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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/15/2025 has been entered.
Priority
This application claims priority from provisional application 62/512,926 filed 05/31/2017
Status of Claims
Claims 2-12 are pending.
Claims 5, 10, and 11 have been withdrawn from consideration.
Claim 1 has been cancelled.
Election/Restrictions
Newly amended claims 5, 10, and 11 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: they are now directed at the embodiments shown in Figures 5A/B. The original disclosure was directed at embodiments with tails (146 Figure 1) not the cantilevered elongate element extending into the tubular element/ delivery device. The claims have been amended to replace tail with elongate element, which on its own still broadly reads upon the elected embodiment of a tail. However, narrowing the claims to now be directed at the embodiments shown in Figures 5A/B by requiring the cantilever structure and extending through the lumen of the tubular body is not appropriate because an action on the merits has been issued.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 5, 10, and 11 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the elongate element being contacted by surfaces of the long leg and constraint (Claims 2 and 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to for confusing formatting. Lines 3-4 should recite “delivering a branched endoprosthesis constrained by a constraint in a collapsed configuration to a vessel”.
Claim Rejections - 35 USC § 112
In view of the applicant’s amendments, the previous 112 rejections have been withdrawn.
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 2-4, 6-9, and 12 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 2 and 12 have been amended to require the elongated element to be constrained by contacting an inner surface of the constraint and an outer surface of the long leg which is considered new matter because the original disclosure never addressed the specifics about the elongated element within the constraint. The applicant cites the paragraphs [0044]-[0046] and Figures 2B-C, 4D for support. However they fail to clarify the specifically claimed steps.
[0044] Fails to address any specifics other than the tail is connected to the shorter leg and is released from the constraint
[0045] Fails to address what surfaces contact the tail. It only supports the tail being secured adjacent to the leg. This is not the equivalent to contacting a surface because it only need be close to the leg
“and at least a portion of tail 146 remaining temporarily constrained by outer sheath 110. In different terms, the outer sheath is configured to secure the tail 146 adjacent to the ipsilateral leg 154 when the contralateral leg 152 is in the deployed state, such that the contralateral leg 152 is maintained in an alignment with the ipsilateral leg 154 when the contralateral leg 152 is in the deployed state.”
[0046] Fails to address what surfaces contact the tail. It only supports the tail being tucked under the constraint. There is no disclosure of contact with the leg
“In this manner, when tucked under outer sheath 110 with undeployed sections of tubular ipsilateral leg 154, tail 146 maintains alignment of tubular ipsilateral leg 154 and tubular contralateral leg 152 during expansion of branched stent graft 140 from collapsed configuration to assist in cannulation of tubular contralateral leg 152.”
Figures 2B and 2C do not show the interior, so it is unknown if the tail engages the leg or is contained wholly by the constraint.
Figure 4D shows the tail but fails to clarify if the tail is folded up, rolled up, or any specifics as to how it extends within the constraint
Therefore the language defining the contacting configuration is considered new matter.
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 2-4, 6-9, and 12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The requirement for the elongate element to have an enlarged tip that increases retention force on the elongate element render claims 2 and 12 indefinite. [0061] merely states that the wider tail of the elected embodiment increases retention force, but it is unclear how.
[0061] As compared to tail 220, tail 226 limits surface area and packing density in the central portion of the extended trim while increasing retention force due to the flared bottom of the trim. For example, tail 226 may have an initial diameter of 2-7 mm wide, and a wider expanded tip. In one particular example, the initial diameter is about 3 mm wide and the tip is about 5 mm wide, although a variety of dimensions are contemplated.
Just being wider doesn’t ensure that the force applied is changed. It appears that the tension force is derived from the constraint not the tail. How does larger tip increase the force? Wouldn’t the increased surface area reduce the force by spreading it out along the widened end? Since we do not have disclosure as to how the tail is configured within the constraint we cannot know how forces are distributed. Is the tail rolled up compared to other tails making it thicker? Is the tail flat allowing for more surface area to distribute the forces? Therefore a person of ordinary skill in the art would not be able to determine how and if the larger tip increases retention force.
