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
The last response received is that of the Appeal Brief Filed January 16th, 2026. After an Appeal Brief Conference applicant arguments were found to be persuasive and prosecution has herein been reopened. Claims 1-15 and 22-23 are currently pending and under consideration.
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed January 16th, 2026, with respect to the rejection(s) of claim(s) 1 and 22 under Lee in view of Balteau have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Snyder et al. (U.S. Publication 2016/0030283) in view of Okiyama (U.S. Publication 2009/0143758).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-15, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (U.S. Publication 2016/0030283) in view of Okiyama (U.S. Publication 2009/0143758) and evidenced by Goodwin et al. (U.S. Publication 2014/0137519).
Regarding claim 1, Snyder discloses a storage bag, comprising: a collapsible pouch 10 comprising an internal volume (internal volume formed by closure of tube 11 ends) and having a first closed end 14a defined by a first seam (joint 15 on side 14a) formed by the collapsible pouch (seam formed by folding of sections 19 along line K and a second substantially closed end 14b defined by a second seam (¶0033 14b provided with lap seam over a joint in similar fashion as described above in connection with handle end 14a) formed by the collapsible pouch (joint formed by pouch in same ways as 15), the second substantially closed end defining an aperture (¶0033 slit formed in extendsion 18 on port end to facilitate attachment of ports) ;a port assembly comprising a body 3 and a snout 2, wherein the body comprises at least two conduits (ports 2 passing therethrough, the body defining a periphery (edge of body); a port reinforcing laminate (Fig. 1, 14b shows element similar to 20 overlapping, ¶0033 provided with lap seam in similar fashion to end 14a) overlapping the end of the collapsible pouch including the aperture (aperture formed in 18 which is covered by 20) to retain the port assembly with the body spaced apart from the collapsible pouch (Fig. 1 shows the port assembly spaced apart from end seam of collapsible pouch 15).
Snyder does not expressly disclose the port assembly being non-collapsible, how the port assembly is attached to port reinforcing laminate as shown or the fluid connection route of the port assembly to the collapsible pouch, it overlapping the port assembly or a snout extending from the body into the internal volume through the aperture; or at least one peripheral cavity formed between the port reinforcing laminate and a portion of the periphery of the body of the port assembly and extending from the collapsible pouch to at least one conduit so that at least one conduit is in fluid communication with the internal volume through the peripheral cavity.
However, Okiyama, in the same field of endeavor of collapsible pouch containers, discloses a non-collapsible (¶0003 hard molded product made of plastic) port assembly comprising a snout 19 extending from the body into an internal volume of a pouch, for the purpose of preventing the surrounding sheet material from being punctured by a metal needle or an introducer needle ¶0052, and heat sealing the non-collapsible port assembly between two flexible sheets such that the flexible sheets overlap the continuous wall 17 of the port assembly (¶0057 secured to sheet by heat sealing after sandwiching the continuous wall portion with two pieces of the sheet), for the purpose of preventing sealing failure ¶0057, such that a peripheral cavity (see below illustrative diagram of Fig. 8) is formed between a portion of the periphery of the body (formed between the entire section of periphery facing the internal area of the pouch and the flexible sheet sealing leading into the main pouch area, see below illustrative diagram) and the flexible sheet sealed periphery, so as to allow for fluid communication between the internal pouch fluid and the port assembly, and the port assembly comprising.
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Illustrative diagram of Fig. 8 of Okiyama.
Regarding the port assembly being non-collapsible and having a snout extending from the body into the internal volume through the aperture, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the port assembly of Snyder that performs the function of providing a connection point for content transfer from the collapsible pouch for the port assembly of Snyder since these elements perform the same function of allowing content transfer from the collapsible pouch. Simply substituting one port assembly means for another would yield the predictable result of allowing a(n) collapsible pouch to have ports for content transfer in and out of the pouch. See MPEP 2143. Furthermore, one of ordinary skill in the art before the effective filing date of the claimed invention, would have been motivated to perform this substitution for the purpose of providing a port assembly that prevents the surrounding sheet material from being punctured by a metal needle or an introducer needle (¶0052 of Okiyama).
Regarding the port reinforcing laminate overlapping the port assembly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the port assembly of Snyder to have been overlapped by the port reinforcing laminate for the purpose of heat sealing the port assembly to the laminate such that sealing failure between the two elements is prevented (¶0057 of Okiyama).
Regarding the peripheral cavity, during the process of heat sealing the port assembly to the port reinforcing laminate, it would have been obvious to one of ordinary skill in the art to have performed the heat sealing in such away to allow the face of the port assembly intended to interact with the fluid from the medical container to have a fluid pathway between the two and thus form a peripheral cavity extending from the inward facing face of the port assembly to the aperture of the container for the purpose of allowing fluid communication between the port assembly and the collapsible pouch contents. Modifying the snout of Snyder to extend into the collapsible pouch volume would have necessitated it be through the aperture as this is the opening into the collapsible pouch provided by the disclosure of Snyder and would be the path by which something would naturally enter the pouch.
