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 . Claims 1-4, & 6-21 are pending and examined below.
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 6-7) and that the dependent claims rise and fall with the same arguments (pages 7-8).
In regards to the amendments of claim 1, applicant argues that the prior art, Spilka, does not teach a set diameter and that the diameter is controlled by monitoring the pressure gauges. The examiner respectfully disagrees. Spilka teaches the electronic controller may also be preprogrammed with a protocol for automatic compression of the stent (¶0040), which would mean that there is a set diameter for the preprogrammed compression. Therefore, the applicant’s argument is not sufficient to overcome the rejection of record and the claims remains rejected.
In regards to claims 9 and 19, applicant's arguments are moot due to the additional references applied to the newly added limitations, as detailed in the rejection below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4 & 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spilka (US 20040078953 A1).
Regarding claim 1, Spilka teaches a crimping device (10, Fig. 2) for an implant (2, Fig. 2), the crimping device comprising:
an implant receiving region (region where 8 is received in Fig. 2); and
one or more bodies (11, Fig. 2) positioned about the implant receiving region and including a fluid chamber (20, Fig.4) and one or more movable walls (12, Fig. 4) between the implant receiving region (region where 8 is received in Fig. 4) and the fluid chamber (20, Fig.4), the one or more movable walls being configured to apply a hydraulic force radially upon the implant within the implant receiving region to compress the implant (hydraulic pressure, ¶0035), and
the one or more movable walls (12, Fig. 4) are non-compliant and configured to move no further radially inward than a set diameter (¶0040).
Regarding claim 2, Spilka teaches
wherein the one or more bodies comprise a cuff (lumen of region where 8 is received in Fig. 2) extending around the implant receiving region (region where 8 is received in Fig. 3).
Regarding claim 3, Spilka teaches
wherein the one or bodies are configured to be inflated with fluid to reduce a size of the implant receiving region and to apply the hydraulic force radially upon the implant within the implant receiving region (hydraulic pressure, fluids (e.g. water, oil, saline) may be used…and compresses the object inside the chamber, ¶0018).
Regarding claim 4, Spilka teaches
wherein the one or more bodies are configured for the fluid to be withdrawn from the one or more bodies to reduce a size of the one or more bodies and increase the size of the implant receiving region (fluid or gas inside the pressure chamber 20 is partially evacuated, ¶0044).
Regarding claim 6, Spilka teaches
wherein one or more movable walls form a cylindrical shape and extend around the implant receiving region (12 is ovoid profile, Fig. 4, ¶0037).
Regarding claim 7, Spilka teaches
further comprising a fluid conduit coupled to the one or more bodies and configured to transfer fluid to or from the one or more bodies (conduit attached to 14 for volume displacement devices, Fig. 4, ¶0039).
Regarding claim 8, Spilka teaches
further comprising a hydraulic actuator configured to transfer fluid to or from the one or more bodies (manual pump, a syringe or other pressure or volume displacement devices, ¶0039).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 9-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spilka in view of Malewicz et al. (US 20110106246 A1) hereinafter, Malewicz.
Regarding claim 9, Spilka teaches a system (Fig. 4, Spilka) comprising:
a delivery apparatus (catheter delivery systems, ¶0043, Spilka) configured to deliver a prosthetic replacement heart valve (2, Fig. 1, Spilka) to a location within a subject and including an elongate shaft having an implant retention area (where 4 is, Fig. 1, Spilka);
the prosthetic replacement heart valve (2, Fig. 2, Spilka) configured to be compressed and expanded (Figs. 1-4, Spilka), and configured to be retained at the implant retention area and deployed to the location within the subject (¶0043, Spilka); and
a crimping device (10, Fig. 2, Spilka) having an implant receiving region (region where 8 is received in Fig. 2, Spilka) and one or more bodies (11, Fig. 2, Spilka) configured to apply a hydraulic force radially upon the prosthetic replacement heart valve within the implant receiving region to compress the prosthetic replacement heart valve (hydraulic pressure, ¶0035, Spilka).
Spilka does not specify a prosthetic replacement heart valve. However, Malewicz teaches a stented heart valve may be crimped using a crimping tool (¶0042, Malewicz) comprising
a delivery apparatus (130, Fig. 13A, Malewicz) configured to deliver an implant a prosthetic replacement heart valve (100, Fig. 12A, Malewicz) to a location within a subject (Fig. 26A, Malewicz),
the prosthetic replacement heart valve (100, Fig. 26A-C, Malewicz) configured to be compressed (Fig. 26A, Malewicz) and expanded (Fig. 26C, Malewicz),
the prosthetic replacement heart valve (100, Fig. 23, Malewicz) within the implant receiving region (26, Fig. 23, Malewicz) to compress the prosthetic replacement heart valve (100, Fig. 23, Malewicz).
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 teachings of Spilka by incorporating the teachings above as taught by Malewicz in order to perform heart valve replacement on a beating heart (¶0011, Malewicz).
Regarding claim 10, Spilka teaches
wherein the implant receiving region (region where 8 is received in Fig. 2) is configured to receive the elongate shaft of the delivery apparatus (Fig. 1).
Spilka does not specify a prosthetic replacement heart valve. However, Malewicz teaches
to compress the prosthetic replacement heart valve to the elongate shaft (¶0104, Malewicz).
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 teachings of Spilka by incorporating the teachings above as taught by Malewicz in order to perform heart valve replacement on a beating heart (¶0011, Malewicz).
