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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,290,676 (‘676). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application recite common subject matter.
As to claim 1 of the instant application, this claim recites common subject matter recited in claim 1 of the ‘676 patent. Additionally, the claim includes features recited using different but commensurate terminology. For example, claim 1 of the instant application recites: “at least one channel formed in the concave depression and extending proximally from the concave surface, the at least one channel opening out to the concave surface; and wherein the convex surface of the proximal end of the drive shaft extends across the at least one channel” whereas claim 1 of ‘the 676 patent recites “wherein the lubricant chamber comprises at least one channel defined in a second side of the bearing, the at least one channel passing through the depression, wherein the at least one channel is configured to retain the lubricant.” However, these limitations equivalently define the configuration of the channel such that, if issued, the instant claims would be anticipated by the ‘676 patented.
As to claim 2, the ‘676 patent is discussed above but is silent as to at least one channel includes a plurality of channels. However, this is simply duplicating the known working elements or channels of the ‘676 patent. To this point, it has been held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Since the channels are used to provide lubricant flow from a supply, having duplicate channels would only produce an expected redundancy. Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to duplicate the channels in order to provide redundancy additional lubricant flow for the bearing surfaces. See MPEP § 2144.04 (VI)(B).
Claims 3-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,290,676 (‘676) in view of Maher (U. S. Patent No. 6,186,665).
As to claim 3, the ‘676 patent is discussed above but is silent as to a driven magnet surrounding the proximal end region of the drive shaft. In this regard, Maher teaches a blood pump (FIG.’s 1-3, Abstract) configured in the manner claimed further including a driven magnet 175 (FIG. 1, col. 4, ll. 40-45) surrounding the proximal end region of the drive shaft 170, 174, 177. With this in mind, it would have been obvious to one having ordinary skill in the art before the effective filing date of the instant application to modify the ‘676 patent with the recited features in order to effectively configure and drive the impeller in rotation for pumping blood as demonstrated by Maher.
As to claim 4, the ‘676 patent is silent as to the recited subject matter.1 In this regard, once modified, Maher the driven magnet 175 [being] positioned between a proximal end of the impeller 171, 172 and the proximal end of the drive shaft 170, 174, 177 (under broadest reasonable interpretation since the end of the draft shaft can be interpreted relatively depending on point of view and definition of the term proximal).
As to claim 5, the ‘676 patent is silent as to the recited subject matter. In this regard, Maher teaches a blood pump (FIG.’s 1-3, Abstract) configured in the manner claimed further including a distal end of the drive shaft 170, 174, 177 (left side of FIG. 1) is positioned proximal of a distal end of the impeller 171, 172 (under broadest reasonable interpretation of terms). With this in mind, it would have been obvious to one having ordinary skill in the art before the effective filing date of the instant application to modify the ‘676 patent with the recited claim features in order to support and drive the impeller in rotation to pump blood as demonstrated by Maher (Abstract).
As to claim 6, the ‘676 patent is silent as to the recited subject matter. In this regard, once modified, Maher further a distal bearing assembly 189 (col. 4 ln. 45) disposed distal of the impeller 171, 172 (FIG. 1, as shown).
As to claim 7, the ‘676 patent is silent as to the recited subject matter. In this regard, once modified, Maher further teaches the distal bearing assembly 189 includes a distal bearing 187 (col. 5, ln. 24) disposed within a lumen 178 (broadly, bearing portion 178 can be considered a lumen of the impeller) of the impeller 171, 172.
As to claim 8, the ‘676 patent is silent as to the recited subject matter. In this regard, once modified, Maher further teaches the distal end of the drive shaft 170, 174, 177 is located proximal of the distal bearing 187 (as shown).
As to claim 9, the ‘676 patent is silent as to the recited subject matter. In this regard, once modified, Maher further teaches the distal bearing assembly 189 includes a stationary shaft mounting pin 186, 187 (col. 5, ln. 25, bearing seat 186 and portion 187 arranged and configured in a manner forming a stationary mounting pin) extending into the lumen 178 of the impeller (as shown).
As to claim 10, the ‘676 patent is silent as to the recited subject matter. In this regard, once modified, Maher further teaches the distal bearing 187 surrounds the stationary shaft mounting pin 186, 187 (as shown).
As to claim 11, the ‘676 patent is silent as to the recited subject matter. In this regard, once modified, Maher further teaches the impeller 171, 172 is configured to rotate relative to the stationary shaft mounting pin 186, 187 (containing bearing 189 which has a rotating part adjacent magnet cap 173 and stationary part 187).
