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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 15 Jun 2026 has been entered.
Claims 1-20 remain pending in the application.
Claims 1, 6, 7, 12-14, 19, and 20 are amended.
Claims 1-20 are pending and under consideration.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Non-Final Office Action mailed 21 Nov 2025 are hereby withdrawn in light of applicant’s amendments of the specification.
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 21 Nov 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 21 Nov 2025 are hereby partially withdrawn in light of applicants amendment of the claims.
Rejections Pursuant to 35 USC § 103
The rejection under 35 U.S.C. 103 as being unpatentable over Dunn et al. (US 5,702,716, published 30 Dec 1997, listed on IDS filed 10/21/2022) in view of Whitcup et al. (US 2014/0328835, published 16 Nov 2016) as evidenced by NIH (Antiretroviral Drug Discovery and Development) and Felstead et al. (WO 2008/099278, published 21 Aug 2008) is withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
The rejection of claims 1-8 and 14-18 under 35 U.S.C. 103 as being unpatentable over Cleland et al. (US 2017/0080092, published 23 Mar 2017) in view of Parent et al. (Journal of Controlled Release 172 (2013) 292–304, listed on IDS filed 12/21/2023) and Shangraw et al. (Chapter 4: Compressed Tablets by Direct Compression) is withdrawn in light of applicant’s amendment of the claims, and the art is reapplied in the new grounds of rejection set forth below.
Rejections Pursuant to Double Patenting
The rejections under double patenting are withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
Rejections 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.
Claim 13 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.
Claim 13 is indefinite in the recitation of an “undefined shape.” It is not clear what limitation is intended to be imposed on the tablet by defining it as an undefined shape. For example, it is not clear if this is intended to require that tablet has a non-polygonal shape or if there is some other structure intended which is understood as undefined.
New Grounds of Rejections
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.
Claim 3 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.
Claim 3 is indefinite for the recitation of “the pharmaceutically active agent.” This lacks proper antecedent basis back to the “at least one pharmaceutically active agent” and it is unclear if the “the pharmaceutically active agent” is intended to include one agent or more than one agent. Amending the claim to recite “the at least one pharmaceutically active agent” would overcome this rejection.
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.
Claims 1-8, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cleland et al. (US 2017/0080092, published 23 Mar 2017) in view of Parent et al. (Journal of Controlled Release 172 (2013) 292–304, listed on IDS filed 12/21/2023) and Shangraw et al. (Chapter 4: Compressed Tablets by Direct Compression).
Cleland teaches controlled delivery formulations for treatment of ocular disorders (abstract). Cleland teaches administration of active compounds over a period of at least two, three, four, five or six months or more in a controlled release that is linear and that is at or above a therapeutically effective dose ([0023]). Cleland does not teach the serum level as in claim 1, however, achieving a therapeutically effective dose requires that the serum level is at a sufficient level for to achieve efficacy. A linear release renders obvious a constant release as in claim 14. Cleland teaches delivery of two active compounds ([0021]). Cleland teaches that the active agent may include Sunitinib ([0022]) which is a cancer drug ([0155]). Cleland teaches an implant as a suitable dosage form ([0322]). Cleland teaches the drug delivery system comprises particles including biocompatible polymers such as poly(lactic-co-glycolic acid) ([0362]-[0363]). Cleland teaches that particles of the invention can be formed from drugs using a phase inversion method where the polymer matrix and one or more drugs is dissolved in a “good” solvent and the solution is poured into a strong non solvent for the drug to spontaneously produce microparticles or nanoparticles ([0394]). Cleland teaches that the particles formed by phase inversion can be formulated into a tablet ([0395]). Regarding claim 3 and the limitation that the solid composition is formed in situ, this limitation is understood broadly in light of the instant specification where compositions formed outside the body and in solution in a beaker are described as in situ (e.g. example 1, Fig 1 A). The formation of particles in a phase inversion method as is obvious over Cleland through normal laboratory practices is thus understood to meet the limitation of “in situ” as claimed.
Cleland does not teach removing residual solvent, micronizing or direct compression, the ratio of polymer to solvent (claim 2), or the solvent NMP (claim 6). These deficiencies are made up for in the teachings of Parent and Shangraw.
