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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the description: 96 and 98 as seen in Fig. 2. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign mentioned in the description: 152 as mentioned in PP [0105] of the present specification, which is missing from Fig. 7. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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 1-11 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stangenes et al. (PGPub US 2017/0252195 A1).
With respect to claim 1, Stangenes et al. discloses a device (110 in Fig. 3) for implantation in a pylorus between a stomach and a duodenum (see Fig. 1) for promoting weight loss (abstract), the device (110 in Fig. 3) comprising:
a stomach portion (130) configured to expand from a collapsed configuration to a first maximum diameter (PP [0007]: “the implant having an expanded configuration and a contracted configuration”, see Fig. 3 for expanded configuration) to anchor the device in the stomach (anchor 110, 130 is within the stomach 16);
a pyloric portion (134) extending from the stomach portion (130) and having a second maximum diameter (see PP [0007], the entire implant expands and contracts therefore 134 has a second maximum diameter);
a duodenal portion (132) extending from the pyloric portion (134) and configured to expand from a collapsed configuration to a third maximum diameter (PP [0007]: “the implant having an expanded configuration and a contracted configuration”, see Fig. 3 for expanded configuration); and
a channel (152) extending through the stomach portion (130), the pyloric portion (134), and the duodenal portion (132) for allowing passage of food material through the device (110) from the stomach to the duodenum (PP [0054]: “the neck portion 134 defines a through-lumen 152 that allows chyme to flow from the stomach 16 to the small intestine 18”),
wherein each of the stomach portion (130), the pyloric portion (143), and the duodenal portion comprises:
a support member (190 in Fig. 21);
and an implant material (162 in Fig. 4) attached to the support member (PP [0067]: “In some embodiments, the anchor 110 also incorporates a structural element contained within the overall structure”),
wherein the first maximum diameter (diameter of 130 in Fig. 3, PP [0058]: “An exemplary anchor 110 has been formed with the diameter of the proximal flange 130 about 40.0 mm”) and the third maximum diameter (diameter of 132, PP [0059]: “An exemplary anchor 110 has been formed with the diameter of the distal flange 132 about 35.0 mm in diameter”) are both larger than the second maximum diameter (diameter of 134, PP [0062]: “An exemplary anchor 110 has been formed with the diameter of the neck portion 134 about 15.0 mm”), and
wherein at least one feature of the device (entrance to 152 of 110) is configured to slow the passage of the food material through the channel (152, PP [0054]: “the neck portion 134 defines a through-lumen 152 that allows chyme to flow from the stomach 16 to the small intestine 18”).
Regarding claim 2, Stangenes et al. further discloses wherein the first maximum diameter (diameter of 130 in Fig. 3, PP [0058]: “An exemplary anchor 110 has been formed with the diameter of the proximal flange 130 about 40.0 mm”) is larger than the third maximum diameter (diameter of 132, PP [0059]: “An exemplary anchor 110 has been formed with the diameter of the distal flange 132 about 35.0 mm in diameter”).
Regarding claim 3, Stangenes et al. further discloses wherein an inner diameter of the channel (152 in Fig. 3) increases between a proximal portion of the pyloric portion (134) at the stomach portion (130) and a distal opening of the pyloric portion (134) at the duodenal portion (132) (PP [0057]: “the proximal flange wall 148 and distal flange wall 150 can be angled in relation to the neck portion 134”, diameter of 152 increases from center of 134 to 150).
With respect to claim 4, Stangenes et al. further discloses wherein an inner diameter of the channel (152 in Fig. 3) decreases between a proximal opening of the pyloric portion (134) at the stomach portion (130) and a distal opening of the pyloric portion (134) at the duodenal portion (132) (PP [0057]: “the proximal flange wall 148 and distal flange wall 150 can be angled in relation to the neck portion 134”, diameter of 152 decreases from 148 to center of 134).
With respect to claim 5, Stangenes et al. further discloses wherein the support member of the stomach portion (130 in Fig. 3), the pyloric portion (134), and the duodenal portion (132) comprises a single shape memory support stent (see Figs. 23-24) that extends from a proximal end of the stomach portion (130 in Fig. 3), through the pyloric portion (134) to a distal end of the duodenal portion (132) (PP [0081]: “The embodiments shown in FIGS. 21 to 24 all have the features of a structural element 190 providing additional strength to the overall structure of the anchor 110”, emphasis added).
Regarding claim 6, Stangenes et al. further discloses wherein the support member comprises three attached piece of shape memory stent material (190 in Fig. 21, each piece is attached via the mesh of 110, 162 in Fig. 4), one for each of the stomach portion, the pyloric portion, and the duodenal portion (each piece can be considered to be “for” each portion, since the claim language is not specific about the location of each stent portion).
With respect to claim 7, Stangenes et al. further discloses wherein the support member (190 in Fig. 21) of the stomach portion (130 in Fig. 3) and the support member (190 in Fig. 21) of the duodenal portion (132 in Fig. 3) each comprises a shape memory material (PP [0069]: “The structural element 170 can be made from a metal such as Nitinol, MP35N, L605, Elgiloy, stainless steel or from a plastic such as PET, PEEK, or Delrin or other suitable material”, 170 is comparable to 190) and wherein the support member of the pyloric portion (134) comprises a different material (PP [0066]: “The membrane covering the anchor 110 may be made from a thin-walled polymer material such as silicone, polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene, expanded poly tetrafluoroethylene (ePTFE) or other suitable material”, this membrane can be considered to be part of the support member of the pyloric portion as it extends across the entire implant) attached at each end to the support member of the stomach portion (130) and the support member of the duodenal portion (132) (note that the claim language does not require direct attachment, all components are unitarily connected through each other and therefore can be considered to be attached).
Regarding claim 8, Stangenes et al. further discloses wherein the different material (PP [0066]: “The membrane covering the anchor 110 may be made from a thin-walled polymer material such as silicone, polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene, expanded poly tetrafluoroethylene (ePTFE) or other suitable material”) comprises a compliant material (silicone is considered to be a compliant material, note that the claim limitation and specification do not provide a metric for determining compliance).
With respect to claim 9, Stangenes et al. further discloses wherein the shape memory material is selected from the group consisting of nitinol and other shape memory materials (PP [0069]: “The structural element 170 can be made from a metal such as Nitinol, MP35N, L605, Elgiloy, stainless steel or from a plastic such as PET, PEEK, or Delrin or other suitable material”, 170 is comparable to 190).
With respect to claim 10, Stangenes et al. further discloses wherein the implant material comprises two layers of material (PP [0066]: “The anchor 110 can be covered on the outside and/or inside side with a polymer membrane covering. The membrane covering the anchor 110 may be made from a thin-walled polymer material such as silicone, polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene, expanded poly tetrafluoroethylene (ePTFE) or other suitable material”, outside and inside layers) and wherein the support member (190 in Fig. 21) is disposed between the two layers (PP [0067]: “the anchor 110 also incorporates a structural element contained within the overall structure”, structural element is within anchor 110 and the membrane covering covers the anchor, therefore the structural member is disposed within the layers of the membrane).
Regarding claim 11, Stangenes et al. further discloses a coating applied to at least one of an inner surface or an outer surface of the device (PP [0066]: “The anchor 110 can be covered on the outside and/or inside side with a polymer membrane covering. The membrane covering the anchor 110 may be made from a thin-walled polymer material such as silicone, polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene, expanded poly tetrafluoroethylene (ePTFE) or other suitable material… The membrane may be made by extrusion, dip coating from a liquid solution, powder coated from fine particles of polymer or paste extruded and then stretched as is the case with ePTFE").
Regarding claim 13, Stangenes et al. further discloses wherein the implant material comprises a coating on both sides of the support member (PP [0066]: “The anchor 110 can be covered on the outside and/or inside side with a polymer membrane covering. The membrane covering the anchor 110 may be made from a thin-walled polymer material such as silicone, polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene, expanded poly tetrafluoroethylene (ePTFE) or other suitable material”, PP [0067]: “the anchor 110 also incorporates a structural element contained within the overall structure”, structural element is within anchor 110 and the membrane covering covers the anchor, therefore the structural member is disposed within the layers of the membrane).
With respect to claim 14, Stangenes et al. further discloses wherein the support member (PP [0067]: “In some embodiments, the anchor 110 also incorporates a structural element contained within the overall structure”) is selected from the group consisting of rings (Figs. 6-8), star-shaped members (Figs. 23-24), a continuous wire extending from the stomach portion to the duodenal portion (see Figs. 14 and 21-24), and braided wire.
Regarding claim 15, Stangenes et al. further discloses wherein the at least one feature of the device configured to slow the passage of food material through the channel (152 in Fig. 3) comprises an inner diameter of at least part of the pyloric portion of the device (152 comprises the inner diameter of 134).
Regarding claim 16, Stangenes et al. further discloses a restrictor (entry lumen of 152 in Fig. 3) attached to the support member (190 in Fig. 21) at or near the pyloric portion (134 in Fig. 3) wherein the at least one feature of the device configured to slow the passage of the food material through the channel comprises the restrictor (the diameter of lumen 152 is smaller than the entrance into 130 therefore it is able to limit the passage of food and can be considered a restrictor).
With respect to claim 17, Stangenes et al. further discloses wherein the restrictor (entry lumen of 152 in Fig. 3) is located at a junction between the stomach portion (130) and the pyloric portion (134).
Regarding claim 18, Stangenes et al. further discloses a restrictor (entry lumen of 152 in Fig. 3) built into the support member at or near the pyloric portion (134, see Fig. 21, the lumen is built into the support member 190) wherein the at least one feature of the device configured to slow the passage of the food material through the channel comprises the restrictor (the diameter of lumen 152 is smaller than the entrance into 130 therefore it is able to limit the passage of food).
With respect to claim 19, Stangenes et al. further discloses a duodenal sleeve (120 in Fig. 2) attached to a distal end of the duodenal portion (attached to unmarked end of 110, 132 shown in Fig. 3) for reducing or eliminating absorption of nutrients by the duodenum (capable of performing this function).
Regarding claim 20, Stangenes et al. further discloses a restrictor (entry lumen of 152 in Fig. 3) coupled with or formed in the duodenal sleeve (120 in Fig. 2, the lumen 152 is coupled with the sleeve 120 via the implant 110) to slow passage of food through the duodenal sleeve (120) (the restricted diameter of 152 is able to slow the passage of food).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Stangenes et al. (PGPub US 2017/0252195 A1) as applied to claim 1 above, and further in view of Liebler et al. (PGPub US 2016/0325010 A1).
Regarding claim 12, Stangenes et al. fails to disclose wherein the coating comprises a bioadhesive coating on the outer surface of the device.
In the related field of tissue adhesion methods (abstract), Liebler et al. teaches using pNIPAM (a known bioadhesive) to form hydrogels to create tissue engineering scaffolds (PP [0031]: “Typically variety of synthetic and naturally derived materials may be used to form hydrogels for tissue engineering scaffolds. Synthetic materials include… (PNIPAM)…”) for adhesion to gastric tissue (PP [0010]: “In some embodiments, the method of the present invention is applied to at least one tissue surface selected from the group consisting of… gastric mucosal tissue, gastric gland tissue…”).
It would have been prima facie obvious for one of ordinary skill in the art to have modified the Stangenes et al. disclosure to incorporate the teachings of Liebler and include wherein the coating comprises a bioadhesive coating on the outer surface of the device. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique to improve a known device and yield predictable results, promoting adhesion between the pyloric implant and the surrounding tissue (Liebler et al. abstract: “a method for adhering a material to a biological tissue in a subject in need thereof”). The Stangenes et al. device would not operate differently with the coating as taught by Liebler, but the coating would further enhance the device’s anchoring within the pylorus.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached on (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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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