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 submitted information disclosure statements (IDSs) were filed on 05/18/2026 and 07/29/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Application
Applicants' arguments/remarks filed 05/18/2026 are acknowledged. Claim 74 is newly added. Claims 56-74 are examined on the merits within and are currently pending.
New and Modified Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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 non-obviousness.
Claims 56-58, 60, 63-73 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 20050181010 A1), Lahann et al. (US 20140147510 A1), David et al. (US 9260803 B2) and Serrano-Garcia et al. (US 20180226582A1) in view of Park et al. (US 9252429 B2) and further in view of O’Malley (US 20090059367 A1).
Claims 56-57,
Hunter et al. teach pumps and sensors for contact with tissue are used in combination with an anti-scarring agent (e.g., a cell cycle inhibitor) in order to inhibit scarring that may otherwise occur when the pumps and sensors are implanted within an animal. (Abs). "Medical device", "implant", "device", "medical device," "medical implant", "implant/device", and the like are placed within a patient's body for one or more therapeutic or prophylactic purposes such as for restoring physiological function, alleviating symptoms associated with disease, delivering therapeutic agents, detecting changes (or levels) in the internal environment, and/or repairing or replacing or augmenting etc. damaged or diseased organs and tissues. While medical devices are normally composed of biologically compatible synthetic materials (e.g., medical-grade stainless steel, titanium and other metals; exogenous polymers, such as polyurethane, silicon, PLA, PLGA), other materials may also be used in the construction of the medical device or implant. (0055). The repair of tissues following a mechanical or surgical intervention, such as the implantation of a pump or sensor, involves two distinct processes: regeneration or the replacement of injured cells by cells of the same type and fibrosis or the replacement of injured cells by connective tissue. (0011). Provided polymeric carriers are adapted to contain and release a hydrophobic fibrosis-inhibiting compound, that may be contained within a hydrophobic core, which contained within a hydrophilic shell. (0544). Collagens for use in the crosslinked polymer compositions of the present invention may start out in fibrillar form, then be rendered nonfibrillar by the addition of one or more fiber disassembly agent. (0599). The form of collagen which is employed may be insoluble fibers. (0691). Each molecular core of the reactive components of the crosslinkable composition is generally selected from synthetic and naturally occurring hydrophilic polymers, hydrophobic polymers. (0658). The implantable sensor may detect body fluid absolute pressure at a selected site and ambient operating temperature by using a lead, sensor module, sensor circuit (including electrical conductors) and means for providing voltage. The combining is performed by completely covering the sensor with an electrospun fabric that contains the agent or the composition. (1009). The device further comprises a visualization agent; the device further comprises a visualization agent, wherein the visualization agent is a radiopaque material, wherein the radiopaque material comprises a metal, a halogenated compound, or a barium containing compound; the device further comprises a visualization agent, wherein the visualization agent is a radiopaque material, wherein the radiopaque material comprises barium, tantalum, or technetium, (0923), which are electroconductive materials.
Hunter et al. do not teach DNA/RNA or nucleic acid in the core, nor specific voltage 100-500 volts.
