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
The amendment filed July 15, 2026 has been entered. Claims 1-2, 4-10, 12, 18-19, and 33-40 remain pending in the application. Claims 3, 11, 13-17, and 20-32 have been cancelled.
Claim Objections
Claim 33 is objected to because there appears to be a typo regarding “wherein the homogenous porous body has a customized, varied pore structure in fluid communication with the reservoir.” in lines 7-8. The limitation “a customized, varied pore structure” was previously introduced in line 2. It is suggested to amend this limitation to “wherein the homogenous porous body with customized, varied pore structure is in fluid communication with the reservoir.”, or similar. 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, 6, 8, 12, 18-19, and 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hennemann et al. (US 20170319472) in view of Mendelsohn et al. (US 2019/0091140).
Regarding claim 1, Hennemann discloses an implantable drug delivery device (implantable cannister 100) comprising:
a homogenous porous body housing (upper shell 110 and lower shell 114; “the nanoscale through-porous membrane structure 10 of the canister 100.” [0116]) forming an external surface (first major surface 102, second major surface 104, side surface 106) of the implantable drug delivery device (Figures 1-1A), having a first end (left side of cannister 100; Figure 1) and a second end (right side of cannister 100 having port 108; Figure 1), and having pores of about 0.1 microns to about 100 microns (“The pore sizes range from approximately 20 nm to 5000 nm with a wall thickness of 5 to 250 microns.” [0089], wherein 20-5000 nm is 0.02-5 microns which overlaps with the claimed range of 0.1-100 microns); and
a reservoir (interior chamber 112) within the homogenous porous body housing (“FIG. 1A shows the canister 100 prior to being sealed shut, including an interior chamber 112 formed by combining both the upper shell 110 and lower shell 114.” [0115]), wherein the reservoir is configured to contain a fluid (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]; “FIG. 12 illustrates the canister 100 being loaded through its port 108 with a biotherapeutic agent.” [0119]);
the homogenous porous body housing in fluid communication with the reservoir (Figures 1-1A; “The nanoscale pore size is sized and exacted to control bioactive factor exchange and diffusion. Specifically, a tailored nanoscale, through-porous feature with bicontinuous morphology within the canister superstructure allows for highly controlled therapeutic factor diffusion, both in and out of the delivery canister.” [0089]),
wherein the external surface of the implantable drug delivery device has a length extending between the first end and the second end (Figure 1), and
wherein the length of the external surface of the implantable drug delivery device formed by the porous body housing is convex or curved to substantially match an anatomy of a patient (Figure 1 and 13, for example).
Hennemann fails to explicitly disclose the homogenous porous body housing having non-uniform pores.
Mendelsohn teaches an implantable drug delivery device (Figure 1) comprising: a homogenous porous body housing (capsule 1001 having nanoporous membrane 1003) having non-uniform pores (“the pores of the nanoporous membrane have a non-uniform distribution of diameters” [0077]); and a reservoir (reservoir 1002) within the homogenous porous body housing (Figure 1), wherein the reservoir is configured to contain a fluid therein (“A liquid composition of the therapeutic agent is formed inside reservoir 1002” [0069]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the homogenous porous body housing of Hennemann to have non-uniform pores based on the teachings of Mendelsohn to achieve sustained constant release of the fluid from the drug delivery device (Mendelsohn [0004], [0077]).
Regarding claim 2, modified Hennemann discloses the implantable drug delivery device of claim 1, further comprising a septum (port 108) at the second end of the homogenous porous body housing in fluid communication with the reservoir (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]; “The internal void chamber of the envisioned canister is accessed through an incorporated silicon septum or attached infusion tube built into the canister, also sealed with a silicon septum for needle injection.” [0088]).
Regarding claim 4, modified Hennemann discloses the implantable drug delivery device of claim 1, wherein the external surface of the implantable drug delivery device formed by the porous body housing is convex (Figures 1-1A, see also Figures 12-13).
