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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/23/26 has been entered.
Response to Amendment
The amendment filed 03/23/26 has been entered. Claims 1, 13, 22-23, 26, and 30 have been amended. Claims 2, 4, 8-12, 14, 16, 19-20, 24, and 27-28 are in the original/ previously presented form. Claims 3, 5-7, 15, 17-18, 21, 25, 29, and 31 are cancelled. Claim 32 is newly presented. Thus, claims 1-2, 4, 8-14, 16, 19-20, 22-24, 26-28, 30, and 32 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Final Office Action mailed 09/23/25.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4, 8-14, 16, 22-24, 26-28, 30, and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding independent claims 1, 13, and 32, claim 1 lines 12-13, claim 13 lines 13-14, and claim 32 lines 14-15 recite wherein the device… “is configured to release the urea according to a second release profile which differs from the first release profile.” However, because urea is recited in both the first and second housing portions of claims 1,13, and 32, it is unclear to the examiner if the urea from the first housing portion, second housing portion, or BOTH housing portions is configured to release “according to a second release profile” from the device. According to Applicant disclosure (see [0075]), the second release profile seems to be specifically for the release of the excipient in the second housing portion. Therefore, the examiner interprets that the “urea” configured to release according to “a second release profile” as recited in claims 1, 13, and 32 refers to the urea from the second housing portion.
Due to claim dependency from claim 1, claims 2, 4, 8-12, 22-24, 26-27 are subsequently rejected under 112b.
Due to claim dependency from claim 13, claims 14, 16, 28, and 30 are subsequently rejected under 112b.
Regarding claim 13, claim 13 lines 15-16 recite “wherein the urea facilitates in vivo controlled release of the gemcitabine HCl from the device”. However, because urea is recited in both the first and second housing portions of claim 13, it is unclear to the examiner if the urea from the first housing portion, second housing portion, or BOTH housing portions “facilitates in vivo controlled release of the gemcitabine HCl from the device”. According to Applicant disclosure, the urea in both the first housing portion (see [0033], [0094]) and the second housing portion (see [0040], [0050]) will facilitate drug delivery/release from the device. Therefore the examiner interprets that prior art having urea in either the first or the second housing portion will facilitate drug release and therefore meet the claim language.
Due to claim dependency from claim 13, claims 14, 16, 28, and 30 are subsequently rejected under 112b.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4, 8-14,16, 19, 20, 23, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Himes et al. (U.S. PGPUB No. 2012/0191068), hereinafter Himes, in view of Lee et al. (U.S. PGPUB No. 2012/0089122), hereinafter Lee, and Sathyan et al. (U.S. PGPUB No. 2009/0221621), hereinafter Sathyan.
Regarding claim 1, Himes discloses an intravesical drug delivery device (see FIG.1) comprising:
a first housing portion (see ‘Modified FIG. 2’ below. see also [0052], [0071], and [0083-0084]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108 separated by a partitioning structure)
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loaded with a first plurality of tablets (‘112a’ in ‘Modified FIG. 2’ above, see [0047]: solid drug tablets 112 & see [0050]: a plurality of drug tablets in reservoir) which comprise:
A drug (see [0104-0105]: tablet includes a drug content);
Polyvinylpyrrolidone (see [0037]: coating substance of tablets may include PVP and [0104]: coating substances may be included in the solid drug units, such as 112); and
Polyethylene glycol (see [0037]: coating substance of tablets may include polyethylene glycolated polymers and [0104]: coating substances may be included in the solid drug units, such as 112); and
a second housing portion (see ‘Modified FIG. 2’ above. see also [0052], [0071], and [0083-0084]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108 separated by a partitioning structure) loaded with a second plurality of tablets (‘112b’ in ‘Modified FIG. 2’ above, see [0052]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108. And further [0084]: drug reservoirs may house same drug formulation, such as a solid drug formulation/tablet as disclosed in [0047]),
wherein the device is configured to release the contents of the first reservoir according to a first release profile and is configured to release the contents of the second reservoir according to a second release profile which differs from the first release profile (see [0072] & [0083-0086]: the device reservoirs are designed to deliver the contents of the different reservoirs according to a desired release profile implemented by the reservoir design. Therefore, via design parameters of the separate reservoirs—such as the reservoir permeability, the number and placement of apertures, the form of the drug, etc.—the contents of each respective drug reservoir are configured to release according to separate release profiles).
Himes is silent to the first plurality of tablets “which comprise: from 75% by weight to 85% by weight gemcitabine HCl, urea”, “wherein each of the second plurality of tablets consists of: 90% by weight urea, and 10% by weight one or more excipients,” and wherein the device is configured to release the “gemcitabine HCl” according to a first release profile and is configured to release “the urea” according to a second release profile which differs from the first release profile.
However, Lee teaches an intravesical drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of tablets (112) which comprise from 75% by weight to 85% by weight gemcitabine HCL (see [0144]: drug may be gemcitabine and [0153]: drug tablet is 75% or more by weight drug).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug in the first plurality of tablets disclosed in Himes to include 75% by weight gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer) and to maximize the amount of drug that can be stored and released from the device (See [0152-0153]: drug provided at high percentage to pack a lot of drug into a small device), thus achieving the first plurality of tablets “which comprise at least 75% weight gemcitabine HCl” and wherein the device is configured to release the “gemcitabine HCl” according to a first release profile.
Himes in view of Lee remain silent to the first plurality of tablets comprise “urea”, “wherein each of the second plurality of tablets consists of: 90% by weight urea, and 10% by weight one or more excipients,” and wherein the device is configured to release “the urea” according to a second release profile which differs from the first release profile.
However, Sathyan teaches an osmotic pump drug delivery device (see FIG. 2 and [0179]) with a first reservoir (40) comprising a drug and urea (see [0179]: drug reservoir 40 includes drug and osmagent and [0204]: osmagents used in the device include urea) and a second reservoir (50, see [0199]), the second reservoir (50) comprises 90% by weight urea and 10% by weight one or more excipients (see [0204]: osmagent, such as urea, provided to reservoir 50 at up to 100% by weight. The “rest” of the composition is an osmopolymer==an excipient because the total amount of osmopolymer and osmagent is equal to 100% in the second reservoir 50. Osmopolymers/excipient options are taught in [0201-0203] and align with Applicant disclosure of excipients listed in at least [0094]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of drug tablets of the first reservoir disclosed in Himes to include urea as taught by Sathyan for the purpose of imbibing fluid into the device to facilitate drug release (see [0179] and [0204]), thus achieving the first plurality of tablets comprise “urea”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second plurality of tablets forming the contents of the second reservoir disclosed in Himes to comprise 90% by weight urea and 10% by weight one or more excipients as taught by Sathyan for the purpose of attracting fluid into the device to increase drug diffusion out of the device (see [0199-0200] and [0204]), thus achieving “wherein each of the second plurality of tablets consists of: 90% by weight urea, and 10% by weight one or more excipients,” and wherein the device is configured to release “the urea” according to a second release profile which differs from the first release profile.
Regarding claim 2, the modified device of Himes teaches the device of claim 1, and Himes further discloses wherein the drug (tablets 112a as seen in ‘Modified FIG. 2’ above contain see [0104-0105]: tablet includes a drug content) is released from the first housing portion (see ‘Modified FIG. 2’ above), through an aperture (118, see FIG. 3 and [0049], [0071-0073] & [0083-0084]: aperture provides passageway to release drug from each drug reservoir) in the first housing portion (see ‘Modified FIG. 2’ above), primarily via osmotic pressure (see [0074]: drug reservoir can operate as osmotic pump where solubilized drug is controllably released through one or more apertures).
Himes is silent to the drug specifically being “gemcitabine HCl”.
However, Lee teaches an intravesical drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of tablets (112) which comprise gemcitabine HCL (see [0144]: drug may be gemcitabine).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of tablets disclosed in Himes to include gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer), thus achieving the drug specifically being “gemcitabine HCl”.
Regarding claim 4, the modified system of Himes teaches the device of claim 1, and Himes further discloses wherein the drug (tablets 112a as seen in ‘Modified FIG. 2’ above contain see [0104-0105]: tablet includes a drug content) is released from the first housing portion (see ‘Modified FIG. 2’ above) by diffusion through (see [0073]: coatings/sheaths control amount of diffusion through tube wall and [0075] & [0084-0085]: device may diffuse drug through wall of the tube itself) a drug permeable wall (see [0084-0085]) in the first housing portion (see ‘Modified FIG. 2’ above).
Himes is silent to the drug specifically being “gemcitabine HCl”.
However, Lee teaches an intravesical drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of tablets (112) which comprise gemcitabine HCL (see [0144]: drug may be gemcitabine).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of tablets disclosed in Himes to include gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer), thus achieving the drug specifically being “gemcitabine HCl”.
Regarding claim 8, the modified system of Himes teaches the device of claim 1, and Himes further discloses wherein the first housing portion (see ‘Modified FIG. 2’ above) comprises an elongated, annular tube (see annular shape of tube in FIG. 3 and [0048]: tube 122 forming device reservoir lumen 108 is substantially cylindrical—see FIG. 2) and the first plurality of tablets (112a) is disposed within (see [0050]: drug units 112 loaded into drug reservoir lumen 108) the annulus (108) of the annular tube (tube 122 forming device reservoir lumen 108 as seen in FIG.2).
Regarding claim 9, the modified system of Himes teaches the device of claim 8, and Himes further discloses wherein the elongated annular tube (122, see FIG. 3 and [0048]) is formed of a water-permeable elastomeric material (see [0074]: tube may be formed from a water permeable material, such as silicone==elastomeric as defined in [0054]: silicone or another elastomeric material may be used to form device body).
Regarding claim 10, the modified system of Himes teaches the device of claim 1, and Himes further discloses wherein the device is elastically deformable (see [0044-0045]: device moves is straightened to shape in FIG. 2 for delivery and then moves to shape in FIG. 3 and therefore is ‘elastically deformable’, [0124]: device is deformable and functions as a spring, and [0126]: device may be formed from shape memory materials) between a relatively straightened shape (as seen in FIG. 2) suited for insertion through the urethra of a patient and into the patient's bladder (see [0044-0045]: shape of FIG. 2 for deploying through cystoscope/ other catheter into bladder) and a retention shape (as seen in FIG. 1) suited to retain the device within the bladder (see [0044]: retention shape of FIG. 1 for retention in body cavity, specifically, see [0045]: the bladder).
