DETAILED ACTION
Claims 1-7, 9-10, 13-15, 17, 20-24, 26, 28-32, and 121-123 are pending and are under consideration on the merits.
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 .
Status of the Rejections
The 103 rejections are maintained.
The double patenting rejection is maintained.
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 9-10 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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.
Claim 9 recites that the first layer comprises 1-15 w% solvent, which introduces a lack of clarity because base claim 1 does not recite a solvent. Since claim 9 introduces a solvent as a new limitation, claim 9 should read that the first layer “further” comprises a solvent. Dependent claim 10 does not clarify the point of confusion, so is also rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-7, 9-10, 13-15, 17, 20-21, and 121-123 are rejected under 35 U.S.C. 103 as unpatentable over Indolfi et al. (US Pat. Pub. 2014/0308336; of record in IDS) in view of Serris et al. (AAPS PharmSciTech (2020) 21:256), Fredenberg et al. (International Journal of Pharmaceutics 415 (2011) 34-52), and Blake et al. (US Pat Pub. 2015/0209487).
As to claims 1, 4-7, 9-10, 13-15, 17, 20-21, and 121-123, Indolfi discloses a drug delivery device comprising a film comprising a biodegradable polymer that preferably is the elected species, (i.e., PLGA of claim 5), mixed with an active pharmaceutical ingredient that is preferably paclitaxel, wherein the device is configured to be inserted into a target tissue site of a patient (paragraphs 30-36 and 44). Indolfi teaches that the therapeutically effective amount of paclitaxel is at least about 1 mg/day and may be 5-125 mg/day (paragraph 44), and teaches that the degradation of the polymer film is tunable from a few days to several months, such as 30-120 days, by selecting the degradable polymer (paragraphs 44 and 49).
Regarding claims 4 and 17, the device may be for the treatment of tumors of the pancreas, biliary system, gallbladder, liver, small bowel, or colon (paragraph 2) and may be a stent (paragraph 9), which is a device that could be delivered with one of the means recited by claim 17 such as a bronchoscope.
As to claims 6 and 121, the PLGA may be 50:50 or 75:25 (paragraph 37).
Regarding 9-10, the PLGA film layer is formed from a composition comprising 5 or 10 wt% acetone solvent (paragraph 68).
As to claim 20, upon implantation in a patient the erosion of the PLGA layer containing the active will allow the API to release multi-directionally as recited by the claim.
Regarding claim 21, Indolfi teaches that release of the active is controlled by in vivo degradation of the biodegradable polymer in the target tissue site (paragraph 7).
As to claims 1, 4-7, 9-10, 13-15, 17, 20-21, and 121-123, Indolfi does not further expressly disclose that there is a second layer comprising PLGA that does not comprise the active and which has a slower degradation rate in vivo that the first biodegradable polymer as recited by claim 1, nor the presence of third and fourth biodegradable layers each of which comprises the elected species, i.e., PLGA along with a second and third API (claims 13-15), nor the amount of the active in the first layer (claims 7 and 122-123)
Serris discloses multi-layered PLGA films for drug delivery, wherein the layers comprise PLGA of differing molecular weights, wherein the layers may comprise the same active or different actives, including an embodiment wherein paclitaxel is incorporated into a higher molecular weight layer and rapamycin is incorporated as an active in a lower molecular weight layer (Abstract and Results section on page 5). Serris reports that the half time of drug release from the layer differed based upon the molecular weight of the PLGA that was used (page 10, 2nd and 3rd full paragraphs). Serris teaches that the films taught therein may be useful in treating tumors (paragraph bridging pages 2-3 and paragraph bridging left and right columns of page 13).
Fredenberg is a review of the mechanisms of drug release in PLGA-based drug delivery systems, and teaches that the choice of the PLGA may be the most important tool in modifying the release of drug, with low molecular weight PLGA polymers being less hydrophobic leading to increased rates of water absorption, hydrolysis, and erosion (Abstract and left column of page 38).
Blake discloses drug delivery devices comprising multiple polymer layers, wherein a first polymer layer carries a first therapeutic agent and a second polymer layer optionally comprises a therapeutic agent that may be the same or different than the first therapeutic agent (paragraphs 67-68). The polymer may be PLGA which degrades over time upon implantation in a patient (paragraph 69).
