DETAILED ACTION
Applicants should note that this case has been transferred to a new examiner, Alexandra Nicole Isnor, and claims reconsidered herein.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Applicants’ amendments and arguments filed 10/02/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 2-4, 7, 14-15, 17-22, 26-27, 30, 34-36, and 38-48 are canceled.
Claims 1 and 5 have been amended.
Claims 1, 5-6, 8-13, 16, 23-25, 28-29, 31-33, and 37 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/02/2025 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
New Rejections Necessitated by Claim Amendments
Claim Interpretation
In regards to claim 1, as to the limitation of 'for enteric delivery of a therapeutic drug’ it is noted that the instant claims are composition claims and future intended use is not given patentable weight. Thus any composition comprising the remaining limitations of the instant claim 1 will meet this limitation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 10-13, 16, 23-25, 31-33, and 37 under 35 U.S.C. 103 as being unpatentable over WO 2015/191920 to Bellinger et al (Bellinger) in view of US 2011/0125091 to Abbate et al and EP0415671 A2 to Takashi et al (Takashi), as evidenced by Helander et al.
Instant claim 1 has been amended to include the new limitation “wherein the one or more carrier members comprise a coating comprising a therapeutic agent”.
Bellinger teaches gastric residence structure comprising one or more active agents, wherein the structure is stable in acidic conditions with mechanical flexibility and strength in the gastric cavity, easily pass through the GI tract and rapidly dissolve and/or degrade in a physiological environment (abstract). Bellinger teaches that in some embodiments that residence structure is present in a containing structure, wherein the residence structure is constructed and arranged to have a first configuration after release from the containing structure and also a second configuration when contained within the residence structure (p 4, l 3-24; p 5, l 25-33). The first and second configurations have a first and second shapes respectively (p 6, 24-26). Further, the residence structure comprising a first elastomeric component, a second component configured to release the active agent, and a linker, is configured to degrade such that the residence structure breaks apart and is released from the location internally of the subject after a predetermined time (see abstract). The structure has a polymeric component, a first linker coupling the loadable polymeric component to a second polymeric component. Bellinger teaches that exposure to an alkali solution, the elastomeric linker accelerates dissociation allowing the ending of the dissociation ending the retention time period and allowing at least one retention structure to pass through the internal orifice; and the retention structure includes a material that can swell, degrade, dissolve, diffusion of the drug (p 10, 17-28). Bellinger teaches that elastomeric polymer comprises an enteric polymer (p 9), which can be a blend of two enteric elastomeric polymers (p9). The enteric polymer is a gel or a blend of polymer gels, which is soluble at a pH greater than 6.0 but not at pH 3.0 (p 10, 7-9). Bellinger describes that the capsule gastric residence structure is folded/compressed, which can reversibly revert to the first configuration, which in some embodiments the structure adopts a shape and/or size configured for retention(p 17).
Instant claim 1 includes the limitation “wherein the system further comprises an elastomeric central member attached to a plurality of arms radiating outwardly from the central member when the system is in an extended configuration, the arms comprising one or more carrier members”. Bellinger teaches that the retention structure further comprises a core and a plurality of radial projections at least one of attached to and incorporated with the core; the first shape comprises the plurality of projections projecting from the core in a plurality of directions, and the second shape comprises the plurality of projections projecting from the core in a substantially parallel directions to each other (p 7, l 1-5, ex 2).
For the claimed expansion of the system from a compacted form, Bellinger teaches that the residence structure swells (p 24, l 4-15). Hence, it is implicit that the gastric residence structure meets the conditions 1) and 2) of instant claim 1, as well as the functional limitations of claims 10-11. This is because Bellinger teaches a loadable polymeric components comprise polycaprolactone, polylactic acid, polylactic co-glycolic acid and/or mixtures thereof and may further comprise excipients, and the degradable linker is a water soluble and/or degradable polymer and blends thereof, including but not limited to, Polyvinylpyrrolidone, polyvinyl alcohol, Kollidon VA 64, polyorthoester, polyhydroxy butyrate, Eudragit and mixtures thereof (p 10, l 14-p 11, 13), and instant page 21 also describes Eudragit polymers. Further, Bellinger recites the same polymers of instant page 21. For the claimed active or drug, Bellinger teaches that device has a therapeutic agent, a diagnostic agent or an enhancement agent during a residence time period longer than 24 hours (p 5, l 17-26), one week, two weeks and one year (p 6, 9-10 & 24-26), hence meet instant claim 12.
