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 Amendment
In response to the amendment filed on 10/27//2025, Claims 7-9, 11-12, 15-17, 24, and 26 have been cancelled, and Claims 1-6, 10, 13, 14, 18-23, 25, and 27-30 are pending.
Response to Arguments
Applicant’s arguments, see Page 7, filed 10/27/2025, with respect to Claims 21-23, 25, 27, and 28 have been fully considered and are persuasive. The 35 USC 103 rejections of Claims 21-23, 25, 27, and 28 in view of Bridgeman (2011/0054515) and Werneth (US PGPub 2015/0223757) has been withdrawn.
The Examiner notes that Applicant has not separately argued the merits of the double patenting rejection of Claims 1-6, 10, 13, 14, 18-23, 25, 27 and 28 in view of US Patent 11,129,622, and therefore the double patenting rejections are maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 10, 13, 14, 18-23, 25, 27 and 28 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10, 13, 14, 18-23, 25, 27, and 28 of U.S. Patent No. 11,129,622. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Present Claim 1, Claim 1 of Pat ‘622 discloses a device for placement in vessels, appendages, and openings in a body, the device comprising:
a unitary self-expanding frame having a proximal end, a distal end, and a longitudinal axis, the unitary self-expanding frame including:
a face portion having a pre-loaded flat configuration and (i) a center frame portion arranged at the proximal end and (ii) a plurality of elongate members extending from the center frame portion, and
a body portion; and
a membrane attached to the unitary self-expanding frame;
wherein the plurality of elongate members are configured to bend or flex substantially in a plane orthogonal to the longitudinal axis and mitigate longitudinal movement of the face portion in response to a compressive force applied to the body portion of the unitary self-expanding frame.
Regarding Present Claim 2, Claim 2 of Pat ‘622 discloses the device of claim 1, wherein the center frame portion is a hole having an inner and outer circumference and the plurality of elongate members radiate outward from the outer circumference of the center frame portion.
Regarding Present Claim 3, Claim 3 of Pat ’622 discloses the device of claim 2, wherein the center frame portion further includes a plurality of arcs arranged around the inner circumference of the center frame portion.
Regarding Present Claim 4, Claim 4 of Pat ‘622 discloses the device of claim 1, wherein a thickness, relative to the longitudinal axis, of the plurality of elongate members is approximately equal to a thickness, relative to the longitudinal axis, of the center frame portion.
Regarding Present Claim 5, Claim 5 of Pat ‘622 discloses the device of claim 1, wherein the center frame portion and the plurality of elongate members are arranged within a first plane substantially orthogonal to the longitudinal axis.
Regarding Present Claim 6, Claim 6 of Pat’622 discloses the device of claim 1, wherein the membrane comprises an occlusive material configured to at least partially inhibit passage of fluid and passage of thrombus therethrough.
Regarding Present Claim 10, Claim 10 of Pat ‘622 discloses the device of claim 1, wherein the unitary self-expanding frame further comprises transition portions arranged between the plurality of elongate members and the body portion, and wherein the transition portions include a curvature to transition the plurality of elongate members toward the body portion.
Regarding Present Claim 13, Claim 13 of Pat ‘622 discloses the device of claim 1, wherein the plurality of elongate members include a first curved section, a second curved section, and a third curved section, a first inflection point between the first curved section and the second curved section, and a second inflection point between the second curved section and the third curved section.
Regarding Present Claim 14, Claim 14 of Pat ‘622 discloses the device of claim 13, wherein the first curved section and the third curved section comprise a curvature in a first direction, the second curved section comprises a curvature in a second direction, and the first direction is opposite of the second direction.
Regarding Present Claim 18, Claim 18 of Pat ‘622 discloses the device of claim 1, wherein the body portion includes a first tapered section and a second tapered section, the first tapered section decreases in circumference at a first rate, the second tapered section decreases in circumference at a second rate, and the first rate is less than the second rate.
Regarding Present Claim 19, Claim 19 of Pat ‘622 discloses the device of claim 1, wherein the body portion further comprises a plurality of anchors, and each of the plurality of anchors includes an anchoring portion and an arm.
Regarding Present Claim 20, Claim 20 of Pat ‘622 discloses the device of claim 19, wherein the plurality of anchors includes a first group of anchors and a second group of anchors, the arm of the first group of anchors includes a first length, the arm of the second group of anchors includes a second length, and the second length is greater than the first length, and the anchoring portion of the first group of anchors is arranged at a first height, relative to the distal end, the anchoring portion of the second group of anchors is arranged at a second height, relative to the distal end, and the first height is greater than the second height.
Regarding Present Claim 21, Claim 22 (which includes the limitations of Claim 21) of Pat ‘622 discloses a device for placement in vessels, appendages, and openings in a body having an elongated configuration and a deployed configuration, the device comprising:
a nitinol cut-tube frame having a proximal end and a distal end, the nitinol cut-tube frame including:
a face portion having
a center frame portion arranged at the proximal end and including a plurality of arcs arranged around a circumference of the center frame portion, and
a plurality of elongate members extending from the center frame portion, and
a body portion; and
a membrane attached to the nitinol cut-tube frame;
wherein the center frame portion and the plurality of elongate members form a substantially uniform surface, wherein the plurality of elongate members are configured to bend or flex in a plane that is substantially orthogonal to a longitudinal axis of the nitinol cut-tube frame to mitigate longitudinal movement of the face portion in response to a compressive force applied to the body portion of the nitinol cut-tube frame, and the center frame portion is configured to provide an attachment point for a delivery system for the device.
Regarding Present Claim 22, Claim 22 of Pat ‘622 discloses the device of claim 21, wherein the center frame portion includes a thickness that is approximately equal to a thickness of the plurality of elongate members.
Regarding Present Claim 23, Claim 23 of Pat ‘622 discloses the device of claim 21, wherein the face portion comprises a surface without protrusions external to the face portion.
Regarding Present Claim 25, Claim 25 of Pat ‘622 discloses the device of claim 21, wherein the body portion further comprises a plurality of anchors, and each of the plurality of anchors includes an anchoring portion and an arm.
Regarding Present Claim 27, Claim 27 of Pat ‘622 discloses the device of claim 21, wherein the plurality of elongate members include a first curved section, a second curved section, and a third curved section, a first inflection point between the first curved section and the second curved section, and a second inflection point between the second curved section and the third curved section.
Regarding Present Claim 28, Claim 28 of Pat ‘622 discloses the device of claim 21, wherein the plurality of arcs arranged around a circumference of the center frame portion configured to distribute strain about the center frame portion in transitioning between the elongated configuration and the deployed configuration.
Allowable Subject Matter
Claims 29-30 are allowed.
The prior art of record fails to teach a method comprising absorbing one or more forces from the left atrial appendage with thereby flexing the plurality of elongate members in a plane orthogonal to the longitudinal axis to mitigate longitudinal movement of the face portion in response thereto.
Claims 1-6, 10, 13, 14, 18-23, 25, 27 and 28 are currently rejected under double patenting, but would be allowable if the double patenting rejections are overcome by either claim amendments or by filing a terminal disclaimer.
The prior art of record fails to teach a plurality of elongate members, of a face portion, are configured to bend or flex substantially in a plane orthogonal to the longitudinal axis and mitigate longitudinal movement of the face portion in response to a compressive force applied to the body portion
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771