DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 01/02/26 have been fully considered but they are not persuasive.
On page 10 regarding drawing objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully withdraws objections that were addressed. As regard reference numbers 100 and 565, the Examiner notes these are present in figures 17c and 17d, respectively.
On pages 11-12 Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding the amended claims.
Election/Restrictions
Newly submitted claims 13-21 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 13 is drawn towards a combination of claim 1’s subcombination. The combination does not require the particulars of the subcombination, including the stent component including a ventricular portion and an aortic portion, a proximal sheath, and a distal sheath, etc. The subcombination has separate utility alone acting as a delivery system which does not require the use of a tip sheath component or a rear sheath with a stepped shape.
Further, claim 20 is drawn towards a method of using the product of claim 1. The method can be used with another and materially different product, such as one which does not include a stent component having a ventricular portion and aortic portion.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 13-21 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Drawings
The drawings are objected to because item number 1602 is used to represent both “valve prosthesis” and “stent”.
Further, item number 100 and 565 are in the figures but not the specification.
Further, the drawings fail to show all the claimed components, including the “fluid-tight conduit” in communication with the piston component, and the pressure source which provides variable fluid pressure to the piston component.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: baseline pressure.
Claim Objections
Claims 1, 5-7, 12 are objected to because of the following informalities:
Claim 1 is objected to for claiming “a collapsible valved stent” when the claim has already referenced the invention being for a “cardiac valved-stent delivery system”. It is unclear if the “valved-stent” and “valved stent” are referring to the same item or not since one includes a hyphen and one does not.
The claim is further objected to for claiming the ventricular portion and aortic portion are “configured for use in fitting towards” a blood vessel, when it is unclear what it means to be “fitting towards” something.
Claims 5-6 are objected to for referring to the “stent-component” and/or “stent component” when it is unclear if/how these are the same things since one include a hyphen and one does not.
Claim 6 is further objected to for having improper antecedent basis for “the self-expandable properties”.
Claim 7 is objected to for having improper antecedent basis for “the proximal end” and “the distal end”.
Claim 12 is objected to for referring to “at least one sheath” when it is unclear how, if at all, this relates to the previously claimed “distal sheath” and/or “proximal sheath”.
The claim is further objected to for referring to “the collapsible valved stent” when it is unclear how, if at all, this relates to the previously claimed “valved-stent” which includes a hyphen in its name.
Further, the claim is unclear for referring to exposing “portions” of the valved stent, when it is unclear how, if at all, these relate to the previously claimed “proximal portion” and “distal portion” of the valved-stent.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 5-6, 9-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Euteneuer et al. (US 5989280 A) hereinafter known as Euteneuer in view of Rowe et al. (US 20090276040 A1) hereinafter known as Rowe.
Regarding claim 1 Euteneuer discloses a stent delivery system (Abstract), comprising:
a collapsible stent with a stent component (Abstract; Figure 1 item 17; Column 1 lines 52-55),
a delivery catheter (Figure 1 item 12) which includes an attachment region for the stent (Figure 1 shows the attachment region of the catheter around which the stent 17 is placed), the attachment region including a distal end and a proximal end (proximal is understood to be closer to the handle, distal is understood to be closer to the tip),
a distal sheath (Figure 2 item 16) slidably configured to cover at least a portion of the distal end of the attachment region (Figure 2; Column 9 lines 45-47) and configured to slide distally to reveal the distal end of the attachment region (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Euteneuer discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example Column 9 lines 52-55),
a proximal sheath (Figure 2 item 14) slidably configured to cover at least a portion of the proximal end of the attachment region (Figure 2; Column 9 lines 45-47) and configured to slide proximally to reveal the proximal end of the attachment region (this is also stated as a functional limitation (see the explanation regarding functional limitations above). See also Column 9 lines 55-58),
a hydraulic actuator system comprising: a piston component (Figures 12-13 item 90) operatively connected to the distal or proximal sheath (Column 9 lines 45-58), a fluid-tight (see Column 6 line 66 to Column 7 line1 which describes how the inside is fluid-tight) conduit (Figure 13 item 92) in communication with the piston (Figures 12-13), and a pressure source (this is considered to be inherent) configured to provide variable fluid pressure to the piston to actuate movement of the distal or proximal sheath (this is also stated as a functional limitation (see the explanation regarding functional limitations above). See also Column 9 lines 53-58. The Examiner notes the fluid pressure is considered to be able to be provided “variably” in that the pressure is able to either be applied (e.g. during deployment) or not applied (e.g. during delivery).),
but is silent with regards to the delivery system being for a cardiac valved stent with a valve component, with the stent including a ventricular portion for fitting towards a ventricle and an aortic portion for fitting towards an aorta,
However, regarding claim 1 Rowe teaches a stent can include a valve component for a cardiac valve (Abstract mitral valve) with a ventricular portion for fitting towards a ventricle and an aortic portion for fitting towards an aorta (Figure 3). Euteneuer and Rowe are involved in the same field of endeavor, namely delivery systems for stented endoprostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the delivery system of Euteneuer by delivering a valved stent for the heart as opposed to a standard stent as is taught by Rowe in order to allow treatment of a patient who has a diseased or damaged heart valve.
