barbed hose fitting in 7 mm ([0104]).
However, modified Kronholm is silent to wherein the spigot has a base diameter of 3.25 mm and/or the sealing ridge has a diameter of 3.45 mm.
With regard to both the spigot base diameter and sealing ridge diameter, the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the spigot of modified Kronholm has a base diameter of 3.25 mm and/or the sealing ridge has a diameter of 3.45 mm, since where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kronholm et al (US 2015/0158736) in view of Maunder (US 2011/0089683) and Blomberg (US 8,821,718), as applied to the claims above, and in further view of Lombardi, III et al (US 2015/0076815).
With regard to Claim 20, modified Kronholm discloses all the limitations in the claims as set forth above.
However, modified Kronholm is silent to the releasable locking clamp being characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions.
Maunder discloses that the sleeve 4 (cylindrical collar element) is essentially cylindrical in shape ([0031], Figure 4) (i.e., with no sudden changes in direction).
Furthermore, Lombardi, III et al (Lombardi) discloses a quick connect fluid conduit connector including male and female connector components that releasably engage with each other to fluidically connect two fluid conduits (Abstract). Lombardi teaches that a user may readily grasp the male connector component at a grip flange (projection) in order to move the male connector component towards and away from engagement with the female connector component ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the releasable locking clamp of modified Kronholm to be characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions, as taught by Maunder and Lombardi, in order for a user to be able to move the sleeve (cylindrical collar element) towards and away from the collet (cylindrical inner component).
However, modified Kronholm is silent to wherein the projection is formed at one end of the cylindrical collar element, wherein the stop portion is formed at one end of the cylindrical inner component, wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the cylindrical collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion.
The projection of modified Kronholm can be placed on the sleeve (cylindrical collar element) in any position and still be used to manually manipulate the cylindrical collar element between the first and second position. Therefore, the placement of the projection is not critical and can be placed wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the projection of modified Kronholm is formed at one end of the cylindrical collar element, wherein the stop portion is formed at one end of the cylindrical inner component, wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the cylindrical collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion, since the projection can be placed on the sleeve (cylindrical collar element) in any position and still be used to manually manipulate the cylindrical collar element between the first and second position.
With regard to Claim 21, modified Kronholm discloses all the limitations in the claims as set forth above. However, modified Kronholm is silent to wherein the releasable locking clamp is characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions, wherein the projection and an outer surface of the cylindrical collar element on which the projection is formed has a continuously curved profile with no sudden changes in direction.
Maunder discloses that the sleeve 4 (cylindrical collar element) is essentially cylindrical in shape ([0031], Figure 4) (i.e., with no sudden changes in direction).
Furthermore, Lombardi, III et al (Lombardi) discloses a quick connect fluid conduit connector including male and female connector components that releasably engage with each other to fluidically connect two fluid conduits (Abstract). Lombardi teaches that a user may readily grasp the male connector component at a grip flange in order to move the male connector component towards and away from engagement with the female connector component ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the releasable locking clamp of modified Kronholm is characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions, wherein the projection and an outer surface of the cylindrical collar element on which the projection is formed has a continuously curved profile with no sudden changes in direction, as taught by Maunder and Lombardi, in order for a user to be able to move the sleeve (cylindrical collar element) towards and away from the collet (cylindrical inner component).
Claims 25-27 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Maunder (US 2011/0089683).
With regard to Claims 25, 30, 31, and 32, Maunder discloses a retaining clamp (coupling) for retaining a tube on a barbed connector (male part) (Abstract).
Maunder discloses the coupling comprises a cylindrical inner component configured to accept the fluid tube, said cylindrical inner component including a resiliently deflectable portion arranged to urge an outer surface of an end of the fluid tube around a male part having an open end, creating a radial locking force on the outer surface of the end of the fluid tube (Claim 25), wherein the resiliently deflectable portion of the cylindrical inner component includes plural circumferentially arranged fingers which are deflectable inwardly in use (Claim 30), wherein the fingers extend from a mid portion of the cylindrical inner component to a distal end thereof (Claim 31), wherein the fingers flare outwardly toward the distal end (Claim 32) (Figure 5, [0034], Abstract, collet 2 (cylindrical inner component) comprises fingers with inward projections 18 (resiliently deflectable portion) which urge the tube against the connector behind the barb (arranged to urge an outer surface of the fluid tubing toward the spigot; creating a radial locking force on the outer surface of the end of the fluid tube); as seen in Figure 5, the fingers extend from a mid portion of the cylindrical inner component to a distal end thereof and flare outwardly toward the distal end).