Lahann et al. teach the multiphasic micro-components comprising one or more active ingredients that provides a diagnostic, therapeutic, prophylactic, cosmetic, sensory, and/or aesthetic benefit to an organism, such as a mammal. In certain aspects, an active ingredient prevents or treats a disease, disorder, or condition of hard or soft tissue in an organism, such as a mammal. (0097). A multiphasic micro-component comprises a first phase (that can include a first polymer) and at least one additional phase distinct from said first phase (that can include a second polymer). One or more of the first phase and additional phase comprises a component that is responsive to an external stimulus, (Abs), dual core/shell fibers (0145). When electric jetting is used to form multiphasic micro-components in the form of fibers (for example, by electrospinning). (0075). Multiphasic polymeric micro-components capable of shape shifting. Such a multiphasic micro-component comprises a first phase (that can include a first polymer) and at least one additional phase distinct from said first phase (that can include a second polymer). One or more of the first phase and additional phase comprises a component that is responsive to an external stimulus. External stimuli include ionic strength, a stimulator chemical, electric energy, pressure, magnetic fields, and combinations thereof. (Abs). The present disclosure provides novel polymeric anisotropic particles comprising at least two distinct phases that are capable of reconfiguration or “shape-shifting by changing from an initial state upon exposure to an external stimulus. Thus, in certain aspects, the multiphasic anisotropic micro-components of the present disclosure have at least one phase that is dynamic or changes its physical or chemical properties in response to a change in the surrounding physical, chemical, or biological environment. For instance, in certain variations, multiphasic anisotropic micro-components can be formed to have at least one phase that swells or has an altered shape when it is exposed to such an external stimulus. The physical or chemical properties of the multiphasic micro-components can change and induce or enhance release of an ingredient within the micro-component, such as an active agent, like a drug, a bioactive material, a fragrance, a chemical, and the like. (0052). Suitable active ingredients for use in such pharmaceutically and/or cosmetically acceptable compositions are well known to those of skill in the art and include, low-molecular weight molecules, quantum dots, natural and artificial macromolecules, such as proteins, sugars, peptides, DNA, RNA, and the like, polymers, dyes and colorants, inorganic ingredients including nanoparticles, nano-materials, and nano-crystals, fragrances, and mixtures thereof. (0098). Shape-shifting of multiphasic microcylinders is per formed by applying an external stimulus to which the micro cylinder is physically responsive (and transforms by shape or volume). (0130).
Lahann et al. do not teach electroconductive material nor specific voltage 100-500 volts.
David et al. teach a method of manufacturing a wound dressing or tissue scaffold comprising the method described for manufacturing a pharmaceutical drug release fibre, and further comprising weaving the fibres to form the wound dressing or tissue scaffold. (Col. 5, lines27-32); electrospinning fibers; the fibers have an inner core surrounded by an outer shell. The fibers comprise co-electrospinning first and second liquids as core and shell, which can be used for controlled release of drug. (Abs). Fiber materials incorporating drugs in the outer shell. (Col 1, lines 47-48). The liquid can be a polymer or liquid with a viscosity due to high molecular weight (col. 1, lines 28-30). By careful choice of polymer and solvent system combined with a high enough electric field, fibers with nanometer scale diameters can be formed. (Col. 1, lines 35-37). The fibers comprise the first liquid comprising a hydride and the second liquid comprises a polymer. (Col. 7, lines 17-19). The hydride may be ammonia borane (AB), metal amido-borane and the polymer polystyrene. (Col. 7, lines 24-27). Ionic and metallic hydrides, can exhibit electrical conductivity, and are being explored for applications in energy storage and conversion.
(https://simple.wikipedia.org/wiki/Hydride#:~:text=A%20hydride%20is%20a%20compound,is%20a%20hydride%20of%20oxygen.).
Core-shell fibers with a porous shell may be electrospun from a core solution having a viscosity as low as 1-2 cP, when the core and shell solutions or liquids are semimiscible, and the core is highly conducting. (Col. 7, lines 41-44).
Serrano-Garcia et al. teach a coaxial nanocomposite including a core, which includes
fibers of a first organic polymer, and a shell, which includes fibers of a second organic polymer, the first polymer and the second polymer forming a heterojunction. (Abs). Intelligent textiles, air/water filters, bone scaffolds, and drug delivery applications have all directly benefitted from the reliable and low-cost electrospinning technique for fiber fabrication. (0005). The internal core also can be inclusive of two or more organic semiconducting fibers having the composition
of blended or distinct polymers. If the internal separation of core nanofibers is larger than 0, a multicore coaxial fiber is created. The core strands can be from the same or different organic semiconductive or conductive polymers. (0025).
Hunter et al. teach electroconductive materials, a metal, tantalum. (0923). David et al., teach metal nanofibers (Col. 1, lines 40-41).
Park et al. (US 9252429 B2) teach electro-conductive metals in the core may be selected from the group consisting of Cu, Ag, Pt and Ni. (Col. 4, lines 29-30).
Hunter et al., Lahann et al., David et al., Serrano-Garcia et al., Park et al. do not teach applying specific voltage 100-500 volts to release bioactive materials.