Parent teaches PLGA in situ implants formed by phase inversion (title). Parent teaches that NMP as a solvent and PLGA as a biodegradable polymer is used in commercialized products (page 293 bottom left column). Parent teaches water as a non-solvent for phase inversion (page 293 right bottom paragraph). Parent teaches a ternary phase diagram for the polymer, solvent, and non-solvent where it is shown that the ratio of each component determines whether the composition is stable or unstable (Figure 1). Parent teaches that injection of the polymeric solution into water leads to a fast diffusion of the solvent towards the aqueous medium (page 294 right column).
Shangraw teaches compressed tablets by direct compression (title), which is the process by which tablets are compressed directly from powder blends of the active ingredient and suitable excipients (page 196 lines 7-9). Shangraw teaches blending and compression as a common process for direct compression and that prior micronization may be necessary (page 198 second paragraph). Shangraw teaches that direct compression of tablets is economical and allows for processing without the need for moisture and heat (page 198 paragraphs 1-3). Shangraw teaches examples where acetaminophen was directly compressed and the material was prepared by spray drying or fluidized bed granulation (page 226).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed a controlled delivery device by a phase inversion process utilizing PLGA as the polymer and NMP as the solvent and to form the material into a dry powder and micronize in order to form a tablet using direct compression. Forming particles from phase inversion and turning the particles into a tablet is known form Cleland. The solvent NMP is known for use in phase inversion and it has been combined with PLGA, as taught by Parent, rendering it obvious to use NMP as the solvent as it is known for use in such a phase inversion process. Further, the process of phase inversion is done in situ, as known from Parent, alternatively rendering obvious the in situ limitation of claim 3. The formation of a tablet is known from Cleland and micronization and direct compression steps are known procedures for forming tablets, as taught by Shangraw. One of ordinary skill would thus have a reasonable expectation of success in forming a tablet from direct compression as Cleland teaches tablets and micronizing and direct compression are known processes for forming tablets, providing one of ordinary skill a reasonable expectation of success in using these techniques in forming the tablets. Further, the direct compression is the process by which tablets are compressed directly from powder blends of the active ingredient and suitable excipients and drying methods such as spray drying and fluidized bed granulation may be used as part of material preparation, as known from Shangraw, rendering these obvious steps for forming the tablet by direct compression. Forming a powder along with drying methods as described renders obvious a dry insoluble solid composition and removal of solvent. Regarding claims 16 and 17, administering the device to a subject afflicted with a communicable disease such as HIV is an intended use of the product and does not distinguish the product from the prior art as the intended use of a product claim carries no patentable weight. See MPEP 2111.02. Regarding the ratio of polymer to solvent as recited in instant claim 2, Parent indicates that the relative amounts of polymer, solvent and non-solvent impact the phase inversion process leading to stable or unstable compositions. Thus, in view of the teachings of Parent, the amounts of polymer and organic solvent in the composition is an art-recognized result effective variable such that determining that the ratio should be 1:2-1:10 as in instant claim 2 would be a matter of optimization through routine experimentation. "[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). In the instant case, it would be obvious to one of ordinary skill to vary the polymer and organic concentrations to achieve stable compositions for use.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 15 Jun 2026 have been fully considered but they are not persuasive. Applicant states that their combination of phase inversion, micronization, and compression provides a solid polymeric drug implant with high drug loading efficiency and lower active agent burst release than an implant made via a similar process that does not combine these methods and that these results are not suggested by Cleland, Parent, and Shangraw and would have been unexpected prior to the instant disclosure (page 17 of remarks). Applicant asserts their method allows for high drug loading and points to examples of the instant specification for evidence of more consistent drug release kinetics (paragraphs 6-8 of 1.132 declaration). The examiner does not find this persuasive at least for the reason that the claims are not commensurate in scope with the examples provided. For instance, claims 1 and 18 are open to any organic solvent and polymer in any ratio combination and there is nothing to indicate that the results demonstrated would be expected across the large range of the claims. Applicant argues that the claimed process offers advantages over commercial implants which involve extrusion in their process (paragraphs 9 and 14 of declaration). The examiner does not find this persuasive as extrusion is not a necessary part of the process rendered obvious over the applied prior art.
