DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Previous Rejections
Applicants' arguments, filed Oct. 30, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Rejections have been made in this office action that are not necessitated by amendment. Therefore, this action is made NON-FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
1. Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3 recite the limitation "after being subjected to a stability test" in the penultimate line. The claim is indefinite because it is unclear what this method is and what steps it encompasses such that one would be able to determine what amount of proton pump inhibitor was released from the capsule and what amount remained. Said “stability test” does not appear to be a known method in the art such that one would know what the method encompasses. The instant specification does not appear to describe said “stability test” in such a way that one would understand what said test entails.
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.
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.
1. Claim(s) 1, 3-4, 11, 15-16, 18-20, 22, 24, 28, and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (WO 2017/095736, Jun. 8, 2017) (hereinafter Ahmad) in view of Worm et al. (US 2019/0211189, Jul. 11, 2019) (hereinafter Worm).
Ahmad teaches a soft gelatin capsule formulation for pharmaceuticals and dietary supplements (¶ [0001]). The soft gel capsules enhance both the stability and solubility of moisture sensitive pharmaceuticals. In addition, the soft gel capsules allow for a long shelf life and desirable solubility in a patient's digestive tract (¶ [0011]). In one aspect, the formulation is in the form of a soft gelatin capsule having a shell and a liquid fill (i.e., suspension system) encapsulated. The liquid fill comprises at least one oil; at least one surfactant; and a moisture sensitive pharmaceutical or a moisture sensitive dietary supplement dispersed in the oil (¶ [0012]). The oil is selected from almond oil, grape seed oil, olive oil, soybean oil, coconut oil, vegetable oil, palm oil, and hydrogenated vegetable oil (satisfies triglycerides of claim 1 & 3) (¶ [0013]). Suitable surfactants include mono-glyceride (i.e., glyceryl monostearate) (satisfies claim 11) (¶ [0014]). The shell may comprise plasticizers such as glycerol and sorbitol (satisfies claim 43) (¶ [0015]). Suitable moisture sensitive pharmaceuticals include esomeprazole (a proton pump inhibitor - satisfies claim 4) (¶ [0016]). The soft gelatin capsule may further comprise one or more of a water scavenger, a solubilizer, an antioxidant, a preservative, a chelating agent, a complexing agent, a viscomodulator, a tonicifier, a flavorant, a colorant, an odorant, an opacifier, a suspending agent, and a binder (¶ [0018]). The composition is particularly suitable for oral administration (i.e., enteric) (¶ [0028]). The active ingredient may also include salts of the moisture sensitive pharmaceuticals (¶ [0038]). The amount of the moisture sensitive pharmaceutical present in the liquid fill may be the required or recommended dosage of the pharmaceutical. Esomeprazole may be included in an amount from about 0.1 to about 30 wt.% of the liquid fill (¶ [0039]). The oil may be used in an amount of up to 90 wt. % (¶ [0043]). Suitable surfactants also include polysorbate 80 (satisfies claim 28) (¶ [0048]). The surfactant in the liquid fill may be used in an amount from about 0.01 wt.% to about 10 wt.% (¶ [0051]). Suitable water scavengers include multivalent alkali metal oxides (MAMOs) (¶ [0064]).
Ahmad differs from the instantly recited claims insofar as not disclosing wherein the shell composition comprises a carrageenan such as iota carrageenan in an amount of 2-4%.
