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 .
Election/Restrictions
Claims 152-170 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/30/2026.
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 140-144 and 147-151 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.
Claim 140 first recites “a first limb stent” and a “second limb stent” in lines 4-5. Claim 140 then recites “at least one stent” in line 7, and this is unclear whether limitation is referring back to one of the first and second limb stents recited in lines 4-5. Subsequent recitations in dependent claims, such as “the at least one stent” in line 4 are further indefinite, as it is unclear which stent is being referred to here.
For purposes of clarity, the Examiner recommends using different terminology for the main graft body stent, such as “at least one main stent.”
In regards to claims 143 and 144, the Examiner further recommends using different terminology for “a first stent” and “a second stent” to avoid confusion with the limb stents, such as “a first main stent.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 140, 142, 143, 148, and 149 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPN 8,328,861 (Martin et al.).
Martin discloses a stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising: a main graft body (402) having a first end and a second end, the second end of the main graft body being bifurcated and including a first limb (404) and a second limb (405), a first limb stent (407) and a second limb stent (408) being disposed respectively in the first limb and the second limb of the main graft body (see Figure 2 and 29; column 3, line 64 to column 4, line 20); at least one stent (411) connected to and/or disposed at least partly with the main graft body (402) (column 4, lines 45-65).
The language “…wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient” is a functional recitation that is not given full patentable weight. The prior art is not required to disclose this function, and the capability of the Martin stent-graft to be deployed through a single incision in a femoral artery, as shown in Figures 16-23 (column 12, lines 7-15) meets the functional requirement.
In regards to claim 142, wherein the at least one stent comprises a first stent adjacent the first end of the main graft body (see position of stents 411 and 422) at the first end of the graft in Fig. 2 and 29) and a first tether (belts 462 and 458) releasably connected to the first stent for positioning the first stent and the first end of the main graft body in the target blood vessel (col 6, lines 31-38).
In regards to claim 143, wherein the at least one stent comprises a first stent (422) adjacent the first end of the main graft body, the stent-graft system further comprising: a connecting ring (see portion of ring 411 with the graft at 403) in the main graft body at a position substantially adjacent the first end of the main graft body, and connecting members connecting the connecting ring to the first stent (see longitudinal struts linking the rings of 411 and 422 in Fig. 2 and 29).
In regards to claims 148 and 149, Martin discloses that the graft material is ePTFE (col 4, lines 40-44).
Claim(s) 140, 142, 143, 148 and 150 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2019/0142571 (Chu et al.).
Chu discloses a stent-graft system for repair of a target blood vessel of a patient comprising:
a main graft body (108) having a first end (122) and a second end, the second end of the main graft body being bifurcated and including a first limb (144) and a second limb (146), a first limb stent (104) and a second limb stent (102) being disposed respectively in the first limb and the second limb of the main graft body (see Figure 1B; 0035-0041); at least one stent (106) connected to and/or disposed at least partly with the main graft body (142) (column 4, lines 45-65).
The language “…wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient” is a functional recitation that is not given full patentable weight. The prior art is not required to disclose this function, and the capability of the Chu stent-graft to be deployed through a single incision in the delivery position of Figure 8A meets the functional requirement.
In regards to claim 142: Chu comprises a stent retaining mechanism in the form of tethers (890) disposed about the main body and tethers (891 and 892) disposed about the first and second limbs (see Figure 8B; [0061]).
Regarding claims 148 and 150, Chu discloses the graft is densified material such as PFE or PET [0009; 0041]. The graft material completely covers the outer surface of the stents (wire portions 102, 104 and 106), such they the stents are encapsulated by the graft material ([0041]; Fig. 1B)
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) 141 is rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. in view of USPAP 2016/0158045 (Havel et al.).
Martin fails to disclose the stent-graft system comprises a centering device in proximity to the first end of the main graft body and configured to be removably or temporarily deployed and expanded in the target blood vessel for centering the main graft body and/or the at least one stent in the target blood vessel. Havel discloses another stent-graft delivery device and teaches a centering device (120/1220) adjacent the first end (300) of the graft. Havel teaches the centering device (120) helps to retain and stabilize the delivery device at the desired deployment site [0038]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the centering device taught by Havel with the Martin delivery device in order to more accurately deploy the stent-graft.
Claim(s) 141 is rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. in view of USPAP 2016/0158045 (Havel et al.).
Chu fails to disclose the stent-graft system comprises a centering device in proximity to the first end of the main graft body and configured to be removably or temporarily deployed and expanded in the target blood vessel for centering the main graft body and/or the at least one stent in the target blood vessel. Havel discloses another stent-graft delivery device and teaches a centering device (120/1220) adjacent the first end (300) of the graft. Havel teaches the centering device (120) helps to retain and stabilize the delivery device at the desired deployment site [0038]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the centering device taught by Havel with the Chu delivery device in order to more accurately deploy the stent-graft.
