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 Status
The amendment filed February 17th, 2026 has been entered. Claims 38, 41-45, 47-49, 51, 55-81 remain pending in the application. Claims 1-37, 39-40, 46, 50, and 52-54 have been cancelled. Claims 76-81 are herein withdrawn from consideration in response to applicant’s election submitted on October 8th, 2025 in accordance with restriction requirement mailed on August 18th, 2025. Claims 38, 41-45, 47-49, 51, and 55-75 are thus currently under consideration.
Response to Arguments
Applicant's arguments filed February 17th, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments pertain to the amended claim limitations of claim 1. While the amended claim language has seen to overcome the previously presented rejection, examiner has presented a new grounds of rejection in response to the amended scope presented in the amendment and does not rely on any reference in a manner specifically challenged by applicant’s arguments and as such the arguments are considered moot.
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) 38, 41-45, 47, 51, 55-58, 60-66, 68, 70-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (U.S. Publication 2017/0312112) in view of Thompson (U.S. Publication 2012/0065571) and Levy et al. (U.S. Publication 2005/0273060).
Regarding claim 38, Gobel discloses a device (Fig. 5) for treatment of obesity and diabetes of a patient (¶0012 developing an implant for treatment of diabetes and obesity), comprising a duodenal tube (4,7 ¶0111 tube element 7) adapted to be placed in the duodenum (Fig 1b shows placement of 7 in duodenum Z), wherein a first anchor (6 and 9) is arranged at a predefined distance from a proximal end (distance of anchor predefined by attachment to element 4) of the duodenal tube (arranged at a distance from the proximal end 4a such that it is located on the duodenal side of the pylorus) adapted for anchoring the tube distally to the pylorus (¶0115 balloon 6 duodenal shoulder 6z presses against the duodenal shoulder surface of the pylorus thus located distally to pylorus on duodenal side as tube is distal to the anchor on duodenum side)
wherein the first anchor 6 comprises a self-expandable (¶0127 elastically erecting) structure 9, further wherein
the self-expandable structure extends circumferentially around (¶0121 annular elements 9, Fig. 5 shows 9 extending around circumference of 4) a portion of the duodenal tube adjacent to the proximal end (Fig. 1c shows 9 adjacent to proximal end located at gastric end 4a) of the duodenal tube 4,7 in order to hold open the duodenal tube and a passage (¶0121 reinforce the conducting element such that they withstand an externally loading fill pressure of 20 to 100 mbar, without collapse of the lumen), for the evacuation of stomach contents (¶0111 receives the chyme from the stomach and conducts it through the pylorus into the duodenum), and further being surrounded circumferentially by a flexible bladder (balloon 6) having an annular shape (¶0002 annular duodenal anchor element) which completely surrounds the duodenal tube (Fig. 5 shows complete surrounding of in a circumferential fashion of tube 4) the duodenal tube creating a regular closure pattern of the passage into the duodenum (¶0025 motility of the pylorus should remain unimpaired, ¶0032 maintaining the closing capability of the pylorus),
further wherein the duodenal tube is provided with a second anchor 8 coupled to its proximal end (proximal end 4a), adapted to be positioned proximally of the pylorus (Fig. 1b shows anchoring in stomach of second anchor equivalent to 8) for anchoring the device in the stomach without substantial mucosal involvement (¶0123 in the filled state of the balloon bodies, the shoulder surfaces then load the pylorus in situ nearly without contact pressure, indicated no substantial mucosal involvement), the second anchor being formed by one balloon 8.
Gobel does not expressly disclose the first anchor being retrievable and repositionable by allowing reduction of a size of the first anchor, or the second anchor balloon being independently inflatable.
Regarding the first anchor being retrievable and repositionable by allowing reduction of a size of the first anchor, while Gobel does not expressly disclose these limitation, the limitation of “retrievable and repositionable by allowing reduction of a size of the first anchor” is considered functional language (describes action of reducing the size of the first anchor, i.e. narrowing, and typically into the initial configuration, allowing removal of the structure and of the entire device from the patient’s body and repositionable, through reduction of the size allowing to displace the device at the application site, followed by another expansion for anchoring at another site, see page 4 lines 24-33 of applicant’s specification). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gobel discloses all the structure as claimed, and is further capable of having the filling inflation adjusted and therefore capable of reducing its size through release of filling fluid (¶0115 force acting in total from the duodenal side and from the gastric side on the pylorus can be adjusted by the user by way of the respective filling pressure in the balloon element and adapted as needed in the individual in the course of application; ¶0134 filling can be readjusted via its terminal closure), and is disclosed as being held reversibly on an applicator shaft indicating it can be attached and detached (¶0077) and is removed from the patient (¶0091 bypass device is removed). As such, it is capable of performing the functions as claimed (i.e. it is capable of reducing in size such that it can be repositioned and retrieved by the applicator).