As to claims 1, 4-7, 9-10, 13-15, 17, 20-21, and 121-123, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the drug delivery device for treatment of biliary tumors via the delivery of paclitaxel as taught by Indolfi by incorporating additional PLGA layers including a second layer comprising PLGA that does not comprise the active and which has a slower degradation rate in vivo that the first biodegradable polymer, as well as third and fourth biodegradable layers each of which comprises the elected species, i.e., PLGA, along with a second and third API, respectively, because Indolfi teaches that the degradation of the polymer film is tunable from a few days to several months by selection of the proper degradable polymer and Serris teaches that PLGA films for drug delivery may comprise multiple layers and that when the layers comprise PLGA of differing molecular weights, the half time of drug release from the layer differed based upon the molecular weight of the PLGA that was used and Fredenberg teaches that the choice of the PLGA may be the most important tool in modifying the release of drug, with low molecular weight PLGA polymers having increased erosion rates, such that the skilled artisan would have been motivated with a reasonable expectation of success to tune the drug delivery device of Inolfi by incorporating multiple PLGA layers of differing molecular weight including a second layer having a slower degradation rate than the first PLGA layer, and which therefore will release drug at different rates, so as to obtain a desired overall release rate of the active. It further would have been prima facie obvious to omit the API from the second layer because Blake expressly teaches that one of the layers in a PLGA drug delivery device may omit the API, and the skilled artisan would have been motivated to do so in those cases when it was desired to impart a delayed release of the drug by incorporating a PLGA layer without the drug that must erode before the drug can release. It further would have been prima facie obvious to incorporate a second and third API because Serris expressly teaches that multilayer PLGA drug delivery devices may comprise more than one API in separate layers, and the skilled artisan would have been motivated to do so in those cases where the device is administered to treat a condition for which a combination therapy is indicated, such as the combination of paclitaxel with rapamycin as taught by Serris.
Regarding claims 7 and 122-123, it further would have been prima facie obvious to select an amount of the paclitaxel within the first layer that is within the recited ranges because the amount of drug is a result effective variable that will affect the therapeutic efficacy of the composition, and Indofi provides guidance to the skilled artisan on how much paclitaxel to incorporate into the polymeric layers by disclosing appropriate therapeutic dosages per day and by disclosing ranges of time in which the polymer layer will completely degrade, which would allow the skilled artisan to determine how much paclitaxel needs to be incorporated into the layer in order to release the suggested daily therapeutic dose over the lifespan of the polymer layer before it degrades. There further would have been a reasonable expectation of success in arriving at the claimed ranges because paclitaxel is the same drug taught by the present specification as useful for incorporation into the inventive drug delivery device and in fact its usage is exemplified by the specification (see, e.g., paragraphs 70 and 125 as published), such that the skilled artisan would have been optimizing a dosage for the same drug.
Claims 2-3, 22-24, 26, and 28 are rejected under 35 U.S.C. 103 as unpatentable over Indolfi et al. (US Pat. Pub. 2014/0308336) in view of Serris et al. (AAPS PharmSciTech (2020) 21:256), Fredenberg et al. (International Journal of Pharmaceutics 415 (2011) 34-52), and Blake et al. (US Pat Pub. 2015/0209487) as applied to claims 1, 4-7, 9-10, 13-15, 17, 20-21, and 121-123 above, and further in view of Hagan et al. (J Control Release 2022 April; 344: 147-156).
The teachings of Indolfi, Serris, Fredenberg, and Blake are relied upon as discussed above, but they do not further expressly disclose that the drug delivery device comprises a tip connected or integrated to a distal end (claim 2) which is to be inserted tip first (claim 3), and which comprises a biodegradable polymer having a slower degradation rate than the first biodegradable polymer (claim 22) such as PLGA 75:25 (claim 23), the tip comprising a tissue retaining mechanism (claim 24) extending outwardly from the tip (claim 26), wherein the tip has at least one vertex at its distal end (claim 28).