O’Malley teach metal nanoparticles can be chemically functionalized so as to enable chemical bond formation with double or single DNA strands. The sequence of these attached DNA strands to the metal can be made to associate with the complimentary sequence DNA strands in a polynucleic acid template. In addition, metal ions can be templated onto the polymer scaffold as precursor metals and subsequently reduced to yield a ground state metal. The bases of DNA can also be modified to allow for binding of precursor metal ions and thus subsequently enable metallization. It is important to note that the resultant metal structure from templating may also be used itself as a template for subsequent metallization. That is to say that the ground state of the metal nanorods can provide a surface for in situ growth of other metals much like a core-shell structure. (0114). The template polymer may be spun into a fiber by, inter alia, electrospinning. (0137). Apply a 100volts current to draw the metallized DNA into the gel exactly as is always done in molecular biology. (0218). It would be obvious that when this system is in tissues, applying a 100volts current would release DNA into cells and the voltage needed to release bioactive materials would be varied depending the composition and the size of the core/shell/metal/bioactive materials.
It would have been obvious to one of ordinary skills in the art before the effective filing date of the invention to prepare "Medical device", "implant", "device", "medical device," "medical implant", "implant/device", and the like are placed within a patient's body for one or more therapeutic or prophylactic purposes such as for restoring physiological function, alleviating symptoms associated with disease, delivering therapeutic agents, detecting changes (or levels) in the internal environment, and/or repairing or replacing or augmenting etc. damaged or diseased organs and tissues, with a core/shell structure, comprising of polymers, taught by Hunter et al.,. an electrospun comprising an electrically conductive central core comprising a first polymer, and electroconductive materials, which can be electroconductive polymer and/or an electroconductive metal; and a shell comprising a second polymer, which can carry drug(s), taught by David et al., Lahann et al. and Serrano-Garcia et al., wherein electro-conductive polymers may be selected from the group consisting of polypyrrole and polyaniline, electro-conductive metals may be selected from the group consisting of Cu, Ag, Pt and Ni., and not particularly limited of electro-conductive polymers or electro-conductive metals, so long as they exhibit excellent conductivity, taught by Park et al. (US 9252429 B2), and to have DNA released when applying a voltage of about 100 voltage taught by O’Malley, since they have proven the method is feasible with the goals to have conductivity for DNA release for repairing damaged tissues.
With regard to claim 58,
Park et al. (US 9252429 B2) teach electro-conductive polymers may be selected from the group consisting of polypyrrole and polyaniline. (Col. 4, lines 34-35).
With regard to claim 60,
Hunter et al. teach the device or therapeutic composition can also comprise radio-opaque, echogenic materials and magnetic resonance imaging (MRI) responsive materials (i.e., MRI contrast agents) to aid in visualization of the device under ultrasound, fluoroscopy and/or MRI. For example, a device may be made with or coated with a composition which is echogenic or radiopaque (e.g., made with echogenic or radiopaque with materials such as powdered tantalum. (0832, 0923, 0925, 0966, 0968, 1009-1011).
With regard to Claim 63,
Park et al. (US 9252429 B2) teach additive material referred to as "core particle", which is coated with electro-conductive materials, referred to as "coating materials", which are coated on core particles, are not particularly limited, so long as they exhibit excellent conductivity without causing chemical changes in the battery of interest. For example, there may be preferably used at least one selected from the group consisting of carbon that has been
used as conductive material for a conventional lithium secondary battery, electro-conductive materials, electro-conductive metals, electro-conductive inorganic materials and electro-
conductive polymers. (Col 3, lines 12-21). Electro-conductive metals may be selected from the group consisting of Cu, Ag, Pt and Ni. (Col. 4, lines 29-30) and electro-conductive polymers may be selected from the group consisting of polypyrrole and polyaniline. (Col. 4, lines 34-35).
With regard to claims 64, 65, 67 and 68
David et al. teach the first polymer may be polystyrene. (Col 5, lines 16-17).
Lahann et al. teach in certain variations, a pharmaceutically and/or cosmetically acceptable polymer for the composition of the first phase or at least one additional phase (e.g., first or second suitable non-limiting polymers for use in the multiphasic compositions include poly(lactide-co-glycolide) polymer. (0090).
Serrano-Garcia et al. teach first polymer like polylactic acid (PLA), can be used. (0033).
With regard to claim 66,
Serrano-Garcia et al. teach in certain embodiments, the coaxial nanocomposite diameter may be from about 200 nm to about 3000 nm. In certain embodiments. The core diameter may be greater than 200 nm, such as about 435 nm, about 713 nm, about 1390 nm, or about 2772 nm. In other embodiments, the shell diameter may be greater than 75 nm, such as about 327 nm, about 520 nm, about 552 nm, about 605 nm, or about 1652 nm. (0042).
With regard to claims 69-70,
David et al. teach the apparatus comprises reservoirs (not shown) fluidly connected to nozzle 40. The nozzle comprises an inner core channel and an outer concentric annular channel that receive the fluids from the reservoirs. The openings in the nozzle are a central circular one for the core, and an annular concentric opening for the shell. Other shapes and arrangements of openings are available. Such as a series of circularly arranged openings for the shell fluid. When the fluid flows through the multiple shell openings the fluid combines to form a shell surrounding the core. (Col. 8, lines 28-37).
Serrano-Garcia et al. teach the electrospinning technique is a reliable and low-cost method that has been broadly used in the fabrication of nanofibers for intelligent textiles, filters, and bone scaffolds. Electrospinning has also been used to fabricate microtubes, drug delivery nanochannels, and devices for multifunctional applications. (0004). It would be obvious that channels would have diameters in the nanometer range from 1nm to less than 1 micrometer or less than 1000nm.
With regard to claim 71,
Lahann et al. teach suitable active ingredients is merely exemplary and should not be considered as limiting as to the scope of active ingredients which can be introduced into the multiphasic micro-components, as all suitable active ingredients known to those of skill in the art. Certain suitable active ingredients, or pharmaceutically active ingredients or drugs, are
known to those of skill in the art and include, but are not limited to, natural and artificial macromolecules, such as, DNA, RNA, and the like, and mixtures thereof. (0098). A gene is a segment of DNA containing the instructions to make a specific protein or functional RNA molecule. DNA stores genetic information, serves as the template from which genes are "read". RNA acts as an intermediary copy of the gene that carries the genetic code from the DNA to the cellular machinery that builds proteins, or it can be the final functional product itself, like certain types of RNA that regulate other genes.
With regard to claims 72 and 73,
Lahann et al. teach the active ingredient can be a therapeutic drug that operates locally or
systemically (non-localized) and may treat, prevent, or diagnose a wide variety of conditions or ailments. Active ingredients may be used to treat or prevent a disease, such as an
infectious disease (a bacterial, viral, or fungal infection), auto-immune disorder. (0103).
With regard to claim 74,
Lahann et al. teach a multiphasic micro-component comprises a first phase (that can include a first polymer) and at least one additional phase distinct from said first phase (that can include a second polymer). One or more of the first phase and additional phase comprises a component that is responsive to an external stimulus. (Abs). To obtain aligned fiber bundles with compositionally dissimilar compartments, a PLGA shell stream is employed that encapsulates a central “core” of the fiber. (0127). In certain embodiments, the first phase comprises materials compatible with the first active ingredient and the second phase similarly has materials compatible with the second active ingredient. A lipophilic, hydrophobic, or charged active ingredient (e.g., cationic oranionic) can be included in one phase of the multi-phasic micro-component and a hydrophilic or oppositely charged colorant or active ingredient can be included in a second phase. (0093). Certain suitable active ingredients, or pharmaceutically active ingredients or drugs, are known to those of skill in the art and include, but are not limited to, DNA, RNA, and the like. (0098). As described above, active ingredients can be suitable for use in a wide variety of applications and include DNA, RNA. The multi-phasic micro-component optionally has such an active ingredient dispersed within one or more phases. For example, such active ingredients can be suspended in a polymer solution, such as dendrimers. (0111). It would be obvious that DNA, RNA could be on the shell, depending on the selected polymer choice and it could be the only active ingredient in that polymer.
