FINAL ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
This action is in response to papers filed 06/17/2026 in which claims 1-19, 24-26, 34, 43-44, and 46 were canceled; and claims 20, 27, 32-33, 39, 45, and 47 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 20-23, 27-33, 35-42, 45, and 47-56 are under examination.
Priority
This application is a CON of 16498746 filed 09/27/2019 (PAT 11554114).
16498746 is a 371 of PCT/US18/25449 filed 03/30/2018.
PCT/US18/25449 has PRO of 62587783 filed 11/17/2017.
PCT/US18/25449 has PRO of 62544375 filed 08/11/2017.
PCT/US18/25449 has PRO of 62479822 filed 03/31/2017.
However, the subject matters of “an ingredient for increasing gastric emptying time, wherein the ingredient for increasing gastric emptying time comprises a monosaccharide, a disaccharide, an oligosaccharide, an amino acid, a peptide, a protein, a monoglyceride, a diglyceride, or a triglyceride” “an ingredient for decreasing gastric acid production” and “delayed released buffering component” in independent claims 20 and 39 are not present in either PRO of 62544375 or PRO of 62479822. Furthermore, the subject matter of “the ingredient for increasing gastric emptying time is separate from the delayed release buffering component” as recited in claim 38 is not present in either PRO of 62544375 or PRO of 62479822. Thus, claims 20, 38, and 39, as well as, all claims dependent therefrom will not receive filing date benefits of PRO of 62544375 and PRO of 62479822.
Accordingly, pending claims 20-23, 27-33, 35-42, 45, and 47-56 are afforded the effective filing date of 11/17/2017.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejections and/or objections not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New Objection
Claim Objections
Claim 39 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 20. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). While claim 20 is to “a delayed release buffering component” and claim 39 is to “a delayed release buffering component particle,” the structure of the delayed release buffering component of both claims 20 and 39 are the same in that claims 20 and 39 both recites “comprising a core comprising a second buffering ingredient, a shell comprising an enteric agent, and a subcoat between the core and the shell.”
Modified Rejections
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 20-23, 27-33, 35-42, 55 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaka et al (1 December 2016; US 2016/0346274 A1) in view of Lovgren et al (22 November 1988; US 4,786,505).
Regarding claims 20 and 39, Vaka teaches a method of treating a disease by a drug susceptible to abuse or overdose comprising administering to a subject in need thereof abuse-deterrent drug formulations and dosage form with built-in overdose protection comprising a drug susceptible to abuse, a cationic pH dependent polymer such as a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate (EUDRAGIT® EPO) (a first acid soluble ingredient), a first buffering agent (multi-particulates B and/or multi-particulates C), and a second buffering component (multi-particulates D) (Abstract; [0008]-[0012], [0033]-[0042], [0051]-[0076] and [0174]-[0181]; Examples 1-2; Tables 5-6 and 14). Vaka teaches in addition to the drug susceptible to abuse, the composition further contains another drug such as an antidepressant or an opioid ([0036]-[0037]; claims 31-37). Vaka teaches a formulation containing multi-particulates A core comprising oxycodone hydrochloride (a drug susceptible to over-ingestion) and Eudragit EPO (a first acid soluble ingredient); functional membrane coating comprising Eudragit EPO; multi-particulates B containing Carbomer 974P, PEG-90M and sodium bicarbonate (a first buffering ingredient); multi-particulate C comprising omeprazole and sodium bicarbonate (a second buffering ingredient); and extra-granular excipients (Example II and Table 6). Vaka teaches the formulation further contains L-arginine, lactose, or a glycerol of fatty acid ester ([0063], [0047], [0078]; claims 11 and 20), thereby meeting the claimed an amino acid, a disaccharide, or a monoglyceride, respectively as the ingredient for increasing gastric emptying. Vaka teaches the formulation further contains an acid suppressing agent such as H2-antagonist ([0071]-[0072]; claims 32-35), thereby meeting the claimed “an ingredient for decreasing gastric acid production.” It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Vaka further teaches in addition to the drug susceptible to abuse, the composition further contains another drug such as an antidepressant or an opioid ([0036]-[0037]; claims 31-37).
