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 .
Response to Amendment
This action is in response to Applicant's reply filed 1/9/26. Claims 1-10 are pending. Claims 1 and 6 are amended.
Response to Arguments
Applicants amendments to claims 1 and 6 do not overcome the 35 U.S.C. 112(b) rejection. Examiner maintains, from the specification paragraph [0176], the sleeve 150 is described as a friction reducing liner between the catheter (stem) 12 and the introducer 19. Further, Figure 20 illustrates the haemostasis valve 19a surrounding the slidable sleeve 150, not the stem portion (catheter 12). For examination purposes, the limitation is interpreted as “the friction between the interior of the sleeve and the stem portion is less than the friction between the/a haemostasis valve and the sleeve".
Applicant’s arguments in the response filed 1/9/26 with respect to the rejections of claims 1-10 under 103(a) as being unpatentable over Roeder (US2007/023322) in view of Lenker (US2010/0114017) and Webler (US7981152) have been fully considered but are not persuasive. Applicant argues, the claim recites “friction between the interior of the sleeve and the stem portion is less than friction between the hemostasis valve and the stem portion” is not taught by the rejection. Applicant draws attention to the previous office action stating “the modified invention discloses the friction between the interior of the slidable sleeve and the stem portion is less than the friction between the hemostasis valve and the sleeve”. Examiner clarifies the statement the friction between the interior of the slidable sleeve and the stem portion is less than the friction between the hemostasis valve and the sleeve because the hemostasis valve provides a sliding seal against the sleeve, whereas the slidable sleeve does not provide a sliding seal against the stem portion. It is clear the Examiner intended to recite the friction between the hemostasis valve and the stem portion in the paragraph.
Applicant further argues, Lenker does not teach relative friction between any components. Examiner disagrees, as stated in the previous rejection, the friction between the interior of the slidable sleeve and the stem portion is less than the friction between the hemostasis valve and the stem portion, since Lenker teaches is a seal between the hemostasis valve and the stem portion and the slidable sleeve does not provide a sliding seal against the stem portion, thereby having less friction.
Applicant draws attention to paragraph [0176] of the instant specification to state that the catheter may be used without the liner sleeve 150. Examiner disagrees with Applicants statement, where the paragraph [0176] states the liner sleeve may be used “when desired” this does not conclude that the catheter interacts with the hemostasis valve without the liner sleeve. It appears the statement is referring to advancing the liner sleeve when its desired for use into the operative position within the introducer.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the stem portion positioned within the hemostasis valve in absence of the sleeve must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-10 are 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.
Claims 1 and 6 recite the limitation “the friction between the interior of the sleeve and the stem portion is less than the friction between the/a haemostasis valve and the stem portion". It is unclear as to how the friction between the interior of the sleeve and the stem portion is less than the friction between the haemostasis valve and the stem portion, since the haemostasis valve does not interact with the stem portion (“the sleeve slidable on the stem portion is advanced into the haemostasis valve of the arterial introducer”). From the specification paragraph [0176], the sleeve 150 is described as a friction reducing liner between the catheter (stem) 12 and the introducer 19. Further, Figure 20 illustrates the haemostasis valve 19a surrounding the slidable sleeve 150, not the stem portion (catheter 12). Therefore, the limitation is rendered indefinite. For examination purposes, the limitation is interpreted as “the friction between the interior of the sleeve and the stem portion is less than the friction between the/a haemostasis valve and the sleeve".
Claims 2-5, 7-10 are rejected under 35 U.S.C. 112(b) by dependency from claims 1 and 6.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Roeder (US2007/0233222) in view of Webler (US7981152) and Lenker (US2010/0114017) .
Regarding claim 1, Roeder discloses a method of introducing a delivery catheter into an arterial introducer (catheter is introduced through an access provided through an artery, [0051]), wherein the delivery catheter is for introducing a stent-valve into the anatomy ([0042]) and comprises:
a distal portion having a stent-valve accommodation region (region prosthesis 12 is situated, see Fig. 2, [0028]);
a stem portion (tubes 16, 42 and 28) extending proximally from the distal portion (see Fig. 2), and comprising a plurality of control tubes (16/42/28) nested one within another (see Fig. 2, [0031]-[0033]), and axially slidable relative to each other to manipulate the distal portion for deploying a stent-valve ([0033]).