Regarding claim 6, modified Hennemann discloses (Currently amended) The implantable drug delivery device of claim 1, wherein the length of the external surface of the implantable drug delivery device formed by the homogenous porous body housing is curved to substantially match an anatomy of a patient (Figures 1-1A, see also Figures 12-13).
Regarding claim 8, modified Hennemann discloses the implantable drug delivery device of claim 1, wherein the porous body housing comprises a material selected from the group consisting of stainless steel, glass, titanium, a biocompatible metal alloy, a ceramic, a polymer, and a combination thereof (“Examples of such biomedical grade metals and alloys include stainless steel based alloys, cobalt-chromium based alloys, alloys and nickel-titanium based alloys. More recently platinum containing alloys have been perfected for intravascular applications. The porous canister is formed of a biocompatible medical grade metal material that elicits only a mild inflammatory response in the body.” [0104-0105]).
Regarding claim 12, modified Hennemann discloses the implantable drug delivery device of claim 1, wherein the porous body housing is configured such that the fluid diffuses from the reservoir through the porous body housing at a constant mass amount per an amount of time over an extended period of time (“Envisioned is a complementing site-specific delivery device such as a canister or tube platform with the potential for the long-term (>12 months) controlled secretion of these living tissue derived, biologically active and cell-based therapeutic agents.” [0006]; “implantable canisters for delivering cells and biotherapeutics in vivo that address the following requirements:…allow for the continuous diffusion of their specific biomolecular factors for treating disease conditions” [0008]; “Tailored pore sizing is a key criterion for the continuous diffusion of specific biomolecular factors for treating disease conditions.” [0012]).
Regarding claim 18, modified Hennemann discloses the implantable drug delivery device of claim 1, wherein the device can be replenished with a drug and/or have products and byproducts evacuated from it (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]).
Regarding claim 19, modified Hennemann discloses the implantable drug delivery device of claim 1.
Modified Hennemann, in the embodiment of implantable canister 100 in Figure 1, fails to explicitly disclose where the device further comprises one or more additional reservoirs.
Hennemann, in the embodiment of Figure 15, discloses an implantable drug delivery device (delivery cannister 1500) comprising a homogenous porous body housing forming an external surface of the implantable drug delivery device (Figure 15); a reservoir (chamber 1508) and one or more additional reservoirs (“the delivery canister 1500 is composed of multiple individual and independent chambers 1508, 1510, 1512, 1514, 1516, 1518.” [0121]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the implantable drug delivery device in the embodiment of Figure 1 of Hennemann to include one or more additional reservoirs based on the teachings of Hennemann in the embodiment of Figure 15 to allow for sequential, phased delivery of multiple therapeutic agents (Hennemann [0098], [0121]).
Regarding claim 33, Hennemann discloses an implantable drug delivery device (implantable cannister 100) comprising:
a homogenous porous body (upper shell 110 and lower shell 114; “the major surfaces can be fitted…along an edge of the joined top and bottom halves, creating a single delivery canister” [0115]; “the nanoscale through-porous membrane structure 10 of the canister 100.” [0116]) with customized pore structure (“The nanoscale pore size is sized and exacted to control bioactive factor exchange and diffusion. Specifically, a tailored nanoscale, through-porous feature with bicontinuous morphology within the canister superstructure allows for highly controlled therapeutic factor diffusion, both in and out of the delivery canister.” [0089]) forming an external surface (first major surface 102, second major surface 104, side surface 106) of the implantable drug delivery device (Figures 1-1A; the nanoscale through-porous membrane structure 10 of the canister 100.” [0116]), having pores of about 0.1 microns to about 100 microns (“The pore sizes range from approximately 20 nm to 5000 nm with a wall thickness of 5 to 250 microns.” [0089], wherein 20-5000 nm is 0.02-5 microns which overlaps with the claimed range of 0.1-100 microns); and
a reservoir (interior chamber 112) within the homogenous porous body with customized pore structure (“FIG. 1A shows the canister 100 prior to being sealed shut, including an interior chamber 112 formed by combining both the upper shell 110 and lower shell 114.” [0115]), wherein the reservoir is configured to contain a fluid (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]; “FIG. 12 illustrates the canister 100 being loaded through its port 108 with a biotherapeutic agent.” [0119]);
wherein the homogenous porous body has a customized pore structure in fluid communication with the reservoir (Figures 1-1A; “The nanoscale pore size is sized and exacted to control bioactive factor exchange and diffusion. Specifically, a tailored nanoscale, through-porous feature with bicontinuous morphology within the canister superstructure allows for highly controlled therapeutic factor diffusion, both in and out of the delivery canister.” [0089]),
Hennemann fails to explicitly disclose the homogenous porous body having customized, varied pore structure with non-uniform pores.
