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 .
Response to Amendment
Regarding the claim objections of claims 1, 5-6, 12-13, and 16 filed 09/29/2024, the amendments to claims have been acknowledged and the claim objections are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 1-2, filed 09/20/2024, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 over of Gonzalez et al. (US 20050137714) in view of Khairkhahan et al. (US 20090287040) have been fully considered and are persuasive. Examiner agrees that of Gonzalez in view of Khairkhahan fails to disclose “wherein the plurality of discrete features include multiple features between each set of adjacent struts of the plurality of struts” as required by amended claims 1 and 16. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Gonzalez in view of Khairkhahan et al. (US 20100262168) and Murphy et al. (US 20120109179).
Regarding the arguments about the swellable bodies 70 of Khairkhahan, applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument due to the amendment of claims 1 and 16 which overcame the rejection of Gonzalez in view of Khairkhahan.
Applicant's arguments filed 09/20/2024 have been fully considered but they are not persuasive.
Applicant argues that the combination of Gonzalez in view of Venkatraman fails to support a primafacie case of obviousness with regard to the currently amended claim 12 because Venkatraman teaches that the thicker portion is only around the "waist" which would not teach or suggest "wherein the thicker region extends proximally over at least a portion of the plurality of struts," as presently required by claim 12.
Examiner respectfully disagrees. Venkatraman teaches a flexible membrane 169 positioned over a plurality of struts (see Fig. 3 of Venkatraman which illustrates the device without the flexible membrane, displaying the struts, and Fig. 4 which illustrates the device with the flexible membrane over the struts) and a thicker region (interpreted as the narrower region of the membrane extending towards a waist portion of the device) along a distal end of the flexible membrane, wherein the thicker region extends proximally over at least a portion of the plurality of struts (see annotated Fig. 4 below, col. 12 lines 44-58 and col. 13 lines 22-37). The examiner notes that the narrow, thicker region, of Venkatraman is similar in shape to the narrow, distal section of Gonzalez. The combination of Gonzalez and Venkatraman would result in a product comprising a distal section of the flexible membrane 160 of Gonzalez (see annotated Fig. 5 of Gonzalez below) having the thicker region of Venkatraman extending proximally over at least a portion of the plurality of struts 144 of Gonzalez (see annotated Fig. 5 of Gonzalez below). Therefore, the rejection is maintained.
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Annotated Fig. 4 of Venkatraman
Claim Objections
Claims 1, 13, and 18 are objected to because of the following informalities:
Claim 1: line 5 recites “membrane in contact” which should recite “membrane is in contact”.
Claim 13: line 4 recites “the a” which should recite “the”.
Claim 18: line 1 recites “the a” which should recite “the”.
Appropriate correction is required.
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.
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(s) 1-3, 6-11, 16, and, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable Gonzalez et al. (US 20050137714) [hereinafter Gonzalez] in view of Khairkhahan et al. (US 20100262168) [hereinafter Khairkhahan] and Murphy et al. (US 20120109179) [hereinafter Murphy].
Regarding claim 1, Gonzalez discloses a device 140 (Figs. 4-8, para. 0041) comprising:
a frame 142 including a plurality of struts 144 distributed radially around a central axis of the device (Fig. 5, para. 0041); and
a flexible membrane 160 having respective opposed inner and outer surfaces (inner surface is interpreted as the surface that contacts the outer surface 162 of struts 144, Fig. 5, para. 0041; outer surface is interpreted as the surface that contacts the bronchial walls, Fig. 6, para. 0044-0047), the flexible membrane 160 in contact with and being supported by the plurality of struts 144 of the frame 142 (Fig. 5, para. 0041, 0051), the flexible membrane 160 is configured to transition between a compressed configuration and an airway occluding configuration in the ventilatory airways (para. 0041, 0044, 0049-0051).
However, Gonzalez fails to disclose that the respective opposed inner and outer surfaces comprise a plurality of discrete features formed into the inner surface of the flexible membrane or the outer surface of the flexible membrane between adjacent struts of the plurality of struts and that change mechanical properties of the flexible membrane, the plurality of discrete features configured to inhibit folding of a proximal end of the flexible membrane when in the airway occluding configuration, wherein the plurality of discrete features include multiple features between each set of adjacent struts of the plurality of struts.
