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
Applicant's election with traverse of Group I, species B in the reply filed on 03/30/2026 is acknowledged. The traversal is on the ground(s) that Species A and B of Group I encompass embodiments of the same invention, Species B includes the addition of a membrane structure and anchor portion around the funnel of species A, per [0143] of the applicant’s specification. This is not found persuasive because the specification does not indicate what the applicant asserts. In the PGPUB [0143] refers to Figs. 3A-3C, not 4A-4B. In the filed specification [0143] simply states “In some embodiments, the flow restrictor 400 comprises a membrane structure 404 with an anchor portion 402, as shown in FIGS. 4A and 4B.” neither teach that they are the same invention/species.
The requirement is still deemed proper and is therefore made FINAL.
The applicant did not elect a species from Group II, hence Group II, species A will be treated as an election without traverse (MPEP § 818.01(a)).
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) 129, 131, 133, 135, 138-140, 144, and 153 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruiz (US 6120534 A), herein referenced to as “Ruiz”.
Claim 129
Ruiz discloses: A method for reducing flow in a blood vessel (see Figs. 5A-7C, see col. 1, lines 5-10) in a pulmonary arterial tree of a pediatric patient (see col. 1, lines 5-10, pediatric congenital defects) having a heart defect, the method comprising: percutaneously advancing a device 50 (see Fig. 7A, col. 3, lines 16-18 and col. 6, lines 29-39, percutaneously, device 50 is crimped, hence collapsed, also as shown in Fig. 5B) in a collapsed configuration (see Fig. 5B and 7A) through a portion of the vasculature of the patient (see Fig. 7A, col. 6, lines 29-39, percutaneously, as shown in Fig. 7A an approach through the superior vena cava into the right atrium then right ventricle and into the main pulmonary artery) to a placement site within the blood vessel; expanding a distal end 54 (see Figs. 5A-7B, col. 6, lines 29-48, the distal end is expanded) of a membrane structure 52 (see Figs. 5A-7B, 52 is expanded when 51 is expanded) of the device from the collapsed configuration (see Fig. 5B) to a radially expanded configuration (see Figs. 5C and 7B) to form a distal opening distal opening of 54 (see Figs. 5C and 7B) of a passageway the lumen of 50 (see Figs. 5A-7B, col. 6, lines 49-62) for blood flow (see col. 6, lines 49-62, desired degree of flow regulation) through the device 50; and forming a proximal opening proximal opening of 53 (see Figs. 5C and 7B) of the passageway for blood flow through the device (see col. 6, lines 49-62, desired degree of flow regulation) by expanding an anchor portion 51 (see Figs. 5A-7C, col. 5, lines 25-39, 51 is expanded hence expanding 53) on a proximal end 53 (see Figs. 5A-7C, col. 5, liens 25-39) of the device 50 from the collapsed configuration (see Figs. 5B and 7A) to a radially expanded configuration (see Figs. 5C and 7B) wherein the distal opening distal opening of 54 of the passageway the lumen of 50 (see Figs. 5A-7C) has a smaller cross- sectional area D0 (see Fig. 5C, col. 5, lines 30-39) than the cross-sectional area DI (see Fig. 5C, lines 30-39) of the proximal opening proximal opening of 53 of the passageway the lumen of 50; further wherein, when the proximal end 53 of the device 50 is in the radially expanded configuration (see Figs. 5C and 7B), a portion of the membrane structure 52 covers a portion (see Fig. 5A, 52 covers 50) of the device 50 contacting tissue within the blood vessel (see col. 6, lines 35-40, 53 is expanded into intimate contact with the wall of the pulmonary artery).
Claim 131
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: wherein the blood vessel in the pulmonary arterial tree is a pulmonary artery (see Figs. 7A-7C, col. 6, lines 36-40, pulmonary artery).
Claim 133
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: wherein in use within the blood vessel in the pulmonary tree (see Fig. 7B) the membrane structure 52 forms a funnel shaped flow restriction (see Figs. 5C and 7B, 52 forms a funnel-like shape with a tapered profile).
