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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/18/2026 has been entered.
Response to Arguments
Applicant's arguments, filed 02/28/2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant contends that “the structural difference between the claimed subject matter and the prior art is the specific positioning of the covering of the protective braid,” where “D’Ambrosio does not describe covering a protective braid in this manner” and “Tuval, which was cited in this regard (a) does not describe covering a protective braid that is placed over a distal conical portion of the frame and (b) does not describe selective covering of portions of the braid.” Additionally, Applicant contends that “neither Tuval nor D’Ambrosio individually describes the specific positioning of the covering of the protective braid (i.e., the protective braid is covered along a distal part of the distal conical portion of the frame)” and that “it would not be obvious to arrive at claim 1 based on Tuval and D’Ambrosio” since “an advantage of the protective braid being covered along a distal part of the distal conical portion of the frame, is to prevent thrombi from forming on the protective braid within the distal part of the distal conical portion of the frame.” Examiner respectfully disagrees.
In response to Applicant’s argument that “the structural difference between the claimed subject matter and the prior art is the specific positioning of the covering of the protective braid,” where “D’Ambrosio does not describe covering a protective braid in this manner,” D’Ambrosio is utilized within the combination of references to teach a protective braid disposed over a distal portion of the frame (Figure 3, filter 130, which Examiner interprets as equivalent to a protective braid, and the plurality of struts 300, 302, and 304, which Examiner interprets as equivalent to a frame, ¶[0085], which describes “filaments of a woven filter 130”), not the specific positioning of the covering of the protective braid. Tuval is utilized to teach that the protective braid is covered along a distal part of the distal conical portion of the frame (¶[0560], where “the struts are covered with a biocompatible blood-impermeable material 250, such as polyurethane, polyester, and/or silicone … the distal tip portion includes a braided shape-memory material 260 … braided shape-memory material is at least partially covered with a biocompatible blood-impermeable material 262, such as polyurethane, polyester, and/or silicone”). Consequently, the combination of Tuval and D’Ambrosio teaches the protective braid with specific positioning of the covering of the protective braid, with further reasoning as explained below.
In response to Applicant’s argument that “Tuval, which was cited in this regard (a) does not describe covering a protective braid that is placed over a distal conical portion of the frame and (b) does not describe selective covering of portions of the braid,” Examiner notes that the combination of Tuval and D’Ambrosio teaches these limitations. Applicant’s independent claim 1 encompasses “a ventricular assist device comprising: … a protective braid disposed over a distal portion of the frame … wherein the protective braid is covered along a distal part of the distal conical portion of the frame.” Under the broadest reasonable interpretation, the ventricular assist device comprises a protective braid that is covered along a distal part of the distal conical portion of the frame, where said covering encompasses the entire protective braid as well as the claimed distal part. The term “comprising” is an inclusive term that does not exclude additional, unrecited elements. Although Applicant claims that the claim language encompasses selective covering of portions of the braid, the claim does not explicitly state where such a covering must be located since Applicant does not positively recite the selective covering nor does Applicant disavow covering the entire portion of the protective braid. Furthermore, Examiner considers the combination of Tuval and D’Ambrosio to be sufficient to teach the limitation that the protective braid is covered along a distal part of the distal conical portion of the frame since D’Ambrosio teaches a protective braid disposed over a distal portion of the frame (Figure 3, filter 130, which Examiner interprets as equivalent to a protective braid, and the plurality of struts 300, 302, and 304, which Examiner interprets as equivalent to a frame, ¶[0085], which describes “filaments of a woven filter 130”) and Tuval teaches that the protective braid is covered along a distal part of the distal conical portion of the frame (¶[0560], where “the struts are covered with a biocompatible blood-impermeable material 250, such as polyurethane, polyester, and/or silicone … the distal tip portion includes a braided shape-memory material 260 … braided shape-memory material is at least partially covered with a biocompatible blood-impermeable material 262, such as polyurethane, polyester, and/or silicone”). The braid of Tuval is at least partially covered by a blood-impermeable material such that the distal part of the protective braid is covered as well. Therefore, the combination of Tuval and D’Ambrosio teaches Applicant’s claimed limitations.