Bellinger teaches that in some embodiments, the residence structure comprises a loadable polymeric component, a first linker coupling the loadable polymeric component to a second polymeric component, a second linker comprising at least a portion of or coupled with the loadable polymeric component and the elastic polymeric component, and wherein the second linker is degradable under a second set of physiological conditions different than the first set of conditions and is not substantially degradable under the first set of conditions (p 2- summary of the invention), and thus meet instant claims 16, 23-25. Further, fig. 1 of Bellinger meets the instant claimed structure having a central member attach to a plurality of arms radiating outwardly from the central member in an expanded configuration, wherein the arms comprise one or more carrier members.
For the instant claimed capsule, Bellinger teaches the containing structure comprises one or more than one capsule (p 6, 16-19). The devices of these embodiments can be contained within a soluble container such as one composed of gelatin and which may optionally comprise excipients (p 10). Thus, the capsule container described above reads on the instant claims, which is also evidenced by figs 4A-4C. Bellinger teaches formulation wherein the composition is filled in a capsule [0027] for oral route delivery. Further, as explained above, instant claim 13 does not particularly describe any size of the device whereas, the device of Bellinger meets the instant functional limitations (of claim 1). Hence, based on the above dimensions and the functions, it is the position of the examiner that the device of Bellinger meets instant claim 13.
Instant claim 1 recites “wherein about 80% or more of the therapeutic drug of the system is disposed on or within distal ends of the arms relative to the elastomeric central member”.
Abbate teaches expandable devices comprising a hub and a plurality of legs extending therefrom. The devices generally comprise a hub and a plurality of legs extending therefrom. In some variations, the hub may comprise one or more domed portions, tapered portions, or the like. The legs may comprise one or more straight segments, one or more curved segments, or a combination thereof. The devices may comprise one or more polymers, and/or one or more portions of the device may be configured to biodegrade. In other variations, the device may be configured to release one or more drugs therefrom. Additionally, in some variations the devices may be configured to be self-expandable from a low-profile configuration to an expanded configuration (abstract; 0005). Fig. 1 of Abbate shows the structure of the device that is similar to that of Bellinger, as well as instant claim 1. Abbate teaches that at least a portion of the devices may be biodegradable and/or configured for drug delivery [0002; 0007], a portion of the device comprising a biodegradable polymer and capable of degrading over a period of time (ex: weeks) [0008].
Abbate further teaches that the device or a portion thereof comprises one or more drugs, one or more drug-release layers, one or more drug depots, reservoirs or combinations thereof, so as to release the drug from the device over a period of time [0009]. Abbate teaches that the device can include one or more drugs [0009] and [0078], and that a portion of the device can include drug [0080]. Further, the drug can be present in drug releasing layers, as a coating over the entire or a part of the device [0082]. Furthermore, the device can contain one or more release rate modifiers [0087].
Hence, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose to prepare the gastric residence structure of Bellinger comprising comprises a core elastomeric component and a plurality of radial projections, and further include a drug or a therapeutic agent, which is also desired by Bellinger. Further, one of an ordinary skill in the art would have modified Bellinger so as to employ all of the drug or a desired amount of the drug over the entire portion of the arm(s) or only a portion of each of the arm, for instance, the outer tip of the arm, as a depot or reservoir . One of an ordinary skill in the art would have been motivated to do so because the analogous art of Abbate suggests employing the drug as a depot or reservoir so as to release the drug over a period of time. Abbate also teaches that the drug can be applied as depot or reservoir, and also as layers or coating of the distinct portion of arm. Even though Abbate does not teach the claimed 80% or more in the distal ends, one of an ordinary skill in the art would have applied all or a portion of the drug as a depot or reservoir with an expectation to provide a timed release of the drug as suggested by Abbate.
Bellinger does not teach the claimed enteric coating capsule.
