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 Arguments
Applicant's arguments filed 03/19/26 have been fully considered but they are not persuasive.
On page 14 regarding prior art rejections to claim 16 Applicant argues Raifee’s helical anchor 345 is not an annuloplasty belt with a tensioning suture since it has a tissue penetrating tip at its distal end that is rotated into the annulus with a driver. Applicant argues an annuloplasty belt on the other hand, is a “flexible belt or band that is placed around or adjacent to cardiac tissue and shortened to apply compression”.
The Examiner respectfully disagrees and points out no requirement for the claimed “annuloplasty belt” to not be rotatable, not have a tissue penetrating tip, to not be able to be rotated via a driver. There is likewise no requirement by the claims for the “annuloplasty belt” to be “a flexible belt or bend that is placed around or adjacent to cardiac tissue and shortened to apply compression” as Applicant’s description states. If Applicant wishes these limitations to be read into the claims, the language of the claim should be adjusted accordingly, while pointing to support in the originally filed disclose for the amendment.
On pages 14-15 regarding claim 16 Applicant argues Raifee does not disclose an “integrated delivery system” where the components “all coexist as a single assembled system”.
The Examiner points out no requirement in the claims regarding the assembly state of the claimed system. This is accordingly not persuasive.
On page 15 Applicant argues Raifee teaches their system is used sequentially as opposed to within a single system.
The Examiner respectfully notes no requirement in the claims regarding an order of use, or assembly at any given point. Merriam-Webster defines “system” as “a regularly interacting or interdependent group of items forming a unified whole; a group of related natural objects or forces; a group of devices or artificial objects or an organization forming a network especially for distributing something or serving a common purpose” etc. No part of the definition of “system” requires the elements being argued by Applicant.
On page 16 Applicant argues Raifee does not teach a suture lock connected to a distal end of the pusher catheter because the knot 2255 is tied in the tether 2250 itself and does not connect to the lock pusher 2170, and since the second end of the tensioning suture is not connected to the tensioning device during severing.
The Examiner respectfully disagrees and maintains the rejection of record. Figure 22a shows the lock 2255 connected to the end of the pusher 2170. Further, at least momentary connection inherently occurs during the severing process.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 is objected to for referring to “the suture lock of claim 18” when claim 18 refers to a system.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rafiee et al. (US 20070244555 A1) hereinafter known as Rafiee.
Regarding claim 16 Rafiee discloses an integrated delivery system for an annuloplasty belt comprising:
a delivery sheath (Figure 3a item 320),
a pusher catheter (Figures 21a-b item 2170) within the sheath having an internal lumen (Figures 21a-b item 2177),
a suture lock (Figure 22a item 2255) connected to a distal end of the pusher catheter (Figure 22a),
an annuloplasty belt (Figure 3c-d item 345) having a tensioning suture (Figure 3c-d item 350), the belt being beside the pusher catheter within the delivery sheath ([0090]-[0091] the belt is delivered and tension applied to modify the shape of the belt with the same delivery member staying in place), and
a tensioning device (Figures 22a-b) within the lumen of the pusher catheter and proximal of the suture lock ([0108]) the tensioning device for applying tension to the tensioning suture,
wherein a first end of the tensioning suture is fixed to a portion of the suture lock ([0108], Figure 22d item 2251), a middle portion of the tensioning suture passes through the suture lock (Figure 22d shows how a middle portion wraps through/within the knot 2255) and a second end of the tensioning suture is connected to the tensioning device (Figure 22d item 2252 the second end connects when it is severed by 2275).
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 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rafiee as is applied above in view of Fung et al. (CA 2757497 A1) hereinafter known as Fung.
Regarding claim 17 Rafiee discloses the delivery system of claim 16 substantially as is claimed,
wherein Rafiee further discloses the lumen of the pusher catheter includes a proximal portion with a first inner diameter (Figure 21b shows how there is an opening in the pusher catheter),
but is silent with regards to there being an end chamber having a second inner diameter which is larger than the first inner diameter, and the suture lock being fitted within the end chamber.
However, regarding claim 17 Fung teaches a pusher catheter which includes a proximal portion with a first inner diameter (Figure 23b item 2318), and an end chamber having a second inner diameter larger than the first inner diameter (Figure 23b item 2316),
wherein the suture lock (Figure 23c item 2320) is fitted within the end chamber of the pusher catheter (Figure 23c). Raifee and Fung are involved in the same field of endeavor, namely suture delivery devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the delivery system of Raifee to include any known pusher catheter, including that of Fung, within the system of Raifee. The courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Allowable Subject Matter
Claims 18-26 are allowed.
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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/07/26
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