Claim(s) 144, 149 and 151 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2019/0142571 (Chu et al.) in view of Martin et al.
Chu discloses a stent-graft system for repair of a target blood vessel of a patient comprising:
a main graft body (108) having a first end (122) and a second end, the second end of the main graft body being bifurcated and including a first limb (144) and a second limb (146), a first limb stent (104) and a second limb stent (102) being disposed respectively in the first limb and the second limb of the main graft body (see Figure 1B; 0035-0041); at least one stent (106) connected to and/or disposed at least partly with the main graft body (142) (column 4, lines 45-65).
Chu illustrates in Figure 8E-G that the delivery device is advanced through vasculature such that the limbs (860 and 864) are advanced ahead of the main body, such that the limbs will separate and advance into the branch vessels while the main body is positioned in the primary vessel (Fig. 8G). Chu states that a system may include a sheath for introduction of the stent-delivery device through vasculature, but fails to explicitly disclose the direction in which the sheath is retracted. Martin discloses another delivery catheter for a bifurcated stent-graft and provides evidence that a sheath (431) of a stent-graft delivery system is retracted towards the proximal end of the catheter to release the graft (col 5, lines 30-36), which corresponds with a downward direction of Fig. 8G of Chu. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to arrange a delivery sheath to that initially exposes the limb stents at the distal end of the catheter and subsequently exposes the main graft body, as Martin teaches that a sheath is retracted in a proximal direction of a catheter body. In this manner, the limb stents at the distal end of the modified Chu assembly would be exposed before the main graft body.
Chu comprises a stent retaining mechanism in the form of snare loops (890) disposed about the main graft body and first stent (106/306) at a plurality of spaced positions. Although Chu discloses the snare loops (890) are retraced by pull members (893) to release the stent-graft to expand (see Figure 8B; [0061]), Chu fails to disclose a snare tube in the delivery sheath through which a snare loop or pull member passes.
Similar to Chu, Martin discloses the stent-graft system includes a snare loop
(primary release wire 442/471 in combination with belts 462 and 458) the snare loop (471/462/458) being releasably engaged with a plurality of circumferentially spaced positions on the first stent (positions where loops 462 and 458 constrict stents 411 and 422; Fig. 2; col 6, line 42 to column 7). Martin teaches that the system includes a snare tube (release wire tube 441) (see Fig. 2; col 10, lines 44-60) passing through the delivery sheath (431), wherein the snare loop (primary release wire 442/471) passes through the snare tube (431).
Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Chu to include a snare tube within the delivery sheath for the snare loop (at least one pull member 893) to extend through, as the modification merely involves a combination of known catheter components according to known methods that obtains a predictable result of a lumen within a catheter for a relatively moveable elongate member to extend therethrough.
Regarding claim 151, Chu discloses the graft material can be PTFE [0041] but fails to disclose ePTFE. Martin discloses that the graft material is ePTFE (col 4, lines 40-44). It would have been obvious to one of ordinary skill in the art at the time the invention was made to form the Chu graft material of ePTFE, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 147 is rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. in view of Martin et al., as applied to claim 144 above, and further in view of USPAP 2011/0276062 (Bolduc).
In regards to claim 147, Chu as modified above in regards to claim 144 comprises the delivery sheath as claimed. Chu additionally discloses an inner member (800) (Fig. 8A) that passes through the sheath, through the main graft body (842) and to a position beyond the two limbs (844 and 846) (see ends 860 and 864 in Fig. 8B). Chu also includes first and second limb tethers connected to the limb stents (see 892 and 894 in Fig. 8B; [0061]).
Chu fails to disclose a wire holder connected to the inner member at a position beyond the first and second limbs. Bolduc discloses another delivery device for a bifurcated stent-graft. Similar to Chu, the delivery system comprises a stent-graft retaining means (220 and 224) in the form of suture loops (252 and 274) that releasably compress the main body (108) of the stent-graft and limbs (112) (Fig. 17-18; [0183; 0189]). Bolduc teaches that the inner member (216) can include wire holders (244 and 276) in order to aid in maintaining a desired position of the wire relative to the inner member (see Fig. 17 & Figure 21; [0187];b [0207]). As shown in Figure 19, a wire holder (276) is positioned beyond the limbs (112) (wherein “beyond” is interpreted as past the terminal end of the limbs). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include a wire holder on the inner member of modified Chu, at a location beyond the limbs, as taught by Bolduc, as the modification merely involves a combination of known release wire retaining mechanisms of stent-graft delivery devices that obtains a predictable result of maintaining a desired position of a release filament relative to the inner member.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
USPAP 2013/0289713 (Pearson) discloses another delivery device for a bifurcated stent-graft having a retaining mechanism.
USPAP 2015/0223704 (Haverkost et al.) discloses a centering device for a catheter.
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.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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