DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
This Office Action is in response to Applicant's arguments filed on September 12, 2025. Claim(s) 43-48 are pending and examined herein.
Response to Arguments
Applicant’s amendment and arguments with respect to the following obviousness-type double patenting rejections have been fully considered.
Claim 35-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,000,011.
Claim 35-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,480,682.
Claim 35-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent 9,987,263.
Claim 35-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,406,143.
Claim 35-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent No.11,241,422.
Claim 35-48 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,383,864.
Claim 35-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 13-15, and 17-20 of U.S. Patent No. 11,033,538.
Claim 35-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,925,866.
Claim 35-48 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,525,045.
Claim 35-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of the following:
** Claims 1, 4-11, and 14-19 of U.S. Patent No. 11,234,972
** Claims 1, 4-11, and 14-19 of U.S. Patent No. 10,537,564
** Claims 1-7 of U.S. Patent No. 10,076,514
** Claims 1-20, 29-39, 48-58, and 67-70 of U.S. Patent No. 11,666,564
** Claims 1-13 and 22-26 of U.S. Patent No. 11,642,334
** Claims 1-18, 27-38, and 47-51 of U.S. Patent No. 11,633,388
** Claims 1-8 and 17-20 of U.S. Patent No. 11,389,437
** Claims 1, 6, 7, and 11-18 of U.S. Patent No. 11,357,761
** Claims 1-20 of U.S. Patent No. 11,357,763
** Claims 1-16 and 19 of U.S. Patent No. 11,278,540
** Claims 1-22 of U.S. Patent No. 10,874,655
** Claims 1-29 of U.S. Patent No. 10,471,053
** Claims 1-21 of U.S. Patent No. 10,251,873
** Claims 1-20 of U.S. Patent No. 11,357,784
The following claims are provisionally rejected as they have not been patented yet:
** Claims 1-3, 6, 10, 11, 20, 21, 48-50, 53, 57, 58, 101-103, 106, 110, and 111 of application 17/269,890 (US 2021/0315875)
** Claims 1-89 of application 17/909,450 (US 2023/0136297)
** Claims 1-35 of application 18/069,732 (US 2023/0218599) (allowed but patent number not yet issued).
** Claims 31, 32, and 34-41 of application 17/838,820 (US 2022/0387462)
Regarding US Patents 10,383,864 and 11,241,422, Applicant contends that the references do not recite oral administration. Examiner respectfully notes that claim 2 in both patents recite oral administration, therefore said limitation is common between both the copending and patent claims.
Applicant argues:
…none of the cited claims include both the features of (1) orally administering to the patient 150 mg of migalastat hydrochloride every other day AND (2) wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
Examiner respectfully notes that all of the patents and applications cited in the double patenting rejections of record teach oral administration either in the independent claim or a subsequent dependent claim thereon. The McLachlan reference is employed to remedy the absence of the limitation regarding no food 2 hours before and after drug administration.
Applicant further argues:
… that McLachlan does not teach either orally administering to the patient 150 mg of migalastat hydrochloride every other day or that the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride. Indeed, McLachlan is only a general article regarding the food effect for various drugs, but makes no specific mention of migalastat. McLachlan also teaches that some drugs should be administered with food (e.g. saquinavir). Thus, without any teachings specific to migalastat, one skilled in the art would not arrive at the claimed invention based on the general disclosure of McLachlan. McLachlan also teaches that “[t]aking medicine on an empty stomach implies taking the dose one hour before or two hours after a meal.” (See note on bottom of Table 1). Thus, even for medicines that should be taken on an empty stomach accordingly to McLachlan, one skilled in the art would not arrive at the claimed invention that requires that patient does not eat food from about 2 hours before to about 2 hours after administration because the claimed fasting period of at least 4 hours is more restrictive than the 3-hour interval of an “empty stomach” described in McLachlan.
Examiner acknowledges that the McLachlan reference does not teach administration of migalastat as set forth in the instant claims. It is respectfully noted that the reference was employed to demonstrate that food has a significant effect on the rate and extent of absorption of drugs after oral administration and such a parameter is obvious to optimize to obtain maximal absorption, absent secondary considerations, i.e., unexpected results.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
MPEP, KSR teaches us that under the right circumstances, “obvious to try” can indeed be the basis for a proper conclusion of obviousness. The attorney’s argument fails to account for KSR, which is a Supreme Court case. MPEP 2144.05(II)(B) states: Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
The argument does not provide a reasonable basis to conclude that the examiner failed to establish a prima facie case of obviousness.
Any rejection from the previous Office action not set forth on record below is hereby withdrawn.
The maintained/modified rejections are made in the Final Office action below as necessitated by amendment.
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 claims at issue 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 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 43-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,000,011 in view of McLachlan (Australian Prescriber, 2006). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease. The patented claims require administering to the patient a therapeutically effective dose of 150 mg 1-deoxygalactonojirimycin or a salt thereof every other day. The same treatment regimen is employed for treating the same disease. See table below.
Instant Claims
Patented Claims US 9,000,011
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. A method for treatment of Fabry disease in a patient in need thereof, the method comprising administering to the patient a formulation comprising 150 mg of 1-deoxygalactonojirimycin or a salt thereof every other day.
6. …administered orally
Col 12, lines 42-44: without food (e.g., no food 2 hours before and for 2 hours after dosing)
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
Column 12, lines 37-38: tablet, a capsule or a solution
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
enhances α-galactosidase A activity is an inherent property
46…wherein the patient is male
47. …wherein the patient is female
Column 2, lines 15-16: subjects can be male or female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
Col. 6, lines 58-67: mutant a-GAL:
L32P; N34S: T41I; M51K; E59K; E66Q: I91T; A97V; R100K; R112C; R112H; F113L.: T 141L: A143T G144V: S148N; A156V; L166V; D170V; C172Y: G183D: P205T Y207C; Y207S; N215S: A228P; S235C; D244N; P259R; N263S; N264A; G272S: S276G; Q279E: Q279K; Q279H; M284T: W287C; I289F; M296I; M296V; L300P; R301Q; V316E; N320Y: G325D: G328A: R342Q; E358A: E358K; R363C: R363H; G370S; and P409A
The patented claims do not teach the limitation, “wherein the patient does not eat food from about 2hours to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim 43-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,480,682 in view of McLachlan (Australian Prescriber, 2006). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease. The patented claims require administering to the patient a therapeutically effective dose of 150 mg 1-deoxygalactonojirimycin or a salt thereof every other day. The same treatment regimen is employed for treating the same disease. See table below.
Instant Claims
Patented Claims US 9,480,682
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. A method for treatment of Fabry disease in a patient in need thereof, the method comprising administering to the patient a formulation comprising 150 mg of 1-deoxygalactonojirimycin or a salt thereof every other day.
4. …oral dosage form
Col 12, lines 62-44: without food (e.g., no food 2 hours before and for 2 hours after dosing)
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
5. tablet, a capsule or a solution
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
9. … enhances α-galactosidase A activity
46…wherein the patient is male
47. …wherein the patient is female
Column 2, lines 18-19: subjects can be male or female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
Col. 6-7, bridging paragraph: mutant a-GAL:
L32P; N34S: T41I; M51K; E59K; E66Q: I91T; A97V; R100K; R112C; R112H; F113L.: T 141L: A143T G144V: S148N; A156V; L166V; D170V; C172Y: G183D: P205T Y207C; Y207S; N215S: A228P; S235C; D244N; P259R; N263S; N264A; G272S: S276G; Q279E: Q279K; Q279H; M284T: W287C; I289F; M296I; M296V; L300P; R301Q; V316E; N320Y: G325D: G328A: R342Q; E358A: E358K; R363C: R363H; G370S; and P409A
The patented claims do not teach the limitation, “wherein the patient does not eat food from about 2hours to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim 43-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent 9,987,263 in view of McLachlan (Australian Prescriber, 2006). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease in a patient in need thereof comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof every other day. The patented claims require specific mutations of -galactosidase. The same treatment regimen is employed for treating the same disease, therefore one of ordinary skill at the time of the invention would find it obvious to treat subjects regardless of the specific mutation that is possessed. See table below.
Instant Claims
Patented Claims US 9,987,263
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. A method for treatment of Fabry disease in a patient in need thereof, the method comprising administering to the patient an oral dosage form comprising 150 mg of 1-deoxygalactonojirimycin or a salt thereof every other day.
Col 12, lines 62-44: without food (e.g., no food 2 hours before and for 2 hours after dosing)
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
2. tablet, a capsule or a solution
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
4. enhances α-galactosidase A activity
46…wherein the patient is male
47. …wherein the patient is female
6. wherein the patient is male
7. wherein the patient is female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
5. α-galactosidase A mutation selected from the group consisting of T41I, A143T, A97V, M51K, L300P, G328A, P205T and N215S
The patented claims do not teach the limitation, “wherein the patient does not eat food from about 2hours to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim 43-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,406,143 in view of McLachlan (Australian Prescriber, 2006). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease in a patient in need thereof comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof every other day. The patented claims require specific mutations of -galactosidase. The same treatment regimen is employed for treating the same disease, therefore one of ordinary skill at the time of the invention would find it obvious to treat subjects regardless of the specific mutation that is possessed. See table below.
Instant Claims
Patented Claims US 10,406,143
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin …and wherein the patient is administered about 150 mg of the 1-deoxygalactonojirimycin or salt thereof every other day.
Col 12, line 61… oral
Col 12-13, bridging ¶: without food (e.g., no food 2 hours before and for 2 hours after dosing)
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
Column 12, lines 61-62: tablet, a capsule or a solution
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
2. enhances α-galactosidase A activity
46…wherein the patient is male
47. …wherein the patient is female
3. …wherein patient is a male
4. …wherein patient is a female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
1. … wherein the patient has an α-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L32P, M284T, M296V, N263S, R363C, R363H, N34S, T41I, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
The patented claims do not teach the limitation, “wherein the patient does not eat food from about 2hours to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim 43-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent No.11,241,422 in view of McLachlan (Australian Prescriber, 2006). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease. The patented claims require administering to the patient a therapeutically effective dose of 150 mg 1-deoxygalactonojirimycin or a salt thereof every other day. The same treatment regimen is employed for treating the same disease. See table below.
Instant Claims
Patented Claims US 11,241,422
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof every other day.
2.… as an oral dosage form
4. …without food (e.g., no food 2 hours before and for 2 hours after dosing)
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
3. tablet, a capsule or a solution
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
5. enhances α-galactosidase A activity
46…wherein the patient is male
47. …wherein the patient is female
6. …wherein patient is a male
7. …wherein patient is a female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
8. … wherein the patient has an α-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L32P, M284T, M296V, N263S, R363C, R363H, N34S, T41I, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
The patented claims do not teach the limitation, “wherein the patient does not eat food from about 2hours to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim 43-48 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,383,864. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease. The patented claims require administering to the patient a therapeutically effective dose of 50 to 250 mg 1-deoxygalactonojirimycin or a salt thereof every other day. The same treatment regimen is employed for treating the same disease. The two inventions overlap greatly in scope. See table below.
Instant Claims
Patented Claims US 10,383,864
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising administering to the patient about 50 to about 250 mg of 1-deoxygalactonojirimycin or a salt thereof every other day.
2. … oral
4. … without food (e.g., no food 2 hours before and for 2 hours after dosing)
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
3. … tablet, a capsule or a solution
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
5. enhances α-galactosidase A activity
46…wherein the patient is male
47. …wherein the patient is female
6. …wherein patient is a male
7. …wherein patient is a female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
Col 7, lines 6-15 … α-GAL mutations associated with Fabry disease which result in unstable α-GAL include L32P; N34S; T41I; M51K; E59K; E66Q; I91T; A97V; R100K; R112C; R112H; F113L; T141L; A143T; G144V; S148N; A156V; L166V; D170V; C172Y; G183D; P205T; Y207C; Y2075; N215S; A228P; 5235C; D244N; P259R; N263S; N264A; G272S; S276G; Q279E; Q279K; Q279H; M284T; W287C; I289F; M296I; M296V; L300P; R301Q; V316E; N320Y; G325D; G328A; R342Q; E358A; E358K; R363C; R363H; G3705; and P409
Claim 43-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 13-15, and 17-20 of U.S. Patent No. 11,033,538 in view of McLachlan (Australian Prescriber, 2006). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease in a patient in need thereof comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof every other day. The patented claims require the patient population to have a particular glomerular filtration rate. The same treatment regimen is employed for treating the same disease, therefore one of ordinary skill at the time of the invention would find it obvious to treat subjects regardless of the specific patient population. See table below.