Mendelsohn teaches an implantable drug delivery device (Figure 1) comprising: a porous body (capsule 1001 having nanoporous membrane 1003) having customized, varied pore structure with non-uniform pores (“the pores of the nanoporous membrane have a non-uniform distribution of diameters” [0077], see all of [0077] for “customized, varied pore structure”); and a reservoir (reservoir 1002) within the homogenous porous body housing (Figure 1), wherein the reservoir is configured to contain a fluid therein (“A liquid composition of the therapeutic agent is formed inside reservoir 1002” [0069]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the homogenous porous body of Hennemann to have customized, varied pore structure with non-uniform pores based on the teachings of Mendelsohn to achieve sustained constant release of the fluid from the drug delivery device (Mendelsohn [0004], [0077]).
Regarding claim 34, Hennemann discloses an implantable drug delivery device (implantable cannister 100) comprising:
a housing (upper shell 110 and lower shell 114);
a reservoir (interior chamber 112) within the housing (“FIG. 1A shows the canister 100 prior to being sealed shut, including an interior chamber 112 formed by combining both the upper shell 110 and lower shell 114.” [0115]) configured to contain a fluid (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]; “FIG. 12 illustrates the canister 100 being loaded through its port 108 with a biotherapeutic agent.” [0119]); and a
homogenous porous body (“the nanoscale through-porous membrane structure 10 of the canister 100.” [0116]) having a tortuous fluid pathway (“FIG. 1C corresponds to the area shown on the first major surface in FIG. 1A and illustrates a microscopic view of the nanoscale through-porous membrane structure 10 of the canister 100. FIG. 2A illustrates a microscopic view of the s nanoscale through-porous metallic membrane material of the canister 100, 300 400, 1400, 1500 having a uniform or homogeneous nanoporous structure.” [0089], at least Figure 2 showing that the nanoscale through-porous membrane structure is a tortuous fluid pathway) through interconnected pores having an average size of about 0.1 microns to about 100 microns (“The pore sizes range from approximately 20 nm to 5000 nm with a wall thickness of 5 to 250 microns.” [0089], wherein 20-5000 nm is 0.02-5 microns which overlaps with the claimed range of 0.1-100 microns) at a first end of the housing in fluid communication with the reservoir (Figures 1-1A; “The nanoscale pore size is sized and exacted to control bioactive factor exchange and diffusion. Specifically, a tailored nanoscale, through-porous feature with bicontinuous morphology within the canister superstructure allows for highly controlled therapeutic factor diffusion, both in and out of the delivery canister.” [0089]).
Hennemann fails to explicitly disclose the homogenous porous body housing having pores having varying pore sizes.
Mendelsohn teaches an implantable drug delivery device (Figure 1) comprising: a housing (capsule 1001), a reservoir (reservoir 1002) within the housing (Figure 1), and a homogenous porous body (nanoporous membrane 1003) having a tortuous fluid pathway through interconnected pores having varying pore sizes (“the pores of the nanoporous membrane have a non-uniform distribution of diameters” [0077]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pores of the homogenous porous body of Hennemann to have varying pore sizes based on the teachings of Mendelsohn to achieve sustained constant release of the fluid from the drug delivery device (Mendelsohn [0004], [0077]).
Regarding claim 35, modified Hennemann discloses the implantable drug delivery device of claim 34, wherein the housing is substantially cylindrical (Figures 1 and 1A, wherein the canister 100 is substantially cylindrical at least at port 108).
