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
Claims 1, 13-15 and 19 are amended. Claims 2-12 and 25-38 are withdrawn. Claim 24 is cancelled. Claims 1 and 13-23 are presently examined.
Applicant’s arguments regarding the objection to the drawings have been fully considered and are persuasive. The objection of 7/25/2025 is withdrawn.
Applicant’s arguments regarding the objection to the drawings have been fully considered and are persuasive. The objection of 7/25/2025 is withdrawn.
Applicant’s arguments regarding the objection to the specification for allegedly including new matter have been fully considered and are persuasive. The objection of 7/25/2025 is withdrawn.
Applicant’s arguments regarding the rejections under 35 USC 112(b) have been fully considered and are persuasive. The rejections of 7/25/2025 are overcome.
The declaration of Mr. Abi Aoun under 37 CFR 1.132 filed 11/21/2025 is insufficient to overcome the rejection of claims 1 and 13-23 based upon Ghanouni (WO 2020/028468) as set forth in the last Office action. The declaration states asserts that the claimed invention produces unexpected results in comparison to the prior art. However, the declaration does not address the closest prior art. Ghanouni discloses all of the limitations except for the specific ratios of the gelling agent, aerosol generating agent, and fibrous organic filler material. The only data proffered by the declaration regards either the presence or absence of wood pulp filler. This data does not rebut the prima facie case of obviousness, since Ghanouni establishes a composition having all of the claimed components as the closest prior art. See MPEP § 716.02(e). Furthermore, the results indicated by the declaration of Mr. Abi Aoun are not commensurate with the scope of the claims since they only address wood pulp (which isn’t claimed) and do not substantiate the assertions regarding guar gum and crosslinking. See MPEP § 716.02(d). This portion of the declaration therefore amounts to arguments that are unsubstantiated. Such arguments cannot take the place of evidence of record when making a showing of unexpected results. See MPEP § 716.01(c) II.
Finally, MPEP § 2145 states that rebutting a prima facie case of obviousness requires rebutting the conclusion of prima facie obviousness. While this may sound circular, it is critical since the declaration of Mr. Abi Aoun does not address the conclusion of obviousness set forth in the Office action, namely, that the overlapping ranges would be obvious. The declaration does not discuss the ratios at all, and therefore does not even attempt to rebut the prima facie case.
Specification
The use of the term Drambuie (page 11, line 16), 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 and/or mark used in commerce Drambuie (page 11, line 16) is used without accompanying generic terminology. Appropriate correction is required.
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 1 and 13-23 are rejected under 35 U.S.C. 103 as being unpatentable over Ghanouni (WO 2020/028468).
Regarding claims 1, 13-15, Ghanouni discloses an aerosol generating substrate comprising an amorphous solid with 1-60 wt% of a gelling agent, 5-80 wt% of an aerosol generating agent, and less than 20 wt% of a filler (page 9, lines 17-19). The filler is a fibrous organic material, specifically, wood pulp (page 9, lines 26-31). Ghanouni does not explicitly disclose the claimed ranges being obvious.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the claimed ranges are unpatentable. 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 16, Ghanouni discloses that the composition may contain a flavorant that is also an active substance (abstract).
Regarding claim 17, Ghanouni discloses that the active substance is eucalyptus (page 27, lines 1-20).
Regarding claim 18, Ghanouni discloses that the active substance is an optional component (abstract), indicating that the composition doesn’t comprise the active substance in some embodiments.
Regarding claim 19, modified Ghanouni teaches all the claim limitations as set forth above. Ghanouni additionally discloses that the active substance is present at 0.1-60 wt% of the composition (abstract). Modified Ghanouni does not explicitly teach the claimed range being obvious.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the claimed range is unpatentable. 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 20, Ghanouni discloses that the gelling agent is a cellulose (page 6, lines 29-33, page 7, lines 1-6).
Regarding claim 21, Ghanouni discloses that the gelling agent is carboxymethylcellulose (page 6, lines 29-33, page 7, lines 1-6).
Regarding claim 22, Ghanouni discloses that the filler is wood pulp (page 9, lines 26-31).
Regarding claim 23, Ghanouni discloses that the aerosol generating agent is glycerol (page 7, lines 14-26).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 18 and 23 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-13 of copending Application No. 18/042,861 (hereafter referred to as Abi Aoun). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Regarding claim 1, Abi Aoun claims an aerosol generating composition comprising an amorphous solid, the amorphous solid comprising aerosol generating agent in an amount of from about 25 to 80 wt% of the amorphous solid, guar gum gelling agent, and filler in an amount of at least about 15 wt% of the amorphous solid, wherein the amount of gelling agent and filler taken together is from about 20 to 75 wt% of the amorphous solid (claim 1). The filler comprises a fibrous organic filler material (claim 1).
Regarding claim 18, Abi Aoun claims the amorphous solid not comprising an active substance (claim 12).
Regarding claim 23, Abi Aoun claims the aerosol generating agent comprising glycerol, optionally in combination with propylene glycol (claim 4).
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 13-15, 20 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/042,861 (hereafter referred to as Abi Aoun). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 13, Abi Aoun claims all the claim limitations as set forth above. Abi Aoun additionally claims the filler being present in an amount of about 15-40 wt% (claim 10). Abi Aoun does not explicitly claim the claimed range being obvious.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the claimed range is obvious. 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 14, Abi Aoun claims the aerosol generating agent being present in an amount of about 40-60 wt% (claim 3).
Regarding claim 15, Abi Aoun claims all the claim limitations as set forth above. Abi Aoun additionally claims the gelling agent being present at 5-50 wt% of the amorphous solid (claim 5). Abi Aoun does not explicitly claim the claimed range being obvious.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the claimed range is obvious. 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 20, Abi Aoun claims the gelling agent being methyl cellulose (claim 7).
Regarding claim 22, Abi Aoun claims the filler being wood pulp (claim 10).
Claims 16-17, 19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/042,861 (hereafter referred to as Abi Aoun) in view of Ghanouni (WO 2020/028468).
Regarding claim 16, Abi Aoun claims all the claim limitations as set forth above. Abi Aoun does not explicitly claim a flavorant being present.
Ghanouni teaches an amorphous solid (abstract) that contains a flavorant to create a desired taste, aroma, or other somatosensorial sensation in a product for adult consumers (page 27, lines 24-33, page 28, lines 1-15).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the amorphous solid of Abi Aoun with the flavorant of Ghanouni. One would have been motivated to do so since Ghanouni teaches an amorphous solid that contains a flavorant to create a desired taste, aroma, or other somatosensorial sensation in a product for adult consumers.
Regarding claim 17, Abi Aoun claims all the claim limitations as set forth above. Abi Aoun does not explicitly claim a eucalyptus as an active substance.
Ghanouni teaches an amorphous solid (abstract) having an active substance that is eucalyptus (page 27, lines 1-20). Ghanouni additionally teaches that the active substance is a physiologically active material that achieves or enhances a physiological response (page 26, lines 7-13).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the amorphous solid of Abi Aoun with the eucalyptus of Ghanouni. One would have been motivated to do so since Ghanouni teaches that eucalyptus is a physiologically active material that achieves or enhances a physiological response.
Regarding claim 19, Abi Aoun claims all the claim limitations as set forth above. Abi Aoun does not explicitly claim an active substance being present at the claimed weight.
Ghanouni teaches an amorphous solid (abstract) having an active substance present at 0.1-60 wt% (abstract). Ghanouni additionally teaches that the active substance is a physiologically active material that achieves or enhances a physiological response (page 26, lines 7-13).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the amorphous solid of Abi Aoun with the active substance of Ghanouni at the taught concentration. One would have been motivated to do so since Ghanouni teaches that active substances are physiologically active materials that achieve or enhance a physiological response when provided at a suitable concentration of an amorphous solid.
Regarding claim 21, Abi Aoun claims all the claim limitations as set forth above. Abi Aoun additionally claims the gelling agent being methyl cellulose (claim 7). Abi Aoun does not explicitly claim the gelling agent being carboxymethylcellulose.
Ghanouni teaches an amorphous solid (abstract) having a carboxymethylcellulose gelling agent (page 6, lines 29-33, page 7, lines 1-6).
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 methyl cellulose of Abi Aoun for the carboxymethylcellulose of Ghanouni. One would have been motivated to do so since Ghanouni teaches that carboxymethylcellulose is a suitable gelling agent for an amorphous solid. The selection of a known material based on its suitability for its intended use supports prima facie obviousness. See MPEP § 2144.07.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Regarding the rejections under 35 USC 103, applicant’s arguments have been fully considered but they are not persuasive. Applicant argues (a) that the claimed ranges of the components Ghanouni demonstrate unexpected results based on the declaration of Mr. Abi Aoun, (b) that the listing of guar gum in Ghanouni would not indicate to one of ordinary skill in the art that it could be used in modified Ghanouni, and (c) that the dependent claims are allowable due to dependence on an allowable claim.
Regarding (a), the declaration of Mr. Abi Aoun does not discuss the ratios that the Office action alleges are obvious to modify. As set forth above, the data of applicant’s specification relied upon on in the declaration of Mr. Abi Aoun do not teach anything regarding guar gum or crosslinking, but rather only show differences in performance when wood pulp (which is not claimed) is either present or absent from the claimed composition. The declaration of Mr. Abi Aoun does not introduce any additional data that would support the conclusion of nonobviousness. The declaration is therefore ineffective to overcome the rejection relying on Ghanouni.
Regarding (b), MPEP § 2131.02 II states that a clearly named species will always anticipate a species claim no matter how many other species are claimed. Case law specifically addresses a situation where 45 different compounds were present, which is far more than the list of Ghanouni from which guar gum is selected in the instant Office action. Although the rejection as set forth above is made under 35 USC 103, no modification to Ghanouni is made to reach the claimed guar gum. Case law originally developed with respect to 35 USC 102 rejections is therefore relevant to the narrow question of the limitation “one or more gelling agents selected from cellulosic gelling agents, guar gum, acacia gum and mixtures thereof” is patentable over the prior art. MPEP § 2123 additionally states that rejections may be made of nonpreferred embodiments such as the guar gum of Ghanouni.
Regarding (c), all examined claims, including the examined independent claim, are rejected as set forth above.
Regarding the double patenting rejections, applicant’s arguments have been fully considered but they are not persuasive since United States patent application 18/042,861 has also been amended to require that the composition include a fibrous organic filler.
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.
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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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/RUSSELL E SPARKS/ Primary Examiner, Art Unit 1755