Claims 56, 59, 61-62 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 20050181010 A1), Lahann et al. (US 20140147510 A1), David et al. (US 9260803 B2) and Serrano-Garcia et al. (US 20180226582A1) in view of Park et al. (US 9252429 B2) and further in view of O’Malley (US 20090059367 A1) and Park et al. (US 8394296 B2).
The teachings of Hunter et al., Lahann et al., David et al., Serrano-Garcia et al. and Park et al. (US 9252429 B2) and O’Malley are described in claim 56 above.
Park et al. (US 8394296 B2) teach an electroconductive fiber, and a fiber complex including an electroconductive fiber are provided, the electroconductive fiber includes an electroconductive polymer, an elastic polymer that forms a structure with the electroconductive polymer, and a carboneous material on at least one of the electroconductive polymer and the elastic polymer.
Claim 59,
Hunter et al., Lahann et al., David et al., Serrano-Garcia et al. and Park et al. (US 9252429 B2) and O’Malley do not teach the weight ratio of the first polymer to the electroconductive polymer is from 2: 1 to 1 :2.
Park et al. (US 8394296 B2) teach the electroconductive polymer may be included in the composition at a concentration of about 0.05% by weight to about 40% by weight. (Col. 8, lines 65-67). A concentration of the elastic polymer in the composition may be about 0.05% by weight to about 50% by weight. (Col. 9, line 1-2).
So the weight ratio of the first polymer to the electroconductive polymer is close to 1:1.
Claim 61,
Hunter et al., Lahann et al., David et al., Serrano-Garcia et al. and Park et al. (US 9252429 B2) and O’Malley do not teach the electroconductive metal comprises a plurality of metal nanoparticles.
Park et al. (US 8394296 B2) teach the fiber may include a plurality of metal nanoparticles. The metal nanoparticles may be metal nanoparticles having electroconductivity. (Col. 6, lines 65-66).
Claim 62,
Hunter et al., Lahann et al., David et al., Serrano-Garcia et al. and Park et al. (US 9252429 B2) and O’Malley do not teach the weight ratio of the first polymer to the electroconductive metal is from 1: 10 to 1: 1.
Park et al. (US 8394296 B2) teach a concentration of the elastic polymer in the composition may be about 0.05% by weight to about 50% by weight. (Col. 9, line 1-2). A concentration of the metal nanoparticles in the composition may be about 0.05% by weight to about 5% by weight. (Col. 9, lines 7-8). So the weight ratio of the first polymer to the electroconductive metal can be 1:1.
It would have been obvious to one of ordinary skills in the art before the effective filing date of the invention to prepare "Medical device", "implant", "device", "medical device," "medical implant", "implant/device", and the like are placed within a patient's body for one or more therapeutic or prophylactic purposes such as for restoring physiological function, alleviating symptoms associated with disease, delivering therapeutic agents, detecting changes (or levels) in the internal environment, and/or repairing or replacing or augmenting etc. damaged or diseased organs and tissues, with a core/shell structure, comprising of polymers, taught by Hunter et al.,. an electrospun comprising an electrically conductive central core comprising a first polymer, and electroconductive materials, which can be electroconductive polymer and/or an electroconductive metal; and a shell comprising a second polymer, which can carry drug(s), taught by David et al., Lahann et al. and Serrano-Garcia et al., wherein electro-conductive polymers may be selected from the group consisting of polypyrrole and polyaniline, electro-conductive metals may be selected from the group consisting of Cu, Ag, Pt and Ni., and not particularly limited of electro-conductive polymers or electro-conductive metals, so long as they exhibit excellent conductivity, taught by Park et al. (US 9252429 B2), and to have DNA released when applying a voltage of about 100 voltage taught by O’Malley, with the weight ratio of the first polymer to the electroconductive polymer is close to 1:1, the fiber may include a plurality of metal nanoparticles and the weight ratio of the first polymer to the electroconductive metal can be 1:1, taught by Park et al. (US 8394296 B2), since they have proven the method is feasible with the goals to have conductivity for DNA release for repairing damaged tissues and these ratios would be preferable to have good electrospun fiber system.
