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 without traverse of invention I (a docking device) in the reply filed on 01/06/26 is acknowledged.
Claims 16 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/06/26.
Claim Objections
Claims 3-5, 7-8, 11-12 are objected to because of the following informalities:
Claims 3 and 5 are objected to for referring to “cuts” and “biasing” when it is unclear how, if at all, this relates to the previously defined “plurality of cuts” and “biasing” from claim 2, which this depends from.
Claims 4 and 11 likewise are objected to for referring to “cuts” when it is unclear how this relates to the previously defined “cuts”.
Claims 7-8 are objected to for referring to “a pitch” when it is unclear how, if at all, this relates to “a pitch” that was referenced in claim 5.
Claim 12 is objected to for referring to “the end of the stabilization turn” with improper antecedent basis.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the transition zone must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because Figure 3 item 308 is not pointing to anything.
Further, item “302” appears to be used to represent both “control assembly” and “actuating assembly”.
Further, items “A” and “B” are in the drawings but not present in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 9-15 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.
Claims 9-10 are indefinite for claiming there is a “transition zone” between the central region and the stabilization turn, when claim 1, from which these claims both depend, requires the stabilization turn to extend “from an opposing end of the central region”. It is unclear how there can be a zone between the central region and stabilization turn, when claim 1 has already required the stabilization turn to extend from the end of the central region (e.g. there cannot possibly be something positioned therebetween).
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.
Claim 14 is indefinite for claiming the actuating assembly comprises a “generally” Y-shaped connector, but it is unclear what it means to be “generally” Y-shaped, as opposed to (for example) being Y-shaped, or not Y-shaped. The specification does not elaborate on any examples that would include something that is “generally Y-shaped” and what would not, meaning the Examiner is unclear what the boundaries of the claim are. Without understanding the claim boundaries, the Examiner is unclear on what might meet the limitation of “generally” Y-shaped, and what would not.
Remaining claims are rejected for depending on a rejected claim.
Claim limitation “actuating assembly” in claim 13 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]-[0033], which states the actuating assembly can include a “generally Y-shaped connector”, and in [0086] and [0089], which only indicate the actuating assembly can be held or pushed, and that the Y-shaped connector is an alternative to the actuating assembly 302. However, it is unclear how a “connector” of a specific shape would be an actuating assembly, and the specification makes it unclear whether or not the actuating assembly includes the connector as a part thereof, or whether it is an alternative. The specification appears to say both things. Neither location explain how/what the assembly for actuating is, how it words, or what it includes. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Further, Claim limitation “control assembly” in claim 13 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 § 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 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)(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.
(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) 1-4, 9-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Patel et al. (US 20180055628 A1) hereinafter known as Patel.
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 extends 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), and
the stabilization (atrial) turn has a diameter around the central axis greater than the diameter of the central region (Figure 3, 10) and extends 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).
Regarding claim 2 Patel discloses 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 Patel discloses 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 Patel discloses 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 Patel discloses the docking device of claim 1 substantially as is claimed,
wherein Patel further discloses the coil includes a transition zone between the central region and the stabilization turn (Figure 10 item 140).
Regarding claim 10 Patel discloses the docking device of claim 2 substantially as is claimed,
wherein Patel further discloses the coil includes a transition zone between the central region and the stabilization turn (Figure 10 item 140).
Regarding claim 11 Patel discloses 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 transition zone ([0090] indicates the depth of the cuts can be varied along the length of the tube, which includes the transition zone 140).
Regarding claim 12 Patel discloses 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 an 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 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 Patel discloses the system of claim 12 substantially as is claimed,
wherein Patel further discloses an actuating 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 and actuating wire are controlled by a control assembly ([0128] the pusher and suture extends to a handle or hub (as is best understood (see the 112 rejection to claim 13 above) a hub constitutes a control assembly)).
Claim Rejections - 35 USC § 103
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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel as is applied above in view of Zerkowski et al. (US 20210212826 A1) hereinafter known as Zerkowski.
Regarding claim 5 Patel discloses 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 Patel 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 as is applied above in view of Von Oepen et al. (US 20180028779 A1) hereinafter known as Von Oepen.
Regarding claim 6 Patel discloses the docking device of claim 1 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 Patel 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 and Zerkowski as is applied above, further in view of Von Oepen as is applied above.
Regarding claim 7 the Patel 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 Patel 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 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 Patel 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 as is applied above in view of Manash et al. (US 20180263764 A1) hereinafter known as Manash.
Regarding claim 14 Patel discloses the system of claim 13 substantially as is claimed,
but is silent with regards to the actuating assembly comprising a generally Y-shaped connector.
However, regarding claim 14 Manash teaches that a system for delivering an endovascular device can include an actuating assembly that comprises a generally Y-shaped connector (Figure 8 shows how 426/428/424 form a general 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 Patel includes a generally 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 Manash Combination teaches the system of claim 14 substantially as is claimed,
wherein Manash further teaches the generally 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
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.
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 on 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.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 01/20/26