DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed March 13, 2026 has been entered.
Claims 17-36 are currently pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WasDyke (US 2006/0095068, hereinafter “WasDyke”) in view of Neeman et al. (US 2008/0234721, hereinafter “Neeman”), Chanduszko et al. (US 8,029,529, hereinafter “Chanduszko”), and Carr et al. (US 2007/0112373, hereinafter “Carr”).
Regarding claims 17-19 and 24-25, WasDyke discloses the invention substantially as claimed including a system fully capable of being used for treating a sinus or nasal condition, comprising: an expandable device (10, Fig 1) fully capable of being inserted into a sinus cavity or nasal passage, the expandable device having an expanded configuration and a low-profile configuration (para [0018]),
[AltContent: textbox (Domed hub oriented in 1st upward direction)]the expandable device including a hub (12) defining a domed outer surface, and a plurality of legs (14), each leg of the plurality of legs extending from a connected end connected to the hub to a free end, wherein each leg of the plurality of legs defines a length extending between the connected and free ends thereof and a plurality of bends along the length, the plurality of bends of each leg of the plurality of legs maintained in each of the expanded and low-profile configuration, and wherein the domed outer surface of the hub is oriented in a first direction and wherein the plurality of legs extend from the hub in a second direction (para [0018]; Fig 1).
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WasDyke teaches the filter may be designed to be removed (para [0004-0005]). Furthermore, WasDyke teaches the legs (14) and hub (12) can be made of the same or different material (para [0019]). However, WasDyke fails to disclose the expandable device is biodegradable, as claimed. Neeman discloses a similar expandable device comprising a hub (812) and a plurality of legs (810) and teaches the device may be made of biodegradable material (para [0075]), wherein the hub is formed from a first biodegradable material and the legs are made of a second biodegradable material such that the legs are designed to degrade before hub (para [0075]). The biodegradable material may include copolymers (para [0061-0063]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify WasDyke such that the hub and legs were formed of a biodegradable copolymer for the purpose of allowing the device to dissolve or degrade at the end of its useful life without requiring a second procedure to remove the device and such that the hub was formed from a first composition ratio of the biodegradable copolymer and the legs were formed from a second composition ratio of the biodegradable copolymer to allow the legs to degrade before the hub and prevent a leg being released prematurely after the hub degrades and before the legs fully degrade, as taught by Neeman (para [0075]). Furthermore, 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.
Furthermore, WasDyke and Neeman fail to teach a therapeutic coating. Chanduszko discloses a similar expandable device comprising a hub and a plurality of legs (Fig 1A) and teaches one or more of the elongate members may be coated with a therapeutic agent comprising at least one anti-inflammatory agent (col 7, ln 39-44) configured for sustained release (col 7, ln 4-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the combination of WasDyke and Neeman such that an anti-inflammatory therapeutic agent contained in a coating layer covered at least a portion of the device including the hub and plurality of legs or both for the purpose of providing a therapeutic agent directly to the target area of treatment, as taught by Chanduszko. Additionally, it would have been obvious to have the coating layer disposed on only one of the hub or the plurality of legs OR be disposed on each of the hub and the plurality of legs depending on the amount of therapeutic agent desired to be delivered to the target area as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success. The modified device is fully capable of being delivered to the sinus or nasal passages and thus is fully capable of releasing the therapeutic agent to adjacent sinus or nasal tissue.
Furthermore, it would have been obvious to have the coating layer include a poly(lactide-co-caprolactone) copolymer 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.
WasDyke teaches the expandable device is configured for insertion into a sinus cavity (The device is fully capable of being placed in a sinus cavity or nasal passage. It is noted a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.) WasDyke teaches in one embodiment the device has an expanded transverse diameter of about 38 mm (para [0022]) after transitioning from a low-profile transverse diameter during insertion through a delivery member (para [0018]). However, WasDyke fails to teach that low-profile transverse diameter. It would have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the combination such that the expandable device had an expanded transverse diameter of from about 15 mm to about 40 mm and a low-profile transverse dimeter of from about 2mm to about 10mm, such that the ratio of the expanded transverse diameter to the low-profile transverse diameter is between about 2:1 to about 20:1 since it has been held that where the general conditions of a claim are disclosed in the prior art (an expanded transverse diameter within the claimed range and a teaching of expanding from a lower profile diameter for insertion to a larger expanded diameter), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, it would have been obvious to one having ordinary skill in the art at the time of the invention to further modify the such that the expandable device had an expanded transverse diameter of from about 15 mm to about 40 mm and a low-profile transverse dimeter of from about 2mm to about 10mm, such that the ratio of the expanded transverse diameter to the low-profile transverse diameter is between about 2:1 to about 20:1 in order to appropriately size the device for its particular use since Applicant has placed no criticality on the particular diameter or ratio of expanded to low-profile diameter as evidenced by the broadly claimed range and since modifying the combination to have the specified dimensions would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
WasDyke fails to specifically teach the amount of force each leg is configured to apply to surrounding tissue. However, it is old and well known in the art that the amount of force each leg is configured to apply to the surrounding tissue is dependent at least in part to the size of the lumen or cavity the expandable device is inserted within and the tissue properties of the of the lumen or cavity the expandable device is inserted within, including the elasticity, compressibility or stiffness of the tissue walls. Therefore, it would have been obvious each leg of the plurality of legs of WasDyke is fully capable of applying between about 3 Newtons and about 8 Newtons of force to sinus or nasal tissue inhibiting expansion of each leg toward the expanded configuration depending on the particular material properties of the sinus or nasal tissue and the particular size of the sinus or nasal tissue. Alternatively, Carr teaches a similar expandable device and teaches the dimensions of the device may be optimized for the dimensions of the target tissue the expandable device is to be inserted within to provide sufficient lateral force against the vessel or tissue wall to center the expandable device, but not so much force as to cause injury to the wall (para [0040,0042]). Therefore, in the alternative it would have been obvious to further modify WasDyke such that each leg of the plurality of legs was configured to apply between about 3 Newtons and about 8 Newtons of force to sinus or nasal tissue inhibiting expansion of each leg toward the expanded configuration since it has been held that where the general conditions of a claim are disclosed in the prior art (properly sizing an expandable device for intended target tissue to provide sufficient lateral force against the vessel or tissue wall to center the expandable device, but not so much force as to cause injury to the wall, as taught by Carr), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 20, the expandable device is biased towards the expanded configuration and self-expandable from the low-profile configuration to the expanded configuration (para [0018]).
Regarding claims 21 and 22, WasDyke fails to teach the device further comprises a connector connecting at least two of the plurality of legs. As discussed above, Neeman discloses a similar expandable device comprising a hub and a plurality of legs. A first embodiment (Fig 1; para [0028]), similar to WasDyke, includes only a hub (118) and a plurality of legs (114). However, in an alternative embodiment, WasDyke teaches providing a plurality of lattice pieces (850) connecting the plurality of legs (para [0074]) and forming a mesh (Fig 9). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify WasDyke to include a connector connecting at least two of the legs of the plurality of legs and forming a mesh for the purpose of providing additional strength to the device and to better contain or capture material within the device.
Regarding claim 23, wherein at least one leg of the plurality of legs includes an anchoring component (16; para [0019]).
Claim 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WasDyke (US 2006/0095068) and Neeman (US 2008/0234721), Chanduszko (US 8,029,529), and Carr et al. (US 2007/0112373), as applied to claim 17 above, further in view of Ravenscroft (US 2005/0234503, hereinafter “Ravenscroft”).
