Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group 1, comprising claims 1-17, in the reply filed on 01/29/2025 is acknowledged.
Response to Arguments
Applicant’s arguments and amendments, see page 1 (labeled page 5), filed 11/06/2025, with respect to the rejection under 35 U.S.C. 112 have been fully considered and are persuasive. The rejection of 05/07/2025 has been withdrawn.
Applicant’s arguments with respect to the 35 U.S.C. § 103 rejections of claim(s) 1-20 have been considered but are moot in view of the new grounds for rejection. Applicant has amended claim to recite “the implanting a valve in the venous outflow track from the brain to permit venous outflow and reduce retrograde pressure through the valve in the venous outflow track from the brain, wherein a support structure for the valve functions to support the valve in an operative orientation and resist migration away from the venous outflow track from the brain.” In response to Applicant’s amendment Examiner has added reference Acosta (US Pub No.: 2002/0177894). Examiner does maintain that Dave in view of Scribner taught a reduction of a retrograde pressure, but the new amendments of 11/06/2025 was not taught by Dave.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 7-11, 16-17, and 23-25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dave (US Pub No.: 2009/0287300) in view of Scribner (US Pub No.: 2009/0149860) and Acosta (US Pub No.: 2002/0177894).
Regarding claim 1, Dave (US Pub No.: 2009/0287300) discloses a method of treating cerebrospinal venous insufficiency (stent disclosed in [0014], use in a brain in [0491], spinal artery in [0443]), comprising the steps of: identifying a patient having at least a partial obstruction at a site in the venous outflow track from the brain (as a treatment of a brain in [0491] and spinal artery in [0443] are present, with a tailoring of therapies and drugs to be coated in the stent present in [0508], an identification of a patient is present. Relieving of an obstruction in [0130]); and implanting a valve (valve in [0348]), to permit venous outflow and reduce retrograde pressure (retrograde flow details in [0442]-[0443], reduction of pressure that causes retrograde bloodflow detailed in [0443]), wherein a support structure for the valve functions to support the valve in an operative orientation and resist migration away from the (the valve presents sliding movement between the shaft and sheath of the stent in [0375], preventing migration away from the site).
However, Dave (US Pub No.: 2009/0287300) does not teach that the valve is specifically reducing a retrograde pressure.
Instead, Scribner (US Pub No.: 2009/0149860) teaches a valve to permit venous outflow and reduce retrograde pressure (in [0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the valve functions of Scribner into Dave for the purpose allowing the valve of Scribner to prevent a flow of blood and body fluids past the valve in an unintended direction, as disclosed in [0037].
From here, Dave in view of Scribner does not teach that the venous outflow is “through the valve in the venous outflow track from the brain” or that the support structure will resist migration away from the “venous outflow track from the brain.” Instead, Acosta (US Pub No.: 2002/0177894) teaches implanting a valve in the venous outflow track from the brain (venous valves in [0004] with a brain blood flow in [0004]) to permit venous outflow and reduce retrograde pressure through the valve in the venous outflow track from the brain (replacing the function of a natural vein valve in [0061], reducing a pressure shock in [0063]. A closing of the valve if a reduced pressure is detected is present in [0028] as the reduced pressure allows for a backflow of blood. As such, [0028] reduction of a backflow reduces a retrograde pressure), wherein a support structure for the valve functions to support the valve in an operative orientation and resist migration away from the venous outflow track from the brain (cylindrical support member in [0026] that retains leaflets of a valve).
Regarding claim 2, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in claim 1, with Dave further comprising removing the obstruction by inflating a balloon at the site (use of a balloon for an angioplasty in [0127], where an angioplasty involves removing an obstruction. “Balloon expandable stent” in [0308]).
Regarding claim 3, Dave in view of Scribner teach the method of treating cerebrospinal venous insufficiency as in Claim 2, wherein Dave teaches the balloon carries an implant (in [0133], the balloon expansion influences the diameter of the stent, implying that the implanted stent interfaces with the balloon).
Regarding claim 4, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 2, with Dave further comprising removing the balloon and thereafter implanting the valve (as Dave teaches a balloon angioplasty in [0127] and [0234], a removal of the balloon after a stent expansion is implied as per the definition of angioplasty. Implantation of the device of Dave also involves implantation of a valve).
Regarding claim 5, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 2, wherein Dave teaches the balloon is carried by a catheter introduced into the vasculature at an access point spaced apart from the site (a microneedle to guide a catheter is inserted away from the treatment site in [0511], where the catheter holds the balloon in [0339]).
Regarding claim 7, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1, wherein Dave teaches that the implanting the valve comprises surgically attaching the valve at the site (in [0375]-[0376], the shaft and shaft are locked together via the valve when inserted into the patient. As the line “when being inserted into a patient” is present in [0375], an attachment of the valve during implantation is occurring).
Regarding claim 8, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1, wherein Dave discloses the support structure comprises a self-expandable support structure (disclosed in [0134]) coupled to the valve (as the self-expanding structure is in part 100 and as the valve of Dave is placed in the stent in [0134], the valve of [0375]-[0376] will also be coupled to the support structure), wherein implanting the valve comprises releasing the valve having the self-expandable support structure coupled to the valve at the site (as the stent has a self-expanding structure in [0134] and comprises a valve in [0375]-[0376], the valve will have the self-expandable support at the implant site).
Regarding claim 9, Dave in view of Scribner teach the method of treating cerebrospinal venous insufficiency as in Claim 1, wherein Dave discloses the implanting the valve comprises inflating a balloon within a balloon expandable portion of the valve support at the site (inflating of a balloon that can increase a lumen size in [0487] and a balloon expandable stent in [0499]. As the stent comprises a valve in [0375]-[0376], the balloon expandable stent also acts upon the valve).
Regarding claim 10, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 7, wherein the implanting the valve comprises implanting a tubular graft (stent-graft in [0308] with more graft details in [0309]) having the valve mounted therein (As the stent comprises a valve in [0375]-[0376], the balloon expandable stent also acts upon the valve).
Regarding claim 11, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 7, wherein the implanting the valve comprises attaching a first end of a graft at a first anastomosis to the left internal jugular vein and attaching a second end of the graft at a second anastomosis to the left innominate vein (as a joining of arteries and veins is present in [0124] of Dave (via the statement of “the joining of arteries, veins, and other fluid carrying conduits), it stands to reason that the device of Dave with the valve of Dave and Scribner can extend between the left jugular vein and the left innominate vein).
Regarding claim 16, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 10, wherein Dave discloses the tubular graft comprises a tubular ePTFE wall (ePTFE for use in a graft disclosed in [0396]).
Regarding claim 17, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 10, wherein Dave discloses the tubular graft comprises a section of saphenous vein (harvesting a portion of a saphenous vein for a graft disclosed in [0309] of Dave).
Regarding claim 23, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1, wherein Dave discloses the support structure and the valve are separately implanted and connected in situ (in [0375]-[0376], the shaft and shaft are locked together via the valve when inserted into the patient. As the line “when being inserted into a patient” is present in [0375], an attachment of the valve during implantation is occurring).
Regarding claim 24, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1, wherein Dave discloses the support structure and the valve are on the same device (the support structure and valve are a part of the same stent device in [0375]-[0376] after insertion into the patient).
Regarding claim 25, Dave in view of Scribner teach and Acosta the method of treating cerebrospinal venous insufficiency as in Claim 1, wherein Dave discloses the support structure comprises an antithrombogenic material (use of pyrolytic carbon that is “highly thromboresistant” in the device is disclosed in [0368]).
Claim 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dave (US Pub No.: 2009/0287300) in view of Scribner (US Pub No.: 2009/0149860) in further view of Hayes (US Patent No.: 4,967,745).
Regarding claim 6, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1. However, Dave in view of Scribner does not teach an instance further comprising removing the obstruction by surgically removing a section of vein.
Instead, Hayes (US Patent No.: 4,967,745) teaches wherein removing the obstruction by surgically removing a section of vein (In column 25 lines 65-67 to column 26 lines 1-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the removing of obstructions and/or veins presented in Hayes via a laser catheter into the combination involving Davis for the purpose of providing a means that can be inserted into the patient’s vasculature (as per column 6 lines 3-19) and can be used to remove obstructions in a vein or the entire vein itself (as per columns 25 lines 51-67 into column 26 lines 1-31) with a controlled removal of the obstructions/veins and a spectroscopic analysis of said obstructions and veins disclosed in column 26 lines 1-31.
Claims 12-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dave (US Pub No.: 2009/0287300) in view of Scribner (US Pub No.: 2009/0149860) in further view of Porter (US Pub No.: 2006/0064159).
Regarding claim 12, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1. However, said combination does not teach an instance wherein the valve is implanted in the left internal jugular vein.
Instead, Porter (US Pub No.: 2006/0064159) teaches wherein the valve is implanted in the left internal jugular vein (implantation of a graft into an internal jugular vein in [0099] wherein the graft comprises a valved interface in [0098])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the placement details of Porter into Dave and Scribner for the purpose of providing specific details as to where the stent, graft, and valve of Dave may be inserted. Insertion into the internal jugular vein, as presented in Porter, is also beneficial as this allows for a specific treatment of a portion of the body, and the structure of Porter also provides for a dialysis use in [0002]-[0003].
Regarding claim 13, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1. However, said combination does not teach wherein the valve is implanted in the right internal jugular vein.
Instead, Porter (US Pub No.: 2006/0064159) teaches wherein the valve is implanted in the left internal jugular vein (implantation of a graft into an internal jugular vein in [0099] wherein the graft comprises a valved interface in [0098]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the placement details of Porter into Dave and Scribner for the purpose of providing specific details as to where the stent, graft, and valve of Dave may be inserted. Insertion into the internal jugular vein, as presented in Porter, is also beneficial as this allows for a specific treatment of a portion of the body, and the structure of Porter also provides for a dialysis use in [0002]-[0003].
Regarding claim 14, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1. However, said combination does not teach wherein the valve is implanted in the azygos vein.
Instead, Porter (US Pub No.: 2006/0064159) teaches wherein the valve is implanted in the left internal jugular vein (implantation of a graft into the azygos vein in [0099] wherein the graft comprises a valved interface in [0098]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the placement details of Porter into Dave and Scribner for the purpose of providing specific details as to where the stent, graft, and valve of Dave may be inserted. Insertion into the azygos vein, as presented in Porter, is also beneficial as this allows for a specific treatment of a portion of the body, and the structure of Porter also provides for a dialysis use in [0002]-[0003].
Regarding claim 15, Dave in view of Scribner and Acosta teach the method of treating cerebrospinal venous insufficiency as in Claim 1. However, said combination does not teach wherein the valve is implanted in the superior vena cava.
Instead, Porter (US Pub No.: 2006/0064159) teaches wherein the valve is implanted in the left internal jugular vein (implantation of a graft into the superior vena cava in [0099] wherein the graft comprises a valved interface in [0098]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the placement details of Porter into Dave and Scribner for the purpose of providing specific details as to where the stent, graft, and valve of Dave may be inserted. Insertion into the superior vena cava, as presented in Porter, is also beneficial as this allows for a specific treatment of a portion of the body, and the structure of Porter also provides for a dialysis use in [0002]-[0003].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sinnreich (US Patent No.: 4,198,981) was considered for an inflating device for a surgical procedure, with disclosures to an implanted inflatable balloon. Doig (US Pub No.: 2004/0215327) considered for a stent (in the abstract) with disclosure for use in spinal arteries (in [0002]).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774