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 .
Response to Arguments
Applicant's arguments filed 05/18/26 have been fully considered but they are not persuasive.
On page 11 Applicant argues amendments overcome the claim objections of record.
The Examiner respectfully disagrees and notes amendments to claims 5-6, 12, and 16 do not overcome the objections of record. The claims were not unclear for the order in which inflating and deflating was named, but rather objected to since claim 1 only requires “repeatedly deflating” the balloon, and does not reference “repeatedly inflating” the balloon anywhere. Accordingly, reference to “repeatedly inflating” is unclear.
On pages 11-12 regarding drawing objections Applicant argues amendments overcome the drawing objections.
The Examiner respectfully agrees and withdraws drawing objections.
On page 12 regarding drawing objections Applicant argues amendments overcome the 112 rejections.
The Examiner respectfully agrees and withdraws 112 rejections.
On pages 13-16 Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Objections
Claims 4-6, 12, 16 are objected to because of the following informalities:
Claim 4 is objected to for referring to “a lumen” with improper antecedent basis.
Claims 5-6, 12, and 16 are objected to for referring to “repeatedly inflating” the balloon when claim 1, from which these claims depend, don’t actually discuss “repeatedly inflating”. Claim 1 only requires “repeatedly deflating” the balloon. Clarification is required.
Claims 6 and 16 are objected to for claiming the inflating and deflating occurs at a frequency of about 30-180 inflations and deflations per minute, but it is unclear if this means 30-180 inflations and 30-180 deflations per minute, or whether there are 30-180 inflations/deflations together, per minute. Clarification is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 10, 12, 14, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pfeifer et al. (US 20170056574 A1) hereinafter known as Pfeifer in view of JP 2016524937 A, hereinafter known as JP, further in view of Ferrari (US 20100087773 A1), and further in view of Frazier (US 6669624 B2).
Regarding claim 1 Pfeifer discloses a method comprising:
inserting a device (Figure 6a-b item 1) within a blood vessel ([0045]), the device comprising:
a hollow covered stent body (Figures 6a-b item 3) having a first end (Figure 6a-b near item 18), a second end (Figure 6a-b near item 7), and a lumen extending between the first and second ends (Figure 6a-b), the lumen being defined at least in part by a wall of the stent body (Figure 6a-b, [0061] sleeve 3 includes, outside of the frame 2, a tube depicted as line 6)),
one or more one-way valves (Figures 6a-b items 18, 10), wherein one or more of the one-way valves comprise an outlet valve arranged in the lumen (Figure 6b item 10), and comprising one or more leaflets ([0076] a foil valve 10 is understood to inherently include a leaflet (e.g. foil),
a catheter connected to the stent body (Figures 6a-b item 4 (8)),
and a balloon within the stent body (Figures 6a-b item 14) between the first and second ends thereof (Figure 6a-b), and
increasing antegrade flow through the blood vessel by repeatedly deflating the balloon to pull the blood through the first end of the stent body and inflating the balloon to push the blood from the stent body through the one-way valve ([0033], Figures 6a-b, and [0076]),
wherein the outlet valve opens when the balloon is inflating (Figure 6b) and closes when the balloon is deflating (Figure 6a),
but is silent with regards to the method being for increasing a flow rate of the blood,
one of the one-way valves being located at the second end of the stent body, and
which direction the leaflet moves when it opens.
However, regarding claim 1 Ferrari teaches that blood pumps can have their outlet arranged within the lumen at the second end of a stent body (Figure 2 shows valve 12 at a stent body end within its lumen). Pfeifer and Ferrari are involved in the same field of endeavor, namely balloon pump catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Pfeifer by having the outlet valve at any location along the stent body, including at the second end as is taught by Ferrari since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C). In this situation, adjusting or switching the location of the outlet valves and/or catheter would have only involved routine skill.
