DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The claim filed 12/12/2023 has been entered. Claims 1-24 are pending and under consideration.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 lines 1-2 “wherein one or more of the number of adhesively bonded sections” which should read “wherein the container includes a number of adhesively bonded sections”
Appropriate correction is required.
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, 10, 11, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alvarado (US 4515270 A).
Regarding claim 1, Alvarado teaches a medical package (figures 1-4), comprising:
a container (figures 1-4, carton 10 ) configured to transition from a first closed configuration (figure 3, carton 10 in closed configuration) to an open configuration (figure 4, carton 10 in open configuration), the container comprising:
a bottom panel (figure 4, floor 22) defining a length and a width of the container (figure 4, length and width of the floor 22);
first and second side panels (figure 4, side flaps 34) pivotably coupled with the bottom panel along opposite sides of the bottom panel (figures 1 and 4, side flaps 34 pivotally attached to floor 22 along fold lines 36); and
first and second end panels (figure 4, end flaps 30 and 31) pivotably coupled with the bottom panel along opposite ends of the bottom panel (figures 1 and 4, the end flaps are pivotably coupled with the floor along fold lines 32), each of the first and second end panels further coupled with each of the first and second side panels (figure 4, the side flaps and end flaps are coupled at its corner), wherein:
in the first closed configuration the first and second end panels and the first and second side panels are disposed substantially parallel to the bottom panel (figure 3, the end flaps and side flaps are folded substantially parallel to the floor in the closed configuration), and
the container is configured to enclose a urinary catheter therein in the first closed configuration (col 1 lines 5-35, the carton is capable of enclosing disposable medical devices, for example urinary catheter in the closed configuration).
Regarding claim 2, Alvarado teaches the package according to claim 1.
Alvarado further teaches wherein in the open configuration, the first and second end panels and the first and second side panels are disposed substantially perpendicular to the bottom panel (figure 4, the flaps 30, 31 and 34 disposed substantially perpendicular to the floor 22).
Regarding claim 3, Alvarado teaches the package according to claim 1.
Alvarado further teaches wherein the container is biased away from the first closed configuration toward the open configuration (col 3 lines 30-35, the cartoon configured to be stay in open configuration, and further folded paper of the cartoon inherently biasing toward to return to a more planar or “open” state when the closing force is removed)
Regarding claim 4, Alvarado teaches the package according to claim 1.
Alvarado further teaches wherein the urinary catheter is a male urinary catheter (Alvarado; the carton is capable of enclosing unitary catheter including a male urinary catheter)
Regarding claim 5, Alvarado teaches the package according to claim 1.
Alvarado further teaches wherein the containers is configured for handling within a clean room (abstract, the cartoon is configured to be used during operating procedure).
Regarding claim 6, Alvarado teaches the package according to claim 1.
Alvarado further teaches wherein the container is configured to enable sterilization of the catheter when the catheter is disposed within the container, the container disposed in the first closed configuration (col 2 lines 20-25, the material of the cartoon withstanding standard sterilization enabling sterilizing catheter when the catheter is disposed in the cartoon in the first closed configuration)
Regarding claim 7, Alvarado teaches the package according to claim 1.
Alvarado further teaches wherein the container defines a sterile barrier for the catheter in the first closed configuration (figure 2, col 1 lines 20-25 col 2 lines 20-25, in the closed configuration, the carton substantially seals interior from the environment defining a sterile barrier).
Regarding claim 10, Alvarado teaches the package according to claim 1.
Alvarado further teaches wherein the container is configured to transition from the first closed configuration to the open configuration in response to a user applying a first pulling force to the first side panel and a second pulling force to the second side panel, the second pulling force directed in opposition to the first pulling force (figures 3-4 and col 3 lines 25-30, the cartoon is configured to transition from the closed configuration to open configuration when taps 54 are pulled by opposing directions)
Regarding claim 11, Alvarado teaches the package according to claim 10.
Alvarado further teaches wherein:
the first side panel includes a first pull tab (figure 4 and col 3 lines 25-30, tabs 54 is configured to be pulled opposing direction) configured for grasping by the user when applying the first pulling force, and
the second side panel includes a second pull tab (figure 4 and col 3 lines 25-30, tabs 54are configured to be pulled opposing direction) configured for grasping by the user when applying the second pulling force.
Regarding claim 14, Alvarado teaches the package according to claim 1.
Alvarado further teaches wherein the urinary catheter includes a bag for collecting urine therein (col 1 lines 5-35, the carton is capable of enclosing disposable medical devices, for example urinary catheter with a bag for collecting urine in the closed configuration)
Regarding claim 15, Alvarado teaches the package according to claim 14.
Alvarado further teaches wherein the bag is coupled with the urinary catheter when the bag is enclosed within the container, such that the bag is in fluid communication with a lumen of the urinary catheter (col 1 lines 5-35, the carton is capable of enclosing disposable medical devices, for example urinary catheter with bag is in fluid communication with a lumen of the urinary catheter, in the closed configuration).
