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 .
Claim Rejections - 35 USC § 112
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 3 and 8-20 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 3 recites the limitation "the flavourings" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites “at least a cyclodextrin”. This is indefinite because it is unclear of other materials are intended to be included with the cyclodextrin, or if at least one cyclodextrin is being claimed.
For examination purposes, “at least a cyclodextrin” will be examined as “a cyclodextrin”. While cyclodextrins are a class of compounds, the instant specification does not indicate that a plurality of cyclodextrins are to be included in the composition.
Claims 9-13 are rejected for depending from claim 8.
Claim 14 recites the limitation "The inhalation device" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 is rejected for depending from claim 14.
Claim 15 recites “at least a cyclodextrin”. This is indefinite because it is unclear of other materials are intended to be included with the cyclodextrin, or if at least one cyclodextrin is being claimed.
For examination purposes, “at least a cyclodextrin” will be examined as “a cyclodextrin”. While cyclodextrins are a class of compounds, the instant specification does not indicate that a plurality of cyclodextrins are to be included in the composition.
Claims 16-19 are rejected for depending from claim 15.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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Claim(s) 1-3, 5-10, 12-17, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over RIGHETTI (US 2015/0351449 in view of MISHRA et al. (US 2016/0120225) and IODICE (US 2018/0199617).
With respect to claim 1, RIGHETTI discloses a liquid composition for inhalation by electronic cigarette (Abstract; Title; Paragraph [0008]) that does not contain propylene glycol (Paragraph [0015]), that comprises water, 1,3-propanediol, glycerol, flavoring and possibly nicotine (Abstract). The water is present in an amount of 4.2-20 wt%, the 1,3-propanediol is present in an amount of 32-70 wt%, the glycerol is present in an amount of 12-37wt% (Paragraphs [0024] and [0027]-[0032]).
RIGHETTI does not explicitly disclose that water is present in the composition in an amount of 25 to 40 wt%. MISHRA et al. discloses a liquid formulation for inhalation in a e-vaping device (Abstract; Paragraph [0025]). The water is present in an amount of between 5 and 40 wt% (Paragraph [0081]) so that the other components of the solution can be dissolved into a homogeneous mixture (Paragraphs [0088] and [0091]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide the water in the solution of RIGHETTI in an amount of between 5 and 40 wt%, as taught by MISHRA et al. so that the other components can be dissolved and mixed homogeneously.
The courts have generally held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05, I
RIGHETTI does not explicitly disclose a preservative. IODICE discloses a composition for inhalation in a hookah (Abstract). The composition comprises a preservative, such as sodium benzoate (Paragraph [0024]) in an amount of between 0.5 and 2 wt% (Paragraph [0008]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to include a preservative in the liquid composition of RIGHETTI, in an amount of between 0.5 and 2 wt%, as taught by IODICE so as to prolong the shelf life of the composition.
The courts have generally held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05, I
With respect to claim 2¸ IODICE discloses that the preservative is sodium benzoate (Paragraph [0024]).
With respect to claim 3¸ RIGHETTI discloses that the flavoring is tobacco (Paragraph [0026]).
With respect to claim 5, RIGHETTI discloses a liquid composition for inhalation by electronic cigarette (Abstract; Title; Paragraph [0008]) that does not contain propylene glycol (Paragraph [0015]), that comprises water, 1,3-propanediol, glycerol, flavoring and possibly nicotine (Abstract). The water is present in an amount of 4.2-20 wt%, the 1,3-propanediol is present in an amount of 32-70 wt%, the glycerol is present in an amount of 12-37wt% (Paragraphs [0024] and [0027]-[0032]).
RIGHETTI does not explicitly disclose that water is present in the composition in an amount of 25 to 40 wt%. MISHRA et al. discloses a liquid formulation for inhalation in a e-vaping device (Abstract; Paragraph [0025]). The water is present in an amount of between 5 and 40 wt% (Paragraph [0081]) so that the other components of the solution can be dissolved into a homogeneous mixture (Paragraphs [0088] and [0091]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide the water in the solution of RIGHETTI in an amount of between 5 and 40 wt%, as taught by MISHRA et al. so that the other components can be dissolved and mixed homogeneously.