With respect to the delayed release buffering component or the delayed release buffering component particle as recited in claims 20 and 39, respectively, Vaka teaches the second buffering ingredient can be optionally coated with an enteric coating (a delayed release buffering component) ([0181]; Table 14).
While Vaka teaches that the second buffering component is optionally coated with an enteric coating, it would have been obvious to one of ordinary skill in the art to include an enteric coating on the second buffering component, as well as, a subcoat between the enteric coating and the second buffering component in view of the guidance from Lovgren.
Lovgren teaches enteric coated granules comprise a core containing omeprazole and an alkaline buffering agent, one or more subcoating layers (separating layers) around the core containing hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and a shell surround the subcoating comprising a Eudragit® enteric polymer (Lovgren: Abstract; columns 3-5; Examples 1-10). Lovgren further established that it is well-understood in the prior art the purpose of enteric coated granules comprising a core containing omeprazole and the alkaline buffering agent is to ensure good stability of the core component(s) during long-term storage of the formulation, as well as, improve resistance towards gastric juice so as the dissolution or release of core material is delayed such that the coating does not dissolve in the stomach and only dissolve in the intestinal juice so as the desired release of the core material can be achieved in the small intestine (Lovgren: Abstract; columns 3-5; Examples 1-10).
It would have been obvious to one of ordinary skill in the art to include an enteric coating on the second buffering component (ingredient) of Vaka, as well as, a subcoat between the enteric coating and the second buffering component and produce the claimed invention. One of ordinary skill in the in art would have been motivated to do so because Lovgren provided the guidance for enteric coated buffering component to comprise a core containing the buffering agent, one or more subcoating layers (separating layers) around the core containing hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and a shell surround the subcoating comprising a Eudragit® enteric polymer (Lovgren: Abstract; columns 3-5; Examples 1-10). Lovgren further established that it is well-understood in the prior art the purpose of enteric coating a core containing a buffering agent is to ensure good stability of the core component(s) during long-term storage of the formulation, as well as, improve resistance towards gastric juice so as the dissolution or release of core material is delayed such that the coating does not dissolve in the stomach and only dissolve in the intestinal juice so as the desired release of the core material can be achieved in the small intestine (Lovgren: Abstract; columns 3-5; Examples 1-10).
Thus, an ordinary artisan seeking to maximize the stability of the second buffering component in the dosage form during long-term storage, as well as, provide improve resistance towards gastric juice so as the dissolution or release of core material (second buffering agent) is delayed, would have looked to include an enteric coating on the second buffering component of Vaka, as well as, a subcoat between the enteric coating and the second buffering component, per guidance from Lovgren, and achieve Applicant’s claimed invention with reasonable expectation of success
Regarding claims 21, 22, 40, and 41, as discussed above, Vaka teaches a cationic pH dependent polymer such as a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate (EUDRAGIT® EPO).
Regarding claims 23 and 42, Vaka teaches the buffering agent is selected from calcium carbonate, sodium bicarbonate, magnesium oxide, trisodium phosphate or mixtures thereof (Examples 1 and 2; Tables 5 and 14).