However, Worm discloses that soft gelatin capsules are commonly used to encapsulate solid and liquid materials, such as nutritional or pharmaceutical products, for oral administration. The use of gelatin to form capsules, however, has drawbacks that include the high cost, often inadequate supply, and tendency to cross-link (¶ [0003]). Thus, compositions are needed that mimic the behavior and characteristics of gelatin, and that can be used to efficiently produce soft capsules, while overcoming the shortcomings of gelatin (¶ [0004]). Accordingly, Worm discloses compositions comprising a carrageenan, a starch, a plasticizer, water, and an optional buffer (¶ [0004 & 0006]). Generally, the carrageenan can comprise an iota carrageenan, and the composition can contain from about 2.5 to about 10 wt.% carrageenan (satisfies carrageenan of claim 1-3 & 18) (¶ [0007]). The compositions are used to make articles such as capsules (¶ [0008]). Suitable plasticizers include glycerin and sorbitol (satisfies claim 43) (¶ [0034]). The pH of the carrageenan-based composition can be adjusted or controlled by adding buffers to improve the stability of any articles produced therefrom such as capsules (¶ [0039]). The capsules comprise a shell and a fill material. The shell comprises the aforementioned carrageenan-based compositions while the fill material is not particularly limited. Thus, the fill material can be a liquid or a solid. The carrageenan-based capsules can be configured to replace gelatin-based capsules (¶ [0045]).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have modified the formulation of Ahmad to utilize the capsule/shell of Worm motivated by the desire to improve the capsule and overcome the drawbacks of gelatin capsules that include their high cost, often inadequate supply, and tendency to cross-link as taught by Worm.
Regarding the limitations recited in instant claims 1, 3, 19-20, 22, and 24 (i.e., how much of the proton pump inhibitor is dissolved and how long it takes for the capsule shell to rupture), active ingredient dissolution rates and shell rupture timings are descriptive and thus would be properties of the claimed soft gel capsule. Ahmad in view of Worm comprising sustainably the same capsule comprising substantially the same shell and fill material. Ahmad in view of Worm disclose substantially the same actives, surfactants, and plasticizers. Therefore, when the shell and fill material of Ahmad and Worm are used to form enteric soft gel capsules, it would have been reasonable for one of ordinary skill in the art to conclude that the capsules of Ahmad in view of Worm would have substantially the same properties, active ingredient dissolution rates and shell rupture timings, as the capsules of the instant claims.
Regarding claim 4, as discussed above, Ahmad in view of Worm disclose wherein suitable moisture sensitive pharmaceuticals include esomeprazole. Accordingly, a composition comprising esomeprazole as an active would have been obvious.
Regarding instant claims 15-16, Ahmad in view of Worm does not teach the use of the conventional enteric polymers recited in claim 16. Accordingly, a composition comprising less than 1% w/w conventional enteric polymers would have been obvious.
Regarding claim 28, as discussed above, Ahmad in view of Worm disclose wherein suitable surfactants include polysorbate 80. Accordingly, a composition comprising a surfactant such as polysorbate 80 would have been obvious.
Therefore, the combined teachings of Ahmad and Worm render obvious claims 1, 3-4, 11, 15-16, 18-20, 22, 24, 28, and 43.
2. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (WO 2017/095736, Jun. 8, 2017) (hereinafter Ahmad) in view of Worm et al. (US 2019/0211189, Jul. 11, 2019) (hereinafter Worm) and further in view of Fang et al. (US 2016/0038425, Feb. 11, 2016) (hereinafter Fang)
The teachings of Ahmad in view of Worm are discussed above.
The combined teachings of Ahmad and Worm do not disclose wherein the shell composition has a pH of about 7.0 to about 9.0.
However, Fang teaches enteric soft capsules comprising carrageenans (Abstract). In an embodiment, Fang discloses an oral enteric soft capsule shell formed from a gel mass composition comprising a carrageenan composition which comprises iota carrageenan and kappa carrageenan (¶ [0006]). The enteric soft capsule further comprises an active ingredient in
the matrix fill which may be liquid (¶ [0011]). The capsules do not dissolve in the gastric environment (pH. 1.2), but readily dissolve in the intestinal environment (pH. 6.8) (¶ [0019]). An amount of an alkali is added as a neutralizing agent to give a final pH value of the gel mass less than or equal to about pH 9.0 (¶ [0026]). Films of the enteric soft capsule shell do not dissolve
or disintegrate in acids, such as 0.1 N hydrochloric acid or simulated gastric fluid (ca. pH 1.2) for at least two hours but readily release the contents upon shifting the pH of the solution to ca. 6.8, such as that of simulated intestinal fluid. (¶ [0054]). Suitable actives include anti-ulcerative agents (¶ [0063]).
As discussed above, Ahmad in view of Worm disclose wherein buffers can be utilized to control the pH and resulting stability of the enteric shell composition.
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the enteric shells of Ahmad in view of Worm to have a pH of less than or equal to about pH 9.0 motivated by the desire to achieve shells which do not dissolve in the gastric environment (pH. 1.2) or in 0.1N HCL, but readily dissolve in the intestinal environment (pH. 6.8) as taught by Fang.
Therefore, the combined teachings of Ahmad, Worm, and Fang render obvious claim 2.
3. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (WO 2017/095736, Jun. 8, 2017) (hereinafter Ahmad) in view of Worm et al. (US 2019/0211189, Jul. 11, 2019) (hereinafter Worm) and further in view of Stabile et al. (US 9,688,658, Jun. 27, 2017) (hereinafter Stabile).
The teachings of Ahmad and Worm are discussed above and Ahmad discloses that the pharmaceuticals of the invention include base drugs as well as any of their salts, esters, solvates, etc. that are useful for delivering the pharmaceutical activity of the compositions (¶ [0038]).
The combined teachings of Ahmad and Worm differ from the instantly recited claims insofar as not explicitly disclosing wherein the active agent is esomeprazole magnesium dihydrate.
However, Stabile discloses that suitable salts of esomeprazole include esomeprazole magnesium dihydrate (col 6, line 64-66).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Ahmad in view of Worm disclose wherein the active ingredient may also include salts of the moisture sensitive pharmaceuticals. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Ahmad in view of Worm to comprise esomeprazole magnesium dihydrate, since it is a known salt of esomeprazole as taught by Stabile.
Therefore, the combined teachings of Ahmad, Worm, and Stabile render obvious claim 5.
4. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (WO 2017/095736, Jun. 8, 2017) (hereinafter Ahmad) in view of Worm et al. (US 2019/0211189, Jul. 11, 2019) (hereinafter Worm) and further in view of Ault et al. (US 2010/0330179, Dec. 30, 2010) (hereinafter Ault).
The teachings of Ahmad and Worm are discussed above.
The combined teachings of Ahmad and Worm differ from the instantly recited claims insofar as not disclosing the specific dosage of the proton pump inhibitor.
However, Ault teaches a pharmaceutical composition in unit dose form comprising naproxen, or pharmaceutically acceptable salt thereof, and esomeprazole, or pharmaceutically acceptable salt thereof (¶ [0001]). An effective dose of esomeprazole to raise the pH of the gastric fluid of a patient to at least 3.5 is about 10 mg to about 50 mg (¶ [0010]). Suitable forms of the unit dosage form include a capsule (¶ [0011]).
As discussed above, Ahmad in view of Worm disclose wherein esomeprazole may be included in an amount of about 0.1 to about 30 wt.% and wherein the selected dosage may be the recommended dosage of the pharmaceutical. Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the capsule of Ahmad in view of Worm to contain about 10 mg to about 50 mg esomeprazole, since this dosage is taught to be effective in raising gastric fluid pH of a patient using a capsule as taught by Ault.
Therefore, the combined teachings of Ahmad, Worm, and Ault render obvious claim 6.
5. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (WO 2017/095736, Jun. 8, 2017) (hereinafter Ahmad) in view of Worm et al. (US 2019/0211189, Jul. 11, 2019) (hereinafter Worm) and further in view of Platt et al. (US 2007/0160659, Jul. 12, 2007) (hereinafter Platt).
The teachings of Ahmad and Worm are discussed above.
The combined teachings of Ahmad and Worm differ from the instantly recited claims insofar as not disclosing wherein the fill material comprises medium chain triglycerides in a ratio of about 1:1 to about 50:1, for example.
However, Platt teaches stabilized phosphatidylserine preparations (¶ [0001]). These preparations are provided in the form of soft gel capsules (¶ [0016]). The phosphatidylserine compositions are dissolved in suitable oils to prepare the stable phosphatidylserine preparations. Suitable oils include medium-chain triglycerides and vegetable oils (¶ [0051]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Ahmad in view of Worm disclose wherein the liquid fill comprises an oil. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Ahmad in view of Worm to comprise medium-chain triglycerides, since it is a known oil for use in dissolving actives for soft gel capsules as taught by Platt.
