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 .
Priority
This application is a continuation application of U.S. patent application Ser. No. 17/650,565, filed Feb. 10, 2022, now U.S. Patent No. 11,980,385, which claims priority and the benefit of provisional application Ser. No. 63/148,425, filed Feb. 11, 2021.
Claim Objections
Claim 2, lines 1-2 recite “the impeller housing comprises a proximal inner surface” (emphasis added). This limitation should be amended to read “the impeller housing comprises an inner surface” because paragraph [0022] of the specification discloses “the inner surface or inner face 25 of impeller housing 24,” (see reference numeral 25 as shown in FIG. 1). Lines 3-4 recite “the proximal inner surface.” This limitation should be amended to read “the .”
Claim 3, “the axial location” should be amended to read “an axial location.”
Claim 10, “the length of the proximal section” should be amended to read “a length of the proximal section.” The limitation of “one or more spaced-apart hypotubes” should be amended to read “one or more hypotubes” because it requires at least two hypotubes to define “spaced-apart hypotubes”.
Claim 12, The limitation of “one or more spaced-apart hypotubes” should be amended to read “one or more hypotubes.” The limitation of “the distal section” (ln 3-4) should be amended to read “a distal section.”
Claims 15-16, the limitation of “one or more spaced-apart hypotubes” should be amended to read “one or more hypotubes” because it requires at least two hypotubes to define “spaced-apart hypotubes”.
Claims 15, line 3, “the wire filars” should be amended to read “a plurality of wire filars.”
Claim 17, which is dependent on claim 14, lines 2-3, “the wire filars of the proximal section” should be amended to read “a plurality of [[the]] wire filars of the proximal section” because claim 14 fails to provide antecedent basis for “the wire filars.”
Claim 18, which is dependent on claim 14, lines 2-3, “the wire filars of the distal section” should be amended to read “a plurality of [[the]] wire filars of the distal section” because claim 14 fails to provide antecedent basis for “the wire filars.”
Claim 20, lines 4-5, the limitation of “a distal section having a length that is longer than the proximal section length spring constant that is greater than the proximal section spring constant.” This limitation should be amended to read “a distal section having a length that is longer than the proximal section length and a distal section spring constant that is greater than the proximal section spring constant.”
Claim 20, line 8, “the wire filars of the drive shaft” should be amended to read “a plurality of [[the]] wire filars of the drive shaft assembly.”
Claim 20, lines 12-13, the limitation of “at least one support mandrel attached to the wire filars of the proximal and/or distal section within the inner lumen” should be amended to read “at least one support mandrel attached to the wire filars of at least one of the proximal and distal section within the inner lumen.”
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 4, which is dependent on claim 1, is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 11,980,385. This is a statutory double patenting rejection. Claims 14-21 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 13-20 of prior U.S. Patent No. 11,980,385. This is a statutory double patenting rejection.
The claims matchup with respect to one another as listed below:
U.S. Patent Application 18/659,770
U.S. Patent No. 11,980,385
Claim 1. A hemodynamic support device comprising: an electric motor having a rotational motor shaft and motor manifold at least partially surrounding the rotational motor shaft, the electric motor configured to rotate the rotational motor shaft; a blood pump comprising an impeller, an impeller shaft and impeller housing at least partially surrounding the impeller and part of the impeller shaft; an elongated flexible drive shaft formed of a plurality of wire filars and having an undeformed length, a proximal end and a distal end, the proximal end of the drive shaft rotationally connected to the rotational motor shaft and the distal end rotationally connected to the impeller shaft; wherein the elongated flexible drive shaft is deformed to a stretched configuration with a length greater than the undeformed length between the rotational motor shaft and impeller shaft to create a biasing build tension force between the impeller and the electric motor shaft.
Claim 4. The hemodynamic support device of claim 1, wherein the impeller resists movement in a distal axial direction within the impeller housing as a result of the biasing build tension force.
