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 07/21/26 have been fully considered but they are not persuasive.
On page 7 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws claim objections.
On pages 7-8 regarding prior art rejections Applicant argues amendments overcome the rejections of record.
The Examiner respectfully disagrees and maintains Maimon teaches or discloses the amended claims. Please see the rejection below. However, the Examiner notes some new claims overcome the prior art rejection of record. Please see the Notice of Allowance below.
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.
Claim 21 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 is indefinite for claiming “and having at least one facet” since it is unclear what has this at least one facet according to the claim. For example, it could be the prosthetic valve, the engagement portion, the socket, the second free end, or adjustable arm. The specification makes it appear as if this could actually be interpreted any of the above ways, making the Examiner unclear on what the facet might belong to.
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 facet (claim 21) 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 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) 1-2, 4-6, 25 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Maimon et al. (WO 2020102487 A1) hereinafter known as Maimon.
Regarding claim 1 Maimon discloses a prosthetic valve (Figure 1) comprising:
a frame (Figure 1 item 12) moveable between a radially compressed configuration and a radially expanded configuration ([097] mechanically-expandable valve),
a leaflet assembly mounted within the frame (Figure 1 item 14) and comprising a plurality of leaflets (Figure 1 item 20) configured to regulate flow through the 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 Maimon 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 Figure 1 which shows leaflets which coapt, indicating they regulate flow therethrough), wherein each leaflet comprises a rounded cusp end portion defining a cusp edge (Figure 1 where the cusp is positioned adjacent the stent frame 12), a free edge opposite to the cusp edge (Figure 1 item 24), and a pair of opposite-directed tabs separating the cusp edge and the free edge (Figure 12 items 242, 246), and
a plurality of adjustable commissure supports (Figure 50a item 1100 (see also Figure 1 item 40)), each commissure comprising a support base attached to the frame (Figure 1 shows the supports connected to the frame), and at least two adjustable arms extending proximally from the support base (Figure 50a items 1102, 1104), wherein each adjustable arm comprises a distal, first end connected to the support base (see Figure 50a, considered to be the location where portions 1106, 1108 attach to the U-shaped element, illustrated further in the annotated figure below), and a proximal, second free end opposite the first end (Figure 50a the free end of arms 1102, 1104) an engagement portion positioned on the second free end of the arm (Figure 50a items 1106, 1108, in the middle of the second free end) which is configured to releasably and non-rotatably couple a tool for rotating the adjustable arm (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 Maimon was considered capable of performing the cited intended use of releasably and non-rotatably coupling with a tool if desired),
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wherein the tabs are attached to the adjustable arms ([0159] leaflets are inserted between the axial members 1102, 1104; [095] the commissure support elements attach to adjacent leaflets at tab portions),
the arms are configured to rotate when rotational force is applied to the engagement portions of the arms (this is also stated as a functional limitation of the arms (see the explanation above regarding “functional limitations” in the claims. The arms are considered capable of rotating if a rotational force is applied to the engagement portions 1106, 1108 of the arms (See [0159] which describes how the engagement portions rotate due to their flexible nature)), and
wherein rotation of the arms causes the tabs attached thereto, to wind around the adjustable arms (the Examiner notes that the direction of the rotation of the tabs (e.g. whether the tabs wind around the arms or unwind from the arms), depends entirely upon the direction the arms are rotated. Paragraph [0159] describes how the leaflets can be inserted between the axial arms 1102, 1104, and rotate/flex either inwardly or outwardly, indicating the tabs are capable of winding around the arms with the appropriate outwardly directed force).
Regarding claim 2 Maimon discloses the valve of claim 1 substantially as is claimed,
wherein Maimon further discloses the tabs are wrapped over the arms ([0159] the leaflets are inserted between the axial members, to engage the arms 1102, 1104. Wrapping is understood when the tab portions of the arms twist when attached to the arms. Also, see Figure 12 which shows leaflet tabs 242, 246 inserted between axial arms and wrapped therearound, Figure 13, Figure 24b-c, 45 which all show the tabs wrapped over arms).
Regarding claim 4 Maimon discloses the valve of claim 1 substantially as is claimed,
wherein Maimon further discloses the arms comprise two arms which are laterally spaced from each other and define a gap therebetween (Figure 50a item 1110).
