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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-22) in the reply filed on 12/11/25 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 23-29 were cancelled.
Claims 1-22 are pending and included in the prosecution.
Information Disclosure Statement
The 11 information disclosure statements (IDSs) filed on 10/21/25 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Claim Objections
Claim 8 is objected to because of the following informalities: In claim 8, line 4, the abbreviation GHB should be spelled out as gamma-hydroxybutyrate. An acronym/abbreviation in the first instance of claims should be expanded upon/spelled out with the acronym/abbreviation indicated in parentheses. The acronym/abbreviations can be used thereafter. Appropriate correction is required.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Allphin et al. (US 10,398,662 B1 – “Allphin”).
Instant claim 1 is drawn to a powder suitable for administration to a human patient in need thereof, comprising a dose equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the dose achieves a relative bioavailability (RBA) of greater than 85%, and wherein the powder is suitable for administration once daily.
Allphin teaches a pharmaceutical composition comprising a plurality of particles, each comprising oxybate ionically bound to an ion exchange matrix which is an anion-exchange resin (Abstract, claims 1-12). A gamma-hydroxybutyrate (GHB) multi-particulate solid composition in the form of a powder is disclosed (Col. 6, lines 37-49). The composition comprises a first population and a second population of particles, wherein each of the first and second populations of particles comprise oxybate ionically bound to an ion exchange matrix, and wherein the first population of particles provides therapeutically effective levels of oxybate for up to 3 hours, and the second population provides therapeutically effective levels of oxybate for an additional 2 to 5 hours (claim 9). Sodium oxybate (Na. GHB), commercially sold as Xyrem®, is approved for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy (Col. 1, lines 34-36). The finished dose compositions may take the form of suspensions (Col. 7, lines 7-10). The formulation is administered to a patient once nightly (Col. 18, lines 8-9). The patient is administered between 4 g and 10 g GHB/day or 6 g and 9 g/day (Col. 18, lines 9-11). The GHB resinate beads may be presented in hydrated form as part of an aqueous suspension, or may be provided as dried beads for mixing with water immediately prior to ingestion (Col. 18, lines 13-17). About 12-13 grams of sodium oxybate would be required for the overall relative bioavailability of an appropriately-timed sustained release of at most about 75% relative to Xyrem (Col. 21, lines 4-12).
Sodium oxybate is included in the examples (Examples 4-6 – Col. 22, line 50 to Col. 23, line 46). The amount of oxybate in the composition ranges from about 40 mEq to about 100 mEq (claim 1). The formulations and dosage forms include an immediate release (IR) component which can form part of a solid controlled release unit dosage form, e.g., combined with a controlled release GHB resinate component, and the IR component may also be formulated as part of a single dosage form that integrates both the components (Col. 4, lines 40-56).
Allphin does not expressly teach that the dose achieves a relative bioavailability (RBA) of greater than 85%.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a powder pharmaceutical composition comprising a first population of IR particles and a second population of controlled release particles, each comprising oxybate, wherein the finished dose takes the form of a suspension, the composition is administered to a patient once nightly, the patient is administered between 4 g and 10 g GHB/day or 6 g and 9 g/day, as taught by Allphin, modify the composition in order to achieve a RBA of greater than 85%, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Allphin teaches that about 12-13 grams of sodium oxybate would be required for the overall RBA of an appropriately-timed sustained release of at most about 75% relative to Xyrem (Col. 21, lines 4-12). One of ordinary skill in the art would have found it obvious to modify the first population and the second population of particles as taught by Allphin in order to achieve the desired pharmacokinetic attributes, including the RBA. Allphin teaches the same composition, comprising the same components, in the same dosage range and in the same form. Therefore, the recited RBA would have been an obvious variant over the RBA taught by Allphin absent evidence of criticality or unexpected results.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 1 and 8, the limitations of a powder suitable for administration to a human patient in need thereof would have been obvious over the GHB multi-particulate solid composition in the form of a powder (Col. 6, lines 37-49), as taught by Allphin.
Regarding instant claims 1, 9, and 16-22, the limitations of the powder and unit dose equivalent to from 3.0 to 12.0 g of sodium oxybate would have been obvious over the administration of between 4 g and 10 g GHB/day or 6 g and 9 g/day to a patient (Col. 18, lines 9-11), as taught by Allphin.
Regarding instant claims 1, 5-7, and 13-15, the limitations of the dose achieving a RBA of greater than 85% (instant claim 1), greater than 90% (instant claims 5 and 13), greater than 95% (instant claims 6 and 14), 100% (instant claims 7 and 15) would have been obvious over the overall RBA of an appropriately-timed sustained release of at most about 75% relative to Xyrem (Col. 21, lines 4-12), as taught by Allphin. Allphin teaches the same composition, comprising the same components, in the same dosage range and in the same form. One of ordinary skill in the art would have found it obvious to modify the first population and the second population of particles as taught by Allphin in order to achieve the desired pharmacokinetic attributes, including increasing the RBA. Therefore, the recited RBA would have been an obvious variant over the RBA taught by Allphin absent evidence of criticality or unexpected results.
Regarding instant claims 1 and 8, the limitations of the powder that is suitable for administration once daily would have been obvious over the formulation administered to a patient once nightly (Col. 18, lines 8-9), as taught by Allphin.
Regarding instant claims 2 and 10, the limitations of the dose equivalent to 3.0 g, 4.5 g, 6.0 g, 7.5 g, 9.0 g, 10.5 g, or 12.0 g of sodium oxybate would have been obvious over the administration of overlapping ranges of between 4 g and 10 g GHB/day or 6 g and 9 g/day to a patient (Col. 18, lines 9-11), as taught by Allphin. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claims 3, 8, and 11, the limitations of the powder suitable for reconstitution as a suspension would have been obvious over the finished dose compositions in the form of suspensions (Col. 7, lines 7-10), the GHB resinate beads in hydrated form as part of an aqueous suspension, or as dried beads for mixing with water immediately prior to ingestion (Col. 18, lines 13-17), as taught by Allphin.
Regarding instant claims 4 and 12, the limitations of the powder suitable for oral administration would have been obvious over the finished ingestible composition for delivery orally (Col. 13, lines 51-58 and claim 21) and the finished dose compositions in the form of suspensions (Col. 7, lines 7-10), the GHB resinate beads in hydrated form as part of an aqueous suspension, or as dried beads for mixing with water immediately prior to ingestion (Col. 18, lines 13-17), as taught by Allphin.
Regarding instant claim 8, the limitation of the powder comprising immediate-release (IR) particles and modified-release (MR) particles would have been obvious over the immediate release (IR) component which can form part of a solid controlled release unit dosage form, e.g., combined with a controlled release GHB resinate component or particles, and the IR component may also be formulated as part of a single dosage form that integrates both the components (Col. 4, lines 40-56), as taught by Allphin.
Regarding instant claim 8, the limitation of the suspension suitable to achieving a RBA of GHB of greater than 80% relative to a comparable amount of an immediate release liquid solution of sodium oxybate administered in equally divided doses would have been obvious over the overall RBA of an appropriately-timed sustained release of at most about 75% relative to Xyrem (Col. 21, lines 4-12), as taught by Allphin. Allphin teaches the same composition, comprising the same components, in the same dosage range and in the same form. One of ordinary skill in the art would have found it obvious to modify the first population and the second population of particles as taught by Allphin in order to achieve the desired pharmacokinetic attributes, including increasing the RBA. Therefore, the recited RBA would have been an obvious variant over the RBA taught by Allphin absent evidence of criticality or unexpected results.
