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 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.
Claims 1, 7-10, and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maahs et al. (US PGPub 2013/0217957 A1).
With respect to claim 1, Maahs et al. discloses a method for suturing a first portion of a wall of a vessel in a cavity in the body of a human or animal subject to a second portion of the wall of the vessel either interiorly in the interior of the vessel, or exteriorly of the vessel in the cavity (abstract: “A surgical method for treating obesity by reducing the size and/or function of the stomach includes forming at least two plications or tissue folds in tissue of a patient using anchor assemblies having a loop”), the method comprising:
forming at least one first mound on a site of the first portion of the vessel wall (first mound 301 in Fig. 18),
forming at least one second mound on a site of the second portion of the vessel wall (second mound 302),
each one of the first and second mounds being formed by forming a pocket in a submucosal layer of the vessel wall (the mounds 301 and 302 in Fig. 18 are formed by pinching the vessel wall such that it forms a pocket, the broadest reasonable interpretation of “a pocket in a submucosal layer of the vessel wall” includes a pocket in the entire vessel wall as a whole which in turn folds the submucosal layer into a pocket) or between the submucosal layer and a muscular layer of the vessel wall (the “or” limitation above renders this an unrequired limitation) adjacent the site at which the corresponding one of the first and second mounds is to be formed (see Fig. 18, the mounds 301 and 302 are formed by pinching the vessel wall into a pocket near the mound locations),
inserting at least one suture into or through a corresponding pair of the at least one first mound (see loop 310, see also Figs. 13-14 showing suture 60 and suture anchors 50A-B), and the at least one second mound (see Fig. 18, second mound 302 also has its own suture and anchors), and
tightening the suture to draw the corresponding pair of the first and second mounds together (see Figs. 19-20, the sutures are tightened via a cinch structure 319 to bring mounds 301 and 302 together).
Regarding claim 7, Maahs et al. further discloses in which a plurality of the first mounds are formed spaced apart on the respective sites on the first portion of the vessel wall, and a plurality of the second mounds are formed spaced apart on the respective sites on the second portion of the vessel wall (see Fig. 17, PP [0049]: “The number of plications used, the positions of the plications, the number of loop sutures used, and the sequence or pattern of plication connections made by a loop suture, may of course vary by patient, condition, and the surgeons preference. In the example shown in FIG. 17, loop suture 312A is routed through the loops 310 at plications 301, 302, 303 and 304, in that order”).
Regarding claim 8, Maahs et al. further discloses in which each one of the first and second mounds (301 and 302 in Fig. 18) comprises a substantially circular mound when viewed in plan (the distal end of each mound 301 and 302 is rounded, a plan view would be substantially circular as it flares out at the base where the mound meets the relatively flattened vessel wall).
Regarding claim 9, Maahs et al. further discloses in which each one of the first and second mounds (301 and 302 in Fig. 18) comprises an elongated mound extending along the corresponding one of the first and second portions of the vessel wall (the mounds 301 and 302 are elongated).
Regarding claim 10, Maahs et al. further discloses in which a plurality of sutures (see loop 310 and 312 in Fig. 19, see also suture 100 in Figs. 13-14 with anchors 50A-B and suture 60) are inserted into or through each one of the first and second mounds (301 and 302 in Figs. 18-19) when each one of the first or second mounds comprises an elongated mound (see 301 in Figs. 8-9 and 14).
Regarding claim 12, Maahs et al. further discloses in which each suture (see unmarked suture in Figs. 18-20, see also suture assembly 100 in Figs. 13-14) comprises a suture thread (60 in Figs. 13-14) terminating at respective opposite ends thereof in respective anchor elements (50A, see Fig. 18, each suture includes two anchor elements), the suture thread (60) defining a loop formed by two legs (310, each half of loop 310 is a leg of suture 60) of the suture thread (60) extending from the respective anchor elements (50A), the loop extending through a cinch clip (312 and 316 in Figs. 19-20), the cinch clip (312 and 316) being urgeable along the loop (310) towards the anchor elements (unmarked 50A, see also Fig. 14) for reducing the effective length of the suture thread (60) extending between the anchor elements to tighten the suture (PP [0053]: “The plications are now drawn towards each other, with a knot or cinch 316 pushed into place to hold the plications next to each other, forming a contracted tissue area generally indicated at 318”).