Applicant argues that Cleland mentions generally that particles formed by phase inversion could be formulated into a tablet but does not provide results for a compressed tablet (page 18 of remarks, paragraph 15 of declaration). The examiner does not find this persuasive the rejection was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While the applied art may not provide a specific embodiment of the instantly claimed invention, the examiner maintains that the invention as claimed is nonetheless made obvious over combined teachings from the prior art. Forming phase inverted particles into tablets is obvious from Cleland and direct compression (with micronization) is a known method of forming tablets, as described in the rejection above, and it would be obvious to combine this known method of forming tablets with the particles of Cleland. It is not necessary for the art to have a specific embodiment of the claimed invention for it to be obvious.
Applicant argues that Parent teaches in-situ forming implants which means they solidify in vivo in the place of injection which would result in the introduction of organic solvent in the body (paragraph 16 of remarks). The examiner first notes that the claims are open to in situ formation as is required in claim 3. Additionally, the examiner is not persuaded by this as Cleland does not require formation in the body and it would be obvious to form the compositions outside the body.
Claims 9, 10, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Cleland et al. (US 2017/0080092, published 23 Mar 2017) in view of Parent et al. (Journal of Controlled Release 172 (2013) 292–304, listed on IDS filed 12/21/2023) and Shangraw et al. (Chapter 4: Compressed Tablets by Direct Compression) as applied to claims 1-8 and 14-17 above and further in view of Whitcup et al. (US 2014/0328835, published 16 Nov 2016) as evidenced by NIH (Antiretroviral Drug Discovery and Development) as evidenced by NIH (Antiretroviral Drug Discovery and Development).
The teachings of Cleland, Parent, and Shangraw are described supra.
Cleland, Parent, and Shangraw do not teach an antiretroviral agent (claims 9 and 10) or tablets of various shapes (claims 12 and 13). These deficiencies are made up for in the teachings of Whitcup.
Whitcup teaches methods and implants which can provide an extended treatment of an ocular condition after release of a therapeutic amount of a drug from an implant (([0006], [0039]). Whitcup teaches that the implants can include an active agent mixed with or dispersed within a biodegradable polymer ([0081]) and teaches that the implant compositions can vary according to the preferred drug release profile, the particular active agent used, the ocular condition being treated, and the medical history of the patient ([0081]). Whitcup teaches that it is desirable to have extended release durations of 6, 8, 12 months or more ([0038]). Whitcup teaches that active agents include anti-viral drugs such as azidothymidine ([0081]). As evidenced by NIH, azidothymidine is known for treating HIV infection and suppressing HIV replication (page 1 AZT: the first drug to treat HIV infection). Whitcup teaches that the active agent may be homogenously dispersed in the biodegradable polymer of the implant ([0086]). Whitcup teaches that the biodegradable polymer may be copolymers of glycolic and lactic acid, where the biodegradation is controlled by the ratio of glycolic to lactic acid and teaches that poly(lactic-co-glycolic) acid (PLGA) copolymer is suitable for the invention and that the percent of each monomer in the PLGA may vary ([0089]). Whitcup teaches that various techniques may be employed to make implants within the scope of the invention, including compression methods ([0101]) and Whitcup teaches an example of forming a compressed tablet where micronized dexamethasone and micronized 50/50 PLGA were formed using a tablet press ([0119]). Whitcupp teaches that the size and shape of the implant may be used to control the rate of release, period of treatment and active agent concentration at the site of implantation ([0095]) and teaches implants as discs and rods ([0096]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the tablet obvious over Cleland, Parent, and Shangraw into shapes such as rods and to incorporate two actives with an active component such as azidothymidine. Ocular implants that include active components such as azidothymidine and that are formed into tablets with rod shapes are known from Whitcup, thus rendering these known and obvious features to include in ocular implants. One of ordinary skill would have a reasonable expectation of success in their inclusion as the same form, namely ocular implant tablets, are obvious from Cleland, Parent, and Shangraw and the inclusion of these features merely represents use of known prior art elements for their known function, namely ocular implant tablets.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
The claims were previously rejected as described above and are alternatively rejected below using additional art.
Claims 1-10, 14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wiles et al. (US 2017/0056428, published 02 Mar 2017) in view of Parent et al. (Journal of Controlled Release 172 (2013) 292–304, listed on IDS filed 12/21/2023) and Shangraw et al. (Chapter 4: Compressed Tablets by Direct Compression).
