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 .
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 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) 1, 3-6, 9, 11, 13-17, and 31-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellomo (US Pub No.: 2020/0297516) in view of Bahler (US Pub No.: 2005/0273155) and Bellomo 2018 (US Pub No.: 2018/0085128).
Regarding claim 1, Bellomo (US Pub No.: 2020/0297516) teaches a device comprising: a constricting portion extending from an inlet at a proximal end for receiving blood flow therethrough to at least one outlet at a distal end through which flow is expelled (a second tubular wall to provide a constriction in [0062]-[0063], where the second tubular wall is part 120 in [0060] and figure 1); wherein said constricting portion includes a neck section and wherein said constricting portion tapers from said inlet to said neck section and wherein said constricting portion comprises a flared section that flares from said neck section to said at least one outlet (shown in figure 1 where parts 121 extend toward each other and form a neck with the diameter Dneck), having a distal end with a diameter larger than the diameter of said neck section (being the leftmost end of figure 1 about part 132) and wherein said tapering and said flared section defines a space substantially surrounding said constricting portion in which flow expelled from said at least one outlet can freely flow (being the end of part 131 where the fluid passing through device 100 passes out from. No element to impede the flow at part 131 is shown in figure 1), wherein the device is configured to direct the blood flow therethrough from said proximal end to said distal end (blood vessel deployment in the abstract with blood flow in [0010], while the space allows backflow therewithin (as fluid will flow through the constricting device, as disclosed in [0092], examiner argues that a backflow will be provided for in the section leading up to the neck, being part 730 in figure 7, as per the structure of the constricting device).
However, Bellomo does not teach and an anchor configured to anchor the device to an inner wall of a blood vessel.
Instead, Bahler (US Pub No.: 2005/0273155) teaches an anchor configured to anchor the device to an inner wall of a blood vessel (proximal anchoring members 18 in [0152], shown in figures 1-2). 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 anchoring means of Bahler in part 18 with barbs 36 into Bellomo as said barbs are disclosed to engage a vessel to hold a prosthetic device in place (as per [0152]). While Bahler is disclosed for renal arteries in [0152], a generic treatment of vessels is disclosed in [0006], with Bahler only being relied upon to teach an anchor and not a treatment means.
Bellomo also does not teach a distal end with a diameter smaller than the diameter of said inlet. Instead, Bellomo 2018 does teach a distal end with a diameter smaller than the diameter of said inlet (shown in figure 3 and disclosed in [0084], where Lin>Lout, with Lin being the inlet diameter and Lout being the outlet diameter in [0084]. Figure 3 also depicts the neck as being smaller than both inlet and outlet parts. Examiner notes that the proximal and distal ends of Bellomo 2018 are reversed with respect to Bellomo, so the proximal end of Bellomo 2018 would be the distal end within Bellomo as the proximal end is equivalent to an inlet end).
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 multiple diameters of Bellomo 2018 into Bellomo fhr the purpose of providing a diameter reduction of an anatomic vessel (in [0096]) that is used to reduce artery pressure as per [0006].
Regarding claim 3, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 1, wherein Bahler teaches that said anchor is an outer frame (shown in figures 1-2) defining an outer cylindrical wall (shown in figures 1-2) with openings through which blood may freely flow (as the barbs 36 of anchor 18 are depicted as having openings in figures 1-3, with the placement of said barbs being at the end of a stent, it stands to reason that blood will flow through the openings of the anchors).
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 anchoring means of Bahler in part 18 with barbs 36 as said barbs are disclosed to engage a vessel to hold a prosthetic device in place (as per [0152]). While Bahler is disclosed for renal arteries in [0152], a generic treatment of vessels is disclosed in [0006], with Bahler only being relied upon to teach an anchor and not a treatment means.
Regarding claim 4, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 3, with Bellomo further comprising an inner frame defining an inner cylindrical wall with openings through which blood may freely flow and a cover partially lining said inner frame (the inner frame being the second tubular wall 120 in [0060]), wherein said constriction portion is formed by a first portion of said inner frame that is lined with said cover, said first portion extending from said inlet to said at least one outlet (being the ePTFE coating material shown in figure [0092] and figure 7. Other coating materials in [0065]).
Regarding claim 5, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 4, wherein Bellomo teaches said inner frame is within said outer frame and oriented in a same direction (shown in figures 1 and 7 of Bellomo).
Regarding claim 6, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 5, wherein Bellomo teaches said inner frame and said outer frame extends from said proximal end to a frame distal end (shown visually in figures 1 and 7 where the frames extend to both ends across the entire distance L).
Regarding claim 9, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 5, wherein Bellomo teaches said cover lines 50% - 90% of a length of said inner frame (while a percentage is not present, the cover material is depicted as extending across about 90% of the length in figure 7).
Regarding claim 11, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 5, wherein Bellomo teaches said cover is a liquid impermeable cover (liquid impermeable materials in [0065]).
Regarding claim 13, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 11, wherein Bellomo teaches a diameter of said neck section is 5 mm - 15 mm (constriction to 10 to 15mm in [0085]).
Regarding claim 14, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 11. However, Bellomo does not teach, wherein said anchor is fixed to said constricting portion at said proximal end and further comprises a circumferential sealing strip extending around said anchor at said proximal end.
Bahler does further comprise a circumferential sealing strip extending around said anchor at said proximal end (cuff portion 15 in [0152] of Bahler wraps around anchor members and barbs in figure 9-10 and 13). 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 anchoring means of Bahler in part 18 with barbs 36 into Bellomo as said barbs are disclosed to engage a vessel to hold a prosthetic device in place (as per [0152]). While Bahler is disclosed for renal arteries in [0152], a generic treatment of vessels is disclosed in [0006], with Bahler only being relied upon to teach an anchor and not a treatment means.
From here, Bellomo 2018 (US Pub No.: 2018/0085128) teaches wherein said anchor is fixed to said constricting portion (the anchor loop section is part 131 in figures 8A-8B. connection to an anchor in [0140], with the constricting portion being part 130) at said proximal end (in figure 8A-8B, anchor part connects to part 132 that extends out a proximal end in figure 8B). 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 constricting portion and anchor arrangement of Bellomo 2018 into Bellomo in view of Bahler for the purpose of providing a constricting element in [0140] that has an adjusting mechanism 320 (also in [0140]) that adjust the diameter of a neck portion, shown in figures 7 and 8A-8B as per [0090]-[0092].
Regarding claim 15, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 14, wherein Bahler teaches that said circumferential sealing strip lines said anchor over a length of 3 mm - 10 mm from said proximal end (in [0152], as said cuff is approximately 10mm and is over the anchor member of Bahler in figures 1-2, said cuff 15 overlaps said anchor for approximately 10 mm away from the proximal end of Bahler). 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 anchoring means of Bahler in part 18 with barbs 36 into Bellomo as said barbs are disclosed to engage a vessel to hold a prosthetic device in place (as per [0152]). While Bahler is disclosed for renal arteries in [0152], a generic treatment of vessels is disclosed in [0006], with Bahler only being relied upon to teach an anchor and not a treatment means.
Regarding claim 16, Bellomo in view of Bahler and Bellomo 2018 teach the device of claim 14. However, Bellomo does not teach said constricting portion is lined with a cover and wherein said circumferential sealing strip is connected to said cover of said constricting portion with a liquid impermeable sealed connection. 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 constricting portion and anchor arrangement of Bellomo 2018 into Bellomo in view of Bahler for the purpose of providing a constricting element in [0140] that has an adjusting mechanism 320 (also in [0140]) that adjust the diameter of a neck portion, shown in figures 7 and 8A-8B as per [0090]-[0092].
Instead, Bellomo 2018 teaches that said constricting portion (part 130 in [0139]-[0140]) is lined with a cover (being the inner tubular wall 120. Said constricting element can be incorporated into the cover of Bellomo).
From here, Bahler teaches wherein said circumferential sealing strip is connected to said cover of said constricting portion with a liquid impermeable sealed connection (as the device of Bahler is made of an ECMM material with ECMM bands in [0145], and as part 15 wraps around the end of the device of Bahler in figures 1-2, the circumferential sealing strip can be configured to connect to the cover of Bellomo and the material of the strip is liquid impermeable). 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 anchoring means of Bahler in part 18 with barbs 36 into Bellomo as said barbs are disclosed to engage a vessel to hold a prosthetic device in place (as per [0152]). While Bahler is disclosed for renal arteries in [0152], a generic treatment of vessels is disclosed in [0006], with Bahler only being relied upon to teach an anchor and not a treatment means.
Regarding claim 17, Bellomo in view of Bahler and Bellomo 2018 teaches the device of claim 1, where Bellomo comprising a constrictor fitted around said neck section and configured to constrict said neck section to a defined diameter (as a constriction force (F) is applied in [0085]-[0086], a constrictor to apply said force should be present), and wherein said constrictor is configured to maintain said defined diameter while implanted within blood vessel (in [0067]-[0068], the constrictor deforms segments of the device, maintaining a diameter is also in [0085]).
Regarding claim 31, Bellomo in view of Bahler teach the device of claim 1, wherein Bellomo teaches said space is configured to provide free blood flow into branch blood vessels along a length of the blood vessel in which the device is implanted (in [0001] and [0007] of Bellomo).
Regarding claim 32, Bellomo in view of Bahler teach the device of claim 1, wherein Bellomo teaches the device is configured for being implanted within a pulmonary artery (pulmonary artery placement in [0001] and [0054]).
Regarding claim 33, Bellomo in view of Bahler teach the device of claim 32, wherein Bellomo teaches the device is configured for being implanted in the right or left pulmonary artery (pulmonary artery placement in [0001] and [0054]).
Regarding claim 34, Bellomo in view of Bahler teach the device of claim 33, wherein Bellomo teaches the device is configured for elevating pressure in the right ventricle (treatment of a right ventricle in [0054]).
Regarding claim 35, Bellomo in view of Bahler teach the device of claim 11, wherein Bellomo teaches said cover extends from said proximal end to said distal end (parts 760 and 770 extend toward the proximal and distal end of the device of figure 7), wherein said distal end is at a distance downstream said neck section, defining a flared section (flared section shown in figures 1 and 7, where the rightmost end of figures 1 and 7 are distal ends).
Claim(s) 20-21, 23-28, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellomo (US Pub No.: 2020/0297516) in view of Bahler (US Pub No.: 2005/0273155).
Regarding claim 20, Bellomo teaches a device comprising: an outer frame defining an outer cylindrical wall with openings through which blood may freely flow (shown in figure 1 with outer frame 110 that defines an outer wall (being the inside portion of 110) with openings on the distal and proximal side of figure 1); an inner frame defining an inner cylindrical wall with openings through which blood may freely flow, wherein said inner frame is within said outer frame (inner frame 120 in figure 1), and wherein at least a portion of said inner frame is fixedly attached to said outer frame (shown in figures 1 and 7), said inner frame having an inner frame length that extends from a proximal end to a frame distal end (shown in figure 1); a cover lining said inner frame from said proximal end to a cover distal end to form a constricting portion (being the ePTFE coating material shown in figure [0092] and figure 7. Other coating materials in [0065]), wherein said constricting portion has a length that is shorter than said inner frame length (shown visually in figure 7 where the cover is part 760 and 770 in [0092]), wherein said cover seals said openings in said inner frame over said length of said constricting portion (shown in figure 7 with part 760 and coating 770); a constrictor configured to constrict a diameter of said inner frame along said constricting portion to form a neck section with a defined neck diameter (as a constriction force (F) is applied in [0085]-[0086], a constrictor to apply said force should be present), wherein said constricting portion tapers from said proximal end to said neck section and wherein said tapering defines a space substantially surrounding said constricting portion in which flow expelled from said constricting portion can freely flow (as the inner wall tapers inward as per figures 1 and 7, the constricting force tapers from the proximal and distal sections toward the neck to form the constricting neck in figures 1 and 7. In figure 7, the constricting portion is about part 730 in [0091], where the tapering occurs to the left and right of part 730 at where reference number 720 is pointing to in figure 7).
