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 .
Election/Restrictions
Applicant’s election without traverse of Species I in the reply filed on 06/22/2026 is acknowledged. Claims 1 and 4-22 remain pending, claims 13-15 are withdrawn, and claims 1, 4-12, and 16-22 are examined herein.
Claim Objections
Claims 17 and 19 are objected to for the following informalities:
Claim 17 recites “when in the aerosolizable material” which appears to be a typo of “when in the second aerosolizable material” which was previously recited in the claim (compare with claim 20);
Claim 19 recites “the at least one active present in the carboxylated form” which should refer back to “the at least one carboxylated active” previously recited in claim 1, for clarity and consistency.
Appropriate correction is required.
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 1, 4-12, and 16-22 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 lacks clarity because it recites “A delivery system comprising… an aerosolizable material” and “the system comprises a first aerosolizable material and a second aerosolizable material”. It is unclear whether the first and second aerosolizable materials are sub-components of the aerosolizable material, or whether “an aerosolizable material” refers to an additional third aerosolizable material. The Examiner recommends amending the claim to recite “the aerosolizable material comprises a first aerosolizable material and a second aerosolizable material” (which appears to be the intended meaning in light of the specification) to resolve the ambiguity (see also claim 21 further limiting “the aerosolizable material”), and the claim is interpreted as such for purposes of this office action.
The term “significant” in claim 5 is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, it is not clear what range of temperatures is required by the claim language “below the temperature at which significant vaporization of the second aerosolizable material would take place”. For purposes of this office action, the claim is interpreted as reciting “below 150 °Csee specification at p. 3).
The term “sustained” in claim 7 is a relative term which renders the claim indefinite. The term “sustained” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, it is not clear what range of times is required by the claim language “a sustained period of time”. For purposes of this office action, the claim is interpreted as reciting “a .
Claim 9 lacks clarity because the claim recites a function performed by “a user” without reciting any structure of the system which performs the function. Thus it is unclear how the system of claim 9 differs structurally from the system of claim 8. For purposes of this office action, the claim is interpreted as reciting “The system according to claim 8, further comprising a pump, wherein a user can operate and/or control the pump to control the extent to which transfer of the second aerosolizable material to the first reservoir occurs” (see specification at p. 3-4).
Regarding claim 16, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of this office action, the claim is interpreted as reciting “wherein the at least one carboxylated active is a cannabinoid
Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of this office action, the claim is interpreted as reciting “wherein the second aerosolizable material comprises one or more further actives,
Claim 17 recites the limitation "the decarboxylated form”. There is insufficient antecedent basis for this limitation in the claim. For purposes of this office action, claim 20 is interpreted as reciting “a
Claim 20 recites the limitations "the one or more further actives" and ”the decarboxylated form”. There is insufficient antecedent basis for these limitations in the claim. For purposes of this office action, claim 20 is interpreted as reciting “wherein the first aerosolizable material comprisesa
Claims 4, 6, 8, 10-12, 18-19, and 21-22 are rejected due to their dependency on the preceding claims.
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 1, 4-7, and 16-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schorr (US 2021/0023316 A1).
Regarding claim 1, Schorr is directed to an inhaler for providing two or more substances by inhalation (Title) (which reads on a “delivery system comprising: a powered aerosol generating device; and an aerosolizable material”).
The inhaler includes a power source and a controller [0071-73] (“wherein the powered aerosol generating device comprises a power source and a controller”);
The inhaler vaporizes a first substance and a second substance [0071] (“the system comprises a first aerosolizable material and a second aerosolizable material”). The first or second substance may be CBDA [0013, 0055], which is decarboxylated to CBD by heating [0172, 0183-4] (“wherein the second aerosolizable material comprises at least one carboxylated active”).
The first and second substances may be stored in independent reservoirs 1503 ([0318-0322], Fig. 15) (“and is stored in the system separately from the first aerosolizable material, wherein the second aerosolizable material is stored in a second reservoir which is separate from a first reservoir in which the first aerosolizable material is located”).
The second reservoir 1503 may be selectively heated to vaporize the second substance therein [0319, 0321] (“wherein one or more heaters are configured to selectively heat the second aerosolizable material in the second reservoir”);
The first and/or second substance may be provided in liquid form [0056, 0324] (“wherein the first aerosolizable material and/or the second aerosolizable material is liquid”).
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Regarding claim 4, the inhaler may be configured to heat source material chips 1601 having cavities 1603, 1604 using heating elements 1609, 1611, which may each be a heating mesh extending across the layer of source material ([0325-9], Fig. 16) (which reads on “wherein the one or more heaters are selected from one or more internal heaters in contact with the second aerosolizable material and/or one or more external heaters which are not in contact with the second aerosolizable material”).
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Regarding claim 5, Schorr discloses heating to the vaporization temperature of the substance or an intermediate or lower temperature, such as 70 °C [0313] (which reads on “wherein the one or more heaters are configured to heat the second aerosolizable material to a temperature above ambient, but below the temperature at which significant vaporization of the second aerosolizable material would take place”; see rejection of claim 5 under 35 USC 112(b) above; see also Applicant’s specification at p. 3 disclosing temperatures between 50-150 °C).
Regarding claim 6, Schorr discloses heating the substance to 70 °C [0313].
Regarding claim 7, Schorr discloses heating the source material for various durations such as 3 seconds [0203] (which reads on “wherein the second aerosolizable material is heated for a sustained period of time”; see rejection of claim 7 under 35 USC 112(b) above).
Regarding claim 16, Schorr discloses CBDA as set forth above in the discussion of claim 1 [0013, 0055] (which reads on “wherein the at least one carboxylated active is a cannabinoid, such as cannabidiolic acid (CBDA)”).
Regarding claims 17-18, Schorr discloses CBDA which decarboxylates to CBD upon heating [0013, 0055, 0172, 0183-4]. The second reservoir 1503 may be selectively heated to vaporize the second substance therein [0319, 0321], which would decarboxylate the CBDA [0313] (which reads on “wherein the second aerosolizable material comprises one or more further actives, such as cannabinoids, wherein the one or more further actives are in the decarboxylated form when in the aerosolizable material” per claim 17 and “wherein the one or more further actives in the decarboxylated form is cannabidiol (CBD)” per claim 18).
Regarding claim 19, in addition to CBDA and CBD as set forth above, Schorr discloses THCA decarboxylting to Δ9-THC [0195] (which similarly reads on “wherein the second aerosolizable material comprises at least one carboxylated active” per claim 1 and “wherein the second aerosolizable material comprises one or more further actives, such as cannabinoids, wherein the one or more further actives are in the decarboxylated form when in the aerosolizable material” per claim 17). Schorr discloses that 50% or 80% of THCA may decarboxylate to Δ9-THC [0195], or there may be a 1:1 ratio of Δ9-THC:THCA [0224] (all of which fall within the claimed range of “99:1 to 1:99”).
Regarding claim 20, as set forth above in the discussion of claims 1 and 17-18, either or both of the first and second substance may be CBDA which decarboxylates to CBD upon heating [0013, 0055, 0172, 0183-4]. The first reservoir 1503 may be selectively heated to vaporize the first substance therein [0319, 0321], which would decarboxylate the CBDA [0313] (which reads on “wherein the first aerosolizable material comprises the one or more further actives in the decarboxylated form when in the first aerosolizable material”).
Regarding claims 21-22, the source material may include an additional substance C which includes a carrier material such as glycerin [0272] (which reads on “wherein the aerosolizable material further comprises a carrier constituent“ per claim 21 and “wherein the carrier constituent comprises…glycerol” per claim 22).
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.
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Schorr (US 2021/0023316 A1) as applied to claim 1, in view of Marsh (US 2017/0045150 A1).
Schorr fails to disclose the limitations of claims 8-12.
Regarding claim 8¸ Schorr discloses that the reservoirs 1503 are independent [0321] and thus fails to disclose “wherein the first and second reservoirs are fluidly connected”.
Marsh is directed to an electronic vaporizer system (Title), which is in the same field of endeavor as the claimed invention. Marsh discloses a refillable PV (personal vaporizer [0003]) with a child reservoir which may receive liquid from a parent reservoir such as a cartridge [0008, 0053, 0237]. This advantageously allows convenient refilling of the PV [0006, 0053, 0058], enables mixing of multiple cartridges [0237], and allows accurate metering of total liquid consumption [0238]. One of ordinary skill in the art would recognize that Schorr’s reservoirs 1503 could similarly be configured as parent/child reservoirs to allow refilling of the first reservoir 1503 from the second reservoir 1503 (which reads on “wherein the first and second reservoirs are fluidly connected”) (see Schorr disclosing cartridges at [0196, 0221] and disclosing various forms and release means for the reservoirs 1503 at [0318-0324]).
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 Schorr by configuring the second reservoir 1503 to refill the first reservoir 1503 as taught by Marsh, because both Schorr and Marsh are in the same field of endeavor as the claimed invention, Marsh teaches numerous advantages associated with such refilling, and this would involve combining prior art elements according to known methods to yield predictable results. 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).
Regarding claims 9-11, Marsh discloses a pump which transfers e-liquid from the parent reservoir to the child reservoir [0237] and which may be manually activated by a user touching a button [0239] (which reads on “wherein a user can control the extent to which transfer of the second aerosolizable material to the first reservoir occurs” per claim 9 (see rejection of claim 9 under 35 USC 112(b) above), “wherein a pump controls the transfer of a particular quantity of the second aerosolizable material when controlled to do so by the user” per claim 10, and “wherein a button, switch, or touchpad is used to control the transfer of the second aerosolizable material to the first reservoir” per claim 11). It would be similarly obvious to incorporate Marsh’s pump into Schorr for refilling the first reservoir 1503 from the second reservoir 1503, for the same reasons as set forth above with regard to claim 8.
Regarding claim 12, Marsh discloses that the pump can be operated automatically by electronics [0239] and may operate according to a certain cycle time, pumping frequency, and/or pumping duration [0110, 0243]. It would be similarly obvious in modified Schorr to configure Schorr’s controller to automatically operate the pump according to a certain cycle time, pumping frequency, and/or pumping duration (which reads on “wherein the controller is configured to initiate the transfer of a particular quantity of the second aerosolizable material to the first reservoir according to a particular schedule”), for the same reasons as set forth above in the discussion of claims 8-11.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H. Wilson can be reached at (571) 270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL PATRICK MULLEN/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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