Claim 135
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: further comprising subsequent to performing the step of forming a proximal opening in the passageway for blood flow (see Figs. 7A-7B), percutaneously accessing the blood vessel and adjusting the cross-sectional area of the distal opening of the passageway to adjust a Qp:Qs ratio (will not be examined here due to being an optional claim limitation) or an arterial saturation level of the patient (see Fig. 7C, col. 6, lines 40-62, later a previously known balloon dilation catheter can be reintroduced to alter the cross-sectional area of the distal opening of 54 can be changed with a balloon catheter, based on the patient vital signs, which in col. 4-col.5, lines 67-3, notes is blood oxygen saturation level, which is in the vessel the device is in, is the arterial saturation level of the patient).
Claim 138
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: further comprising subsequent to performing the step of forming a proximal opening in the passageway for blood flow (see Figs. 7A-7B), percutaneously accessing the blood vessel and adjusting the distal opening of the passageway (see Fig. 7C, col. 6, lines 40-62, later a previously known balloon dilation catheter can be reintroduced to alter the cross-sectional area of the distal opening of 54 can be changed with a balloon catheter, based on the patient vital signs).
Claim 139
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: further comprising subsequent to performing the step of forming a proximal opening in the passageway for blood flow (see Figs. 7A-7B), percutaneously accessing the blood vessel and plastically deforming the distal opening of the passageway (see Fig. 7C, col. 6, lines 40-62, later a previously known balloon dilation catheter can be reintroduced to alter the cross-sectional area of the distal opening of 54 can be changed with a balloon catheter, based on the patient vital signs, see also col. 5, lines 40-49, plastically deformed via stent/mesh 51).
Claim 140
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: further comprising directing substantially all of the blood within the blood vessel through the passageway for blood flow subsequent to performing the step of forming a proximal opening in the passageway for blood flow (see col. 6, lines 35-47, the stent is put into intimate contact with the wall of pulmonary artery to provide flow constriction, hence narrowing the effective lumen to that of 54, funneling the blood through the stent, see also col. 5, lines 33-39).
Claim 144
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: further comprising subsequent to performing the step of forming a proximal opening in the passageway for blood flow (see Figs. 7A-7B), percutaneously accessing the blood vessel and adjusting the cross-sectional area of the distal opening of the passageway to increase or decrease pulmonary artery pressure or adjust a dimension of the device to accommodate for growth (will not be examined here due to being an optional claim limitation) of the blood vessel (see Fig. 7C, col. 6, lines 40-62, later a previously known balloon dilation catheter can be reintroduced to alter the cross-sectional area of the distal opening of 54 can be changed with a balloon catheter, based on the patient vital signs, see also col. 5, lines 40-49, plastically deformed via stent/mesh 51, adjusting the cross-sectional area of the distal opening of 54 changes pulmonary artery pressure at 54, for example decreasing the cross-sectional decreases the pressure while increasing the velocity of blood as according to the Venturi effect).
Claim 153
Ruiz discloses: The method of claim 139, see 102 rejection above. Ruiz further discloses: wherein plastically deforming the distal opening of the passageway (see also col. 5, lines 40-49, plastically deformed via stent/mesh 51) comprises deforming a plastically deformable component the plastically deformed mesh 51 (see col. 5, lines 49-49, which is also included around near the opening of 54) positioned at or around the distal opening distal opening of 51 of the passageway the lumen of 50.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 150 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz.
Claim 150
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: further wherein when the proximal end of the device is in the radially expanded configuration (see Fig. 5C and 7B), a length the length of 51 is covered by 52 (see Fig. 5C, col. 5, lines 25-39) of the anchor portion 51 of the device 50 is covered by the membrane structure 52.