In response to Applicant’s argument that “neither Tuval nor D'Ambrosio individually describes the specific positioning of the covering of the protective braid (i.e., the protective braid is covered along a distal part of the distal conical portion of the frame),” where Applicant's arguments are against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that “it would not be obvious to arrive at claim 1 based on Tuval and D’Ambrosio” since “an advantage of the protective braid being covered along a distal part of the distal conical portion of the frame, is to prevent thrombi from forming on the protective braid within the distal part of the distal conical portion of the frame,” a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, as explained above, the combination of Tuval and D’Ambrosio teaches the protective braid being covered along a distal part of the distal conical portion of the frame, and further teaches that the struts are covered with a biocompatible blood-impermeable material, where the blood-impermeable material is capable of preventing thrombus-formation since the blood-impermeable material prevents the adhesion and permeation of blood that would create thrombi (Tuval ¶[0560], where “the struts are covered with a biocompatible blood-impermeable material 250, such as polyurethane, polyester, and/or silicone … the distal tip portion includes a braided shape-memory material 260 … braided shape-memory material is at least partially covered with a biocompatible blood-impermeable material 262, such as polyurethane, polyester, and/or silicone”), such that Tuval as modified is capable of performing the intended use.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (hereinafter “Tuval”) (U.S. Pub. No. 2019/0209758 A1) in view of D'Ambrosio et al. (hereinafter “D’Ambrosio”) (U.S. Pub. No. 2021/0236797 A1).
Regarding claim 1, Tuval teaches an apparatus, comprising: a ventricular assist device (¶[0009], where “a ventricular assist device includes an impeller disposed upon an axial shaft, with a frame disposed around the impeller”) comprising:
a frame comprising struts that define a plurality of cells (Figure 4, Element 111, where the rigid struts form a plurality of cells, ¶[0009], where “a frame [is] disposed around the impeller,” ¶[0454], where “the frame includes a plurality of rigid struts 111 that are disposed in parallel to each other, and in parallel to the longitudinal axis of the frame”), the frame being configured such that, in a non-radially-constrained configuration of the frame (¶[0387], which teaches “the frame being configured to … assume non-radially-constrained configuration”), the frame comprises a generally cylindrical central portion (¶[0461], where “frame 34 is shaped such that the frame defines … a central cylindrical portion 38”);
a pump-outlet tube that defines one or more blood outlet openings (¶[0352], which teaches “one or more blood outlet openings within the proximal portion of the tube,” ¶[0353], where “a blood pump is configured to be disposed within the tube, and to pump blood … out of the tube into the aorta through the one or more blood outlet openings”), a portion of the pump-outlet tube being disposed outside the frame (Figure 2A, proximal portion 106 of tube 24 and frame 34), a lining coupled to the frame (¶[0530], where “the flexible material is coupled to frame 34, such that the flexible material defines a lumen 188”);
an impeller disposed inside the frame (¶[0009], where “a frame [is] disposed around the impeller”) and configured to pump blood through the tube and out of the one of more blood outlet openings (¶[0009], where “the impeller is configured to pump blood from the left ventricle into the aorta by rotating … the proximal portion of the tube defines one or more blood outlet openings, via which blood flows from the tube into the ascending aorta, during operation of the impeller”);
a braid at a distal portion of the frame (¶[0560], where “the distal tip portion includes a braided shape-memory material 260”);
wherein the distal portion of the frame is conical (¶[0461], where “frame 34 is shaped such that the frame defines … a distal conical portion 40”); and
wherein the protective braid is covered along a distal part of the distal conical portion of the frame (¶[0560], where “the struts are covered with a biocompatible blood-impermeable material 250, such as polyurethane, polyester, and/or silicone … the distal tip portion includes a braided shape-memory material 260 … braided shape-memory material is at least partially covered with a biocompatible blood-impermeable material 262, such as polyurethane, polyester, and/or silicone”), in order to prevent thrombi from forming on the protective braid within the distal part of the distal conical portion of the frame (Examiner takes the position that the blood-impermeable material is capable of preventing thrombus-formation since the blood-impermeable material prevents the adhesion and permeation of blood that would create thrombi.).
