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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/10/2026 has been entered.
Response to Arguments
Applicant's arguments filed 4/10/2026 have been fully considered but they are not persuasive. Beddow does teach a first compartment (the lower level tray with compartment Y) with a continuous ledge (Z) at a constant level (see annotated fig. 6).
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.
Claim(s) 1-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serany et al. (US 3329261 A) in view of Beddow (US 4226328 A).
Regarding claim 1, Serany discloses a multi-level packaging assembly (fig. 5), comprising:
a top tray level (12);
a lower tray level (10) upon which the top tray level (12) is removably positioned (column 2 lines 33-35);
one or more compartment barriers (Z, annotated fig. 6) which define a first compartment (Y, annotated fig. 6) within the lower tray level (10);
wherein the first compartment barriers (Z) have a continuous ledge at a constant level with respect to a bottom of the lower tray level (annotated fig. 6) defined within the first compartment (Y);
a base (A, underside of compartment Y) defined within the first compartment (Y), wherein the base (A, annotated fig. 7) is uninclined relative to the bottom of the lower tray level (annotated fig. 6); and
at least one layer of wrap (14) sized so as to fold over and enclose both the lower tray (10) level and the top tray level (24) when the top tray level (12) is positioned upon the lower tray level (10, column 1 lines 60-63) such that unfolding of the at least one layer of wrap reveals the top tray level (12, column 2 lines 1-8).
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Put simply, Serany discloses a catheterization tray with two levels that separate the catheter on the bottom level from the preparatory materials, such as gloves and other items needed for the procedure, on an upper level. However, Serany fails to disclose such that the first compartment is sized to accommodate a single syringe.
Beddow teaches a similar device in the same field of endeavor such that the first compartment (X, annotated fig. 1) is sized to accommodate a single syringe (14, column 2 lines 47-55).
Put simply, Beddow discloses a catheterization tray with two levels and the syringe is housed in the bottom tray. Sereny discloses a syringe but it is housed in the top tray; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottom tray level of Sereny and incorporate the syringe compartment of Beddow to utilize the bottom space. Further, it would have been obvious to move the syringe to the bottom compartment as taught by Beddow since it has been held that rearranging parts of an invention involves only routine skill in the art and the placement of the syringe in the it is not integral to the function of the assembly.
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Regarding claim 2, the combination of Serany and Beddow discloses the assembly of claim 1. Serany further discloses where folds or corners (18a, 18b, 18c, figs. 2, 2a) of the at least one layer of wrap (14) are free of any items (column 2 lines 1-21).
Regarding claim 3, the combination of Serany and Beddow discloses the assembly of claim 2. Serany further discloses wherein folds or corners (18a, 18b, 18c, figs. 2, 2a) of the at least one layer of wrap (14) are free of hand sanitizer, additional wrap, and instructions (figs. 2, 2a, column 2 lines 1-21).
Regarding claim 4, the combination of Serany and Beddow discloses the assembly of claim 1. Serany further discloses wherein the top tray level (12) comprises at least one ridge (26) along a surface (C, side edge surface, annotated fig. 6) of the top tray level (12).
Regarding claim 5, the combination of Serany and Beddow discloses the assembly of claim 1. Serany further discloses further comprising at least one pair of gloves (22) positioned upon the top tray level (24, fig. 5, column 2 lines 29-33).
Regarding claim 6, the combination of Serany and Beddow discloses the assembly of claim 1. Serany further discloses comprising at least one drape (24) in a folded configuration positioned upon the top tray level (12, fig. 5).
Regarding claim 7, the combination of Serany and Beddow discloses the assembly of claim 1. However, Serany fails to disclose further comprising a single syringe positioned within the first compartment.
Beddow teaches further comprising a single syringe (14) positioned within the first compartment (X, column 2 lines 47-55).
Put simply, Beddow discloses a catheterization tray with two levels and the syringe is housed in the bottom tray. Sereny discloses a syringe but it is housed in the top tray; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottom tray level of Sereny and incorporate the syringe compartment of Beddow to utilize the bottom space. Further, it would have been obvious to move the syringe to the bottom compartment as taught by Beddow since it has been held that rearranging parts of an invention involves only routine skill in the art and the placement of the syringe in the it is not integral to the function of the assembly.
Regarding claims 8 and 9, the combination of Serany and Beddow discloses the assembly of claim 1. However, Serany fails to disclose (claim 8) wherein the lower tray level further defines a second compartment adjacent to the first compartment and (claim 9) wherein the second compartment is sized for receiving a sample bottle.
