DETAILED ACTION
Receipt of Arguments/Remarks filed on March 30 2026 is acknowledged. Claims 1-79 and 87 were/stand cancelled. Claims 80-86, 88-97 and 101 were amended. Claims 103-105 were added. Claims 80-86 and 88-105 are pending. Claims 81, 88 and 97-102 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 11 2023. Claims 80, 82-87, 89-96 and 103-105 are directed to the elected invention.
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 .
Withdrawn Rejections
The amendments filed March 30 2026 are sufficient to overcome the rejection of claims 82 and 87 under 35 USC 112(d). The polycaprolactone and poly(lactic-co-glycolic acid) were removed from claim 82. The cancellation of claim 87 renders the rejection moot.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 1 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
New and Modified Rejections Necessitated by the Amendments
filed March 30 2026
Claim Rejections - 35 USC § 112-Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 103 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 103 recites the location internal to the subject a stomach of the subject. However, claim 103 depends from claim 80 which recites a gastric residence structure. In order for the structure to actually reside in the gastric cavity it has to be in the stomach. The instant specification provides no limiting definition of gastric. Gastric by definition involves the stomach (see Merriam Webster). Therefore, claim 103 fails to further limit.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 80, 82-86, 89-96 and 103-105 are rejected under 35 U.S.C. 103 as being unpatentable over Gracias et al. (USPGPUB No. 20130045530) in view of Berner et al. (USPGPUB No. 20130149379) and Cargill et al. (Pharm Res. 1988, cited on PTO Form 1449).
Applicant Claims
The instant application claims a gastric residence structure, comprising: three or more loadable polymeric component coupled to a central polymeric component; and a linker comprising at least one polymer selected from the group consisting of poly(propylene fumarate), poly(glycerol sebacate), poly(lactic acid), poly(glycolic acid), polybutyrate, polyhydroxyalkanoate, polyamide, polyvinyl alcohol, polyoxetane, polyacrylate, polymethacrylate, polyanhydride, polyurethane, an enteric polymer, and co-polymers thereof; wherein the gastric residence structure is sized and configured such that upon reaching a location internal to a subject, it is retained at the location internal to the subject for at least 24 hours, wherein each of the three or more loadable polymer components is directly coupled to the central polymeric component via the linker and wherein the linker is selected such that a connection between the loadable polymeric component and the second polymeric component mechanically weakens or separates when the linker dissolves, degrades, mechanically weakens, or mechanically separates which results in loss of retention shape integrity and passage of the gastric residence structure out of the location internal to the subject.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Gracias et al. is directed to a self-folding sub-centimeter structure. Claimed is a sub-centimeter structure, comprising a first structural component, a second structural component arranged proximate to said first structural compound and a joint connecting said first and second structural components wherein said first and second structural components comprise a polymer (claim 1). As claimed, there are a plurality of structural components and a plurality of joints (claim 4). Polymers include poly(caprolactone) and polyesters (claim 13). The joint comprises a biodegradable material which is poly(caprolactone) (claims 16-17). As shown in Figure 1(b) the device has the following structure:
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which contains a central polymeric component (204), with 4 polymeric components coupled to the central polymeric component (202, 206, 208, 210) with a joint in-between each (216, 218, 220 and 222). Taught is the hinge being biodegradable to cause the device to come apart over time (paragraph 0027). It is taught that PCL degradation can be carefully timed and controlled through its copolymerization with other biocompatible material. This copolymerization strategy can be utilized to precisely engineer the kinetics of hinge degradation (paragraph 0046). Gracias et al. teaches that therapeutic agents can be contained within, loaded into, or otherwise associated with the microstructure. The materials or substances (i.e. therapeutic agents) can subsequently be released from the microstructure. In some embodiments, the release can be a slow or time-elapsed release to provide a pre-determined amount of the material or substance to a subject over a period of time. (paragraph 0052). As claimed the enclosing structure can be selectively opened (claim 5) and the enclosing structure has a maximum dimension of at least 10 nm and less than 10 mm (1 cm).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Gracias et al. teaches the joint is made from a biodegradable polymer, Gracias et al. does not expressly teach the instantly claimed linker polymers.