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) 2-4, 6, 8-9, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al. (Buckley) U.S. 2013/0211501 in view of Brodie et al. (Brodie) WO 2014/096811 A2 (Cited in applicant’s IDS).
Regarding claim 2, Buckley discloses a method of using an endoluminal delivery device, the method comprising:
delivering an assembly comprising a branched endoprosthesis (140, Fig. 1E) a and a constraint (110, Fig. 1A; “outer sheath,” paragraph 0023) releasably retaining the branched endoprosthesis in a collapsed configuration to a trunk vessel (Fig.1A paragraph 0011)
wherein the branched endoprosthesis includes a tubular body portion (upper portion between 140 and 160 Fig. 1C), a long leg defining a long leg end (“ipsilateral leg,” and lower end paragraph 0020, Fig. 1E) and a short leg defining a short leg end (“contralateral leg,” and lower end paragraph 0020, Fig. 1E), and an elongate element (tether 245)
partially retracting the constraint to release a distal section of the branched endoprosthesis (Figure 1D clearly shows withdrawn of constraint 110 to release the distal upper end of the endoprosthesis and the end of the short leg), to assume an expanded configuration (Figure 1D clearly shows they are expanded compared to Figure 1A), the distal section including the tubular body portion (upper portion between 140 and 160 Fig. 1D), a distal portion of the long leg (inner upper portion of the long leg is expanded in Figure 1D compared to Figure 1A), and the short leg (the entire short leg is expanded in Figure 1D compared to Figure 1A), with undeployed sections of the long leg (Figure 1D clearly shows compressed lower portions) and a portion of the elongate element (Figure 1D shows the tether still pulled within the constraint) remaining constrained by the constraint (Fig. 1C-D paragraphs 0023 0031); such that the portion of the elongate element is constrained by contacting the elongate element with an inner surface of the constraint and an outer surface of the long leg to define a retention force on the elongate element (as explained in the 112 rejections above the applicant’s own invention is silent with respect to the configuration of the components within the constraint, since the constraint/legs are the same structures as the applicant’s current application and the elongate element is a flexible strand, it is fully capable of the claimed configuration and reads upon this limitation as much as the applicant’s own invention), and
fully retracting the constraint to deploy the undeployed sections of the long leg to release the elongate element by reducing the retention force (Fig. 1E clearly shows the long leg end released to an expanded state and [0034] discloses the tether is released which inherently means any retention force is reduced because it is removed).
Buckley discloses that elongate element 245 may be used with this embodiment [0029], and later discloses the elongate element can have force applied in multiple ways and secured by the constraint by tucking it under the deployed constraint [0031]-[0034].
However. Buckley does not specifically disclose that the elongate element extends beyond the end of the short leg (its looped around and extends away from the end towards the long leg) or that it includes an enlarged tip.
Brodie discloses a stent graft analogous to that of Buckley, the stent graft of Brodie has a long leg (24, Fig. 6) and a short leg (23) with an elongate element (30) which is used to apply tension to the short leg (23) in order to correctly position the short leg (23) for insertion (pg. 19, lines 12-18). The elongate element of Brodie is a seamless extension of a graft material (“fabric,” pg. 19, line 1) forming a graft component of the short leg (Fig. 6; pg. 18, line 31 – pg. 19, line 1). The elongate element of Brodie comprises a small tip 33 and an enlarged tip (the thicker rounded portion directly connected to the small tip in Figure 6). Additionally, Brodie teaches that such a elongate element allows the short leg to be held securely during cannulation and prevent inversion (pg. 19, lines 11-15).
