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 .
Election/Restrictions
Applicant’s election without traverse of Group I: Claims 20-29 and 41-53 in the reply filed on 01/29/2026 is acknowledged.
Applicant's election with traverse of Group 1: Species A and Subspecies C and Group 2: Species E in the reply filed on 01/29/2026 is acknowledged. The traversal is on the ground(s) that the current species groupings are incorrect. This is found persuasive because the applicant correctly points out that FIGS. 7-8B are generic to the embodiment of FIG. 6 and should be grouped with FIG. 6, as well as, the new groupings should be, Group 1: FIGS. 6-8B, FIG. 11, FIGS. 12A-12B, or FIG. 13 and Subspecies of FIGS. 6-8B being depicted between FIGS. 9A-9B or FIGS. 10A-10B. However, this argument is not found persuasive in regards to Group 2 because the applicant argues that FIGS. 14, its subspecies, and FIGS. 17A-17E are generic to all other embodiments; examiner agrees that FIGS. 14-15B are generic to all other embodiments, as they depict the general structure of the overall suturing device, however, examiner disagrees and argues that each of the rest of the embodiments depict alternate configurations for the suturing mechanism since the embodiment in FIG. 16 has arcuate tracks 228A and 228B while the elected embodiment in FIG. 19 has a single circular track 284, therefore, these embodiments have independent and distinct structures. Examiner asserts that FIGS. 17A-17E are generic to the embodiment of FIG. 16, so the new groupings should be, Group 2: FIGS. 16-17E, FIG. 18, FIG. 19, FIG. 20, FIG. 21, FIG. 22, FIG. 23. The elected species for Group 1 (FIGS. 6-8B and FIGS. 9A-9B) and Group 2 (FIG. 19) are readable together on claims 20-21, 23-24, 26-29, 41-46, 48-49, 51-53.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 20-21, 23-24, 26-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Terliuc et al. (US 20110251458 A1, hereinafter Terliuc).
Regarding Claim 20, Terliuc discloses
A re-insertion sheath (endoscope overtube 100, FIG. 1A) for an endoscope (endoscope 130, FIG. 1A),
the re-insertion sheath comprising:
an elongate body (sleeve 102, FIG. 1A) comprising:
a proximal end portion (depicted in FIG. 1A);
a distal end portion (depicted in FIG. 1A); and
a skin (balloon 120, FIG. 1A) extending axially between the proximal and distal end portions (depicted in FIG. 1A); and
a slit (slit 106, FIG. 1A) extending along the elongate body to allow circumferential expansion of the elongate body (depicted in FIGS. 1A-4A).
Regarding Claim 21, Terliuc discloses
The re-insertion sheath of claim 20, wherein the re-insertion sheath comprises a closure mechanism (plurality of latches 170, FIG. 1A-1B) for the slit of the elongate body (par. 87 discloses edges of sleeve can be joined, via latches, to effectively close the sheath).
Regarding Claim 23, Terliuc discloses
The re-insertion sheath of claim 21, wherein the closure mechanism comprises an arcuate door (arm portion 172, FIG. 1A) configured to rotate in a circumferential direction (FIG. 1A-1B, par. 87 disclose arm portion attached to attachment portion, i.e. via movement in circumferential direction).
Regarding Claim 24, Terliuc discloses
The re-insertion sheath of claim 20, wherein the elongate body comprises an axially expandable and contractable skin (selectively inflating/deflating wrap-around balloon 120, FIGS. 1A, 4D-4E) and an axially adjustable support structure (plurality of latches 170, FIG. 1A-1B).
Regarding Claim 26, Terliuc discloses
The re-insertion sheath of claim 24, wherein the axially adjustable support structure comprises a plurality of collapsible cross supports (plurality of latches 170) positioned along the elongate body (FIGS. 1A-1B, par. 87-88 disclose latches can be collapsed to securely support endoscope).
Regarding Claim 27, Terliuc discloses
The re-insertion sheath of claim 20, wherein the skin is fabricated from a polymeric material (par. 86 discloses balloon may be made of polyurethane).
Regarding Claim 28, Terliuc discloses
The re-insertion sheath of claim 27, wherein the skin is fabricated from a material comprising webbing (par. 86 discloses balloon may be made of polyurethane, which is commonly known in the art to contain webbing, i.e. thermoplastic polyurethane).
Regarding Claim 29, Terliuc discloses
The re-insertion sheath of claim 27, wherein the skin is configured to be furrowed and un-furrowed (depicted in FIGS. 4D-4E).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 41, 52-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (US 20030216613 A1, hereinafter Suzuki) in view of Terliuc et al. (US 20110251458 A1, hereinafter Terliuc).
Regarding Claim 41, Suzuki discloses
A system (anastomosis system 1, FIG. 1) for intraoperatively attaching a suturing device (suture machine 3, FIGS. 17-18) to an in situ endoscope (endoscope 12, FIG. 1) including the re-insertion sheath (flexible tubular member 85, FIG. 17) of claim 20, the system comprising:
the re-insertion sheath comprising:
the elongate body extending from the proximal end portion to the distal end portion (depicted in FIGS. 17-18),
the elongate body defining an internal lumen to receive an endoscope (endoscope 12, FIG. 1; FIGS. 17-18, par. 225-226 disclose flexible tubular member is hollow and has an axial hole, i.e. internal lumen),
the elongate body being flexible (par. 225-226 disclose flexible tubular member is flexible); and
a suturing device (suture machine 3, FIGS. 17-18) couplable in a releasable manner to the endoscope (par. 207 discloses suture machine is detachably fixed to the distal end of the endoscope),
wherein the suturing device can be guided through the internal lumen (depicted in FIGS. 17-18).
However, Suzuki does not disclose the slit extending axially along the elongate body to provide access to the internal lumen.
Terliuc teaches an analogous re-insertion sheath (endoscope overtube 100, FIG. 1A) for an endoscope (endoscope 130, FIG. 1A), the re-insertion sheath (100) having an elongate body (sleeve 102, FIG. 1A). The elongate body (102) is provided with a balloon (120, i.e. skin) on its outer surface (depicted in FIG. 1), which comprises a slit (106) allowing for the expansion of the elongate body (102) and provides access to an internal lumen (main lumen 128, FIG. 1A).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the re-insertion sheath of Suzuki with the slit of Terliuc in order to provide an elongate body which can allow for endoscopes of different sizes upon expansion and more conveniently be openable and closable [Terliuc - 0072, 0090].
Regarding Claim 52, Suzuki, as previously modified by Terliuc, teaches all of the
elements of the current invention disclosed in claim 41, and Terliuc further teaches
wherein the slit allows the elongate body to be radially expanded to fit over the endoscope (par. 90 discloses overtube is expanded open such that slit can accommodate the thickness of endoscope).
Regarding Claim 53, Suzuki, as previously modified by Terliuc, teaches all of the
elements of the current invention disclosed in claim 41, and Suzuki further discloses
further comprising an endoscope (endoscope 12, FIG. 1) configured to couple with the suturing device and fit into the elongate body (depicted in FIGS. 17-18), wherein:
wherein the endoscope extends from a proximal handle section (proximal end of insertion portion 7, FIGS. 17-18) to a distal functional section (distal end of insertion portion 7, FIGS. 17-18); and
the re-insertion sheath has a length that can extend from the proximal handle section to the distal functional section (depicted in FIGS. 17-18).
Claim(s) 42-46, 48-49 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (US 20030216613 A1, hereinafter Suzuki) in view of Terliuc et al. (US 20110251458 A1, hereinafter Terliuc) as applied to claim 41 above, and further in view of Aravalli et al. (US 20210282766 A1, hereinafter Aravalli).
Regarding Claim 42, Suzuki, as previously modified by Terliuc, teaches all of the elements of the current invention disclosed in claim 41, however, Suzuki does not disclose wherein the suturing device comprises an electro-magnetic actuation mechanism.
Aravalli teaches an analogous suturing device (tool assembly 16, FIG. 1) coupled to a stitching device (10, i.e. endoscope) in a releasable manner (depicted in FIG. 2A). The tool assembly (16) comprises jaws (40+42, FIG. 2A) which each have respective electromagnetic coils (80, 98, FIG. 2A) that actuate the jaws [0056].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the suturing device of Suzuki, as previously modified by Terliuc, with the electro-magnetic actuation mechanism of Aravalli in order to provide a system capable of being electro-magnetically actuated for surgical operations, via a handle device, upon connection to a primary medical device, i.e. an endoscope/ endoscope handle, and capable of having energized components [Aravalli - 0007].
Regarding Claim 43, Suzuki, as previously modified by Terliuc, and further in view of Aravalli, teaches all of the elements of the current invention disclosed in claim 42, and Suzuki further discloses wherein the suturing device comprises:
an annular coupler (fixing member 40, FIG. 8) for attaching to a distal end an endoscope (12, FIG. 8, par. 207 disclose suture machine is attached to distal end of endoscope by annular coupler); and
a suturing body (channel member 35, FIG. 5) for housing a motive suturing element (suture thread 4 + curved needle 34; depicted in FIGS. 3-4, 13).
Regarding Claim 44, Suzuki, as previously modified by Terliuc, and further in view of Aravalli, teaches all of the elements of the current invention disclosed in claim 43, and Suzuki further discloses
further comprising a hinge (screws 50/51, FIG. 11) connecting the annular coupler and the suturing body (FIG. 8, par. 217 disclose channel member is connected to the fixing member, via an L-shaped support member, and screws allow the support member of the channel member to have its position adjusted, i.e. channel member can pivot relative to connection with fixing member).
Regarding Claim 45, Suzuki, as previously modified by Terliuc, and further in view of Aravalli, teaches all of the elements of the current invention disclosed in claim 43, and Suzuki further discloses
The system of claim 43, wherein the suturing device comprises an arcuate pathway (thread guide 55, FIG. 13) for the motive suturing element (depicted in FIG. 13).
Regarding Claim 46, Suzuki, as previously modified by Terliuc, and further in view of Aravalli, teaches all of the elements of the current invention disclosed in claim 43, and Aravalli further teaches
wherein the suturing device further comprises a first coil (electromagnetic coil 80, FIG. 2A) and a second coil (electromagnetic coil 98, FIG. 2A) within the suturing body (proximal hub portion 90 + body 66; depicted in FIG. 2A),
wherein the motive suturing element (jaws 40+42, FIG. 2A) is configured to be directly driven by at least one magnetic field generated by the first coil and second coil (par. 56 discloses coils drive jaws via energization, i.e. magnetic field generation).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the suturing device of Suzuki, as previously modified by Terliuc, with the electro-magnetic coils of Aravalli in order to provide a system capable of being electro-magnetically actuated for surgical operations, via a handle device, upon connection to a primary medical device, i.e. an endoscope/ endoscope handle, and capable of having energized components [Aravalli - 0007].
Regarding Claim 47, Suzuki, as previously modified by Terliuc, and further in view of Aravalli, teaches all of the elements of the current invention disclosed in claim 46, and Aravalli further teaches
wherein the motive suturing element is configured to circulate between the first coil and the second coil (par. 50 energy flows in jaws via coils and a magnetic field is created on jaws via the energizing of the coils).
Regarding Claim 49, Suzuki, as previously modified by Terliuc, and further in view of Aravalli, teaches all of the elements of the current invention disclosed in claim 46, and Aravalli further teaches
further comprising a controller (switch 22, FIG. 1) configured to selectively activate the first and second coils (par. 56 discloses energizing of coils selectively actuated via switch).
Regarding Claim 51, Suzuki, as previously modified by Terliuc, and further in view of Aravalli, teaches all of the elements of the current invention disclosed in claim 46, and Suzuki further discloses
further comprising a magnet mounted to the motive suturing element to enhance interaction with the at least one magnetic field (par. 836 discloses magnet connected to suture thread, par. 855 discloses magnet allows thread to be engaged by a magnetic force).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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