While Gracias et al. teaches a drug can be included, Gracias et al. does not expressly teach a drug in the structural components.
However, these deficiencies are cured by Berner et al. and Cargill et al.
Berner et al. is directed to gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract. Taught is the use of a polymer to deliver the drug. The polymers are swellable, bioerodible polymers. (paragraph 0060). Polymers suitable (i.e. those which swell and erode over time) include polyethers (aka polyalkylene oxides) (Paragraph 0063); acrylic acid and methacrylic acid polymers (paragraph 0065); maleic anhydride copolymers (paragraph 0066); polyurethanes (paragraph 0077); polyvinyl alcohol (paragraph 0069), etc. The polymer may include biodegradable segments and blocks, either distributed throughout the polymer's molecular structure or present as a single block, as in a block copolymer. Biodegradable segments are those that degrade so as to break covalent bonds. Typically, biodegradable segments are segments that are hydrolyzed in the presence of water. Biodegradable segments may be composed of small molecular segments such as ester linkages, anhydride linkages, ortho ester linkages, ortho carbonate linkages, amide linkages, phosphonate linkages, etc. (paragraph 0089). Taught is the inclusion of drugs which can either act locally within the gastrointestinal tract or systemically absorption into circulation via the gastrointestinal mucosa (paragraph 0096). Drugs include: non-opioid analgesics include buprenorphine and methadone (paragraph 0107). Neuroleptic agents such as risperidone (paragraph 0115). Lipid lowering agents include HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, pravastatin, lovastatin and cerivastatin (i.e. statins) (paragraph 0121). Once the fed mode is established, the stomach generates 3-4 continuous and regular contractions per minute, similar to those of the fasting mode but with about half the amplitude. The pylorus is partially open, causing a sieving effect in which liquids and small particles flow continuously from the stomach into the intestine while indigestible particles greater in size than the pyloric opening are retropelled and retained in the stomach. This sieving effect thus causes the stomach to retain particles exceeding about 1 cm in size for approximately 4 to 6 hours (paragraph 0049). Swelling promotes the retention in the stomach (paragraph 0003). Taught is for the use of drug where restricted delivery is desirable (paragraph 0009).
Cargill et al. is directed to controlled gastric emptying. As shown in Table III, rings with a 2.5 cm diameter retained 33% at 24 hrs, rings with a 3.6 cm diameter showed 100% retention at 24 hrs, tetrahedrons with each leg having 1.5 cm diameter showed 100% retention,
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gracias et al., Berner et al. and Cargill et al. and utilize any known biodegradable/bioerodible polymer as the joint/hinge in Gracias et al. Gracias et al. generally teaches that the polymer of the joint can be biodegradable. Berner et al. also teaches polymers which can be biodegradable. Both recognize that release rate can be manipulated by the choice of the polymer. Therefore, one skilled in the art would have been motivated to try any specifically taught polymer and manipulate the content/type in order to achieve the desired release/retention rate. It is noted that the use of these types of polymers would result in the structural components to separate as required in instant claim 80.
Regarding the claimed loadable polymeric components, claim 80 and dependents (except claim 89-96) do not actually require an active agent to be present, just that the material is capable of being loaded with an active. Therefore, the structure of Gracias et al. teaches the same loadable polymeric component.
Regarding the claimed structure, as set forth above, Fig. 1(b) shows a central polymeric component coupled via a linker (i.e. joint/hinge) to 4 loadable polymeric components. Reading on claim 80.
Regarding the claimed gastric retention and claims 103-105, Gracias et al. teaches the enclosed structure has a dimension up to 10 mm (aka 1 cm). Berner et al. teaches that 1 cm sized particles are retained in the stomach. Cargill et al. shows different shapes with show 100% retention in the stomach at 24 hours. Therefore, even in the enclosed dimension of Gracias et al., it appears that the size encompasses those sufficient to be retained in the stomach. Gracias et al. also teaches that the enclosed device can be selectively opened. Shown in figure 1 which open configuration would be expected to possess a dimension larger than 10 mm (when comparing b. i. to b. iii.). Furthermore, Berner et al. provides motivation for gastric retention. One skilled in the art would have been motivated to manipulate the size in order to have a greater in size than the pyloric opening so the device is retropelled and retained in the stomach. There would be a reasonable expectation of success as Cargill et al. shows different shapes and sizes which can be retained in the stomach for 24 hours.
Regarding claims 82-86, Gracias et al. teaches polymers include polyesters. Gracias et al. also teaches that additional polymers can be included with the polycaprolactone in order to engineer the kinetics of hinge degradation. Berner et al. teaches polymer such as poly(ethylene oxide) (paragraph 0063), poly(acrylamides) (paragraph 0068), acrylic acid and methacrylic acid polymers (paragraph 0065), etc. It would have been obvious to one of ordinary skill in the art to try any of the specifically taught polymers as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). Furthermore, based on the specific teachings of Gracias et al. and Berner et al., one skilled in the art would have been motivated to manipulate not only the type of polymer but the combination of polymers utilized in order to achieve the desired release rate.
Regarding claims 89-96, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gracias et al. and Berner et al. and utilize a drug in the structural components of the device. One skilled in the art would have been motivated to utilize a drug in the structural components as Gracias et al. teaches that therapeutic agents can be contained within, loaded into, or otherwise associated with the microstructure. Berner et al. teaches dispersion of the drug in a polymeric matrix can be utilized to control the release of the drug. One skilled in the art would have been motivated to add a drug such as risperidone, methadone, statin or buprenorphine in order to treat the respective conditions these drugs are known to treat. Since Gracias et al. suggests a drug can be included there is a reasonable expectation of success.
Response to Arguments
Applicants’ arguments filed March 30 2026 have been fully considered but they are not persuasive.
Applicants argue that claim 80 has been amended. Gracias does not teach or make obvious a gastric resident structure, let alone a resident structure capable of being retained at a location internal to a subject. It is argued Gracias teaches microcontainers and such micro-sized structures would be significantly too small to act as a gastric residence structure. Berner fails to cure the above-noted deficiencies. It is argued that Berner teaches at most 2-12 hrs.
Regarding Applicants arguments, firstly, nowhere does Gracias teach away from gastric retention. While Applicants are correct Gracias does teach smaller sizes, Gracias claims the enclosing structure can be selectively opened (claim 5) and the enclosing structure has a maximum dimension of at least 10 nm and less than 10 mm (1 cm). Berner et al. teaches that 1 cm sized particles are retained in the stomach. Therefore, Gracias teaches enclosed structure which possess an upper limit dimension which would be expected to be retained in the stomach. Since Gracias also teaches that the structure can be selectively opened and Figure 1b shows an opened structure, it would reasonably be expected to possess a dimension significantly longer than 1 cm when the enclosed structure has a maximum dimension of 1 cm. Secondly, while neither reference expressly teach retention for at least 24 hrs, neither reference teaches away from retention of this length. Applicants point to paragraph 0061 of Berner, while this paragraph does teach a time period in the range of about 2-12, longer times are not excluded. This paragraph expressly teaches in that same paragraph, 2hile swelling and erosion occur at the same time, it is preferred herein that drug release should be erosion-controlled, meaning that the selected polymer should be such that complete drug release occurs primarily as a result of erosion rather than swelling and dissolution. However, swelling should take place at a rate that is sufficiently fast to allow the tablet to be retained in the fed stomach for a time period in the range of about 2-12 hours. This makes it clear that swelling of the polymer and erosion can be manipulated in order to achieve the desired retention time. Furthermore, Berner teaches once the fed mode is established, the stomach generates 3-4 continuous and regular contractions per minute, similar to those of the fasting mode but with about half the amplitude. The pylorus is partially open, causing a sieving effect in which liquids and small particles flow continuously from the stomach into the intestine while indigestible particles greater in size than the pyloric opening are retropelled and retained in the stomach. This sieving effect thus causes the stomach to retain particles exceeding about 1 cm in size for approximately 4 to 6 hours (paragraph 0049). Swelling promotes the retention in the stomach (paragraph 0003). Suggesting that particles above 1 cm can be retained. One skilled in the art would recognize the various parameters (polymer type and size) which can be manipulated in order to achieve the desired length of retention. Finally, newly cited Cargill et al. clearly shows that various shapes and sizes which achieve 100% retention at 24 hours.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 10182985 (cited on PTO Form 1449) in view of Berner et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims a gastric residence structure, comprising: three or more loadable polymeric component coupled to a central polymeric component; and a linker comprising at least one polymer selected from the group consisting of poly(propylene fumarate), poly(glycerol sebacate), poly(lactic acid), poly(glycolic acid), polybutyrate, polyhydroxyalkanoate, polyamide, polyvinyl alcohol, polyoxetane, polyacrylate, polymethacrylate, polyanhydride, polyurethane, an enteric polymer, and co-polymers thereof; wherein the gastric residence structure is sized and configured such that upon reaching a location internal to a subject, it is retained at the location internal to the subject for at least 24 hours, wherein each of the three or more loadable polymer components is directly coupled to the central polymeric component via the linker and wherein the linker is selected such that a connection between the loadable polymeric component and the second polymeric component mechanically weakens or separates when the linker dissolves, degrades, mechanically weakens, or mechanically separates which results in loss of retention shape integrity and passage of the gastric residence structure out of the location internal to the subject.
Patent ‘985 claims a gastric residence structure comprising: a loadable polymeric component; an elastic polymeric component; and a separate linker component, said linker connecting the loadable polymeric component 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 said 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. Active substance is claimed. Same elastic polymers are claimed. A multi-armed star shape is claimed.
While Patent ‘985 claims the linker degrades, dissolves, disassociates or mechanically weakens, Patent ‘985 does not expressly claim the same polymeric linker material. While Patent ‘985 claims an active, Patent ‘985 does not claim the instantly claimed actives. However, these deficiencies are cured by Berner et al.
Berner et al. is directed to gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract. Taught is the use of a polymer to deliver the drug. The polymers are swellable, bioerodible polymers. (paragraph 0060). Polymers suitable (i.e. those which swell and erode over time) include polyethers (aka polyalkylene oxides) (Paragraph 0063); acrylic acid and methacrylic acid polymers (paragraph 0065); maleic anhydride copolymers (paragraph 0066); polyurethanes (paragraph 0077); polyvinyl alcohol (paragraph 0069), etc. The polymer may include biodegradable segments and blocks, either distributed throughout the polymer's molecular structure or present as a single block, as in a block copolymer. Biodegradable segments are those that degrade so as to break covalent bonds. Typically, biodegradable segments are segments that are hydrolyzed in the presence of water. Biodegradable segments may be composed of small molecular segments such as ester linkages, anhydride linkages, ortho ester linkages, ortho carbonate linkages, amide linkages, phosphonate linkages, etc. (paragraph 0089). Taught is the inclusion of drugs which can either act locally within the gastrointestinal tract or systemically absorption into circulation via the gastrointestinal mucosa (paragraph 0096). Drugs include: non-opioid analgesics include buprenorphine and methadone (paragraph 0107). Neuroleptic agents such as risperidone (paragraph 0115). Lipid lowering agents include HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, pravastatin, lovastatin and cerivastatin (i.e. statins) (paragraph 0121).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘985 and Berner et al. and utilize any known biodegradable/bioerodible polymer as the linker in Patent ‘985. Patent ‘985 generally teaches that the polymer of the linker degrades, dissolves, disassociates or mechanically weakens. Berner et al. also teaches polymers which can be biodegradable. Therefore, one skilled in the art would have been motivated to try any specifically taught polymer and manipulate the content/type in order to achieve the desired release rate. It is noted that the use of these types of polymers would result in the structural components to separate as required in instant claim 80 and 82-83.
Regarding the claimed loadable polymeric components, claim 80 and dependents (except claim 89-96) do not actually require an active agent to be present, just that the material is capable of being loaded with an active. Therefore, the structure of Patent ‘985 teaches the same loadable polymeric component.
Regarding claim 84-86, Patent ‘985 claims the same polymers.
Regarding claims 89-96, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘985 and Berner et al. and utilize a drug in the structural components of the device. One skilled in the art would have been motivated to utilize a drug in the structural components as Patent ‘985 teaches that active agents can be included. Berner et al. teaches dispersion of the drug in a polymeric matrix can be utilized to control the release of the drug. One skilled in the art would have been motivated to add a drug such as risperidone, methadone, statin or buprenorphine in order to treat the respective conditions these drugs are known to treat.
Regarding claims 103-105, Patent ‘985 claims a gastric retention device. Berner et al. teaches that greater than 1 cm allows for retention.
Claims 80, 82-87, 89 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent No. 11992552 (copending Application No. 15782021, USPGPUB No. 20190262265, cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘552 claims a gastric residence system for administration to a stomach of a patient, comprising: a central elastomer component, wherein the elastomer component is mono-concave, bi-concave, concavo-convex, or toroidal; a plurality of at least three carrier polymer-agent components comprising a carrier polymer and a therapeutic agent or a salt thereof, wherein each of the plurality of carrier polymer-agent components comprises an elongate member comprising a proximal end, a distal end, and an outer surface there between; wherein the proximal end of each elongate member is attached to the elastomer component and projects radially from the elastomer component, each elongate member having its distal end not attached to the elastomer component and located at a larger radial distance from the elastomer component than the proximal end; wherein the elastomer component is attached directly or indirectly to each elongate member by an intercomponent anchor; wherein the gastric residence system is configured to have a compacted form when constrained within a container, suitable for administration orally or through a feeding tube; and an uncompacted form resulting from elastic recoil of the gastric residence system when released from the constraint by the container in the stomach of the patient; wherein the gastric residence system is configured to be retained in the stomach for a period of at least about 24 hours; and wherein the gastric residence system is configured to release a therapeutically effective amount of the therapeutic agent or the salt thereof over at least a portion of the period in which the gastric residence system is retained in the stomach. A linker is claimed. Same polymers are claimed. The elastomeric component reads on the second polymeric component and the carrier polymer agent component reads on the first component. Linkers claimed include PLGA and further comprise plasticizers such as polyethylene glycol reading on the instantly claimed polyethers.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 10596110 (cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘110 claims a gastric residence structure comprising at least one active substance, the gastric residence structure comprising: one or more arms comprising a loadable polymeric component, wherein the loadable polymeric component comprises an active substance, and at least one active substance comprises an antiretroviral 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; wherein the gastric residence structure is configured such that it is retained in the gastric cavity for at least about 24 hours; 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. Actives are claimed. The elastic polymeric component reads on the instantly claimed second polymeric component. Antiretroviral agents are claimed. Plurality of actives are claimed. Linkers claimed include hydroxypropyl methyl cellulose acetate succinate which is an enteric polymer (see column 38, line 52-54)..
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10532027 (cited on PTO Form 1449) in view of Berner et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘027 claims an article, comprising: a containing structure; and a gastric residence structure contained within the containing structure, the residence structure comprising at least three loadable polymeric arms and a second polymeric component coupled to the loadable polymeric arms by at least one degradable linker, wherein at least one loadable polymeric arm comprises an active substance, and the second component is free of active substance, wherein the residence structure is constructed and arranged to have a first configuration when constrained by the containing structure, and configured to mediate a change in shape upon release from the containing structure in the stomach to assume a second configuration, the residence structure being retained in the stomach and unable, in the second configuration, to pass through the gastric pyloric orifice of the subject under gastrointestinal physiological conditions. Therapeutic agents are claimed.
While Patent ‘027 claims the linker that degrades, Patent ‘027 does not expressly claim the same polymeric linker material. While Patent ‘027 claims an active, Patent ‘027 does not claim the instantly claimed actives. However, these deficiencies are cured by Berner et al.
The teachings of Berner et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘027 and Berner et al. and utilize any known biodegradable/bioerodible polymer as the linker in Patent ‘027. Patent ‘027 generally teaches that the polymer of the linker degrades. Berner et al. also teaches polymers which can be biodegradable. Therefore, one skilled in the art would have been motivated to try any specifically taught polymer and manipulate the content/type in order to achieve the desired release rate. It is noted that the use of these types of polymers would result in the structural components to separate as required in instant claim 80 and 82-83.
Regarding the claimed loadable polymeric components, claim 80 and dependents (except claim 89-96) do not actually require an active agent to be present, just that the material is capable of being loaded with an active. Therefore, the structure of Patent ‘027 teaches the same loadable polymeric component.
Regarding claim 84-86, Patent ‘027 claims elastic polymers.
Regarding claims 89-96, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘027 and Berner et al. and utilize a drug in the structural components of the device. One skilled in the art would have been motivated to utilize a drug in the structural components as Patent ‘985 teaches that active agents can be included. Berner et al. teaches dispersion of the drug in a polymeric matrix can be utilized to control the release of the drug. One skilled in the art would have been motivated to add a drug such as risperidone, methadone, statin or buprenorphine in order to treat the respective conditions these drugs are known to treat.
Claims 80, 82-87, 89 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-113 of U.S. Patent No. 10610482 (cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘482 claims gastric residence structure comprising at least one active substance, the gastric residence structure comprising: one or more arms comprising a loadable polymeric component, wherein the loadable polymeric component comprises an active substance, and at least one active substance comprises an antiretroviral 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. Plurality of actives are claimed. The same polymers are claimed. The elastic polymeric component reads on the instantly claimed second polymeric component.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-74 of U.S. Patent No. 10517819 (cited on PTO Form 1449) in view of Berner et al. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘819 claims 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. Overlapping actives are claimed. The same polymers are claimed. The elastic polymeric component reads on the instantly claimed second polymeric component. Risperidone is claimed. Methadone is claimed. Statin is claimed. Buprenorphine is claimed.
While Patent ‘819 claims the linker degrades, dissolves, disassociates or mechanically weakens, Patent ‘819 does not expressly claim the same polymeric linker material. However, these deficiencies are cured by Berner et al.
The teachings of Berner et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘819 and Berner et al. and utilize any known biodegradable/bioerodible polymer as the linker in Patent ‘819. Patent ‘819 generally teaches that the polymer of the linker degrades, dissolves, disassociates or mechanically weakens. Berner et al. also teaches polymers which can be biodegradable. Therefore, one skilled in the art would have been motivated to try any specifically taught polymer and manipulate the content/type in order to achieve the desired release rate. It is noted that the use of these types of polymers would result in the structural components to separate as required in instant claim 80 and 82-83.
Regarding the claimed loadable polymeric components, claim 80 and dependents (except claim 89-96) do not actually require an active agent to be present, just that the material is capable of being loaded with an active. Therefore, the structure of Patent ‘819 teaches the same loadable polymeric component.
Regarding claim 84-86, Patent ‘819 claims the same polymers.
Claims 80, 82-87, 89-91, 95-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-69 of U.S. Patent No. 10517820 (cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘820 claims a method of making a gastric residence structure comprising an active substance comprising: forming one or more arms comprising a loadable polymeric component, wherein the loadable polymeric component comprises one or more polymeric materials and at least one active substance; and connecting the one or more arms to an elastic polymeric component using a separate linker 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. While ‘820 is directed to a method of making, the product made is similar in scope to the instantly claimed product. Overlapping actives are claimed. Same polymers are claimed. The elastic polymeric component reads on the instantly claimed second polymeric component. Risperidone and buprenorphine are claimed. Linker can be enteric.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10716752 (cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘752 claims an article, comprising: a retaining element; and a gastric residence structure constrained by the retaining element, the residence structure comprising at least three loadable polymeric arms and a second polymeric component coupled to the loadable polymeric arms by at least one degradable linker, wherein at least one loadable polymeric arm comprises an active substance, and the second component is free of active substance, wherein the residence structure is constructed and arranged to have a first configuration when constrained by the retaining element, and configured to mediate a change in shape as a result of release by the retaining element in the stomach to assume a second configuration, the residence structure being retained in the stomach and unable, in the second configuration, to pass through the gastric pyloric orifice of the subject under gastrointestinal physiological conditions. Same polymers are claimed. Risperidone, methadone, rosuvastatin (statin) and buprenorphine is claimed. Enteric linkers are claimed.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 11077056 (cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘056 claims a gastric residence system, comprising: one or more arms comprising a first polymeric component, wherein the polymeric component comprises an active substance or salt thereof; a second polymeric component; and a linker component, said linker coupling the one or more arms with the second polymeric component; wherein the system 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 second polymeric component that undergoes elastic deformation when the residence system is in the folded shape and recoils when the gastric residence system assumes the open retention shape, wherein the system is configured such that it is retained at the location internally of the subject for at least about 24 hours in the open retention shape, and wherein the system releases between about 0.05 wt% and about 50 wt% of the active substance during the first day of release. Risperidone, methadone, rosuvastatin (statin) and buprenorphine are claimed. Same polymers are claimed. Enteric linker is claimed.