DETAILED ACTION
Formal Matters
Claims 1-15 are cancelled. Claims 16-31 are new, pending and under examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a continuation of 17/647,149 filed on 1/5/2022, which is a continuation of 16/880,639 filed on 5/21/2020, which is a divisional of 16/399,571 filed on 4/30/2019, which is a continuation of 16/120,999 filed on 9/4/2018, which is a continuation of 15/958,413 filed on 4/20/2018, which is a continuation of 14/928,276 filed on 10/30/2015, which claims priority from US provisional application 62/122,847 filed on 10/31/2014 and foreign priority from Canadian application CA2902911 filed on 08/27/2015.
Information Disclosure Statement
The information disclosure statement filed 5/15/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claim 1 is object to for the “BKH1” that follows “comprising” in the first line of the claim. This item should be deleted.
Claim 30 is objected to for missing a period at the end of the claim. A period is needed.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112(a) – Written Description
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 21 contains the limitation of “a polyvinyl alcohol derivate”, but the specification does not define what polyvinyl alcohol derivate is nor provide an adequate number of species of derivates of polyvinyl alcohol that would encompass the genus of polyvinyl alcohol derivates (derivatives). This is a genus that could include various addition compounds and polymers with polyvinyl alcohol being a portion thereof or where polyvinyl alcohol was used to produce other compounds. Thus, there is adequate description for polyvinyl alcohol itself, but not for the genus to provide for polyvinyl alcohol derivates.
Claim Rejections - 35 USC § 112(b)
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 21, 29 and 30 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.
The term “about” in claims 29 and 30 in relation to Tmax values is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Tmax is in presented in hours but as pharmacokinetics may be determined by various means (various simulations vs. various experimental methods), it is unclear what percent error/deviation would be provided by “about” in the claim in regards to Tmax as stated. There is also no definition provided for “about” itself in the specification. It is unclear what the range “about” provides around the given Tmax value. If the prior art provides for the different coated methylphenidate beads/granules of the formulation with immediate, controlled and delayed release and similar polymers, the formulation will be presumed to have a Tmax of about 13.5 hours as “about 13.5 hours” in this context is not provided. Applicant may provide how “about” is offered to Tmax in terms of the originally filed disclosure or delete “about” from these claims.
Claim 21 is indefinite for the term “polyvinyl alcohol derivate” as “derivate” is not definite or provided a reasonable meaning by applicant’s specification. Thus, it is unclear what compounds are provided by “polyvinyl alcohol derivate” to offer metes and bounds for this limitation. For compact prosecution, if a compound can reasonably be considered to have a PVA group or have been made from PVA, it will be considered a polyvinyl alcohol derivate during search.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-18, 20, 21, 23, 28, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shojaei WO 2007/133203A1.
Shojaei teaches a multiple pulsed dose drug delivery system for pharmaceutically acceptable amphetamine salts (abstract, claims 1 and 2 of Shojaei). Shojaei teaches an immediate release formulation with sugar spheres coated with amphetamine salts including dextroamphetamine salts (example 1). Example 2 provides for an intermediate formulation where the immediate release pellets of example 1 are coated with Eudragit FS30D (MAA/MA/MMA (methyl acrylate, methyl methacrylate and methacrylic acid copolymer, a methacrylic acid copolymer) or Eudragit 4110D and then coated with OPADRY Beige (Example 2, table 2, and under table 2). Shojaei teaches a delayed release formulation where the pellets of example 1 are coated with Eudragit L30D-55 (methacrylic acid copolymer) and then provided with OPADRY Beige (example 3). Shojaei teaches a sustained release formulation where intermediate formulations of example 2 are coated with SURELEASE (ethyl cellulose dispersion) solids(example 4, table 4). Shojaei teaches a controlled release capsule produced with pellets of examples 1 (immediate release), 3 (delayed release), and 4 (delayed release) (Examples 5 and 6, tables 6 and 7). Example 5 has 25 mg capsules. Shojaei teaches “The drug delivery system of the present invention as described herein preferably comprises one or a number of beads or beadlets in a dosage form, either capsule, tablet, sachet or other method of orally administering the beads. In a specific embodiment of the present invention, the drug delivery system comprises three beads or beadlets in a dosage form, either capsule, tablet, sachet or other method of orally administering the beads. In a preferred embodiment, the immediate release beads, the delayed pulsed release beads, and the sustained release beads are present in the composition in an about 1:1:1 ratio.” (page 13, just prior to Brief Description of Drawings). Shojaei teaches different doses of 12.5 mg to 75 mg (claims 24-32 of Shojaei). Shojaei teaches sustained release coatings and protective coating layers including ethyl cellulose dispersions (SURELEASE) (page 21) and table 4 provides for 8 wt% of SURELEASE. Shojaei teaches a protective layer applied immediately outside the drug containing core where the polymer can be hydroxyethylcellulose, polyvinylpyrrolidone or ethyl cellulose (page 21). Shojaei teaches enteric delayed pulse release or sustained release coating layer with pH-sensitive polymer (page 21). Shojaei provides the OPADRY overcoating is optional (page 22). Shojaei teaches “intermediate release bead of Example 1 {see Examples 1 and 2) is coated with a sustained release coating (SURELEASE®), the sustained release coating is coated with a delayed release coating (EUDRAGIT® FS30 D)” (page 5). Shojaei teaches a full day treatment (i.e. about 14 to about 16 hours) (page 7). Shojaei provides for exemplary sustained release coatings including Eudragit RS and enteric delayed pulsatile release and sustained release polymers that include such coating products include the neutral methacrylic acid esters with a small portion of trimethylammonioethyl methacrylate chloride, sold currently under the trade names EUDRAGIT® RS (pages 19 and 22). Table 12 provides for a Tmax of 12 for a dosage form of d-amphetamine, but range of 8 to 14 based on min and max. Thus, 13.5 hours is encompassed. As the dosage form shares the bead structure/makeup and similar delayed release coating polymers of applicant’s claims, the granules/beads with the delayed release coating polymers are capable of releasing the drug to the distal portion of the intestine. Shojaei does provide that “Various enteric materials, e.g., cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate, and the EUDRAGIT® acrylic polymers, have been used as gastroresistant, enterosoluble coatings for single drug pulse release in the intestine (Xu X and Lee P, Pharm Res. 1993; 10(8): 1144-1152). The enteric materials, which are soluble at higher pH values, are frequently used for colon-specific delivery systems” (Background of Invention). Shojaei’s invention uses Eudragit acrylic polymers as enteric materials and the colon is a distal part of the intestine. Shojaei does not have an immediate release coating on its sustained or delayed release beads where the beads are separate in multi-bead formulations.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22, 24, and 25 in addition to Claims 16-18, 20, 21, 23, 28, and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shojaei WO 2007/133203A1.
Shojaei teaches a multiple pulsed dose drug delivery system for pharmaceutically acceptable amphetamine salts (abstract, claims 1 and 2 of Shojaei). Shojaei teaches an immediate release formulation with sugar spheres coated with amphetamine salts including dextroamphetamine salts (example 1). Example 2 provides for an intermediate formulation where the immediate release pellets of example 1 are coated with Eudragit FS30D (MAA/MA/MMA (methyl acrylate, methyl methacrylate and methacrylic acid copolymer, a methacrylic acid copolymer) or Eudragit 4110D and then coated with OPADRY Beige (Example 2, table 2, and under table 2). Shojaei teaches Eudragit RL 30D as a coating (claim 43 of Shojaei, page 19 and page 21). Shojaei teaches a delayed release formulation where the pellets of example 1 are coated with Eudragit L30D-55 (methacrylic acid copolymer) and then provided with OPADRY Beige (example 3). Shojaei teaches a sustained release formulation where intermediate formulations of example 2 are coated with SURELEASE (ethyl cellulose dispersion) solids(example 4, table 4). Shojaei teaches a controlled release capsule