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 .
DETAILED ACTION
Applicant’s preliminary amendment dated 6 November 2023, in which claims 1, 2, 7, 9, 28, 29, 31-33, 36-37, 43, 45, 47-48, 53, 55, 74-75, 77-79, 82, 89, 91, 94, 100 have been amended, and claims 3-6, 8, 10-27, 30, 34-35, 38-42, 44, 46, 49-52, 54, 56-73, 76, 80-81, 83-88, 90, 92, 95-99, 102-109, 111-118 have been cancelled, is acknowledged.
Applicant’s preliminary amendment of 30 April 2026, in which claims 1, 2, 47, 48 have been amended, and claims 7, 9, 53, 55 have been cancelled, is acknowledged.
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91, 93-94, 100-101, 110 are pending in the instant application.
Claims 93-94, 100-101, 110 are withdrawn, as being drawn to a non-elected invention.
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are being examined herein.
Priority
The instant application is a National Stage entry of International Application No. PCT/US2021/049677, filed on 9 September 2021, which claims priority from U.S. Provisional Patent Application No. 63/076,761, filed on 10 September 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 21 July 2023, 26 September 2024 (two documents), and 2 January 2025, are acknowledged and considered.
Election/Restrictions
Applicant’s election without traverse of Group (II), claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91, drawn to a method of treating a disease or disorder in a subject in need thereof, comprising administering a dose comprising an effective amount of ribitol, wherein the disease or disorder is associated with a defect in fukutin (FKTN), Fukutin-related protein (FKRP), or isoprenoid synthase domain-containing protein (ISPD), in the reply filed on 30 April 2026, is acknowledged. Claims 93-94, 100-101, 110 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Applicant’s election without traverse of a disease or disorder associated with a defect in Fukutin-related protein (FKRP), as the disease to be treated, in the reply of 30 April 2026, is acknowledged. Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 read on the elected species.
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 have been examined to the extent they read on the elected species and the following rejections are made below.
Claim Rejection- 35 USC 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
It is unclear what is the amount of ribitol administered to a subject weighing 50 kg- is it 9 grams, or is it 12 grams? - since 50 kg is body weight 30 to 50 kg and is also encompassed by the range at least 50 kg.
Appropriate clarification is required.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim interpretation: the term “disease or disorder associated with a defect in fukutin (FKTN), Fukutin-related protein (FKRP), or isoprenoid synthase domain-containing protein (ISPD)” in instant claims is interpreted, based on [0091] Specification, to be a disease or disorder caused by a mutation in a fukutin, or fukutin related protein (FKRP) or ISPD.
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected under 35 U.S.C. 103 as being unpatentable over Lu (US 2018/0169036, published 21 June 2018, cited in IDS).
Lu (US 2018/0169036) teaches [0025] a method of treating a disorder associated with (e.g., caused by or resulting from) a mutation in a fukutin related protein (FKRP) gene in a subject, comprising administering to the subject an effective amount of a ribitol, thereby treating the disorder associated with a mutation in a fukutin related protein (FKRP) gene disorder associated with a mutation in a fukutin related protein (FKRP) gene in the subject.
Lu teaches [0030] that nonlimiting examples of a disorder associated with a mutation in, or loss of function of, the FKRP gene include limb-girdle muscular dystrophy (LGMD2I), which is a muscular dystrophy of instant claims 29, 31-33, 75, 77-79.
Lu teaches [0028] that the use of ribitol restores and/or enhances levels of glycosylated α-DG, as in instant claims 45, 91.
Lu teaches [0043] that the therapeutically effective amount or dosage of ribitol of the invention will vary depending on the subject's condition and therapeutic need, and will also depend, among other things, upon the effect or result to be achieved, the status of the subject and/or the route and/or mode of delivery. Lu teaches [0043] that the total amount of ribitol for daily use can be from about 0.001 g to about 500 g, depending on the nature and formulation of the drug. The range disclosed by Lu encompasses the instantly claimed daily amounts.
Lu teaches [0043] that ribitol can be delivered orally in drinking water containing from about 0.1 to about 100% concentration of the drug as many times as desirable, e.g., from about 1 time to about 100 times a day. The drug can also be taken as pellet about 1 to about 10 times daily. The frequency of administration taught by Lu encompasses twice daily administration in the instant claims.
Lu teaches [0054] that determination of a therapeutically effective amount, as well as dosage forms, routes of administration, and frequency of dosing, depend upon the subject and condition being treated or addressed, the severity of the condition in a particular subject, the particular route of administration being employed, the frequency of dosing, and the particular formulation being employed. Determination of a therapeutically effective treatment regimen for a subject of this invention is within the level of ordinary skill in the medical or veterinarian arts.
