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 .
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.
Claims 17-20 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "the housing" in the limitation wherein the housing includes a plurality of blood outlet apertures defined therein. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is dependent on claim 11 which recites both “an impeller housing” and a “motor housing”. Claim 17 doesn’t make a distinction between whether “the housing” in claim 17 is referring to the impeller housing or the motor housing. This raises questions as to which housing is being referred to in claim 17. For this examination, the interpretation taken is that the housing in the cited limitation in claim 17 is referring to the “impeller housing”.
Claim 18 recites the limitation "the impeller housing" in the limitation “a proximal bearing assembly including a thrust plate disposed within the impeller housing, the thrust plate having a distal-facing concave surface and being in contact with the proximal-facing convex bearing surface of the drive shaft”. There is insufficient antecedent basis for this limitation in the claim.
The claim only recites a “housing” before reciting “the impeller housing”. This raises questions, is applicant referring the previously recited housing or introducing an additional limitation in the form of an impeller housing? For this examination, the interpretation taken is that “the impeller housing” is referring to the previously recited “housing”. Additionally, claims 19-20 are rejected under 112(b) as well based on dependency to claim 18.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 12171994 hereafter known as Pat ‘994. Although the claims at issue are not identical, they are not patentably distinct from each other because Pat ‘994 anticipates the limitations as outlined in the table below.
Claim in in this application
Where limitation(s) are found in Pat ‘994
Further clarification (if needed)
Claim 1
Claims 1 and 4
Please note the “magnetic cover” in dependent claim 4 of Pat ‘994 is interpreted as a “magnetic stator” as recited in claim 1 of this application.
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.
The factual inquiries 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seiss et al (US 20180228953) hereafter known Seiss in view of Franano et al (US 20130338559) hereafter known as Franano.
Independent claim:
Regarding claim 1:
Seiss discloses
A percutaneous blood pump [see Fig. 1 and para 74… “Referring to FIGS. 1 and 2, a perspective and cross-sectional view of a blood pump 1 are respectively illustrated.”], comprising:
a housing [see Fig. 1 element 2 and para 74… “a pump casing 2”];
an impeller assembly disposed within the housing [see Fig. 26 and para 58-59… “FIG. 25 shows a side elevation view of an impeller assembly according to another embodiment. FIG. 26 shows a cross-sectional view of the assembly of FIG. 25.”], the impeller assembly comprising:
a drive shaft including a proximal-facing bearing surface [see labelled figure(s) directly below rejection to this claim];
an impeller coupled to the drive shaft [see Figs. 25-26 and para 90… “the impeller 303”]; and
a thrust plate [see Fig. 26 element 311 and para 90… “a stationary bearing portion 311”] disposed within the housing [see Fig. 2], the thrust plate having a distal-facing surface and being in contact with the proximal-facing bearing surface of the drive shaft [see labelled figure(s) below];
wherein a proximal-facing surface of a rotor is disposed adjacent the distal-facing surface of the thrust plate such that a gap is defined between the proximal-facing surface of the rotor and the distal-facing surface of the thrust plate [see Figs. 25-26 element 336 which is a rotor and labelled figure(s) directly below rejection to this claim].
However, this embodiment of Seiss fails to disclose: “the impeller configured to rotate with the drive shaft relative to the housing”, “a magnetic rotor positioned on the drive shaft proximal of the impeller”, “a magnetic stator configured to drive the magnetic rotor via a magnetic field applied to the magnetic rotor by the magnetic stator thereby causing the impeller to rotate” and since no magnetic rotor is disclosed, Seiss fails to fully disclose “wherein a proximal-facing surface of the magnetic rotor is disposed adjacent the distal-facing surface of the thrust plate such that a gap is defined between the proximal-facing surface of the magnetic rotor and the distal-facing surface of the thrust plate”
Another embodiment of Seiss discloses a magnetic rotor positioned on a drive shaft proximal of the impeller [see Fig 19-20 element 271 and para 88… “The impeller 203 can be further adjusted or also driven by an arrangement including magnets or electromagnets 270, 271 as schematically shown in FIG. 20. Magnets 271 in the stationary bearing portion 211 interact with magnets 270 in the impeller 203 to form a magnetic coupling. The magnets 270, 271 can be arranged to cause an attractive or repulsive magnetic force to support axial alignment of the impeller 203. It will be appreciated that any suitable drive can be used to cause rotation of the impeller 203 about the axis of rotation.”] and a magnetic stator configured to drive the magnetic rotor via a magnetic field applied to the magnetic rotor by the magnetic stator thereby causing the impeller to rotate [see Fig. 19-20 element 270 and para 88… “The impeller 203 can be further adjusted or also driven by an arrangement including magnets or electromagnets 270, 271 as schematically shown in FIG. 20. Magnets 271 in the stationary bearing portion 211 interact with magnets 270 in the impeller 203 to form a magnetic coupling. The magnets 270, 271 can be arranged to cause an attractive or repulsive magnetic force to support axial alignment of the impeller 203. It will be appreciated that any suitable drive can be used to cause rotation of the impeller 203 about the axis of rotation. For example, the magnets 270 in the impeller 203 can interact with a rotating magnetic field that is caused either by an electrical unit in the stationary bearing portion 211, i.e. axial, or by an electrical unit surrounding the impeller, i.e. radial.”] and that the scope of the disclosure includes combinations of different embodiments [see para 100… “In particular, various aspects and features of the embodiments could be combined or independently employed in a different embodiment. For instance, the features and different designs described with respect to the outer blades, the inner blades, the pin, blood flow passages through the pin or the impeller, the drive unit, magnets for axial alignment, etc., could be variably combined without departing from the scope of the invention.”]
Franano discloses in the analogous art of blood pumps [see para 2… “The present invention relates to a blood pump system that includes a pump, conduits, a control unit, and a source of power, whereby the system may be used for a variety of peripheral vascular clinical indications.”] using a impeller shaft with a distal bearing assembly with a shaft extending into the impeller and a proximal end of the shaft spaced apart from the distal end of the impeller shaft (i.e. drive shaft) and a proximal bearing assembly with concave bearing surface that mates with a convex surface of the drive shaft with the impeller shaft rotating the impeller relative to the housing, for the purpose of a creating a tolerant design that can operate continuously for long periods of time without breakdown [see Fig. 2 and 12 element 130 (i.e. distal bearing), element 160 (i.e. proximal bearing), impeller shaft (i.e. element 145) and labelled figures direct below rejection to this claim And para 116… “Accordingly, the impeller assembly may freely rotate in the impeller chamber 205 on the impeller pivot 145, which is supported end to end with the bearing pins 130 and 160, in a configuration commonly known as a "double pin bearing." And para 109… “the impeller pivot 145 is pivotally supported (i.e. restrained in all degrees of freedom except rotation about a single axis)” And para 118… “the impeller assembly is a composite of the impeller shaft 145, top bearing pin 130, and bottom bearing pin 160. The composite design is beneficial with regard to the simplicity, tolerances, and cost of the machined bearing components. All of these constructions are designed to allow the motor to function in a continuous state for around a day to 1-12 weeks or longer, without breakdown.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Seiss’s first embodiment shown in Figs 25-26 by including a magnetic rotor and magnetic stator similarly to that disclosed by Figs. 19-20 because this is a subcombination of different combinations disclosed by Seiss.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Seiss by including replacing the pin with an impeller shaft and proximal and distal bearings so that the proximal bearing assembly is disposed adjacent thrust plate and is configured to rotate the impeller similarly to that disclosed by Franano because such a design would provide the advantage of allowing the impeller to be used continuously for long periods of time without breaking down.
