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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Applicant argues that Kerzman/Terry does not anticipate the amended limitations of claims 1, 12, and 20. However, the examiner is relying on Gordon to teach the amended limitations as set forth below. In regards to Gordon, Applicant argues that bonding the lubricant pouch 17 to the envelope 40 of the catheter package as previously applied to now canceled dependent claim 40 does not transform the lubricant pouch 17 into the lubricant section as claimed. However, the claimed separator does not require any specific structure or materials that would preclude the region 26 of Gordon from reading on the claim, as region 26 is a part of the envelope 40 and separates the catheter section holding the catheter from the lubricant section 17 as set forth in the rejection below for claims 1, 12, and 20.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 7, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kerzman (US 20050109648 A1) in view of Terry (US 20120316515 A1) further in view of Gordon (US 3967728 A).
Regarding Claim 1, Kerzman teaches a urinary-catheter package (packaging assembly 10, Fig 1-4), comprising: a urinary catheter (catheter 12, Fig 1-4) including: a catheter tube (tubular portion of catheter 12 disposed between distal end 26 and proximal end 30, Fig 1-4); and a drainage lumen (catheter 12 is a urinary catheter thus implying a drainage lumen, Fig 1-4) extending through the urinary catheter fluidly coupling an eyelet in a distal-end portion of the catheter (eyelet in distal end 26, Fig 1-4) tube with an opening in a proximal end of the urinary catheter (proximal end 30 fluidly communicates with eyelet in distal end 26, Fig 1-4); and a container including a body (packaging assembly 10 includes catheter chamber 18 and lubricant pouch 20, Fig 1-4) defining a catheter section (chamber 18, Fig 1-4); a lubricant section in a distal-end portion of the container (pouch 20 containing lubricant 22 in first end 24 of chamber 18, Fig 1-4); wherein the catheter section of the container holds the urinary catheter (chamber 18 holds catheter 12, Figs 1-4), and the lubricant section of the container holds a lubricant for lubricating the urinary catheter (first end 24 of chamber 18 holds pouch 20 containing lubricant 22, Fig 1-4).
Kerzman is silent regarding a plurality of eyelets, and a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section.
However, Terry teaches a urinary catheter packaging assembly, thus from the same field of endeavor as the claimed invention, wherein the urinary catheter includes a plurality of eyelets (catheter 1 may have one or more drainage eyelets 5, Fig 1 ¶[0012][0025]) because multiple eyelets are typical in urinary catheters for further facilitating urine drainage from the bladder (¶[0024]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman so that the urinary catheter includes a plurality of eyelets as taught by Terry because multiple eyelets are typical in urinary catheters for further facilitating urine drainage from the bladder (as motivated by Terry ¶[0024]).
Kerzman/Terry is silent regarding a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section.
However, Gordon teaches a catheter package with lubricant, thus from the same field of endeavor, wherein a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section (region 26 is a separator between lubricant pouch 17 and the portion of envelope 40 housing catheter 12, Figs 1-4 Col 2 ln 51-Col 3 ln 5, Col 3 ln 56-58) so that one edge is adapted to locally fail when pressure is applied (Col 2 ln 51-Col 3 ln 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry to include a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section, as taught by Gordon so that one edge is adapted to locally fail when pressure is applied (as motivated by Gordon Col 2 ln 51-Col 3 ln 5).
Regarding Claim 7, Kerzman/Terry/Gordon discloses that the separator is a burstable membrane configured to be burst by pressure applied by the user to minor sides of the container (pouch 20 may be made of foil, thus creating a separation between lubricant 22 and the catheter chamber 18 until ruptured by the user by applying pressure to the minor side of the container as shown in Fig 2 ¶[0039]).
Regarding Claim 9, Kerzman/Terry/Gordon discloses that the container is configured to double as a handle when the distal-end portion of the catheter tube is disposed beyond the distal-end portion of the container, the handle allowing the user to manipulate the urinary catheter without touching or contaminating the catheter tube (container 10 may be used as a handle without touching or contaminating catheter tube 12 while inserting the exposed distal end 26, Fig 3 ¶[0010-0013]).
Regarding Claim 10, Kerzman/Terry/Gordon discloses that the container further including a proximal peelable seal over a proximal-end portion of the container, the proximal peelable seal configured to create an opening of the proximal-end portion of the container when the proximal peelable seal is peeled away from the proximal-end portion of the container by the user in a distal direction of the container (proximal end of container 10 may be peeled open by peeling away from the proximal end portion of the container as shown in Fig 17 ¶[0011-0012]).
