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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 27, 2026 has been entered.
Status of Claims
Claims 1-2, 4-15 and 17-24 are pending. Claims 3 and 16 are canceled. Claim 1 is amended.
Claims 18-24 are withdrawn as being drawn to a non-elected invention or species, there being no linking or generic claim.
Claims 1-2, 4-15 and 17 are examined on their merits in light of the elected species of Compound I.
Previous Rejections
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
Rejections Withdrawn
Claim Rejections - 35 USC § 103
In light of the amendments to the claims the rejection of claims 1-2 and 4-17 under 35 U.S.C. 103 as being unpatentable over CN 105726488 (7/6/2016)(“CN”) in view of Zhang et al. WO 2017/009316 (1/19/2017) as evidenced by www.reference.com/science-technology/density-sugar-6b6c05ee13db5c32(accessed 7/24/2025) is withdrawn.
New Rejections
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.
Claims 13-14 are 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.
Claim 13 contains the trademark/trade name Tween. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe surfactants that are derivatives of fatty acid esters of sorbitan and, accordingly, the identification/description is indefinite.
Claim 14 contains the trademark/trade name Eudragit. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe synthetic polymer composed of methacrylic acid and acrylic esters and, accordingly, the identification/description is indefinite.
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/e 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 1-2, 4-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over CN 105726488 (7/6/2016)(“CN”) in view of Zhang et al. WO 2017/009316 (1/19/2017) and Anderson et al. US 5508276 (4/16/1996) as evidenced by www.reference.com/science-technology/density-sugar-6b6c05ee13db5c32(accessed 7/24/2025).
CN discloses enteric coated micro pellets comprising a core bead; a first sealing layer, a drug loaded layer comprising RSV inhibitor and adhesive agent, a second sealing layer, and an enteric coating layer. (See CN claim 1). The core bead with a diameter of 0.2 to 2 mm is selected from a sucrose sphere and an enteric coating layer. (See claim 2). The core bead with a diameter of 0.1 to 2 mm is selected from a sucrose sphere, a microcrystalline cellulose sphere and a starch sphere. (See CN claim 1). The first and the second sealing layer includes Opadry. (See Abstract). The enteric coating material is selected from acrylic resin, hydroxypropyl methyl cellulose phthalate, cellulose acetate phthalate. (See CN claim 8). Acrylic resin is selected from Eudragit L30D-55 and Eudragit L100. (See [0019]). Eudragit L100 is called for in instant claim 14. CN teaches a capsule as called for in instant claim 4.
The binding and adhesive agent can be hydroxypropyl methylcellulose. (See claim 4). Hydroxymethylcellulose is called for in instant claims 9 and 13.
A core bead is called for in instant claim 1 and a first sealing layer is called for in instant claim 1. A core bead that comprises a sucrose sphere is called for in instant claim 5. A core bead of 0.2 to 2 mm overlaps with the diameter of 0.2 to 2 mm called for in instant claim 5. With a diameter of 0.2 mm, the weight of a sugar sphere is (Volume=4/3 π radius3= 0.000004188 cm3; Weight = 0.000004188 cm3 x 1.59 g/cm3 = 0.007 mg. (The density of sugar is 1.59 g/cm3 as evidenced by https://www.reference.com/science-technology/density-sugar-6b6c05ee13db5c32) 0.007 mg falls within the 0.05 to 0.5 mg.
The enteric coating layer includes 50-90 wt% of an enteric coating material, 1-40 wt% of a plasticizer, 1-20 wt% of an anti-caking agent, and 1-20 wt% of an emulsifier. The first sealing layer has a weight gain of 2-10% and the drug-loaded layer has a weight gain of 10-200 wt%. 50-90 wt% of an enteric coating material overlaps with the 30-95 wt% called for in claim 13. 1-40 wt% of a plasticizer overlaps with the 1-40% of a plasticizer called for in instant claim 13, and 1-20 wt% of an anti-caking agent is called for in claim 13 as well. (See [0015-20]). 1-20 wt% of an emulsifier overlaps with the 0.5 -20 wt% of an emulsifier called for in instant claim 13. CN teaches that the enteric coating layer provides steady supply of RSV discharged in the intestine and optimizes the RSV inhibitor and as such the enteric coating layer is taught to be a results-effective variable. (See [0005]). Therefore, it would be no more than routine experimentation to experiment to arrive at the optimal weight of the enteric coating layer as called for in instant claims 13, 14 and 15.
