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 04/06/26 have been fully considered but they are not persuasive.
On pages 7-10 Applicant argues Masuzawa’s mechanism to control the axial position of the impeller comprises permanent magnets (within 7b), as well as electromagnetic means (8a, 8b), and Yaegashi teaches hydrodynamic bearings can be utilized when the magnetic bearing stops. Applicant argues that the combination of these two would create a groove present between the rotor 7a and electromagnetic means 8a of Masuzawa. Applicant argues further that Finocchiaro teaches a hydrodynamic bearing would act on the axial part 3a to maintain the distance between axial part 3a and the structure with magnets. Applicant concludes the axial positioning of the impeller in Finocchiaro can’t be easily adapted to Masuzawa, since the electromagnetic means 8b of Masuzawa would have to also control axial movement – but they only teach that 8a controls the axial position. Applicant argues Finocchiaro does not teach how to exert an attractive force using circumferentially spaced drive coils, and Masuzawa fails to teach the drive coil not being used to control axial position of the impeller. Accordingly, Applicant concludes one of ordinary skill could not combine the prior art references to control the drive current as is claimed.
The Examiner respectfully disagrees, maintaining that the person of ordinary skill within the art of pumps would fully understand how to combine the references as is required for the combination to function as is claimed. The Examiner also notes no proof in the record for Applicant’s statement that the references couldn’t be combined as the Examiner suggests. The arguments of counsel cannot take the place of evidence in the record. See MPEP 716.01(c).
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.
Claim(s) 59-60, 62-63, 70-73, 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuzawa et al. (US 20120245680 A1) hereinafter known as Masuzawa in view of Yaegashi et al. (US 20030152462 A1 ) hereinafter known as Yaegashi, further in view of Finocchiaro et al. (US 20100234941 A1) hereinafter known as Finocchiaro,
Regarding claim 59 Masuzawa discloses a heart pump including:
a housing (110) defining a cavity (120) which includes an inlet aligned with an axis of the cavity (141 (at least part of the inlet is aligned with an axis of the cavity)), and an outlet provided in a circumferential outer wall of the cavity (151);
an impeller within the cavity (130a), which includes a rotor and vanes mounted on the rotor ([0223], Figure 16a the impeller/rotor/vanes are integral), wherein the impeller is configured to rotate about a rotational axis urge fluid from the inlet radially outwardly to the inlet (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Masuzawa discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0223]); and
a drive (170) configured to rotate the impeller in the cavity (This is stated as a functional limitation (see explanation above). See also [0261]), the drive including a plurality of circumferentially spaced permanent drive magnets (174; [0280]) mounted within and proximate a first face of the rotor (Figure 10b shows magnets 174 within the impeller 130 of rotor; [0280]), and a plurality of circumferentially spaced drive coils (172) mounted within the housing proximate a first end of the cavity (Figure 6a; [0223] the drive 170 includes at least one coil positioned at a first end of the housing 110),
but is silent with regards to the vanes of the impeller and the first end of the housing cooperate to define a hydrodynamic bearing, so that a controller detects failure of the magnetic bearing and controls a drive current to the drive coils to increase an axial attractive force between the coils and permanent magnets in response to detecting the failure in order to urge the impeller towards the first end of the cavity so the hydrodynamic bearing operates in response to failure of the magnetic bearing.
However, regarding claim 59 Yaegashi teaches a pump which includes an impeller (21) within a housing (20) cavity so the surface of the impeller and a first end of the housing cooperate to define a hydrodynamic bearing (Figures 4, 6, item 38; [0042], [0056]),
a controller including at least one hardware processor and a memory which stores instructions (this is considered inherent with the control system 6 (see at least [0060] which indicates the control system can store values and determine current at speed) configured to cause the controller to detect failure of the magnetic bearing ([0023]), and control the drive to generate an axial attractive force in response to the detection, to thereby urge the impeller toward the first end of the cavity so the hydrodynamic bearing operates in response to the failure of the magnetic bearing ([0027]-[0028], [0056]). Masuzawa and Yaegashi are involved in the same field of endeavor, namely pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of Masuzawa to include the hydrodynamic bearing on the surfaces of the impeller (e.g. the vanes of the impeller of Masuzawa) in order to allow the bearing to aid in axial and radial positioning within the housing in case of magnetic bearing failure.
