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 .
Claim Objections
Claim 17 is objected to because of the following informalities: Claim 17, line 6 recites “coupled the body” which should read “coupled to the body” or similar language. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 9-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by LaRose (US 2018/0110908 A1, supported by patent US 9,050,418 incorporated by reference in par 0028 of LaRose).
Regarding claim 1, LaRose discloses a percutaneous circulatory support device (pars 0004-0006), comprising: a housing comprising an outlet (par 0020-0021, implantable blood pump 12; shown in figure 2 to include an impeller contained in a housing); an impeller disposed within the housing and being rotatable relative to the housing to cause blood to flow through the housing and out of the outlet (par 0020-0021; see figure 2 where the pump is positioned in the aorta and extends a left ventricle through an aortic valve into the aorta such that blood flows through the housing and through the pump into the ventricle); a cannula coupled to the housing (par 0020-0021, inflow cannula 10), the cannula having a body extending between a proximal end and a distal end and along a longitudinal axis (shown in figure 2), a structural body portion (par 0031-0032, where the structural body portion includes deflection conduit 48), a surface coating disposed onto the structural body portion of the cannula (par 0031-0032, where the surface coating includes the wall 42 of cannula 10), and a channel defined between the structural body portion of the cannula and the surface coating (pars 0031-0032; channels which contain actuator members 44 as shown in figure 8 which are between the surface coating and the structural body portions as described above); a pull wire coupled to the cannula and extending through the channel of the cannula (pars 0031-0032; actuation members 44); and wherein manipulation of the pull wire causes a change in a shape profile of the cannula body (par 0031, where the deflection is shown in figure 4).
Regarding claim 2, LaRose discloses the device comprises two pull wires (pars 0031-0032; actuation members 44).
Regarding claim 3, LaRose discloses the cannula body is defined by a longitudinal axis (cannula 10, shown in figures 2, 4; par 0021 where the longitudinal axis exists between the distal and proximal portions), and the two pull wires are coupled to the cannula body on opposing sides of the cannula body relative to the longitudinal axis (pars 0031-0032; actuation members 44; see figure 8 where the members are shown on opposing sides of the cannula body).
Regarding claim 4, LaRose discloses the surface coating is composed of a polymer coating (par 0028, where patent number 9,050,418 is incorporated by reference in its entirety and discloses in col 5, ln 28-57 the use of a cannula composed of polymers for insertion into the body).
Regarding claim 9, LaRose discloses manipulation of the pull wire causes the cannula body to have a curved profile (par 0027, 0031).
Regarding claim 10, LaRose discloses the manipulation of the pull wire includes retracting the pull wire in a proximal direction (par 0027, 0031).
Regarding claim 11, LaRose discloses the channel is positioned on an interior surface of the structural body portion (pars 0031-0032, as shown in figure 8 where the channel including the actuator member 44 is positioned on top of an interior surface of the conduit 48).
Regarding claim 12, LaRose discloses the channel is positioned on an exterior surface of the structural body portion (pars 0031-0032, as shown in figure 8 where the channel including the actuator member 44 is positioned on top of an exterior surface of the conduit 48).
Regarding claim 13, LaRose discloses a percutaneous circulatory support device (pars 0004-0006), comprising: a housing (par 0020-0021, implantable blood pump 12; shown in figure 2 to include an impeller contained in a housing); an impeller disposed within the housing and being rotatable relative to the housing (par 0020-0021; see figure 2 where the pump is positioned in the aorta and extends a left ventricle through an aortic valve into the aorta such that blood flows through the housing and through the pump into the ventricle); a cannula coupled to the housing (par 0020-0021, inflow cannula 10), the cannula having a body extending between a proximal end and a distal end along a longitudinal axis (shown in figure 2); a first pull wire coupled to the body of the cannula on a first side of the cannula (pars 0031-0032; actuation members 44; see figure 8 where the members are shown on opposing sides of the cannula body); a second pull wire coupled to the body of the cannula on a second side of the cannula (pars 0031-0032; actuation members 44; see figure 8 where the members are shown on opposing sides of the cannula body); and wherein the body of the cannula comprises a structural body portion and a surface coating disposed on the structural body portion (par 0031-0032, where the surface coating includes the wall 42 of cannula 10); wherein the first pull wire is disposed radially between the structural body portion and the surface coating, and the second pull wire is disposed radially between the structural body portion and the surface coating (pars 0031-0032; actuation members 44; see figure 8 where the members are shown on opposing sides of the cannula body in a radial arrangement), wherein manipulation of the first or second pull wires causes a change in configuration of the cannula body (par 0031, where the deflection is shown in figure 4).
Regarding claim 14, LaRose discloses the first side is opposite the second side relative to the longitudinal axis (pars 0031-0032; actuation members 44; see figure 8 where the members are shown on opposing sides of the cannula body relative to the longitudinal axis).
Regarding claim 16, LaRose discloses the cannula comprises a channel defined between the structural body portion and the surface coating configured to receive at least one pull wire (pars 0031-0032; channels which contain actuator members 44 as shown in figure 8 which are between the surface coating and the structural body portions as described above).
Regarding claim 17, LaRose discloses a method for positioning a blood pump within a subject (pars 0020, 0022), the method comprising: advancing the blood pump through the vasculature of the subject (pars 0004-0005, 0020); wherein the blood pump comprises a cannula having a body extending along a longitudinal axis (par 0020-0021, inflow cannula 10) and a pull wire coupled to the body (pars 0031-0032; actuation members 44; see figure 8 where the members are shown on opposing sides of the cannula body), wherein the pull wire is disposed radially between a structural body portion of the body and a surface coating disclosed on the structural body portion of the body (par 0031-0032, where the surface coating includes the wall 42 of cannula 10 located on the structural body portion of the body); manipulating the pull wire to cause a change in a shape profile of the cannula (par 0027, 0031, where the deflection is shown in figure 4); crossing the aortic valve of the subject with the blood pump such that the cannula is at least partially positioned in the left ventricle of the subject (par 0020); manipulating the pull wire to cause a change in a shape of the cannula body (par 0027, 031).
Regarding claim 18, LaRose discloses manipulating the pull wire includes retracting the pull wire in a proximal direction (par 0027, 0031).
Regarding claim 19, LaRose discloses that prior to the manipulating of the pull wire, the cannula body extends along the longitudinal axis (cannula 10, shown in figures 2, 4; par 0021 where the longitudinal axis exists between the distal and proximal portions prior to actuation).
Regarding claim 20, LaRose discloses that after the manipulating of the pull wire, the cannula body comprises a curved profile. (par 0027, 0031; figure 4 showing curves after actuation).
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.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over LaRose in view of Demarchi et al (WO 2005/123169 A1, hereinafter “Demarchi”; copy of document provided with this action).
Regarding claim 5, LaRose discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose wherein the pull wire is composed of nitinol. Demarchi is analogous art in regard to structures for surgical vascular access devices as known in the art. Demarchi discloses it was known in the art to provide a tensioning device to navigate an elongate body through the circulatory system that is made of nitinol. Applied to the invention of LaRose, the features of Demarchi would provide a pull wire composed of nitinol as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Demarchi in the invention of LaRose, since such a modification would provide the predictable results of kink resistant material used in a feature to more easily navigate through the circulatory system.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over LaRose in view of Ostrovsky et al (EP 2 155 037 B1, hereinafter “Ostrovsky”; copy of document provided with this action).
Regarding claim 6, LaRose discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the pull wire comprises a radiopaque coating. Ostrovsky is analogous art in regard to device structure including articulating catheters for the body. LaRose discloses it was known in the art to provide an articulation mechanism coated with radiopaque coating (pars 0018, 0025, 0030). Applied to the invention of LaRose, the features of Ostrovsky would provide the pull wire comprising a radiopaque coating as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Ostrovsky in the invention of LaRose, since such a modification would provide the predictable results of means for ensuring proper positioning as known in the art.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over LaRose in view of Carroll et al (US 2005/0209557 A1, hereinafter “Carroll”).
Regarding claims 7 and 8, LaRose discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the body is the cannula is formed of a plurality of wires in a braided configuration, nor that the body of the cannula is composed of a plurality of wires in a helical configuration. Carroll is analogous art in regard to known constructions for steerable elongated members. Carroll discloses it was known in the art to provide a cannula body formed of a plurality of wires in a braided configuration (pars 0080, 0082), as well as a cannular body composed of a plurality of wires in a helical configuration (pars 0062, 0068, 0080). Applied to the invention of LaRose, the features of Carroll would provide a cannula body formed of a plurality of wires in a braided configuration, as well as a cannula body composed of a plurality of wires in a helical configuration as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Carroll in the invention of LaRose, since such a modification would provide the predictable results of improved steering and deflection control as known in the art.
Response to Arguments
Applicant's arguments filed 7/16/2025 have been fully considered but they are not persuasive for the reasons set forth below.
Regarding claim 1, Applicant argues that the cited LaRose reference does not disclose a surface coating disposed onto a structural body portion of the cannula 10, further that there is no disclosure distinguishing the structural body portion from the wall 42. Examiner respectfully disagrees. Element 42 is cited to provide a surface coating that is disposed onto a structural body portion, since it is provided on a surface of the deflection conduit as shown in figure 9. The claim as currently worded merely requires a surface coating disposed onto the structural body portion, but does not say how the coating is applied or any features related to its structure other than its position. In LaRose, wall 42 is shown to be disposed onto (as described in cited paragraph 0032, where a deflection conduit can be attached to the wall by known methods such as adhesive) against the deflection conduit 48. Examiner notes that the claim only requires that the surface coating is disposed onto the structural body portion of the cannula, which for the reasons above, is disclosed by LaRose as cited.
As noted by Applicant, Examiner references deflection conduit 48 to read on the claimed structural body portion. In that case, Applicant requests clarification how the deflection conduit 48 reads on a structural body portion. Further, what would lead a PHOSITA to consider wall 42 to be a surface coating? Applicant notes that claim terms must be given their plain meaning and the meaning of a claim term must be consistent with the use of a claim term in the specification and drawings. Examiner maintains that LaRose includes a surface coating and a structural body portion. The claims as currently worded are broad enough that they are encompassed by the disclosure of LaRose. The deflection conduit 48 reads on a structural body portion because it inherently has a structure and a body. It is unclear how these features differ from the requirements of the claim as currently worded. Further, as explained above, wall 42 is shown to be disposed onto (as described in cited paragraph 0032, where a deflection conduit can be attached to the wall by known methods such as adhesive) against the deflection conduit 48 and thus is considered a coating as required by the claim. Examiner notes that the claim only requires that the surface coating is disposed onto the structural body portion of the cannula and that those features are provided by LaRose since those features are broadly recited in the claim as currently worded.
Applicant argues that there is no disclosure that any aspect of actuator members 44 are disposed in a channel between a structural body portion including the deflection conduit 48 and the wall 42. Examiner points to the annotated figure below to address these remarks. LaRose is directed to an arrangement that includes an actuator member disposed in a channel of one deflection conduit, such that the channel is between the structural body portion 48 and a further portion of the wall 42.
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Applicant argues the same points above with reference to independent claims 13 and 17. Examiner maintains the rejections above for the reasons set forth above with regard to claim 1.
Applicant argues the same points above with reference to claims 6, 7, and 8. Examiner maintains the rejections above for the reasons set forth above with regard to claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/ Primary Examiner, Art Unit 3799
3/27/2026