Regarding claim 5 Maimon discloses the valve of claim 4 substantially as is claimed,
wherein Maimon further discloses a first tab of the plurality is wrapped over the first adjustable arm and a second tab of the plurality is wrapped over the second adjustable arm ([0159] the leaflets are inserted between the axial members, to engage the arms 1102, 1104. Wrapping is understood when the tab portions of the arms twist when attached to the arms. Also, see Figure 12 which shows leaflet tabs 242, 246 inserted between axial arms and wrapped therearound, Figure 13, Figure 24b-c, 45 which all show the tabs wrapped over arms).
Regarding claim 6 Maimon discloses the valve of claim 5 substantially as is claimed,
wherein Maimon further discloses the first and second tabs are wrapped over the arms in opposite directions with respect to each other ([0159] the leaflets are inserted between the axial members, to engage the arms 1102, 1104. Wrapping is understood when the tab portions of the arms twist when attached to the arms. The direction of their wrapping would depend upon the direction force is applied to each arm. Also, see Figure 12 which shows leaflet tabs 242, 246 inserted between axial arms and wrapped in opposite directions away from one another, Figure 13, Figure 24b-c, 45 which all show the tabs wrapped in opposite directions over arms).
Regarding claim 25 Maimon discloses the valve of claim 1 substantially as is claimed,
wherein Maimon further discloses the support base is integrally formed with the frame at a junction of the frame (“integral” is defined by Merriam-Webster as “essential to completeness: constituent; formed as a unit with another part. The base and frame are considered to be essential to completeness or a unit within the valve).
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 3, 21-23, 26, 29, 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maimon as is applied above.
Regarding claim 3 Maimon discloses the valve of claim 1 substantially as is claimed,
and further teaches wherein commissure support arms (Figures 2-3 item 44, 46) can includes a plurality of apertures (Figure 3 items 66). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Maimon so that the arms included a plurality of apertures as is taught by Maimon in order to provide a mechanism to suture the leaflets to the arms for secure attachment ([0106]).
Regarding claim 26 Maimon teaches the valve of claim 3 substantially as is claimed,
wherein Maimon further teaches the tabs are sutured to the arms by sutures extending through the tabs and apertures ([0106]).
Regarding claim 27 Maimon teaches the valve of claim 26 substantially as is claimed,
wherein Maimon further teaches for each tab, the sutures extend through portions of the tab disposed over opposite sides of the arm to which the tab is attached (Figures 2-3 and [0106]).
Regarding claim 23 Maimon discloses the valve of claim 4 substantially as is claimed,
wherein Maimon further discloses the arms are rotatably coupled to the support base ([0159] which describes how the engagement portions rotate due to their flexible nature, indicating a rotatable coupling. Alternatively the person of ordinary skill in the art would consider this to be a rotatable coupling since the two elements are coupled in a way that allows rotation).
Regarding claim 21 Maimon discloses the valve of claim 1 substantially as is claimed,
wherein Maimon further teaches each engagement portion comprises a socket defined in the free end of the arm (see Figure 3 which shows sockets 66 in another embodiment of arms of Maimon in what would be considered the free end) and having at least one facet (Figure 50a shows the arm second free end having a facet). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Maimon so that the engagement portion comprises at least one socket in the free end as is taught by Maimon in order to provide a mechanism to suture the leaflets to the arms for secure attachment ([0106]).
Regarding claim 22 Maimon teaches the valve of claim 21 substantially as is claimed,
wherein Maimon further teaches the socket is configured to receive a non-cylindrical extension of the tool (this is stated as an intended use of the socket (see the explanation regarding intended use statements in the rejection to claim 1 above). The socket 66 of Maimon is understood to be capable of receiving a non-cylindrical extension of some tool if appropriately sized, if desired.).
Regarding claim 29 Maimon discloses the valve of claim 1 substantially as is claimed,
wherein Maimon further discloses the arms are rotatably coupled to their respective support base ([0159] which describes how the engagement portions rotate due to their flexible nature, indicating a rotatable coupling. Alternatively the person of ordinary skill in the art would consider this to be a rotatable coupling since the two elements are coupled in a way that allows rotation).
Regarding claim 34 see the rejection to claim 1 above.
Regarding claim 35 see the rejection to claim 21 above.
Allowable Subject Matter
Claims 24, 28, 30-33 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 at 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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