DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims included in prosecution are claims 1-12.
Restriction Requirement
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-12, drawn to a formulation of gabapentin.
Group II, claim(s) 13-14, drawn to a unit dosage.
Group III, claim(s) 15, drawn to a method of preparing.
Group IV, claim(s) 16-21, drawn to a method of treating.
Group V, claim(s) 22-24, drawn to a use of a powder formulation.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-V lack unity of invention because even though the inventions of these groups require the technical feature of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kulkarni et al. (US 2004/0072904, Apr. 15, 2004) (hereinafter Kulkarni) in view of Rampoldi et al. (US 2008/0058420, Mar. 6, 2008) (hereinafter Rampoldi).
Kulkarni discloses a two component liquid pharmaceutical composition comprising a first component comprising powder mixture of a GABA analog and a solid polyhydric alcohol and a second component comprising a liquid base (Abstract). Gabapentin has a very bitter taste (¶ [0010]). It is an object of the invention to produce a composition which is stable and has low levels of lactam (¶ [0014]). In a particular aspect, the composition comprises less than 0.5% of the lactam corresponding to the GABA analog (¶ [0028]). Suitable polyhydric alcohols include xylitol, sorbitol, mannitol, and the like (¶ [0030]). Suitable GABA analogs include gabapentin (¶ [0031]). The solid preparations which are intended to be converted, shortly before use, to liquid form preparations for oral administration may contain, in addition to the active component, flavors and natural/artificial sweeteners (satisfies sweetener of claim 1) (¶ [0070]). In Table 2, 9 g of gabapentin were used while sorbitol was used in an amount of 22.5 g (¶ [0094]).
Kulkarni differs from the instant claims insofar as not disclosing wherein the composition comprises erythritol.
However, Rampoldi discloses pharmaceutical compositions comprising gabapentin and a mixture of excipients capable of not promoting the conversion of gabapentin into the corresponding lactamic impurity (Abstract). Suitable excipients for the stable composition include diluting agents such as monosaccharidic sugars like sorbitol, xylitol, mannitol, and erythritol (¶ [0012-0015]). A stable pharmaceutical composition containing gabapentin is one in which the content of the corresponding lactamic impurity does not exceed 0.2% by weight of gabapentin, after being maintained for 3 months at the storage conditions of 25° C with 60% of relative humidity, and/or at 30° C with 65% of relative humidity (¶ [0028]).
It is obvious to replace one component for another equivalent component if it is recognized in the art that the two components are equivalent and is not based on the Applicant disclosure. See MPEP 2144.06. Accordingly, it would have been obvious for one of ordinary skill in the art ordinary skill in the art, prior to the filing of the instant application, to have formulated the composition of Kulkarni to contain erythritol in place of sorbitol because they are taught as equivalents by Rampoldi.
Alternatively, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the composition of Kulkarni to contain erythritol in place of sorbitol motivated by the desire to benefit from the fact that it does not promote the conversion of gabapentin into the corresponding lactamic impurity as taught by Rampoldi.
Regarding the amounts gabapentin and erythritol recited in instant claim 1, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, 9 g of gabapentin were used while sorbitol was used in an amount of 22.5 g. The total amount of both in the powder formulation is 31.5 g, meaning that gabapentin was used in a concentration of about 28.6 wt.% while the sorbitol was used in a concentration of 71.4 wt.%. Accordingly, because the amounts recited in the instant claims overlap with the amounts disclosed by Kulkarni, the amounts disclosed by Kulkarni meet the instantly recited limitations.
Regarding the level of impurities recited in instant claims 1, as noted by (¶ [0029]) of the instant specification, the recited combination results in the lactam impurities being controlled and results in lactam impurities being at the recited levels. As discussed above, the composition of Kulkarni in view of Rampoldi contains substantially the same components where it comprises gabapentin, erythritol, and may further comprise a sweetener. Furthermore, in an aspect of Kulkarni’s invention the composition comprises less than 0.5% of the lactam corresponding to the GABA analog. Accordingly, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Kulkarni in view of Rampoldi would contain the lactam impurities in amounts such as those instantly claimed.
Regarding the amount of sweetener recited in instant claim 1, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, gabapentin has a very bitter taste. Accordingly, amounts of sweetener is a result effective variable, since amounts thereof have a direct impact on the masking of the bitter taste of gabapentin. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of sweetener to yield the desired bitter taste masking.
Regarding claim 1 reciting wherein the composition does not further comprise any additional preservatives, the composition of Kulkarni in view of Rampoldi does not require any additional components such as preservatives. Accordingly, a composition free of preservatives would have been obvious.
In view of this document, the common technical feature linking Groups I-V does not constitute a special technical feature as defined by PCT Rule 13.2, as it does not define a contribution over prior art for the reasons set forth above.
During a telephone conversation with Lisa Mueller on 12/17/25 a provisional election was made without traverse to prosecute the invention of I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 1 is objected to because of the following informalities: “last” in line 7 should be recited as --- least ---. Appropriate correction is required.
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, 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.
1. Claim(s) 1 and 4-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. (US 2004/0072904, Apr. 15, 2004) (hereinafter Kulkarni) in view of Rampoldi et al. (US 2008/0058420, Mar. 6, 2008) (hereinafter Rampoldi).
Kulkarni discloses a two component liquid pharmaceutical composition comprising a first component comprising powder mixture of a GABA analog and a solid polyhydric alcohol and a second component comprising a liquid base (Abstract). Gabapentin has a very bitter taste (¶ [0010]). It is an object of the invention to produce a composition which is stable and has low levels of lactam (¶ [0014]). In a particular aspect, the composition comprises less than 0.5% of the lactam corresponding to the GABA analog (¶ [0028]). Suitable polyhydric alcohols include xylitol, sorbitol, mannitol, and the like (¶ [0030]). Suitable GABA analogs include gabapentin (¶ [0031]). The solid preparations which are intended to be converted, shortly before use, to liquid form preparations for oral administration may contain, in addition to the active component, flavors and natural/artificial sweeteners (satisfies sweetener of claim 1 and flavoring agent of claim 4) (¶ [0070]). In Table 2, 9 g of gabapentin were used while sorbitol was used in an amount of 22.5 g (¶ [0094]).
Kulkarni differs from the instant claims insofar as not disclosing wherein the composition comprises erythritol.
However, Rampoldi discloses pharmaceutical compositions comprising gabapentin and a mixture of excipients capable of not promoting the conversion of gabapentin into the corresponding lactamic impurity (Abstract). Suitable excipients for the stable composition include diluting agents such as monosaccharidic sugars like sorbitol, xylitol, mannitol, and erythritol (¶ [0012-0015]). A stable pharmaceutical composition containing gabapentin is one in
which the content of the corresponding lactamic impurity does not exceed 0.2% by weight of gabapentin, after being maintained for 3 months at the storage conditions of 25° C with 60% of relative humidity, and/or at 30° C with 65% of relative humidity (¶ [0028]).
It is obvious to replace one component for another equivalent component
if it is recognized in the art that the two components are equivalent and is not based on the
Applicant disclosure. See MPEP 2144.06. Accordingly, it would have been obvious for one of
ordinary skill in the art, prior to the filing of the instant application, to have formulated
the composition of Kulkarni to contain erythritol in place of sorbitol because they are taught as
equivalents by Rampoldi.
Alternatively, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the composition of Kulkarni to contain erythritol in place of sorbitol motivated by the desire to benefit from the fact that it does not promote the conversion of gabapentin into the corresponding lactamic impurity as taught by Rampoldi.
Regarding the amounts gabapentin and erythritol recited in instant claim 1, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, 9 g of gabapentin were used while sorbitol was used in an amount of 22.5 g. The total amount of both in the powder formulation is 31.5 g, meaning that gabapentin was used in a concentration of about 28.6 wt.% while the sorbitol was used in a concentration of 71.4 wt.%. Since, erythritol may be used as an equivalent to sorbitol, as disclosed Rampoldi, it would have been obvious to have used erythritol in substantially the same amount as sorbitol when used in the composition of Kulkarni. Accordingly, because the amounts recited in the instant claims overlap with the amounts disclosed by Kulkarni, the amounts disclosed by Kulkarni meet the instantly recited limitations.
Regarding the level of impurities recited in instant claims 1 and 6-10, as noted by (¶ [0029]) of the instant specification, the recited combination results in the lactam impurities being controlled and results in lactam impurities being at the recited levels. As discussed above, the composition of Kulkarni in view of Rampoldi contains substantially the same components where it comprises gabapentin, erythritol, and may further comprise a sweetener. Furthermore, in an aspect of Kulkarni’s invention the composition comprises less than 0.5% of the lactam corresponding to the GABA analog. Accordingly, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Kulkarni in view of Rampoldi would contain the lactam impurities in amounts such as those instantly claimed.
Regarding the amount of sweetener recited in instant claim 1 and the amount of flavoring agent recited in instant claim 5, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, gabapentin has a very bitter taste. Accordingly, amounts of sweeteners and flavoring agents are a result effective variable, since amounts thereof have a direct impact on the masking of the bitter taste of gabapentin. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of sweetener and flavoring agent to yield the desired bitter taste masking.
Regarding claim 1 reciting wherein the composition does not further comprise any
additional preservatives, the composition of Kulkarni in view of Rampoldi does not require any additional components such as preservatives. Accordingly, a composition free of preservatives would have been obvious.
Regarding the dissolution times recited in instant claims 11-12, the composition of Kulkarni in view of Rampoldi contains substantially the same components where it comprises gabapentin, erythritol, and may further comprise a sweetener. Furthermore, in an example, the actives claimed were used in amounts/concentrations that overlap with those instantly claimed. Accordingly, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Kulkarni in view of Rampoldi would exhibit dissolution times such as the ones instantly claimed.
Therefore, the combined teachings of Kulkarni and Rampoldi render obvious claims 1 and 4-12.
2. Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. (US 2004/0072904, Apr. 15, 2004) (hereinafter Kulkarni) in view of Rampoldi et al. (US 2008/0058420, Mar. 6, 2008) (hereinafter Rampoldi) and further in view of Yi et al. (WO 2016/190638, Dec. 1, 2016) (hereinafter Yi).
The teachings of Kulkarni and Rampoldi are discussed above.
The combined teachings of Kulkarni and Rampoldi differ from the instant claims insofar as not explicitly disclosing wherein the sweetener used is acesulfame potassium and saccharin sodium.
However, Yi teaches a composition comprising carisbamate and gabapentin (Abstract). The composition may comprise pharmaceutically acceptable carriers such as sweeteners (Pg. 8-9). Suitable sweeteners include sodium saccharin, acesulfame potassium, and mixtures thereof (Pg. 9). The composition may be in the form of a powder (Pg. 9).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Kulkarni in view of Rampoldi discloses wherein the composition may comprise sweeteners. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Kulkarni in view of Rampoldi to comprise sodium saccharin and acesulfame potassium, since they are known sweeteners for use in compositions comprising gabapentin as taught by Yi.
Therefore, the combined teachings of Kulkarni, Rampoldi, and Yi render obvious claims 2-3.
Conclusion
Claims 1-12 are rejected.
Claims 13-24 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612