Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 04 August 2025.
CLAIMS UNDER EXAMINATION
Claims 17-26 and 33-34 are pending. Claims 17-20, 26 and 33-34 have been examined on their merits.
PRIORITY
Provisional Application 61/4511798 filed on 11 March 2011 is acknowledged.
WITHDRAWN REJECTIONS
The rejection of claim 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn due to claim amendment.
The rejection of claim 19 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, has been withdrawn due to claim amendment.
The rejection of claim 18 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kaneski and Trubiano, and further in view of Rinker et al has been withdrawn due to claim amendment.
REJECTIONS
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-20, 26 and 33-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kaneski et al. (Assays For Diagnosing and Evaluating Treatment Options For Fabry Disease. WO2007137072A2) in view of Trubiano al. (Compressible starches as binders for tablets or capsules. Patent US4551177).
Kaneski teaches 1-deoxygalactonojirimycin (DGJ) is a pharmacological chaperone (page 10, lines 18-19). 1-deoxygalactonojirimycin includes any salt form (page 10, lines 20-22). Kaneski teaches the hydrochloride salt of DGJ is known as migalastat hydrochloride (Migalastat) (page 10, line 20-25). The art teaches DGJ can be administered in an oral dosage form such as a capsule (page 18, line 3). Patients can be orally administered capsules each containing 25 mg, 50 mg, 75 mg or 100 mg (see page 18, lines 4-5). The art teaches a patient can be administered DGJ daily at 150 mg/day (see page 17, line 1; see page 33, line 29).
Kaneski teaches a pharmaceutical composition comprising migalastat hydrochloride.
The art teaches a capsule.
The art teaches administering a dose of 150 mg.
Kaneski does not teach the use of magnesium stearate and pregelatinized starch in the composition.
Trubiano teaches starch mixtures for tablet and capsule formation (Abstract).
Trubiano teaches pregelatinized starch can be used as a binder to make a capsule (Abstract; column 1, line 65; column 4, line 6). It is identified as a wet granulation binder than can be used most preferably in an amount of 25% (column 4, lines 6-10). The art teaches 0.5% magnesium stearate as a lubricant (column 14, line 46).
It would have been obvious to combine the teachings of the prior art by using magnesium stearate and pregelatinized starch in a formulation comprising migalastat hydrochloride. One would have been motivated to do so since Kaneski teaches a pharmaceutical that can be a capsule or tablet and Trubiano teaches magnesium stearate and pregelatinized starch can be used to make capsules and tablets. The skilled artisan would use 0.5% magnesium stearate and 25% pregelatinized starch since Trubiano teaches using these amounts to make the disclosed oral formulations. Kaneski teaches a capsule can contain 100 mg migalastat hydrochloride. One would optimize the final percentage of migalastat hydrochloride based on the desired concentration of migalastat hydrochloride in the tablet. One would have had a reasonable expectation of success using the claimed ingredients since Trubiano teaches they can be used to make a capsule. One would have expected similar results since both references are directed to capsules containing active ingredients. Therefore claim 17 is rendered obvious.
Kaneski teaches DGJ can be administered in an oral dosage form such as a capsule (supra). Therefore claim 18 is rendered obvious.
A capsule containing about 76.5% migalastat hydrochloride is rendered obvious on the grounds set forth above. Trubiano teaches 0.5% magnesium stearate and 25% pregelatinized starch. These amounts are interpreted to read on about 23% and about 0.5%. Therefore claim 19 is included in this rejection.
Kaneski teaches 150 mg migalastat hydrochloride can be administered each day (supra). One would optimize the amount of migalastat hydrochloride in a composition comprising magnesium stearate and pregelatinized starch to deliver the desired dose. Therefore claim 20 is included in this rejection.
Regarding independent claim 26:
The teachings of Kaneski as set forth above are reiterated.
Kaneski does not teach magnesium stearate and pregelatinized starch.
The teachings of Trubiano are reiterated.