Regarding Claim 11, Kerzman/Terry/Gordon discloses that the container is configured to double as a drainage extension tube for the urinary catheter when the distal-end portion of the catheter tube is disposed beyond the distal-end portion of the container and the proximal peelable seal is peeled away from the distal-end portion of the container (urine may be drained into a toilet from funnel end 28 while disposed in packaging and using the packaging as a handle Figs 4-5 ¶[0047]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kerzman (US 20050109648 A1) in view of Terry (US 20120316515 A1), further in view of Gordon (US 3967728 A), further in view of Uson (US 4269310 A).
Regarding Claim 6, Kerzman/Terry/Gordon is silent whether the separator is a pierceable membrane configured to be pierced by a tip of the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container into the lubricant section.
However, Uson teaches a urinary catheter container with lubricant, thus from the same field of endeavor, wherein the separator is a pierceable membrane (wall 3 separating lubricant 4 from the rest of container 1 is fragile and pierceable, Fig 1 [abstract]) configured to be pierced by a tip of the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container into the lubricant section (catheter tip may pass through membrane 3 into enclosure 2 which contains lubricant 4 Col 1 ln 42-48) so that the catheter may be inserted into the patient by manipulating the outer sleeve of the container, without the physician requiring sterile gloves, forceps, or other instruments ([abstract]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry/Gordon so that the separator is a pierceable membrane configured to be pierced by a tip of the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container into the lubricant section, as taught by Uson so that the catheter may be inserted into the patient by manipulating the outer sleeve of the container, without the physician requiring sterile gloves, forceps, or other instruments (as motivated by Uson [abstract]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kerzman (US 20050109648 A1) in view of Terry (US 20120316515 A1), further in view of Gordon (US 3967728 A), further in view of Yin (US 20180104444 A1).
Regarding Claim 8, Kerzman/Terry is silent wherein the separator is a pressed seal formed between major sides of the container, the pressed seal coupled to a pull tab configured to unseal the pressed seal when the pull tab is pulled away from the pressed seal by the user.
However, Gordon teaches a catheter package with lubricant, thus from the same field of endeavor, wherein the separator is a pressed seal formed between major sides of the container (region 26 of lubricant pouch 17 is a heat seal, Figs 1-4 Col 2 ln 51-Col 3 ln 5) so that one edge is adapted to locally fail when pressure is applied (Col 2 ln 51-Col 3 ln 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry so that the separator is a pressed seal formed between major sides of the container, as taught by Gordon so that one edge is adapted to locally fail when pressure is applied (as motivated by Gordon Col 2 ln 51-Col 3 ln 5).
Kerzman/Terry/Gordon is silent whether the pressed seal is coupled to a pull tab configured to unseal the pressed seal when the pull tab is pulled away from the pressed seal by the user.
However, Yin teaches a urinary catheter and container, thus from the same field of endeavor, wherein a seal is coupled to a pull tab configured to unseal the seal when the pull tab is pulled away from the seal by the user (adhesive tab 222 is coupled to sealed opening 220 in urinary catheter packaging 200, which is pulled by the user to open the sealed area, Fig 4A-C ¶[0045-0046]) to facilitate opening of the container with more ease (¶[0047])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry/Gordon so that the pressed seal is coupled to a pull tab configured to unseal the pressed seal when the pull tab is pulled away from the pressed seal by the user, as taught by Yin to facilitate the unsealing of the pressed seal with more ease (as motivated by Yin ¶[0047]).
Claims 2-5, 12-19 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Kerzman (US 20050109648 A1) in view of Terry (US 20120316515 A1), in view of Gordon (US 3967728 A), further in view of Golden (WO 9806642 A1).
