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 Objections
Claim 3 is objected to because of the following informalities: claim limitation “wherein two non-radially expandable regions” in lines 3-4 should read “wherein the two non-radially expandable regions". Appropriate correction is required.
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 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.
Claims 1-2, 4, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi (US 20110301696 A1) in view of Helmus et al. (US 20080208325 A1) in further view of Amos et al. (US 20050234388 A1) in further view of Kokish (US 6544223 B1) in view of Palasis et al. (US 20180296736 A1).
Regarding Claim 1, Mangiardi discloses a device (stent, Fig 3) comprising: a chamber (inner surface of stent, Fig 3) comprising a first opening (distal open end of stent), a second opening (proximal open end of stent) and at least one expandable wall (stent wall comprised of body + first cover + second cover; [0064];[0066];[0084]), wherein: said first opening and said second opening are void (both proximal and distal opening of stent are void, please see Figs 1A and 1D); said expandable wall (stent wall) comprises: (i) an inner biodegradable layer comprising a first biodegradable polymer (stent body; [0082]: “the stent like body itself is made from a biodegradable material”; examples of biodegradable polymers [0083]), (ii) a second layer (first cover; [0066]:“the covering is an electrospun fibrous covering comprising a biodegradable material”;[0090]: “A therapeutic agent may be applied to the exterior of the cover or may be mixed or imbedded into the covering material”; Therefore, second layer (first cover) is comprised of matrix of electrospun fibers imbedded with a therapeutic agent; in contact with the inner layer (the first covering covers the stent body), and (iii) an outer layer (second cover; [0084]: “the device is covered in a single layer, double layer, triple layer or multiple layers depending on the need.”) in contact with the second layer (second cover is located on top of the first cover), wherein the outer layer (second cover) comprises a second biodegradable polymer ([0066]; [0090]); wherein the second layer (first cover) is in a form of a fibrous matrix consisting essentially of electrospun biodegradable fibers ([0066]) and at least one active agent ([0090]: “A therapeutic agent may be applied to the exterior of the cover or may be mixed or imbedded into the covering material”) the active agent is a therapeutical agent (therapeutic agent, [0090]) and is encapsulated within the electrospun biodegradable fibers ([0090]); said inner biodegradable layer (stent body) comprises a plurality of apertures ([0064]: body is a slotted tube); said outer layer (second cover) is a film (film coating; [0080]) and said inner biodegradable layer (stent body) and said second layer (first cover) are continuous layers (stent body and the first cover do not have discontinuity; body and cover are continuous from first distal opening to the second proximal opening); said electrospun biodegradable fibers consist essentially of a third biodegradable polymer (Claim 6-7); said expandable wall (stent wall) defines a lumen (lumen defined by the stent body) being in fluid communication with a target site; and when located at the target site said device (stent, Fig 3) is configured to support (i) a longitudinal flow of a biological fluid through said lumen, and (ii) a radial flow of the biological fluid through said lumen (lumen defined by the stent body) ([0084]: “coating and covering of the device allow normal body fluids to flow unobstructed”; Therefore, both radial and longitudinal flow will not be obstructed; stent is structurally capable to support both longitudinal and radial flow of body fluids); [0086]); and wherein said device is a drug delivery device (([0090]) and wherein in the fully expanded state said drug delivery device is adapted for retention at the target site.
Mangiardi discloses wherein the renal systems is a target site ([0063]).
Mangiardi is silent regarding said expandable wall is characterized by effective porosity of at least 70% and by water permeability of at least 3x10-13m2; said device adapted for retention at the target site, wherein the target site is renal pelvis; wherein said expandable wall comprises a radially expandable region flanked by two non-radially expandable regions and wherein the plurality of apertures are solely located in the radially expandable region; wherein upon application of a contraction force to said device the radially expandable region of the device is configured to change from a contracted state to a fully expanded state.
