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 Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 7, 13, 17-19, 39, 40, 44, 55, 60, are rejected under 35 U.S.C. 102(a)1) as being anticipated by Kugelmann et al. US Patent Application Publication 2013/0281964.
As to claim 1, Kugelmann teaches a flexible container 101 for storing a biological material (para. 0024), comprising:
a first layer 102a coupled to a second layer 102b via a plurality of seals 108, 108a, 108b, 108c, 108d to define a storage volume 110 (Fig. 1; paras. 0058, 0062-0066), the plurality of seals 108,108a,108b, 108c, 108d defines an opening 120 between the storage volume 110 and an external environment; and
an internal port 106, 107 positioned within the storage volume 110 and in fluid communication with the opening 120, the internal port 106 positioned to maintain a separation volume between the first layer and the second layer, the internal port 106 having a wall that defines an interior passage, the interior passage being in fluid communication with the storage volume 110 (Fig. 1; paras. 0058-0065).
As to claim 7, the wall 106c of the internal port 106 defines an aperture between the interior passage and the storage volume (Fig. 1; para. 0058, 0063).
As to claim 13, the internal port 106 is a first internal port and the opening 120 is a first opening, the flexible container 101 further comprising: a second internal port 125 positioned within the storage volume110 and in fluid communication with a second opening defined by the plurality of seals 108, 108a-d, the second internal port 125 having a wall that defines an interior passage that is in fluid communication with the storage volume 110 (para 0066).
As to claim 17, the internal port 106 extends from the opening 120 into the storage volume 110 (Fig. 1; para. 0066).
As to claim 18, the internal port 106 extends through a seal of the plurality of seals - where Kugelmann teaches the ports 106, 107, 124, 125 pass through the peripheral line 108 at the locations 120, 120a, 120b, 120c (Fig. 1; para. 0067).
As to claim 19, Kugelmann teaches the flexible container 101 of claim 1, further comprising: an external fitting 121 coupled to the internal port 106, the external fitting being outside the storage volume 110 (Fig. 1; para. 0058).
As to claim 39, the opening120 is a first opening in fluid communication with the internal port 106, the flexible container 101 further comprising: an external port 107b, the external port defining a second opening 113 in the plurality of seals – where Kugelmann teaches at another end 107b serves to return spent medical fluid (Fig. 1; para. 0059) and through port 107 and opening 113 (para. 0068).
As to claim 40, the external port 107b and the second opening 113 are positioned at a first end portion of the flexible container; and the first opening 120a is positioned at a second end portion of the flexible container (Fig. 1).
As to claim 44, the opening 120 in fluid communication with the internal port 106 is positioned at a second end portion of the flexible container 101 – where port 106 of the flexible container 101 further comprising: a sealable opening 120a defined by the first layer 102a and the second layer 102b (Fig. 1; paras. 0059,0067), wherein: the sealable opening 120a extends between a first side of the flexible container and a second side of the flexible container (between longitudinal peripheries 108, Fig. 1), the sealable opening 120a is positioned at a first end portion of the flexible container, the sealable opening is configured to facilitate an introduction of the biological material into the storage volume and a removal of the biological material from the storage volume, and the sealable opening is configured to form a seal following the introduction of the biological material into the storage volume – where Kugelmann teaches the bag is filled through port 106 (paras. 0058, 0064). Port 106 passes through the peripheral line 108 at location 120 forming a seal and is held by the flexurally rigid plastic part 122 (Fig. 1; para. 0067). Port 107 serves to return spent medical fluid (para. 0059) and port 107 passes through the peripheral line 108 at location 120a forming a seal and is held by the flexurally rigid plastic part 122 (para. 0067).
As to claim 55, Kugelmann teaches a flexible container for storing a biological material (para. 0024), comprising: a first layer 102a coupled to a second layer 102b via a plurality of seals 108, 108a, 108b, 108c, 108d to define a storage volume 110 (Fig. 1; paras. 0058, 0062-0066), the plurality of seals 108,108a,108b, 108c, 108d defines a second opening 120a between the storage volume 110 and an external environment; and
an internal port 106 positioned within the storage volume 110, the internal port 106 having a first end portion106a in fluid communication with the first opening 120 and a second end portion 106b in fluid communication with the second opening 113, the internal port 106 positioned to maintain a separation – where Fig. 1 shows the openings and corresponding ports 106a,106b are separated in the longitudinal direction of the container. The internal port having a wall that defines an interior passage – where Kugelmann teaches port 106 consists of a tube passing through the bag in the interior in its longitudinal extent - in fluid communication with the first opening and the second opening (Fig. 1, para. 0058).
As to claim 60, the interior passage is configured to receive a treatment media; and the internal port is positioned to convey the treatment media through the storage volume to affect the biological material in the storage volume – where Kugelmann teaches port 106 consists of a tube passing through the bag in the interior in its longitudinal extent. Thus it is ensured in the filling process that that when the bag is stored upright, for example, by accommodating the bag on a retaining rail through the flexurally rigid plastic part 122, the bag is filled from beneath and the compartments A, B, C1, C2 are opened in sequence (para. 0058). Kugelmann teaches port 106 connects the filling chamber 110 of the bag to the exterior of the bag via a first end in the interior of the bag 106b and an additional end 106a outside of the bag 101 (para. 0058).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8, 25, 37, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Kugelmann et al. US Patent Application Publication 2013/0281964
As to claim 8, the internal port 106 is fluidly coupled to a connector unit 123; and the connector unit 123 is configured to be fluidly coupled to a gas source and to a biological material source – where Kugelmann teaches connector 123 is provided for bringing the dialysis fluid into fluid connection with another fluid processing device such as a dialysis machine (para. 0065). The function of the connector is directed to an intended use of the connector. Intended use 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. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The connector 123 is capable of being fluidly coupled to a gas source.