Further, regarding claim 1, since Euteneuer discloses the sheaths meet in the middle of the stent (see Figure 2), and Rowe teaches the ventricular portion of the stent is on one half of the stent (Figure 3 shows how the bottom half of the stent is positioned in the ventricle) and describes how the device can be delivered transeptally, with the catheter extending from the right atrium to the left atrium and then through the mitral valve (e.g. into the ventricle) ([0068]), which results in the distal end of the catheter and stent reaching the ventricle, and the proximal end of the stent reaching the atrium for deployment in place as is seen in Figure 3), the Combination of the two references thus teaches the distal sheath being configured to extend proximally to cover the ventricular portion of the stent as the claim requires.
Regarding claim 2 the Euteneuer Rowe Combination teaches the delivery system of claim 1 substantially as is claimed,
wherein Euteneuer further discloses the piston component is configured to move the distal sheath distally upon application of increased hydraulic pressure relative to a baseline pressure (this is also stated as a functional limitation (see the explanation regarding functional limitations above). See also Column 9 lines 53-55. The “baseline pressure” is understood to be that which exists during delivery through the vasculature as opposed to pressure applied during expansion.).
Regarding claim 5 the Euteneuer Rowe Combination teaches the delivery system of claim 1 substantially as is claimed,
wherein Euteneuer further discloses the stent component is self-expanding (Abstract).
Regarding claim 6 the Euteneuer Rowe Combination teaches the delivery system of claim 5 substantially as is claimed,
wherein Euteneuer further discloses the stent is configured to automatically detach via self-expansion (this is also stated as a functional limitation (see the explanation regarding functional limitations above). See also the Abstract “the stent…release means is a single layer sheath retaining sleeve means for retaining the stent in its delivery configuration attached to a slipping sleeve means for releasing the stent to self-expand”).
Regarding claim 10 the Euteneuer Rowe Combination teaches the delivery system of claim 1 substantially as is claimed,
wherein Euteneuer further teaches the fluid comprises a liquid (Column 3 lines 15-21, Column 10 lines 36-41; the disclosure of Euteneuer describes how the “fluid” allows swelling, or water solubility to aspects of another embodiment of Euteneuer’s system. Accordingly, it would have been obvious to one of ordinary skill to use a water-based or liquid-based fluid within the dual-sheath hydraulic delivery embodiment of the Combination, as a known type of fluid useable and safe within catheter delivery systems.).
Regarding claim 11 the Euteneuer Rowe Combination teaches the delivery system of claim 1 substantially as is claimed,
wherein Euteneuer further discloses the piston component has a sliding action (this is also stated as a functional limitation (see the explanation regarding functional limitations above). See also item 90 within Figure 12 to Figure 13).
Regarding claim 12 the Euteneuer Rowe Combination teaches the delivery system of claim 1 substantially as is claimed,
wherein Euteneuer further discloses the hydraulic actuator system is configured to apply a first hydraulic pressure in a closed state and apply a second hydraulic pressure greater than the first to drive the piston and displace at least one sheath to expose portions of the stent (this is also stated as a functional limitation (see the explanation regarding functional limitations above). See also Column 9 lines 45-58 the “first” hydraulic pressure is understood to be that applied during delivery of the device through the vasculature which maintains the sheaths 14, 16 around the stent 17. The “second” hydraulic pressure is understood to be that discussed within the deployment (Column 9 lines 45-58).
Claim(s) 7-8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Euteneuer in view of Rowe as is applied above, further in view of Bortlein et al. (US 20100100167 A1) hereinafter known as Bortlein.
Regarding claims 7-8 the Euteneuer Rowe Combination teaches the delivery system of claim 1 substantially as is claimed,
wherein Euteneuer further discloses the proximal and distal sheath are configured to meet near the proximal end of the distal sheath and near the distal end of the proximal sheath (Figure 2; Column 7 lines 6-7),
but is silent with regards to the sheaths meeting at the proximal end of the distal sheath and at the distal end of the proximal sheath so they meet edge-to-edge.
However, regarding claims 7-8 Bortlein teaches proximal and distal sheaths can be configured to meet at the proximal end of the distal sheath and the distal end of the proximal sheath (Figure 1a-b; [0025] the two sheaths meet at join 36).Euteneuer and Bortlein are involved in the same field of endeavor, namely delivery devices for endovascular devices. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Euteneuer to have the sheaths meet edge-to-edge as is taught by Bortlein as since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would find it obvious to modify the sheaths to meet in any known configuration in the art.
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 01/22/26
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