Regarding Claims 2 and 3, Kerzman/Terry/Gordon is silent whether the container further including a tapered outlet in the distal-end portion of the container, the tapered outlet opposite the catheter section with the lubricant section therebetween, the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, wherein the container further including a tapered outlet in the distal-end portion of the container (package 11 includes a tapered section at opening 52 in first end portion 21, Fig 1-3A), the tapered outlet opposite the catheter section with the lubricant section therebetween (tapered area at opening 52 is opposite catheter subchamber 45 with lubricant subchamber 40 therebetween, Fig 1-3A), the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container (located adjacent opening 52, peelable first opening initiating means 72 is created by manually gripping and pulling end portions 70 and 71, Fig 1-3A Col 18 ln 8-14) to assist with guiding the catheter out of the packaging assembly (Col 4 ln 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry/Gordon so that the container further including a tapered outlet in the distal-end portion of the container, the tapered outlet opposite the catheter section with the lubricant section therebetween, the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container, as taught by Golden to assist with guiding the catheter out of the packaging assembly (as motivated by Golden Col 4 ln 7-10).
Regarding Claim 4, the combination of Kerzman/Terry/Gordon/Golden teaches the distal peelable seal and tapered opening as set forth above for claims 2-3. Kerzman further discloses a set of one or more indicators printed thereon, the set of indicators configured to guide the user in sizing the opening (printed instructions for the user to cut or tear to make a specifically sized opening. Kerzman also discloses printed instructions at the funnel end to peel the packaging open ¶[0007]).
Kerzman/Terry/Gordon is silent regarding the set of indicators configured to guide the user in sizing the opening of the tapered outlet when peeling the first peelable seal from the tapered outlet.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, and teaches in that a peelable opening may be used at both ends of the catheter packaging, and teaches that a peel opening and tear opening are structural equivalents to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (Col 4 ln 11-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry/Gordon/Golden to guide the user in sizing the opening of the tapered outlet when peeling the distal peelable seal from the tapered outlet to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (as motivated by Golden Col 4 ln 11-16). In combination Kerzman/Terry/Gordon/Golden would include the printed indicia for sizing the opening disclosed by Kerzman at the distal end which includes the tapering outlet and peelable opening taught by Golden. Thus, in combination Kerzman/Terry/Gordon/Golden would include the set of indicators configured to guide the user in sizing the opening of the tapered outlet when peeling the first peelable seal from the tapered outlet.
Regarding Claim 5, Kerzman/Terry/Gordon/Golden teaches the invention of claim 4 as set forth above. Kerzman/Terry/Gordon is silent whether a size of the opening of the tapered outlet defines an amount of the lubricant that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section, and out the opening of the tapered outlet.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, wherein a size of the opening of the tapered outlet defines an amount of the lubricant (a size of opening 52 necessarily defines the amount of substance that can flow therethrough, Fig 1-3A) that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section, and out the opening of the tapered outlet (advancement of the catheter from the packaging is described in Col 8 ln 16-Col 9 ln-20) to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (Col 4 ln 11-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry/Gordon/Golden so that a size of the opening of the tapered outlet defines an amount of the lubricant that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section, and out the opening of the tapered outlet, as taught by Golden to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (as motivated by Golden Col 4 ln 11-16).
Regarding Claims 12-13, Kerzman teaches a urinary-catheter package (packaging assembly 10, Fig 1-4), comprising: a urinary catheter (catheter 12, Fig 1-4) including: a catheter tube (tubular portion of catheter 12 disposed between distal end 26 and proximal end 30, Fig 1-4); a funnel coupled to a proximal-end portion of the catheter tube (funnel 28, Fig 1-4); an eyelet in a distal-end portion of the catheter (eyelet in distal end 26, Fig 1-4); and a drainage lumen (catheter 12 is a urinary catheter thus implying a drainage lumen, Fig 1-4) extending through the urinary catheter fluidly coupling an eyelet in a distal-end portion of the catheter (eyelet in distal end 26, Fig 1-4) tube with an opening in a proximal end of the funnel (proximal end 30 which includes funnel 28 fluidly communicates with eyelet in distal end 26, Fig 1-4); and a container including a body (packaging assembly 10 includes catheter chamber 18 and lubricant pouch 20, Fig 1-4) defining a catheter section (chamber 18, Fig 1-4); a lubricant section in a distal-end portion of the container (pouch 20 containing lubricant 22 in first end 24 of chamber 18, Fig 1-4), wherein the catheter section of the container holds the urinary catheter (chamber 18 holds catheter 12, Figs 1-4), and the lubricant section of the container holds a lubricant for easing insertion of the urinary catheter into a urethra of a user (first end 24 of chamber 18 holds pouch 20 containing lubricant 22, Fig 1-4).