Furthermore, the technique of utilizing specific heat sealing points to form fluid pathways is well known in the art as evidenced by Goodwin et al., in the same field of endeavor of flexible storage containers, as evidenced by the fluid flow paths of 484 and 478 of Fig. 23 showing heat welded (¶0118 welded, ¶0063 heat welding) seams 472 which illustrate selective welding to create fluid flow paths from an internal volume of a collapsible pouch to a port element 486. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Snyder in view of Okiyama since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of heat welding to create fluid paths would have yielded predictable results of creating a fluid flow pathway from the collapsible pouch to the port assembly through the reinforcing laminate 20. See MPEP 2143.
and substitute the port assembly of Snyder to have been the non-collapsible port assembly including the snout on one of the ports that extended into the container for the purpose of preventing the surrounding sheet material from being punctured by a metal needle or an introducer needle (¶0052 of Okiyama).
Regarding claim 2, Snyder in view of Okiyama suggest the storage bag of claim 1. Snyder does not expressly disclose the non-collapsible port assembly comprising a filling conduit and an extraction conduit.
However, the limitations of “filling” and “extraction” are considered functional language (describe the ability of the port conduits to fill the collapsible pouch or extract contents of collapsible pouch). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Snyder in view of Okiyama suggests all the structure as claimed, and the term port denotes the ability to be used for a substance to move in and out of. As such, it is capable of performing the functions as claimed (i.e. the ports are capable of being extraction and filling ports).
Regarding claim 3, Snyder in view of Okiyama suggest the storage bag of claim 1. Snyder does not expressly disclose the non-collapsible port assembly comprising a sampling conduit.
However, the limitation of “sampling” is considered functional language (describe the ability of the port conduits to fill the collapsible pouch or extract contents of collapsible pouch). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Snyder in view of Okiyama suggests all the structure as claimed, and the term port denotes the ability to be used for a substance to move in and out of. As such, it is capable of performing the functions as claimed (i.e. the ports are capable of being a sampling conduit).
Regarding claim 4, Snyder in view of Okiyama suggest the storage bag of claim 1. Snyder in view of Okiyama further suggest the at least two conduits being in fluid communication with the internal volume through the at least one peripheral cavity and the aperture as Okiyama suggests forming a fluid pathway between the port element and the cavity of the collapsible pouch (see the above rejection of claim 1). This would result in the conduits formed by the ports 2 being in fluid communication with the internal volume through the peripheral cavity and the aperture.
Regarding claim 5, Snyder in view of Okiyama suggest the storage bag of claim 1. Snyder in view of Okiyama further suggest one of the conduits being in fluid communication with the internal volume through the non-collapsible snout as the combination of the Snyder in view of Okiyama to modify a port to include thesnout that extends into the container for the purpose of preventing the surrounding sheet material from being punctured by a metal needle or an introducer needle (¶0052 of Okiyama) would result in the modified port/conduit being in fluid communication with the internal volume, for the purpose of preventing the surrounding sheet material from being punctured by a metal needle or an introducer needle (¶0052 of Okiyama).
Regarding claim 6, Snyder in view of Okiyama suggest the storage bag of claim 1. Snyder further discloses the port assembly furhte rcomprising one or more tapered heads that extend outside the port reinforcing laminate (trapezoidal heads of element 2 as depicted in Fig. 1).
While Snyder does not expressly disclose these head being connectors for connecting one or ore tubes to the port assembly so each tube is in fluid communication with at least one conduit of the port assembly, the limitations of “connectors” and “connecting one or more tubes to the port assembly so each tube is in fluid communication with at least one conduit of the port assembly” are considered functional language (describe function of connection of tube to port). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited by the claim, then it meets the claim. In the instant case, the device of Snyder discloses all the structure as claimed, and the ports are further used to allow flow of fluid internal contents out of the device (in fluid communication ¶0026 holes are punctured therein and then ports are attached, definition of ports is to allow movement of contents through them) and consist of a tapered end (Fig. 1) which function to provide increased force to a tube such as to connect them. As such, it is capable of performing the functions as claimed (i.e. it is capable of functioning as a connector for connecting one or more tubes to the port assembly so each tube is in fluid communication with at least one conduit of the port assembly).
