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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/28/2026 has been entered.
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.
Claims 15-18 are 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 15 recites the limitation "the flexible tubular body" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the limitation is being interpreted as the same as “the tubular body” recited in line 2.
Claims 16-18 are rejected due to their dependence on claim 15.
Claim Rejections - 35 USC § 102
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) 1-5, 8, 10-11, 14-15, 17 and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Terliuc et al. (US Patent Pub. 20110251458 hereinafter “Terliuc”) or, in the alternative, under 35 U.S.C. 103 as obvious over Terliuc et al. (US Patent Pub. 20110251458 hereinafter “Terliuc”) in view of Faith (US 20170157369).
Regarding Claim 1, Terliuc teaches (Fig 1a-1b) an overtube assembly for use with an elongate medical device (see [0072] teaching 100 is an overtube assembly for an endoscopic device), the overtube assembly comprising:
a flexible tubular body (102, [0082] teaches 102 is flexible) having a proximal end (Section B-B in Fig 1A) and a distal end (Section A-A in Fig 1A), the flexible tubular body including a tube split (106) extending longitudinally from the proximal end (Section B-B in Fig 1A) to the distal end (Section A-A in Fig 1A),
wherein the flexible tubular body defines each of a primary lumen (128) extending from the proximal end to the distal end and accessible through the tube split (106) and a secondary lumen (134; see [0076]) separate from the primary lumen (128), and
wherein the primary lumen (128) of the flexible tubular body (102) frictionally engages (See [0041] teaching the tube “additionally or alternatively” includes “a low friction surface coating”; this is coating would provide “a frictional engagement”, the disclosure of “additionally or alternatively” also implies an embodiment that has regular friction, which is interpreted to also provide “frictional engagement”; also see [0082] teaching that 102 has a low friction material) the elongate medical device (130) to maintain the flexible tubular body in a closed configuration about the elongate medical device (this is considered a functional recitation; the tubular body includes a frictional coating, therefore the tubular body of Terliuc is considered to meet the functional limitation to ‘maintain the flexible body in a closed configuration about the elongate medical device’; furthermore, see Fig 2 and [0077] teaching how the device is securely mounted onto endoscope 130).
In the instance the applicant does not agree with the interpretation of Terliuc having frictional engagement with the medical device to maintain the flexible tubular body in a closed configuration about the elongate medical device, the examiner relies on Faith as a teaching reference.
Faith teaches [0090] that an alternative to a locking mechanism, a tube (stabilizing member) may use a friction fit between the tube and medical device (catheter body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible tubular body of Terliuc such that it frictionally engages the elongate medical device as taught by Faith. One of ordinary skill in the art would recognize this as an alternative design to engage the two members without having a locking member (see Faith [0090]).
Regarding Claim 2, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly wherein the flexible tubular body comprises a primary tubular portion (annotated Fig 1A) defining the primary lumen (128) and a lobe portion (annotated Fig 1A) coupled to the primary tubular portion defining the secondary lumen (134).
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Annotated Fig 1A (Terliuc)
Regarding Claim 3, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly further comprising a reinforcing rib (160, 162; [0077] teaches that 160 and 162 are sealing collars, these are interpreted to be ribs) extending about the flexible tubular body (102), wherein the reinforcing rib (160, 162) defines a rib split (164, 166) aligned with the tube split (106).
Regarding Claim 4, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly further comprising a reinforcing rib (160, 162; [0077] teaches that 160 and 162 are sealing collars, these are interpreted to be ribs) extending about the flexible tubular body (102), wherein the reinforcing rib (160, 162) defines a rib split (164, 166) aligned with the tube split (106), and the reinforcing rib extends about each of the primary lumen and the secondary lumen (see Figs 1a-1b, ribs 160 and 162 extend around both primary lumen 128 and secondary lumen 134).
Regarding Claim 5, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly wherein: the flexible tubular body (102) comprises a wall (122) defining the primary lumen (128), and the wall (122) defines the secondary lumen (134).