Kerzman is silent regarding a plurality of eyelets, and a tapered outlet in a distal-end portion of the container, the lubricant disposed in the lubricant section between the urinary catheter and the tapered outlet, the lubricant section between the catheter section and the tapered outlet of the container, the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container; and a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section.
However, Terry teaches a urinary catheter packaging assembly, thus from the same field of endeavor as the claimed invention, wherein the urinary catheter includes a plurality of eyelets (catheter 1 may have one or more drainage eyelets 5, Fig 1 ¶[0012][0025]) because multiple eyelets are typical in urinary catheters for further facilitating urine drainage from the bladder (¶[0024]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman so that the urinary catheter includes a plurality of eyelets as taught by Terry because multiple eyelets are typical in urinary catheters for further facilitating urine drainage from the bladder (as motivated by Terry ¶[0024]).
Kerzman/Terry is silent regarding a tapered outlet in a distal-end portion of the container, the lubricant disposed in the lubricant section between the urinary catheter and the tapered outlet, the lubricant section between the catheter section and the tapered outlet of the container, the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container; and a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, including a tapered outlet in a distal-end portion of the container, the lubricant disposed in the lubricant section between the urinary catheter and the tapered outlet (package 11 includes a tapered section at opening 52 in first end portion 21, with tapered area at opening 52 is opposite catheter subchamber 45 with lubricant subchamber 40 therebetween, Fig 1-3A), the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container (located adjacent opening 52, peelable first opening initiating means 72 is created by manually gripping and pulling end portions 70 and 71, Fig 1-3A Col 18 ln 8-14) to assist with guiding the catheter out of the packaging assembly (Col 4 ln 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry so that he container further including a tapered outlet in the distal-end portion of the container, the lubricant disposed in the lubricant section between the urinary catheter and the tapered outlet, the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container, as taught by Golden to assist with guiding the catheter out of the packaging assembly (as motivated by Golden Col 4 ln 7-10).
Kerzman/Terry/Golden is silent regarding a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section.
However, Gordon teaches a catheter package with lubricant, thus from the same field of endeavor, wherein a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section (region 26 is a separator between lubricant pouch 17 and the portion of envelope 40 housing catheter 12, Figs 1-4 Col 2 ln 51-Col 3 ln 5, Col 3 ln 56-58) so that one edge is adapted to locally fail when pressure is applied (Col 2 ln 51-Col 3 ln 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry to include a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section, as taught by Gordon so that one edge is adapted to locally fail when pressure is applied (as motivated by Gordon Col 2 ln 51-Col 3 ln 5).
Regarding Claim 14, the combination of Kerzman/Terry/Gordon/Golden teaches the distal peelable seal and tapered opening as set forth above for claims 12-13. Kerzman further discloses a set of one or more indicators printed thereon, the set of indicators configured to guide the user in sizing the opening (printed instructions for the user to cut or tear to make a specifically sized opening. Kerzman also discloses printed instructions at the funnel end to peel the packaging open ¶[0007]).
Kerzman/Terry/Gordon is silent regarding the set of indicators configured to guide the user in sizing the opening of the tapered outlet when peeling the distal peelable seal from the tapered outlet.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, and teaches in that a peelable opening may be used at both ends of the catheter packaging, and teaches that a peel opening and tear opening are structural equivalents to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (Col 4 ln 11-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry/Gordon/Golden to guide the user in sizing the opening of the tapered outlet when peeling the first peelable seal from the tapered outlet to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (as motivated by Golden Col 4 ln 11-16). In combination Kerzman/Terry/Gordon/Golden would include the printed indicia for sizing the opening disclosed by Kerzman at the distal end which includes the tapering outlet and peelable opening taught by Golden. Thus, in combination Kerzman/Terry/Golden would include the set of indicators configured to guide the user in sizing the opening of the tapered outlet when peeling the distal peelable seal from the tapered outlet.
Regarding Claim 15, Kerzman/Terry/Gordon/Golden teaches the invention of claim 14 as set forth above. Kerzman/Terry/Gordon is silent whether a size of the opening of the tapered outlet defines an amount of the lubricant that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section of the container, and out the opening of the tapered outlet.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, wherein a size of the opening of the tapered outlet defines an amount of the lubricant (a size of opening 52 necessarily defines the amount of substance that can flow therethrough, Fig 1-3A) that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section of the container, and out the opening of the tapered outlet (advancement of the catheter from the packaging is described in Col 8 ln 16-Col 9 ln-20) to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (Col 4 ln 11-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry/Gordon/Golden so that a size of the opening of the tapered outlet defines an amount of the lubricant that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section of the container, and out the opening of the tapered outlet, as taught by Golden to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (as motivated by Golden Col 4 ln 11-16).
