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 Arguments
Applicant's arguments filed 9/25/2025 have been fully considered but they are not persuasive.
With respect to the teachings of Campbell and Keenan in the rejection of claim 49 under 35 U.S.C. § 103, Applicant argues that Keenan teaches a support member that is a separate structure from the shroud, and therefore is not the shroud itself. Applicant goes on to state that the present invention does not require a separate structure and instead relies upon material properties of the shroud itself to provide the needed stiffness.
However, this is not persuasive because in claim 49, the limitation does not require that the shroud itself comprise a stiffer region due to inherent material properties of the shroud, only that the “proximal impeller region” of the shroud is stiffer than the central region of the shroud. This does not disavow any intervening or additional elements providing the increased stiffness. Applicant has claimed the invention using transitional phrase “comprising” providing open claim construction, therefore the support structure of Keenan providing the increased stiffness as claimed nevertheless meets the required structure under BRI.
New grounds for rejection under 35 U.S.C. § 103 are presented for new claims 69-70, see rejection below.
Claim Rejections - 35 USC § 103
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(s) 49-59, 61-63, and 68-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (U.S. Patent Application Publication No. 2019/0184078) hereinafter referred to as Campbell; in view of Keenan et al. (U.S. Patent Application Publication No. 2018/0064862) hereinafter referred to as Keenan.
Regarding claim 49, Campbell teaches a blood pump (¶[0006] heart pump), comprising:
a shroud that defines a blood lumen (¶[0039], ¶[0052]) impeller assembly conveys blood), the shroud comprising a proximal impeller region (Fig. 2, proximal region of impeller section) and a central region positioned distally to the proximal impeller region (Fig. 2, any of the space distal to the most proximal region of the impeller section).
a proximal impeller disposed at least partially within the proximal impeller region of the shroud (Fig. 13A-B, impeller hub element 208).
Campbell does not teach that the shroud is expandable and collapsible with a proximal region that has a first stiffness greater than the stiffness of a central region.
Attention is brought to the Keenan reference, which teaches a shroud, which is expandable and collapsible (¶[0068] expandible and collapsible cannula) with a proximal region that has a first stiffness greater than the stiffness of a central region (Fig. 15, ¶[0088] support member 328).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the blood pump of Campbell to include an expansible and collapsible shroud with different stiffness along the length of the shroud, as taught by Keenan, because it prevents unacceptable variance in the gap between the tip of the impeller and the inside surface of the cannula (Keenan ¶[0088]).
Regarding claim 50, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the expandable and collapsible shroud includes a plurality of helical arms to define at least one helical region (Fig. 4, 15, helical arms structure, ¶[0071]).
Regarding claim 51, Campbell as modified teaches the blood pump of claim 50.
Keenan further teaches wherein at least one helical region axially overlaps with the proximal impeller (Fig. 4, 15, impeller element 112).
Regarding claim 52, Campbell as modified teaches the blood pump of claim 50.
Keenan further teaches wherein a plurality of helical regions axially overlaps with the proximal impeller (Fig. 4, 15, impeller element 112, coaxial helical structure of cannula has plurality of helical regions).
Regarding claim 53, Campbell as modified teaches the blood pump of claim 50.
Keenan further teaches wherein at least one of the plurality of helical arms extends between adjacent non-helical regions (Fig. 4, 11, 15, the helical portion extends through all regions of, e.g. non helical support member 328).
Regarding claim 54, Campbell as modified teaches the blood pump of claim 50.
Keenan as modified further teaches wherein at least one helical region extends between adjacent non-helical regions of the expandable and collapsible shroud (Fig. 4, 11, 15, the helical portion extends through all regions of, e.g. non helical support member 328).
Regarding claim 55, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the proximal impeller region of the expandable and collapsible shroud includes a plurality of helical arms to define at least one helical region (Fig. 4, plurality of helical arms overlapping proximal impeller region).
Regarding claim 56, Campbell as modified teaches the blood pump of claim 55.
Keenan further teaches wherein at least one helical region axially overlaps with the proximal impeller (Fig. 4, plurality of helical arms coaxial and overlapping proximal impeller region).
Regarding claim 57, Campbell as modified teaches the blood pump of claim 55.
Keenan further teaches wherein a plurality of helical regions axially overlaps with the proximal impeller (Fig. 4, plurality of helical arms coaxial and overlapping proximal impeller region).
Regarding claim 58, Campbell as modified teaches the blood pump of claim 55.
Keenan further teaches wherein at least one of the plurality of helical arms extends between adjacent non-helical regions (Fig. 4, 11, 15, the helical portion extends through all regions of, e.g. non helical support member 328).
Regarding claim 59, Campbell as modified teaches the blood pump of claim 50.
Keenan further teaches wherein the proximal impeller region comprises at least one helical region (Fig. 4, 11, 15, helical arms form a plurality of helical regions) and the central region comprises at least one non-helical region (Fig. 11, 15, support member 328 is not helical and more distal than the proximal impeller region therefore meeting the requirement of the central region).
Regarding claim 61, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the expandable and collapsible shroud comprises nitinol (¶[0084] expandable nitinol structure).
Regarding claim 62, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the expandable and collapsible shroud comprises a polymeric structure (¶[0087] polymeric structure).
Regarding claim 63, Campbell as modified teaches the blood pump of claim 62.
Keenan further teaches wherein a first durometer of the proximal impeller region is greater than a second durometer of the central region (Fig. 15, ¶[0088] support member 328 greater stiffness in reinforced region).
Regarding claim 68, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the greater stiffness of the proximal impeller region is configured to maintain concentricity between the proximal impeller and the expandable and collapsible shroud (Fig. 15, ¶[0080], ¶[0088] support member 328).
Regarding claim 69, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches the proximal impeller region has a first shroud pattern (Fig. 15, ¶[0088] support member 328 has a first pattern) and the central region has a second shroud pattern (Fig. 15, shroud beyond support member 328 has a second pattern), the first shroud pattern causing the proximal impeller region to have greater stiffness than the central region (¶[0088] pattern of support member provides the support).
Claim(s) 60 and 64-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell and Keenan as applied to claim 49 above, and further in view of Schwammenthal et al. (U.S. Patent Application Publication No. 2020/0254161) hereinafter referred to as Schwammenthal.
Regarding claim 60, Campbell as modified teaches the blood pump of claim 49.
Campbell as modified does not teach comprising a membrane coupled to the expandable and collapsible shroud to define a fluid conduit that is impermeable to blood.
Attention is brought to the Schwammenthal reference, which teaches a membrane coupled to an expandable and collapsible shroud to define a fluid conduit that is impermeable to blood (¶[0357]).
It would have been obvious to one of ordinary skill in the art at the time of filing to include a membrane coupled to a shroud, as taught by Schwammenthal, because it lowers a blood pressure when necessary while allowing significant blood flow (Schwammenthal ¶[0354]).
Regarding claims 64-65, Campbell as modified teaches the blood pump of claim 49.
Campbell as modified does not teach wherein the expandable and collapsible shroud comprises a distal impeller region positioned distally to the central region, wherein the distal impeller region has a third stiffness that is greater than the second stiffness of the central region, the blood pump further comprising a distal impeller disposed at least partially within the distal impeller region of the shroud.
However, Keenan further teaches a shroud, which is expandable and collapsible (¶[0068] expandible and collapsible cannula) with an impeller region that has a first stiffness greater than the stiffness of a central region (Fig. 15, ¶[0088] support member 328).
Keenan does not teach two impellers or two impeller regions separated by a central region.
Attention is brought to the Schwammenthal reference, which teaches the expandable and collapsible shroud comprises a distal impeller region positioned distally to the central region, the blood pump further comprising a distal impeller disposed at least partially within the distal impeller region of the shroud (Fig. 1C, two impellers, two shrouds, ¶[0313]), therefore showing that two substantially identical impeller regions are known in the art.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter of Campbell as modified to include a duplication of the impeller, impeller region, and shroud properties of Keenan, therefore the distal impeller region has a third stiffness that is greater than the second stiffness of the central region wherein the first stiffness of the proximal impeller region is substantially similar to the third stiffness of the distal impeller region, because the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 66-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell and Keenan as applied to claim 49 above, and further in view of Korakianitis et al. (U.S. Patent Application Publication No. 2019/0321529) hereinafter referred to as Korakinitis.
Regarding claims 66-67, Campbell as modified teaches the blood pump of claim 49.
Campbell as modified does not teach a tip gap between the proximal impeller and the expandable and collapsible shroud ranging from 0.01 mm to 1 mm.
Keenan teaches that the tip gap between the impeller and expandable and collapsible shroud is critical and should be maintained.
Attention is brought to the Korakinitis reference, which teaches wherein a proximal impeller region is configured to maintain a tip gap between the proximal impeller and a shroud ranging from 0.5 mm to 1 mm (¶[0233] 710 µm, e.g.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter of Campbell as modified to include a tip gap range of 0.5 mm to 1 mm as taught by Korakinitis, because a minimal but stable gap reduces backflow and may improve the efficiency of the device (Korakinitis ¶[0318]).
Claim(s) 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell and Keenan as applied to claim 49 above, and further in view of Kariniemi et al. (U.S. Patent Application Publication No. 2018/0125683) hereinafter referred to as Kariniemi.
Regarding claim 70, Campbell as modified teaches the blood pump of claim 49.
Campbell as modified does not teach wherein the proximal impeller region has different material properties than the central region.
Attention is drawn to the Kariniemi reference, which teaches a proximal impeller region with different material properties than the central region (¶¶[0105-0106]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the shroud and support of Campbell as modified to use a integral construction where the material properties vary along the impeller region length, as taught by Kariniemi, because Kariniemi teaches that it increases radial stiffness without decreasing fatigue resistance, and without increasing profile (Kariniemi ¶[0107]).
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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, James Kish can be reached at (571) 272-5554. 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.
/AMANDA L STEINBERG/ Examiner, Art Unit 3792