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 .
Response to Amendment
This action is in response to the amendment filed on 4/23/2026. In the amendment, claims 1, 3, 4, 6, 10, 13, & 20 have been amended, claims 2, 5, 18, & 19 have been cancelled, and claims 23-24 have been added.
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.
Claims 1, 3, 4, 6-8, 10-12, & 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peter (US Pub. No. 2014/0277403 A1).
Regarding claim 1, Peter discloses a system for the delivery of an embolization device (Figs. 4a-4e) (although the embolization device is not positively recited as part of the claimed system until claim 11, it is noted that the prosthetic heart valve in Peter’s disclosure is considered to read on an ‘embolization device’ since it is configured to block flow in at least one direction) comprising a delivery wire 56 (Figs. 4a-4e) and an expandable structure 42 (Figs. 4a-4e), wherein the system comprises a sheath 70 (Figs. 4a-4e) connectable to a delivery catheter, and a loading device 102 (Figs. 3 & 4a-4e) comprising: a compartment 142 (Figs. 4a-4e) configured to contain the expanded structure of the embolization device; a conduit 140 configured to receive the delivery wire of the embolization device, wherein the conduit is coupled to the compartment 142 (paragraph [0031]); wherein the loading device comprises a proximal seal 106 configured to selectively allow passage of the sheath 70 therethrough and into the conduit 142 (sheath 70 is able to pass through seal 106); a distal seal 104 (Figs. 4a-4e) configured to selectively allow passage of the sheath therethrough (seal 104 is configured to be capable of receiving sheath 70 as it is capable of receiving nose cone 58 seen in Figs. 4a-4b); and a fluid inlet 108 (and open ends of loading device 102 - Fig. 3) in fluid communication with the compartment 142.
Regarding claim 3, Peter further discloses wherein the distal seal 104 of the loading device is coupled to a Tuohy Borst valve or a Y-connector (paragraph [0010] - ‘the sealing apparatuses each include a Tuohy-Borst valve).
Regarding claim 4, Peter further discloses wherein the loading device comprises a proximal seal 106 configured to selectively allow fluid flow therethrough (valve within the sealing apparatus allows for selective fluid flow by design - paragraph [0010]).
Regarding claim 6, Peter further discloses wherein the proximal seal 106 and the distal seal 104 are aligned along the longitudinal axis of the loading device (Figs. 4a-4e).
Regarding claim 7, Peter further discloses wherein the loading device further comprises a fluid outlet (either of the open ends of the loading device can be used as a fluid outlet).
Regarding claim 8, Peter further discloses wherein the loading device is made, partly or completely, of a transparent or semi-transparent material (paragraph [0035] - ‘housing 102 is illustrated as being transparent in the view of Figs. 4A-4E’).
Regarding claim 10, Peter further discloses wherein the system further comprises a delivery catheter (sheath 70 is part of a delivery catheter system).
Regarding claim 11, Peter further discloses wherein the system further comprises the embolization device 22 (the prosthetic heart valve 22 in Peter’s disclosure is considered to read on an ‘embolization device’ since it is configured to block flow in at least one direction).
Regarding claim 12, Peter further discloses wherein the system further comprises a source of fluid (paragraph [0038]), said source of fluid being fluidly coupled to the fluid inlet of the loading device (as noted in claim 1 rejection, the open ends of the loading device 102 are considered as fluid inlets - since the lumen 74 of sheath 70 (source of the fluid) is coupled to the proximal open end of the loading device 102, it is considered to be fluidly coupled to the fluid inlet of the loading device).
Regarding claim 24, Peter further discloses wherein the fluid inlet 108 is located longitudinally between opposing proximal and distal ends of the loading device (Fig. 3 - 108 is a port and is configured for fluid communication with the loading device, since the fluid source is not positively recited in this claim and not further positively recited as being attached to the fluid inlet, it is considered that this inlet 108 is capable of being connected to a fluid source and is located in the claimed position relative to the ends of the loading device).
Claim Rejections - 35 USC § 103
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 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Peter (US Pub. No. 2014/0277403 A1) in view of Lehrberg (WO 2018060795 A1).
Regarding claim 9, Peter discloses wherein the loading device 102 is made of hardened plastic (paragraph [0029]) but fails to explicitly disclose the material to be one of polycarbonate, nylon, and/or PTFE. However, Lehrberg teaches a common plastic to be used in medical device containers to be polycarbonate (paragraph [0054]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose polycarbonate as the plastic in the ’container’ of the loading device since this is considered to be a common material in the art as suggested and taught by Lehrberg.
Allowable Subject Matter
Claims 13-17, 20, 21, & 23 are allowed.
The following is an examiner’s statement of reasons for allowance: claim 13 has been amended to incorporate the limitations of previously indicated allowable subject matter from claim 19, see Non-Final Rejection mailed on 1/26/2026 for Reasons for Allowance.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 4/23/2026 have been fully considered but they are not persuasive. Regarding the arguments with respect to the rejection of claim 1 (now amended to include the limitations of prior claims 2 and 5), examiner disagrees. The only comments provided by applicant regarding the amendment to claim 1 is that the limitations added are similar to the limitations added to claim 13 that were previously indicated as allowable subject matter. Examiner draws attention to the claim differences: claim 1 is a device claim and claim 13 is a method claim. Claim 1’s proximal and distal seals only need to be capable of selectively allowing passage of the sheath therethrough, whereas the similar limitation of claim 13 requires there to be an actual step of inserting a sheath through the proximal and distal seals. Since the seals of Peter’s device are capable of receiving a sheath therethrough, the claim is still rejected under the prior art. However, as indicated in the Reasons for Allowance of Non-Final mailed 1/26/2026, there is no step disclosed, suggested, or taught to have the sheath inserted through the distal seal. Therefore, the method claim is allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 26, 2026
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