Takashi teaches a device for extended retention in the stomach, the device comprising a molding which comprises shape memory material (A) joined to or mixed with material erodible in vivo (B), said molding being of a size, shape and durability to remain in the stomach for a definite residence time. The device can be of a shape such as not to hinder passage of food in the stomach and is capable of being folded to an orally administrable form. It is used for drug delivery (abstract). The device shown in Fig.3(c) has 4 extending limbs. At the central portion of the device, a shape memory material or a conventional pharmaceutically acceptable pillar-shaped substance is jointed - where shape memory material (A) is used, erodible substance (B) is further adhered to the tip portion. Takashi teaches that the device is coated by Eudragit polymers, enclosed in a capsule and coated with conventional coating agents (p 4, 20-57).
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose to prepare the gastric residence structure of Bellinger (modified by Abbate) to encapsulate the device in a capsule and further coat with coating because Takashi teaches analogous coated compressible and expandable oral drug delivery device, with similar structure to that of Bellinger and Abbate, for providing a controlled or timed release of the therapeutic agent in the device (p 4 and 6, l 4-10).
Instant claims recites the limitation of “wherein the diameter of the expanded enteric delivery system is about 1 to about 2 times the diameter of the small intestine”.
It is noted that Bellinger teaches that in certain embodiments, the device has a minimum uncompressed, cross sectional dimension of about 3-5.5 cm, about 4 cm, of about 5 cm, or of about 5.5 cm. (p 10, l 14-p 11, 13).
In this regard, the inner diameter of small intestine is known to be 2.5 cm, as described by Helander et al (abstract - results section, Table II & p 685- col. 1).
Therefore, one of an ordinary skill in the art, before the effective filing date of the instant invention, would have envisaged an embodiment of the drug delivery device of Bellinger wherein the uncompressed form has a dimeter of the uncompressed form (expanded form) in the intestine that is at least 1 times to 2 times the diameter of the small intestine because as described by Helander the diameter of small intestine is 2.5 cm and Bellinger teaches the expanded form of the delivery device is between 3 and 5.5 cm, including 5 cm.
Instant claim 1 now recites the limitation of “wherein the system is configured to expand from the compacted configuration to the expanded configuration within the small intestine”.
It is noted Bellinger teaches the residence structures, systems, and related methods comprise one or more materials configured for one or more of (and in any combination) active substances (e.g., a therapeutic agent) loading (in some cases at relatively high levels,) active substance and/or structure stability in acidic environments, mechanical flexibility and strength when contained in an internal cavity, easy passage through the GI tract until delivery to a desired internal cavity (abstract).
Further, Abbate teaches the expandable devices may be delivered to one or more openings or cavities, specifically gastrointestinal organs such as the stomach or intestines ([0145]).
It would be obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose to prepare the residence structure of Bellinger for the desired internal cavity as taught by Bellinger with the ready for improvement with the known technique of delivering the expandable device/structure to the intestines as outlined by Abbate. Utilizing an expandable residence structure in the intestines as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Claims 5-6, 8-9, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/191920 to Bellinger et al (Bellinger) in view of US 2011/0125091 to Abbate et al and EP0415671 A2 to Takashi et al (Takashi)., as evidenced by Helander et al., as applied to claims 1, 10-13, 16, 23-25, 31, 32, and 37 above, and further in view of Wagner et al (cited on IDS dated 8/4/22).
*Note: Wagner et al has a publishing date of 2 March 2018 and hence constitutes prior art.
Bellinger teaches that device has a therapeutic agent, a diagnostic agent or an enhancement agent during a residence time period longer than 24 hours (p 5, l 17-26), one week, two weeks and one year (p 6, 9-10 & 24-26). However, Bellinger and Takashi do not teach the polypeptide of claims 28-29, permeation enhancers of claims 5-6 and 8-9.
Abbate further teaches several active agents/drugs including monoclonal antibodies [0096], which meet the instant claim 28, but fails to explicitly envisage the same.
