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 Amendment
This Office Action is responsive to the amendment filed on 20 Jun 2025. As directed by the amendment: claims 1, 9-12, and 19-20 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Claim Objections
Applicant’s arguments, see Remarks, filed 20 Jun 2025, with respect to the claim objections have been fully considered and are persuasive in light of the claim amendments. The claim objections have been withdrawn.
Response to Rejections 35 U.S.C 112
Applicant’s arguments, see Remarks, filed 20 Jun 2025, with respect to the claim rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the claim amendments. The claim objections under 35 U.S.C. 112(b) have been withdrawn.
Response to Rejections 35 U.S.C 103
Applicant's arguments filed 20 Jun 2025 with respect to the claim rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that “In the design that is described in Bredenbreuker and shown in the above figure, the inner lining of the frame and/or the outer skin to the frame would prevent suction of surrounding tissue such that there would be no need to additionally limit the width of the cells of the frame to prevent suction of tissue” (Remarks, pages 8-9). Although Examiner agrees with this argument, Applicant fails to offer an explanation as to the significance and effect of the claimed cell size. Therefore, the rejections of claims 1 and 12 under 35 U.S.C. 103 are maintained below.
Furthermore, before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to make the width of each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion less than 2 mm, for the purpose of improving structural integrity, since applicant has not disclosed that having cells with a width less than 2 mm provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that a frame with cells of a width less than 2 mm provides a specific advantage, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
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.
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 1-8 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bredenbreuker et al. (US Patent Application Publication 2014/0255176, previously cited), hereinafter Bredenbreuker, and Salahieh et al. (US Patent Application Publication 2020/0114053, previously cited), hereinafter Salahieh.
Regarding claim 1, Bredenbreuker discloses an apparatus comprising:
a left-ventricular assist device (Fig. 1, paragraphs [0074]-[0076], heart pump 8) comprising:
a tube (Fig. 13, paragraph [0101], exterior skin 43') configured to traverse an aortic valve of a subject (paragraph [0025]), such that a proximal end of the tube is disposed within an aorta of the subject and a distal end of the tube is disposed within a left ventricle of the subject (Fig. 10, paragraphs [0095], [0097]);
a frame disposed within at least a portion of the tube (Fig. 13, paragraph [0101], reinforcement elements 49), the frame defining a plurality of cells (annotated Fig. 13 below), and the frame being configured such that, in a non-radially-constrained configuration of the frame, the frame comprises a generally cylindrical portion (paragraph [0101], "The stretch-resistant element 50 is cylindrically shaped and has a dimension such that if it is stretched by the reinforcement elements 49, the housing skin 43' is also correspondingly stretched.");
an inner lining that lines at least one of the cylindrical portion of the frame (Fig. 13, paragraphs [0101]-[0102], housing 39'''); and
an impeller disposed inside the frame, the impeller being configured to rotate such as to pump blood from the left ventricle to the aorta (Fig. 10, paragraph [0095], rotor 10'''; paragraph [0076]).
Bredenbreuker does not explicitly disclose that a width of each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, is less than 2 mm.
However, Salahieh teaches an intravascular blood pump (paragraph [0010]), comprising an impeller that is between 0.5 and 10 cm in length (paragraph [0153]), and between 1 and 10 mm in diameter (paragraph [0156]). Thus, it is possible for the width of the cells of the frame surrounding the impeller (Fig. 2, paragraph [0099], apertures 1130 in expandable members 1108 and 1110) to be smaller than 2 mm.
Although neither Bredenbreuker nor Salahieh explicitly discloses that each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, is less than 2 mm, it would have been an obvious matter of design choice to do so, for the purpose of improving structural integrity of the frame, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 2, the apparatus according to claim 1 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker does not explicitly disclose that the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is between 1.4 mm and 1.6 mm.
However, Salahieh teaches an intravascular blood pump (paragraph [0010]), comprising an impeller that is between 0.5 and 10 cm in length (paragraph [0153]), and between 1 and 10 mm in diameter (paragraph [0156]). Thus, it is possible for the width of the cells of the frame surrounding the impeller (Fig. 2, paragraph [0099], apertures 1130 in expandable members 1108 and 1110) to be between 1.4 mm and 1.6 mm.
