Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 02/23/2026 have been fully considered but they are not persuasive. Applicant argues that the amended claims overcome the rejection of prior art Provenza in view of Teague and Provenza in view of Teague and Hambly. Examiner respectfully disagrees.
Applicant argues that Provenza does not disclose a one-piece unitary member because it is formed of an inner tube and a vacuum shaft. However, the inner tube and vacuum shaft are coupled together such that they are a one-piece unitary member. For example, if one were to pick up the inner tube, the vacuum shaft would also be lifted. Note that the term unitary is not so limiting as to require the device to be monolithic. As such, the apertures do extend from the passageway defined by the inner surface of the cylindrical sidewall and through the sidewall as claimed. Regarding the limitation of bending to conform to the stomach, it is noted this limitation is functional language and does not impart any structural differences between the prior art and the instant invention. If the prior art structure is capable of performing the intended use, then it meets the claim. It is examiner’s position that the Provenza device is capable of conforming to the stomach since Provenza does in fact show the device bending and further since the modification results in a more flexible device.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6 and 9-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Provenza et al. (2009/0275960) in view of Teague (9,999,753).
Provenza et al discloses the invention substantially as claimed. Provenza et al. disclose, in figures 18-22B and 25-33 and para. [0091], [0133]-[0149], and [0166]- [0179]; a device for use in a system including a suction controller for sizing the stomach of a patient for a bariatric procedure, the stomach of the patient having a lesser curvature and a greater curvature, said device comprising: an elongated sizing tube (combination of 1090 and 1160) formed of a flexible material (e.g., PTFE, according to para. [0091]), said elongated sizing tube being a one-piece unitary member in the form of a cylindrical sidewall (all parts of the device are connected and therefore is considered a one piece unitary member) said sidewall having a longitudinal axis extending along the length thereof, a distal end portion, a proximal portion, a single longitudinally extending passageway (vacuum passageway 1161 is in communication with passageway of 1090 and considered a single passageway -see Fig. 18), an exterior periphery, a free end tip, and a plurality of apertures (1168, according to para. [0140]), said single longitudinally extending passageway being defined by an interior surface of said cylindrical sidewall and extending the length of said cylindrical sidewall (see Fig. 18), said plurality of apertures extending through said cylindrical sidewall along said longitudinal axis and in fluid communication with said single longitudinally extending passageway (see Fig 18. where apertures 1168 are in communication with passageway 1161 which is coupled to passageway of 1090 and defining a single longitudinal passageway), said plurality of apertures extending in at least three different radial directions outward from said longitudinal axis (as shown in cross-section in fig. 22B) and around said exterior periphery, said elongated sizing tube being configured for introduction into the patient's stomach and bent for conformance with the patient’s stomach (see for example Fig. 25 through 27 shows the device bends and is therefore capable of conforming to the patient’s stomach. Note that this is functional language that is dependent on shape and size of stomach the device is fully capable of performing the function) so that a first portion of the periphery extends along and conforms to the lesser curvature of the stomach (as noted above this is functional language and does not define a structural limitation), with a second portion of the periphery extending towards the greater curvature of the patient's stomach (as shown in fig. 29 and 30), and with said free end tip being located within the patient's stomach, said proximal portion of said sizing tube (at 1090) being configured to be coupled to the suction controller for applying controlled suction to the interior of the patient's stomach via said plurality of apertures to pull a portion of the lesser curvature of the patient's stomach into direct engagement with said first portion of said periphery and to pull other portions of the patient's stomach adjacent to said second section into direct engagement with said second portion of said periphery to produce a suction-created visually perceptible delineation line on the exterior of the patient's stomach along said second section thereby enabling a portion of the patient's stomach adjacent the suction-created visually perceptible delineation line to be sealed by a device located outside the patient's stomach; wherein said elongated sizing tube comprises a single passageway; wherein said free end tip (surrounding aperture 1172, shown in fig. 18) is closed (by a seal at 1172, according to para. [0149]) and rounded; wherein said distal end portion is resistant to longitudinal collapse; wherein said distal end portion has an inherent flexural rigidity (for insertion into the patient's stomach) ; wherein said elongated sizing tube is configured for introduction by itself without any other component into the patient's stomach in any orientation about said longitudinal axis to extend along the lesser curvature of the patient's stomach with plural ones of said plurality of apertures facing towards the lesser curvature of the patient's stomach irrespective of the particular orientation of said sizing tube about said longitudinal axis; wherein said exterior periphery has an outside diameter symmetrical about said longitudinal axis (as shown in cross-section in fig. 22B); wherein said passageway is a single passageway extending from said proximal portion towards said free end tip and has a maximum cross- sectional area, and wherein each of said plurality of apertures is of smaller cross sectional area than said maximum cross-sectional area (as shown in fig. 18); wherein said plurality of apertures extend along said longitudinal axis from a first point located immediately adjacent said free end tip to a second point located proximally of said first
point (as shown in fig. 18); wherein each of said plurality of apertures is flared in the direction from said passageway outward (via curved surfaces 1167, shown in fig. 22B and described in para. [0144]); and wherein said plurality of apertures includes plural groups of plural apertures, each of said plural groups of plural apertures having more than two apertures in each group, with each of said more than two apertures in each group being located on a respective radial axis, each of said radial axes of each of said groups extending outward radially from said longitudinal axis and intersecting each other at a respective longitudinally located position along said longitudinal axis (as shown in fig. 18 an 21).
