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 .
Status of Claims
Claims 1-28 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Nov. 12, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “410” has been used to designate both “motor section” and “drive section”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: element 452 in Fig. 3. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because element 1410 appears twice in Fig. 14 as annotated below, the circled occurrence should be removed. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Specification
The disclosure is objected to because of the following informalities: “tubular body 510 may defining a lumen 520” in ¶[0070] should be changed to “tubular body 51 may define a lumen 520”.
Appropriate correction is required.
The use of the term “Nitinol” in ¶[0055], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 5 is objected to because of the following informalities: “the motor housing and the impeller housing form a single combined housing” should be changed to either “wherein the motor housing and the impeller housing form a single combined housing”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 8, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c)(I) “If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim”. For purposes of examination, “wherein an average outer diameter of the motor housing is no larger than 12 french, preferably no larger than 10 french” will be interpreted as “wherein an average outer diameter of the motor housing is no larger than 12 french”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “no larger than 12 french”, and the claim also recites “no larger than 10 french” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “about” in claim 23 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, “about 10 French” will be interpreted as “10 French” and “about 21 French” will be interpretated as “21 French”.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 9-10, 13-15, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller et al. (US 20180021494 A1, published Jan. 25, 2018, hereinafter referred to as “Muller”).
Regarding claim 1, Muller teaches an intravascular blood pump (¶[0020] and “pump 100A” in Fig. 1C ¶[0040]; “FIG. 1C is similar to FIG. 1B, except the motor 1 is miniaturized for insertion into the body” in ¶[0050]), comprising: a catheter (“a catheter body having a lumen” ¶[0020] and “catheter assembly 101” in Fig. 1C ¶[0040]); and a pump section coupled to a distal end of the catheter (“distal end 1450 of the catheter assembly 101 of the catheter pump 100A of FIG. 1B” ¶[0056]; distal end 1450 also appears in Fig. 1C), the pump section comprising: an electric motor (“motor assembly 1 can comprise a motor 300 (e.g., an electric motor such as a direct drive electric motor)” Fig. 1C and ¶[0088]) comprising a stator and a rotor operably coupled to the stator (“motor assembly 1 can include a stator assembly 2 (FIGS. 2-3) and a rotor 15 disposed radially within the stator assembly 2 (FIG. 3)” ¶[0068]); a drive shaft disposed within the pump section (“a drive shaft disposed inside the catheter body” ¶[0020]), the drive shaft operably coupled to the rotor (“rotor mechanically coupled with a proximal portion of the drive shaft” ¶[0020] and “FIG. 4A shows that the output shaft 13 (which is secured to the rotor 15) can be mechanically coupled with the proximal end portion of a drive shaft 16.” ¶[0070]); and an impeller housing (“impeller housing” in ¶[0059]) in which an expandable impeller is housed (“impeller assembly 116A (e.g., the impeller and cannula) can be expandable and collapsible” Fig. 1C and ¶[0052]), the expandable impeller being coupled to the drive shaft (“A distal end portion of the drive shaft 16 is mechanically connected with the impeller.” ¶[0070]).
Regarding claim 2, Muller teaches wherein the expandable impeller is coupled to the drive shaft at a location distal to the rotor (“FIG. 4A shows that the output shaft 13 (which is secured to the rotor 15) can be mechanically coupled with the proximal end portion of a drive shaft 16. The drive shaft 16 extends distally through an internal lumen of the catheter body 120A. A distal end portion of the drive shaft 16 is mechanically connected with the impeller.” ¶[0070]).
Regarding claim 3, Muller teaches wherein the pump section further comprises a motor housing disposed around the electric motor, and a portion of the drive shaft (“the external motor housing (e.g., the outer shell or housing surrounding the motor assembly)” ¶[0076], further Fig. 4A is a cross sectional view of the motor assembly (¶[0031]) including element 16 drive shaft (¶[0070])).
Regarding claim 9, Muller teaches wherein the rotor and stator of the electric motor are coaxially aligned (“The journal bearings 18A (FIGS. 3 and 5) and 18B (FIG. 3) can be provided on opposite axial sides of the rotor 15 to help maintain the rotor 15 … in axial alignment with the stator assembly 2.” ¶[0085]).
