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 .
Status of the Claims
Claims 1-16 are pending in the instant application and subject to examination herein.
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.
Claims 1-16 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 1 is drawn to a method of treatment of nicotine dependence, and recites the limitation "the composition" in regard to an amount of 6-methylnicotine to be “used” the method claimed therein. There is insufficient antecedent basis for this limitation in the claim, as the claim does not define any composition and does not depend from any other claim that claims a composition.
Claims 1-2, 7 and 12 are each drawn to a method of treating nicotine dependence; however, these claims are indefinite because none of the claims define a population of patient(s) to be treated. A person of ordinary skill in the art would not understand the metes and bounds of the claims because it is unclear for whom the method(s) are intended. Additionally, none of these claims provides any step(s) to be performed: the claims are drawn to “using” the compound 6-methylnicotine1 (claims 1 and 12) or a composition (claim 2) or pharmaceutical composition thereof (claim 7). These claims are indefinite because none of these claims define how the compound, composition thereof, or pharmaceutical composition thereof, is to be used. A person of ordinary skill in the art would not know whether the “use” of the compound, composition, or pharmaceutical composition corresponds to being administered, used in the manufacture of a medicament, or some other use. Claims 3-6 depend from claim 2 and do not resolve the indefiniteness of claim 2. Claims 8-11 depend from claim 7 and do not resolve the indefiniteness of claim 7.
Claim 4 further limits the method of claim 2 regarding the “use” of a pharmaceutical composition comprising 6-methylnicotine to wherein the composition is further defined by regard to a Markush group; however, the claim is indefinite because the claim is ambiguous as to whether the composition must be selected from the Markush group or the Markush group is a non-limiting list of exemplary compositions, because the claim states that the pharmaceutical composition is “selected from such as” before listing the elements of the group. If the pharmaceutical composition must be selected from the group, then the term “such as” does not fit in the claim; alternatively, if the term “such as” is meant to be used, then it is not clear whether the composition is limited to the listed elements. For purpose of examination, the claim will be interpreted as requiring that the composition is “selected from” the Markush group.
Claim 5 further limits the method of claim 2 regarding the “use” of a pharmaceutical composition comprising 6-methylnicotine to wherein the composition is further defined by regard to a Markush group of excipients; however, the claim is indefinite because the claim is ambiguous as to whether the excipient must be selected from the Markush group or the Markush group is a non-limiting list of exemplary excipients, because the claim states that the excipients are “selected from such as at least one” before listing the elements of the group. If the excipient must be selected from the group, then the term “such as” does not fit in the claim; alternatively, if the term “such as” is meant to be used, then it is not clear whether the composition is limited to the listed elements. Additionally, it is not clear whether the term “at least one” is meant to modify “selected from” or “such as”. For purpose of examination, the claim will be interpreted as requiring that the excipient is “selected from” the Markush group.
Claim 9 further limits the method of claim 7 regarding the “use” of a composition comprising 6-methylnicotine to wherein the composition is further defined by regard to a Markush group; however, the claim is indefinite because the claim is ambiguous as to whether the composition must be selected from the Markush group or the Markush group is a non-limiting list of exemplary compositions, because the claim states that the composition is “selected from such as” before listing the elements of the group. If the composition must be selected from the group, then the term “such as” does not fit in the claim; alternatively, if the term “such as” is meant to be used, then it is not clear whether the composition is limited to the listed elements. For purpose of examination, the claim will be interpreted as requiring that the composition is “selected from” the Markush group.
Claim 10 further limits the method of claim 7 regarding the “use” of a composition comprising 6-methylnicotine to wherein the composition is further defined by regard to a Markush group of excipients; however, the claim is indefinite because the claim is ambiguous as to whether the excipient must be selected from the Markush group or the Markush group is a non-limiting list of exemplary excipients, because the claim states that the excipients are “selected from such as at least one” before listing the elements of the group. If the excipient must be selected from the group, then the term “such as” does not fit in the claim; alternatively, if the term “such as” is meant to be used, then it is not clear whether the composition is limited to the listed elements. Additionally, it is not clear whether the term “at least one” is meant to modify “selected from” or “such as”. For purpose of examination, the claim will be interpreted as requiring that the excipient is “selected from” the Markush group.
Claim 13 is drawn to a composition comprising 6-methylnicotine and excipients further defined by regard to a Markush group; however, the claim is indefinite because the claim is ambiguous as to whether the excipient(s) must be selected from the Markush group or the Markush group is a non-limiting list of exemplary excipients, because the claim states that the excipients are “selected from such as at least one” before listing the elements of the group. If the excipient must be selected from the group, then the term “such as” does not fit in the claim; alternatively, if the term “such as” is meant to be used, then it is not clear whether the composition is limited to the listed elements. Additionally, it is not clear whether the term “at least one” is meant to modify “selected from” or “such as”. For purpose of examination, the claim will be interpreted as requiring that the excipient is “selected from” the Markush group.
