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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on January 12, 2026 is acknowledged.
Claims 1, 5-6, 13-14, 17, 23, 25-26, 32, 36, 38-39, 41, 43, 47, 52-53, 56, 58, 60, 62, 64, and 76 are pending in this application.
Claims 2-4, 7-12, 15-16, 18-22, 24, 27-31, 33-35, 37, 40, 42, 44-46, 48-54, 54-55, 57, 59, 61, 63, 65-75, and 77-78 have been cancelled.
Claims 6, 13, 23, 25, 43, and 52 have been amended.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on January 12, 2026 is acknowledged. A signed copy is attached to this office action.
Withdrawn Objections/Rejections
Claim Objections
The objection to claim 23 because since the claim depends from claim 1, the claim should recite “wherein the pharmaceutically acceptable excipient further comprises..” has been withdrawn in view of the amendment to the claim as suggested by the Examiner.
The objection of claim 52 because the claim recites the acronym VMAT2 for vesicular monoamine transporter 2 has been withdrawn in view of the amendment to recite “vesicular monoamine transporter 2 (VMAT2)” as suggested by the Examiner.
Claim Rejections - 35 USC § 112
The rejection of claims 6 and 13 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 because:.
claim 6 recites “wherein the controlled release polymer or an additional…”. Claim 6 depends from claim 1 which recites “at least two control release polymers” therefore, it is unclear what controlled release polymer claim 6 is regarding has been withdrawn in view of the amendment to the claim to recite “one or both of the control release polymers…”; and
claim 13 recites “a controlled release polymer mixture of…”. However, it is unclear if this mixture is comprises of the “at least two controlled release polymers” or if it is in addition to them has been withdrawn in view of the amendment to the claim to recite “wherein the at least two control release polymers comprises….”.
Maintained Rejections
Claim Rejections - 35 USC § 102
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.
Claims 1, 5-6, 14, 17, 23, 25-26, 41, 43, 47, 52-53, 56, 58, 60, and 76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sommer et al. (US 2017/0087147).
Sommer discloses an oral dosage form comprising:
about 1-15% by weight of deutetrabenazine;
about 5-20% by weight of a poly(ethylene oxide) polymer,
about 60-70% by weight of mannitol;
about 15-25% by weight of microcrystalline cellulose;
about 1-10% by weight of a polyvinylpyrrolidone;
about 0.5-2% by weight of a polysorbate;
about 0.5-2% by weight of magnesium stearate; and,
about 0.1-0.2% by weight of one or both of butylated hydroxyanisole and butylated hydroxytoluene (claim 12).
It is noted that poly(ethylene oxide) polymer, also known as PEO or PEG, microcrystalline cellulose (MCC), polyvinylpyrrolidone (PVP) are known controlled release polymers.
It is additionally noted that mannitol and MCC are known disintegrants.
Sommer additionally discloses sustained release polymers including Kollidon SR (a blend of polyvinyl acetate and povidone), HPMC (hydroxypropyl methylcellulose), HPC (hydroxypropyl cellulose), Carbopol (crosslinked polyacrylic acids), and Ethocel (ethylcellulose) (paragraphs 0314-0315).
Regarding claim 5, as noted above, claim 12 discloses the use of at least 3 controlled release polymers.
Regarding claim 6, as noted above, PEO, MCC, and PVP are discloses as controlled release polymers. It is noted that PEO and PVP are water soluble and MCC is water insoluble.
Regarding claim 14, as noted above, the composition can comprise MCC, which provided dual functionality as a controlled release polymer and a disintegrant. Starch is also disclosed (paragraph 0310).
Regarding claim 17, the composition can additionally comprise diluents (paragraph 0310), binders (paragraph 0312), lubricants (paragraph 0313), and antioxidants (paragraph 0316).
Regarding claim 23, disclosed binders include starches (paragraph 0312).
Regarding claim 25, as noted above, the deutetrabenazine is present from 1-15% by weight of the formulation.
Regarding claim 26, extended release formulations comprise 5 mg to 30 mg deutetrabenazine (paragraph 0095).
Regarding claim 41, the oral dosage form can be formulated as a tablet (paragraph 0308).
Regarding claims 43, 47, 56, 58, 60, and 76, the claims recites functional properties. Since the prior art discloses the same composition, it would necessarily have the same functional properties, absent a showing of evidence to the contrary.
Regarding claim 52, the composition is used to treat vesicular monoamine transporter 2 (VMAT2) (abstract). As noted above, the composition is disclosed to be an oral dosage form.
Regarding claim 53, the composition is used to treat chronic hyperkinetic movement disorders (abstract).
Sommer, therefore, anticipated the rejected claims.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
* It is well established that, under 35 U.S.C. § 102, for a prior art reference to anticipate a claimed invention, every element of a claim must identically appear in a single prior art reference. Sommer does not anticipate a claimed invention in accordance with this standard, because the cited reference does not specifically disclose an embodiment in which the total amount of control release polymers is at least 30 wt.% relative to the total weight of the dosage form. The ranges in claim 16 do not necessarily encompass a claimed dosage form. Accordingly, withdrawal of the rejection under § 102 is appropriate.
The Examiner disagrees with Applicant’s analysis of the standard. Applicant’s attention is directed to MPEP 2131.03 which discloses "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed range of compositions.). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448. The instant claims recite “wherein the total amount of controlled release polymers is at least 30 wt.% relative to the total weight of the dosage form. As noted by the Examiner, poly(ethylene oxide) polymer, also known as PEO or PEG, microcrystalline cellulose (MCC), polyvinylpyrrolidone (PVP) are known controlled release polymers. Each of these polymers is present in the composition of claim 16 in the prior art reference of Sommer as follows:
about 5-20% by weight of a poly(ethylene oxide) polymer,
about 15-25% by weight of microcrystalline cellulose;
about 1-10% by weight of a polyvinylpyrrolidone.
Therefore, the prior art discloses “a point within the claimed range”, thus the teachings of Sommer anticipate the claims.
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.
Claims 1, 5-6, 14, 17, 23, 25-26, 32, 38-39, 41, 43, 47, 52-53, 56, 58, 60, 62, 64, and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Duffield et al. (US 2014/0030249) in view of Sommer et al. (US 2017/008714).
Duffield discloses a pharmaceutical composition comprising tetrabenazine and a release retarding agent.
A variety of release-retarding agents can be included. Examples include cellulose derivatives, polyoxyalkylene block co-polymers, and mixtures thereof. The release-retarding agents can be present in the amount of about 10% (w/w) to about 60% (w/w) (paragraph 0074).
The controlled release matrix can comprise release resistant or controlled release materials such as hydrophobic polymers, hydrophilic polymers, lipophilic materials and mixtures thereof (paragraph 0210).
In one embodiment, PEO and HPMC are combined within the same controlled release matrix. The HPMC has a viscosity of range of about 4,000 cP to about 200,000 cP (paragraph 0218).
The composition can additionally comprise a disintegrant, such as starch, in the amount of about 7.5% (w/w) to about 45% (w/w) (paragraph 0068).
Example 6 discloses a tablet of tetrabenazine comprising:
PNG
media_image1.png
206
394
media_image1.png
Greyscale
Regarding claim 5, as noted above, the matrix can comprise mixtures of polymers. Ethylcellulose can also be added to the controlled release matrix. It is disclosed ethyl cellulose has a viscosity from about 7 to about 100cP (paragraph 0219).
Example 10 discloses:
PNG
media_image2.png
230
488
media_image2.png
Greyscale
Regarding claim 6, the controlled release matrix can comprise hydrophobic polymers and hydrophilic polymers. Examples include hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), polyoxyethylene, alginic acid, polyacrylic acid, polymethacrylate polymers, acrylic acid polymers, polyvinyl alcohols and mixtures thereof (paragraph 0214). Polyethylene oxide is also disclosed (paragraph 0217).
Regarding claims 14 and 23, as noted above, example 6 discloses microcrystalline cellulose.
Regarding claim 17, the composition can further include at least one of a diluent, disintegrant, and lubricant (claim 7).
Regarding claim 25, the percentage of tetrabenazine is from about 5% (w/w) to about 20% (w/w) of the composition (paragraph 0022).
Regarding claim 26, the compoisition can comprise 10, 12.5, 15, 20, 25, 30 or 50 mg of tetrabenazine (paragraph 0022). Ranges of dosing can be 1 mg to about 100 mg (paragraph 0063).
Regarding claim 32, the rate of the diffusion of the tetrabenazine out the swellable matrix can be slowed by increasing the drug particle size (paragraph 0239), therefore, while Duffield discloses the microparticles have particle size of about 150 to about 800 mm (paragraph 0307), it would have been obvious to one of ordinary skill in the to adjust the particle size in order to alter the diffusion profile of the tetrabenazine from the swellable matrix.
Regarding claim 36, as noted above, tetrabenazine can be present in the amount of 5-20%; crospovidone can be present in the amount of 0-20%; HPMC and polyacrylic acid can be present in the amount of 10-60%; and examples of lubricants include magnesium stearate in the amount of about 0.1 (w/w) to about 2% (w/w) (paragraph 0021).
Regarding claim 38, as noted above, tetrabenazine can be present in the amount of 5-20%; MCC can be present in the amount of 10-60%; copovidone can be present in the amount of 8.7%; crospovidone can be present in the amount of 0-20%; HPMC and polyacrylic acid can be present in the amount of 10-60%; and magnesium stearate can be present in the amount of 0.1-2%.
Regarding claim 39, as noted above, tetrabenazine can be present in the amount of 5-20%; butylated hydroxyanisole can be present in the amount of 0.007%; MCC can be present in the amount of 10-60%; copovidone can be present in the amount of 8.7%, crospovidone can be present in the amount of 0-20%; HPMC and polyacrylic acid can be present in the amount of 10-60%; and magnesium stearate can be present in the amount of 0.1-2%.
Regarding claim 41, the pharmaceutical composition can be in the form of a tablet (paragraph 0065).
Regarding claims 43, 47, 56, 58, 60, 62, 64, and 76, the claims recites functional properties. Since the prior art discloses the same composition, it would necessarily have the same functional properties, absent a showing of evidence to the contrary.
Regarding claims 52-53, a method of treating hyperkinetic movement disorder is disclosed by the oral administration of the pharmaceutical composition (abstract). The composition is administered once a day (paragraph 0009).
Duffield does not disclose deutetrabenazine.
Sommer is described above.
It would have been obvious to one of ordinary skill in the art to have substituted tetrabenazine disclosed by Duffield for the deutetrebenazine disclosed by Sommer since it is disclosed that deutetrebenazine has been designed with the intent to improve the pharmacokinetic profile of active metabolites a HTBZ and b HTBZ (paragraph 0008).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
* The Office has alleged that Duffield discloses the possibility of including release-retarding agents in a tetrabenazine dosage form, the evidence of record does not demonstrate that those of ordinary skill in the art would have had any reason to prepare the specific combination that is required by Applicant's claims. The Office has highlighted Example 6 of Duffield, but the total amount of PEO and HPMC in that embodiment is only 20 wt.%, which is not within the scope of Applicant's claims. The Office has also highlighted Example 10 of Duffield, but it has not been specifically demonstrated how the exemplified formulations would represent a claimed invention. Furthermore, although the Office has alleged that Duffield renders obvious various mixtures of polymers, the evidence of record does not demonstrate that any particular mixture that is derivable from Duffield would represent a claimed combination. In at least these respects, the allegation of obviousness is legally insufficient. See In re Oetiker, 977 F.2d 1443 (Fed. Cir. 1992) (an alleged prima facie case of obviousness must be supported by a preponderance of the evidence).
Again, the Examiner disagrees with Applicant’s analysis of the standard. Applicant’s attention is directed to MPEP 2144.05 which discloses In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the instant case, as noted in the body of the rejection, a variety of release-retarding agents can be included. Examples include cellulose derivatives, polyoxyalkylene block co-polymers, and mixtures thereof. The release-retarding agents can be present in the amount of about 10% (w/w) to about 60% (w/w) (paragraph 0074). Therefore, the skilled artisan could easily envision adjusting and optimizing the control release polymers of within the Duffield in order to arrive at the instant invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Duffield et al. (US 2014/0030249) in view of Sommer et al. (US 2017/008714) as applied to Claims 1, 5-6, 14, 17, 23, 25-26, 32, 38-39, 41, 43, 47, 52-53, 56, 58, 60, 62, 64, and 76 above, and further in view of Staric et al. (WO 2015/011113).
The teachings of Duffield and Sommer are discussed above.
The combination does not disclose the oral dosage form control release mixture contains copovidone, hydroxypropyl methylcellulose and polyacrylic acid polymer.
Staric discloses pharmaceutical composition dispersions. The dispersion comprises a polymer matrix comprising a polymer selected from a finite group comprising of polyacrylic acid, hydroxypropyl methyl cellulose, and copovidone and mixutres thereof.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used the polymeric dispersion disclosed by Staric in order to improve performance and stability.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
*Staric does not supply any reasonable expectation that a dosage form that has been demonstrated to provide a patient with a stable regimen of tetrabenazine could successfully be modified to include deutetrabenazine in place of the tetrabenazine. Withdrawal of the rejection under § 103 is therefore appropriate. See In re Royka, 490 F.2d 981 (C.C.P.A. 1974) (all limitations set forth in a patent claim must be taught or suggested in the prior art to establish a prima facie case of obviousness).
*it is noted by the Examiner that deutetrabenazine is a primary alternative to tetrabenazine for the treatment of Huntington’s and tardive dyskinesia.
It is also noted that the structure of tetrabenazine is:
PNG
media_image3.png
230
290
media_image3.png
Greyscale
and
The structure of deutetrabenazine is:
PNG
media_image4.png
218
266
media_image4.png
Greyscale
Therefore, it would be expected to behaving similarly in chemical formulations. The skilled artisan would be motivated to substitute the deutetrabenazine for the tetrabenazine in the composition.
Conclusion
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 MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
Prosecution Insights