CN teaches that its invention will not disintegrate or dissolve in stomach acid but will dissolve in the small bowel and enter the bloodstream. CN teaches that its invention allows for the optimization of the pharmacokinetic profile of the RSV inhibitor API and improves the safety window of the medicine as well as its anti-RSV activity. (See [0004]). CN also teaches that the sealing coats, the first sealing coat and the second sealing coat prevent the API from contacting the core bead and reacting with it and reacting with it chemically possibly degrading it, so the sealing coats are taught to be a results-effective variable. Therefore, it would be no more than routine experimentation to experiment to arrive at the optimal weight of the first sealing layer as called for in instant claim 6, 7. Therefore, it would be no more than routine experimentation to experiment to arrive at the optimal weight of the second sealing layer as called for in instant claim 10, 12.
The emulsifier can be Tween as called for in instant claim 13. The plasticizer can be polyethylene glycol as called for in claim 13. (See CN claim 8). Talc is taught as an anti-plastering or anti-caking aid. Talc is called for in instant claim 13. CN teaches that the first sealing coat includes talc. (See CN claim 8). Talc in the first sealing layer is called for in instant claim 7.
CN teaches RSV inhibitors but does not teach N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine or a dosage amount of it. CN teaches talc but does not teach talc and silicone dioxide. These deficiencies are made up for with the teachings of Zhang et al. and Anderson et al.
Zhang et al. (Zhang) teaches crystalline forms of N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine for the treatment of respiratory syncytial virus infections (RSV). (See Abstract). N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine corresponds to the structure of Compound I wherein R1 is methyl and R2 is hydrogen as called for in instant claim 2. N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine is the elected species that falls with scope of Compound I in instant claim 1. Zhang teaches that its compounds show good stability and solubility, as well as good anti-RSV activity. (See page 2, lines 10-15). Zhang also states that it is teaching therapeutically effective amounts of compound (I) and is also teaching therapeutically effective amounts of compound (I) in a pharmaceutical dosage form. (See page 6).
N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine corresponds to the structure of Compound I wherein R1 is methyl and R2 is hydrogen as called for in instant claim 2. Zhang teaches 10-20 mg of N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine. (See Table 16). 10-20 mg overlaps with the 10 to 300 mg called for in instant claim 1.
Zhang teaches a size of the compound N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine as 0.1 mm which overlaps with the less than 100 micrometers called for in instant claim 17.
Anderson et al. (Anderson) teaches encapsulated sustained-release pharmaceutical pellets of the antidepressant drug duloxetine. (See Abstract). Anderson teaches that its formulation is a multi-layered enteric micropellets in which a core is coated with an active layer, a separating layer and an enteric layer. Talc and colloidal silicone dioxide are used in the outer layers to reduce static charge and to reduce particle adhesion. (See Example 1 and column 7, lines 10-40). The amount of talc and silicone dioxide is in the range of 5% to 30% of the final product. (See col.7, lines 10-35). 5% falls within the weight ratio of 0.0005-0.1:1 called for in instant claim 1 (it is 0.05:1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention making the CN formulation of a sugar sphere with 0.2 mm diameter and a first seal coat, a drug layer, an enteric coating layer including 50-90 wt% of an enteric coating material, 1-40 wt% of a plasticizer like polyethylene glycol, and 1-20 wt% of an emulsifier like Tween, and a second seal coat to use 10-20 mg of N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine taught by Zhang in the drug layer in light of the teachings of Zhang that its compound N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine shows good stability and solubility as well as good anti-RSV activity.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention making the CN formulation of a sugar sphere with 0.2 mm diameter and a first seal coat, a drug layer, an enteric coating layer including 50-90 wt% of an enteric coating material, 1-40 wt% of a plasticizer like polyethylene glycol, and 1-20 wt% of an emulsifier like Tween, and a second seal coat to use 5% talc and silicon dioxide together in order to have a mixture that reduces static charge and reduces particle adhesion as taught by Anderson.
There would be a reasonable expectation of success because Zhang teaches a known RSV inhibitor that possesses good stability, solubility and anti-RSV activity and CN teaches a dosage formulation that is directed to a RSV inhibitors. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-2, 4-15 and 17 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 5-7 and 9-10 of U.S. Patent No. 12582661 in view of CN 105726488 (7/6/2016)(“CN”), Zhang et al. WO 2017/009316 (1/19/2017) and Anderson et al. US 5508276 (4/16/1996) as evidenced by www.reference.com/science-technology/density-sugar-6b6c05ee13db5c32(accessed 7/24/2025).
Although the claims are not identical, they are not patentably distinct from each other because the instant claims are directed to a 0.2 mm diameter sugar sphere and a first seal coat, a drug layer with 10-20 mg of N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine, an enteric coating layer including 50-90 wt% of an enteric coating material, 1-40 wt% of a plasticizer like polyethylene glycol, and 1-20 wt% of an emulsifier like Tween, and a second seal coat.
Claims 1-3, 5-7 and 9-10 of U.S. Patent No. 12582661 are directed to a pharmaceutical composition containing compounds including N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine.