Roeder is silent regarding the stem portion being flexible. Webler teaches in the same field of endeavor, a method of placing a device in the heart (see Abstract). The delivery includes an introducer sheath 102 and a guide catheter 104 inserted into the sheath 102 to provide access to a vessel. Then a catheter 108 is inserted into the guide catheter 104 to position the catheter 108 at the region of interest (C5:L40-65). The catheters 104 and 108 are interpreted as the stem portion that comprises nested tubes, wherein the catheters are desired to be flexible (C6:L7-15). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the delivery catheter of Roeder to be flexible, as taught by Webler, in order to aid in accessing the desired delivery site within the heart by increasing ability to navigate the catheter (C6:L7-15).
Roeder is also silent regarding introducing the delivery catheter into a haemostasis valve of an arterial introducer, a sleeve slidable on the stem portion, the sleeve having an interior configured for permitting sliding of the stem portion with respect to the sleeve, wherein the sleeve slidable on the stem portion is advanced into the haemostasis valve of the arterial introducer. Lenker teaches the step of introducing a delivery catheter (2616) into a haemostasis valve (2606) of an introducer (16), a sleeve (2620) having an interior configured for permitting sliding of the delivery catheter with respect to the sleeve ([0215]), wherein the sleeve (2620) slidable on the delivery catheter ([0215]) is advanced into the hemostasis valve (2606) of the introducer ([0216]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have provided the device of Roeder with an introduction system including an arterial introducer having a haemostasis valve and a slidable sleeve and perform the step of advancing the slidable sleeve into the haemostasis valve of the arterial introducer as taught by Lenker, in order to provide a method of inserting a catheter into the body with fluid-tight sliding seals against the shaft of the catheter to prevent fluid from entering the space between ([0215]). Where the sleeve provides the added benefit of expanding the valve of the introducer and providing an introduction tube that has kink resistance and column strength ([0219]).
The modified invention discloses the friction between the interior of the slidable sleeve and the stem portion is less than the friction between the haemostasis valve and the sleeve because the haemostasis valve provides a sliding seal against the sleeve, whereas the slidable sleeve does not provide a sliding seal against the stem portion, thereby having less friction.
Furthermore, this would occur when the stem portion is positioned within the hemostasis valve in the absence of the sleeve. Since, the modified invention is capable of having the stem portion slide within the hemostasis valve of Lenker without the sleeve.
Regarding claim 2, Roeder/Lenker/Webler makes obvious the method of claim 1, Lenker further teaches wherein the sleeve comprises a seal member (2608 has a hemostasis valve that provides a sliding seal, [0215] of Lenker) for forming a substantially blood-tight seal between an interior surface of the sleeve and an exterior surface of the stem portion (fluid tight seal provided, [0215]).
Regarding claim 3, Roeder/Lenker/Webler makes obvious the method of claim 2; yet, does not explicitly disclose wherein the seal member is formed by an O-ring. Lenker teaches the seal member 2608 being a haemostasis valve ([0215]). Lenker further teaches a seal formed by an O-ring ([0261]). It would have been obvious to have the seal as taught by Lenker be an O-ring as further taught by Lenker, since Lenker teaches the seal being an O-ring is an art recognized equivalent. Therefore, one having ordinary skill in the art would have found it obvious to substitute an O-ring for a haemostasias valve.
Regarding claim 4, Roeder/Lenker/Webler makes obvious the method of claim 1, the modified invention further discloses wherein the sleeve is slidably captive on the stem portion (Lenker teaches the sleeve is slidable on the catheter, [0215]).
Regarding claim 5, Roeder/Lenker/Webler makes obvious the method of claim 1; yet, does not explicitly disclose wherein the sleeve is proximal of the distal portion and configured for insertion into an introducer after the distal portion has been inserted through the introducer.
It is also noted that to switch the order of performing process steps, i.e. the order of the addition of the distal portion of catheter and the sleeve through the introducer, would be obvious absent any clear and convincing evidence and/or arguments to the contrary, because both methods would produce an introducer and sleeve inserted through the introducer (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”.
