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 .
Information Disclosure Statement
An information disclosure statement was filed on 06/25/2024.
A preliminary amendment was filed 11/19/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for formulations for liquid suspensions, which are orally administered, does not reasonably provide enablement for all forms of administration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Applicant states that the formulations of the instant composition are directed towards oral administration ([0002], [0012] – [0013]). The specification also goes into detail as to the disadvantages of solid oral dosage forms ([0006] – [0007]). Clarification is requested.
Claims 20-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) determined that factors which enable an invention. These are:
(A) The breadth of the claims;
The instant claims set out a composition for a pharmaceutical in general.
(B) The nature of the invention;
The composition is used for its treating psychotic behavior.
(C) The state of the prior art;
The art of shows problems with bioavailability and dosing for solid oral formulations.
(D) The level of one of ordinary skill;
The ordinary practitioner is either a PhD or medical practitioner.
(E) The level of predictability in the art;
Because of the short plasma half life, and poor bioavailability due to first pass metabolism, patient response to medication is not always predictable. This is especially the case for solid oral formulations.
(F) The amount of direction provided by the inventor;
No direction is given as to treatment protocols, dosage or frequency.
(G) The existence of working examples;
There are no working examples on the treatment of eumycetoma in any patients with anything other than liquid suspensions of quetiapine.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Because each patient response is unique , each one must be evaluated by carefully step by step as to dosage, frequency, patient reaction, and efficacy. This involves painstaking, undue experimentation to determine what is efficacious for dosage forms which are not liquid suspensions.
The claim for the instant pharmaceutical is not enabled for dosage forms which are not liquid suspensions for oral administration by the original specification.
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 20-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,993,486 (US’486). Although the claims at issue are not identical, they are not patentably distinct from each other because US’486 claims a pharmaceutical composition comprising a pharmaceutically effective amount of quetiapine fumarate particles dispersed in suspension, wherein the composition is suitable for oral delivery, has a pH between about 5.0 and 6.0, and is storage stable, wherein the composition viscosity is approximately 700-2000 cP. (Claim 1). The concentration of quetiapine fumarate is set out as 12.5 mg/ 5 ml to 200 mg/5 ml (claims 2-5). The composition is bioequivalent to commercially approved solid formulations of quetiapine fumarate (claim 6). Particle diameter is between 20 um and 70 um. The quetiapine fumarate is fully dissolved in 45 minutes (claim 12). The quetiapine fumarate is substantially comprised of the Form 1 polymorph. The formulations include excipients listed at [0012] – [0015] , which include water, propylene glycol, suspending agents, preservatives, buffering agents and defoamers. Particles with the claimed D90 is set out at [0028]. These limitations could have been claimed previously in US’486. The ordinary practitioner would therefore expect similar therapeutic results from the instantly claimed composition given the claims of US’486. The instantly claimed invention would have therefore been obvious to one of ordinary skill in the art at the time of filing to claims the instant quetiapine fumarate composition given the claims of US’486.
Claims 20-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,561,669 (US’669). Although the claims at issue are not identical, they are not patentably distinct from each other because US’669 claims a pharmaceutical composition comprising a pharmaceutically effective amount of quetiapine fumarate particles dispersed in suspension, wherein the composition is suitable for oral delivery, has a pH between about 5.0 and 6.0, and is storage stable, wherein the composition viscosity is approximately 700-2000 cP. (Claim 1). The concentration of quetiapine fumarate is set out as 12.5 mg/ 5 ml to 200 mg/5 ml (claims 2-5). The composition is bioequivalent to commercially approved solid formulations of quetiapine fumarate (claim 6). Particle diameter is between 20 um and 70 um (claim 9). The D(0.9) value and viscosity of the final product is set out in claims 10-12. The quetiapine fumarate is fully dissolved in 45 minutes (claim 13). The quetiapine fumarate is substantially comprised of the Form 1 polymorph (claim 14). ). The quetiapine fumarate is substantially comprised of the Form 1 polymorph. The formulations include excipients listed at [0012] – [0015] , which include water, propylene glycol, suspending agents, preservatives, buffering agents and defoamers. Particles with the claimed D90 is set out at [0028]. These limitations could have been claimed previously in US’486. The ordinary practitioner would therefore expect similar therapeutic results from the instantly claimed composition given the claims of US’669. The instantly claimed invention would have therefore been obvious to one of ordinary skill in the art at the time of filing to claims the instant quetiapine fumarate composition given the claims of US’669.
Claims 20-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12, 023,340 (US’340). Although the claims at issue are not identical, they are not patentably distinct from each other because US’340 claims an oral suspension of particles with a pH of between 5.0 – 6.0 ). The quetiapine fumarate is substantially comprised of the Form 1 polymorph. The formulations include excipients listed at [0012] – [0015], which include water, propylene glycol, suspending agents, preservatives, buffering agents and defoamers. Particles with the claimed D90 is set out at [0028]. These limitations could have been claimed previously in US’340. The instant formulations could have been claimed in US’340. The instant claims would have been obvious to one of ordinary skill at the time of filing given the teachings of US’340.
Conclusion
No claims are allowed.
The pamphlet entitled “Quetiapine 20 mgs/ml Oral Suspension” is cited as state of the art in drug delivery.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/ Primary Examiner, Art Unit 1617 caz
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