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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the asymmetric ramp (claim 14) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not contain reference to the asymmetric ramp discussed in claim 14.
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 13, 14 and 19-22 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.
In claims 13 and 14, the term “to each other” is vague and indefinite. It will be assumed that the applicant is attempting to describe the inner surface of the funnel.
In claim 19, lines 8 and 9, reference to the housing region H lacks antecedent basis. It is assumed that it was the applicant’s intent to delete all reference letters such as “H” (line 9) and “I” (line 8).
Reference to the funnel in claim 22 lacks antecedent basis.
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.
Claim(s) 1, 2, 4-9, 15, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voelker (Pat. No. 6,248,091).
Regarding claim 1, Voelker discloses a blood pump 16 comprising: a housing 17 defining an interior space; a rotatable impeller 20 disposed within the interior space and comprising an impeller hub 19 and one or more impeller blades 22 disposed along the impeller hub; a stationary bearing region 18 to which a proximal end of the impeller is rotationally operationally engaged (see Fig. 2); a stationary guidewire path 26 defined along at least a portion of the stationary bearing region, the stationary guidewire path located within the interior space defined by the housing; and a non-stationary guidewire path extending through the interior space of the housing along the impeller (see path of guidewire 25 in Fig. 2 extending between rotatable blades 22), wherein the stationary and non-stationary guidewire paths are configured to be substantially align-able and substantially linear in a longitudinal direction when the non- stationary guidewire path is moved into alignment with the stationary guidewire path (as shown in Fig. 2).
Regarding claim 2, note proximal groove or channel 26 configured to receive guidewire 25 and located proximal of the rotatable impeller as shown in Fig. 2.
Regarding claim 4, as shown in Fig. 2, at least a portion of the groove or channel 26 is at least partially defined by the stationary bearing region 18.
Regarding claims 5-7, the space between impeller blades 22 and the space between the impeller hub upon which the blades are attached and the housing 17, forms at least one notch or aperture configured to receive a guidewire therethrough (see col. 2, lines 34-55).
Regarding claim 8, as shown in Fig. 2, the guidewire located between the blades and extending from the proximal to the distal end of the pump, exhibits a twist of less than 180 degrees, thus requiring the blades themselves to comprise a twist angle of less than 180 degrees in order for the guidewire to transition between the blades as shown.
Regarding claim 9, see col. 3, lines 3-21.
Regarding claims 15 and 19, note the comments made above in the rejection of similar limitations in claims 1 and 9. The notch or aperture existing between the impeller blades must be aligned with the stationary guidewire path in order for the guidewire to be placed as shown in Fig. 2.
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(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voelker.
Regarding claim 10, while Voelker does not explicitly state that the twist angle is about 140 degrees, Voelker does teach that the twist angle may be at least 150 degrees (col. 3, lines 3-21). The applicant gives no criticality to the exact twist angle, and states that 140 degrees is merely exemplary. It is stated that any blade twist less than 180 degrees is within the scope of the invention so long as the guidewire is enabled to pass through the notch or aperture (par. 0048). The courts have long determined that, lacking any criticality, the rearrangement of parts (e.g., the rearrangement of blades from a 150-degree twist angle to about 140 degrees of twist), would be considered a matter of obvious design to those of ordinary skill in the art. Any degree allowing the guidewire to conveniently translate through the blade arrangement and into the stationary guidewire path would have been considered suitable to the invention.
Claim(s) 11-13, 16, 18, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voelker in view of Schellenberg et al. (Schellenberg: Pub. No. 2024/0075277).
Regarding claim 11, while Voelker does not disclose a stationary guidewire path in the shape of a funnel, Voelker does show a lumen for a guidewire that transitions from a large diameter area (distal region including balloon support lumen 13 and pump region 17) to a small diameter guidewire region 26. Anytime it is desired to insert a guidewire into a narrow lumen, it behooves the designer to provide a tapered or funnel shaped guide to assist in guiding the wire through the transition region. An abrupt change between diameters could result in the guidewire not consistently entering the narrower passage and/or damaging the guidewire and surrounding structure, as one attempts to forcibly feed the guidewire through the pump. It is old and well-known that the tapered funnel shape allows greater alignment tolerances when attempting to insert the tip of any object into a narrow channel or lumen, and provides a smooth transition region for facilitating insertion of the guidewire into narrower passageways. Schellenberg, for example, discloses a related system wherein the use of a symmetric funnel-shaped guide 92 with a large diameter distal end and a ramp that tapers down in the proximal direction is used to assist placement of a guidewire into a narrow passage (par. 0066) for placement of the pump within the body. Those of ordinary skill in the art recognizing that the funnel shape aids in placing guidewires within blood pump or other invasive devices by providing a smooth transition region whenever attempting to place guidewire into a smaller diameter lumen, would have considered it a matter of obvious design to modify the stationary guidewire path to include this well-known geometric structure, with the exact positioning and location of the funnel shape dependent upon the geometry and configuration of the system within which the guidewire is to be inserted.
Related comments apply to substantially similar limitations in claims 12, 13, 16, 18, 21 and 22.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voelker and Schellenberg as applied to claims 11-13, 16, 18, 21 and 22 above, and further in view of Lupton (Pub. No. 2013/0317485).
Regarding claim 14, while Voelker and Schellenberg do not explicitly discuss the option of using an asymmetric ramp, Lupton discloses a system for placing a guidewire wherein it is known to use an asymmetric tapering ramp to engage and direct the guidewire (see Fig. 5). Those of ordinary skill in the art would have recognized that any shape facilitating relative insertion of the guidewire into the narrower lumen of the stationary guidewire path would suffice. The applicant gives no criticality to the use of such a shape. The courts have long determined that changes in shape not sufficiently affecting operation would have been considered a matter of obvious design (see MPEP 2144.04).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Narciso ‘661, Doiron ‘917, Laymon ‘022 and Mitze ‘018 disclose funnel-shaped guidewire guides for use with medical devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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, David E. Hamaoui can be reached at 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
September 17, 2026
