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 .
Detailed Action
This in response to the non-provisional application filed 09/26/2024.
Allowable Subject Matter
Claims 2, 14-19 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: Claim 2 pushing the first anchor distally with a plurality of curved hypotubes of the delivery device that house the tethers. Claim 14 distally advancing the outer sheath and distally advancing an inner sheath such that a marker is aligned with the mitral valve annulus.
The Office agrees the art of record fails to teach or suggest these features.
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(s) 1 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0310267 (Zeng et al.) in view of U.S. Patent Publication Number 2015/0112430 (Creaven et al.)
Regarding claim 1, 5-7, Zeng et al. discloses as shown in Figures 8A-8E, a method of delivering a prosthetic mitral valve into the heart of a patient, the method comprising: extending a delivery device into the heart with the prosthetic mitral valve collapsed within an outer sheath (capsule 2010, see paragraph [0037]) of the delivery device; sliding the outer sheath to expose at least a first anchor (flange 111, see paragraph [0038]) of the prosthetic mitral valve; see paragraph [0038]; allow the first anchor to self-expand to an expanded annular configuration on a first side of the mitral valve annulus; see paragraph [0038]; and allowing a second anchor (v-shaped supports 105, see paragraph [0038]) of the prosthetic mitral valve to self-expand on a second side of the mitral valve annulus, the expansion of the first anchor and the second anchor causing the first anchor and the second anchor to move towards each other and capture tissue of the mitral valve annulus between the first anchor and the second anchor, distally advancing the plurality of tethers to loosen the plurality of tethers that are coupled to the first anchor, wherein the plurality of tethers extend axially to a tether retainer (primary shaft 530, see paragraph [0061]), wherein each of the plurality of tethers are configured to loop through the first anchor of the prosthetic heart valve, wherein the first anchor is a proximal anchor of the prosthetic mitral valve and the second anchor is a distal anchor of the prosthetic mitral valve. See paragraph [0038]
Zeng fails to disclose loosening a plurality of tethers of the delivery device that are coupled to the first anchor.
Creaven et al., from the same field of endeavor taches a similar method as shown in Figures 10A, 10B where the method includes the step of providing a delivery device with a plurality of tethers (tethers 514, see paragraph [0060]) and the step of loosening a plurality of tethers of the delivery device that are coupled to the first anchor for the purpose of releasing the first anchor after preventing the first anchor from rapidly expanding and optionally allowing recapture if the first anchor needs to be repositioned. See paragraph [0068].
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 method disclosed by Zeng to include the plurality of tethers taught by Creaven et al. and the step of loosening a plurality of tethers of the delivery device that are coupled to the first anchor in order to prevent the first anchor from rapidly expanding and optionally allowing recapture if the first anchor needs to be repositioned and the finally deploying it, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 3, 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0310267 (Zeng et al.) in view of U.S. Patent Publication Number 2015/0112430 (Creaven et al.) as applied to claim 1above, and further in view of U.S. Patent Publication Number 2005/0149159 (Andreas et al.)
Regarding claim 3, 4 Zeng et al. fails to disclose rotating a sheath control knob to slide the outer sheath proximally to expose at least the first anchor of the prosthetic mitral valve.
Andreas et al. from the same field of endeavor teaches a similar method as shown in Figures 7A-B where the method includes the step of outer sheath proximally to expose at least the first anchor, wherein rotating a sheath control knob to slide the outer sheath proximally to expose at least the first anchor of the prosthetic mitral valve, wherein the sheath control knob is positioned on a handle of the delivery device. See paragraph [0072].
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 method disclosed by Zeng et al. by substituting the means for retracting the outer sheath disclosed by Zeng et al. for the knob and handle taught by Andreas et al. and include the steps of rotating a sheath control knob to slide the outer sheath proximally to expose at least the first anchor of the prosthetic mitral valve because it would only require the simple substitution of one known alternative structure and steps for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0310267 (Zeng et al.) in view of U.S. Patent Publication Number 2015/0112430 (Creaven et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2014/0243959 (Nelson et al.)
Regarding claims 8-10 Zeng et al. fails to disclose moving a tether control knob axially from a first position to a second position; distally advancing the plurality of tethers to loosen the plurality of tethers that are coupled to the first anchor; and moving the tether control knob axially from the second position to the first position, wherein the first position of the tether control knob is distal to the second position.
Nelson et al., from the same field of endeavor teaches as similar method as shown Figures 17, 18 where moving a tether control knob (control knob 314, see paragraph [0084]) axially from a first position to a second position; distally advancing the plurality of tethers to loosen the plurality of tethers that are coupled to the first anchor; and moving the tether control knob axially from the second position to the first position, wherein the first position of the tether control knob is distal to the second position, wherein distally advancing the plurality of tethers to loosen the plurality of tethers that are coupled to the first anchor includes rotating the tether control knob. See paragraphs [0084], [0087].
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 method disclosed by Zeng et al. by substituting the means for manipulating the tethers and steps for manipulating the tethers disclosed by Zeng for the control knob and steps for manipulating the tethers because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regrading claim 11, Zeng et al. in view of Creaven discloses further comprising: proximally retracting the plurality of tethers. See paragraph [0068]
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0310267 (Zeng et al.) in view of U.S. Patent Publication Number 2015/0112430 (Creaven et al.) as applied to claim 12 above, and further in view of U.S. Patent Publication Number 2015/0119978 (Tegels et al.)
Regarding claim 12, Zeng fails to disclose wherein proximally retracting the plurality of tethers includes rotating a tether control knob to tighten the tethers to proximally retract the plurality of tethers.
Tegels et al., from the same field of endeavor teaches a similar method as shown in Figure 3 where the method includes the step of proximally retracting the plurality of tethers includes rotating a tether control knob to tighten the tethers to proximally retract the plurality of tethers. See paragraph [0047].
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 method disclosed by Zeng to include the steps of proximally retracting the plurality of tethers includes rotating a tether control knob to tighten the tethers to proximally retract the plurality of tethers taught by Tegels et al. in order to tighten the tethers.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0310267 (Zeng et al.) in view of U.S. Patent Publication Number 2015/0112430 (Creaven et al.), U.S. Patent Publication Number 2015/0119978 (Tegels et al.) as applied to claim 12 above, and further in view of U.S. Patent Publication Number 2004/0006380 (Buck et al.)
Regarding claim 13, Zeng et al. fails to disclose providing auditory feedback indicative of whether the plurality of tethers are proximally retracting.
Buck et al., from the same field of endeavor teaches a similar method as shown in Figure 1, where the method includes providing auditory feedback indicative of whether a knob is turned. See paragraph [0019].
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 method disclosed by Zeng et al. in view of Creaven and Tegels to include the mechanism which produces an audible click in the control knob such that the method included providing auditory feedback indicative of whether the plurality of tethers are proximally retracting in order to give the operator and idea of how far they turned the control knob, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
Prosecution Insights