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 .
This office action is in response to the reply filed on 12/18/2025, wherein no claims were amended. Claims 1-14 are pending.
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 1-3 and 5-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Connolly (US 2016/0213441).
Regarding claim 1, Connolly discloses a packaging arrangement (See Figs. 1-2) capable of holding a medical device, comprising: at least one device recess (at 238) capable of receiving a medical device; a loading basin (See Fig. 2 labeled below) capable of receiving a liquid that can manipulate the medical device housed in the at least one device recess or can be connected to a medical device housed in the at least one device recess; and a spillway basin (See Fig. 2 labeled below), wherein the loading basin is connected to the spillway basin via a spillway passage (See Fig. 2 labeled below) having a spillway passage inflow (See Fig. 2 labeled below) and a spillway passage outflow (See Fig. 2 labeled below), wherein the spillway passage comprises a downward slope (See Fig. 2 labeled below) from the spillway passage inflow to the spillway passage outflow capable of promoting a liquid flow to the spillway passage outflow.
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Regarding claim 2, Connolly discloses the spillway passage comprises a spillway barrier (See Fig. 2 labeled above) between the inflow and outflow, wherein a liquid flow must overcome the spillway barrier to reach the outflow.
Regarding claim 3, Connolly discloses the top of the spillway barrier is higher than the outflow.
Regarding claim 5, Connolly discloses the bottom of the spillway basin is located at a height not lower than a height of the loading basin.
Regarding claim 6, Connolly discloses the loading basin comprises a sidewall (See Fig. 2 labeled above) having a rim (See Fig. 2 labeled above) between a top of the sidewall and a bottom of the sidewall, the rim providing an additional volume for a liquid present in a compartment confined by the sidewall.
Regarding claim 7, Connolly discloses a discharging element (See Fig. 2 labeled above) in fluid communication with an interior of the loading basin.
Regarding claim 8, Connolly discloses the discharging element comprises a discharging element inflow (See Fig. 2 labeled above) oriented to the interior of the loading basin and located at a height that corresponds to a height between an optimum fill level of the loading basin and a top of a sidewall of the loading basin.
Regarding claims 9 and 14, Connolly discloses the discharging element comprises a removable plug/plugging structure (portion of lid 250 as shown in Fig. 1 will plug the discharging element as labeled in Fig. 2 above, when the lid in in place) via which a fluid passage within the discharging element can be opened or closed.
Regarding claim 10, Connolly discloses the discharging element is arranged in a corner of the packaging arrangement.
Regarding claim 11, the spillway basin or loading basin of Connolly is capable of accommodating a removable rinsing tray comprising one or more recesses for receiving a rinsing liquid, in a storage or transport state of the packaging arrangement
Regarding claim 12, the at least one device recess of Connolly is capable of receiving an oblong medical device in a curved position.
Regarding claim 13, the at least one device recess of Connolly is capable of receiving at least in part a delivery catheter for a prosthetic heart valve.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Connolly (US 2016/0213441) as applied to claim 2, in view of Heimann (US 4,216,860). As described above, Connolly discloses the claimed invention except for the spillway barrier being movable to allow adjustment of a top height of the spillway barrier. However, Heimann teaches a medical device packaging (See Fig. 1) comprising a channel (at 24), wherein the channel is provided with a barrier element (at 30), wherein the top portion of the barrier element is movable (See Figs. 2-3 wherein the top wall of 30 moves/flexes downward) when the medical device is disposed thereon, for the purpose of securing the portion of the medical device during shipment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the barrier of Connolly to be movable/flexible as taught by Heimann in order to more securely hold the contents in place.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
Applicant argues that regarding claim 1, Connelly lacks the "a spillway basin, wherein the loading basin is connected to the spillway basin via a spillway passage having a spillway passage inflow and a spillway passage outflow, wherein the spillway passage comprises a downward slope from the spillway passage inflow to the spillway passage outflow configured to promote a liquid flow to the spillway passage outflow." The Examiner labels and slope in Fig. 2, but there is no support in the drawing for alleging this portion is a downward slope from what the Examiner labels as an inflow and outflow. The only mention of a fluid in Connolly is that the reservoir 234 holds a fluid. [0022]. Other portions of the tray body 202 are receptacles for parts of the medical device: "tray body 202 defines a handle assembly receptacle 236 for seating a catheter handle assembly (not shown), an elongate delivery shaft receptacle 238 for seating a sheath assembly (not shown), and a reservoir 234 for holding a fluid (not shown). Other receptacles are also defined by walls and spaces of tray body 202." [0022]. No slope is shown, and the Examiner should explain the support for the labelled "slope" if this contention is not withdrawn.