Further, regarding claim 1 JP teaches that outlet valves can be designed so that they open by moving towards the wall of the lumen in which they are positioned (Figure 6b, with reference to Figure 4a-b shows leaflets 6.5a-b (4.5a-b) which are positioned adjacent one another when closed, and which move towards the wall of frame 6.4 (4.2) when opened). Pfeifer and JP are involved in the same field of endeavor, namely circulatory support devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Pfeifer by having the outlet valve have a leaflet which opens toward the wall of the lumen as is taught by JP since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the choice of using any known valve construction would have been considered obvious to try.
Further, regarding claim 1 Pfeifer discloses the IABP allows adjustment of frequency of the inflations/deflations ([0033]), and Frazier teaches that the use of a blood pump allows for increasing the flow rate of blood (Column 8 lines 19-20). Pfeifer and Frazier are involved in the same field of endeavor, namely balloon pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Pfeifer Ferrari JP Combination so that the rate of blood flow is increased with the IBAP as is taught by Frazier since the adjustment of blood flow rate either up or down with a blood pump is considered to be necessary within a blood pump, which must mimic the natural heart to approximate its normal actions in order to maintain health of the patient using the pump. Since the heart must increase/decrease its flow rate in order to keep up with demands of respiration, exertion, pregnancy, altitude, etc., the pump should also allow these normal physiological adjustments.
Regarding claim 3 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
wherein Pfeifer further discloses supplying and removing a fluid to and from the balloon with the catheter ([0033]).
Regarding claim 4 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
wherein Pfeifer further discloses inflating the balloon comprises filling a lumen of the stent body (Figure 6b).
Regarding claim 10 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
wherein Ferrari further teaches IABPs can be inserted within an aorta or vena cava (Figure 2; [0023] the aorta). Pfeifer and Ferrari are involved in the same field of endeavor, namely balloon pump catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Pfeifer Ferrari JP Frazier Combination so that the device is inserted into an aorta as is taught by Ferrari in order to allow the assistance in blood pumping to assist in the aorta.
Regarding claim 12 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
wherein Ferrari further teaches an IABP can be inserted into an aorta (Figure 2; [0023] the aorta) so that repeatedly inflating and deflating the balloon decreases afterload on a left ventricle ([0036], [0006]). Pfeifer and Ferrari are involved in the same field of endeavor, namely balloon pump catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Pfeifer Ferrari Frazier Combination so that the device is inserted into an aorta as is taught by Ferrari in order to allow the assistance in blood pumping to assist in the aorta.
Regarding claim 14 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
wherein Ferrari further teaches an IBAP can be inserted by with the aid of a guide wire ([0037]), and further teaches it is known to insert a device via the femoral artery ([0006]). Pfeifer and Ferrari are involved in the same field of endeavor, namely balloon pump catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Pfeifer Ferrari JP Frazier Combination so that the device is placed via the femoral artery as is taught by Ferrari since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). Any known, successful location for inserting a balloon pump device would have been obvious to try.
Further, it would have also been obvious to modify the Combination to place the device over a guide wire as is taught by Ferrari since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any successful and known insertion method would have been obvious to try.
Regarding claim 22 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 12 substantially as is claimed,
wherein Ferrari further teaches an IBAP can be inserted in the aorta ([0023]), which decreases the afterload on the left ventricle by decreasing a pressure in the aorta between the first end of the stent body and the left ventricle (this is considered inherent by the function of the device. See also [0006] which describes the basic mechanism). Pfeifer and Ferrari are involved in the same field of endeavor, namely balloon pump catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Pfeifer Ferrari JP Frazier Combination so that the device is inserted into an aorta as is taught by Ferrari in order to allow the assistance in blood pumping to assist in the aorta.
Claim 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pfeifer, Ferrari, JP and Frazier as is applied above, further in view of Tansley et al. (WO 2011117566 A1) hereinafter known as Tansley.
Regarding claim 2 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to the balloon being an integral part of a liner along the inner circumference of the stent body so inflating the balloon places inflation fluid between the liner and inner circumference of the stent body.
