DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to because the lead lines for numerals 500, 502 and 803 appear incorrect in Fig. 9C. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 17 and 22 is/are objected to because of the following informalities:
Claim 17, Ln. 1 recites “wherein said structure” which should read “wherein said drug dose structure” for consistency with claim 1
Claim 17, Ln. 2 recites “such that air flows traverses” which should read either “such that air flow traverses” or “such that air flows traverse”
Claim 17, Ln. 2 recites “said air permeable layer” which should read “said first air permeable layer” for consistency with claim 1
Claim 17, Ln. 2-3 recites “an electrically resistive material” which should read “said electrically resistive material” for consistency with claim 1
Claim 17, Ln. 3-4 recites “said additional air permeable layer” which should read “said second air permeable layer” for consistency with claim 2
Claim 22, Ln. 2 recites “drug dose structure” which should read either “drug dose structures”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 23-25 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 23 recites the limitation “moving a single dose structure comprised in the cartridge of claim 1 towards a heating element” which is not found to be supported by the application as originally filed when considered together with the requirements of claim 1. Specifically, claim 1 has recited “a first air permeable layer which comprises an electrically resistive material which, when contacted by electrodes, acts as a thermal emitter that generates and emits heat.” The only portion of the originally filed application which has mention of electrodes is the discussion of Figs. 6E-6F. While the discussion of Figs. 6E-6F is drawn to a “tape” embodiment and not a stacked embodiment, as required by claim 1, the discussion in relation to Figs. 9A-9C is found to reasonably support the integration of the embodiment of Figs. 6E-6F into a stacked configuration. Notably, though, the discussion of Figs. 9A-9C discusses the embodiment as having “a ‘no moving parts’ operation” (¶0300 of the PGPub copy of the instant application). Thus, the combination of Figs. 6E-6F and Figs. 9A-9C do not provide sufficient written description support for the claim. There is a further embodiment disclosed in Figs. 10A-10D which discusses moving an active disc 989 toward a thermal emitter 990 (¶¶0306-0308 of the PGPub copy of the instant application). Notably, though, that embodiment uses only a single thermal emitter in the form of thermal emitter 990 while claim 1 has instead recited a thermal emitter which comes into contact electrodes as an element of each drug dose structure of the stack of layered drug dose structures. Thus, the embodiment of Figs. 10A-10D is not suitable for reading on the requirements of instant claim 1. It is thus found that the application as originally filed fails to provide sufficient written description support for the particular claimed combination of elements in claim 1 together with the movement recited by claim 23.
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.
Claim(s) 14 is/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 pre-AIA the applicant regards as the invention.
Claim 14 recites the limitation “said particles” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “particles”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-7 and 10-22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 11,071,712. Although the claims at issue are not identical, they are not patentably distinct from each other because the plurality of stacked drug dose structures in patent claim 19 are readable as a cartridge in accordance with instant claim 1 in the absence of any further defining structure of the cartridge. While patent claim 19, following from patent claim 1, does not expressly recite the vaporized amount being sufficient for a single treatment dose one of ordinary skill in the art reading such portions of patent claim 1 as “configured to heat a volume of said source material layer when activated so as to vaporize said at least one active substance from said source material” would have obviously concluded the intent of patent claim 1 was to vaporize a dose of the plant matter. A further mapping of dependent claims is as follows:
Instant claim 2 vs. limitations in patent claim 1
Instant claim 3 vs. limitations in patent claim 1
Instant claim 4 as obvious in view of limitations in patent claim 1 – a plant matter with active substance which is being heated to be vaporized, as recited in patent claim 1, would obviously have led one of ordinary skill in the art to expect a thickness within the claimed range so the plant matter was neither too thin not too thick for effective vaporization
Instant claim 5 vs. limitations in patent claim 1
Instant claim 6 as obvious in view of limitations in patent claim 1 – an air permeable resistive material, as recited in patent claim 1, would obviously have led one of ordinary skill in the art to consider a mesh structure
Instant claim 7 vs. limitations in patent claim 1
Instant claim 10 as obvious in view of limitations in patent claim 1 – a plant matter with active substance, as recited in patent claim 1, would obviously have led one of ordinary skill in the art to consider cannabis as a particular plant matter
Instant claim 11 as obvious in view of limitations in patent claim 1 – a plant matter with active substance, as recited in patent claim 1, would obviously have led one of ordinary skill in the art to consider tobacco as a particular plant matter
Instant claim 12 as obvious in view of limitations in patent claim 1 – a plant matter with active substance, as recited in patent claim 1, would obviously have led one of ordinary skill in the art to consider a particular dosage size, with the instant claim not being outside of what would ordinarily be expected for an active plant matter substance
