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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 56 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 56, “the one or more tubes” lack antecedent basis and it is unclear what it is referring to.
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) 25-26, 28, 30, 32-33, 47, 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 5,441,707 to Lewis et al. (Lewis) in view of US 2006/0201950 to Liu, US 2014/0110296 to Terzibashian and US 2015/0196379 to Norris et al. (Norris).
Regarding claim 25, Lewis discloses a medical tubing packaging system (Fig 1) comprising a tubing set comprising first and second components (instruments, abstract), an inlay (14) with a top surface defining one or more recesses (40), the one or more recesses accommodate at least a first component of a tubing set (instrument, col. 3, ll. 20-25), a tray (12) configured to receive the inlay, an inner wall (24) of the tray comprising a substantially horizontal support surface (48) which inlay can be placed, the support surface above a bottom (42) of the tray, wherein the tray (12) and inlay (14) and configured to be detachably secured to one another via a fastening device (60) since it has the structure as recited, wherein when the packaging is assembled, the inlay (14) rests on the substantially horizontal support surface (48) of the inner wall (24) of the tray (12), a cavity (30) formed between bottom (42) of the tray and bottom surface (44) of the inlay (Fig 3), first component of tubing set (instrument, col. 3, ll. 20-25) disposed within recess of inlay. Lewis does not teach a cover that partially covers and contacts the inlay as recited. Liu discloses a packaging system where a cover (20) covers the recess of a tray (10) accommodating a first component and in particular discloses the cover comprising a top surface defining one or more recesses (23a-c) for accommodating a second component, the cover (20) is placed on the tray (10) and at least partially cover the recess of the tray and first component in the recess of the inlay, the second component (41) is disposed within the one or more recess of the top surface of the cover, the top surface being opposite a bottom surface that contacts the tray (Fig 4). One of ordinary skill in the art would have found it obvious to incorporate a cover having recesses to the Lewis packaging system such that it covered the inlay in order to store additional contents. In particular, the modification would have resulted in the components configured to be unpacked in same order of use since it has the structure as recited. Lewis does not teach the tubing set comprising one or more tubes, the inlay having two recesses connected by a cutout, a partition arranged in the cut-out in form-fitting manner, the partition movable from open position to insert a tube to closed position in which the partition forms a form fitting closure around the tube. However, Terzibashian discloses a medical device tray (Fig 1) and in particular discloses the tray comprising at least two recesses (254, 258) connected by a cutout (A, Fig 10b below), a partition (nubs 670) arranged in the cutout to grasp a tubing in form-fitting manner. One of ordinary skill in the art would have found it obvious to substitute the inlay tray of Lewis with a functionally equivalent medical device tray as suggested by Terzibashian in order to provide a tray for catheter procedure. Norris discloses a medical device tray (180) and in particular discloses a partition (100, Fig 1) arranged in a cut-out (184) in form fitting manner (Fig 5), the partition moveable from open position (Fig 8b) to insert a tube (190) to a closed position (Fig 8a) in which the partition forms a form-fitting closure around the tube. Taken as a whole, one of ordinary skill in the art would have found it obvious to substitute the partition of the modified Lewis with a functionally equivalent moveable partition as suggested by Norris in order to hold the tubing in place 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).
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Regarding claim 26, Lewis further discloses the packaging system sterile (abstract).
Regarding claim 28, Lewis further discloses inlay (14) comprising receiving section (44) for receiving an oxygenator (intended use).
Regarding claim 30, Lewis further discloses inlay (14) configured such that the tubing set may be fully packaged on the inlay since it has the structure as recited.
Regarding claim 32, Lewis further discloses the system comprising the fastening device (60) being configured to detachably fasten the inlay (14) in the tray (10).
Regarding claim 33, Lewis further discloses the fastening device (60) can detachably fasten the inlay (14) in the tray (10) with locking mechanism (col. 3, ll. 10-20).
Regarding claim 47, Lewis further discloses packaging system configured to be unpacked in predefined order since it has the structure as recited.
Regarding claim 56, Lewis discloses a medical tubing packaging system (Fig 1) comprising a tray (12) comprising a bottom (42) and inner wall (24), the inner wall (24) comprising a substantially horizontal support surface (48) separated by a distance from bottom (42) of the tray, an inlay (14) positioned on the support surface and configured to be detachably secured to the tray via a fastening device (60), wherein a cavity (30) is formed between a bottom surface (42) of the inlay and bottom (42) of the tray (Fig 3), the inlay having a top surface (56) defining a recess (40), a first component of tubing (instrument) positioned within the recess of the inlay. Lewis does not teach a cover covering the inlay. Liu discloses a packaging system where a cover (20) covers the recess of a tray (10) accommodating a first component and in particular discloses the cover comprising a top surface defining one or more recesses (23a-c) for accommodating a second component, the cover (20) is placed on the tray (10) and at least partially cover the recess of the tray and first component in the recess of the inlay, the second component (41) is disposed within the one or more recess of the top surface of the cover, the top surface being opposite a bottom surface that contacts the tray (Fig 4). One of ordinary skill in the art would have found it obvious to incorporate a cover having recesses to the Lewis packaging system such that it covered the inlay in order to store additional contents. Lewis does not teach the tubing set comprising one or more tubes, the inlay having two recesses connected by a cutout, a partition arranged in the cut-out in form-fitting manner, the partition movable from open position to insert a tube to closed position in which the partition forms a form fitting closure around the tube. However, Terzibashian discloses a medical device tray (Fig 1) and in particular discloses the tray comprising at least two recesses (254, 258) connected by a cutout (A, Fig 10b above), a partition (nubs 670) arranged in the cutout to grasp a tubing in form-fitting manner. One of ordinary skill in the art would have found it obvious to substitute the inlay tray of Lewis with a functionally equivalent medical device tray as suggested by Terzibashian in order to provide a tray for catheter procedure. Norris discloses a medical device tray (180) and in particular discloses a partition (100, Fig 1) arranged in a cut-out (184) in form fitting manner (Fig 5), the partition moveable from open position (Fig 8b) to insert a tube (190) to a closed position (Fig 8a) in which the partition forms a form-fitting closure around the tube. Taken as a whole, one of ordinary skill in the art would have found it obvious to substitute the partition of the modified Lewis with a functionally equivalent moveable partition as suggested by Norris in order to hold the tubing in place 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).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Liu, Terzibashian, Norris and US 2021/0196922 to Hughett, Sr (Hughett).