Regarding claims 27-33, Lovgren teaches and provide guidance for the enteric coated buffering component to comprise a core containing the buffering agent, a subcoating around the core containing hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and a shell surround the subcoating comprising a Eudragit® enteric polymer (Lovgren: Abstract; columns 3-5; Examples 1-10). Lovgren teaches the subcoating can contain a second buffering agent such as calcium carbonate, and the buffering agent in the core and subcoating can be the same (Lovgren: column 4, lines 4-45; Examples 1-10). Vaka teaches inclusion of a cationic copolymer such as EUDRAGIT® in a coating layer, thereby providing guidance for including a cationic copolymer in coating layer(s) surrounding a core material (Vaka: [0065] and [0081]; Example II, Table 6). Vaka and Lovgren teach the buffering agent is selected from calcium carbonate, sodium bicarbonate, magnesium oxide, trisodium phosphate or mixtures thereof (Vaka: [0063], Examples 1 and 2, Tables 5 and 14, and claim 20: Lovgren: columns 3-4; claims 1-6). Vaka and Lovgren teaches the first and second buffering agent can be the same (Vaka: claim 18; Lovgren: column 4, lines 4-45; Examples 1-10). Vaka and Lovgren teaches the enteric coating agent can be hydroxypropyl methylcellulose phthalate (Vaka: [00165] and [0181]; Lovgren: column 4, lines 60-end, and Examples 7-8).
Regarding claims 35 and 56, Vaka teaches the formulation contains an acid suppressing agent such as H2-antagonist ([0071]-[0072]; claims 32-35).
Regarding claim 36, Vaka teaches the formulation further contains an acid suppressing agent such as H2-antagonist ([0071]-[0072]; claims 32-35). Vaka teaches the acid suppressing agent is present in the formulation can be optimize an amount that when the formulation is taken in the prescribed amount, it does not suppress gastric acid secretion or increase the pH of the gastric fluid but does raise the pH of the gastric fluid when multiple dosage units are taken ([0071]), thereby would be a lowest therapeutic dose of the acid suppressing agent such as H2-antagonist. Thus, it would have been obvious to optimize the amount of acid suppressing agent in the formulation to an amount that is 10-50% of the lowest therapeutic dose of the H2 antagonist for reducing stomach secretion, as Vaka suggested the routine optimization of the amount of acid suppressing agent when the formulation is taken in the prescribed amount, it does not suppress gastric acid secretion or increase the pH of the gastric fluid but does raise the pH of the gastric fluid when multiple dosage units are taken. Thus, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 37 and 55, as discussed above, Vaka teaches the formulation further contains L-arginine, lactose, or a glycerol of fatty acid ester, thereby meeting the claimed an amino acid, a disaccharide, or a monoglyceride, respectively as the ingredient for increasing gastric emptying. Thus, the L-arginine, lactose, a glycerol of fatty acid ester, antidepressant or opioid is structurally the same as claimed the ingredient for increasing gastric emptying, and thus, would inherently function to increase the gastric emptying time of the subject upon ingestion of the formulation. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Regarding claim 38, as discussed above, Vaka teaches the second buffering that is optionally coated with an enteric coating (a delayed release buffering component) ([0181]; Table 14). Lovgren provided the direct guidance and motivation for enteric coating on the second buffering component. Thus, the L-arginine, lactose, or a glycerol of fatty acid ester (an ingredient for increasing gastric emptying time) that is also part of the formulation of Vaka ([0063], [0047], [0078]; claims 11 and 20), would be separate from the enterically coated second buffering component.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the in art the before the effective filing date of Applicant’s invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Claims 45 and 47-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vaka et al (1 December 2016; US 2016/0346274 A1) in view of Lovgren et al (22 November 1988; US 4,786,505), as applied to claim 39 above, and further in view of Pettersson et al (US 2013/0017263 A1).
The method of claim 39 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 45, as discussed above, it would have been obvious to one of ordinary skill in the art to include an enteric coating on the second buffering component (ingredient) of Vaka, as well as, a subcoat between the enteric coating and the second buffering component and produce the claimed invention. One of ordinary skill in the in art would have been motivated to do so because Lovgren provided the guidance for enteric coated buffering component to comprise a core containing the buffering agent, one or more subcoating layers (separating layers) around the core containing hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and a shell surround the subcoating comprising a Eudragit® enteric polymer (Lovgren: Abstract; columns 3-5; Examples 1-10). Lovgren further established that it is well-understood in the prior art the purpose of enteric coating a core containing a buffering agent is to ensure good stability of the core component(s) during long-term storage of the formulation, as well as, improve resistance towards gastric juice so as the dissolution or release of core material is delayed such that the coating does not dissolve in the stomach and only dissolve in the intestinal juice so as the desired release of the core material can be achieved in the small intestine (Lovgren: Abstract; columns 3-5; Examples 1-10).
