DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
Claims 1-20, as originally filed 27 December 2023, are pending and under consideration.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 2-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claims 2-20, each of these claims recites a preamble (“The method of claim 1”) that conflicts with claim 1, which is directed to “An orally disintegrating tablet (ODT) prepared by a process comprising….” The examiner notes that product-by-process claims are not method claims. MPEP § 2113(I) (“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.”). In order to clarify the claims, the preamble of claims 2-20 must be directed to: “The ODT of claim 1.”
Claim Rejections - Double Patenting (Non-Statutory)
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 CFR1.321(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 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 eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-22 of Patent No. 10,441,554 in view of Venkatesh 2011 (US 2011/0212171 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: The conflicting claims (the claims of the ’554 Patent) disclose an orally disintegrating pharmaceutical composition of racemic amphetamine that anticipates or renders obvious nearly all the structural/compositional limitations recited in the claims of the present application. The only deficiency concerns compressing the foregoing composition to yield an orally disintegrating tablet (ODT), as recited in step (f) of present claim 1. Claim 27 of Venkatesh 2011, which teaches “compressing the mixture to form said orally disintegrating tablet,” compensates for this deficiency. See also Venkatesh 2011 at paras. [0027], [0031], [0062], [0080]-[0083], and [0085]. The examiner notes that claim 21 of Venkatesh 2011 recites amphetamine, thereby providing some additional motivation to compress the orally disintegrating pharmaceutical composition defined by the claims of the ’554 Patent into a tablet.
Claims 1-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of Patent No. 11,160,772 in view of Venkatesh 2011 (US 2011/0212171 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: The conflicting claims (the claims of the ’772 patent) disclose an orally disintegrating pharmaceutical composition of racemic amphetamine that anticipates or renders obvious nearly all the structural/compositional limitations recited in the claims of the present application. The only deficiency concerns compressing the foregoing composition to yield an orally disintegrating tablet (ODT), as recited in step (f) of present claim 1. Claim 27 of Venkatesh 2011, which teaches “compressing the mixture to form said orally disintegrating tablet,” compensates for this deficiency. See also Venkatesh at paras. [0027], [0031], [0062], [0080]-[0083], and [0085]. The examiner notes that claim 21 of Venkatesh 2011 recites amphetamine, thereby providing some additional motivation to compress the orally disintegrating pharmaceutical composition defined by the claims of the ’772 Patent into a tablet.
Claims 1-28 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of Patent No. 11,896,562 in view of Venkatesh 2011 (US 2011/0212171 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: The conflicting claims (the claims of the ’562 patent) disclose a method of treatment requiring administration of an orally disintegrating pharmaceutical composition of racemic amphetamine. That composition, as defined in the conflicting claims, anticipates or renders obvious nearly all the structural/compositional limitations recited in the claims of the present application. The only deficiency concerns compressing the foregoing composition to yield an orally disintegrating tablet (ODT), as recited in step (f) of present claim 1. Claim 27 of Venkatesh 2011, which teaches “compressing the mixture to form said orally disintegrating tablet,” compensates for this deficiency. See also Venkatesh at paras. [0027], [0031], [0062], [0080]-[0083], and [0085]. The examiner notes that claim 21 of Venkatesh 2011 recites amphetamine, thereby providing some additional motivation to compress the orally disintegrating pharmaceutical composition defined by the claims of the ’562 Patent into a tablet.
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Conclusion
Claims 1-20 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
15 November 2025
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611