Regarding claim 11, the modified system of Himes teaches the device of claim 1, and Himes further discloses wherein the device is configured to spontaneously assume a shape in the absence of a compressive load (see [0124]: device spontaneously returns to initial shape when compressive load is removed), which shape comprises an interconnected and overlapping pair of coils (see interconnected/ overlapping pair of coils in at least FIG. 1 and described in [0053] & [0125]: pretzel shape with overlapping sub-circles and [0127]: other embodiments of overlapping coils).
Regarding claim 12, the modified system of Himes teaches the device of claim 1, and Himes further discloses wherein the first (see ‘Modified FIG. 2’ above) and/or second (see ‘Modified FIG. 2’ above) housing portion comprises a retention frame lumen (110, see FIG. 3 and [0047]) and a retention frame (114) positioned in (see [0047]: retention frame lumen 110 designed to house retention frame 114) the retention frame lumen (110).
Regarding claim 13, Himes discloses a drug delivery device comprising:
a first housing portion (see ‘Modified FIG. 2’ below. see also [0052], [0071], and [0083-0084]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108 separated by a partitioning structure)
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loaded with a first plurality of mini-tablets (‘112a’ in ‘Modified FIG. 2’ above, see [0047]: solid drug tablets 112, see [0050]: a plurality of drug tablets in reservoir, and see [0108]: tablets may be mini-tablets to minimize size of device and facilitate insertion) which comprise:
a drug (see [0104-0105]: tablet includes a drug content),
Polyvinylpyrrolidone (see [0037]: coating substance of tablets may include PVP and [0104]: coating substances may be included in the solid drug units, such as 112), and
Polyethylene glycol (see [0037]: coating substance of tablets may include polyethylene glycolated polymers and [0104]: coating substances may be included in the solid drug units, such as 112); and
a second housing portion (see ‘Modified FIG. 2’ above. see also [0052], [0071], and [0083-0084]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108 separated by a partitioning structure) loaded with only a second plurality of mini-tablets (‘112b’ in ‘Modified FIG. 2’ above, see [0052]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108. And further [0084]: drug reservoirs may house same drug formulation, such as a solid drug formulation/tablet as disclosed in [0047] and again [0108]: tablets may be mini-tablets)
wherein the device is configured to release the contents of the first housing portion according to a first release profile and is configured to release the contents of the second housing portion according to a second release profile which differs from the first release profile (see [0072] & [0083-0086]: the device reservoirs are designed to deliver the contents of the different reservoirs according to a desired release profile implemented by the reservoir design. Therefore, via design parameters of the separate reservoirs—such as the reservoir permeability, the number and placement of apertures, the form of the drug, etc.—the contents of each respective drug reservoir are configured to release according to separate release profiles).
Himes is silent to the first plurality of mini-tablets comprise “from 75% by weight to 85% by weight gemcitabine HCl, urea,”, “wherein each of the second plurality of mini-tablets consists of: 90% by weight urea, and with the balance being 10% by weight one or more excipients,” wherein the device is configured to release the “gemcitabine HCl” according to a first release profile and is configured to release “the urea” according to a second release profile, and “wherein the urea facilitates in vivo controlled release of the gemcitabine HCl from the device.”
However, Lee teaches a drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of mini-tablets (see [0155]: drug tablets of device may be mini-tablets) which comprise from 75% by weight to 85% by weight gemcitabine HCl (see [0144]: drug may be gemcitabine and [0153]: drug tablet is 75% or more by weight drug).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mini-tablets of the first housing portion disclosed in Himes to include 75% by weight gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer) and to maximize the amount of drug that can be stored and released from the device (See [0152-0153]: drug provided at high percentage to pack a lot of drug into a small device), thus achieving the first housing portion loaded with mini-tablets “which comprise at least 75% weight gemcitabine HCl” and wherein the device is configured to release the “gemcitabine HCl” according to a first release profile.
Himes in view of Lee remain silent to the first plurality of mini-tablets comprise “urea”, “wherein each of the second plurality of mini-tablets consists of: 90% by weight urea, and with the balance being 10% by weight one or more excipients,” wherein the device is configured to release “the urea” according to a second release profile, and “wherein the urea facilitates in vivo controlled release of the gemcitabine HCl from the device.”
However, Sathyan teaches an osmotic pump drug delivery device (see FIG. 2 and [0179]) with a first reservoir (40) comprising a drug and urea (see [0179]: drug reservoir 40 includes drug and osmagent and [0204]: osmagents used in the device include urea) and a second reservoir (50, see [0199]), the second reservoir contents consist of (see [0204]: the two parts form 100%) 90% by weight urea, and with the balance being 10% by weight one or more excipients (see [0204]: osmagent, such as urea, provided to reservoir 50 at up to 100% by weight. The “rest” of the composition is an osmopolymer==an excipient because the total amount of osmopolymer and osmagent is equal to 100% in the second reservoir 50. Osmopolymers/excipient options are taught in [0201-0203] and align with Applicant disclosure of excipients listed in at least [0094]), wherein the urea facilitates in vivo controlled release of the gemcitabine HCl from the device (see [0204]: the osmagents, such as urea, imbibe fluid into the system to push the active agent/drug from the device and therefore ‘facilitate’ controlled release of the drug).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of drug mini-tablets of the first reservoir disclosed in Himes to include urea as taught by Sathyan for the purpose of imbibing fluid into the device to facilitate drug release (see [0179] and [0204]), thus achieving the first plurality of mini- tablets comprise “urea”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second plurality of mini-tablets forming the contents of the second reservoir disclosed in Himes to consist of 90% by weight urea and 10% by weight one or more excipients to facilitate release of a drug from the device as taught by Sathyan for the purpose of attracting fluid into the device to increase drug diffusion out of the device (see [0199-0200] and [0204]), thus achieving “wherein each of the second plurality of mini-tablets consists of: 90% by weight urea, and with the balance being 10% by weight one or more excipients” and wherein the device is configured to release “the urea” according to a second release profile, and “wherein the urea facilitates in vivo controlled release of the gemcitabine HCl from the device.”
