54DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 18-20 of U.S. Patent No. 10,799,377. Although the claims at issue are not identical, they are not patentably distinct from each other because all the limitations of the claims of this application are anticipated by the claims of the ‘377 patent. Independent claim 16 of the ‘377 patent is narrower in scope than claim 1 of this application, reciting more specific limitations directed to a central portion of the expandable centering device, and the position of the expandable centering device relative to a “stent portion” (which corresponds to a proximal or distal end) of the stent graft. It is considered to be obvious to broaden the scope of a claim by removing limitations. Claims 6-7 are rendered obvious by claim 18 of ‘377 that recites an expandable basket formed of tines, and claim 8 is anticipated by claim 20 of ‘377.
Claims 3-5, 11-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 18-20 of U.S. Patent No. 10,799,377 in view of USPAP 2007/0203561 (Forster).
Regarding claims 3 and 11, Forster teaches it is known to release a constraint (tethers) to release the stent-graft to fully expanded against the vessel ([0081]; [0092]; [0097]; [0100-0101]).
Regarding claims 4 and 12, Forster teaches that a stent may have barbs [0113] on the outer surface.
Regarding claim 5 and 13, Forster discloses collapse and removal of the expandable device after deploying the stent-graft [0124]. Since all the steps and structures in claims 3-5 and 11-13 were known in the art before the effective filing date of the claimed invention, it would have been further obvious to recite these limitations in the claims of the ‘377 patent.
Claim 16 of ‘377 anticipates “a stent” of claim 16 with limitation “stent portion”.
Claim 9, 10, 18 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over claims 16 and 18-20 of U.S. Patent No. 10,799,377 in view of
US PG Pub. 2002/0161377 (Rabkin).
Regarding claims 9 and 18: the claims of ‘377 do not recite the balloon comprises vias, but Rabkin teaches that an inflatable balloon (20) may be configured to define a clover-leaf shaped cross- section that defines vias (radial spaces) that extend from proximal to distal ports on the surface of the balloon ([0133] and Figure 14a). Rabkin discloses inflating the balloon with inflation fluid, such as saline, from a pressurized fluid source, such as a syringe or pump [0110- 0111,0137-0140]. Since a balloon having vias was known the art before the effective filing date of the claimed invention, it would have been further obvious to recite these limitations in the claims of the ‘377 patent.
Claims 1, 2, and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-17 of U.S. Patent No. 12,004,980. Although the claims at issue are not identical, they are not patentably distinct from each other because all the limitations of the claims of this application are anticipated by the claims of the ‘980 patent. Independent claim 1 of the ‘980 patent is narrower in scope than claim 1 of this application, reciting more specific limitations directed to Claims 1 and 2 are anticipated by claim 12 of ‘980, which has a narrower scope due to additional limitations regarding the stent graft. It is considered to be obvious to broaden the scope of a claim by removing limitations.
Claims 6-7 are rendered obvious by claims 14-15 of ‘980 that recite an expandable basket formed of tines, and claim 8 is anticipated by claim 16 of ‘980.
Claims 3-5, 11-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-17 of U.S. Patent No. 12,004,980 in view of USPAP 2007/0203561 (Forster).
Regarding claims 3 and 11, Forster teaches it is known to release a constraint (tethers) to release the stent-graft to fully expanded against the vessel ([0081]; [0092]; [0097]; [0100-0101]).
Regarding claims 4 and 12, Forster teaches that a stent may have barbs [0113] on the outer surface.
Regarding claim 5 and 13, Forster discloses collapse and removal of the expandable device after deploying the stent-graft [0124]. Since all the steps and structures in claims 3-5 and 11-13 were known in the art before the effective filing date of the claimed invention, it would have been further obvious to recite these limitations in the claims of the ‘980 patent.
Claim 12 of ‘980 anticipates “a stent” of claim 16 with limitation “stent portion”.
