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 Arguments
Applicant's arguments filed 05/07/26 have been fully considered but they are not persuasive.
On page 8 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully withdraws claim objections which were addressed.
On pages 8-9 regarding drawing objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws drawing objections.
On page 9 regarding 112b rejections Applicant argues amendments overcome the 112 rejections of record.
The Examiner respectfully notes that the 112s which were addressed are herein withdrawn.
On page 9 regarding 112f, Applicant argues amendments overcome any interpretation over 112f.
The Examiner respectfully disagrees, noting the “control assembly” remains in the claim and so is still indefinite under 112f and 112b.
On pages 9-11 regarding prior art rejections, Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claims 3 and 5 are objected to because of the following informalities:
Claims 3 and 5 are objected to for referring to “biasing” when it is unclear how, if at all, this relates to the previously defined “biasing” from claim 2, which this depends from.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 12 is indefinite for claiming “a system to deliver a docking device” comprising a “docking device”. It is unclear how a system for delivering a device includes the device it is intended to deliver.
Remaining claims are rejected for depending on a rejected claim.
Claim limitation “control assembly” in claims 13 and 14 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not discuss anywhere what this structure might be. The only reference made appears to be in [0032], which states the pusher shaft and actuating wire can be controlled via a control assembly, and in [0086], which only states the control assembly is able to “manipulate and/or delivery a docking device”, includes a “hub assembly”, and that the control assembly can work together with the wire actuating handle 310. It is possible the “control assembly” structurally includes the hub, based on this information, but the Examiner is unaware of how a hub acts to be a control assembly which is able to manipulate and/or deliver a docking device as is discussed throughout the specification, or to control the pusher shaft and actuating wire as is required by claim 13.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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) 1-4, 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 20180055628 A1) hereinafter known as Patel in view of Vidlund et al. (US 20150223934 A1) hereinafter known as Vidlund.
Regarding claim 1 Patel discloses a docking device (Abstract) for docking a prosthetic valve at a native heart valve (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Patel discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example the Abstract), the docking device comprising:
a coil (Figure 10 item 100 or Figure 3 item 1) constructed of a hypotube (Figure 11; [0017] the docking device incudes an opening/bore with a suture threaded therethrough) and extending along a central axis, the coil including an encircling turn (Figure 10 item 120 or Figure 3 item 20), a central region (Figure 10 item 110 or Figure 3 item 10), and a stabilization turn (Figure 10 item 130 or Figure 3 item 30), wherein:
the central region possesses approximately one turn (Applicant’s specification [0063] defines this as +/- 0.125 turns) ([0011] the docking device “has at least one central turn” with “one or more functional turns/coils”),
the encircling (ventricular) turn is disposed distally from one end of the central region (Figures 3/10 shows how the encircling ventricular turn 20/120 extends from the central region 10/110) and has a diameter around the central axis greater than a diameter of the central region (Figure 3, 10),
the stabilization (atrial) turn has a diameter around the central axis greater than the diameter of the central region (Figure 3, 10) and is disposed proximally from an opposing end of the central region from the encircling turn (Figure 3 shows how the atrial stabilization turn 30 extends from the end of the central region 10), and
an actuating wire disposed within the coil (Figure 11a item 219),
wherein the wire engages the coil via a pawl (Figure 11 item 218),
but is silent with regards to the pawl being on an inner surface of the coil, and the actuating wire including one or more teeth to engage with the pawl.
However, regarding claim 1 Vidlund teaches that a locking/tensioning wire within a heart valve device can include one or more pawls which interact with one or more teeth ([0031] tooth and pawl device). Patel and Vidlund solve the same problem, namely tensioning within heart devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the docking device of Patel so the actuating wire and coil engaged via a pawl and teeth as is taught by Vidlund since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known locking mechanism would have been obvious to one of ordinary skill to try. As regards whether the teeth/pawl are located on the wire versus the inside of the coil, the person of ordinary skill would have found it obvious for either the coil or wire to include the teeth and either to include the pawl, as these are obvious equivalents in the art.
Regarding claim 2 the Patel Vidlund Combination teaches the docking device of claim 1 substantially as is claimed,
wherein Patel further discloses the tube comprises a plurality of cuts (Figure 11 item 211) to allow biasing of the tube (this is stated as a functional limitation of the cuts (see the explanation above regarding how a “functional limitation” is understood. In this case, the cuts are understood to functionally allow the tube to bias. See for example, [0090]-[0091] which describes how the cuts adjust the flexibility and final shape of the tube upon deployment.).
Regarding claim 3 the Patel Vidlund Combination teaches the docking device of claim 2 substantially as is claimed,
wherein Patel further discloses a width or depth of cuts on one side of the tube (Figure 11 shows how the width of the cuts 216 is spaced further apart from cuts 211) allow for biasing of the tube (this is stated as a functional limitation of the cuts (see the explanation above regarding how a “functional limitation” is understood. In this case, the cuts are understood to functionally allow the tube to bias. See for example, [0090]-[0091] which describes how the cuts adjust the flexibility and final shape of the tube upon deployment).
Regarding claim 4 the Patel Vidlund Combination teaches the docking device of claim 2 substantially as is claimed,
wherein Patel further discloses a width or depth of cuts on one side of the tube are varied along a length thereof (Figure 11 shows how the width of the cuts 216 is spaced further apart from cuts 211 along the tube’s length. See also [0090] which describes how the cut dimensions can vary along the tube length), allowing for varied biasing of the tube along its length (this is stated as a functional limitation of the cuts (see the explanation above regarding how a “functional limitation” is understood. In this case, the cuts are understood to functionally allow the tube to bias. See for example, [0090]-[0091] which describes how the cuts adjust the flexibility and final shape of the tube upon deployment).
Regarding claim 9 the Patel Vidlund Combination teaches the docking device of claim 1 substantially as is claimed,
wherein Patel further discloses the coil includes a proximal transition zone between the central region and the stabilization turn (Figure 10 item 140).
Regarding claim 10 the Patel Vidlund Combination teaches the docking device of claim 2 substantially as is claimed,
wherein Patel further discloses the coil includes a distal transition zone between the central region and the encircling turn (considered to be the zone between the central region 10/110 and encircling turn 20/120).
Regarding claim 11 the Patel Vidlund Combination teaches the docking device of claim 10 substantially as is claimed,
wherein Patel further discloses a depth of the cuts are varied along a length of the distal transition zone ([0090] indicates the depth of the cuts can be varied along the length of the tube, which includes the distal transition zone).
Regarding claim 12 the Patel Vidlund Combination teaches the docking device of claim 1 substantially as is claimed,
wherein Patel further discloses a system to deliver the docking device at the native valve (This is claimed as a “functional limitation” of the system (see the explanation regarding “functional limitations”, above. See also [0017] which describes how there is a system for implanting the docking device; Abstract at how this can occur at a native valve) comprising:
a delivery catheter ([0124]),
a pusher shaft disposed in the delivery catheter ([0124] pusher in the delivery catheter; Figure 22c) and coupled to a proximal end portion of the docking device ([0128] the pusher shaft 1165 is coupled to the end of the docking device 1100 via suture 1163), the proximal end portion of the docking device being at an end of the stabilization turn located opposite the central region (see Figures 6-7 which show how the delivery catheter 1010 connects to the proximal end of the device 1 near the end of the stabilization (atrial) turn, as it delivers the distal/ventricular/encircling end while still attached to the pusher),
an actuating wire (Figure 11a item 219) connected to a distal end of the docking device ([0091]) and running coaxially with the pusher shaft (Figure 11a; [0017], [0074] everything is coaxial with the delivery catheter during delivery),
wherein the system is configured to the pusher shaft and actuating wire operate in parallel ([0128], [0017]).
Regarding claim 13 the Patel Vidlund Combination teaches the system of claim 12 substantially as is claimed,
wherein Patel further discloses a control assembly (this is considered inherent since [0092], [0094]-[0095] describes how the docking device is actuated from a delivery configuration to a deployed configuration and there is a locking and tensioning wire which are actuated), wherein the pusher shaft is coupled to the control assembly (Figure 22a, [0084]),
and wherein Vidlund further teaches that tensioning wires can extend through a control assembly ([0024] the tether which is tensioned can extend through and out of the proximal end of the catheter). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Patel Vidlund Combination so the actuating wires extends through the control assembly since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, it would have been obvious to one of ordinary skill to utilize any known mechanism to allow the user to control the wire, including one where the wire extends through the control assembly.
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel and Vidlund as is applied above in view of Zerkowski et al. (US 20210212826 A1) hereinafter known as Zerkowski.
Regarding claim 5 the Patel Vidlund Combination teaches the docking device of claim 2 substantially as is claimed,
but is silent with regards to the pitch (defined by the specification [0074] as “spacing distance”) to be varied between the cuts.
