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 .
Response to Amendment
Claim 6 is amended. Claim 15 is cancelled. Claims 14 and 16-21 are withdrawn. Claims 1-13 are presently examined.
Applicant’s arguments regarding the objection to the drawings have been fully considered and are persuasive. The objection of 8/20/2025 is withdrawn.
Specification
Note: All citations to applicant’s specification are based on the Marked-Up Copy of the Specification filed 11/17/2023.
The use of the term Drambuie (page 14, line 31), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: The trade name or mark used in commerce “Drambuie” (page 14, line 31) without any accompanying generic terminology.
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 6-8 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.
Regarding claim 6, the phrase "included" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In this case, the limitations listed after each recitation of “included” will be considered to not limit the claim. Claims 7 and 8 are indefinite by dependence.
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.
Claims 1, 3 and 5-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aoun (WO 2020/025730).
Regarding claims 1 and 3, Aoun discloses an aerosol forming composition (abstract) having a gelling agent (page 26, lines 29-30), 20-40 wt% of an aerosol generating agent on a dry weight basis (page 28, lines 1-16), and an active substance at about 30 wt% to about 40 wt% on a dry weight basis (page 29, lines 24-27). The active substance is CBDA (page 38, lines 20-32, page 39, lines 1-2). The aerosol forming composition is dried to form an amorphous solid (page 2, lines 15-19).
Regarding claim 5, Aoun discloses that the gelling agent is present about about 15-27 wt% (page 27, lines 1-5).
Regarding claims 6 and 7, Aoun discloses that the gelling agent is alginate (page 27, lines 11-23).
Regarding claim 8, Aoun discloses that the gelling agent is hydroxypropyl cellulose (page 27, lines 11-23).
Regarding claim 9, Aoun discloses that a setting agent may be added to the slurry during the formation of the amorphous solid (page 32, lines 31-32, page 33, lines 1-2) to form a cross linked gel (page 33, lines 11-19), indicating that the setting agent isn’t necessary and may be excluded. The amorphous solid would not be cross linked in that scenario.
Regarding claim 10, Aoun discloses that the gelling agent is carboxymethylcellulose (page 27, lines 11-23).
Regarding claim 11, Aoun discloses that the gelling agent is guar gum (page 27, lines 11-23).
Regarding claims 12 and 13, Aoun discloses that the aerosol generating agent is glycerol (page 28, lines 1-16).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Aoun (WO 2020/025730).
Regarding claim 2, Aoun discloses all the claim limitations as set forth above. Aoun additionally discloses that the active substance can be present at about 1 wt% to about 40 wt% (page 28, lines 27-32, page 29, lines 1-4). Aoun does not explicitly disclose the claimed range being obvious.
However, one of ordinary skill in the art would recognize that the claimed range is obvious since it overlaps the claimed range. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding claim 4, Aoun discloses all the claim limitations as set forth above. Aoun additionally discloses that that the aerosol generating agent can be present at from about 20 wt% to about 80 wt% (page 28, lines 1-16). Aoun does not explicitly disclose the claimed range being obvious.
However, one of ordinary skill in the art would recognize that the claimed range is obvious since it overlaps the claimed range. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
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 1-10 and 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-13 and 15-16 of copending Application No. 18/043,926 (hereafter referred to as Abi Aoun ‘926).
Regarding claim 1, Abi Aoun ‘926 claims an amorphous solid for use in aerosol generation, the amorphous solid comprising about 1 to about 50 wt% of a cannabis derivative, about 10 to about 80 wt% aerosol former material, gelling agent, wherein the wt% values are calculated on a dry weight basis (claim 1). The cannabis derivative is CBDA (claim 16).
Regarding claim 2, Abi Aoun ‘926 claims the solid comprising about 1 to about 12 wt% of the cannabis derivative (claim 2).
Regarding claim 3, Abi Aoun ‘926 claims the solid comprising about 15 to about 50 wt% of the cannabis derivative (claim 3).
Regarding claim 4, Abi Aoun ‘926 claims the solid comprising about 60 to about 80 wt% aerosol former material (claim 4).
Regarding claim 5, Abi Aoun ‘926 claims the solid comprising about 15 to about 40 wt% gelling agent (claim 5).
Regarding claim 6, Abi Aoun ‘926 claims the gelling agent being alginate (claim 9).
Regarding claims 7-8 and 10, Abi Aoun ‘926 claims the gelling agent comprising carboxymethyl cellulose (claim 10).
Regarding claim 9, Abi Aoun ‘926 claims the gelling agent not being crosslinked (claim 12).
Regarding claims 12 and 13, Abi Aoun ‘926 claims the aerosol former material being glycerol (claim 13).
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 18/043,926 (hereafter referred to as Abi Aoun ‘926) in view of Aoun (WO 2020/025730).