Regarding claim 14, the modified device of Himes teaches the device of claim 13, and Himes further discloses wherein the drug (tablets 112a as seen in ‘Modified FIG. 2’ above contain see [0104-0105]: tablet includes a drug content) is released from the first housing portion (see ‘Modified FIG. 2’ above), through an aperture (118, see FIG. 3 and [0049], [0071-0073] & [0083-0084]: aperture provides passageway to release drug from each drug reservoir) in the first housing portion (see ‘Modified FIG. 2’ above), primarily via osmotic pressure (see [0074]: drug reservoir can operate as osmotic pump where solubilized drug is controllably released through one or more apertures).
Himes is silent to the drug specifically being “gemcitabine HCl”.
However, Lee teaches a drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of mini-tablets (see [0155]: drug tablets of device may be mini-tablets) which comprise gemcitabine HCl (see [0144]: drug may be gemcitabine).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of mini-tablets disclosed in Himes to include gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer), thus achieving the drug specifically being “gemcitabine HCl”.
Regarding claim 16, the modified system of Himes teaches the device of claim 13, and Himes further discloses wherein the drug (tablets 112a as seen in ‘Modified FIG. 2’ above contain see [0104-0105]: tablet includes a drug content) is released from the first housing portion (see ‘Modified FIG. 2’ above) by diffusion through (see [0073]: coatings/sheaths control amount of diffusion through tube wall and [0075] & [0084-0085]: device may diffuse drug through wall of the tube itself) a drug permeable wall (see [0084-0085]) in the first housing portion (see ‘Modified FIG. 2’ above).
Himes is silent to the drug specifically being “gemcitabine HCl”.
However, Lee teaches a drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of mini-tablets (see [0155]: drug tablets of device may be mini-tablets) which comprise gemcitabine HCl (see [0144]: drug may be gemcitabine).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of mini-tablets disclosed in Himes to include gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer), thus achieving the drug specifically being “gemcitabine HCl”.
Regarding claim 19, Himes discloses a method of administering a drug to a patient, the method comprising:
Inserting the device of claim 13 into a patient (see [0044-0045]: device inserted via cystoscope or other catheter); and then (see [0054]: solubilizing of drug occurs after implantation)
Releasing the drug from the device (see at least [0073]: timing of drug release is controllable by device design).
Himes is silent to the drug specifically being “gemcitabine HCl”.
However, Lee teaches a drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of mini-tablets (see [0155]: drug tablets of device may be mini-tablets) which comprise gemcitabine HCl (see [0144]: drug may be gemcitabine).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of mini-tablets disclosed in Himes to include gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer), thus achieving the drug specifically being “gemcitabine HCl”.
Regarding claim 20, the modified system of Himes teaches the method of claim 19, and Himes further discloses wherein the device is inserted into the patient’s bladder (see [0044-0045]: device inserted into bladder and [0055-0057]: design constraints related to achieving insertion into bladder via cystoscope).
Regarding claim 23, the modified system of Himes teaches the device of claim 1, and Himes further discloses wherein the first plurality of tablets (‘112a’ in ‘Modified FIG. 2’ above) and the second plurality of tablets (‘112b’ in ‘Modified FIG. 2’ above, see [0052]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108. And further [0084]: drug reservoirs may house same drug formulation, such as a solid drug formulation/tablet as disclosed in [0047]) are mini-tablets (see [0108]: tablets may be mini-tablets to minimize size of device and facilitate insertion).
Regarding claim 28, the modified system of Himes teaches the device of claim 13, and Himes further discloses wherein the first housing portion (see ‘Modified FIG. 2’ above) comprises an elongated, annular tube (see annular shape of tube in FIG. 3 and [0048]: tube 122 forming device reservoir lumen 108 is substantially cylindrical—see FIG. 2) and the first plurality of mini-tablets (see [0108]: tablets may be mini-tablets to minimize size of device and facilitate insertion) is disposed within (see [0050]: drug units 112 loaded into drug reservoir lumen 108) the annulus (108) of the annular tube (tube 122 forming device reservoir lumen 108), wherein the elongated annular tube (122, see FIG. 3 and [0048]) is formed of a water-permeable elastomeric material (see [0074]: tube may be formed from a water permeable material, such as silicone==elastomeric as defined in [0054]: silicone or another elastomeric material may be used to form device body).
Claims 22, 24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Himes in view of Lee and Sathyan as applied to claim 1 above, and further in view of Lee et al. (U.S. PGPUB No. 2010/0331770), hereinafter Lee1770.
Regarding claim 22, the modified system of Himes teaches the device of claim 1, and Himes discloses the drug tablets (‘112a’ in ‘Modified FIG. 2’ above) comprise polyethylene glycol (see [0037]: coating substance of tablets may include polyethylene glycolated polymers and [0104]: coating substances may be included in the solid drug units, such as 112).
