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 .
Claim Objections
Claim 12 objected to because of the following informalities: Use of “low” in place of “lower.” Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 6-9, and 13-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel et al. US 20180055628 A, herein referred to as Patel.
Regarding claim 1, Patel discloses a system ([0017]) for treating a diseased native valve of a heart ([0054]), the system comprising: an anchor (Fig 19, 1110 center) having a spiral shape (Fig 19) that is configured to engage with chordae tendineae and/or leaflets of the diseased native valve and to provide a securing force around a valve prosthesis ([0112-0113] teaches capturing chordae and securing valve prosthesis); and a tether (Fig 19, 1130 and 1140; [0111]) configured to provide access to the anchor when the anchor is deployed around the chordae tendineae and/or leaflets of the native valve ([0113], chordae capture taught, allowing access), the tether having a distal region (Fig 19, distal region1130)and a proximal region (Fig 19, proximal Extension region 1140), the distal region having a distal end connected to the anchor (1140 is coupled to central region 1110), wherein the distal region and the proximal region have different bending stiffnesses ([0117]; Teaches thinner wire for region 1140 for ease in deployment ).
Regarding claim 2, Patel discloses wherein the tether has a sufficiently high tensile strength to support an anchor delivery catheter ([0091] Patel teaches using Dyneema for the tether. It would have been readily understood by one of ordinary skill in the art that, Dyneema has high tensile strength and is often used to support medical devices in some fashion) and a valve delivery catheter tracked thereover ([0072] see Fig 6 and 7, delivery catheter 1010; claim is aimed at intended use).
Regarding claim 3, Patel discloses wherein the distal region has a sufficiently high tensile strength to allow a user to manipulate a position of the anchor when the anchor is deployed around the chordae of the native valve ([0124 teaches push and pull to desired positioned; [0012] teaches using sufficiently high thickness/strength tether around docking region).
Regarding claim 4, Patel discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the proximal region has a sufficiently high compressive strength to resist axial compression when an axial compressive force is applied to the tether ([0124 teaches push and pull to desired positioned; [0012] teaches using sufficiently high thickness/strength tether around docking region).
Regarding claim 6, Patel discloses wherein the distal region has a lower bending stiffness than the proximal region ([0017] teaches thinner wire 1140 for easier bending).
Regarding claim 7, Patel discloses wherein the tether includes an inner cable (Fig 19, 1160 inner wire) housed within a tubular housing (Fig 19,1170 cover; [0118]).
Regarding claim 8, Patel discloses wherein the cable is translatable within the tubular housing ([0128] teaches securing elements together, would yield translatable motion and limit rotation).
Regarding claim 9, Patel discloses wherein the tubular housing includes one or more of: a tubular coil, a braided tube, and a tubular jacket (Fig 22, 1170 and [0119].
Regarding claim 13, Patel discloses wherein the tubular housing includes one or more radio-opaque markers (Patel [0104]).
Regarding claim 14, Patel discloses wherein the tubular housing at the proximal region includes a stacked tubular coil (Fig 19), and the tubular housing at the distal region includes a slitted tube (Patel Fig 19, slit 1164; [0126] teaches securing with coil or suture or another tie-down).
Regarding claim 15, Patel discloses wherein the distal region is configured to transition between a flexible state and a stiff state (state when the extension region 1140 is sheathed within the delivery catheter, not pictured, [0120]; formed of a shape memory material, para. [0117]; made of shape memory material so that the device can be straightened for delivery, para. [0062]; flexible state in that the device is not in its preferred shape-set configuration), wherein the distal region has a pre- determined shape when in the stiff state (state when the extension region 1140 is unsheathed from the delivery catheter [0120]; formed of a shape memory material [0117]; thus, when delivered, the device is 'stiff' in that it is shape set to assume the preferred configuration).
Regarding claim 16, Patel discloses wherein the pre-determined shape includes an L-shaped bend (Fig 19, 1140).
Regarding claim 17, Patel discloses wherein the pre-determined shape includes a U-shaped bend (Fig 19, 1140).
Regarding claim 18, Patel discloses wherein the distal region has a shorter length than the proximal region (Fig 19).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Woo et al, WO 2021119026 A1, herein referred to as Woo.
Regarding claim 5, Patel discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not explicitly disclose wherein the distal end of the tether is releasably connected to the anchor.