However, Provenza et al. do not explicitly disclose that the elongated sizing tube is formed of a flexible material comprising either a second generation styrenic block copolymer with a hydrogenated midblock of styrene-ethylene/butylene-styrene (SEBS) or styrene-ethylene/propylene-styrene (SEPS). Nevertheless, Provenza et al. disclose, in para. [0091], that the elongated sizing tube may comprise a "flexible chemically inert material that is commonly known by persons of ordinary skill." Teague teaches, col. 6, line 23 to col. 7, line 25; components of an elongated tube (e.g. 122) comprising flexible, polymeric materials which include SEBS, according to col. 6, lines 47-54. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Teague, to modify the elongated sizing tube of Provenza et al., so that it is formed of SEBS. Such a modification would make for a flexible and biocompatible tube suitable for implantation or insertion into a patient's body.
Provenza et al. also do not explicitly disclose that the distal end portion has a flexural rigidity in the range of 1.4 to 0.6 pounds inch squared, while at least another portion of said elongated sizing tube adjacent said distal end portion has a flexural rigidity in the range of 3 to 1 pounds inch squared. Nevertheless, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the distal end portion, SO that it has a flexural rigidity as desired, since it has been held that where the general conditions for a claim are disclosed in the prior art, discovering the optimal or workable ranges (of flexural rigidity) involves only routine skill in the art. In re Aller.
Additionally, Provenza et a. do not explicitly disclose that said first and second points are separated by a distance of within the range of 2 - 10 inches. Nevertheless, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the plurality of apertures, so that they extend between first and second points within a distance ranging as desired, since it has been held that where the general conditions for a claim are disclosed in the prior art, discovering the optimal or workable ranges (of distance between first and second points) involves only routine skill in the art. In re Aller.
Claims 15-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Provenza et al. (2009/0275960) in view of Teague (9,999,753), and further in view of Hambly et al. (2009/0125040). Provenza et al. disclose the invention substantially as claimed. Provenza et al. disclose, in figures 18-22B and 25-33 and para. [0091], [0133]- [0149], and [0166]-[0179]; a system for sizing the stomach of a patient for a bariatric procedure, the stomach of the patient having a lesser curvature and a greater curvature, said system comprising: an elongated sizing tube (combination of 1090 and 1160) formed of a flexible material, said elongated sizing tube being a one-piece unitary member in the form of a cylindrical sidewall (all parts of the device are connected and therefore is considered a one piece unitary member) having a longitudinal axis extending along the length thereof, a distal end portion, a proximal portion, a single longitudinal extending passageway (vacuum passageway 1161 is in communication with passageway of 1090 and considered a single passageway -see Fig. 18), an exterior periphery, a free end tip, and a plurality of apertures (1168, according to para. [0140]), said single longitudinally extending passageway being defined by an interior surface of said cylindrical sidewall and extending the length of said cylindrical sidewall (see Fig. 18), said plurality of apertures extending through said cylindrical sidewall along said longitudinal axis and in fluid communication with said single longitudinally extending passageway (see Fig 18. where apertures 1168 are in communication with passageway 1161 which is coupled to passageway of 1090 and defining a single longitudinal passageway), said plurality of apertures extending along said longitudinal axis and extending in at least three different radial directions outward from said longitudinal axis and around said exterior periphery, said elongated sizing tube being configured for introduction into the patient's stomach and bent for conformance with the patient’s stomach (see for example Fig. 25 through 27 shows the device bends and is therefore capable of conforming to the patient’s stomach. Note that this is functional language that is dependent on shape and size of stomach the device is fully capable of performing the function) so that a first portion of the periphery extends along and conforms to the lesser curvature of the stomach (as noted above this is functional language and does not define a structural limitation), so that a first portion of the periphery extends along the lesser curvature of the stomach, with a second portion of the periphery extending towards the greater curvature of the patient's stomach (as shown in fig. 29 and 30), and with said free end tip being located within the patient's stomach; and a source of suction and to said proximal portion of said sizing tube for applying controlled suction to the interior of the patient's stomach via said plurality of apertures to pull a portion of the lesser curvature of the patient's stomach into direct engagement with said first portion of said periphery and to pull other portions of the patient's stomach adjacent to said second section into direct engagement with said second portion of said periphery to produce a suction-created visually perceptible delineation line on the exterior of the patient's stomach along said second section thereby enabling a portion of the patient's stomach adjacent the suction- created visually perceptible delineation line to be sealed by a device located outside the patient's stomach.
However, Provenza et al. do not explicitly disclose that the elongated sizing tube is formed of a flexible material comprising either a second generation styrenic block copolymer with a hydrogenated midblock of styrene-ethylene/butylene-styrene (SEBS) or styrene-ethylene/propylene-styrene (SEPS). Nevertheless, Provenza et al. disclose, in para. [0091], that the elongated sizing tube may comprise a "flexible chemically inert material that is commonly known by persons of ordinary skill." Teague teaches, col. 6, line 23 to col. 7, line 25; components of an elongated tube (e.g. 122) comprising flexible, polymeric materials which include SEBS, according to col. 6, lines 47-54. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Teague, to modify the elongated sizing tube of Provenza et al., so that it is formed of SEBS. Such a modification would make for a flexible and biocompatible tube suitable for implantation or insertion into a patient's body.
However, Provenza et a. in view of Teague do not explicitly disclose that said system additionally comprises a suction controller configured for connection to the source of suction, wherein a control valve connected to said elongated sizing tube member, said control valve being configured to be selectively opened to enable controlled suction from said suction controller to be provided to said passageway. Hambly et al. teach, in figure 1 and para. [0027], a system comprising a suction controller (16) including a control valve connected to an elongated tube member, said control valve being configured to be selectively opened to enable controlled suction from said suction controller to be provided to a passageway. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Hambly et al., so that the system includes a suction controller and control valve. Such modifications would allow the vacuum applied to the plurality of apertures to be controlled with pressures sufficient for a given surgical procedure.
However, Provenza et al. in view of Teague and Hambly et al. do not explicitly disclose that the suction controller is arranged to limit the level of suction applied to said passageway to result in a force in the range of 0.1 to 200 pounds holding said elongated sizing tube in position within the patient's stomach. Nevertheless, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the suction controller, so that it is arranged to limit the level of suction applied to the passageway to result in a force in the range as desired, since it has been held that where the general conditions for a claim are disclosed in the prior art, discovering the optimal or workable ranges (of suction force) involves only routine skill in the art. In re Aller.
Claims 18 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Provenza et al. (2009/0275960) in view of Teague (9,999,753) and Hambly et al. (2009/0125040), and further in view of Yam et al. (6,024,120). Provenza et al. in view of Teague and Hambly et al. disclose the invention substantially as claimed, but do not explicitly disclose that the suction controller comprises at least one chamber, a movable separator and a resilient member, said movable separator separating said at least one chamber from ambient atmospheric air, and wherein a differential pressure force is imparted on said movable separator due to the difference between the pressure within said at least one chamber and the pressure of the ambient atmospheric air, said resilient member being configured to impart a counter force on said movable separator that opposes said differential pressure force; wherein said at least one chamber further comprises an egress for fluids within said at least one chamber and a blocking member, said blocking member blocking said egress when said differential pressure reaches a predetermined level. Yam et al. teach, in figures 1, 9, and 11 and col. 7, line 56 to col. 8, line 33; a suction controller comprising at least one chamber (e.g., 106), a movable separator (26), and a resilient member (30), said movable separator separating said at least one chamber from ambient atmospheric air, and wherein a differential pressure force is imparted on said movable separator due to the difference between the pressure within said at least one chamber and the pressure of the ambient atmospheric air, said resilient member being configured to impart a counter force on said movable separator that opposes said differential pressure force; wherein said at least one chamber further comprises an egress (60, shown in fig. 11) for fluids within said at least one chamber and a blocking member (55), said blocking member blocking said egress when said differential pressure reaches a predetermined level. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Yam et al., to modify the suction controller of Provenza et al. in view of Teague and Hambly et al., so that it comprises, as claimed, at least one chamber, a movable separator, and a resilient member. Such modifications would allow a vacuum applied to the plurality of apertures to be controlled with a pressure sufficient for a given surgical procedure.
Allowable Subject Matter
Claims 7 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. See reasons for allowance in NonFinal Office Action 12/19/2025.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH HOUSTON whose telephone number is (571)272-7134. The examiner can normally be reached generally M-F 8:00-4:30.
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ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771
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