Regarding claim 13, Maahs et al. further discloses in which the cinch clip (312 and 316 in Figs. 19-20) of each structure is configured to be a tight sliding fit on the loop (310) sufficient to resist movement of the cinch clip (312 and 316) along the loop in a direction away from the anchor elements (cinch 316 and 312 is tightly secured on the loops 310 in Fig. 20 and resists movement).
Regarding claim 14, Maahs et al. further discloses in which each suture (see unmarked suture in Figs. 18-20, see also suture assembly 100 in Figs. 13-14) is inserted into the first and second mounds (301 and 302 in Figs. 18-20) of the corresponding pair thereof by inserting the anchor elements into the pockets of the respective first and second mounds (301 and 302) of the pair thereof (PP [0044]: “The needle 76 may pass through an opening in the upper jaw to pierce through the grasped tissue. A first tissue anchor [50A] is then deployed on the distal side of the engaged tissue. The needle is withdrawn out from the tissue and a second tissue anchor [50B] is deployed on the proximate side of the engaged tissue”, the first anchor is inserted into and through the pocket) with the legs of the suture thread (310 of 60 in Fig. 14) extending from the anchor elements (50A in Fig. 14) through the corresponding mounds (see PP [0044] as cited above, the legs 310 extend through the corresponding mounds upon insertion).
Regarding claim 15, Maahs et al. further discloses in which each suture (see unmarked suture in Figs. 18-20, see also suture assembly 100 in Figs. 13-14) is inserted into the first and second mounds (310 and 302) of the corresponding pair thereof by urging the anchor elements (unmarked inner anchors in Figs. 18-20, see 50A in Fig. 14) of the suture through the respective ones of the first and second mounds (310 and 302) from an entry side of the corresponding ones of the first and second mounds ((310 and 302)) to an exit side thereof (PP [0044]: “The needle 76 may pass through an opening in the upper jaw to pierce through the grasped tissue. A first tissue anchor [50A] is then deployed on the distal side of the engaged tissue. The needle is withdrawn out from the tissue and a second tissue anchor [50B] is deployed on the proximate side of the engaged tissue”, the first anchor is inserted into and through the pocket) with the anchor elements (50A) located on the exit side of the corresponding ones of the first and second mounds (301 and 302) and the legs of the suture thread extending from the anchor elements (50A) through the corresponding ones of the first and second mounds (301 and 302) from the exit side thereof to and through the entry side thereof (see PP [0044] cited above, the legs 310 extend through both the entry and exit side upon insertion).
Regarding claim 16, Maahs et al. further discloses in which each suture (see unmarked suture in Figs. 18-20, see also suture assembly 100 in Figs. 13-14) is tightened by urging the cinch clip (312 and 316 in Figs. 19-20) thereof along the loop (310) formed by the suture thread (60) thereof towards the anchor elements (unmarked inner anchors, see also 50A in Fig. 14) for drawing the first and second mounds (301 and 302) of the corresponding pair thereof together (PP [0053]: “The plications are now drawn towards each other, with a knot or cinch 316 pushed into place to hold the plications next to each other, forming a contracted tissue area generally indicated at 318”).
Regarding claim 17, Maahs et al. further discloses in which the suturing of the first and second portions of the vessel is carried out endoscopically internally within the vessel (PP [0034]: “The endoscopic system 12 includes an endoscopic device having a distal portion that is articulated and steered to position its distal end at a desired location within the stomach S”).
Regarding claim 18, Maahs et al. further discloses in which the method is carried out endoscopically by inserting an endoscope into the vessel orally, rectally or vaginally (PP [0036]: “As shown in FIG. 2, an endolumenal tool 25 includes a tissue manipulation assembly 27 and an anchor deployment assembly 70. The tissue manipulation assembly 27 includes a tubular body 29 which is flexible so that it can be readily advanced into a body lumen, e.g., transorally, percutaneously, laparoscopically, etc.”).
Regarding claim 19, Maahs et al. further discloses in which the suturing of the first and second portions of the vessel together is carried out in the cavity externally of the vessel (see Fig. 17, the method is done within the stomach but externally of the vessel walls).
Regarding claim 20, Maahs et al. further discloses a method for carrying out a sleeve gastroplasty procedure in the stomach of a human or animal subject (PP [0004]: “The method may be performed in the stomach for treatment of obesity, with the plications reducing the volume of the stomach and/or changing the fundamental function of the stomach as a reservoir and emulsifier of food”) in which first and second portions of the wall of the stomach are sutured together (see Fig. 17) to form a gastric sleeve by the method as claimed in Claim 1 (see rejection of claim 1 above).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Maahs et al. (US PGPub 2013/0217957 A1), as applied to claim 1 above, in view of Kelleher (US PGPub 2011/0098730 A1).
Regarding claim 2, Maahs et al. fails to disclose in which each pocket is formed by injecting an injectable fluid into the submucosal layer of the vessel wall or between the submucosal layer and the muscular layer of the vessel wall where the pocket is to be formed.
In the related field of soft tissue anchor implantation (abstract), Kelleher teaches a method of implanting a soft tissue anchor (29 in Figs. 5a-b) comprising injecting (see needle 40) a fluid (42) between two layers (22 and 24) to atraumatically separate said layers (PP [0069]: “a gas or liquid 42 has been injected in order to create a bolus which atraumatically separates the layers”) in order to embed the anchor (29).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Maahs et al. disclosure to incorporate the teachings of Kelleher and include injecting fluid into the layers of the vessel wall to form the pocket and implant the sutures. One of ordinary skill in the art would have been motivated to perform this modification because doing so is a simple substitution of pocket formation methods that would have yielded predictable results, as the Kelleher method similarly is concerned with the embedding of an anchor into the soft tissue layers of the stomach (PP [0004]: “when performing a gastric restriction procedure, such as gastroplasty, simply sewing the anterior and posterior walls of the stomach together often does not hold up over time. Part of the reason for this is that the lining of the stomach does not tend to grow across the sewn seam, as is often the case for other types of tissues and organs when sewn together. Also, with a gastric restriction in particular, the sewn [seam] is subject to significant stresses post-operatively, when patients try to eat more food than can fit into the reduced stomach compartment created by the sewn seam”, PP [00096]: “the target layers may be the submucosa or one of several muscle layers”).
Regarding claim 3, Maahs et al. as modified by Kelleher further discloses in which the injectable fluid comprises an injectable liquid (Kelleher PP [0069]: “a gas or liquid 42 has been injected in order to create a bolus which atraumatically separates the layers”).
Regarding claim 6, Maahs et al. as modified by Kelleher fails to explicitly disclose in which the quantity of the injectable fluid injected into the submucosal layer or between the submucosal layer and the muscular layer of the corresponding one of the first and second portions of the vessel wall to form the pocket of the corresponding one of the first or second mounds lies in the range of 1ml to 10ml.
However, Maahs et al. contemplates a variety of different sizes of the mounds (PP [0037]: “The location of the jaw pivot may be positioned at various locations along the lower jaw 18 depending upon a number of factors, e.g., the desired size of the "bite" or opening for accepting tissue between the jaw members”) in order to control the size and shape of the stomach after the procedure (PP [0003]: “The tool is then used by the surgeon to make substantially permanent tissue folds or plications in the stomach tissue, which reduces the size and changes the function of the stomach”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed such that 1ml to 10ml of fluid is injected into the submucosal layer or between the submucosal layer and the muscular layer of the first and second portions of the vessel wall. One of ordinary skill in the art would have been motivated to perform this modification since Maahs et al. recognizes that mound size (which, in the combination as proposed is dependent upon the volume of injection fluid) is a result effective variable, and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Additionally, the present disclosure does not provide any statements of criticality regarding the volume of injectable fluid, reciting only that “In one embodiment of the invention the quantity of the injectable fluid injected into the submucosal layer or between the submucosal layer and the muscular layer of the corresponding one of the first and second portions of the vessel wall to form the pocket of the corresponding one of the first and second mounds lies in the range of 1ml to 10ml, and preferably, lies in the range of 1ml to 5ml, and more preferably, lies in the range of 1ml to 2ml… [or] as much as 10ml and greater” (page 4 line 30 to page 5 line 2).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Maahs et al. (US PGPub 2013/0217957 A1) and Kelleher (US PGPub 2011/0098730 A1), as applied to claim 2 above, and further in view of Mitelberg et al. (US PGPub 2009/0019604 A1).
Regarding claim 4, Maahs et al. as modified by Kelleher fails to disclose in which the injectable fluid comprises a viscous solution.
In the related field of endoscopic mucosal resection (PP [0002]), which is pertinent to the application at hand due to being concerned with the delivery of fluid within the submucosal layer of the stomach (see submucosal layer 48 in Figs. 8A-E), Mitelberg et al. teaches a method including injecting a viscous solution into the submucosal layer of the stomach (PP [0008]: “An injection catheter is used to deliver a viscous fluid within the submucosal layer, which does not readily dissipate, throughout the target resection area”, PP [0078]: “FIG. 8E illustrates the delivery of fluid through needle shaft 74 exiting needle tip 76 into the submucosal layer 48 thereby elevating mucosal layer 46 to form a submucosal bleb”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to incorporate the teachings of Mitelberg et al. and include wherein the injectable fluid is a viscous solution. One of ordinary skill in the art would have been motivated to perform this modification because it is a simple substitution of injection fluids, as Mitelberg et al. teaches that viscous fluids are appropriate for injection into the submucosal layer (PP [0078]), and because performing the substitution as proposed would yield the simple result of preventing the fast dissipation of the injection fluid during the procedure (PP [0008]: “An injection catheter is used to deliver a viscous fluid within the submucosal layer, which does not readily dissipate, throughout the target resection area”). Mitelberg et al. teaches that a slower dissipation is advantageous in that it prevents “portions of the underlying muscular layer… [from being] included… and inadvertently damaged” during resection (PP [0007]), which would be similarly advantageous for the Maahs et al. and Kelleher combination in preventing the applied sutures from interfering with or damaging layers of the stomach wall by mistake.
Regarding claim 5, Maahs et al. as modified by Kelleher and Mitelberg et al. further discloses in which the viscosity of the injectable liquid is sufficient to minimize dispersal of the injectable fluid from the corresponding pocket for a predetermined time period at least sufficient to allow the suture to be inserted into the mound (Mitelberg et al. PP [0008]: “An injection catheter is used to deliver a viscous fluid within the submucosal layer, which does not readily dissipate, throughout the target resection area”, the dissipation is delayed giving sufficient time for the suture to be inserted in the combination as proposed).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Maahs et al. (US PGPub 2013/0217957 A1), as applied to claim 1.
Regarding claim 11, Maahs et al. fails to explicitly disclose in which the height of each one of the first and second mounds from a surface of the vessel wall adjacent the site at which the mound is formed lies in the range of 5mm to 10mm.
However, Maahs et al. contemplates a variety of different sizes of the mounds (PP [0037]: “The location of the jaw pivot may be positioned at various locations along the lower jaw 18 depending upon a number of factors, e.g., the desired size of the "bite" or opening for accepting tissue between the jaw members”) in order to control the size and shape of the stomach after the procedure (PP [0003]: “The tool is then used by the surgeon to make substantially permanent tissue folds or plications in the stomach tissue, which reduces the size and changes the function of the stomach”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed such that the mounds are 5mm to 10mm in height. One of ordinary skill in the art would have been motivated to perform this modification since Maahs et al. recognizes that mound size, which includes height, is a result effective variable, and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Additionally, the present disclosure does not provide any statements of criticality regarding the height of the mounds, reciting only that “In another embodiment of the invention the height of each one of the first and second mounds from a surface of the vessel wall adjacent the site at which the mound is formed lies in the range of 5mm to 10mm, and preferably, the height of each one of the first and second mounds lies in the range of 6mm to 8mm, and preferably, the height of each one of the first and second mounds from the surface adjacent the site at which the mound is formed is approximately 7mm” (page 6, lines 25-30).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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