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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/17/26 has been entered.
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. discloses a provisional application date of July, 12, 2011 which is dated prior to the provisional 61/649,248 of the present application filed on 5/19/12. Hernandez et al. discloses an anastomosis device comprising a first and second implant and an exoskeleton (or sheath) surrounding the outer wall of the implant member. Examiner notes that although present in the US 11,344,308 disclosure, the provisional fails to explicitly disclose various shaped magnets or the exoskeleton being biodegradable. However, Cope et al. teaches any shape magnets may be used for the anastomosis device. Swain et al. teaches biodegradable or disassemblable segments to come apart within the digestive tract. Therefore, in combination the amendment fails to overcome the prior art of record, as further discussed 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 21-40 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, lines 9-10 disclose “the first exoskeletal retention member configured to at least temporarily retain the first implant member along the outer side wall of the first implant member”. This language is unclear as to how the implant member may be retained alongside itself.
Claim 21 recites the limitation "”the first implant member" in at least lines 3, 7-8, 10 and 13-14. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "”the first implant member" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation "”the anastomosis forming segment" in at least lines 5 and 8. There is insufficient antecedent basis for this limitation in the claim.
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, a first and second implants configured to magnetically couple to each other through the adjacent walls of the magnetic compression anastomosis, wherein at least one of the first or second implants comprising an implant for magnetic compression anastomosis, the implant comprising: a first implant member including a magnet (chain of magnets 3, figure 4), the first implant member having an outer side wall (outer side wall of magnet 3); and a first exoskeletal retention 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 elongated implant member (outer flexible jacket enveloping the magnets, flexible material sheath, figure 4, column 1, lines 50-51; column 2, lines column 11-17, column 4, lines 58-65), the first exoskeletal retention 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 .
Hernandez et al. discloses implant members, but fails to explicitly disclose 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, wherein the first exoskeletal retention 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 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 22 and 30, Hernandez et al. 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 retention 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 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. discloses wherein the second implant member includes a magnet (chain of magnets 3).
Regarding claims 24-27 and 32-35, Hernandez et al. in combination with Swain et al. discloses wherein the wherein the first exoskeletal retention 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 retention 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 retention member is configured to break down over time and pass naturally through the, digestive tract (exoskeleton being biodegradable, 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 retention 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 (chain of magnets 3, figure 4) at least temporarily retained along an outer side wall of each anastomosis forming segment by an exoskeletal retention member (retained within resilient material 1, 2) , the exoskeleton retention 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, column 1, lines 50-51; column 2, lines column 11-17, column 4, lines 58-65), 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 retention 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 retention 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 retention 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 retention 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
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