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 I, Species D, claims 1-4, 7-10, 12 in the reply filed on 5/8/26 is acknowledged.
Claims 5-6, 11, 13-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/8/26.
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) 1-3, 7-10, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller (US 2021/0069392).
PNG
media_image1.png
512
438
media_image1.png
Greyscale
Regarding claim 1, Muller discloses the same invention as claimed (Figure 19 shown above for example), including a cardiac pump system (abstract; Figures 1-3), comprising: a catheter shaft having a proximal end region coupled to a handle and a distal end region coupled to a cardiac pump (Figure 1), wherein the cardiac pump includes an impeller housing, a cannula and an impeller (Figures 2-3; Paragraphs 62-64), wherein the cannula includes a distal end region and a proximal end region (Figure 2), wherein the distal end region of the cannula is configured to be positioned in a left ventricle of a heart (Figure 3); and a first flow sensor coupled to the cannula or the catheter shaft (Figures 18A-B: 521, 524; Paragraph 121+), wherein the first flow sensor is configured to directly sense a first velocity of blood flowing adjacent to the first flow sensor (Paragraph 111: velocity flowmeter; Paragraph 121: flow rate).
Regarding claims 2-3, Muller discloses a console as recited (Figure 1; Paragraph 111).
Regarding claim 7, Muller discloses both cannula and catheter shaft sensors as recited (Figure 18B: 521, 524).
Regarding claim 8, Muller discloses the catheter shaft velocity flow sensor as recited (Figure 1; Paragraph 111).
Regarding claim 9, Muller discloses comparing catheter and cannula flow as recited (Paragraph 146).
Regarding claim 10, Muller discloses calculating a pump position as recited (Paragraphs 143, 146; Figures 21A-C).
Regarding claim 12, Muller discloses a catheter shaft sensor positioned along the shaft to be proximal of a subclavian artery when the cannula is properly positioned in the left ventricle as recited (Figure 19; Paragraph 131).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller (US 2021/0069392) in view of Mitze (US 2022/0161019).
Regarding claim 4, Muller discloses assessing cardiac output (Paragraph 146) but does not explicitly disclose calculating cardiac output based on flow measurements. However, Mitze teaches calculating cardiac output based on flow measurements as recited (Paragraph 222), in order to assess operational cardiac output with the pump. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Muller as taught by Mitze to include calculating cardiac output based on flow measurements as recited, in order to assess operational cardiac output with the pump.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tuval (US 2022/0088368) and Mitze (US 2022/0161019) show cardiac pumps with a flow sensor.
D’Ambrosio (US 2017/0348470), Higgins (US 2020/0030510), Goldvassar (US 2020/0288988), Schlebusch (US 2022/0039669), Stigloher (US 2023/0173250), Winzer (US 2024/0011808) show cardiac pumps with a flow sensor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-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, Carl Layno can be reached at 571-272-4949. 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.
/Eugene T Wu/Primary Examiner, Art Unit 3796
Prosecution Insights