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
Regarding the previous 112, 2nd indefiniteness rejections. Applicant’s amendments have overcome these rejections and they are hereby withdrawn.
Regarding the 102 rejection to Muller, applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Muller fails to teach the newly claimed magnetic members with alternating polarity. However, the examiner has found a new reference (LaRose) to teach these limitations, which has been combined in a new 103; see details below.
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.
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, 3-5, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0028115 to Muller in view of US 2009/0234447 to LaRose et al.
[Claim 1] Muller discloses a catheter blood pump (500, Figs 15-17; para [0089]; note also see Figs 4 and 8 which have similar components as the catheter blood pump 500 in Fig 15), comprising:
a motor (532, Fig 16; para [0090] coupled to and in rotational communication with a mechanical driving member (548, Fig 16; para [0090]- see drive component 548 coupled to motor via output shaft 540), the mechanical driving member rotatable about a first axis (552, Fig 16; para [0090]-[0091] - see drive component 548 which is rotatable around axis 552), the mechanical driving member mechanically coupled to a mechanical driven member (572, Fig 16; para [0091],[0093],[0095]-[0096] - see driven member 572 coupled to drive member 548 through tension member 604) rotatable about a second axis that is spaced from the first axis (576, Fig 16; para [0091] - see driven member 572 rotatable about the second axis 576), wherein rotation of the mechanical driving member by the motor causes rotation of the mechanical driven member about the second axis (see Fig 16; para [0095] - see motor 532 which rotates driving member 548 which in turn rotates the driven member 572), the mechanical driven member coupled to a rotatable outer magnetic assembly (see Fig 16; para [0094]; see 221, Fig 8; para [0064] - see drive component 596 can have a rotatable magnet 221 as illustrated in Fig 8) that is rotatable about the second axis such that rotation of the mechanical driven member causes rotation of the outer magnetic assembly (see Fig 16; para [0094]; see 221, Fig 8; para [0064] - see drive component 596 can have a rotatable magnet 221 wherein the magnet 221 is rotatable around second axis 576);
a rotatable inner magnetic assembly magnetically coupled with the outer magnetic assembly (see Figs 8, 16; para [0064],[0094] - see inner rotatable magnet 204 which is magnetically coupled to outer magnet 221) such that rotation of the outer magnetic assembly causes rotation of the inner magnetic assembly about the second axis (see Figs 16, 8; para [0064],[0094] - see magnet 204 which rotates when outer magnet 221 rotates around the second axis 576);
a stationary return fluid member disposed around the rotatable inner magnetic assembly (205, Fig 5, 15; para [0057] - see non rotating flow diverter 205 within which magnet 204 is disposed) and forming a return fluid pathway between the rotatable inner magnetic assembly and the stationary return fluid member (see Fig 5, 15-16; para [0014],[0057],[0092] - see conduit 584 in communication with a second lumen within catheter 100A which carries the operating fluid, flow diverter 205), the inner magnetic assembly coupled with a proximal end of a drive shaft (see para [0095]; note also see Fig 15-17, 5 - see inner magnet 204 coupled to shaft 208 illustrated in Fig 5 which is present in embodiment of Fig 15-17) such that rotation of the inner magnetic assembly causes rotation of the drive shaft about the second axis (see para [0095]; note also see Fig 15-17, 5 - see inner magnet 204 coupled to shaft 208 which rotates around second axis 576), the drive shaft in rotational communication with an impeller of the catheter blood pump (see Fig 15; 92, Fig 2; para [0040],[0095] - shaft 208 is connected to impeller 92 as illustrated in Fig 2 wherein rotation of shaft 208 by motor 532 would rotate shaft 208 to rotate the impeller 92);
a purge fluid inlet distal to the mechanical driven member (195, Fig 15; para [0051] - see infusate device 195 which has an inlet port to introduce infusing fluid in the catheter), the purge inlet in communication with a clean purge pathway of the catheter blood pump (see, Fig 15; para [0014],[0051] - see infusate device communicating with a first lumen in catheter assembly 100A); and
a return fluid outlet that is proximal to the mechanical driven member (584, Fig 16; para [0092] - see conduit 584 to a waste vessel which is proximal to member 572), the return fluid outlet in communication with a return fluid pathway (see Figs 5, 15-16; para [0014],[0057],[0092] - see conduit 584).
