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 .
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.
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Claims 59-64, 68, 69, 71, 75-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,758,241. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to the instant application’s claim 59, the reference patent claims a method of reshaping, closing, or occluding a cavity (claim 1), comprising: advancing an implant (claim 1) into the cavity, the implant including a contact member (claim 1), the contact member including an outer surface (claim 1) and one or more tissue anchors (claim 1) extending away from the outer surface; moving the implant to move at least a portion of the outside surface or the one or more tissue anchors against an inner wall surface of the cavity (claim 1); rotating the contact member from a first position to a second position to twist tissue defining the cavity (claim 1); and preventing the contact member from rotating back to the first position (claim 1).
As to the instant application’s claim 60, see reference patent claim 2.
As to the instant application’s claim 61, see reference patent claim 2.
As to the instant application’s claim 62, see reference patent claim 3.
As to the instant application’s claim 63, see reference patent claim 4-7.
As to the instant application’s claim 64, see reference patent claim 4-7.
As to the instant application’s claim 68, see reference patent claim 1.
As to the instant application’s claim 69, see reference patent claim 4-7.
As to the instant application’s claim 71, see reference patent claim 1.
As to the instant application’s claim 75, see reference patent claim 10.
As to the instant application’s claim 76, see reference patent claim 12.
As to the instant application’s claim 77, the reference patent claims a method of reshaping, closing, or occluding a cavity (claim 1), comprising: advancing an implant (claim 1) into the cavity, the implant including a contact member (claim 1) and a securing element (claim 4-7); rotating the contact member within the cavity in a first angular direction, from a first position to a second position (claim 1), thereby twisting tissue defining the cavity; and moving the securing element relative to the contact member to engage tissue outside the cavity (claim 4-7), thereby preventing the contact member from rotating in a second angular direction back to the first position (claim 4-7).
Claims 59-64, 66, 68, 69, 74, 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21-26, 31-34 of U.S. Patent No. 12,303,116. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to the instant application’s claim 59, the reference patent claims a method of reshaping, closing, or occluding a cavity (claim 21, 32, 33), comprising: advancing an implant (claim 21, 32, 33) into the cavity, the implant including a contact member (claim 21, 32, 33), the contact member including an outer surface (claim 21, 32, 33) and one or more tissue anchors (claim 21, 32, -33) extending away from the outer surface; moving the implant to move at least a portion of the outside surface or the one or more tissue anchors against an inner wall surface of the cavity (claim 21, 32, 33); rotating the contact member from a first position to a second position to twist tissue defining the cavity (claim 21, 32, 33); and preventing the contact member from rotating back to the first position (claim 21, 31-33).
As to the instant application’s claim 60, see reference patent claim 22.
As to the instant application’s claim 61, see reference patent claim 22.
As to the instant application’s claim 62, see reference patent claim 23.
As to the instant application’s claim 63, see reference patent claim 24.
As to the instant application’s claim 64, see reference patent claim 24.
As to the instant application’s claim 66, see reference patent claim 21, 1.
As to the instant application’s claim 68, see reference patent claim 21.
As to the instant application’s claim 69, see reference patent claim 21.
As to the instant application’s claim 74, see reference patent claim 26.
As to the instant application’s claim 77, the reference patent claims a method of reshaping, closing, or occluding a cavity (claim 21), comprising: advancing an implant (claim 21) into the cavity, the implant including a contact member (claim 21) and a securing element (claim 21); rotating the contact member within the cavity in a first angular direction, from a first position to a second position (claim 21), thereby twisting tissue defining the cavity; and moving the securing element relative to the contact member to engage tissue outside the cavity (claim 21), thereby preventing the contact member from rotating in a second angular direction back to the first position (claim 21).
Claims 65, 70, 72-74, 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,758,241 in view of U.S. Patent Publication 2012/0283585 to Werneth.
As to the instant application’s claim 65, the reference patent is silent about claiming the securing element and the contact member each being coaxially with a central longitudinal axis, advancing the securing element toward the contact member comprising advancing the securing element along the central longitudinal axis.
