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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/13/2026 has been entered.
Response to Amendment
Claims 1, 21, 23-25 and 27-28 are amended. Claims 5, 8, 12-13, 22, 26 and 29 are cancelled. Claims 21, 23-25 and 27-28 are withdrawn. Claims 1-4, 6-7, 9-11, 14-20 and 30 are presently examined.
Information Disclosure Statement
The information disclosure statement filed 9/20/2022 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered. Specifically, a copy of AU 199861959 B2 is provided, but the document is not listed on the information disclosure statement.
The information disclosure statement filed 9/20/2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Specifically, copies of AU 717600 B2 and GB 201718035 D0 have not been received.
The information disclosure statement filed 2/19/2024 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered. Specifically, a copy of AU 199861959 B2 is provided, but the document is not listed on the information disclosure statement.
The information disclosure statement filed 2/19/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Specifically, no copy of AU 717600 B2 is provided.
Terminal Disclaimer
The terminal disclaimer filed on 8/22/2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Application No’s. 16/761,060, 17/290,319, 17/290,323, 17/290,323, 17/290,328, 17/290,411, and 17/290,652 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 pr-e-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 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 1-4, 6-7, 14-18 and 30 are rejected under 35 U.S.C. 103 as being obvious over Cameron (US 11,517,039) in view of Muhammed (US 2017/0079319).
Regarding claims 1-4, 6-7, 9-11 and 30, Cameron discloses a water based vaporizable liquid for use in an electronic vapor device (abstract). The liquid contains an agent (column 9, lines 21-24) that is present at between 0.1 to about 1% by weight (column 9, lines 25-46) and is nicotine (column 9, lines 51-56). The vaporizable composition has citric acid (column 20, lines 60-67, column 21, lines 1-67, column 22, lines 1-67, column 23, lines 1-67, column 24, lines 1-24). Water is present in a weight percent of about 84% to about 94% (column 8, lines 60-67, column 9, lines 1-17). Cameron does not explicitly disclose (a) a molar ratio or weight of the citric acid and (b) the claimed ranges being obvious.
Regarding (a), Muhammed teaches a method of administering a nicotine salt to a human in the form of an aerosol derived from a liquid formulation (abstract) that has a 2:1 ratio of citric acid to nicotine that forms a salt to reduce irritation caused by the formulation [0018]. One of ordinary skill in the art would recognize the ratio is a molar ratio since weight ratios are separately taught by Muhammed and such a notation is used in the chemical arts to refer to molar ratios.
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the nicotine of Cameron in the salt form of Muhammed. One would have been motivated to do so since Muhammed teaches that providing nicotine in a salt form in an aerosolizable formulation reduces irritation.
Regarding (b), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the claimed ranges are obvious. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
One of ordinary skill in the art would recognize that combining the relative weight of nicotine of Cameron (0.1-1 %) and the molar water of citric acid to nicotine of Muhammed (2:1) would result in a composition having approximately 0.24-2.4 wt% of citric acid, based on the respective molar masses of nicotine and citric acid, which overlaps the claimed acid range and would therefore be obvious.
Regarding claim 14, Cameron discloses that the composition comprises a flavorant (column 24, lines 55-62, table 1).
Regarding claims 14-16, Cameron discloses that the solution contains menthol (column 20, lines 60-67, column 21, lines 1-67, column 22, lines 1-67, column 23, lines 1-67, column 24, lines 1-24), which applicant’s specification discloses is a flavorant (page 16, lines 6-24).
Regarding claims 17 and 18, modified Cameron teaches all the claim limitations as set forth above. Cameron additionally teaches that the flavorant is present at about 0.12 wt% to about 30.8 wt% (column 17, lines 25-44). Modified Cameron does not explicitly teach the flavorant weight percent overlapping the claimed range in the relied upon embodiment.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow the flavorant content of the relied upon embodiment of Cameron to vary such that it overlaps the claimed range. One would have been motivated to do so since Cameron discloses a suitable range of flavorant content for a water based electronic vaporizer formulation. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being obvious over Cameron (US 11,517,039) in view of Muhammed (US 2017/0079319) as applied to claim 1 above, and further in view of Kuntawala (US 2016/0198759) and Manas (US 2019/0183185).
Regarding claims 19 and 20, modified Cameron teaches all the claim limitations as set forth above. Modified Cameron does not explicitly teach (a) the formulation containing a cyclodextrin not encapsulating a flavor and (b) the composition not containing any flavorings that may be encapsulated by the cyclodextrin.
Regarding (a), Kuntawala teaches a vaping fluid containing active ingredients (abstract) such as caffeine combined with a cyclodextrin to enhance absorption and avoid irritation [0014]. The caffeine is a stimulant [0013]. It is noted that caffeine falls outside the types of molecules described in applicant’s specification as flavorants which produce desired flavors in the formulation (page 16, lines 6-24).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the formulation of modified Cameron with the cyclodextrin encapsulating caffeine of Kuntawala. One would have been motivated to do so since Kuntawala teaches that caffeine is provided in a cyclodextrin to function as a stimulant.
Regarding (b), Manas teaches a nicotine delivery system [0002] having a cartridge with a nicotine liquid that does not have any flavors to match the flavors of a conventional tobacco based cigarette [0075].
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the formulation of modified Cameron without any flavorants. One would have been motivated to do so since Manas teaches a nicotine liquid that does not have any flavors so that it matches the flavor of a conventional tobacco cigarette.
Response to Arguments
Regarding the rejections under 35 USC 103, applicant’s arguments have been fully considered and are persuasive. However, upon further consideration, new grounds of rejections relying on a different disclosure of Cameron are entered as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL E SPARKS whose telephone number is (571)270-1426. The examiner can normally be reached Monday-Friday, 9:00 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at 571-270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUSSELL E SPARKS/ Primary Examiner, Art Unit 1755
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