Helmus teaches a device (stent Fig 4B) said expandable wall (claim 23) is characterized by effective porosity of at least 70% ([0023]: “The porosity of such layers may also vary widely, with 25 to 90 % porosity being typical. "Porosity" is defined herein as pore volume (i.e., void space) divided by total volume.”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mangiardi with the teaching of an expandable wall having a porosity of 90% as taught by Helmus to allow water and nutrient permeation ([0025]).
Mangiardi /Helmus are silent regarding said expandable wall having water permeability of at least 3x10-13m2; wherein the target site is renal pelvis; wherein said expandable wall comprises a radially expandable region flanked by two non-radially expandable regions and wherein the plurality of apertures are solely located in the radially expandable region; wherein upon application of a contraction force to said device the radially expandable region of the device is configured to change from a contracted state to a fully expanded state.
Amos teaches a device (ureteral stent 10, Fig 1) wherein said device is adapted for retention at the target site (renal pelvis), wherein the target site is renal pelvis ([0042]; Fig 4)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mangiardi /Helmus for retention at the renal pelvis as taught by Amos for the purpose of retain the stent in place and deliver intended medication ([0042])
Mangiardi/Helmus/Amos are silent regarding said expandable wall having water permeability of at least 3x10-13m2. wherein said expandable wall comprises a radially expandable region flanked by two non-radially expandable regions and wherein the plurality of apertures are solely located in the radially expandable region; wherein upon application of a contraction force to said device the radially expandable region of the device is configured to change from a contracted state to a fully expanded state.
The examiner notes that water permeability is a result effective variable, dependent on the desired water flow rate. Further, the water permeability range in the instant specification is lacking specific criticality ([086], in the instant specification). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the water permeability to include the claimed ranged since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05)
Mangiardi/Helmus/Amos are silent wherein said expandable wall comprises a radially expandable region flanked by two non-radially expandable regions and wherein the plurality of apertures are solely located in the radially expandable region; wherein upon application of a contraction force to said device the radially expandable region of the device is configured to change from a contracted state to a fully expanded state.
Kokish teaches a device (Fig 2) comprising an expandable wall (balloon 24, Fig 3A) comprises a radially expandable region (central portion of balloon 24, Fig 3A ) flanked by two non-radially expandable regions (distal end 26, and proximal end 28, Fig 3A) and wherein the plurality of apertures (34) are solely located in the radially expandable region (Fig 3A-3C).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mangiardi/Helmus/Amos with a similar expandable region flanked by two non-expandable ends and the location of the apertures to the be on the expandable region as taught by Kokish for the purpose of permitting targeted expansion and controlled released of medicaments over a short and localized anatomical regions (abstract).
Mangiardi/Helmus/Amos/Kokish are silent wherein upon application of a contraction force to said device the radially expandable region of the device is configured to change from a contracted state to a fully expanded state.
Palasis teaches a device (Fig 1) wherein upon application of a contraction force (compression force, claim 39) to said device, the radially expandable region (region of self-expansion, claim 39) of the device is configured to change from a contracted state to a fully expanded state (claim 39 discloses a change from a non-expanded configuration to an expanded configuration).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mangiardi/Helmus/Amos/Kokish with teaching of a self-expanding stent upon exposure to a compression force as taught by Palasis to achieve expansion without the aid of any additional expansion devices ([0014]).
Regarding claim 2, Mangiardi/Helmus/Amos/Kokish/Palasis discloses the device of claim 1. Mangiardi discloses wherein the expandable wall is characterized by effective porosity between 80 and 95% (porosity of 90%;please see modification of Mangiardi with the teaching of Helmus , Claim 1).
Regarding claim 4, Mangiardi/Helmus/Amos/Kokish/Palasis discloses the device of claim 1. Mangiardi discloses wherein the contracted state is suitable for inserting the device to the target site ([0027]).
Mangiardi is silent wherein each of the two non-radially expandable regions in the expanded state adopt a tubular shape.
