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 .
Status of Claims
Claims 1-17 and 21-23 are pending. Claims 18-20 are canceled. Claims 21-23 are newly added. Claims 1, 3, 6, 8-9 and 13-16 are amended.
Claim 4 is withdrawn, there being no linking or generic claim.
Claims 1-3, 5-17 and 21-23 are examined on their merits in light of all of the species of semaglutide as the GLP-1 receptor agonist, the release of the first therapeutic agent substantially simultaneously as the second therapeutic agent as the timing of release, citric acid as the antioxidant, and citrate as the buffer.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Rejections Withdrawn
Claim Rejections - 35 USC § 103
In light of the amendments to the claims the rejection of claims 1-3 and 5-17 under 35 U.S.C. 103 as being unpatentable over Patel et al. WO 2018/067882 (4/12/2018)(2/2/2022 IDS) in view of Leung US 2012/0208755 (5/29/2008) are withdrawn.
Double Patenting
In light of the amendments to the claims the provisional rejection of claims 1-3 and 5-17 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of copending US Patent Application No. 19/305,392 in view of Patel et al. WO 2018/067882 (4/12/2018)(2/2/2022 IDS) in view of Leung US 2012/0208755 (5/29/2008) is withdrawn.
New Rejections
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 of this title, 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 1-3, 5-17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. WO 2018/067882 (4/12/2018)(2/2/2022 IDS) in view of Leung US 2012/0208755 (5/29/2008) and Adams US 2016/0022819 (1/28/2016).
Patel et al. (Patel) WO discloses an implantable device comprising a core with a first polymer and a pharmaceutical and a shell with a second polymer and a releasing agent and optionally a second drug wherein the device has a reduced burst release as compared to a device made entirely of the first polymer and pharmaceutical. (See Abstract, [0007-0008], [0064]-[0065]). After implantation into the patient, the porogen dissolves leaving pores in the shell polymer. (See [0066]). A method of treating type II diabetes is also taught wherein the core comprises liraglutide. Liraglutide is a GLP-1 receptor agonist. (See [0014]).
This reads on an implantable device with a therapeutic region with a first bioerodible polymer and GLP-1 inhibitor and a control region comprising a bioresorbable polymer and a second releasing agent that is configured to dissolve when the device is placed in vivo thereby creating openings in the control region wherein the depot releases the GPL-1 receptor agonist for a period of time as called for in instant claim 1.
The first and second polymer can be bioerodible. (See [0009], [0010]). A bioerodible device is called for in instant claim 8. Patel teaches that the use of two polymers can modulate the release rate. (See [0111]). Patel teaches that the core drug and the shell drug can be different. (See [0016]). Patel teaches that the core drug can comprise between about 1 wt% to about 80 wt% of the composition which overlaps with the at least 50% called for in claim 6. (See [0032]).
Patel teaches citric acid as a preferred porogen. (See [0062], [0113]). Patel teaches that citric acid is preferred because it is inexpensive and commonly available. (See [0091]). Citric acid is called for in instant claim 15 and it is an antioxidant as called for in instant claim and a thermal stabilizer as called for in instant claim 12.
Patel teaches that its device is intended and particularly suitable for long-term, regular dosing with drugs or pharmaceutical substances. (See [0111]). Patel teaches that the drug is released at a steady rate over time as called for in instant claim 11. (See [0042], [0133]). Patel teaches that its device can release drugs over an extended amount of time which is from a period of about 3 months to a period of about 1 year. (See [0136]). About 3 months to a period of about 1 year overlaps with the period of time being no less than 1 month called for in instant claim 7.
A method of treating type II diabetes is also taught wherein the core comprises liraglutide. Liraglutide is a GLP-1 receptor agonist. (See [0014]). Patel teaches that the implantable device can release about 10 µg to about 150 µg of the liraglutide per day. (See [0039]). 10 µg to about 150 µg overlaps with the about 2 µg/day to about 10 mg/day called for in instant claim 10.
Patel does not teach semaglutide, metformin, trehalose or a citrate buffer. Patel does not teach multiple discrete therapeutic regions, These deficiencies are made up for with the teachings of Leung and Adams.