Regarding claim 36, modified Hennemann discloses the implantable drug delivery device of claim 35, further comprising a solid endcap (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]; “The internal void chamber of the envisioned canister is accessed through an incorporated silicon septum or attached infusion tube built into the canister, also sealed with a silicon septum for needle injection.” [0088], wherein the septum of the port 108 forms a solid endcap).
Regarding claim 37, modified Hennemann discloses the implantable drug delivery device of claim 36, further comprising a septum in the solid endcap (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]; “The internal void chamber of the envisioned canister is accessed through an incorporated silicon septum or attached infusion tube built into the canister, also sealed with a silicon septum for needle injection.” [0088]).
Regarding claim 38, modified Hennemann discloses the implantable drug delivery device of claim 33, wherein the housing is substantially cylindrical (Figures 1 and 1A, wherein the canister 100 is substantially cylindrical at least at port 108).
Regarding claim 39, modified Hennemann discloses the implantable drug delivery device of claim 38, further comprising a solid endcap (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]; “The internal void chamber of the envisioned canister is accessed through an incorporated silicon septum or attached infusion tube built into the canister, also sealed with a silicon septum for needle injection.” [0088], wherein the septum of the port 108 forms a solid endcap).
Regarding claim 40, modified Hennemann discloses the implantable drug delivery device of claim 39, further comprising a septum in the solid endcap (“A port 108 extends from the side surface 106, allowing access to the interior chamber 112 for infusion or flushing.” [0115]; “The internal void chamber of the envisioned canister is accessed through an incorporated silicon septum or attached infusion tube built into the canister, also sealed with a silicon septum for needle injection.” [0088]).
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hennemann et al. (US 20170319472) in view of Mendelsohn et al. (US 2019/0091140) as applied to claim 1 above, and further in view of Verbeek et al. (USPN 6592571).
Regarding claim 5, modified Hennemann discloses the implantable drug delivery device of claim 1.
Modified Hennemann fails to explicitly disclose one or more surgical loop filaments disposed on the drug delivery device configured to attach the drug delivery device to a tissue.
Verbeek discloses an implantable drug delivery device (pump 23) comprising a housing (outside surface 22) and a reservoir (within interior 28; Figure 7); further comprising one or more surgical loop filaments (suture loops 46) disposed on the drug delivery device configured to attach the drug delivery device to a tissue (Figure 6; “a space 52 is created between the suture loop 46 and the depression surface 44 of depression 42. This allows the surgeon to place a suture between the suture loop 46 and the depression surface 44 to hold the pump 12 in place in a pocket in tissue.” [Col 5, lines 32-37]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the implantable drug delivery device of Hennemann to include one or more surgical loop filaments based on the teachings of Verbeek to provide a means to secure the implantable drug delivery device in the subcutaneous tissue (Verbeek [Col 2, lines 51-64]).
Regarding claim 7, modified Hennemann discloses the implantable drug delivery device of claim 1.
Modified Hennemann fails to explicitly disclose a channel disposed on the homogenous porous body housing configured to accept a suture configured to anchor the implantable drug delivery device to a tissue.
Verbeek discloses an implantable drug delivery device (pump 23) comprising a housing (outside surface 22) and a reservoir (within interior 28; Figure 7); further comprising a channel (space 52) disposed on the homogenous porous body housing configured to accept a suture configured to anchor the implantable drug delivery device to a tissue (Figure 6; “a space 52 is created between the suture loop 46 and the depression surface 44 of depression 42. This allows the surgeon to place a suture between the suture loop 46 and the depression surface 44 to hold the pump 12 in place in a pocket in tissue.” [Col 5, lines 32-37]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the implantable drug delivery device of Hennemann to include a channel disposed on the homogenous porous body housing based on the teachings of Verbeek to provide a means to secure the implantable drug delivery device in the subcutaneous tissue (Verbeek [Col 2, lines 51-64]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hennemann et al. (US 20170319472) in view of Mendelsohn et al. (US 2019/0091140) as applied to claim 1 above, and further in view of Palumbo et al. (US 2017/0239726).