As to claim 12 of the instant application, this claim recites common subject matter recited in the ‘676 patent. Additionally, the claim recites some features using different terminology. For example, claim 1 of the instant application recites: “at least one channel formed in the concave depression and extending proximally from the concave surface, the at least one channel opening out to the concave surface; and wherein the convex surface of the proximal end of the drive shaft extends across the at least one channel” whereas claim 1 of ‘the 676 patent recites “wherein the lubricant chamber comprises at least one channel defined in a second side of the bearing, the at least one channel passing through the depression, wherein the at least one channel is configured to retain the lubricant.” However, these limitations equivalently define the configuration of the channel.
The ‘676 patent is silent as to a distal bearing assembly disposed distal of the impeller, wherein the proximal bearing assembly and the distal bearing assembly support the impeller within the impeller housing. In this regard, Maher teaches a blood pump (FIG.’s 1-3, Abstract) configured in the manner claimed having a distal bearing assembly 189 disposed distal of the impeller 171, 172, wherein the proximal bearing assembly 169 and the distal bearing assembly 189 support the impeller 171, 172 within the impeller housing (as shown). With this in mind, it would have been obvious to one having ordinary skill in the art before the effective filing date of the instant application to modify the ‘676 patent with the distal and proximal bearing features configured as claimed in order to support and drive the impeller in rotation for pumping blood as demonstrated by Maher (Abstract).
As to claim 13, the ‘676 patent is silent as to the distal bearing assembly includes a distal bearing disposed within the lumen of the impeller. However, once modified, Maher further teaches the distal bearing assembly 189 includes a distal bearing 187 disposed within the lumen 178 178 (broadly, bearing portion 178 can be considered a lumen of the impeller) of the impeller 171, 172. It would therefore have been further obvious to modify the ‘676 patent with the claimed subject matter for the same rationale set forth above for claim 12.
As to claim 14, the ‘676 patent is silent as to the recited subject matter.2 Once modified, Maher further teaches a distal end of the drive shaft 170, 174, 177 is located proximal of the distal bearing 187 (as shown).
As to claim 15, the ‘676 patent is silent as to the recited subject matter. Once modified, Maher further teaches the distal bearing assembly 189 includes a stationary shaft mounting pin 186, 187 (col. 5, ln. 25, bearing seat 186 and portion 187 arranged and configured in a manner forming a stationary mounting pin) extending into the lumen 178 of the impeller (as shown).
As to claim 16, the ‘676 patent is silent as to the recited subject matter. Once modified, Maher further teaches the distal bearing 187 surrounds the stationary shaft mounting pin 186, 187 (as shown).
As to claim 17, the ‘676 patent is silent as to the recited subject matter. Once modified, Maher further teaches the impeller 171, 172 is configured to rotate relative to the stationary shaft mounting pin 186, 187 (containing bearing 189 which has a rotating part adjacent magnet cap 173 and stationary part 187).
As to claim 18, the ‘676 patent is silent as to the recited subject matter. Once modified, Maher further teaches a driven magnet 175 (FIG. 1, col. 4, ll. 40-45) surrounding the proximal end region of the drive shaft 170, 174, 177.
As to claim 19, the ‘676 patent is silent as to the recited subject matter. Once modified, Maher further teaches the driven magnet 175 is positioned between a proximal end of the impeller 171, 172 and the proximal end of the drive shaft 170, 174, 177 (under broadest reasonable interpretation since the end of the draft shaft can be interpreted relatively depending perspective with respect to the term proximal).
As to claim 20, the ‘676 patent is silent as to the recited subject matter. Once modified, Maher further teaches a distal end of the drive shaft 170, 174, 177 (left side of FIG. 1) is positioned proximal of a distal end of the impeller 171, 172 (under broadest reasonable interpretation of terms).
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maher et al. (U. S. Patent No. 6,186,665) in view of Middleton (U. S. Patent No. 4,427,310).
As to claim 1, Maher discloses a blood pump (FIG.’s 1-3, Abstract), comprising:
an impeller 171, 172 (FIG. 1, col. 4, ll. 43-60, formed by blades 171, 172 attached to rotor hub 174);
a drive shaft 170, 174, 177 (Id., motor rotor 170, hub 174 and bearing portion 177 form recited drive shaft) coupled to the impeller 171, 172 and configured to rotate with the impeller 171, 172 (under normal operation), a proximal end region of the drive shaft 170, 174, 177 extending proximal of the impeller 171, 172 (right end of rotor hub 174 shown in FIG. 1);
a motor 120, 150 (col. 3, ll. 45-60, motor stator 120 and rotor 150) configured to drive the impeller 171, 172; and
a proximal bearing assembly 169 (col. 4, ll. 60-65, formed by bearing assembly 169) disposed proximal of the impeller 171, 172 and configured to receive a proximal end of the drive shaft 170, 174, 177 (via bearing portion 177), the bearing assembly 169 comprising a proximal bearing 168 (col. 5, ll. 5-10), wherein the proximal end of the drive shaft 177 has a convex surface (shown adjacent 190), and wherein the proximal bearing includes a concave depression (shown opposite convex surface) having a concave surface (shown), wherein the concave depression is configured to receive the proximal end of the drive shaft (via portion 177) such that the concave surface contacts the convex surface (as shown).
