CLAIMS 21-42 AND 90 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s Election of Species Requirement reply/amendment filed August 03, 2025 and Information Disclosure Statements filed June 19, 2024, July 03, 2024 and July 11, 2025 have been received and entered into the application.
As reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner. Also attached to this Office action is a form PTO/SB/429 which lists references included with a third party submission of references dated June 12, 2024.
Election/Restrictions
Applicant's election with traverse of dimethyltryptamine as the ayahuasca-like substance specie in the reply filed on August 03, 2025 is acknowledged. The traversal is on the grounds that it would not be an undue burden on the Examiner to examine all of the claimed species “given the nature of the application”, (reply at pg. 5).
This is not found persuasive because here it is the delivery of a particular compound, by vaporization, that is being claimed and different chemical substances react in a dissimilar manner to being vaporized/heated etc. Further, each of the chemical species of the claims is separately classified thus indicating a separate status in the art for each.
The requirement is still deemed proper and is maintained. Claims
Claims 21-38, 42 and 90 read on the elected species and are herein examined on the merits.
Claims 39-41 read on a deuterium isotopomer/isotopologue of dimethyltryptamine and thus are withdrawn from further consideration as being directed to a non-elected species.
Claim Rejection - 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.
Claims 21-30, 35, 37, 38, 42 and 90 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rose et al., (US 10,688,058 B2, (“Rose”); cited by the Examiner).
Rose teaches a method of delivering various medicaments through inhalation using any one of various devices, (col. 3, line 50 – col. 4, line 57 and Figs. 1-15), including dimethyltryptamine as the medicament, (abstract and at least col. 11, Table 1, line item 9).
In particular, Rose teaches the features of present claim 21, namely a device (at least Fig. 4) for the delivery of a substance, e.g., dimethyltryptamine, comprising: a chamber (50) comprising at least one vaporizable formulation (30, 40). Rose also teaches the further features of dependent claims 22-30, 35, 38, 42 and 90. Namely in, for example, Fig. 4, wherein the chamber comprises a top portion (right side of 50) adapted for coupling to a mouthpiece (180) wherein the tap portion of the chamber comprises at least one aperture adapted to permit flow of air, liquid, solids, or vapor between the top portion of the chamber and the mouthpiece (flow arrow at 180 in Fig. 4); additionally comprising a mouthpiece coupled to the top portion of the chamber wherein the mouthpiece (180) comprises a top aperture, a central open bore, a bottom portion comprising an aperture, and wherein the bottom portion of the mouthpiece is coupled to the tap portion of the chamber; additionally comprising at least one seal (at left of 180 in Fig. 4) shunted between the bottom portion of the mouthpiece comprising an aperture and the top portion of the chamber.
Additionally, wherein the mouthpiece is releasably coupled to the top portion of the chamber (180); wherein the mouthpiece is lockably coupled to the top portion of the chamber (180); wherein the chamber comprises a bottom portion (left side of 50) adapted for coupling to a power unit capable of providing power to vaporize the vaporizable formulation; wherein the chamber is coupled to the power unit (130 in Fig. 4) capable of providing power to vaporize the vaporizable formulation; wherein the chamber is releasably (130 as shown in Fig, 4) coupled to the power unit or wherein the chamber is lockably (130) coupled to the power unit. Additionally, a device is taught wherein the vaporizable formulation comprises one or more of propylene glycol (PG), vegetable glycerin (VG), or polyethylene glycol (PEG), (Table 2 at col. 18).
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.
Claims 31-38, 42 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Rose, as relied upon above under 35 USC 102, for the reasons set forth above which reasons are here incorporated by reference.
The differences between the above and the presently claimed subject matter lies in that Rose fails to teach (a) wherein the chamber comprises one or more of specifically a 401, S10, 601, S10, 710, 808, 901, 4081, CE-4, CE-5, ES, or eGo connector, (b) wherein the chamber comprises specifically a 510 connector, (c) wherein the chamber is specifically transparent to permit visualization of levels of the vaporizable formulation or (d) wherein the chamber is specifically refillable.
However, 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 as each is considered to be merely design choices available to one of ordinary skill in the art, the selection between such choices cannot be viewed as inventive.
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.
Claims 31-38, 42 and 90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,235,110, (cited by Applicant).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to a device containing the elected dimethyltryptamine substance which in the present claims is the means for accomplishing the claim method of delivery.
Insofar as the patented claims clearly indicate it is a device for delivery, it would have clearly been obvious to actually go forward and to operate the patented device and deliver the substance by the same method as is presently claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 December 12, 2025