However, regarding claim 5 Zerkowski teaches that the distance between cuts within a biased tube can be varied (Figure 7a shows the distance between a cut tube’s portions can be varied along the length, with the central area 111 having wider spaces than the end of the tube 101, 102. See also [0085]). Patel and Zerkowski are involved in the same field of endeavor, namely endovascular devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the docking device of the Patel Vidlund Combination so that the spacing distance between the cuts is varied as is taught by Zerkowski since this is another known mechanism to vary flexibility of a tubular structure Zerkowski [0085]) known in the art. The courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any mechanism to adjust the cuts to vary the biasing as Patel describes as being desirable, would have been obvious to try.
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel and Vidlund as is applied above in view of Von Oepen et al. (US 20180028779 A1) hereinafter known as Von Oepen.
Regarding claim 6 the Patel Vidlund Combination teaches the docking device of claim 2 substantially as is claimed,
but is silent with regards to the pitch (defined by the specification [0074] as “spacing distance”) of the central region to be approximately 1.5 mm (Applicant’s specification [0079] defines this as +/- 0.25mm).
However, regarding claim 6 Von Oepen teaches that the distance between cuts within a biased tube can be approximately 1.5 mm ([0077]). Patel and Von Oepen are involved in the same field of endeavor, namely endovascular devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the docking device of the Patel Vidlund Combination so that the spacing distance between the cuts is approximately 1.5 mm as is taught by Von Oepen since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would have been motivated to try any known spacing distance between cuts within an endovascular device in order to vary its flexibility based on its intended use.
Claims 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel, Vidlund, and Zerkowski as is applied above, further in view of Von Oepen as is applied above.
Regarding claim 7 the Patel Vidlund Zerkowski Combination teaches the docking device of claim 5 substantially as is claimed,
but is silent with regards to the pitch (defined by the specification [0074] as “spacing distance”) of the central region to be approximately 1.5 mm (Applicant’s specification [0079] defines this as +/- 0.25mm).
However, regarding claim 7 Von Oepen teaches that the distance between cuts within a biased tube can be approximately 1.5 mm ([0077]). Patel and Von Oepen are involved in the same field of endeavor, namely endovascular devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the docking device of the Patel Vidlund Zerkowski Combination so that the spacing distance between the cuts is approximately 1.5 mm as is taught by Von Oepen since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would have been motivated to try any known spacing distance between cuts within an endovascular device in order to vary its flexibility based on its intended use.
Regarding claim 8 the Patel Vidlund Zerkowski Combination teaches the docking device of claim 5 substantially as is claimed,
but is silent with regards to the pitch (defined by the specification [0074] as “spacing distance”) of the central region to be approximately 2 mm (Applicant’s specification [0079] defines this as +/- 0.25mm).
However, regarding claim 8 Von Oepen teaches that the distance between cuts within a biased tube can be approximately 2 mm ([0077]). Patel and Von Oepen are involved in the same field of endeavor, namely endovascular devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the docking device of the Patel Vidlund Zerkowski Combination so that the spacing distance between the cuts is approximately 2 mm as is taught by Von Oepen since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would have been motivated to try any known spacing distance between cuts within an endovascular device in order to vary its flexibility based on its intended use.
Claims 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel and Vidlund as is applied above in view of Manash et al. (US 20180263764 A1) hereinafter known as Manash.
Regarding claim 14 the Patel Vidlund Combination teaches the system of claim 13 substantially as is claimed,
but is silent with regards to the control assembly comprising a Y-shaped connector.
However, regarding claim 14 Manash teaches that a system for delivering an endovascular device can include a control assembly that comprises a Y-shaped connector (Figure 8 shows how 426/428/424 form a Y-shape). Patel and Manash are involved in the same field of endeavor, namely endovascular delivery devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Patel so that the actuating assembly of the Patel Vidlund Combination includes a Y-shaped connector as is taught by Manash since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Patel.
Regarding claim 15 the Patel Vidlund Manash Combination teaches the system of claim 14 substantially as is claimed,
wherein Manash further teaches the Y-shaped connector comprises a straight section (Figure 8 item 424) and a branch (428).
The Combination is silent with regards to the extent of the actuating wire, but the Examiner notes that Manash teaches the catheter handle includes control mechanisms within the straight part ([0081] indicates item 426 acts to help control the pusher). Since Patel indicates the actuating wire is controlled by the user ([0088], [0091]), and Manash teaches the control can occur on the end 426 of the straight section 424, the person of ordinary skill would understand it is obvious to ensure the actuating wire (Patel 219) extends to the end of the straight section (Manash 426) in order to ensure the user can maneuver and control the actuating wire 219 as Patel describes.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/18/26
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