Leung teaches the use of GLP-1 receptor agonists for the treatment of cancer. (See Abstract). The GLP-1 receptor agonists are typically delivered using an implanted delivery device that provides for continuous delivery of the GLP-1 receptor agonists for at least one month. (See Abstract). Additional drugs such as anticancer agents can also be administered. (See Abstract). Leung expressly teaches that its formulation is suitable for an implantable device. (See [0207]).
Leung teaches an embodiment wherein the suspension formulation comprises a particles formulation comprising a GLP-1 receptor agonist and a beneficial agent such as a sugar, and a citrate buffer. (See [0015]). Leung teaches that trehalose is a stabilizer for the formulation. (See [0018]). Trehalose is a stabilizer for the GLP-1 receptor agonist and is thus a chemical compound configured to inhibit denaturing of the therapeutic agent in vivo as called for in instant claim 17. A citrate buffer is called for in instant claim 16.
Leung teaches that GLP-1 receptor agonists are selected from the group consisting of liraglutide, semaglutide and taspoglutide. (See [0011]). Leung thus teaches that liraglutide and semaglutide are equivalents. Leung teaches that metformin is a suitable drug for use in combination with the GLP-1 receptor agonists because it causes hypoxia in tumor tissues. (See [0131]). Therefore, it is an effective combination therapy and the drugs can be released together. (See [0166-0167]). A simultaneous release of the two drugs is called for in instant claim 5.
Adams teaches an implantable medical device in which there are non-randomly located biodegreadable materials as part of the drug-containing matrix to eliminate an undesired drug “burst” and to assist in the consistency and extension of drug delivery over a period of 3, 7, or even 30 or more days. (See Abstract and [0004]). By selecting the location of these biodegradable materials and barriers, it is possible to intentionally create mini-chambers of drug materials that are designed to regulate the delivery of the drug materials to the patient. (See [0005]). This reads on a plurality of discrete therapeutic regions with a control region containing a bioresorbable polymer as called for in instant claim 1. The depot is bioresorbable, which is biodegradeable, as called for in instant claim 8.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Patel implantable device of a core with a first bioerodible polymer and GLP-1 inhibitor and a shell with a second bioerodible polymer of citric acid and a porogen to have the second drug be metformin in light of Leung’s teaching that metformin can be used in combination with the GLP-1 receptor agonists for an effective combination therapy for cancer.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Patel implantable device of a core with a first bioerodible polymer and GLP-1 receptor inhibitor and a shell with a second bioerodible polymer of citric acid and a porogen to replace the liraglutide with semaglutide. It is prima facie obvious to substitute one component for another, each of which is recognized by the art as GLP-1 receptor inhibitors, are equivalents and are known components for the same purpose as taught by [0011].
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Patel implantable device of a core with a first bioerodible polymer and GLP-1 receptor inhibitor and a shell with a second bioerodible polymer of citric acid and a porogen to have multiple mini-chambers of drug materials that are separated by bioresorbable polymers in order to control and regulate the delivery of the drug materials to the patient and enable the consistency and extension of drug release as taught by Adams.
There would be a reasonable expectation of success because Patel teaches a formulation in an implantable device, Leung teaches that its formulation is suitable for an implantable device and Adams teaches an implantable medical device.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. WO 2018/067882 (4/12/2018)(2/2/2022 IDS) in view of Leung US 2012/0208755 (5/29/2008) and Adams US 2016/0022819 (1/28/2016) as applied to claims 1-3, 5-17 and 21 and further in view of Rizzo US 5141748 (8/25/1992).
Patel in view of Leung and Adams is described supra. Patel in view of Leung and Adams do not teach an elongated shape or a depot that is configured to be implanted into the body via injection. These deficiencies are made up for with the teachings of Rizzo.
Rizzo teaches a rod-shaped implant that is configured to fit inside a hypodermic needle for subcutaneous and intramuscular placement. (See Abstract, col. 2, lines 45-55 and Rizzo claim 1). An elongated shape for the depot is called for in instant claim 22.
Rizzo teaches that its implant is designed for and configured to fit inside a hypodermic needle for subcutaneous and intramuscular placement. (See Abstract, col. 2, lines 45-55 and Rizzo claim 1). An implant that is configured to be implanted via injection through a needle is called for in instant claim 23. Rizzo teaches that its implant has superior properties in terms of convenience, reliability and ability to be implanted subcutaneously. (See col.2, lines 45-60). This is so much the case that it can be administered to a large number of patients in a commercial setting. (See col. 1).
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Patel in view of Lueng and Adams implantable device of a core with a first bioerodible polymer and GLP-1 inhibitor and a shell with a second bioerodible polymer of citric acid and a porogen to have the device be an elongated device that is implantable subcutaneously via a hypodermic needle as taught by Rizzo in order to have a convenient and reliable way to administer a medical implant to multiple patients as taught by Rizzo..
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3, 5-17 and 21-23 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 12-21 of copending US Patent Application No. 19/305,392 in view of Patel et al. WO 2018/067882 (4/12/2018)(2/2/2022 IDS), Leung US 2012/0208755 (5/29/2008), Adams US 2016/0022819 (1/28/2016) and Rizzo US 5141748 (8/25/1992).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are directed to an implantable device with a therapeutic region with a first bioerodible polymer and semaglutide and a control region comprising citric acid and a second releasing agent, citrate buffer, trehalose mixed with the polymer with a second bioerodible polymer of citric acid and a porogen, metformin, trehalose and sodium citrate buffer.
The claims of US Patent Application No. 19/305392 are directed to an implantable depot for the treatment of postoperative pain via sustained release of an analgesic, comprising a therapeutic region comprising the analgesic, a control region comprising a bioresorbable polymer and a releasing agent mixed with the polymer, wherein the releasing agent is configured to dissolve when the depot is placed in vivo to form diffusion openings in the control region and wherein the depot is configured to be implanted at a treatment site in vivo and release the analgesic at the treatment site for no less than 7 days.
The claims of US Patent Application No. 19/305392 differ from those of the instant claims in that active is not semaglutide, and there is no citric acid, trehalose, metformin, citrate buffer, multiple separated therapeutic regions or being configured to be injected into the body. These deficiencies are remedied by the teachings of Patel, Leung, Adams and Rizzo.
The teachings of Patel are described supra. It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the device of US Patent Application No. 19/305392 to have the releasing agent in the control region be citric acid in light of Patel’s teaching that citric acid is a preferred releasing agent because it is inexpensive and commonly available.
The teachings of Leung are described supra. It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the device of US Patent Application No. 19/305392 to have the first drug be semaglutide and the second drug be metformin in combination with trehalose and citric acid in light of Leung’s teaching that metformin can be used in combination with the GLP-1 receptor agonists and trehalose and sodium citrate can stabilize the semaglutide formulation in light of Leung’s teaching that semaglutide and metformin are a good combination therapy to treat cancer.
The teachings of Adams are described supra. It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the device of US Patent Application No. 19/305392 to have multiple mini-chambers of drug materials that are separated by bioresorbable polymers in order to control and regulate the delivery of the drug materials to the patient and enable the consistency and extension of drug release as taught by Adams.
The teachings of Rizzo are described supra. It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the device of US Patent Application No. 19/305392 to have the device be an elongated device that is implantable subcutaneously via a hypodermic needle as taught by Rizzo in order to have a convenient and reliable way to administer a medical implant to multiple patients as taught by Rizzo.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-17 and 21-23 are directed to an invention not patentably distinct from claim 1 of commonly assigned US Patent Appn. No. 19/305392 as described above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned US Patent Appn. No. 17/594317, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than 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 not later than 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. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicants’ arguments of March 10, 2026 have been fully considered and are found to be mostly persuasive.
Applicants note the amendment to the claims and the support for these amendments. Applicants argue that the claims are patentable over Patel in view of Leung because they do not teach every feature of the claims, namely a plurality of discrete therapeutic regions and a control region surrounding each of the discrete therapeutic regions.
Applicants note that Patel lacks a plurality of discrete therapeutic regions and only teaches one core which is a single unitary structure. Leung cannot cure the above-referenced deficiencies of Patel because Leung only describes suspension formulations comprising particles dispersed in a suspension vehicle.
Applicants submit that the claims are patentably distinct from the ‘392 patent and elect not to file a terminal disclaimer, although no explanation as to the patentable distinction is provided.
In light of the amendments to the claims, the rejection is withdrawn above and a new rejection is applied.
The remainder of Applicants arguments are moot in view of the new rejections applied above.
Conclusion
Claims 1-3, 5-17 and 21-23 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619