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 Objections
Claim 2 is objected to because of the following informalities: claim 2 appears to have language added which is not underlined – “along a common axis”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6, 7, 9, 12, 13, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gordon (US 4,397,647).
With regard to claims 1, 7, and 9, Gordon teaches an extendable tubing extension set comprising: a tubing cradle (Fig. 3 member 16) comprising a first end (Fig. 5 at 17), a second end (Fig. 5 at 18), and a tubing passage extending through the first and second ends of the tubing cradle (Fig. 5 passage where 35 is inserted between 22 and upper portions 25 and 25’), wherein the tubing cradle comprises a tubing cradle length from the first end to the second end of the tubing cradle (Figs. 3 and 5 between 17 and 18); an un-extended configuration wherein the first end of the tubing cradle is positioned a first distance from the second end of the tubing cradle, and the first distance is less than the tubing cradle length (from Fig. 3 the un-extend configuration is when the cradle is bent about 23 and 24 resulting in the first end positioned a first distance from the second end, in which the first end is closer to the second end such that the first distance is less than the tubing cradle length); an extended configuration wherein any of the first end or the second end of the tubing cradle are moved in a direction away from the other of the first end and the second end, such that the first end of the tubing cradle is positioned a second distance from the second end of the tubing cradle, and the second distance is greater than the first distance (position as shown in Fig. 3 where 23 and 24 are not bent, the first and second ends are at a second distance greater than the first distance as they are farther apart); and a base having a top surface and a bottom surface, the bottom surface configured to engage against a patient and the top surface configured to engage against the tubing cradle (Fig. 3 including 14 and 11, lower surface of 11 engages the patient upper surface of 14 engages the cradle), wherein the tubing cradle is coupled to the base along a second portion of the tubing cradle length (Fig. 3 second length is the lower surface of 16 extending from 23 towards 18) and is movable relative to the base along a first portion of the tubing cradle length (Fig. 3, first length along 25 movable relative to the base extending along 25 from 23 towards 17) such that the first end of the tubing cradle extends beyond a perimeter of the base in the extended configuration (Fig. 3 the end at 17 extends beyond the periphery in a direction extending from 14 towards 25).
With regard to claim 2, the first longitudinal wall is taken to include the half of the retainer with wall 20 and the second longitudinal wall is taken to include the opposing half with wall 19 (Fig. 3, each half is about a common axis through the center of the cradle).
With regard to claim 6, see Col. 3 line 63.
With regard to claim 12, 11 is adhered to the patient (Col. 11 line 50, Fig. 2 member 12).
With regard to claim 21, see Fig. 5, zig-zag between 21 and 28.
With regard to claim 22, the second portion also can be considered as extending from 18 towards 23 which is towards 17 (Fig. 3).
With regard to claim 13, Gordon teaches an extendable tubing extension set comprising: a tubing cradle (Fig. 3 member including at least walls 16, 18, 19, 20, 25, and 25’) comprising a first end (Fig. 5 at 17), a second end (Fig. 5 at 18), and a tubing passage extending through the first and second ends of the tubing cradle (Fig. 5 passage where 35 is inserted), wherein the tubing cradle comprises a tubing cradle length from the first end to the second end of the tubing cradle (Figs. 3 and 5 between 17 and 18); a tubing comprising a proximal end portion, a distal end portion, and a middle portion, wherein the middle portion of the tubing is positioned within the tubing passage with the proximal end portion of the tubing extending beyond the first end of the tubing cradle and the distal end portion of the tubing extending beyond the second end of the tubing cradle (Fig. 5 tubing 35, the middle portion is within the cradle, distal end proximal ends extends past the ends); an un-extended configuration wherein the first end of the tubing cradle is positioned a first distance from the second end of the tubing cradle, and the first distance is less than the tubing cradle length (from Fig. 3 the un-extend configuration is when the cradle is bent about 23 and 24 resulting in the first end positioned a first distance from the second end, in which the first end is closer to the second end such that the first distance is less than the tubing cradle length); an extended configuration wherein any of the first end or the second end of the tubing cradle are moved in a direction away from the other of the first end and the second end, such that the first end of the tubing cradle is positioned a second distance from the second end of the tubing cradle, and the second distance is greater than the first distance (position as shown in Fig. 3 where 23 and 24 are not bent, the first and second ends are at a second distance greater than the first distance as they are farther apart); and a base having a top surface and a bottom surface, the bottom surface configured to engage against a patient and the top surface configured to engage against the tubing cradle (Fig. 3 including 14 and 11, lower surface of 11 engages the patient upper surface of 14 engages the cradle), wherein the tubing cradle is coupled to the base along a second portion of the tubing cradle length (Fig. 3 second length is the lower surface of 16 extending from 23 towards 17) and is movable relative to the base along a first portion of the tubing cradle length (Fig. 3, first length along 25’ movable relative to the base extending along 25’ from 23 towards 18) such that the first end of the tubing cradle extends beyond a perimeter of the base in the extended configuration (Fig. 3 the end at 17 extends beyond the periphery in a direction extending from 14 towards 25).