Wiles teaches use of a compound of Formula I for the treatment of a disorder ([0019]). Wiles teaches dosage forms include implants ([0165]), a tablet and a dry powder ([0325]). Wiles teaches administration to the eye in a controlled release fashion ([0027]), and teaches an optical implant ([0165]). Wiles teaches the compounds may be formulated as particles such as micro or nanoparticles ([0330]) and teaches techniques for preparing the particles include phase inversion ([0331]). Wiles teaches with phase inversion, the compound (or polymer matrix and one or more active compounds) is dissolved in a suitable solvent, and the solution poured into a strong non-solvent for the compound to spontaneously produce, under favorable conditions, microparticles or nanoparticles ([0338]) (the one or more active compounds renders obvious the at least two drugs of claim 10). Wiles teaches that particles formed by phase inversion can be formulated into a tablet ([0339]), rendering obvious a single tablet as in claim 7. Wiles teaches extended release delivery ([0344]) and releasing compounds at a sustained rate ([0345]), rendering obvious the constant release rate of claim 14. Wiles teaches oral and subdermal administration ([0324]), rendering obvious claim 18. Wiles teaches use of active compounds for treatment of selected disorders ([0358]) including HIV ([0389]) and retroviruses ([0390]), rendering it obvious to include an antiretroviral gent and to treat HIV as in claims 8-10, 16, 17, 19, and 20. Regarding claim 3 and the limitation that the solid composition is formed in situ, this limitation is understood broadly in light of the instant specification where compositions formed outside the body and in solution in a beaker are described as in situ (e.g. example 1, Fig 1 A). The formation of particles in a phase inversion method as is obvious over Wiles through normal laboratory practices is thus understood to meet the limitation of “in situ” as claimed.
Wiles does not teach removing residual solvent, micronizing or direct compression, the ratio of polymer to solvent (claim 2), or the polymer PLGA (claim 5) or solvent NMP (claim 6). These deficiencies are made up for in the teachings of Parent and Shangraw.
Parent teaches PLGA in situ implants formed by phase inversion (title). Parent teaches that NMP as a solvent and PLGA as a biodegradable polymer is used in commercialized products (page 293 bottom left column). Parent teaches water as a non-solvent for phase inversion (page 293 right bottom paragraph). Parent teaches a ternary phase diagram for the polymer, solvent, and non-solvent where it is shown that the ratio of each component determines whether the composition is stable or unstable (Figure 1). Parent teaches that injection of the polymeric solution into water leads to a fast diffusion of the solvent towards the aqueous medium (page 294 right column).
Shangraw teaches compressed tablets by direct compression (title), which is the process by which tablets are compressed directly from powder blends of the active ingredient and suitable excipients (page 196 lines 7-9). Shangraw teaches blending and compression as a common process for direct compression and that prior micronization may be necessary (page 198 second paragraph). Shangraw teaches that direct compression of tablets is economical and allows for processing without the need for moisture and heat (page 198 paragraphs 1-3). Shangraw teaches examples where acetaminophen was directly compressed and the material was prepared by spray drying or fluidized bed granulation (page 226).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed a controlled delivery device by a phase inversion process utilizing PLGA as the polymer and NMP as the solvent and to form the material into a dry powder and micronize in order to form a tablet using direct compression. Forming particles from phase inversion and turning the particles into an implant, dry powder or tablet is known from Wiles. The solvent NMP is known for use in phase inversion and it has been combined with PLGA, as taught by Parent, rendering it obvious to use NMP as the solvent as it is known for use in such a phase inversion process. Further, the process of phase inversion is done in situ, as known from Parent, alternatively rendering obvious claim 3. The formation of a tablet is known from Wiles and micronization and direct compression of a powder are steps known for forming tablets, as taught by Shangraw. One of ordinary skill would thus have a reasonable expectation of success in forming a tablet from direct compression as Wiles teaches forming dry powders and tablets and micronizing and direct compression are known processes for forming tablets, providing one of ordinary skill a reasonable expectation of success in using these techniques in forming the tablets. The use of a dry powder, as is obvious from Wiles, is understood to render obvious the removal of solvents as this is necessary for form a dry powder. Additionally, the direct compression is the process by which tablets are compressed directly from powder blends of the active ingredient and suitable excipients and drying methods such as spray drying and fluidized bed granulation may be used as part of material preparation, as known from Shangraw, rendering these obvious steps for forming the tablet by direct compression. Forming a powder along with drying methods as described also renders obvious a dry insoluble solid composition and removal of solvent. Regarding the ratio of polymer to solvent as recited in instant claim 2, Parent indicates that the relative amounts of polymer, solvent and non-solvent impact the phase inversion process leading to stable or unstable compositions. Thus, in view of the teachings of Parent, the amounts of polymer and organic solvent in the composition is an art-recognized result effective variable such that determining that the ratio should be 1:2-1:10 as in instant claim 2 would be a matter of optimization through routine experimentation. "[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). In the instant case, it would be obvious to one of ordinary skill to vary the polymer and organic concentrations to achieve stable compositions for use.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wiles et al. (US 2017/0056428, published 02 Mar 2017) in view of Parent et al. (Journal of Controlled Release 172 (2013) 292–304, listed on IDS filed 12/21/2023) and Shangraw et al. (Chapter 4: Compressed Tablets by Direct Compression) as applied to claims 1-10, 14, and 16-20 above, and further in view of Lanquetin et al. (US 5,565,443, 15 Oct 1996).
The teachings of Wiles, Parent, and Shangraw are described supra.
Wiles, Parent, and Shangraw do not teach a contraceptive agent or delivery from about 6 months to about 1 year. These deficiencies are made up for in the teachings of Lanquetin.
Lanquetin teaches a subcutaneous implant for preventing conception for at least one year (abstract). Lanquetin teaches implants of nomegestrol acetate are an efficient contraceptive agent (col 6 lines 61-65).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed an implant material from phase inversion with a contraceptive for subcutaneous delivery of at least one year. It is obvious from Wiles, Parent, and Shangraw to form implants that may be subdermally delivered for an extended release and it is known from Lanquetin that contraceptive agents may be used with a subcuntaneous implant for at least a year. The use of a contraceptive with the implant formed by phase inversion thus merely represents the combination of known prior art elements according to their known function, namely delivery of active agents with implants that have been formed by phase inversion. One of ordinary skill would have a reasonable expectation of success as subdermal delivery of actives with implants formed from phase inversion is obvious from Wiles, Parent, and Shangraw and the use of a contraceptive for subcutaneous implants is known from Lanquetin, indicating the suitability of contraceptives with such implant delivery forms.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wiles et al. (US 2017/0056428, published 02 Mar 2017) in view of Parent et al. (Journal of Controlled Release 172 (2013) 292–304, listed on IDS filed 12/21/2023) and Shangraw et al. (Chapter 4: Compressed Tablets by Direct Compression) as applied to claims 1-10, 14, and 16-20 above, and further in view of Whitcup et al. (US 2014/0328835, published 16 Nov 2016).
The teachings of Wiles, Parent, and Shangraw are described supra.
Wiles, Parent, and Shangraw do not teach forming the tablet into shapes such as rods or delivery between six months and a year. These deficiencies are made up for in the teachings of Whitcup.
