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 the Application
This Office Action is in response to applicant’s arguments filed on 11/17/25. Claims 1-13, 15-17, 26-127 have been cancelled. Claims 14, 18-25, 128 are pending. Claim 14 has been amended. Claims 14, 18-25, 128 are examined herein.
Applicant’s arguments have been fully considered but found not persuasive. The rejections of the last Office Action are maintained for reasons of record and repeated below for Applicant’s convenience.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 14, 18-25, 128 are rejected under 35 U.S.C. 103 as being unpatentable over Giugliani et al. (“A Phase 2 study of migalastat hydrochloride in females with Fabry disease: Selection of population, safety and pharmacodynamic effects,” Molecular Genetics and Metabolism 109 (2013) 86–92; of record) and Fan et al. (WO 99/62517, of record) in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198, of record).
The instant claims are generally drawn to the treatment of diarrhea symptoms in a classic male Fabry disease patient who has diarrhea comprising administering about 123 mg (related to claim 19) of migalastat free base of HCl salt (related to claims 20-22) once every other day orally in a tablet, a capsule or a solution (related to claims 23 and 24), wherein the migalastat or salt thereof enhances α-galactosidase A activity (related to claim 18), and wherein the migalastat is administered for at least 6 months (related to claim 25), wherein the administration provides an average decrease in Gastrointestinal Symptoms Rating Scale for Diarrhea (GSRS-D) of at least about 0.6 after 24 months of the administration of the migalastat or salt thereof (related to claims 26 and 127).
Giugliani et al. discloses the treatment of Fabry disease with 150 mg migalastat hydrochloride administered orally every other day for 48 weeks (see, for example, the title, abstract, and the whole document; related to claims 19-23 and 25), and further discloses that it was administered to patients with an amenable P259R mutation in α-Gal A (see, for example, Tables 1 and 2 on pg. 89; related to claim 17).
Fan et al. teach that Fabry disease is caused by an inherited deficiency of lysosomal α-galactosidase A, an enzyme responsible for the hydrolysis of terminal α-galactosyl residue from glycosphingolipids. A deficiency in the enzyme activity results in a progressive deposition of neutral glycosphingolipids, predominantly globotriaosylceramide (ceramide trihexoside, CTH), in vascular endothelial cells causing renal failure along with premature myocardial infarction and strokes in patients with this condition (page 1). Therapeutic agents will result in an increase in a α-Gal A activity of the cells of a patient sufficient to improve the symptoms. It is expected that an enzyme activity level of 30% of normal could significantly improve the symptoms in Fabry patients (page 6). Fan et al. also teach that G373S is a known α-Gal A mutation associated with Fabry disease (example 9 on page 18). It is noted that Fabry disease is associated with any α-Gal A activity below normal, including the claimed <3% of normal.
Giugliani et al. does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease in both male and female patients with migalastat (see, for example, the title and the whole document), and further teaches that these patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
It would have been obvious to one of ordinary skill to treat diarrhea in a male patient with Fabry’s disease with migalastat because the prior art teaches all of the concrete imitations of the instant claims.
One of ordinary skill would have been motivated to treat diarrhea in a male patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
One of ordinary skill would have combined the teachings of the prior art, and would have treated diarrhea in a male patient with Fabry’s disease with migalastat with a reasonable expectation of success.
With respect to the limitations drawn to “wherein the migalastat or salt thereof enhances α-galactosidase A activity”, “an average decrease in Gastrointestinal Symptoms Rating Scale for Diarrhea (GSRS-D) of at least about 0.6 or 0.9 after 24 months of the administration of the migalastat or salt thereof”, “a decrease in Gastrointestinal Symptoms Rating Scale for Diarrhea (GSRS-D) of at least about 0.33 in the patient”, etc., the prior art has disclosed the administration of the instantly claimed composition to the instantly claimed patient population. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
With respect to the limitation drawn to the formulation being a tablet, capsule, or solution, these are well-known to both those of skill and to the layman alike to be the most common forms of orally administered compositions. One of ordinary skill would have immediately envisaged that the administration disclosed by Giugliani et al. could be done in a format of a tablet, capsule, or solution.
Response to Arguments
Applicant argues that none of the cited references describe a patient population having a particular phenotype (multiorgan system involvement AND a residual peripheral blood mononuclear cell [PBMC] a-Gal A activity <3% of normal) as well as a particular genotype (mutation in a-Gal A selected from I253T, L243F, C174R, D55V/Q57L, G373S, D322E, G325R and Y216C).
This is not persuasive because Giugliani et al. teaches the treatment of patients with Fabry disease having mutation in α-Gal A. Furthermore, Fan et al. teach that Fabry disease is caused by an inherited deficiency of lysosomal α-galactosidase A, an enzyme responsible for the hydrolysis of terminal α-galactosyl residue from glycosphingolipids, which leads to renal failure along with premature myocardial infarction and strokes (multiorgan involvement). It is noted that Fabry disease is associated with any α-Gal A activity below normal, including the claimed <3% of normal.