It would have been obvious to combine the teachings of the prior art by using magnesium stearate and pregelatinized starch in the composition aught by Kaneski. One would have been motivated to do so since Kaneski teaches a pharmaceutical that can be a capsule or tablet and Trubiano teaches magnesium stearate and pregelatinized starch can be used to make capsules and tablets. The skilled artisan would use about 0.5% magnesium stearate and 25% pregelatinized starch (hence, about 23%) since Trubiano teaches using these amounts to make the disclosed formulations. Kaneski teaches 150 mg migalastat hydrochloride can be administered each day (supra). One would optimize the amount of migalastat hydrochloride in a composition to deliver the desired dose of migalastat hydrochloride. One would have had a reasonable expectation of success using the claimed ingredients since Trubiano teaches they can be used to make a capsule. One would have expected similar results since both references are directed to capsules containing active ingredients. Therefore claim 26 is rendered obvious.
Regarding independent claim 33:
The teachings of Kaneski as set forth above are reiterated.
Kaneski teaches migalastat hydrochloride (supra).
The art teaches DGJ can be administered as a capsule (supra).
The art teaches a patient can be administered DGJ daily at 150 mg/day (supra).
Kaneski does not teach magnesium stearate and pregelatinized starch.
The teachings of Trubiano are reiterated.
It would have been obvious to combine the teachings of the prior art by using magnesium stearate and pregelatinized starch in the composition aught by Kaneski. One would have been motivated to do so since Kaneski teaches a pharmaceutical that can be a capsule or tablet and Trubiano teaches magnesium stearate and pregelatinized starch can be used to make capsules and tablets. The skilled artisan would use about 0.5% magnesium stearate and 25% pregelatinized starch (hence, about 23%) since Trubiano teaches using these amounts to make the disclosed formulations. Kaneski teaches 150 mg migalastat hydrochloride can be administered each day (supra). One would optimize the amount of migalastat hydrochloride in a composition to deliver the desired dose of migalastat hydrochloride. One would have had a reasonable expectation of success using the claimed ingredients since Trubiano teaches they can be used to make a capsule. One would have expected similar results since both references are directed to capsules containing active ingredients. Therefore claim 33 is rendered obvious.
A capsule containing about 76.5% migalastat hydrochloride is rendered obvious on the grounds set forth above. Trubiano teaches 0.5% magnesium stearate and 25% pregelatinized starch. These amounts are interpreted to read on about 23% and about 0.5%. Therefore claim 34 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 04 August 2025 are acknowledged. The arguments acknowledge Trubiano teaches pregelatinized starch as a binder in an amount of 25% and 0.5% magnesium stearate as lubricant. The Applicant argues
the percentages relate to the starch-containing admixture, not to the formulation as a whole. The Applicant states the same passage indicates that the compressible starch powder is most preferably in an amount of 75% by weight and the wet granulation binder is most preferably 25% by weight, and that the percentages total 100%. Therefore the Applicant argues one skilled in the art would include both compressible starch powder and wet granulation binder according to the teachings of Trubiano. The Applicant argues one skilled in the art would not arrive at the claimed pharmaceutical composition comprising about 20-25% pregelatinized starch relative to the total weight of the pharmaceutical composition.
EXAMINER’S RESPONSE
The arguments are not persuasive. The arguments are only directed to Trubiano, and not the teachings of Kaneski in view of Trubiano. Kaneski teaches a pharmaceutical composition comprising migalastat hydrochloride. The art teaches capsule formulation. Kaneski teaches capsules each containing 25 mg, 50 mg, 75 mg or 100 mg, and an administration of 150 mg. The deficiency of Kaneski is that it does not teach the use of magnesium stearate and pregelatinized starch in the composition. Trubiano is relied upon because it teaches capsules are made using a mixture of pregelatinized starch as a binder and magnesium stearate as a lubricant.
Trubiano teaches an admixture as a binder-diluent. The admixture comprises 15-85% compressible starch and 15-85% of a wet granulation binder (pregelatinized starch). About 20-25% pregelatinized starch would have been obvious because Trubiano teaches 15-85%, preferably 25% can be used. While the cited passage of Trubiano states the percentages by weight totals 100% of the admixture, Trubiano teaches additional ingredients can be included. Trubiano teaches addition of an active ingredient (supra) and a lubricant (supra). Trubiano teaches the amount of binder admixture, active ingredient, lubricant and diluent will depend on various factors including desired potency, desired hardness and dissolution stability. The weight ratio of components depend on preferred characteristics (column 8, lines 20-25). Therefore the arguments are not persuasive.
CONCLUSION
No Claims Are Allowed
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653