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 1-3.
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) 1-3, drawn to a pharmaceutical composition.
Group II, claim(s) 4, drawn to a method for relieving opioid withdrawal comprising administering a composition.
Group III, claim(s) 5-8, drawn to a pharmaceutical dosage form.
Group IV, claim(s) 9, drawn to a method for preparing a pharmaceutical dosage form.
Group V, claim(s) 10, drawn to a method for relieving opioid withdrawal comprising administering a dosage form.
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:
Group 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 Gurses et al. (CAN J ANESTH; 2003; 50:2; pp 147–152) (hereinafter Gurses) as evidenced by Edgren et al. (US 2005/0260264, Nov. 24, 2005) (hereinafter Edgren).
Gurses conducted a study with the purpose of comparing tramadol alone and the combinations of either tramadol-clonidine or tramadol-droperidol with regard to analgesic and adverse effects (Abstract). Group III received an epidural injection containing 75 mg tramadol plus 150 μg clonidine (Pg. 149, Col. 1).
Regarding the ratio recited in instant claim, the specific amounts of tramadol and clonidine disclosed by Gurses result in a clonidine to tramadol ratio of 0.1:50, thereby meeting the instantly recited limitation.
Regarding the instant claims reciting clonidine hydrochloride and tramadol chloride, as evidenced by Edgren, HCL salts of drugs such as tramadol HCL are by far the most common salt forms that are commercially available (¶ [0110]).
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 Alex Nie on 1/5/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-3. Affirmation of this election must be made by applicant in replying to this Office action. Claims 4-10 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Joint Inventors
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).
Rejoinder
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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gurses et al. (CAN J ANESTH; 2003; 50:2; pp 147–152) (hereinafter Gurses) as evidenced by Edgren et al. (US 2005/0260264, Nov. 24, 2005) (hereinafter Edgren).
Gurses conducted a study with the purpose of comparing tramadol alone and the combinations of either tramadol-clonidine or tramadol-droperidol with regard to analgesic and adverse effects (Abstract). Group III received an epidural injection containing 75 mg tramadol plus 150 μg clonidine (Pg. 149, Col. 1).
Regarding the ratio recited in instant claim, the specific amounts of tramadol and clonidine disclosed by Gurses result in a clonidine to tramadol ratio of 0.1:50, thereby meeting the instantly recited limitation.
Regarding the instant claims reciting clonidine hydrochloride and tramadol chloride, as evidenced by Edgren, HCL salts of drugs such as tramadol HCL are by far the most common salt forms that are commercially available (¶ [0110]).
The prior art anticipates the instant claims where it discloses a composition comprising tramadol and clonidine present together in a mass ratio of 0.1:50.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gurses et al. (CAN J ANESTH; 2003; 50:2; pp 147–152) (hereinafter Gurses) in view of Edgren et al. (US 2005/0260264, Nov. 24, 2005) (hereinafter Edgren).
Gurses conducted a study with the purpose of comparing tramadol alone and the combinations of either tramadol-clonidine or tramadol-droperidol with regard to analgesic and adverse effects (Abstract). Group III received an epidural injection containing 75 mg tramadol plus 150 μg clonidine (Pg. 149, Col. 1).
It is believed that Gurses anticipates the instant claims. However, purely arguendo and for the purposes of this rejection, Gurses differs from the instant claims insofar as not explicitly disclosing wherein the tramadol/clonidine included is in hydrochloride form. However, Edgren discloses that HCL salts of drugs such as tramadol HCL are by far the most common salt forms that are commercially available (¶ [0110]).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have formulated the composition of Gurses to comprise tramadol/clonidine in their HCL salt form since these are the most common salt forms that are commercially available as taught by Edgren.
Regarding the ratio recited in instant claim, 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, Gurses’s injection contained 75 mg tramadol plus 150 μg clonidine. This results in a clonidine to tramadol ratio of 0.1:50. Accordingly, because the ratio recited in the instant claims overlaps with the values disclosed by Gurses, the values disclosed by Gurses meet the instantly recited limitation.
2. Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (CN 103495172, Aug. 1, 2014) (hereinafter Lu) in view of Edgren et al. (US 2005/0260264, Nov. 24, 2005) (hereinafter Edgren).
Lu discloses a medicament for treating amphetamine type stimulant dependency and mixed dependency of amphetamine type stimulants and opiates substances comprising by weight percent: 2-95% of antipsychotics, 0.001-5% of α2 adrenergic agonists, 0-5% of anticholinergic agent, 0-80% of nonopioid analgesic, and 0-10% of benzodiazepine (Abstract). Suitable α2 adrenergic agonists include clonidine (Summary of the Invention). Suitable nonopioid analgesics include tramadol (Summary of the Invention).
Lu differs from the instant claims insofar as not explicitly disclosing wherein the tramadol/clonidine included is in hydrochloride form. However, Edgren discloses that HCL salts of drugs such as tramadol HCL are by far the most common salt forms that are commercially available (¶ [0110]).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have formulated the composition of Lu to comprise tramadol/clonidine in their HCL salt form since these are the most common salt forms that are commercially available as taught by Edgren.
In regards to the specific ratio of the instant claims, 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, α2 adrenergic agonists such as clonidine are included in the medicament in an amount of 0.001-5% and nonopioid analgesics such as tramadol are included in an amount of up to 80% by weight. Accordingly, the claimed ratio would have been obvious from one of ordinary skill in the art selecting an amount of clonidine and an amount of tramadol from the aforementioned ranges and such ratio overlapping with the claimed ratio.
Regarding the concentrations recited in instant claims 2-3, 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, α2 adrenergic agonists such as clonidine are included in the medicament in an amount of 0.001-5% and nonopioid analgesics such as tramadol are included in an amount of up to 80% by weight. Accordingly, the claimed concentrations would have been obvious since when combined the two components can be included an amount that collectively overlaps with the claimed ranges.
Therefore, the teachings of Lu render obvious claims 1-3.
Conclusion
Claims 1-3 are rejected.
Claims 4-10 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.
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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.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612