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
Newly submitted claims 58-59 are directed to an invention that lacks unity with the invention originally claimed for the following reasons: The groups of inventions, Group I, claims 36, 44-48, and 56-57 and Group IV, claims 58-59 lack unity of invention because even though the inventions of these groups require the technical feature of an aerosolizable material comprising at least one cannabinoid and at least one carrier constituent, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Naheed (US-20170021025-A1).
Naheed directed to a medication dispensing system, discloses a pharmaceutical formulation that can be used for vaporization (i.e., aerosolizable material) ([0077]) comprising a cannabinoid ([0079]-[0083]) and plasticizers including but not limited to triethyl citrate (i.e., carrier constituent) ([0335]).
Since the “special technical feature” linking Groups I-IV is disclosed by Naheed, the “special technical feature” lacks novelty or inventive step and does not make a contribution over the prior art. Therefore, no single general inventive concept exists and restriction is appropriate.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 58-59 are withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The office action is in response to Applicant’s amendment filed on 05/14/2026.
Claims 36, 44-54, and 56-59 are pending and are subject to this Office Action.
Claims 36 and 45 are amended.
Claims 1-35, 37-43, and 55 are cancelled.
Claims 56-59 are new.
Claims 49-54 and 58-59 have been withdrawn as being directed to a non-elected group.
The 35 U.S.C. 112(a) rejection has been withdrawn due to amendments made to the claims.
Response to Arguments
Applicant' s arguments, see pages 4-6, filed 05/14/2026, with respect to the rejection of claims 36-48 under 35 U.S.C. 103, have been fully considered and are persuasive. The arguments regarding the rejection of claim 36 are persuasive because the Applicant has amended claim 36 to include limitations that were not previously presented. Specifically, the Applicant has introduced limitations regarding the carrier constituent comprising triethyl citrate. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of newly found prior art.
The following is modified rejection based on amendments made to the claims.
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.
Rejection #1
Claims 36, 44-45, and 47-48 rejected on the ground of nonstatutory double patenting as being unpatentable over claim1, 21-22, and 27-28 of U.S. Application No. 17/754,672. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to aerosolizable material comprising a cannabinoid and a carrier constituent comprising triethyl citrate.
The rejected claims differ from the conflicting claims in that the conflicting claims recite an article for use with an aerosol provision system in addition to the aerosolizable material, however the rejected claims are present in their entirety in the conflicting claims and therefore all elements of the rejected claims are present and obvious over the conflicting claims.
Claim 36 is obvious over claim 1.
Claim 44 is obvious over claim 21.
Claim 45 is obvious over claim 22.
Claim 47 is obvious over claim 27.
Claim 48 is obvious over claim 28.
Rejection #2
Claims 36, 44-45, and 47-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35-36, 42, and 46-47 of U.S. Application No. 17/767,731. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to aerosolizable material comprising a cannabinoid such as cannabidiol and a carrier constituent comprising triethyl citrate.
The rejected claims differ from the conflicting claims in that the conflicting claims recite at least 55% of the cannabidiol is present in the form of (+)(-) which is not required but the rejected claims, however the rejected claims are present in their entirety in the conflicting claims and therefore all elements of the rejected claims are present and obvious over the conflicting claims.
Claim 36 is obvious over claims 35-36.
Claim 44 is obvious over claim 35.
Claim 45 is obvious over claim 42.
Claim 47 is obvious over claim 46.
Claim 48 is obvious over claim 47.
Rejection #3
Claims 36, 44, and 46-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36, 44, 47-48 and 60 of U.S. Application No. 17/767,738. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to aerosolizable material comprising a cannabinoid such as cannabidiol and a carrier constituent comprising triethyl citrate.
The rejected claims differ from the conflicting claims in that the conflicting claims recite additional constituents such as propylene glycol which is not required by the rejected claims, however the rejected claims are present in their entirety in the conflicting claims and therefore all elements of the rejected claims are present and obvious over the conflicting claims.
Claim 36 is obvious over claims 36 and 60.
Claim 44 is obvious over claim 36.
Claim 46 is obvious over claim 44.
Claim 47 is obvious over claim 47.
Claim 48 is obvious over claim 48.
Rejection #4
Claims 35-36, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16-18 and 24 of U.S. Application No. 18/728,316. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to aerosolizable material comprising a cannabinoid such as cannabidiol and a carrier constituent comprising triethyl citrate.
The rejected claims differ from the conflicting claims in that the conflicting claims recite additional constituents such as propylene glycol which is not required by the rejected claims, however the rejected claims are present in their entirety in the conflicting claims and therefore all elements of the rejected claims are present and obvious over the conflicting claims.
Claims 35-36 are obvious over claims 1 and 25.
Claim 44 is obvious over claims 16-18.
Rejection #5
Claims 36 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-13 and 22 of U.S. Application No. 18/580,835. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to aerosolizable material comprising a cannabinoid such as cannabidiol and a carrier constituent comprising triethyl citrate.
The rejected claims differ from the conflicting claims in that the conflicting claims recite additional constituents such as a gelling agent which is not required by the rejected claims, however the rejected claims are present in their entirety in the conflicting claims and therefore all elements of the rejected claims are present and obvious over the conflicting claims.
Claim 36 is obvious over claims 1 and 12-13
Claim 44 is obvious over claim 22.
Rejection #6
Claims 36 and 44-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 36, and 42-47 of U.S. Patent No. 17/767,724. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to aerosolizable material comprising a cannabinoid such as cannabidiol and a carrier constituent comprising triethyl citrate.
The rejected claims differ from the conflicting claims in that the conflicting claims recite additional constituents such as propylene glycol and water which are not required by the rejected claims, however the rejected claims are present in their entirety in the conflicting claims and therefore all elements of the rejected claims are present and obvious over the conflicting claims.
Claim 36 is obvious over claims 34, 36, and 47.
Claim 44 is obvious over claim 42.
Claim 45 is obvious over claim 43.
Claim 46 is obvious over claim 44.
Claim 47 is obvious over claim 45.
Claim 48 is obvious over claim 46.
Rejection #7
Claims 36 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11 and 13-14 of U.S. Application No. 18/579,670. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to aerosolizable material comprising a cannabinoid such as cannabidiol and a carrier constituent comprising triethyl citrate.
The rejected claims differ from the conflicting claims in that the conflicting claims recite additional constituents such as a gelling agent which is not required by the rejected claims, however the rejected claims are present in their entirety in the conflicting claims and therefore all elements of the rejected claims are present and obvious over the conflicting claims.
Claim 36 is obvious over claims 1, 11, and 13-14.
Claim 44 is obvious over claim 14.
Rejection #8
Claims 36, 44-45, and 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 16-18, 20, and 23 of U.S. Application No. 19/103,089. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to aerosolizable material comprising a cannabinoid such as cannabidiol and a carrier constituent comprising triethyl citrate.
The rejected claims differ from the conflicting claims in that the conflicting claims recite additional constituents such as propylene glycol and water which are not required by the rejected claims, however the rejected claims are present in their entirety in the conflicting claims and therefore all elements of the rejected claims are present and obvious over the conflicting claims.
Claim 36 is obvious over claims 1, 9, 16, and 20.
Claim 44 is obvious over claim 17.
Claim 45 is obvious over claim 18.
Claim 57 is obvious over claim 23.
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.
Claim(s) 36, 44, 47-48, and 56-57 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Naheed (US-20170021025-A1).
In regards to claim 36, Naheed directed to a medication dispensing system, discloses a pharmaceutical formulation that can be used for vaporization (i.e., aerosolizable material) ([0077]) comprising a cannabinoid ([0079]-[0083]) and plasticizers including but not limited to triethyl citrate (i.e., carrier constituent) ([0335]).
In regards to claim 44, Naheed discloses the cannabinoid can be cannabidiol (CBD) ([0021]; [0082]; [0085]).
In regards to claims 47-48, Naheed discloses the aerosolizable material further comprises gelling agents, aerosol former materials, flavors (i.e., olfactory active constituent), solvents, or fillers (i.e., further constituents) ([0051]).
Naheed further discloses the aerosolizable material can comprise terpenes, alkaloids and flavonoids (i.e., olfactory active constituents) ([0079]).
In regards to claim 56, Naheed discloses the flavor in the aerosolizable material (i.e., flavor block) can be at least 1 weight percent which is within the claimed range of a flavor block from 1 to 10 weight percent ([0139]).
In regards to claim 57, Naheed discloses the flavor compound can include extracts from cannabis ([0146]), which include terpenes ([0079]-[0080]).
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.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Naheed (US-20170021025-A1) as applied to claim 36 above, and further in view of Whittle et al. (US-20190270563-A1).
In regards to claim 45, Naheed discloses a weight percentage of the cannabinoid ([0026];[0127]-[0132]) and that cannabinoids are effective in pain relief and curing types of cancer ([0014]), but is silent regarding the amount of cannabinoid present in the aerosolizable material and therefore does not explicitly disclose 5 mgt/mL to 100 mg/mL. However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the amount of cannabinoid since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed cannabinoid amount is critical and has unexpected results. In the present invention, one would have been motivated to optimize the amount of cannabinoid present in the aerosolizable material motivated by the desire to have a desirable amount present in order to effectively provide pain relief ([0014]).
Alternatively, Whittle, directed to a pharmaceutical composition that can be used in aerosols (i.e., aerosolizable material) (abstract; [0007]), discloses a standard dose of THC (i.e., cannabinoid) to meet clinical needs in aerosol formulations would be up to 50 mg cannabinoids per mL ([0008]).
Whittle further discloses a typical liquid pharmaceutical formulation is preferably 25 mg/mL ([0017]-[0018]).
Whittle further discloses 50 mg/mL of cannabinoids is a therapeutically desirable level of cannabinoids ([0116]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Naheed by making the aerosolizable formulation comprise cannabinoids in a range of 5 to 100 mg/ml, as taught by Whittle, because both are directed to aerosolizable formulations, Whittle teaches a standard aerosolizable formulation comprises up to 50 mg/ml of cannabinoids which is a therapeutically desirable amount ([0116]), it would be obvious to look to a similar reference for a known amount of cannabinoids when the prior art is silent to one, and this merely involves applying a known amount of cannabinoid to a similar composition to yield predictable results.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Naheed (US-20170021025-A1) as applied to claim 36 above.
In regards to claim 46, Naheed discloses the aerosolizable material can be a liquid ([0077]) and further discloses the carriers are liquids ([0085]). Since Naheed discloses embodiments with a liquid formulation, it would be obvious to one of ordinary skill in the art that the formulation would be a liquid at 25C, which is approximately room temperature and is the expected temperature of a room where an aerosol device is operated.
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 MADELEINE PAULINA DELACRUZ whose telephone number is (703)756-4544. The examiner can normally be reached Monday - Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at (571)270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MADELEINE P DELACRUZ/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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