40DETAILED 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 with respect to claim(s) 21-40 have been considered but are moot because the new ground of rejection over Hernandez et al. US 11,344,308 in view of Cope et al. US 5,690,656 and in view of Swain et al. US 2009/0227828.
Hernandez et al. US 11,344,308 discloses a retention member 6 extending outwardly from the outer side wall of the first implant member 3 and the first exoskeletal member (shown as outer layer 2, figure 3; or outer layer 1, figure 17), the retention member being configured to at least temporarily retain the first elongated implant member and the first exoskeletal member (figures 3, 10, wires 4 and/or 6 extend outwardly away from the exoskeleton and inner magnet; column 5, lines 1-9; wires 6 are connected to retain the magnet and the exoskeleton in a retained configuration by bringing the terminal parts of the magnetic chain into proximity).
Claim Objections
Claim 37 is objected to because of the following informalities: Claim 37 discloses “a plurality of elongated anastomosis forming segments” in line 2-3, “each anastomosis forming segment” in line 4, “the plurality of elongated anastomosis forming segments” in lines 6-7, “each anastomosis forming segment” in line 11, and “the plurality of anastomosis forming segments” in lines 12-13. The claim language regarding the anastomosis forming segments or elongated anastomosis forming segments is not consistent throughout the claim. Appropriate correction is required.
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(s) 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez et al. US 11,344,308 in view of Cope et al. US 5,690,656 in view of Swain et al. US 2009/0227828.
Regarding claims 21 and 29, Hernandez et al. discloses a system for forming an anastomosis between two adjacent walls of a digestive tract (column 1, lines 23-26, magnetic anastomosis between two adjacent organs or hollow viscera), a first and second implants configured to magnetically couple to each other through the adjacent walls of the digestive tract to form a magnetic compression anastomosis (first and second magnets 3, column 2, lines 11-16), wherein at least one of the first or second implants comprising an implant for magnetic compression anastomosis (column 1, lines 23-26, magnetic anastomosis), the implant comprising: a first implant member including a magnet (magnets 3, figure 4, 17), the first implant member having an outer side wall (outer side wall of magnet 3); and a first exoskeletal member having an outer side wall provided in a longitudinally adjacent relationship relative to along the outer side wall of the first implant member and extending outwardly from the outer side wall of the first implant member (outer flexible jacket enveloping the magnets 3, flexible material sheath, figure 4, column 1, lines 50-51; column 2, lines column 11-17, column 4, lines 58-65, shown as outer layer 2, figure 3; outer layer 1, figure 17), the first exoskeletal member configured to at least temporarily retain the first implant member along the outer side wall of the first implant member during delivery of the implant to a first wall of the digestive tract and creation of the magnetic compression anastomosis through the first wall of the digestive tract using the implant (figures 3, 4, column 1, lines 21-26, column 1 lines 50-51; column 2, lines column 11-17, column 4, lines 58-65, 8 outer flexible jacket 1 enveloping the magnets 3, device inserted between adjacent organs or two hollow viscera); and a retention member 6 extending outwardly from the outer side wall of the first implant member and the first exoskeletal member (figures 3, 10, wires 4 and/or 6 extend outwardly away from the exoskeleton and inner magnet), the retention member being configured to at least temporarily retain the first elongated implant member and the first exoskeletal member (column 5, lines 1-9; wires 6 are connected to retain the magnet and the exoskeleton in a retained configuration by bringing the terminal parts of the magnetic chain into proximity).
Hernandez et al. discloses a chain of magnetic implant members, but fails to explicitly disclose a first elongated implant member, the first elongated implant member having an outer side wall, wherein the outer side wall is a long edge of the first elongated implant member, wherein the first exoskeletal member is disassemblable from the first implant member within the digestive tract after formation of the magnetic compression anastomosis.
Cope et al. discloses an anastomosis device comprising an implant comprising a magnet 90 the magnet may be constructed in any shape suitable for a particular procedure, such as a rectangular configuration (figure 14; column 9-20), the rectangular configuration first implant member having an outer side wall, wherein the outer side wall is a long edge of the first elongated implant member (figure 14). It would have been an obvious matter of design choice to a first elongated implant member including a magnet, the first implant member having an outer side wall, wherein the outer side wall is a long edge of the first elongated implant member, as taught by Cope et al., since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Swain et al. teaches an anastomosis device (32, 42, paragraph 0050) comprising at least one magnet attached thereto (paragraph 0048), the device being comprised of a biodegradable material to reduce the possibility of the magnet and/or anastomotic device getting stuck in the gastrointestinal tract (paragraph 0050). The term "disassemble" may be defined by Merriam Webster's dictionary as "to come apart" or "to disperse or scatter". The components of the anastomosis device, or the exoskeleton and first implant member, may be considered to be disassembled as they are degraded or absorbed and the device comes apart within the digestive tract to avoid getting stuck. Examiner notes in combination, the magnets may remain in place due to the tissue overgrowth, while the exoskeleton may be absorbed or disassembled within the digestive tract after placement and formation of the anastomosis.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hernandez et al. with an exoskeleton member being comprised of a biodegradable material to be disassemblable from the first implant member to reduce the possibility of getting stuck in the gastrointestinal tract after formation of the anastomosis and the exoskeleton retention member being absorbed.