Claim 9, 10, 18 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over claims 12-17 of U.S. Patent No. 12,004,980 in view of
US PG Pub. 2002/0161377 (Rabkin).
Regarding claims 9 and 18: the claims of ’980 do not recite the balloon comprises vias, but Rabkin teaches that an inflatable balloon (20) may be configured to define a clover-leaf shaped cross- section that defines vias (radial spaces) that extend from proximal to distal ports on the surface of the balloon ([0133] and Figure 14a). Rabkin discloses inflating the balloon with inflation fluid, such as saline, from a pressurized fluid source, such as a syringe or pump [0110- 0111,0137-0140]. Since a balloon having vias was known the art before the effective filing date of the claimed invention, it would have been further obvious to recite these limitations in the claims of the ‘377 patent.
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.
Claim(s) 1-7 and 11-16 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by USPAP 2007/0203561 (Forster et al.).
Forster discloses a discloses a method of centering and deploying a stent-graft (see valve 30 in Figure 1A having a frame 38 and a graft leaflets [0016]; also see [0026]; [0038] of USPAP 2005/0203617 incorporated by reference) comprising steps of:
Placing a catheter within a patient’s vessel [0021],
placing an expandable device (deployment mechanism 200 having outwardly bowing wire forms 214) within the lumen of the stent-graft (30) (see Figures 25A; [0124]), the expandable device on a catheter shaft (106) [0124]; wherein the proximal and distal ends of the stent-graft (30) are radially constrained by tethers (124) (see especially Figures 9-10; [0081]; [0092]; [0097]);
and expanding the expandable device (200) within the lumen of the stent-graft (30) while maintaining a proximal or distal end of the stent-graft (30) in a radially constrained configuration (see Figures 25A-C; [0124]). The phrase “radially constrained configuration” is given its broadest reasonable interpretation to encompass a partially deployed state in which the tethers (124) remain attached to the stent-graft to allow for further adjustment of the diameter and/or repositioning of the stent-graft (30) ([0100-0101]).
Although Forster discloses the expandable device (200) is placed within the lumen of the stent-graft (30) after the catheter is placed in the patient’s vessel and that the expandable device is expanded after partial deployment of the valve (30), this is considered to meet the claimed method, since the method steps of the claim are not construed to require any particular order in which they occur.
Regarding claim 2, Forster discloses the stent-graft is expanded against the vessel before the constraining tethers are released ([0081]; [0092]; [0097]; [0100-0101]).
Regarding claim 3 and 11, Forster discloses release of the constraint to allow the stent to radially expand to engage the patient’s vessel [0100-0101].
Regarding claims 4 and 12, the stent comprises barbs [0113] on the outer surface.
Regarding claim 5 and 13, Forster discloses collapse and removal of the expandable device after deploying the stent-graft [0124].
Regarding claims 6, 7, 14 and 15: Forster discloses the expandable device comprises tines (wire forms 214) that are parallel to the longitudinal axis of the catheter (not shown) when collapsed and bowed outwardly when expanded (see “lie flat” for parallel configuration at [0124]).
Regarding claim 16, Forster discloses the stent frame (38) of the stent-graft is fully expanded against the vessel by the expandable device (200) before the constraining tethers are released (see description of expanding a partially deployed panel 36 at [0124], wherein the tethers are illustrated as being engaged with the stent. Forster explains tether are released after proper placement is confirmed [0101]).
Claim(s) 1-3, 5, 8, 11, 13, and 17 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by USPAP 2009/0018635 (Holman et al.).
Holman discloses a discloses a method of centering and deploying a stent-graft (30) (see description of stent being a stent-graft at [0002]) comprising steps of:
placing an expandable device (balloon 20) within the lumen of the stent-graft (30) (see Figures 1 and 5; [0032]; [0051]), the expandable device (balloon 20) on a catheter shaft (12/14) [0032]; wherein the proximal and distal ends of the stent-graft (30) are radially constrained by sleeves (50) (see especially Figure 5; [0051]);
Placing a catheter within a patient’s vessel [0051],
and expanding the expandable device (20) within the lumen of the stent-graft (30) while maintaining a proximal or distal end of the stent-graft (30) in a radially constrained configuration (at least during expansion of the balloon to a particular degree). The phrase “radially constrained configuration” is given its broadest reasonable interpretation to encompass a partially deployed state in which the sleeves (50) remain over the ends of stent-graft ([0051]).