With respect to the delayed release buffering component particle further comprises a core coating comprising a sustained-release ingredient, wherein the subcoat comprises the ingredient for decreasing gastric acid production, as recited in claim 45, it would also have been obvious to one of ordinary skill in the art to modify the enteric coating of Vaka in view of Lovgren such that the core containing the buffering agent is coated with two subcoating layers or separating layers in which the inner subcoating layer which surrounds the core to contain hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and the outer subcoating layer which is between the inner subcoating layer and the enteric coating to contain a H2 receptor antagonist, and produce the claimed invention. One of ordinary of ordinary skill in the art would have been motivated to do so because Pettersson provided the guidance for such modification by teaching that the enterically coated core containing the buffering agent with two subcoating layers or separating layers as guided by Lovgren can further be modified by including a H2 receptor antagonist in the outer subcoating layer (separating layer which is between the inner subcoating layer and the enteric coating, and such inclusion of H2 receptor antagonist in the outer subcoating layer between the inner subcoating layer and the enteric coating provided a resultant enteric coated buffering core or delayed release buffering core which provide good stability of the core component(s) during long-term storage of the formulation and maintaining gastric pH above 4 for extended period of time (Pettersson: Abstract; [0011], [0012], [0035], [0039], [0047]-[0054], [0057]-[0058], [0069], [0074]-[0075], [0077]-[0081], [0084], [0087], [0091], [0099], [0109]-[0111], [0116]; claim 1, 4, 6-14, 19, 22, 30-32 and 36-38).
Thus, an ordinary artisan interested in maximizing the stability of the second buffering component in the dosage form during long-term storage, as well as, providing a resultant dosage form which maintains gastric pH above 4 for extended period of time, would have looked to further modifying the subcoat of the enterically coated second buffering core material of Vaka in view of Lovgren to two subcoating layers or separating layers in which the inner subcoating layer which surrounds the core to contain hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and the outer subcoating layer containing a H2 receptor antagonist (which the outer subcoating layer is between the inner subcoating layer and the enteric coating) so as the enteric coated buffer core would serves its function of maintaining elevated gastric pH, thereby prolonging the suppression of drug dissolution through the cationic pH-dependent polymer. Per Vaka the increase in pH due to the buffering agent will prevent the cationic pH-dependent polymer from releasing the drug, thereby allowing the drug to slowly diffuse from the polymer over an extended period of time and diminishing or eliminating the euphoric effect associated with overdoses (Vaka: [0033], [0040], [0057], [0061]-[0062]).
One of ordinary skill in the art would have reasonable expectation of modifying the formulation of the dosage form of Vaka in view of Lovgren such that the second buffering core material is coated with two subcoating layers or separating layers in which the inner subcoating layer which surrounds the core to contain hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and the outer subcoating layer containing a H2 receptor antagonist (which the outer subcoating layer is between the inner subcoating layer and the enteric coating) because enteric coating of the second buffering core material with the addition of an acid suppressing agent such as a H2-blocker to the formulation are modifications that are permissible as an alternative embodiments of Vaka ([0071]-[0074]) so as to achieve the desired rapid and maintained rise in gastric fluid pH to above 4 over a prolong-period of time per Pettersson ([0054]-[0069]), thereby suppressing the dissolution rate of the cationic-pH dependent polymer, which in turn suppresses or delays release of the drug susceptible to abuse, and providing the ultimate goal abuse deterrence and protection against overdose and tampering of the drug susceptible to abuse per Vaka ([0008] and [0023]), and achieve Applicant’s claimed invention with reasonable success.
