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
The amendments and arguments filed on 06/30/2024 are acknowledged and have been fully considered. Claims 1,3,6,19,27, and 33 have been amended. Claims 14-21 and 24-31 have been withdrawn. Claims 2,9, and 22-23 have been canceled; Applicants’ amendments are supported by the originally filed disclosure.
No new matter has been added.
Thus, claims 1,3-8,10-13 and 32-35 will be examined on the merits herein.
Withdrawn Rejections
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicant’s amendment to claim 3 correcting the dependency of the claim.
Rejections Maintained and Made Again in view of Applicant’s Amendments
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 1,3-8,10-13 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over PATEL et al (US 20210007973 A1; also available as WO2018067882A1) and Patel et al (US 20130189342 A1; referred to as Patel (2013) herein).
PATEL et al disclose implantable drug delivery devices comprising a core comprising a polymer (or polymer blend) and one or more drugs or pharmaceutical substances, and an outer shell comprising a polymer (or polymer blend) and one or more porogen materials (abstract). Patel teaches continuous release of a compound in vivo over an extended duration may be achieved via implantation of a device containing the compound encapsulated in a polymeric matrix ([0005]).
Regarding instant claim 1, 3,6-7 and 12 PATEL et al disclose a method of forming an implantable device comprising: extruding a first composition to form a core, the first composition comprising a first polymeric material ([0018], claim 31). The implantable device can be washed with ethanol, water, or a mixture of ethanol and water [0020]. Washing the device can dissolve the porogen material, or dissociate the porogen material, from the implantable device to form a plurality of pores in the shell ([0020]; claims 35 and 37). PATEL discloses the shell can lack a pharmaceutical substance ([0008]). PATEL et al disclose Patel the porogen material can comprise a bioerodible material ([0009]). The porogen material can comprise a non-bioerodible material ([0009]). The porogen material can comprise a material selected from the group consisting of an alkyl cellulose, a hydroxyalkyl cellulose, ethylcellulose, methylcellulose, hydroxymethylcellulose, a fatty acid, stearic acid, palmitic acid, myristic acid, linoleic acid, a biocompatible salt, sodium chloride, calcium chloride, and sodium phosphate; in some embodiments, the porogen material comprises ethyl cellulose (lack a pharmaceutical substance) ([0009], claim 10). PATEL discloses citric acid (a solid organic acid per instant spec [0071]) and benzoic acid are particularly useful as shell porogens in an implant with an EVA shell, or an implant with an EVA shell and an EVA core (see entire document, for instance ([0091]). PATEL teaches soluble polymers such as low molecular weight polyvinylpyrollidone (PVP) ([0112]). PATEL teaches non-biodegradable polymer ([0104]- [0105]). Patel teaches reinforcing member can comprise a polymer with good mechanical strength and resilience, such as pure ethylene-vinyl acetate (a matrix material) ([0087]).
PATEL et al teaches each blended mixture is heated to a temperature suitable for extrusion, such as the softening point of the polymer ([0127]). However, they do not expressly disclose including an extrudate having porogen in the bulk of the extrudate. Patel et al (2013) remedy this deficiency.
Patel (2013) discloses an implantable device for delivery of a pharmaceutical substance to a patient, comprising a core comprising a core polymeric material optionally containing a core pharmaceutical substance, surrounded by a first layer comprising a first-layer pharmaceutical substance and a first-layer polymeric material, optionally surrounded by one or more additional layers comprising an additional pharmaceutical substance and an additional polymeric material, where the core, first, and optional additional polymeric materials may be the same or different, and where the optional core pharmaceutical substance, first-layer pharmaceutical substance, and optional additional pharmaceutical substances are the same or different(see entire document, for instance, abstract). Patel (2013) teaches continuous release of a compound in vivo over an extended duration may be achieved via implantation of a device containing the compound encapsulated in a polymeric matrix ([0005]). Patel (2013) discloses incorporation of buprenorphine into the polymeric matrix causes the formation of a series of interconnecting channels and pores that are accessible to the surface for release of the drug ([0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instantly claimed invention to utilize an extrudate having porogen in the bulk of the extrudate as taught in Patel (2013) in the method of PATEL et al. One would have been motivated to do so in order to arrive at a composition with superior thermal properties. There would be a reasonable expectation of success since PATEL et al disclose a method of forming an implantable device comprising: extruding a first composition to form a core, the first composition comprising a first polymeric material ([0018], claim 31). PATEL et al teaches mechanical strength and resilience of ethylene-vinyl acetate. Patel (2013) disclose an implantable device for delivery of a pharmaceutical substance to a patient, comprising a core comprising a core polymeric material optionally containing a core pharmaceutical substance, surrounded by a first layer comprising a first-layer pharmaceutical substance and a first-layer polymeric material, optionally surrounded by one or more additional layers comprising an additional pharmaceutical substance and an additional polymeric material, where the core, first, and optional additional polymeric materials may be the same or different, and where the optional core pharmaceutical substance, first-layer pharmaceutical substance, and optional additional pharmaceutical substances are the same or different(see entire document, for instance, abstract). Patel (2013) teaches a series of interconnecting channels and pores that are accessible to the surface for release of the drug and the release rate can be altered by modifying the percent drug loading, porosity of the matrix ([0119]).