WasDyke, Neeman, and Chanduszko disclose the invention substantially as claimed, as shown above, including the device assuming a radially compressed configuration within a delivery device (para [0018]). However, WasDyke fails to teach the details of the delivery device. Ravenscroft discloses a similar expandable device (Figs 1, 5) comprising a hub (12) and a plurality of legs (18 or 26), wherein the device has an expanded configuration (Figs 1, 5) and a low-profile configuration (Fig 8). The device is delivered with an introducer comprising a sheath (34) and a shaft (32), wherein the distal portion of the sheath holds the distal ends of legs in the low-profile configuration (Fig 8), and wherein the shaft includes at least one tapered portion (Fig 6) to at least partially match the legs of the device to releasably mount the legs on the shaft when the device is in the low-profile configuration (Fig 8; para [0043-0047]). Thus, the sheath may be withdrawn and the legs will still be held by the shaft in a partially-expanded configuration to allow for repositioning as needed prior to final expansion. Additionally, to load the expandable device, the shaft (32) is inserted through the expandable device until the distal end (40) of the shaft (82) engages the underside of the hub (12) of the expandable device (para [0046]) such that a pushing force on the shaft pushes against the hub and allows the shaft and expandable device to be pushed/advanced out of the sheath. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the combination of WasDyke and Neeman such that the delivery device included a shaft including at least one tapered portion to at least partially match the at least one bend of each leg such that the shaft is configured for positioning between the plurality of legs and a sheath configured to surround and engage the free ends of the legs of the plurality of legs and wherein the shaft is configured to abut an underside of the hub when the expandable device is engaged by the delivery device, as taught by Ravenscroft. Such a modification would provide a controlled mechanism of delivering the expandable device with the additional benefit of a partial expansion stage that allows for repositioning as needed.
Claims 27-36 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WasDyke (US 2006/0095068) and Neeman (US 2008/0234721) and Chanduszko (US 8,029,529), as applied to claim 17 above, further in view of Ravenscroft (US 2005/0234503, hereinafter “Ravenscroft”).
Regarding claims 27-29 and 31-36, WasDyke discloses the invention substantially as claimed including a system fully capable of being used for treating a sinus or nasal condition, comprising: an expandable device (10, Fig 1) fully capable of being inserted into a sinus cavity or nasal passage, the expandable device having an expanded configuration and a low-profile configuration (para [0018]),
the expandable device including a hub (12) defining a domed outer surface, and a plurality of legs (14), each leg of the plurality of legs extending from a connected end connected to the hub to a free end, wherein each leg of the plurality of legs defines a length extending between the connected and free ends thereof and a plurality of bends along the length, the plurality of bends of each leg of the plurality of legs maintained in each of the expanded and low-profile configuration, and wherein the domed outer surface of the hub is oriented in a first direction and wherein the plurality of legs extend from the hub in a second direction (para [0018]; Fig 1).
WasDyke teaches the filter may be designed to be removed (para [0004-0005]). Furthermore, WasDyke teaches the legs (14) and hub (12) can be made of the same or different material (para [0019]). However, WasDyke fails to disclose the expandable device is biodegradable, as claimed. Neeman discloses a similar expandable device comprising a hub (812) and a plurality of legs (810) and teaches the device may be made of biodegradable material (para [0075]), wherein the hub is formed from a first biodegradable material and the legs are made of a second biodegradable material such that the legs are designed to degrade before hub (para [0075]). The biodegradable material may include copolymers (para [0061-0063]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify WasDyke such that the hub and legs were formed of a biodegradable copolymer for the purpose of allowing the device to dissolve or degrade at the end of its useful life without requiring a second procedure to remove the device and such that the hub was formed from a first composition ratio of the biodegradable copolymer and the legs were formed from a second composition ratio of the biodegradable copolymer to allow the legs to degrade before the hub and prevent a leg being released prematurely after the hub degrades and before the legs fully degrade, as taught by Neeman (para [0075]). Furthermore, 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.
Furthermore, WasDyke and Neeman fail to teach a therapeutic coating. Chanduszko discloses a similar expandable device comprising a hub and a plurality of legs (Fig 1A) and teaches one or more of the elongate members may be coated with a therapeutic agent comprising at least one anti-inflammatory agent (col 7, ln 39-44) configured for sustained release (col 7, ln 4-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the combination of WasDyke and Neeman such that an anti-inflammatory therapeutic agent contained in a coating layer covered at least a portion of the device including the hub and plurality of legs or both for the purpose of providing a therapeutic agent directly to the target area of treatment, as taught by Chanduszko. Additionally, it would have been obvious to have the coating layer disposed on only one of the hub or the plurality of legs OR be disposed on each of the hub and the plurality of legs depending on the amount of therapeutic agent desired to be delivered to the target area as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success. The modified device is fully capable of being delivered to the sinus or nasal passages and thus is fully capable of releasing the therapeutic agent to adjacent sinus or nasal tissue.
Furthermore, it would have been obvious to have the coating layer include a poly(lactide-co-caprolactone) copolymer 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.
WasDyke teaches the expandable device is configured for insertion into a sinus cavity (The device is fully capable of being placed in a sinus cavity or nasal passage. It is noted a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.) WasDyke teaches in one embodiment the device has an expanded transverse diameter of about 38 mm (para [0022]) after transitioning from a low-profile transverse diameter during insertion through a delivery member (para [0018]). However, WasDyke fails to teach that low-profile transverse diameter. It would have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the combination such that the expandable device had an expanded transverse diameter of from about 15 mm to about 40 mm and a low-profile transverse dimeter of from about 2mm to about 10mm, such that the ratio of the expanded transverse diameter to the low-profile transverse diameter is between about 2:1 to about 20:1 since it has been held that where the general conditions of a claim are disclosed in the prior art (an expanded transverse diameter within the claimed range and a teaching of expanding from a lower profile diameter for insertion to a larger expanded diameter), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, it would have been obvious to one having ordinary skill in the art at the time of the invention to further modify the such that the expandable device had an expanded transverse diameter of from about 15 mm to about 40 mm and a low-profile transverse dimeter of from about 2mm to about 10mm, such that the ratio of the expanded transverse diameter to the low-profile transverse diameter is between about 2:1 to about 20:1 in order to appropriately size the device for its particular use since Applicant has placed no criticality on the particular diameter or ratio of expanded to low-profile diameter as evidenced by the broadly claimed range and since modifying the combination to have the specified dimensions would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
WasDyke teaches the device assumes a radially compressed configuration within a delivery device (para [0018]). However, WasDyke fails to teach the details of the delivery device. Ravenscroft discloses a similar expandable device (Figs 1, 5) comprising a hub (12) and a plurality of legs (18 or 26), wherein the device has an expanded configuration (Figs 1, 5) and a low-profile configuration (Fig 8). The device is delivered with an introducer comprising a sheath (34) and a shaft (32), wherein the distal portion of the sheath holds the distal ends of legs in the low-profile configuration (Fig 8), and wherein the shaft includes at least one tapered portion (Fig 6) to at least partially match the legs of the device to releasably mount the legs on the shaft when the device is in the low-profile configuration (Fig 8; para [0043-0047]). Thus, the sheath may be withdrawn and the legs will still be held by the shaft in a partially-expanded configuration to allow for repositioning as needed prior to final expansion. Additionally, to load the expandable device, the shaft (32) is inserted through the expandable device until the distal end (40) of the shaft (32) engages the underside of the hub (12) of the expandable device (para [0046]) such that a pushing force on the shaft pushes against the hub and allows the shaft and expandable device to be pushed/advanced out of the sheath. With the sheath (34) of the delivery device engaging the free end of each leg of the plurality of legs (Fig 8 – sheath 34 engaging free end of legs 18 and 26 at least at proximal end adjacent spline 48 of shaft 32) portions of each leg of the plurality of legs extend distally from the sheath (34) of the delivery device such that the hub (12) is distally spaced from the sheath of the delivery device as hub is pushed/advanced out of the sheath (para [0047]). Thus, upon further actuation of the delivery device, the shaft (32) is advanced distally relative to the expandable device to urge the underside of the hub distally, thereby moving the expandable device distally to disengage the sheath (34) from the free ends of the legs of the plurality of legs (para [0047-0048]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the combination such that the delivery device included a shaft including at least one tapered portion to at least partially match the at least one bend of each leg such that the shaft is configured for positioning between the plurality of legs and a sheath configured to surround and engage the free ends of the legs of the plurality of legs and wherein the shaft is configured to abut an underside of the hub when the expandable device is engaged by the delivery device to push/advance the expandable device out from the sheath, as taught by Ravenscroft. Such a modification would provide a controlled mechanism of delivering the expandable device with the additional benefit of a partial expansion stage that allows for repositioning as needed.
WasDyke teaches the device assumes a radially compressed configuration within a delivery device (para [0018]) and thus it is obvious the legs would project at a minimal angle relative to a longitudinal axis of the expandable device in the low-profile or radially compressed configuration within the delivery device. Furthermore, WasDyke teaches legs projects at an acute angle relative to the longitudinal axis of the expandable device in the expanded configuration (Fig 1). However, WasDyke fails to teach the specific angles the legs project relative to the longitudinal axis of the expandable device in each configuration. It would have been obvious to further modify WasDyke such that in the low-profile configuration, each leg of the plurality of legs projects at an angle that is approximately zero relative to a longitudinal axis of the expandable device to be able to be compressed within a delivery device, and, wherein, in the expanded configuration, at least one leg of the plurality of legs projects at an angle of at least about 15 degrees relative to the longitudinal axis, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, it alternately would have been obvious to one having ordinary skill in the art at the time of the invention to modify the combination such that in the expanded configuration, at least one leg of the plurality of legs projects at an angle of at least about 15 degrees relative to the longitudinal axis in order to appropriately size the device for its particular use since Applicant has placed no criticality on the particular dimensions as evidenced by the broadly claimed range and since modifying the combination to have the specified dimensions would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Regarding claim 30, WasDyke discloses the expandable device is biased towards the expanded configuration and self-expandable from the low-profile configuration to the expanded configuration upon release of the expandable device from the delivery device (para [0018]).
Response to Arguments
Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive.
Regarding claim 17, Applicant argues the prior art fails to teach or disclose each leg is configured to apply between about 3 Newtons and about 8 Newtons of force to tissue inhibiting expansion of each leg to the expanded configuration. The Examiner respectfully disagrees and notes the force applied to the tissue is at least in part dependent on the size and material properties of the tissue the device is inserted and expanded within. As explained above, each leg of the plurality of legs of WasDyke is fully capable of applying between about 3 Newtons and about 8 Newtons of force to sinus or nasal tissue inhibiting expansion of each leg toward the expanded configuration depending on the particular material properties of the sinus or nasal tissue and the particular size of the sinus or nasal tissue. In the interest of compact prosecution, an alternative rejection is made further in view of Carr (US 2007/0112373), who discloses a similar expandable device and teaches the dimensions of the device may be optimized for the dimensions of the target tissue the expandable device is to be inserted within to provide sufficient lateral force against the vessel or tissue wall to center the expandable device, but not so much force as to cause injury to the wall (para [0040,0042]).
Regarding claim 17, Applicant argues the prior art fails to teach the legs project at an angle of approximately zero relative to a longitudinal axis of the expandable device in a low-profile configuration and project at an angle of at least about 15 degrees relative to the longitudinal axis of the expandable device in an expanded configuration. Although the prior art fails to explicitly disclose the claimed angles, as discussed above, modifying the prior art to extend at the claimed angles in the low-profile and expanded configurations would have been obvious to one of ordinary skill in the art.
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.
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/KATHERINE M RODJOM/ Primary Examiner, Art Unit 3771
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