Maunder discloses a cylindrical collar element having an internal through-aperture configured to accept the cylindrical inner component, the internal-through aperture and the resiliently deflectable portion having complementary surface formations which in a first position of the cylindrical collar element mounted to the cylindrical inner component provide for said resilient deflection in use, and which in a second different position do not cause said resilient deflection, wherein in the first position, the cylindrical collar element is on the open end of the fluid tube (Figure 5, [0029]-[0034], sleeve 4 (cylindrical collar element) has an internal through-aperture for slideably accepting the collet 2 (cylindrical inner component), the sleeve 4 comprising inward projections 28 which are designed to mate with the projections 19 of the collet 2 and lock the collet and sleeve together, urging the fingers of the collet inwards and together (the aperture and resiliently deflectable portion having complementary surface formations which in a first position of the collar element mounted to the inner component provide for said resilient deflection in use; wherein in the first position, the cylindrical collar element is on the open end of the fluid tube); when the projections of the sleeve and collet are not locked together, the sleeve and collet are in the second position (and which in a second different position do not cause said deflection)). Maunder teaches the fluid handling component such that the releaseable locking clamp contacts the face of the fluid handling component when locked (Figure 5, [0029]-[0036], retainer (locking clamp) comprises collet 2 and sleeve 4); this limitation is only required in the condition when locked, when the system is not locked this limitation is not required. Maunder teaches the chromatography system comprises plural fluid handling components fluidically interconnected by fluid tubing to form a bioprocess fluid flow path (Figure 5, [0034], Abstract), the male part extending from a face of at least one of the plural fluid handling components of the chromatography system (Figure 5, [0034], Abstract). Maunder teaches a sealing ridge and direct seal (Figure 5).
However, Maunder is silent to the coupling being releasable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the coupling of Maunder to be releasable, in order to remove the tubing from the spigot (male part) and reuse the coupling and the spigot, thus reducing costs and waste.
With regard to Claims 26 and 27, modified Maunder is silent to wherein the cylindrical inner component further includes a stop portion co-operable with the cylindrical collar element to prevent or inhibit the movement of the cylindrical collar element off the cylindrical inner component in at least one direction (Claim 26), wherein said cylindrical collar element is slideable on the cylindrical inner component from said first position where said resilient deflection is provided, to the second position where said cylindrical collar element abuts the stop portion (Claim 27).
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Maunder discloses in a separate embodiment that an additional projection 140 (stop portion) is provided on the outside of the annular ring of the collet 102, which can be used to hold the collet and sleeve together (Figure 6, [0043]). As shown on Figure 6 the sleeve is slideable between a first position where the projections 119 are located to a second position where the sleeve abuts the stop portion.
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention for wherein the cylindrical inner component of Maunder further includes a stop portion co-operable with the cylindrical collar element to prevent or inhibit the movement of the cylindrical collar element off the cylindrical inner component in at least one direction (Claim 26), wherein said cylindrical collar element is slideable on the cylindrical inner component from said first position where said resilient deflection is provided, to the second position where said cylindrical collar element abuts the stop portion (Claim 27), as taught by Maunder, in order to hold the collar element and cylindrical inner component together.
With regard to Claim 33, Maunder discloses that the retainer will be made from polypropylene, but may also be made from any other plastics materials ([0020]).
Furthermore, “formed from two plastics material moldings” is a product-by-process limitation. MPEP § 2113 states that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. Therefore, the structure implied by the process step of “formed from two plastics material moldings” will be considered when assessing patentability of Claim 33. However, the Applicant should note that “the Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). See MPEP § 2113(II).
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Maunder (US 2011/0089683), as applied to the claims above, in view of Lombardi, III et al (US 2015/0076815).
With regard to Claim 28, modified Maunder discloses all the limitations in the claims as set forth above.
However, modified Maunder is silent to the releasable locking clamp being characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions (Claim 28), or wherein the releasable coupling assembly being characterized in that the cylindrical collar element includes a collar flange projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions (Claim 72).
Maunder discloses that the sleeve 4 (cylindrical collar element) is essentially cylindrical in shape ([0031], Figure 4) (i.e., with no sudden changes in direction).
Furthermore, Lombardi, III et al (Lombardi) discloses a quick connect fluid conduit connector including male and female connector components that releasably engage with each other to fluidically connect two fluid conduits (Abstract). Lombardi teaches that a user may readily grasp the male connector component at a grip flange (projection) in order to move the male connector component towards and away from engagement with the female connector component ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the releasable locking clamp of modified Maunder to be characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions (Claim 28) as taught by Maunder and Lombardi, in order for a user to be able to move the sleeve (cylindrical collar element) towards and away from the collet (cylindrical inner component).