Regarding the ratio recited in the instant claim (i.e., about 1:1 to about 50:1), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Ahmad in view of Worm disclose wherein the composition comprises up to 90 wt. % of an oil and about 0.01 wt.% to about 10 wt.% of a surfactant. Accordingly, the claimed weight ratio would have been obvious from one of ordinary skill in the art selecting an amount of oil (i.e., medium chain triglycerides) and an amount of surfactant (i.e., glyceryl monostearate) from the above ranges and the ratio thereof overlapping with the claimed ratio.
Therefore, the combined teachings of Ahmad, Worm, and Platt render obvious claim 13.
6. Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al. (WO 2017/095736, Jun. 8, 2017) (hereinafter Ahmad) in view of Worm et al. (US 2019/0211189, Jul. 11, 2019) (hereinafter Worm) and further in view of Hackett et al. (WO 2004/062695, Jul. 29 2004) (hereinafter Hackett).
The teachings of Ahmad and Worm are discussed above.
The combined teachings of Ahmad and Worm differ from the instantly recited claims insofar as not disclosing wherein the composition comprises magnesium oxide.
However, Hackett teaches compositions comprising a multivalent alkali metal salt of a protein pump inhibitor (PPI) or a combination of a protein pump inhibitor and a corresponding multivalent alkali metal salt thereof, a multivalent alkali metal oxide (MAMO) in an amount sufficient to scavenge water (Abstract). The composition may utilize a oily liquid carrier for filling into capsules (page 7, line 12-15). Preferred pharmaceutically acceptable multivalent alkali metal oxides (MAMO) which act as water scavengers include magnesium oxide (page 10, line 28-31).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Ahmad in view of Worm disclose wherein the composition may comprise water scavengers such as multivalent alkali metal oxides (MAMOs). Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Ahmad in view of Worm to comprise magnesium oxide, since it is a known multivalent alkali metal oxides (MAMO) which act as water scavenger for use with protein pump inhibitors in a fill for capsules as taught by Hackett.
Therefore, the combined teachings of Ahmad, Worm, and Hackett render obvious claim 31.
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.
1. Claims 1-6, 11, 13, 15-16, 18-20, 22, 24, 28, 31, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,090,232 in view of Ahmad et al. (WO 2017/095736, Jun. 8, 2017) (hereinafter Ahmad).
Both the instant claims and the patented claims disclose an enteric soft gel capsule comprising a fill material and a shell composition comprising a pharmaceutically active ingredient and overlapping amounts of carrageenan. The difference between the instant claims and the patented claims lies in that the patented claims do not specify wherein active pharmaceutical ingredient in the fill material comprises a proton pump inhibitor. However, the claims of the ‘232 patent recite the broad recitation of “at least one pharmaceutically active ingredient”, which would encompass active agents not recited by the patented claims. Further the patented claims do not exclude proton pump inhibitors from being encompassed by the patented claims. Another difference between the instant claims and the patented claims lies in that the patented claims do not recite wherein the fill material further comprises triglycerides.
However, Ahmad teaches a soft capsule having a shell and liquid fill material where the comprises at least one oil along with the moisture sensitive pharmaceutical ingredient dispersed in said oil (¶ [0012]). Suitable oils include almond oil, grape seed oil, olive oil, soybean oil, coconut oil, vegetable oil, palm oil, and hydrogenated vegetable oil (satisfies triglycerides) (¶ [0013]). In one aspect, the oil is used in the capsule fill to stabilize the moisture sensitive pharmaceutical supplement (¶ [0030]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated oils (i.e., triglycerides) into the claimed invention since they are a known additive to the fill material of a soft capsule comprising a shell and fill material motivated by the desire to stabilize the active as taught by Ahmad.
Response to Arguments
Applicant’s arguments with respect to claims 1-6, 11, 13, 15-16, 18-20, 22, 24, 28, 31, and 43 have been considered but are moot because new rejections have been made.
Conclusion
Claims 1-6, 11, 13, 15-16, 18-20, 22, 24, 28, 31, and 43 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612