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 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 20-21, 27-29, 32, 51-52, 58-60, and 71-80 of U.S. Patent No. 10,272,062 B2 (the ‘062 Patent).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a powder suitable for administration to a human patient in need thereof, comprising a dose equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the dose achieves a RBA of greater than 85%, and wherein the powder is suitable for administration once daily, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claims 20, 21, 51, 52, and 82 of the ‘062 Patent recite that the formulation achieves a RBA of greater than 80% when compared to an equal dose of an IR liquid solution of sodium oxybate whereas instant claim 1 recites a RBA of greater than 85%. However, instant claim 8 recites a RBA of greater than 80% thereby rendering this limitation obvious.
Another difference is that instant claim 1 recites a powder and instant claim 8 recites a powder for suspension whereas claim 1 of the ‘062 Patent doesn’t recite this limitation. However, claims 27-28 and 58-59 of the ‘062 Patent recite powder formulations and claims 29, 60, 78-80 recite that the formulation comprises a suspending agent, thereby rendering limitation of a powder for suspension obvious.
Therefore, instant claims are obvious over claims of the ‘062 Patent and they are not patentably distinct over each other.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 9, 20, 24, 28-32, and 39-52 of U.S. Patent No. 10,736,866 B2 (the ‘866 Patent).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a powder suitable for administration to a human patient in need thereof, comprising a dose equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the dose achieves a RBA of greater than 85%, and wherein the powder is suitable for administration once daily, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claims 9, 28, and 43-44 of the ‘866 Patent recite that the formulation achieves a RBA of greater than 80% when compared to an equal dose of an IR liquid solution of sodium oxybate whereas instant claim 1 recites a RBA of greater than 85%. However, instant claim 8 recites a RBA of greater than 80% thereby rendering this limitation obvious.
Another difference is that instant claim 1 recites a powder and instant claim 8 recites a powder for suspension whereas claim 1 of the ‘866 Patent doesn’t recite this limitation. However, claims 5 and 24 of the ‘866 Patent recite powder formulations and claims 1-3, 20-22, and 39-52 recite that the formulation comprises a suspending agent, thereby rendering limitation of a powder for suspension obvious.
Therefore, instant claims are obvious over claims of the ‘866 Patent and they are not patentably distinct over each other.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, 15, and 17 of U.S. Patent No. 12,226,388 B2 (the ‘388 Patent).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a powder suitable for administration to a human patient in need thereof, comprising a dose equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the dose achieves a RBA of greater than 85%, and wherein the powder is suitable for administration once daily, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘388 Patent recites a method of treating a disorder treatable with a pharmaceutically acceptable salt of GHB in a human subject in need thereof, whereas instant claims are drawn to a powder suitable for administration to a human patient. However, since claim 15 of the ‘388 Patent recites a powder oral suspension it renders obvious instant claims drawn to a powder and a powder for suspension.
Another difference is that claim 17 of the ‘388 Patent recites that the single nighttime daily dose achieves a RBA of greater than 80% whereas instant claim 1 recites a RBA of greater than 85%. However, instant claim 8 recites a RBA of greater than 80% thereby rendering this limitation obvious.
Therefore, instant claims are obvious over claims of the ‘388 Patent and they are not patentably distinct over each other.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 12,257,223 B2 (the ‘223 Patent).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a powder suitable for administration to a human patient in need thereof, comprising a dose equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the dose achieves a RBA of greater than 85%, and wherein the powder is suitable for administration once daily, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘223 Patent recites a method of treating a disorder treatable with GHB in a human subject in need thereof, whereas instant claims are drawn to a powder suitable for administration to a human patient. However, since claim 9 of the ‘223 Patent recites a powder oral suspension it renders obvious instant claims drawn to a powder and a powder for suspension.
Another difference is that claim 1 of the ‘223 Patent recites that the once-nightly formulation achieves a RBA of greater than 80% whereas instant claim 1 recites a RBA of greater than 85%. However, instant claim 8 recites a RBA of greater than 80% thereby rendering this limitation obvious.
Therefore, instant claims are obvious over claims of the ‘223 Patent and they are not patentably distinct over each other.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615