Regarding claim 11, Abi Aoun ‘926 claims all the claim limitations as set forth above. Abi Aoun does not explicitly claim the gelling agent comprising guar gum.
Aoun discloses an amorphous solid (abstract) having a gelling agent that is either alginate or carboxymethylcellulose (page 27, lines 11-23).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the carboxymethylcellulose of Abi Aoun ‘926 for the alginate of Aoun. One would have been motivated to do so since Aoun teaches that alginate and carboxymethylcellulose are equivalent gelling agents for amorphous solids. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See MPEP § 2143, B.
Claims 1-2 and 4-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-10 and 12-13 of copending Application No. 18/043,935 (hereafter referred to as Abi Aoun ‘935).
Regarding claims 1 and 2, Abi Aoun ‘935 claims an amorphous solid for use in aerosol generation comprising about 1 to about 12 wt% cannabis derivative, about 10 to about 80 wt% aerosol former material, and gelling agent, wherein the wt% values are calculated on a dry weight basis (claim 1). The cannabis derivative is CBDA (claim 13).
Regarding claim 4, Abi Aoun ‘935 claims the solid comprising about 60 to about 80 wt% aerosol former material (claim 2).
Regarding claim 5, Abi Aoun ‘935 claims the solid comprising about 15 to about 40 wt% gelling agent (claim 2).
Regarding claims 6 and 7, Abi Aoun ‘935 claims the gelling comprising alginate (claim 6).
Regarding claims 8 and 10, Abi Aoun ‘935 claims the gelling agent being CMC (claim 9).
Regarding claim 9, Abi Aoun ‘935 claims the gelling agent not being crosslinked (claim 8).
Regarding claim 11, Abi Aoun ‘935 claims the gelling agent being guar gum (claim 6).
Regarding claims 12 and 13, Abi Aoun ‘935 claims the aerosol former being glycerol (claim 10).
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Response to Amendment
Regarding the objection to the specification, applicant does not submit any argument that the trade name and/or mark used in commerce Drambuie is accompanied by generic terminology. The rejection is therefore maintained.
Regarding the rejections under 35 USC 112(b), applicant’s arguments have been fully considered but they are not persuasive. Applicant argues that the replacement of the term “such as” with “including” eliminates the exemplary language, however, use of “including” combined with the same recitation of specific examples within the claimed genus does not eliminate the confusion over the intended scope of the claim. See MPEP § 2173.05(d).
Regarding the rejections under 35 USC 102, applicant’s arguments have been fully considered but they are not persuasive. Applicant argues (a) that there is no disclosure of all the features of Aoun in combination, (b) that Aoun does not specifically relate to aerosol generation for delivery of cannabidiol, (c) that the use of cannabidiol provides unexcepted results that are not foreseen by Aoun, (d) that it is insufficient to propose that a medication could be made, rather that the prior art must show that a modification would be made and (e) that the dependent claims are allowable due to dependence on an allowable claim.
Regarding (a), the operative standard for determining anticipation is whether each and every element of the claim is described within a single prior art reference, not whether a single embodiment containing all the features is known in the prior art reference. See MPEP § 2131. In this case, applicant does not challenge the finding of the Office action that each feature of the claimed invention is found within Aoun.
Regarding (b), a reference may anticipate a claimed invention even if the reference is directed to an entirely different problem than that addressed by the claimed invention. See MPEP § 2131.05.
Regarding (c), secondary conditions such as unexpected results are irrelevant to anticipation rejections. See MPEP § 2131.04.
Regarding (d), the case law cited by applicant is irrelevant to anticipation rejections since modifications based on the skill of one in the art are not part of anticipation rejections.
Regarding (e), all examined claims are rejected as set forth above.
Regarding the rejections under 35 USC 103, applicant’s arguments have been fully considered but they are not persuasive. Applicant recites general legal principles applicable to determinations of obviousness, however, they are recited without any connection to the specific conclusions of obviousness set forth in the Office action, namely, that one of ordinary skill in the art would recognize the obviousness of the claimed ranges. Aoun discloses all the limitations that applicant specifically discusses without any reference to the principles of obviousness.
Regarding the rejections over nonstatutory double patenting, applicant’s arguments have been fully considered but they are not persuasive. Applicant simply asserts that Abi Aoun ‘926 and Abi Aoun ‘935 do not claim the instantly claimed features, however, no specific argument is presented that could be considered by the Examiner. The Examiner therefore restates the rejections above.
Conclusion
THIS ACTION IS MADE FINAL. 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 RUSSELL E SPARKS whose telephone number is (571)270-1426. The examiner can normally be reached Monday-Friday, 9:00 am-5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/RUSSELL E SPARKS/ Primary Examiner, Art Unit 1755