It would have been obvious to one skilled in the art at the time of filing to have to modified the endoprosthesis of Buckley with the teachings of Brodie by substituting the short loop of Buckley with the elongate element of Brodie which is an extension beyond the end of the short leg in order to help hold the short leg securely during cannulation, prevent inversion, and help guide the leg to the desired implant site. The invention of Buckley would still function in the same manner, tucking the entire length of the now elongated tail within the constraint along the length of the long leg. The partial and full retraction would still function in the same manner, but by having the more elongated extension tucked in along the entire length of the long leg, it will maintain tension on the short leg keeping it from inverting as disclosed by Brodie. Additionally, this configuration reads upon the surface contact configuration of claims 2 and 12 as much as the applicant’s own invention.
Regarding claim 3, Buckley as modified discloses deploying the tubular body portion (“body portion,”) in the trunk vessel and deploying the short leg in a contralateral branch vessel using an alignment of the short leg and the long leg (paragraph 0044) provided by a mechanism (paragraph 0043) the elongate element (paragraphs 0029-0030) to locate a proximal opening of the short leg; cannulating the short leg (paragraph 0044); and after cannulating the short leg, releasing the elongate element from the constraint (paragraph 0034).
Regarding claim 4, Buckley as modified discloses that the delivering the assembly to the trunk vessel comprises delivering the assembly to the trunk vessel via an ipsilateral branch vessel (paragraph 0044).
Regarding claim 6, Buckley as modified that the long leg is substantially axially longer than the short leg such that the end of the long leg is located proximal to the end of the short leg (paragraph 20, Fig. 1e).
Regarding claim 8, Buckley as modified discloses the constraint is an outer sheath having a tubular configuration (110, Fig. 1a; shows “outer sheath” with a tubular configuration paragraph 0023).
Regarding claim 9, Buckley as modified discloses that delivering the assembly comprises: delivery the assembly comprising the branched endoprosthesis (Figures 1a-e paragraph 0044), a tubular element (120 partially inserted into the long leg, and the constraint (120 partially inserted and partially extending out of these elements Figures 1a-e).
Regarding claim 12, Buckley as modified by Brodie above discloses a method of deploying an endoluminal delivery device, the method comprising:
delivering to a vessel [0011] a branched endoprosthesis (140) constrained by a constraint (110) in a collapsed configuration (Figures 1A-1E), the branched endoprosthesis having a long leg defining a long leg end (“ipsilateral leg,” and lower end paragraph 0020, Fig. 1E) and a short leg defining a short leg end (“contralateral leg,” and lower end paragraph 0020, Fig. 1E), the short leg including an elongate element (245 Figures 2A-2B) that extends from the short leg end Figures 2A-2B),
wherein a portion of the elongate element is constrained by between an inner surface of the constraint and an outer surface of the long leg to define a retention force on the elongate element (as explained in the 112 rejections above the applicant’s own invention is silent with respect to the configuration of the components within the constraint, since the constraint/legs are the same structures as the applicant’s current application and the elongate element is a flexible strand, it is fully capable of the claimed configuration and reads upon this limitation as much as the applicant’s own invention), the elongate element having an enlarged tip that increases the retention force on the elongate element (see modification in view of Brodie above);
partially releasing the constraint such that the short leg is allowed to expand while the retention force is maintained on the elongate element (Figure 1D clearly shows withdrawn of constraint 110 to release the distal upper end of the endoprosthesis and the end of the short leg); and
further releasing the constraint such that the long leg is expanded and the retention force is reduced (Fig. 1E clearly shows the long leg end released to an expanded state and [0034] discloses the tether is released which inherently means any retention force is reduced because it is removed).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of Brodie (Combination 1) as applied to claims 2-4, 6, 8-9, and 12 above, and further in view of Joh et al. (“Reference Diameters of the Abdominal Aorta and Iliac Arteries in the Korean Population”) (Cited in applicant’s IDS) and Sithian (U.S. 8,475,513).