Werneth discloses a similar method (occluding treatment, abstract) comprising a securing element (570) and the contact member (562) each being coaxially with a central longitudinal axis (figure 31a-f), advancing the securing element toward the contact member comprising advancing the securing element along the central longitudinal axis (figure 31a-f) for the purpose of optimizing the delivery of the device for blocking the cavity as desired (paragraph 110). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the securing element and the contact member of the reference claims be coaxial and advancing the advancing the securing element toward the contact member comprising advancing the securing element along the central longitudinal axis in order to efficiently deliver the securing element and contact member to block the cavity as desired.
As to claim 70, with the reference patent is silent about claiming the implant having an overall length, at least 90% of the overall length of the implant being positioned within the cavity after preventing the contact member from back to the first position, up to 10% of the of the overall length of the implant being positioned outside the cavity after preventing the contact member from rotation back for the position.
Werneth discloses a similar method (occluding treatment, abstract) comprising an implant having an overall length, at least 90% of the overall length of the implant being positioned within the cavity after preventing the contact member from back to the first position, up to 10% of the of the overall length of the implant being positioned outside the cavity after preventing the contact member from rotation back for the position (figure 10, 12, 13a, 31a-f) for the purpose of securing the device within the cavity to occlude the cavity (paragraph 83). Werneth teaches multiple embodiments where 90% of the implant can be within the cavity after it is secured. It would have been obvious to one of ordinary skill in the art before the effective filing date to have at least 90% of the overall length of the implant being positioned within the cavity after preventing the contact member from back to the first position, up to 10% of the of the overall length of the implant being positioned outside the cavity after preventing the contact member from rotation back for the position in order to secure the device within the cavity to occlude the cavity.
As to claim 72-74, with the reference patent is silent about claiming the cavity is a wound or a wound cavity, a stomach cavity, a mitral valve or commissure of the mitral valve.
Werneth discloses a similar method (occluding treatment, abstract) comprising occluding a cavity which can be a wound or a wound cavity, a stomach cavity, a mitral valve or commissure of the mitral valve (paragraph 68) for the purpose of providing therapy to a similar cavity and/or to close or alter undesirable orifices in the body. It would have been obvious to one of ordinary skill in the art before the effective filing date for the cavity in the claimed reference to be a wound or a wound cavity, a stomach cavity, a mitral valve or commissure of the mitral valve in order for providing therapy to a similar cavity and/or to close or alter undesirable orifices in the body.
As to claim 78, the reference patent claims a method of reshaping, closing, or occluding a cavity (claim 1), comprising: advancing an implant (claim 1) into the cavity, the implant including a contact member (claim 1, 4-7) and a securing element (claim 4-7); rotating the contact member about a central longitudinal axis from a first position to a second position (claim 1, 4-7), thereby twisting tissue defining the cavity; and moving the securing element relative to the contact member to engage tissue outside the cavity (claim 1, 4-7), thereby preventing the contact member from rotating about the central longitudinal axis back to the first position (claim 1, 4-7) but is silent about securing element and the contact member being aligned with each other along a central longitudinal axis and advancing the securing element along the central longitudinal axis.
Werneth discloses a similar method (occluding treatment, abstract) comprising a securing element (570) and the contact member (562) being aligned along a central longitudinal axis (figure 31a-f) and advancing the securing element along the central longitudinal axis (figure 31a-f) for the purpose of optimizing the delivery of the device for blocking the cavity as desired (paragraph 110). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the securing element and the contact member of the reference claims be aligned and advancing the securing element along the central longitudinal axis in order to efficiently deliver the securing element and contact member to block the cavity as desired.
Claims 65, 70-73, 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21-26 of U.S. Patent No. 12,303,116 in view of U.S. Patent Publication 2012/0283585 to Werneth.
As to the instant application’s claim 65, the reference patent is silent about claiming the securing element and the contact member each being coaxially with a central longitudinal axis, advancing the securing element toward the contact member comprising advancing the securing element along the central longitudinal axis.
Werneth discloses a similar method (occluding treatment, abstract) comprising a securing element (570) and the contact member (562) each being coaxially with a central longitudinal axis (figure 31a-f), advancing the securing element toward the contact member comprising advancing the securing element along the central longitudinal axis (figure 31a-f) for the purpose of optimizing the delivery of the device for blocking the cavity as desired (paragraph 110). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the securing element and the contact member of the reference claims be coaxial and advancing the advancing the securing element toward the contact member comprising advancing the securing element along the central longitudinal axis in order to efficiently deliver the securing element and contact member to block the cavity as desired.