However, regarding claim 2 Tansley teaches a balloon pump wherein an inflation balloon (Figure 2 item 14) is an integral part of a liner (Page 14, lines 8-10) positioned along an inner circumference of a stent body (Figure 2), and wherein inflating the balloon comprises providing inflation fluid between the liner and the inner circumference of the stent body (Figure 2). Pfeifer and Tansley are involved in the same field of endeavor, namely balloon pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Combination so that the balloon is an integral part of a liner as is taught by Tansley since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, any structural configuration of the balloon/stent which allows the pump to function as is disclosed within Pfeifer is considered obvious to one of ordinary skill to try.
Claims 5-6, 16-17, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pfeifer, Ferrari, JP and Frazier as is applied above, further in view of Azzolina (US 20070004960 A1).
Regarding claim 5 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to the balloon’s inflation/deflation frequency.
However, regarding claim 5 Azzolina teaches that an blood pump can be run at a frequency of at least 0.5-3x a normal heart rate ([0065] 90-180 pulses/min (The specification [0044] defines a “normal heart rate” as about “about 60-180 oscillations per minute”. The specification indicates “[t]he phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc.”. The Examiner notes that while Azzolina does not rely on balloon inflations/deflations per minute, the Combination which is based on the balloon inflation/deflation per minute of Pfeifer would have the balloon inflating/deflating at this frequency.). Pfeifer and Azzolina are involved in the same field of endeavor, namely balloon pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the frequency of the inflation/deflation of the balloon so it falls within the claimed range in order to ensure the pump is working around a normal heart beat frequency, thus mimicking the natural heart rate.
Regarding claim 6 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to the balloon’s inflation/deflation frequency.
However, regarding claim 6 Azzolina teaches that a blood pump can be inflated/deflated at a frequency of about 30-180 inflations and deflations per minute ([0065] 90-180 pulses/min. The Examiner notes that while Azzolina does not rely on balloon inflations/deflations per minute, the Combination which is based on the balloon inflation/deflation per minute of Pfeifer would have the balloon inflating/deflating at this frequency.). Pfeifer and Azzolina are involved in the same field of endeavor, namely balloon pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the frequency of the inflation/deflation of the balloon so it falls within the claimed range in order to ensure the pump is working around a normal heart beat frequency, thus mimicking the natural heart rate.
Regarding claim 16 Pfeifer discloses a method comprising:
inserting a device (Figure 6a-b item 1) within a blood vessel ([0045]), the device comprising:
a hollow covered stent body (Figures 6a-b item 3) having a first end (Figure 6a-b near item 18), a second end (Figure 6a-b near item 7), and a lumen extending between the first and second ends (Figure 6a-b), the lumen being defined at least in part by a wall of the stent body (Figure 6a-b, [0061] sleeve 3 includes, outside of the frame 2, a tube depicted as line 6)),
one or more one-way valves (Figures 6a-b items 18, 10), wherein one or more of the one-way valves comprise an outlet valve arranged in the lumen (Figure 6b item 10), and comprising one or more leaflets ([0076] a foil valve 10 is understood to inherently include a leaflet (e.g. foil),
and a balloon within the stent body (Figures 6a-b item 14) between the first and second ends thereof (Figure 6a-b), and
increasing antegrade flow through the blood vessel by repeatedly deflating the balloon to pull the blood through the first end of the stent body and inflating the balloon to push the blood from the stent body through the one-way valve ([0033], Figures 6a-b, and [0076]),
but is silent with regards to the method being for increasing a flow rate of the blood,
one of the one-way valves being located at the second end of the stent body, and having a central axis aligned with the longitudinal axis of the stent body,
the balloon’s inflation/deflation frequency.
