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 preliminary amendment filed on 3/24/2025. In the amendment, claims 4 and 20 have been amended and claim 22 has been cancelled.
Claim Objections
Claim 10 is objected to because of the following informalities: claim 10 currently depends on itself - for the purpose of examination, examiner will read claim 10 as depending . Appropriate correction is required.
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 1-8 & 10-18 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]); and a fluid inlet 108 (and open ends of loading device 102 - Fig. 3) in fluid communication with the compartment 142.
Regarding claim 2, Peter further discloses wherein the loading device comprises 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).
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 5, Peter further discloses 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).
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 13, Peter discloses a method for delivering an 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) comprising a delivery wire 56 (Figs. 4a-4e) and an expandable structure 22 (Figs. 4a-4e), wherein the method comprises the step of providing a loading device 102 (Figs. 3 & 4a-4e) comprising: a compartment 140 (Fig. 3) configured to contain the expanded structure of the embolization device 22 (Figs 4a-4e); a conduit 142 (Fig. 3; paragraph [0031]) configured to receive the delivery wire 56 of the embolization device 22, wherein the conduit 142 is coupled to the compartment 140 (paragraph [0031]); and a fluid inlet (108 and open ends of loading device 102 - Fig. 3) in fluid communication with the compartment 140.
Regarding claim 14, Peter further discloses the step of connecting a source of fluid (paragraph [0038]) to the fluid inlet of the loading device 102 (as noted in claim 13 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 15, Peter further discloses the step of delivering fluid into the loading device 102 (paragraph [0038]; Fig. 4D).
Regarding claim 16, Peter further discloses the step of positioning the loading device 102 substantially vertically during the fluid delivery step (‘upright orientation’ noted in paragraph [0038]; Fig. 4D), so that the fluid is delivered to the proximal conduit 142 first before the fluid is delivered to the distal compartment 140.
Regarding claim 17, Peter further discloses the step of substantially immersing the embolization device 22 with fluid or flushing the embolization device with fluid (paragraphs [0038]-[0039]).
Regarding claim 18, Peter further discloses wherein the loading device 102 comprises a proximal seal 106, and wherein the method further comprises the step of inserting a sheath 70 through said proximal seal 106 and over the embolization device 22 (sheath is inserted through seal 106 as seen in Fig. 4B, and the retraction of the embolization device 22 places the sheath 70 over the device 22 - Fig. 4e)
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 19-21 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: regarding claim 19, the prior art fails to further disclose, teach, or suggest the step of inserting the sheath through said distal seal - the sheath 70 in Peter’s loading device is never inserted through the distal seal 104, moving the sheath through this seal would destroy Peter’s loading method as it is not designed or intended to be used in such a way; regarding claim 20, Peter fails to further disclose the step of connecting the sheath with a delivery catheter. Since the sheath 70 is an element of the delivery catheter system, there would be no step of connecting the sheath to a delivery catheter since this would require an additional delivery catheter to be present in Peter’s method/system (which is not disclose, suggested, or taught in Peter, nor would this be necessary to add for any benefit or purpose).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat. No. 5,486,193 discloses a system of loading a prosthetic occluder using a loading device.
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.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 January 10, 2026