Regarding claim 29, Lewis teaches the system of claim 25 but does not teach inlay over entire area of tray. However, Hughett discloses packaging system and in particular discloses further discloses inlay (110) extends essentially over the entire area of the tray (120) (Fig 1a). One of ordinary skill in the art would have found it obvious to change the size of the inlay such that it covered all of the tray in order to facilitate protection of the tray contents.
Claim(s) 34-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Liu, Terzibashian, Norris and US Patent No. 6,182,482 to Issitt.
Regarding claim 34, the modified Lewis teaches the packaging system of claim 32 but does not teach the recited fastening device. Issit discloses a fastening device (Fig 1) for two elements (10, 12) and in particular discloses the device comprising a handle (46) and a base (50), the handle comprising a gripping section and an extension (48) for connection to the base, the handle is configured to be passed through an opening (26) in first element (10). One of ordinary skill in the art would have found it obvious to substitute the fastening element of Lewis with a functionally equivalent fastening mechanism as suggested by Issitt in order to facilitate attachment of the inlay to the tray 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 35, the modified Lewis teaches system of claim 34 and further teaches the handle (46, Issit) of the fastening device connected to the inlay (10, Issit) and configured to serve for removal and/or transport of the inlay since it has the structure as recited.
Regarding claim 36, the modified Lewis teaches the system of claim 35 and further teaches the handle (46, Issit) configured to transport the inlay (10, Isset) with components of the tubing set thereon since it has the structure as recited.
Regarding claim 37, the modified Lewis teaches the system of claim 35 and further teaches fastening device being rotatable, base (50, Issett) of the fastening device comprising a wing, inner wall of the tray (12, Issett) comprises one or more projections (40, 42, Isset) which depending on the position of the wing cause the inlay to be fastened or detached in the tray.
Regarding claim 38, the modified Lewis teaches the system of claim 37 and further teaches the wing (50, Issett) displaced relative to the one or more projections of the inner wall of the tray (12, Issett) such that fastening or detaching the inlay is achieved when fastening device is rotated.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Liu, Terzibashian, Norris and US Patent No. 4,226,328 to Beddow.
Regarding claim 43, the modified Lewis teaches the system of claim 25 but does not teach the set comprising clamps. However, Beddow discloses an instrument packaging system (Fig 1) and in particular discloses tubing set comprising clamps (23). One of ordinary skill in the art would have found it obvious to incorporate clamps to the Lewis instrument tray in order to sterilize the clamps for medical procedure.
Claim(s) 44-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Liu, Terzibashian, Norris and US 2015/0305460 to Mathews et al. (Mathews).
Regarding claim 44, the modified Lewis teaches the system of claim 25 but does not teach the system further comprising a strap. However, Mathews discloses a packaging system (Fig 1) and in particular discloses a strap (36) for securing contents. One of ordinary skill in the art would have found it obvious to incorporate straps to the Lewis packaging system as suggested by Mathews in order to facilitate securing of the contents.
Regarding claim 45, the modified Lewis teaches the system of claim 44 but does not teach cover having a guide configured to receive the strap. However, Mathews further discloses packaging system (Fig 1) comprising a cover (12) having a guide (66) configured to receive a strap (61). One of ordinary skill in the art would have found it obvious to incorporate a guide to the cover of the modified Lewis packaging system as suggested by Mathews in order to protect and secure the contents.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Liu, Terzibashian, Norris and US 2007/0034538 to Landis.
Regarding claim 55, the modified Lewis teaches the system of claim 25 but does not teach arrow-shaped recesses in the inlay and tray. However, Landis discloses medical packaging (Fig 1) and in particular discloses two arrow-shaped recesses (53) positioned in diagonally opposing corners of an inlay (50), a tray (150) comprising two arrow-shaped recesses (158) configured to receive the two arrow-shaped recesses of the inlay (€0030). Taken as a whole, one of ordinary skill in the art would have found it obvious to incorporate snap lugs and recesses to the corner of the inlay and tray of Lewis as suggested by Landis if one desired to increase the size of the inlay to match that of the tray and retain the inlay to the tray at the corners.
Response to Arguments
Applicant's arguments filed 2/18/2026 have been fully considered but they are not persuasive. Initially, it is noted that applicant does not argue the rejection of the dependent claims. Applicant argues that prior art does not teach a moveable partition in a cutout to open and close a tube. However, Terzibashian discloses incorporating partitions to hold tubing within a partition and Norris discloses partitions that are moveable between open and closed positions and positioned within a cutout to keep tubing in place. Taken as a whole, one of ordinary skill in the art would have found it obvious to incorporate such a partition to the inlay of the modified Lewis in order to keep tubing in place.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ROBERT POON/ Examiner, Art Unit 3735
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