Regarding claim 10, Muller teaches the device further comprising at least one bearing within a motor housing (“the external motor housing (e.g., the outer shell or housing surrounding the motor assembly)” ¶[0076]) disposed around the electric motor (“The journal bearings 18A (FIGS. 3 and 5) and 18B (FIG. 3) can be provided on opposite axial sides of the rotor 15” ¶[0085]).
Regarding claim 13, Muller teaches the device further comprising one or more wires extending proximally from the pump section (“one or more electrical lines may extend from the motor to the console outside the patient” ¶[0050]).
Regarding claim 14, Muller teaches wherein the one or more wires are coupled to a circuit disposed within the pump section, the circuit configured to control electricity provided to the stator (“the electrical lines can send signals for controlling the operation of the motor.” ¶[0050], and Fig. 1B “The console 122 can provide electrical power (e.g., 24V) to the stator assembly 2 to drive the motor assembly 1. One or more leads 9 can electrically communicate with the stator assembly 2” ¶[0069]).
Regarding claim 15, Muller teaches further comprising a purge fluid lumen extending through the catheter, the purge fluid lumen being operably coupled to the pump section (“FIG. 1B, a fluid supply line 6 can fluidly couple with the console 122 to supply saline or other fluid to the catheter pump 100A. The saline or other fluid can pass through an internal lumen of the internal catheter body 120A and can provide lubrication to the impeller assembly 116A and/or chemicals to the patient.” ¶[0061]).
Regarding claim 27, Muller teaches where there is an axial gap between a proximal end of blades of the expandable impeller and a distal end of a motor section (see annotated Fig. 1B below).
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Claims 16 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller as further evidenced by Campbell et al. (US 20120172655 A1, published Jul. 5, 2012, hereinafter referred to as “Campbell”).
Muller incorporates by reference Campbell (¶[0055]). Various aspects of the pump and associated components can be combined with or substituted for those disclosed in the incorporated by reference publications.
Regarding claim 16, Muller does not explicitly teach the pump wherein the catheter comprises a defined bend.
Campbell teaches the atraumatic tip 182 in the catheter in Fig.’s 1A and 2 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto ¶[0082].
Regarding claim 21, Muller does not explicitly teach the pump further comprising a flexible atraumatic tip coupled to a distal end of the impeller housing.
Campbell teaches in Fig.’s 1A and 2 that the distal end 108 of the catheter assembly 100 includes an atraumatic tip 182 disposed distal of the impeller assembly 116. The tip is designed to be atraumatic so that after retraction of the guidewire, when the tip is left inside, for example, a ventricle, it cannot cause injury or trauma to the inner wall or endocardial surface of the ventricle resulting from motion of the ventricle (¶[0082]).
Claim 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller as further evidenced by Aboul-Hosn et al. (US 7022100 B1, published Apr. 4, 2006, hereinafter referred to as “Aboul-Hosn”).
Muller incorporates by reference Aboul-Hosn (¶[0055]). Various aspects of the pump and associated components can be combined with or substituted for those disclosed in the incorporated by reference publications.
Regarding claim 24, Muller does not explicitly disclose wherein the pump section forms an extended cannula extending distally from a motor housing.
Aboul-Hosn teaches the cannula 14 of Fig. 2 (downstream tubing) is fixedly attached to the rotor shroud 36 (impeller housing) and may extend any suitable length therefrom depending upon the particular intravascular application. The cannula 14 preferably includes a plurality of ports or fenestrations 40 about its distal region, as well as an end port 42, which allow for the ingress or egress of blood into or from the cannula 14 depending upon the operation of the blood pump 12 (Col. 8 ln. 21-28). The pump is distal from motor assembly 20.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Isaacson (US 5205721 A, published Apr. 27, 1993, hereinafter referred to as “Isaacson”).
Regarding claim 4, Muller teaches the intravascular blood pump of claim 3.
Muller does not disclose wherein an outer surface of the motor housing is partially disposed within the catheter.