As to claim 70, with the reference patent is silent about claiming the implant having an overall length, at least 90% of the overall length of the implant being positioned within the cavity after preventing the contact member from back to the first position, up to 10% of the of the overall length of the implant being positioned outside the cavity after preventing the contact member from rotation back for the position.
Werneth discloses a similar method (occluding treatment, abstract) comprising an implant having an overall length, at least 90% of the overall length of the implant being positioned within the cavity after preventing the contact member from back to the first position, up to 10% of the of the overall length of the implant being positioned outside the cavity after preventing the contact member from rotation back for the position (figure 10, 12, 13a, 31a-f) for the purpose of securing the device within the cavity to occlude the cavity (paragraph 83). Werneth teaches multiple embodiments where 90% of the implant can be within the cavity after it is secured. It would have been obvious to one of ordinary skill in the art before the effective filing date to have at least 90% of the overall length of the implant being positioned within the cavity after preventing the contact member from back to the first position, up to 10% of the of the overall length of the implant being positioned outside the cavity after preventing the contact member from rotation back for the position in order to secure the device within the cavity to occlude the cavity.
As to claim 71-73, with the reference patent is silent about claiming the cavity is a left atrial appendage, a wound or a wound cavity, a stomach cavity, a mitral valve or commissure of the mitral valve.
Werneth discloses a similar method (occluding treatment, abstract) comprising occluding a cavity which can be a left atrial appendage, a wound or a wound cavity, or a stomach cavity (paragraph 68) for the purpose of providing therapy to a similar cavity and/or to close or alter undesirable orifices in the body. It would have been obvious to one of ordinary skill in the art before the effective filing date for the cavity in the claimed reference to be a wound or a wound cavity, a stomach cavity, a mitral valve or commissure of the mitral valve in order for providing therapy to a similar cavity and/or to close or alter undesirable orifices in the body.
As to claim 78, the reference patent claims a method of reshaping, closing, or occluding a cavity (claim 21), comprising: advancing an implant (claim 21) into the cavity, the implant including a contact member (claim 21) and a securing element (claim 21, 1, 24); rotating the contact member about a central longitudinal axis from a first position to a second position (claim 21), thereby twisting tissue defining the cavity; and moving the securing element relative to the contact member to engage tissue outside the cavity (claim 21), thereby preventing the contact member from rotating about the central longitudinal axis back to the first position (claim 21, 24) but is silent about securing element and the contact member being aligned with each other along a central longitudinal axis and advancing the securing element along the central longitudinal axis. .
Werneth discloses a similar method (occluding treatment, abstract) comprising a securing element (570) and the contact member (562) being aligned along a central longitudinal axis (figure 31a-f) and advancing the securing element along the central longitudinal axis (figure 31a-f) for the purpose of optimizing the delivery of the device for blocking the cavity as desired (paragraph 110). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the securing element and the contact member of the reference claims be aligned and advancing the securing element along the central longitudinal axis in order to efficiently deliver the securing element and contact member to block the cavity as desired.
Claim 67 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21-26 of U.S. Patent No. 12,303,116 in view of U.S. Patent Publication 2007/0073337 to Abbott.
As to the instant application’s claim 67, the reference patent is silent about the retaining member comprising a threaded shaft, engaging the tissue wall with the securing member comprising providing relative rotation between the threaded shaft and the securing element. The reference patent does claim that the retaining member is coupled to the securing element a retaining member (claim 1).
Abbott teaches a similar method (occluding treatment, abstract) comprising a threaded shaft coupling elements of an implant where engaging tissue wall with a securing member comprising providing relative rotation between the threaded shaft and a securing element (paragraph 221,222) for the purpose of providing the ability to couple element and adjust the length between them. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to the retaining member comprise a threaded shaft, engaging the tissue wall with the securing member comprising providing relative rotation between the threaded shaft and the securing element in order to provide the ability to couple the securing element and the contact member and adjust the length between them.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,919,207 to Taheri (as cited in the IDS filed 04/18/2025), U.S. Patent 2010/0324588 to Miles, U.S. Patent Publication 2013/0197570 to Ebata (as cited in the IDS filed 04/18/2025), U.S. Patent 8,672,953 to Reyes, U.S. Patent Publication 2014/0200409 to Green, and U.S. Patent Publication 2017/0079655 to Walters all disclose similar methods pertinent to the scope of the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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