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 .
Election/Restrictions
Applicant’s election without traverse of Species IV (figures 37A-37C and claims 1-20) in the reply filed on 15 April 2026 is acknowledged.
Claim Rejections - 35 USC § 102
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, 3, 4, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 20070084742).
Regarding claim 1, Miller teaches a catheterization system (figures 1A-2B), comprising: a catheterization container (figure 1A and 2A, reference 20) having a length greater than a width (figure 2A, as shown in the annotated figure below), the catheterization container comprising: a bottom panel (figure 2A, reference 30) fixed to opposing side panels (figure 2A, reference 34 and as shown in the annotated figure below) and a first end panel (figure 2A, reference 36); and a top panel (figure 2A, reference 40) fixed to a second end panel (figure 2A, as shown in the annotated figure below), the second end panel fixed to the bottom panel (figure 2A, as shown in the annotated figure below), wherein the top panel and second end panel have a storage configuration enclosing catheterization components in the catheterization container (figure 1A and paragraph 69) and a use configuration exposing the catheterization components in the catheterization container (figure 2A and paragraph 69); and a Foley catheter assembly (paragraph 42, 49, 68 and 69) in the catheterization container (figure 1A).
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Regarding clam 3, Miller teaches all of the claim limitations of claim 1, as shown above. Furthermore, Miller teaches at least some of the catheterization components are secured to an inner surface of the top panel and/or an inner surface of the second end panel (figure 2A, reference 41 and paragraph 69).
Regarding clam 4, Miller teaches all of the claim limitations of claim 3, as shown above. Furthermore, Miller teaches the inner surface of the top panel and/or the inner surface of the second end panel include pockets configured to accommodate the at least some of the catheterization components (figure 2A, as shown in the annotated figure below and paragraph 69).
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Regarding clam 7, Miller teaches all of the claim limitations of claim 3, as shown above. Furthermore, Miller teaches the inner surface of the top panel and/or the inner surface of the second end panel include straps configured to constrain the at least some of the catheterization components (figure 2A, reference 41 and paragraph 69: Inner surface 41 includes straps).
Regarding clam 9, Miller teaches all of the claim limitations of claim 3, as shown above. Furthermore, Miller teaches the inner surface of the top panel and/or the second end panel include procedural indicators near corresponding catheterization components (paragraph 69: the instructions are procedural indicators).
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.
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.
Claims 8, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 20070084742).
Regarding claim 8, Miller teaches all of the claim limitations of claim 3, as shown above. Furthermore, Miller teaches the at least some of the catheterization components include a syringe (figure 2B, reference 136), and wherein the syringe is constrained by straps (figure 2B: syringe 136 is constrained by straps).
Miller does not explicitly teach the syringe is constrained by straps on the inner surface of the top panel. However, Miller does teach straps on the inner surface of the top panel (paragraph 69) and syringes stored within straps (figure 2B, reference 136). Furthermore, Miller states “interior surface 41 of cover 40 may also function as page three with additional devices, components and instructions attached thereto” [paragraph 69]. This would just be a rearrangement of working parts. It has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Miller to have the syringe is constrained by straps on the inner surface of the top panel since the location the syringe Is placed depends on the function and use of the system and where a user prefers the devices and components located, as stated by Miller (paragraph 69).
Regarding clam 10, Miller teaches all of the claim limitations of claim 9, as shown above. Furthermore, Miller teaches the procedural indicators comprise instructions (paragraph 69).
Miller discloses the claimed invention except for the specific arrangement and/or content of indicia (printed matter) set forth in the claim(s). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have the procedural indicators comprise numbers of suggested steps in a sequence of steps for a catheterization procedure since it would only depend on the intended use of the assembly and the desired information to be displayed. Further, it has been held that when the claimed printed matter is not functionally related to the substrate it will not distinguish the invention from the prior art in terms of patentability. In re Gulack, 217 USPQ 401, (CAFC 1983). The fact that the content of the printed matter placed on the substrate may render the device more convenient by providing an individual with a specific type of instruction does not alter the functional relationship. Mere support by the substrate for the printed matter is not the kind of functional relationship necessary for patentability. Thus, there is no novel and unobvious functional relationship between the printed matter e.g. the procedural indicators comprise numbers of suggested steps in a sequence of steps for a catheterization procedure and the substrate e.g. top panel which is required for patentability.
Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004).
Regarding clam 11, Miller teaches all of the claim limitations of claim 10, as shown above. Furthermore, Miller teaches an outer surface of the top panel includes instructions (figure 1A, reference 42 and paragraph 70), the instructions related to the instructions on the inner surface of the top panel and/or the second end panel (figure 2A, reference 41 and paragraph 69).