Claim 1. A hemodynamic support device comprising: an electric motor having a rotational motor shaft and motor manifold at least partially surrounding the rotational motor shaft, the electric motor configured to rotate the rotational motor shaft; a blood pump comprising an impeller, an impeller shaft and impeller housing at least partially surrounding the impeller and part of the impeller shaft; an elongated flexible drive shaft formed of a plurality of wire filars and having an undeformed length, a proximal end and a distal end, the proximal end of the drive shaft rotationally connected to the rotational motor shaft and the distal end rotationally connected to the impeller shaft; wherein the elongated flexible drive shaft is deformed to a stretched configuration with a length greater than the undeformed length between the rotational motor shaft and impeller shaft to create a biasing build tension force between the impeller and the electric motor shaft,
wherein the impeller resists movement in a distal axial direction within the impeller housing as a result of the biasing build tension force.
Claim 14. A flexible drive shaft assembly for an intravascular medical device comprising: a proximal section having a length and a spring constant, and a distal section having a length that is longer than the proximal section length and a spring constant that is greater than the proximal section spring constant.
Claim 13. A flexible drive shaft assembly for an intravascular medical device comprising: a proximal section having a length and a spring constant, and a distal section having a length that is longer than the proximal section length and a spring constant that is greater than the proximal section spring constant.
Claim 15. The drive shaft assembly of claim 14, further comprising one or more spaced-apart hypotubes (see claim objection for “spaced-apart”) surrounding a portion of the length of the proximal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars attached to the one or more hypotubes in an axial position relative to each other.
Claim 14. The drive shaft assembly of claim 13, further comprising one or more hypotubes
surrounding a portion of the length of the proximal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars attached to the one or more hypotubes in an axial position relative to each other.
Claim 16. The drive shaft assembly of claim 15, further comprising one or more spaced-apart hypotubes (see claim objection for “spaced-apart”) surrounding a portion of the length of the distal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars that are attached to the one or more hypotubes in an axial position relative to each other.
Claim 15. The drive shaft assembly of claim 14, further comprising one or more hypotubes
surrounding a portion of the length of the distal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars that are attached to the one or more hypotubes in an axial position relative to each other.
Claim 17. The drive shaft assembly of claim 14, wherein the drive shaft assembly further defines an inner lumen therethrough, and comprising at least one support mandrel attached to the wire filars of the proximal section within the inner lumen, and wherein the wire filars attached to the at least one support mandrel are configured to be fixed in axial position relative to each other.
Claim 16. The drive shaft assembly of claim 13, wherein the drive shaft assembly further defines an inner lumen therethrough, and comprising at least one support mandrel attached to the wire filars of the proximal section within the inner lumen, and wherein the wire filars attached to the at least one support mandrel are configured to be fixed in axial position relative to each other.
Claim 18. The drive shaft assembly of claim 14, wherein the drive shaft assembly further defines an inner lumen therethrough, and comprising at least one support mandrel attached to the wire filars of the distal section within the inner lumen, and wherein the wire filars attached to the at least one support mandrel are configured to be fixed in axial position relative to each other.
Claim 17. The drive shaft assembly of claim 13, wherein the drive shaft assembly further defines an inner lumen therethrough, and comprising at least one support mandrel attached to the wire filars of the distal section within the inner lumen, and wherein the wire filars attached to the at least one support mandrel are configured to be fixed in axial position relative to each other.
Claim 19. The flexible drive shaft assembly of claim 14, wherein the intravascular medical device comprises one or more of the group consisting of: a blood pump, a rotational atherectomy device, and a rotational thrombectomy device.
Claim 18. The flexible drive shaft assembly of claim 13, wherein the intravascular medical device comprises one or more of the group consisting of: a blood pump, a rotational atherectomy device, and a rotational thrombectomy device.
Claim 20. A flexible drive shaft assembly for an intravascular medical device comprising: a proximal section having a length and a spring constant; a distal section having a length that is longer than the proximal section length spring constant that is greater than the proximal section spring constant; one or more spaced-apart hypotubes (see claim objection for “spaced-apart”) surrounding a portion of the length of the proximal section and/or distal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars attached to the one or more hypotubes in an axial position relative to each other, wherein the drive shaft assembly further defines an inner lumen therethrough, and comprising at least one support mandrel attached to the wire filars of the proximal and/or distal section within the inner lumen, and wherein the wire filars attached to the at least one support mandrel are configured to be fixed in axial position relative to each other.
Claim 19. A flexible drive shaft assembly for an intravascular medical device comprising: a proximal section having a length and a spring constant; a distal section having a length that is longer than the proximal section length and a distal section spring constant that is greater than the proximal section spring constant; one or more hypotubes
surrounding a portion of the length of the proximal section and/or distal section, wherein each of the one or more hypotubes are attached to a plurality of wire filars of the drive shaft assembly and configured to fix the wire filars attached to the one or more hypotubes in an axial position relative to each other, wherein the drive shaft assembly further defines an inner lumen therethrough, and comprising at least one support mandrel attached to the wire filars of at least one of the proximal and distal section within the inner lumen, and wherein the wire filars attached to the at least one support mandrel are configured to be fixed in axial position relative to each other.
Claim 21. The flexible drive shaft assembly of claim 20, wherein the intravascular medical device comprises one or more of the group consisting of: a blood pump, a rotational atherectomy device, and a rotational thrombectomy device.
Claim 20. The flexible drive shaft assembly of claim 19, wherein the intravascular medical device comprises one or more of the group consisting of: a blood pump, a rotational atherectomy device, and a rotational thrombectomy device.
Nonstatutory 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,980,385 (hereinafter “the patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitation in claims 1-13 can be found in claims 1-12 of the patent.
The claims match-up with respect to one another as listed below:
U.S. Patent Application 18/659,770
U.S. Patent No. 11,980,385
Claim 1. A hemodynamic support device comprising: an electric motor having a rotational motor shaft and motor manifold at least partially surrounding the rotational motor shaft, the electric motor configured to rotate the rotational motor shaft; a blood pump comprising an impeller, an impeller shaft and impeller housing at least partially surrounding the impeller and part of the impeller shaft; an elongated flexible drive shaft formed of a plurality of wire filars and having an undeformed length, a proximal end and a distal end, the proximal end of the drive shaft rotationally connected to the rotational motor shaft and the distal end rotationally connected to the impeller shaft; wherein the elongated flexible drive shaft is deformed to a stretched configuration with a length greater than the undeformed length between the rotational motor shaft and impeller shaft to create a biasing build tension force between the impeller and the electric motor shaft.
Claim 1. A hemodynamic support device comprising: an electric motor having a rotational motor shaft and motor manifold at least partially surrounding the rotational motor shaft, the electric motor configured to rotate the rotational motor shaft; a blood pump comprising an impeller, an impeller shaft and impeller housing at least partially surrounding the impeller and part of the impeller shaft; an elongated flexible drive shaft formed of a plurality of wire filars and having an undeformed length, a proximal end and a distal end, the proximal end of the drive shaft rotationally connected to the rotational motor shaft and the distal end rotationally connected to the impeller shaft; wherein the elongated flexible drive shaft is deformed to a stretched configuration with a length greater than the undeformed length between the rotational motor shaft and impeller shaft to create a biasing build tension force between the impeller and the electric motor shaft,
wherein the impeller resists movement in a distal axial direction within the impeller housing as a result of the biasing build tension force.
Claim 2. The hemodynamic support device of claim 1, wherein the impeller housing comprises a proximal inner surface (see claim objection for “a proximal inner surface”) and the impeller comprises a proximal surface, and wherein the biasing build tension force maintains the impeller's proximal surface in contact with the proximal inner surface of the impeller housing.
Claim 2. The hemodynamic support device of claim 1, wherein the impeller housing comprises an inner surface
and the impeller comprises a proximal surface, and wherein the biasing build tension force maintains the impeller's proximal surface in contact with the inner surface of the impeller housing.