However, modified Maunder is silent to wherein the projection is formed at one end of the cylindrical collar element, wherein the stop portion is formed at one end of the cylindrical inner component, wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the cylindrical collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion (Claim 28).
The projection of modified Maunder can be placed on the sleeve (cylindrical collar element) in any position and still be used to manually manipulate the cylindrical collar element between the first and second position. Therefore, the placement of the projection is not critical and can be placed wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the projection of modified Maunder is formed at one end of the cylindrical collar element, wherein the stop portion is formed at one end of the cylindrical inner component, wherein the projection and stop portion can be brought into proximity by manual manipulation to the second position, and wherein the cylindrical collar element can be further moved by manual manipulation to the first position whereat the projection is spaced from the stop portion (Claim 28), since the projection can be placed on the sleeve (cylindrical collar element) in any position and still be used to manually manipulate the cylindrical collar element between the first and second position.
With regard to Claim 29, modified Maunder discloses all the limitations in the claims as set forth above. However, modified Maunder is silent to wherein the releasable locking clamp is characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions, wherein the projection and an outer surface of the cylindrical collar element on which the projection is formed has a continuously curved profile with no sudden changes in direction.
Maunder discloses that the sleeve 4 (cylindrical collar element) is essentially cylindrical in shape ([0031], Figure 4) (i.e., with no sudden changes in direction).
Furthermore, Lombardi, III et al (Lombardi) discloses a quick connect fluid conduit connector including male and female connector components that releasably engage with each other to fluidically connect two fluid conduits (Abstract). Lombardi teaches that a user may readily grasp the male connector component at a grip flange in order to move the male connector component towards and away from engagement with the female connector component ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the releasable locking clamp of modified Maunder is characterized in that the cylindrical collar element includes at least one projection extending outwardly away from the internal through-aperture of a size allowing manual manipulation of the cylindrical collar element between the first and second positions, wherein the projection and an outer surface of the cylindrical collar element on which the projection is formed has a continuously curved profile with no sudden changes in direction, as taught by Maunder and Lombardi, in order for a user to be able to move the sleeve (cylindrical collar element) towards and away from the collet (cylindrical inner component).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Maunder (US 2011/0089683), as applied to the claims above, in view of Hofmann (US 2015/0360145).
With regard to Claim 34, modified Maunder discloses all the limitations in the claims as set forth above.
However, modified Maunder is silent to wherein the cylindrical inner component and the cylindrical collar element are formed from transparent plastics.
Hofmann discloses a chromatography apparatus and methods, especially for expanded bed adsorption (Abstract). Hofman discloses that transparent plastics for column tubes are preferred in some processes for visual monitoring ([0038]). Such a rationale would also be applicable for the retainer of Maunder in order for a user to see through the retainer and visually inspect that the tubing is sealed against the spigot (male part).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the cylindrical inner component and the cylindrical collar element of modified Maunder are formed from transparent plastics, as taught by Hofman, in order for a user to see through the retainer and visually inspect that the tubing is sealed against the spigot (male part).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Maunder (US 2011/0089683), as applied to the claims above, in view of Rhinehart (US 2016/0158519).
With regard to Claim 35, modified Maunder discloses all the limitations in the claims as set forth above. However, modified Maunder is silent to wherein a distal end of the cylindrical collar element comprises a pair of bayonet type openings for accepting complementary locking pins.
Rhinehart discloses a fluid delivery system including a first container configured for storing a first fluid therein and a second container configured for storing a second fluid therein (Abstract). Rhinehart discloses that a fluid tight connection may be made using a bayonet connection on one component and the other component has one or more pins which engage a matching slot ([0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein a distal end of the cylindrical collar element of modified Maunder comprises a pair of bayonet type openings for accepting complementary locking pins, as taught by Rhinehart, for making a fluid-tight connection with the collar element.
Allowable Subject Matter
Claim 36 is 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. It would not be obvious to modify the tubing retainer of Maunder (US 2011/0089683) to be capable of twisting to meet the limitations of Claim 36. Claim 37 is dependent on Claims 36.
Response to Arguments
Applicant's arguments filed 3/6/2026 have been fully considered but they are not persuasive.
The 112b rejections have been removed in light of the Applicant’s amendments.
In regard to the Applicant’s argument regarding a pocket-less seal; minimize dead-ends and O-rings harboring unwanted contaminants; quick to connect and disconnect and does not have pockets, dead ends, the Examiner does not find this persuasive. The Examiner notes the rejection is updated above.
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., quick to connect and disconnect, minimize dead-ends and unwanted contaminants) 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 regarding minimizing dead end and harboring unwanted contaminants, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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 KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached 9 to 5:30.
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/KARA M PEO/ Primary Examiner, Art Unit 1777
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