Hagan discloses 3D printed implantable devices for the treatment cancer that are loaded with drugs such as paclitaxel (Title and Abstract). Hagan teaches that the devices can be inserted into the target site and secured to the tissue to prevent migration and detachment using an array comprising a contoured base (a “tip” comprising a “tissue retaining mechanism”) from which arrowheads extend, the arrowheads comprising a vertex at a distal end)(last paragraph of page 8 and Figure 1).
As to claims 2-3, 22-24, 26, and 28, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the drug delivery device of Indolfi, Serris, Fredenberg, and Blake as combined supra by incorporating a tip comprising a tissue retaining mechanism at a proximal end extending outwardly and which comprises arrowheads having vertices at their distal end for insertion into a patient tip first, because Hagan teaches that doing so advantageously will prevent migration and detachment from the targeted tissue site. It further would have been prima facie obvious to select PLGA 75:25 having a slower degradation rate than the first biodegradable polymer as recited by claims 22-23 because the purpose of the tip is to prevent migration and detachment such that the skilled artisan would recognize that the tip should be made of a polymer having a slower degradation rate so it will be available to prevent migration over the entire lifespan of the other PLGA layers of the device.
Claims 29-32 are rejected under 35 U.S.C. 103 as unpatentable over Indolfi et al. (US Pat. Pub. 2014/0308336) in view of Serris et al. (AAPS PharmSciTech (2020) 21:256), Fredenberg et al. (International Journal of Pharmaceutics 415 (2011) 34-52), Blake et al. (US Pat Pub. 2015/0209487), and Hagan et al. (J Control Release 2022 April; 344: 147-156) as applied to claims 2-3, 22-24, 26, and 28 above, and further in view of Ruane et al. (US Pat. Pub. 2008/0167724; of record in IDS).
The teachings of Indolfi, Serris, Fredenberg, Blake, and Hagan are relied upon as discussed above, but they do not further expressly disclose that the body comprises a disengagement mechanism towards a proximal end (claim 29) and a flexible shaft connected to the proximal end (claim 30), wherein the disengagement mechanism disengages the drug delivery device from the flexible shaft (claim 31) such as by twisting (claim 32).
Ruane discloses a drug delivery device comprising a medical device for implantation such as a stent graft comprising a therapeutic agent for release such as paclitaxel for the treatment of a condition such as a biliary tumor (paragraphs 2, 8, 12). The device is configured to be inserted into the target tissue site using an endoscope (paragraph 120). The stent graft can be delivered to the point of treatment in any suitable manner, such as by mounting it on a delivery catheter (“flexible shaft”) having a stent engaging member that engages with one end of the stent graft wherein the catheter rotates and the stent is releasable from the catheter (paragraph 120).
As to claims 29-32, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the biliary drug delivery device of Indolfi, Serris, Fredenberg, Blake, and Hagan as combined supra by incorporating a flexible shaft connected to the proximal end and a disengagement mechanism towards a proximal end of the body of wherein the disengagement mechanism disengages the drug delivery device from the flexible shaft by twisting because Ruane teaches that such an arrangement is suitable for delivering biliary drug delivery devices to the target site. These modifications are merely the combining of known elements according to known methods to achieve predictable results, which is prima facie obvious. MPEP 2143.
Response to Applicant’s Arguments
Applicant argues against the rejection by listing the individual deficiencies of each of Indolfi, Serris, Fredenberg, and Blake.
In response, this argument is not persuasive because the rejection is based upon the teachings of all of the cited references in combination, such that the teachings of the references must be considered not individually but rather for what they teach as a whole. See MPEP 2145 IV.
Applicant argues that the cited references pursue different objectives and employ fundamentally different release strategies, with Indolfi focusing on localized biliary and pancreatic tumor treatment using single layer degradable drug containing films, Serris focusing on experimental 3D printed multilayer PLGA systems for sustained release of multiple drugs, and Blake relating to porous PLGA films having breath-figure structures, while Fredenberg is merely a broad review article. Applicant alleges that the rejection does not identify any teaching in these references that would have motivated the skilled artisan to modify Indolfi’s monolithic drug/polymer film into Applicant’s layered structure having an adjacent API free slower degrading polymer layer.
In response, and as discussed in the rejection, Indolfi teaches that the degradation of the polymer film is tunable from a few days to several months by selection of the proper degradable polymer and Serris teaches that PLGA films for drug delivery may comprise multiple layers and that when the layers comprise PLGA of differing molecular weights, the half time of drug release from the layer differed based upon the molecular weight of the PLGA that was used and Fredenberg teaches that the choice of the PLGA may be the most important tool in modifying the release of drug, with low molecular weight PLGA polymers having increased erosion rates, such that the skilled artisan would have been motivated with a reasonable expectation of success to tune the drug delivery device of Inolfi by incorporating multiple PLGA layers of differing molecular weight including a second layer having a slower degradation rate than the first PLGA layer, and which therefore will release drug at different rates, so as to obtain a desired overall release rate of the active. Therefore, it is the teachings of the cited secondary references that one can alter the rate of drug release by the use of different molecular weights of PLGA in multiple layers that would have motivated the skilled artisan to modify Indolfi’s monolayer device into a multilayer structure.
Applicant further argues that the proposed modification would alter the principle of operation of Indolfi, which discloses a release mechanism depending upon a single degradable drug/polymer mixture, and Applicant questions why one would reasonably expect predictable results from imposing the layered release control structure of the claims onto Indolfi’s monolithic system.
In response, the proposed modification is not viewed as altering the principle of operation of Indolfi because both the claimed invention and the Indolfi device utilize the same principle of using PLGA as an erodible polymer for enabling release of an active over time. The rejection does not propose to replace the basic principle of operation of Indolfi but rather to fine tune the rate at which drug is released by adding additional PLGA layers, and there would have been a reasonable expectation of success in doing so based upon the evidence currently of record in light of the teachings of Serris and Fredenberg that the rate of drug release from a PLGA drug delivery device can be varied by using multiple layers comprising PLGA of differing molecular weights.
Applicant argues that the cited references do not recognize the problem solved by the claimed invention because they do not suggest that using a slower degrading adjacent biodegradable layer lacking the API would have the effect of controlling release behavior from a neighboring layer comprising the API.
In response, and as discussed in the rejection, Blake expressly teaches drug delivery devices comprising multiple polymer layers wherein one layer comprises an API and another layer may not comprise an API as recited by the claims. Additionally, the Office notes that it is not necessary for the prior art to recognize a problem solved by the claimed invention in order to render the claims prima facie obvious. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 20pref06) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
Applicant also argues that the claims require that the second biodegradable polymer degrades more slowly in vivo than the first polymer, while the cited references merely discuss generalized PLGA degradation behavior or molecular weight effects without disclosed the claimed degradation relationship between adjacent layers, such that the rejection allegedly relies on hindsight construction.
In response, and as discussed in the rejection, Serris expressly teaches an embodiment comprising multiple PLGA layers of differing molecular weights and discloses that the half time of drug release from the layer differed based upon the molecular weight, while Fredenberg teaches that PLGA polymers with differing molecular weights have differing rates of erosion in PLGA-based drug delivery systems. Therefore, the skilled artisan reading Serris and Fredenberg readily would have recognized that multiple PLGA layers comprising PLGA of differing molecular weights will result in one or more of the layers having slower degradation in vivo than other layers having other molecular weights, and that this relationship could be used to fine tune the rate of release of the drug.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7, 9, 13-15, 17, 20-24, 26, 28-32, and 121-124 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. No. 12,508,222 and in view of Indolfi et al. (US Pat. Pub. 2014/0308336), Serris et al. (AAPS PharmSciTech (2020) 21:256), Fredenberg et al. (International Journal of Pharmaceutics 415 (2011) 34-52), Blake et al. (US Pat Pub. 2015/0209487), Hagan et al. (J Control Release 2022 April; 344: 147-156), and/or Ruane et al. (US Pat. Pub. 2008/0167724 where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a drug delivery device comprising a first layer comprising an API, a first biodegradable polymer that is PLGA 50:50, and a second layer comprising a second biodegradable polymer that is PLGA 75:25 and not comprising an API and which has a slower degradation rate than the first biodegradable polymer, the first layer comprising 2-15 wt% acetone, the device configured to be inserted using a trocar, and will be suitable for delivery to the target sites recited by claim 4. The device will be able to release the API multi-directionally due to the layered configuration.