Modified Himes is silent to wherein the polyethylene glycol “comprises PEG 8000”.
However, Lee1770 teaches a drug delivery device (see FIG. 3) comprising a plurality of drug tablets (312, see [0045]: solid drug tablets 312), wherein the plurality of drug tablets (see section II. “Solid Drug Tablets” that includes [0141]: drug tablet includes lubricants) comprise polyethylene glycol, wherein the polyethylene glycol comprises PEG 8000 (see [0155]: lubricant is PEG 8000).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the polyethylene glycol in the plurality of tablets disclosed in Himes to specifically be PEG 8000 as taught by Lee1770 for the purpose of using a molecular weight of PEG that facilitates the drug tableting process (see [0155]), thus achieving wherein the polyethylene glycol “comprises PEG 8000”.
Regarding claim 24, the modified system of Himes teaches the device of claim 1, but Himes is silent to “wherein each of the tablets of the first plurality of tablets consists of:80.0% by weight gemcitabine HCl;13.3% by weight urea;4.2% by weight polyvinylpyrrolidone; and 2.5% by weight polyethylene glycol 8000.”
However, Lee1770 teaches a drug delivery device (see FIG. 3) comprising a plurality of drug tablets (312, see [0045]: solid drug tablets 312), wherein each of the tablets of the plurality of drug tablets (see section II. “Solid Drug Tablets” that includes [0141]: drug tablet includes binders and lubricants) consists of: 80.0% by weight a drug (see [0143] and [0157]: at least 75% by weight drug and up to 92%. Therefore, 80% is taught); 4.2% by weight polyvinylpyrrolidone (see [0157]: binder content 1-10% by weight, teaching 4.2% and [0151]: one exemplary binder includes PVP); and 2.5% by weight polyethylene glycol 8000 (see [0157]: lubricant 1-11% by weight, teaching 2.5% and [0156]: lubricant is PEG 8000). Lee1770 further teaches that the excipient content is selected to form tablets with a certain drug release profile suitable for the intended use (see [0149-0150]), that other excipients may be used in combination with the taught excipients (see [0151]: excipients in addition to the binders and lubricants may be used, especially to achieve a desired drug release profile, such as described in [0149-0150]), and that any combination of excipient weight fractions may be incorporated into the device, including a percentage of an agent that increases the solubility of the drug (see [0171]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the plurality of drug tablets of the first reservoir disclosed in Himes to include the weight percentages of the drug, PVP, and PEG 8000 as taught by Lee for the purpose of forming a solid drug tablet with a relatively higher percentage of active ingredients than excipients for delivery through the device (see [0168-0169]), thus achieving “wherein each of the tablets of the first plurality of tablets consists of:80.0% by weight” drug and “4.2% by weight polyvinylpyrrolidone; and 2.5% by weight polyethylene glycol 8000.”
Himes in view of Lee1770 is silent to the drug in the tablets specifically being “gemcitabine HCl” and each of the plurality of drug tablets including “13.3% by weight urea”.
However, Lee teaches an intravesical drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of tablets (112) which comprise 80% by weight gemcitabine HCL (see [0144]: drug may be gemcitabine and [0153]: drug tablet may comprise 80% or more by weight drug).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of tablets including 80% by weight drug as taught by Himes in view of Lee1770 to include 80% by weight gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer), thus achieving the drug in the tablets specifically being “gemcitabine HCl”
Himes in view of Lee1770 and Lee remain silent to each of the plurality of drug tablets including “13.3% by weight urea”.
However, Sathyan teaches an osmotic pump drug delivery device (see FIG. 2 and [0179]) with a first reservoir (40) comprising a drug and urea (see [0179]: drug reservoir 40 includes drug and osmagent and [0204]: osmagents used in the device include urea).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of drug tablets of the first reservoir taught by Himes in view of Lee1770 and Lee to include the rest of the weight fraction of the drug tablet as urea as taught by Sathyan for the purpose of imbibing fluid into the device to facilitate drug release (see [0179] and [0204]), which is advantageous to the drug tablet taught by Himes in view of Lee1770 and Lee because urea would enhance the solubilization of the drug and modify the drug release profile (see again Lee1770 [0149-0151] and [0171]), thus achieving each of the plurality of drug tablets including “13.3% by weight urea”.
Regarding claim 26, the modified system of Himes teaches the device of claim 24, and Himes further discloses wherein the first plurality of tablets (112a in ‘Modified FIG. 2’ above) and the second plurality of tablets (‘112b’ in ‘Modified FIG. 2’ above, see [0052]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108. And further [0084]: drug reservoirs may house same drug formulation, such as a solid drug formulation/tablet as disclosed in [0047]) are mini-tablets (see [0108]: tablets may be mini-tablets to minimize size of device and facilitate insertion).
Regarding claim 27, the modified system of Himes teaches the device of claim 26, and Himes further discloses wherein the first housing portion (see ‘Modified FIG. 2’ above) comprises an elongated, annular tube (see annular shape of tube in FIG. 3 and [0048]: tube 122 forming device reservoir lumen 108 is substantially cylindrical—see FIG. 2) and the first plurality of tablets (112a) is disposed within (see [0050]: drug units 112 loaded into drug reservoir lumen 108) the annulus (108) of the annular tube (tube 122 forming device reservoir lumen 108), wherein the elongated annular tube (122, see FIG. 3 and [0048]) is formed of a water-permeable elastomeric material (see [0074]: tube may be formed from a water permeable material, such as silicone==elastomeric as defined in [0054]: silicone or another elastomeric material may be used to form device body).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Himes in view of Lee and Sathyan as applied to claim 13 above, and further in view of Lee1770 (U.S. PGPUB No. 2010/0331770).