Maher is silent as to the proximal bearing includes at least one channel formed in the concave depression and extending proximally from the concave surface, the at least one channel opening out to the concave surface, and wherein the convex surface of the proximal end of the drive shaft extends across the at least one channel. To this point, Middleton teaches a bearing assembly 1, 2 with a convex surface of shaft 11 received in a concave depression 7 of the bearing 1, 2 (FIG. 1, col. 3, ll.30-55, inner surface 7 of bearing cup 2). A channel 8 is formed in the concave depression 7 that extends proximally from the concave surface (as shown) such that the convex surface of the shaft extends across the channel 8 (col. 3, ll. 40-45). With this in mind, it would have been obvious to one having ordinary skill in the art before the effective filing date of the instant application to modify the bearing of Maher with a channel arranged in the manner shown by Middleton in order to lubricate the bearing surfaces from a lubricant supply chamber in communication with the channel as taught by Middleton (col. 4, ll. 5-10).
As to claim 2, the applied art is discussed above but is silent as to the at least one channel includes a plurality of channels. However, this is simply duplicating the known working elements, i. e., the channels of Middleton upon modification into Maher. To this point, it has been held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Since the channels are used to provide lubricant flow from a supply, having duplicate channels would only produce an expected redundancy. Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to duplicate the channels in order to provide redundancy additional lubricant flow for the bearing surfaces. See MPEP § 2144.04 (VI)(B).
As to claim 3, Maher further discloses a driven magnet 175 (FIG. 1, col. 4, ll. 40-45) surrounding the proximal end region of the drive shaft 170, 174, 177.
As to claim 4, Maher further discloses the driven magnet 175 is positioned between a proximal end of the impeller 171, 172 and the proximal end of the drive shaft 170, 174, 177 (under broadest reasonable interpretation since the end of the draft shaft can be interpreted relatively depending on point of view and definition of the term proximal).
As to claim 5, Maher further discloses a distal end of the drive shaft 170, 174, 177 (left side of FIG. 1) is positioned proximal of a distal end of the impeller 171, 172 (under broadest reasonable interpretation of terms).
As to claim 6, Maher further discloses a distal bearing assembly 189 (col. 4 ln. 45) disposed distal of the impeller 171, 172 (FIG. 1, as shown).
As to claim 7, Maher further discloses the distal bearing assembly 189 includes a distal bearing 187 (col. 5, ln. 24) disposed within a lumen 178 (broadly, bearing portion 178 can be considered a lumen of the impeller) of the impeller 171, 172.
As to claim 8, Maher further discloses the distal end of the drive shaft 170, 174, 177 is located proximal of the distal bearing 187 (as shown).
As to claim 9, Maher further discloses the distal bearing assembly 189 includes a stationary shaft mounting pin 186, 187 (col. 5, ln. 25, bearing seat 186 and portion 187 arranged and configured in a manner forming a stationary mounting pin) extending into the lumen 178 of the impeller (as shown).
As to claim 10, Maher further discloses the distal bearing 187 surrounds the stationary shaft mounting pin 186, 187 (as shown).
As to claim 11, Maher further discloses the impeller 171, 172 is configured to rotate relative to the stationary shaft mounting pin 186, 187 (containing bearing 189 which has a rotating part adjacent magnet cap 173 and stationary part 187).
