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
Newly submitted claims 22-25, as well as, amended claims 6 and 14 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 6 recites the limitation “inserting the first device with the first sheath thereon… with second sheath on the first sheath” which is an aspect only disclosed in relation to non-elected FIG. 3A of Species B in paragraphs 38 and 42.
Claim 14 recites the limitation “inserting one or more… tools through the second device” which is an aspect only disclosed in relation to non-elected FIG. 3H of Species B.
Claim 22 recites the limitation “robotically steerable overtube” which is an aspect directed to non-elected Species A as the only mention is in paragraph 42 where it is discussed as being drawn to the instruments disclosed in non-elected FIG. 3G.
Claims 23-24 are directed to an overtube with working channels, which is only disclosed in relation to non-elected FIG. 3H of Species B.
Claim 25 recites the limitation “respective tapered distal ends” which is only disclosed in paragraph 40 and is specifically directed to non-elected FIG. 3A of Species B.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 22-25 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The Amendment filed February 10th, 2026 has been entered. Claims 1-3, 5-6, 8-9 and 12-15 have been amended. Claims 21-25 has been newly added and Claims 16-20 have been cancelled. Claims 1-15, 21-25 are now pending in the application with claims 22-25 withdrawn. The previous 35 U.S.C. 112(b) rejections of claims 9 and 15 are withdrawn in light of Applicant's amendment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner’s Comments
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
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) 1-5, 7-13, 15 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (US 20020147385 A1, hereinafter Butler) in view of Rabiner et al. (US 20030212333 A1, hereinafter Rabiner).
Regarding Claim 1, Butler discloses
A method (par. 52 discloses method of performing a colonoscopy procedure) for deploying a medical device (depicted in FIG. 1), comprising:
inserting a first device (colonoscope 14), having a first device outer diameter (par. 91 discloses diameter of colonoscope, i.e. outer diameter),
into a body lumen (colon 18) having a bend (sigmoid colon 21, FIG. 11);
sliding a second sheath (overtube 1/ overtube 100, FIG. 1, 22) having a second sheath inner diameter (par. 102 discloses overtube is advanced over the colonoscope; par. 123 discloses overtube working channel has large diameter, i.e. inner diameter);
navigating the first device through and beyond the bend (FIG. 13 depicts colonoscope traveling beyond sigmoid colon);
at least partially straightening the first device to at least partially straighten the bend (par. 101 discloses sigmoid colon is straightened by manipulating the colonoscope);
removing the first device from the body lumen, leaving the second sheath in place within the at least partially straightened bend (FIG. 22, par. 121 disclose colonoscope can be removed from overtube, leaving it in place within the straightened colon); and
introducing a second device, having a second device outer diameter, into the second sheath to navigate the second device through the at least partially straightened bend to a distal opening of the second sheath (par. 123 discloses once colonoscope is removed, any instrument may be easily passed to access any point in the colon through the large diameter working channel of overtube, i.e. second device will have outer diameter smaller than overtube working channel).
However, Butler does not disclose sliding a first sheath having a first sheath inner diameter and a first sheath outer diameter over first device; having a second sheath inner diameter larger than the first sheath outer diameter over the first device.
Rabiner teaches an analogous method (par. 11 discloses method) for deploying a medical device (conventional endoscope body 10, FIG. 1). The method involving the insertion of an endoscope flexible insertion tube (12, i.e. first device) into the body so that it may bend with respect to the body [0042]. The tube (12) of the device (10) is further provided with a first thin-walled sleeve (20, i.e. first sheath, FIGS. 2-3), having an inner diameter and an outer diameter, and a second thin-walled sleeve (22, i.e. second sheath, FIGS. 2-3), having an inner diameter larger than the outer diameter of the first sleeve [0044-0045]. The first sleeve (20) is slidable over the tube (12) and the second sleeve (22) is slidable over the first sleeve and the tube [FIG. 3, 0047] and the entire device may be inserted within the body and/ or the sleeves may be fit/ slid over the already inserted tube [0022, 0032].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the medical device of Butler with the first sheath of Rabiner in order to provide a specialized sheath capable of varying the stiffness of a device which it surrounds over a wide range allowing for completely even and/or incremental stiffness/ straightening [Rabiner - 0043, 0047].
Additionally, the second sheath (overtube 1) of Butler would have a larger diameter, upon combination, than the first sheath (first sleeve 20) of Rabiner since the Butler reference discloses that the overtube has a much larger diameter than a typical colonoscope working channel, with a diameter of 15 mm, and is capable of accepting large instruments [Butler - 0123, 0133], and the Rabiner reference teaches a mother-daughter design where the first sleeve (20) is already adapted to being a smaller diameter sheath capable of having a larger diameter sheath introduced over itself (depicted in FIG. 3) and is sized to fit over the device being used in a given application [Rabiner - 0022].
Regarding Claim 2, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 1, and Rabiner further teaches
wherein the step of sliding the first sheath over the first device is performed after the step of at least partially straightening the first device and before the step of removing the first device from the body lumen (FIG. 1 depicts varying stiffness/ straightening of tube without sleeves, par. 11 discloses initial rigidity of device within body, par. 47 discloses first sleeve slidable over the insertion tube, par. 22 discloses sleeve fitted over already inserted tube).
Regarding Claim 3, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 2, and Butler further discloses
wherein the step of sliding the second sheath over the first sheath is performed after step of sliding the first sheath over the at least partially straightened first device and before the step of removing the first device from the body lumen (FIG.15-16, par. 101-102 disclose the overtube is advanced through the colon over the colonoscope after the colonoscope has straightened the sigmoid colon; Upon the combination of Butler and Rabiner, the sheath of Rabiner would assist in the straightening process of the colonoscope of Butler and be advanced along the colonoscope [Rabiner - 0047], therefore the overtube would cover the colonoscope with after the sheath is already on it).
Regarding Claim 4, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 2, and Rabiner further teaches
wherein the first sheath and the second sheath are slid over the first device together (par. 43-45, 47 disclose sleeves may be slid over tube together or independently).
Regarding Claim 5, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 3, and Rabiner further teaches
wherein the step of removing the first device and the first sheath includes removing the first device and the first sheath together (par. 32 discloses sleeve positioned on tube and then may be withdrawn, i.e. together).
Regarding Claim 7, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 1, and Butler further discloses
wherein the second device is less compliant and/or less steerable than the first device (par. 123 discloses second device can be any instrument with any characteristics, i.e. less compliant and/or less steerable).
Regarding Claim 8, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 7, and Butler further discloses
wherein a diameter of the second device outer diameter is larger than a first device outer diameter (par. 123 discloses second device can be any instrument with any characteristics and larger instruments can be used during colonoscopy, i.e. larger than colonoscope).
Regarding Claim 9, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 8, and Butler further discloses
wherein the first device outer diameter is 13 mm or less (par. 133 discloses colonoscope lumen of overtube has a diameter of approximately 15 mm, par. 97 discloses tubular sheath has a smaller diameter than the overtube, par. 91 discloses size of seal adjusted to size of colonoscope; it is inherent that the colonoscope will be slightly smaller to allow the overtube to slide over efficiently, i.e. 13mm),
and the second device outer diameter is 18 mm or greater (par. 123 discloses instrument channel much larger than colonoscope channel and large instruments may be used during procedure, par. 133 discloses colonoscope lumen of overtube has a diameter of approximately 15 mm, i.e. instrument will be much larger than 15 mm).
Regarding Claim 10, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 8, and Rabiner further teaches
wherein the first device is an endoscope (endoscope body 10, FIGS. 1-3) configured to fit within the first sheath (depicted in FIGS. 2-3).
Regarding Claim 11, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 10, and Butler further discloses
wherein the second device is or includes an overtube configured to fit within the second sheath (par. 123 discloses second device can be any instrument with any characteristics, including larger instruments which may be passed through a large working channel of the overtube).
Regarding Claim 12, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 1, and Butler further discloses
wherein the step of navigating the bend includes positioning the distal opening of the second sheath at or near a target site (FIG. 21, par. 120 disclose overtube reaches any desired point of interest in the colon as far distally as the caecum).
Regarding Claim 13, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 1, and Butler further discloses
further comprising the step of extending the second device from the second sheath to the target site (par. 123 discloses any instrument may be passed to access any point in the colon as far distally as the caecum).
Regarding Claim 15, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 1, and Butler further discloses
wherein the body lumen is a colon (colon 18), and
wherein the bend is a sigmoid colon (sigmoid colon 21, FIG. 11).
Regarding Claim 21, Butler, as previously modified by Rabiner, discloses all of the elements of the current invention disclosed in claim 3, and Rabiner further teaches
wherein the step of removing the first device and the first sheath includes successively removing the first device and the first sheath (par. 32 discloses sleeve positioned on tube and then may be withdrawn, par. 21 discloses obturator, i.e. first sleeve, is removed prior to removing instrument, i.e. successive removals).
Conclusion
THIS ACTION IS MADE FINAL. 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 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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