Lu teaches [0113] treatment with ribitol for 6 months, which is consistent with chronically administering ribitol to the subject, as in instant claims 28, 74.
Lu teaches [0050] that the subject treated is a human, as in instant claims 43, 89.
Lu does not specifically teach that the therapeutically effective amount of ribitol administered in the method of treatment is 9, 12, 15, or 18 grams administered twice daily, as in instant claims 1, 47; or is 9 grams administered twice daily for subjects with a body weight of 30-50 kg, or 12 grams administered twice daily for subjects with a body weight of at least 50 mg/kg, as in instant claims 2, 48.
It would have been obvious to a person of ordinary skill in the art to use the teachings of Lu to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to determine the therapeutic dose and frequency of administration of ribitol in the method of Lu, within the ranges taught by Lu, because determining the therapeutic dose and frequency of administration of a known therapeutic agent in a known method of treatment, is routine, well within the skill of the artisan. Further, Lu teaches that determination of a therapeutically effective treatment regimen for a subject of the invention is within the level of ordinary skill in the medical or veterinarian arts. Thus, the person of ordinary skill in the art would have explored different daily doses and frequency of administration of ribitol in a method
of treating a disorder caused by a mutation in a fukutin related protein (FKRP) gene in a subject, such as limb-girdle muscular dystrophy (LGMD2I), taught by Lu, and would have administered said doses to a human subject using daily administration, or twice a day administration, for several days/6 months, with monitoring for PK parameters, because such a protocol for determining the dose for achieving efficacy in treating a disease upon administration of a therapeutic agent to humans is routine, well within the skill of the artisan.
With respect to the PK limitations in claim 36, 37, 47, 82, the properties of the composition are inherent to the composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
With respect to the limitation in instant claims 36, 37, 47, 82, even though prior art does not specifically teach the AUC or Cmax levels achieved in the subject upon administration of ribitol, the ability to achieve said AUC or Cmax of ribitol levels in a subject upon administration is an inherent property of the ribitol composition. In the instant case, achieving the claimed AUC and Cmax levels is inherently associated with treatment of a disease such as LGMD2i by administering a composition comprising ribitol.
Since Lu teaches administration of a composition comprising ribitol, to the very same patient population, patients suffering from a disease such as LGMD2i, to treat said patients, said composition, upon administration, will inherently achieve the same AUC and Cmax ribitol levels in said patients. The claiming of a new function or unknown property that is inherently present in the prior art, although not necessarily specifically disclosed therein, does not make the present claims patentable. See MPEP 2112(I).
As such, claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected as prima facie obvious.
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 2020/0061092, published 27 February 2020, cited in IDS).
Lu et al. (US2020/0061092) teach [0041] a method of treating a disorder associated with a mutation or loss of function in a fukutin related protein (FKRP) gene such as, for example, limb-girdle muscular dystrophy type 2i (LGMD2i), which is a muscular dystrophy of instant claims 29, 31-33, 75, 77-79, comprising administering to the subject an effective amount of ribitol.
Lu teaches (Example 1) that the administration of ribitol restores and/or enhances levels of glycosylated α-DG, as in instant claims 45, 91.
Lu teaches [0084] that the therapeutically effective amount or dosage of ribitol of the invention will vary depending on the subject's condition and therapeutic need, and will also depend, among other things, upon the effect or result to be achieved, the status of the subject and/or the route and/or mode of delivery. Lu teaches [0084] that the total amount of ribitol for daily use can be from about 0.001 g to about 500 g, depending on the nature and formulation of the drug. The range disclosed by Lu encompasses the instantly claimed daily amounts.
Lu teaches [0084] that ribitol can be delivered orally in drinking water containing from about 0.1 to about 100% concentration of the drug as many times as desirable, e.g., from about 1 time to about 100 times a day. The drug can also be taken as pellet about 1 to about 10 times daily. The frequency of administration taught by Lu encompasses twice daily administration in the instant claims.
Lu teaches [0099] that determination of a therapeutically effective amount, as well as dosage forms, routes of administration, and frequency of dosing, depend upon the subject and condition being treated or addressed, the severity of the condition in a particular subject, the particular route of administration being employed, the frequency of dosing, and the particular formulation being employed. Determination of a therapeutically effective treatment regimen for a subject of this invention is within the level of ordinary skill in the medical or veterinarian arts.
Lu teaches [0013] treatment with ribitol for 6 months, which is consistent with chronically administering ribitol to the subject, as in instant claims 28, 74.
Lu teaches [0095] that the subject treated is a human, as in instant claims 43, 89.
Lu teaches [0039] administering a controlled releaser composition of ribitol comprising an effective amount of ribitol that results in a serum level in the subject of ribitol in a range from about 0.5 mg/L to about 5 mg/L.
Lu teaches [0060] that the effective amount of ribitol administered to the subject over 24 hours can be about 0.1 g/kg to about 0.2 g/kg, based on the body weight of the subject. The dose taught by Lu, 0.2 g/kg, corresponds, for a person weighing 45 kg, to 9 grams daily, as in instant claims 1, 2, 47, 48; or, for a person weighing 60 kg, it corresponds to 12 grams/day, as in instant claims 1, 2, 47, 48.
Lu teaches [0061] that the controlled-release composition can be administered 1, 2, 3, or 4 times daily, which includes twice daily as in the instant claims.
Lu does not specifically teach that the therapeutically effective amount of ribitol administered in the method of treatment is 9, 12, 15, or 18 grams administered twice daily, as in instant claims 1, 47; or is 9 grams administered twice daily for subjects with a body weight of 30-50 kg, or 12 grams administered twice daily for subjects with a body weight of at least 50 mg/kg, as in instant claims 2, 48.
It would have been obvious to a person of ordinary skill in the art to use the teachings of Lu to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to determine the therapeutic dose and frequency of administration of ribitol in the method of Lu, within the ranges taught by Lu, because determining the therapeutic dose and frequency of administration of a known therapeutic agent in a known method of treatment, is routine, well within the skill of the artisan. Further, Lu teaches that the effective amount of ribitol administered to the subject over 24 hours can be 0.2 g/kg, based on the body weight of the subject, which corresponds, for a person weighing 45 kg, to 9 grams daily; or, for a person weighing 60 kg, it corresponds to 12 grams/day, as in instant claims. Furthermore, Lu teaches that the ribitol composition can be administered 1, 2, 3, or 4 times daily, which includes twice daily as in the instant claims. Thus, the person of ordinary skill in the art would have explored different daily doses and frequency of administration of ribitol taught by Lu in a method
of treating a disorder caused by a mutation in a fukutin related protein (FKRP) gene in a subject, such as limb-girdle muscular dystrophy (LGMD2I), taught by Lu, and would have administered said doses to a human subject using daily administration, or twice a day administration, chronically, for 6 months, with monitoring for PK parameters, because such a protocol for determining the dose for achieving efficacy in treating a disease upon administration of a therapeutic agent to humans is routine, well within the skill of the artisan.
With respect to the PK limitations in claim 36, 37, 47, 82, the properties of the composition are inherent to the composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
With respect to the limitation in instant claims 36, 37, 47, 82, even though prior art does not specifically teach the AUC or Cmax levels achieved in the subject upon administration of ribitol, the ability to achieve said AUC or Cmax of ribitol levels in a subject upon administration is an inherent property of the ribitol composition. In the instant case, achieving the claimed AUC and Cmax levels is inherently associated with treatment of a disease such as LGMD2i by administering a composition comprising ribitol.
Since Lu teaches administration of a composition comprising ribitol, to the very same patient population, patients suffering from a disease such as LGMD2i, to treat said patients, said composition, upon administration, will inherently achieve the same AUC and Cmax ribitol levels in said patients. The claiming of a new function or unknown property that is inherently present in the prior art, although not necessarily specifically disclosed therein, does not make the present claims patentable. See MPEP 2112(I).
As such, claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected as prima facie obvious.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent 10,245,235 (cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of U.S. Patent 10,245,235 render obvious the instant claims.
Claims 1-2 of U.S. Patent 10,245,235 are drawn to a method of treating a disorder associated with a mutation or loss of function in a fukutin related protein (FKRP) gene in a subject, comprising administering a therapeutically effective amount of a ribitol to a subject in need thereof daily for at least 30 days, thereby treating the disorder associated with a mutation or loss of function in a fukutin related protein (FKRP) gene in a subject, wherein the disorder associated with a mutation or loss of function in the FKRP gene is, for example, limb-girdle muscular dystrophy (LGMD), which is a muscular dystrophy of instant claims 29, 31-33, 75, 77-79.
It would have been obvious to a person of ordinary skill in the art to use the teachings of claims 1-2 of U.S. Patent 10,245,235 to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to determine the therapeutic dose and frequency of administration of ribitol in the method of claims 1-2 of U.S. Patent 10,245,235, because determining the therapeutic dose and frequency of administration of a known therapeutic agent in a known method of treatment, is routine, well within the skill of the artisan. Thus, the person of ordinary skill in the art would have explored different daily doses and frequency of administration of ribitol in a method of treating a disorder caused by a mutation in a fukutin related protein (FKRP) gene in a subject, such as limb-girdle muscular dystrophy (LGMD2I), taught by claims 1-2 of U.S. Patent 10,245,235, and would have administered said doses to a human subject using daily administration, or twice a day administration, for at least 30 days, with monitoring for PK parameters, because such a protocol for determining the dose for achieving efficacy in treating a disease upon administration of a therapeutic agent to humans is routine, well within the skill of the artisan.
With respect to the PK limitations in claim 36, 37, 47, 82, the properties of the composition are inherent to the composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
With respect to the limitation in instant claims 36, 37, 47, 82, even though claims 1-2 of U.S. Patent 10,245,235 do not specifically teach the AUC or Cmax levels achieved in the subject upon administration of ribitol, the ability to achieve said AUC or Cmax of ribitol levels in a subject upon administration is an inherent property of the ribitol composition. In the instant case, achieving the claimed AUC and Cmax levels is inherently associated with treatment of a disease such as LGMD2i by administering a composition comprising ribitol.
Since claims 1-2 of U.S. Patent 10,245,235 teach administration of a composition comprising ribitol, to the very same patient population, patients suffering from a disease such as LGMD2i, to treat said patients, said composition, upon administration, will inherently achieve the same AUC and Cmax ribitol levels in said patients. The claiming of a new function or unknown property that is inherently present in the prior art, although not necessarily specifically disclosed therein, does not make the present claims patentable. See MPEP 2112(I).
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent 10,993,954 (cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of U.S. Patent 10,993,954 render obvious the instant claims.
Claims 1-20 of U.S. Patent 10,993,954 are drawn to a method of treating limb girdle muscular dystrophy 2I (LGMD-2I), which is a muscular dystrophy of instant claims 29, 31-33, 75, 77-79, in a subject in need thereof, comprising administering to the subject an effective amount of a pharmaceutical composition comprising ribitol, thereby treating the LGMD-2I in the subject. Claim 2 recites that the subject has a loss-of-function mutation in a fukutin-related protein (FKRP) gene. Claim 9 recites that the method increases α-dystroglycan (α-DG) glycosylation in muscle tissue of the subject. Claim 13 recites that the method comprises administering the pharmaceutical composition for at least 6 months.
It would have been obvious to a person of ordinary skill in the art to use the teachings of claims 1-20 of U.S. Patent 10,993,954 to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to determine the therapeutic dose and frequency of administration of ribitol in the method of claims 1-20 of U.S. Patent 10,993,954, because determining the therapeutic dose and frequency of administration of a known therapeutic agent in a known method of treatment, is routine, well within the skill of the artisan. Thus, the person of ordinary skill in the art would have explored different daily doses and frequency of administration of ribitol in a method of treating limb-girdle muscular dystrophy (LGMD2I), taught by claims 1-20 of U.S. Patent 10,993,954, and would have administered said doses to a human subject using daily administration, or twice a day administration, for at least 6 months, with monitoring for PK parameters, because such a protocol for determining the dose for achieving efficacy in treating a disease upon administration of a therapeutic agent to humans is routine, well within the skill of the artisan.
With respect to the PK limitations in claim 36, 37, 47, 82, the properties of the composition are inherent to the composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
With respect to the limitation in instant claims 36, 37, 47, 82, even though claims 1-20 of U.S. Patent 10,993,954 do not specifically teach the AUC or Cmax levels achieved in the subject upon administration of ribitol, the ability to achieve said AUC or Cmax of ribitol levels in a subject upon administration is an inherent property of the ribitol composition. In the instant case, achieving the claimed AUC and Cmax levels is inherently associated with treatment of a disease which is LGMD2i by administering a composition comprising ribitol.
Since claims 1-20 of U.S. Patent 10,993,954 teach administration of a composition comprising ribitol, to the very same patient population, patients suffering from a disease which is LGMD2i, to treat said patients, said composition, upon administration, will inherently achieve the same AUC and Cmax ribitol levels in said patients. The claiming of a new function or unknown property that is inherently present in the prior art, although not necessarily specifically disclosed therein, does not make the present claims patentable. See MPEP 2112(I).
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-6, 9-11 of U.S. Patent 11,931,371 (cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-6, 9-11 of U.S. Patent 11,931,371 render obvious the instant claims.