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.
Claims 8, 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Alvarado (US 4515270 A) in view of Frojd (US 20110056852 A1).
Regarding claim 8, Alvarado teaches the package according to claim 1.
Alvarado does not teach wherein the container includes a number of adhesively bonded sections of one or more of the first and second side panels or the first and second end panels, the adhesively bonded sections configured to secure the container in the first closed configuration.
In the same field of endeavor, namely a catheter assembly with resealable opening, Frojd teaches wherein the container includes a number of adhesively ([0011]-[0016] a third sheet connected by means of an adhesive over flap opening, and the adhesive is adapted to maintain a sterile closure of the package before use) bonded sections of one or more of the first and second side panels or the first and second end panels, the adhesively bonded sections configured to secure the container in the first closed configuration.
Therefore, 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 Alvarado, to incorporate the teachings of Frojd and provide the adhesively bonded sections as claimed for the purpose of maintaining a sterile closure of the package before use as taught by Frojd ([0015]).
Regarding claim 9, Alvarado, as modified by Frojd, teaches the package according to claim 8.
The combination further teaches wherein the number of adhesively bonded sections are configured to define a sealed cavity for containing the urinary catheter therein in the first closed configuration (Fjord; the combination having adhesively bonded section, for example adhesively bonding flaps 30 and 31 to flaps and floor of Alvarado in closed continuation, defines a sealed cavity in the closed configuration capable of containing the urinary catheter).
Regarding claim 17, Alvarado teaches the package according to claim 16.
Alvarado does not teach wherein the container includes a number adhesively bonded sections are configured to further secure the container in the second closed configuration.
In the same field of endeavor, namely a catheter assembly with resealable opening, Frojd teaches wherein the container includes a number adhesively bonded sections are configured to further secure the container in the second closed configuration ([0011]-[0016] and [0022] flaps are provided with an adhesive configured to be resealed).
Therefore, 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 Alvarado, as modified by Frojd and provide the container as claimed for the purpose of safely discard a wet product and/or a wetting fluid without any risk for spillage as taught by Fjord ([0004])
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Alvarado (US 4515270 A) in view of Anders et al (US 5958483 A)
Regarding claim 12, Alvarado teaches the package according to claim 11.
Alvarado does not teach wherein at least one of the first and second pull tabs includes a pull ring.
However, Anders teaches a package for food, which relatively pertinent to applicant’s posed problem of providing sterile package for its content and facilitating the opening of the packaging system, wherein at least one of the first and second pull tabs includes a pull ring (figure 3, pull-rings/tab 7).
Therefore, 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 Alvarado to incorporate the teachings of Anders and provide the first and second pull tabs as claimed for the purpose of providing improved grip as taught by Anders (col 2 lines 30-40).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Alvarado (US 4515270 A) in view of Barnes et al (US 2823847 A).
Regarding claim 13, Alvarado teaches the package according to claim 11.
Alvarado does not teach wherein at least a portion of each of the first and second pull tabs extends outward beyond a perimeter of the container in the first closed configuration.
In the same field of endeavor, namely a collapsible container structure, Barnes teaches wherein at least a portion of each of the first and second pull tabs extends outward beyond a perimeter of the container in the first closed configuration (figure 1, pull-tabs 21 and 22 extend outward beyond a perimeter of the bottom 10 of the box in the closed configuration).
Therefore, 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 Alvarado to incorporate the teachings of Barnes and provide the pull tabs as claimed, and one of skill in the art motivated to do so, for the purpose of providing gripping surface that can be accessible while the container is in the first closed configuration.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Alvarado (US 4515270 A) in view of Campbell (US 4186955 A).
Regarding claim 16, Alvarado teaches the package according to claim 1.
Alvarado does not expressly teach wherein the container is configured to:
transition from the opened configuration to a second closed configuration, and
enclose the urinary catheter within the container in the second closed configuration after use of the urinary catheter
In the same field of endeavor, namely a waste matter removal implement and receptacle, Campbell teaches wherein the container (figures 1-6, 14) is configured to:
transition from the opened configuration to a second closed configuration (from open configuration of figure 3, to closed configuration in figure 6), and
enclose the urinary catheter within the container in the second closed configuration after use of the urinary catheter (col 3 lines 1-16, after disposing waster matter 44, flap 12 and glove 42 within the receiver, the receiver 14 can be collapsed to form a retentive envelope).
Therefore, 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 Alvarado, to incorporate the teachings of Campbell and provide the container as claimed for the purpose of providing convenient disposal of used urinary catheter as taught by Campbell (col 3 lines 1-16)
Claims 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Alvarado (US 4515270 A) in view of Degoerge (US 20130167857 A1).
Regarding claim 18, Alvarado teaches the package according to claim 16.