Isaacson’s invention relates to a split stator for a motor that drives an axial flow blood pump in a heart/lung machine (Col. 1 ln. 6-8). The pump includes a housing connected in line with the blood flow path. To connect the pump to the blood flow path, tubes are connected to the ends of the housing (Col. 1 ln. 42-46). As shown in Fig.’s 1 and 4, housing assembly 21, includes an interior sleeve 22 with exterior sections 23 and 24 inserted into outer ends of the sleeve 22 (Col. 4 ln. 62-65). Sections 23 and 24 have fluted outer ends onto which tubes (shown in FIG. 4) are connected (Col. 5 ln. 9-10).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to dispose part of the motor housing within the catheter as taught by Isaacson in the device of Muller since it is a successful and art-recognized method of connecting tubing to pumps.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Neumann (US 20170119945 A1, published May 4, 2017, hereinafter referred to as “Neumann”).
Regarding claim 5, Muller teaches the intravascular blood pump of claim 3.
Muller does not teach wherein the motor housing and the impeller housing form a single combined housing.
Neumann’s invention relates to a pump for implantation into a vessel or a heart (¶[0012]). The stator S with rotor R (motor) as well as delivery part FE (impeller) are arranged within the support structure SG (cannula) in Fig.’s 1A-1B. The pump 1 is embodied according to the invention such that it can produce the required pump output and yet be small enough that it can be transported through an appropriate vessel (lumen) to the application site without damaging this vessel (¶[0028]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to house the motor and the impeller in one single housing as taught by Neumann in the device of modified Muller in order to transport the device without damaging the vessel as well as produce the required pump output. Further, by making the drive shaft and rotor one material, production costs and sources of error can be minimized (¶[0061]) and therefore, the same idea can be applied to combining the motor housing and impeller housing within one housing component.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Earles et al. (US 20220080183 A1, published Mar. 17, 2022, hereinafter referred to as “Earles”).
Regarding claim 6, Muller teaches the intravascular blood pump of claim 3.
Muller does not disclose wherein an outer surface of the motor housing is partially disposed within the impeller housing.
Earles’s invention relates to improved blood pumps (¶[0002]). In Fig.’s 1A-1C, a motor is disposed in the motor housing 29 capped by a distal drive unit cover 11 (¶[0071]). The impeller assembly 4 can be disposed in a shroud 16 and the sleeve bearing 15, and the shroud 16 can cooperate to at least partially define the pump housing 35 (¶[0072]). The shroud 16 can comprise a tube with an inlet end and an outlet end. The shroud 16 can be placed over the various internal components that make up the pump rotor (e.g., the impeller assembly 4 and the rotor assembly 46). The outlet end of the shroud 16 can be secured to the drive unit cover 11 of the drive unit 9 (¶[0119]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to partially dispose the outer surface of the motor housing in the impeller housing as taught by Earles in the device of Muller since having a motor partially disposed within impeller housing is known in the art to would have yielded predictable results to connect the two components for an effective operation of a blood pump.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Beekman et al. (US 20230149699 A1, published May 18, 2023; filed Nov. 16, 2022, hereinafter referred to as “Beekman”).
Regarding claim 7, Muller teaches the intravascular blood pump of claim 3.
Although Muller discloses that the motor housing is connected to the catheter (¶[0063]), Muller does not disclose wherein the pump section further comprises a housing connector coupling the motor housing to the catheter.
Beekman’s invention relates to percutaneous circulatory support systems (¶[0002]). Referring to Fig. 1, the motor housing 104 couples to a catheter 126 opposite the impeller housing 102. The catheter 126 may couple to the motor housing 104 in various manners, such as laser welding, soldering, or the like (¶[0053]). The instant specification defines the housing connector may include any appropriate means for doing so, including, e.g., axially welding two components, or bonding two components together (¶[0042]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a housing connector (such as welding) as taught by Beekman in the device of Muller as it is a way to secure the motor housing to the catheter.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Siess (US 7011620 B1, published Mar. 14, 2006, hereinafter referred to as “Siess ‘620”).
Regarding claim 8, Muller discloses the intravascular blood pump of claim 3.
The specification discloses the appropriate ranges that apply to the claimed invention on page(s) ¶[0039], [0040], [0048]-[0050]. However, the specification does not disclose that the specifically claimed range(s) of no larger than 12 or 10 french is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Muller does not disclose wherein an average outer diameter of the motor housing is no larger than 12 french.