Regarding claim 11, Spilka does not specify a prosthetic replacement heart valve. However, Malewicz teaches
wherein the elongate shaft includes a capsule (136, Fig. 22, Malewicz) configured to extend over the prosthetic replacement heart valve (100, Fig. 23, Malewicz).
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 teachings of Spilka by incorporating the teachings above as taught by Malewicz in order to define a stent chamber for delivery of the stented heart valve (¶0082, Malewicz).
Regarding claim 12, Spilka teaches
wherein the one or more bodies are expandable and are configured to be filled with fluid to apply the hydraulic force radially upon the prosthetic replacement heart valve (hydraulic pressure, fluids (e.g. water, oil, saline) may be used…and compresses the object inside the chamber, ¶0018, Spilka).
Spilka does not specify a prosthetic replacement heart valve. However, Malewicz teaches
the prosthetic replacement heart valve (100, Fig. 12A, Malewicz).
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 teachings of Spilka by incorporating the teachings above as taught by Malewicz in order to perform heart valve replacement on a beating heart (¶0011, Malewicz).
Regarding claim 13, Spilka teaches
wherein the one or more bodies are configured for the fluid to be withdrawn from the one or more bodies (fluid or gas inside the pressure chamber 20 is partially evacuated, ¶0044, Spilka).
Regarding claim 14, Spilka teaches
wherein the implant receiving region has a cylindrical shape (Fig. 2, Spilka), and the one or more bodies include one or more movable walls forming a cylindrical shape and extending around the implant receiving region (12 is ovoid profile, Fig. 4, ¶0037, Spilka).
Regarding claim 15, Spilka does not specify a prosthetic replacement heart valve. However, Malewicz teaches
wherein the prosthetic replacement heart valve (100, Fig. 12A, Malewicz) comprises one or more of a mechanically expandable prosthetic replacement heart valve (100, Fig. 12A, Malewicz), a self-expanding prosthetic replacement heart valve (100, Fig. 12A, Malewicz), or a balloon expandable prosthetic replacement heart valve (100, Fig. 12A, Malewicz).
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 teachings of Spilka by incorporating the teachings above as taught by Malewicz in order to perform heart valve replacement on a beating heart (¶0011, Malewicz).
Regarding claim 16, Spilka teaches
further comprising a hydraulic actuator configured to transfer fluid to or from the one or more bodies (manual pump, a syringe or other pressure or volume displacement devices, ¶0039, Spilka).
Regarding claim 17, Spilka teaches
wherein the hydraulic actuator includes a fluid chamber and a piston configured to move within the fluid chamber (manual pump, a syringe or other pressure or volume displacement devices, ¶0039, Spilka).
Regarding claim 18, Spilka teaches
further comprising a controller configured to operate the hydraulic actuator (controller, ¶0039-0040, Spilka), and the controller includes a processor configured to operate a program to operate the hydraulic actuator (computer or a microprocessor based device, ¶0040, Spilka), and the system further comprises one or more sensors configured to provide feedback to the processor, the one or more sensors include one or more of a force sensor, a flow sensor, or an optical sensor (pressure sensor, ¶0040, Spilka).
Regarding claim 19, Spilka teaches a method (¶0032, Spilka) comprising:
positioning a prosthetic replacement heart valve (2, Fig. 2, Spilka) within an implant receiving region (region where 8 is received in Fig. 2, Spilka) of a crimping device (10, Fig. 2, ¶0035, Spilka),
the crimping device including one or more bodies (11, Fig. 2, Spilka) configured to apply a hydraulic force to the prosthetic replacement heart valve (hydraulic pressure, ¶0035, Spilka); and applying the hydraulic force radially upon the prosthetic replacement heart valve with the one or more bodies to compress the prosthetic replacement heart valve within the implant receiving region (hydraulic pressure, ¶0035, Spilka).
Spilka does not specify a prosthetic replacement heart valve. However, Malewicz teaches
a prosthetic replacement heart valve (100, Fig. 12A, Malewicz).
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 teachings of Spilka by incorporating the teachings above as taught by Malewicz in order to perform heart valve replacement on a beating heart (¶0011, Malewicz).
Regarding claim 20, Spilka teaches
further comprising moving the one or more bodies (11, Fig. 2, Spilka) from an open state in which the implant receiving region (region where 8 is received in Fig. 2, Spilka) is configured to receive the prosthetic replacement heart valve (2, Fig. 2, Spilka) to a closed state in which the prosthetic replacement heart valve is enclosed within the implant receiving region (Figs. 2-4, Spilka).
Spilka does not specify a prosthetic replacement heart valve. However, Malewicz teaches
a prosthetic replacement heart valve (100, Fig. 12A, Malewicz).
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 teachings of Spilka by incorporating the teachings above as taught by Malewicz in order to perform heart valve replacement on a beating heart (¶0011, Malewicz).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spilka in view of Malewicz and further in view of Braun et al. (US 20220187058 A1) hereinafter, Braun.
Regarding claim 21, Spilka teaches sensors but does not specify an optical sensor. However, Braun teaches a crimping machine for crimping a cable with a contact sleeve and using a first optical sensor (abstract, Braun)
wherein the one or more sensors include the optical sensor (61-63, Figs. 1A-C, Braun).
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 teachings of Spilka and Malewicz by incorporating the teachings above as taught by Braun in order to monitor the result of a crimping that has been carried out.
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 KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
Prosecution Insights