Regarding Claim 16, Kerzman/Terry/Gordon/Golden discloses that the separator is configured to be burst and release lubricant by pressure applied by the user to minor sides of the container (pouch 20 may be made of foil, thus creating a separation between lubricant 22 and the catheter chamber 18 until ruptured by the user by applying pressure to the minor side of the container as shown in Fig 2 ¶[0039]).
Regarding Claim 17, Kerzman/Terry/Gordon/Golden discloses that the container is configured to double as a handle when the distal-end portion of the catheter tube is disposed beyond the distal-end portion of the container, the handle allowing the user to manipulate the urinary catheter without touching or contaminating the catheter tube (container 10 may be used as a handle without touching or contaminating catheter tube 12 while inserting the exposed distal end 26, Fig 3 ¶[0010-0013]).
Regarding Claim 18, Kerzman/Terry/Gordon/Golden discloses that the container further including a proximal peelable seal over a proximal-end portion of the container, the proximal peelable seal configured to create an opening of the proximal-end portion of the container when the proximal peelable seal is peeled away from the proximal-end portion of the container by the user in a distal direction of the container (proximal end of container 10 may be peeled open by peeling away from the proximal end portion of the container as shown in Fig 17 ¶[0011-0012]).
Regarding Claim 19, Kerzman/Terry/Gordon/Golden discloses that the container is configured to double as a drainage extension tube for the urinary catheter when the distal-end portion of the catheter tube is disposed beyond the distal-end portion of the container and the proximal peelable seal is peeled away from the proximal-end portion of the container (urine may be drained into a toilet from funnel end 28 while disposed in packaging and using the packaging as a handle Figs 4-5 ¶[0047]).
Regarding Claim 42, Kerman/Terry/Gordon is silent regarding a distal peelable seal over the lubricant section in the distal-end portion of the container is configured to define an amount of the lubricant that lubricates the urinary catheter by a size of the opening created when the distal peelable seal is peeled away from the container.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, including a distal peelable seal over the lubricant section in the distal-end portion of the container is configured to define an amount of the lubricant that lubricates the urinary catheter by a size of an opening created when the distal peelable seal is peeled away from the container (located adjacent opening 52, peelable first opening initiating means 72 is created by manually gripping and pulling end portions 70 and 71. The degree to which end portions 70 and 71 are pulled necessarily defines an amount of lubricant by a size of an opening created by pulling 70 and 71 Fig 1-3A Col 18 ln 8-14) to assist with guiding the catheter out of the packaging assembly (Col 4 ln 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerman/Terry/Gordon to include a distal peelable seal over the lubricant section in the distal-end portion of the container is configured to define an amount of the lubricant that lubricates the urinary catheter by a size of the opening created when the distal peelable seal is peeled away from the container.
Claims 20-23, 25, 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Kerzman (US 20050109648 A1) in view of Gordon (US 3967728 A), in view of Golden (WO 9806642 A1).
Regarding Claims 20-21, Kerzman teaches a container for a urinary-catheter package (packaging assembly 10, Fig 1-4), comprising a body (packaging assembly 10 includes catheter chamber 18 and lubricant pouch 20, Fig 1-4) defining a catheter section (chamber 18, Fig 1-4); a lubricant section in a distal-end portion of the container (pouch 20 containing lubricant 22 in first end 24 of chamber 18, Fig 1-4); wherein the catheter section of the container holds the urinary catheter (chamber 18 holds catheter 12, Figs 1-4), and the lubricant section of the container holds a lubricant for easing insertion of the urinary catheter into a urethra of a user (first end 24 of chamber 18 holds pouch 20 containing lubricant 22, Fig 1-4).