Ruiz does not explicitly disclose: a length of 10 mm or less.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Ruiz to have a length of 10 mm or less of the anchor portion of the device is covered by the membrane structure since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ruiz would not operate differently with a length of 10 mm or less of the anchor portion of the device is covered by the membrane structure. Further, applicant places no criticality on the range claimed, (see [0130] of applicant’s patent application publication “PGPUB”) the length can be 4-11 mm, or 5-12 mm as possible alternatives, hence the length being less than 10 mm is not critical, as lengths of 11 and 12 mm are possible.
Claim(s) 130 and 132 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz in view of Sudhir et al (US 9408952 B2), herein referenced to as “Sudhir”.
Claim 130
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: wherein the heart defect is Hypoplastic Left Heart Syndrome (HLHS).
However, Sudhir in a similar field of invention teaches a method for regulating blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect (see Figs. 1-2, col. 2-3, lines 59-3) with a stent-like device (see Figs. 1-2, col. 2, lines 59-3, scaffold). Sudhir further teaches: wherein the heart defect is Hypoplastic Left Heart Syndrome (HLHS) (see col. 13, lines 10-13).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Sudhir and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with the heart defect is Hypoplastic Left Heart Syndrome (HLHS). Motivation for such can be found in Sudhir as this is a palliative measure that to allow delayal of surgical intervention at later time that is safer for the patient (see col. 3, lines 55-60).
Claim 132
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: wherein the blood vessel in the pulmonary arterial tree is a branch pulmonary artery.
However, Sudhir in a similar field of invention teaches a method for regulating blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect (see Figs. 1-2, col. 2-3, lines 59-3) with a stent-like device (see Figs. 1-2, col. 2, lines 59-3, scaffold). Sudhir further teaches: wherein the blood vessel in the pulmonary arterial tree is a branch pulmonary artery (col. 11, lines 10-30, peripheral branch).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Sudhir and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with the blood vessel in the pulmonary arterial tree is a branch pulmonary artery. Motivation for such can be found in Sudhir as this can be used to treat peripheral pulmonary stenosis (see col. 11, lines 10-15).
Claim(s) 134 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz in view of Teitelbaum (US 20210161644 A1), herein referenced to as “Teitelbaum”.
Claim 134
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: wherein in use within the blood vessel in the pulmonary tree the distal end of the membrane structure is self-centering.
However, Teitelbaum in a similar field of invention teaches a method for regulating blood flow in a blood vessel (see Figs. 8 and 10, [0050], interior vena cava) with a distal end distal end of 215 of a membrane 215. Teitelbaum further teaches: wherein in use within the blood vessel the distal end of the membrane structure is self-centering (see [0055], self-centering within the interior vena cava/blood vessel).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the membrane structure of Ruiz to incorporate the teachings of Teitelbaum and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with in use within the blood vessel in the pulmonary tree the distal end of the membrane structure is self-centering. Motivation for such can be found in Sugimoto as this simplifies the delivery of the device to a suitable target location and prevents creating undesirable space between the outer surface of the stent and the blood vessel interior or intima (see [0039]).
Claim(s) 135-137 and 143 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz in view of Sugimoto et al (US 20140012181 A1), herein referenced to as “Sugimoto”.
Claim 135
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: further comprising subsequent to performing the step of forming a proximal opening in the passageway for blood flow (see Figs. 7A-7B), percutaneously accessing the blood vessel and adjusting the cross-sectional area of the distal opening of the passageway or an arterial saturation level of the patient (see Fig. 7C, col. 6, lines 40-62, later a previously known balloon dilation catheter can be reintroduced to alter the cross-sectional area of the distal opening of 54 can be changed with a balloon catheter, based on the patient vital signs, which in col. 4-col.5, lines 67-3, notes is blood oxygen saturation level, which is in the vessel the device is in, is the arterial saturation level of the patient).
Ruiz does not explicitly disclose: to adjust a Qp:Qs ratio.
