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 08/06/26 have been fully considered but they are not persuasive.
On pages 2-3 Applicant argues amendments to the figures overcome the drawing objections.
The Examiner respectfully withdraws the drawing objections which were addressed.
On page 4 regarding 101 rejections Applicant argues amendments overcome the rejections of record.
The Examiner respectfully agrees and withdraws 101 rejections.
On pages 4-5 regarding 112 rejections, Applicant argues amendments overcome the rejections of record.
The Examiner respectfully agrees and withdraws the 112 rejections of record.
On pages 5-6 regarding prior art rejections Applicant argues their plug is “to provide occlusion or obstruction”, and provides two definitions for a “plug”. Applicant argues that Argento’s frame is not a plug/stopper.
The Examiner respectfully disagrees. First, the Examiner points out that the definition of a plug according to the Applicant appears to depend on the element’s “intended use”, and is not otherwise structurally defined in any way. Since intended use limitations only have influence in the situation of a claimed object if it CANNOT perform the intended use, the use of the object as a stopper need not be mentioned or disclosed as Applicant appears to be arguing. Second however, as can be clearly seen throughout Argento, the frame absolutely is positioned within a hole/aperture (i.e. an annulus) to fill it and provide obstruction to blood flow (see the Abstract and Figures 25-26). This argument is accordingly unpersuasive.
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 central axis, the braided weave, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Objections
Claims 1, 5, 11, 20 are objected to because of the following informalities:
Claim 1 is objected to for referring to “a native heart valve” with improper antecedent basis.
Claim 5 is objected to for referring to “the outflow side” with improper antecedent basis.
Claim 11 is objected to for referring to “a memory material” when it is unclear what this is. The Examiner understands what shape-memory material is, for example, but a “memory material” is not a term known in the art.
Claim 20 is objected to for claiming the covering comprises “other” organic and “other” non-organic tissues, when it is unclear what it means for there to be “other” organic or non-organic tissues (e.g. it is unclear if there are already “organic tissues” (or “non-organic” tissues) that are a part of this listing of materials or not, since the claim does not specific which of the listed materials are “organic tissues” or “non-organic tissues”.).
The claim is further objected to for claiming there are “other non-organic tissues” when it is unclear to the Examiner what non-organic tissues are. As the Examiner best understands, tissues are organic by nature, making it unclear exactly what non-organic tissues are considered to be.
Appropriate correction is required.
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, 3, 5-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Argento et al. (US 20200261220 A1) hereinafter known as Argento.
Regarding claim 1 Argento discloses an occluding device (Figure 6 item 10; the limitation of the device being “occluding” is considered to be a functional limitation. 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 Argento 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 [0044], [0005] a valve with leaflets is understood to be capable of acting as an occluding device when the leaflets are closed.) for preventing regurgitation or prolapse at a native heart valve (this is also stated as a “functional limitation” of the claimed device (see the explanation directly above regarding functional limitations). See also [0102].) comprising:
a central plug (Figure 6 item 12) having a conical shape (Figure 30e; [0139]) which defines a proximal side defining a base of the conical shape (Figure 30e top), and a distal side defining a narrow end of the conical shape (Figure 30e, bottom), and a central axis running between the proximal and distal sides ([0131], see also Figures 6 and 30e),
and a coil possessing at least one turn extending along the central axis (Figure 6 item 15; [0131]),
wherein the coil is sized to encircle native chordae tendineae of the valve (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Argento was considered capable of performing the cited intended use. See, for example [0125] and Figures 23-24 the coil facilitates capture of the chordae during rotation of the prosthesis) and provide a retention force between the coil and the plug when installed (Figures 23-24, [0125]).
Regarding claim 3 Argento discloses the device of claim 1 substantially as is claimed,
wherein Argento further discloses the coil is joined to the plug at the proximal side (Figure 6).
Regarding claim 5 Argento discloses the device of claim 1 substantially as is claimed,
wherein Argento further discloses the plug is configured to traverse a native annulus such that the proximal side resides on an inflow side of an annulus and the distal side resides on an outflow side of the annulus (this is stated as an “intended use” of the plug (see the explanation and rejection to intended use statements in the rejection to claim 1 above). See also Figures 23-24).
Regarding claim 6 Argento discloses the device of claim 1 substantially as is claimed,
wherein Argento further discloses the at least one turn comprises at least two turns (Figure 6 shows at least two turns).
Regarding claim 7 Argento discloses the device of claim 1 substantially as is claimed,
wherein Argento further discloses the plug comprises a covering ([0106] the frame 12 can include a metal covered in polymer).
Regarding claim 8 Argento discloses the device of claim 7 substantially as is claimed,
wherein Argento further discloses the covering comprises a biocompatible or atraumatic material ([0106] a polymer is considered to be atraumatic).
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.
Claims 2, 4, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento as is applied above.
Regarding claim 2 Argento discloses the device of claim 1 substantially as is claimed,
wherein Argento further teaches the coil can be joined to the plug at the distal side ([0255] of Figure 29). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Argento so that the coil is joined to the plug at either end of the device since Argento teaches the two are known alternatives in the art, equally successful.
Regarding claim 4 Argento discloses the device of claim 1 substantially as is claimed,
wherein Argento further teaches the plug comprises a flange extending from a distal tip (Figure 29 shows how this embodiment with the valve on the bottom includes a flange on the distal tip). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Argento so that the distal end includes a flange since Argento teaches the two configurations are known alternatives in the art, equally successful.
Regarding claim 16 Argento discloses an occluding device (Figure 6 item 10; The requirement for the device to be an “occluding” device is a functional limitation of the device. See the explanation in the rejection to claim 1 above regarding functional limitations. See also [0044], [0005] a valve with leaflets is understood to be capable of acting as an occluding device when the leaflets are closed.) for preventing regurgitation or prolapse at a native heart valve (this is also stated as a “functional limitation” of the claimed device (see the explanation directly above regarding functional limitations). See also [0102].) comprising:
comprising:
a central plug (Figure 6 item 12) having a conical shape (Figure 30e; [0139]) which defines a proximal side defining a base of the conical shape (Figure 30e top), and a distal side defining a narrow end of the conical shape (Figure 30e, bottom), and a central axis running between the proximal and distal sides ([0131], see also Figures 6 and 30e),
and a plurality of tissue anchors (Figure 30f items 22f, 22f’) extending radially (Figure 30f) and sized to be able to capture valvular leaflets against the central plug (this is stated as an intended use of the tissue anchors (see the explanation in the rejection to claim 1 above regarding intended use limitations. See also [0142] the anchor can capture native leaflets),
and wherein Argento further teaches the tissue anchors can extend from the distal side ([0255] or Figure 29). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Argento so that the coil is joined to the plug at either end of the device since Argento teaches the two are known alternatives in the art, equally successful.
Regarding claim 17 Argento teaches the device of claim 16 substantially as is claimed,
wherein Argento further discloses the tissue anchors possess a contoured shape (Figure 30f).
Regarding claim 18 Argento teaches the device of claim 17 substantially as is claimed,
wherein Argento further discloses the tissue anchors comprise a covering disposed at the contoured shape ([0254] the anchor 15 can be coated with a polymer).
Regarding claim 19 Argento teaches the device of claim 16 substantially as is claimed,
wherein Argento further discloses the plug comprises a biocompatible or atraumatic material ([0254] a polymer coating is understood to be atraumatic).
Regarding claim 20 Argento teaches the device of claim 19 substantially as is claimed,
wherein Argento further discloses the biocompatible or atraumatic material or covering is organic or non-organic tissue ([0254] a polymer is understood to be either non-organic or organic).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento as is applied above in view of Nguyen et al. (US 20060265056 A1) hereinafter known as Nguyen.
Regarding claim 9 Argento discloses the device of claim 7 substantially as is claimed,
but is silent with regards to the covering being ePTFE.
However, regarding claim 9 Nguyen teaches a plug covering can be made of ePTFE ([0030]). Argento and Nguyen are involved in the same field of endeavor, namely implantable prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Argento so that it included any polymer covering known in the art, including ePTFE as is taught by Nguyen since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento as is applied above in view of Stocker et al. (US 20090164029 A1) hereinafter known as Stocker.
Regarding claim 10 Argento discloses the device of claim 1 substantially as is claimed,
but is silent with regards to the covering comprising a material or compound configured to encourage ingrowth.
However, regarding claim 10 Stocker teaches a covering for a device that includes a material or compound to encourage ingrowth ([0031]). Argento and Stocker are involved in the same field of endeavor, namely occluding valve devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Argento by having the covering include a material configured to encourage ingrowth as is taught by Stocker in order to provide a material that will encourage and help the device as a whole anchor in place without shifting or moving over time, thus increasing safety and duration of treatment for the patient.
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento as is applied above in view of Haug et al. (US 20050137702 A1) hereinafter known as Haug.
Regarding claim 11 Argento discloses the device of claim 1 substantially as is claimed,
wherein Argento further discloses the coil and plug possess a braided weave ([0140] the coil can have a braided surface).
but is silent with regards to the plug comprising a braided weave.
However, regarding claim 11 Haug teaches that a plug device can include a braided weave ([0036]). Argento and Haug are involved in the same field of endeavor, namely occluding valve devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Argento by having the plug comprise a braided weave as is taught by Haug 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 type of surface for the plug would have been obvious to try.
Claims 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento as is applied above in view of Vidlund et al. (US 9480559 B2) hereinafter known as Vidlund.
Regarding claim 12 Argento discloses the device of claim 1 substantially as is claimed,
but is silent with regards to there being a lubricious outer surface.
However, regarding claim 12 Vidlund teaches a device which includes a lubricious outer surface (Column 22 lines 49-53, Column 24 lines 32-42; PEG, PLA, PLLA, PLGA are understood to be lubricious). Argento and Vidlund are involved in the same field of endeavor, namely occluding valve devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Argento by having the device comprise a lubricious outer surface as is taught by Vidlund in order to encourage gliding around the outer surface during installation, thus easing the delivery and implantation of the device.
Regarding claim 13 the Argento Vidlund Combination teaches the device of claim 12 substantially as is claimed,
but is silent with regards to the lubricious outer surface being on the coil.
However, regarding claim 13 the person of ordinary skill would have found it obvious to have the outer surface of the coil be coated in the lubricious coating since Vidlund teaches the device includes a coating on both its inner and outer surface (Column 22 lines 49-53) and the outer surface of Argento includes the coil (Figure 6). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Argento Vidlund Combination so that the anchor of Argento (coil 15) includes the same covering as the stent since the anchor would also benefit from encouraging gliding/reducing friction during installation.
Regarding claim 14 the Argento Vidlund Combination teaches the device of claim 12 substantially as is claimed,
wherein Vidlund further teaches the lubricious outer surface is on the plug (Column 22 lines 49-53).
Regarding claim 15 the Argento Vidlund Combination teaches the device of claim 12 substantially as is claimed,
wherein Vidlund further discloses the lubricious outer surface is constructed of a bioabsorbable material (Column 24 line 33).
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.
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.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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