Kerzman is silent regarding a tapered outlet in a distal-end portion of the container, the tapered outlet opposite the catheter section with the lubricant section therebetween, the lubricant section between the catheter section and the tapered outlet of the container, the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container, and a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, including a tapered outlet in a distal-end portion of the container, the tapered outlet opposite the catheter section with the lubricant section therebetween the lubricant section between the catheter section and the tapered outlet of the container (package 11 includes a tapered section at opening 52 in first end portion 21, with tapered area at opening 52 is opposite catheter subchamber 45 with lubricant subchamber 40 therebetween, Fig 1-3A), the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container (located adjacent opening 52, peelable first opening initiating means 72 is created by manually gripping and pulling end portions 70 and 71, Fig 1-3A Col 18 ln 8-14) to assist with guiding the catheter out of the packaging assembly (Col 4 ln 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Terry so that he container further including a tapered outlet in the distal-end portion of the container, the tapered outlet opposite the catheter section with the lubricant section therebetween, the lubricant section between the catheter section and the tapered outlet of the container, the container further including a distal peelable seal over a major side of the tapered outlet, the distal peelable seal configured to create an opening of the tapered outlet when the distal peelable seal is peeled away from the tapered outlet by the user in a proximal direction of the container, as taught by Golden to assist with guiding the catheter out of the packaging assembly (as motivated by Golden Col 4 ln 7-10).
Kerzman/Golden is silent regarding a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section.
However, Gordon teaches a catheter package with lubricant, thus from the same field of endeavor, wherein a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section (region 26 is a separator between lubricant pouch 17 and the portion of envelope 40 housing catheter 12, Figs 1-4 Col 2 ln 51-Col 3 ln 5, Col 3 ln 56-58) so that one edge is adapted to locally fail when pressure is applied (Col 2 ln 51-Col 3 ln 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Golden to include a separator between the lubricant section and the catheter section to separate the lubricant section from the catheter section, as taught by Gordon so that one edge is adapted to locally fail when pressure is applied (as motivated by Gordon Col 2 ln 51-Col 3 ln 5).
Regarding Claim 22, the combination of Kerzman/Golden/Gordon teaches the distal peelable seal and tapered opening as set forth above for claims 20-21. Kerzman further discloses a set of one or more indicators printed thereon, the set of indicators configured to guide the user in sizing the opening (printed instructions for the user to cut or tear to make a specifically sized opening. Kerzman also discloses printed instructions at the funnel end to peel the packaging open ¶[0007]).
Kerzman is silent regarding the set of indicators configured to guide the user in sizing the opening of the tapered outlet when peeling the distal peelable seal from the tapered outlet.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, and teaches in that a peelable opening may be used at both ends of the catheter packaging, and teaches that a peel opening and tear opening are structural equivalents to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (Col 4 ln 11-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Golden/Gordon to guide the user in sizing the opening of the tapered outlet when peeling the distal peelable seal from the tapered outlet to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (as motivated by Golden Col 4 ln 11-16). In combination Kerzman/Golden would include the printed indicia for sizing the opening disclosed by Kerzman at the distal end which includes the tapering outlet and peelable opening taught by Golden. Thus, in combination Kerzman/Golden would include the set of indicators configured to guide the user in sizing the opening of the tapered outlet when peeling the first peelable seal from the tapered outlet.
Regarding Claim 23, Kerzman/Golden/Gordon teaches the invention of claim 22 as set forth above. Kerzman/Terry is silent whether a size of the opening of the tapered outlet defines an amount of the lubricant that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section, and out the opening of the tapered outlet.
However, Golden teaches a urinary catheter assembly with lubricant, thus from the same field of endeavor, wherein a size of the opening of the tapered outlet defines an amount of the lubricant (a size of opening 52 necessarily defines the amount of substance that can flow therethrough, Fig 1-3A) that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section, and out the opening of the tapered outlet (advancement of the catheter from the packaging is described in Col 8 ln 16-Col 9 ln-20) to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (Col 4 ln 11-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Golden so that a size of the opening of the tapered outlet defines an amount of the lubricant that lubricates the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container, through the lubricant section, and out the opening of the tapered outlet, as taught by Golden to allow for better controlling of the opening of the catheter chamber so as not to expose the catheter to a contaminated surface as it is extended from the package (as motivated by Golden Col 4 ln 11-16).
Regarding Claim 25, Kerzman/Gordon/Golden discloses that the separator is a burstable membrane configured to be burst by pressure applied by the user to minor sides of the container (pouch 20 may be made of foil, thus creating a separation between lubricant 22 and the catheter chamber 18 until ruptured by the user by applying pressure to the minor side of the container as shown in Fig 2 ¶[0039]).