However, Sugimoto in a similar field of invention a method for regulating blood flow in a blood vessel in a pulmonary arterial tree (see Figs. 13-16) with percutaneously accessing the blood vessel (see Figs. 13-16) and adjusting the cross-sectional area of the distal opening 102 (see Figs. 14-16, 102 is expanded, from a contracted form) of the passageway. Sugimoto further teaches: to adjust a Qp:Qs ratio (see [0048], Qp:Qs ratio could be restored to or close to the normal range).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Sugimoto and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with to adjust a Qp:Qs ratio. Motivation for such can be found in Sugimoto as this allows correction of the ratio of the pulmonary blood flow to the systemic blood flow assuring that systematic oxygen saturation level is maintained at its safe range (see [0047]-[0048]).
Claim 136
The combination of Ruiz and Sugimoto teaches: The method of claim 135, see 103 rejection above. Sugimoto further teaches: wherein after adjusting the cross sectional area of the distal opening of the passageway the patient has Qp:Qs ratios of between 0.8:1 and 2:1 (see [0048], Qp:Qs ratio during and after treatment is 1:1 to 1.5:1, which is between 0.8:1 and 2:1).
Claim 137
The combination of Ruiz and Sugimoto teaches: The method of claim 135, see 103 rejection above. Sugimoto further teaches: wherein after adjusting the cross sectional area of the distal opening of the passageway the patient has arterial oxygen saturations between about 70%-90% (see [0047]-[0048], after treatment oxygen saturation is maintained in the range of 75%-100%, which includes saturations between 70%-90%).
Claim 143
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: further comprising accessing a femoral vein of the patient prior to the step of percutaneously advancing a device in a collapsed configuration through a portion of the vasculature of the patient.
However, Sugimoto in a similar field of invention a method for regulating blood flow in a blood vessel in a pulmonary arterial tree (see Figs. 13-16) with percutaneously advancing a device 100 (see Figs. 13-16) in a collapsed configuration (see Figs. 13-15) through a portion of the vasculature of the patient (see Figs. 13-16). Sugimoto further teaches: further comprising accessing a femoral vein (see Figs. 13-16, [0081], advancing distally through the femoral vein) of the patient prior to the step of percutaneously advancing a device 100 in a collapsed configuration (see Figs. 13-15) through a portion of the vasculature of the patient (see Figs. 13-16).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Sugimoto and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with accessing a femoral vein of the patient prior to the step of percutaneously advancing a device in a collapsed configuration through a portion of the vasculature of the patient. Motivation for such can be found in Sugimoto as this a known, standard right heart catheterization procedure to avoid blood back-flow from the pulmonary artery (see [0081]).
Claim(s) 141-142 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz in view of Eigler et al (US 20190008628 A1), herein referenced to as “Eigler”.
Claim 141
Ruiz discloses: The method of claim 133, see 102 rejection above. Ruiz further discloses: wherein the funnel shaped flow restriction 52 forms a funnel-like shape (see Figs. 5C and 7B) is a continuous membrane structure (see Figs. 5A-5C, 52 is continuously over 51) from the device 50 proximal opening proximal opening of 53 to the device distal opening distal opening of 54 (see Fig. 5C).
Ruiz does not explicitly disclose: wherein the membrane structure is made of ePTFE.
However, Eigler in a similar field of invention teaches a method for regulating blood flow (see Figs. 1A-6, [0040], Qp/QS ratio) with a device 10 (see Figs. 1A-6) with a membrane structure (see [0038], ePTFE to cover over the frame). Eigler further teaches: wherein the membrane structure is made of ePTFE (see [0038], ePTFE is the membrane to cover the frame of 10).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the membrane of Ruiz to incorporate the teachings of Eigler and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with the membrane structure is made of ePTFE. Motivation for such can be found in Eigler as this prevents pannus formation or narrow of the lumen (see [0052]) and acts as a barrier to isolate the shunt lumen from the exterior of the conduit (see [0075]).
Claim 142
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: wherein the membrane structure covering the anchor portion of the device prevents tissue ingrowth of the anchor portion into a vessel wall of the blood vessel subsequent to performing the step of forming a proximal opening in the passageway for blood flow.