Although neither Bredenbreuker nor Salahieh explicitly discloses that each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, is between 1.4 mm and 1.6 mm, it would have been an obvious matter of design choice to do so, for the purpose of improving structural integrity of the frame, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 3, the apparatus according to claim 1 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker does not explicitly disclose that the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is between 1.6 mm and 1.8 mm.
However, Salahieh teaches an intravascular blood pump (paragraph [0010]), comprising an impeller that is between 0.5 and 10 cm in length (paragraph [0153]), and between 1 and 10 mm in diameter (paragraph [0156]). Thus, it is possible for the width of the cells of the frame surrounding the impeller (Fig. 2, paragraph [0099], apertures 1130 in expandable members 1108 and 1110) to be between 1.6 mm and 1.8 mm.
Although neither Bredenbreuker nor Salahieh explicitly discloses that each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, is between 1.6 mm and 1.8 mm, it would have been an obvious matter of design choice to do so, for the purpose of improving structural integrity of the frame, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 4, the apparatus according to claim 1 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that the impeller is configured such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller (paragraphs [0036], [0039]).
Regarding claim 5, the apparatus according to claim 4 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that the gap is less than 1 mm (paragraph [0039], "the pump gap should be between 0.01 mm and 1 mm").
Regarding claim 6, the apparatus according to claim 5 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that the gap is less than 0.4 mm (paragraph [0039], "the pump gap should be between 0.01 mm and 1 mm, in particular between 0.01 mm and 0.3 mm, further advantageously between 0.03 mm and 0.15 mm.").
Regarding claim 7, the apparatus according to claim 1 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that the impeller is stabilized with respect to the frame (paragraphs [0036], [0039], [0092], the mention of an optimal pump gap makes it clear that the impeller must be stable within the frame).
Regarding claim 8, the apparatus according to claim 7 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that:
the left-ventricular assist device further comprises an axial shaft (Fig. 1, paragraph [0075], drive shaft 6);
the impeller is coupled to the axial shaft (Fig. 1, paragraph [0075], "The heart pump 8 has a rotor inside, which may be driven by a drive shaft 6"); and
the impeller is stabilized with respect to the frame by the impeller being held in a radially-fixed position with respect to the axial shaft (paragraphs [0036], [0039], [0092], the mention of an optimal pump gap makes it clear that the impeller must be stable within the frame).
Bredenbreuker does not explicitly disclose that the the left-ventricular assist device further comprises proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings, nor that the axial shaft is rigid.
However, Salahieh further teaches an axial shaft (Fig. 3C, paragraph [0114], second section 348 of drive cable) and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame (Fig. 3C, paragraph [0115], bearings 349 and 361), the axial shaft passing through the proximal and distal radial bearings (paragraph [0115], "The proximal struts in proximal expandable member 343 extend to and are secured to shaft section 345, which is coupled to bearing 361, through which the drive cable extends ... The proximal end of central tubular member 346 is coupled to bearing 349, as shown in FIG. 3C, through which the drive cable extends and rotates."); and wherein the axial shaft is rigid (paragraph [0114], "the second and fourth sections can be stiffer").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bredenbreuker with the teachings of Salahieh so that the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings; and the axial shaft is rigid, because doing so axially stabilizes the axial shaft (Salahieh, paragraph [0093]).
Regarding claim 10, the apparatus according to claim 7 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that:
the left-ventricular assist device further comprises an axial shaft (Fig. 1, paragraph [0075], drive shaft 6);
the impeller is coupled to the axial shaft (Fig. 1, paragraph [0075], "The heart pump 8 has a rotor inside, which may be driven by a drive shaft 6"); and
the impeller is stabilized with respect to the frame (paragraphs [0036], [0039], [0092], the mention of an optimal pump gap makes it clear that the impeller must be stable within the frame).
Bredenbreuker does not explicitly disclose that the left-ventricular assist device further comprises proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings, nor that the impeller is stabilized with respect to the frame by a ratio of a length of the generally cylindrical portion of the frame to a total length of the frame being more than 1:2, such as to substantially prevent vibration of the frame with respect to the axial shaft.
However, Salahieh further teaches an axial shaft (Fig. 3C, paragraph [0114], second section 348 of drive cable) and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame (Fig. 3C, paragraph [0115], bearings 349 and 361), the axial shaft passing through the proximal and distal radial bearings (paragraph [0115], "The proximal struts in proximal expandable member 343 extend to and are secured to shaft section 345, which is coupled to bearing 361, through which the drive cable extends ... The proximal end of central tubular member 346 is coupled to bearing 349, as shown in FIG. 3C, through which the drive cable extends and rotates.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bredenbreuker with the teachings of Salahieh so that the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings; and the axial shaft is rigid, because doing so axially stabilizes the axial shaft (Salahieh, paragraph [0093]).
Salahieh does not explicitly disclose that a ratio of a length of the generally cylindrical portion of the frame to a total length of the frame is more than 1:2. However, it would have been an obvious matter of design choice to make the frame so that the ratio of a length of the generally cylindrical portion of the frame to a total length of the frame is more than 1:2, for the purpose of improving maneuverability within the subject's blood vessels, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 11, the apparatus according to claim 10 is obvious over Bredenbreuker and Salahieh, as explained above. Neither Bredenbreuker nor Salahieh explicitly discloses that the ratio of the length of the generally cylindrical portion of the frame to the total length of the frame is more than 2:3. However, it would have been an obvious matter of design choice to make the frame so that the ratio of a length of the generally cylindrical portion of the frame to a total length of the frame is more than 2:3, for the purpose of improving maneuverability within the subject's blood vessels, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 12, Bredenbreuker discloses a method, comprising:
deploying a left-ventricular assist device within a body of a subject (Fig. 1, paragraphs [0074]-[0076], heart pump 8) by:
placing a tube of the left-ventricular assist device (Fig. 13, paragraph [0101], exterior skin 43') such that the tube traverses an aortic valve of the subject (paragraph [0025]), such that a proximal end of the tube is disposed within an aorta of the subject and a distal end of the tube is disposed within a left ventricle of the subject (Fig. 10, paragraphs [0095], [0097]),
a frame disposed within at least a portion of the tube (Fig. 13, paragraph [0101], reinforcement elements 49), the frame defining a plurality of cells (annotated Fig. 13 below), and the frame being configured such that, in a non-radially-constrained configuration of the frame, the frame comprises a generally cylindrical portion (paragraph [0101], "The stretch-resistant element 50 is cylindrically shaped and has a dimension such that if it is stretched by the reinforcement elements 49, the housing skin 43' is also correspondingly stretched."), and
an inner lining that lines at least one of the cylindrical portion of the frame (Fig. 13, paragraphs [0101]-[0102], housing 39'''); and
an impeller disposed inside the frame, the impeller being configured to rotate such as to pump blood from the left ventricle to the aorta (Fig. 10, paragraph [0095], rotor 10'''; paragraph [0076]).
Bredenbreuker does not explicitly disclose that a width of each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, is less than 2 mm.
However, Salahieh teaches an intravascular blood pump (paragraph [0010]), comprising an impeller that is between 0.5 and 10 cm in length (paragraph [0153]), and between 1 and 10 mm in diameter (paragraph [0156]). Thus, it is possible for the width of the cells of the frame surrounding the impeller (Fig. 2, paragraph [0099], apertures 1130 in expandable members 1108 and 1110) to be smaller than 2 mm.
Although neither Bredenbreuker nor Salahieh explicitly discloses that each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, is less than 2 mm, it would have been an obvious matter of design choice to do so, for the purpose of improving structural integrity of the frame, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 13, the method according to claim 12 is obvious over Bredenbreuker, as explained above. Bredenbreuker does not explicitly disclose that the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is between 1.4 mm and 1.6 mm.