Khairkhahan teaches an implantable device 3001 configured to be positioned within a body cavity (Figs. 30A-B, para. 0016, 0132) comprising a flexible membrane having an inner surface (interpreted as inner surface of peripheral region 3009) and a respective opposed outer surface (interpreted as an outer surface of peripheral region 3009) comprise a plurality of features 3003 formed into an inner surface of the flexible membrane between adjacent struts of a plurality of struts 3011 (Fig. 30A, para. 0132) and that change mechanical properties of the flexible membrane (para. 0140 teaches that the plurality of inflatable elements/balloons provide an outward, expansive force to the membrane to seal the device against a wall of the body cavity, para. 0017, 0025 teaches that the outward, expansive force prevents formation of inwardly directed folds or wrinkles (see Figs. 12-13 which illustrate an example of a membrane with and without a sealing element). Therefore, the inflatable elements provide sufficient strength to change the mechanical properties of the flexible membrane to prevent folding/wrinkling during deployment), the plurality of features 3003 configured to inhibit folding of a proximal end of the flexible membrane when in the airway occluding configuration (Fig. 30A, para. 0017, 0025, 0132, 0140), wherein the plurality of features include multiple features between each set of adjacent struts of the plurality of struts 3011 (Fig. 30A, para. 0132).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the flexible membrane in Gonzalez to include the plurality of features formed into the inner surface of the flexible membrane, as taught by Khairkhahan in order to ensure an adequate seal between the membrane and the bronchial wall of the airway at a proximal end of the device and prevent inwardly directed folds or wrinkles when the struts are in at least a partially contracted configuration (para. 0017, 0025, 0112, 0132, 0140 of Khairkhahan).
Gonzalez in view of Khairkhahan further discloses that each of the plurality of features 3003 comprise an inflation channel, such that the elements may be separately inflatable (para. 0134 of Khairkhahan). However, Gonzalez in view of Khairkhahan discloses that the plurality of balloons are integral with the membrane, and therefore fails to disclose that the plurality of features are discrete.
Murphy teaches an inflatable device 1 (Fig. 8A-B, para. 0136) comprising a plurality of separate inflatable balloons positioned within lumens 2 of a membrane (interpreted as annular sheath 35) (Figs. 8A-B, para. 0136), thereby forming a plurality of discrete features, as a known alternative to a plurality of inflatable balloons formed integral with the membrane (see Fig. 1, para. 0104-0105).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the plurality of inflatable balloons in modified Gonzales to be a plurality of discrete inflatable balloon, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Newin v. Erlichman, 168 USPQ 177 (BdPatApp&Int 1969).
Regarding claim 2, modified Gonzalez discloses wherein the device is a one-way valve used to prevent airflow into a targeted area of a lung (para. 0037-0039 of Gonzalez).
Regarding claim 3, modified Gonzalez discloses wherein the flexible membrane includes a distal section and a proximal section (see annotated Fig. 5 of Gonzalez below).
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Annotated Fig. 5 of Gonzalez
Regarding claim 6, modified Gonzalez discloses wherein the flexible membrane seals the ventilatory airway without forming air gaps when in the occluding configuration (Fig. 6, para. 0039, 0052 of Gonzalez) and substantially reduces the number of valve sizes required to cover the ventilatory airway sizes (para. 0052, 0054 discloses that the flexible membrane forms an air-tight seal between a first (proximal) side and a second (distal) side of the membrane and is capable of expanding to a range of outer diameters to form that seal and thereby reduce the number of valve sizes required to cover the ventilatory airway sizes).
Regarding claim 7, Modified Gonzalez discloses wherein the plurality of discrete features are configured to change mechanical properties of the flexible membrane without changing the outer surface of the flexible membrane (para. 0140 of Khairkhahan teaches that the plurality of inflatable elements/balloons provide an outward, expansive force to the membrane to seal the device against a wall of the body cavity, para. 0017, 0025 of Khairkhahan teaches that the outward, expansive force prevents formation of inwardly directed folds or wrinkles (see Figs. 12-13 of Khairkhahan which illustrate an example of a membrane with and without a sealing element). Therefore, the inflatable elements provide sufficient strength to change the mechanical properties of the flexible membrane to prevent folding/wrinkling during deployment without changing the outer surface of the flexible membrane).
Regarding claim 8, modified Gonzalez discloses wherein the plurality of discrete features 3003 are defined by at least one of an arcuate stiffening member on the inner surface of the flexible membrane (Fig. 30A, para. 0132 of Khairkhahan).