But Woo teaches wherein the distal end (Fig 2, 12 end near 14) of the tether is releasably connected to the anchor (Fig 2, 14; pg 10, lines 27- pg 11 lines 2).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Patel to incorporate wherein the distal end of the tether is releasably connected to the anchor, as taught and suggested by Woo, in order to allow the securing of additional components such as screws (Woo pg 10, lines 27- pg 11 lines 2]).
Claim(s) 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel.
Regarding claim 19, Patel discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not explicitly disclose wherein a length of the distal region ranges between 5% and 20% of a length of the proximal region.
But Patel teaches wherein a length of the distal region ranges between 5% and 20% of a length of the proximal region ([0012] Patel teaches a length of the extension region 1140 being significantly less than a length of the upper region 1130 (Fig. 19); Fig 19 appears to be between 5 and 20%; recited claim is a design choice; optimization of parameters is routine procedure in the art).
It would have been obvious to one of ordinary skill in the art to modify Patel to incorporate wherein a length of the distal region ranges between 5% and 20% of a length of the proximal region, to provide for desired stabilization of the docking device, in order to secure device (Patel [0116]).
In addition, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the length required desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the length of the distal region, would have been obvious at the time of applicant's invention in view of the teachings of Patel. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Regarding claim 21, Patel discloses Patel discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does disclose wherein the distal region has an axial length that is at least double an axial length of the valve prosthesis.
But in another embodiment Patel teaches an extension 140 having a length of 100 mm ([0084]), and further teaches an average mitral valve in humans measures approximately 50 mm along its long axis ([0087]) (depends on size of prosthesis, valve not positively recited).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base invention of Patel to incorporate wherein the distal region has an axial length that is at least double an axial length of the valve prosthesis, through routine experimentation, to provide a desired retention force (Patel [0019]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Argento et al. WO 2020073050 A1, herein referred to as Argento.
Regarding claim 10, Patel discloses the invention substantially as claimed and as discussed above with respect to claim 9, but does not explicitly disclose wherein the tubular coil at the distal region of the tether has a larger pitch than the tubular coil at the proximal region of the tether.
But Argento teaches wherein the tubular coil at the distal region of the tether has a larger pitch than the tubular coil at the proximal region of the tether ([0015] Fig 3I, coil 20).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Patel to incorporate wherein the tubular coil at the distal region of the tether has a larger pitch than the tubular coil at the proximal region of the tether, as taught and suggested by Argento in order to allow concentric wrapping (Argento [0015]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Haarer et al. WO 2020256853 A1, herein referred to as Haarer.
Regarding claim 11, Patel discloses the invention substantially as claimed and as discussed above with respect to claim 9, but does not explicitly disclose wherein the braided tube at the distal region of the tether has a higher pics per inch (PPI) braid than the braided tube at the proximal region of the tether.
But Hareer teaches wherein the braided tube at the distal region of the tether has a higher pics per inch (PPI) braid than the braided tube at the proximal region of the tether ([0079] teaching lowering/raising braid angle, in turn increasing/decreasing PPI as desired. Also teaches increasing braid strength near distal region, therefore braided region would have higher PPI see Figs 4-7).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Patel to incorporate in wherein the braided tube at the distal region of the tether has a higher pics per inch (PPI) braid than the braided tube at the proximal region of the tether, as taught and suggested by Haarer in order to anchoring portion to encompass various shapes (Haarer [0082]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Devereux WO 2018089185 A1, herein referred to as Devereux.
Regarding claim 11, Patel discloses the invention substantially as claimed and as discussed above with respect to claim 9, but does not disclose wherein the tubular jacket at the distal region of the tether is made of a low durometer material than the tubular jacket at the proximal region of the tether.
But Devereux teaches wherein the tubular jacket at the distal region (Fig 30, 2978) of the tether is made of a low durometer material than the tubular jacket at the proximal region of the tether (Fig 30, 2978; [0108-0109]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify wherein the tubular jacket at the distal region of the tether is made of a low durometer material than the tubular jacket at the proximal region of the tether, as taught and suggested by Devereux in order to make distal region atraumatic (Devereux [0108]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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, Melanie Tyson can be reached at (571) 272-9062. 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.
/A.F./Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights