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 .
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.
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Claims 55 and 57-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,241,391 in view of Santosh et al (Impact of comorbid autism spectrum disorders on stimulant response in children with attention deficit hyperactivity disorder: a retrospective and prospective effectiveness study, Child: care, health and development, 32, 5, 575-583, 2006). Although the claims at issue drawn to identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of treating a subject having ADHA with an oral formulation comprising a core and comprises methylphenidate where the composition has a Tmax of about 12-16 hours. The dosage form comprises a sustained release layer enclosing the core and a delayed release layer enclosing the sustained release layer, where the coated particles comprise microcrystalline cellulose, and talc.
The claims differ in that the instant claims recite specific improvement measured by the SKAMP score while the 391 claims only recite a general measurement. However, the method of administration and the formulation being administered remains the same and as such the properties and results that fall naturally from the completion of the method would also, obviously be present in the 391 formulation barring evidence to the contrary. The claims further differ in that the instant claims recite an application for the treatment of autism while the 391 claims only recite a treatment for ADHA. However as seen in the Santosh study, methylphenidate treatments have been effective for individuals that have an ASD and ADHA comorbidity both ADHA and autism symptoms, showing improvements in multiple behaviors, including aggression, inattention and impulsivity (Abstract, pg. 579). It would have been obvious to apply the formulation of 391 to the instant claims as they have the same components and can be used for similar conditions. The claims overlap in scope and cannot be allowed together.
Claims 55, 57-59, 68 and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,881,618 in view of Santosh et al (Impact of comorbid autism spectrum disorders on stimulant response in children with attention deficit hyperactivity disorder: a retrospective and prospective effectiveness study, Child: care, health and development, 32, 5, 575-583, 2006). Although the claims at issue drawn to identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of treating a subject having ADHA with an oral formulation comprising a core and comprises methylphenidate where the composition has a Tmax of about 12-16 hours. The claims differ in that the instant claims are silent to the constituents of the sustained release coating, however the release kinetics are identical. The method of administration and the formulation being administered remains the same and as such the properties and results that fall naturally from the completion of the method would also, obviously be present in the 618 formulation barring evidence to the contrary. The claims further differ in that the instant claims recite an application for the treatment of autism while the 618 claims only recite a treatment for ADHA. However as seen in the Santosh study, methylphenidate treatments have been effective for individuals that have an ASD and ADHA comorbidity both ADHA and autism symptoms, showing improvements in multiple behaviors, including aggression, inattention and impulsivity (Abstract, pg. 579). It would have been obvious to apply the formulation of 618 to the instant claims as they have the same components and can be used for similar conditions. The claims overlap in scope and cannot be allowed together.
Claims 57, 58, 68 and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10/317,651 in view of Santosh et al (Impact of comorbid autism spectrum disorders on stimulant response in children with attention deficit hyperactivity disorder: a retrospective and prospective effectiveness study, Child: care, health and development, 32, 5, 575-583, 2006). Although the claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn toa method of treating a patient with ADHD by oral administration of a coated formulation comprising a core sustained release coating and delayed release coating. In both sets of claims the sustained release coating comprises cellulose excipients such that the formulation has a lag time of at least 6 hours (8 hours in 651 claims) and overlapping Tmax times. The claims differ in that the instant claims are silent to the constituents of the sustained release coating, however the release kinetics are identical. The method of administration and the formulation being administered remains the same and as such the properties and results that fall naturally from the completion of the method would also, obviously be present in the 651 formulation barring evidence to the contrary. The claims further differ in that the instant claims recite an application for the treatment of autism while the 651 claims only recite a treatment for ADHD. However as seen in the Santosh study, methylphenidate treatments have been effective for individuals that have an ASD and ADHA comorbidity both ADHA and autism symptoms, showing improvements in multiple behaviors, including aggression, inattention and impulsivity (Abstract, pg. 579). It would have been obvious to apply the formulation of 661 to the instant claims as they have the same components and can be used for similar conditions. The claims overlap in scope and cannot be allowed together.
Claims 55, 57, 68, 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,292,937 in view of Santosh et al (Impact of comorbid autism spectrum disorders on stimulant response in children with attention deficit hyperactivity disorder: a retrospective and prospective effectiveness study, Child: care, health and development, 32, 5, 575-583, 2006). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn toa method of treating a patient with ADHD by oral administration of a coated formulation comprising a core sustained release coating and delayed release coating. In both sets of claims the sustained release coating comprises cellulose excipients such that the formulation. The claims differ in that the instant claims are silent to the constituents of the sustained release coating, however the release kinetics are identical. The method of administration and the formulation being administered remains the same and as such the properties and results that fall naturally from the completion of the method would also, obviously be present in the 937 formulation barring evidence to the contrary. The claims further differ in that the instant claims recite an application for the treatment of autism while the 937 claims only recite a treatment for ADHA. However as seen in the Santosh study, methylphenidate treatments have been effective for individuals that have an ASD and ADHA comorbidity both ADHA and autism symptoms, showing improvements in multiple behaviors, including aggression, inattention and impulsivity (Abstract, pg. 579). It would have been obvious to apply the formulation of 937 to the instant claims as they have the same components and can be used for similar conditions. The claims overlap in scope and cannot be allowed together.
Claims 55 and 57-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 9,603,809 in view of Santosh et al (Impact of comorbid autism spectrum disorders on stimulant response in children with attention deficit hyperactivity disorder: a retrospective and prospective effectiveness study, Child: care, health and development, 32, 5, 575-583, 2006). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn toa method of treating a subject having ADHD with an oral formulation comprising a core and layers where the core comprises methylphenidate where the composition has a Tmax of about 12-16 hours. The dosage form comprises a sustained release layer enclosing the core and a delayed release layer enclosing the sustained release layer, where the coated particles comprise microcrystalline cellulose, and talc. The claims differ in that the instant claims recite specific improvement measured by the SKAMP score while the 809 claims only recite a general measurement. However, the method of administration and the formulation being administered remains the same and as such the properties and results that fall naturally from the completion of the method would also, obviously be present in the 809 formulation barring evidence to the contrary. The claims further differ in that the instant claims recite an application for the treatment of autism while the 809 claims only recite a treatment for ADHA. However as seen in the Santosh study, methylphenidate treatments have been effective for individuals that have an ASD and ADHA comorbidity both ADHA and autism symptoms, showing improvements in multiple behaviors, including aggression, inattention and impulsivity (Abstract, pg. 579). It would have been obvious to apply the formulation of 809 to the instant claims as they have the same components and can be used for similar conditions. The claims overlap in scope and cannot be allowed together.
Claims 55, 57, 68 and 72-74 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,603,808 in view of Santosh et al (Impact of comorbid autism spectrum disorders on stimulant response in children with attention deficit hyperactivity disorder: a retrospective and prospective effectiveness study, Child: care, health and development, 32, 5, 575-583, 2006). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of treating a patient with ADHD by oral administration of a coated formulation comprising a core sustained release coating and delayed release coating. In both sets of claims the sustained release coating comprises cellulose excipients such that the formulation. The claims differ in that the instant claims are silent to the constituents of the sustained release coating, however the release kinetics are identical. The method of administration and the formulation being administered remains the same and as such the properties and results that fall naturally from the completion of the method would also, obviously be present in the 808 formulation barring evidence to the contrary. The claims further differ in that the instant claims recite an application for the treatment of autism while the 808 claims only recite a treatment for ADHA. However as seen in the Santosh study, methylphenidate treatments have been effective for individuals that have an ASD and ADHA comorbidity both ADHA and autism symptoms, showing improvements in multiple behaviors, including aggression, inattention and impulsivity (Abstract, pg. 579). It would have been obvious to apply the formulation of 808 to the instant claims as they have the same components and can be used for similar conditions. The claims overlap in scope and cannot be allowed together.
Claims 55, 57, 68 and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 8,916,588 in view of Santosh et al (Impact of comorbid autism spectrum disorders on stimulant response in children with attention deficit hyperactivity disorder: a retrospective and prospective effectiveness study, Child: care, health and development, 32, 5, 575-583, 2006). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn toa method of treating a subject with an oral formulation comprising a core, delayed and sustained release coatings where the core comprises methylphenidate. The conditions treated by the methods both include ADHD. The method disclose a Tmax for the formulation between 12-16 hours after administration. The claims differ in the that the 588 claims recite further release kinetics such as Cmax and AUC for the formulation, however, the formulations have sufficient overlapping scopes for their compositional components that the formulation and methods of application would be obvious variants of each other. The method of administration and the formulation being administered remains the same and as such the properties and results that fall naturally from the completion of the method would also, obviously be present in the 588 formulation barring evidence to the contrary. The claims further differ in that the instant claims recite an application for the treatment of autism while the 588 claims only recite a treatment for ADHA. However as seen in the Santosh study, methylphenidate treatments have been effective for individuals that have an ASD and ADHA comorbidity both ADHA and autism symptoms, showing improvements in multiple behaviors, including aggression, inattention and impulsivity (Abstract, pg. 579). It would have been obvious to apply the formulation of 588 to the instant claims as they have the same components and can be used for similar conditions. The claims overlap in scope and cannot be allowed together.
Response to Arguments
Applicant's arguments filed 3/3/26 have been fully considered but they are not persuasive. Applicant argues that the Non-Statutory Obvious Type Double Patenting Rejections over the Applicant’s previous patents (USPNs 11,241,391, 10881,618, 10317,651, 10,292,937, 9,603,809, 9,603,808 and 8,916,588) in view of Santosh et al, as described above, do not render the claims obvious as there is no expectation of success to an artisan of ordinary skill int heart at the time of the invention.
Regarding these arguments, it remains the position of the Examiner that instant claims remain obviated. Applicant argues that Santosh does not provide sufficient disclosures that would provide reasonable expectation of success for the treatment of comorbid ADHA and ASD juvenile patients. However Santosh specifically looks at two studies treating this exact population of juvenile patients diagnosed with comorbid Autism Spectrum Disorder and Attention Deficit Disorder (abstract). The studies show an improvements in targeted symptoms related to the ADHD symptoms as recited in the instant claims. . Applicant argues that other studies indicate that methylphenidate or other stimulants “may worsen ASD symptoms”, however the instant claims are silent to this and only require improvement in ADHA symptoms, which are shown in Santosh. Further obviousness does not require absolute predictability. The prior art patents provide a method of treating ADHD, and Santosh establishes that similar stimulant dosage forms. Applicant argues that Santosh is an incomplete study and the authors write that the studies can be expanded, however Santosh is not being used a primary reference for establishing obviousness. Santosh is a supporting, secondary reference that establishes the level of skill in the art that patients with a comorbid diagnosis of ADHA and Autism Spectrum Disorder, can also be treated by the same stimulant formulation and still experience improvements. Santosh clearly establishes that while other side effects may persist, improvements in attention, impulsivity and oppositionality are all observed. For these reasons the claims remains rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Struman et al (Methylphenidate for children and adolescents with autism spectrum disorder, Cochrane Databases of Systematic Review, 2017, Issue 11) discloses the results of four cross-over studies from 113 children aged 5 to 13 with comorbid ASD and ADHD diagnoses showed improved in ADHD symptoms when treated with methylphenidate.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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