Instant Claims
Patented Claims US 11,033,538
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. method of treating Fabry disease, the method comprising administering a capsule comprising 100 to 250 mg of a compound selected from the group…
15. … wherein the capsule is administered every other day.
Col. 27, lines 45-46: … patients will have no food for two hours prior and two hours following drug administration
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
20. … a capsule
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
enhances α-galactosidase A activity inherent property
46…wherein the patient is male
47. …wherein the patient is female
Col 33, line 61 …wherein patient is a male and female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
17. … wherein the patient has an α-galactosidase A mutation selected from the group consisting of L32P, N34S, T41L, M51K, E59K, E66Q, I91T, A97V, R100K, R112C, R112H, F113L, G132R, A143T, G144V, S148N, D170V, C172Y, G183D, P205T, Y207S, Y207C, N215S, R227X, R227Q, S235C, D244N, P259R, N263S, G271C, S276G, M284T, W287C, I289F, F295C, M296V, L300P, V316E, N320Y, G325D, G328A, R342Q, E358A, E358K, R363C, R363H, and P409A.
The patented claims do not teach the limitation (in the claim set), “wherein the patient does not eat food from about 2hours to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim 43-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,925,866 in view of McLachlan (Australian Prescriber, 2006). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease in a patient in need thereof comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof every other day. The patented claims require the dose provide one or more of a series of pharmacological parameters. The same treatment regimen is employed for treating the same disease, therefore one of ordinary skill at the time of the invention would achieve the same pharmacological parameters with the same treatment regimen. See table below.
Instant Claims
Patented Claims US 10,925,866
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof, wherein the therapeutically effective dose … wherein the 1-deoxygalactonojirimycin or salt thereof is administered every other day.
2. … oral
Col 27, lines 37-38. … without food (e.g., no food 2 hours before and for 2 hours after dosing)
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
3. … tablet, a capsule or a solution
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
4. enhances α-galactosidase A activity
46…wherein the patient is male
47. …wherein the patient is female
5. …wherein patient is a male
6. …wherein patient is a female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
Col 32, lines 40-49 … L32P, N348, T41L, MS51K, E59K, E66Q, I91T, A97V, R1O0K, R112C, R112H, F113L, G132R, A143T, G144V, S148N, DI70V, C172Y, G183D, P205T, Y207S, Y207C, N215S, R227X, R227Q, A228P, S235C, D244N, P259R, N263S, N264A, G271C, S276G, Q279E, M284T, W287C, I289F, F295C, M2961, M296V, L300P, R301Q, V316E, N320Y, G325D, G328A, R342Q, R356W, E358A, E358K, R363C, R363H, and P409A
The patented claims do not teach the limitation (in the claim set), “wherein the patient does not eat food from about 2hours to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claims 43-48 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,525,045 in view of McLachlan (Australian Prescriber, 2006). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease in a patient in need thereof comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof every other day. The patented claims require the dose provide one or more of a series of pharmacological parameters. The same treatment regimen is employed for treating the same disease, therefore one of ordinary skill at the time of the invention would achieve the same pharmacological parameters with the same treatment regimen. The two inventions overlap greatly in scope. See table below.
Instant Claims
Patented Claims US 10,525,045
43. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising orally administering to the patient 150 mg of migalastat hydrochloride every other day and wherein the patient does not eat food from about 2 hours before to about 2 hours after administering the migalastat hydrochloride.
1. A method for treatment of Fabry disease in a human patient in need thereof, the method comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof, wherein the therapeutically effective dose … wherein the 1-deoxygalactonojirimycin or salt thereof is administered every other day.
2. … oral
Col 28, lines 35-36. … without food (e.g., no food 2 hours before and for 2 hours after dosing)
44. … wherein the 1-deoxygalactonojirimycin or salt thereof is administered as an oral dosage form selected from a tablet, a capsule or a solution
3. … tablet, a capsule or a solution
45. …wherein the 1-deoxygalactonojirimycin or salt thereof enhances a-galactosidase A activity
4. enhances α-galactosidase A activity
46…wherein the patient is male
47. …wherein the patient is female
5. …wherein patient is a male
6. …wherein patient is a female
48. …wherein the patient has an a-galactosidase A mutation selected from the group consisting of D244N, E59K, F113L, G144V, G183D, G328A, I91T, L82P, M284T, M296V, N263S, R3863C, R363H, N34S, T411, M51K, A97V, R112H, A143T, P205T, Y207S, N215S, P259R, N263S, L300P, E358A, P409A, S201F and F295C
Col 32, lines 19-27 … L32P, N348, T41L, MS51K, E59K, E66Q, I91T, A97V, R1O0K, R112C, R112H, F113L, G132R, A143T, G144V, S148N, DI70V, C172Y, G183D, P205T, Y207S, Y207C, N215S, R227X, R227Q, A228P, S235C, D244N, P259R, N263S, N264A, G271C, S276G, Q279E, M284T, W287C, I289F, F295C, M2961, M296V, L300P, R301Q, V316E, N320Y, G325D, G328A, R342Q, R356W, E358A, E358K, R363C, R363H, and P409A
The patented claims do not teach the limitation (in the claim set), “wherein the patient does not eat food from about 2h to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim 43-48 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of the following:
** Claims 1, 4-11, and 14-19 of U.S. Patent No. 11,234,972
** Claims 1, 4-11, and 14-19 of U.S. Patent No. 10,537,564
** Claims 1-7 of U.S. Patent No. 10,076,514
** Claims 1-20, 29-39, 48-58, and 67-70 of U.S. Patent No. 11,666,564
** Claims 1-13 and 22-26 of U.S. Patent No. 11,642,334
** Claims 1-18, 27-38, and 47-51 of U.S. Patent No. 11,633,388
** Claims 1-8 and 17-20 of U.S. Patent No. 11,389,437
** Claims 1, 6, 7, and 11-18 of U.S. Patent No. 11,357,761
** Claims 1-20 of U.S. Patent No. 11,357,763
** Claims 1-16 and 19 of U.S. Patent No. 11,278,540
** Claims 1-22 of U.S. Patent No. 10,874,655
** Claims 1-29 of U.S. Patent No. 10,471,053
** Claims 1-21 of U.S. Patent No. 10,251,873
** Claims 1-20 of U.S. Patent No. 11,357,784
The following claims are provisionally rejected as they have not been patented yet:
** Claims 1-3, 6, 10, 11, 20, and 21 of application 17/269,890 (US 2021/0315875)
** Claims 1-11 and 43-51 of application 17/909,450 (US 2023/0136297)
** Claims 1-35 of application 18/069,732 (US 2023/0218599) (allowed but patent number not yet issued).
** Claims 31, 32, and 34-41 of application 17/838,820 (US 2022/0387462)
In all patents and applications above, although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treatment of Fabry disease in a patient in need thereof comprising administering to the patient a therapeutically effective dose of 1-deoxygalactonojirimycin or a salt thereof every other day, administered orally in overlapping doses. The patented/copending claims require specific patient population, either male or female. The same treatment regimen is employed for treating the same disease, therefore one of ordinary skill at the time of the invention would find it obvious to treat subjects regardless of the specific mutation that is possessed.
The patented claims/copending application above do not teach the limitation, “wherein the patient does not eat food from about 2hours to about 2h after administering the migalastat hydrochloride”.
McLachlan teaches food and its constituents may have a significant effect on both the rate and extent of absorption of drugs after oral administration (abstract). The formulation of a drug influences its absorption. Food can affect both the rate and extent of absorption (Table 1). Meals slow down gastric emptying and this can delay drug absorption. The composition of the meal influences the rate of gastric emptying – high fat meals lead to delayed gastric emptying. A delay in the drug reaching the small intestine can delay its subsequent absorption into the systemic circulation. Based on these observations, oral administration of a medicine under fasting conditions is often recommended when rapid absorption (and hence rapid onset of therapeutic effect) is needed (page 40, column 1, Rate of Absorption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advised the patient to avoid food 2 hours before and after drug intake. The motivation, provided by McLachlan, teaches that food can affect both the rate and extent of absorption. Meals slow down gastric emptying and this can delay drug absorption. According to Table 1, McLachlan discloses a number of drugs wherein, depending on the solubility of the drug, food-drug interactions will vary. The skilled artisan would have known that these parameters are within the purview of the skilled artisan to modify in order to obtain maximal drug absorption.
Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of dosage regimen in which it is well established that food has effects on both the rate and extent of absorption of drugs after oral administration would have been obvious at the time of Applicant's invention.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Conclusion
Claims 43-48 are not allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 mailing date of this final action.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627
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