Regarding instant claims 4-5, PATEL et al teach the polymeric material can comprise a bioerodible material ([0010]). The polymeric material can comprise one or more materials selected from the group consisting of polybutylene terephthalate, polycarbonate, polyester, polyether ether ketone, polyethylene-co-tetrafluoroethylene, polymethylmethacrylate, polyolefin, polypropylene, polysulfones, polytetrafluoroethylene, polyurethane, polyvinylchloride, polyvinylidene fluoride, silicone, ABS resins, acrylic polymers and copolymers, acrylonitrile-styrene copolymers, alkyd resins, ethylene-vinyl acetate copolymers, copolymers of vinyl monomers with each other and olefins ([0010], [0012]; claim 15-16).
Regarding instant claims 8 and 10, PATEL et al teach the method further comprises washing the implantable device ([0020]; claims 35-37). The implantable device can be washed with ethanol, water, or a mixture of ethanol and water ([0020]; claim 36). Washing the device can dissolve the porogen material, or dissociate the porogen material, from the implantable device to form a plurality of pores in the shell ([0020]). PATEL et al disclose the extrudate can then be washed in a solvent, such as a solvent which dissolves and removes excess drug from the surface of the implant, or a solvent which assists in sterilization ([0128]). Washing with or immersing in solvents which remove the porogen from the shell can also be used if it is desired that the porogen be removed prior to implantation ([0128]). Examples of solvents which can be used for washing the implant include water, saline, aqueous buffers, and alcohols such as ethanol or isopropanol ([0128]). Mixtures of water and alcohols can also be used, such as ethanol-water mixtures ([0128]). Preferable solvents are 100% ethanol or water-ethanol mixtures ([0128]).
Regarding instant claims 11,13 and 34-35, PATEL discloses washing the device can dissolve the porogen material, or dissociate the porogen material, from the implantable device to form a plurality of pores in the shell ([0020]). PATEL teaches the porogen is removed from the device prior to implantation ([0067]). PATEL discloses a porogen is a first material which is embedded or mixed into a second material, which can be removed (for example, by dissolution, diffusion, or degradation) from the second material ([0070]). The removal of the porogen results in the creation of pores in the second material ([0070]). Washing with or immersing in solvents which remove the porogen from the shell can also be used if it is desired that the porogen be removed prior to implantation ([0128]). PATEL teaches and an outer shell comprising a polymer (or polymer blend) and one or more porogen materials (see entire document, for instance, abstract). PATEL discloses for rod-shaped devices, a reinforcing member can be incorporated into the core ([0087]). Such a reinforcing member can be incorporated by co-extrusion of a polymer substance within the drug-containing core, which will then form a third portion of the device, having a reinforcing member, a drug-containing core containing or surrounding the reinforcing member, and the porogen-containing shell ([0087]). PATEL discloses the capping material can be impermeable to the core pharmaceutical substance, which serves to prevent elution of core pharmaceutical substance from the ends of the device ([0088]). PATEL teaches a different polymer used for the shell than the polymer used for the core ([0090]). Looking into instant specification, "[i]n some embodiments, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, or at least about 99% of fluid-accessible porogen is removed from the extrudate by treating the extrudate with porogen removal fluid. ...If the desired amount of porogen removal is not attained with a single treatment of the extrudate with porogen removal fluid, the treatment can be repeated as needed until the desired amount of porogen is removed.” See instant specification ([0093]). The broadest reasonable interpretation of this disclosure is that all of the porogen is removed. Thus, it is in the purview of the skilled artisan to treat the extrudate with a fluid until the desired amount of porogen is removed. One would be motivated to do so with a reasonable expectation of success in the use of known technique to improve similar devices (methods, or products) in the same way. Thus, it is in the purview of the skilled artisan create pores accessible by fluid for loading a pharmaceutical substance into the bulk of the loadable porous structure; and fluid-inaccessible porogen. One would be motivated to do so with a reasonable expectation of success in the use of known technique to improve similar devices (methods, or products) in the same way.
Regarding instant claims 32, PATEL teaches pharmaceutical substance is releasable in a subdermal implant environment (see entire document, for instance [0137], [0270]).
Regarding instant claims 33, PATEL discloses the release of the pharmaceutical substance is sustained for a period of at least about 3 months in the subdermal implant environment. (see entire document, for instance [0136], [0138]).
Response to Arguments
Applicant's arguments filed 06/30/2025 have been fully considered but they are not persuasive. Applicant argues that instant claim 1 recites "extruding a mixture of a biocompatible, polymeric matrix material and a porogen at a temperature of at least the softening point of the matrix material" and that the pores formed after porogen removal are "loadable with a pharmaceutical substance, the loading occurring at a temperature below the softening point of the matrix." This provides a distinct advantage of avoiding exposure of the pharmaceutical substance to the heat, pressure, and mechanical forces present during extrusion. Applicant's argument is not found persuasive. The Examiner respectfully notes that the prior art is not required to have the same motivation as Applicant, wherein in the instant Application, the prior art provides motivation for the modifications. Further, “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” (MPEP 2144 (IV)). Patel teaches that reinforcing member can comprise a polymer with good mechanical strength and resilience, such as pure ethylene-vinyl acetate (a matrix material) ([0087]).
Applicant argues, PATEL et al. does not teach or provide motivation for producing an extrudate which does not contain drug. Applicant's argument is not found persuasive. First, it is noted that the instant claims do not exclude the presence of an active agent, rather, instant claim 12 recites that the porogen is not an active or drug, wherein a drug can be presence for a different purpose than as a porogen. The claims notably utilize “comprising” language, allowing additional components to be present. Second, it is noted that drugs and active agents have known functions within the art, wherein if their presence is not desired, one is able to exclude said component. It is noted that MPEP 2144.04 states, “Omission of an element and its function is obvious if the function of the element is not desired.”
Conclusion
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611