As to claim 25, Kugelmann teaches the flexible container 101 of claim 1, wherein: the internal port 106 facilitates at least one of a delivery of the biological material into the storage volume 110 or a removal of the biological material from the storage volume; the interior passage has a cross-sectional area sized to facilitate passage of the biological material (Fig. 1); the wall 106c of the internal port 106 defines an aperture between the interior passage and the storage volume 110. It would have been obvious to one having ordinary skill in the art to provide an aperture is sized to facilitate passage of the biological material therethrough (paras. 0063-0065).
As to claim 37, Kugelmann teaches the flexible container 101 of claim 1, wherein: the internal port 6 has a first cross-sectional shape on a condition that the storage volume does not contain the biological material; the internal port 6 is configured to have a second cross-sectional shape on a condition that the storage volume contains the biological material; and the first cross-sectional shape is different from the second cross-sectional shape – where Kugelmann teaches port 106 is preferably attached to the welded zone 120 by welded joints in a fluid-tight manner in the sealing peripheral line 108 and accommodated by the receptacle area 121 of the flexurally rigid plastic part 122 by welding, gluing or blocking with a seal, which would provide a first cross-sectional shape. Kugelmann also teaches port 106 is provided at one end 106b with a turbulence-generating nozzle or a turbulence-generating frit for when the bag is filled from beneath, which provides another cross-section (para 0058). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide different cross-sectional parts for different ends of the port which provide different functions.
As to claim 64, Kugelmann teaches the flexible container 101 of claim 55, further comprising: an external port 107b, the external port 107b defining a third opening 113 in the plurality of seals, the external port being configured to facilitate a removal of the biological material from the storage volume (para. 0059). Kugelmann does not teach the same port facilitates an introduction of the biological material into the storage volume 111. Port 106 facilitates an introduction of the biological material into the storage volume 111 (para. 0058). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to integrate the external ports, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Claims 9, 11, 24 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Kugelmann et al. US Patent Application Publication 2013/0281964 in view of Ilyin US Patent Application Publication 2018/0249703.
As to claim 9, Kugelmann teaches the present invention substantially as claimed. Kugelmann does not specifically teach the connector unit includes a flow control member. Ilyin, from the same field of endeavor, containers for storing biological materials, has a bag that can be used to store blood product (Ilyin Abstract) where the bag gas permeable. Ilyin teaches using a valve (flow control) for a connector so that a gas can be inserted into the bag after it has been sealed (Ilyin para. 0015). It would have been obvious to one having ordinary skill in the art to use valve members in the connectors in order to control the flow of fluid (gas) in and out of the bags in a sterile environment.
As to claim 11, Kugelmann/Ilyin teaches the flexible container further comprising: a sleeve positionable within the interior passage, the sleeve being configured to transition the internal port from a first transmission state to a second transmission state, wherein: in the first transmission state, the internal port is configured to deliver the biological material into the storage volume, and in the second transmission state, the internal port is configured to convey a treatment media – where Kugelmann/Ilyin teaches the valve is made of a flexible sleeve attached to the one end of the bag in such a way that the valve at least partially extends inside the bag. The outlet of the gas supply line can be partially inserted in the sleeve or releasable connected to the sleeve of the valve. When gas is supplied under pressure, the sleeve of the valve can be configured to allow the gas to freely flow into the cavity of the bag (Ilyin para. 0015).
As to claims 24 and 57, Kugelmann/Ilyin teaches at least one of the first layer or the second layer of the flexible container is gas permeable; and the gas permeability facilitating a gas transfer between the storage volume and an external environment – where Ilyin teaches a hermetically-sealed conventional storage bag 32 made of gas-permeable material used to preserve the blood product. Ilyin teaches the when implementing the preservation method of his invention which involves the use of xenon or a xenon mixture, a bag material for the storage bag should be permeable to xenon (Ilyin para. 0073). Ilyin teaches using a valve (flow control) for a connector so that a gas can be inserted into the bag after it has been sealed (Ilyin para. 0015). It would have been obvious to one having ordinary skill in the art to use valve members in the connectors in order to control the flow of fluid (gas) in and out of the bags in a sterile environment.
Allowable Subject Matter
Claim 61 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 61, Fresenius teaches the flexible container of claim 60, wherein: the interior passage of the internal port (fig. 1 - see the internal port 107 having a wall which defines an interior passage) is fluidically isolated from the storage volume (fig. 1 - see how the portion of the interior passage defined by the wall is fluidically isolated from the storage volume). However, the prior art does not disclose/teach individually nor fairly suggest in combination wherein the treatment media is a heat transfer media; and the heat transfer media is configured to affect a temperature within the storage volume.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Balteau et al. WO 8/06897 is cited to show a storage bag from the same field of endeavor having valve members 40 and 42 to control fluid flow through the respective pathways where Balteau teaches the system is connected to a peritoneal dialysis catheter of a patient using the connectors 34 and 36 (page 5, last paragraph through page 6, first paragraph).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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