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
The Amendment filed 03/30/26 has been entered. Claims 1-2, 7, and 9 have been amended, claims 3-4 and 13-14 have been cancelled, and new claims 15-22 have been entered. Claims 1-2, 5-12, and 15-22 are addressed in the following office action.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 5-10, 12, and 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melanson et al. (US 2018/0116678), cited in previous office action.
Regarding claim 1, an invention relating to an occlusion device, Melanson discloses (Figs. 86C-93B) a system for occluding a left atrial appendage (Abstract), comprising: a delivery device (3201) including an outer sheath (3220) and an inner elongate member (3230) slidably disposed within a lumen of the outer sheath (Par. 0358); an implant (3000) configured to occlude the left atrial appendage (Par. 0109 & 0111) comprising: an expandable framework (3040) having a proximal end (3060) and a distal end (3044), the expandable framework configured to shift between a collapsed configuration when disposed within the outer sheath and an expanded configuration when disposed outside of the outer sheath (Par. 0341 & 0362), wherein the expandable framework includes a proximal hub (3180) and a pin (3051) extending laterally across the proximal hub (Par. 0308), the pin configured to releasably secure the expandable framework to the delivery device (Par. 0353), and two sets of anchors (3090 & 3094), a first set of anchors (3090) being disposed proximally of a second set of anchors (3094) proximate the distal end of the expandable framework, each anchor having a base portion [i.e. proximal portion] and a tip (Par. 0327); an occlusive element (3002) disposed on the expandable framework, wherein the occlusive element covers the pin (Fig. 86C), the occlusive element defining a proximalmost surface (3008) of the implant across an entirety of the implant (Par. 0275), and the occlusive element extending distally from the proximalmost surface covering the base portion of each anchor, the tip of each anchor extending though the occlusive element (Fig. 87C); and an annular ring (3050) extending around the pin and securing the occlusive element to the pin (Par. 0293 & 0308); and wherein the inner elongate member is connected to the pin (Par. 0358).
Regarding claim 2, Melanson discloses the system of claim 1. Melanson further discloses (Fig. 90A) wherein the occlusive element includes two or more pores, and the annular ring extends through two of the two or more pores (Par. 0268).
Regarding claim 5, Melanson discloses the system of claim 1. Melanson discloses wherein the plurality of anchor members are configured to secure the implant to tissue within the left atrial appendage (Par. 0327).
Regarding claim 6, Melanson discloses the system of claim 1. Melanson further discloses wherein the occlusive element includes a porous mesh [i.e. porous foam that is net-like] (Par. 0268-0271).
Regarding claim 7, Melanson discloses the system of claim 1. Melanson discloses (Fig. 90B) further including a tether (3240) extending longitudinally within the inner elongate member, the tether engaging the pin in a delivery configuration (Par. 0308, 0358, 0367).
Regarding claim 8, Melanson discloses the system of claim 7. Melanson further discloses wherein the tether extends through the occlusive element in the delivery configuration (Fig. 92; Par. 0353 & 0356).
Regarding claim 9, Melanson discloses the system of claim 7. Melanson further discloses wherein the tether is disengaged from the pin in a released configuration (Par. 0362-0363).
Regarding claim 10, Melanson discloses the system of claim 7. Melanson discloses further comprising a release mechanism disposed within the lumen of the inner elongate member, wherein the release mechanism is configured to sever [i.e. cut] the tether within the lumen of the inner elongate member (Par. 0363).
Regarding claim 12, Melanson discloses the system of claim 7. Melanson discloses (Fig. 92) further comprising a turnstile (3246) movably engaged with a proximal end of the inner elongate member (Par. 0363).
Regarding claim 15, an invention relating to an occlusion device, Melanson discloses (Figs. 86C-93B) a system for occluding a left atrial appendage (Abstract), comprising: a delivery device (3201) including an outer sheath (3220) and an inner elongate member (3230) slidably disposed within a lumen of the outer sheath (Par. 0358); an implant (3000) configured to occlude the left atrial appendage (Par. 0109 & 0111) comprising: an expandable framework (3040) configured to shift between a collapsed configuration when disposed within the outer sheath and an expanded configuration when disposed outside of the outer sheath (Par. 0341 & 0362), wherein the expandable framework includes a proximal hub (3180) and a pin (3051) extending laterally across the proximal hub (Par. 0308), the pin configured to releasably secure the expandable framework to the delivery device (Par. 0353), and two sets of anchors (3090 & 3094), a first set of anchors (3090) being disposed proximally of a second set of anchors (3094), each anchor having a base portion [i.e. proximal portion] and a tip (Par. 0327); an occlusive element (3002) disposed on the expandable framework, wherein the occlusive element covers the pin (Fig. 86C), the occlusive element defining a proximal most surface (3008) of the implant across an entirety of the implant (Par. 0275), and the occlusive element extending distally from the proximal most surface covering the base portion of each anchor, the tip of each anchor extending though the occlusive element (Fig. 87C); and an annular ring (3050) extending around the pin and securing the occlusive element to the pin (Par. 0293 & 0308).
Regarding claim 16, Melanson discloses the system of claim 15. Melanson further discloses wherein the plurality of anchor members are configured to secure the implant to tissue within the left atrial appendage (Par. 0327).
Regarding claim 17, Melanson discloses the system of claim 15. Melanson further discloses wherein the occlusive element includes a porous mesh [i.e. porous foam that is net-like] (Par. 0268-0271).
Regarding claim 18, Melanson discloses the system of claim 15. Melanson discloses (Fig. 90B) further including a tether (3240) extending longitudinally within the inner elongate member, the tether engaging the pin in a delivery configuration (Par. 0308, 0358, 0367).
Regarding claim 19, Melanson discloses the system of claim 18. Melanson discloses wherein the tether extends through the occlusive element in the delivery configuration (Fig. 92; Par. 0353 & 0356).
Regarding claim 20, Melanson discloses the system of claim 18. Melanson discloses wherein the tether is disengaged from the pin in a released configuration (Par. 0362-0363).
Regarding claim 21, Melanson discloses the system of claim 18. Melanson discloses further comprising a release mechanism disposed within the lumen of the inner elongate member, wherein the release mechanism is configured to sever [i.e. cut] the tether within the lumen of the inner elongate member (Par. 0363).
Claim Rejections - 35 USC § 103
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Melanson et al. (US 2018/0116678) as applied to claim 10 above, and further in view of Christianson et al. (US 2006/0009800), cited in previous office action.
Regarding claim 11, Melanson discloses the system of claim 10. Melanson fails to further disclose wherein the release mechanism includes a cutting blade disposed within the inner elongate member.
In the analogous art of closure device, Christianson teaches (Figs. 12 & 22) a release mechanism (80) includes a cutting blade (90) disposed within an inner elongate member (38; Par. 0110).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Melanson to have wherein the release mechanism includes a cutting blade disposed within the inner elongate member. Doing so would have been obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results to one of ordinary skill in the art (MPEP 2143). Specifically, cutting or severing of the tether (Par. 0109-0110), as taught by Christianson.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Melanson et al. (US 2018/0116678) as applied to claim 21 above, and further in view of Christianson et al. (US 2006/0009800).
Regarding claim 22, Melanson discloses the system of claim 21. Melanson fails to further disclose wherein the release mechanism includes a cutting blade disposed within the inner elongate member.
In the analogous art of closure device, Christianson teaches (Figs. 12 & 22) a release mechanism (80) includes a cutting blade (90) disposed within an inner elongate member (38; Par. 0110).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Melanson to have wherein the release mechanism includes a cutting blade disposed within the inner elongate member. Doing so would have been obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results to one of ordinary skill in the art (MPEP 2143). Specifically, cutting or severing of the tether (Par. 0109-0110), as taught by Christianson.
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 1-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-10 of U.S. Patent No. 11,944,314. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
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Claims
US Patent No. 11,944,314
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Response to Arguments
Applicant’s arguments, see page 6, filed 03/30/26, with respect to claim 1 has been fully considered and are persuasive. The objections of claim 1 has been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive. Applicant argues previously cited prior art Melanson et al. is not believed to disclose "the expandable framework includes a proximal hub and a pin extending laterally across the proximal hub, the pin configured to releasably secure the expandable framework to the delivery device, and two sets of anchors, a first set of anchors being disposed proximally of a second set of anchors proximate the distal end of the expandable framework, each anchor having a base portion and a tip" in combination with "an annular ring extending around the pin and securing the occlusive element to the pin". Examiner respectfully disagrees.
Melanson discloses (Figs. 86C-93B) wherein an expandable framework (3040) includes a proximal hub (3180) and a pin (3051) extending laterally across the proximal hub (Par. 0308), the pin configured to releasably secure the expandable framework to a delivery device (3201; Par. 0353), and two sets of anchors (3090 & 3094), a first set of anchors (3090) being disposed proximally of a second set of anchors (3094) proximate the distal end of the expandable framework, each anchor having a base portion [i.e. proximal portion] and a tip (Par. 0327); and an annular ring (3050) extending around the pin and securing an occlusive element (3002) to the pin (Par. 0293 & 0308).
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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 15, 2026
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