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 .
Election/Restrictions
Applicant’s election without traverse of Group II (Claims 9-14) in the reply filed on November 24, 2025 is acknowledged.
Claim Rejections - 35 USC § 102
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 9-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Keenan (US 20130303970 A1).
With respect to claim 9, Keenan discloses
A catheter assembly for use in a percutaneous heart pump (see paragraph 0024, percutaneous catheter pump), the catheter assembly comprising:
an impeller assembly (see Fig. 2, impeller assembly #92; and see Fig. 7A-7B) comprising:
an impeller (see Figs. 3A-3B and paragraph 0028-0030, impeller #300; and see Figs. 7A-7B and paragraph 0061-0068, impeller #703);
an impeller tip positioned distal of the impeller (see Figs. 3A-3B and paragraph 0028-0030, impeller tip is the most distal end of #300; and see Figs. 7A-7B and paragraph 0061-0068, #709); and
a distal septum positioned between the impeller and the impeller tip (see paragraph 0012, a re-sealable member interpreted to be a septum can be disposed distally of impeller; and see Figs. 7A-7B and paragraph 0061-0068, re-sealable member or a septum #754);
a flexible atraumatic tip (FAT) positioned distal of the impeller assembly (see Fig. 3A, atraumatic tip is positioned distal of impeller assembly and as seen in Fig. 3A it is curved at the end); and
a guidewire guide (GWG) coupled between the impeller assembly and the flexible atraumatic tip (see Figs. 7A-7B and paragraph 0061-0068, a guidewire guide tube #750 can pass through impeller shaft and is coupled between the tip and impeller assembly), wherein a proximal end of the guidewire guide is positioned distal of the distal septum (see Figs. 7A-7B and paragraph 0061-0068).
With respect to claim 10, all limitations of claim 9 apply in which Keenan further discloses wherein the GWG is flexible and resilient (see paragraph 0060, the guidewire guide tube may be disposed through a central lumen of the catheter pump to the heart; and see paragraph 0064, guidewire guide is stainless steel and has high durometer polymer used to re-seal it) to facilitate (a) reducing kinking as the catheter assembly is delivered to a left ventricle of a patient’s heart and (b) maintaining a rigid length of the catheter assembly (intended use; the guidewire guide tube is capable of facilitating reduced kinking and maintaining rigid length of catheter assembly).
With respect to claim 11, all limitations of claim 9 apply in which Keenan further discloses wherein the GWG is constructed from flexible alloys including at least one of nitinol, a grade of stainless steel (see paragraph 0064, guidewire guide is stainless steel) , or advanced polymers such as polyamide, HDPE, LLDPE, FEP, PET, Pebax, etc.
With respect to claim 12, all limitations of claim 9 apply in which Keenan further discloses wherein the distal septum is pierceable when a guidewire passes through the GWG prior to a procedure (see Figs. 7A-7B and paragraph 0061-0068, a guidewire guide tube #750 can pass through impeller shaft and a guidewire passes through the tube and pierces the re-sealable member #754).
With respect to claim 13, all limitations of claim 9 apply in which Keenan further discloses wherein the distal septum is configured to seal after a guidewire is removed (see Figs. 7A-7B and paragraph 0061-0068, re-sealable member #754 can be employed to reseal the aperture formed with the guidewire or guidewire guide is removed).
With respect to claim 14, all limitations of claim 9 apply in which Keenan further discloses an expandable cannula (see paragraph 0012, catheter pump includes an expandable cannula).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
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