Regarding claim 7, Snyder in view of Okiyama suggest the storage bag of claim 1. Snyder further discloses the collapsible pouch 11 comprising an inner surface 12 formed from a first polymer (¶0028 higher melting polymer) and an external surface 13 formed from a second polymer (¶0028 lower melting polymer), wherein the relative melting points of the first and second polymers are such that the collapsible pouch can be heated to a temperature high enough to melt bond the second polymer without melting the first polymer (¶0028higher melting polymer is non-melt processible and lower melting polymer is melt processible).
Regarding claim 8, Snyder in view of Okiyama suggest the storage bag of claim 7. Snyder further discloses the melting point of the first polymer being at least 30 degrees Celsius higher than the melting point of the second polymer (¶0028 having a melting onit at least 30 degrees Celsius above the lower melting polymer).
Regarding claim 9, Snyder in view of Okiyama suggest the storage bag of claim 7. Snyder further discloses the first polymer being polytetrafluoroethylene (¶0028 polytetrafluoroethylene) and the second polymer comprising fluorinated ethylene propylene (¶0028 fluorinated ethylene propylene).
Regarding claim 10, Snyder in view of Okiyama suggest the storage bag of claim 7. Snyder does not expressly disclose the non-collapsible port assembly being formed of FEP, PVDF, ETFE, OR ECTFE.
Regarding claim 11, Snyder in view of Okiyama suggest the storage bag of claim 7. Snyder further discloses the port reinforcing laminate comprising two composite layers (¶0031 two separate composite sheets), each layer comprising a first surface comprising a third polymer (¶0030 higher melting surface of composite sheet) and an opposing second surface comprising a fourth polymer (¶0031 lower melting surface), and wherein the two layers are positioned on either side of the port assembly (as modified by Okinawa to attach to 17) and the collapsible pouch (¶0031 on each side of the composite tube) with the second surface of each layer in contact with at least a portion of the non-collapsible port assembly (as modified by Okinawa to attach to surface 17) and at least a portion of the collapsible pouch (¶0031 create lap seam over joint 15), wherein the relative melting points of the third and fourth polymers are such that the composited layers can be heated to a temperature high enough to melt bond the fourth polymer without melting the third polymer (¶0030 and 0031 (higher and lower melting polymer ¶0028 higher melting polymer is a non-melt processible polymer and lower melting polymer is a melt processible polymer).
Regarding claim 12, Snyder in view of Okiyama suggest the storage bag of claim 11. Snyder further discloses the melting point of the third polymer being at least 30 degrees Celsius higher than the melting point of the fourth polymer (¶0028 having a melting onit at least 30 degrees Celsius above the lower melting polymer).
Regarding claim 13, Snyder in view of Okiyama suggest the storage bag of claim 11. Snyder further discloses the fourth polymer bonding the two composite layers to at least a portion of the collapsible pouch and to each other (¶0031 lower melting surface of the composite sheet bonds with the lower melting surface of composite tube, as the surfaces are facing each other by being on opposite sides of the composite tube and still binding the composite tube they lower melting polymers would also bind themselves at point where the composites overlap on another past the composite tube as illustrative by 20 in Fig. 1).
Snyder does not expressly disclose the fourth polymer bonding the two composite layers to at least a portion of the port assembly however, as suggested in the modification of claim 1, it would have been obvious to one of ordinary skill in the art as suggested by Okiyama in the same field of endeavor of collapsible storage pouches, to have heat sealed the non-collapsible port assembly between two flexible sheets such that the flexible sheets overlap the continuous wall 17 of the port assembly (¶0057 secured to sheet by heat sealing after sandwiching the continuous wall portion with two pieces of the sheet), for the purpose of preventing sealing failure ¶0057.
As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have been made of a material that is capable of being heat bonded to the fourth polymer since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 14, Snyder in view of Okiyama suggest the storage bag of claim 11. Snyder further discloses the third polymer comprising PTFE (¶0028polytetrafluoroethylene) and the fourth polymer comprising FEP (¶0028 FEP).
Regarding claim 15, Snyder in view of Okiyama suggest the storage bag of claim 11. Snyder further discloses the portion of the collapsible pouch overlapped by the port reinforcing laminate comprising a joint 15, and wherein the port reinforcing laminate covers the joint (¶0031 create a lap seam over joint 15).
Regarding claim 22, Snyder discloses a storage bag, comprising: a collapsible pouch 10 comprising an internal volume (internal volume formed by closure of tube 11 ends) defined partially by a first end 14a having a first seam (joint 15 on side 14a) formed by the collapsible pouch (seam formed by folding of sections 19 along line K and a second end 14b having a second seam (¶0033 14b provided with lap seam over a joint in similar fashion as described above in connection with handle end 14a) formed by the collapsible pouch (joint formed by pouch in same ways as 15), the second substantially closed end defining an aperture (¶0033 slit formed in extendsion 18 on port end to facilitate attachment of ports) ;a non-collapsible port assembly comprising a body 3 and a snout 2, wherein the body comprises at least two conduits (ports 2 passing therethrough, the body defining a periphery (edge of body); a port reinforcing laminate (Fig. 1, 14b shows element similar to 20 overlapping, ¶0033 provided with lap seam in similar fashion to end 14a) overlapping the end of the collapsible pouch including the aperture (aperture formed in 18 which is covered by 20) to retain the port assembly with the body spaced apart from the collapsible pouch (Fig. 1 shows the port assembly spaced apart from end seam of collapsible pouch 15).