Although Tuval teaches a lining that is coupled to the frame of the device and a braided distal portion at the tip of the device, Tuval does not explicitly teach an inner lining coupled to an inside of the frame, a protective braid disposed over a distal portion of the frame and configured to block structures from the subject's left ventricle from entering into the frame, a proximal end of the protective braid being embedded between the pump-outlet tube and the inner lining, such that, during crimping of the frame, the braid becomes crimped with the pump-outlet tube and the inner lining, thereby preventing the braid from moving with respect to pump-outlet tube or the inner lining, nor that the protective braid extends until the end of the distal conical portion of the frame.
D’Ambrosio teaches an intravascular blood pump has an intake filter that reduces risk of heart tissue being sucked into an intake port of the pump (Abstract), and further teaches an inner lining coupled to an inside of the frame (¶[0072], where “an inside central portion of the housing 122 may have a sleeve or coating 310 (best seen in FIG. 11), which defines a channel, through which the blood is pumped by the impeller 200,” ¶[0082], which describes an “inside sleeve or coating 310 of the housing 122”);
a protective braid disposed over a distal portion of the frame (Figure 3, filter 130, which Examiner interprets as equivalent to a protective braid, and the plurality of struts 300, 302, and 304, which Examiner interprets as equivalent to a frame, ¶[0085], which describes “filaments of a woven filter 130”) and configured to block structures from the subject's left ventricle from entering into the frame (¶[0052], where “an intake filter that reduces the risk of heart tissue being sucked into an intake port of the intravascular blood pump”), and
a proximal end of the protective braid being embedded between the pump-outlet tube and the inner lining (¶[0082], where “a proximal outer foil 522 is disposed on top of the intermediate tubular housing part 504. The proximal tubular section 516 of the expandable filter 130 is sandwiched between the proximal outer foil 522 and the intermediate tubular housing part 504, albeit only at a distal region of the proximal outer foil 522”), such that, during crimping of the frame, the braid becomes crimped with the pump-outlet tube and the inner lining, thereby preventing the braid from moving with respect to pump-outlet tube or the inner lining, and that the protective braid extends until the end of the distal conical portion of the frame (Figure 3, filter 130, plurality of struts 300, 302, and 304, which Examiner interprets as equivalent to a frame, and where the woven filter extends until the end of a tapered portion equivalent to a conical portion of the frame).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches an inner lining coupled to an inside of the frame, a protective braid disposed over a distal portion of the frame and configured to block structures from the subject's left ventricle from entering into the frame, a proximal end of the protective braid being embedded between the pump-outlet tube and the inner lining, such that, during crimping of the frame, the braid becomes crimped with the pump-outlet tube and the inner lining, thereby preventing the braid from moving with respect to pump-outlet tube or the inner lining, nor that the protective braid extends until the end of the distal conical portion of the frame, with the invention of Tuval in order to define a channel for the blood to be pumped through by the impeller (D’Ambrosio ¶[0072]), to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]), and to prevent damage to the proximal tubular section of the protective braid (D’Ambrosio ¶[0082]).
Regarding claim 2, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the inner lining is coupled to the generally cylindrical central portion of the frame, such as to provide the generally cylindrical portion of the frame with a smooth inner surface (¶[0072], where “an inside central portion of the housing 122 may have a sleeve or coating 310 (best seen in FIG. 11), which defines a channel, through which the blood is pumped by the impeller 200”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to cobine the above-described teachings of D’Ambrosio, which teaches that the inner lining is coupled to the generally cylindrical central portion of the frame, such as to provide the generally cylindrical portion of the frame with a smooth inner surface, with the invention of Tuval in order to define a channel for the blood to be pumped through by the impeller (D’Ambrosio ¶[0072]).
Regarding claim 3, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
Tuval teaches that the portion of the pump-outlet tube is coupled to the generally cylindrical central portion of the frame, such that the portion of the pump-outlet tube conforms with a structure of struts of the frame (Figure 2A, proximal portion 106 of tube 24 and cylindrical central portion 44).
Regarding claim 4, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
Tuval teaches that the impeller is disposed at least partially inside the generally cylindrical central portion of the frame (Figure 2A, impeller 50, ¶[0009], where “an impeller is disposed upon an axial shaft, with a frame disposed around the impeller”).
Regarding claim 5, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the protective braid is woven into struts of the distal portion of frame (Figure 5, where filter 130 is woven into the struts 300-304, which secures the filter to the frame).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that the protective braid is woven into struts of the distal portion of frame, with the invention of Tuval in order to properly secure the braid to the frame of the device.
Regarding claim 10, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the protective braid is cut such as to define one or more large apertures, in order to prevent thrombi from forming on the braid within the distal part of the distal conical portion of the frame (¶[0100], where “a mandrel 900 should have the desired shape of the finished filter 130 in the expanded state … apertures 702-706 can then be defined in the shaped tube, such as by cutting,” ¶[0101], where “additional holes may be defined in the shaped tube, ¶[0106], which describes larger holes 726”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that the protective braid is cut such as to define one or more large apertures, in order to prevent thrombi from forming on the braid within the distal part of the distal conical portion of the frame, with the invention of Tuval in order to reduce the risk of blood damage or an increased risk of clotting (D’Ambrosio ¶[0106]).
Regarding claim 11, Tuval in combination with D’Ambrosio teaches all limitations of claim 10 as described in the rejection above.
D’Ambrosio teaches that an aperture is cut from the protective braid around the full circumference of the frame, such that that the protective braid defines an aperture that extends around the full circumference of the distal part of the distal conical portion of the frame (Figure 5, where the filter 130 is cut to surround a plurality of struts 300, 302, and 304, where Examiner interprets that the plurality of struts are equivalent to a frame).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that an aperture is cut from the protective braid around the full circumference of the frame, such that that the protective braid defines an aperture that extends around the full circumference of the distal part of the distal conical portion of the frame, with the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump with apertures sized to prevent ingestion, by the input port, of heart tissue (D’Ambrosio ¶[0052]).
Regarding claim 12, Tuval in combination with D’Ambrosio teaches all limitations of claim 11 as described in the rejection above.
D’Ambrosio teaches that the aperture is cut such that it extends until a distal end of the distal conical portion of the frame, such that there is a single aperture that extends around a full circumference of the frame and until the distal end of the distal conical portion of the frame (Figure 5, where the filter 130, which tapers into a conical portion, is cut to surround a plurality of struts 300, 302, and 304, which Examiner interprets as equivalent to a frame).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that the aperture is cut such that it extends until a distal end of the distal conical portion of the frame, such that there is a single aperture that extends around a full circumference of the frame and until the distal end of the distal conical portion of the frame, with the invention of Tuval in order to reduces the risk of heart tissue being sucked into an intake port of the intravascular blood pump with apertures sized to prevent ingestion, by the input port, of heart tissue (D’Ambrosio ¶[0052]).
Regarding claim 13, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
Although Tuval teaches that a portion of the distal tip portion is uncovered (¶[0560], where the struts are covered with a biocompatible blood-impermeable material 250, such as polyurethane, polyester, and/or silicone … the distal tip portion includes a braided shape-memory material 260 … braided shape-memory material is at least partially covered with a biocompatible blood-impermeable material 262, such as polyurethane, polyester, and/or silicone. Examiner takes the position that since the braided shape-memory material, which is included in the distal tip portion, is at least partially covered, that this teaches a portion that is uncovered as well as a covered portion.), Tuval does not explicitly teach that the protective braid is uncovered along a proximal part of the distal conical portion of the frame, which is proximal to the distal part of the distal conical portion of the frame.
D’Ambrosio teaches that the protective braid is uncovered along a proximal part of the distal conical portion of the frame, which is proximal to the distal part of the distal conical portion of the frame (Figure 3, filter 130, which Examiner interprets as equivalent to a protective braid, and the plurality of struts 300, 302, and 304, which Examiner interprets as equivalent to a frame, where the proximal portion of the filter is uncovered, ¶[0085], which describes “filaments of a woven filter 130”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that the protective braid is uncovered along a proximal part of the distal conical portion of the frame, which is proximal to the distal part of the distal conical portion of the frame, with the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEFRA D. MANOS whose telephone number is (703)756-5937. The examiner can normally be reached M-F: 7:00 AM - 3:30 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEFRA D. MANOS/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights