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
This action is in response to papers filed May 1, 2026. Applicant’s reply to the restriction/election requirement of March 11, 2026 has been entered. Claims 1-55 are pending in the application.
Priority
Applicant’s claim for the benefit as a continuation-in-part (CIP) of prior-filed U.S. Patent Application No. 17/156,053, filed January 22, 2021, which claims the benefit as a continuation of prior-filed U.S. Patent Application No. 16/223,940, filed December 18, 2018, which claims the benefit of prior-filed U.S. Provisional Patent Application Nos. 62/607,937 and 62/618,832, filed December 20, 2017 and January 18, 2018, respectively, under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant’s elections of i) “amount of gamma-butyrolactone” as the species of comparative parameter employed as an index of stability in the packaged formulation, ii) “xanthan gum” as the species of suspending/viscosifying agent, iii) “malic acid” as the species of acidifying agent, iv) “7.5 g” as the species of amount of sodium oxybate to which the amount of gamma-hydroxybutyrate is equivalent, and v) “6.8” as the species of pH at which the gamma-hydroxybutyrate dissolution rate at 25C and 60-75% RH is determined after at least 72 months of storage are all acknowledged. The Examiner has determined that claims 14-26 read on the elected subject matter.
Accordingly, claims 1-13 and 27-55 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Election was made without traverse in the reply filed on May 1, 2026. Claims 14-26 are currently under examination.
Abstract
The abstract of the disclosure is objected to for the following reasons:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract merely informs the reader about gamma-hydroxybutyrate formulations, and “uses” thereof, which are certainly not new to the art at all. If Applicant has a new gamma-hydroxybutyrate formulation, the abstract should recite the key requisite ingredients. If Applicant has a new method of “use” for a gamma-hydroxybutyrate formulation, the abstract should recite the key requisite active steps.
3. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. However, this is precisely what the abstract does.
4. The abstract recites awkward and incongruous phrases, such as “for up to at least”.
***Applicant is advised that the abstract should inform the reader of the key technical aspects of what the physical invention actually is, e.g. a composition comprising A, B, C, and D. The abstract is not intended to be a promotional advertisement for the product.
Correction is required. See MPEP § 608.01(b).
Claim Objections
Claim 24 is objected to because of the following:
1. Claim 24 is in awkward and improper Markush format. A Markush claim should have the general format “selected from the group consisting of A, B, C, D, and E”, not “selected from the group consisting of A, mixtures of B and C, D, mixtures of E and F, G, and mixtures thereof”. In other words, by specifying “and mixtures thereof” as a constituent of the Markush claim, each and every mixture is thus covered. Reciting specific mixtures beforehand is redundant.
Appropriate correction is required.
Obviousness-Type Double Patenting (I - VIII)
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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
I. Claims 14-23 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 27-46, 58-66, 69-81 of U.S. Patent No. 10,272,062 in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300).
Applicant’s elected subject matter is directed to a pharmaceutical composition in a package, the pharmaceutical composition comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the said composition can exhibit the properties recited.
***In light of the specification, the package is recognized as having a water vapor transmission rate less than 7 mg/liter/day.
Claims 1-15, 27-46, 58-66, 69-81 of U.S. Patent No. 10,272,062 discloses a once-nightly pharmaceutical composition comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising a core comprising gamma-hydroxybutyrate and 10-50 wt% of a coating comprising hydrophobic compound (e.g.hydrogenated vegetable oil) with a mixture of methacrylic acid copolymers (e.g. acid-ethyl acrylate copolymer and methacrylic acid-methyl methacrylate copolymer (1:2)) in a weight ratio of 0.4 to 4.
Mogna disclose a package that can be in the form of e.g. an aluminum foil sachet for holding and protecting e.g. pharmaceuticals, which package is composed of two or more layers of aluminum, each layer being 20 microns thick, and which is impermeable to water vapor and oxygen, with the water vapor transmission rate being less than 1 g/m3/24 hours (i.e. precisely equivalent to less than 1 mg/L/day) (abstract; paragraphs 0001, 0002, 0008, 00130015, 00160023. 0028, 0048-0050, 0055, 0057, 0058, 0060, 0061, 0066, 0067, 0070, 0073, 0075).
Claims 1-15, 27-46, 58-66, 69-81 of U.S. Patent No. 10,272,062 discloses a pharmaceutical composition comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising a core comprising gamma-hydroxybutyrate and 10-50 wt% of a coating comprising hydrophobic compound (e.g.hydrogenated vegetable oil) with a mixture of methacrylic acid copolymers (e.g. acid-ethyl acrylate copolymer and methacrylic acid-methyl methacrylate copolymer (1:2)) in a weight ratio of 0.4 to 4; wherein the pharmaceutical composition further comprises 1.2-15 wt% malic acid and 1-15 wt% of the mixture of xanthan gum, carrageenan gum, and hydroxyethylcellulose; wherein the pharmaceutical composition comprises 4.5, 6.0, 7.5, or 9.0 g of gamma-hydroxybutyrate present in a weight ratio of 10/90 to 65/35 in the immediate-release and modified-release components. Since Mogna discloses that pharmaceuticals susceptible to water vapor or oxygen can be protected by storing the pharmaceutical in a package that can be in the form of e.g. a sachet composed of two or more layers of aluminum which is impermeable to water vapor and oxygen, with the water vapor transmission rate being less than 1 g/m3/24 hours (i.e. precisely equivalent to less than 1 mg/L/day); one of ordinary skill in the art would thus be motivated to package the pharmaceutical composition in Mogna’s aluminum sachet, with the reasonable expectation that the resulting packaged pharmaceutical composition will be well protected from water vapor and oxygen, to thus prevent leakage of the gamma-hydroxybutyrate and other undesired chemical processes from occurring that would spoil the composition.
One of ordinary skill in the art is thus lead to the claimed packaged pharmaceutical composition. Since the composition is the same, the properties must necessarily be the same as well. Hence, the packaged pharmaceutical composition one of ordinary skill in the art would thus arrive at as just described would thus have the stability properties recited.
II. Claims 14-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-52 of U.S. Patent No. 10,736,866, in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300).
Applicant’s elected subject matter is directed to a pharmaceutical composition in a package, the pharmaceutical composition comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the composition further comprises a suspending/viscosifying agent, e.g. xanthan gum, in the amount of 1-15 wt%, and an acidifying agent, e.g. malic acid, in the amount of 1.2-15 wt%; wherein the suspending/viscosifying agent and the acidifying agent are separate and distinct from the immediate release portion and the modified release portion; wherein the amount of gamma-hydroxybutyrate is “equivalent to” 7.5 g; and wherein the said composition can exhibit the properties recited.
Claims 1-52 of U.S. Patent No. 10,736,866 disclose a formulation comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the composition further comprises a suspending/viscosifying agent, e.g. xanthan gum, in the amount of 1-15 wt%, and an acidifying agent, e.g. malic acid, in the amount of 1.2-15 wt%; wherein the suspending/viscosifying agent and the acidifying agent are separate and distinct from the immediate release portion and the modified release portion; and wherein the amount of gamma-hydroxybutyrate is “equivalent to” 7.5 g
Mogna disclose a package that can be in the form of e.g. an aluminum foil sachet for holding and protecting e.g. pharmaceuticals, which package is composed of two or more layers of aluminum, each layer being 20 microns thick, and which is impermeable to water vapor and oxygen, with the water vapor transmission rate being less than 1 g/m3/24 hours (i.e. precisely equivalent to less than 1 mg/L/day) (abstract; paragraphs 0001, 0002, 0008, 00130015, 00160023. 0028, 0048-0050, 0055, 0057, 0058, 0060, 0061, 0066, 0067, 0070, 0073, 0075).
Claims 1-52 of U.S. Patent No. 10,736,866 disclose a formulation comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the composition further comprises a suspending/viscosifying agent, e.g. xanthan gum, in the amount of 1-15 wt%, and an acidifying agent, e.g. malic acid, in the amount of 1.2-15 wt%; wherein the suspending/viscosifying agent and the acidifying agent are separate and distinct from the immediate release portion and the modified release portion; and wherein the amount of gamma-hydroxybutyrate is “equivalent to” 7.5 g. The compound gamma-hydroxybutyrate is well known in the art to be susceptible to moisture. Since Mogna discloses that pharmaceuticals susceptible to water vapor or oxygen can be protected by storing the pharmaceutical in a package that can be in the form of e.g. a sachet composed of two or more layers of aluminum which is impermeable to water vapor and oxygen, with the water vapor transmission rate being less than 1 g/m3/24 hours (i.e. precisely equivalent to less than 1 mg/L/day); one of ordinary skill in the art would thus be motivated to package the pharmaceutical composition in Mogna’s aluminum sachet, with the reasonable expectation that the resulting packaged pharmaceutical composition will be well protected from water vapor and oxygen, to thus prevent leakage of the gamma-hydroxybutyrate and other undesired chemical processes from occurring that would spoil the composition.
Mogna discloses that regardless of the specific decay mechanism underlying a pharmaceutical material’s susceptibility to moisture, it is certain that a series of detrimental cascading events will unfold leading to the decay of a moisture-susceptible material at a relative humidity above 60% (see paragraph 0063). Moreover, anyone of ordinary skill in the art would certainly know that the ambient indoor relative humidity of nearly all climate-controlled buildings, including a typical medical laboratory or processing facility, is about 30-60%. Since Mogna discloses that the moisture-susceptible medicines should certainly not be exposed to a relative humidity of above 60%, but otherwise don’t specify any critical relative humidity at which they are packaged, it can reasonably be presumed that Mogna packages the pharmaceutical under typical, ambient conditions in a climate-controlled indoor facility with a relative humidity of 30-60%.
One of ordinary skill in the art is thus lead to the claimed packaged pharmaceutical composition. Since the composition is the same, the properties must necessarily be the same as well. Hence, the packaged pharmaceutical composition one of ordinary skill in the art would thus arrive at as just described would thus have the various stability properties recited.
III. Claims 14-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,896,572 in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300).
Applicant’s elected subject matter is directed to a pharmaceutical composition in a package, the pharmaceutical composition comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the composition further comprises a suspending/viscosifying agent, e.g. xanthan gum, in the amount of 1-15 wt%, and an acidifying agent, e.g. malic acid, in the amount of 1.2-15 wt%; wherein the suspending/viscosifying agent and the acidifying agent are separate and distinct from the immediate release portion and the modified release portion; wherein the amount of gamma-hydroxybutyrate is “equivalent to” 7.5 g; and wherein the said composition can exhibit the properties recited.
Claim 1 of U.S. Patent No. 11,896,572 disclose a formulation comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the composition further comprises a suspending/viscosifying agent, e.g. xanthan gum, in the amount of 2-5 wt%, and an acidifying agent, e.g. malic acid, in the amount of 1.2-5 wt%; wherein the suspending/viscosifying agent and the acidifying agent are separate and distinct from the immediate release portion and the modified release portion; and wherein the amount of gamma-hydroxybutyrate is 3-12 g
Mogna disclose a package that can be in the form of e.g. an aluminum foil sachet for holding and protecting e.g. pharmaceuticals, which package is composed of two or more layers of aluminum, each layer being 20 microns thick, and which is impermeable to water vapor and oxygen, with the water vapor transmission rate being less than 1 g/m3/24 hours (i.e. precisely equivalent to less than 1 mg/L/day) (abstract; paragraphs 0001, 0002, 0008, 00130015, 00160023. 0028, 0048-0050, 0055, 0057, 0058, 0060, 0061, 0066, 0067, 0070, 0073, 0075).
Claim 1 of U.S. Patent No. 11,896,572 disclose a formulation comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the composition further comprises a suspending/viscosifying agent, e.g. xanthan gum, in the amount of 2-5 wt%, and an acidifying agent, e.g. malic acid, in the amount of 1.2-5 wt%; wherein the suspending/viscosifying agent and the acidifying agent are separate and distinct from the immediate release portion and the modified release portion; and wherein the amount of gamma-hydroxybutyrate is 3-12 g. The compound gamma-hydroxybutyrate is well known in the art to be susceptible to moisture. Since Mogna discloses that pharmaceuticals susceptible to water vapor or oxygen can be protected by storing the pharmaceutical in a package that can be in the form of e.g. a sachet composed of two or more layers of aluminum which is impermeable to water vapor and oxygen, with the water vapor transmission rate being less than 1 g/m3/24 hours (i.e. precisely equivalent to less than 1 mg/L/day); one of ordinary skill in the art would thus be motivated to package the pharmaceutical composition in Mogna’s aluminum sachet, with the reasonable expectation that the resulting packaged pharmaceutical composition will be well protected from water vapor and oxygen, to thus prevent leakage of the gamma-hydroxybutyrate and other undesired chemical processes from occurring that would spoil the composition.
Mogna discloses that regardless of the specific decay mechanism underlying a pharmaceutical material’s susceptibility to moisture, it is certain that a series of detrimental cascading events will unfold leading to the decay of a moisture-susceptible material at a relative humidity above 60% (see paragraph 0063). Moreover, anyone of ordinary skill in the art would certainly know that the ambient indoor relative humidity of nearly all climate-controlled buildings, including a typical medical laboratory or processing facility, is about 30-60%. Since Mogna discloses that the moisture-susceptible medicines should certainly not be exposed to a relative humidity of above 60%, but otherwise don’t specify any critical relative humidity at which they are packaged, it can reasonably be presumed that Mogna packages the pharmaceutical under typical, ambient conditions in a climate-controlled indoor facility with a relative humidity of 30-60%.
One of ordinary skill in the art is thus lead to the claimed packaged pharmaceutical composition. Since the composition is the same, the properties must necessarily be the same as well. Hence, the packaged pharmaceutical composition one of ordinary skill in the art would thus arrive at as just described would thus have the various stability properties recited.
IV, V, VI, VII, and VIII: Similar rejections are made over claims 1-25 of U.S. Patent No. 11,504,347 in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300); claims 1-30 of U.S. Patent No. 12,097,175, in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300); claims 1-26 of U.S. Patent No. 12,115,143, in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300); claims 1-29 of U.S. Patent No. 12,115,145, in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300); and claims 1-23 of U.S. Patent No. 12/144,793, in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300).
Claim Rejections - 35 USC § 112(b)
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.
Claim 14-26 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.
Claim 14 is indefinite for the following reasons:
1. Claim 14 is directed to a pharmaceutical formulation “stored within a package” then later stipulates that the pharmaceutical formulation is “stored for up to at least 72 months at 25-40C and 60-75% relative humidity”, which renders the claim indefinite. One of ordinary skill in the art cannot definitively ascertain whether the “package” is a requisite component of the claimed composition, or rather whether the package is merely the storage medium in which the composition is, or could be, contained for “up to at least 72 months”. Moreover, one of ordinary skill in the art cannot definitively ascertain whether or not the recited storage conditions, i.e. 25-40C and 60-75% relative humidity, are the requisite conditions inside the package or outside the package in which the formulation is contained.
***For examination at this time, the claim is being interpreted as the package is a requisite element of the claimed product, and that the recited storage conditions exist outside the package in which the formulation is contained.
2. Claim 14 stipulates in a wherein clause that less than 0.18% w/w gamma-butyrolactone is present…after the pharmaceutical formulation has been stored “for up to at least 72 months”. The expression “for up to at least 72 months” is awkward and incongruous, i.e. “for up to” denotes a maximum or ceiling, while “for at least” denotes a minimum or floor. Hence, one of ordinary skill in the art cannot definitively ascertain if “for up to at least 72 months” stipulates that 72 months is the maximum or is the minimum, and in the case of “for up to 72 months”, whether or not the limitation includes 72 months itself. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
***For examination at this time, the limitation is being interpreted as intending to mean “at least 72 months”.
Claim 24 recites the limitation “medium viscosity” with respect to sodium carboxymethyl cellulose, hydroxyethyl cellulose, and hydroxypropylmethyl cellulose, which is an arbitrary, subjective and relative criterion not defined by the claim. One of ordinary skill in the art cannot definitively ascertain what viscosity constitutes a “medium viscosity” and what viscosity is not a “medium viscosity”, and thus one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 26, which depends from claim 14, stipulates in a wherein clause that “the amount of gamma-hydroxybutyrate is equivalent to 4.5 g, 6.0 g, 7.5 g, or 9 g of sodium oxybate”, which renders the claim indefinite for the following reasons:
1. First, regarding “the amount of gamma-hydroxybutyrate”, claim 14 provides for an immediate-release portion comprising gamma-hydroxybutyrate or a salt thereof, and a modified release portion comprising gamma-hydroxybutyrate or a salt thereof. Then the claim appears to provide for a total amount of gamma-hydroxybutyrate or a salt thereof in the formulation at some start time (t=0) and at some time in the future (which is not definitively defined) when presumably some fraction of the gamma-hydroxybutyrate has been converted to gamma-butyrolactone. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “the amount of gamma-hydroxybutyrate” being referenced, e.g. the amount in the immediate release portion, or the amount in the modified release portion, or the total amount in the formulation as a whole at time t=0, or the total amount in the formulation at the later time, after some fraction of the gamma- hydroxybutyrate has been converted to gamma-butyrolactone, or what?
2. Regarding the stipulation that the amount of gamma-hydroxybutyrate or a salt thereof “is equivalent to” the recited amounts of sodium oxybate, one of ordinary skill in the art cannot make heads or tails out of this limitation at all. First, sodium oxybate is the sodium salt of gamma-hydroxybutyrate, which is provided for in claim 14, i.e. “gamma-hydroxybutyrate or a salt thereof” includes sodium gamma-hydroxybutyrate. Hence, one of ordinary skill in the art cannot definitively ascertain whether claim 26 limits the “gamma-hydroxybutyrate or a salt thereof” to “sodium oxybate”, or, alternatively, whether claim 26 excludes the “gamma-hydroxybutyrate or a salt thereof” compound from being “sodium oxybate”, or what? Second, the phrase “is equivalent to” is not defined by the claim, appears to be an arbitrary and subjective criterion, and one of ordinary skill in the art cannot definitively ascertain in what manner and to what extent “is equivalent to” is assessed and determined, and thus the metes and bounds of the limitation. For example, is 4.23 g of the sodium salt of gamma-hydroxybutyrate “equivalent to” 4.5 g of sodium oxybate? What about 6.0 g of sodium oxybate?
3. One of ordinary skill in the art cannot definitively ascertain whether claim 26 necessarily limits the claimed formulation to containing these specific amounts of gamma-hydroxybutyrate, or rather this limitation is merely intended to be based on some sort of comparative and undefined pharmacokinetics parameter(s) of the claimed formulation compared to pure sodium oxybate, or what?
Claims 15-26 are (also) indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15-23, each of which depends from claim 14, stipulates that the formulation is stored under the same requisite temperature and relative humidity conditions for various times, e.g. up to 72 months, up to 60 months, up to 48 months, up to 36 months, up to 24 months, up to 18 months, up to 12 months, up to 6 months, and up to 3 months, respectively. However, claim 14 provides that the storage time under these temperature and relative humidity conditions should be for at least 72 months. Hence, claims 15-23 appear to be broader in scope than claim 14 from which they depend, or fail to include all the limitations of the claim upon which it depends.
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.
Claims 14-23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al. (U.S. Patent Application Pub. No. 2006/0210630), in view of Mogna (U.S. Patent Application Pub. No. 2014/0231300).
Applicant Claims
Applicant’s elected subject matter is directed to a pharmaceutical composition in a package, the pharmaceutical composition comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the said composition can exhibit the stability properties recited.
***In light of the specification, the package is recognized as having a water vapor transmission rate less than 7 mg/liter/day.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Liang et al. disclose a pharmaceutical composition for once-nightly administration to e.g. a human for treating narcolepsy comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate; wherein the gamma-hydroxybutyrate daily dose for treating narcolepsy is e.g. 4.5-9 g (abstract; paragraphs 0001, 0005, 0026, 0027, 0032, 0039, 0040, 0047, 0051, 0052, 0054-0058, 0060, 0061, 0067, 0068, 0075, 0076, 0080, 0082, 0083, 0085, 0086; examples; claim 56).
Mogna discloses a package that can be in the form of e.g. an aluminum foil sachet for holding and protecting e.g. pharmaceuticals, which package is composed of two or more layers of aluminum, each layer being 20 microns thick, and which is impermeable to water vapor and oxygen, with the water vapor transmission rate being less than 1 g/m3/24 hours (i.e. precisely equivalent to less than 1 mg/L/day) (abstract; paragraphs 0001, 0002, 0008, 00130015, 00160023. 0028, 0048-0050, 0055, 0057, 0058, 0060, 0061, 0066, 0067, 0070, 0073, 0075).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Liang et al. do not explicitly disclose that the pharmaceutical composition is in a package with a water vapor transmission rate of less than 7 mg/L/day. This deficiency is cured by the teachings of Mogna.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Liang et al. and Mogna, outlined supra, to devise Applicant’s claimed packaged composition.
Liang et al. disclose a pharmaceutical composition comprising i) an immediate-release component comprising gamma-hydroxybutyrate, and ii) a modified-release component comprising gamma-hydroxybutyrate, and further disclose that gamma-hydroxybutyrate is highly water-soluble and hygroscopic, and that this high water-solubility likely leads to drug migration into the coating layer over time to form pores upon exposure to water or moisture, thus allowing leakage of the drug (see paragraph 0005). Since Mogna discloses that pharmaceuticals susceptible to water vapor or oxygen can be protected by storing the pharmaceutical in a package that can be in the form of e.g. a sachet composed of two or more layers of aluminum foil which is impermeable to water vapor and oxygen, with the water vapor transmission rate being less than 1 g/m3/24 hours (i.e. precisely equivalent to less than 1 mg/L/day); one of ordinary skill in the art would thus be motivated to package the Liang et al. pharmaceutical composition in Mogna’s aluminum sachet, with the reasonable expectation that the resulting packaged pharmaceutical composition will be well protected from water vapor and oxygen over time, to thus prevent leakage of the gamma-hydroxybutyrate and other undesired chemical processes from occurring that would spoil the composition over time (i.e. to extend the shelf life of the product).
The cited prior art would thus lead one of ordinary skill in the art to the claimed packaged pharmaceutical composition. Since the composition is the same, the properties must necessarily be the same as well, even if the cited prior art does not expressly disclose these properties. Hence, the packaged pharmaceutical composition one of ordinary skill in the art would thus arrive at by following the cited prior art as just described would thus have the various stability properties recited.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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