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 11/26/25 have been fully considered but they are not persuasive.
On page 8 regarding drawing objections Applicant argues element 222 is located in [0027].
The Examiner respectfully agrees and withdraws drawing objections.
On pages 8-9 regarding drawing objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws objections.
On page 9 regarding 112a rejections Applicant argues the amended specification [0031] provides support for the new matter identified by the Examiner.
The Examiner respectfully disagrees, noting the subject matter added to the specification [0031] is simply the same new matter not supported by the originally field disclosure, added to put new matter into the specification. Please see the objection below.
On page 10 regarding 112b rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully agrees and withdraws 112b rejections.
On page 13 regarding prior art rejections Applicant argues the prior art fails to teach amended claims.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Objections
Claim 22 is objected to because of the following informalities:
Claim 22 is objected to for referring to the first and second wire comprising “a plurality of undulations” when claim 1, from which this depends has already established that the first and second wire each comprise undulations, making it unclear if these are referring to the same or different undulations
Further, there is improper antecedent basis for “a proximal end of the main body portion”. Appropriate correction is required.
Specification
The amendment filed 11/26/25 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
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Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13, 23-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13 is rejected for having new matter for claiming the second wire is welded to the second wire (e.g. itself). The originally filed disclosure fails to mention or support this.
Claim 23 is rejected for having new matter for claiming the first and second contact areas are located at “a proximal end” of the stent when there is no support for this in the originally filed disclosure.
Claim 24 is rejected for having new matter for claiming the first wire’s second end is attached to the first wire (e.g. itself). The originally filed disclosure fails to mention or support this.
Claim 25 is rejected for having new matter for claiming the second wire’s second end is attached to the second wire (e.g. itself). The originally filed disclosure fails to mention or support this.
Remaining claims are rejected for depending on a claim with new matter.
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.
Claims 1-4, 6, 8, 12-13, 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin et al. (US 20020052648 A1) hereinafter known as McGuckin in view of Molony (US 20080133000 A1), or in the alternative, over McGuckin in view of Molony, further in view of Su (US 20130310920 A1).
Regarding claims 1-2 and 22 McGuckin discloses a stent (Figure 16) comprising:
a first wire (Figure 17 item 602) helically wound (Figure 17) along an axis of a main body portion (Figure 17 item 603) of the stent and along an axis of a first branch portion (Figure 17 item 605) of the stent so it extends from a proximal end of the main body portion to a distal end of the first branch portion (clm 22) (Figure 17);
and a second wire (Figure 17 item 612) that is helically wound (Figure 17) along the axis of the main body portion of the stent (Figure 17 item 613) and along an axis of a second branch portion of the stent (Figure 17 item 615) so it extends from a proximal end of the main body portion to a distal end of the second branch portion (clm 22) (Figure 17),
wherein windings of the second wire along the main body portion of the stent alternate with windings of the first wire along the main body portion of the stent (see at least annotated Figure 16 where at least two windings of the second wire are seen to have at least one winding of the first wire therebetween),
but is silent with regards to the wires each comprising undulations,
with the second wire’s undulations including a first and second side that meet at a peak.
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However, regarding claims 1-2 and 22 Molony teaches helically extending stents which includes a first body portion can comprise undulations (Figure 7 shows zigzags along the main body portion 402);
wherein an undulation of the stent has a first side and a second side that meet at a peak (Figure 5 shows a peak 322 with first and second sides 318 on either side of the peak). McGuckin and Molony are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of McGuckin to have the stent wires include undulations as is taught by Molony since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the use of undulating strut patterns is a known technique in the art.
Further, regarding claims 1-2 and 22 McGuckin Figures 16-17 shows that the first and second wires and contact one another along the main body portion (603, 613), and the locations at which they overlap can be considered to be at least a first contact area (claim 2). Alternatively, Su teaches that stents having multiple wires making up a main body portion can contact one another at contact areas (Figure 1 item 101; [0020]). McGuckin and Su are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the McGuckin Molony Combination so that the wires have two contact areas as is taught by Su in order to increase the strength of the main body portion by having double the amount of wall support, creating a two-ply structure.
The Combination is understood to have a first of the contact areas on (at least) one of the sides of the undulation.
Regarding claim 3 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 1 substantially as is claimed,
wherein McGuckin further discloses the main body branches to the first and second branch at a bifurcated portion (Figure 16 understood to be the portion at the intersection of the main and branch portions).
Regarding claim 4 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 1 substantially as is claimed,
wherein McGuckin further discloses windings (Figure 17 shows looped windings in portion 613) of the second wire along the main body alternate with windings (Figure 17 shows looped windings in portion 603) of the first wire along the main body (Figure 16 shows the looped windings of the wires along the main body portion, which includes locations where the wires alternate).
