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 group 1, drawn to an assembly, claims 1-13 in the reply filed on 01/30/2026 is acknowledged. The traversal is on the ground(s) that the stent graft does not include a valve component as recited by each of the method claims 14 and 20, therefore the restriction does not show the process can be used with the different product. This is not found persuasive because even if a stent valve was used, the stent valve can be used with a different process of using that product, such that the transcatheter heart valve prosthesis having a crimping chamber with a crimping accessory could be used with a self-expandable heart valve prosthesis.
The requirement is still deemed proper and is therefore made FINAL.
Allowable Subject Matter
Claims 6-10 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 prior art fails to teach nor render obvious wherein the body of the crimping accessory further includes at least one hinge such that the crimping accessory has a clam-shell configuration that allows the crimping accessory to snap onto the balloon catheter of the delivery system.
The prior art fails to teach nor render obvious wherein the fluid chamber is annular and is disposed radially outward from the channel configured to receive the balloon catheter.
The prior art fails to teach nor render obvious wherein the transcatheter heart valve prosthesis includes exactly three leaflets and the crimping accessory includes exactly three nozzles, each nozzle being configured to remove or apply fluid to or from a leaflet of the exactly three leaflets.
The prior art fails to teach nor render obvious wherein the body of the crimping accessory includes a slot extending from a first end to a second end thereof, the slot being configured to receive a balloon catheter of a delivery system for the transcatheter heart valve prosthesis, and wherein the crimping accessory slides onto the balloon catheter of the delivery system via the slot.
The prior art fails to teach nor render obvious wherein the slot configured to house the balloon catheter extends an entire longitudinal length of the crimping accessory and has a substantially U- shaped cross-section, and wherein the fluid chamber is C-shaped and disposed radially outward from the slot configured to house the balloon catheter.
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)(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) 1-5 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frisby et al. U.S. Publication 2021/0186692 A1.
Regarding Claim 1, Frisby et al. discloses an assembly 100 as seen in Figures 1-18 comprising: a transcatheter heart valve prosthesis including a frame 120 and a valve component 110 including at least one leaflet disposed within and secured to the frame (as seen in the prior art encorporated by reference, publication 20180296335, see paragraph [0062]) the transcatheter heart valve prosthesis 100 having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve (as seen in Figures 2A-2B); and a crimping accessory 860 configured for use with a crimper 800 when radially compressing the transcatheter heart valve prosthesis into the crimped configuration, wherein the crimping accessory 860 includes a body having an aperture formed on an outer surface thereof (as seen in Figure 10), at least one nozzle (piston chamber) coupled to the body (as seen in Figure 10), and at least one fluid chamber (889, the lumen) formed between the aperture and the nozzle such that the aperture and the at least one nozzle are in fluid communication (paragraphs [0088], [0090]). The limitation “the crimping accessory configured to apply or remove pressurized fluid via the at least one nozzle to or from the at least one leaflet of the transcatheter heart valve prosthesis to hold the at least one leaflet in a substantially closed state when the crimper is radially compressing the transcatheter heart valve prosthesis into the crimped configuration” is a recitation of intended use of the crimping accessory. 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. Frisby’s crimping accessory is structured as claimed and is capable of applying or removing pressurized fluid via the at least one nozzle to or from the at least one leaflet of the transcatheter heart valve prosthesis to hold the at least one leaflet in a substantially closed state when the crimper is radially compressing the transcatheter heart valve prosthesis into the crimped configuration.
Regarding Claim 2, Frisby et al. discloses wherein the crimping accessory includes a first end and a second end 872 (having opening 856, see Figure 8) opposing the first end 874, the first end 874 and the second end 872 of the crimping accessory being substantially circular in shape (as seen in Figure 10).
Regarding Claim 3, Frisby et al. discloses wherein the first end 874 of the crimping accessory has a first circumference which is larger (as seen in Figures 8 and 10) than a second circumference of the second end 872 (having opening 856) of the crimping accessory.
Regarding Claim 4, Frisby et al. discloses wherein the aperture disposed on the outer surface of the body is configured to receive tubing 876 configured to connect the crimping accessory to a fluid source or a suction source (paragraph [0088]).
Regarding Claim 5, Frisby et al. discloses wherein the body of the crimping accessory further includes a channel 894 extending from a first end to a second end 874, 872 thereof, (paragraph [0086]). The channel 894 is configured to receive a delivery system through the lumen in order to attach a prosthetic heart valve device, see paragraph [0086]. Therefore, Frisby’s channel is capable of being configured to receive a balloon catheter of a delivery system for the transcatheter heart valve prosthesis
Regarding Claim 11, Frisby et al. discloses wherein the crimping accessory is configured to be disposed within and attached to an interior surface of the crimper 800 (as seen in Figures 8-10).
Regarding Claim 12, Frisby et al. discloses wherein the crimping accessory contains a singular, annular nozzle that at least one of applies pressurized fluid to and removes pressurized fluid from the at least one leaflet of the transcatheter heart valve prosthesis (paragraphs [0088], [0090]).
Regarding Claim 13, Frisby et al. discloses wherein the crimping accessory includes a seal 898 (O-ring) around an outer perimeter of a first end configured to seal around the crimper 800 (paragraph [0088]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774