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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 24, 2026 has been entered.
Claims 1-2, 4-10, 12-14, 16-21, and 33-34 remain pending in the application. Claims 3, 11, 15, and 22-32 have been cancelled.
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, 12-13, 16-20, and 33-34 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 13, modified Hennemann discloses the implantable drug delivery device of claim 12, wherein the period of time is about 90 days (“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], wherein the disclosed 12 months includes at least the claimed 90 days).
Regarding claim 16, modified Hennemann discloses the implantable drug delivery device of claim 1, wherein the device causes a protrusion to be felt on a patient's skin when located subcutaneously in the patient (“The septum is positioned to one side of the delivery canister, thereby facilitating manual palpation when implanted in subcutaneous tissues.” [0100]).
Regarding claim 17, modified Hennemann discloses the implantable drug delivery device of claim 1, wherein the device is locatable under a patient's skin using a detector (“Deep tissue placement and access will likely involve image-guided technology commonly used in other medical device implant procedures. As a metallic device, medically accepted imaging is readily enhanced.” [0109]).
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 claims 19-20, 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, a required by claim 19; and where at least one of the additional reservoirs are operative to deliver an antidote to a patient, as required by claim 20.
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]); and where at least one of the additional reservoirs are operative to deliver an antidote to a patient (“Another embodiment of the cell and biotherapeutics delivery canister includes multiple divided, internal chambers within the canister…This embodiment would for example, facilitate the delivery of multiple biotherapeutic compounds where phased delivery is critical to therapeutic endpoints.” [0098]).
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 that are operative to deliver an antidote to a patient 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 body housing (upper shell 110 and lower shell 114) 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 body housing 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]);
the body housing with 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 body housing having customized, varied pore structure with non-uniform pores.
Mendelsohn teaches an implantable drug delivery device (Figure 1) comprising: a body housing (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 body housing 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]).
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]).
Claim 14 is 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 Limon et al. (US 20130102876).
Regarding claim 14, modified Hennemann teaches the implantable drug delivery device of claim 1, wherein the device is configured to be located subcutaneously in a patient (“Applied surgical implantation can occur at the following anatomical locations: subcutaneous” [0107]).
Modified Hennemann fails to explicitly teach wherein the device is configured to be of a shape and size that does not permit its detection by human touch when located subcutaneously in a patient.
Limon teaches an implantable medical device (implantable port system 10) that is configured to be of a shape and size that does not permit its detection by human touch when located subcutaneously in a patient (“At the location of the incision 223, it is not unusual to experience a thickness of up to about 7 cm of fat in the subcutaneous fat layer 135. This can make location of the port by palpation post-implantation difficult and may require the patient to go to radiology for fluoroscopic assistance in locating the port 10 so that the treatment professional can adjust the amount of inflation of the expandable member 1000 through port 10.” [0177]).
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 device of Hennemann to be configured to be of a shape and size that does not permit its detection by human touch when located subcutaneously in a patient based on the teachings of Limon to allow the device to properly positioned at the target location in a manner that still allows the user to access the device using a detector (Limon [0177-0178]).
Claim 21 is 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 Johnson et al. (US 20140200553).
Regarding claim 21, modified Hennemann teaches the implantable drug delivery device of claim 1.
Modified Hennemann fails to explicitly teach the device is controlled remotely.
Johnson teaches an implantable drug delivery device (Figure 8A-8C having actuation system 838) comprising: a homogenous porous body housing (housing 802 having porous membrane sidewall 840) having pores of about 0.1 to about 100 microns (“the porous sidewall membrane has a pore size from about 0.2 micrometers to about 25 micrometers.” [0045]); a reservoir within the homogenous porous body housing configured to contain a fluid (“the housing 802 includes a porous membrane sidewall 840 in fluid communication with the release end of the reservoir” [0045]); the homogenous porous body housing in fluid communication with the reservoir (Figure 8A-8C); wherein the device is controlled remotely (“the actuation system further includes a wireless receiver for receiving wireless control signals from a separate, detached transmitting device. The device may be deployed into the lumen by the patient, physician, veterinarian, or the like, and thereafter, the patient, physician, veterinarian, or the like, may actuate the release of the drug formulations using the transmitting device to transmit control signals to the deployed device.” [0071]; “actuation of the drug formulation dispensing may be done from a remote controller, e.g., external to the human or animal subject” [0072]).
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 be controlled remotely based on the teachings of Johnson to allow the patient or practitioner to adjust remotely adjust drug delivery and allow for the drug to be delivered on an as-needed basis (Johnson [0071-0072]).
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-10, 12-14, 16-21, and 33-34 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.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, specifically regarding the argument that “a suggestion to modify the pore structure of the body housing of Reich to including non-uniform pores of about 0.1 microns to about 100 microns has been inappropriately gleaned only for Appellant’s disclosure” (Remarks Page 10 and similarly argued with respect to the rejection of claim 34 on Remarks page 11), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In response to applicant's argument that “one of ordinary skill in the art would have neither been motivated to modify nor had a reasonable expectation of suggest in modifying Reich in view of Mendelsohn” (Remarks, page 10, similar on page 11), the examiner respectfully disagrees. Though Reich is not relied upon in the present rejection, a similar rejection has been presented in view of Hennemann et al. (US 20170319472). As detailed above, Hennemann discloses a homogenous porous body housing having pores of about 0.1 microns to about 100 microns (see at least [0089]); however, Hennemann fails to explicitly disclose the pores are non-uniform pores. Mendelsohn discloses 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]). Mendelsohn discloses that this non-uniform distribution assist in achieving sustained constant release of the fluid from the reservoir of the drug delivery device (Mendelsohn [0004], [0077]). Mendelsohn additionally discloses that the non-uniform distribution of diameters is in the range of 1-100 nm (“The diameters of the pores may be within a range between 1 nm to about 100 nm.” [0077]). This range is equivalent to 0.001-0.1 microns, overlapping the diameters of 0.1-100 microns as required by the claims and as disclosed by Hennemann. Though Mendelsohn discloses that the diameters of the non-uniform pores can also have a “diameter greater than 5 times…the molecular diameter of the therapeutic agent” [0079], this disclosure does not teach away from the disclosure of non-uniform pores or away from the pore diameters being between 0.1-100 as required by the claims and as disclosed by Hennemann. It is therefore maintained that it would have been obvious to one having ordinary skill in the art to modify the homogenous porous body housing having a pore diameter of 0.1-100 microns 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]).
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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