Wagner teaches those therapeutic proteins and peptide have revolutionized treatment for a number of diseases, and the expected increase in macromolecule-based therapies brings a new set of challenges for the pharmaceutics field. Due to their poor stability, large molecular weight, and poor transport properties, therapeutic proteins and peptides are predominantly limited to parenteral administration, and that oral formulations have the potential to address some issues associated with non-adherence including the interference with daily activities, embarrassment, and injection pain. Oral delivery can also help to eliminate the adverse effects and scar tissue buildup associated with repeated injections (abstract). However, Wagner teaches that oral delivery has several drawbacks such as instability in GI tract, low permeability, narrow window of absorption in the intestine, and suggests the use of improved targeted and controlled release carriers (abstract and table 1). Wagner suggests several methods such as employing permeation enhancers such as fatty acids, chitosan (instant claims 5-6 and 8-9), employing enzyme inhibitors, enteric coatings, degradable polymeric matrices, mucoadhesive carriers, complex hydrogel carriers for orally delivering protein and peptides (Table 1) having a size of less than 3 kDa (fig 4c). It is described that permeation enhancers typically enhance intestinal permeability by disrupting the epithelium's tight junctions. A variety of permeation enhancers have been described including surfactants, fatty acids, medium chain glycerides (usually monoglycerides and diglycerides of caprylic and capric acid), steroidal detergents, acylcarnitines and alkanoylcholines, N-acetylated-α-amino acids and N-acetylated non-α-amino acids, and chitosans and other mucoadhesive polymers (section 4.1). Wagner suggests that polymeric matrices of two kinds: enteric coatings and polymer networks, and that main advantage of using a polymer coating or matrix to encapsulate a protein drug is to protect the protein drug from degradation in the stomach and improve absorption. Wagner suggests enteric coatings, such as the Eudragit® systems, are non-crosslinked polymers that dissolve to release the drug. It is stated enteric coatings dissolve at a neutral pH to allow protection of the drug in the stomach at low pH. Because dissolution of the coating occurs at specific pH values, coatings can be selected such that release occurs in one segment of the small intestine (section 4.4). Among the mucoadhesive polymers, Wagner suggests mucoadhesive carriers to interact with mucus at the site of absorption was proposed to prolong the residence time of carriers at the site of absorption, and extension of the residence time would allow for an increase in drug bioavailability (section 4.5.2). Wagner also suggests hydrogel polymers that are crosslinked and that can be tailored to swell in response to pH and provide controlled diffusion of drug, which is particularly advantageous for oral delivery (section 4.5.4).
In this regard, Bellinger also suggests gastric drug delivery system that provides effective oral delivery, which provides the desired residence time as well as tailored to provide targeted and controlled release in the intestinal region, without being degraded in the stomach acids (discussion on page 2 of Bellinger & p12, l 6-10). Hence, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose to prepare the gastric residence structure of Bellinger (modified by Abbate and Takashi) comprising a first elastomeric component, a second component configured to release the active agent, and a linker, is configured to degrade such that the residence structure breaks apart and further employ oral therapeutic peptides of Wang et al. One would have been motivated to do so because Bellinger teaches that the structure is stable in acidic conditions with mechanical flexibility and strength in the gastric cavity, easily pass through the GI tract, rapidly dissolve and/or degrade in a physiological environment and is released from the location internally of the subject after a predetermined time. Further, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention was filed to further modify the gastric residence structure comprising polypeptide therapeutic agent, by employing a permeability enhancing agent such as fatty acids or chitosan, in the enteric coating polymer comprising gastric residence structure of Bellinger because Wagner teaches that permeation enhancers typically enhance intestinal permeability by disrupting the epithelium's tight junctions and enteric coatings dissolve at a neutral pH to allow protection of the drug in the stomach at low pH. Because the dissolution of the coating occurs at specific pH values, coatings can be selected such that release occurs in one segment of the small intestine. Further, with respect to the location of the therapeutic drug, it would have been an ordinary skill in the art before the effective filing date of the instant invention to choose the location of the permeability enhancing agent and the active agent in the coating or in the core of the structure because Bellinger suggests including the therapeutic agent at a desired location (page 17).
Double Patenting
Claims 1, 10-13, 16, 23-25, 31-33, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-74 of U.S. Patent No. 10517819 OR claims 1-48 of US patent No. 10596110 OR claims 1-57 of US 12023406 OR claims 1-20 of US 11992552 or claims 1-34 of US 12109305, each in view of US 2011/0125091 to Abbate et al, EP0415671 A2 to Takashi et al (Takashi) and WO 2015/191920 to Bellinger et al (Bellinger), as evidenced by Helander et al.