Although the reference claims do not recite the presence of 3rd and 4th PLGA layers comprising additional actives, it would have been prima facie obvious to incorporate such layers because Indolfi teaches that the degradation of a PLGA polymer film is tunable from a few days to several months by selection of the proper degradable polymer and Serris teaches that PLGA films for drug delivery may comprise multiple layers and that when the layers comprise PLGA of differing molecular weights, the half time of drug release from the layer differed based upon the molecular weight of the PLGA that was used and Fredenberg teaches that the choice of the PLGA may be the most important tool in modifying the release of drug, with low molecular weight PLGA polymers having increased erosion rates, such that the skilled artisan would have been motivated with a reasonable expectation of success to tune the drug delivery device of the reference claims by incorporating multiple PLGA layers of differing molecular weight including a second layer having a slower degradation rate than the first PLGA layer, and which therefore will release drug at different rates, so as to obtain a desired overall release rate of the active. It further would have been prima facie obvious to omit the API from the second layer because Blake expressly teaches that one of the layers in a PLGA drug delivery device may omit the API, and the skilled artisan would have been motivated to do so in those cases when it was desired to impart a delayed release of the drug by incorporating a PLGA layer without the drug that must erode before the drug can release. It further would have been prima facie obvious to incorporate a second and third API because Serris expressly teaches that multilayer PLGA drug delivery devices may comprise more than one API in separate layers, and the skilled artisan would have been motivated to do so in those cases where the device is administered to treat a condition for which a combination therapy is indicated, such as the combination of paclitaxel with rapamycin as taught by Serris.
Although the reference claims do not recite that the drug delivery device comprises a tip connected or integrated to a distal end (claim 2) which is to be inserted tip first (claim 3), and which comprises a biodegradable polymer having a slower degradation rate than the first biodegradable polymer (claim 22) such as PLGA 75:25 (claim 23), the tip comprising a tissue retaining mechanism (claim 24) extending outwardly from the tip (claim 26) for delivery tip first (claim 3), wherein the tip has at least one vertex at its distal end (claim 28), it would have been prima facie obvious to incorporate a tip comprising a tissue retaining mechanism at a proximal end comprising arrowheads having vertices at their distal end, because Hagan teaches that doing so advantageously will prevent migration and detachment from the targeted tissue site. It would have been obvious to select PLGA 75:25 having a slower degradation rate than the first biodegradable polymer as recited by claims 22-23 because the purpose of the tip is to prevent migration and detachment such that the skilled artisan would recognize that the tip should be made of a polymer having a slower degradation rate so it will be available to prevent migration over the entire lifespan of the other PLGA layers of the device.
Although the reference claims do not recite that the body comprises a disengagement mechanism towards a proximal end (claim 29) and a flexible shaft connected to the proximal end (claim 30), wherein the disengagement mechanism disengages the drug delivery device from the flexible shaft (claim 31) such as by twisting (claim 32), it would have been prima facie obvious to incorporate a flexible shaft connected to the proximal end and a disengagement mechanism towards a proximal end of the body of wherein the disengagement mechanism disengages the drug delivery device from the flexible shaft by twisting because Ruane teaches that such an arrangement is suitable for delivering biliary drug delivery devices to the target site. These modifications are merely the combining of known elements according to known methods to achieve predictable results, which is prima facie obvious. MPEP 2143.
Although the reference claims do not recite the amount of the active recited by claims 7 and 122-123, it further would have been prima facie obvious to select an amount of an active such as paclitaxel within the first layer that is within the recited ranges because the amount of drug is a result effective variable that will affect the therapeutic efficacy of the composition, and Indofi provides guidance to the skilled artisan on how much paclitaxel to incorporate into PLGA polymeric layers as an active by disclosing appropriate therapeutic dosages per day and by disclosing ranges of time in which the polymer layer will completely degrade, which would allow the skilled artisan to determine how much paclitaxel needs to be incorporated into the layer in order to release the suggested daily therapeutic dose over the lifespan of the polymer layer before it degrades.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Response to Applicant’s Arguments
Applicant argues that a terminal disclaimer is enclosed herewith.
In response, Examiner has searched the file history but could not locate a terminal disclaimer. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
Prosecution Insights