Beddow teaches wherein the lower tray level (11) with first compartment (X, annotated fig. 1), but Beddow does not expressly disclose a second compartment. Both Beddow and Serany teach a sample bottle, but is housed in the upper trays not the lower trays. Beddow teaches a lower tray with a compartment housing the syringe but does not teach another compartment; however, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to move the sample bottle to the lower tray as an obvious rearrangement of the included items in the kit with predictable and reasonable results. Further, it would have been obvious to duplicated a similar compartment as Beddow’s syringe compartment to house the sample bottle, since it has been held that mere duplication of the working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced.
Regarding claims 10-12, the combination of Serany and Beddow teaches the assembly of claim 8. However, Serany fails to disclose:
(claim 10) wherein the lower tray level further defines a third compartment having one or more additional compartment barriers defined within the third compartment.
(claim 11) comprising one or more instruments positioned within the third compartment.
(claim 12) wherein the one or more instruments comprise a catheter, a drainage line, a fluid receptacle, a drainage bag, or combinations thereof.
Beddow teaches:
(claim 11) comprising one or more instruments (fluid receptacle, column 3 lines 28-38) positioned within the third compartment (X, annotated fig. 1, fig. 3).
(claim 12) wherein the one or more instruments comprise a catheter, a drainage line, a fluid receptacle (column 3 lines 28-38, fig. 3), a drainage bag, or combinations thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottom tray of Serany and Beddow and duplicate a compartment similar to the multiple compartments of the upper tray since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Further, no new or unexpected result is likely to be produced. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Serany already discloses a catheter and fluid receptacle in the lower tray but does not specifically put it in a third compartment. But, incorporating a third compartment to house that instrument would yield predictable results.
Regarding claim 13, Serany discloses a method of using a multi-level packaging assembly figs. 2, 5), comprising:
unfolding at least one layer of wrap (14) enclosing a top tray level (12) positioned upon a lower tray level (10, column 1 lines 60-63) to reveal the top tray level (12, fig. 3);
removing the top tray level (12) from the lower tray level (10) to access the lower tray level (column 2 lines 33-38),
wherein the lower tray level comprises one or more compartment barriers (Z) having a continuous ledge at a constant level with respect to a bottom of the lower tray level (annotated fig. 6) defined within the first compartment (10); and
wherein the first compartment further defines a base (A, underside of compartment Y) which is uninclined relative to the bottom of the lower tray level (annotated fig. 6).
However, Serany fails to disclose a first compartment having a single syringe positioned within the first compartment.
Beddow teaches a similar device in the same field of endeavor such that the first compartment (X, annotated fig. 1) is sized to accommodate a single syringe (14, column 2 lines 47-55).
Put simply, Beddow discloses a catheterization tray with two levels and the syringe is housed in the bottom tray. Sereny discloses a syringe but it is housed in the top tray; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottom tray level of Sereny and incorporate the syringe compartment of Beddow to utilize the bottom space. Further, it would have been obvious to move the syringe to the bottom compartment as taught by Beddow since it has been held that rearranging parts of an invention involves only routine skill in the art and the placement of the syringe in the it is not integral to the function of the assembly.
Regarding claim 14, the combination of Serany and Beddow discloses the method of claim 13. Serany further discloses wherein unfolding at least one layer of wrap (14) comprises revealing at least one pair of gloves (22) positioned upon the top tray level (12, column 2 lines 21-29).
Regarding claim 14, the combination of Serany and Beddow discloses the method of claim 13. Serany further discloses wherein unfolding at least one layer of wrap (14) comprises revealing at least one pair of gloves (22) positioned upon the top tray level (12, column 2 lines 21-29).
Regarding claim 15, the combination of Serany and Beddow discloses the method of claim 13. Serany further discloses wherein unfolding at least one layer of wrap (14) comprises revealing at least one drape (24) in a folded configuration positioned upon the top tray level (12, column 2 lines 21-33).
Regarding claim 16, the combination of Serany and Beddow discloses the method of claim 13. However, Serany fails to disclose comprising accessing a single syringe positioned within the first compartment.
Beddow teaches comprising accessing a single syringe (14) positioned within the first compartment (X, annotated fig. 1).
Put simply, Beddow discloses a catheterization tray with two levels and the syringe is housed in the bottom tray. Sereny discloses a syringe but it is housed in the top tray; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottom tray level of Sereny and incorporate the syringe compartment of Beddow to utilize the bottom space. Further, it would have been obvious to move the syringe to the bottom compartment as taught by Beddow since it has been held that rearranging parts of an invention involves only routine skill in the art and the placement of the syringe in the it is not integral to the function of the assembly.
Regarding claim 17, the combination of Serany and Beddow discloses the method of claim 13. Serany further discloses comprising accessing one or more instruments (48) positioned within an additional compartment (fig. 6) defined within the lower tray level (10, column 3 lines 23-26).
Regarding claim 18, the combination of Serany and Beddow discloses the method of claim 17. Serany further discloses wherein accessing one or more instruments further comprises accessing a catheter (48, column 3 lines 23-26), a drainage line, a fluid receptacle, a drainage bag, or combinations thereof from within the lower tray level.
Regarding claim 19, the combination of Serany and Beddow discloses the method of claim 17. Serany further discloses wherein unfolding at least one layer of wrap (14) comprises unfolding folds or corners (18a, 18b, 18c) of the at least one layer of wrap (14) which are free of any items (figs. 2, 2a, 3, column 2 lines 1-21).
Regarding claim 20, the combination of Serany and Beddow discloses the method of claim 17. Serany further discloses wherein unfolding at least one layer of wrap (14) comprises unfolding folds or corners (18a, 18b, 18c) of the at least one layer of wrap (14) which are free of hand sanitizer, additional wrap, and instruction (figs. 2, 2a, 3, column 2 lines 1-21).
Regarding claim 21, the combination of Serany and Beddow discloses the method of claim 17. Serany further discloses wherein the top tray level (12) comprises at least one ridge (26) along a surface C, side edge surface, annotated fig. 6) of the top tray level (12).
Regarding claim 22, Serany discloses a method of producing a multi-level packaging assembly (fig. 5), comprising:
providing a lower tray level (10) having one or more compartment barriers (Z, annotated fig. 6) and a base (A, annotated fig. 7) which together define a first compartment (Y) within the lower tray level (10), wherein the one or more compartment barriers (Z, annotated fig. 6) have a continuous ledge at a constant level with respect to a bottom of the lower tray level (annotated fig. 6), and wherein the base is uninclined relative to the bottom of the lower tray level (annotated fig. 6);
positioning a removable top tray level upon the lower tray level (; and enclosing the lower tray level (10) and the top tray level with at least one layer of wrap (14) such that unfolding of the at least one layer of wrap reveals the top tray level.
However, Serany fails to disclose securing a single syringe (14) within the first compartment (Y) and one or more instruments (fluid receptacle) within the lower tray level (11, column 3 lines 28-38, fig. 3).
Beddow teaches securing a single syringe (14) within the first compartment (Y) and one or more instruments (fluid receptacle) within the lower tray level (11, column 3 lines 28-38, fig. 3).
Put simply, Beddow discloses a catheterization tray with two levels and the syringe is housed in the bottom tray. Sereny discloses a syringe but it is housed in the top tray; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bottom tray level of Sereny and incorporate the syringe compartment of Beddow to utilize the bottom space. Further, it would have been obvious to move the syringe to the bottom compartment as taught by Beddow since it has been held that rearranging parts of an invention involves only routine skill in the art and the placement of the syringe in the it is not integral to the function of the assembly.
Regarding claim 23, the combination of Serany and Beddow discloses the method of claim 22. Serany further discloses wherein securing one or more instruments (48) within the lower tray level (10) comprises positioning a catheter (48, column 3 lines 23-36), a drainage line, a fluid receptacle, a drainage bag, or combinations thereof.
Regarding claim 24, the combination of Serany and Beddow discloses the method of claim 22. Serany further discloses wherein positioning the removable top tray level (12) further comprises positioning at least one pair of gloves (22) upon the top tray level (12) prior to enclosing the lower tray level (10) and top tray level (12, column 2 lines 22-33).
Regarding claim 25, the combination of Serany and Beddow discloses the method of claim 22. Serany further discloses wherein positioning the removable top tray level (12) further comprises positioning at least one drape (24) in a folded configuration (fig. 5) positioned upon the top tray level (12) prior to enclosing the lower tray level and top tray level (column 2 lines 22-33).
Regarding claim 26, the combination of Serany and Beddow discloses the method of claim 22. Serany further discloses where folds or corners (18a, 18b, 18c) of the at least one layer of wrap (14) are free of any items (figs. 2, 2a, 3, column 2 lines 1-21).
Regarding claim 27, the combination of Serany and Beddow discloses the method of claim 26. Serany further discloses wherein folds or corners (18a, 18b, 18c) of the at least one layer of wrap (14) are free of hand sanitizer, additional wrap, and instructions (figs. 2, 2a, 3, column 2 lines 1-21).
Regarding claim 28, the combination of Serany and Beddow discloses the method of claim 22. Serany further discloses wherein the top tray level (12) comprises at least one ridge (26) along a surface (C, side edge surface, annotated fig. 6) of the top tray level (12).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 26 May 2026
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