DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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, 5-7, 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 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) 8-10, 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 8, the modified Hughett teaches the kit of claim 7 and further discloses catheter retention device consists essentially of four catheter devices (Spaargaren, 211, 213, 217, 203) but does not teach the devices arranged and sized to define apertures. 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). The modification would have resulted in the retention device permit sliding release as recited since it has the structure as recited.
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). The modification would have resulted in the retention device permit sliding release as recited since it has the structure as recited.
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).
Response to Arguments
Applicant's arguments filed 7/9/2026 have been fully considered but they are not persuasive. Applicant argues that claims 4, 15, 19-20 are not directed to non-elected embodiments. This is not persuasive because the elected embodiment does not disclose another cutout as recited in the claims.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that Hughett and Spaargaren is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both are directed to catheter kits
In response to applicant's argument that adding clips to Hughett would solve different problems and frustrate Hughett, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, incorporating retention devices to Hughett as suggested by Spaargaren would keep the elongated medical instrument in place within the tray.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