However, Salahieh teaches an intravascular blood pump (paragraph [0010]), comprising an impeller that is between 0.5 and 10 cm in length (paragraph [0153]), and between 1 and 10 mm in diameter (paragraph [0156]). Thus, it is possible for the width of the cells of the frame surrounding the impeller (Fig. 2, paragraph [0099], apertures 1130 in expandable members 1108 and 1110) to be between 1.4 mm and 1.6 mm.
Although neither Bredenbreuker nor Salahieh explicitly discloses that each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, is between 1.4 mm and 1.6 mm, it would have been an obvious matter of design choice to do so, for the purpose of improving structural integrity of the frame, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 14, the method according to claim 12 is obvious over Bredenbreuker, as explained above. Bredenbreuker does not explicitly disclose that the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is between 1.6 mm and 1.8 mm.
However, Salahieh teaches an intravascular blood pump (paragraph [0010]), comprising an impeller that is between 0.5 and 10 cm in length (paragraph [0153]), and between 1 and 10 mm in diameter (paragraph [0156]). Thus, it is possible for the width of the cells of the frame surrounding the impeller (Fig. 2, paragraph [0099], apertures 1130 in expandable members 1108 and 1110) to be between 1.6 mm and 1.8 mm.Although neither Bredenbreuker nor Salahieh explicitly discloses that each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, is between 1.6 mm and 1.8 mm, it would have been an obvious matter of design choice to do so, for the purpose of improving structural integrity of the frame, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 15, the method according to claim 12 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that the impeller is configured such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller (paragraphs [0036], [0039]).
Regarding claim 16, the method according to claim 15 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that the gap is less than 1 mm (paragraph [0039], "the pump gap should be between 0.01 mm and 1 mm").
Regarding claim 17, the method according to claim 16 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that the gap is less than 0.4 mm (paragraph [0039], "the pump gap should be between 0.01 mm and 1 mm, in particular between 0.01 mm and 0.3 mm, further advantageously between 0.03 mm and 0.15 mm.").
Regarding claim 18, the method according to claim 12 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that the impeller is stabilized with respect to the frame (paragraphs [0036], [0039], [0092], the mention of an optimal pump gap makes it clear that the impeller must be stable within the frame).
Regarding claim 19, the method according to claim 18 is obvious over Bredenbreuker, as explained above. Bredenbreuker further discloses that:
the left-ventricular assist device further comprises an axial shaft (Fig. 1, paragraph [0075], drive shaft 6); and
the impeller is stabilized with respect to the frame by the impeller being held in a radially-fixed position with respect to the axial shaft (paragraphs [0036], [0039], [0092], the mention of an optimal pump gap makes it clear that the impeller must be stable within the frame).
Bredenbreuker does not explicitly disclose that the the left-ventricular assist device further comprises proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings, nor that the axial shaft is rigid.
However, Salahieh further teaches an axial shaft (Fig. 3C, paragraph [0114], second section 348 of drive cable) and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame (Fig. 3C, paragraph [0115], bearings 349 and 361), the axial shaft passing through the proximal and distal radial bearings (paragraph [0115], "The proximal struts in proximal expandable member 343 extend to and are secured to shaft section 345, which is coupled to bearing 361, through which the drive cable extends ... The proximal end of central tubular member 346 is coupled to bearing 349, as shown in FIG. 3C, through which the drive cable extends and rotates."); and wherein the axial shaft is rigid (paragraph [0114], "the second and fourth sections can be stiffer").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bredenbreuker with the teachings of Salahieh so that the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings; and the axial shaft is rigid, because doing so axially stabilizes the axial shaft (Salahieh, paragraph [0093]).
Regarding claim 20, the method according to claim 18 is obvious over Bredenbreuker and Salahieh, as explained above. Bredenbreuker further discloses that:
the left-ventricular assist device further comprises an axial shaft (Fig. 1, paragraph [0075], drive shaft 6); and
the impeller is stabilized with respect to the frame by the impeller being held in a radially-fixed position with respect to the axial shaft (paragraphs [0036], [0039], [0092], the mention of an optimal pump gap makes it clear that the impeller must be stable within the frame).