Further, regarding claim 59 Finocchiaro teaches a pump which includes a moveable part (rotor equivalent) and a stationary part (housing equivalent) ([0001]), which cooperate to define a hydrodynamic bearing ([0089]), wherein the controller controls a drive current to drive coils to adjust an axial attractive force between the coils and permanent magnets on the stationary part ([0046]) in order to urge the moveable part axially so the hydrodynamic bearing operates ([0090], [0064]). Masuzawa and Finocchiaro are involved in the same field of endeavor, namely heart pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of the Masuzawa Yaegashi Combination by ensuring the controller can control the amount of current extending to the drive coils as is taught by Finocchiaro in order to ensure the controller has the best amount of control possible over the various parts of the pump, allowing a specific amount of current (and therefore pump output) whenever needed. As regards whether the controller increases the axial force, the person of ordinary skill understands that in order for the controller to function as is described by Finocchiaro, the controller would necessarily be able to both increase the axial force, as well as decrease it, based on the current, depending on the detected need.
Regarding claim 60 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 59 substantially as is claimed,
wherein the Combination further teaches the hydrodynamic bearing is defined by an upper surface of the vanes facing the first end of the cavity (Yaegashi teaches the hydrodynamic bearing is formed via the groove 38 in the housing 20a and impeller 21. When incorporated into Masuzawa, this bearing would obviously be incorporated onto the outermost surfaces of the impeller of Masuzawa in order to provide this axial assistance, which means their location on the vanes would have likewise been obvious to one of ordinary skill, since they are the outermost part of the impeller).
Regarding claim 62 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 61 substantially as is claimed,
wherein Masuzawa further teaches the flat pad has an inner radius between 16-22 mm OR the flat pad has a length between 1-5 mm OR the ramp has a length between 5-15 mm OR the ramp has a height between 0.02-0.1 mm (For the purposes of this claim, the Examiner understands the “vanes” from claim 59 to be vanes 132, the “cavity” to be the second cavity portion 122a, the inlet referring to inlet 142, the outlet referring to outlet 152. The Examiner further refers to [0225] which indicates the drive 170 and bearing 180 locations able to be reversed, indicating the vanes 132 and second cavity 122a provide the hydrodynamic bearing as claim 59 all requires. Also for the purposes of this claim, the “upper surface” of the vanes is understood to be relative, based on the orientation of the device as a whole, and the side of the vanes 132 which face towards the end of the cavity 122a are understood to be the upper side, which form the bearing according to the paragraphs referenced in the rejection to claim 59 above. Accordingly, since [0349] indicates the diameter of the vanes 132 of the second cavity 122a have a diameter of 25 mm, but [0241]-[0242] indicate the diameter of the smaller sided rotor can actually be 30-40 mm, the radius of the impeller would be 15-20mm. Similarly, since this refers to the space occupied by the vanes 132 and flat pads lying therebetween, both of these are understood to obviously have an “inner radius” of 15-20mm, which falls within Applicant’s claimed 16-22 mm range.).
Regarding claim 63 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 60 substantially as is claimed,
wherein Masuzawa further discloses the vanes have an inner radius between 10-20 mm OR an outer radius between 20-30 mm ([0349] impeller 130a shows the vanes of the top cavity 121 having a diameter of 50 mm, and thus a radius of 25 mm. Figure 16d-e shows the vanes extending throughout the entire diameter of the impeller 130a, making their radius also 25mm. This is considered to be an ‘outer’ radius).
Regarding claim 70 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 69 substantially as is claimed,
wherein Masuzawa further discloses the controller is configured to detect failure of the magnetic bearing based on a bearing indicator indicative of a current used by the magnetic bearing OR a drive indicator indicative of a current used by the drive OR sensor signals (this is stated as an “intended use” of the controller (see the explanation above) which the controller is capable of doing if programmed to do so. See also [0268]-[0269]).
Regarding claim 71 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 59 substantially as is claimed,
but is silent with regards to the drive and rotor are arranged so that the spacing between a first face of the rotor and first end of the cavity are between 2-5 mm in use.
However, regarding claim 71 Masuzawa teaches that the outflow flow from the pump, in order to meet physiological circulatory requirements at a set rotational speed, should have a specific impeller blade height to axial clearance between the rotor face and end of the cavity ([0300]). While Masuzawa teaches this to be 1.4mm:0.5mm(±0.3mm), or an approximate ratio of 3:1 at rest, the person of ordinary skill in the art would understand that the dimensions of the gap between the can be adjusted as desired as long as the height of the blade is adjusted. The person of ordinary skill in the art would accordingly find it obvious to adjust the spacing between a first face of the rotor and first end of the cavity so that it is 2 mm in use, by adjusting both the spacing and the blade height at the same time.
Alternatively, the Examiner notes that the distance between a “first face” of the rotor (e.g. the face with vanes 132 within cavity 122a) is positioned at a distance from a first end of the cavity (121), by at least 0.5mm ±0.3mm (or 0.2-0.8mm). Since the distance between the bottom face and the top cavity also must include the space occupied by the impeller 130a, it is understandable that the distance between the two elements would increase. While Masuzawa is silent with regards to the dimensions of the impeller 130a, and the Examiner does not understand the drawings to be drawn to-scale, the person of ordinary skill at the time the invention was filed would have found it obvious to view the figures and be able to estimate how thick the impeller could be. The Examiner annotated Figure 18a which shows, at rest, the distance between the top of the cavity 121 and the vanes 123 being about 4 times the distance between the top of cavity 121 and the face of vanes 122. With [0300] indicating the distance between the top of cavity 121 and the face of the vanes 122 as being 0.5 mm in a neutral configuration (e.g. the configuration shown in Figure 18a), the bottom face with vanes 123 would be about 0.5mmx4=2mm. While not understood to be a perfect science, the Examiner notes the obviousness of understanding the bottom face being at least, around, or about 2 mm would have occurred to the person of ordinary skill.
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Regarding claim 72 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 59 substantially as is claimed,
wherein Masuzawa further discloses the vanes each have a height of 1.4 mm ([0349] the vanes have a height of 1.4 mm),
but is silent with regards to the vanes each having a height between 1.5-5 mm.
However, regarding claim 72 the courts have held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 (I).). Accordingly, it is considered obvious for the vanes to have a height of 1.5 mm instead of 1.4 mm.
Regarding claim 73 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 59 substantially as is claimed,
wherein Masuzawa further discloses the inlet is included in a plurality of inlets, and the outlet is included in a plurality of outlets, and
the impeller includes a first set of the vanes (131) and a second set of the vanes (132) provided on a rotor body (Figure 6a, the rotor, vanes, and impeller are integral), and
wherein the rotor is positioned within the cavity to define a first cavity portion (121) having a first inlet of the inlets (141) and a first outlet of the outlets (151), the first set of vanes within the first cavity portion to define a first pump that is capable of providing at least partial left ventricular function (this is stated as an “intended use” of the first pump (see explanation above). Further, the entire disclosure of Masuzawa describes the purpose of their invention as being a two-cavity pump for biVAD pumping ([0021]). See also [0185] which, while referencing another embodiment, is analogous to the two chamber, dual-pump embodiment used throughout), and to define a second cavity portion (122a) having a second inlet of the inlets (142) and a second outlet of the outlets (152), the second set of vanes being provided within the second cavity portion to define a second pump that is capable of providing at least partial right ventricular function (this is stated as an “intended use” of the first pump (see explanation above). Further, the entire disclosure of Masuzawa describes the purpose of their invention as being a two-cavity pump for biVAD pumping ([0021]). See also [0185] which, while referencing another embodiment, is analogous to the two chamber, dual-pump embodiment used throughout).
Regarding claim 75 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 73 substantially as is claimed,
wherein Masuzawa further discloses an axial position of the impeller determines a separation between the first set of the vanes and a respective cavity surface ([0223]), the separation being used to control fluid flows from one of the inlets to one of the outlets ([0223]-[0224]).
Claims 61, 74, and 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuzawa, Yaegashi, and Finocchiaro as is applied above, further in view of Hvorath et al. (US 20120328460 A1) hereinafter known as Hvorath.
Regarding claims 61 and 78 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 60 substantially as is claimed,
but is silent with regards to the upper surface of the vanes including a leading ramp and a trailing flat pad, and the leading ramp length and height.
However, regarding claims 61 and 78 Hvorath teaches a heart pump with vanes with a leading ramp and flat pads (See Annotated Figure 2, below). Masuzawa and Hvorath are involved in the same field of endeavor, namely heart pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of the Masuzawa Yaegashi Finocchiaro Combination so that the vanes include a leading ramp and flat pad as is taught by Hvorath 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). The use of any known shape of vane would have been obvious to try. Further, it would have been obvious to modify the length of the leading ramp on the upper surface of each of the vanes to be between 5-15 mm and the height of the leading ramp to be between 0.02-0.1 mm in order to optimize the characteristics of the vanes. The person of ordinary skill in the art understands how vane dimensions can be adjusted in order to adjust the desired direction, speed, smoothness, and other characteristics of flow.
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Regarding claim 74 the Masuzawa Yaegashi Finocchiaro Combination teaches the pump of claim 73 substantially as is claimed,
but is silent with regards to the pump being a total artificial heart.
However, regarding claim 74 Hvorath teaches pumps can be useful in both ventricular assist devices, as well as a total artificial heart ([0004]-[0005], [0084]). Masuzawa and Hvorath are involved in the same field of endeavor, namely heart pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of the Masuzawa Yaegashi Finocchiaro Combination so that it was used in a total artificial heart as is taught by Hvorath in order to allow the technologies of Masuzawa to be applied to a wider range of patients, for example those that need total heart replacement, thus ensuring more people can benefit therefrom.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/17/26
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