Regarding Claim 27, Kerzman/Gordon/Golden discloses that the container is configured to double as a handle when the distal-end portion of the catheter tube is disposed beyond the distal-end portion of the container, the handle allowing the user to manipulate the urinary catheter without touching or contaminating the catheter tube (container 10 may be used as a handle without touching or contaminating catheter tube 12 while inserting the exposed distal end 26, Fig 3 ¶[0010-0013]).
Regarding Claim 28, Kerzman/Gordon/Golden discloses that the container further including a second peelable seal over a proximal-end portion of the container, the proximal peelable seal configured to create an opening of the proximal-end portion of the container when the proximal peelable seal is peeled away from the proximal-end portion of the container by the user in a distal direction of the container (proximal end of container 10 may be peeled open by peeling away from the proximal end portion of the container as shown in Fig 17 ¶[0011-0012]).
Regarding Claim 29, Kerzman/Gordon/Golden discloses that the container is configured to double as a drainage extension tube for the urinary catheter when the distal-end portion of the catheter tube is disposed beyond the distal-end portion of the container and the second peelable seal is peeled away from the proximal-end portion of the container (urine may be drained into a toilet from funnel end 28 while disposed in packaging and using the packaging as a handle Figs 4-5 ¶[0047]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Kerzman (US 20050109648 A1) in view of Gordon (US 3967728 A), in view of Golden (WO 9806642 A1), further in view of further in view of Uson (US 4269310 A).
Regarding Claim 24, Kerzman/Gordon/Golden is silent whether the separator is a pierceable membrane configured to be pierced by a tip of the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container into the lubricant section.
However, Uson teaches a urinary catheter container with lubricant, thus from the same field of endeavor, wherein the separator is a pierceable membrane (wall 3 separating lubricant 4 from the rest of container 1 is fragile and pierceable, Fig 1 [abstract]) configured to be pierced by a tip of the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container into the lubricant section (catheter tip may pass through membrane 3 into enclosure 2 which contains lubricant 4 Col 1 ln 42-48) so that the catheter may be inserted into the patient by manipulating the outer sleeve of the container, without the physician requiring sterile gloves, forceps, or other instruments ([abstract]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Gordon/Golden so that the separator is a pierceable membrane configured to be pierced by a tip of the catheter tube when the user distally advances the distal-end portion of the catheter tube from the catheter section of the container into the lubricant section, as taught by Uson so that the catheter may be inserted into the patient by manipulating the outer sleeve of the container, without the physician requiring sterile gloves, forceps, or other instruments (as motivated by Uson [abstract]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Kerzman (US 20050109648 A1) in view of Golden (WO 9806642 A1), further in view of Gordon (US 3967728 A), further in view of Yin (US 20180104444 A1).
Regarding Claim 26, Kerzman/Golden is silent wherein the separator is a pressed seal formed between major sides of the container, the pressed seal coupled to a pull tab configured to unseal the pressed seal when the pull tab is pulled away from the pressed seal by the user.
However, Gordon teaches a catheter package with lubricant, thus from the same field of endeavor, wherein the separator is a pressed seal formed between major sides of the container (region 26 of lubricant pouch 17 is a heat seal, Figs 1-4 Col 2 ln 51-Col 3 ln 5) so that one edge is adapted to locally fail when pressure is applied (Col 2 ln 51-Col 3 ln 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Golden so that the separator is a pressed seal formed between major sides of the container, as taught by Gordon so that one edge is adapted to locally fail when pressure is applied (as motivated by Gordon Col 2 ln 51-Col 3 ln 5).
Kerzman/Golden/Gordon is silent whether the pressed seal is coupled to a pull tab configured to unseal the pressed seal when the pull tab is pulled away from the pressed seal by the user.
However, Yin teaches a urinary catheter and container, thus from the same field of endeavor, wherein a seal is coupled to a pull tab configured to unseal the seal when the pull tab is pulled away from the seal by the user (adhesive tab 222 is coupled to sealed opening 220 in urinary catheter packaging 200, which is pulled by the user to open the sealed area, Fig 4A-C ¶[0045-0046]) to facilitate opening of the container with more ease (¶[0047])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kerzman/Golden/Gordon so that the pressed seal is coupled to a pull tab configured to unseal the pressed seal when the pull tab is pulled away from the pressed seal by the user, as taught by Yin to facilitate the unsealing of the pressed seal with more ease (as motivated by Yin ¶[0047]).
Conclusion
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781