Alvarado does not teach wherein the container is configured to inhibit fluid disposed within the container from exiting the container with the container disposed in the second closed configuration.
In the same field of endeavor, namely a paperboard packaging containers, Degoerge teaches wherein the container is configured to inhibit fluid disposed within the container from exiting the container with the container disposed in the second closed configuration ([0022] inner surface of the packaging container is coated with hydrophobic material inhibits fluid from exiting the container).
Therefore, 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 Alvarado to incorporate the teachings of Degoerge and provides the container as claimed, and one of skill in the art motivated to do so, for the purpose of providing fluid-impermeable barrier as taught by Degoerge ([0022]). The fluid-impermeable barrier prevent the egress of liquid waste, such as residual fluid from discarded medical gloves, thereby preventing the saturation or structure failure of the paperboard substrate during disposal and preventing spillage.
Regarding claim 21, Alvarado teaches the package according to claim 1.
Alvarado does not teach wherein a bottom panel, the first and second side panels, and the first and second end panels each include a hydrophobic inside surface.
In the same field of endeavor, namely a paperboard packaging containers, Degoerge teaches wherein a bottom panel, the first and second side panels, and the first and second end panels each include a hydrophobic inside surface [0022] inner surface of the packaging container is coated with hydrophobic material to provide a barrier to the liquid).
Therefore, 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 Alvarado to incorporate the teachings of Degoerge and provide the container as claimed for the purpose of providing fluid-impermeable barrier as taught by Degoerge ([0022]). The fluid-impermeable barrier prevent the egress of liquid waste, such as residual fluid from discarded medical gloves, thereby preventing the saturation or structure failure of the paperboard substrate during disposal and preventing spillage.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Alvarado (US 4515270 A) in view of Inwood (US 20210292041 A1)
Regarding claim 19, Alvarado teaches the package according to claim 1.
Alvarado does not teach further comprising a tamper evident mechanism configured to indicate that the container has been transitioned away from the first closed configuration.
In the same field of endeavor, namely a tamper-evident paperboard food container, Inwood teaches further comprising a tamper evident mechanism configured to indicate that the container has been transitioned away from the first closed configuration (figure 1 [0022], tamper-evident feature 172 is irreversibly split to open the closure).
Therefore, 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 Alvarado to incorporate the teachings of Inwood and provide the tamper evident mechanism as claimed for the purpose of providing visual indication of container sealing integrity as taught by Inwood ([0003]). For instance, the tamper evident mechanism would prevent accidental use of a contaminated device.
Regarding claim 20, Alvarado, as modified by Inwood, teaches the package according to claim 19.
The combination further teaches wherein the tamper evident mechanism includes a tear-able adhesive tape extending between the first and second side panels (Inwood; figure 1, [0022] and [0025], region 156 with adhesive assembly 170 can be tearable along perforations 174 extending between panels 132 and 136 when the box is assembled ).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Conway et al ( US 20120239005 A1) in view of Alvarado (US 4515270 A).
Regarding claim 22, Conway teaches a urinary catheter assembly, comprising:
a urinary catheter (figure 3, catheter 3 ); and
a package (figure 3, package 29),
wherein the urinary catheter is enclosed within the container of the package (figure 3 [0024] the catheter is enclosed within the package 29).
Conway does not teach the package according to claim 1.
In the same field of endeavor, namely a surgical glove carton and trash receptacle, Alvarado teaches the package according to claim 1 (see 102 claim rejection 1 above).
Therefore, 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 Conway to incorporate the teachings of Alvarado and provide the package as claimed for the purpose of keeping the urinary catheter and sterile before use and to enable easy disposal afterwards as taught by Alvarado (col 1 lines 5-10).
Claims 23 and 24 rejected under 35 U.S.C. 103 as being unpatentable over Conway et al ( US 20120239005 A1) in view of Alvarado (US 4515270 A) and in further view of Knapp (US 20140262859 A1).
Regarding claim 23, Conway, as modified by Alvarado, teaches the assembly according to claim 22.
The combination does not teach further comprising a collection bag enclosed within the container.
In the same field of endeavor, namely an intermittent catheter, Knapp teaches further comprising a collection bag enclosed within the container ([0044] and figures 7a, bag 40 is packaged together with the catheter).
Therefore, 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 Conway, as modified by Alvarado, to incorporate the teachings of Knapp and provide the collection bag as claimed for the purpose of providing closed system that prevent exposure to contaminants to the user as taught by Knapp ([0043]).
Regarding claim 24, Conway, as modified by Alvarado and Knapp, teaches the assembly according to claim 23.
The combination further teaches wherein the collection bag is coupled with the catheter such that the bag is in fluid communication with a lumen of the urinary catheter (Knapp; figure 7a and [0043] bag sealed to funnel 26 of catheter).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
https://www.paperkawaii.com/origami-envelope-box-instructions/
Chalifoux (US 20150076144 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/SETH HAN/ Examiner, Art Unit 3781