Claim 3. The hemodynamic support device of claim 1, wherein the axial location of the impeller is maintained as a result of the biasing build tension force.
Claim 3. The hemodynamic support device of claim 1, wherein an axial location of the impeller is maintained as a result of the biasing build tension force.
Claim 5. The hemodynamic support device of claim 1, wherein the biasing build tension force is within the range of 20 grams to 500 grams.
Claim 4. The hemodynamic support device of claim 1, wherein the biasing build tension force is within the range of 20 grams to 500 grams.
Claim 6. The hemodynamic support device of claim 5, wherein the biasing build tension force is within the range of 220 grams to 240 grams.
Claim 5. The hemodynamic support device of claim 4, wherein the biasing build tension force is within the range of 220 grams to 240 grams.
Claim 7. The hemodynamic support device of claim 1, further comprising an outer sheath connected with the impeller housing and the motor manifold.
Claim 6. The hemodynamic support device of claim 1, further comprising an outer sheath connected with the impeller housing and the motor manifold.
Claim 8. The hemodynamic support device of claim 7, further comprising an inner sheath disposed within the outer sheath and surrounding at least part of the length of the drive shaft.
Claim 7. The hemodynamic support device of claim 6, further comprising an inner sheath disposed within the outer sheath and surrounding at least part of the length of the drive shaft.
Claim 9. The hemodynamic support device of claim 1, further comprising the drive shaft being configured to remove constructional stretch by stretching the shaft axially with an applied force between 20 grams and 500 grams, then removing the applied force.
Claim 8. The hemodynamic support device of claim 1, further comprising the drive shaft being configured to remove constructional stretch by stretching the shaft axially with an applied force between 20 grams and 500 grams, then removing the applied force.
Claim 10. The hemodynamic support device of claim 1, wherein the flexible drive shaft comprises one or more spaced-apart hypotubes (see claim objection for “spaced-apart”) surrounding a portion of the length of the proximal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars attached to the one or more hypotubes in an axial position relative to each other.
Claim 9. The hemodynamic support device of claim 1, wherein the flexible drive shaft comprises one or more hypotubes
surrounding a portion of a length of the proximal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars attached to the one or more hypotubes in an axial position relative to each other.
Claim 11. The hemodynamic support device of claim 1, wherein the drive shaft further comprises: a proximal section having a length and a spring constant, and a distal section having a length that is longer than the proximal section length and a spring constant that is greater than the proximal section spring constant.
Claim 10. The hemodynamic support device of claim 1, wherein the drive shaft further comprises: a proximal section having a length and a spring constant, and a distal section having a length that is longer than the proximal section length and a spring constant that is greater than the proximal section spring constant.
Claim 12. The hemodynamic support device of claim 1, wherein the drive shaft further comprises one or more spaced-apart hypotubes (see claim objection for “spaced-apart”) surrounding a portion of the length of the distal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars that are attached to the one or more hypotubes in an axial position relative to each other.
Claim 11. The hemodynamic support device of claim 1, wherein the drive shaft further comprises one or more hypotubes
surrounding a portion of the length of a distal section, wherein each of the one or more hypotubes are attached to the wire filars of the drive shaft and configured to fix the wire filars that are attached to the one or more hypotubes in an axial position relative to each other.
Claim 13. The hemodynamic support device of claim 1, wherein the drive shaft defines an inner lumen therethrough, wherein at least one support mandrel is disposed and attached to the wire filars of the drive shaft within the inner lumen, and wherein the wire filars attached to the at least one support mandrel are configured to be fixed in axial position relative to each other.
Claim 12. The hemodynamic support device of claim 1, wherein the drive shaft defines an inner lumen therethrough, wherein at least one support mandrel is disposed and attached to the wire filars of the drive shaft within the inner lumen, and wherein the wire filars attached to the at least one support mandrel are configured to be fixed in axial position relative to each other.