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Regarding claim 11:
Seiss discloses:
A percutaneous blood pump [see Fig. 1 and para 74… “Referring to FIGS. 1 and 2, a perspective and cross-sectional view of a blood pump 1 are respectively illustrated.”], comprising:
an impeller housing [see Fig. 1 element 2 and para 74… “a pump casing 2”];
an impeller assembly disposed within the impeller housing [see Fig. 25-26 and para 58-59… “FIG. 25 shows a side elevation view of an impeller assembly according to another embodiment. FIG. 26 shows a cross-sectional view of the assembly of FIG. 25.”], the impeller assembly comprising
an impeller [see Figs. 25-26 and para 90… “the impeller 303”];
a drive shaft extending into and coupled to the impeller and a proximal end of the drive shaft defining proximal-facing bearing surface [see labelled figure directly below rejection(s) to this claim]; and
a rotor positioned on the drive shaft proximal of the impeller [see Fig. 25-26 element 336 (i.e. rotor)];
a motor housing coupled to the impeller housing and extending proximally therefrom [see para 23… “The outer hub may accommodate a set of magnets that form the rotor of the electric motor that is driven by stator coils situated on the outer surface of the pump casing.” The outer hub’s accommodation of the motor is at least a housing];
a motor disposed within the motor housing, the motor including a stator configured to drive the rotor thereby causing the impeller to rotate [see para 23… “The outer hub may accommodate a set of magnets that form the rotor of the electric motor that is driven by stator coils situated on the outer surface of the pump casing.”];
a proximal bearing assembly including a thrust plate [see Fig. 26 element 311 and para 90… “a stationary bearing portion 311”] disposed within the impeller housing [see Fig. 2], the thrust plate having a distal-facing surface and being in contact with a proximal-facing bearing surface of the drive shaft [see labelled figure(s) directly below rejection to this claim]; and
However, Seiss fails to fully disclose “the impeller configured to rotate with the drive shaft relative to the impeller housing, the drive shaft including a proximal end extending proximal of the impeller and a distal end located within the impeller proximal of a distal end of the impeller, the proximal end of the drive shaft defining proximal-facing bearing surface”. Also Siess fails to fully disclose “a magnetic rotor positioned on the drive shaft proximal of the impeller”, “the motor including a magnetic stator configured to drive the magnetic rotor via a magnetic field applied to the magnetic rotor by the magnetic stator thereby causing the impeller to rotate” and “a distal bearing assembly located at the distal end of the impeller, the distal bearing assembly including a shaft extending proximally into the impeller from the distal end of the impeller”.
Another embodiment of Seiss discloses a magnetic rotor positioned on a drive shaft proximal of the impeller [see Fig 19-20 element 271 and para 88… “The impeller 203 can be further adjusted or also driven by an arrangement including magnets or electromagnets 270, 271 as schematically shown in FIG. 20. Magnets 271 in the stationary bearing portion 211 interact with magnets 270 in the impeller 203 to form a magnetic coupling. The magnets 270, 271 can be arranged to cause an attractive or repulsive magnetic force to support axial alignment of the impeller 203. It will be appreciated that any suitable drive can be used to cause rotation of the impeller 203 about the axis of rotation.”] and a magnetic stator configured to drive the magnetic rotor via a magnetic field applied to the magnetic rotor by the magnetic stator thereby causing the impeller to rotate [see Fig. 19-20 element 270 and para 88… “The impeller 203 can be further adjusted or also driven by an arrangement including magnets or electromagnets 270, 271 as schematically shown in FIG. 20. Magnets 271 in the stationary bearing portion 211 interact with magnets 270 in the impeller 203 to form a magnetic coupling. The magnets 270, 271 can be arranged to cause an attractive or repulsive magnetic force to support axial alignment of the impeller 203. It will be appreciated that any suitable drive can be used to cause rotation of the impeller 203 about the axis of rotation. For example, the magnets 270 in the impeller 203 can interact with a rotating magnetic field that is caused either by an electrical unit in the stationary bearing portion 211, i.e. axial, or by an electrical unit surrounding the impeller, i.e. radial.”] and that the scope of the disclosure includes combinations of different embodiments [see para 100… “In particular, various aspects and features of the embodiments could be combined or independently employed in a different embodiment. For instance, the features and different designs described with respect to the outer blades, the inner blades, the pin, blood flow passages through the pin or the impeller, the drive unit, magnets for axial alignment, etc., could be variably combined without departing from the scope of the invention.”]
Franano discloses in the analogous art of blood pumps [see para 2… “The present invention relates to a blood pump system that includes a pump, conduits, a control unit, and a source of power, whereby the system may be used for a variety of peripheral vascular clinical indications.”] using an impeller shaft with a distal bearing assembly with a shaft extending into the impeller and a proximal end of the shaft spaced apart from the distal end of the impeller shaft (i.e. drive shaft) and a proximal bearing assembly with concave bearing surface that mates with a convex surface of the drive shaft with the impeller shaft rotating the impeller relative to the housing, the proximal assembly for the purpose of a creating a tolerant design that can operate continuously for long periods of time without breakdown [see Fig. 2 and 12 element 130 (i.e. distal bearing), element 160 (i.e. proximal bearing), impeller shaft (i.e. element 145) and labelled figures direct below rejection to this claim And para 116… “Accordingly, the impeller assembly may freely rotate in the impeller chamber 205 on the impeller pivot 145, which is supported end to end with the bearing pins 130 and 160, in a configuration commonly known as a "double pin bearing." And para 109… “the impeller pivot 145 is pivotally supported (i.e. restrained in all degrees of freedom except rotation about a single axis)” And para 118… “the impeller assembly is a composite of the impeller shaft 145, top bearing pin 130, and bottom bearing pin 160. The composite design is beneficial with regard to the simplicity, tolerances, and cost of the machined bearing components. All of these constructions are designed to allow the motor to function in a continuous state for around a day to 1-12 weeks or longer, without breakdown.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Seiss’s first embodiment shown in Figs 25-26 by including a magnetic rotor and magnetic stator similarly to that disclosed by Figs. 19-20 because this is a subcombination of different combinations disclosed by Seiss.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Seiss by including replacing the pin with an impeller shaft and proximal and distal bearings so that the proximal bearing assembly is disposed adjacent thrust plate and is configured to rotate the impeller similarly to that disclosed by Franano because such a design would provide the advantage of allowing the impeller to be used continuously for long periods of time without breaking down.
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Regarding claim 18:
Seiss discloses:
A percutaneous blood pump [see Fig. 1 and para 74… “Referring to FIGS. 1 and 2, a perspective and cross-sectional view of a blood pump 1 are respectively illustrated.”], comprising:
a housing [see Figs. 1-2 element 2 and para 74… “a pump casing 2”];
an impeller assembly disposed within the housing [see Fig. 25-26 and para 58-59… “FIG. 25 shows a side elevation view of an impeller assembly according to another embodiment. FIG. 26 shows a cross-sectional view of the assembly of FIG. 25.”], the impeller assembly comprising:
an impeller [see Figs. 25-26 and para 90… “the impeller 303”];
a drive shaft extending into and coupled to the impeller, the drive shaft, a proximal end of the drive shaft defining proximal-facing bearing surface [see labelled figure(s) directly below rejection to this claim]; and
a rotor positioned on the drive shaft proximal of the impeller [see Fig. 25-26 element 336 (i.e. rotor)];
a motor disposed within the housing, the motor including stator [see para 23… “The outer hub may accommodate a set of magnets that form the rotor of the electric motor that is driven by stator coils situated on the outer surface of the pump casing.” The outer hub’s accommodation of the motor is at least a housing];
a proximal bearing assembly including a thrust plate [see Fig. 26 element 311 and para 90… “a stationary bearing portion 311”] disposed within the impeller housing [see Fig. 2], the thrust plate having a distal-facing surface and being in contact with the proximal-facing bearing surface of the drive shaft [see labelled figure(s) directly below rejection to this claim]; and
However, Seiss fails to fully disclose “the impeller configured to rotate with the drive shaft relative to the housing, the drive shaft including a proximal end extending proximal of the impeller and a distal end located within the impeller proximal of a distal end of the impeller, the proximal end of the drive shaft defining proximal-facing convex bearing surface”, “a magnetic rotor positioned on the drive shaft proximal of the impeller”, “a magnetic stator configured to drive the magnetic rotor via a magnetic field applied to the magnetic rotor by the magnetic stator thereby causing the impeller to rotate”, “a proximal bearing assembly including a thrust plate disposed within the impeller housing, the thrust plate having a distal-facing concave surface and being in contact with the proximal-facing convex bearing surface of the drive shaft”; and “a distal bearing assembly located at the distal end of the impeller, the distal bearing assembly including a shaft extending proximally into the impeller from the distal end of the impeller”.
Another embodiment of Seiss discloses a magnetic rotor positioned on a drive shaft proximal of the impeller [see Fig 19-20 element 271 and para 88… “The impeller 203 can be further adjusted or also driven by an arrangement including magnets or electromagnets 270, 271 as schematically shown in FIG. 20. Magnets 271 in the stationary bearing portion 211 interact with magnets 270 in the impeller 203 to form a magnetic coupling. The magnets 270, 271 can be arranged to cause an attractive or repulsive magnetic force to support axial alignment of the impeller 203. It will be appreciated that any suitable drive can be used to cause rotation of the impeller 203 about the axis of rotation.”] and a magnetic stator configured to drive the magnetic rotor via a magnetic field applied to the magnetic rotor by the magnetic stator thereby causing the impeller to rotate [see Fig. 19-20 element 270 and para 88… “The impeller 203 can be further adjusted or also driven by an arrangement including magnets or electromagnets 270, 271 as schematically shown in FIG. 20. Magnets 271 in the stationary bearing portion 211 interact with magnets 270 in the impeller 203 to form a magnetic coupling. The magnets 270, 271 can be arranged to cause an attractive or repulsive magnetic force to support axial alignment of the impeller 203. It will be appreciated that any suitable drive can be used to cause rotation of the impeller 203 about the axis of rotation. For example, the magnets 270 in the impeller 203 can interact with a rotating magnetic field that is caused either by an electrical unit in the stationary bearing portion 211, i.e. axial, or by an electrical unit surrounding the impeller, i.e. radial.”] and that the scope of the disclosure includes combinations of different embodiments [see para 100… “In particular, various aspects and features of the embodiments could be combined or independently employed in a different embodiment. For instance, the features and different designs described with respect to the outer blades, the inner blades, the pin, blood flow passages through the pin or the impeller, the drive unit, magnets for axial alignment, etc., could be variably combined without departing from the scope of the invention.”]
Franano discloses in the analogous art of blood pumps [see para 2… “The present invention relates to a blood pump system that includes a pump, conduits, a control unit, and a source of power, whereby the system may be used for a variety of peripheral vascular clinical indications.”] using a impeller shaft with a distal bearing assembly with a shaft extending into the impeller and a proximal end of the shaft spaced apart from the distal end of the impeller shaft (i.e. drive shaft) and a proximal bearing assembly with concave bearing surface that mates with a convex surface of the drive shaft with the impeller shaft rotating the impeller relative to the housing, the proximal assembly for the purpose of a creating a tolerant design that can operate continuously for long periods of time without breakdown [see Fig. 2 and 12 element 130 (i.e. distal bearing), element 160 (i.e. proximal bearing), impeller shaft (i.e. element 145) and labelled figures direct below rejection to this claim And para 116… “Accordingly, the impeller assembly may freely rotate in the impeller chamber 205 on the impeller pivot 145, which is supported end to end with the bearing pins 130 and 160, in a configuration commonly known as a "double pin bearing." And para 109… “the impeller pivot 145 is pivotally supported (i.e. restrained in all degrees of freedom except rotation about a single axis)” And para 118… “the impeller assembly is a composite of the impeller shaft 145, top bearing pin 130, and bottom bearing pin 160. The composite design is beneficial with regard to the simplicity, tolerances, and cost of the machined bearing components. All of these constructions are designed to allow the motor to function in a continuous state for around a day to 1-12 weeks or longer, without breakdown.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Seiss’s first embodiment shown in Figs 25-26 by including a magnetic rotor and magnetic stator similarly to that disclosed by Figs. 19-20 because this is a subcombination of different combinations disclosed by Seiss.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Seiss by including replacing the pin with an impeller shaft and proximal and distal bearings so that the proximal bearing assembly is disposed adjacent thrust plate and is configured to rotate the impeller similarly to that disclosed by Franano because such a design would provide the advantage of allowing the impeller to be used continuously for long periods of time without breaking down.
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Dependent claims:
Regarding claim 2:
Seiss in view of Franano discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above.
However, Seiss in view of Franano fails to disclose “wherein a distal end of the impeller extends distal of a distal end of the drive shaft” as claimed.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Seiss in view of Franco to extend the impeller to extend the impeller to be distal of the distal end of the drive shaft because there are a limited number of choices for the size of the impeller relative to the distal end of the drive shaft (the impeller extends equal to the distal end of a drive shaft, the impeller is stops short of the distal end of the drive shaft or the impeller extends past the distal end of the drive shaft) and this is one of those limited number of choices.
Regarding claims 3-5, see labelled figure(s) of Franano directly below rejection to claim 1 above this claim which discloses Seiss in view of Franano’s drive shaft and bearing assemblies are positioned relative to each other.
Regarding claims 6-7, see Fig. 26 elements 335 of Seiss and para 90 of Seiss [see “Secondary blades 335 are provided to enhance blood flow through the gap 314 and to provide a hydrodynamic bearing. It will be appreciated, however, that the secondary blades 335 can be omitted.”] which discloses how Seiss in view of Franano discloses multiple washout blades (i.e. two or more).
Regarding claims 8-9: see labelled figure(s) directly below rejection to claim 1 above.
Regarding claims 10 and 17:
Seiss in view of Franano discloses the invention substantially as claimed including all the limitations of claims 1 and 11 as outlined above. Additionally, Seiss in view of Franano discloses a blood outlet aperture on the housing [see Fig. 2 element 22 and para 78 of Seiss… “Once rotation of the impeller 3 is caused by the drive unit 5, blood is pumped from the blood flow inlet 21 to the blood flow outlet 22 by means of the outer blades 31.”].
However, while Seiss in view of Franano discloses a blood outlet aperture, Seiss in view of Franano fails to disclose “a plurality of blood outlet apertures” as claimed.
It would have been obvious to one having ordinary skill at the time the invention was filed to modify Seiss in view of Franano to include a plurality of blood outlet apertures on the housing because absent unpredictable results such a modification is a mere duplication of parts which has been deemed obvious [see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)].
Regarding claim 12, see labelled figure(s) directly below rejection to claim 11 above.
Regarding claims 13-14, see Fig. 26 elements 335 of Seiss and para 90 of Seiss [see “Secondary blades 335 are provided to enhance blood flow through the gap 314 and to provide a hydrodynamic bearing. It will be appreciated, however, that the secondary blades 335 can be omitted.”] which discloses how Seiss in view of Franano discloses multiple washout blades (i.e. two or more).
Regarding claims 15-16, see labelled figures directly below rejection to claim 11 above.
Regarding claim 19, see labelled figures directly below rejection to this claim 18 above.
Regarding claim 20, see Fig. 26 elements 335 of Seiss and para 90 of Seiss [see “Secondary blades 335 are provided to enhance blood flow through the gap 314 and to provide a hydrodynamic bearing. It will be appreciated, however, that the secondary blades 335 can be omitted.”] which discloses how Seiss in view of Franano discloses at least one washout blade as claimed.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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