The courts have generally held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05, I
RIGHETTI does not explicitly disclose a preservative. IODICE discloses a composition for inhalation in a hookah (Abstract). The composition comprises a preservative, such as sodium benzoate (Paragraph [0024]) in an amount of between 0.5 and 2 wt% (Paragraph [0008]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to include a preservative in the liquid composition of RIGHETTI, in an amount of between 0.5 and 2 wt%, as taught by IODICE so as to prolong the shelf life of the composition.
The courts have generally held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05, I
With respect to claim 6, RIGHETTI discloses composition (see rejection of claim 1) with a dose of flavoring and an electronic cigarette (Paragraphs [0002]-[0008], [0026] and [0010]). The percentage of flavoring represents the claimed dose. The composition and flavoring represent the claimed kit.
With respect to claim 7, RIGHETTI discloses the composition (See rejection of claim 1) with a flavoring and an inhaling device having a container having the liquid for vaporization (Paragraph [0003], [0010] and [0026]). The percentage of flavoring represents the claimed dose. The total amount of composition represents the claimed dose.
With respect to claim 8, RIGHETTI discloses a flavoring that is present in an amount of 3-9 wt% (Paragraphs [0031], [0024]).
With respect to claim 9, IODICE discloses that the preservative is sodium benzoate (Paragraph [0024], [0008]).
With respect to claim 10, RIGHETTI discloses that the flavoring is tobacco (Paragraph [0026]).
With respect to claim 12, RIGHETTI discloses composition (see rejection of claim 8 and 1) with a dose of flavoring and an electronic cigarette (Paragraphs [0002]-[0008], [0026] and [0010]). The percentage of flavoring represents the claimed dose of flavoring. The composition and flavoring represent the claimed kit
With respect to claim 13, RIGHETTI discloses the composition (See rejection of claims 8 and 1) with a flavoring and an inhaling device having a container having the liquid for vaporization (Paragraph [0003], [0010] and [0026]). The percentage of flavoring represents the claimed dose. The composition and flavoring represent the claimed kit.
With respect to claim 14, RIGHETTI discloses the composition (See rejection of claim 1) with a flavoring and an inhaling device having a container having the liquid for vaporization (Paragraph [0003], [0010] and [0026]). The percentage of flavoring represents the claimed dose. The total amount of composition represents the claimed dose.
With respect to claim 15, RIGHETTI discloses a flavoring that is present in an amount of 3-9 wt% (Paragraphs [0031], [0024]).
With respect to claim 16, IODICE discloses that the preservative is sodium benzoate (Paragraph [0024], [0008]).
With respect to claim 17, RIGHETTI discloses that the flavoring is tobacco (Paragraph [0026]).
With respect to claim 19, RIGHETTI discloses composition (see rejection of claim 8 and 1) with a dose of flavoring and an electronic cigarette (Paragraphs [0002]-[0008], [0026] and [0010]). The percentage of flavoring represents the claimed dose of flavoring). The composition and flavoring represent the claimed kit.
With respect to claim 20, RIGHETTI discloses the composition (See rejection of claims 8 and 1) with a flavoring and an inhaling device having a container having the liquid for vaporization (Paragraph [0003], [0010] and [0026]). The total amount of composition represents the claimed dose.
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Claim(s) 4, 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over RIGHETTI (US 2015/0351449 in view of MISHRA et al. (US 2016/0120225) and IODICE (US 2018/0199617) as applied to claims 1-3, 5-10, 12-17, 19 and 20 above, and further in view of KUNTAWALA et al. (US 2016/0198759).
With respect to claims 4, 11 and 18, RIGHETTI does not explicitly disclose that the composition comprises cyclodextrins. KUNTAWALA et al. discloses vaping fluids used in an electronic cigarette (Abstract; Title). The fluids contain cyclodextrins to enhance absorption and avoid irritation (Abstract; Paragraphs [0014]-[0017]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide cyclodextrins in the composition of modified RIGHETTI, as taught by KUNTAWALA et al. so as to improve absorption and reduce irritation.
Conclusion
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/ALEX B EFTA/Primary Examiner, Art Unit 1745