Gobel does not expressly disclose any structure on how the device would be retrieved or repositioned as Gobel does not disclose how the device is attached to the applicator, however, Thompson, in the same field of endeavor of expandable pyloric anchors (Title), teaches a first anchor (¶0064 anchor) that is retrievable (¶0064 integral retrieval loop that can be grabbed to recover or remove the device) through the use of an integral retrieval loop 125 that allows the device to be grabbed by a separate device to recover and remove the device (¶0064 grabbed to recover or remove the device).
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 device of Gobel to have included an integral loop as taught by Thompson for the purpose of allowing the applicator device to grab and thus attach itself to the first anchor and to allow for selected movement of the device once attached.
Regarding the second anchor balloon being independently inflatable, Levy, in the same field of endeavor of obesity treatment devices (Title), teaches a device (Fig. 12) comprising a first and second anchors (30’ and 40’) comprising inflatable balloons (¶0128 30’ 40’ chambers inflatable) in which each of the anchors is independently inflatable (¶0128 separately inflatable) for the purpose of being able to apply a greater pressure to proximal chamber to increase antral pressure and create an enhanced sensation of satiety while not transmitting increased pressure to distal chamber and therefore not transmitting the increased pressure to the duodenal wall (¶0129).
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 anchors disclosed by Gobel to have been independently fillable as taught by Levy for the purpose of being able to apply a greater pressure to proximal chamber to increase antral pressure and create an enhanced sensation of satiety while not transmitting increased pressure to distal chamber and therefore not transmitting the increased pressure to the duodenal wall (¶0129 of Levy).
Regarding claims 41 and 42, Gobel in view of Thompson and Levy suggest the device according to claim 39. Gobel does not expressly disclose the self-expandable structure being made of metal (41) or a shape memory metal (42).
However, Levy in the same field of endeavor of obesity treatment devices (Title), further teaches the expandable structure is made of a metal (¶0167 expansion of expandable chambers assisted by structural members made of shape memory metals).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the self-expandable structure of Gobel out of the shape memory metals of Levy, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 43, Gobel in view of Thompson and Levy suggest the device according to claim 38. Gobel does not expressly disclose the self-expandable structure being braided.
However, Thompson, in the same field of endeavor of expandable pyloric anchors (Title), teaches an expandable structure being self-expandable (¶0057 collapsed for delivery then after delivery to the desired implantation site and release from a delivery instrument or tool the expandable anchors expand to a post-implant configuration) and braided (¶0060 braided configuration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the self-expandable structure of Gobel that performs the function of self-expanding for the self-expandable braided structure of Thompson since these elements perform the same function of self-expanding to support a lumen open configuration and anchoring. Simply substituting one self-expanding anchoring and support means for another would yield the predictable result of allowing a(n) tube to be anchored and supported through self-expanding means. See MPEP 2143.
Regarding claim 44, Gobel in view of Thompson and Levy suggest the device according to claim 39. Gobel further discloses the self-expandable structure is covered by at least one layer of material (balloon material cover the self-expandable structure).
Regarding claim 45, Gobel in view of Thompson and Levy suggest the device according to claim 44. Gobel further discloses the self-expandable structure is covered by a polymeric layer that is at least partially made of polyurethane (¶0035 the wall of the balloon elements…preferably consist of polyurethane).
Regarding claim 47, Gobel in view of Thompson and Levy suggest the device according to claim 39. Gobel further discloses the first self-expandable structure being at least one of retrievable and repositionable (see above rejection of claim 1).
Regarding claim 51, Gobel in view of Thompson and Levy suggest the device according to claim 50. Levy further discloses the second anchor is adapted to be positioned within the patient's stomach (Fig. 1 shows positioning in stomach) such as to reduce the gastric functional volume (expands in stomach and therefore would reduce volume of stomach) and shaped such as to avoid a tight contact with the inner wall of the stomach (¶0123 filled state of the balloon bodies load the pylorus in situ nearly without contact pressure).
Regarding claim 55, Gobel in view of Thompson and Levy suggest the device according to claim 54. Gobel further discloses the balloon has a crown shape (¶0063 toroidal and surrounds element 4 and thus is shaped like a crown in that it circular and surrounds the tube).
Regarding claim 56, Gobel in view of Thompson and Levy suggest the device according to claim 51. Levy further discloses the balloon has a toroidal shape (¶0063 toroidal).
Regarding claim 57, Gobel in view of Thompson and Levy suggest the device according to claim 51. Gobel further discloses the balloon having, in an area neighboring the connection to the duodenal tube, a conical outer shape (Fig. 2a shows 8 tapering toward pyloric junction during expansion) in a cross section through a plane running through an axis of the device (cross section shown in Fig. 2a).
Regarding claim 58, Gobel in view of Thompson and Levy suggest the device according to claim 51. Gobel further discloses the balloon has a tulip shape in the area neighboring the connection to the duodenal tube (balloon tapers to proximal end creating a tapered tulip shape on proximal end as seen in Fig. 2a).
Regarding claim 60, Gobel in view of Thompson and Levy suggest the device according to claim 50. Gobel further discloses the second anchor 8 comprises a second expandable structure (Fig. 5 element 9 present in both anchors 6 and 8).
Regarding claim 61, Gobel in view of Thompson and Levy suggest the device according to claim 50. Gobel further discloses the second anchor has an at least partly hour-glass shape (Fig. 2a shows the second anchor tapering toward the pylorus resulting in second anchor forming half of an hourglass shape resulting from tapering toward pylorus).
Regarding claim 62, Gobel in view of Thompson and Levy suggest the device according to claim 60. Gobel does not expressly disclose the self-expandable structure being made of metal.
However, Levy in the same field of endeavor of obesity treatment devices (Title), further teaches the expandable structure is made of a metal (¶0167 expansion of expandable chambers assisted by structural members made of shape memory metals).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the self-expandable structure of Gobel out of the shape memory metals of Levy, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 63, Gobel in view of Thompson and Levy suggest the device according to claim 60. Gobel does not expressly disclose the second self-expandable structure being braided.
However, Thompson, in the same field of endeavor of expandable pyloric anchors (Title), teaches an expandable structure being self-expandable (¶0057 collapsed for delivery then after delivery to the desired implantation site and release from a delivery instrument or tool the expandable anchors expand to a post-implant configuration) and braided (¶0060 braided configuration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the self-expandable structure of Gobel that performs the function of self-expanding for the self-expandable braided structure of Thompson since these elements perform the same function of self-expanding to support a lumen open configuration and anchoring. Simply substituting one self-expanding anchoring and support means for another would yield the predictable result of allowing a(n) tube to be anchored and supported through self-expanding means. See MPEP 2143.
Regarding claim 64, Gobel in view of Thompson and Levy suggest the device according to claim 60. Levy further discloses the second expandable structure is covered by at least one layer of material (expandable structure 9 covered by material of balloon as seen in Fig. 5).
Regarding claims 65 and 66, Gobel in view of Thompson and Levy suggest the device according to claim 38. Gobel does not expressly disclose providing a radiopaque element to the device.
However, Levy, in the same field of endeavor of gastrointestinal devices, further teaches a gastrointestinal device being provided with at least one additional element that is a radiopaque element (¶0164 radiopaque markers incorporated into device), for the purpose of visualizing the location of the device when the device is deployed within the body of a patient (¶0164), but does not expressly disclose the placement of the radiopaque element being on the duodenal tube as Levy does not directly disclose the elements position on the device.
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 device of Gobel to have included a radiopaque element as taught by Levy, for the purpose of visualizing the location of the device when the device is deployed within the body of a patient (¶0164 of Levy).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the radiopaque element to be on the duodenal tube since this claimed position of the radiopaque element being on the duodenal tube does not change the radiopaque element’s ability to allow for visualization of the position of the device within a patient. Since applicant has not given any criticality to why the position of the radiopaque element disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 68, Gobel in view of Thompson and Levy suggest the device according to claim 38. Gobel further discloses the duodenal tube is adapted to be shortened for adaptation to at least one characteristic of the patient (¶0132 length of tube is dimensioned such that the aboral end extends up into the terminal duodenum or also into the beginning jejunum showing that the length dimension is selected and thus capable of being longer or shorter).
Regarding claim 70, Gobel in view of Thompson and Levy suggest the device according to claim 38. Gobel further discloses the first anchor has an axial length of between 1.5-5 cm (¶0133 cylindrical length).
While this range does not encompass the totality of 1 cm to 10 cm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of Gobel, from between 1.5-5 cm to 1 cm to 10 cm as applicant appears to have placed no criticality on the claimed range (Page 13 of applicant’s specification 1 to 10 cm) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Gobel would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the first anchor has an axial length of 1 to 10 cm.
Regarding claim 71, Gobel in view of Thompson and Levy suggest the device according to claim 50. Levy further discloses the second anchor has an axial length of 3 cm to 10 cm (¶0133 cylindrical length 30 to 100 mm).
While this range does not encompass the totality of 2 cm to 10 cm, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of Gobel, from between 3-10 cm to 2 cm to 10 cm as applicant appears to have placed no criticality on the claimed range (Page 13 of applicant’s specification 2 to 10 cm) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Gobel would not operate differently with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the second anchor has an axial length of 2 to 10 cm.
Regarding claim 72, Gobel in view of Thompson and Levy suggest the device according to claim 38. Gobel does not expressly disclose or suggest the duodenal tube being made of a material that reduces a contact of nutrients migrating with the tube with the duodenal wall.
However, Levy, in the same field of endeavor of obesity treatment devices (Title), teaches a duodenal tube being made of a material that reduces a contact of nutrients migrating with the tube with the duodenal wall (¶0170 sleeve may be permeable for nutrients to pass through the wall of the sleeve at a reduced rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the duodenal tube of Gobel that performs the function of allowing transport of material from the stomach through the duodenum for the material of the duodenal tube of Levy since these elements perform the same function of transporting fluid from the stomach through the tube to the placement of the distal end of the tube in the duodenum. Simply substituting one fluid tube material for another would yield the predictable result of allowing a(n) fluid tube to transport fluid. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the duodenal tube of Gobel out of the material taught by Levy, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 73 and 74, Gobel in view of Thompson and Levy suggest the device according to claim 38. Gobel further discloses the duodenal tube having a diameter of 20 mm and a length of 60 cm being common in the art ¶0021. Gobel does not expressly disclose the duodenal tube having a length in the range of 300 mm to 800 mm or the duodenal tube having a diameter in the range of 25 to 35 mm.
it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length and diameter of Gobel, from approximately 60 cm and 20 mm respectively to a range of 300 mm to 800 mm and 25 to 35 mm respectively, as applicant appears to have placed no criticality on the claimed range (Page 13 of applicant’s specification the tube may have a length in the range of 300 to 800 mm…it may have a diameter in the range of 20 to 35 mm) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Gobel would not operate differently with the claimed range and the dimensions disclosed lie inside of the ranges. Further, applicant places no criticality on the ranged claimed, indicating simply that the tube may have a length in the range of 300 to 800 mm…it may have a diameter in the range of 20 to 35 mm.
Regarding claim 75, Gobel in view of Thompson and Levy suggest the device according to claim 38. Gobel further disclose amongst the first anchor and the second anchor, only one of said anchors comprises a combination of a self-expandable structure coupled to the balloon (each self-expandable structure is coupled to their corresponding balloon and as such only one self-expandable structure is coupled to the balloon and the self-expandable structure of the first anchor is not coupled to the balloon).
Claim(s) 48 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (U.S. Publication 2017/0312112) in view of Thompson (U.S. Publication 2012/0065571), Levy et al. (U.S. Publication 2005/0273060), and Reisin (U.S. Publication 2020/0268537).
Regarding claims 48 and 49, Gobel in view of Thompson and Levy suggest the device according to claim 38 but fails to discloses the first anchor comprising patches attachable to the mucosa and linked to the duodenal tube via connectors or the patch comprising a biocompatible adhesive.
However, Reisin, in the same field of endeavor of pylorically positioned obesity treatment devices, teaches providing a thermos-reversible adhesive in regions of stippling on the surface of a pyloric implant ¶0126, the regions of stippling acting as connectors for linking patches of biocompatible adhesive polymerized N-isopropyl acrylamide which attaches to the mucosa of the stomach pylorus and/or duodenum for the purpose of facilitating removability and initially attaching the pyloric implant (¶0126 surface feature of the pyloric implant may facilitate removability. For example, a thermos-reversible adhesive, which solidified at body temperature, may be useful to initially attach a pyloric implant and subsequently reverse the attachment temporarily to readjust the implant position).
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 first anchor of Gobel to have included regions of stippling or patches on the surface of the biocompatible adhesive of polymerized N-isopropyl acrylamide, as taught by Reisin for the purpose of facilitating removability and initially attaching and adjusting the pyloric implant (¶0126 of Reisin, surface feature of the pyloric implant may facilitate removability. For example, a thermos-reversible adhesive, which solidified at body temperature, may be useful to initially attach a pyloric implant and subsequently reverse the attachment temporarily to readjust the implant position).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (U.S. Publication 2017/0312112) in view of Thompson (U.S. Publication 2012/0065571), Levy et al. (U.S. Publication 2005/0273060), and Dominguez et al. (U.S. Publication 2013/0296765).
Regarding claim 59, Gobel in view of Thompson and Levy suggest the device according to claim 38. Levy does not expressly disclose the volume of inflation of the balloon being to a volume of 200 mL to 800 mL.
However, Dominguez, in the same field of endeavor of gastrointestinal implants, teaches inflating a of an anchor positioned on the stomach side of a pyloric orifice being inflated to 200 mL or more for the purpose of preventing the gastric balloon from migrating into a pylorus region of the patient (¶0014 to prevent the gastric balloon from migrating into a pylorus region of the patient).
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 balloon of Gobel to have been inflated to 200 mL, as taught by Dominguez, for the purpose of preventing the gastric balloon from migrating into a pylorus region of the patient (¶0014 of Dominguez, to prevent the gastric balloon from migrating into a pylorus region of the patient).
Claim(s) 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (U.S. Publication 2017/0312112) in view of Thompson (U.S. Publication 2012/0065571), Levy et al. (U.S. Publication 2005/0273060), and Brister (U.S. Publication 2010/0137897).
Regarding claim 67, Gobel in view of Thompson and Levy suggest the device according to claim 65. Gobel does not expressly disclose or suggest the at least one element being formed as a ring mounted on at least one of a distal end of the duodenal tube and an area distant from the distal end of the duodenal tube.
However, Brister, in the same area of endeavor of intragastric devices, teaches placing two concentric ring shaped radiopaque elements (markers 510) positioned apart for the purpose of visually indicated the inflation state and position of the gastric device when placed in the patient (¶0181 distance between markers indicates inflation state, vertical positioning indicates axis that is bounded by markers is approximately perpendicular with respect to reference line).
It would have been obvious to one of ordinary skill in the art to have modified the device of Gobel to have included circular ring shaped radiopaque elements positioned apart from one another, and thus at the very least an area distant from the distal end of the duodenal tube, as taught by Brister for the purpose of visually indicated the inflation state and position of the gastric device when placed in the patient (¶0181 of Brister distance between markers indicates inflation state, vertical positioning indicates axis that is bounded by markers is approximately perpendicular with respect to reference line).
Claim(s) 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (U.S. Publication 2017/0312112) in view of Thompson (U.S. Publication 2012/0065571), Levy et al. (U.S. Publication 2005/0273060), and Burnett et al. (U.S. Publication 2005/0055039).
Regarding claim 69, Gobel in view of Thompson and Levy suggest the device according to claim 38. Gobel does not expressly disclose at least one of the duodenal tube, the first anchor and the second anchor being activatable by contact with contents of at least one of the intestine and the stomach.
However, in the same field of endeavor of devices for treating obesity ¶0010 (minimally invasive or non-invasive devices and methods for obesity) to be placed in the gastrointestinal tract of a patient ¶0011, Burnett teaches configuring a duodenal (Fig. 8 shows spanning of tube across pylorus from the stomach into the duodenum) tube 18 with a valve 12 that is configured to open upon sensing a predetermined pressure from the contents of the stomach (¶0072) and thus activates by contact with contents of the stomach for the purpose of actively metering the contents of gastric lumen flowing into the intestine through the device (¶0072 metering the contents of the gastric lumen into the intestine through the device).
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 duodenal tube of Gobel to have included a valve configured to open upon sensing a predetermined pressure from the contents of the stomach (¶0072) and thus activates by contact with contents of the stomach for the purpose of actively metering the contents of gastric lumen flowing into the intestine through the device (¶0072 of Burnett, metering the contents of the gastric lumen into the intestine through the device).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781