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 .
Terminal Disclaimer
The terminal disclaimer filed on 8/31/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 18/218959 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, see page 3, filed 8/31/2026, with respect to the claim objection, have been fully considered and are persuasive. The objection to claim 7 has been withdrawn.
Applicant's arguments with respect to the 112 rejection and 103 rejection have been fully considered but they are not persuasive.
In regard to the rejection of claim 10, the phrase “at least one stent optionally attached at the proximal end of the tubular graft body” can be read as the stent being completely optional and/or its attachment to the graft being optional. The claimed structure is unclear and the rejection is maintained.
In regard to the rejection under a combination of Styrc and Ohlenschlaeger, Applicant argues that substituting the implant would require significant modification of the Ohlenschlaeger stent graft and is there not obvious. For clarification, Ohlenschlaeger is only relied upon for teaching that the constrained implant has a tubular graft body in combination with the stent, wherein the retention member (25) of the Ohlenschlaeger assembly passes through openings at the end of the frame (defined by exposed stent 11) that are not covered by the tubular graft material (13) (see especially Figure 5-6; [0046]). Since the retention member of Styrc extends through eyelets disposed at the ends of the stent frame, modifying Styrc to have a tubular graft covering a portion of the frame, as taught by Ohlenschlaeger, would not require a modification to the graft itself, because the implant of Ohlenschlaeger has exposed openings (exposed stent 11) at the ends of the stent frame. It is understood that the retaining filaments do not extend through a wall of the graft. While Ohlenschlaeger discloses retention members (25) that remain attached to the stent, this element is not incorporated into the modified Styrc assembly. It is only the implant itself being substituted, wherein the tubular graft covers a length of the stent while leaving openings at the end for engagement with retaining members.
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.
Claim 10 is 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. Due to the term “optionally”, it is unclear whether a stent is required or not and/or whether a stent would be required to be attached to the proximal end of the graft body. The Examiner recommends deleting the term “optionally.”
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, 6, 9, 10, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2005/0119722 (Styrc et al.) in view of USPAP 2005/0107862 (Ohlenschlaeger).
Styrc discloses a medical device system, comprising:
a tubular medical device (11) comprising a tubular body having a proximal end and a distal end;
a diameter reducing arrangement configured for constricting a diameter of the medical device, the diameter reducing arrangement including a strand section (33), a first length of the strand section extending from a first point of the strand section to a second point of the strand section (the Examiner notes that the points can be arbitrarily designated at any location along the length of the strand; see annotated figure below), the second point of the strand section being a first circumferential distance from the first point of the strand section by way of a path along the first length of the strand section; wherein, in a constricted configuration of the medical device, a first portion of the first length of the strand section extends back on itself to form a first double-stranded tail leading to a first loop (the first loop being formed at the knot (93) [0077]), the first double-stranded tail extending circumferentially against the graft body to constrict the medical device by the strand section restricting the first circumferential distance between the first and second points of the strand section.
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Styrc fails to disclose a graft body on the medical device. Ohlenschlaeger discloses another delivery device comprising a retaining mechanism comprising a strand (retention loop 25) retained by a release wire (17) [0046], and teaches that the delivery device is used to constrain and deliver a stent-graft having a tubular graft body (13) (abstract). Ohlenschlaeger discloses the stent frame defines openings at one end (see exposed stent 11) through which the retention member (25) extends, wherein the tubular graft (13) does not obstruct the openings (see Figures 5-6; abstract; [0046]). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to substitute the stent of Styrc with a stent-graft taught by Ohlenschlaeger, as the modification merely involves a substitution of one known implant for another that obtains a predictable result of constraining a stent-graft for delivery with a restraining loop mechanism.
Regarding claim 6, Styrc discloses the first circumferential distance traverses and defines a first circumferential region of the medical device, wherein in an expanded configuration of the medical device at least a majority of the first portion is disposed in the first circumferential region of the medical device (wherein “the region” generally corresponds in length with the first circumferential distance).
Regarding claim 9, the loop is retained by a release mechanism in the form of a retaining rod (31C/ 31D) [0096].
Regarding claim 10, the medical device of modified Styrc comprises a stent graft with a stent body attached at a proximal end.
Regarding claim 11, Styrc discloses the double-stranded tail passes through the wall of the medical device and is retained by a release mechanism internal to the graft body (see above).
Regarding claim 13, the modified Styrc assembly meets all the structural limitations of the claim. The step of “pulling” is met by Styrc’s disclosure of tightening the loop (circumferentially extending filament) [0052; 0093].
Allowable Subject Matter
Claims 2-5, 12 and 14-15 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
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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