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 .
Priority
This application claims priority to several provisional applications. It appears that the earliest provisional application that provides support for the instant application is 62/086,208, for an effective filing date of 12/01/2014.
Information Disclosure Statement
Due to a long list of IDS submitted, highlight those documents which have been specifically brought to applicant’s attention, and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Note that consideration by the examiner of the information submitted in the IDS means nothing more than considering the documents in the same manner that the examiner considers other documents in Office search files while conducting a prior art search in the proper field of search. See MPEP 609. In the present application, Applicant has filed 5 different information disclosure statements with more than 700 different references.
Specification
The disclosure is objected to because of the following informalities: it appears that the claimed “air conduit” refers to the passageway between air intake 2312 and output 2312B (see specification page 52, fig. 2A-E, 3A). It appears that the term “conduit” is used in the specification to refer to a different structure than the claimed “air conduit” (see page 54 and fig. 4B, 2401, 2408). It is suggested that the claim terminology match the terminology used in the specification to ensure antecedent basis.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “vaporizing apparatus” in claims 10-11. It has been interpreted that the “vaporizing apparatus” is as described in the specification to at least include electrodes for making electrical contact to heat and vaporize a substance (page 41, 50).
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 11, and 20 are objected to because of the following informalities:
Claim 1 limitation “the bioactive agent” has not been previously recited and should be amended to “a bioactive agent”. It is also suggested to include the relationship between the bioactive agent and the dose unit to ensure that it is clear that the bioactive agent is included in the structure of the dose unit by amending to include a limitation such as “the dose unit comprising a bioactive agent”, or similar.
Claim 11 is objected to: “where it attaches to the dose unit” should be amended to “where the dose puller attaches to the dose unit” to ensure clarity.
Claim 11 is further objected to for the limitation “wherein the dose actuator is actuated to extend … where it attaches to the dose unit”. Since this claim appears to be directed toward an apparatus and not a method, this claim should be amended as follows: “wherein the dose puller is configured to extend upon actuation …. where the dose puller is configured to attach to the dose unit”, or similar.
Claims 10-17 and 20 begin with “The device” which was previously referred to in parent claims 8 and 2 as “the inhaler device”. It is suggested to amend these claims to have consistent terminology with the parent claims.
Claim 20 should end with a period.
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, 5-6, 10 and 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 limitation “a holder configured for holding the dose unit such that the bioactive agent is in sealed alignment with an air conduit of the activating unit” is not clear, since it is not clear whether the holder is in sealed alignment with an air conduit in both the storage condition and the use position. It appears based on the disclosure that the sealed alignment with the air conduit only occurs in the use position. This claim would have improved clarity if amended to state that the sealed arrangement with an air conduit is in the use position, rather than the storage position recited in the immediately preceding limitation.
Claims 5 and 16 recite the limitation "said pallet". There is insufficient antecedent basis for this limitation in the claim. It has been interpreted that “said pallet” refers to the dose unit recited in parent claims 1 and 2, respectively. This claim limitation has been interpreted to mean “said dose unit”.
Claim 6 limitation “said mechanism” where there is no antecedent basis for “a mechanism” in the claims. In order to advance prosecution, this limitation has been interpreted as “a mechanism”.
Claim 10 is rejected since “said interlock” has insufficient antecedent basis in the claims. This limitation has been interpreted as “an interlock”.
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 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 1-2, 5-6,8-9, 16-17, and 20 are rejected under 35 U.S.C. 103 as unpatentable over Davidson et al. (US 2013/0276799 A1), hereafter Davidson, in view of Harmer et al. (US 2007/0074721 A1), hereafter Harmer.
Regarding Claim 1, Davidson discloses an activating unit for a dose unit (fig. 4A, [0234]), comprising: a dose puller (fig. 4A, mechanism 62 [0234]) configured to move the dose unit from a storage position into a use position (fig. 4A, 62 moves dose unit tape 63 from storage position in supply reel 65 to use position across element 64 [0234]); a holder configured for holding the dose unit such that the bioactive agent is in alignment with an air conduit of the activating unit (fig. 5A, tape 63 is shown in alignment with the delivery tract [0234]); and electrodes positioned to be in electrical contact (fig. 5A, thermal emitted 301/heating element 64 [0230]) with at least two electrical contact receiving regions (fig. 6E, 25A, 25B [0288]) of an electrically resistive heating element (fig. 6E [0288]) of the dose unit when in the activating unit (fig. 6E [0288]).
Davidson is silent on whether the dose unit is in sealed alignment with the air conduit.
Harmer teaches an inhaler for delivering a dose of aerosolized drug (abstract) that includes a seal (fig. 2, 20 [0043]) which seals a bioactive agent contained within a dose unit (fig. 2, blister 12 [0042]) while aligned with an air conduit (fig. 2, 21 [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a seal in Davidson’s air conduit so that the bioactive agent of the dose unit is in sealed alignment with the air conduit, as taught by Harmer, in order to ensure that substantially all of the medicament is delivered as a dose to the user and dosing is more consistent (Harmer [0042]).
Regarding Claim 2, Davidson discloses an inhaler device comprising the activating unit of claim 1 (Davidson [0015]).
Regarding Claim 5, Davidson as modified discloses an activating unit of claim 1, wherein said sealed alignment defines a pathway through said pallet (examiner’s note: “said pallet” is interpreted as “said dose unit”; Davidson fig. 6E and fig. 4B, vapor 502 passes through [0271]; as modified by Harmer, the pathway is sealed around tape 63) within a lumen along which air passing through said pallet continues until reaching an exit aperture (Davidson fig. 4B, mouthpiece 47 [0180] and [0290]).
Regarding Claim 6, Davidson discloses an activating unit of claim 1, wherein said holder comprises said mechanism (examiner’s note: “said mechanism” is interpreted to mean “a mechanism”) configured to move the dose unit (fig. 4B, motor 53, drive mechanism 54, supply reel 65, intake reel 68 [0234]).
Regarding Claim 8, Davidson discloses an inhaler device of claim 2, comprising a dose unit dispensing apparatus (fig. 4B, supply reel 65 and intake reel 68 [0234]) that comprises a plurality of dose units within a closed container (fig. 4A, supply reel 65 is provided in a cassette 58 [0187]).
Regarding Claim 9, Davidson discloses an inhaler device of claim 8, wherein said closed container includes an interlock which, after dispensing of a first dose unit from the container, prevents dispensing of a second dose unit from the container until the first dose unit is returned to the dispensing apparatus ([0234] the next dose of the tape 63 is not able to be dispensed until the last dose unit is recovered by intake reel 68).
Regarding Claim 16, Davidson discloses a device of claim 2, configured to release at least one pre-determined vaporized amount of said bioactive agent upon controllably heating said pallet (examiner’s note: “said pallet” has been interpreted to mean “dose unit”) comprising said bioactive agent ([0376]).
Regarding Claim 17, Davidson discloses a device of claim 2, comprising a temperature sensor for sensing the temperature in one or more of in said dose unit and on said dose unit ([0335]).
Regarding Claim 20, Davidson discloses a device of claim 16, wherein said bioactive agent is THC ([0359]) or Nicotine ([0319]).
Claim 7 is rejected under 35 U.S.C. 103 as unpatentable over Davidson in view of Harmer, further in view of Neumann et al. (US 2003/0049025 A1), hereafter Neumann.
Regarding Claim 7, Davidson discloses an activating unit of claim 1, wherein said electrodes (fig. 6E, 25A, 25B) are positioned such that current follows pathways extending over at least one side of a dosing substance load (fig. 6E, [0288]), such that heat is conducted to a surface of said dosing substance load ([0289]).
Davidson does not explicitly disclose whether the heat is evenly distributed over the dosing substance load.
Neumann teaches an electrode and heating element (fig. 2a, contacts 3 and 4, heating element 2 [0098]) which results in heat being evenly distributed over a chip ([0020-0021]) for evaporative heating of an active compound (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that the electrodes are positioned such that current follows pathways so that the heat is evenly distributed, s taught by Neumann, in order to prevent uneven release of an active compound (Neumann [0009]).
Claims 13-14 and 18-19 are rejected under 35 U.S.C. 103 as unpatentable over Davidson and Harmer, further in view of Ruskewicz et al. (US 5855564 A1), hereafter Ruskewicz.
Regarding Claim 13, Davidson discloses a device of claim 8, comprising a clamping chamber apparatus (fig 5B 60 [0182]) that comprises: at least two clamping members (see annotated fig. below) such that vaporizing bioactive agent is in alignment with an air conduit of said clamping chamber (fig. 5B [0182]).
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However, Davidson is silent on the clamping members being configured to move one with respect to the other for selectively clamping said dose unit therebetween.
Ruskewicz teaches a clamping member (fig. 11, 47, col. 20 lines 21-25) for securing a continuous package (fig. 11, 46, col. 18 lines 39-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include Ruskewicz’s clamping mechanism in Davidson’s clamping members in order to firmly secure the dose unit, which prevents accidental rupture of the dose unit around its periphery (Ruskewicz, col. 20 lines 27-31). This clamping mechanism would further enhance the seal created in the modified device by allowing the dose unit to slide during dose changes while the clamping mechanism is unclamped, and sealing while the dose is being dispensed.
Regarding Claim 14, Davidson discloses a device of claim 13, wherein a power unit ([0122] batteries) operable, while said selectively clamping said dose unit, to deliver current to said electrically resistive heating element of said dose unit, for vaporization of the bioactive agent contained in the dose unit ([0122] and [0189]).
Regarding Claim 18, Davidson discloses an inhaler device of claim 13, wherein at least one of said clamping members comprises at least one air seal (as taught by Harmer fig. 2, the seals 20 would have been obvious to apply to the clamping members of Davidson’s fig. 5B to seal the air channel).
Regarding Claim 19, Davidson discloses an inhaler device of claim 13, wherein each of said at least two clamping members comprises a portion of said air conduit (Davidson fig. 5B, the clamping members define at least a part of the air channel 60).
Claims 1, 2, 4, 8, 10, 11, and 15 are rejected over Marshall et al. (WO 2011/073306 A1), hereafter Marshall, in view of Rabinowitz et al. (US 2005/0126562 A1), hereafter Rabinowitz.
Regarding Claim 1, Marshall discloses an activating unit (fig. 4, page 12 lines 28-30) for a dose unit (fig. 4, blister 24, page 12 last line), comprising: a dose puller (fig. 4, carrier 18, page 12 line 29) configured to move the dose unit from a storage position (fig. 4, storage position is within carousel 20, page 12 last line) into a use position (fig. 6, page 13 first para.); a holder configured for holding the dose unit such that the bioactive agent is in sealed alignment with an air conduit of the activating unit (fig. 4, rear portion 38 of carrier 18, page 12 line 29-page 13 line 5).
However, Marshall is silent on electrodes positioned to be in electrical contact with at least two electrical contact receiving regions of an electrically resistive heating element of the dose unit when in the activating unit.
Rabinowitz teaches a dose unit (figs. 5A-B, support 13 carries vaporizable compound 16 to vaporize into airway [0036]) which includes electrodes (fig. 4, 18) positioned to be in electrical contact with at least two electrical contact receiving regions of an electrically resistive heating element of the dose unit (fig. 5B, heating elements 32 with electrical contacts 34 [0117]) when in the activating unit (fig. 4 and fig. 9 [0126]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include electrodes positioned to be in electrical contact with at least two electrical contact receiving regions of an electrically resistive heating element of the dose unit when in the activating unit as taught by Rabinowitz in order to provide a heating source to vaporize the medicament in the dose unit, in order to control titration of the dose by adjusting the temperature (Rabinowitz [0110]).
Regarding Claim 2, Marshall as modified discloses an inhaler device comprising the activating unit of claim 1 (Marshall page 14 line 2).
Regarding Claim 4, Marshall discloses an activating unit of claim 1, wherein said dose puller comprises a dose pulling arm (fig. 2, carrier 18 is arm-shaped), shaped to interlock with a receiving region of the dose unit such that movement of said dose pulling arm moves the dose unit into or out of said use position (fig. 2, dispensing aperture 16 is shaped to interlock with carrier 18, page 13 lines 1-11).
Regarding Claim 8, Marshall discloses an inhaler device of claim 2, comprising a dose unit dispensing apparatus that comprises a plurality of dose units within a closed container (fig. 4, a plurality of blisters 24 are enclosed within carousel 20, shown closed in fig. 3, page 12 first para.).
Regarding Claim 10, Marshall discloses a device of claim 8, wherein the dose unit is dispensed to a vaporizing apparatus (fig. 6, 50, page 13 last para.), and an operation of said interlock comprises inserting said vaporizing apparatus into said dose unit dispensing apparatus (fig. 6, piercing members 52 and 54 are inserted into the blister, which is a portion of the dose unit dispensing apparatus).
Regarding Claim 11, Marshall discloses a device of claim 10, but does not explicitly disclose wherein the dose puller is actuated to extend from the vaporizing apparatus into a dose unit container containing a plurality of said dose units, where it attaches to the dose unit.
However, it has been held that a reversal of parts is an obvious modification (see MPEP 20144.04(VI)(a)), In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification.).
Regarding Claim 15, Marshall discloses a device of claim 11, wherein said dose unit container is in the form of a carousel enclosure, allowing rotationally selectable access (fig. 4, 20 is a carousel and allows selection of a dose, page 12 first para.).
Claim 12 is rejected under 35 U.S.C. 103 as unpatentable over Marshall and Rabinowitz, further in view of Dalziel et al. (US 5449091), hereafter Dalziel.
Regarding Claim 12, Marshall discloses a device of claim 11, but is silent on wherein attachment of said dose puller to said dose unit is by means of latch mandibles (examiner’s note: “latch mandibles” has been interpreted to mean a latching mechanism which uses two opposing parts for grasping).
Dalziel teaches a carousel for dispensing cartridges (fig. 2, abstract) which uses latch mandibles (fig. 8, 188, col. 6 lines 18-28) to engage a cartridge and pull the cartridge from the carousel.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall’s dose puller (figs. 3 and 5, 18) to instead use the latch mandibles on a pulling arm taught by Dalziel, since both mechanisms would work equally well at pulling a dose cartridge from a carousel dispenser. Dalziel’s latch mandibles are used for the same purpose as Marshall’s dose puller, which is to retrieve a selection from a carousel of stored cartridges.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 9802011 to the same applicant; figures 6A-9
US 2001/0035184 figs. 15-31
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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