The composition claimed in U.S. Patent No. 12582661 differs from that of the instant claims in that it does not require a 0.2 mm diameter sugar sphere and a first seal coat, a drug layer with 10-20 mg of N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine, an enteric coating layer including 50-90 wt% of an enteric coating material, 1-40 wt% of a plasticizer like polyethylene glycol, and 1-20 wt% of an emulsifier like Tween, and a second seal coat. These deficiencies are made up for with the teachings of CN, Zhang and Anderson.
The teachings of CN are described supra.
It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12582661 to use a formulation of a sugar sphere with 0.2 mm diameter and a first seal coat, a drug layer, an enteric coating layer including 50-90 wt% of an enteric coating material, 1-40 wt% of a plasticizer like polyethylene glycol, and 1-20 wt% of an emulsifier like Tween, and a second seal coat as taught by CN in light of the teachings of CN that this formulation allows for the optimization of the pharmacokinetic profile of the RSV inhibitor API and improves the safety window of the medicine as well as its anti-RSV activity.
The teachings of Zhang are described supra. It would have been obvious to one of ordinary skill in the art making the composition of U.S. Patent No. 12582661 to use 10-20 mg of N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine taught by Zhang in the drug layer in light of the teachings of Zhang that its compound N-[3-Amino-3-oxetanyl)methyl]-2-(2,3-dihydro-1,1-dioxido-1,4-benzothiazepin-4(5 H))-yl) -6- methyl-4-quiazolinamine shows good stability and solubility as well as good anti-RSV activity.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention making the composition of U.S. Patent No. 12582661 to use 5% talc and silicon dioxide together in order to have a mixture that reduces static charge and reduces particle adhesion as taught by Anderson.
.
Claims 1-2, 4-15 and 17 are directed to an invention not patentably distinct from claims 1-3, 5-7 and 9-10 of commonly assigned of U.S. Patent No. 12582661 as described above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned US Patent No. 12582661 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicants’ comments of April 23, 2026 have been fully reviewed and are found to unpersuasive for the reasons described below.
Applicants argue that CN ‘488 fails to teach or suggest at least the element of amended claim 1 that recites “a pharmaceutical unit dosage composition comprising a plurality of enteric coated micro pellets and an anti-sticking agent . . the anti-sticking agent is a combination of silicone dioxide and talc . . a weight ratio of the anti-sticking agent to the enteric coated micro pellets is 0.0005-0.1:1.” Applicants assert that CN ‘488 does not teach or suggest “a combination of silicon dioxide and talc”.
Applicants also assert that Zhang does not teach or suggest “a combination of silicone dioxide and talc” in the claimed amounts in the formulation.
Applicants argue that their invention has unexpected results in the form of a Tmax values that were significantly shorter than that of the enteric micro pellets. Exposure in terms of Cmax reached 4-5 fold of that observed with micropellets. Applicants assert that these unexpected results show that a combination of silicon dioxide and talc is not a results-effective variable and it will require more than routine experimentation to experiment to arrive at the claimed amounts.
Applicants’ argument regarding the failure of the cited prior art to teach the combination of silicone dioxide and talc in the claimed amounts is found to be persuasive in light of the amendments to the claims. The rejections are withdrawn above.
As described in the new rejection applied above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention making the CN formulation of a sugar sphere with 0.2 mm diameter and a first seal coat, a drug layer, an enteric coating layer including 50-90 wt% of an enteric coating material, 1-40 wt% of a plasticizer like polyethylene glycol, and 1-20 wt% of an emulsifier like Tween, and a second seal coat to use 5% talc and silicon dioxide together in order to have a mixture that reduces static charge and reduces particle adhesion as taught by Anderson.
Applicants assertion of unexpected results is not found to be persuasive, however.
Claim 1 is not commensurate in scope with the evidence that Applicants are citing to support their assertion of unexpected results. The Examples show only a few formulations tested. Claim 1 covers 10 to 300 mg of any API with a structure of Compound I. However, it appears from the Examples that only a single species of Compound I was tested in the Examples. Additionally, any core bead is covered by the language of claim 1 but only sugar spheres were tested in the Examples.
All showings of secondary considerations of obviousness must be commensurate in scope with the claims. Unexpected results must be commensurate in scope with the claims which the evidence is offered to support. See In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 196 (CCPA 1980). See MPEP 716.02(d). The submission of objective evidence of patentability does not mandate a conclusion of patentability in and of itself. In re Chupp, 816 F.2d 643, 2 USPQ2d 1437 (Fed. Cir. 1987). Facts established by rebuttal evidence must be evaluated along with the facts on which the conclusion of a prima facie case was reached, not against the conclusion itself. In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990). MPEP 716.01(d).
The remainder of Applicants arguments are moot in view of the new rejection applied above.
Conclusion
No claims are allowed.
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SARAH CHICKOS
Examiner
Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
Prosecution Insights