produced with pellets of examples 1 (immediate release), 3 (delayed release), and 4 (delayed release) (Examples 5 and 6, tables 6 and 7). Example 5 has 25 mg capsules. Shojaei teaches “The drug delivery system of the present invention as described herein preferably comprises one or a number of beads or beadlets in a dosage form, either capsule, tablet, sachet or other method of orally administering the beads. In a specific embodiment of the present invention, the drug delivery system comprises three beads or beadlets in a dosage form, either capsule, tablet, sachet or other method of orally administering the beads. In a preferred embodiment, the immediate release beads, the delayed pulsed release beads, and the sustained release beads are present in the composition in an about 1:1:1 ratio.” (page 13, just prior to Brief Description of Drawings). Shojaei teaches different doses of 12.5 mg to 75 mg (claims 24-32 of Shojaei). Shojaei teaches sustained release coatings and protective coating layers including ethyl cellulose dispersions (SURELEASE) (page 21) and table 4 provides for 8 wt% of SURELEASE. Shojaei teaches a protective layer applied immediately outside the drug containing core where the polymer can be hydroxyethylcellulose, polyvinylpyrrolidone or ethyl cellulose (page 21). Shojaei teaches enteric delayed pulse release or sustained release coating layer with pH-sensitive polymer (page 21). Shojaei provides the OPADRY overcoating is optional (page 22). Shojaei teaches “intermediate release bead of Example 1 {see Examples 1 and 2) is coated with a sustained release coating (SURELEASE®), the sustained release coating is coated with a delayed release coating (EUDRAGIT® FS30 D)” (page 5). Shojaei teaches a full day treatment (i.e. about 14 to about 16 hours) (page 7). Shojaei provides for exemplary sustained release coatings including Eudragit RS and enteric delayed pulsatile release and sustained release polymers that include such coating products include the neutral methacrylic acid esters with a small portion of trimethylammonioethyl methacrylate chloride, sold currently under the trade names EUDRAGIT® RS (pages 19 and 22). Table 12 provides for a Tmax of 12 for a dosage form of d-amphetamine, but range of 8 to 14 based on min and max. Thus, 13.5 hours is encompassed. As the dosage form shares the bead structure/makeup and similar delayed release coating polymers of applicant’s claims, the granules/beads with the delayed release coating polymers are capable of releasing the drug to the distal portion of the intestine. Shojaei does provide that “Various enteric materials, e.g., cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate, and the EUDRAGIT® acrylic polymers, have been used as gastroresistant, enterosoluble coatings for single drug pulse release in the intestine (Xu X and Lee P, Pharm Res. 1993; 10(8): 1144-1152). The enteric materials, which are soluble at higher pH values, are frequently used for colon-specific delivery systems” (Background of Invention). Shojaei’s invention uses Eudragit acrylic polymers as enteric materials and the colon is a distal part of the intestine. Shojaei teaches that enteric coatings for sustained release are pH dependent (page 18). Shojaei provides for the suggestive coating levels to be 1 to 6% (w/w) (page 21). Shojaei teaches coating weight percent of about 24 to about 30 wt% for enteric coating (page 11) (serves as outer delay release coating). “About 24” is able to reasonably overlap with “about 20” in the range of “about 3% to about 20%”. “About” can be up to 20% of the given value in Shojaei (page 16, definition of “about”).
One of ordinary skill in the art before the time of filing would have seen Eudragit RS (ammonio methacrylate copolymer) and poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) copolymer as being suitable preferred coating ingredients for these formulations in the controlled/sustained release coating and delayed release (enteric) coatings. One of ordinary skill in the art would work with ranges and with amounts of the coating polymers in the prior art when manufacturing modified release bead formulations by teachings of Shojaei to obtain desired release rates that would allow for the up to 14-16 hours of efficacy. There is a reasonable expectation of success in producing formulations of applicant’s claims by the teachings of Shojaei and obtaining multi-bead formulations with claimed polymers and amounts thereof.
Claims 16-19, 21-23, 25-29 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goldenheim US 6673367.
Goldenheim teaches “oral modified/controlled release methylphenidate formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release methylphenidate formulations” (abstract). Goldenheim teaches formulation 2 in example 6B that has immediate release methylphenidate beads from example 1 and enteric coated controlled release methylphenidate beads from example 5. Goldenheim teaches preferred embodiments having ammonio methacrylate copolymers (column 12, lines 29-40). Goldenheim teaches these for hydrophobic coating material that make up the controlled release coating (column 12, lines 18-28). Goldenheim teaches methacrylic acid copolymers as Eudragits that are pH dependent or pH independent (column 12, lines 41-57). Example 1 of Goldenheim provides for immediate release beads of methylphenidate that are on sugar beads (the granules) (table 1). Microcrystalline cellulose spheronizing agents are also taught in Goldenheim. Example 5 provides methylphenidate CR beads coated with enteric coating of Eudragit L 30 D55 (methacrylic acid/ethyl acrylate) at 9.9% by weight (table 7). The enteric coating would be the outer coating and the CR coating represents the inner controlled release coating in this example of Goldenheim. Example 2 provides for the methylphenidate CR/controlled release beads which are IR beads coated with Eudragit RS 30 D (ethyl acrylate/methyl methacrylate/methacrylic acid ester with quaternary ammonium groups) at 8.63 wt% (table 3). Goldenheim provides the embodiments of “In other embodiments of the invention, the formulations of the invention are composed of: (i) a mixture of immediate release particles (e.g., beads) and enteric coated immediate release particles (e.g., beads); (ii) a mixture of immediate release particles (e.g., beads) and enteric coated controlled release particles (e.g., beads) or (iii) a mixture of immediate release particles (e.g., beads) and controlled release particles (e.g., beads). In each such instance, the mixture of particles possessing different release properties are blended together and filled into hard gelatin capsules” (bottom of column 5 to top of column 6). Goldenheim teaches maintaining effective plasma levels for about 16 to about 18 hours (column 4, lines 54-55). Goldenheim teaches time to maximum plasma concentration of between 0.5 to 4 hours (column 4, lines 11-14). Goldenheim teaches 15, 20 and 30 mg strengths of methylphenidate (table in column 21). Goldenheim teaches sustained release coatings (columns 10-12), alkylcellulose polymers (columns 11 and 12), and acrylic polymers (columns 12 and 13). Goldenheim teaches acrylic acid and methacrylic acid copolymers, methyl methacrylate copolymers, and others (column 12, lines 19-28). Goldenheim teaches tables with 1 hour methylphenidate HCl dissolution of 5-50% or 10-50%, 4 hour dissolution of 40-90% or 30-80%, 8 hour dissolution of NLT 60% or NLT 65% and 12 hour dissolution of NLT 80% (column 10). Goldenheim provides diverse factors for influencing dissolution of a drug substance including the carrier (column 9, lines 52-65). Goldenheim provides that the formulations are designed to produce rapid rise in therapeutic levels, followed by period of reduced absorption and then controlled release (column 9, lines 23-32).
Goldenheim does not provide an embodiment with the immediate release granules and the second granules with the delayed release coat over the active pharmaceutical agent coat, although it does provide for “(i) a mixture of immediate release particles (e.g., beads) and enteric coated immediate release particles (e.g., beads); (ii) a mixture of immediate release particles (e.g., beads) and enteric coated controlled release particles (e.g., beads)” as options. One of ordinary skill in the art before the time of filing seeking to provide a modified release formulation of methylphenidate would look to teachings of Goldenheim for the types of granules it presents for making such formulations and would be motivated to combine enteric coated immediate release particles and enteric coated controlled release particles with the immediate release particles as they would be seen as offering the advantages of immediate release to gain immediate effect and then a longer term controlled effect to increase the effectiveness with Goldenheim recognizing the achievement of 16-18 hours of methylphenidate effectiveness. Goldenheim recognizes the use of acrylic and alkylcellulose polymers for the coatings of its particles and in such acrylic copolymers in the example beads. Goldenheim also recognizes that there is a Tmax of between 0.5 to 4 hours which includes about 3 hours. Thus, there is a reasonable expectation of success in producing formulations of applicant’s claims with the teachings of Goldenheim as it allows for the production of the different beads and a motivation to make modified release formulations having immediate release, controlled release and delayed release abilities to allow for formulations that can be effective for up to 16-18 hours.
Claim 24 in addition to Claims 16-19, 21-23, 25-29 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goldenheim US 6673367 and Shojaei WO 2007/133203A1.
Goldenheim teaches the claims as discussed above.
Goldenheim does not teach the use of poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1.
Shojaei teaches a formulation with beads of drugs (amphetamines which are also stimulants), where the beads have release coatings (abstract and claims of Shojaei). Shojaei teaches MAA/MA/MMA copolymer (methyl acrylate, methyl methacrylate and methacrylic acid copolymer, a methacrylic acid copolymer) suspension to coat pellets for controlling release of drug (example 2, under table 2).
One of ordinary skill in the art before the time of filing would have utilized MAA/MA/MMA copolymers as methacrylic acid copolymer coating polymers for formulations of Goldenheim as they are acceptable coating polymers for such coated drug bead formulations and are used by Shojaei for the purpose of coating drug release beads. Thus, there is a reasonable expectation of success in using MAA/MA/MMA copolymers as coatings of the beads in Goldenheim to produce new modified release formulations of methylphenidate as MAA/MA/MMA copolymers were known for this purpose in the art of drug released coated bead formulations.
Claims 20, 24 and 30 in addition to Claims 16-19, 21-23, 25-29 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goldenheim US 6673367 and Lickrish US 20120276017A1.
Goldenheim teaches the claims as discussed above.
Goldenheim does not teach poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1.
Lickrish teaches therapeutic compositions for the treatment of ADHD (abstract). Lickrish teaches methylphenidate and amphetamines as nervous system stimulants for the invention (paragraphs 10 and 16). Lickrish teaches Eudragits like EUDRAGIT® FS 30 D is the aqueous dispersion of an anionic copolymer based on methyl acrylate, methyl methacrylate and methacrylic acid (paragraph 70). Table 5 and paragraph 132 provides for Eudragit FS 30D for a pH dependent formulation (paragraph 132). Eudragit FS30D is listed as a delayed release layer (claim 16 of Lickrish). Lickrish teaches maximum serum concentration occurring from 10 to 16 hours after administration and at least 12 hours (paragraphs 21-22 and 30). This is the Tmax and encompasses 13.5 hours. Note that Lickrish’s formulation has a core comprising stimulant, a sustained release layer enclosing the core and a delayed release layer enclosing the sustained release layer (claim 1 of Lickrish). Lickrish’s core includes a bead of sugar or starch (paragraph 61). Lickrish teaches 22 mg and 30 mg of dextroamphetamine sulfate (examples 5 and 17) as well as 54 mg of methylphenidate (example 24, also see paragraph 28 for doses). It is noted that Lickrish does not have an immediate release bead, but it provides for a controlled release formulation and the primary teachings of the bead formulation come from Goldenheim.
One of ordinary skill in the art before the time of filing would have utilized an MAA/MA/MMA copolymer (Eudragit FS30 D) as a delayed release coating for a formulation where delayed release was needed as a component by the teachings of Lickrish and obtained an additional Tmax (time to Cmax) between 10 to 16 hours in the formulation of Goldenheim. There was a reasonable expectation of success in combining the particles/beads of Lickrish as a delayed/controlled release component into modified release formulations of Goldenheim with the reasonable expectation of success in obtaining a formulation that has 16 hours of effectiveness and a Tmax between 10 and 16 hours due to having all the immediate release, delayed release and delayed/controlled release beads in the formulation (delayed release being enteric coated). Lickrish also recognizes the alternative use of amphetamines to methylphenidate as a nervous system stimulant.
Non-Statutory 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 §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9974752. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘752. ‘752 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10111839. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘839. ‘839 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10292939. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘939. ‘939 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10292938. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘938. ‘938 provides for both the methods and the dosage forms utilized.
Claims 16-19. 21-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of US Patent 10500162. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘162. ‘162 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of US Patent 10449159. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘159. ‘159 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of US Patent 10688060. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘060. ‘060 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of US Patent 10507186. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘186. ‘186 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of US Patent 10512613. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘613. ‘613 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of US Patent 10512612. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘612. ‘612 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of US Patent 10568841. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘841. ‘841 provides for both the methods and the dosage forms utilized.
Claims 16-19, 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of US Patent 11896722. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for compositions of methylphenidate hydrochloride with immediate and controlled/delayed release components with similar dissolution and pharmacokinetic profiles. Since the instant specification provides formulations I and J for this purpose, the instant claims represent species of the claims of ‘722. ‘722 provides for both the methods and the dosage forms utilized.
Conclusion
No claims are allowed.
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/MARK V STEVENS/
Examiner, Art Unit 1613