However, Eigler in a similar field of invention teaches a method for regulating blood flow (see Figs. 1A-6, [0040], Qp/QS ratio) with a device 10/shunt (see Figs. 1A-6, [0038] and [0075]) with a membrane structure (see [0038], ePTFE to cover over the frame) and an anchor portion frame (see [0038] and [0075]). Eigler further teaches: wherein the membrane structure covering the anchor portion frame of the device 10/shunt prevents tissue ingrowth of the anchor portion into a vessel wall of the blood vessel subsequent to performing the step of forming a proximal opening in the passageway for blood flow (see [0038] and [0075], after implantation there is no pannus formation or narrowing of the lumen and the membrane acts as a barrier to isolate the shunt lumen/the anchor portion from the exterior of device).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the membrane of Ruiz to incorporate the teachings of Eigler and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with the membrane structure covering the anchor portion of the device prevents tissue ingrowth of the anchor portion into a vessel wall of the blood vessel subsequent to performing the step of forming a proximal opening in the passageway for blood flow. Motivation for such can be found in Eigler as this prevents pannus formation or narrow of the lumen (see [0052]) and acts as a barrier to isolate the shunt lumen from the exterior of the conduit (see [0075]).
Claim(s) 145 and 147 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz in view of Passman et al (US 20200391016 A1), herein referenced to as “Passman”.
Claim 145
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: the step of percutaneously advancing a device in a collapsed configuration through a portion of the vasculature of the patient to a placement site within the blood vessel further comprising: crossing the valves of heart of the patient using a catheter-based delivery without causing regurgitation and hemodynamic instability.
However, Passman in a similar field of invention teaches a method for regulating blood flow in a pulmonary artery (see Figs. 5-7) with percutaneously advancing a device 130 (see Figs. 5-9) in a collapsed configuration (see Figs. 5 and 8) through a portion of the vasculature of the patient to a placement site within the blood vessel (see Figs. 5-9). Passman further teaches: crossing the valves of heart of the patient (see Fig. 6, the catheter 102 cross the valves of the patient’s heart) using a catheter-based delivery 102 (see Fig. 6, [0063]-[0064]) without causing regurgitation and hemodynamic instability (see [0117], the catheter is less than 6 french, therefore not including a 6 french catheter, at 5 french or less, the catheter does not cause regurgitation and hemodynamic instability).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Passman and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with the step of percutaneously advancing a device in a collapsed configuration through a portion of the vasculature of the patient to a placement site within the blood vessel further comprising: crossing the valves of heart of the patient using a catheter-based delivery without causing regurgitation and hemodynamic instability. Motivation for such can be found in Passman as these transcatheter procedures are less traumatic for the patient and quicker and easier to perform (see [0016]), additionally, the same sized catheter can be used in multiple different kits for either the Fontan, Glenn, or Blalock-Taussig procedures (see [0117]-[0120]).
Claim 147
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: wherein the device in a collapsed configuration is adapted and configured to be advanced through a sheath with a diameter of 5F or less.
However, Passman in a similar field of invention teaches a method for regulating blood flow in a pulmonary artery (see Figs. 5-7) with percutaneously advancing a device 130 (see Figs. 5-9) in a collapsed configuration (see Figs. 5 and 8) through a portion of the vasculature of the patient to a placement site within the blood vessel (see Figs. 5-9). Passman further teaches: wherein the device 130 in a collapsed configuration (see Figs. 5 and 8) is adapted and configured to be advanced through a sheath with a diameter of 5F or less (see [0117], the catheter is less than 6 french, therefore not including a 6 french catheter, at 5 french or less).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Passman and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with the device in a collapsed configuration is adapted and configured to be advanced through a sheath with a diameter of 5F or less. Motivation for such can be found in Passman as these transcatheter procedures are less traumatic for the patient and quicker and easier to perform (see [0016]), additionally, the same sized catheter can be used in multiple different kits for either the Fontan, Glenn, or Blalock-Taussig procedures (see [0117]-[0120]).
Claim(s) 148-149 and 154 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz in view of Bluecher et al (US 20180193175 A1), herein referenced to as “Bluecher”.
Claim 148
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: wherein after the step of expanding an anchor portion on a proximal end of the device from the collapsed configuration to a radially expanded configuration the distal most end of the passageway extends beyond a distal most end of the anchor portion.
However, Bluecher in a similar field of invention teaches a method for regulating blood flow (see Fig. 2B, [0004], keeping body lumen open, [0026], blood vessels) with expanding an anchor portion 202 (see Fig. 2B, [0025], radially-expandable implant from unexpanded to an expanded state) on a proximal end 216 (see Fig. 2B) of the device 200 (see Fig. 2B) from the collapsed configuration to a radially expanded configuration. Bluecher further teaches: wherein after the step of expanding an anchor portion 210 (see Fig. 2B, [0025], radially-expandable implant from unexpanded to an expanded state) on a proximal end 216 of the device 200 from the collapsed configuration to a radially expanded configuration the distal most end the distal most end of the lumen at 223 (see Fig. 2B) of the passageway the lumen of 200 (see Fig. 2B) extends beyond a distal most end 222 of 220 (see Fig. 2B, [0062]) of the anchor portion 202.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Bluecher and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with after the step of expanding an anchor portion on a proximal end of the device from the collapsed configuration to a radially expanded configuration the distal most end of the passageway extends beyond a distal most end of the anchor portion. Motivation for such can be found in Bluecher as the extension of the lumen via a delivery sleeve assists in positioning and deployment of the stent within the body lumen (see [0065]).
Claim 149
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz further discloses: wherein the membrane structure 52 that contacts the wall of the vessel (see col. 6, lines 35-40, 53 is expanded into intimate contact with the wall of the pulmonary artery).
Ruiz does not explicitly disclose: creates a seal that prevents peri-device flow.
However, Bluecher in a similar field of invention teaches a method for regulating blood flow (see Fig. 5, [0004], keeping body lumen open, [0026], blood vessels) with the membrane structure 535 (see Fig. 5) covering the anchor portion 510 (see Fig. 5, [0090], hydrogel covered stent) and contacts the wall of the vessel (see [0091], sealing force against the wall of the body vessel). Bluecher further teaches: creates a seal that prevents peri-device flow (see [0091], exert a sealing force against the wall of the body vessel, this sealing force stops the bodily fluid from flowing between the cuffs and the vessel wall, thereby, forcing all of the fluid flow to enter and exit through the stent).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Bluecher and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with creates a seal that prevents peri-device flow. Motivation for such can be found in Bluecher as this sealing force stops the bodily fluid from flowing between the cuffs and the vessel wall, thereby, forcing all of the fluid flow to enter and exit through the stent (see [0091]).
Claim 154
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: further wherein when the proximal end of the device is in the radially expanded configuration, a distal portion of the anchor portion of the device is flared.
However, Bluecher in a similar field of invention teaches a method for regulating blood flow (see Fig. 2B, [0004], keeping body lumen open, [0026], blood vessels) with expanding an anchor portion 202 (see Fig. 2B, [0025], radially-expandable implant from unexpanded to an expanded state) on a proximal end 216 (see Fig. 2B) of the device 200 (see Fig. 2B) from the collapsed configuration to a radially expanded configuration. Bluecher further teaches: further wherein when the proximal end 216 of the device 200 is in the radially expanded configuration (see Fig. 2B), a distal portion 214 (see Fig. 2B, [0061] and [0065]) of the anchor portion 202 of the device 200 is flared (see Fig. 2B, [0061], 214 is flared).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Bluecher and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with when the proximal end of the device is in the radially expanded configuration, a distal portion of the anchor portion of the device is flared. Motivation for such can be found in Bluecher as this aids in fixation of the stent when inserted in a body lumen (see [0061]).
Claim(s) 146 and 151-152 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz in view of Goldie et al (US 20170215885 A1), herein referenced to as “Goldie”.
Claim 146
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: wherein the anchor portion is configured to self-expand as the blood vessel grows.
However, Goldie in a similar field of invention teaches a method for regulating blood flow in a pulmonary artery (see Figs. 1- 5) with forming a proximal opening proximal base wide opening 16 (see Figs. 1-5) in the passageway for blood flow through the device 10 (see Figs. 4E-4H) with an anchor portion 14 (see Figs. 1-5). Goldie further teaches: wherein the anchor portion 14 is configured to self-expand as the blood vessel grows (see [0029], self expanding and maintains contact with pulmonary artery wall even as the pulmonary artery grows in size).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Sudhir and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with the anchor portion is configured to self-expand as the blood vessel grows. Motivation for such can be found in Goldie as this allows the device to remain in contact with the pulmonary artery wall even as the pulmonary artery grows in size (see [0029]).
Claim 151
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: further comprising subsequent to performing the step of forming a proximal opening in the passageway for blood flow through the device, surgically removing the device from the blood vessel.
However, Goldie in a similar field of invention teaches a method for regulating blood flow in a pulmonary artery (see Figs. 1- 5) with forming a proximal opening proximal base wide opening 16 (see Figs. 1-5) in the passageway for blood flow through the device 10 (see Figs. 4E-4H). Goldie further teaches: further comprising subsequent to performing the step of forming a proximal opening proximal base wide opening 16 (see Figs. 1-5) in the passageway for blood flow through the device 10 (see Figs. 4E-4H), surgically removing the device from the blood vessel (see [0033], removing the frame and the membrane from the pulmonary artery).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Goldie and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with subsequent to performing the step of forming a proximal opening in the passageway for blood flow through the device, surgically removing the device from the blood vessel. Motivation for such can be found in Goldie as this allows for future follow-up on MIS procedures to reduce resistance may be periodically necessary to maintain desired apportionment of blood flow between the lungs and the remainder of the body as the patient grows (see [0022]) and this is preferable as this minimally invasive procedure reduces/eliminates post-surgery recovery time in an intensive care unit and hospital stay duration when compared to conventional pulmonary artery banding which requires open surgery.
Claim 152
Ruiz discloses: The method of claim 129, see 102 rejection above. Ruiz does not explicitly disclose: further comprising subsequent to performing the step of forming a proximal opening in the passageway for blood flow through the device, percutaneously accessing the blood vessel, grabbing a feature on the device and thereafter removing the device from the blood vessel.
However, Goldie in a similar field of invention teaches a method for regulating blood flow in a pulmonary artery (see Figs. 1- 5) with forming a proximal opening proximal base wide opening 16 (see Figs. 1-5) in the passageway for blood flow through the device 10 (see Figs. 4E-4H). Goldie further teaches: further comprising subsequent to performing the step of forming a proximal opening proximal base wide opening 16 (see Figs. 1-5) in the passageway for blood flow through the device 10 (see Figs. 4E-4H), grabbing a feature 80 (see Fig. 5, [0033]) on the device 10 and thereafter removing the device 10 from the blood vessel (see [0033], for collapsing the frame and removing the frame and the membrane from the pulmonary artery).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ruiz to incorporate the teachings of Goldie and teach a method for reducing blood flow in a blood vessel in a pulmonary arterial tree of a pediatric patient having a heart defect with subsequent to performing the step of forming a proximal opening in the passageway for blood flow through the device, grabbing a feature on the device and thereafter removing the device from the blood vessel. Motivation for such can be found in Goldie as this allows for future follow-up on MIS procedures to reduce resistance may be periodically necessary to maintain desired apportionment of blood flow between the lungs and the remainder of the body as the patient grows (see [0022]) and this is preferable as this minimally invasive procedure reduces/eliminates post-surgery recovery time in an intensive care unit and hospital stay duration when compared to conventional pulmonary artery banding which requires open surgery.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Celermajer et al (US 20200375721 A1) teaches a method of regulating blood flow with altering the cross-sectional area of a distal/proximal opening after a period of time has elapsed, either months or years
Shahriari (US 20170312103 A1) teaches a method of regulating blood flow with sequential deployment of a stent from a proximal end to a distal end
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