Kokish teaches a device (Fig 2) comprising an expandable wall (balloon 24, Fig 3A) that comprises a radially expandable region (central portion of balloon 24, Fig 3A ) flanked by two non-radially expandable regions (distal end 26, and proximal end 28, Fig 3A), wherein each of the two non-radially expandable regions (26, 28) in the expanded state adopts a tubular shape (26, 28 are tubular when device is in its expanded state, Fig 2).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mangiardi/Helmus/Amos/Kokish/Palasis with a similar expandable region flanked by two non-expandable ends and the location of the apertures to the be on the expandable region as taught by Kokish for the purpose of permitting targeted expansion and controlled released of medicaments over a short and localized anatomical regions (abstract).
Regarding claim 8, Mangiardi/Helmus/Amos/Kokish/Palasis discloses the device of claim 1. Mangiardi wherein each of said first biodegradable polymer, said second first biodegradable polymer and said third biodegradable polymer is independently selected from the group consisting of poly (lactic-co-glycolic) acid (PLGA), poly-d,l-lactide (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polypropyleneglycol (PPG), polyvinyl alcohol (PVA), poly-l-lactide (PLLA), polydioxanone, polyhydroxybutyrate,polyhydroxyvalerate, polyphosphoester, polyurethane, polyamino acid and polyethyleneglycol (PEG) including any combination or a copolymer thereof. ([0083]: “Examples of biodegradable polymers include, but are not limited to (...)polycaprolactone (…) polyglycolic acid (…) polypropylene glycol”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi (US 20110301696 A1) in view of Helmus et al. (US 20080208325 A1) in further view of Amos et al. (US 20050234388 A1) in view of Kokish (US 6544223 B1) in view of Palasis et al. (US 20180296736 A1) in view of Helmus (US 20030153972 A1), hereinafter Helmus2.
Regarding claim 3, Mangiardi/Helmus/Amos/Kokish/Palasis discloses the device of claim 1. Mangiardi discloses wherein said chamber is void (inner surface of stent forms a chamber that is void, Fig 3); wherein said plurality of apertures (slots of stent tube; [0064]) is configured to support the radial flow (slots on the tube are structurally capable to support radial flow);
Mangiardi is silent wherein said inner biodegradable layer consists of biodegradable fibers; wherein two non-radially expandable regions are non-expandable regions.
Kokish teaches a device (Fig 2) comprising an expandable wall (balloon 24, Fig 3A) comprises a radially expandable region (central portion of balloon 24, Fig 3A ) flanked by two non-radially expandable regions (distal end 26, and proximal end 28, Fig 3A) and wherein the plurality of apertures (34) are solely located in the radially expandable region (Fig 3A-3C); wherein two non-radially expandable regions are non-expandable regions (distal end 26, and proximal end 28, Fig 3A are non-expandable).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mangiardi/Helmus/Amos/Kokish/Palasis with a similar expandable region flanked by two non-expandable ends and the location of the apertures to the be on the expandable region as taught by Kokish for the purpose of permitting targeted expansion and controlled released of medicaments over a short and localized anatomical regions (abstract).
Mangiardi/Helmus/Amos/Kokish/Palasis are silent wherein said inner biodegradable layer consists of biodegradable fibers.
Helmus2 teaches a device (implantable or insertable medical device; [0046]) comprising an inner biodegradable layer consists of biodegradable fibers ([0049]: “For example, the biodegradable core may be constructed of a woven or braided network of biodegradable filaments or fibers”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the biodegradable inner layer of Mangiardi/Helmus/Amos/Kokish/Palasis to consist of biodegradable fibers as taught by Helmus2 for the purpose of making the inner layer biodegradable at a different rate from the other layers ([0047]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi (US 20110301696 A1) in view of Helmus et al. (US 20080208325 A1) in further view of Amos et al. (US 20050234388 A1) in view of Kokish (US 6544223 B1) in view of Palasis et al. (US 20180296736 A1) in view of Shalev (US 20080154357 A1).
Regarding claim 5, Mangiardi/Helmus/Amos/Kokish/Palasis discloses the device of claim 1. Mangiardi discloses wherein the outer layer (second coating) faces the target site ([0081]); wherein the outer layer (second coating) is a film (second coating; [0080], outer layer is a film coating covering the first coating); the inner layer is a biodegradable layer (stent body; [0082]).