Siess ‘620’s invention relates to an intravascular blood pump comprising a housing accommodating an electric motor, with the proximal end of the housing being connected to a catheter and the distal end thereof carrying a pump (Col. 1 ln. 1-6). In the blood pump of the invention, the housing containing the electric motor can be reduced to an outer diameter of about 4 mm, which corresponds to a catheter of 12 F (F=French). Thus, the intravascular blood pump can be advanced through the blood vessel system of the patient and be placed at the desired site. The dimensions also make it possible to maneuver the blood pump in an unobstructed and controlled manner through the arcus aortae (Col. 2 ln. 21-30).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have an average outer diameter of the motor housing 12 French as taught by Siess ‘620 in the device of Muller in order to maneuver the blood pump in an unobstructed and controlled manner through the patient.
Since Siess teach that the dimension of intravascular blood pump housing can be adjusted to allow maneuver of the blood pump in an unobstructed and controlled manner through the arcus aortae as set forth above, the prior art therefore provides teaching that the size of the blood pump motor housing is a variable that achieves a recognized result.
Because Applicants fail to disclose that the claimed range(s) of no larger than 12 or 10 french provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that size of the motor housing can be adjusted absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of no larger than 12 or 10 french by normal optimization procedures known in the catheter pump arts.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Spanier et al. (US 20150051436 A1, published Feb. 19, 2015, hereinafter referred to as “Spanier”).
Regarding claim 11, Muller discloses the intravascular blood pump of claim 10. Muller teaches wherein the at least one bearing includes a plurality of bearings (“journal bearings 18A (FIGS. 3 and 5) and 18B (FIG. 3)” ¶[0085])
Muller does not disclose where one or more bearings of the plurality of bearings is a ceramic bearing.
Spanier’s invention relates to an intravascular blood pump for supporting blood circulation in human. It is preferred to make the radial sliding bearing of the device located at the proximal end of the motor housing of ceramic, with the ceramic bearing lying directly against the circumferential surface of the motor shaft ¶[0021]. Surfaces made of ceramic have high strength and low wear ¶[0016].
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have constructed one or more bearings out of a ceramic material as taught by Spanier in the device of Muller because ceramics have high strength and low wear.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Yamazaki et al. (EP 0768091A1, published Apr. 16, 1997, hereinafter referred to as “Yamazaki”).
Regarding claim 12, Muller teaches the intravascular blood pump of claim 1.
Muller does not disclose wherein the drive shaft is ceramic.
Yamazaki’s invention relates to an artificial organ, for example an artificial heart (Col. 1 ln. 1-4). The driving shaft is made from ceramic material which is stable both chemically and dimensionally and highly resistant against abrasion making the artificial heart more reliable and prolonging its service life (Col. 6 ln. 19-25).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to construct the drive shaft out of a ceramic material as taught by Yamazaki in the device of Muller in order to create a more reliable device and prolong its service life.
Claims 17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of D'Ambrosio et al. (US 20210236797 A1, published Aug. 5, 2021, hereinafter referred to as “D'Ambrosio ‘797”).
Regarding claim 17, Muller does not explicitly disclose further comprising downstream tubing coupled to the impeller housing and to a portion of the catheter, wherein the downstream tubing has one or more blood flow outlets.
D’Ambrosio ‘797’s invention relates to intravascular blood pumps and, more particularly, to intravascular blood pumps that include intake filters (¶[0002]). Fig. 2 depicts a limp collapsible outflow hose (downstream tubing) 204 in fluid communication between the output of the impeller 200 and the output port 128 (blood flow outlet) (¶[0066]). The downstream tubing enables the impeller to be positioned much closer to the input port (¶[0068]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to incorporate this downstream tubing with one of more blood flow outlets as taught by D’Ambrosio ‘797 in the device of Muller in order to enable to impeller positioning to be closer to the input port.
Regarding claim 22, Muller does not disclose wherein the impeller housing comprises a mesh filter at a blood flow inlet.
D’Ambrosio ‘797 teaches an intake filter reduces the risk of heart tissue being sucked into an intake port of the intravascular blood pump (¶[0052]). The filter 130 is disposed on the input port (¶[0068]) and Fig.’s 3-5 depict mesh filter element 130 (¶[0074]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to add a mesh filter at the blood flow inlet as taught by D’Ambrosio ‘797 in the device of Muller in order to reduce the risk of heart tissue being sucked into the pump.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Muller as evidenced by Aboul-Hosn in view of D'Ambrosio et al. (US 20210236797 A1, published Aug. 5, 2021, hereinafter referred to as “D'Ambrosio ‘797”).