As to claim 12, Maher discloses a blood pump (FIG.’s 1-3, Abstract), comprising:
an impeller housing (FIG. 1, surrounding conduit 112);
an impeller 171, 172 (FIG. 1, col. 4, ll. 43-60, formed by blades 171, 172 attached to rotor hub 174) disposed within the impeller housing (shown);
a drive shaft 170, 174, 177 (Id., motor rotor 170, hub 174 and bearing portion 177 form recited drive shaft) having a distal end region extending into a lumen 178 (broadly, bearing portion 178 considered a lumen of the impeller) formed by of the impeller 171, 172 and a proximal end region extending proximal of the impeller 171 172 (right end of rotor hub 174 shown in FIG. 1) wherein the impeller 171, 172 is configured to rotate with the drive shaft 170, 174 relative to the impeller housing (normal operation);
a motor 120, 150 (col. 3, ll. 45-60, motor stator 120 and rotor 150) configured to rotate the drive shaft 170, 174 to drive the impeller 171, 172;
a proximal bearing assembly 169 (col. 4, ll. 60-65, bearing assembly 169)3 disposed proximal of the impeller 171, 172 (shown on left side of FIG. 1);
a distal bearing assembly 189 (col. 4 ln. 45) disposed distal of the impeller 171, 172 (shown on left side of FIG. 1);
wherein the proximal bearing assembly 169 and the distal bearing assembly 189 support the impeller 171, 172 within the impeller housing (nominally supporting impeller for rotation therebetween);
wherein the proximal bearing assembly 169 includes a proximal bearing 168 (col. 5, ll. 5-10) having a distally facing concave depression (shown) defining a concave surface (shown), wherein a proximal end of the drive shaft 177 has a convex surface (shown adjacent 190) contacting the concave surface of the concave depression (as shown).
Maher is silent as to the proximal bearing includes at least one channel formed in the concave depression and extending proximally from the concave surface, the at least one channel opening out to the concave surface, and wherein the convex surface of the proximal end of the drive shaft extends across the at least one channel. To this point, Middleton teaches a bearing assembly 1, 2 with a convex surface of shaft 11 received in a concave depression 7 of the bearing 1, 2 (FIG. 1, col. 3, ll.30-55, inner surface 7 of bearing cup 2). A channel 8 is formed in the concave depression 7 that extends proximally from the concave surface (as shown) such that the convex surface of the shaft extends across the channel 8 (col. 3, ll. 40-45). With this in mind, it would have been obvious to one having ordinary skill in the art before the effective filing date of the instant application to modify the bearing of Maher with a channel arranged in the manner shown by Middleton in order to lubricate the bearing surfaces from a lubricant supply chamber in communication with the channel as taught by Middleton (col. 4, ll. 5-10).
As to claim 13, Maher further discloses the distal bearing assembly 189 includes a distal bearing 187 disposed within the lumen 178 (broadly, bearing portion 178 can be considered a lumen of the impeller) of the impeller 171, 172.
As to claim 14, Maher further discloses a distal end of the drive shaft 170, 174, 177 is located proximal of the distal bearing 187 (as shown).
As to claim 15, Maher further discloses the distal bearing assembly 189 includes a stationary shaft mounting pin 186, 187 (col. 5, ln. 25, bearing seat 186 and portion 187 arranged and configured in a manner forming a stationary mounting pin) extending into the lumen 178 of the impeller (as shown).
As to claim 16, Maher further discloses the distal bearing 187 surrounds the stationary shaft mounting pin 186, 187 (as shown).
As to claim 17, Maher further discloses the impeller 171, 172 is configured to rotate relative to the stationary shaft mounting pin 186, 187 (containing bearing 189 which has a rotating part adjacent magnet cap 173 and stationary part 187).
As to claim 18, Maher further discloses a driven magnet 175 (FIG. 1, col. 4, ll. 40-45) surrounding the proximal end region of the drive shaft 170, 174, 177.
As to claim 19, Maher further discloses the driven magnet 175 is positioned between a proximal end of the impeller 171, 172 and the proximal end of the drive shaft 170, 174, 177 (under broadest reasonable interpretation since the end of the draft shaft can be interpreted relatively depending perspective with respect to the term proximal).
As to claim 20, Maher further discloses a distal end of the drive shaft 170, 174, 177 (left side of FIG. 1) is positioned proximal of a distal end of the impeller 171, 172 (under broadest reasonable interpretation of terms).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zimmermann et al. (U. S. Patent Application Publication No.
2014/0275722) discloses a state of the art blood pump having spherical bearing
assemblies (FIG.'s 2-5, Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH J HANSEN whose telephone number is (571)272-6780. The examiner can normally be reached Monday Friday 7:00 AM to 4:00 PM (MT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Laurenzi can be reached at (571) 270-7878. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNETH J HANSEN/Primary Examiner, Art Unit 3746
1 The claimed subject matter is not repeated herein for brevity.
2 Ibid.
3 Interpretation Notes: The terms proximal and distal are defined relative to respective ends of the pump shaft and impeller. For examination, proximal is interpreted as closer to the right side of FIG .1 adjacent impeller blades 171, 172 next to stator hub 164. Distal is the opposite end on the left side of FIG. 1 next to stator hub 184.