Bredenbreuker does not explicitly disclose that the the left-ventricular assist device further comprises proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings, nor that the impeller is stabilized with respect to the frame by a ratio of a length of the generally cylindrical portion of the frame to a total length of the frame being more than 1:2, such as to substantially prevent vibration of the frame with respect to the axial shaft.
However, Salahieh further teaches an axial shaft (Fig. 3C, paragraph [0114], second section 348 of drive cable) and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame (Fig. 3C, paragraph [0115], bearings 349 and 361), the axial shaft passing through the proximal and distal radial bearings (paragraph [0115], "The proximal struts in proximal expandable member 343 extend to and are secured to shaft section 345, which is coupled to bearing 361, through which the drive cable extends ... The proximal end of central tubular member 346 is coupled to bearing 349, as shown in FIG. 3C, through which the drive cable extends and rotates.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bredenbreuker with the teachings of Salahieh so that the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings; and the axial shaft is rigid, because doing so axially stabilizes the axial shaft (Salahieh, paragraph [0093]).
Salahieh does not explicitly disclose that a ratio of a length of the generally cylindrical portion of the frame to a total length of the frame is more than 1:2. However, it would have been an obvious matter of design choice to make the frame so that the ratio of a length of the generally cylindrical portion of the frame to a total length of the frame is more than 1:2, for the purpose of improving maneuverability within the subject's blood vessels, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bredenbreuker et al. (US Patent Application Publication 2014/0255176, previously cited), hereinafter Bredenbreuker, Salahieh et al. (US Patent Application Publication 2020/0114053, previously cited), hereinafter Salahieh, and Pfeffer et al. (US Patent Application Publication 2018/0228952, previously cited), hereinafter Pfeffer.
Regarding claim 9, the apparatus according to claim 8 is obvious over Bredenbreuker and Salahieh, as explained above. Neither Bredenbreuker nor Salahieh explicitly discloses that the impeller comprises bushings that are disposed around the axial shaft, and at least one of the bushings is configured to be slidable with respect to the axial shaft, wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing and the axial shaft.
However, Pfeffer teaches a percutaneous blood pump (paragraph [0012]) wherein the impeller comprises bushings that are disposed around the axial shaft (Fig. 6, paragraph [0094], distal rotor bearing 17 comprising bearing washer 15), and at least one of the bushings is configured to be slidable with respect to the axial shaft (paragraph [0094], "the distal spacer sleeve 16 of the rotor 3.2 contacts the bearing washer 15 in the manner of a sliding bearing"), wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing and the axial shaft (paragraph [0096], blood or serum coats the bearing washer 15).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bredenbreuker and Salahieh with the teachings of Pfeffer so that the impeller comprises bushings that are disposed around the axial shaft, and at least one of the bushings is configured to be slidable with respect to the axial shaft, wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing and the axial shaft, because doing so reduces play of the drive shaft (Pfeffer, paragraph [0094]) while also enabling smooth rotation of the impeller.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-19 of U.S. Patent No. 12329957 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite an apparatus comprising a ventricular assist device comprising a tube, a frame with cells that have a width less than 2 mm, an inner lining, and an impeller. The claims of the instant application are broader in scope than the claims of U.S. Patent No. 12329957 B2, and thus the subject matter of the claims are fully encompassed by the claims of U.S. Patent No. 12329957 B2. Therefore, instant claims 1-20 are anticipated by claims 1 and 11-19 of U.S. Patent No. 12329957 B2.
A brief matching of the claims in each document is provided below.
