DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 23 is objected to because of the following informalities: line 1 should be amended to -The method of claim 20, wherein the receiving [[a]] the flow of liquid comprises-. Appropriate correction is required.
Claims 24-28 are objected to due to their dependence on claim 23.
Claim 24 is objected to because of the following informalities: line 1 should be amended to - further comprising maintaining the [[fluid]] liquid supply at a-. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: line 1 should be amended to - The method of claim 23, wherein the receiving [[a]] the flow of liquid further comprises-. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: line 1 should be amended to - The method of claim 23, wherein the receiving [[a]] the flow of liquid further-. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: line 1 should be amended to - The method of claim 23, wherein the receiving [[a]] the flow of liquid further-. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: line 1 should be amended to - The method of claim 23, wherein the receiving [[a]] the flow of liquid further comprises-. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: line 2 should be amended to - outside of [[the]] a patient-. Appropriate correction is required.
Claim 35 is objected to because of the following informalities: line 1 should be amended to - wherein the supplying the liquid comprises supplying-. Appropriate correction is required.
Claim 36 is objected to because of the following informalities: line 1 should be amended to - wherein the supplying the liquid comprises supplying-. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: line 1 should be amended to - wherein the supplying the liquid comprises supplying-. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: line 1 should be amended to - wherein the supplying the liquid comprises supplying-. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: line 1 should be amended to - wherein the supplying the liquid comprises supplying-. Appropriate correction is required.
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)(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 31-32, 34-36 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 4908012 A to Moise et al. (Moise).
Moise discloses:
Regarding claim 31:
A method (as shown in figure 1) of cooling a motor assembly (14) in the operation of a catheter pump system (figure 1), the method comprising:
flowing a liquid (blood flowing from right to left in 12; column 3, lines 45-57) toward and away from a percutaneously insertable impeller assembly (flows through 12 from right to left indicating that it flows toward 24 and 26 and away from them outward the left) being driven by the motor assembly (driven by 14); and
passing at least a portion of the flowing liquid toward or away from the percutaneously insertable impeller assembly (blood flowing from right to left in 12 through the impellers 24/26; column 3, lines 45-57) through at least one internal motor assembly passage (through the passage of 12 between the stator 14 and rotor 18 of the internal motor) to cool the motor assembly while driving the percutaneously insertable impeller assembly (heat is transferred to the blood flowing between 14 and 18; column 3, lines 29-36).
Regarding claim 32:
The method of claim 31, further comprising percutaneously inserting the impeller assembly into a vasculature of a patient (column 2, lines 25-30).
Regarding claim 34:
The method of claim 31, further comprising supplying the liquid (liquid supplied via the blood vessel to 12 or saline solution supplied via 50 to purge the pump which is supplied to the blood; column 3, lines 8-15).
Regarding claim 35:
The method of claim 32, wherein supplying the liquid comprises supplying the liquid from a location outside of the patient (the saline solution supplied via 50 comes from delivery device 60 outside of the patient as shown in figure 4; column 4, lines 6-14).
Regarding claim 36:
The method of claim 34, wherein supplying the liquid comprises supplying saline (see saline solution supplied via 50; column 3, lines 8-15).
Regarding claim 39:
The method of claim 34, wherein supplying the liquid comprises supplying infusate (see saline solution supplied via 50; column 3, lines 8-15; as evidenced by US 20150290372 to Muller et al. saline solutions are considered infusate (¶0072)).
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.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4908012 A to Moise et al. (Moise) as applied to claim 31 above, and further in view of US 7731675 B2 to Aboul-Hosn et al. (Aboul-Hosn).
Regarding claim 33:
Moise fails to disclose:
The method of claim 31, further comprising maintaining the motor assembly outside of the patient.
Aboul-Hosn teaches:
A system (figure 1 and 11) where the catheter pump system (12) is located inside the patient (as shown in figure 1) and the motor assembly (20) is located outside of the patient.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Moise to leave the catheter pump system of Moise inside the patient while the motor assembly is located outside of the patient as taught by Aboul-Hosn. This is a simple substitution of one known element (motor assembly located within the patient as disclosed in Moise) for another (motor assembly located outside of the patient as taught by Aboul-Hosn) to obtain predictable results (to actuate the pump of the impeller inside to patient).
Claim(s) 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4908012 A to Moise et al. (Moise) as applied to claim 31 above, and further in view of US 20120172656 A1 to Walters et al. (Walters).
Regarding claim 37:
Moise fails to disclose:
The method of claim 34, wherein supplying the liquid comprises supplying dextrose.
Walters teaches:
A heart pump (figure 1a) that includes a catheter pump (116) that can be supplied with lubricant via a catheter body (120). The catheter body can further supply a dextrose or glucose solution for lubricant to the pump (¶0046).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Moise to replace the saline for lubricant for dextrose or glucose solution as taught by Walters. This is a simple substitution of one known element (saline lubricant as disclosed by Moise) for another (glucose or dextrose solution for lubricant as taught by Walters) to obtain predictable results (to lubricate the bearings or impeller of the pump).
Regarding claim 38:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 37 by Moise and Walters:
The method of claim 34, wherein supplying the liquid comprises supplying glucose solution (see the glucose solution of Walter incorporated into Walter).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: claims 20-30 is/are allowed primarily because the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Furthermore, the prior art of record does not teach “channeling the first portion of the return flow of the liquid within the output shaft lumen proximally within the output shaft lumen to cool the motor assembly” and “channeling the second portion of the return flow of the liquid proximally at least partially about the periphery of the rotor within the flow diverter to cool the motor assembly during operation” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 20.
Therefore, the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior are:
US-20160213827-A1
Tanner
See the catheter pump system as shown in figure 1c
US-20080168796-A1
MASOUDIPOUR
See the pump/compressor as shown in figure 2 that includes coolant and compressed gas flowing through the pump via lines 52 and 46
US-7229258-B2
Wood
See the pump in figure 6 with the fluid passage 32
US-5098256-A
Smith
See lubricant line 106 to the bearings 72
WO-2016116608-A2
LIEBING
See pump as shown in figure 6 with fluid flow in passage 88
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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, Michael Tsai can be reached on (571) 270-5246. 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.
/WESLEY G HARRIS/Examiner, Art Unit 3783
Prosecution Insights