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 .
Claim Status
Claim 1 is pending and under examination.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Allphin et al. (US 8,591,922).
Claimed invention
A pharmaceutical composition of gamma-hydroxybutyrate comprising a mixture of two or more salts of gamma-hydroxybutyrate (GHB), wherein the mixture comprises at least 50% of a sodium salt of gamma-hydroxybutyrate (Na.GHB) and further comprises one or more of a potassium salt of gamma-hydroxybutyrate (K.GHB) and a calcium salt of gamma-hydroxybutyrate (Ca.(GHB)2).
Prior art
Allphin teaches a pharmaceutical composition of gamma-hydroxybutyrate (GHB) comprising a mixture of salts of GHB, wherein the mixture consists of a sodium salt of gamma-hydroxybutyrate (Na.GHB), a potassium salt of gamma-hydroxybutyrate (K.GHB), a magnesium salt of gamma-hydroxybutyrate (Mg.(GHB)2), and a calcium salt of gamma-hydroxybutyrate (Ca.(GHB)2); and optionally, one or more of a buffering agent, sweetening agent, flavoring agent or coloring agent, in a pharmaceutically acceptable carrier. See Claim 1. In certain embodiments, the pharmaceutical composition comprises varying weight/weight percentages (wt/wt %) of Na.GHB, K.GHB, Mg.(GHB)2, and Ca.(GHB)2. See section “6.2.2 Weight/Weight and Molar Equivalents Percents’ bridging columns 10 and 11. The Na.GHB salt is present in a wt/wt % of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. Allphin also exemplifies a composition containing a mixture of GHB salts comprising sodium GHB (Na.GHB) as the predominant GHB salt, and further comprising potassium GHB (K.GHB). magnesium GHB (Mg.GHB), and calcium GHB (Ca.GHB). See Id.
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See Table 5.
Allphin does not expressly teach the composition wherein the amount of Na.GHB is at least 50% of the mixture of GHB salts.
A person of ordinary skill in the art (POSA) would have found it obvious prepare a composition comprising a mixture of GHB salts of at least 50% NaGHB in combination with K.GHB and/or Ca.GHB because Allphin teaches GHB salt compositions and Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. The selection is an obvious matter of routine optimization within the disclosed percentages as Allphin teaches mixed cation salts and include these percentages within its expressly enumerated embodiments (see Allphin, cols. 10-11).
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.
A. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 9,795,567 B2 in view of Allphin et al. (US 8,591,922). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims teach an immediate release formulation comprising a pharmaceutically acceptable salt of GHB (in an amount of 600 mg to about 1,500 mg) and comprising at least 70% by weight of the immediate release formulation. The GHB salt is at least one of sodium oxybate, calcium oxybate, lithium oxybate, potassium oxybate, and magnesium oxybate, suggesting a combination of any of these. The immediate release formulation comprises a salt of GHB in an amount selected from at least one of 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, and 98% by weight.
The reference claims do not expressly teach the composition wherein the amount of Na.GHB is at least 50% of the mixture of GHB salts.
Allphin teaches GHB salt compositions containing a mixture of GHB salts, e.g., Na.GHB, K.GHB, Mg.(GHB)2, and Ca.(GHB)2. See section “6.2.2 Weight/Weight and Molar Equivalents Percents’ bridging columns 10 and 11. Allphin teaches Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%.
A person of ordinary skill in the art (POSA) would have found it obvious prepare a composition comprising a mixture of GHB salts of at least 50% NaGHB in combination with K.GHB and/or Ca.GHB because the reference claims teach a composition that comprises at least one of NaGHB, K.GHB and Ca.GHB and Allphin teaches GHB salt compositions where Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. The selection of a concentration is an obvious matter of routine optimization within the disclosed percentages of the reference claims or Allphin as the reference claims teach the composition can comprise at least one of the claimed salts and Allphin teaches mixed cation salts and include these percentages within its expressly enumerated embodiments (see Allphin, cols. 10-11).
B. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8,771,735 B2 in view of Allphin et al. (US 8,591,922). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims teach a compressed tablet of sodium oxybate or of another oxybate salt (e.g., potassium oxybate, calcium oxybate, lithium oxybate and magnesium oxybate) comprising 80-95 wt % oxybate salt for oral delivery.
The reference claims do not expressly teach the composition wherein the amount of Na.GHB is at least 50% of the mixture of GHB salts in combination with another GHB salt.
Allphin teaches GHB salt compositions containing Na.GHB, K.GHB, Mg.(GHB)2, and Ca.(GHB)2. See section “6.2.2 Weight/Weight and Molar Equivalents Percents’ bridging columns 10 and 11. Allphin teaches Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%.
A person of ordinary skill in the art (POSA) would have found it obvious prepare a composition comprising a mixture of GHB salts of at least 50% NaGHB in combination with K.GHB and/or Ca.GHB because the reference claims teach a composition that comprises Na.GHB or one that comprises another oxybate salt (e.g., potassium oxybate, calcium oxybate, lithium oxybate and magnesium oxybate) and Allphin teaches GHB salt compositions where Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. The selection of a concentration is an obvious matter of routine optimization within the disclosed percentages of the reference claims or Allphin as the reference claims teach the composition can comprise at least one of the claimed salts and Allphin teaches mixed cation salts and include these percentages within its expressly enumerated embodiments (see Allphin, cols. 10-11).
C. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 8,591,922. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims teach a pharmaceutical composition of gamma-hydroxybutyrate (GHB) comprising a mixture of salts of GHB, wherein the mixture consists of a sodium salt of gamma-hydroxybutyrate (Na.GHB), a potassium salt of gamma-hydroxybutyrate (K.GHB), a magnesium salt of gamma-hydroxybutyrate (Mg.(GHB)2), and a calcium salt of gamma-hydroxybutyrate (Ca.(GHB)2). The amount of Na.GHB can be present at different amount ranges but 35% to 40%.is the highest amount claimed.
The reference claims do not expressly teach the composition wherein the amount of Na.GHB is at least 50% of the mixture of GHB salts.
The specification (which is available as prior art) teaches GHB salt compositions containing Na.GHB, K.GHB, Mg.(GHB)2, and Ca.(GHB)2 and further teach Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. See section “6.2.2 Weight/Weight and Molar Equivalents Percents’ bridging columns 10 and 11.
A person of ordinary skill in the art (POSA) would have found it obvious prepare a composition comprising a mixture of GHB salts of at least 50% NaGHB in combination with K.GHB and/or Ca.GHB because the reference claims teach a composition that comprises a combination of GHB salts including Na.GHB K.GHB, Mg.(GHB)2, and Ca.(GHB)2 and further teaches GHB salt compositions where Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. The selection of a concentration is an obvious matter of routine optimization within the disclosed percentages of the reference claims or Allphin as the reference claims teach the composition can comprise at least one of the claimed salts and Allphin teaches mixed cation salts and include these percentages within its expressly enumerated embodiments (see Allphin, cols. 10-11).
D. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 9,050,302 B2 in view of Allphin et al. (US 8,591,922). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims teach a method for treating narcolepsy with a composition containing a GHB salt.
The reference claims do not expressly teach the composition comprising Na.GHB or wherein the amount of Na.GHB is at least 50% of a mixture of GHB salts in combination with another Ca.(GHB)2 or K.GHB.
Allphin teaches GHB salt compositions containing Na.GHB, K.GHB, Mg.(GHB)2, and Ca.(GHB)2. See section “6.2.2 Weight/Weight and Molar Equivalents Percents’ bridging columns 10 and 11. Allphin teaches Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. The compositions are useful treating narcolepsy. See abstract
A person of ordinary skill in the art (POSA) would have found it obvious prepare a composition comprising a mixture of GHB salts of at least 50% NaGHB in combination with K.GHB and/or Ca.GHB because the reference claims teach a composition that comprises GHB for treating narcolepsy and Allphin teaches GHB salt compositions for treating narcolepsy where Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. The selection of a concentration is an obvious matter of routine optimization within the disclosed percentages of the reference claims or Allphin as the reference claims teach the composition can comprise at least one of the claimed salts and Allphin teaches mixed cation salts and include these percentages within its expressly enumerated embodiments (see Allphin, cols. 10-11). The artisan would have reasonably believed that the mixed a GHB salt composition would provide therapeutic effects for treating narcolepsy.
E. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,132,107 B2 in view of Allphin et al. (US 8,591,922). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims teach an immediate release formulation comprising a pharmaceutically acceptable salt of GHB) mixture of at least three salts of GHB. The GHB salt mixture comprises calcium oxybate, magnesium oxybate, and one or more of sodium oxybate and potassium oxybate. Although the broadest reference claim does not require specific amounts, the Na.GHB may be present at an amount of about 5% to about 40%. wt/wt % in an dependent claim.
The reference claims do not expressly teach the composition wherein the amount of Na.GHB is at least 50% of the mixture of GHB salts.
Allphin teaches GHB salt compositions containing a mixture of GHB salts, e.g., Na.GHB, K.GHB, Mg.(GHB)2, and Ca.(GHB)2. See section “6.2.2 Weight/Weight and Molar Equivalents Percents’ bridging columns 10 and 11. Allphin teaches Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%.
A person of ordinary skill in the art (POSA) would have found it obvious prepare a composition comprising a mixture of GHB salts of at least 50% NaGHB in combination with K.GHB and/or Ca.GHB because the reference claims teach a composition that comprises at least three GHB salts including Mg.GHB, Ca.GHB and Na.GHB or K.GHB and Allphin teaches GHB salt compositions where Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. The selection of a concentration is an obvious matter of routine optimization within the disclosed percentages of the reference claims or Allphin as the reference claims teach the composition can comprise at least one of the claimed salts and Allphin teaches mixed cation salts and include these percentages within its expressly enumerated embodiments (see Allphin, cols. 10-11).
F. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No 8,901,173 B2 in view of Allphin et al. (US 8,591,922). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims teach an immediate release formulation comprising a pharmaceutically acceptable salt of GHB) mixture of at least three salts selected from sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate. Although the broadest reference claim does not require specific amounts, the Na.GHB may be present at an amount of about 35% to about 40% wt/wt % in an dependent claim.
The reference claims do not expressly teach the composition wherein the amount of Na.GHB is at least 50% of the mixture of GHB salts.
Allphin teaches GHB salt compositions containing a mixture of GHB salts, e.g., Na.GHB, K.GHB, Mg.(GHB)2, and Ca.(GHB)2. See section “6.2.2 Weight/Weight and Molar Equivalents Percents’ bridging columns 10 and 11. Allphin teaches Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%.
A person of ordinary skill in the art (POSA) would have found it obvious prepare a composition comprising a mixture of GHB salts of at least 50% Na.GHB in combination with K.GHB and/or Ca.GHB because the reference claims teach a composition that comprises at least three GHB salts including Mg.GHB, Ca.GHB, Na.GHB and K.GHB and Allphin teaches GHB salt compositions where Na.GHB can be present at an amount of about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 100%. The selection of a concentration is an obvious matter of routine optimization within the disclosed percentages of the reference claims or Allphin as the reference claims teach the composition can comprise at least one of the claimed salts and Allphin teaches mixed cation salts and include these percentages within its expressly enumerated embodiments (see Allphin, cols. 10-11).
Conclusion
No claims are allowed.
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CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/ Examiner, Art Unit 1622