With regard to claim 19, the base further includes surface 22 and includes arms 21 for coupling with the tubing (Fig. 3).
With regard to claim 23, at least prior to closure of 25 and 25’ the tubing is movable relative to the cradle to position it.
With regard to claim 24, see Fig. 5, zig-zag between 21 and 28.
Claim Rejections - 35 USC § 103
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) 14-17, 20, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US 4,397,647) as applied to claim 13 above, and further in view of Erskine et al. (US 5,820,614).
With regard to claims 14-17 and 20, Gordon teachings tubing substantially as claimed but does not show details of the proximal and distal ends or a fluid disconnection. However, Erksine et al. teach tubing for delivering fluid to a patient in which either end of the tube comprises a connector (Fig. 1 members 12 and 40, either of which may be considered alternatively as an auxiliary port) with a fluid disconnection therebetween (Fig. 1 members 30). This is beneficial as it prevents disruption of the device inserted into the patient is the line is accidentally pulled on (Col. 2 lines 43-59, Col. 4 lines 5-8). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use proximal and distal fluid connectors and a fluid disconnection device in Gordon as in Erskine et al. as this allows the tubing to connect to a patient and fluid source and aids in reducing harm to the patient. Further regarding claims 16 and 17, there are a limited number of options for placement of the cradle relative to the disconnection device, it may be placed between the disconnection device and either the proximal or distal end of the tubing. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place the disconnection device between the cradle and the distal end of the tubing in Gordon as combined with Erskine et al. as there are only two options for placement. One of ordinary skill would be able to place the device as best suited to prevent injury to the patient. It would further be obvious that placement closer to the distal end would be preferable as this is the end connected to the patient and where injury may occur if the tube is pulled on.
With regard to claim 25, the cradle is designed to bend at 23 upon force exerted exceeding a first threshold. As combined the disconnection device would separate at a force exceeding a second threshold. The references as combined do not recite relative forces. However, there are a limited number of options for the relative forces, they are either equal or one is higher than the other. In regular use the cradle should move with the patient so this would be a lower force threshold. As combined the tubing is designed to stay connected baring accidental pulling. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the disconnection threshold be higher as there are a limited number of options for relative forces and further one or ordinary skill in the art would not want the device to be too easily disconnected as this would interrupt treatment unnecessarily while a user would want the cradle to move comfortably with the patient. One or ordinary skill would be able to select construction to achieve desired forces based on use.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US 4,397,647) and Erskine et al. (US 5,820,614) as applied to claim 20 above, and further in view of Kahn (US 2010/0228233 A1).
With regard to claim 26, Gordon and Erskine et al. teach a device substantially as claimed but do not disclose the auxiliary port to be a y-connection. However, Kahn teaches port connections at either ends of tubing which are beneficial to allow introduction of additional fluid without the use of a syringe (Fig. 2 members 54). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a y-connection in Gordon and Erskine et al. as Kahn teaches this is beneficial to allow introduction of additional fluid without the use of a syringe.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new limitations are found to be taught by the references as interpreted in the above rejections. The Examiner finds there are portions of Gordon which do move relative to the base and extend beyond the perimeter.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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