DETAILED ACTIONNotice 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 (Fig 12, claims 1-20) in the reply filed on 10/27/2025 is acknowledged. However, upon further review, claims 4, 15, 19-20 are directed to non-elected embodiments and are thus hereby WITHDRAWN. Claims 1-3, 5-14, 16-18 are examined accordingly.
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.
Claim(s) 1-2, 5-8, 11, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0196922 to Hughett, Sr (Hughett) in view of US Patent No. 9,022,212 to Spaargaren et al. (Spaargaren).
Regarding claim 1, 11, Hughett discloses a medical procedure kit (100) comprising a first tray (120), a second tray (110) nested atop and suspended by the first tray, the second tray (110) defining a plurality of preformed compartments configured to receive and house a plurality of medical implements, a foley catheter (132) positioned within a foley catheter compartment of the preformed compartments of the second tray, a drainage system stowed within interior of the first tray (abstract), the drainage system comprising at least a portion of a coiled tubing coupled between the catheter and fluid drain bag (abstract). Hughett does not teach a catheter retention device/plurality of retention devices to retain a different portion of the catheter within the catheter compartment. However, Spaargeren discloses a catheter kit (Fig 2) and in particular discloses a compartment holding elongated medical devices such as a catheter, the compartment comprising retention devices (211, 213, 217, 203) to retain different portions of the catheter within the compartment. One of ordinary skill in the art would have found it obvious to incorporate retention devices to the catheter compartment of Hughett as suggested by Spaargaren to releasably hold the catheter in the compartment and prevent it from falling out.
Regarding claim 2, the modified Hughett further discloses plurality of catheter retention devices (Spaargaren, 211, 213, 217, 203).
Regarding claim 5, Hughett further discloses swab stick compartment (119) with presaturated swab sticks (144).
Regarding claim 6, Hughett further discloses syringe receiving compartment (114) comprising syringe (136).
Regarding claim 7, the modified Hughett further discloses catheter retention devices each configured to retain different portions of the foley catheter (Spaargaren, Fig 2).
Regarding claim 8, the modified Hughett further discloses catheter retention device consists essentially of four catheter devices (Spaargaren, 211, 213, 217, 203).
Regarding claim 18, the modified Hughett teaches the kit of claim 11 and further teaches each catheter retention device (211, 213, 217, 203) partially encircling portions of the catheter (702) (Fig 7).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hughett in view of Spaargaren and US Patent No. 4,226,328 to Beddow.
Regarding claim 3, the modified Hughett teaches the kit of claim 2 but does not explicitly teach the material of the first tray. However, Beddow discloses a catheterization kit and in particular discloses a first tray (11) and second tray (12), the first tray comprising a rigid tray made of thermoplastic material (col. 2, ll. 55-60). One of ordinary skill in the art would have found it obvious to manufacture the tray of Hughett out of thermoplastic material as suggested by Beddow in order to facilitate holding of the contents since it has been held that selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 9-10, 12-14, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hughett in view of Spaargaren and US Patent No. 10,532,184 to De Soto.
Regarding claim 9, the modified Hughett teaches the kit of claim 7 but does not teach retention device defining an aperture through which a portion of the catheter passes. However, De Soto discloses a catheter tray (Fig 5) and in particular discloses a catheter retention device (80) defining an aperture (ties 52) through which a portion of the catheter (50) may pass. One of ordinary skill in the art would have found it obvious to substitute the retention device of the modified Hughett with a functionally equivalent retention device having an aperture as suggested by De Soto in order to retain the catheter since it has been held that simple substitution of one known element for another to obtain predictable results would have been obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Regarding claim 10, the modified Hughett further discloses each catheter device comprising a polygonal protrusion (80, De Soto) extending from a base (72, De Soto) of the second tray (110, Hughett).
Regarding claim 12, the modified Hughett teaches the kit of claim 11 but does not teach retention device comprising a protrusion from a base of the second tray and defining an aperture into which the catheter inserts. However, De Soto discloses a catheter tray (Fig 5) and in particular discloses a catheter retention device comprising a protrusion (80) from the base of the tray defining an aperture (ties 52) through which a portion of the catheter (50) may pass. One of ordinary skill in the art would have found it obvious to substitute the retention device of the modified Hughett with a functionally equivalent retention device having an aperture as suggested by De Soto in order to retain the catheter since it has been held that simple substitution of one known element for another to obtain predictable results would have been obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Regarding claim 13, the modified Hughett teaches the kit of claim 12 and Hughett further teaches catheter compartment defining a barrier wall (A, Fig 1a below) extending from an end of the compartment across a majority of a length of the compartment toward a distal end of the catheter compartment.
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Regarding claim 14, the modified Hughett teaches the kit of claim 13 and Hughett further teaches a connector (134) configured to connect catheter to coiled tubing that includes urine sampling port, the barrier wall (A, Fig 1a above) situated between the port and some of the catheter (Fig 1 above).
Regarding claim 16, the modified Hughett teaches the kit of claim 11 but does not teach each catheter retention device having a polygonal cross section and defining an aperture through which a section of the catheter may pass. However, De Soto discloses a catheter tray (Fig 5) and in particular discloses a catheter retention device (80) having a polygonal cross section and defining an aperture (ties 52) through which a portion of the catheter (50) may pass. One of ordinary skill in the art would have found it obvious to substitute the retention device of the modified Hughett with a functionally equivalent retention device having an aperture as suggested by De Soto in order to retain the catheter since it has been held that simple substitution of one known element for another to obtain predictable results would have been obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Regarding claim 17, the modified Hughett teaches the kit of claim 16 and further teaches swab stick and syringe compartments (119, 114) comprising swab stick (144) and syringes (136).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT POON whose telephone number is (571)270-7425. The examiner can normally be reached Monday thru Friday, 8:30 am to 6:00 pm.
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/ROBERT POON/ Examiner, Art Unit 3735
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