Regarding Claim 8, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly further comprising an inflatable balloon (120) coupled to a distal portion of the flexible tubular body (102; see Fig 1A, balloon 120 is considered to be at a distal portion).
Regarding Claim 10, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly wherein the secondary lumen (134) is one of a plurality of secondary lumens (See Section B-B, there is also side lumen 132; see [0073]) defined by the flexible tubular body (102).
Regarding Claim 11, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly wherein the primary lumen (128) defines a longitudinal axis and wherein the secondary lumen (134) includes a distal opening (154) that is non- perpendicular relative to the longitudinal axis (104; see Fig 1A, 154 is parallel to the axis 104) .
Regarding Claim 14, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly further comprising a tubule disposed along a length of the secondary lumen (134 is considered a tubule along the length of 102).
Regarding Claim 15, Terliuc teaches (Figs 1A-1B) an overtube assembly comprising:
a tubular body (102) having a proximal end and a distal end, the tubular body including a tube split (106) extending longitudinally from the proximal end to the distal end, wherein the flexible tubular body (102; see [0082] teaching 102 is flexible) defines each of
(i) a primary lumen (128) accessible through the tube split (106) and extending from the proximal end (Section B-B in Fig 1A) to the distal end (Section A-A in Fig 1A), the primary lumen (128) being configured to receive an elongate medical device (130);
(ii) a secondary lumen (134) separate from the primary lumen (128); and
(iii) a fluid supply lumen (132) separate from each of the primary lumen and the secondary lumen; and
an inflatable balloon (120) disposed on a distal portion of the tubular body and in communication with the fluid supply lumen (132) such that inflation of the inflatable balloon is controllable by selectively providing or removing fluid via the fluid supply lumen (See [0074]),
wherein the primary lumen (128) of the tubular body (102) frictionally engages (See [0041] teaching the tube “additionally or alternatively” includes “a low friction surface coating”; this is coating would provide “a frictional engagement”, furthermore the disclosure of “additionally or alternatively” implies an embodiment with normal friction, which would also result in “frictional engagement”); also see [0082] teaching that 102 has a low friction material) the elongate medical device (130) to maintain the tubular body in a closed configuration about the elongate medical device (this is considered a functional recitation; the tubular body includes a frictional coating, therefore the tubular body of Terliuc is considered to meet the functional limitation to ‘maintain the flexible body in a closed configuration about the elongate medical device’; also see Fig 1B and [0077] teaching how the device is securely closed/mounted on endoscope 130).
In the instance the applicant does not agree with the interpretation of Terliuc having frictional engagement with the medical device to maintain the flexible tubular body in a closed configuration about the elongate medical device, the examiner relies on Faith as a teaching reference.
Faith teaches [0090] that an alternative to a locking mechanism, a tube (stabilizing member) may use a friction fit between the tube and medical device (catheter body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible tubular body of Terliuc such that it frictionally engages the elongate medical device as taught by Faith. One of ordinary skill in the art would recognize this as an alternative design to engage the two members without having a locking member (see Faith [0090]).
Regarding Claim 17, the combination of Terliuc and Faith teaches all elements of claim 15. Terliuc further teaches the overtube assembly wherein the secondary lumen (134) includes a distal opening (154) disposed distal the inflatable balloon (120; see Fig 1A).
Regarding Claim 21, the combination of Terliuc and Faith teaches all elements of claim 1. Terliuc further teaches the overtube assembly wherein the flexible tubular body (102) is configured to be laterally applied onto the elongate medical device (130) through the tube split (106) while a distal portion of the elongate medical device remains within a patient (See [0079] teaching that 102 is shorter than 130, therefore, it is capable of being applied to 130 at a proximal portion while a distal portion of 130 is within a patient).
Regarding Claim 22, the combination of Terliuc and Faith teaches all elements of claim 21. Terliuc further teaches the overtube assembly wherein, after the flexible tubular body (102) receives the elongate medical device (130) through the tube split (106), the flexible tubular body (102) is configured to return to the closed configuration (Fig 1B) about the elongate medical device (130).
