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 06/15/26 have been fully considered but they are not persuasive.
On page 7 Applicant argues amendments overcome claim objections.
The Examiner respectfully agrees and withdraws objections.
On page 8 regarding specification objections Applicant argues the amendment of the title overcomes the objection of record.
The Examiner respectfully agrees and withdraws the specification objection.
On pages 9-11 Applicant argues amendments overcome the rejection of record to claim 1 since Yamaguchi’s wire abuts the distal end 934.
The Examiner respectfully disagrees and maintains the body is free of the wire in “an area surrounding the distal opening”, as there is no wire surrounding the opening. As can be seen in Figure 10, there might be a part of the metal webs which come close to the opening, but there is no discussion of the wire touching or surrounding the opening. There is also no discussion of the wire abutting anything. Coming near the opening is not the same as there being wire in the area surrounding the distal opening. This is accordingly maintained. Further, even though the drawings cannot be considered accurately drawn to scale, when zoomed in, the wire of the body and the distal opening are seen to be discrete lines (see below):
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Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “fixation feature” in claims 3-4. Paragraph [0045] and [0052] of the specification indicates that these can be “protruding barbs, sharpened protruding barbs, an adhesive, inflatable portions, flared portions, strut hooks, or any combination thereof”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 17-18, 20-21 are 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 pre-AIA the applicant regards as the invention.
Claim 17 is indefinite for claiming the wire pattern deviates “substantially at or near a border” when it is unclear exactly what is means to be “substantially at or near a border”. The specification does not elaborate on what this means, and where the boundary lies between being substantially at/near a border, at/near a border, and/or not at/near a border. Without guidelines, the Examiner cannot determine the boundaries of the claim.
Claim 21 is indefinite for the same reason as claim 17.
Remaining claims are rejected for depending on an indefinite claim.
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) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yamaguchi (US 20160324670 A1).
Regarding claim 1 Yamaguchi discloses a bifurcated endovascular prosthesis (Figure 10 item 900) comprising:
a primary stent graft (900) comprising:
a body (Figure 10 item 910) comprising a proximal portion (912) and a distal portion (914), wherein the proximal portion is configured to be disposed in a diseased vessel and the distal portion is configured to be disposed within a first branch vessel (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Yamaguchi was considered capable of performing the cited intended use of being positioned with the proximal portion 912 in a diseased vessel and the distal portion 914 in a first branch vessel, if desired.),
a bore disposed through the body (through from end 914 to end 912; [0006]), and
a pocket disposed within the bore (Figure 10 item 930) and coupled to a body wall of the body (Figure 10, left figure shows the attachment of the pocket 930 to the side wall of 910),
wherein the pocket comprises a proximal opening (932), a distal opening (934), and a pocket lumen disposed between the proximal and distal openings (Figure 10 shows the opening between ends 932 and 934), and
wherein the distal opening is disposed in the body wall (Figure 10 shows how the opening 934 forms the opening in the wall 910), and
a secondary stent graft (Figure 10 item 940) comprising:
a proximal portion disposable within the pocket lumen (Figure 10 shows the proximal (bottom) portion of secondary stent graft 940 within the pocket 930), and
a distal portion (Figure 10 shows the distal (top) portion of the secondary stent graft 940 extending outward and away from the body 910 and pocket 930) configured to be disposed within a second branch vessel (this is also stated as an “intended use” of the distal portion of the secondary stent graft (see the explanation regarding intended use statements above). The top, distal portion of stent graft 940 is understood to be positionable within a branch vessel since it extends outward and away from the main stent body 910. See also for example, Figure 12),
wherein the distal portion extends from the distal opening of the pocket (Figure 10),
wherein the body comprises a wire structure ([0043] the main body is a tubular metal web), and
wherein the body is free of the wire structure in an area surrounding the distal opening (Figure 10 shows the area surrounding the distal opening free of the wire; see also Figures 15-16: the body does not have a wire in the area surrounding the distal opening).
Regarding claim 7 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Yamaguchi further discloses the pocket further comprises a distal end wall disposed at an angle relative to a longitudinal axis of the primary stent graft (the distal end wall is considered to be the distalmost end of the main body stent graft 914 which marks the distal end 914, which is relatively thin and is seen to be perpendicular to the longitudinal axis of the prosthesis (Figure 10)), the angle ranging from 30-90 degrees (Figure 10).