Regarding claim 9, modified Gonzalez discloses wherein the flexible membrane is generally made of a biocompatible polyurethane or other thin, air impermeable material (para. 0051 of Gonzalez).
Regarding claim 10, modified Gonzalez discloses wherein the frame 142 comprises the plurality of struts 144, a central connector rod 170, and a plurality of anchor members 150, all of which are joined to one another at a central joint 152 (Fig. 5, para. 0041 of Gonzalez).
Regarding claim 11, modified Gonzalez discloses wherein the plurality of struts 144 are configured to support the flexible membrane (para. 0041 of Gonzalez) and wherein each of the plurality of struts 144 includes enhanced surface area to permit precise folding and/or bending of the frame (para. 0041-0047 of Gonzalez disclose that the struts function to seal an airway through expansion, wherein the struts fold and bend in a closed configuration and elastically deform into an open configuration to move the membrane into contact with the airway. Therefore, the struts have an enhanced surface area to permit precise folding and/or bending of the frame without collapse).
Regarding claim 16, Gonzalez discloses a therapeutic device 140 for sealing fluid passageways ventilatory airways (Figs. 4-8, para. 0041), comprising:
a plurality of struts 144, a central connector rod 170, and a plurality of anchor members 150, all of which are joined to one another at a central joint 152 to define a frame 142 (Fig. 5, para. 0041); and
a flexible membrane 160 having respective opposed inner and outer surfaces (inner surface is interpreted as the surface that contacts the outer surface 162 of struts 144, Fig. 5, para. 0041; outer surface is interpreted as the surface that contacts the bronchial walls, Fig. 6, para. 0044-0047) and disposed over and in contact with and being supported by the plurality of struts 144 of the frame 142 (Fig. 5, para. 0041, 0051, 0053), the flexible membrane 160 includes respective distal (interpreted as the end that includes a narrow, tapered region extending towards anchor members 150) and proximal ends (interpreted as end that includes a wider tapered region extending towards the proximal knob 192 of central rod 170) in which the frame 142 extends in a proximal direction from the distal end of the flexible membrane and (Figs. 5-6, para. 0047-0051).
However, Gonzalez fails to disclose wherein the inner surface includes a plurality of discrete patterns defined by fishbone stiffening members, zigzag stiffening members, arcuate stiffening members, parallel stiffening members, or V-shape stiffening members formed into the flexible membrane between adjacent struts of the plurality of struts to prevent the flexible membrane from forming one or more air gaps when the flexible membrane is in an occluding configuration, wherein the plurality of discrete patterns include multiple features between each set of adjacent struts of the plurality of struts.
Khairkhahan teaches an implantable device 3001 configured to be positioned within a body cavity (Figs. 30A-B, para. 0016, 0132) comprising a flexible membrane having an inner surface (interpreted as inner surface of peripheral region 3009) including a plurality of patterns 3003 defined by arcuate stiffening members formed into the flexible membrane between adjacent struts of a plurality of struts 3011 (Fig. 30A, para. 0132) to prevent the flexible membrane from forming one or more air gaps when the flexible membrane is in an occluding configuration (Fig. 30A, para. 0017, 0025, 0132, 0140), wherein the plurality of patterns include multiple features between each set of adjacent struts of the plurality of struts 3011 (Fig. 30A, para. 0132).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the flexible membrane in Gonzalez to include the plurality of patterns formed into the inner surface of the flexible membrane, as taught by Khairkhahan in order to ensure an adequate seal between the membrane and the bronchial wall of the airway at a proximal end of the device and prevent inwardly directed folds or wrinkles when the struts are in at least a partially contracted configuration (para. 0017, 0025, 0112, 0132, 0140 of Khairkhahan).
Gonzalez in view of Khairkhahan further discloses that each of the plurality of patterns 3003 comprise an inflation channel, such that the elements may be separately inflatable (para. 0134 of Khairkhahan). However, Gonzalez in view of Khairkhahan discloses that the plurality of balloons are integral with the membrane, and therefore fails to disclose that the plurality of patterns are discrete.
Murphy teaches an inflatable device 1 (Fig. 8A-B, para. 0136) comprising a plurality of separate inflatable balloons positioned within lumens 2 of a membrane (interpreted as annular sheath 35) (Figs. 8A-B, para. 0136), thereby forming a plurality of discrete patterns, as a known alternative to a plurality of inflatable balloons formed integral with the membrane (see Fig. 1, para. 0104-0105).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the plurality of inflatable balloons in modified Gonzales to be a plurality of discrete inflatable balloon, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Newin v. Erlichman, 168 USPQ 177 (BdPatApp&Int 1969).
