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 10/24/2025 have been fully considered but they are not persuasive. Although the amendment have overcome the 102 rejection under Devellian, the amendments to recite rotation to expand the wings does not overcome the previous 103 rejection under a combination of Coleman and Devellian. Coleman discloses relative rotation of the inner and outer tubes upon application of torsional force to expand the wings (see description of rotation to expand wings at least at [0005]; [0064]; [0071]).
Applicant argues that the modification of Coleman by Devellian renders it unsatisfactory for its intended purpose. This argument is not found to be persuasive, as Devellian functions in the same manner of Coleman to expand a set of proximal wings and distal wings. The only difference is the location along the tubes at which they are connected to one another. Modifying Coleman in view of Devellian merely involves a change in the attachment location of the inner tube and outer tube. As disclosed by Devellian, forming the attachment point at the distal ends of the tubes is merely an alternative way to connect the tubes of an implantable component such that one tube is axially compressed to allow two sets of wings to expand. The outer tube is compressed in a similar manner to the Coleman device, except that both sets of wings are expanded by moving the outer tube in one direction, instead of moving two ends of the tube towards the center.
Coleman is relied upon for teaching that the axial movement can be in combination with rotational movement (at least [0005]; [0064]; [0071]). Although Coleman discloses that both ends of the outer tube are rotated to expand the wings, this is due to the location of the attachment point to the inner tube. Devellian is relied upon for teaching that two sets of wings can be expanded by an actuation force directed towards only one end of the device, wherein the tubes are connected to one another at their respective ends. One of ordinary skill in the art would be capable of configuration the modified Coleman assembly to expand both sets of the wings upon application of a combination of axial and torsional forces, since Devellian teaches that relative movement between inner and outer tubes results in expansion of two sets of wings.
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, 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 negated by the manner in which the invention was made.
Claim(s) 1, 2, 6, 7, 10, 11, 15 and 16 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US Patent App. Pub. No. 2009/0105733 (Coleman et al.) in view of US Patent App. Pub. No. 2005/0267523 (Devellian).
Regarding claim 1: Coleman discloses surgical implant that comprises an elongate tubular body having an inner tube (18) nested within an outer tube (12) (Figure 4);
an elongate guide member (26) is disposed within the elongated tubular body and capable of functioning to occlude flow at least to some degree through the elongate tubular body when attached thereto during delivery (see Figures 11-12), wherein the elongate guide member (26) extends proximally from a proximal end of the elongate tubular body (proximal end being right side of Fig. 11-12);
the outer tube (12) moves relative to the inner tube (18) in both axial and rotational directions such that the proximal portion and distal portion splay radially outwardly to form proximal wings and distal wings (abstract; see description of wings 16a, 16b at [0068-0070]; Fig. 5 & 8; see description of rotation to expand wings at [0005]; [0064]; [0071]);
and wherein the elongate guide member (26) is separable from the elongate tubular body ([0079]).
The inner and outer tube are connected at location (19) at their mid-portions, so Coleman fails to disclose the inner and outer tubes (12 and 18) are fixedly mated at their distal ends. Devellian discloses another implantable device having proximal and distal expandable wings, wherein the wings expand upon relative movement between an inner tube (catch 116) and an outer tube (102). Devellian teaches the configuration of the inner and outer tubes (116 and 102) being fixedly mated at distal ends, wherein this location of connection allows for relative movement of the tubes and expansion of the wings. One of ordinary skill in the art at the time of invention would have found it obvious to modify Coleman such that the inner and outer tube are fixed to one another at their distal ends, as taught by Devellian, as the modification merely involves a combination of known expandable implantable devices that achieves a predictable result of expanding proximal and distal wings with relative movement between an inner tube and a slotted outer tube.
In regards to claim 2, a conical/pointed tip of the guide member (26) extends distally from the elongate tubular body (Fig. 11-12).
Regarding claims 6 and 7, the guide member (26) extends proximally from and entirely through the elongate tubular body, such that when the guide (26) is removed a flow path is defined therethrough.
Regarding claim 10: Coleman discloses surgical implant that comprises an elongate tubular body having an inner tube (18) nested within an outer tube (12) (see elongated delivery configuration of Figure 4),
the outer tube (12) longitudinally compressing relative to the inner tube (18) to form radial proximal and distal wings (16a and 16b; [0068-0070]; Fig. 5 and 8);
an elongate guide member (former 24) disposed within the elongated tubular body and separable from the elongate tubular body (removal [0079]; Fig 21), the guide member (24) capable of functioning to occlude flow at least to some degree through the elongate tubular body when attached thereto during delivery (see Figures 11, 12, 19-20), wherein the elongate guide member (24) extends proximally from a proximal end of the elongate tubular body (proximal end being left side of illustrations of Fig. 11, 12, 19-20);
and a tether (inner shaft 26) having a distal portion disposed within the elongate tubular body and extending proximally therefrom (the Examiner notes the claim does not specify whether the tether is directly coupled to the elongate tubular body, so the removable arrangement of the inner shaft meets the broad requirement).
The inner and outer tube are connected at location (19) at their mid-portions, so Coleman fails to disclose the tubes (12 and 18) are fixedly mated at their distal ends. Devellian teaches that an implantable device having proximal and distal expandable wings can have inner and outer tubes fixed at their distal ends in order to achieve longitudinal compression of the outer tube relative to the inner tube to expand the wings. Coleman teaches that rotational movement can be combined with axial movement to expand wings at [0005]; [0064]; [0071]);
One of ordinary skill in the art at the time of invention would have found it obvious to modify Coleman such that the inner and outer tube are fixed to one another at their distal ends, as taught by Devellian, as the modification merely involves a combination of known expandable implantable devices that achieves a predictable result of expanding proximal and distal wings with relative movement between an inner tube and a slotted outer tube.
In regards to claim 11, a pointed tip of the tether (26) extends distally from the elongate tubular body (Fig. 11-12).
Regarding claims 15 and 16, the elongate guide member (former 24) extends proximally from and entirely through the elongate tubular body, such that when the guide (24) is removed a flow path is defined therethrough.
Allowable Subject Matter
Claims 3-5, 8-9, 12-14, 17 and 18 are 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
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774