DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The Supplemental Amendment filed 14 May 2026 has been entered. Claims 1-23 and 25-40 are pending in the application with claim 24 canceled. Applicant’s amendment to the Drawings and Claims have overcome each and every objection and 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 15 Jan 2026.
The prior nonstatutory double patenting has not been resolved.
Response to Arguments
Applicant's arguments filed 14 May 2026 have been fully considered but they are not persuasive. Applicant indicates that the nonstatutory double patenting is overcome by the filing of a statutory disclaimer against claim 19 of U.S. Patent 11,071,712.
It is respectfully submitted the nonstatutory double patenting has not been overcome, for two reasons. Firstly, the statutory disclaimer has been incorrectly filed in the instant application instead of the application from which the ‘712 patent originated. Thus, the USPTO cannot properly process the statutory disclaimer and produce a certificate of correction as the statutory disclaimer has been filed in the wrong application.
Secondly, and of greater importance, MPEP 1490(I) states in citing to Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 n.5, 58 USPQ2d 1869, 1878 n.5 (Fed. Cir. 2001) “[a] patent owner cannot avoid double patenting by disclaiming the earlier patent". Upon consultation by the examiner with the USPTO’s Office of Patent Legal Administration (OPLA) it has been confirmed that the above cited MPEP section clearly precludes use of a statutory disclaimer to avoid double patenting. Thus, even if applicant were to refile the statutory disclaimer in the proper application it would not serve to remove the below nonstatutory double patenting rejection.
Claim Objections
Claim(s) 6-22, 27-28, 30-31 and 35-38 is/are objected to because of the following informalities:
Each of claims 6-22 recites in its preamble “The cartridge according to …” while dependent claims 2-5 instead read “The cartridge of …”. One phrasing should be selected for consistency in all dependent claims (i.e. either “according to” or “of”).
Each of claims 35-38 recites in its preamble “The cartridge according to …” while dependent claims 33-34 instead read “The cartridge of …”. One phrasing should be selected for consistency in all dependent claims (i.e. either “according to” or “of”).
The chemicals recited in claims 27-28 & 30-31 should not be capitalized (except when written in acronym form)
Appropriate correction is required.
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, 10-23, 25 and 29 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. Further, the terminology “drug dose structure” would have been obviously suggestive to one of ordinary skill in the art of a structure configured for delivery of a dose of a drug. The distinction of the drug dose structure providing “a single treatment dose” would have thus been an obvious expectation of one of ordinary skill in the art. This is further substantiated by the recitations in patent claim 19 where a plurality of drug dose structures are recited, which one of ordinary skill in the art would thus have obviously expected to be used to deliver individual doses from the respective plurality of drug dose structures. 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
Instant claim 23 as obvious in view of patent claim 19 – the instant claim merely recites a method which would have been obviously expected to have been performed on the structure recited in patent claim 19 based upon the functional language found in the totality of patent claim 19
Instant claim 25 as obvious in view of patent claim 19 – each of the plurality of drug dose structures in patent claim 19 will be obviously expected to include the same unique set of structures recited of the single drug dose structure in patent claim 1
Instant claim 29 as obvious in view of patent claim 19 – patent claim 19 is suitable for use in delivering an active substance which is non-restricted
Claim(s) 8-9, 26-28 and 30-31 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 19 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.
Patent claim 19 is silent on whether the active substance is a restricted substance, to include a cannabinoid with THC. Whittle teaches a resistive heater vaporizing device and teaches dried medicinal cannabis are one particular plant material desirably used in the vaporizing device (¶¶0088-0093). Whittle teaches medicinal cannabis as a desirable plant material for use in a vaporizing device to provide a therapeutic vapor (¶¶0088-0093).
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 19 the active substance is a restricted substance, to include a cannabinoid with THC in order to provide the benefit of specifying a particular plant material desirable for use in a vaporizing device to provide a therapeutic vapor in view of Whittle.
Allowable Subject Matter
Claims 1-23 and 25-31 are allowed over the prior art. However, the claims are subject to the above nonstatutory double patenting rejection.
Claims 32-34 and 39-40 are allowed. Claims 35-38 are allowed over the prior art but are objected to based upon the above claim objection.
The following is an examiner’s statement of reasons for allowance: the claim 1 remains allowed over the prior art for the same reasons stated in the preceding Office action. New claim 32 is allowed over the prior art as it is more narrowly recites the limitations of claim 1 by specifying DMT as the substance to be vaporized.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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