Mangiardi/Helmus/Amos/Kokish/Palasis are silent regarding the outer layer being characterized by lower porosity than the second layer and wherein the inner biodegradable layer is characterized by lower porosity than the second layer.
Shalev teaches a device (prosthetic graft; [0080]) comprising an outer layer being characterized by lower porosity than the second layer and wherein the inner biodegradable layer is characterized by lower porosity than the second layer ([0080]; liner and outer layer of graft have lower porosity (50%-70% ) compared to the middle layer (80%-90%))
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mangiardi/Helmus/Amos/Kokish/Palasis with the relative porosity between inner, second and outer layer as taught by Shalev to enhance support of the second layer ([0080]; [0127]: “Since the porosity of the layer depends on the density of fiber, such process can be used for manufacturing multilayer electrospun structures in which the layers have predetermined and different porosities. Additionally, each layer can have a different wall thickness, which can also be controlled
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi (US 20110301696 A1) in view of Helmus et al. (US 20080208325 A1) in further view of Amos et al. (US 20050234388 A1) in view of Kokish (US 6544223 B1) in view of Palasis et al. (US 20180296736 A1) in view of Moloney (US 20090118811 A1).
Regarding claim 6, Mangiardi/Helmus/Amos/Kokish/Palasis discloses the device of claim 2. Mangiardi/Helmus/Amos/Kokish/Palasis are silent wherein the contraction force is applied along a longitudinal axis of said device; and wherein in the expanded state said radially expandable region adopts a spherical shape.
Moloney teaches a device (stent 200, Fig 3) that changes from a contracted state (compressed state, Fig 10) to a fully expanded state (expanded state, Fig 12), wherein the contraction force (Force applied by pusher on the stent 200 as sleeve is being removed) is applied along a longitudinal axis of said device ([0038]: force is being applied by pusher 408 along the longitudinal axis) wherein in the expanded state said radially expandable region adopts a spherical shape (Fig 12; claim 1; [0031]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mangiardi/Helmus/Amos/Kokish/Palasis with similar deployment method and spherical shape of the stent upon expansion as taught by Moloney for the purpose of effectively maintains flow through cavities and lumens or junctions ([0029]; [0039])
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi (US 20110301696 A1) in view of Helmus et al. (US 20080208325 A1) in further view of Amos et al. (US 20050234388 A1) in view of Kokish (US 6544223 B1) in view of Palasis et al. (US 20180296736 A1) in view of Moloney (US 20090118811 A1) in view of Dubson et al. (WO 02074189 A2).
Regarding claim 7, Mangiardi/Helmus/Amos/Kokish/Palasis/Moloney discloses the device of claim 6. , Mangiardi/Helmus/Amos/Kokish/Palasis/Moloney are silent wherein a diameter of said radially expandable region being in the contracted state is between 0.1mm and 1 cm; and wherein a diameter of said radially expandable region being in the expanded state is between 0.5 and 5 cm; and wherein said force is in a range between 0.05 and 2 N.
Dubson teaches a device (tubular element; Claim 80; page 8 lines 17-20) wherein a diameter of said device being in the contracted state is between 0.1mm and 1 cm; and wherein a diameter of said device being in the expanded state is between 0.5 and 5 cm (Page 8, line 27-Page 9; Line 6: “According to still further features in the described preferred embodiments the tubular element having at least one characteristic selected from the group consisting of: (a) having a diameter ranging from 0.01 mm to 100 mm; (b) capable of expanding by at least 150 %; (c) having a porosity of at least 60 %; (d) having pores, a diameter of which is ranging from 50 nm to 20 μm; and (e) having a predetermined permeability to liquid passing therethrough.; a diameter of 2mm, when expanded 150% =5mm).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the expandable region device of Mangiardi/Helmus/Amos/Kokish/Palasis/Moloney to have a diameter of 2mm in the contracted state and 5mm in the expanded state as taught by Dubson to be able to be retained at the specific target site. It is within the ordinary skill of an artisan to adjust the diameter of the stent to fit the cavity in which is going to be implanted.