Regarding Applicant’s argument, the portion labeled as the “Slope” in Fig. 2 above is the downward extending wall portion between the two portions of the spillway passage (See “Slope” extending between the “Upper portion” and the “Lower portion” labeled in the portion of Fig. 2 below). As defined in claim 1, the spillway passage of Connolly comprises a downward slope (at the “Slope” labeled in Fig. 2) extending at least partially between the spillway passage inflow to the spillway passage outflow capable of promoting a liquid flow to the spillway passage outflow. Furthermore, even though Connolly does not mention the various portions (loading basin, spillway basin, spillway passage, etc.) of the packaging having liquid therein, since the liquid is not positively recited in the claim, the portion of the packaging of the prior art must only be capable of holding liquid in the manner recited in the claim. The loading basin (See Fig. 2 labeled above) of Connolly is fully capable of receiving a liquid that can manipulate the medical device housed in the at least one device recess; and the downward slope (See Fig. 2 labeled above and below) from the spillway passage inflow to the spillway passage outflow of Connolly is fully capable of promoting a liquid flow to the spillway passage outflow, if liquid is placed therein. Regarding the intended use of the claimed invention “configured to receive a liquid” and “configured to promote a liquid flow”, it has been held that 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 satisfying the claimed structural limitations. If the prior art structure is capable of performing the intended use, then it meets the claim. Ex parte Masham, 2 USPQ2d 1647 (1987).
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Applicant argues that based upon the description in [0022], there is also no support for the label of a loading basin the Examiner's figure. There is only one fluid reservoir described, and the remaining portions of the tray body 202 are "[o]ther receptacles are also defined by walls and spaces of tray body 202," which are for holding medical device parts. The Examiner should explain support for the labelled "loading basin" if this contention is not withdrawn.
Regarding Applicant’s argument, as described above, even though Connolly does not mention the various portions (e.g. the loading basin) of the packaging having liquid therein, since the liquid is not positively recited in the claim, the portion of the packaging of the prior art must only be capable of holding liquid in the manner recited in the claim. Regarding the intended use of the claimed invention “a loading basin configured to receive a liquid”, it has been held that 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 satisfying the claimed structural limitations. If the prior art structure is capable of performing the intended use, then it meets the claim. Ex parte Masham, 2 USPQ2d 1647 (1987). The loading basin (cavity labeled in Fig. 2 above) of Connolly is fully capable of receiving a liquid therein since it is a shallow cavity with side walls that can hold liquid therein.
Applicant argues that no artisan would interpret Connolly in the way that the Examiner has done in the marked-up figure. According to [0022], the tray body 202 defines a handle assembly receptacle 236 for seating a catheter handle assembly and an elongate delivery shaft receptacle 238 for seating a sheath assembly and a reservoir 234 for holding a fluid. There is no disclosure referring to rinsing and spillage.
Regarding Applicant’s argument, the rinsing and spillage (and liquid in general) are only mentioned as functional language in the claim since the liquid is not positively recited within the package. Therefore, the various portions (loading basin, spillway basin, spillway passage, etc.) of the prior art must only be capable of holding liquid in the manner recited in the claims. The packaging of Connolly (as described in the rejection above) is fully capable of holding a medical device and liquid in the manner recited in the claims.
Applicant argues that in general, Connolly addresses a different problem solved by the present invention and uses a different structure to address the different problem. Connolly concerns a tray design with a tray body 202 and a tray lid 250 and connector arms 100, 101 at both sides. Each connector arm 100, 101 is coupled to the tray body or the tray lid and has a first, open position that permits the separation of the tray body and tray lid, and a second position that couples tray body to tray lid.
Regarding Applicant’s argument, even though the Connolly reference may address a different problem than the present invention, the structural elements of the Connolly reference read on the limitations of the pending claims. Therefore, the rejections of the claims in view of Connolly is proper.
With respect to the art rejections, in accordance with MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, 367 F.3d 1359, 70 USPQ2D 1827, 1834 (Fed. Cir. 2004).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-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, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735