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) 6 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc (US Patent Pub. 20110251458) in view of Faith (US 20170157369) and further in view of Belson (US Patent Pub. 20060235457).
Regarding Claim 6, the combination of Terliuc and Faith teaches all elements of claim 1 as described above. Terliuc does not specify the overtube assembly further comprising a handle disposed on the proximal end of the flexible tubular body, wherein the secondary lumen includes a proximal opening disposed distal a distal end of the handle.
Belson teaches (Fig 2C) an overtube assembly (100) with a handle (120) disposed on the proximal end (110) of the tubular body (102), wherein the secondary lumen (lumen within 170) includes a proximal opening (130 or 132) disposed distal a distal end of the handle (120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the overtube assembly of Terliuc such that it includes a handle disposed on the proximal end of the flexible tubular body, wherein the secondary lumen includes a proximal opening disposed distal a distal end of the handle as taught by Belson. One of ordinary skill in the art would have been motivated to do so in order to hold and steer the device (Belson [0067-0068]).
Regarding Claim 12, the combination of Terliuc and Faith teaches all elements of claim 1 as described above. Terliuc further teaches that the secondary lumen (134) is made of a flexible material (see [0091]). However, Terliuc does not specify wherein the secondary lumen is collapsible.
Belson teaches (Figs 2A-2B) an instrument with two lumens, a primary lumen (33) and a secondary lumen (48, see Fig 2B) that is collapsable (See Fig 2A, lumen 48 is collapsed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the secondary lumen of Terliuc to be a collapsable lumen as taught by Belson. One of ordinary skill in the art would have been motivated to do so in order to allow the device to navigate smaller spaces in the collapsed state, and once positioned the device could expand to advance medical tools to the desired location (See Belson [0060]).
Regarding Claim 13, the combination of Terliuc and Faith teaches all elements of claim 1 as described above. Terliuc does not specify the overtube assembly wherein the secondary lumen is bistable between an open configuration and a closed configuration.
Belson teaches (Figs 2A-2B) an instrument with two lumens, a primary lumen (33) and a secondary lumen (48, see Fig 2B) that is collapsable (See Fig 2A, lumen 48 is collapsed). The instrument of Belson is bistable between an open configuration (Fig 2B) and a closed configuration (Fig 2A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the secondary lumen of Terliuc such that the secondary lumen is bistable between an open configuration and a closed configuration as taught by Belson. One of ordinary skill in the art would have been motivated to do so in order to allow the device to navigate smaller spaces in the collapsed state, and once positioned the device could expand to advance medical tools to the desired location (See Belson [0060]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc (US Patent Pub. 20110251458) in view of Faith (US 20170157369) and further in view of Farhadi (US Patent Pub. 20150105621).
Regarding Claim 7, the combination of Terliuc and Faith teaches all elements of claim 5 as described above. Terliuc does not specify the overtube assembly further comprising a handle disposed on the proximal end of the flexible tubular body, wherein the secondary lumen is at least partially defined by the handle.
Farhadi teaches (Fig 1) a handle (19) disposed on a proximal end (14) of a tubular body (11, 12). Farhadi further teaches the handle comprising a proximal opening (64) for a secondary lumen, disposed a portion of the handle (See Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the overtube assembly of Terliuc such that it includes a handle disposed on the proximal end of the flexible tubular body, wherein the secondary lumen is at least partially defined by the handle as taught by Farhadi. One of ordinary skill in the art would have been motivated to do so in order to grasp and manipulate the overtube (See Farhadi [0079]).
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc (US Patent Pub. 20110251458) in view of Faith (US 20170157369) and further in view of Singh (US Patent Pub. 20040254422).
Regarding Claim 9, the combination of Terliuc and Faith teaches the overtube assembly of claim 1, further comprising an inflatable balloon (120) coupled to a distal portion of the flexible tubular body (102). Terliuc does not specify wherein the secondary lumen includes a distal opening and the distal opening is proximate the inflatable balloon.
Singh teaches (Fig 2) an overtube assembly (10) with a balloon (24) coupled to a distal portion of the tubular body (12), wherein a secondary lumen (36) includes a distal opening (38) and the distal opening (38) is proximal to the balloon (24; see Fig 2 and [0034] teaching “an opening 38 located a short distance, e.g., 1 or 2 cm, proximal of the balloon 24”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the distal opening of the secondary lumen of Terliuc such that the distal opening of the secondary lumen is proximate the balloon as taught by Singh. One of ordinary skill in the art would have been motivated to do so in order to provide anesthesia to the location proximal of the balloon to prevent pain, discomfort and prevent flushing to provide longer retention and tissue contact effectiveness (See Singh [0034- 0035]).
Regarding Claim 16, the combination of Terliuc and Faith teaches all elements of claim 15 as described above. Terliuc does not teach the overtube assembly wherein the secondary lumen includes a distal opening disposed proximate the inflatable balloon.
Singh teaches (Fig 2) an overtube assembly (10) with a balloon (24) coupled to a distal portion of the tubular body (12), wherein a secondary lumen (36) includes a distal opening (38) and the distal opening (38) is proximal to the balloon (24; see Fig 2 and [0034] teaching “an opening 38 located a short distance, e.g., 1 or 2 cm, proximal of the balloon 24”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the distal opening of the secondary lumen of Terliuc such that the distal opening of the secondary lumen is proximate the balloon as taught by Singh. One of ordinary skill in the art would have been motivated to do so in order to provide anesthesia to the location proximal of the balloon to prevent pain, discomfort and prevent flushing to provide longer retention and tissue contact effectiveness (See Singh [0034- 0035]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terliuc (US Patent Pub. 20110251458) in view of Faith (US 20170157369) and further in view of Kucharski et al. (US Patent Pub. 20170035277 hereinafter “Kucharski”).
Regarding Claim 18, the combination of Terliuc and Faith teaches all elements of claim 15 as described above. Terliuc does not specify the overtube assembly further comprising an electronic component, wherein the electronic component is at least one of disposed within and routed through the secondary lumen.
Kucharski teaches [0045] that the working channels could include various tools including electrodes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the secondary lumen of Terliuc such that it comprises an electronic component, wherein the electronic component is at least one of disposed within and routed through the secondary lumen as taught by Kucharski. One of ordinary skill in the art would recognize this is a known form of tool used with endoscopic treatments (Kucharski [0044] teaches this is an endoscopic instrument; [0045] teaches the known tools used with the instrument in the other channels/lumens).
Response to Arguments
Applicant's arguments filed 4/28/2026 have been fully considered but they are not persuasive.
As to the remarks on Pg. 1 line 9 - end of Pg. 2, the applicant argues that Terliuc does not teach “the primary lumen of the flexible tubular body frictionally engages the elongate medical device to maintain the flexible tubular body in a closed configuration about the elongate medical device.” The applicant argues that Terliuc does not teach the frictional engagement due to the latches 170 that are on the overtube assembly. The examiner does not find this to be persuasive. Terliuc teaches in [0041] that the tube may additionally or alternatively include a low friction inner surface coating. This low friction inner surface coating would provide a ‘frictional engagement’ between the tube and the elongate medical device that is inserted within the tube. Furthermore, with the disclosure of “additionally or alternatively”, it is interpreted that if the inner surface does not have a “low friction” then the alternative would be a “high friction” or a “normal friction”, and as such the tube would similarly have a “frictional engagement” with the elongate medical device. Terliuc also teaches [0077] how the sleeve is securely mounted on the endoscope, as such the device has the capability to be in a closed configuration around the elongate medical device. The examiner also provides reference Faith as an alternative 103 rejection that shows that the teaching of a high friction fit between a tube and device in place of a locking mechanism is well known. The applicant also argues that the tube of Terliuc could not be applied on the medical device without removing the device from the body due to the latches/locks. The examiner does not find this persuasive. Terliuc [0079] teaches that the tube/sleeve is shorter than the device/endoscope, therefore the tube/sleeve of Terliuc would be capable of being placed on the device at the proximal end while a distal portion of the device is within a body. For these reasons the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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