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 without traverse of invention I (claims 1-18), species 1a (the device is for placement within the aorta – figures 1, 14a), 2c (the device of figures 5a-c, 10a, 10b, and 13a-c – a single balloon that inflates/deflates which is positioned inside a method, with the addition of inlet and outlet valves), subspecies 2cii (the catheter attaches to the method as is seen in figures 10a-b), subspecies 2iii (the balloon is shaped as is shown in figure 6), 3b (the device does not include a liner with faps), 4b (the device does not include a sealing sleeve), 5b (the device does not include an occlusive balloon), 6b (the balloon is separate from the liner), 7a (there is one balloon around the circumference of the device), and 8b (the liner does not have ridges and valleys) in the reply filed on 12/16/25 is acknowledged.
Claims 7-9, 11, 13, 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/25.
Claim Objections
Claims 1, 3, 5-6, 10, 12, 14, 16-17 are objected to because of the following informalities:
Claims 1 and 16 are objected to for referring to “blood” when it is unclear if it is the same blood referred to earlier in the claim, or whether this is distinct from the previously claimed “blood”.
Claim 3 is objected to for referring to “flow” when it is unclear if this is the same “flow” referred to in claim 1, or whether this is a distinct “flow”.
Claims 5-6, 12, and 16 are objected to for referring to “repeatedly inflating” 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 10, 14, and 17 are objected to for referring to inserting “a device” but it is unclear if this is the same device claimed in claim 1 or not.
Appropriate correction is required.
Drawings
The drawings are objected to because:
-item 557 in figure 5a points to the same structure as item 551 in figures 5b-c
-item 551 in figures 5b-c are used to point to two different structures
-items 657, 658, 607, 604, 1400, 1615 are in the drawings but not the specification
-item 1517 is supposed to be pointing to “lobes” but is instead pointing into space in figures 15b-c
-item 1669 and item 1668 are both used to represent “proximal portion”
- item 1668 is described in the specification as both “jog portion” and “proximal portion”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 4 is indefinite for claiming the balloon “substantially” fills a lumen of the hollow covered stent body, but it is unclear how full the balloon has to fill the lumen for it to be considered “substantially filling”. The specification does not give any upper or lower limits on what would constitute “substantially filling”, making the Examiner unclear on where the boundaries of the claim lie.
Remaining claims are rejected for depending on a rejected claim.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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 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) and a second end (Figure 6a-b near item 7),
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 (Figure 6b item 10),
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 blood through the first end of the stent body and inflating the balloon to push 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,
However, regarding claim 1 Ferrari teaches that blood pumps can have their outlet at the second end of a stent body (Figure 2 shows valve 12 at a stent body end). 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 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 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 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 Frazier Combination teaches the method of claim 1 substantially as is claimed,
wherein Pfeifer further discloses inflating the balloon comprises substantially filling a lumen of the stent body (Figure 6b).
Regarding claim 10 the Pfeifer Ferrari 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 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 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 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 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 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 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, 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 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, and Frazier as is applied above, further in view of Azzolina (US 20070004960 A1).
Regarding claim 5 the Pfeifer Ferrari 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 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) and a second end (Figure 6a-b near item 7),
a catheter connected to the stent body (Figures 6a-b item 4 (8)),
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 (Figure 6b item 10),
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 blood through the first end of the stent body and inflating the balloon to push 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
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 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 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 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 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, 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 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
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 01/09/26