Response to Arguments
Rejection under 35 U.S.C. § 103,
Applicant argues that for Claim 56 the Examiner relies upon the teachings of O'Malley. Referring to paragraph [0216], a 100-volt current was applied to metal templated DNAs to draw the metallized DNA into an agarose gel. Based on this teaching, the Examiner asserts the following (emphasis added):
The template polymer may be spun into a fiber by, inter alia, electrospinning. (0137). Apply a 100volt current to draw the metallized DNA into the gel exactly as is always done in molecular biology. (0218). It would be obvious that when this system is in tissues, applying a 100 volts current would release DNA into cells and the voltage needed to release bioactive materials would be varied depending the composition and the size of the Core/shell/metal/ bioactive materials.
Applicant recites In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (Emphasis added). See also KSR, 82 USPQ2d at 1396 (quoting Federal Circuit statement with approval). "rejections on obviousness cannot be sustained with mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." In the absence of any teaching in O'Malley or any other art cited by the Examiner to apply an electric field of about 100 volts to about 500 volts to electrospun core-shell fibers composed of a nucleic acid in order to deliver the nucleic acid to one or more cells of the damaged tissue, the present claims would not have been obvious in view of KSR.
Applicant’s arguments have been fully considered but they are not persuasive since under KSR International Co. v. Teleflex Inc. (2007), the obviousness analysis is flexible and relies on common sense, legal precedents, and the knowledge of a Person Having Ordinary Skill in the Art (PHOSITA). Combining a known system (core/shell/metal/bioactive materials) with a known technique (applying 100V current) to achieve a predictable result (releasing or moving DNA/bioactive materials) is a textbook case of obviousness. With reasonable expectation of success, O’Malley explicitly teaches that 100V draws metallized DNA into a gel. A PHOSITA would have a reasonable expectation that applying a similar electrical current to the same system inside tissue would successfully mobilize and release that DNA into surrounding cells. Voltage, size, and composition are result-effective variables. It is considered inherently obvious to discover the optimum workable value of a variable through routine experimentation if the prior art recognizes that the variable affects the system. A PHOSITA would routinely adjust the voltage based on the physical parameters (core/shell/metal size) to achieve the desired release without exercising inventive ingenuity, so a range of voltage would be possible, and O’Malley’s teaching of 100V would be a good start.
Applicant argues that the bioactive gent as recited in claim 74 includes only a nucleic acid and not other bioactive agents. The primary reference Hunter et al. discloses pumps and sensors for contact with tissue are used in combination with an anti-scarring agent in order to inhibit scarring that may otherwise occur when the pumps and sensors are implanted within an animal (Abstract). In the Summary of the Invention at paragraph [0019], the skilled artisan is taught implantable pumps and sensors that include a medical implant and at least one of (i) an anti-scarring agent and (ii) a composition that comprises an anti-scarring agent. The agent is present so as to inhibit scarring that may otherwise occur when the implant is placed within an animal. Finally, in all the claims of Hunter et al., an anti-scarring agent is present. Thus, an anti-scarring agent is a critical component of the pumps and sensors of Hunter et al. and not merely optional.
Applicant’s arguments have been fully considered and they are not persuasive since Lahann et al. teach certain suitable active ingredients, or pharmaceutically active ingredients or drugs, are known to those of skill in the art and include, but are not limited to, DNA, RNA, and the like. (0098). Active ingredients can be suitable for use in a wide variety of applications and include DNA, RNA. The multi-phasic micro-component optionally has such an active ingredient dispersed within one or more phases. For example, such active ingredients can be suspended in a polymer solution, such as dendrimers. (0111). It would be obvious that DNA, RNA could be on the shell, depending on the selected polymer choice and it could be the only active ingredient in that polymer.
Conclusion
No claim is allowed.
Applicants' 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGOC-ANH THI NGUYEN whose telephone number is (571)270-0867. The examiner can normally be reached Monday - Friday 8:00 am.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