Combination 1 discloses the endoprosthesis and the method of using. However Buckley does not specifically disclose any dimensions for the endoprosthesis, or that a length of the elongate element as measured extending away from the second end of the short leg is greater than twice a cross-sectional width of the second end of the short leg as measured perpendicular to the length of the elongate element.
Buckley does disclose that the short leg is designed to interface with the iliac artery (paragraph 0004) and would therefore have the same width. According to Joh, which discloses information about the abdominal aorta and iliac artery, an average iliac artery can be in a range from 1.15-1.22 cm (pg. 48).
It would have been obvious to one skilled in the art at the time of filing that the short leg of Buckley in view of Brodie could have a width of 1.15-1.22 cm to fit in the average iliac artery
Sithian discloses a stent graft analogous to that of Buckley et al. The elongate element of Sithian is at least 65 cm, and is of a length long enough to allow a surgeon to manipulate the short leg (26, Fig. 1) in order to position it to align with iliac artery (col. 6, lines 1-15).
It would have been obvious to one skilled in the art at the time of filing to have modified the method of Buckley in view of Brodie and Joh with the teachings of Sithian by having the elongate element be at least 65 cm in order to allow the surgeon to manipulate the short leg. This would result in the endoprosthesis with a length of the elongate element as measured extending away from the second end of the short leg is greater than twice a cross-sectional width of the second end of the short leg as measured perpendicular to the length of the elongate element
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
The applicant argues that Brodie elongate element is incapable of being tensioned solely by being constrained and that Buckley is incapable of tensioning the loop of Brodie because Buckley never describes his tether being tensioned or constrained, let alone by a constraint disposed around the tether. This argument is appearing to me misinterpreting the structures of Brodie. The elongate element of Brodie is merely a strip of graft fabric. Tensioning a thin narrow strip of fabric does not require any extraordinary measures or structures. Furthermore Brodie clearly states that the flange can be held under “gentle tension”. Taking the strip of graft material making the elongated extension and wrapping it up along the entire length of the constraint of Buckley will inherently apply the gentle tension needed. The tension is merely to prevent the shorter leg from inverting during the short period of time before the remainder of the constraint is removed. Additionally, as explained in the interview Buckley discloses his elongated element as being pulled into and tucked under the constraint. This tucking motion is considered to be providing at least a gentle tension. Therefore a person of ordinary skill in the art would find it obvious that Buckley’s teaching of tucking and tensioning the shorter elongated element could be modified to include a longer elongated element in view of the teachings of Brodie in order to provide a longer element for increased control over the short leg and to provide more material to be tucked in and contained by the constraint.
The applicant then points out the following amendments which they contend overcome the prior art rejection:
(1) in the "partially retracting" step, "the portion of the elongate element is
constrained by contacting the elongate element with an inner surface
of the constraint and an outer surface of the long leg to define a
retention force on the elongate element';
(2) also in the "partially retracting" step, "the elongate element has an
enlarged tip that increases the retention force on the elongate
element'; and
(3) the "fully retracting" step causes to "deploy the undeployed sections of
the long leg and release the elongate element by reducing the
retention force."
In regards to element 1, as explained above this limitation is considered new matter because the surfaces are not disclosed within the specification or drawings. At best the original disclosure supports the elongate element being constrained by the sheath adjacent the leg. This is the same level of disclosure by the prior art combination. Therefore the prior art reads upon this limitation as much as the applicant’s own invention.
In regards to element 2, as explained above this limitation is disclosed by Brodie and clearly shown in figure 6. The elongated element has multiple tips including portion 33 and a larger tip formed by the rounded edge just above tip 33.
In regards to element 3, as explained above this limitation the elongated element of the prior art combination is tucked into the constraint in the same manner as the applicant’s invention. Fully retracting is considered to mean opening and withdrawing the constraining member, which will inherently let go of the elongated element. Therefore there is no tension force which means the retention force has been reduced to zero. It is also noted that new claim does not even require fully retracting, just further releasing, which is anticipated in the same manner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (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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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774