Allowable Subject Matter
Claims 1-3 and 5-13 are allowable if a terminal disclaimer is filed to overcome the nonstatutory double patenting rejection set forth above.
Referring to claim 1, Flores (US 10,668,195) discloses a hemodynamic support device 100 (Fig. 1A) comprising:
an electric motor 422 (Figs. 4A-4B; col. 8, ln 37-42, 46-49, 61-64) having a rotational motor shaft 116 (Fig. 1A; col. 8, ln 61-64; col. 11, ln 17-21, 41-46; col. 12 ln 4-8) and motor manifold (444, 446, 458, Figs. 4A-4B; col 11, ln 17-21, 41-46; col. 12, ln 4-8) at least partially surrounding the rotational motor shaft, the electric motor configured to rotate the rotational motor shaft;
a blood pump (104, 118, 120; Fig. 1A; col. 8, ln 39-42; col. 9, ln 1-3, 37-42) comprising an impeller (120; Fig. 1A; col. 8, ln 39-42), an impeller shaft (118, Fig. 1A, 5C; col. 8, ln 39-42; col. 9, ln 37-42) and impeller housing (104, Fig. 1A; col. 8, ln 39-42) at least partially surrounding the impeller and part of the impeller shaft;
an elongated flexible drive shaft (116, Fig. 1A; col. 8, ln 39-42; col. 9, ln 1-3, 37-42) formed of a plurality of wire filars (col. 9, ln 3-6) and having an undeformed length, a proximal end and a distal end, the proximal end of the drive shaft 116 rotationally connected to the rotational motor shaft 443 and the distal end rotationally connected to the impeller shaft.
Flores fails to disclose wherein the elongated flexible drive shaft is deformed to a stretched configuration with a length greater than the undeformed length between the rotational motor shaft and impeller shaft to create a biasing build tension force between the impeller and the electric motor shaft, wherein the impeller resists movement in a distal axial direction within the impeller housing as a result of the biasing build tension force.
Wulfman et al. (WO 2004/080345 A2) discloses a flexible drive shaft assembly for an atherectomy device. Wulman discloses “Drive shafts for use in interventional catheters of the present invention generally comprise helical coil or braided shafts may comprise composite drive shafts having variable flexibility and/or torque carrying capability at different sections along their length. In one embodiment, a helical coil drive shaft is provided having a less flexibility and higher torque carrying capability at a proximal portion and greater flexibility and less torque carrying capability at a distal portion. The proximal portion of the drive shaft may comprise a helical coil shaft having more files than the helical coil shaft forming the distal portion of the drive shaft. In one embodiment, a proximal drive shaft section comprises a tri- or quad-filar helical coil, while a distal drive shaft section comprises a bi- or tri-filar helical coil, respectively. In a drive shaft having a braided construction, a proximal drive shaft section comprises more strands than a distal drive shaft section.” (page 16, last paragraph and page 17, ln 1-3). Based on the disclosure above one of ordinary skill in the art will understand that the flexible drive shaft of Wulman is capable of stretch when a tension force is applied to the shaft. Based on the disclosure above one of ordinary skill in the art will understand that the flexible drive shaft of Wulman has a proximal section includes a spring constant greater than a spring constant of a distal section.
Shturman et al. (US 7,507,245) discloses an atherectomy device. Shturman discloses drive shaft 10 (Fig. 1; para. [0025]) includes an inner lumen therethrough (an inner lumen including the space internal to the coils 28; Figs. 2-3; para. [0028], [0030]), at least one support mandrel 26 (Figs. 2-3; para. [0028]) is disposed and attached to the wire filars 28.
As to claim 1, prior art of record alone or in combination fail to disclose the recited limitations of wherein the elongated flexible drive shaft is deformed to a stretched configuration with a length greater than the undeformed length between the rotational motor shaft and impeller shaft to create a biasing build tension force between the impeller and the electric motor shaft.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771