DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
The claims contain minor informalities.
In claim 4, the language “… wherein one of the first syringe or the second syringe [[it]] is at least …” should be changed for clarity.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Independent claims 1, 8 and 14 are rejected over one or more of the following patents. Table 1 shows which claims of each patent correspond to the independent claims of the present invention.
Table 1: double patenting references
Patent cited in rejection
For claims 1 and 8
For claim 14
Tomes; Jennifer E. et al.
US 12458329 B2
18, 20
(none)
Lockwood; Robert et al.
US 10946169 B2
1, 17, 19
(none)
Tomes; Jennifer E. et al.
US 10512752 B2
1, 10,
(none)
Tomes; Jennifer E. et al.
US 9522753 B2
1, 11-13
1, 11-13, 16, 17
Tomes; Jennifer E. et al.
US 9745088 B2
1, 45, 46, 50, 51
1, 17, 18, 45, 46, 50, 51
Tomes; Jennifer E. et al.
US 11661220 B2
8, 9, 11, 12, 15
(none)
Tomes; Jennifer E. et al.
US 11684347 B2
17-19
(none)
Claims 2, 3, 5-7, 9-11, 13, 15, 16, 18-20 and 21-28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4, 45-46, 49, 51-52, 54 and 56 of Tomes; Jennifer E. et al. (US 9745088 B2).
Regarding pending claims 2, 3 and 11, Tomes claims that the first and second syringes contains one of the lubricating jelly or water (claim 46, wherein one of the first syringe or the second syringe contains lubricating jelly). Although Tomes does not specify which of the first or second syringes contains lubricating jelly or water, Tomes provides only two options. Selecting one of these two options would have been obvious due to the small number of options to select.
Regarding pending claims 5-7, 9, 10, 13, 15, 16 and 18-20, Tomes claims a kit wherein the first compartment is adjacent to, and separated by a wall from, the second compartment (claim 1, A medical procedure kit, comprising: a tray having a compartment … and the tray comprises a surface defining at least two compartments, claim 4, the at least two compartments bounded by a perimeter wall less than three inches in height);
wherein the lubricating jelly application chamber is configured to lubricate at least a portion of the medical assembly when the portion of the medical assembly is passed from the first compartment to the second compartment (claim 51, the lubricating jelly application compartment to receive lubricating jelly from one of the first syringe or the second syringe to lubricate at least some of the Foley catheter);
the tray comprising a single layer tray (claim 45, a single layer tray);
further comprising one or more swab sticks disposed within the single layer tray (claim 54, further comprising one or more swabsticks disposed within the single layer tray);
the first compartment comprising one or more contours for accommodating flanges of one or more of the first syringe or the second syringe (claim 4, the first compartment defines one or more contours for accommodating flanges of one or more of the first syringe or the second syringe).
Regarding pending claims 21-28, Tomes claims a kit wherein the one or more folds of the at least one layer of wrap enclosing the single layer tray are configured such that the single layer tray and other implements are revealed when the one or more folds are unfolded (claim 45, at least one layer of wrap material enclosing the single layer tray within one or more folds of the at least one layer of wrap material; claim 49, further comprising a specimen jar disposed within the single layer tray; claim 52, further comprising printed instructions for using the single layer tray; claim 54, further comprising one or more swabsticks disposed within the single layer tray; claim 56, further comprising an underbuttocks drape disposed within the outer packaging);
wherein the other implements comprise an additional layer of wrap material comprising an underbuttocks drape (claim 56, further comprising an underbuttocks drape disposed within the outer packaging);
wherein removal of the additional layer of wrap material reveals at least portions of one or more items situated within the single layer tray, comprising the Foley catheter (claim 45, wherein the medical assembly comprises a coiled tubing coupled between a fluid drain bag and a Foley catheter);
wherein the one or more folds of the at least one layer of wrap enclosing the single layer tray are configured such that an additional layer of wrap and the Foley catheter are revealed when the one or more folds are unfolded (claim 45, wherein the medical assembly comprises a coiled tubing coupled between a fluid drain bag and a Foley catheter, claim 56, further comprising an underbuttocks drape disposed within the outer packaging).
Although Tomes does not explicitly claim that unfolding the wrap reveals the single layer tray and other implements. However, Tomes stores the other implements in the tray, and then encloses them inside the wrap. Therefore, when the wrap is unfolded, it will reveal the other implements.
Each of the following references claims a catheter kit, tray or assembly. However, none of the cited references claims all features of claims 1, 8 or 14. Therefore none of these references are cited in a double patenting rejection.
Tomes; Jennifer E. et al. US 9808596 B2
Tomes; Jennifer E. et al. US 10512752 B2
Tomes; Jennifer E. et al. US 10946992 B2
Tomes; Jennifer E. et al. US 8678190 B2
Tomes; Jennifer E. et al. US 9693756 B2
Allowable Subject Matter
Claims 4, 12 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Alternatively, the double patenting rejections may be overcome by a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d).
The following is a statement of reasons for the indication of allowable subject matter.
All references cited in the following IPR cases have been reviewed.
IPR2015-00509
IPR2015-00511
IPR2015-00513
IPR2019-00035
IPR2019-00036
IPR2019-00109
IPR2025-00401
The most recent case IPR2025-00401 cites the following references.
Disston; Hamilton S US 3166189 A
Serany; Frank J. Jr. et al. US 3329261 A
Rauschenberger; Richard A. US 4160505 A
Beddow; David V. US 4226328 A
Salvadori; Lawrence A. US 5931303 A
Vagley; Richard T. US 6158437 A
Solazzo; Anthony US 7278987 B2
Fulbrook; Jason D. et al. US 7967137 B2
Tomes; Jennifer E. et al. US 11661219 B2
On 26 March 2025, IPR2025-00401 was abandoned due to a Joint Motion to Terminate. The BPAI has not issued any decision on the merits in this proceeding.
Case IPR2019-00109 cites the following references.
Disston; Hamilton S US 3166189 A
Serany; Frank J. Jr. et al. US 3329261 A
Franks-Farah; Judith et al. US 6840379 B2
Solazzo; Anthony US 7278987 B2
On 04 May 2020 the BPAI issued a decision for IPR2019-00109. The BPAI found that claims 1–19 and 22–25 of Lockwood; Robert et al. (US 9795761 B2) are not unpatentable over the cited references.
Conclusion
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/Adam Marcetich/
Primary Examiner, Art Unit 3781