However, regarding claim 16 Ferrari teaches that blood pumps can have their outlet at the second end of a stent body (Figure 2 shows the outlet valve 12 at the end of the stent body). Pfeifer and Ferrari are involved in the same field of endeavor, namely balloon pump catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Pfeifer by having the outlet valve at any location along the stent body, including at the second end as is taught by Ferrari since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C). In this situation, adjusting or switching the location of the outlet valves and/or catheter would have only involved routine skill.
Further, regarding claim 16 JP teaches that a circulatory assist device can have a distal outflow valve that is aligned with a longitudinal axis of the assist device itself (Figure 6b shows how the bulk of the device including 6.9, 6.7, 6.2, 6.1, 6.4 has a longitudinal axis which aligns with the central axis of the outflow valve (Figure 6b item 6.5a-b). Pfeifer and JP are involved in the same field of endeavor, namely circulatory support devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Pfeifer by having the outlet valve have a central axis which aligns with the circulatory assist device as a whole, as is taught by JP, since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C).
Further, regarding claim 16 Frazier teaches that the use of a blood pump allows for increasing the flow rate of blood (Column 8 lines 19-20). Pfeifer and Frazier are involved in the same field of endeavor, namely balloon pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Pfeifer Ferrari Combination so that the rate of blood flow is increased with the IBAP as is taught by Frazier since the adjustment of blood flow rate either up or down with a blood pump is considered to be necessary within a blood pump, which must mimic the natural heart to approximate its normal actions in order to maintain health of the patient using the pump. Since the heart must increase/decrease its flow rate in order to keep up with demands of respiration, exertion, pregnancy, altitude, etc., the pump should also allow these normal physiological adjustments.
Further, regarding claim 16 Azzolina teaches that a blood pump can be inflated/deflated at a frequency of about 30-180 inflations and deflations per minute ([0065] 90-180 pulses/min. The Examiner notes that while Azzolina does not rely on balloon inflations/deflations per minute, the Combination which is based on the balloon inflation/deflation per minute of Pfeifer would have the balloon inflating/deflating at this frequency.). Pfeifer and Azzolina are involved in the same field of endeavor, namely balloon pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the frequency of the inflation/deflation of the balloon so it falls within the claimed range in order to ensure the pump is working around a normal heart beat frequency, thus mimicking the natural heart rate.
Regarding claim 17 the Pfeifer Ferrari JP Frazier Azzolina Combination teaches the method of claim 16 substantially as is claimed,
wherein Ferrari further teaches IABPs can be inserted within an aorta or vena cava (Figure 2; [0023] the aorta). Pfeifer and Ferrari are involved in the same field of endeavor, namely balloon pump catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Pfeifer Ferrari JP Frazier Azzolina Combination so that the device is inserted into an aorta as is taught by Ferrari in order to allow the assistance in blood pumping to assist in the aorta.
Regarding claim 23 the Pfeifer Ferrari JP Frazier Azzolina Combination teaches the method of claim 16 substantially as is claimed,
wherein Pfeifer further discloses the one or more one-way valves comprises a one-way valve at the first end of the stent body (Figures 6a-b item 18),
wherein the valve at the first end of the stent body closes when the balloon is inflating (Figure 6b, [0076]) and opens when the balloon is deflating (Figure 6a; [0076]).
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pfeifer, Ferrari, JP and Frazier, as is applied above, further in view of Maguire et al. (US 7063679 B2) hereinafter known as Maguire.
Regarding claim 15 the Pfeifer Ferrari JP Frazier Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to removing the device from the blood vessel after increasing antegrade flow.
However, regarding claim 15 Maguire teaches that a balloon pump device can be removed after increasing antegrade flow (Column 30 line 1-2; after the interventional procedure is completed the device can be removed. In the case of the Combination, the interventional procedure includes increasing antegrade flow). Pfeifer and Maguire are involved in the same field of endeavor, namely blood pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Combination so that the device is removed after the increase in blood flow is achieved, in order to ensure the device is not removed before the goal of the device is actually met.
Conclusion
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 06/02/26
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