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 .
Claim Objections
Claims 1 and 21-23 are objected to because of the following informalities:
Claim 1, lines 18-19 recite “while maintaining the flexibility of the first rigidizing device is greater than the flexibility of the second rigidizing device” however the wording makes the language unclear, therefore the examiner suggests amending the claim to recite “while maintaining the flexibility of the first rigidizing device of being greater than the flexibility of the second rigidizing device”.
Claim 21, line 2 recites “0.04”-03””, however it appears the “03” may be erroneous and should read “0.04”-0.3”” as disclosed in the specification in Paragraph [0325].
Claim 22, lines 17-18 recite “while maintaining the flexibility of the first rigidizing device is greater than the flexibility of the second rigidizing device” however the wording makes the language unclear, therefore the examiner suggests amending the claim to recite “while maintaining the flexibility of the first rigidizing device of being greater than the flexibility of the second rigidizing device”.
Claim 23, lines 19-20 recite “while maintaining the flexibility of the first rigidizing device is greater than the flexibility of the second rigidizing device” however the wording makes the language unclear, therefore the examiner suggests amending the claim to recite “while maintaining the flexibility of the first rigidizing device of being greater than the flexibility of the second rigidizing device”.
Appropriate correction is required.
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.
Claims 1-4, 6, 10, 12-17, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vargas et al. (US 20110282149 A1).
Regarding claim 1, Vargas discloses a method (Figs. 2A-2D and 17A-17B, Paragraphs [0048], [0050], [0052], [0054], and [0088]), the method comprising:
positioning a nested system in a body (Paragraphs [0048], [0050], [0052], and [0054], Figs. 2A-2D and 17A-17B) by:
moving a first rigidizing device (1) of the nested system axially relative to a second rigidizing device (2/180) of the nested system that is nested over the first rigidizing device while the first rigidizing device is more flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D),
changing a flexibility of the first rigidizing device and a flexibility of the second rigidizing device so that the first rigidizing device is less flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D),
moving the second rigidizing device axially relative to the first rigidizing device while the first rigidizing device is less flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D), and
changing the flexibility of the first rigidizing device and of the second rigidizing device so that the first rigidizing device is more flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D);
maintaining the flexibility of the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D) and:
removing the first rigidizing device from a lumen of the second rigidizing device while maintaining the flexibility of the first rigidizing device is greater than the flexibility of the second rigidizing device (Paragraph [0048]); and
inserting one or more tools through the lumen of the second rigidizing device (Paragraph [0048]).
Regarding claim 2, Vargas discloses the method of claim 1, further comprising iteratively repeating the steps of the positioning step to position a distal end of the nested system at a target site within the body (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D).
Regarding claim 3, Vargas discloses the method of claim 1, wherein changing the flexibility of the first rigidizing device and the flexibility of the second rigidizing device so that the first rigidizing device is less flexible than the second rigidizing device comprises changing a pressure within a wall of the first rigidizing device and changing a pressure within a wall of the second rigidizing device (Paragraph [0088]).
Regarding claim 4, Vargas discloses the method of claim 1, wherein changing the flexibility of the first rigidizing device and the flexibility of the second rigidizing device so that the first rigidizing device is less flexible than the second rigidizing device comprises changing a pressure within a wall of the first rigidizing device to compress a material within the wall of the first rigidizing device to reduce movement of the material within the wall, and changing a pressure within a wall of the second rigidizing device so that a material within the wall of the second rigidizing device is movable within the wall (Paragraph [0088]).
Regarding claim 6, Vargas discloses the method of claim 4, wherein changing the pressure within the wall of the first rigidizing device comprises applying negative pressure (Paragraph [0088]).
Regarding claim 10, Vargas discloses the method of claim 1, wherein inserting one or more tools through the lumen of the second rigidizing device comprises inserting a tube through the lumen of the second rigidizing device (Paragraph [0048]).
Regarding claim 12, Vargas discloses the method of claim 1, wherein positioning the nested system in the body comprises positioning the nested system within a body lumen (Paragraph [0052]).
Regarding claim 13, Vargas discloses the method of claim 1, wherein positioning the nested system in the body comprises positioning the nested system within a gastrointestinal (GI) tract (Paragraph [0052]).
Regarding claim 14, Vargas discloses the method of claim 1, wherein positioning the nested system in the body comprises positioning the nested system within a colon (Paragraph [0052]).
Regarding claim 15, Vargas discloses the method of claim 1, wherein positioning the nested system in the body comprises positioning the nested system within a heart (Paragraph [0052]) or vasculature.
Regarding claim 16, Vargas discloses the method of claim 1, wherein positioning the nested system in the body comprises positioning the nested system within one of: abdomen, small intestine, brain vasculature, lungs (Paragraph [0052]), urethra, bladder, kidneys, ear, nose, and throat.
Regarding claim 17, Vargas discloses the method of claim 1, wherein maintaining the flexibility of the second rigidizing device further comprises operating the one or more tools to perform a procedure on the body (Paragraphs [0048] and [0052]).
Regarding claim 22, Vargas discloses a method (Figs. 2A-2D and 17A-17B, Paragraphs [0048], [0050], [0052], [0054], and [0088]), the method comprising:
positioning a nested system in a body lumen (Paragraphs [0048], [0050], [0052], and [0054], Figs. 2A-2D and 17A-17B) by:
moving a first rigidizing device (1) axially relative to a second rigidizing device (2/180) that is nested over the first rigidizing device while the first rigidizing device is more flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D),
changing a flexibility of the first rigidizing device and a flexibility of the second rigidizing device so that the first rigidizing device is less flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D),
moving the second rigidizing device axially relative to the first rigidizing device while the first rigidizing device is less flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D), and
changing the flexibility of the first rigidizing device and of the second rigidizing device so that the first rigidizing device is more flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D); and
maintaining the flexibility of the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D) and:
removing the first rigidizing device from a lumen of the second rigidizing device while maintaining the flexibility of the first rigidizing device is greater than the flexibility of the second rigidizing device (Paragraph [0048]),
inserting one or more tools through the lumen of the second rigidizing device (Paragraph [0048]), and
performing a procedure within the body lumen using the one or more tools (Paragraphs [0048] and [0052]).
Regarding claim 23, Vargas discloses a method (Figs. 2A-2D and 17A-17B, Paragraphs [0048], [0050], [0052], [0054], and [0088]), the method comprising:
positioning a distal end region of a nested system at a target location within a body lumen (Paragraphs [0048], [0050], [0052], and [0054], Figs. 2A-2D and 17A-17B) by iteratively:
moving a first rigidizing device (1) axially relative to a second rigidizing device (2/180) that is nested over the first rigidizing device while the first rigidizing device is more flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D),
changing a flexibility of the first rigidizing device and a flexibility of the second rigidizing device so that the first rigidizing device is less flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D),
moving the second rigidizing device axially relative to the first rigidizing device while the first rigidizing device is less flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D), and
changing the flexibility of the first rigidizing device and of the second rigidizing device so that the first rigidizing device is more flexible than the second rigidizing device (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D); and
maintaining the flexibility of the second rigidizing device while a distal end region of the second rigidizing device is at the target location (Paragraphs [0048], [0050], and [0054], Figs. 2A-2D), and:
removing the first rigidizing device from a lumen of the second rigidizing device while maintaining the flexibility of the first rigidizing device is greater than the flexibility of the second rigidizing device (Paragraph [0048]),
inserting one or more tools through the lumen of the second rigidizing device (Paragraph [0048]), and
performing a procedure within the body lumen using the one or more tools (Paragraphs [0048] and [0052]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (US 20110282149 A1) in view of Gregorich et al. (US 20070060880 A1).
Regarding claim 5, Vargas discloses the method of claim 4, wherein changing the pressure within the wall of the first rigidizing device comprises applying negative pressure (Paragraph [0088]).
Vargas is silent regarding wherein changing the pressure within the wall of the first rigidizing device comprises applying positive pressure.
In analogous art, Gregorich teaches wherein changing a pressure within the wall of a first rigidizing device comprises applying positive pressure (96, Fig. 11, Paragraphs [0069]-[0071]).
The substitution of one known material (positive pressure as taught in Gregorich) for another (negative pressure as taught in Vargas) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since the substitution of the positive pressure as taught in Gregorich would have yielded predictable results, namely, a rigidizing device of Vargas that would rigidize when pressure is applied. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (US 20110282149 A1) in view of Gregorich et al. (US 20070060880 A1) further in view of Alston, Jr. et al. (US 4425919 A).
Regarding claim 7, Vargas discloses the method of claim 1, but is silent regarding wherein changing the flexibility of the first rigidizing device and the flexibility of the second rigidizing device so that the first rigidizing device is less flexible than the second rigidizing device comprises changing a pressure within a wall of the first rigidizing device to drive a bladder layer within the wall of the first rigidizing device against a plurality of strands within the wall of the first rigidizing device to reduce movement of the plurality of strands within the wall, and changing a pressure within a wall of the second rigidizing device so that a bladder layer within the wall of the second rigidizing device is not driven against a plurality of strands within the wall of the second rigidizing device.
In analogous art, Gregorich teaches changing a pressure within a wall of a device (96) to drive a bladder layer (102) within a wall of the device against a layer within the wall of the first rigidizing device to reduce movement of the layer within the wall (Paragraphs [0069][-[0071]), and changing a pressure within a wall of the device so that the bladder layer within the wall of the device is not driven against the layer within the wall of the device (Paragraphs [0069]-[0071], when 102 is not inflated, 102 would not be pressed up against a layer within 98).
The substitution of one known material (rigidizing system as taught in Gregorich) for another (rigidizing system as taught in Vargas) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since the substitution of the rigidizing system as taught in Gregorich would have yielded predictable results, namely, a rigidizing device of Vargas that would rigidize when pressure is applied. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Vargas in view of Gregorich are silent regarding
wherein changing the flexibility of the first rigidizing device and the flexibility of the second rigidizing device so that the first rigidizing device is less flexible than the second rigidizing device comprises changing a pressure within a wall of the first rigidizing device to drive a bladder layer within the wall of the first rigidizing device against a plurality of strands within the wall of the first rigidizing device to reduce movement of the plurality of strands within the wall, and changing a pressure within a wall of the second rigidizing device so that a bladder layer within the wall of the second rigidizing device is not driven against a plurality of strands within the wall of the second rigidizing device.
In analogous art, Alston, Jr. teaches a plurality of strands (14, Fig. 1) within a wall of a device (Fig. 1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first rigidizing device and second rigidizing device of Vargas in view of Gregorich to incorporate the teachings of Alston, Jr. to incorporate a plurality of strands within their walls in order to reinforce the device (Col 3, line 12) and promote torque transmission (Cols 4-5, lines 65-3).
The modification of Vargas in view of Gregorich further in view of Alston, Jr. would teach wherein changing the flexibility of the first rigidizing device and the flexibility of the second rigidizing device so that the first rigidizing device is less flexible than the second rigidizing device (as taught by Vargas) comprises changing a pressure within a wall of the first rigidizing device to drive a bladder layer within the wall of the first rigidizing device (as taught by Gregorich) against a plurality of strands within the wall of the first rigidizing device (Gregorich taught layers, which was modified by Alston, Jr. to incorporate being braids) to reduce movement of the plurality of strands within the wall (the inflated bladder layer of Gregorich would push up against the braid of Alston, Jr, which would prevent movement of the braid due to the force of the inflated bladder layer), and changing a pressure within a wall of the second rigidizing device so that a bladder layer within the wall of the second rigidizing device (as taught by Gregorich) is not driven against a plurality of strands (Gregorich taught layers, which was modified by Alston, Jr. to incorporate being braids) within the wall of the second rigidizing device (not inflating the bladder layer of Gregorich would not push the bladder layer against the braid of Alston, Jr.).
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (US 20110282149 A1) in view of Wilk (US 5183471 A).
Regarding claim 8, Vargas discloses the method of claim 1, but is silent regarding wherein inserting one or more tools through the lumen of the second rigidizing device comprising inserting one or more of: a camera, lights, water, and suction, or a combination thereof.
In analogous art, Wilk teaches inserting one or more tools (68) through a lumen of a device (64) comprising inserting one or more of: a camera (Col 5, lines 3-11), lights, water, and suction, or a combination thereof.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the insertion of one or more tools through the lumen of the second rigidizing device of Vargas to incorporate the teachings of Wilk to incorporate inserting a camera in order to perform a laparoscopy (Col 5, lines 3-11).
Regarding claim 11, Vargas discloses the method of claim 1, but is silent regarding wherein inserting the one or more tools through the lumen of the second rigidizing device comprises inserting one or more laparoscopic tools.
In analogous art, Wilk teaches inserting one or more tools (68) through a lumen of a device (64) comprises inserting one or more laparoscopic tools (Col 5, lines 3-11).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the insertion of one or more tools through the lumen of the second rigidizing device of Vargas to incorporate the teachings of Wilk to incorporate inserting one or more laparoscopic tools in order to perform a laparoscopy (Col 5, lines 3-11).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (US 20110282149 A1) in view of Snoke et al. (US 5342299 A).
Regarding claim 9, Vargas discloses the method of claim 1, wherein inserting one or more tools through the lumen of the second rigidizing device comprising inserting one or more of biopsy probes (Paragraph [0048]).
Vargas is silent regarding wherein inserting one or more tools through the lumen of the second rigidizing device comprising inserting one or more of: an anchoring device, a traction device, a cutting device.
In analogous art, Snoke teaches a lumen for providing access to a surgical tool such as a cutting instrument (Col 6, lines 32-35).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the biopsy probe of Vargas to incorporate the teachings of Snoke to incorporate a cutting device in order to cut tissue to perform biopsies.
Clam 18 is rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (US 20110282149 A1) in view of Chu et al. (US 5961526 A).
Regarding claim 18, Vargas discloses the method of claim 17, wherein biopsy probes may be introduced in order to perform biopsies (Paragraph [0048]).
Vargas is silent regarding the procedure comprises an endoscopic submucosal dissection (ESD) and/or Endoscopic Mucosal Resection (EMR).
In analogous art, Chu teaches performing endoscopic mucosal resection (EMR) to diagnose and treat diseases of the gastrointestinal tract by Saline-Assisted Polypectomy (SAP), or "strip biopsy (Col 2, lines 1-16).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the procedure of Vargas to incorporate the teachings of Chu to incorporate being Endoscopic Mucosal Resection (EMR) in order to diagnose and treat diseases of the gastrointestinal tract (Col 2, lines 1-16).
Clam 19 is rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (US 20110282149 A1) in view of Stigall et al. (US 20140171736 A1).
Regarding claim 19, Vargas discloses the method of claim 17, but is silent regarding wherein the procedure comprises treatment of vascular occlusions.
In analogous art, Stigall teaches using intravascular ultrasound (IVUS) imaging to visualize the anatomy of vascular occlusions (Paragraph [0007]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the procedure of Vargas to incorporate the teachings of Stigall to incorporate treatment of vascular occlusions in order to visualize the anatomy of vascular occlusions via IVUS imaging (Paragraph [0007]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (US 20110282149 A1) in view of Ben-Haim (US 6203493 B1).
Regarding claim 20, Vargas discloses the method of claim 1, wherein a diameter of the lumen of the second rigidizing device is selected depending on a specific application (Paragraph [0050]), the application being in the gastrointestinal tract (Paragraphs [0052] and [0054]).
Vargas is silent regarding wherein a diameter of the lumen of the second rigidizing device is between 0.3″-0.8″.
In analogous art, Ben-Haim teaches the use of endoscopes for diagnostic and therapeutic indications, such as colonoscopes for the colon, wherein the endoscopes can have a diameter ranging between 15-25 mm (Col 1, lines 33-42).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the diameter of the lumen of the second rigidizing device of Vargas to incorporate the teachings of Ben-Haim to incorporate being between 0.3″-0.8″ in order to be used for diagnostic and therapeutic indications, such as colonoscope applications (Paragraphs [0052] and [0054]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (US 20110282149 A1) in view of Kovalcheck (US 5549542 A).
Regarding claim 21, Vargas discloses the method of claim 1, wherein a diameter of the lumen of the second rigidizing device is selected depending on a specific application (Paragraph [0050]), the application being in the heart (Paragraphs [0052] and [0054]).
Vargas is silent regarding wherein a diameter of the lumen of the second rigidizing device is between 0.04”-03”.
In analogous art, Kovalcheck teaches endoscopes being inserted into the heart (Col 1, lines 63-65) and a diameter of a lumen of a device is between 0.04”-0.3” (Col 12, lines 28-31).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the diameter of the lumen of the second rigidizing device of Vargas to incorporate the teachings of Kovalcheck to incorporate being between 0.04”-0.3” in order to be used in applications, such as cardiovascular surgery, where there is a demand for smaller and smaller diameter endoscopes (Col 2, lines 3-7).
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783