Snyder does not expressly disclose the port assembly being non-collapsible, how the port assembly is attached to port reinforcing laminate as shown or the fluid connection route of the port assembly to the collapsible pouch, it overlapping the port assembly or a snout extending from the body into the internal volume through the aperture; or at least one peripheral cavity formed between the port reinforcing laminate and a portion of the periphery of the body of the port assembly and extending from the collapsible pouch to at least one conduit so that at least one conduit is in fluid communication with the internal volume through the peripheral cavity.
However, Okiyama, in the same field of endeavor of collapsible pouch containers, discloses a non-collapsible (¶0003 hard molded product made of plastic) port assembly comprising a snout 19 extending from the body into an internal volume of a pouch, for the purpose of preventing the surrounding sheet material from being punctured by a metal needle or an introducer needle ¶0052, and heat sealing the non-collapsible port assembly between two flexible sheets such that the flexible sheets overlap the continuous wall 17 of the port assembly (¶0057 secured to sheet by heat sealing after sandwiching the continuous wall portion with two pieces of the sheet), for the purpose of preventing sealing failure ¶0057, such that a peripheral cavity (see above illustrative diagram of Fig. 8) is formed between a portion of the periphery of the body (formed between the entire section of periphery facing the internal area of the pouch and the flexible sheet sealing leading into the main pouch area, see above illustrative diagram) and the flexible sheet sealed periphery, so as to allow for fluid communication between the internal pouch fluid and the port assembly, and the port assembly comprising.
Regarding the port assembly being non-collapsible and having a snout extending from the body into the internal volume through the aperture, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the port assembly of Snyder that performs the function of providing a connection point for content transfer from the collapsible pouch for the port assembly of Snyder since these elements perform the same function of allowing content transfer from the collapsible pouch. Simply substituting one port assembly means for another would yield the predictable result of allowing a(n) collapsible pouch to have ports for content transfer in and out of the pouch. See MPEP 2143. Furthermore, one of ordinary skill in the art before the effective filing date of the claimed invention, would have been motivated to perform this substitution for the purpose of providing a port assembly that prevents the surrounding sheet material from being punctured by a metal needle or an introducer needle (¶0052 of Okiyama).
Regarding the port reinforcing laminate overlapping the port assembly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the port assembly of Snyder to have been overlapped by the port reinforcing laminate for the purpose of heat sealing the port assembly to the laminate such that sealing failure between the two elements is prevented (¶0057 of Okiyama).
Regarding the peripheral cavity, during the process of heat sealing the port assembly to the port reinforcing laminate, it would have been obvious to one of ordinary skill in the art to have performed the heat sealing in such away to allow the face of the port assembly intended to interact with the fluid from the medical container to have a fluid pathway between the two and thus form a peripheral cavity extending from the inward facing face of the port assembly to the aperture of the container for the purpose of allowing fluid communication between the port assembly and the collapsible pouch contents. Modifying the snout of Snyder to extend into the collapsible pouch volume would have necessitated it be through the aperture as this is the opening into the collapsible pouch provided by the disclosure of Snyder and would be the path by which something would naturally enter the pouch.
Furthermore, the technique of utilizing specific heat sealing points to form fluid pathways is well known in the art as evidenced by Goodwin et al., in the same field of endeavor of flexible storage containers, as evidenced by the fluid flow paths of 484 and 478 of Fig. 23 showing heat welded (¶0118 welded, ¶0063 heat welding) seams 472 which illustrate selective welding to create fluid flow paths from an internal volume of a collapsible pouch to a port element 486. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Snyder in view of Okiyama since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of heat welding to create fluid paths would have yielded predictable results of creating a fluid flow pathway from the collapsible pouch to the port assembly through the reinforcing laminate 20. See MPEP 2143.
and substitute the port assembly of Snyder to have been the non-collapsible port assembly including the snout on one of the ports that extended into the container for the purpose of preventing the surrounding sheet material from being punctured by a metal needle or an introducer needle (¶0052 of Okiyama).
Regarding claim 23, Snyder in view of Okiyama suggest the storage bag of claim 1. Snyder further discloses the first seam and the second seam being comprised of a lap seam (¶0005 engages the joint and forming a lap seam over the joint).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781