Regarding claim 25, Muller teaches the intravascular blood pump of claim 24.
Muller does not disclose wherein the expandable impeller is disposed within the extended cannula.
D’Ambrosio ‘797 teaches the impeller 200 is shown located inside the housing 122 (extended cannula) (¶[0065]). Conventionally, intravascular blood pumps have not included such downstream tubing. Such a conventional intravascular blood pump therefore has a relatively long intake cannula, upstream of its impeller, to make the intravascular blood pumps sufficiently long to span the heart valve into which it is to be inserted. This length allows for some longitudinal displacement, such as due to heart action and patient movement, without risking displacing the intake and output ports to the same side of the heart valve. Although not consciously designed to do so, such a long intake cannula also makes it almost impossible to damage heart tissue by the impeller (¶[0067]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the expandable impeller within the extended cannula as taught by D’Ambrosio ‘797 in the device of Muller so that the impeller is placed where it will be effective without causing damage to the heart tissue.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of D’Ambrosio ‘797 (hereinafter referred to as “modified Muller”) as applied to claim 17, and in further view of Campbell.
Regarding claim 18, modified Muller teaches the device of claim 17.
Modified Muller does not teach wherein the catheter comprises a defined bend, the defined bend occurring inside the downstream tubing.
Campbell teaches the atraumatic tip 182 in the catheter in Fig.’s 1A and 2 can have an arcuate configuration such that interactions with a patient's internal tissues are controlled and do not cause trauma thereto ¶[0082].
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a defined bend in the downstream tubing of the catheter as taught by Campbell in the device of modified Muller in order to control interactions with the patient’s internal tissues and avoid causing trauma to them.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over modified Muller as applied to claim 17, and in further view of Neumann.
Regarding claim 19, modified Muller teaches the intravascular blood pump of claim 17.
Modified Muller does not disclose wherein the downstream tubing is disposed around a motor housing.
Neumann teaches the stator S (motor) are arranged within the support structure SG (cannula) in Fig.’s 1A-1B. The pump 1 is embodied according to the invention such that it can produce the required pump output and yet be small enough that it can be transported through an appropriate vessel (lumen) to the application site without damaging this vessel (¶[0028]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to dispose the motor within the downstream tubing as taught by Neumann in the device of modified Muller in order to transport it without damaging the vessel as well as produce the required pump output. Further, by making the drive shaft and rotor one material, production costs and sources of error can be minimized (¶[0061]) and therefore, the same idea can be applied to combining the motor housing within one housing component.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over modified Muller as applied to claim 17 above, and in further view of Carmel et al. (US 20150359998 A1, published Dec. 17, 2015, hereinafter referred to as “Carmel”).
Regarding claim 20, modified Muller teaches the intravascular blood pump of claim 17.
Modified Muller does not disclose wherein the downstream tubing includes a slit extending from a proximal end of a blood flow outlet to a proximal end of the downstream tubing.
Carmel’s invention relates to medical devices, and in particular to balloon catheters applicable for treating blood vessels (¶[0002]). The device includes fluid outlet 117 (Fig. 6A) which may include any number of openings of any form and size, and of any arrangement with any pattern. As such, fluid outlet may include at least one hole (i.e. a through opening), at least one slit and/or at least one pressure sensitive opening. Optionally the at least one slit is configured to open above a predetermined infusion pressure (¶[0075]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a slit extending from the blood flow outlet as taught by Carmel in the device of modified Muller in order to open when there is a certain amount of pressure in from the flow.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Muller as evidenced by Campbell, and further in view of Siess (US 20080103591 A1, published May 1, 2008, hereinafter referred to as “Siess ‘591”).
Regarding claim 23, Muller teaches the intravascular blood pump of claim 1. Muller also teaches wherein the impeller housing has a compressed state and an expanded state (Fig.’s 1B and 1C “The impeller assembly 116A (e.g., the impeller and cannula) can be expandable and collapsible” ¶[0052]).
As discussed earlier, Muller incorporates Campbell by reference.
Campbell teaches the impeller housing having a maximum outer diameter of about 21 French (21F) in the expanded state. In Fig. 1A, the distal end 108 of the catheter assembly 100 can be configured to have about an 11 French (approximately 3.5 mm) size in a first configuration for insertion and an expanded configuration, such as up to about 21 French (approximately 7 mm) once in place in the body. The larger size facilitates greater flow rates (¶[0072]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to expand up to 21 French as taught by Campbell in order to facilitate greater flow rates by the pump.
Muller and Campbell do not teach the impeller housing having a maximum outer diameter of about 10 French (10F) in the compressed state.
Siess ‘591’s invention relates to a foldable intravascularly insertable blood pump comprising a rotor provided with vanes, a flexible shaft extending through a catheter and adapted to drive the impeller, and an envelope enclosing the impeller (¶[0002]). Insertion is performed intra-vascularly, namely through the blood vessel system of the patient. It is thus required that, upon insertion, the maximum diameter of the blood pump does not exceed 3 mm (9 French in a compressed state), if the insertion is to be carried out through an insertable tube and with as little complication as possible (¶[0004]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to compress the pump no larger than 9 French as taught by Siess ‘591 in the device of Muller as evidenced by Campbell in order to insert the device through the blood vessel system of a patient with minimal complication.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Muller as evidenced by Aboul-Hosn in view of D’Ambrosio et al. (US 20170348470 A1, published Dec. 7, 2017, hereinafter referred to as “D’Ambrosio ’470”).
Regarding claim 26, Muller does not disclose wherein the extended cannula includes a defined bend distal to the expandable impeller.
D’Ambrosio ‘470’s invention relates to blood pump assembly, such as an intracardiac blood pump assembly (¶[0002]). D’Ambrosio ‘470 teaches the cannula assembly 102 in Fig. 1 includes a bend 112. In some embodiments, the bend 112 is 45°. In certain implementations being designed for use in the right heart, the cannula assembly 102 can have one or more bends and may have different and/or multiple bend radii to adapt to the needs of passage and final position of the cannula assembly 102 (¶[0048]). This bend is distal to the impeller hub 113.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include a defined bend in the cannula as taught by D’Ambrosio ‘470 in the device of Muller in order to adapt the blood pump for suitable conditions of use such as for use in the right heart.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Muller in view of Nix et al. (US 6176822 B1, published Jan. 23, 2001, hereinafter referred to as “Nix”).
Regarding claim 28, Muller teaches the intravascular blood pump of claim 1. Muller also teaches a controller operably coupled to the intravascular blood pump (“A controller within the console 122 can control the operation of the motor assembly 1 during use.” Fig. 1B and ¶[0061]).
Muller does not disclose the controller configured to control a rotational speed of the electric motor.
Nix’s invention relates to an intracardiac blood pump, and in particular to a blood pump that may be inserted entirely into the heart to assist the natural cardiac pump function or to replace the same by a continuous pumping operation (Col. 1 ln. 3-6). The pumps are driven by synchronous motors, with the control unit 66 (fig. 3) (controller) supplying the required drive frequency or rotational speed (Col. 5 ln. 40-41). The rotational speed of the respective pump will then be reduced for a certain time so that the cardiac tissue may disengage itself, and, subsequently, the rotational speed will be increased again to the desired number. When the measured absolute pressure becomes too high, the control unit 66 will affect a limitation--and, if need be, a reduction--of the volume flow to avoid damage to downstream organs (lungs) (Col. 6 ln. 1-9).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to control the rotational speed of the electric motor as taught by Nix in the device of Muller in order to moderate the flow rate to avoid damage to organs.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jarvik (US 5376114 A, published Dec. 27, 1994) – connector for motor and catheter shown in Fig. 7
Siess et al. (US 20040044266 A1, published Mar. 4, 2004) – extended cannula
Aboul-Hosn et al. (US 6935344 B1, published Aug. 30, 2005) – potentially slits
McBride et al. (US 7841976 B2, published Nov. 30, 2010) – similar French dimensions
Siess et al. (EP 3108909 A1, published Nov. 28, 2016) – expandable with multiple openings
Cambronne et al. (US 20190321530 A1, published Oct. 24, 2019) – bend in the cannula and impeller in the cannula section
Wallin (US 20210252271 A1, published Aug. 19, 2021) – retraction of sheath allows it to expand
Siess et al. (US 20230086096 A1, published Mar. 23, 2023) – common applicant
Spanier (US 20230414921 A1, published Dec. 28, 2023) – common applicant, discloses a slit in the catheter
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/E.N.C./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792