Regarding claim 9, modified Hennemann discloses the implantable drug delivery device of claim 1, wherein the porous body housing comprises a metal (“The porous canister is formed of a biocompatible medical grade metal material that elicits only a mild inflammatory response in the body.” [0105]).
Modified Hennemann fails to explicitly teach the porous body housing comprises a selective laser sintered metal.
Palumbo teaches a porous body housing for drug delivery (“The present invention utilizes laser additive manufacturing technology (“LAMT”) for the creation of porous media that can be used in filtration devices, flow control devices, drug delivery devices” [0021]), wherein the porous body housing comprises a selective laser sintered metal (“The type of laser additive manufacturing used in the present invention is any applicable technique, such as…selective laser sintering” [0023]; “The delivery of the various forms of drug molecules through the device is controlled by diffusion across a barrier medium, i.e., the porous sintered metal that is produced.” [0030]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the porous body housing of Hennemann to comprise a selective laser sintered metal based on the teachings of Palumbo to tailor the size of the pores to the desired drug diffusion rate to achieve constant-rate drug delivery (Palumbo [0030]).
Regarding claim 10, modified Hennemann discloses the implantable drug delivery device of claim 1, wherein the porous body housing comprises a metal (“The porous canister is formed of a biocompatible medical grade metal material that elicits only a mild inflammatory response in the body.” [0105]).
Modified Hennemann fails to explicitly teach the porous body housing comprises an additive metal.
Palumbo teaches a porous body housing for drug delivery (“The present invention utilizes laser additive manufacturing technology (“LAMT”) for the creation of porous media that can be used in filtration devices, flow control devices, drug delivery devices” [0021]), wherein the porous body housing comprises an additive metal (“The type of laser additive manufacturing used in the present invention is any applicable technique, such as…selective laser sintering” [0023]; “The delivery of the various forms of drug molecules through the device is controlled by diffusion across a barrier medium, i.e., the porous sintered metal that is produced.” [0030]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the porous body housing of Hennemann to comprise an additive metal based on the teachings of Palumbo to tailor the size of the pores to the desired drug diffusion rate to achieve constant-rate drug delivery (Palumbo [0030]).
Response to Arguments
Applicant's arguments filed July 15, 2026 have been fully considered but they are not persuasive.
Regarding the argument that “Hennemann does not disclose or suggest a homogenous porous body housing” (Remarks, page 7), the examiner respectfully disagrees. As detailed in the rejections of claims 1, 33, and 34 above, Hennemann discloses an implantable drug delivery device (100) comprising a homogenous porous body (110, 114; [0116]). The major surfaces of the upper shell 110 and lower shell 114 are disclosed as being “fitted and/or joined and/or welded along an edge of the joined top and bottom halves, creating a single delivery canister.” [0115]. Applicant presents the argument that “that joining (e.g. welding) major surfaces of an upper shell and a lower shell would not result in a homogenous porous body, as claimed. For example, the porosity at the weld or edge would not be the same as the porosity of non-welded surfaces of the canister.” (Remarks, page 8). However, Hennemann does not discloses that the upper and lower shells 110, 114 must be welded together at the edges, and can alternatively be “fitted” together to form the homogenous porous body.
Regarding the argument that Hennemann does not disclose “wherein the length of the external surface of the implantable drug delivery device formed by the porous body housing is convex or curved to substantially match an anatomy of a patient” as required by claim 1 (Remarks, page 8-9), the examiner respectfully disagrees. Hennemann discloses an implantable drug delivery device (100) having an external surface (Figures 1-1A), wherein a length of the external surface is convex or curved to substantially match an anatomy of a patient (Figure 1 and 13). Figure 1 shows that the side surface 106 of the implantable cannister 100 has a convex curvature, and Figure 13 shows the implantable cannister 100 implanted within the body, matching an anatomy of a patient. The claims as currently presented do not require that the implantable drug delivery device is shaped to match a specific body structure.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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