Muller is discussed above, including specifically teaching the rotatable inner and outer magnetic assemblies, but fails to explicitly teaching that these rotatable magnetic assemblies include a plurality of magnetic members having alternating polarity around the assemblies. However, in the same field of endeavor, specifically blood pumps, LaRose discloses similar inner and outer rotatable magnetic assemblies for driving/rotating an impeller that include a plurality of magnetic members having alternating polarity around the assemblies (Figs. 9-10; at least Pars 0067-68). Therefore, it would have been obvious to one of ordinary skill in the art to substitute the inner and outer rotatable magnetic assemblies taught by Muller for the inner and outer rotatable magnetic assemblies having a plurality of magnetic members with alternating polarity, as taught by LaRose, as this is a simple substitution of one type of rotatable magnetic assembly, i.e. one without a plurality of magnetic members having alternating polarity, for another, i.e. one with a plurality of magnetic members having alternating polarity, to obtain predictable results, i.e. driving an impeller of a blood pump.
[Claim 3] Muller discloses the catheter blood pump of Claim 1, wherein the rotatable outer magnetic assembly is coupled to an outer surface of the mechanical driven member (see Fig 16-17; para [0094]; see 221, Fig 8; para [0061],[0064] - see drive component 596 having a rotatable magnet 221 as which is coupled to outer surface of shaft 222).
[Claim 4] Muller discloses the catheter blood pump of Claim 1, wherein the mechanical coupling between the mechanical driving member and the mechanical driven member comprises a geared mechanical coupling (see Fig 16; para [0093] - see driving member 548 and driven member 572 which can be coupled by gears).
[Claim 5] Muller discloses the catheter blood pump of Claim 4, wherein the geared mechanical coupling comprises a plurality of teeth on the mechanical driving member (see Fig 16; para [0093] - see driving member 548 and driven member 572 which can be coupled by gears wherein the driving member 548 would have gears with a plurality of teeth thereby) and a plurality of teeth on the mechanical driven member (see Fig 16; para [0093] - see driving member 548 and driven member 572 which can be coupled by gears wherein the driven member 572 would have gears with a plurality of teeth thereby).
[Claim 8] Muller discloses the catheter blood pump of claim 1, further comprising a housing in which at least a portion of the motor is disposed (524, Fig 16; para [0090]-[0091] - see motor in housing 524), the housing sized and configured to maintain a force on the driven member by the driving member in the event of wear from at least one of the driving member or the driven member (524, Fig 16; para [0090)-[0091] - see housing 524 along with second housing 564 along with tension member 604 is capable of maintaining sufficient force on the driven member 572 via driving member 548 in any event of wear by keeping a stable structure).
[Claim 11] Muller discloses the driving member and driven member as gears of a power train (Par 0093). Implicitly/inherently the outer surface of gears interface with each other. As seen in Fig. 17, the driven member (572) has a smaller outer diameter than the outer magnetic assembly (596 in Fig. 17, equivalent to 221 in Fig. 8). Since these drawings are not necessarily drawn to scale, if applicant disagrees with the examiner’s position on relative size between the driven member and the outer magnetic assembly, as shown explicitly in the drawings, then an additional or alternative 103 rejection is presented below.
Muller is discussed above, but fails to explicitly teach the outer surface of the driven member has a smaller diameter than at least a portion of the outer magnetic assembly (as the drawings are not necessarily to scale). However, the Federal Circuit 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; MPEP 2144.04. Therefore, it would have been obvious to one of ordinary skill in the art to modify the size of either the driven member or outer magnetic housing assembly so that the driven member is smaller than the outer magnetic housing, as a matter of routine engineering/design considerations. Furthermore, while the drawings are not necessarily to scale, the examiner contends that it is logical/reasonable to assume that at the very least, it would be obvious to size these two elements in the way they are currently shown in the drawings, i.e. with the outer diameter of the driven member smaller than the outer magnetic assembly.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Muller and LaRose as applied to claim 1 above, and further in view of US 5,147,186 to Buckholtz, as evidence by “How Gear Ratios Work”.
Muller and LaRose are discussed above, with Muller specifically teaching a driving and driven members as a gear train (Par 0093), but is silent as to the relative diameters between these members or any gear ratios for speed multiplication. However, in the same field of endeavor, Buckholtz discloses that gear trains are used to either increase or decrease the speed of rotation based on their gear ratios and the specific gear ratios are selected based on the requirements of the pump being driven (Col 5, line 40 to Col 6, line 22). Furthermore, it is well understood that the diameter of the gears define the gear ratios; See NPL “How Gear Ratios Work”. Therefore, it would be obvious to one of ordinary skill in the art to choose the diameter of the gears to increase speed, as taught by Buckholtz, as this merely choosing from a finite number of identified, predictable solutions (either increasing or decreasing the speed of rotation), with a reasonable expectation of success, in order to effectively drive the pump. Furthermore, the examiner takes the position that this is merely optimizing a result effective variable (MPEP 2144.05) and/or an obvious change in size (Gardner v. TEC Syst., Inc; MPEP 2144.04).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/ Primary Examiner, Art Unit 3796