Regarding claim 18, modified Gonzalez discloses wherein the plurality of discrete patterns are configured to change mechanical properties of the flexible membrane without changing the outer surface of the flexible membrane (para. 0140 of Khairkhahan teaches that the plurality of inflatable elements/balloons provide an outward, expansive force to the membrane to seal the device against a wall of the body cavity, para. 0017, 0025 of Khairkhahan teaches that the outward, expansive force prevents formation of inwardly directed folds or wrinkles (see Figs. 12-13 of Khairkhahan which illustrate an example of a membrane with and without a sealing element). Therefore, the inflatable elements provide sufficient strength to change the mechanical properties of the flexible membrane to prevent folding/wrinkling during deployment without changing the outer surface of the flexible membrane).
Regarding claim 19, modified Gonzalez discloses wherein the plurality of struts 144 are configured to support the flexible membrane (para. 0041 of Gonzalez) and wherein each of the plurality of struts 144 includes enhanced surface area to permit precise folding and/or bending of the frame (para. 0041-0047 of Gonzalez disclose that the struts function to seal an airway through expansion, wherein the struts fold and bend in a closed configuration and elastically deform into an open configuration to move the membrane into contact with the airway. Therefore, the struts have an enhanced surface area to permit precise folding and/or bending of the frame without collapse).
Claim(s) 4-5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable Gonzalez et al. (US 20050137714) [hereinafter Gonzalez] in view of Khairkhahan et al. (US 20100262168) [hereinafter Khairkhahan] and Murphy et al. (US 20120109179) [hereinafter Murphy], as applied to claims 1 and 16 above, and in further view of Venkatraman et al. (US 10905405) [hereinafter Venkatraman].
Regarding claim 4, modified Gonzalez discloses all of the limitations set forth above in claim 1. However, Modified Gonzalez fails to disclose wherein the flexible membrane is thicker at the distal section than at the proximal section.
Venkatraman teaches an implantable occlusion device (Fig. 2) comprising a flexible membrane 169 comprising a distal section (interpreted as the narrower section of the membrane extending towards a waist portion of the device) (Fig. 4, col. 12 lines 44-58 and col. 13 lines 22-37) and a proximal section (interpreted as the wider section of the membrane including a proximal opening disposed around folding segments 167-b, Fig. 4, col. 12 lines 44-58 and col. 13 lines 22-37), wherein the flexible membrane is thicker at the distal section than at the proximal section (col. 13 lines 22-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the distal section in Modified Gonzalez to have a thickness great than the proximal section, as taught by Venkatraman in order to increase the flexibility of the proximal section of the flexible membrane while maintaining a stiffer, more rigid distal section of the flexible membrane, thereby preventing damage of the flexible membrane during the devices’ expansion (col. 13 lines 22-37).
Regarding claim 5, modified Gonzalez discloses wherein the thicker distal section forces the flexible membrane to fold an arcuate or diamond shape when the device is at least partially compressed (see note below).
Note: “wherein the thicker distal section forces the flexible membrane to fold an arcuate or diamond shape when the device is at least partially compressed” is interpreted as functional language, therefore the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Modified Gonzalez discloses wherein the flexible membrane is thicker at the distal section than at the proximal section (col. 13 lines 22-37 of Venkatraman) which is the structural requirement for the claim. Since, the device of Modified Gonzalez meets the structural limitation of the claim, the device of Modified Gonzalez is capable of folding in an arcuate or diamond shape when the device is at least partially compressed (see MPEP 2112.01: Composition, Product, and Apparatus Claims for more information).
Regarding claim 17, modified Gonzalez discloses all of the limitations set forth above in claim 16. However, Modified Gonzalez fails to disclose wherein the outer surface includes a thicker region along the distal end of the flexible membrane as compared to the proximal end of the flexible membrane in which the thicker region forces the flexible membrane to completely seal the ventilatory airways.
