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 Amendment
Claims 1-3, 5-7, and 11-20 are pending in the application. Claims 4 and 8-10 have been canceled. Claims 1 and 5 have been amended.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3, 5-7, 11, and 15 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nadal (US 6,302,891).
Regarding claim 1, Nadal discloses (Figures 6-14) a medical device, comprising: a catheter shaft (56) having a distal end and a proximal end (Figure 9), and a constraining line maintaining component (54) located between the proximal end and the distal end of the catheter shaft; an expandable implant (30) having a proximal end (31) and a distal end (33a) and being arranged at a predetermined position (Column 5, line 64 – Column 6, line 4) along the catheter shaft in a collapsed configuration (Figure 10), the expandable implant further being expandable to an expanded configuration (Figure 14) from the collapsed configuration (Figures 6-10 and 13); a sleeve (52) having a proximal end and a distal end, the sleeve being disposed around the expandable implant to maintain the expandable implant in the collapsed configuration (Figures 8 and 9); and a constraining line (69) having a first end and a second end, the constraining line extending along the catheter shaft radially from the catheter shaft to form: (1) a primary loop surrounding the distal end of the expandable implant, the constraining line extending about and constraining the proximal end of the expandable implant relative to the catheter shaft (Column 6, lines 57-64), and (2) a secondary loop which the first end and the second end of the constraining line pass through to form a slip knot (73; Column 6, lines 57-64), wherein tensioning both the first end and the second end of the constraining line disclosed by Nadal is capable of tightening of the slip knot which maintains the expandable implant in the predetermined position relative to the catheter shaft, and wherein releasing the first end of the constraining line and tensioning the second end of the constraining line disclosed by Nadal is capable of causing the constraining line to be released from the expandable implant (Column 7, lines 30-39).
Regarding claim 2, Nadal discloses (Figure 10) the expandable implant comprises a stent pattern including straight segments and apices (see Figure 10 annotated below), and wherein the constraining line (69) is woven through alternating straight segments or apices around a circumference of the expandable implant (Column 3, lines 10-20).
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Regarding claim 3, Nadal discloses (Figure 10) the constraining line (69) is woven through the straight segments or apices at an angle (approximately 90 degrees) relative to a longitudinal axis of the expandable implant (see Figure 10 annotated above).
Regarding claim 5, the slip knot (73) disclosed by Nadal is configured to releasably restrain the proximal end of the expandable implant (Column 6, lines 57-64).
Regarding claim 6, the slip knot (73) disclosed by Nadal is capable of axially restraining the proximal end of the expandable implant with respect to the catheter shaft (56).
Regarding claim 7, the slip knot (73) disclosed by Nadal is configured to radially restrain the proximal end of the expandable implant with respect to the catheter shaft (Column 6, lines 57-64).
Regarding claim 11, Nadal discloses (Figure 10) that the expandable implant includes a self-expandable stent-graft (Column 3, lines 9-16).
Regarding claim 15, Nadal discloses (Figure 10) the expandable implant is positioned concentrically around the catheter shaft.
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.
Claims 12-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nadal (US 6,302,891) in view of Osborne et al. (US 2006/0009835 A1) (“Osborne”).
Regarding claims 12-14, Nadal discloses the invention substantially as claimed. However, Nadal fails to disclose the stent-graft comprises one or more coatings applied thereon, wherein the one or more coatings include one or more bio-active agents, and wherein the one or more coatings are adapted to controllably release the one or more bio-active agents when the stent- graft is implanted in a body.
In the same field of endeavor, Osborne teaches (Figures 1-5) a stent graft that is provided with one or more coatings applied thereon, wherein the one or more coatings include one or more bio-active agents, and wherein the one or more coatings are adapted to controllably release the one or more bio-active agents when the stent-graft is implanted in a body (paragraphs 0059-0064).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stent-graft disclosed by Nadal to include one or more coatings applied thereon, wherein the one or more coatings include one or more bio-active agents, and wherein the one or more coatings are adapted to controllably release the one or more bio-active agents when the stent- graft is implanted in a body, as taught by Osborne. This modification will allow the bioactive agent(s) to be released over time from the coating to achieve desired physiological effects (e.g., anti-inflammatory effects; Osborne, paragraphs 0059-0064).
Allowable Subject Matter
Claim 16 is 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.
Claims 17-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Claim 16 recites that the expandable implant is positioned adjacent and parallel to the catheter shaft. These limitations, in combination with the limitations in claim 1 as amended, are not disclosed or suggested in the prior art of record. The previously cited Styrc reference fails to disclose the features of the constraining line that have been included in the amendment of claim 1. Styrc fails to disclose or suggest the constraining line forming a secondary loop which the first end and the second end of the constraining line pass through to form a slip knot, wherein tensioning both the first end and the second end of the constraining line causes tightening of the slip knot which maintains the expandable implant in the predetermined position relative to the catheter shaft, and wherein releasing the first end of the constraining line and tensioning the second end of the constraining line causes the constraining line to be released from the expandable implant. The Nadal reference cited above fails to disclose or suggest the expandable implant positioned adjacent and parallel to the catheter shaft. The expandable implant disclosed by Nadal is concentrically mounted on the catheter shaft.
The following is an examiner’s statement of reasons for allowance: Claims 17-20 are allowable over the prior art of record for the reasons provided in the previous Office Action.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 7/6/26 regarding the rejections under 35 U.S.C. § 102 citing the Nadal reference have been fully considered but they are not persuasive.
The Applicant has argued that retracting one of the three threads would not cause the stent 31 to be allowed to expand; rather, the stent expansion requires retracting all three threads in a certain order. The Applicant has submitted that there is not a single thread in the three threads capable of achieving “tensioning both the first end and the second end [to cause] tightening of the slip knot which maintains the expandable implant in the predetermined position relative to the catheter shaft” and “releasing the first end of the constraining line and tensioning the second end of the constraining line [to cause] the constraining line to be released from the expandable implant as recited in claim 1. The Examiner respectfully disagrees with these arguments.
First, there is no language in the claim that requires retracting the constraining line causes the stent to expand. The implant is recited as “expandable” and further “being expandable to an expanded configuration from the collapsed configuration.” However, the new language in the claim only requires that “releasing the first end of the constraining line and tensioning the second end of the constraining line causes the constraining line to be released from the expandable implant.” It does not require that releasing the first end and tension the second end causes the constraining line to be released from the expandable implant and the expandable implant to expand. The Applicant is arguing language that is not present in the claims.
Second, claim 1 recites “a medical device, comprising: …a constraining line…” There is no language in the claim limiting the number of threads/lines that constrain the expandable implant.
Third, "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The order that the three threads disclosed by Nadal are released is not relevant to the claims. Claim 1 is an apparatus claim, not a method claim. The thread 69 cited in the rejections forms a slip knot (running knot 73, shown in Figure 10) as claimed (Column 6, lines 57-64) with the ends of the thread emerging through the lateral branching 66b as shown in Figure 8. The ends of the threads are capable of being both tensioned as claimed to tighten the knot and one end released/one end tensioned to release the thread from the expandable implant (Column 7, lines 34-40). Nadal discloses all of the structural limitations of the claim.
For these reasons, the Examiner maintains that the claims as currently written to not distinguish over the disclosure of the Nadal reference.
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.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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