Instant claim 13 as obvious in view of limitations in patent claim 1 – the recitation in patent claim 1 of “at least one active substance” obviously suggests more than one active substance and one of ordinary skill in the art would then obviously expect those two substances to not necessarily be perfectly evenly spread across the layer of plant material
Instant claim 14 as obvious in view of limitations in patent claim 1 – the instant claim is recited in product-by-process language as fails to patentably distinguish over the requirements of the plant matter of patent claim 1
Instant claim 15 as obvious in view of limitations in patent claim 1 – patent claim 1 recites the plant matter of compressed to a density and the presently claimed density is not an unexpected amount recognizing the intent of the claimed invention to allow for air permeability through the compressed plant matter
Instant claim 16 as obvious in view of limitations in patent claim 1 – patent claim 1 recites the plant matter of compressed to a density and the presently claimed density is not an unexpected amount recognizing the intent of the claimed invention to allow for air permeability through the compressed plant matter
Instant claim 17 vs. limitations in patent claim 1
Instant claim 18 as obvious in view of limitations in patent claim 1 – an air permeable resistive material, as recited in patent claim 1, would obviously have led one of ordinary skill in the art to consider steel as a common resistive heating material in the art
Instant claim 19 as obvious in view of limitations in patent claim 1 – a plant matter with active substance, as recited in patent claim 1, would obviously have led one of ordinary skill in the art to specifying the plant matter as a therapeutic drug substance
Instant claim 20 vs. limitations in patent claim 1
Instant claim 21 vs. limitations in patent claim 1
Instant claim 22 vs. limitations in patent claim 19
Claim(s) 8-9 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 11,071,712 in view of Whittle et al. (U.S. Pub. 2005/0063686). Patent claim 19 is silent on aperture size. Whittle teaches a resistive heater vaporizing device including a mesh (Fig. 5A; ¶0070) with apertures of 36 microns. Whittle teaches this as a suitable size for apertures when using a stainless steel mesh to heat cannabis for vaporization (¶¶0033-0034, 0070).
It would have been prima facie obvious to one having ordinary skill in the art at the time of the invention to have specified in patent claim 18 the apertures having a size of 36 microns based upon the teaching by Whittle that this size is effective when using a stainless steel mesh to heat cannabis for vaporization.
Allowable Subject Matter
Claims 1-25 are allowed over the prior art. All claims are subject to the above nonstatutory double patenting rejections and some of the claims are additionally subject to above rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112(b).
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the prior art fails to teach or suggest a cartridge including all elements and functionality recited by the instant claim. It is initially noted that the term “cartridge” is understood in light of its usage in the specification as a term of art which implies a continuous structure for implementation with an inhaler device. Next, the claim recites the cartridge as comprising a stack of layered drug dose structures, with the term “structures” specifically recited in plural which implies that multiple layered drug dose structures must be included. Additionally, the first air permeable layer is recited as being of an electrically resistive material which, when contacted by electrodes, acts as a thermal emitter and as being in contact with the layer of plant material. Thus, the first air permeable layer needs to be configured for contact with electrodes to cause it to emit heat and needs to be in direct contact with the plant material.
Closest prior art to the instant claim include: Sprinkel et al. (U.S. Patent 5649554), Pienemann (WO 00/28844 A1), Whittle et al. (U.S. Pub. 2005/0063686) and Todd (U.S. Pub. 2012/0304990).
Sprinkel teaches a plurality of stacked discs 112 containing tobacco, with each disc including an individual heater 32 (Fig. 6A; Col. 11, Ln. 11-23). However, Sprinkel fails to teach or suggest contact between a resistive heater material and the tobacco. Instead, Sprinkel only teaches moving the disc with tobacco into thermal registry with the heater, but not into contact with the heater.
Pienemann teaches a disk 5 with substrate portions 1 (Figs 4a-4b) or a carrier 6 with substrate portions 1 (Figs. 5a-5b). However, the substrate portions 1 are not taught as including an electrically resistive material to be contacted by electrodes, as required by the claim.
Whittle teaches a dose structure for vaporizing cannabis but fails to teach or suggest a stacked configuration of drug dose structures. While Fig. 7 shows a strip format which can be wound onto a reel that format is firstly not “stacked” and secondly is only for the purposes of storage and not for actual implementation into an inhaler. Instead, the use of a reel in Whittle is only for storage purposes and actual implementation into an inhaler involves tearing off a single of the foil 9 at a time instead of placing into the inhaler a cartridge with stacked foils 9.
Todd teaches a dose cartridge 6 inserted into a vaporizer (Fig. 2). However, the vaporizer does not receive multiple, stacked dose cartridges 6 at a time. While Fig. 6 shows a packaging container with multiple dose cartridges that type of packaging container, while holding multiple dose structures, would not be reasonably read as a “cartridge” in light of how that term is used throughout the instant application.
It is thus found that one having ordinary skill in the art at the time of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 16, it is noted that the term “about” is defined in the specification as meaning ±10%.
Regarding claim 17, it is noted that the language “in its entirety” is understood to imply that each individual element which comprises the drug dose structure is air permeable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additionally attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785