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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/4/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In light of “remarks” of 9/4/2025 and interview of 9/11/2025 (see section 112(b) rejection below), the examiner was unable to find support in the originally-filed disclosure for the new limitations drawn to “a cooling liquid flow path extending radially between the rotor and the stator, wherein the cooling liquid flow path is fluidly sealed about the rotor to prevent the fluid from contacting the stator.” Page 8 of remarks argues that the claimed subject matter avoids Moise because Moise “permits liquid to pass through the sleeve from inlet to outlet” and so is not “fluidly sealed,” apparently construing “fluidly sealed” to require a closed chamber about the rotor that does not permit a bulk longitudinal flow of fluid through the rotor chamber. The examiner was unable to find support in the original disclosure for such a concept. During the interview of 9/11/2025, Applicant’s representative pointed to paragraph 0070 as an example for such support, where the disclosure notes that “[a] sleeve 21 can be disposed about the proximal portion of the catheter body 120A, and the seal 19 can be provided about the seal 21 to seal the distal chamber 5 from the rotor chamber 4.” This passage is referring to Figs. 6A and 6B, showing seal 19 around the outer surface of output shaft 13 with lumen 55 of the catheter 120A. This seal 19 is further depicted in Fig. 4B, showing this element sealing the distal chamber 5 from the rotor chamber 4 around the outer circumference of the catheter assembly 120A and output shaft 13 while still providing for a flow of fluid within the catheter assembly 120A and outside of output shaft 13 (see arrows depicting flow at 17A and 17B, described at, e.g., par. 0059). In other words, it does appear that seal 21 seals the distal chamber 5 from the rotor chamber 4 around the outside of the catheter assembly, neither this element, nor any other element(s) the examiner was able to locate in the original disclosure, supports the concept of “fluidly sealing” in the sense that no bulk flow into or out of the rotor chamber occurs. All embodiments appear to be drawn to the concept of flowing a cooling fluid through the rotor chamber via an input and an output as described in par. 0059.
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.
Claim 25 is 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. Claim 25 recites “a cooling liquid flow path extending radially between the rotor and the stator, wherein the cooling liquid flow path is fluidly sealed about the rotor to prevent the fluid from contacting the stator.” The plain language of “fluidly sealed about the rotor to prevent the fluid from contacting the stator” appears to require a scope of the fluid being sealed in at least the region around the rotor from contacting the stator. However, “remarks” of 9/4/2025 and the interview of 9/11/2025 appear to indicate an intended claim scope of the fluid being completely sealed in the rotor chamber and not allowing a flow of fluid into or out of the rotor chamber. Accordingly, based on the record, the scope of “fluidly sealed” is vague.
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.
(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.
Claim 25 is rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Moise et al. (US 4,895,557, hereinafter “Moise”).
In regards to claim 25, Moise discloses a mechanical circulatory support device for assisting a blood pumping function of a heart in a medical treatment of a patient (col. 1, lines 14-42), the mechanical circulatory support device comprising: a catheter body having a distal end (Figs. 1a and 2, element 20); a heart pump at the distal end (element 12; pump for assisting the heart), the heart pump being percutaneously insertable into a vasculature of the patient and positionable therein to a desired location (col. 1, lines 14-23; col 2, lines 3-8); a drive shaft extending through the catheter body for operating the heart pump at the distal end to assist the blood pumping function (element 22); and an electric motor rotatably coupled to the drive shaft to operate the heart pump to pump blood at the desired location (element 26), the electric motor comprising: a stator and a rotor operable in combination to rotate the drive shaft at a predetermined speed (element 24; col. 2, lines 52-58; col. 3, lines 21-25); and a cooling liquid flow path extending radially between the rotor and the stator (Figs. 1a and 3; col. 3, lines 39-47; housing 22 including elements 55, 57, 59, and 56), wherein the cooling liquid flow path is fluidly sealed about the rotor to prevent the fluid from contacting the stator (Figs. 1a, 3; col. 2, lines 53-68, col. 4, lines 1-8, “encased in a sleeve 84”; abstract, “rotor enclosed in a fluid-tight enclosure which can be slipped into the stator of a drive motor”).
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Allowable Subject Matter
Claims 21 and 26-40 are allowed.
Response to Arguments
Applicant's arguments filed 9/4/2025 have been fully considered but they are not persuasive. The examiner incorporates the substance of the “response to arguments” of 6/4/2025 for similar limitations drawn to similar concepts, and presents new grounds of rejection, necessitated by amendment under sections 112 and 102 above. In short, the above rejections take the position that (1) the scope of “fluidly sealed” is unclear; (2) if the scope of the phrase requires a completely closed rotor chamber that precludes inflow and outflow from the rotor chamber, such a scope is unsupported in the original disclosure; and (3) if the scope merely requires the flow path to be sealed from the stator in the region of the rotor (“about the rotor”), such scope of anticipated by Moise.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792