Claim 14 further limits the composition of claim 13 to wherein the composition is further defined by regard to a Markush group; however, the claim is indefinite because the claim is ambiguous as to whether the composition must be selected from the Markush group or the Markush group is a non-limiting list of exemplary compositions, because the claim states that the composition is “selected from such as” before listing the elements of the group. If the composition must be selected from the group, then the term “such as” does not fit in the claim; alternatively, if the term “such as” is meant to be used, then it is not clear whether the composition is limited to the listed elements. For purpose of examination, the claim will be interpreted as requiring that the composition is “selected from” the Markush group.
Claims 5, 10 and 13 include Markush groups of excipients, including the terms “substance responsible for the flavour” and “the like”. These claims are indefinite because a person of ordinary skill in the art cannot reasonably determine the metes and bounds of the claims. These terms are not defined by the claim to any specific substance(s). The instant disclosure also does not provide any scope to the terms “substance responsible for the flavour” or “the like” despite including each of the terms three times in the disclosure (page 6, lines 20-23 and page 7, lines 11-13 and 20-23). A person of ordinary skill in the art would not understand the metes and bounds of the claims with regard to what substance(s) may be included in the composition in the context of a “substance responsible for the flavour”, or “the like”.
Claims 6, 11-12 and 15 include the term “nicotine or its derivatives”. These claims are indefinite because a person of ordinary skill in the art cannot reasonably determine the metes and bounds of the claims. The term “derivatives” is mentioned 9 times in the instant disclosure in the context of derivatives of nicotine, but the term “derivative” is not defined in any of these instances.2 A search on the internet shows that “derivative” is defined by the Merriam-Webster online dictionary as “a chemical substance related structurally to another substance and theoretically derivable from it”3 which allows for a breadth of compounds that cannot be estimated by a person of ordinary skill in the art when the compound upon which the “derivative” is based is nicotine.
Claim 16 is drawn to a therapeutic treatment of nicotinic addition in humans, wherein the treated patient is administered 6-methylnicotine in an amount of 0.1-5% by weight. The claim is indefinite because the claim does not define any patient population, therefore a person of ordinary skill in the art would not understand the metes and bounds of the method, and additionally the claim does not define whether the “0.1-5% by weight” refers to a proportion of 6-methylnicotine in a composition to be administered, or a dosage defined by the weight of the “treated patient”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are anticipated by Owen.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Owen (U.S. Patent No. 11,964,958 B1).
Claim 1 is directed to a method for the treatment of nicotine dependence, comprising 6-methylnicotine4 in an amount of “0.1-5% by weight of the composition”.
Owen discloses vaporizable alkaloid compositions capable of forming an inhalable vapor when dispensed from an electronic device such as an e-cigarette (Abstract). Owen also discloses a method for promoting smoking cessation in an individual desirous of cessation, comprising administering to the individual a series of vaporizable alkaloid compositions for the individual to inhale by vaping, each composition in the series comprising at least one substituted pyridine compound of a formula that encompasses 6-methylnicotine (Col. 5, lines 38-67 and Col. 6, lines 1-9) and further discloses an embodiment of this method wherein the substituted pyridine compound is 6-methylpyridine or a salt or mixed salt thereof (Col. 6, lines 10-13). The series of vaporizable alkaloid compositions begins with the composition having the highest concentration of the substituted pyridine compound and finishes with the composition having the lowest concentration of the substituted pyridine compound, such that at the end of the time period of the method the individual ceases smoking. Owen further discloses an exemplary series of compositions for a cessation program in Table 6 (Col. 40, lines 1-28), starting in week 1 with a composition having a concentration of 1002 mg/mL of alkaloid compound and ending in week 25 with a composition having a concentration of zero (0) mg/mL. Owen discloses that the compositions are made by dilution of a parent composition as disclosed, for example in Table 2 (Cols. 35-36), wherein the alkaloid is specifically 6-methylnicotine, and that such dilutions are made by taking the parent composition and further diluting in propylene glycol or vegetable glycerin (Col. 36, lines 35-42). By week 8 of the series shown in Owen’s Table 6, the concentration of the alkaloid drops to 65 mg/mL, which in glycerin (having a well-known density of 1.26 g/mL)5 would correspond to a wt% of below 5%, as follows: wt% = [65 mg/(1.26 +0.065)g] * 100% = (65mg/1325mg)*100% = 4.9%. The penultimate week of the program, having 1 mg/mL, similarly corresponds to a wt% of 0.1%. Thus, Owen’s exemplary cessation program comprises administering a series of compositions across 25 weeks, for which during 17 weeks of the program the concentration of the alkaloid, which as discussed above can be specifically 6-methylnicotine, is within the stated range of wt% of 6-methylnicotine of instant claim 1.
Thus, claim 1 is anticipated by the disclosure of Owen.
Claim 2 is drawn to a treatment of nicotine dependence using a pharmaceutical composition comprising 6-methylnicotine in an amount of 0.1-5% by weight of the composition of oral, inhalation and dermal products for humans.
Claim 3 further limits claim 2 to wherein the composition is in the form of a liquid or a solid.
Claim 4 is understood, as discussed in the rejection above, to further limit claim 2 to wherein the pharmaceutical composition is selected from a Markush group that includes e-cigarette liquids.
Claim 5 is understood, as discussed in the rejection above, to further limit claim 2 to wherein the pharmaceutical composition comprises an excipient selected from a Markush group that includes glycerol.
Claim 6 further limits claim 2 to wherein the pharmaceutical composition additionally comprises nicotine or its derivatives in an amount of 0.01-5% by weight of the composition.
As discussed above, Owen discloses compositions of 6-methylnicotine, a derivative of nicotine, in glycerol, having weight % concentrations within 0.01-5 wt%, as vaporizable alkaloid compositions capable of forming an inhalable vapor when dispensed from an electronic device such as an e-cigarette. While Owen does not describe the compositions as “pharmaceutical compositions”, a person of ordinary skill in the art would at once recognize the compositions as pharmaceutical compositions because the compositions include 6-methylnicotine and glycerol, a an excipient known to be a pharmaceutically acceptable solvent, as evidenced by Rowe (Rowe, R. C., et al.; Handbook of Pharmaceutical Excipients, Sixth Edition, Royal Pharmaceutical Society Publishing, London, UK, page 283; 2009). Rowe provides a catalog of known pharmaceutical excipients and their properties and typical application in pharmaceutical formulations, including glycerin (page 283).
Thus, claims 2-6 are anticipated by the disclosure of Owen.
Claim 7 is drawn to a method for the treatment of nicotine dependence, comprising “using” a composition comprising 6-methylnicotine in an amount of 0.1-5% by weight as a substitute for nicotine composition in food, inhalation, and dermal products for humans, and is met by the disclosure of Owen.
Claim 8 further limits claim 7 to wherein the composition is in the form of a liquid or a solid, and is met by the disclosure of Owen.
Claim 9 is understood, as discussed in the rejection above, to further limit claim 7 to wherein the composition is selected from a Markush group that includes e-cigarette liquids, and is met by the disclosure of Owen.
Claim 10 is understood, as discussed in the rejection above, to further limit claim 7 to wherein the composition comprises an excipient selected from a Markush group that includes glycerol, and is met by the disclosure of Owen.
Claim 11 further limits claim 7 to wherein the composition additionally comprises nicotine or its derivatives in amount of 0.01-5% by weight of the composition and is met by the disclosure of Owen.
Claim 12 is drawn to a method for the treatment of nicotine dependence, comprising “using” 6-methylnicotine in an amount of 0.1-5% by weight, as a substitute for nicotine or its derivatives in food, inhalation and dermal products for humans, and is met by the disclosure of Owen.
Claim 13 is drawn to a composition comprising 6-methylnicotine in an amount of 0.1-5% by weight and an excipient selected from a Markush group that includes glycerol, and is met by the disclosure of Owen.
Claim 14 is understood, as discussed in the rejection above, to further limit claim 13 to wherein the composition is selected from a Markush group that includes e-cigarette liquids, and is met by the disclosure of Owen.
Claim 15 further limits claim 13 to wherein the composition additionally comprises nicotine or its derivatives in amount of 0.01-5% by weight of the composition and is met by the disclosure of Owen.
Claim 16 is drawn to a method of therapeutic treatment of nicotinic addiction in humans, wherein the treated patient is administered 6-methylnicotine in an amount of 0.1-5% by weight, and is met by the disclosure of Owen.
Thus, claims 7-16 are anticipated by the disclosure of Owen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 (S)-2-Methyl-5-(1-methyl-2-pyrrolidinyl)pyridine
2 1. Page 1, lines 20-21; 2. Pages 6-7, bridging paragraph; 3. Page 7, lines 15-16; 4. Page 7, lines 17-19; 5. Page 8, lines 4-6; 6. Page 8, lines 13-16; 7. Page 23, lines 3-5; 8-9. Pages 23-24, bridging paragraph.
3 https://www.merriam-webster.com/dictionary/derivative
4 (S)-2-Methyl-5-(1-methyl-2-pyrrolidinyl)pyridine
5 https://en.wikipedia.org/wiki/Glycerol