Each of the above patent claims are directed to a gastric residence structure comprising an active substance, the gastric residence structure comprising: one or more arms comprising a loadable polymeric component, wherein the loadable polymeric component comprises the active substance, and the active substance is a therapeutic agent or a diagnostic agent; an elastic polymeric component; and a separate linker component, said linker connecting the one or more arms with the elastic polymeric component; wherein the gastric residence structure is configured to be folded and physically constrained during administration and is configured to assume an open retention shape upon removal of a constraint, wherein change between the folded shape and the open retention shape is mediated by the elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape; and wherein the linker degrades, dissolves, disassociates, or mechanically weakens in a gastric environment which results in loss of retention shape integrity and passage out of a gastric cavity. Both sets of patent claims recite the enteric delivery system such as that in the instant claims, particularly comprising n elastic polymeric component; and a separate linker component, said linker connecting the one or more arms with the elastic polymeric component. The above patented claims do not recite the limitations that the system expands from a compacted configuration i.e., 1) and 2) of instant claim 1. Instant claims do not recite any specific polymer whereas the patented claims recite that the residence structure is retained in the stomach for 48 hours, and upon the dissolution or degradation of the linker, results in the change in the shape of the structure to open shape and passes out of the stomach through the gastric pyloric orifice. Thus, instant and the patented claims function in the same process.
The patented claims meet the instant claimed structure but does not teach the instant claimed enteric capsule and “wherein about 80% or more of the therapeutic drug of the system is disposed on or within distal ends of the arms relative to the elastomeric central member”.
The teachings of Abbate and Takashi, discussed above, are incorporated herewith.
Thus, it would have been it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose to prepare the gastric residence structure of patented claims, and further include a drug on the distal portions of the plurality of radially extending arms and further coat with an enteric coating so as to form the instant enteric capsule. One of an ordinary skill in the art would have been motivated to do so because the analogous art of Abbate suggests employing the drug as a depot or reservoir so as to release the drug over a period of time. Abbate also teaches that the drug can be applied as depot or reservoir, and also as layers or coating of the distinct portion of arm. Even though Abbate does not teach the claimed 80% or more in the distal ends, one of an ordinary skill in the art would have applied all or a portion of the drug as a depot or reservoir with an expectation to provide a timed release of the drug as suggested by Abbate; and Takashi teaches analogous coated compressible and expandable oral drug delivery device, for providing a controlled or timed release of the therapeutic agent in the device (p 4 and 6, l 4-10).
The above patented claim sets do not recite the new limitations “wherein the diameter of the expanded enteric delivery system is about 1 to about 2 times the diameter of the small intestine”.
The teachings of Bellinger have been addressed above and incorporated in full herewith. Bellinger teaches gastric residence structure comprising one or more active agents, wherein the structure is stable in acidic conditions with mechanical flexibility and strength in the gastric cavity. Bellinger teaches that the retention structure further comprises a core and a plurality of radial projections at least one of attached to and incorporated with the core; the first shape comprises the plurality of projections projecting from the core in a plurality of directions, and the second shape comprises the plurality of projections projecting from the core in a substantially parallel directions to each other (p 7, l 1-5, ex 2).
Bellinger teaches that in certain embodiments, the device has a minimum uncompressed, cross sectional dimension of about 3-5.5 cm, about 4 cm, of about 5 cm, or of about 5.5 cm. (p 10, l 14-p 11, 13).
In this regard, the inner diameter of small intestine is known to be 2.5 cm, as described by Helander et al (abstract - results section, Table II & p 685- col. 1).
Therefore, one of an ordinary skill in the art, before the effective filing date of the instant invention, to choose to prepare the gastric residence structures of each of the above patented claims, comprising an elastomeric component and radially projecting arms comprising a linker and a therapeutic agent, such that the uncompressed or expanded form has a diameter of 3 cm -5.5 cm because Bellinger suggests that the uncompressed form of the device maintains the structure (p 7) and is retained in or at the proximity to the location within the subject for at least 24 hours (p 6). While Bellinger does not state the claimed limitation “diameter of the expanded enteric delivery system is about 1 to about 2 times the diameter of the small intestine”, one of an ordinary skill in the art would have recognized that a diameter of 3 cm and above would be greater than the diameter of the intestine because Helander describes that the diameter of small intestine is 2.5 cm.