Regarding claim 30, the modified system of Himes teaches the device of claim 29, but Himes is silent to “wherein each of the tablets of the mini-tablets of the first plurality of mini-tablets consists of:80.0% by weight gemcitabine HCl;13.3% by weight urea;4.2% by weight polyvinylpyrrolidone; and 2.5% by weight polyethylene glycol 8000.”
However, Lee1770 teaches a drug delivery device (see FIG. 3) comprising a plurality of drug mini-tablets (312, see [0045]: solid drug tablets 312 and [0037]: mini-tablets), wherein each of the mini-tablets of the plurality of drug mini-tablets (see section II. “Solid Drug Tablets” that includes [0141]: drug tablet includes binders and lubricants) consists of: 80.0% by weight a drug (see [0143] and [0157]: at least 75% by weight drug and up to 92%. Therefore, 80% is taught); 4.2% by weight polyvinylpyrrolidone (see [0157]: binder content 1-10% by weight, teaching 4.2% and [0151]: one exemplary binder includes PVP); and 2.5% by weight polyethylene glycol 8000 (see [0157]: lubricant 1-11% by weight, teaching 2.5% and [0156]: lubricant is PEG 8000). Lee1770 further teaches that the excipient content is selected to form tablets with a certain drug release profile suitable for the intended use (see [0149-0150]), that other excipients may be used in combination with the taught excipients (see [0151]: excipients in addition to the binders and lubricants may be used, especially to achieve a desired drug release profile, such as described in [0149-0150]), and that any combination of excipient weight fractions may be incorporated into the device, including a percentage of an agent that increases the solubility of the drug (see [0171]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the plurality of drug mini-tablets in the first housing portion disclosed in Himes to include the weight percentages of the drug, PVP, and PEG 8000 as taught by Lee for the purpose of forming a solid drug tablet with a relatively higher percentage of active ingredients than excipients for delivery through the device (see [0168-0169]), thus achieving “wherein each of the tablets of the mini-tablets of the first plurality of mini-tablets consists of: 80.0% by weight” drug and “4.2% by weight polyvinylpyrrolidone; and 2.5% by weight polyethylene glycol 8000.”
Himes in view of Lee1770 is silent to the drug in the tablets specifically being “gemcitabine HCl” and each of the plurality of drug tablets including “13.3% by weight urea”.
However, Lee teaches an intravesical drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of tablets (112) which comprise 80% by weight gemcitabine HCL (see [0144]: drug may be gemcitabine and [0153]: drug tablet may comprise 80% or more by weight drug).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of tablets including 80% by weight drug as taught by Himes in view of Lee1770 to include 80% by weight gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer), thus achieving the drug in the tablets specifically being “gemcitabine HCl”
Himes in view of Lee1770 and Lee remain silent to each of the plurality of drug tablets including “13.3% by weight urea”.
However, Sathyan teaches an osmotic pump drug delivery device (see FIG. 2 and [0179]) with a first reservoir (40) comprising a drug and urea (see [0179]: drug reservoir 40 includes drug and osmagent and [0204]: osmagents used in the device include urea).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of drug tablets of the first reservoir taught by Himes in view of Lee1770 and Lee to include the rest of the weight fraction of the drug tablet as urea as taught by Sathyan for the purpose of imbibing fluid into the device to facilitate drug release (see [0179] and [0204]), which is advantageous to the drug tablet taught by Himes in view of Lee1770 and Lee because urea would enhance the solubilization of the drug and modify the drug release profile (see again Lee1770 [0149-0151] and [0171]), thus achieving each of the plurality of drug tablets including “13.3% by weight urea”.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Himes U.S. PGPUB No. 2012/0191068) in view of Lee1770 (U.S. PGPUB No. 2010/0331770), Lee (U.S. PGPUB No. 2012/0089122), and Sathyan (U.S. PGPUB No. 2009/0221621).
Regarding claim 32, Himes discloses an intravesical drug delivery device (see FIG. 1) comprising:
a first housing portion (see ‘Modified FIG. 2’ below. see also [0052], [0071], and [0083-0084]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108 separated by a partitioning structure)
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containing only a first plurality of tablets (‘112a’ in ‘Modified FIG. 2’ above, see [0047]: solid drug tablets 112 & see [0050]: a plurality of drug tablets in reservoir); and
a second housing portion (see ‘Modified FIG. 2’ above. see also [0052], [0071], and [0083-0084]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108 separated by a partitioning structure) containing only a second plurality of tablets (‘112b’ in ‘Modified FIG. 2’ above, see [0052]: drug tablets 112 may have different compositions and may be in distinct reservoirs, axially or radially, along the lumen 108. And further [0084]: drug reservoirs may house same drug formulation, such as a solid drug formulation/tablet as disclosed in [0047]),
wherein the first (‘112a’) and second (‘112b’) pluralities of tablets (see ‘Modified FIG. 2’ above) are disposed within a single drug reservoir lumen (108, see FIG. 2 &3 and [0050], [0083-0084]) shared by the first and second housing portions (as shown in FIG.2), and
wherein the device is configured to release the contents of the first housing portion according to a first release profile and is configured to release the contents of the second housing portion according to a second release profile which differs from the first release profile (see [0072] & [0083-0086]: the device reservoirs are designed to deliver the contents of the different reservoirs according to a desired release profile implemented by the reservoir design. Therefore, via design parameters of the separate reservoirs—such as the reservoir permeability, the number and placement of apertures, the form of the drug, etc.—the contents of each respective drug reservoir are configured to release according to separate release profiles).
Himes is silent to the first plurality of tablets consist of “80.0% by weight gemcitabine HCl, 13.3% by weight urea, 4.2% by weight polyvinylpyrrolidone, and 2.5% by weight polyethylene glycol 8000”, the second plurality of tablets consist of “90% by weight urea, and 10% by weight one or more excipients,” and wherein the device is configured to release the “gemcitabine HCl” according to a first release profile and is configured to release “the urea” according to a second release profile which differs from the first release profile.
However, Lee1770 teaches a drug delivery device (see FIG. 3) comprising a plurality of drug tablets (312, see [0045]: solid drug tablets 312), wherein each of the tablets of the plurality of drug tablets (see section II. “Solid Drug Tablets” that includes [0141]: drug tablet includes binders and lubricants) consists of: 80.0% by weight a drug (see [0143] and [0157]: at least 75% by weight drug and up to 92%. Therefore, 80% is taught); 4.2% by weight polyvinylpyrrolidone (see [0157]: binder content 1-10% by weight, teaching 4.2% and [0151]: one exemplary binder includes PVP); and 2.5% by weight polyethylene glycol 8000 (see [0157]: lubricant 1-11% by weight, teaching 2.5% and [0156]: lubricant is PEG 8000). Lee1770 further teaches that the excipient content is selected to form tablets with a certain drug release profile suitable for the intended use (see [0149-0150]), that other excipients may be used in combination with the taught excipients (see [0151]: excipients in addition to the binders and lubricants may be used, especially to achieve a desired drug release profile, such as described in [0149-0150]), and that any combination of excipient weight fractions may be incorporated into the device, including a percentage of an agent that increases the solubility of the drug (see [0171]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the first plurality of drug tablets of the first housing portion disclosed in Himes to include the weight percentages of the drug, PVP, PEG 8000, and an excipient as taught by Lee for the purpose of forming a solid drug tablet with a relatively higher percentage of active ingredients than excipients for delivery through the device (see [0168-0169]), thus achieving the first plurality of tablets consist of “80.0% by weight” drug, 4.2% by weight polyvinylpyrrolidone, and 2.5% by weight polyethylene glycol 8000” and an excipient.
Himes in view of Lee1770 remain silent to the first plurality of tablets consist of “13.3% by weight urea” with the drug being “gemcitabine HCl”, the second plurality of tablets consist of “90% by weight urea, and 10% by weight one or more excipients,” and wherein the device is configured to release the “gemcitabine HCl” according to a first release profile and is configured to release “the urea” according to a second release profile which differs from the first release profile.
However, Lee teaches an intravesical drug delivery device (see FIG. 1 and [0027]: solid drug tablets 112 released in vivo) with a plurality of tablets (112) which comprise 80% by weight gemcitabine HCL (see [0144]: drug may be gemcitabine and [0153]: drug tablet may comprise 80% or more by weight drug).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of tablets including 80% by weight drug as taught by Himes in view of Lee1770 to include 80% by weight of specifically gemcitabine HCl as taught by Lee for the purpose of choosing the drug to target a specific disease such as urinary tract cancer (see [0144]: gemcitabine to treat urinary tract cancer), thus achieving the drug in the first plurality of tablets specifically being “gemcitabine HCl” and wherein the device is configured to release the “gemcitabine HCl” according to a first release profile.
Himes in view of Lee1770 and Lee remain silent to the first plurality of tablets consist of “13.3% by weight urea”, the second plurality of tablets consist of “90% by weight urea, and 10% by weight one or more excipients,” and wherein the device is configured to release “the urea” according to a second release profile which differs from the first release profile.
However, Sathyan teaches an osmotic pump drug delivery device (see FIG. 2 and [0179]) with a first reservoir (40) comprising a drug and urea (see [0179]: drug reservoir 40 includes drug and osmagent and [0204]: osmagents used in the device include urea) and a second reservoir (50, see [0199]), the second reservoir (50) comprises 90% by weight urea and 10% by weight one or more excipients (see [0204]: osmagent, such as urea, provided to reservoir 50 at up to 100% by weight. The “rest” of the composition is an osmopolymer==an excipient because the total amount of osmopolymer and osmagent is equal to 100% in the second reservoir 50. Osmopolymers/excipient options are taught in [0201-0203] and align with Applicant disclosure of excipients listed in at least [0094]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plurality of drug tablets of the first reservoir having an excipient as taught by Himes in view of Lee1770 and Lee to include the rest of the weight fraction of the drug tablet as the excipient urea as taught by Sathyan for the purpose of imbibing fluid into the device to facilitate drug release (see [0179] and [0204]), which is advantageous to the drug tablet taught by Himes in view of Lee1770 and Lee because urea would enhance the solubilization of the drug and modify the drug release profile (see again Lee1770 [0149-0151] and [0171]), thus achieving each of the plurality of drug tablets including “13.3% by weight urea”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second plurality of tablets forming the contents of the second reservoir disclosed in Himes to comprise 90% by weight urea and 10% by weight one or more excipients as taught by Sathyan for the purpose of attracting fluid into the device to increase drug diffusion out of the device (see [0199-0200] and [0204]), thus achieving the second plurality of tablets consist of “90% by weight urea, and 10% by weight one or more excipients,” and wherein the device is configured to release “the urea” according to a second release profile which differs from the first release profile.