Applicant argues unexpected results in that the claimed invention provides improvements in diarrhea symptoms from treatment of Fabry disease with migalastat in classic male Fabry patients versus other Fabry patients (non-classic male and females). The mean (SD) change in classic male patients with diarrhea using GSRS-D was -0.9 (1.75) as compared to -0.5 (1.01) in other patients. Furthermore, claims 26 describes an average decrease in GSRS-D of at least 0.6 in classic male patients after 24 months after administration of migalastat, and claim 127 describes a decrease in GSRS-D of at least about 0.33 in the patient. Migalastat administration provided a reduction of at least 0.33 in GSRS-D from baseline levels in 88% of the classic male patients. Therefore, the claims disclose additional improvements in the administration of migalasat for the treatment of the subpopulation of classic Fabry male patients over other Fabry patients.
This is not persuasive because a mean change of -0.9 versus -0.5 in GSRS-D does not rise to the level of unexpected results. Applicant claims unexpected results but does not properly and fully explain why this difference would be unexpected to one of ordinary skill in the art. In the absence of a clear and convincing explanation, the differences in the results for classic male Fabry disease patients with diarrhea versus other patients are a product of the normal variability of the disease in different patient populations. Furthermore, Applicant is reminded that any evidence of unexpected results must not only be clear and convincing but also commensurate with the scope of the claims. Finally, Applicant is reminded that any showing of unexpected results must be submitted in a declaration.
Regarding the establishment of unexpected results or synergism, a few notable principles are well settled. The Applicant has the initial burden to explain any proffered data and establish how any results therein should be taken to be unexpected and significant. See MPEP 716.02 (b). It is applicant’s burden to present clear and convincing factual evidence of nonobviousness or unexpected results, i.e., side-by-side comparison with the closest prior art in support of nonobviousness for the instant claimed invention over the prior art. The claims must be commensurate in the scope with any evidence of unexpected results. See MPEP 716.02 (d). With regard to synergism, a prima facie case of synergism has not been established if the data or result is not obvious. The synergism should be sufficient to overcome the obviousness, but must also be commensurate with the scope of the claims. Further, if the Applicant provides a DECLARATION UNDER 37 CFR 1.132, it must compare the claimed subject matter with the closest prior art in order to be effective to rebut a prima facie case of obviousness. See MPEP 716.02 (e).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. RE48,608 E in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease in a narrower patient population comprising administering 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the amount of the migalastat, the diarrhea, or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
One of ordinary skill would have found the instant claims to be obvious because the dosage of active principles is a known result-effective variable that those of skill know to adjust and optimize. One of ordinary skill would have adjusted the dose, including to about 100-150 mg free base equivalent during the routine adjustment and optimization of the dose in the treatment of Fabry disease, and would have done so with a reasonable expectation of success.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,000,011 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 150 mg of 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,480,682 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 150 mg of 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea or resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,694,056 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea, the amount of the migalastat, or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
One of ordinary skill would have found the instant claims to be obvious because the dosage of active principles is a known result-effective variable that those of skill know to adjust and optimize. One of ordinary skill would have adjusted the dose, including to about 100-150 mg free base equivalent during the routine adjustment and optimization of the dose in the treatment of Fabry disease, and would have done so with a reasonable expectation of success.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,987,263 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 150 mg of 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,999,618 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering 123 mg of 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,076,514 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease in a narrower patient population comprising administering 150 mg 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,155,027 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering about 0.1-15 mg/kg, for example 1 or 3 mg/kg, of 1-deoxygalactonojirimycin (i.e. migalastat; the Examiner calculates that a range of 1-3 mg/kg would be 60-180 mg for a 60 kg adult).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,251,873 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering 100-150 mg free base equivalent migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,357,548 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering about a concentration of about 50-20,000 μM, for example 1 or 3 mg/kg, of 1-deoxygalactonojirimycin (i.e. migalastat; the Examiner calculates that a range of 1-3 mg/kg would be 60-180 mg for a 60 kg adult).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,383,864 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering about 150 mg 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
One of ordinary skill would have found the instant claims to be obvious because the dosage of active principles is a known result-effective variable that those of skill know to adjust and optimize. One of ordinary skill would have adjusted the dose, including to about 100-150 mg free base equivalent during the routine adjustment and optimization of the dose in the treatment of Fabry disease, and would have done so with a reasonable expectation of success.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,406,143 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease in a narrower patient population comprising administering 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the amount of the migalastat, the diarrhea, or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
One of ordinary skill would have found the instant claims to be obvious because the dosage of active principles is a known result-effective variable that those of skill know to adjust and optimize. One of ordinary skill would have adjusted the dose, including to about 100-150 mg free base equivalent during the routine adjustment and optimization of the dose in the treatment of Fabry disease, and would have done so with a reasonable expectation of success.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10,471,053 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease in a narrower patient population comprising administering about 150 mg migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,525,045 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea, the amount of the migalastat, or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
One of ordinary skill would have found the instant claims to be obvious because the dosage of active principles is a known result-effective variable that those of skill know to adjust and optimize. One of ordinary skill would have adjusted the dose, including to about 100-150 mg free base equivalent during the routine adjustment and optimization of the dose in the treatment of Fabry disease, and would have done so with a reasonable expectation of success.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,537,564 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease in a narrower patient population comprising administering 150 mg 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,792,278 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 150 mg of migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 10,792,279 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering 150 mg of migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,799,491 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering 123 mg of migalastat free base equivalent.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,806,727 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering 123 mg of migalastat free base equivalent.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,813,921 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease in a narrower patient population comprising administering 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea, the amount of the migalastat, or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
One of ordinary skill would have found the instant claims to be obvious because the dosage of active principles is a known result-effective variable that those of skill know to adjust and optimize. One of ordinary skill would have adjusted the dose, including to about 100-150 mg free base equivalent during the routine adjustment and optimization of the dose in the treatment of Fabry disease, and would have done so with a reasonable expectation of success.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,849,889 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg of migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,849,890 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg of migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,857,141 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg of migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,857,142 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg of migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,874,655 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 150 mg of migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,874,656 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,874,657 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,925,866 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 150 mg of migalastat hydrochloride.
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,234,972 B2 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The patented claims are generally drawn to the treatment of Fabry disease comprising administering 150 mg of 1-deoxygalactonojirimycin (i.e. migalastat).
The patent does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 23-39, and 75 of copending Application No. 16/642,620 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-31 of copending Application No. 16/806,404 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending application claims are generally drawn to the treatment of Fabry disease comprising administering, for example, about 150 mg of 1-deoxygalactonojirimycin (i.e. migalastat).
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 17, 19-21, and 60 of copending Application No. 16/967,827 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending application claims are generally drawn to the treatment of Fabry disease comprising administering about 100-150 mg of migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13, 37-42, 115, 117, 167-169, and 172 of copending Application No. 16/987,884 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending application claims are generally drawn to the treatment of Fabry disease comprising administering about 100-150 mg of migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/076,336 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending application claims are generally drawn to the treatment of Fabry disease comprising administering about 100-150 mg of migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/077,389 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/077,393 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/077,397 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/077,402 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/078,765 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/078,840 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-15, 18-23, and 25 of copending Application No. 17/172,846 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/213,632 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending application claims are generally drawn to the treatment of Fabry disease comprising administering about 100-150 mg of migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 10, 11, 20, 21, 48-50, 53, 57, 58, 101-103, 106, 110, and 111 of copending Application No. 17/269,890 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending application claims are generally drawn to the treatment of Fabry disease comprising administering about 100-150 mg of migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/400,548 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending application claims are generally drawn to the treatment of Fabry disease comprising administering about 100-150 mg of migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/400,623 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/400,922 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/400,927 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14, 18-25, 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/401,629 in view of Germain et al. (D.P. Germain, et al., Treatment of Fabry’s Disease with the Pharmacologic Chaperone Migalastat, N Engl J Med 2016;375:545-55., DOI: 10.1056/NEJMoa1510198). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are generally drawn to the treatment of Fabry disease and diarrhea comprising administering about 100-150 mg free base equivalent migalastat, and the resultant effects of said treatment.
The copending claims are generally drawn to the treatment of a patient who has Fabry disease comprising administering about 100-150 mg free base equivalent migalastat.
The copending application does not specifically disclose the diarrhea or the resultant effects.
Germain et al. discloses the treatment of Fabry’s disease with migalastat (see, for example, the title and the whole document), and further teaches that patients with Fabry’s disease frequently have debilitating gastrointestinal symptoms and that six months of treatment with migalastat improved the diarrhea symptoms of patients using the Gastrointestinal Symptom Rating Scale (see, for example, pg. 554, left column, second paragraph).
One of ordinary skill would have been motivated to treat diarrhea in a patient with Fabry’s disease with migalastat because the prior art discloses that migalastat was considered to be useful for the treatment of Fabry’s disease, that Fabry’s disease frequently has debilitating gastrointestinal symptoms including diarrhea, and that the administration of migalastat provided measurable improvement in the diarrhea symptoms.
With respect to the instant limitations drawn to the resultant effects of the treatment, the administration of the same composition to the same patient population is disclosed, the resultant effects would have necessarily followed. “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the claims of these references patents and applications do not disclose treating diarrhea in the claimed patient population.
This is not persuasive because Applicant is reminded that these obviousness double patenting rejections are made in view of Germain, which teaches the nexus between diarrhea symptoms and Fabry disease.
In response to applicant’s arguments against the references, one cannot show nonobviousness by attacking references individually where the rejections are based on the combination of references. See In re Keller, 642 F. 2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F. 2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623