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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 06/29/2026 has been entered.
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 § 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) 1 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis (US 20060041230 A1 – hereinafter Davis) in view of Stack (US 20210085848 A1 – hereinafter Stack).
Re. claim 1, Davis teaches a sheath assembly comprising: a removable hub having a lumen extending therethrough and comprising: a first circumferential hub portion that spans a first circumferential segment about a longitudinal axis of the removable hub, (see at least figure 2 which shows a first hub portion 21),
a second circumferential hub portion that spans a second circumferential segment about the longitudinal axis of the removable hub, the second circumferential segment being greater than the first circumferential segment, and first and second connector portions connecting the first circumferential hub portion and the second circumferential hub portion; (see at least figure 2 which shows a second hub portion 22. It is considered to be an obvious design choice yielding predictable results to make circumferential segments different sizes. For example, differently shaped medical devices to be inserted into the patient made require the hubs to be sized differently),
and a removable shaft configured to extend distally from a distal end of the removable hub, the removable shaft being configured such that separation of the first circumferential hub portion from the second circumferential hub portion causes a first circumferential shaft portion to separate from a second circumferential shaft portion (see at least figure 2 which shows shaft 18. Further, the hub portions and shaft peel away from each other along tear lines 43,44, also see at least ¶72).
Davis does not expressly teach a removable knob having a lumen extending therethrough, a distal portion of the removable knob being configured to be received within the lumen of the removable hub; and a removable seal configured to be received within the lumen of the removable hub distally of the distal portion of the removable knob, the removable seal comprising a lumen extending therethrough and being configured to be aligned with the lumen of the removable shaft and the lumen of the removable knob, wherein advancing the removable knob distally within the lumen of the removable hub compresses the removable seal.
Stack teaches a similar sheath assembly (abstract – “Percutaneous access sheaths used to provide access to the vasculature and heart for the introduction of percutaneous ventricular assist devices (pVADs), and to remain in place for the duration of pVAD use”) which includes a removable knob (paragraph 0044 – “This proximal cap 64 has an opening on its proximal face, allowing access through the knob housing 62 into the lumen 20 of the sheath”) having a lumen extending therethrough, a distal portion of the removable knob being configured to be received within the lumen of the removable hub (paragraph 0045 – “As best seen in the exploded view of FIG. 10, the rotatable knob housing 62 includes first and second rings 62a, 62b, each having a central opening”),
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and a removable seal (paragraph 0046 – “A seal 66 is disposed within the volume enclosed by the proximal housing 88 and the proximal cap 64. The seal is formed of elastomeric material such as silicone and may have a cylindrical shape or an alternate shape”),
configured to be received within the lumen of the removable hub distally of the distal portion of the removable knob, the removable seal comprising a lumen extending therethrough and being configured to be aligned with the lumen of the removable shaft and the lumen of the removable knob, wherein advancing the removable knob distally within the lumen of the removable hub compresses the removable seal (paragraph 0046 – “The seal includes a seal lumen 68 oriented along the pathway between the opening of the sheath and the lumen 20, and preferably aligned with its longitudinal axis along the longitudinal axis of the lumen 20”).
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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 the sheath assembly of Davis, to incorporate the knob and seal parts as taught by Stack, since such modification would predictably result in providing structural integrity to the sheath assembly.
Re. claim 11, Davis of the combined invention further teaches wherein the removable hub comprises a handle extending laterally from a proximal portion of the first circumferential hub portion, wherein pivoting the handle distally is configured to effect separation of the first circumferential hub portion from the second circumferential hub portion. (see at least Davis figure 2 which shows a handle 30; see also ¶64).
Re. claim 12, Davis of the combined invention further teaches wherein a proximal portion of the removable shaft is received within a distal portion of the lumen of the removable hub and coupled to the removable hub within the distal portion of the lumen. (see at least Davis figure 4 which shows proximal portion of shaft 18 in distal portion of lumen 23).
Allowable Subject Matter
Claims 13-21 are allowed.
Claims 3-10 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, alone or in combination, fails to anticipate and/or render obvious to claim 13 in its entirety, including at least to a removable knob being configured to be split into two halves, and the lumen of the removable knob being configured to be aligned with a lumen of the removable shaft to allow advancement of at least a portion of a medical device through the lumen of the removable knob and into the lumen of the removable shaft, in combination with the other limitations of claim 13.
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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