Regarding claims 22 and 30, Hernandez et al. in combination further comprising: a second implant member provided in a longitudinally adjacent relationship relative to the first implant member (chain of magnets 3, figure 5, for example), the second implant member having an outer side wall, wherein the first exoskeletal member is configured to span a transition between the first elongate implant member and second implant members and at least temporarily retain the first and second implant members along the outer side walls of the first and second elongated implant members during delivery of the implant to the first wall of the digestive tract and formation of the magnetic compression anastomosis through the first wall of the digestive tract using the implant (exoskeletal member surrounds the chain of magnets in a linear formation, for example, figure 5, or deployed configuration, figure 4).
Regarding claims 23 and 31, Hernandez et al. in combination discloses wherein the second elongated implant member includes a magnet (chain of magnets 3).
Regarding claims 24-27 and 32-35, Hernandez et al. in combination discloses wherein the wherein the first exoskeletal member is configured to disassemble the implant into separate segments including the first and second implant members (exoskeleton may be biodegradable, which retained magnets 3, figures 1-11), wherein the first exoskeletal member comprises at least one biodegradable component for disassembly of the implant (as taught in combination with Swain et al., the device may be biodegradable to allow it to break apart, Swain et al, paragraph 0050), wherein the first exoskeletal member is configured to break down over time and pass naturally through the, digestive tract (biodegradable, as taught by Swain et al, paragraph 0050, thereby breaking down and passing naturally), further comprising a structure that can be cut or detached for disassembly of the implant (material surrounding magnets is configured to be cut, cutting the jacket would separate the first and second magnet implant members 3).
Regarding claims 28 and 36, Hernandez et al. discloses wherein the first exoskeletal member is configured to direct self-assembly of the implant (resilient material allows for self-assembly from a linear to round configuration, figures 5 and 11 for example, exoskeleton with guides 4 to reassemble).
Regarding claim 37, Hernandez et al. discloses an apparatus for forming a magnetic compression anastomosis within a digestive tract, the apparatus comprising a plurality of anastomosis forming segments (magnets 3, figure 4) at least temporarily retained along an outer side wall of each anastomosis forming segment by an exoskeletal member (outer flexible jacket enveloping the magnets 3, flexible material sheath, figure 4, column 1, lines 50-51; column 2, lines column 11-17, column 4, lines 58-65, shown as outer layer 2, figure 3; outer layer 1, figure 17), the apparatus further including a retention member 6 extending outwardly from the outer side wall of the first anastomosis forming segment and the first exoskeletal member (figures 3, 10, wires 4 and/or 6 extend outwardly away from the exoskeleton and inner magnet), the retention member being configured to at least temporarily retain the first elongated implant member and the first exoskeletal member (column 5, lines 1-9; wires 6 are connected to retain the magnet and the exoskeleton in a retained configuration by bringing the terminal parts of the magnetic chain into proximity), the exoskeleton member extends outwardly from the outer side wall of the each anastomosis forming segment (outer flexible jacket enveloping the magnet or anastomosis forming segments 3, flexible material sheath to move easily, figure 4, 10), but fails to disclose wherein the outer side wall of each anastomosis forming segment is a long edge of the anastomosis forming segment, and the exoskeletal member is disassemblable from the plurality of anastomosis forming segments within the digestive tract after formation of the magnetic compression anastomosis.
Cope et al. discloses an anastomosis device comprising an implant comprising a magnet 90 the magnet may be constructed in any shape suitable for a particular procedure, such as a rectangular configuration (figure 14; column 9-20), the rectangular configuration first implant member having an outer side wall, wherein the outer side wall is a long edge of the first elongated implant member (figure 14). It would have been an obvious matter of design choice to a first elongated implant member including a magnet, the first implant member having an outer side wall, wherein the outer side wall is a long edge of the first elongated implant member, as taught by Cope et al., since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Swain et al. teaches an anastomosis device (32, 42, paragraph 0050) comprising at least one magnet attached thereto (paragraph 0048), the device being comprised of a biodegradable material to reduce the possibility of the magnet and/or anastomotic device getting stuck in the gastrointestinal tract (paragraph 0050). The term "disassemble" may be defined by Merriam Webster's dictionary as "to come apart" or "to disperse or scatter". The components of the anastomosis device, or the exoskeleton and first implant member, may be considered to be disassembled as they are degraded or absorbed and the device comes apart within the digestive tract to avoid getting stuck. Examiner notes in combination, the magnets may remain in place due to the tissue overgrowth, while the exoskeleton may be absorbed or disassembled within the digestive tract after placement and formation of the anastomosis.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hernandez et al. with an exoskeleton retention member being comprised of a biodegradable material to be disassemblable from the first implant member to reduce the possibility of getting stuck in the gastrointestinal tract after formation of the anastomosis and the exoskeleton retention member being absorbed.
Regarding claims 38 and 39, Hernandez et al. in combination with Swain et al. discloses wherein the wherein the first exoskeletal member is configured to disassemble the implant into separate segments including the first and second implant members (exoskeleton may be biodegradable, which retained magnets 3, figures 1-11), wherein the first exoskeletal member comprises at least one biodegradable component for disassembly of the implant (as taught in combination with Swain et al., the device may be biodegradable to allow it to break apart, Swain et al, paragraph 0050).
Regarding claim 40, Hernandez et al. discloses wherein the first exoskeletal member is configured to direct self-assembly of the implant (resilient material allows for self-assembly from a linear to round configuration, figures 5 and 11 for example, exoskeleton with guides 4 to reassemble, magnets within the device allow for exoskeleton to move with self-assembly of the implant).
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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