Whitcup teaches methods and implants which can provide an extended treatment of an ocular condition after release of a therapeutic amount of a drug from an implant (([0006], [0039]). Whitcup teaches that the implants can include an active agent mixed with or dispersed within a biodegradable polymer ([0081]) and teaches that the implant compositions can vary according to the preferred drug release profile, the particular active agent used, the ocular condition being treated, and the medical history of the patient ([0081]). Whitcup teaches that it is desirable to have extended release durations of 6, 8, 12 months or more ([0038]). Whitcup teaches that the active agent may be homogenously dispersed in the biodegradable polymer of the implant ([0086]). Whitcup teaches that the biodegradable polymer may be copolymers of glycolic and lactic acid, where the biodegradation is controlled by the ratio of glycolic to lactic acid and teaches that poly(lactic-co-glycolic) acid (PLGA) copolymer is suitable for the invention and that the percent of each monomer in the PLGA may vary ([0089]). Whitcupp teaches that the size and shape of the implant may be used to control the rate of release, period of treatment and active agent concentration at the site of implantation ([0095]) and teaches implants as discs and rods ([0096]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed an ocular implant in shapes such as a rod for delivery over 6, 8, 12 months. Tablets and optical implants formed by phase inversion for extended release is obvious over Wiles, Parent, and Shangraw and ocular implants with shapes such as rod that delivery over 6, 8, or 12 months is known from Whitcup. Thus, one of ordinary skill would have a reasonable expectation of success in forming tablets as optical implants with a rod shape with delivery of 6, 8, or 12 months as these are features known to be suitable for ocular implants and their inclusion thus represents the use of known elements for their known use as ocular implants. Rod shapes are suitable for ocular implants and it is known to have delivery over 6, 8 , or 12 months, rendering these obvious features to include for optical implants.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S Patent No. 12,576,035 (previously rejected as application 17/427,190) in view of Whitcup et al. (US 2014/0328835, published 16 Nov 2016) as evidenced by NIH (Antiretroviral Drug Discovery and Development. The ‘190 application has been allowed and claims referenced below refer to the claims as presented in the examiner’s amendment of the notice of allowance.
Claim 7-14 of the ‘035 patent are presented below.
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These claims render obvious instant claims 1-11 and 14-20.
The claims of the reference patent do not recite forming the tablet into shapes and sizes such as those of instant claims 12 and 13. This deficiency is made up for in the teachings of Whitcupp.
The teachings of Whitcupp are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the tablet implant of the reference patent in various shapes such as discs and rods. The formation of tablets for implantation, where the tablets have various shapes such as discs and rods is known from the teachings of Whitcupp. Thus, it would have been obvious to one of ordinary skill to form the tablets of the reference patent with shapes such as discs and rods as these are suitable shapes for implants.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 15 Jun 2026 have been fully considered. Applicant notes that a terminal disclaimer was filed for the reference patent. The examiner acknowledges that the terminal disclaimer has been filed but notes that it has not been officially approved yet and the rejection will be maintained until the terminal disclaimer is officially approved.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-10, 14-21 and 23-26 of copending Application No. 18/836,156 in view of Wiles et al. (US 2017/0056428, published 02 Mar 2017), Parent et al. (Journal of Controlled Release 172 (2013) 292–304, listed on IDS filed 12/21/2023), Shangraw et al. (Chapter 4: Compressed Tablets by Direct Compression), Whitcup et al. (US 2014/0328835, published 16 Nov 2016) and Lanquetin et al. (US 5,565,443, 15 Oct 1996)
Claim 1 of the ‘156 application recites an extended release composition comprising a drug or active agent, a biocompatible solvent, a biodegradable polymer and an amphiphilic or hydrophobic additive. Claim 2 recites an in-situ forming implant, claim 14 recites that the solvent is NMP and claim 18 recites that the polymer is PLGA.
The ‘156 application does not teach the phase inversion method, removal of solvent, micronization and compression, formation of a tablet with rod shape, the active agents of the instant claims or administering to a subject with a communicable disease such as HIV. These deficiencies are made up for in the teachings of Wiles, Parent, Shangraw, Whitcup, and Lanquetin.
The teachings of Wiles, Parent, Shangraw, Whitcup, and Lanquetin are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the extended release composition as a tablet by introducing the PLGA and NMP with active agent into an aqueous medium and to micronize and compress solid resulting from phase inversion. Formation of implantable components such as tablets formed by phase inversion is known from Wiles and PLGA and NMP are known from Parent as components for phase inverion and direct compression with micronization is a standard methods for forming implantable tablets, as taught by Shangraw. Contraceptives are known from Lanquetin as components to include in extended release implants rendering this an obvious active for such components. The formation of the tablets with various shapes such as rods and discs is known from Whitcupp, rendering these features as obvious for ocular implants. It is further known from Wiles that such compositions may be delivered orally and subdermally and may include antiretrovirals for HIV, rendering these obvious limitations for such compositions.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 15 Jun 2026 have been fully considered but they are not persuasive. Applicant states that the ‘156 application is filed later than the instant application. The examiner does not find this persuasive as the provisional double patenting rejection is withdraw if it is the only rejection remaining in an application having the earlier patent term filing date. There are other rejections currently remaining.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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