Application No. 17/677,571 (Instant Application)
Patent No. US 12329957 B2 (Reference)
Claim
Element
Claim
Element
1
An apparatus, comprising:
1
An apparatus, comprising:
1
a left-ventricular assist device comprising:
1
a ventricular assist device comprising:
1
a tube configured to traverse an aortic valve of a subject, such that a proximal end of the tube is disposed within an aorta of the subject and a distal end of the tube is disposed within a left ventricle of the subject;
1
a tube that defines one or more blood outlet openings, a portion of the tube being disposed outside the frame and coupled to the generally cylindrical portion of the frame, such that the portion of the tube conforms with a structure of struts of the frame;
1
a frame disposed within at least a portion of the tube, the frame defining a plurality of cells, and the frame being configured such that, in a non-radially-constrained configuration of the frame, the frame comprises a cylindrical portion, a width of each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, being less than 2 mm;
1
a frame comprising struts that define a plurality of cells, the frame being configured such that, in a non-radially-constrained configuration of the frame, the frame comprises a generally cylindrical portion;
11
The apparatus according to claim 1, wherein, in the non-radially-constrained configuration of the frame, a width of each of each of the cells within the generally cylindrical portion as measured around a circumference of the generally cylindrical portion is less than 2 mm.
1
an inner lining that lines at least some of the cylindrical portion of the frame; and
1
an inner lining coupled to an inside of the generally cylindrical portion of the frame, such as to provide the generally cylindrical portion of the frame with a smooth inner surface;
1
an impeller disposed inside the frame, the impeller being configured to rotate such as to pump blood from the left ventricle to the aorta.
1
an impeller disposed at least partially inside the generally cylindrical portion of the frame and configured to pump blood through the tube and out of the one of more blood outlet openings.
2
The apparatus according to claim 1, wherein the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is between 1.4 mm and 1.6 mm.
12
The apparatus according to claim 11, wherein, in the non-radially-constrained configuration of the frame, the width of each of the cells within the generally cylindrical portion as measured around the circumference of the generally cylindrical portion is between 1.4 mm and 1.6 mm.
3
The apparatus according to claim 1, wherein the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is between 1.6 mm and 1.8 mm.
13
The apparatus according to claim 11, wherein, in the non-radially-constrained configuration of the frame, the width of each of the cells within the generally cylindrical portion as measured around the circumference of the generally cylindrical portion is between 1.6 mm and 1.8 mm.
4
The apparatus according to claim 1, wherein the impeller is configured such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
14
The apparatus according to claim 1, wherein the impeller is stabilized with respect to the frame such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
5
The apparatus according to claim 4, wherein the gap is less than 1 mm.
15
The apparatus according to claim 14, wherein the impeller is stabilized with respect to the frame such that a gap of less than 1 mm is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
6
The apparatus according to claim 5, wherein the gap is less than 0.4 mm.
16
The apparatus according to claim 15, wherein the impeller is stabilized with respect to the frame such that a gap of less than 0.4 mm is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
7
The apparatus according to claim 1, wherein the impeller is stabilized with respect to the frame.
14
The apparatus according to claim 1, wherein the impeller is stabilized with respect to the frame such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
8
The apparatus according to claim 7, wherein:
17
The apparatus according to claim 14, wherein:
8
the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, and proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings;
17
the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings;
8
the impeller is coupled to the axial shaft; and
17
the impeller is coupled to the axial shaft; and
8
the impeller is stabilized with respect to the frame by the impeller being held in a radially-fixed position with respect to the axial shaft and the axial shaft being rigid.
17
the impeller is stabilized with respect to the frame by the impeller being held in a radially-fixed position with respect to the axial shaft and the axial shaft being rigid.
9
The apparatus according to claim 8, wherein the impeller comprises bushings that are disposed around the axial shaft, and at least one of the bushings is configured to be slidable with respect to the axial shaft, wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing and the axial shaft.
18
The apparatus according to claim 17, wherein the impeller comprises bushings that are disposed around the axial shaft, and at least one of the bushings is configured to be slidable with respect to the axial shaft, wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing and the axial shaft.
10
The apparatus according to claim 7, wherein:
19
The apparatus according to claim 18, wherein:
10
the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, and proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings;
19
the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings;
10
the impeller is coupled to the axial shaft; and
19
the impeller is coupled to the axial shaft; and
10
the impeller is stabilized with respect to the frame by a ratio of a length of the cylindrical portion of the frame to a total length of the frame being more than 1:2, such as to prevent vibration of the frame with respect to the axial shaft.
19
the impeller is stabilized with respect to the frame by a ratio of a length of the generally cylindrical portion of the frame to a total length of the frame being more than 1:2, such as to substantially prevent vibration of the frame with respect to the axial shaft.
11
The apparatus according to claim 10, wherein the ratio of the length of the cylindrical portion of the frame to the total length of the frame is more than 2:3.
12
A method, comprising:
1
An apparatus, comprising:
12
deploying a left-ventricular assist device within a body of a subject by:
1
a ventricular assist device comprising:
12
placing a tube of the left-ventricular assist device such that the tube traverses an aortic valve of the subject, such that a proximal end of the tube is disposed within an aorta of the subject and a distal end of the tube is disposed within a left ventricle of the subject,
1
a tube that defines one or more blood outlet openings, a portion of the tube being disposed outside the frame and coupled to the generally cylindrical portion of the frame, such that the portion of the tube conforms with a structure of struts of the frame;
12
wherein the left-ventricular assist device further comprises:
1
a frame comprising struts that define a plurality of cells, the frame being configured such that, in a non-radially-constrained configuration of the frame, the frame comprises a generally cylindrical portion;
12
a frame disposed within at least a portion of the tube, the frame defining a plurality of cells, and the frame being configured such that, in a non-radially-constrained configuration of the frame, the frame comprises a cylindrical portion, a width of each
11
The apparatus according to claim 1, wherein, in the non-radially-constrained configuration of the frame, a width of each of each of the cells within the generally cylindrical portion as measured around a circumference of the generally cylindrical portion is less than 2 mm.
12
an inner lining that lines at least some of the cylindrical portion of the frame; and
1
an inner lining coupled to an inside of the generally cylindrical portion of the frame, such as to provide the generally cylindrical portion of the frame with a smooth inner surface;
12
operating an impeller to rotate within the frame such as to pump blood from the left ventricle to the aorta.
1
an impeller disposed at least partially inside the generally cylindrical portion of the frame and configured to pump blood through the tube and out of the one of more blood outlet openings.
13
The method according to claim 12, wherein the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is between 1.4 mm and 1.6 mm.
12
The apparatus according to claim 11, wherein, in the non-radially-constrained configuration of the frame, the width of each of the cells within the generally cylindrical portion as measured around the circumference of the generally cylindrical portion is between 1.4 mm and 1.6 mm.
14
The method according to claim 12, wherein the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is between 1.6 mm and 1.8 mm.
13
The apparatus according to claim 11, wherein, in the non-radially-constrained configuration of the frame, the width of each of the cells within the generally cylindrical portion as measured around the circumference of the generally cylindrical portion is between 1.6 mm and 1.8 mm.
15
The method according to claim 12, wherein the impeller is configured such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
14
The apparatus according to claim 1, wherein the impeller is stabilized with respect to the frame such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
16
The method according to claim 15, wherein the gap is less than 1 mm.
15
The apparatus according to claim 14, wherein the impeller is stabilized with respect to the frame such that a gap of less than 1 mm is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
17
The method according to claim 16, wherein the gap is less than 0.4 mm.
16
The apparatus according to claim 15, wherein the impeller is stabilized with respect to the frame such that a gap of less than 0.4 mm is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
18
The method according to claim 12, wherein the impeller is stabilized with respect to the frame.
14
The apparatus according to claim 1, wherein the impeller is stabilized with respect to the frame such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
19
The method according to claim 18, wherein:
17
The apparatus according to claim 14, wherein:
19
the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, and proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings;
17
the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings;
19
the impeller is coupled to the axial shaft; and
17
the impeller is coupled to the axial shaft; and
19
the impeller is stabilized with respect to the frame by the impeller being held in a radially-fixed position with respect to the axial shaft and the axial shaft being rigid.
17
the impeller is stabilized with respect to the frame by the imp