DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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.
Claims 1-3, 7-9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2004087250 A1 to Navarro et al. (Navarro)(see English language machine translation attached to this or a previous office action).
Navarro discloses:
Regarding claim 1:
A fixing device (figures 1 or 5) for fixing a catheter (4) on skin (“P” as shown in figure 1), the fixing device comprising:
a base body (5a) with a proximodistal longitudinal axis (axis A as shown in figure 1 below), a mediolateral transverse axis (axis B as shown in figure 1 below) and an anteroposterior vertical axis (vertical axis normal to the plane of 5a), and with a posterior underside (under side of 5a that is connected to 7 and the skin “P”) configured for placing on the skin (“P”) (as shown in figure 1);
a fixing element (see element C in figure 1 below, 11 and 13 which hold the hub 3 in place) arranged on the base body (5a) and configured for form-fit and/or force-fit fixing of a catheter hub (3) of the catheter (4) (these structures form-fit the hub in place by sandwiching it between them) and by which the catheter hub (3) is fixable relative to the base body (5a) (as shown in figure 1); and
a guide recess (15) arranged distally on the base body (5a) relative to the fixing element (C/11/13) (arranged on a distal end relative to C/11/13 as shown in figures 1 and 5) and which extends proximodistally over a guide length (they extend over the axis A as shown in figure 1) and has guide walls (see the guide walls D in figure 1 below) that are mediolaterally opposite to one another (arranged opposite of each other in the direction B (mediolaterally) as shown in figure 1 below),
the guide recess (15) being configured to receive a catheter tube portion (see the portion of catheter 4 within 15) of a catheter tube of the catheter (4), secured distally to the catheter hub (3) (distally in the direction A as shown in figure 1 below), and
the catheter tube portion (see the portion of catheter 4 within 15) being guidable between the guide walls (D) over the guide length (as shown in figure 1 below) and is thus protected against mediolateral buckling (inherent since tubing of 4 within 15 is prevented from kinking since it held straight by 15).
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Figure 1 – figure 5 of Navarro, annotated by the examiner
Regarding claim 2:
The fixing device according to claim 1, wherein the guide walls (D) and/or the base body (5a) have/has length markings (see the planar surfaces E in figure 1 above) spaced proximodistally apart from one another and distributed over the guide length (distributed over the length of 5a), each representing a defined length portion of the guide length (inherent, they define length and the space to receive 3), wherein the base body (5a) is able to be severed at least in a region of the length markings (the top and bottom of 5 can be separated as shown in figure 1 and 5 which is in the region of E as shown in figure 1 above).
Regarding claim 3:
The fixing device according to claim 1, wherein the guide walls (D) and/or the base body (5a) have/has predetermined separation points (see the separation points F in figure 1 above) spaced proximodistally apart from one another and distributed over the guide length (as shown in figure 1 above), each forming a mechanical weakening and being able to be severed in a defined manner (these points are able to be severed or separated by the hinge/separation of 5a from 5b).
Regarding claim 7:
The fixing device according to claim 1, wherein the fixing element (C/11/13) and the guide recess (15) are each arranged on an anterior top (as shown in figure 5) of the base body (5a).
Regarding claim 8:
The fixing device according to claim 1, wherein the fixing element (C/11/13) and the guide recess (15) are each open anteriorly (see the opening H in figure 1 above) , as a result of which the catheter hub (3) and the catheter tube portion (see the portion of catheter 4 within 15) are each insertable in a posterior direction (can be inserted from the posterior or anterior direction as shown in figure 1 above) into the fixing device (C/11/13).
Regarding claim 9:
The fixing device according to claim 1, wherein the fixing element (C/11/13) and the guide recess (15) are each open posteriorly (see the posterior opening G in figure 1 above), as a result of which the fixing device can be mounted in a posterior direction (can be inserted from the posterior or anterior direction as shown in figure 1 above) onto the catheter hub (3) and the catheter tube portion (see the portion of catheter 4 within 15).
Regarding claim 11:
The fixing device according to claim 1, further comprising a stop element (11) arranged proximally on the base body (5a) relative to the fixing element (C/11/13) and by which at least a proximal mobility of the catheter hub (3) (as shown in figure 5, the hub 3 is restrained in its position because of 11) and/or of a fluid-carrying component of the catheter (4) attached to the catheter hub (3) is positively limited.
Regarding claim 12:
The fixing device according to claim 1, wherein the base body (5a) is made of a dimensionally stable plastics material (translation, page 6, ¶4).
Regarding claim 13:
The fixing device according to claim 1, wherein the base body (5a) has a proximodistal extent and a mediolateral extent (5a extends along direction B and A as shown in figure 1 above), and wherein the base body (5a) is thin along a vertical axis and/or is designed as a proximodistally and mediolaterally planar plate relative to the proximodistal extent and the mediolateral extent (as shown in figure 1 above 5a is a plate that extends in the B and A directions).
Regarding claim 14:
The fixing device according to claim 1, further comprising a dimensionally flexible cushion body (see base 7 which is described as a flexible material sheet (flexible cushion body); translation, page 6, ¶7) to which the base body (5a) is firmly applied, and of which the posterior underside (as shown in figure 5) is configured for placing on the skin (“P”).
Regarding claim 15:
The fixing device according to claim 1, further comprising an adhesive coating on an underside of the base body (5a), the adhesive coating (“adhesive”, translation, page 2, ¶2) configured for releasably gluing the fixing device to the skin (“P”).
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) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004087250 A1 to Navarro et al. (Navarro) as applied to claim 1 above, and further in view of US 4224937 A to Gordon.
Regarding claim 4:
Navarro fails to disclose:
The fixing device according to claim 1, wherein the guide walls are each formed by proximodistally spaced apart web elements with intermediate gaps.
Gordon teaches:
A fixing device (figure 11) that includes guide walls (60) that include web elements (60) with intermediate gaps between them (see the gap between the web elements).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Navarro to replace the guide wall in Navarro with the guide wall including web elements and intermediate gaps between them as taught by Gordon to reduce the weight of the guide walls. Further, this is a simple substitution of one known element (guide wall in Navarro) for another (guide wall including web elements and intermediate gaps as taught by Gordon) to obtain predictable results (to support the catheter tube in Navarro).
Regarding claim 5:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 4 by Navarro and Gordon:
The fixing device according to claim 4, wherein the intermediate gaps (see the intermediate gaps of Navarro incorporated into Gordon) each form a length marking (inherent that the gaps between the webs 60 of Navarro define a length or mark a length) and/or a predetermined separation point.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004087250 A1 to Navarro et al. (Navarro) as applied to claim 1 above, and further in view of WO 9721459 A1 to Kornerup.
Regarding claim 6:
Navarro fails to disclose:
The fixing device according to claim 1, wherein a proximodistal guide length measures between 10 mm and 60 mm.
Kornerup teaches:
A fixing device (figure 4a) that includes a guide (58/56 and 54) that guides the catheter (5). Further, the reference indicates the guide length can be 30mm (page 20, lines 20-26).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Navarro to further include modifying the guide length that is 30mm as taught by Kornerup to support the catheter (page 20, lines 20-30).
Allowable Subject Matter
Claim 10 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-5865808-A
Corn
See the guide recess 64
US-5037398-A
Buchanan
See the guide recess 74
US-4316461-A
Marais
See the guide recess 25
CN-118718233-A
WINE
See the guide recess 108
EP-0916361-A1
KRUETTEN
See the guide recess 4
WO-2025024644-A1
NOYMER
See the base body 116
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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