Claims 1-6, 9-11 of U.S. Patent 11,931,371 are drawn to a method of delaying the development of muscle weakness or improving muscle function in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of ribitol, wherein the subject has a loss-of-function mutation in a fukutin-related protein (FKRP) gene. Claim 11 recites that the subject has been diagnosed with limb-girdle muscular dystrophy type 2I, which is a muscular dystrophy of instant claims 29, 31-33, 75, 77-79. Claim 2 recites that the subject has a loss-of-function mutation in a fukutin-related protein (FKRP) gene. Claim 5 recites that the method comprises administering the ribitol for at least 6 months.
It would have been obvious to a person of ordinary skill in the art to use the teachings of claims 1-6, 9-11 of U.S. Patent 11,931,371 to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to determine the therapeutic dose and frequency of administration of ribitol in the method of claims 1-6, 9-11 of U.S. Patent 11,931,371, because determining the therapeutic dose and frequency of administration of a known therapeutic agent in a known method of treatment, is routine, well within the skill of the artisan. Thus, the person of ordinary skill in the art would have explored different daily doses and frequency of administration of ribitol in a method of treating limb-girdle muscular dystrophy (LGMD2I), taught by claims 1-6, 9-11 of U.S. Patent 11,931,371, and would have administered said doses to a human subject using daily administration, or twice a day administration, for at least 6 months, with monitoring for PK parameters, because such a protocol for determining the dose for achieving efficacy in treating a disease upon administration of a therapeutic agent to humans is routine, well within the skill of the artisan.
With respect to the PK limitations in claim 36, 37, 47, 82, the properties of the composition are inherent to the composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
With respect to the limitation in instant claims 36, 37, 47, 82, even though claims 1-6, 9-11 of U.S. Patent 11,931,371 do not specifically teach the AUC or Cmax levels achieved in the subject upon administration of ribitol, the ability to achieve said AUC or Cmax of ribitol levels in a subject upon administration is an inherent property of the ribitol composition. In the instant case, achieving the claimed AUC and Cmax levels is inherently associated with treatment of a disease which is LGMD2i by administering a composition comprising ribitol.
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent 12,478,634 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-10 of U.S. Patent 12,478,634 render obvious the instant claims.
Claims 1-10 of U.S. Patent 12,478,634 are drawn to a method of treating a Fukutin related protein (FKRP)-related muscular dystrophy, comprising administering to a human subject in need thereof a therapeutically effective amount of a compound of the following formula:
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(which is ribitol), thereby treating the FKRP-related muscular dystrophy in the subject. Claim 8 recites that administration of the therapeutically effective amount of the compound to the subject increases a-dystroglycan glycosylation in muscle tissue of the subject. Claim 10 recites that the method comprises administering the ribitol for at least 6 months.
The Specification of U.S. Patent 12,478,634 teaches limb-girdle muscular dystrophy type 2I, which is a muscular dystrophy of instant claims 29, 31-33, 75, 77-79, as a Fukutin related protein (FKRP)-related muscular dystrophy to be treated.
It would have been obvious to a person of ordinary skill in the art to use the teachings of claims 1-10 of U.S. Patent 12,478,634 to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to determine the therapeutic dose and frequency of administration of ribitol in the method of claims 1-10 of U.S. Patent 12,478,634, because determining the therapeutic dose and frequency of administration of a known therapeutic agent in a known method of treatment, is routine, well within the skill of the artisan. Thus, the person of ordinary skill in the art would have explored different daily doses and frequency of administration of ribitol in a method of treating a Fukutin related protein (FKRP)-related muscular dystrophy such as limb-girdle muscular dystrophy (LGMD2I), taught by claims 1-10 of U.S. Patent 12,478,634, and would have administered said doses to a human subject using daily administration, or twice a day administration, for at least 6 months, with monitoring for PK parameters, because such a protocol for determining the dose for achieving efficacy in treating a disease upon administration of a therapeutic agent to humans is routine, well within the skill of the artisan.
With respect to the PK limitations in claim 36, 37, 47, 82, the properties of the composition are inherent to the composition. Therefore, if the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
With respect to the limitation in instant claims 36, 37, 47, 82, even though claims 1-10 of U.S. Patent 12,478,634 do not specifically teach the AUC or Cmax levels achieved in the subject upon administration of ribitol, the ability to achieve said AUC or Cmax of ribitol levels in a subject upon administration is an inherent property of the ribitol composition. In the instant case, achieving the claimed AUC and Cmax levels is inherently associated with treatment of a disease which is LGMD2i by administering a composition comprising ribitol.
For similar reasons, instant claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of co-pending U.S. Patent application 19/377,792 (cited in PTO-892).
Conclusion
Claims 1-2, 28-29, 31-33, 36-37, 43, 45, 47-48, 74-75, 77-79, 82, 89, 91 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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