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 .
Applicant's election with traverse of groups I-III in the restriction requirement in the reply filed on 02/17/2026 is acknowledged. The traversal is on the ground(s) that It is the Applicants' position that it would not be unduly burdensome to perform a search on all of the claims together in the present application. This is not found persuasive because the shared technical feature of oxybutynin between Groups I and II and oxybutynin and pilocarpine between Groups I and III is not a special technical feature as it does not make a contribution over the prior art in view of McGraw et al. (US20200188360). McGraw teaches a composition formulated to include an immediate release muscarinic antagonist or pharmaceutically acceptable salt thereof and a delayed onset immediate release muscarinic agonist or a pharmaceutically acceptable salt thereof. McGraw teaches the compositions may include an immediate release oxybutynin or a pharmaceutically acceptable salt thereof and a delayed-immediate release pilocarpine or a pharmaceutically acceptable salt thereof. See Para [0081]. McGraw teaches that the immediate release muscarinic antagonist is formulated as beads including a core with muscarinic antagonist or a pharmaceutically acceptable salt thereof (e.g., oxybutynin or oxybutynin HCl) layered on top of the core. McGraw teaches an immediate release formulation of about 4 mg, 6 mg, or 8 mg of oxybutynin, or a pharmaceutically acceptable salt thereof, and a delayed-immediate release formulation of about 4 mg, 6 mg, or 8 mg of pilocarpine, or a pharmaceutically acceptable salt thereof. See claim 1.
Furthermore, applicant’s attention is drawn to the following reasons:
(a)the inventions have acquired a separate status in the art in view of their different
classification;
(b) the inventions have acquired a separate status in the art due their recognized divergent
subject matter;
(c) the inventions have acquired a different field of search (for example searching different
classes/subclasses or electronic resources, or employing different search queries);
(d) the prior at applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35
U.S.C. 112 first paragraph.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 02/17/2026.
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, 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 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 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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paborji et al. (US 20170065522 submitted by the applicant).
The claims are drawn A fixed dose pharmaceutical composition comprising an oxybutynin component and a pilocarpine component,
wherein the oxybutynin component is a plurality of immediate release beads, each immediate release bead comprises: an inert core of the immediate release bead having a diameter of about 450 µm to about 700 µm, and a drug layer of the immediate release bead comprising oxybutynin, or a pharmaceutically acceptable salt thereof, coated on the inert core of the immediate release bead, and wherein the pilocarpine component is a plurality of delayed-immediate release beads, each delayed-immediate release bead comprises: an inert core of the delayed-immediate release bead having a diameter of about 250 µm to about 700 µm,
a drug layer of the delayed-immediate release bead comprising pilocarpine, or a pharmaceutically acceptable salt thereof, coated on the inert core of the delayed- immediate release bead, and a delayed release coating of the delayed-immediate release bead coated on the drug layer of the delayed-immediate release bead, wherein the oxybutynin component contains about 2 mg to about 10 mg of oxybutynin, or
pharmaceutically acceptable salt thereof, and wherein the pilocarpine component contains about 2 mg to about 10 mg of pilocarpine, or pharmaceutically acceptable salt thereof.
Regarding claim 1, Paborji teaches pharmaceutical compositions comprising a plurality of first beads each comprising: a core; a first layer comprising pilocarpine or a pharmaceutically acceptable salt thereof; and a second layer comprising a first polymer. Also disclosed are pharmaceutical compositions comprising a plurality of second beads each comprising: a core; and a first layer comprising a muscarinic antagonist or a pharmaceutically acceptable salt thereof. Oxybutynin is taught to a be a muscarinic antagonist. See Para [0007]. Further disclosed are pharmaceutical formulations comprising: a) a plurality of the first beads; b) a plurality of the second beads; or c) a plurality of the first beads and a plurality of the second beads. See Para [0005]. Paborji teaches that a muscarinic antagonist in an immediate release formulation. See Para [0006]. Paborji teaches that The muscarinic agonist of the pharmaceutical formulations is present in a delayed immediate release formulation. See Para [0006]. The use of oxybutynin as a muscarinic antagonist is taught in Para [0007]. Paborji teaches that a single administrable dose of pilocarpine is selected from the group consisting of 3 mg, 4 mg, 5 mg, 6 mg, 10 mg, 11 mg, and 12 mg. See Para [0054]. Such dosage overlaps with the claimed dosage of 2 mg to about 10 mg. Paborji teaches a single administrable dose for the muscarinic antagonist is between 0.1-10 mg, which reads on the claimed dosage. See Para [0054]. Oxybutynin is taught to be a muscarinic antagonist. See Para [0007]. Paborji does not teach the diameter of the core of the delayed-immediate-release. However, the determination of optimum diameter is considered to be within the skill of the artisan in the absence of evidence to the contrary.
Regarding claim 2, Paborji teaches the pharmaceutical formulations are in the form of capsules. The capsules may include push-fit capsules made of gelatin, push-fit capsules, for example those made of hydroxypropyl methyl cellulose, banded push-fit capsules, as well as soft, sealed capsules made of gelatin and a plasticizer, such as glycerol or sorbitol. See Para [0055]. Paborji does not teach wherein the plurality of immediate release beads and the plurality of delayed-immediate-release beads are encapsulated in a size 3 capsule. It would have been obvious to a person skilled in the art to determine the size of the capsule in the absence of evidence to the contrary.
Regarding claim 3, Paborji teaches Beads were produced by drug layering microcrystalline cellulose beads with aqueous, cellulosic coating systems containing pilocarpine HCl or tolterodine tartrate. The beads were formulated into single dose units. See Para [0071].
Regarding claim 4, Paborji does not teach the percentages of seal coating. However, the determination of optimum proportions or amounts is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 5, Paborji teaches in certain embodiments, the core polymer is a cellulose polymer. In some of these embodiments, the cellulose polymer is microcrystalline cellulose. See Para [0015].
Regarding claim 6, Paborji teaches the first bead further comprises a de-tackifier or a glidant. In some embodiments, the de-tackifier or glidant is an inert mineral. An inert mineral is a mineral, i.e., an inorganic compound or salt, that is pharmaceutically acceptable and does not interfere with the pharmacological action of the therapeutic compound. See Para [0031].
Regarding claim 7, Paborji does not teach the concentration of oxybutynin. However, Paborji teaches that oxybutynin is a muscarinic antagonist and a single administrable dose for the muscarinic antagonist is between 0.1-10 mg, which reads on the claimed dosage. See Paras [0007] and [0054]. Paborji teaches the concentration of de-tackifier being between 2% to 40%. See Para [0031. Paborji teaches the use of excipients, but does not teach the concentration of a binder. See Claim 30. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary.
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, 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 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 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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGraw et al. (US 20200188360 submitted by the applicant).
The claims are drawn A fixed dose pharmaceutical composition comprising an oxybutynin component and a pilocarpine component,
wherein the oxybutynin component is a plurality of immediate release beads, each immediate release bead comprises: an inert core of the immediate release bead having a diameter of about 450 µm to about 700 µm, and a drug layer of the immediate release bead comprising oxybutynin, or a pharmaceutically acceptable salt thereof, coated on the inert core of the immediate release bead, and wherein the pilocarpine component is a plurality of delayed-immediate release beads, each delayed-immediate release bead comprises: an inert core of the delayed-immediate release bead having a diameter of about 250 µm to about 700 µm,
a drug layer of the delayed-immediate release bead comprising pilocarpine, or a pharmaceutically acceptable salt thereof, coated on the inert core of the delayed- immediate release bead, and a delayed release coating of the delayed-immediate release bead coated on the drug layer of the delayed-immediate release bead, wherein the oxybutynin component contains about 2 mg to about 10 mg of oxybutynin, or
pharmaceutically acceptable salt thereof, and wherein the pilocarpine component contains about 2 mg to about 10 mg of pilocarpine, or pharmaceutically acceptable salt thereof.
Regarding claim 1, McGraw teaches a composition formulated to include an immediate release muscarinic antagonist or pharmaceutically acceptable salt thereof and a delayed onset immediate release muscarinic agonist or a pharmaceutically acceptable salt thereof. McGraw teaches the compositions may include an immediate release oxybutynin or a pharmaceutically acceptable salt thereof and a delayed-immediate release pilocarpine or a pharmaceutically acceptable salt thereof. The terms immediate release and delayed onset immediate release are used herein in their conventional sense to refer to the timing that the muscarinic antagonist or a pharmaceutically acceptable salt thereof and muscarinic agonist or a pharmaceutically acceptable salt are released. See Para [0081]. McGraw teaches that the immediate release muscarinic antagonist is formulated as beads including a core with muscarinic antagonist or a pharmaceutically acceptable salt thereof (e.g., oxybutynin or oxybutynin HCl) layered on top of the core. In some embodiments, the core comprises between about 10% to about 90% of the total weight of the finally-formulated bead. In some embodiments, the core comprises between about 25% to about 85% of the total weight of the finally-formulated bead. In some embodiments, the core comprises between about 40% to about 80% of the total weight of the finally-formulated bead. In some embodiments, the core comprises about 80% of the total weight of the finally-formulated bead. See Para [0086]. McGraw teaches an immediate release formulation of about 4 mg, 6 mg, or 8 mg of oxybutynin, or a pharmaceutically acceptable salt thereof, and a delayed-immediate release formulation of about 4 mg, 6 mg, or 8 mg of pilocarpine, or a pharmaceutically acceptable salt thereof. See claim 1.
McGraw does not teach the diameter of the inert core of the delayed-immediate-release bead. However, the determination of optimum diameter is considered to be within the skill of artisan in the absence of evidence to the contrary. It would have been obvious to a person skilled in the art to determine the optimum diameter of the inert core in the absence of evidence to the contrary.
Regarding claim 2, McGraw teaches that subjects may be orally administered a capsule containing immediate release oxybutynin or a pharmaceutically acceptable salt thereof and delayed-immediate release pilocarpine or a pharmaceutically acceptable salt thereof. See Para [0051]. The determination of capsule size is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 3, McGraw teaches that onset immediate release formulations of muscarinic agonists or pharmaceutically acceptable salts thereof include a polymer layer (second layer) formed on top of the muscarinic agonist or a pharmaceutically acceptable salt thereof layer. See Para [0100]. The concentration of the polymer layer being about 1% to 50% of the bead. See Para [0010].
Regarding Claim 5, McGraw teaches In some embodiments, the core comprises between about 25% to about 85% of the total weight of the finally-formulated bead. In some embodiments, the core comprises between about 40% to about 80% of the total weight of the finally-formulated bead. In some embodiments, the core comprises about 80% of the total weight of the finally-formulated bead. In some embodiments, the core comprises about 75% of the total weight of the finally-formulated bead. In some embodiments, the core comprises about 85% of the total weight of the finally-formulated bead. See Para [0086]. McGraw teaches In certain embodiments, the core includes a Cellets 700 microcrystalline cellulose bead. See Para [0094] and [0106].
Regarding claim 6, McGraw teaches the use of a binder, such as crystalline cellulose, cellulose derivatives, acacia, corn starch or gelatins. See Para [0074]. The use of anti-tacking agent is taught in Paras [0085], [0097] and table 2.
Regarding claim 7, McGraw teaches the layer of muscarinic antagonist or a pharmaceutically acceptable salt thereof comprises between about 1% to about 50% of the total weight of the bead. See Para [0088]. The binder is taught to be at the concentration of 3.75% . See table 5. The de-tackifier is taught to be 4%. See Table 2.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617