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-63 of US Patent No. 11246829 (cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘829 claims a gastric residence structure, comprising: an elastic polymeric component; a first polymeric component coupled to the elastic component via a separate first degradable linker; a second polymeric component coupled to the first polymeric component via a separate second degradable linker; wherein each linker component is the same or different, and wherein at least one 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 wherein the residence structure is configured such that it is retained at the location internally of the subject for at least about 24 hours. The 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. Overlapping polymers are claimed. Risperidone, methadone, rosuvastatin (statin) and buprenorphine are claimed. Enteric linkers are claimed.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11357723. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘723 claims a gastric residence structure, comprising: multiple interconnected components including at least a plurality of first polymeric components, one or more second polymeric components, and at least a plurality of degradable linkers, wherein the plurality of degradable linkers interconnect the plurality of first polymeric components and the one or more second polymeric components, wherein the plurality of first polymeric components comprise an active substance, and the one or more second polymeric components are free of active substance, wherein the gastric residence structure comprises one or more hinges that facilitate folding of the gastric residence structure and/or packing into a constrained form, and wherein the gastric residence structure has a first configuration, and wherein the one or more second polymeric components are configured to elastically mediate a change in shape at the one or more hinges to obtain a second configuration, the gastric residence structure being retained in the stomach and unable, in the second configuration, to pass through the gastric pyloric orifice of the subject under gastrointestinal physiological conditions. Overlapping polymers are claimed. Risperidone, methadone, rosuvastatin (statin) and buprenorphine are claimed. Enteric linkers are claimed.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of U.S. Patent No. 11389399 (cited on PTO Form 1449). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant claims are set forth above.
Patent ‘399 claims a gastric residence structure, comprising: a containing structure; and a gastric residence structure contained within the containing structure, the gastric residence structure comprising: a first polymeric component; a second polymeric component coupled to the first polymeric component; and at least one degradable linker coupled with the first polymeric component, wherein the gastric residence structure is constructed and arranged to have a first configuration when constrained by the containing structure, and configured to undergo a change in shape upon release from the containing structure in the stomach to assume a second configuration, wherein change between the first configuration and the second configuration is mediated by the second polymeric component that undergoes elastic deformation when the gastric residence structure is in the first configuration and recoils when the gastric residence structure assumes the second configuration, wherein the first polymeric component and/or second polymeric component comprises an active substance or salt thereof, and wherein the gastric residence structure has a cross-sectional area having a shape selected from the group consisting of square, circle, oval, polygon, tubes, and rings. Overlapping polymers are claimed. Risperidone, methadone, rosuvastatin (a statin) and buprenorphine are claimed. Enteric linkers are claimed.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
Claims 80, 82-87, 89-91 and 103-105 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 31, 33-35, 37-38, 40-41, 46-48, 51-52, 55, 57, 82 and 90 of copending Application No. 18272786 (US PGPUB No. 20240390270). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims are set forth above.
Copending ‘786 claims a gastric residence system comprising: six arms affixed to a central elastomer, wherein at least one arm comprises a drug-eluting segment; each arm comprising a proximal end, a distal end, and an outer surface therebetween; wherein the proximal end of each arm is attached to the central elastomer and projects radially from the central elastomer, each arm having its distal end not attached to the central elastomer component and located at a larger radial distance from the central elastomer component than the proximal end; wherein the at least one arm comprising a drug eluting segment comprises: a first inert segment; a first disintegrating matrix segment attached to the first inert segment; a second inert segment attached to the first disintegrating matrix segment; a second disintegrating matrix segment attached to the second inert segment; a third inert segment attached to the second disintegrating matrix segment; a fourth inert segment attached to the third inert segment; the drug eluting segment attached to the fourth inert segment, wherein the drug eluting segment comprises a carrier polymer, and risperidone or a salt thereof, and wherein the drug eluting segment further comprises a coating comprising a release rate-modulating polymer film; an optional fifth inert segment attached to the drug eluting segment; and a third disintegrating matrix segment which is attached to the optional fifth inert segment when the optional fifth inert segment is present, or which is attached to the drug eluting segment when the optional fifth inert segment is not present; and a filament circumferentially connecting each arm. Overlapping drugs and polymers are claimed.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 80, 82-87, 89-96 and 103-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent No. 11992552 OR claims 1-42 of U.S. Patent No. 10596110 OR claims 1-113 of U.S. Patent No. 10610482 OR claims 1-69 of U.S. Patent No. 10517820 in view of Berner et al. (USPGPUB No. 20130149379). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims the active substance is methadone, a statin or buprenorphine.
