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 § 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) 15, 19, 20 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fleming (US 5,718,678).
Regarding claim 15, Fleming discloses a rapidly insertable central catheter ("RICC"), comprising: a catheter tube (fig 1) including: a first section in a distal portion of the catheter tube defined by monoluminal tubing 12 consisting of a first polymeric material (Col.6 ll 10-14); and a second section proximal of the first section defined by a transition to layered tubing (fig 1), the second section including an outer layer 42 of a second polymeric material extruded over an inner layer of the monoluminal tubing of the first polymeric material such that an outer diameter of the catheter tube is larger in the second section than the first section (fig 1), the catheter tube having a column strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site and advanced through a vasculature of a patient without use of the Seldinger technique (Col.6 ll 20-38).
Regarding claim 19, wherein each layer of the inner and outer layers of the catheter tube is formed of a same polymeric material (Col.6 ll 10-14).
Regarding claim 20, wherein the polymeric material is a polyurethane (Col.6 ll 10-14).
Regarding claim 23, wherein the catheter tube is a triluminal catheter tube including a first lumen 22 extending from a first opening in a proximal end of the catheter tube to an opening in a distal end of the first section of the catheter tube (fig 5A), a second lumen 40 extending from a second opening in the proximal end of the catheter tube to a first eyelet 68 in a distal portion of the second section of the catheter tube, and a third lumen 58 extending from a third opening in the proximal end of the catheter tube to a second eyelet 70 in the distal portion of the second section of the catheter tube.
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) 1, 5, 6, 1, 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleming (US 5,718,678) in view of Martin (US 5,207,650).
Regarding claim 1, Fleming discloses a rapidly insertable central catheter ("RICC"), comprising: a catheter tube (fig 1) including: a first section in a distal portion of the catheter tube defined by monoluminal tubing 12 consisting of a first polymeric material (Col.6 ll 10-14); and a second section proximal of the first section defined by a transition to layered tubing (fig 1), the second section including an outer layer 42 of a second polymeric material extruded over an inner layer of the monoluminal tubing of the first polymeric material such that an outer diameter of the catheter tube is larger in the second section than the first section (fig 1); a hub 74 coupled to a proximal-end portion of the catheter tube (fig 1); and a number of extension legs 78 extending from the hub equal to a number of lumens extending through the RICC (figs 1 and 4).
While Fleming substantially discloses the invention as claimed, it does not disclose a suture wing disposed over a medial portion of the catheter tube.
Martin discloses a suture wing 50 which is removable and may be moved along a length of the device. This length is a medial portion (area between hub and distal portion of second section).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Fleming with a suture wing disposed over a medial portion of the catheter tube as taught by Martin to allow the position of the suture wing to be changed/customized depending on how much of the catheter is implanted/inserted into the patient.
Regarding claim 5, wherein each layer of the inner and outer layers of the catheter tube is formed of a same polymeric material (Col.6 ll 10-14).
Regarding claim 6, wherein the polymeric material is a polyurethane (Col.6 ll 10-14).
Regarding claim 10, wherein the RICC is a triluminal catheter including a trifurcated hub as the hub having three extension legs extending therefrom (fig 1), each extension leg of the three extension legs including a Luer connector coupled to a proximal-end portion of the extension leg (Col.9 ll 52).
Regarding claim 11, wherein the RICC includes a first lumen 22 extending from an opening in a proximal end of a first Luer connector to an opening in a distal end of the first section of the catheter tube (fig 1), a second lumen 40 extending from an opening in a proximal end of a second Luer connector to a first eyelet 68 in a distal portion of the second section of the catheter tube, and a third lumen 58 extending from an opening in a proximal end of a third Luer connector to a second eyelet 70 in the distal portion of the second section of the catheter tube.
Regarding claim 14, wherein the catheter tube has a column strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site and advanced through a vasculature of a patient (Col.6 ll 20-38).
Claim(s) 2, 4, 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleming (US 5,718,678) in view of McGuckin (US 7,077,829); also in view of Martin (US 5,207,650) when considering claims 2 and 4 below.
Regarding claims 2 and 16, while Fleming substantially discloses the invention as claimed, it does not disclose wherein the inner layer of the catheter tube is formed of the first polymeric material having a first durometer and the outer layer of the catheter tube is formed of the second polymeric material having a second durometer less than the first durometer.
McGuckin discloses a catheter with inner and outer layers, similar in some ways to Fleming. McGuckin discloses it is desirable to have a higher durometer tip (compared to the body) to facilitate tunneling through and dilating tissue (Col.13 ll 64 to Col.14 ll 1).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Fleming such that the inner layer of the catheter tube is formed of the first polymeric material having a first durometer and the outer layer of the catheter tube is formed of the second polymeric material having a second durometer less than the first durometer as suggested by McGuckin to facilitate tunneling through and dilating tissue.
Regarding claims 4 and 18, wherein each polymeric material of the first and second polymeric materials is a polyurethane (Col.6 ll 10-14).
Claim(s) 7-9, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleming (US 5,718,678) in view of Martin et al (US 5,135,599; referred to as Martin ‘599 below); also in view of Martin (US 5,207,650) when considering claims 7-9 below.
Regarding claims 7-9, 21 and 22, while Fleming substantially discloses the invention as claimed, it does not disclose wherein the catheter tube includes a bump demarcating a third section of the catheter tube proximal of the second section, the third section having a larger outer diameter than both the first and second sections of the catheter tube, the suture wing is disposed over the bump of the catheter tube such that the catheter tube proximal of the suture wing has a larger outer diameter than the catheter tube distal of the suture wing, nor the catheter tube between the bump and a proximal end of the third section of catheter tube has a reverse taper in which the outer diameter of the catheter tube continuously increases from the bump to the proximal end of the third section of catheter tube..
Martin ‘599 discloses the catheter tube includes a bump 42 demarcating a third section of the catheter tube proximal of the second section (fig 12), the third section having a larger outer diameter than both the first and second sections of the catheter tube (fig 12), the suture wing 23 is disposed over the bump of the catheter tube such that the catheter tube proximal of the suture wing has a larger outer diameter than the catheter tube distal of the suture wing (fig 12) and the catheter tube between the bump and a proximal end of the third section of catheter tube has a reverse taper in which the outer diameter of the catheter tube continuously increases from the bump to the proximal end of the third section of catheter tube (fig 12). This bump/reinforcing portion 42 assists in strengthening the catheter to minimize the likelihood of kinking and assist in sealing the puncture site where the catheter enters the patient (Col.5 ll 50-56).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Fleming such that the catheter tube includes a bump demarcating a third section of the catheter tube proximal of the second section, the third section having a larger outer diameter than both the first and second sections of the catheter tube, and the suture wing is disposed over the bump of the catheter tube such that the catheter tube proximal of the suture wing has a larger outer diameter than the catheter tube distal of the suture wing and the catheter tube between the bump and a proximal end of the third section of catheter tube has a reverse taper in which the outer diameter of the catheter tube continuously increases from the bump to the proximal end of the third section of catheter tube as taught by Martin ‘599 to reinforce the catheter and assist in sealing the puncture site where the catheter enters the patient.
Response to Arguments
Applicant’s arguments with respect to all 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.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (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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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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