Regarding claims 47-52, Lovgren teaches and provide guidance for the enteric coated buffering component to comprise a core containing the buffering agent, a subcoating around the core containing hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and a shell surround the subcoating comprising a Eudragit® enteric polymer (Lovgren: Abstract; columns 3-5; Examples 1-10). Lovgren teaches the subcoating can contain a second buffering agent such as calcium carbonate, and the buffering agent in the core and subcoating can be the same (Lovgren: column 4, lines 4-45; Examples 1-10). Vaka teaches inclusion of a cationic copolymer such as EUDRAGIT® in a coating layer, thereby providing guidance for including a cationic copolymer in coating layer(s) surrounding a core material (Vaka: [0065] and [0081]; Example II, Table 6). Vaka and Lovgren teach the buffering agent is selected from calcium carbonate, sodium bicarbonate, magnesium oxide, trisodium phosphate or mixtures thereof (Vaka: [0063], Examples 1 and 2, Tables 5 and 14, and claim 20: Lovgren: columns 3-4; claims 1-6). Vaka and Lovgren teaches the first and second buffering agent can be the same (Vaka: claim 18; Lovgren: column 4, lines 4-45; Examples 1-10). Vaka and Lovgren teaches the enteric coating agent can be hydroxypropyl methylcellulose phthalate (Vaka: [00165] and [0181]; Lovgren: column 4, lines 60-end, and Examples 7-8).
Regarding claim 53, Vaka teaches the formulation contains an acid suppressing agent such as H2-antagonist ([0071]-[0072]; claims 32-35).
Regarding claim 54, Vaka teaches the formulation contains an acid suppressing agent such as H2-antagonist ([0071]-[0072]; claims 32-35). Vaka teaches the acid suppressing agent is present in the formulation can be optimize an amount that when the formulation is taken in the prescribed amount, it does not suppress gastric acid secretion or increase the pH of the gastric fluid but does raise the pH of the gastric fluid when multiple dosage units are taken ([0071]), thereby would be a lowest therapeutic dose of the acid suppressing agent such as H2-antagonist. Thus, it would have been obvious to optimize the amount of acid suppressing agent in the formulation to an amount that is 10-50% of the lowest therapeutic dose of the H2 antagonist for reducing stomach secretion, as Vaka suggested the routine optimization of the amount of acid suppressing agent when the formulation is taken in the prescribed amount, it does not suppress gastric acid secretion or increase the pH of the gastric fluid but does raise the pH of the gastric fluid when multiple dosage units are taken. Thus, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the in art the before the effective filing date of Applicant’s invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 06/17/2026 have been fully considered but they are not persuasive.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 103 rejections.
Applicant argues that Vaka fails to teach or suggest the delayed release buffering component as amended in claims 20 and 39. Applicant alleges that Lovgren fails to cure the deficiencies of Vaka, in that Lovgren’s “disclosure is aimed at protecting an acid-labile active ingredient from degradation and discoloration and at ensuring stability during storage and release in the small intestine, not at the overdose-triggered pH-modulated suppression of release from a self-regulating abuse-deterrent composition.” Applicant alleges that Lovgren “is a directed to a fundamentally different formulation problem” than the claimed invention in which Applicant alleges that the specification described that “the delayed release buffering component may extend the duration of elevated gastric pH and may in some embodiments serve as a "back-up reservoir" of buffering ingredient that is not readily discharged by the stomach” and thus, “[t]his may represent a system-level abuse-deterrence function directed to modulating gastric pH over time and across multiple ingested dosage units, rather than merely a storage-stability or intestinal- release function of the kind taught by Lovgren.” Thus, Applicant alleges that “[t]he Office Action does not explain how or why a person of ordinary skill in the art would have modified Vaka with Lovgren in the manner recited in amended claims 20 and 39. Applicant further alleges that “the Office Action provides no explanation as to how Lovgren's localized, stability- oriented buffering system would be modified to yield a delayed-release buffering component capable of modulating gastric pH, including in a dose-dependent manner in certain embodiments.” Applicant further alleges that neither Vaka nor Lovgren “teaches nor suggests that Lovgren's stability-oriented layered architecture should be repurposed into the claimed delayed release buffering component of an overdose-protection system in which the buffering component is itself a delayed-release reservoir designed to prolong elevated gastric pH in response to excessive ingestion.” As such, Applicant alleges that “[t]he absence of a reasoned explanation supporting the proposed modification is especially important here because the references solve different problems. Vaka is concerned with reducing overdose and tampering by using cationic pH-dependent polymeric multi-particulates and a buffering population to suppress drug release when multiple doses are taken.” (Remarks, pages 15-19).
In response, the Examiner disagrees. Applicant is noted that even if the technical problems to be solved or the technical objective of the cited prior art (Lovgren) is different from the claimed invention, the Courts have made clear: [t]he reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention).
The proposed modification using the combined teachings of Vaka and Lovgren to render obvious the delayed release buffering component as amended in claims 20 and 39 in the pending 103 rejection as set forth of pages 5-8 of this office action is proper for establishing a prima facie case of obviousness, as a motivation to combine and a reasonable expectation of success in doing so as been adequately articulated in the obviousness analysis of the pending 103 rejection.
Applicant argues that “Pettersson fails to remedy the deficiencies of Vaka in view of Lovgren because it does not teach or suggest the claimed delayed release buffering component or its function within a coordinated overdose-deterrent system.” Applicant alleges that neither the H2 receptor antagonist nor the proton pump inhibitor disclosed in Pettersson “directed to buffering the gastric environment through release of alkaline materials, nor is either component disclosed as part of a delayed release buffering system of the type recited in the amended claims” and thus, alleges that “Pettersson relies on pharmacological acid suppression through receptor inhibition and enzyme inhibition, which is technically distinct in mechanism from the chemical buffering mechanisms employed by Vaka and the structural coating system disclosed in Lovgren.” Applicant goes on to allege that “Pettersson provides no teaching or suggestion that its acid-suppressive agents should be incorporated into, or combined with, a delayed-release buffering structure such as a core comprising a buffering ingredient surrounded by a subcoat and an enteric shell” and that Pettersson does not “teach or suggest using such a structure as part of a dose-dependent, self- regulating system that responds to ingestion of multiple dosage units including embodiments in which gastric pH may be modulated over time.” As such Applicant alleges that “[t]he Office Action likewise does not articulate how Pettersson's teachings would be applied to modify the combined teachings of Vaka and Lovgren to arrive at the claimed invention” and that “the Office Action does not explain how the addition of a rapidly released H2 antagonist or a delayed-release PPI would result in, or motivate, the claimed delayed release buffering component comprising a core, a subcoat, and an enteric shell functioning as a buffering reservoir.” (Remarks, pages 20-22).
In response, the Examiner disagrees. The combined teachings of Vaka, Lovgren, and Pettersson are properly combined to render obvious dependent claim 45. As discussed in the pending 103 rejection for dependent claim 45, a motivation to combine and a reasonable expectation of success in doing so as been adequately articulated in the obviousness analysis of the pending 103 rejection.
As discussed in the pending 103 rejection, Vaka indicated that increase in pH due to the buffering agent will prevent the cationic pH-dependent polymer from releasing the drug, thereby allowing the drug to slowly diffuse from the polymer over an extended period of time and diminishing or eliminating the euphoric effect associated with overdoses (Vaka: [0033], [0040], [0057], [0061]-[0062]). Thus, Vaka allows for such modification as suggested and motivated by Pettersson in which the modification is to further modifying the subcoat of the enterically coated second buffering core material of Vaka in view of Lovgren to two subcoating layers or separating layers in which the inner subcoating layer which surrounds the core to contain hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and the outer subcoating layer containing a H2 receptor antagonist (which the outer subcoating layer is between the inner subcoating layer and the enteric coating) so as the enteric coated buffer core would serves its function of maintaining elevated gastric pH, thereby prolonging the suppression of drug dissolution through the cationic pH-dependent polymer.