The teachings of Patent ‘552, ‘110, ‘482 OR ‘820 are set forth above. Patent ‘552, ‘110, ‘482 OR ‘820 do not claim the specific drugs instantly claimed. However, this deficiency is cured by Berner et al.
Berner et al. is directed to gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract. Taught is the use of a polymer to deliver the drug. The polymers are swellable, bioerodible polymers. (paragraph 0060). Taught is the inclusion of drugs which can either act locally within the gastrointestinal tract or systemically absorption into circulation via the gastrointestinal mucosa (paragraph 0096). Drugs include: non-opioid analgesics include buprenorphine and methadone (paragraph 0107). Neuroleptic agents such as risperidone (paragraph 0115). Lipid lowering agents include HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, pravastatin, lovastatin and cerivastatin (i.e. statins) (paragraph 0121).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patent ‘552, ‘110, ‘482 OR ‘820 and Berner et al. and manipulate the drug included. One skilled in the art would have been motivated to add a drug such as risperidone, methadone, statin or buprenorphine in order to treat the respective conditions these drugs are known to treat.
Claims 80, 82-87, 89-96 and 103-105 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 31, 33-35, 37-38, 40-41, 46-48, 51-52, 55, 57, 82 and 90 of copending Application No. 18272786 in view of Berner et al. (USPGPUB No. 20130149379). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims the active substance is methadone, a statin or buprenorphine.
The claims of Copending ‘786 are set forth above.
Copending ‘786 does not expressly claim methadone, a statin or buprenorphine. However, this deficiency is cured by Berner et al.
The teachings of Berner et al. are set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘786 and Berner et al. and manipulate the drug included. One skilled in the art would have been motivated to add a drug such as risperidone, methadone, statin or buprenorphine in order to treat the respective conditions these drugs are known to treat.
Response to Arguments
Applicants’ arguments filed March 30 2026 have been fully considered but they are not persuasive.
Applicants argue since the instant application does not contain claims deemed allowable it is premature to address these rejections.
Applicants argue that the claims of the ‘552 patent differ from the instant claims at least by the linker. None of the claims of the ‘552 patent recite the linker is responsive for a connection between at least one loadable polymer component and a central polymeric component mechanically weakens or separate or that the linker dissolves, degrades, weakens or separates.
Regarding Applicants arguments, the examiner cannot agree, as pointed to by the examiner Patent ‘552 claims a linker and the linker is the same polymeric material as instantly claimed, specifically an enteric polymer. Therefore, while Patent ‘552 does not expressly state that it dissolves, degrades, weakens or separates, it is the same chemical composition as the instant claims. Note MPEP 2112.01: "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Nothing in the arguments establish how the enteric polymers instantly claimed can degrade, dissolve, weaken or separate but the enteric polymer in the patent cannot.
Applicants argue that copending ‘786 has an earliest effective filing date of January 19 2021. It is argued that ‘786 does not claim the instantly claimed linker.
Regarding Applicants arguments, firstly, the examiner agrees the copending ‘786 is later filed. Therefore, if this is the only rejection remaining, absent allowance of the ‘786 application prior to allowance of the instant claims, the double patenting rejection could be dropped. The examiner cannot agree that copending ‘786 does not claim a linker. A linker is expressly claimed and none of the arguments establish why the instantly claimed linker degrades whereas the linker of copending ‘786 would not.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636
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