Miller discloses the claimed invention except for the specific arrangement and/or content of indicia (printed matter) set forth in the claim(s). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have an outer surface of the top panel includes one or more numbers of suggested steps in the sequence of steps for the catheterization procedure, the one or more numbers preceding the numbers on the inner surface of the top panel and/or the second end panel since it would only depend on the intended use of the assembly and the desired information to be displayed. Further, it has been held that when the claimed printed matter is not functionally related to the substrate it will not distinguish the invention from the prior art in terms of patentability. In re Gulack, 217 USPQ 401, (CAFC 1983). The fact that the content of the printed matter placed on the substrate may render the device more convenient by providing an individual with a specific type of instruction does not alter the functional relationship. Mere support by the substrate for the printed matter is not the kind of functional relationship necessary for patentability. Thus, there is no novel and unobvious functional relationship between the printed matter e.g. an outer surface of the top panel includes one or more numbers of suggested steps in the sequence of steps for the catheterization procedure, the one or more numbers preceding the numbers on the inner surface of the top panel and/or the second end panel and the substrate e.g. outer surface which is required for patentability.
Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 20070084742), as applied to claim 1 above, and further in view of Brady (US 1,705,149).
Regarding claim 2, Miller teaches all of the claim limitations of claim 1, as shown above.
Miller does not explicitly teach the top panel and second end panel lie parallel to the bottom panel in the use configuration. However, Brady does teach the top panel (figure 1 and 2, reference 2) and second end panel (figure 1 and 6, reference 6) lie parallel to the bottom panel in the use configuration (figure 1).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Miller to have the top panel and second end panel lie parallel to the bottom panel in the use configuration, as disclosed by Brady, because having the top panel and second end panel lie parallel to the bottom panel in the use configuration allows for full access of the whole container and allows for the container to lay flat.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 20070084742), as applied to claim 4 above, and further in view of Pick (US 4,170,300).
Regarding clam 5, Miller teaches all of the claim limitations of claim 4, as shown above. Furthermore, Miller teaches a plurality of items are disposed in the pockets (figure 2A and paragraph 69).
Miller does not teach a plurality of swabs are disposed in the pockets, each swab of the plurality of swabs including an elongated stem and an absorbent head secured to or integrated with the elongated stem. However, Pick does teach a plurality of swabs (figure 1, reference 48) are disposed in the pocket (figure 1 and 2, reference 22), each swab of the plurality of swabs including an elongated stem (figure 2, as shown in the annotated figure below) and an absorbent head secured to or integrated with the elongated stem (figure 2, as shown in the annotated figure below).
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It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Miller to include a plurality of swabs are disposed in the pockets, each swab of the plurality of swabs including an elongated stem and an absorbent head secured to or integrated with the elongated stem, as disclosed by Pick, because including the plurality of swabs allows for including additional cleansing tools within the system, as explained by Pick (column 2, lines 23-32).
Regarding clam 6, Miller, in view of Pick, teach all of the claim limitations of claim 5, as shown above. Furthermore, Pick teaches a distal portion of the absorbent head is wider than a proximal portion of the absorbent head (figure 2, as shown in the annotated figure above for claim 5), the proximal portion being secured to or integrated with the elongated stem (figure 2, as shown in the annotated figure above for claim 5).
Claims 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 20070084742), as applied to claim 4 above, and further in view of Tomes et al. ( (US 20110290262).
Regarding clam 12, Miller teaches all of the claim limitations of claim 1, as shown above.
Miller does not teach a sterile wrap folded around the catheterization container, the sterile wrap having a folded configuration and an unfolded configuration. However, Tomes does teach a sterile wrap (figure 22, reference 2200 and paragraph 98) folded around the catheterization container (figure 22-30), the sterile wrap having a folded configuration (figure 28) and an unfolded configuration (figure 22).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Miller to include a sterile wrap folded around the catheterization container, the sterile wrap having a folded configuration and an unfolded configuration, as discloses by Tomes, because including the sterile wrap allows for protecting the system within the wrap and also providing an additional accessory for use during a catheterization procedure, as explained by Tomes (paragraph 97 and 98).
Regarding claim 14, Miller, in view of Tomes, teach all of the claim limitations of claim 12, as shown above. Furthermore, Tomes teaches the sterile wrap includes a pocket on an inner surface accessible in the unfolded configuration (paragraph 103: One or more layers of the sterile wrap 2200 includes pockets), the pocket configured to hold items used during a catheterization procedure (paragraph 103: Furthermore, this limitation has been treated as an intended use recitation. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Since the limitation has not been positively claimed, the system of modified Miller is capable of performing the recited function).
Regarding claim 15, Miller, in view of Tomes, teach all of the claim limitations of claim 12, as shown above. Furthermore, Tomes the sterile wrap includes a drape (paragraph 40 and 107, reference 2701) attached to an inner surface accessible in the unfolded configuration (figure 27-29 and paragraph 40 and 106-109), the drape removable from the sterile wrap for use in a catheterization procedure (paragraph 40 and 106).
Claim 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 20070084742), in view of Tomes et al. (US 20110290262), as applied to claim 12 above, and further in view of Clay (US 20020017468).
Regarding claim 13, Miller, in view of Tomes, teach all of the claim limitations of claim 12, as shown above.