Venkatraman teaches an implantable occlusion device (Fig. 2) comprising a flexible membrane 169 comprising an outer surface that includes a thicker distal region (interpreted as the narrower section of the membrane extending towards a waist portion of the device) (Fig. 4, col. 12 lines 44-58 and col. 13 lines 22-37) along a distal end of the flexible membrane 169 as compared to a proximal end of the flexible membrane (interpreted as the wider end of the membrane including a proximal opening disposed around folding segments 167-b, Fig. 4, col. 12 lines 44-58 and col. 13 lines 22-37) in which the thicker region forces the flexible membrane to completely seal the ventilatory airways (see note below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the distal section in Modified Gonzalez to have a thickness great than the proximal section, as taught by Venkatraman in order to increase the flexibility of the proximal section of the flexible membrane while maintaining a stiffer, more rigid distal section of the flexible membrane, thereby preventing damage of the flexible membrane during the devices’ expansion (col. 13 lines 22-37).
Note: “the thicker region forces the flexible membrane to completely seal the ventilatory airways” is interpreted as functional language, therefore the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Modified Gonzalez discloses wherein the flexible membrane is thicker at the distal section than at the proximal section (col. 13 lines 22-37 of Venkatraman) which is the structural requirement for the claim and further discloses that device is used to seal (col. 25 lines 1-20 of Venkatraman). Since, the device of Modified Gonzalez meets the structural limitation of the claim, the device of Modified Gonzalez is capable of folding in an arcuate or diamond shape when the device is at least partially compressed (see MPEP 2112.01: Composition, Product, and Apparatus Claims for more information).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable Gonzalez et al. (US 20050137714) [hereinafter Gonzalez] in view of Venkatraman et al. (US 10905405) [hereinafter Venkatraman].
Regarding claim 12, Gonzalez discloses a therapeutic device 140 for sealing fluid passageways ventilatory airways (Figs. 4-8, para. 0041), comprising:
a plurality of struts 144, a central connector rod 170, and a plurality of anchor members 150, all of which are joined to one another at a central joint 152 to define a frame 142 (Fig. 5, para. 0041), wherein the plurality of struts 144 extend proximally away from the central joint 152 at a distal end of the frame (Figs. 5-6, para. 0041, 0050); and
a flexible membrane 160 disposed over and in contact with the plurality of struts 144 (Figs. 4-5, para. 0041, 0053), the flexible membrane 160 includes respective distal (interpreted as the end that includes a narrow, tapered region extending towards anchor members 150) and proximal ends (interpreted as end that includes a wider tapered region extending towards the proximal knob 192 of central rod 170) in which the frame 142 extends in a proximal direction from the distal end of the flexible membrane 160 (Figs. 5-6, para. 0047-0051) and
However, Gonzalez fails to disclose wherein the flexible membrane includes a thicker region along the distal end as compared to the proximal end of the flexible membrane in which the thicker region forces the flexible membrane to completely seal the ventilatory airways without forming air gaps when therapeutic device is in an occluding configuration, wherein the thicker region extends proximally over at least a portion of the plurality of struts.
Venkatraman teaches an implantable occlusion device (Fig. 2) comprising a flexible membrane 169 comprising a thicker region (interpreted as the narrower region of the membrane extending towards a waist portion of the device) (Fig. 4, col. 12 lines 44-58 and col. 13 lines 22-37) along a distal end as compared to a proximal end of the flexible membrane (interpreted as the end having a wider region of the membrane including a proximal opening disposed around folding segments 167-b, Fig. 4, col. 12 lines 44-58 and col. 13 lines 22-37) in which the thicker region forces the flexible membrane to completely seal the ventilatory airways without forming air gaps when therapeutic device is in an occluding configuration (see note below), wherein the thicker region extends proximally over at least a portion of the plurality of struts (see annotated Fig. 4 below, col. 12 lines 44-58 and col. 13 lines 22-37; see note below).
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Annotated Fig. 4 of Venkatraman
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the distal section in Modified Gonzalez to have a thickness great than the proximal section, as taught by Venkatraman in order to increase the flexibility of the proximal section of the flexible membrane while maintaining a stiffer, more rigid distal section of the flexible membrane, thereby preventing damage of the flexible membrane during the devices’ expansion (col. 13 lines 22-37).
Note: “the thicker region forces the flexible membrane to completely seal the ventilatory airways without forming air gaps when therapeutic device is in an occluding configuration” is interpreted as functional language, therefore the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Modified Gonzalez discloses wherein the flexible membrane is thicker at the distal section than at the proximal section (col. 13 lines 22-37 of Venkatraman) which is the structural requirement for the claim and further discloses that device is used to seal (col. 25 lines 1-20 of Venkatraman). Since, the device of Modified Gonzalez meets the structural limitation of the claim, the device of Modified Gonzalez is capable of folding in an arcuate or diamond shape when the device is at least partially compressed (see MPEP 2112.01: Composition, Product, and Apparatus Claims for more information).
Note: The examiner notes that the narrow, thicker region, of Venkatraman is similar in shape to the narrow, distal section of Gonzalez. The combination of Gonzalez and Venkatraman would result in a product comprising a distal section of the flexible membrane 160 of Gonzalez (see annotated Fig. 5 of Gonzalez above) having the thicker region of Venkatraman extending proximally over at least a portion of the plurality of struts 144 of Gonzalez (see annotated Fig. 5 of Gonzalez above).
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable Gonzalez et al. (US 20050137714) [hereinafter Gonzalez] in view of Venkatraman et al. (US 10905405) [hereinafter Venkatraman], as applied to claim 12 above, and further in view of Khairkhahan et al. (US 20100262168) [hereinafter Khairkhahan] and Murphy et al. (US 20120109179) [hereinafter Murphy].
Regarding claim 13, Modified Gonzalez discloses all of the limitations set forth above in claim 12. Modified Gonzalez further discloses wherein the flexible membrane 160 having respective opposed inner and outer surfaces (inner surface is interpreted as the surface that contacts the outer surface 162 of struts 144, Fig. 5, para. 0041; outer surface is interpreted as the surface that contacts the bronchial walls, Fig. 6, para. 0044-0047 of Gonzalez).
However, Modified Gonzalez fails to disclose wherein the flexible membrane includes respective opposed inner and outer surfaces wherein the inner surface includes a plurality of discrete patterns of thicker membrane material disposed on the inner surface between adjacent struts of the plurality of struts, the plurality of discrete patterns of thicker membrane material configured to prevent the flexible membrane from forming one or more air gaps when the flexible membrane is in the occluding configuration.
Khairkhahan teaches an implantable device 3001 configured to be positioned within a body cavity (Figs. 30A-B, para. 0016, 0132) comprising a flexible membrane having an inner surface (interpreted as inner surface of peripheral region 3009) and a respective opposed outer surface (interpreted as an outer surface of peripheral region 3009) including a plurality of patterns of thicker membrane material 3003 disposed on the inner surface of the flexible membrane between adjacent struts of a plurality of struts 3011 (Fig. 30A, para. 0132), the plurality of discrete patterns of thicker membrane material configured to prevent the flexible membrane from forming one or more air gaps when the flexible membrane is in an occluding configuration (Fig. 30A, para. 0017, 0025, 0132, 0140).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the flexible membrane in Gonzalez to include the plurality of patterns of thicker membrane material disposed on the inner surface of the flexible membrane, as taught by Khairkhahan in order to ensure an adequate seal between the membrane and the bronchial wall of the airway at a proximal end of the device and prevent inwardly directed folds or wrinkles when the struts are in at least a partially contracted configuration (para. 0017, 0025, 0112, 0132, 0140 of Khairkhahan).
Gonzalez in view of Khairkhahan further discloses that each of the plurality of patterns of thicker membrane material 3003 comprise an inflation channel, such that the elements may be separately inflatable (para. 0134 of Khairkhahan). However, Gonzalez in view of Khairkhahan discloses that the plurality of balloons are integral with the membrane, and therefore fails to disclose that the plurality of patterns are discrete.
Murphy teaches an inflatable device 1 (Fig. 8A-B, para. 0136) comprising a plurality of separate inflatable balloons positioned within lumens 2 of a membrane (interpreted as annular sheath 35) (Figs. 8A-B, para. 0136), thereby forming a plurality of discrete patterns of thicker membrane material, as a known alternative to a plurality of inflatable balloons formed integral with the membrane (see Fig. 1, para. 0104-0105).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the plurality of inflatable balloons in modified Gonzales to be a plurality of discrete inflatable balloon, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Newin v. Erlichman, 168 USPQ 177 (BdPatApp&Int 1969).
Regarding claim 14, modified Gonzalez discloses wherein the one or more patterns comprise at least one of an arcuate stiffening member on the inner surface of the flexible membrane (Fig. 30A, para. 0132 of Khairkhahan).
Regarding claim 15, modified Gonzalez discloses wherein the flexible member 160 is conical in shape with the outer surface positioned against the ventilatory airways, which allows trapped air and secretions to escape away from diseased or damaged lung (Fig. 6, para. 0041, 0046-0047 0051-0052 of Gonzalez).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Thursday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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