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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. In particular, pages 44-49.
Specification
The use of the at least the terms Gelucire and Tween, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Status of the Claims
Claims 1-11, 14-17, 20, 23, and 51-54 are pending and examined.
Claim Rejections - 35 USC § 112
Claim 2 is 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. The phrase “concentration beyond a saturation concentration in a placebo formulation” is not clear. It is not clear what concentration this is nor is it clear what a “placebo formulation” means.
Claim 15 refers to a “high drug loading capacity” and then claims “up to about 600 mg/ml.” The examiner notes that “up to” includes anything less and “high” is a relative term. Thus, it is not clear where the line of demarcation is with respect to a high amount that is up to about 600 mg/ml.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 7-9, 11, 16, 17, 20, 23, 51, 53, and 54 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dadey et al., (U.S. Pat. No. 10,010,612).
Dadey teaches an injectable composition including a biodegradable polymer, an organic liquid, and a drug, e.g. See Abstract. The injection is capable of lasting for about 3 months and providing sustained release. When injected, the flowable composition can transform in situ into a solid or gel. The delivery implant allows for a 1 month and 3 month in situ release profile. See col. 2, lines 21-26. The biodegradable polymer can be a polylactide or polyglycolide or copolymer thereof. See col. 3, lines 3-5. The polymer can be present in a broad concentration range of 10 to 95% and the average molecular weight can be from 10,000 to 45,000 Daltons. See col. 3, lines 40, and 45-47. The organic solvent can be preferably selected from NMP, dimethyl sulfoxide (DMSO), triacetin, and a mixture thereof. The concentration can range from 10 to 90%. See col. 4, lines 3-4, 9-10. The active agent can be included in an amount of 50%. See col. 4, line 17. Claims include 15% API, e.g. See prior art claim 28. Compounds that can be used as rate release modifiers include those that are hydrophobic and/or hydrophilic. See col. 26, lines 61-64. PLGA is a preferred biodegradable polymer. See col. 7, line 64. Examples use PLGA and NMP. See col. 29, lines 27-29. The polymer to solvent ratio in some examples was 1:1. See col. 35, line 29 and Table 1. Suspensions are contemplated. See Examples 6-1 to 6-4. Even further, advantages of using a flowable compositions include that it can be removable up to 8 weeks. See col. 30, lines 10-11. Other compounds that can be included in the composition include antimicrobial agents. See col. 27, line 52. For the particular drug used in the prior art, when concentrations of API exceeded 5%, the formulations were suspensions.
Claims 1, 3-5, 7-9, 11, 16, 17, 20, 23, 51, 53, and 54 are anticipated by the prior art.
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.
Claims 1-11, 14-17, 20, 23, and 51-54 are rejected under 35 U.S.C. 103 as being unpatentable over Benhabbour et al., “Ultra-long-acting tunable biodegradable and removable controlled release implants for drug delivery,” Nature Communications (2019)10:4324, in view of Dadey et al., (U.S. Pat. No. 10,010,612).
Benhabbour teaches an ultra-long lasting and removable polymer based sustained release HIV treatment for up to one year. NMP was used as a solvent. See Abstract. The ISFI has been used for sustained release and water miscible organic solvents are used to deliver and solubilize the API. This includes NMP and PLGA is highly soluble in NMP. See p2, 1st par. Benhabbour teaches a long-acting release, flexibility on drug choice, and more. Antiretrovirals were used and some in combination with other drugs. Formulations were prepared with 100 mg/ml and 300 mg/ml drug. See p2. A PLGA to NMP ratio of 1:30 to 1:2 were created. Formulations were shown to be stable for 4 months in terms of physical appearance. See p3. Ratios of PLGA to NMP were tested at 1:2, 1:4, and 1:8. Release periods depending on the API reached 208 days and 120 days, e.g. See p5. The ability to change the erosion rate dependent on the ratio of polymer to solvent. When a higher amount of NMP is used, a larger amount of solvent diffused out leaving behind a smaller implant of PLGA, which accelerated the hydrolysis of the PLGA. Further, the ability to remove the implant and efficiently terminate treatment is taught to be of great importance. See p8. ISFI systems exhibit phase inversion once injected. Use of a co-solvent and using and a desired MW of polymer can be used to control the rate of release. See p2, 2nd par. The physical and chemical stability of ISFIs are stable over 4 months when stored at room temperature. See p7. They can deliver drugs for one year and can be readily removed to terminate drug delivery. See p7.
Benhabbour does not teach a suspension.