Miller, in view of Tomes, do not explicitly teach the sterile wrap is maintained in the folded configuration by a belly band, and wherein the belly band includes orientation instructions and instructions for use of the catheterization tray. However, Clay does teach package is maintained in a configuration by a belly band (figure 5, reference 26 and paragraph 31), and wherein the belly band includes orientation instructions and instructions for use of the catheterization tray (figure 5, reference 26 and 31: the belly band 26 can include printed matter. Furthermore, where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of modified Miller, to include the sterile wrap is maintained in the folded configuration by a belly band, and wherein the belly band includes orientation instructions and instructions for use of the catheterization tray, as disclosed by Clay, because including the belly band allows for holding the package together an allows for providing colored or printed matter for increasing marketing, as explained by Clay (paragraph 31).
Regarding claim 17, Miller, in view of Tomes and Clay, teach all of the claim limitations of claim 13, as shown above. Furthermore, Tomes teaches a pair of sterile gloves (figure 24, reference 2402) are positioned on top of the catheterization container (figure 25) and are accessible after removal of the belly band and transitioning the sterile wrap from the folded configuration to the unfolded configuration (figure 24).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 20070084742), in view of Tomes et al. (US 20110290262), as applied to claim 12 above, and further in view of Primer et al. (US 20080283426).
Regarding claim 16, Miller, in view of Tomes, teach all of the claim limitations of claim 12, as shown above. Furthermore, Tomes teaches a packaging label (figure 29, reference 1001) disposed on top of the sterile wrap (figure 29 and 30, reference 1001) wherein the packaging label is visible to a user after packaging of the catheterization system (figure 30).
Miller, in view of Tomes, do not teach the packaging label including at least three sides folded into a different plane from a top portion of the packaging label, wherein each of the at least three sides of the packaging label are visible to a user after packaging of the catheterization system. However, Primer does teach the packaging label (figure 16, as shown in the annotated figure below) including at least three sides (figure 16, as shown in the annotated figure below) folded into a different plane (figure 16, as shown in the annotated figure below) from a top portion (figure 16, as shown in the annotated figure below) of the packaging label, wherein each of the at least three sides of the packaging label are visible to a user after packaging of the system (figure 16, as shown in the annotated figure below).
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It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of modified Miller, to include the packaging label including at least three sides folded into a different plane from a top portion of the packaging label, wherein each of the at least three sides of the packaging label are visible to a user after packaging of the catheterization system, as disclosed by Primer, because including the packaging label visible from multiple sides allows for viewing pertinent information of the package, as disclosed by Primer (paragraph 76).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 20070084742), in view of Tomes et al. (US 20110290262) and Clay (US 20020017468), as applied to claim 17 above, and further in view of Primer et al. (US 20080283426).
Regarding claim 18, Miller, in view of Tomes and Clay, teach all of the claim limitations of claim 17, as shown above. Furthermore, Tomes teaches a packaging label (figure 29, reference 1001) is positioned over the sterile wrap (figure 29 and 30, reference 1001) in the folded configuration (figure 29 and 30), the packaging label including information squares (figure 12 and 13, reference 1001 and paragraph 66 and 116).
Miller, in view of Tomes and Clay, do not explicitly teach the packaging label including information squares on a top surface and at least two side surfaces. However, Primer does teach the packaging label (figure 16, as shown in the annotated figure below) including information squares on a top surface (figure 16, as shown in the annotated figure below and paragraph 76) and at least two side surfaces (figure 16, as shown in the annotated figure below and paragraph 76).
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It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of modified Miller, to include the packaging label including information squares on a top surface and at least two side surfaces, as disclosed by Primer, because including the packaging label visible from multiple sides allows for viewing pertinent information of the package, as disclosed by Primer (paragraph 76).
Regarding claim 19, Miller, in view of Tomes, Clay and Primer, teach all of the claim limitations of claim 18, as shown above. Furthermore, Tomes teaches a sealed bag (figure 29 and 30, reference 2902) is positioned around the catheterization tray and the packaging label (figure 30) such that the at least two side surfaces are disposed orthogonal to the top surface of the packaging label, thereby providing visibility of the packaging label in multiple planes (figure 30: when combining the teachings of the system of Miller with the sealed bag and packaging label of Tomas and the multiple sides of the packaging label of Primer, this limitation is met).
Regarding claim 20, Miller, in view of Tomes, Clay and Primer, teach all of the claim limitations of claim 19, as shown above. Furthermore, Tomes teaches a perineal care packet (figure 24, reference 2401 and 2402 and paragraph 77) positioned between the sterile wrap in the folded configuration (figure 27-30) and the packaging label (figure 30), wherein the perineal care packet includes one or more items in a sealed baggy (figure 24, reference 2401 and 2402).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alder et al. (US 20140021087) discloses a system with a packaging label and a sealed bag.
Barnett (US 2,804,969) discloses a system comprising a container with top side and bottom panels and straps attached to the inner surface of the top panel with a plurality of tools.
Morelli et al. (US 20100274205) discloses a system within a sealed bag and procedural indicators comprising numbers of suggested steps.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAVIER A PAGAN whose telephone number is (571)270-7719. The examiner can normally be reached Monday - Thursday: 6:30am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER A PAGAN/ Primary Examiner, Art Unit 3735
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