Response to Arguments
Applicant's arguments filed 03/23/26 have been fully considered but they are not persuasive.
On page 8, Applicant submits that none of the references teach two specific tablet formulations and therefore the 35 U.S.C. § 103 claim rejections of at least claims 1 and 13 should be withdrawn. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Himes discloses two separate tablet formulations in two separate reservoirs. Himes in view of the other references then in combination together teach each individually recited type of tablet formulation as claimed (see at least the rejection of claims 1 and 13 above). Therefore, the examiner was not persuaded by this argument and has maintained the rejections.
Next on page 8, Applicant argues that none of the references teach two different housing portions of the same device and therefore the 35 U.S.C. § 103 claim rejections of at least claims 1 and 13 should be withdrawn. However, the examiner disagrees because the primary reference, Himes, clearly discloses two separated reservoir/ housing portions of the device (for example, see ‘Modified FIG.2’ and the cited paragraphs & explanations in the rejection of at least claim 1 above). Therefore, the examiner was not persuaded by this argument and has maintained the rejections.
To continue with the arguments on page 8, Applicant argues that the references fail to teach one of the reservoir portions that “releases urea” and therefore the 35 U.S.C. § 103 claim rejections of at least claims 1 and 13 should be withdrawn. However, the examiner disagrees with this argument because the argument does not align with the breadth of the claim language in claims 1 and 13. Claims 1 and 13 only require the first and second housing portions “configured to release” the contents of each reservoir. In response to applicant's argument that the device does not release only “urea” from at least one of the reservoirs, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Himes discloses that the contents of each individual reservoir can be separately released and therefore is capable of performing the intended use and meets the claim. Therefore, the examiner was not persuaded by this argument and has maintained the rejections.
Lastly on page 8, Applicant appears to argue that the device has unexpected results related to the release profile of the drug and therefore the 35 U.S.C. § 103 claim rejections of at least claims 1 and 13 should be withdrawn. However, the claims do not recite a specific release profile for the device (i.e.: a certain percentage release or a specific release rate of the drug over a period of time). Thus, this argument of unexpected results is not related to the claim language and is therefore unpersuasive to the examiner (see MPEP § 716.01(b): any evidence presented for section 716.01(a), like unexpected results, must be related to the claims and see MPEP § 2145: “In other words, in order for evidence of secondary considerations to be accorded substantial weight, there must be a nexus, i.e., a legally and factually sufficient connection or correspondence between the submitted evidence and the claimed invention. Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373, 2019 USPQ2d 483355 (Fed. Cir. 2019), cert. denied, 141 S.Ct. 373 (2020).”)
On page 9, Applicant first argues that Himes only teaches tablets with drug formulations and there is no suggestion that any of the tablets should be “drug-free”. Applicant then concludes that the 35 U.S.C. § 103 claim rejections of at least claims 1 and 13 should be withdrawn. However, the examiner disagrees and has maintained the claim rejections. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Himes alone does not teach the drug-free tablets because the drug-free formulation is taught by the combination of Himes in view of the other references. Further, this argument suggests that Applicant believes that Himes teaches away from the use of a drug-free tablet in the device. However, the examiner is not persuaded by such an argument that Himes teaches away from the use of a drug-free tablet. Himes may disclose that drug formulations are preferable or are used in the specific embodiment described, but Himes does not discourage/discredit/ or criticize the use of other tableted formulations and therefore fails to rise to the level of truly teaching away from the use of a drug-free tablet (see MPEP § 2141.02.VI or 2143.01.I: “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed” and see MPEP § 2123.II: “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).”). Therefore, the examiner was not persuaded by this argument and has maintained the rejections.
Lastly on page 9, Applicant submits that modifying Himes to include drug-free tablets for release from the device would change the principle operation and therefore the 35 U.S.C. § 103 claim rejections of at least claims 1 and 13 should be withdrawn. Applicant cites Himes [0084] to support the assertion that Himes’ principle operation is to release only drug formulations from the device (“segregating two or more different drug formulations in different reservoirs, delivering a single drug from different reservoirs at different rates or times”). However, the examiner is not persuaded by this argument and has maintained the rejections. The examiner argues that Himes discloses releasing drugs of different dosages (disclosing the release of drug-free/ 0% drug formulations) from the reservoirs (see [0085]). Himes also discloses releasing prophylactic or diagnostic agents (see [0096]), further supporting that Himes’ device contemplates the release of drug-free/ non-therapeutic formulations. Therefore, the examiner argues that Himes’ device does not require the release of only drug formulations from its device as the principle operation. Further, the examiner argues that Himes’ device would function equally well for the delivery of a drug formulation or non-drug formulation from the reservoirs because the release of the reservoir contents can be modified by the device design, such as wall permeability, apertures, etc., (see Himes see [0072] & [0083-0086] and see MPEP § 2123.I: “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…”). Thus, the examiner was not persuaded by this argument and has maintained the rejections.
Because no further arguments were presented, the depending claim rejections were subsequently maintained by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights