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 .
Receipt is acknowledged of Applicant’s Arguments and Request for Continued Examination filed on 01/20/2026.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/20/2026 has been entered.
Any previous rejections and/or objections not reiterated herein have been withdrawn in view of arguments filed on 01/20/2026. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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.
Claim(s) 1-7, 11-24 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Huffstetler et al. (US 2015/0057509) in view of Hughes et al. (US 2014/0275896), Williams et al. (US 20190083512) and Siddhesh Patil et al. (Diabetes Tech and Therapeutics, 6(6), 887-897, 2004).
Huffstetler discloses a sensor (e.g., an optical sensor) that may be implanted within a living animal (¢€.g., a human) and may be used to measure an analyte (é.g., glucose or oxygen) in a medium (e.g., interstitial fluid, blood, or intraperitoneal fluid) within the animal. The sensor may include a sensor housing, an analyte indicator covering at least a portion of the sensor housing, and one or more therapeutic agents. The one or more therapeutic agents may reduce deterioration of the analyte indicator. The one or more therapeutic agents may be incorporated within the analyte indicator, a membrane covering at least a portion of the analyte indicator, and/or one or more drug eluting polymer matrices, which may be external to or within the sensor housing. The sensor housing may be perforated to allow elution of the one or more therapeutic agents from a drug eluting polymer matrix within the sensor housing (abstract and 0013). In some embodiments, sensor 100 may include an analyte indicator. In some non-limiting embodiments, the analyte indicator may be a polymer graft 106 coated, diffused, adhered, or embedded on at least a portion of the exterior surface of the sensor housing 102. The polymer graft 106 may cover the entire surface of sensor housing 102 or only one or more portions of the surface of housing 102 (0033). The sensor 100 may include one or more drug-eluting polymer matrices. The drug eluting polymer matrix may cover at least a portion of the sensor housing 102. One or more therapeutic agents may be dispersed within the drug eluting polymer matrix (e.g., an inert polymer matrix). In some embodiments, the one or more therapeutic agents may reduce or stop the migration of neutrophils from entering the wound space and, thus, reduce or stop the production of
hydrogen peroxide and fibrotic encapsulation. Accordingly, in some embodiments, the one or more therapeutic agents may reduce deterioration of the analyte indicator (e.g., polymer graft 106) (0053). The drug-eluting polymer matrix may have a pre-formed shape such as, for example, a ring or sleeve. Other pre-formed shapes are possible, such as, for example and without limitation, a shell (e.g., conformal shell), cylinder, or any suitable monolith (e.g., rectangular) (0055). In some embodiments, the analyte indicator (e.g., polymer graft 106) may a have thin layer (e.g., 10 nm) on the outside of the graft 106. The thin layer may protect against indicator molecule degradation. The thin layer may be platinum, and platinum rapidly catalyzes the conversion of hydrogen peroxide into water and oxygen, which are harmless to the sensor (0057). In some non-limiting embodiments, as illustrated in FIG. 9E, the sensor 100 may include a membrane 934 covering at least a portion of the analyte indicator and the membrane 934 may be a porous, opaque diffusion membrane that is configured to: substantially prevent white blood cells from passing through the membrane, permit an analyte of interest to pass through the membrane to the graft (0058-0061). In some embodiments, the one or more therapeutic agents, which may be dispersed within the drug eluting polymer matrix, may include one or more anti- inflammatory drugs, such as, for example, non-steroidal anti-inflammatory drug (e.g., acetylsalicylic acid (aspirin) and/or isobutylphenyl propanoic acid (ibuprofen)). In some non-limiting embodiments, the one or more therapeutic agents may include one or more of dexamethasone, triamcinolone, betamethasone, methylprednisolone, beclometasone, derivatives thereof, and analogs thereof. In some embodiments, the one or more therapeutic agents may reduce deterioration of the analyte indicator (e.g., polymer graft 106) (0064). In some non-limiting embodiments, the drug eluting polymer matrix may release the one or more therapeutic agents distributed throughout the polymer matrix in a controlled manner. For instance, in various embodiments, the drug eluting polymer matrix may release the one or more therapeutic agents in a controlled manner over a period of hours, days, weeks, or months. FIG. 10 illustrates the release profile of dexamethasone acetate from a drug-eluting polymer matrix (0065). Additional disclosure includes that the sensor 100 may include a first drug eluting polymer matrix and a second drug eluting polymer matrix, the first drug eluting polymer matrix may release one or more therapeutic agents dispersed within the first drug eluting polymer matrix at a first rate, and the second drug eluting polymer matrix may release one or more therapeutic agents dispersed within the second drug eluting polymer matrix at a second rate that is different from the first rate. For example, in one non-limiting embodiment, a faster release rate may be used on the initial immune response (e.g., 0-21 days), and a slower release rate may be used as a maintenance release to moderate any chronic immune response (e.g.,14-365+ days).
Huffstetler fails to disclose drug eluting material comprising 1 wt% to 50 wt% of drug, silicon-based matrix, additives such as polyalkylene glycol, organic-based matrix, acrylics, silicone additive, catalytic additives, injection molded and the drug eluting material is configured to release the drug in a steady state release profile.
Hughes discloses a device comprises sensor configured to generate a signal indicative of a concentration of an analyte and a sensing membrane located over the sensor, where the sensing membrane comprises enzyme domain comprising an enzyme, a base polymer, and a hydrophilic polymer and the hydrophilic polymer comprises 5-30 wt.% enzyme domain (abstract). In some embodiments, the hydrophilic polymer is selected from the group consisting of poly(ethylene glycol) (PEG), polyacrylamide, acetates, polyethylene oxide (PEO), polyethylacrylate (PEA), polymers with pendent ionizable groups and copolymers or blends thereof (0006). In some embodiments, the base polymer comprises at least one polymer selected from the group consisting of epoxies, polyolefins, polysiloxanes, polyethers, acrylics, polyesters, carbonates, and polyurethanes (0008 and 0024). Alternatively, the analyte can be introduced into the body or exogenous, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition (0042). Although some of the description that follows is directed at glucose-measuring devices, including the described membrane systems and methods for their use, these
membrane systems are not limited to use in devices that measure or monitor glucose. These membrane systems are suitable for use in any of a variety of devices, including, for example, devices that detect and quantify other analytes present in biological fluids (0067). In some embodiments, one or more domains of the sensing membranes may be formed from materials such as silicone (reads on silicone based-matrix), cellulosic polymers, poly(ethylene oxide), poly(propylene oxide) and copolymers and blends
thereof, polysulfones and block copolymers thereof including, for example, di- block, tri-block, alternating, random and graft copolymers (reads on additives) (0092). The interference domain is formed from a silicone-containing polymer, such as a polyurethane containing silicone, or a silicone polymer and the silicone-containing interference domain may comprise a polymer with a high percentage of silicone (e.g., from about 25%, 30%, 35%, 40%, 45%, or 50% to about 60%, 70%, 80%, 90% or 95%) (0151). It is contemplated that any of a variety of bioactive (therapeutic) agents can be used with the analyte sensor systems described herein, such as the analyte sensor system shown in FIG. 1 (0170). These bioactive agents can be used alone or in combination. The bioactive agents can be dispersed throughout the material of the sensor, for example, incorporated into at least a portion of the membrane system, or incorporated into the device (e.g., housing) and adapted to diffuse through the membrane (0185). The bioactive agent can include a carrier matrix, wherein the matrix includes a system in which a bioactive agent is physically entrapped within a polymer network. The bioactive agent can be deposited in or on the membrane system, for example, by coating, filling, or solvent casting. (0188). In general, bioactive agents can be incorporated in (1) the polymer matrix forming the microspheres, (2) microparticle(s) surrounded by the polymer which forms the microspheres. The microspheres can be formed of biodegradable polymers, most preferably synthetic polymers or natural polymers such as proteins and polysaccharides (reads on organic-based matrix, (0191). In some embodiments, the bioactive agents of the preferred embodiments are designed to aid or overcome factors associated with short-term effects (e.g., acute inflammation or thrombosis) of sensor insertion and designed to aid or overcome factors associated with long- term effects, for example, chronic inflammation or build-up of fibrotic tissue or plaque material. In some embodiments, the bioactive agents of the preferred embodiments combine short- and long-term release to exploit the benefits of both (0195). Additional disclosure includes that 'controlled,' 'sustained' or 'extended' release of (bioactive agent) the factors can be continuous or discontinuous, linear or non-linear. This can be accomplished using one or more types of polymer compositions, drug loadings, selections of excipients or degradation enhancers, or other modifications, administered alone, in combination or sequentially to produce the desired effect.
Williams discloses engineered biodegradable drug delivery systems comprising intravitreal ocular implants suitable for delivery of corticosteroids to the posterior segment of a human eye (abstract). In one embodiment provides implants with highly uniform, tunable and reproducible size, shape, loading, composition, and load distribution, which provide implants having a desired extended drug release profile suitable for treating desired indications. In a particular embodiment, the implant is utilized to treat an ocular indication of inflammation (0008). In certain embodiments, the biodegradable polymer matrix contains one or more polymers, wherein the one or polymers is a biodegradable a poly(D,L-lactide) homopolymer, a biodegradable poly(D,L-lactide-co-glycolide) copolymer, or combinations thereof, wherein the biodegradable polymer matrix comprises about 80-90 weight percent of the pharmaceutical composition, and wherein the at least one therapeutic agent comprises about 10-20 weight percent of the pharmaceutical composition. (0032). In certain embodiments, the intravitreal implant comprises as a therapeutic agent content: about 1% to about 100%, or about 1% to about 90% w/w (0060). In certain embodiments, the therapeutic agent is a corticosteroid, the corticosteroid is selected from the group consisting of dexamethasone, fluocinolone acetonide, and combinations thereof. In a particular embodiment, the therapeutic agent is dexamethasone (0069). Additional disclosure includes that, an initial burst of at least one therapeutic agent may be desirable, followed by a more gradual release thereafter. The release rate may be steady state (commonly referred to as “timed release” or zero order kinetics), that is the at least one therapeutic agent is released in even amounts over a predetermined time (with or without an initial burst phase), or may be a gradient release (0174). Williams discloses that, any extended-release implant is highly dependent on the selection of polymers, co-polymers, drug-polymer interaction, load uniformity, porosity, size, surface-area to volume ratio, and the like for providing its drug release and degradation characteristics and the manufacturing techniques used in the prior art implants can induce inherent drawbacks in each of these parameters (0006).
Siddhesh discloses use of novel poly(lactic-co-glycolic) acid (PLGA) microsphere/poly(vinyl alcohol) (PVA) hydrogel composite coatings for implantable biosensors to control localized inflammation and fibrosis at the sensor/tissue interface. Composites were implanted into subcutaneous tissue of rats. In vitro and in vivo drug release kinetics were studied. Dexamethasone released at a steady rate of 0.17 g/day was sufficient to control acute and chronic inflammation as well as fibrosis (abstract). PLGA microsphere/PVA hydrogel composites delivered dexamethasone at approximately zero-order release kinetics in vivo as well as in vitro. These composites could be used as coatings for a variety of implantable devices with diverse architectures and applications (page 894). Additional disclosure includes that composite hydrogels show tremendous promise as versatile coatings for glucose biosensors and other implantable devices to control negative tissue responses and ensure device functionality. Such composite coatings coupled with advances in sensor technology will help realize the clinical application of long-term implantable glucose biosensors in the management of diabetes and for metabolic monitoring in general (page 895).
NOTE: With respect to the drug eluting material is configured to release the drug in a steady state release profile it, is well known in the art that (for example, . dexamethasone released at a steady rate of 0.17 µg/day was sufficient to control acute and chronic inflammation as well as fibrosis as taught by Siddhesh), by adjusting in particular the concentration of the release modifier (drug eluting polymer) and the active ingredient, and using routine testing of appropriate variations in vitro and in vivo, a person skilled in the art will readily be able to arrive at sensor that provide release profile for a given active substance under a given set of circumstances, and improve the safety profile of the drug. Drug release can also be tailored to avoid side effects of slower and longer release of the drug by engineering the article to provide steady release over a comparatively shorter period of time. Since Williams teaches that release rate may be steady state (commonly referred to as “timed release” or zero order kinetics), that is the at least one therapeutic agent is released in even amounts over a predetermined time (with or without an initial burst phase), or may be a gradient release (0174) and any extended-release implant is highly dependent on the selection of polymers, co-polymers, drug-polymer interaction, load uniformity, porosity, size, surface-area to volume ratio, and the like for providing its drug release and degradation characteristics and the manufacturing techniques used in the prior art implants (0006).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate drug eluting material comprising silicon-based matrix, polyalkylene glycol, organic-based matrix, acrylics, silicone additive, as taught by Hughes into Huffstetler's implantable sensors. The person of ordinary skill in the art would have been motivated to make those modifications because Hughes teaches that 'controlled,' 'sustained' or 'extended' release of (bioactive agent) the factors can be continuous or discontinuous, linear or non-linear and this can be accomplished using one or more types of polymer compositions, drug loadings, selections of excipients or degradation enhancers, or other modifications, administered alone, in combination or sequentially to produce the desired effect and the bioactive agent can be optimized for short- or long-term release and are designed to aid or overcome factors associated with short-term effects (e.g., acute inflammation or thrombosis) of sensor insertion and to aid or overcome factors associated with long-term effects, for example, chronic inflammation or build-up of fibrotic tissue or plaque material, and the bioactive agents of the preferred embodiments combine short-and long-term release to exploit the benefits of both (0195 and 0196). Therefore, one of ordinary skill in the art would have had a reasonable expectation of success because both Huffstetler and Hughes teaches sensor devices that can be used in same field of endeavor such as for measure analyte concentration and controlled release of drug diffused through polymer.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate drug eluting material comprising a wt% of the polymer matrix 85 +5% of a biodegradable poly(D,L-lactide) homopolymer and 15+5% of a biodegradable poly(D, L-lactide-co-glycolide) copolymer with homogenously dispersed therapeutic agent therein as taught by Williams into Huffstetler's implantable sensors. The person of ordinary skill in the art would have been motivated to make those modifications because Williams teaches that , an initial burst of at least one therapeutic agent may be desirable, followed by a more gradual release thereafter. The release rate may be steady state (commonly referred to as “timed release” or zero order kinetics), that is the at least one therapeutic agent is released in even amounts over a predetermined time (with or without an initial burst phase), or may be a gradient release (0174). Williams additionally teaches that more recent advancements in PLGA-based drug delivery systems have allowed for biphasic release characteristics with an initial high (burst) rate of therapeutic agent release followed by substantially sustained zero-order (linear) kinetic release (i.e., therapeutic agent release rate from the polymer matrix is steady and independent of the therapeutic agent concentration in the surrounding milieu) over longer periods. In addition, when desired for treating chronic diseases such as elevated IOP, these therapeutic agent delivery systems can be designed to have substantially steady state release following zero order kinetics from the onset (0226).
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGADISHWAR RAO SAMALA whose telephone number is (571)272-9927. The examiner can normally be reached Monday-Friday 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Hartley G Michael can be reached at 571 272 0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights