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 with traverse of claims 1-10 in the reply filed on 08/21/2026 is acknowledged. The traversal is on the ground(s) that claims 1-10 and 19-20 are not mutually exclusive, or do not contain mutually exclusive elements. This is not found persuasive because although Applicant interprets the sheaths to be substantially the same, specific sheath terms in claim 19 require specific searches that extend from the broad claim 1 sheaths due to its specific/diverging subject matter. Furthermore, claim 19 requires a repositioning sheath with ”a length that is longer than a length of the introducer sheath”, however claim 1 only requires that the “second sheath is configured to advance through the lumen of the first sheath and extend distally beyond a distal end of the first sheath”; claim 19 specifies the lengths of the sheaths, and claim 1 requires the second sheath advancing through the first sheath lumen and extending distally beyond a distal end of the first sheath, where the second sheath and first sheaths could be interpreted as the same lengths but the second sheath is merely extending outward distally from the first sheath as claimed in claim 1, since no mention of their lengths is expressly mentioned in claim 1.
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Due to the inclusions of mutually exclusive elements between claims 1-10 and 19-20 as stated in the restriction requirement mailed 08/14/2026 as well as the interpretations of claims 1 and 19 as stated above, the species are not considered obvious variants of each other and would require a serious search AND examination burden at least for their divergent subject matter and requirement for different fields of search. Since claims 1-10 and 19-20 are interpreted to require mutually exclusive elements as well as mutually exclusive interpretations of the claims, as stated above, the restriction requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement(s) filed 01/08/2025 has/have been considered by the Examiner.
Claim Interpretation
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality since the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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.
(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(s) 1-7, 10 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Fantuzzi (US 20190076167 A1 – hereinafter Fantuzzi).
Re. claim 1, Fantuzzi teaches a mechanical circulatory support system (paragraph 0034 – “FIG. 1 shows an illustrative mechanical assist device (MAD)…”),
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the system comprising:
a blood pump (figure 1, pump head 130) configured to pump blood from a ventricle of a heart of a patient to vasculature of the patient (paragraph 0031 – “Although the embodiments and features described herein are specifically described for use in connection with a percutaneous heart pump system…”; paragraph 0032 – “The systems, methods and devices described herein provide a sheath assembly for the insertion of a medical device (e.g., a percutaneous heart pump) into a blood vessel through a vessel aperture”);
a housing (figure 1, pump handle/housing 110);
an elongate shaft (figure 1, pump body 120) coupled with the blood pump and extending proximally from the blood pump to the housing (figure 1, pump body 120 is on the proximal end adjacent the handle 110);
a first sheath having a first hub (paragraph 0032 – “The first sheath has a first hub coupled to its proximal end for attachment with other components of the integrated sheath assembly”; figure 4, hub 410 on sheath 400), the first sheath has a lumen with an inner diameter (paragraph 0042 – “The expandable body 420 has an unexpanded diameter 425. The expandable body 420 may be enlarged by an object inserted into the lumen 430”);
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and a second sheath having a second hub (figure 2, sheath 200 with diameter 208 and hub 210), the second sheath has an outer diameter that is less than the inner diameter of the lumen (paragraph 0041 – “The opening 450 has a diameter 405 which is designed to be larger than the diameter 208…within the lumen 430”), and
wherein the first sheath and the second sheath are configured to longitudinally advance over the elongate shaft (figure 8, first shaft body 420 and second shaft 200 are over the pump body 120),
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and a distal end of the second sheath is configured to advance through the lumen of the first sheath and extend distally beyond a distal end of the first sheath (figure 9 shows the second sheath body 220 advancing with the lumen of the first sheath body 420; paragraph 0051 – “The method 500 of FIG. 5 therefore ensures that when the repositioning sheath is inserted into the lumen of the expandable sheath…”).
Re. claim 2, Fantuzzi further teaches wherein the first sheath is an introducer sheath configured to allow the blood pump to pass through the lumen (figure 7, pump body 120 advances though lumen of first sheath body 420).
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Re. claim 3, Fantuzzi further teaches wherein the second sheath is a dual lumen sheath (paragraph 0038 – “In certain implementations, the sheath body 220 may have a second lumen 250, such as the second lumen in the dual lumen sheath…”; see figure 2).
Re. claim 4, Fantuzzi further teaches wherein the dual lumen sheath comprises a first tube defining a first lumen (figure 2, first lumen 230), a second tube extending along the first tube and defining a second lumen (figure 2, second lumen 250), and a third tube extending over the first tube and the second tube (figure 2, sheath body extending over the first and second lumens).
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Re. claim 5, Fantuzzi further teaches a wire (paragraph 0009 – “In certain implementations, the first hub includes a third port in communication with the further lumen for passage of the guidewire”), and
wherein the dual lumen sheath defines a first lumen configured to receive the elongate shaft (figure 3 shows the pump body 120 within the first shaft 200),
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and a second lumen configured to receive the wire (paragraph 0066 – “Additionally, guidewire access through the second lumen 250 of the repositioning sheath 200 is also possible when the assembly 900 is in position in the vasculature of the patient”).
Re. claim 6, Fantuzzi further teaches wherein the second sheath includes an internal hemostasis valve (paragraph 0036 – “The passageway 212 is configured with a valve 216, such as a hemostatic valve…”).
Re. claim 7, Fantuzzi further teaches wherein the first hub is configured to couple with the second hub when the distal end of the second sheath is distal of the distal end of the first sheath (figure 9, first hub 410 couples to the second hub 210).
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Allowable Subject Matter
Claims 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record and searched, alone or in combination, fails to anticipate and/or render obvious to claim 8 in its entirety, including to the first hub includes a suture pad configured to detach from the first hub and slide over the first sheath to a location around the second sheath when the distal end of the second sheath is distal of the distal end of the first sheath. Dependent claim 9 is further objected.
Closest prior art is considered as Korkuch (US 20210236783 A1 – hereinafter Korkuch), which teaches an expandable sheath assembly (paragraph 0034 – “The systems, methods, and devices described herein provide an expandable sheath assembly for the insertion of a medical device (e.g., an intracardiac heart pump) into a blood vessel through a vessel aperture”) for connection to an intracardiac pump system (paragraph 0033 – “Although the embodiments and features described herein are specifically described for use in connection with an intracardiac heart pump system …”), and further includes a hub (figure 1, hub 110) coupled to a suture pad (figures 1 and 6, suture pad 140).
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However, Korkuch does not include any teaching of the suture pad configured to detach as claimed in claim 8 in its entirety. Dependent claim 9 is further objected for its dependency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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