Although Holman does not explicitly disclose that expansion of the expandable member (balloon 20) centers the balloon with a vessel, it is understood that this naturally results from engagement of the balloon with vessel walls, wherein expansion of the balloon would direct the catheter and stent graft (30) towards a longitudinal axis of the vessel.
Regarding claims 3 and 11, Holman discloses the constraining sleeves (50) are released from the stent graft [0051].
Regarding claims 5 and 13, Holman discloses removal of the expandable device (20) after deploying the stent-graft [0051].
Regarding claims 8 and 17, Holman discloses the expandable device is an inflatable balloon [0045].
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.
Claim 9, 10, 18 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Holman in view of USPAP 2002/0161377 (Rabkin).
Regarding claims 9 and 18: Although Holman fails to disclose the balloon comprises vias, Rabkin teaches that an inflatable balloon (20) may be configured to define a clover-leaf shaped cross- section that defines vias (radial spaces) that extend from proximal to distal ports on the surface of the balloon ([0133] and Figure 14a). Rabkin discloses inflating the balloon with inflation fluid, such as saline, from a pressurized fluid source, such as a syringe or pump [0110- 0111,0137-0140]. Similar to Holman, the balloon aids in delivery of a stent (abstract). One of ordinary skill in the art at the time the invention was made would have found it obvious to use a balloon with vias taught by Rabkin in the Holman assembly, as the modification merely involves the substation of one known expandable balloon structure for another that obtains the predictable result of engaging and supporting the lumen of a stent-graft during delivery.
Regarding claims 10 and 19: Holman discloses the balloon is inflated to engage the stent graft with lumen walls, wherein it is well known in the art that inflation of a balloon deflects and steers the center the shaft towards a longitudinal axis of a vessel to result in centering of the catheter.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Holman in view of USPAP 2011/0218609 (Chobotov et al.).
Although Holman fails to disclose the stent graft comprises inflatable channels, Chobotov teaches a stent graft having a having inflatable channels [0082] was known at the time of invention to aid in sealing the prosthesis against vessel walls [0085]. It would have been obvious to one of ordinary skill in the art at the time the invention as made to combine inflatable channels taught by Chobotov with the stent graft of Holman, as the modification merely involves a combination of known stent grafts according to known methods that obtains a predictable result of a stent graft in combination with a delivery assembly, wherein the inflatable channels aid in sealing the prosthesis against vessel walls [0085].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
USPAP 2009/0143851 (Paul, Jr.) discloses an expandable device having tines that outwardly bow when expanded (32) with a patient’s vessel (12) ([0032-0034]), but fails to disclose delivery of a stent-graft.
USPAP 2009/0228093 (Taylor et al.) discloses a method of placing an expandable device (100) into a lumen of a stent graft (152) (Fig. 9 [0063]), the expandable device on a catheter shaft (156), expanding the expandable device (152) to center the shaft (and the stent-graft 152) toward a longitudinal axis of the patient’s vessel (see Figure 13; [0065]). Taylor fails to disclose or render obvious that a proximal or distal end of the stent graft (152) is radially constrained while the expandable device is expanded.
US PG Pub. 2009/0264988 (Mafi et al.) discloses a delivery system for deploying a stent-graft that comprises expanding an expandable device (132) within the lumen of a stent-graft (540) and ends of the stent (780) constrained by the end of the delivery catheter (130), as shown in Figure 7 [0031]). Mafi discloses the expandable structure is expanded after the ends of the stent is fully expanded and released from constraints ([0036-0038]; Figures 8-9).
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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