As discussed in the 103 rejection, one of ordinary skill in the art would have reasonable expectation of modifying the formulation of the dosage form of Vaka in view of Lovgren such that the second buffering core material is coated with two subcoating layers or separating layers in which the inner subcoating layer which surrounds the core to contain hydroxypropyl methylcellulose phthalate (a sustained-release ingredient), and the outer subcoating layer containing a H2 receptor antagonist (which the outer subcoating layer is between the inner subcoating layer and the enteric coating) because enteric coating of the second buffering core material with the addition of an acid suppressing agent such as a H2-blocker to the formulation are modifications that are permissible as an alternative embodiments of Vaka ([0071]-[0074]) so as to achieve the desired rapid and maintained rise in gastric fluid pH to above 4 over a prolong-period of time per Pettersson ([0054]-[0069]), thereby suppressing the dissolution rate of the cationic-pH dependent polymer, which in turn suppresses or delays release of the drug susceptible to abuse, and providing the ultimate goal abuse deterrence and protection against overdose and tampering of the drug susceptible to abuse per Vaka ([0008] and [0023]). Accordingly, the combined teachings of Vaka, Lovgren, and Pettersson as provided in the pending 103 rejection have render obvious Applicant’s dependent claim 45, thereby Applicant’s alleged goal of providing an overdose-deterrent system is reasonably obvious based on the combined teachings of Vaka, Lovgren, and Pettersson.
As a result, for at least the reasons discussed above, claims 20-23, 27-33, 35-42, 45, and 47-56 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 20-23, 27-33, 35-42, 45, and 47-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over following U.S. Patents in view of Vaka et al (US 2016/0346274 A1) and Lovgren et al (22 November 1988; US 4,786,505):
Claims 1-6 of U.S. Patent No. 9101636.
Claims 1-7 of U.S. Patent No. 9320796.
Claims 1-13 of U.S. Patent No. 9662393.
claims 1-46 of U.S. Patent No. 10441657.
Claims 1-23 of U.S. Patent No. 10688184.
Claims 1-9 of U.S. Patent No. 11083794.
Claims 1-18 of U.S. Patent No. 11857629.
Claims 1-16 of U.S. Patent No. 11103581.
Although the claims at issue are not identical, they are not patentably distinct from each other because while the claims in the instant application being a method of treating a disease alleviated by a drug susceptible to over-ingestion, the instant claims are using substantially the same composition as the claims in the aforementioned Patents, thereby significantly overlap with the subject matter of the aforementioned Patents, i.e., an abuse deterrent pharmaceutical composition comprising a drug susceptible to abuse, an acid soluble ingredient such as a cationic copolymer of dimethylaminoethyl methacrylate, butyl methacrylate and methyl methacrylate, and a buffering ingredient. The difference between the aforementioned patents and the claims of the instant application is that the claims in the instant application further contains an ingredient for increasing gastric emptying time and a delayed release buffering component. However, it would have been obvious to include an ingredient for increasing gastric emptying time and the delayed release buffering component in the composition of the aforementioned Patents in view of the guidance from Vaka (Abstract; [0008]-[0012], [0033]-[0042], [0047], [0051]-[0076], [0078], and [0174]-[0181]; Examples 1-2; Tables 5-6 and 14; claims 11 and 20) and Lovgren (Abstract; columns 3-5; Examples 1-10).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No(s). 9101636, 9320796, 9662393, 10441657, 10688184, 11083794, 11857629, and 11103581 in view of Vaka and Lovgren.
Response to Arguments
Applicant's arguments filed 06/17/2026 have been fully considered but they are not persuasive.
Applicant indicated that consideration of filing a terminal disclaimer upon an indication that the claims are otherwise in condition for allowance. (Remarks, pages 24-25).
In response, the double patenting rejections as set forth in the office action are maintained for the reason of record, pending filing of a terminal disclaimer.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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