Regarding claims 6 and 7, Roeder discloses a delivery catheter for introducing a stent-valve into the anatomy (catheter is introduced through an access provided through an artery, [0051]), the delivery catheter comprising:
a distal portion having a stent-valve accommodation region (region prosthesis 12 is situated, see Fig. 2, [0028]);
a stem portion (tubes 16, 42 and 28) extending proximally from the distal portion (see Fig. 2), and comprising a plurality of control tubes (16/42/28) nested one within another (see Fig. 2, [0031]-[0033]), and axially slidable relative to each other to manipulate the distal portion for deploying a stent-valve ([0033]).
Roeder is silent regarding the stem portion being flexible. Webler teaches in the same field of endeavor, a method of placing a device in the heart (see Abstract). Where the delivery includes an introducer sheath 102, a guide catheter 104 inserted into the sheath 102 to provide access to a vessel. Then a catheter 108 is inserted into the guide catheter 104 to position the catheter 108 at the region of interest (C5:L40-65). Where the catheters 104 and 108 are interpreted the stem portion that comprises nested tubes. Where the catheters are desired to be flexible (C6:L7-15). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the delivery catheter of Roeder to be flexible as taught by Webler in order to aid in accessing the desired delivery site within the heart by increasing ability to navigate the catheter (C6:L7-15).
Roeder is further silent regarding a sleeve slidable on the stem portion, the sleeve having an interior configured for permitting sliding of the stem portion with respect to the sleeve, wherein the sleeve comprises a seal member for forming a substantially blood-tight seal between an interior surface of the sleeve and an exterior surface of the stem portion.
Lenker teaches the step of introducing a delivery catheter (2616) into a haemostasis valve (2606) of an introducer (16), a sleeve (2620) having an interior configured for permitting sliding of the delivery catheter with respect to the sleeve ([0215]), wherein the sleeve (2620) slidable on the delivery catheter ([0215]) is advanced into the hemostasis valve (2606) of the introducer ([0216]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have provided the device of Roeder with an introduction system including an arterial introducer having a haemostasis valve and a slidable sleeve and perform the step of advancing the slidable sleeve into the haemostasis valve of the arterial introducer as taught by Lenker, in order to provide a method of inserting a catheter into the body with fluid-tight sliding seals against the shaft of the catheter to prevent fluid from entering the space between ([0215]). Where the sleeve provides the added benefit of expanding the valve of the introducer and providing an introduction tube that has kink resistance and column strength ([0219]).
The modified invention discloses the friction between the interior of the slidable sleeve and the stem portion is less than the friction between the haemostasis valve and the sleeve because the haemostasis valve provides a sliding seal against the sleeve, whereas the slidable sleeve does not provide a sliding seal against the stem portion, thereby having less friction.
Furthermore, this would occur when the stem portion is positioned within the hemostasis valve in the absence of the sleeve. Since, the modified invention is capable of having the stem portion slide within the hemostasis valve of Lenker without the sleeve.
Regarding claim 8, Roeder/Lenker/Webler makes obvious the delivery catheter of claim 7; yet, does not explicitly disclose wherein the seal member is formed by an O-ring. Lenker teaches the seal member 2608 being a haemostasis valve ([0215]). Lenker further teaches a seal formed by an O-ring ([0261]). It would have been obvious to have the seal as taught by Lenker be an O-ring as further taught by Lenker, since Lenker teaches the seal being an O-ring is an art recognized equivalent. Therefore, one having ordinary skill in the art would have found it obvious to substitute an O-ring for a haemostasis valve.
Regarding claim 9, Roeder/Lenker/Webler makes obvious the delivery catheter of claim 7, the modified invention discloses wherein the sleeve is slidably captive on the stem portion (Lenker teaches the sleeve is slidable on the catheter, [0215]).
Regarding claim 10, Roeder/Lenker/Webler makes obvious the delivery catheter of claim 8, the modified invention discloses wherein the sleeve is proximal of the distal portion and configured for insertion into an introducer after the distal portion has been inserted through the introducer (the sleeve is capable of being inserted through the introducer after the catheter has been inserted through the introducer).
Conclusion
THIS ACTION IS MADE FINAL. 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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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