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 2-3, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi as is applied above in view of Goicoechea et al. (EP 0783873 A2), hereinafter known as Goicoechea
Regarding claim 2 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
but is silent with regards to the diameter of the pocket lumen relative to the diameter of the secondary stent graft.
However, regarding claim 2 Goicoechea teaches that a diameter of a pocket lumen within a stent graft is smaller than or equal to a diameter of a secondary stent graft which attaches thereto (Column 2 lines 36-43 the two stent grafts would not resist separation if the secondary stent graft were smaller than the primary stent graft; see also Figures 1a-b, 6 which shows the diameter of the secondary stent graft being significantly larger than the primary stent graft’s pocket), and so the secondary stent graft is configured to form a fluid-tight seal with the pocket (Column 14 lines 48-59). Yamaguchi and Goicoechea 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 prosthesis of Yamaguchi by having the pocket lumen be the same/smaller than the diameter of the secondary stent graft which is inserted therein as is taught by Goicoechea in order to facilitate coupling of the two parts of the prosthesis together and ensure they do not decouple during use, which increase patient safety and device success.
Regarding claim 3 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
but is silent with regards to the secondary stent graft including a proximal fixation feature at its proximal end that is configured to couple with the proximal end of the pocket to prevent axial movement.
However, regarding claim 3 Goicoechea teaches a prosthesis wherein a secondary stent graft comprises a proximal fixation feature disposed at a proximal end which is configured to couple with a proximal end of a pocket to prevent the secondary stent graft from distal axial movement relative to a primary stent graft (Column 15 lines 8-14; “barbs”).Yamaguchi and Goicoechea 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 prosthesis of Yamaguchi by having a fixation feature on the proximal end of the secondary stent graft as is taught by Goicoechea in order to facilitate coupling of the two parts of the prosthesis together and ensure they do not decouple during use, which increase patient safety and device success.
Regarding claim 5 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Yamaguchi further discloses the pocket is inwardly tapered from a proximal end to a distal end ([0010]), and
wherein the secondary stent graft is selectively secured within the pocket ([0014])
but is silent with regards to whether the proximal portion of the secondary stent graft is also inwardly tapered, to prevent axial displacement of the secondary stent graft relative to the primary stent graft.
However, regarding claim 5 Goicoechea teaches a prosthesis wherein the shape of a secondary stent graft (Figure 6 item 88) matches the shape of the opening into which is inserted (Figure 6 item 78) to prevent axial displacement of the second stent graft relative to the primary stent graft (Column 2 lines 36-43). Yamaguchi and Goicoechea 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 prosthesis of Yamaguchi by having the shape of the secondary stent graft match the shape of the pocket into which it is being inserted (e.g. inwardly tapered from a proximal end toward a distal portion, as is taught by Yamaguchi [0010]) as is taught by Goicoechea in order to facilitate coupling of the two parts of the prosthesis together and ensure they do not decouple during use, which increase patient safety and device success.
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi as is applied above in view of Quinn (US 6645242 B1).
Regarding claim 4 Yamaguchi discloses the prosthesis of claim 1 substantially as is claimed,
wherein Yamaguchi further discloses the pocket comprises a fixation feature configured to couple with the secondary stent graft ([0010] a frustoconical shape is considered to be a “flared portion” (see 112f interpretation above).),
but is silent with regards to whether or not this prevents proximal or distal axial movement of the secondary stent graft relative to the primary stent graft.
However, regarding claim 4 Quinn teaches a prosthesis wherein a fixation feature is configured to prevent proximal or distal axial movement of the secondary stent graft relative to a primary stent graft (Column 8 line 67 -Column 9 line 4). Yamaguchi and Quinn 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 prosthesis of Yamaguchi by having a fixation feature on the proximal end of the secondary stent graft as is taught by Quinn in order to facilitate coupling of the two parts of the prosthesis together and ensure they do not decouple during use, which increase patient safety and device success.
Claims 17-18, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi as is applied above in view of Hidari (US 20200214826 A1).
Regarding claim 17 Yamaguchi discloses a primary stent graft (Figure 10, left figure item 900) of a bifurcated endovascular prosthesis (Figure 10, right figure) comprising;
a body (Figure 10 item 910) comprising a proximal portion (912) and a distal portion (914), wherein the proximal portion is configured to be disposed in a diseased vessel (this is stated as an “intended use” of the proximal portion of the body of the primary stent graft (see the explanation regarding “intended use” statements in the rejection to claim 1 above. The proximal portion is disposed in a diseased vessel, if desired. See also [0003] which describes how stent grafts are disposed in vessels with aneurysms) and the distal portion is configured to be disposed within a first branch vessel (This is also stated as an “intended use” of the distal portion of the primary stent graft (see the explanations above). The distal portion is understood to be capable of being positioned in a first branch vessel, if desired.),
a bore disposed through the body (through from end 914 to end 912; [0006]), and
a pocket disposed within the bore (Figure 10 item 930) and coupled to a body wall (Figure 10, left figure shows the attachment of the pocket 930 to the side wall of 910),
wherein the pocket comprises a proximal opening (932), a distal opening (934), and a pocket lumen disposed between the proximal and distal openings (Figure 10 shows the opening between ends 932 and 934),
wherein the distal opening is disposed in the body wall (Figure 10 shows how the opening 934 forms the opening in the wall 910),
wherein the body comprises a wire structure ([0043] the main body is a tubular metal web),
but is silent with regards to the wire structure having a pattern which deviates near a border of the area surrounding a distal opening so the body is free of a wire structure in that area.
However, regarding claim 17 Hidari teaches a wire structure of a prosthesis which has a pattern (Figure 2b shows items 321, 322, 324, 325 having a zig-zag pattern) which deviates near a border of an opening (Figure 2a item 35) such that the body is free of the wire structure in the area (Figures 2a-b shows the wire 323 deviating from the pattern set by 321, 322, 324, 325 where it ceases to exist near the opening 35). Yamaguchi and Hidari 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 stent graft of Yamaguchi to alter the pattern of the wire near the border of the distal opening as is taught by Hidari in order to ensure the opening and any attached branch graft can move freely and with flexibility without potential interference from the wire of the body stent.
Regarding claim 18 the Yamaguchi Hidari Combination teaches the primary stent graft of claim 17 substantially as is claimed,
wherein Yamaguchi further teaches a diameter of the pocket lumen is from 10-90% of a diameter of the bore of the body (Figure 10; while the Examiner does not understand the figures to be drawn to-scale, it is not understood that they should be drawn completely inaccurately either. Accordingly, the person of ordinary skill in the art, in viewing figure 10, would find it obvious to modify the primary stent graft of Yamaguchi so that the diameter of the pocket lumen is from 10-90% of the diameter of the bore of the body, since the figure appears to show the diameter of the primary stent graft body 910 to be about 4.5x the width of the pocket lumen 930 (e.g. the figures appear to show the pocket lumen being about 45% of the diameter of the bore of the body), which falls within the range of the claim).
Regarding claim 20 the Yamaguchi Hidari Combination teaches the primary stent graft of claim 17 substantially as is claimed,
wherein Yamaguchi further discloses the pocket further comprises a distal end wall disposed at an angle relative to a longitudinal axis of the body (the distal end wall is considered to be the distalmost end of the main body stent graft 914 which marks the distal end 914, which is relatively thin and is seen to be perpendicular to the longitudinal axis of the prosthesis (Figure 10)), the angle ranging from 30-90 degrees (Figure 10).
Regarding claim 21 Yamaguchi discloses the primary stent graft of claim 1 substantially as is claimed,
but is silent with regards to the wire structure having a pattern which deviates near a border of the area surrounding a distal opening so the body is free of a wire structure in that area.
However, regarding claim 21 Hidari teaches a wire structure of a prosthesis which has a pattern (Figure 2b shows items 321, 322, 324, 325 having a zig-zag pattern) which deviates near a border of an opening (Figure 2a item 35) such that the body is free of the wire structure in the area (Figures 2a-b shows the wire 323 deviating from the pattern set by 321, 322, 324, 325 where it ceases to exist near the opening 35). Yamaguchi and Hidari 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 stent graft of Yamaguchi to alter the pattern of the wire near the border of the distal opening as is taught by Hidari in order to ensure the opening and any attached branch graft can move freely and with flexibility without potential interference from the wire of the body stent.
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 06/29/26
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