Claims 5-6, 8-9, and 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-74 of U.S. Patent No. 10517819 OR claims 1-48 of US patent No. 10596110 OR claims 1-57 of US 12023406 OR claims 1-20 of US 11992552 or claims 1-34 of US 12109305, each in view of US 2011/0125091 to Abbate et al., EP0415671 A2 to Takashi et al (Takashi), and WO 2015/191920 to Bellinger et al (Bellinger), as evidenced by Helander et al. as applied to claims 1, 10-13, 16, 23-25, 31, 32 and 37 and further each in view of Wagner et al (cited on IDS dated 8/4/22).
The above patented claims, Abbate and Takashi do not recite the instant claimed active agents and permeation enhancers. The teachings of Wagner discussed above have been incorporated herewith.
Hence, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose to prepare the gastric residence structure of each the patented claims (modified by Abbate and Takashi) comprising a first elastomeric component, a second component configured to release the active agent, and a linker, is configured to degrade such that the residence structure breaks apart and further employ oral therapeutic peptides of Wang et al. One would have been motivated to do so because Bellinger teaches that the structure is stable in acidic conditions with mechanical flexibility and strength in the gastric cavity, easily pass through the GI tract, rapidly dissolve and/or degrade in a physiological environment and is released from the location internally of the subject after a predetermined time. Further, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention was filed to further modify the gastric residence structure of patented claims, comprising polypeptide therapeutic agent of Wagner, by employing a permeability enhancing agent such as fatty acids or chitosan, in the enteric coating polymer comprising gastric residence structure of the patented claims because Wagner teaches that permeation enhancers typically enhance intestinal permeability by disrupting the epithelium's tight junctions and enteric coatings dissolve at a neutral pH to allow protection of the drug in the stomach at low pH. Because the dissolution of the coating occurs at specific pH values, coatings can be selected such that release occurs in one segment of the small intestine. Further, with respect to the location of the therapeutic drug, it would have been an ordinary skill in the art before the effective filing date of the instant invention to choose the location of the permeability enhancing agent and the active agent in the coating or in the core of the structure depending on the desired release of the active agent.
Response to Applicant’s Arguments
Applicant’s arguments filed on 10/02/2025 have been considered by the examiner.
In regards to the 35 USC § 103 rejections, Applicant argues that instant claim 4 was not rejected under 35 USC § 103 rejection and that instant claim 1 now possesses the claim 4 limitations of “wherein the one or more carrier members comprise a coating comprising a therapeutic agent”.
As noted above, this case has been transferred to a new examiner, and as taught in the previous 35 USC § 103 rejection (pg 7 printed), the new 35 USC § 103 rejection above, and reiterated here, Abbate teaches that the device or a portion thereof comprises one or more drugs, one or more drug-release layers, one or more drug depots, reservoirs or combinations thereof, so as to release the drug from the device over a period of time [0009]. Additionally, Abbate teaches that the device can include one or more drugs [0009] and [0078], and that a portion of the device can include drug [0080]. Further, Abbate teaches the drug can be present in drug releasing layers, as a coating over the entire or a part of the device [0082]. Hence, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose to prepare the gastric residence structure of Bellinger comprising comprises a core elastomeric component and a plurality of radial projections, and further include a drug or a therapeutic agent, which is also desired by Bellinger. Further, one of an ordinary skill in the art would have modified Bellinger so as to employ all of the drug or a desired amount of the drug over the entire portion of the arm(s) or only a portion of each of the arm, for instance, the outer tip of the arm, as a depot or reservoir. One of an ordinary skill in the art would have been motivated to do so because the analogous art of Abbate teaches that the drug can be applied as depot or reservoir, and also as layers or coating of the distinct portion of arm.
Therefore, in summary, the examiner is not persuaded by Applicant’s argument. The rejections of record are updated to account for claim amendments.
In regards to the Non-Statutory Double Patenting rejections, Applicant argues that the instant application is directed towards an enteric residence system while the cited patents are directed towards gastric structures.
It is noted that both enteric and gastric are related to the gastrointestinal system and therefore, are in the same field of art. Furthermore, the MPEP 2111.03(III) states “applicant has the burden of showing that the introduction of additional steps or specific components which would materially change the characteristics of the claimed invention.” In summary, Applicants have failed to properly demonstrate how modifying a gastric residence system would materially affect the basic and novel characteristics of the claimed invention.
Therefore, the examiner is not persuaded by Applicant’s arguments. The non-statutory double patenting rejections of record are updated to account for claim amendments.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611