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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/14/2026 has been entered.
Response to Arguments
Applicant’s arguments, see 9, filed 03/24/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) in view of Aoki have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lessing/Moll.
Applicant's arguments pertaining to claim 10 have been fully considered but they are not persuasive. It is the examiners position that the one or more tissue engagement features “extending from” the elongate cylindrical body is not sufficient structure to overcome the previous rejection. In the previous interview, examiner noted that the disclosed loops or projections which extend from the elongate cylindrical body (See elements 122 in FIG 1 of the present invention) are not found in the device of Aoki, nor would it be obvious to modify the device in such a manner. However, the submitted amendments are broader than the distinguishing features which were discussed. It is the examiners position that tube 33 of Aoki is capable of performing the function of the tissue engagement feature as claimed because it extends from the elongate cylindrical body (as shown in FIG 5) and it provides a surface which can be grasped by a tissue engagement member. Therefore, it could be used to attach said tissue traction device to the target tissue, if another structure were used to facilitated such an attachment, and it can be used to apply traction to the target tissue by applying a force which contacts and manipulates the tissue.
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.
Claim(s) 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aoki (US 2017/0196436).
Regarding claim 10, Aoki et al. discloses a tissue traction device (10, 20, FIGs 1-4) for applying traction to a target tissue (The bendable elongate device is at least usable to articulate and apply a retracting force on a target tissue), the tissue traction device comprising: an elongate cylindrical body (One of tubes A-D, FIG 3-4) extending along a longitudinal axis and having a distal end (Left side as viewed in FIG 3a) and a proximal end (Right side as viewed in FIG 3a) and a flexible segment therebetween extending along only a portion of the perimeter of said cylindrical body (Segment 31, and more specifically elastic tube body section 11, which extends along only a portion of the perimeter of one of the tubes, as shown in FIG 4); and one or more tissue-engagement features (Rigid tube 33 of non-bending portion 32, FIG 3 and 5. This features is interpreted as an equivalent structure as outline previously under 35 USC 112(f) interpretation because it is formed on the outer surface of the device and therefore is exposed to the tissue, and has a rigidity capable of being secured to a tissue) extending from the distal end of the elongate cylindrical body (See FIG 3a-3b wherein the distal end of the elongate cylindrical body comprises segment 32, which has tube 33 and FIG 5 where 33 is in direct contact with the outer circumference of any one of A-D) and configured to be engaged by a tissue engagement member to attach said tissue traction device to the target tissue to apply traction to the target (The rigid tube 33 is interpreted as at least configured to be engaged by another structure to facilitate attachment to tissue. Because of the rigidity of the tube segment, it is capable of forming a connect to tissue via use of a tissue engagement member which could be adhesively attached, for example); wherein said flexible segment is more flexible than surrounding circumferential portions of said cylindrical body to facilitate bending of said cylindrical body along said flexible segment (The flexible segment 11 is more flexible around a segment of the circumference than segment 13, [0065-0066] and section 31 is more flexible than segment 32, [0057], thereby facilitating bending, FIGs 3a-3b, [0076-0078]) to apply traction to the target tissue (The bending of the device is at least capable of applying traction to an target tissue if being sued as a retractor).
Regarding claim 11, Aoki et al. discloses said cylindrical body is tubular (FIG 4) and inflatable ([0076-0078]); and said flexible segment is more expandable than surrounding portions of said cylindrical body so that inflation of said tubular cylindrical body causes expansion of said flexible segment (FIG 4 shows only the flexible segments are expanded while segment 13 remains unchanged) and bending of said flexible segment towards an opposite, less expandable side of said cylindrical body (FIGS 3-4, inflation causes bending in a direction towards 13 for example FIG 3b shows that the tube 1a is inflated, it bends downward, which is towards the center of the device comprising region 13).
Regarding claim 12, Aoki et al. discloses said flexible segment extends only along a limited extent along the longitudinal axis of said cylindrical body (FIG 1-3 shows the flexible segment 31 is along only a limited extent of the longitudinal length of the cylindrical body.
Regarding claim 13, Aoki et al. discloses said cylindrical body is formed of a flexible material (Elastic tube body 11, [0065-0066]) and a stiffening element (13, 4) is applied to a limited extent around the perimeter of said flexible cylindrical body (FIG 4 shows that 4/13 are located on only a limited perimeter of the cylindrical body), said flexible segment being defined opposite said stiffening element (FIG 4 shows the positions are opposed).
Regarding claim 14, Aoki et al. discloses said cylindrical body is formed of a flexible material (Elastic tube body 11, [0065-0066]) and a stiffening element (13, 4) is applied to a limited extent around the perimeter of said flexible cylindrical body (FIG 4 shows that 4/13 are located on only a limited perimeter of the cylindrical body), said flexible segment being defined opposite said stiffening element (FIG 4 shows the positions are opposed).
Regarding claim 15, Aoki et al. discloses said cylindrical body is a distal segment of a flexible tubular element of a tissue traction system (FIG 1-3, the cylindrical body is interpreted as the distal most bending segment 31, thereby being formed by a distal segment of a flexible tubular element of a tissue traction system).
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) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lessing et al. (US 10,028,734) in view of Moll et al. (US 5,865,728).
Regarding claim 1, Lessing et al. discloses a tissue traction system (Body tissue retractor, FIGs 2A-2D) for applying traction to a target tissue (Col 8 lines 7-41), said tissue traction system comprising: one or more elongate elements (See elongate body of device from 112 to 110, FIG 2C) each having a distal end (110); a tissue traction device (Base 102 and accordion extensions 104, col 4 line 62-col 5 line 33); wherein at least one of said one or more elongate elements is a tubular element (see tubular shape of FIG 5A-5B, 7D) with a longitudinal extent (See longitudinal length in FIG 2C), extending proximally from the distal end of said tubular element (Wherein at least some region of the distal is the tubular element and the elongate element extends a length proximally of said distal end), defining at least a flexible tubular portion of said tissue traction device (The region comprising the accordion extension 104 forms the flexible portion); a longitudinal circumferential region of said tissue traction device (104) is more flexible than surrounding regions of said tissue traction device (102) so that actuation of said tissue traction device causes bending along the more flexible region toward a less flexible region (Bending as shown in FIG 2D when 104 are inflated. Col 9 lines 52-56 discloses that actuator 100 of the “body tissue retractor” is generally similar to 100 as described above as the “incision retractor”. Col 4 lines 54-61 and col 5 lines 25-32 describe introduction of an inflation medium to cause bending along 104, towards the direction of stiffer 102); and said at least one flexible tubular portion of said tissue traction device (104) is configured to expand (via the inflation medium) and thereby bend along the more flexible region when an inflation medium is applied into said at least one flexible tubular portion (As shown in FIG 2D and 5C).
Lessing et al. is silent regarding at least one tissue-engagement feature extending from said tissue traction device and configured to be engaged by a tissue-engagement member to couple said tissue traction device to the target tissue.
However, Moll et al. teaches in the same field of endeavor a tissue retractor device (“Type IA retraction device”, FIG 1) insertable into an incision to apply tractions to a target treatment tissue (FIG 4A-4D, col 11 lines 4-col 13 line 47) having an insertion configuration (FIG 4B) and an inflatable deployed state (FIG 4D), and at least one tissue-engagement feature (56) extending from said tissue traction device (FIG 2-3, col 11 lines 4-19) and configured to be engaged by a tissue-engagement member (“suitable gripping tool”) to couple said tissue traction device to the target tissue (The tabs provide an extension/projection which is at least configured to be engaged by a tissue engagement member and coupled to a target tissue. Further “The gripping tool allows the inflated retraction device to be manipulated to change its position so that, for instance, one of its windows can be aligned with the organ or tissue to be treated or observed”, therefore being used to position the traction device within the target tissue and coupling it thereto, via direct mechanical contact. Examiner notes the claim does not positively recite the tissue engagement member or require a direct coupling between the tissue engagement feature and the target tissue).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the tissue traction device of Lessing to comprise at least one tab/tissue engagement feature, as taught by Moll, for the purpose of providing a feature which can be gripped by a tissue engagement member to assist in the manipulation or positioning to the traction device within the target treatment site (Moll: col 11 lines 4-19).
Regarding claim 2, Lessing/Moll discloses the invention substantially as claimed, as set forth above for claim 1. Lessing further discloses said tissue traction device is defined by a distal extent of said one or more elongate elements extending a length proximal to distal ends of said one or more elongate elements (FIG 2B-C and 5A-C shows the bending sections 104 which forms the tissue traction device is formed by a distal section of the elongate elements).
Regarding claim 3, Lessing/Moll discloses the invention substantially as claimed, as set forth above for claim 1. Lessing further discloses each of said elongate elements is a flexible tubular element (FIG 2A-2D shows actuator 100 is a tubular element and shows the flexibility of the elements due to their elastic inflatable nature).
Regarding claim 4, Lessing/Moll discloses the invention substantially as claimed, as set forth above for claim 1. Lessing further discloses said at least one flexible tubular element has a sealed distal end (FIGs 2D and 5B shoe the distal ends are sealed in order to be able to inject an inflation medium to expand the bending portions).
Regarding claim 5, Lessing/Moll discloses the invention substantially as claimed, as set forth above for claim 1. Lessing further discloses an actuation mechanism (handle 200 including inflation device 202, FIG 2A) operatively coupled to said tubular element to cause bending of said flexible tubular portion of said tissue traction device (col 8 lines 7-52 disclose the injection of inflation medium to cause bending) to apply traction to the target tissue (Bending of the device is used to apply pressure to the tissue, col 8 lines 4-6 describe applying safe pressure to the retracted tissue, FIGs 7E-7G show the device bent and in contact with tissue).
Regarding claim 6, Lessing/Moll discloses the invention substantially as claimed, as set forth above for claim 1. Lessing further discloses said longitudinal circumferential region of said tissue traction device is formed along said flexible tubular portion of said tissue traction device (The circumferential region containing 104, FIGs 2C-2D) and is more expandable than surrounding circumferential or longitudinal regions of said tissue traction device (104 is more expandable than base 102, therefore allowing for the bending shown in FIG 2D); and said actuation mechanism delivers an inflation medium through said flexible tubular element to said flexible tubular portion of tissue traction device to expand said longitudinal circumferential region of said tissue traction device relative to surrounding circumferential and longitudinal regions of said tissue traction device to cause said tissue traction device to bend to apply traction to the target tissue (FIGs 2C-2D, col 8 lines 8-41 and col 9 lines 52-62).
Regarding claim 7, Lessing/Moll discloses the invention substantially as claimed, as set forth above for claim 1. The device as modified by Moll further discloses wherein said at least one tissue engagement feature is an extension or projection (the tissue engagement feature in the modified device is a tab) configured to be engaged by a tissue engagement member (Examiner notes the tissue engagement member is not positively recited in the claim. The tab provides an extension of material which is at least configured to be gripped or engaged by at least some tissue engagement member such as a gripper tool).
Regarding claim 8, Lessing/Moll discloses the invention substantially as claimed, as set forth above for claim 1. Lessing further discloses a stiffening element is applied along a limited region along the perimeter of said tissue traction device (col 5 lines 5-8 “the base 102 may incorporate one or more overmolded slats or other suitable stiff structures”), resulting in surrounding circumferential regions being relatively more flexible (The remaining regions of 102 and 104 are more flexible than the region at 102 containing the stiff structure).
Regarding claim 9, Lessing/Moll discloses the invention substantially as claimed, as set forth above for claim 8. Lessing further discloses said tubular element has a sealed distal end (FIG 5B, the distal ends are sealed in order to be able to inject an inflation medium to expand the bending portions.); and said tissue traction device is directionally inflatable upon application of an inflation medium to said tubular element to cause the more flexible region of said tissue traction device to expand and to bend said tissue traction device toward said stiffening element to apply traction to the target tissue (FIGS2C-2D and 5B-5C, inflation causes bending in a direction towards 102 which comprises the stiffening element. 13 for example FIG 2D shows that the tube is inflated, it bends downward).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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