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 Objections
Claim 21 is objected to because it recites “the nicotine production step” which appears to be a typo of the “nicotine generation step” previously introduced in claim 12.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 12-15 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rose (US 2008/0241255 A1).
Regarding claim 12, Rose is directed to a method of enhancing nicotine concentrations in a gaseous carrier (Abstract). A liquid nicotine source 40 is introduced to a heating element 95 (which reads on a “feeding step” as claimed) [0151, 0236], while a gaseous delivery enhancing compound passes over and evaporates the nicotine source 40 (“a vaporizing step”) [0139-0140]. The resulting aerosol is delivered to a user (“a dispensing step”) [0091]. The nicotine source 40 may include nicotine base (“precursor substance”) which reacts with the delivery enhancing compound to form a nicotine salt [0140]. Rose’s nicotine salt reads on “nicotine” as claimed (see Rose [0148] describing nicotine salts as a volatile form of nicotine; see also Applicant’s specification at [0009] describing high concentration of nicotine salts in US liquids). The use of the gaseous delivery enhancing compound to evaporate nicotine enhances the concentration of nicotine in the resulting aerosol in comparison to an aerosol produced without such delivery enhancing compound (“nicotine generation step”) ([0017, 0057, 0145], Abstract).
Regarding claims 13-14, one of ordinary skill in the art would recognize that reacting a nicotine base to form a nicotine salt involves protonating the nicotine (see [0098, 0161, 0164] disclosing an acid-base reaction, and [0140] disclosing reaction to form a nicotine salt), which increases the oxidation state of the nicotine (which reads on an “oxidation reaction”) and reduces the oxidation state of the delivery enhancing compound (which reads on a “reduction reaction”).
Regarding claim 15, Rose discloses that the reaction between the nicotine base and delivery enhancing compound occurs “instantly” upon evaporation of the nicotine (which reads on “simultaneously with the vaporizing step” as claimed) (see [0139] describing evaporation of nicotine, see also [0160-0166] describing mixing two liquids to instantly react them as a suitable experimental approximation of the nicotine aerosolization reaction).
Regarding claims 19-20, Rose discloses an exemplary device for delivering aerosol which includes a nicotine reservoir 510 and a delivery enhancing compound reservoir 500, each holding liquids (the nicotine within reservoir 510 reads on the “first liquid” containing “nicotine” and the “precursor substance” per claim 19 and the “first liquid containing nicotine” per claim 20; the delivery enhancing compound within reservoir 500 reads on the “further liquid containing a reactant” of claim 20) ([0242], Fig. 7).
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.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rose (US 2008/0241255 A1) as applied to claims 12 and 20, in view of Taurino (WO 2020/002693 A1).
Regarding claims 16-17, Rose discloses the method of enhancing nicotine concentrations in a gaseous carrier, as set forth above in the discussion of claim 12, but fails to disclose the precursor substances recited in claims 16-17.
Taurino is directed to a cartridge for an aerosol-generating system comprising an alkaloid source comprising a liquid alkaloid formulation (Title). The liquid alkaloid formulation reacts with an acid to generate nicotine having improved perceived sensorial harshness for a user as compared to Rose’s device and components (p. 1 l. 9-18, p. 1 l. 33-p. 2 l. 17). The liquid alkaloid formulation may comprise one or more tobacco alkaloids such as cotinine and nornicotine (which read on claims 16 and 17, respectively).
Therefore, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify Rose by substituting at least the nicotine source with Taurino’s liquid alkaloid formulation including cotinine and/or nornicotine, because both Rose and Taurino are directed to aerosol-generating systems with nicotine-producing reactions, Taurino teaches using the liquid alkaloid formulation to decrease harshness, and this would involve the use of a known technique to improve a similar device in the same way. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claims 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rose (US 2008/0241255 A1) as applied to claim 12.
Regarding claim 18, Rose discloses an exemplary device (“inhaler”) for delivering aerosol which includes a delivery enhancing compound source 30 and a nicotine source 40 (“two vaporizer tank chambers”) which may be independent components ([0236], Figs. 4-6). A single heating element 95 (“vaporizer”) heat both sources 30, 40 [0236]. Thus, Rose fails to disclose “each vaporizer tank chamber is configured to be assigned to a respective vaporizer”. But dividing the heating element 95 into respective heating elements 95 for individually heating each of the delivery enhancing compound source 30 and the nicotine source 40 would be merely making a component separable which is obvious in view of Rose. See MPEP 2144.04(V)(C); see also In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claim 21, Rose discloses the nicotine reservoir 510 and the delivery enhancing compound reservoir 500 as set forth above in the discussion of claim 20. Rose also discloses a PET source element for containing a wet delivery enhancing compound such as pyruvic acid, but the acid vapors contact the liquid nicotine rather than the nicotine being brought into contact with the PET source element [0249], and thus Rose fails to specifically disclose “wherein, in the nicotine production step, the precursor substance is brought into contact with the reactant in the contact element”. However, it would be a simple and obvious rearrangement of parts to contact Rose’s liquid or evaporated nicotine with the PET source element, for instance to further enhance nicotine delivery with the delivery enhancing compound. See MPEP 2144.04(VI)(C); see also In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Rose (US 2008/0241255 A1) as applied to claim 12, in view of Sheldon (WO 2014/174505 A2).
Rose discloses the method of enhancing nicotine concentrations in a gaseous carrier, as set forth above in the discussion of claim 12. However, Rose fails to disclose a “catalyst” or an “enzyme” as recited in claims 22-23.
Sheldon is directed to a process for the preparation of nicotine with an enzymatic reduction (Title). The process includes reacting pseudooxynicotine or any of its forms with an enzyme to catalytically reduce the pseudooxynicotine (p. 3, last full paragraph). The use of enzymes as catalysts is typically environmentally and cost advantageous and is more selective (p. 5, 2nd paragraph).
Therefore, before the effective filing date of the claimed invention, it would have been obvious for one having ordinary skill in the art to modify Rose by using Sheldon’s enzymatic, catalytic reduction to form nicotine, because both Rose and Sheldon are directed to nicotine production, Sheldon teaches that enzymatic catalysts are environmentally friendly and cost advantageous, and this would involve the use of a known technique to improve a similar device in the same way. See MPEP 2143(I); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PATRICK MULLEN whose telephone number is (571)272-2373. The examiner can normally be reached M-F 10-7 ET.
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/MICHAEL PATRICK MULLEN/Examiner, Art Unit 1747
/Michael J Felton/Primary Examiner, Art Unit 1747