Mangiardi/Helmus/Amos/Kokish/Palasis/Moloney/Dubson are silent wherein said force is in a range between 0.05 and 2 N.
The examiner notes that force is a result effective variable, dependent on the stent construction and target site. Further, the force range in the instant specification is lacking specific criticality ([0175], in the instant specification). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the force to include the claimed ranged since such modification would involve the optimization of a result effective variable, obtained through routine experimentation in determining optimum results which has been held to be within the skill of the ordinary artisan (see MPEP 2144.05)
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi (US 20110301696 A1) in view of Helmus et al. (US 20080208325 A1) in further view of Amos et al. (US 20050234388 A1) in view of Kokish (US 6544223 B1) in view of Palasis et al. (US 20180296736 A1) in view of Weber et al. (US 20070244569 A1).
Regarding claim 9, Mangiardi/Helmus/Amos/Kokish/Palasis discloses the device of claim 1. Mangiardi discloses wherein said drug delivery device is adapted and for administration of the therapeutical agent at the target site [0102]; [0089]: “the therapeutic agent is delivered in a vehicle that is both delayed release and sustained release.” ([0085], discloses the therapeutic agent can be an antibiotic). However, Mangiardi is silent regarding administration of the therapeutic agent during a period ranging from 1 day to 40 days and wherein a length of said device is between 0.1 and 5 cm.
Weber teaches a device (device 1 (stent), Fig 1A-B) wherein a length of said device is between 0.1 and 5 cm. [0164]: “16 mm length”. Weber further teaches an administration of a therapeutical agent at the target site over a period ranging from 1 day to 40 days. [0041]: “Fiber meshwork 20 can be formed from a material impregnated with a therapeutic agent that releases such an agent slowly over time.”; [0099]: “at least about six days”; [0100]: “In some embodiments, biodegradable polyelectrolytes can be used so that a therapeutic agent can be released into the subject at a rate that is dependent upon the rate of degradation of the polyelectrolyte layers.”); [0139] teaches that the active agent can be an antibiotic)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the stent disclosed by Mangiardi/Helmus/Amos/Kokish/Palasis to be of a similar length and have a release period of at least 6 days as the stent taught by Weber to treat affected areas of the body ([0158]) for the recommended amount of time ([0099]) base on the antibiotic needed ([0139]).
Response to Arguments
Applicant’s arguments with respect to claims 1-9 have been considered.
Applicant explained the limitations being silent in Kokish; however Kokish is being relied upon to teach the limitation: “(…) wherein said expandable wall comprises a radially expandable region flanked by two non-radially expandable regions and wherein the plurality of apertures are solely located in the radially expandable region”. The primary reference is being modified to make the central portion expandable with apertures, being the ends non-expandable as taught by Kokish for the purpose of permitting targeted expansion and controlled released of medicaments over a short and localized anatomical regions (abstract). The remainder of the limitations are being taught by the additional references cited in claim 1.
Applicant submits that Moloney do not teaches nor suggests the instantly claimed device which undergoes expansion only upon application of contraction force, as recited by instant claim 1 or an expandable device configured to change from a contracted state to a fully expanded state upon application of contraction force along a longitudinal axis of said device, as recited in instant claim 6.
Examiner respectfully disagrees.
Moloney teaches a device (stent 200, Fig 3) that changes from a contracted state (compressed state, Fig 10) to a fully expanded state (expanded state, Fig 12), wherein the contraction force (Force applied by pusher on the stent 200 as sleeve is being removed)is applied along a longitudinal axis of said device ([0038]: force is being applied by pusher 408 along the longitudinal axis) wherein in the expanded state said radially expandable region adopts a spherical shape (Fig 12; claim 1; [0031]).
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/KAMI A BOSWORTH/ Primary Examiner, Art Unit 3783
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