Dadey teaches an injectable composition including a biodegradable polymer, an organic liquid, and a drug, e.g. See Abstract. The injection is capable of lasting for about 3 months and providing sustained release. When injected, the flowable composition can transform in situ into a solid or gel. The delivery implant allows for a 1 month and 3 month in situ release profile. See col. 2, lines 21-26. The biodegradable polymer can be a polylactide or polyglycolide or copolymer thereof. See col. 3, lines 3-5. The polymer can be present in a broad concentration range of 10 to 95% and the average molecular weight can be from 10,000 to 45,000 Daltons. See col. 3, lines 40, and 45-47. The organic solvent can be preferably selected from NMP, dimethyl sulfoxide (DMSO), triacetin, and a mixture thereof. The concentration can range from 10 to 90%. See col. 4, lines 3-4, 9-10. The active agent can be included in an amount of 50%. See col. 4, line 17. Claims include 15% API, e.g. See prior art claim 28. Compounds that can be used as rate release modifiers include those that are hydrophobic and/or hydrophilic. See col. 26, lines 61-64. PLGA is a preferred biodegradable polymer. See col. 7, line 64. Examples use PLGA and NMP. See col. 29, lines 27-29. The polymer to solvent ratio in some examples was 1:1. See col. 35, line 29 and Table 1. Suspensions are contemplated. See Examples 6-1 to 6-4. Even further, advantages of using a flowable compositions include that it can be removable up to 8 weeks. See col. 30, lines 10-11. Other compounds that can be included in the composition include antimicrobial agents. See col. 27, line 52. For the particular drug used in the prior art, when concentrations of API exceeded 5%, the formulations were suspensions.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed invention in view of Benhabbour and Dadey. One would be motivated to do so because an ISFI comprising a wide range of APIs can be administered in a form that includes a suspension and can be stable for long periods of time. Further, such embodiments are removable in the case of a need to stop treatment, such as an allergic reaction. Further, PLGA along with NMP and DMSO are known biodegradable polymers and solvent/cosolvent that can be used for such ISFI. They are preferred polymer and solvents, respectively. Even further, release kinetics are modifiable by altering the molecular weight of polymer and the ratios of solvent to polymer and drug, e.g. These provide a tunable and predictable response. For example, and increase in percentage and MW of polymer will slow release kinetics while a higher concentration of solvent combination can increase release rate. Optimizing the ratio of a limited number of result effective variables would require nothing more than routine experimentation. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). An active agent is taught to include a wide breadth of APIs and examples include those drugs used to treat viral conditions as well as psychosis, depression, and others. A POSA would understand that almost any drug can be administered through the ISFI described by the prior art.
As such, no claim is allowed.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-11, 14-17, 20, 23, and 51-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,576,035, in view of Dunn et al., (U.S. Pat. No. 5,702,716) (cited in IDS), and in view of Whitcup et al., (US2014/0328835) (as applied in copending application 18/391,998). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘035 patent are directed to an implantable controlled release device that utilizes phase inversion. This include IFSI compositions. Further the biodegradable polymer for use in an implant includes PLGA and the solvent includes NMP with a claimed ratio of 1:2. Further, the solid can be micronized sufficient to deliver a host of APIs for up to about one year. Whitcup and Dunn collectively teach an implant comprising the claimed components wherein a micronized form can be used for a solid drug-polymer and administration would yield an extended release. Whitcup teaches a micronized dexamethasone, e.g.
Claims 1-11, 14-17, 20, 23, and 51-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/391,998, in view of Benhabbour et al., “Ultra-long-acting tunable biodegradable and removable controlled release implants for drug delivery,” Nature Communications (2019)10:4324, in view of Dadey et al., (U.S. Pat. No. 10,010,612).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘998 application are directed to treating HIV with a controlled release implant that include a “phrase inversion technique.” According to the prior art, an ISFI is a form of phase inversion technique and Benhabbour specifically uses HIV antiretroviral drugs therein. Further, the ‘998 application uses an organic solvent and PLGA as claimed and preferred biodegradable polymer. See claims 4 and 5. Even further, solvents include NMP and DMSO. See claim 6. The implant is designed to last from 6 months to one year, which is taught by the prior art. The sole distinction is that a solid is micronized while the instant claims provide for a suspension, which can certainly include a micronized solid. As such, it would be obvious to arrive at the instant claims in view of those of the ‘998 application in view of the teachings of the cited prior art. ISFI systems exhibit phase inversion once injected.
Claims 1-11, 14-17, 20, 23, and 51-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-10, 14-21, 23-26 of copending Application No. 18/836,156, in view of Benhabbour et al., “Ultra-long-acting tunable biodegradable and removable controlled release implants for drug delivery,” Nature Communications (2019)10:4324, in view of Dadey et al., (U.S. Pat. No. 10,010,612).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘156 application are directed to a drug, polymer, solvent, and additive that ius hydrophobic or hydrophilic. The instant claims include these components. Further, the composition include a long lasting injectable that can include NMP and DMSO at broad ratios, with a polymer of a MW that is 25kDa. Even further, the formulation can be an ISFI implant with sustained release of over 1 week. PLGA is claimed as a biodegradable polymer. See claim 21. As such, it would be obvious to arrive at the instant claims in view of those of the ‘156 application in view of the teachings of the cited prior art. ISFI systems exhibit phase inversion once injected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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