However, Bellomo does not teach that the device is configured for being anchored within a blood vessel.
Instead, Bahler (US Pub No.: 2005/0273155) teaches a device configured for being anchored within a blood vessel (proximal anchoring members 18 in [0152], shown in figures 1-2
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 anchoring means of Bahler in part 18 with barbs 36 into Bellomo as said barbs are disclosed to engage a vessel to hold a prosthetic device in place (as per [0152]). While Bahler is disclosed for renal arteries in [0152], a generic treatment of vessels is disclosed in [0006], with Bahler only being relied upon to teach an anchor and not a treatment means.
Regarding claim 21, Bellomo in view of Bahler teach the device of claim 20, wherein Bellomo teaches said cover lines 50% - 90% of a length of said inner frame (while a percentage is not present, the cover material is depicted as extending across about 90% of the length in figure 7).
Regarding claim Regarding claim 23, Bellomo in view of Bahler teach the device of claim 20, wherein Bellomo teaches a second portion of said inner frame extending from said cover distal end to said frame distal end is not lined with said cover and is exposed (shown in figure 7 where the leftmost end of figure 7 is the distal portion).
Regarding claim 24, Bellomo in view of Bahler teach the device of claim 23, wherein Bellomo teaches an edge of said inner frame at said cover distal end is configured to be spaced away from an inner wall of a blood vessel when the device is implanted therein (as the inner cover with parts 760 and 770 is spaced away from part 710 in figure 7, and as the outer tubular wall 710 in [0088] will be the wall that is contacting a vessel wall, the cover is spaced away from an inner wall of a blood vessel).
Regarding claim 25, Bellomo in view of Bahler teach the device of claim 24, wherein Bellomo teaches a diameter of said inner frame at said cover distal end is at least 10% smaller than a diameter of said inner frame at said distal end (in [0085], as the second tubular wall is 26 mm before constriction and 10-15 mm after constriction, the inner frame diameter at the neck is at least 10% smaller than the diameter at the ends, which will be 26mm as this is the uncompressed tubular wall diameter).
Regarding claim 26, Bellomo in view of Bahler the device of claim 20, wherein Bellomo teaches said outer frame is fixed to said inner frame at said proximal end and further comprising a circumferential sealing strip extending around said outer frame at said proximal end.
Regarding claim 27, Bellomo in view of Bahler teach the device of claim 26, wherein Bellomo teaches said circumferential sealing strip lines said outer frame over a length of 3 mm - 10 mm from said proximal end.
Regarding claim 28, Bellomo in view of Bahler teach the device of claim 20, wherein Bellomo teaches a diameter of said neck section is 5 mm - 15 mm (constriction to 10 to 15 mm in [0085]).
Regarding claim 36, Bellomo in view of Bahler teach the device of claim 20, wherein Bellomo teaches said constricting portion comprises a flared section that flares from said neck section to said cover distal end parts 760 and 770 extend toward the proximal and distal end of the device of figure 7), having a distal end with a diameter larger than the diameter of said neck section and smaller than the diameter of said proximal end (flared section shown in figures 1 and 7, where the rightmost end of figures 1 and 7 are distal ends).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sheehan (US Pub No.: 2013/0178750) considered for a blood pressure control apparatus with a constricting of flow shown in figure 15b. Manash (US Pub No.: 2022/0031327) considered for a fluid connection device with a constricted portion around parts 16 and 22 in figure 1.
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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