Regarding claim 6 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 1 substantially as is claimed,
wherein McGuckin further discloses windings of the first wire are only along the main body and first branch (Figures 16-17 show the looped windings of the first wire 602 extending only along the main body portion 603 and branch 605),
and windings of the second wire are only along the main body and second branch (Figures 16-17 show the looped windings of the second wire 612 extending only along the main body portion 613 and branch 615).
Regarding claim 8 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 1 substantially as is claimed,
wherein Molony further teaches an undulation of the stent has a first side and second side that meet at a peak (Figure 5 shows an undulation peak 322 with two sides 318),
wherein a length of the first side is shorter than a length of the second side (Figure 7 shows how zigzag undulations take on different size lengths in order to create a helical winding).
Regarding claim 12 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 2 substantially as is claimed,
but is silent with regards to the first wire being welded/crimped to the second wire at the first contact area.
However, regarding claim 12 Molony teaches a stent wherein connections between two wires can be welded ([0025], [0026]). McGuckin and Molony are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the McGuckin Molony Combination, or the McGuckin Molony Su Combination to have the wires welded together at contact areas as is taught by Molony 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 use of any known method of connection between the two-ply main body section would have been obvious to one of ordinary skill to try.
Regarding claim 13 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 12 substantially as is claimed,
wherein Molony further teaches a wire can be welded/crimped to itself at a second contact area ([0036]).
Regarding claim 21 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 13 substantially as is claimed,
wherein Molony further teaches an undulation of the stent has a first side and second side that meet at a peak (Figure 5 shows an undulation peak 322 with two sides 318),
wherein the Combination teaches the second contact area is located on the first or second side (Su shows how the contact area will extend along the length of both wires in the main portion of the stent).
Regarding claim 23 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 22 substantially as is claimed,
wherein McGuckin further discloses the first and second contact area are located at a proximal end of the stent (Figure 16).
Regarding claim 24 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 1 substantially as is claimed,
wherein McGuckin further discloses the first wire has a first end (Figure 17 shows one end on the left of main body 603) and second end (Figure 17 shows one end on the right of branch portion 605),
wherein Su further teaches a first end of the wire of the Combination is attached to the second wire (see Su who teaches the wires in the main portion (e.g. at the first end of both the first and second wires) is attached to one another,
and wherein Molony further teaches the second end of the first wire of the Combination is attached to the first wire (itself) (Molony [0036] teaches that the free ends of the wires can be welded to itself).
Regarding claim 25 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 24 substantially as is claimed,
wherein McGuckin further discloses the second wire has a first end (Figure 17 shows one end on the left of main body 613) and second end (Figure 17 shows one end on the right of branch portion 615),
wherein Su further teaches a first end of the wire of the Combination is attached to the first wire (see Su who teaches the wires in the main portion (e.g. at the first end of both the first and second wires) is attached to one another,
and wherein Molony further teaches the second end of the second wire of the Combination is attached to the second wire (itself) (Molony [0036] teaches that the free ends of the wires can be welded to itself).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin and Molony [and Su] as is applied above , further in view of Dereume et al. (US 5723004 A) hereinafter known as Dereume.
Regarding claim 5 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 1 substantially as is claimed,
wherein McGuckin further discloses the first and second wires are [connected to] a graft member along the main body portion, with the first wire being [connected] along the first branch portion, and the second wire being [connected] along the second branch portion ([0083], [0061]),
but is silent with regards to the wires being encapsulated by the graft.
However, regarding claim 5 Dereume teaches that stents can be encapsulated by grafts (Column 4 lines 10-24). McGuckin and Dereume are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the graft of McGuckin so that it encapsulates the wires as is taught by Dereume in order to provide a smooth and biocompatible surface which will not catch on delivery systems or biological structures when implanted.
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin and Molony [and Su ], as is applied above , further in view of Su.
Regarding claim 14 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 1 substantially as is claimed,
but is silent with regards to a distance between adjacent windings of the first wire along the main body is greater than a second distance between adjacent windings of the first wire along the first branch.
However, regarding claim 14 Su teaches a stent which has a first distance between adjacent windings along a main body is greater than a second distance between adjacent windings along a first branch (see Figure 3 which shows a main body portion 301 with windings positioned further apart from one another than windings in branch 302). McGuckin and Su are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Combination so the distance between windings along the main body portion for the first wire is greater than its windings along the first branch as is taught by Su 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 have found it obvious to try windings separated by any distance which would reasonably be expected to support the vessels into which the stent is intended to be implanted.
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin and Molony [and Su] as is applied above, as is evidenced by Lam (US 20080097583 A1).
Regarding claim 9 the McGuckin Molony Combination, or the McGuckin Molony Su Combination teaches the stent of claim 1 substantially as is claimed,
wherein Molony further teaches an undulation of the stent has a first side and second side that meet at a peak (Figure 5 shows an undulation peak 322 with two sides 318),
and wherein a length of the first side is equal to the length of the second side (Figure 5). Further, regarding claim 9 Lam teaches how a helical stent (Figure 1) can include undulations having equal size lengths on either size of a peak (Figure 1; [0024]).
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 12/08/25