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 1-3, 5-7 and 9-10 are amended. Claims 11, 16-18, 21 and 26 are cancelled. Claims 14-15, 19-20 and 22-24 are withdrawn. Claims 1-10 and 12-13 are presently examined.
Applicant’s arguments regarding the objection to the drawings have been fully considered and are persuasive. The objection of 7/23/2025 is withdrawn.
Applicant’s arguments regarding the objection to the specification have been fully considered and are persuasive. The objection of 7/23/2025 is withdrawn.
Applicant’s arguments regarding the rejections under 35 USC 112(b) have been fully considered and are persuasive. The rejections of 7/23/2025 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.
Additionally, 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.
Finally, the declaration discusses the modification of Ghanouni and Hedge. While providing no additional data that would suggest unexpected results, the declaration makes the following arguments about the combination: (a) that Hedge is directed to a traditional smoking article rather than that of Ghanouni and (b) that Hedge only discusses using methylcellulose in the context of a product containing a high amount of inorganic diluent.
Regarding (a), while there may be some differences between tobacco sheets that are intended for use in traditional cigarettes and those used in heat not burn smoking articles, one of ordinary skill in the art would recognize many similarities as well. Ghanouni discloses that the carrier may be any material that supports an amorphous solid, including a sheet of reconstituted tobacco (page 4, lines 24-33). Similarly Hedge teaches that the sheet is formed in part from reconstituted tobacco (column 1, lines 12-18). The sheet shape alone provides many points of commonality, since the dimensions would be similar since both products are intended for oral consumption and a certain level of structural integrity is needed to maintain it in sheet form. One of ordinary skill in the art would therefore suspect some commonality is required for materials such as binders that maintain the basic integrity of sheet. Furthermore, Hedge teaches that the methyl cellulose is thermos-gelling (abstract), which fits with the amorphous material required by Ghanouni.
Regarding (b), one of ordinary skill in the art would expect the binder of Hedge to provide similar binding properties even when not used in combination with a diluent. As set forth above, a binder provides certain baseline properties such as maintain structural integrity which are required to preserve any sheet in its form. Hedge further suggests that its binder is suitable for use in Ghanouni since Hedge teaches that the methyl cellulose is thermos-gelling material (column 1, lines 12-18) and Ghanouni requires an amorphous solid (page 4, lines 24-33).
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 1-6, 10 and 12-13 are rejected under 35 U.S.C. 103 as being obvious over Ghanouni (WO 2020/028468).
Regarding claims 1 and 10, 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 (abstract), and less than 20 wt% of a filler (page 9, lines 19-17). The gelling agent is guar gum (page 6, lines 29-33, page 7, lines 1-7). Ghanouni discloses that the filler is wood pulp (page 9, lines 20-25). Ghanouni does not explicitly disclose the claimed ranges being obvious.
However, it would have been obvious to one of ordinary skill in the art 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). It is evident that, at at least some points in these ranges, the total amount of gelling agent and filler taken together falls within the claimed range.
Regarding claims 2 and 3, modified Ghanouni teaches all the claim limitations as set forth above. Ghanouni additionally discloses that the aerosol generating agent is present at 5-80 wt% (abstract). 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 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 4, Ghanouni discloses that the aerosol generating agent is glycerol (page 7, lines 14-26).
Regarding claim 5, modified Ghanouni teaches all the claim limitations as set forth above. Ghanouni additionally discloses that the gelling agent is present at 1-60 wt% (abstract). 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 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 6, Ghanouni discloses that the gelling agent is guar gum (page 6, lines 29-34, page 7, lines 1-6).
Regarding claim 12, Ghanouni discloses that an active substance is optionally present (abstract), indicating that in some embodiments the amorphous solid doesn’t include any active substance.
Regarding claim 13, Ghanouni discloses that the amorphous solid has only gelling agent, aerosol generating agent (abstract), and can include filler in some embodiments (page 9, lines 15-16).
Claims 7-9 are rejected under 35 U.S.C. 103 as being obvious over Ghanouni (WO 2020/028468) as applied to claim 1 above, and further in view of Hedge (US 4,109,664).
Regarding claims 7 and 8, modified Ghanouni teaches all the claim limitations as set forth above. Ghanouni additionally discloses that the amorphous material is formed into a sheet (page 9, lines 26-31). Modified Ghanouni does not explicitly teach the gelling agent being methyl cellulose.
Hedge teaches a tobacco substitute material (column 1, lines 12-18) comprising a thermo gelling methyl cellulose that forms a binder (abstract) so that a sheet of material is produced (column 2, lines 5-34).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the methyl cellulose of Hedge as the gelling agent of modified Ghanouni. One would have been motivated to do so since Hedge teaches that methyl cellulose is a suitable gelling agent for a tobacco sheet. The selection of a known material based on its suitability for its intended use supports prima facie obviousness. See MPEP § 2144.07.
Regarding claim 8, Ghanouni discloses that the gelling agent is a mixture that includes xanthan gum (page 6, lines 29-34, page 7, lines 1-6).
Regarding claim 9, modified Ghanouni teaches all the claim limitations as set forth above. Ghanouni additionally teaches that the gelling agent comprises a mixture of different components including xanthan gum (page 6, liens 29-33) that have a total weight of 1-60 wt% (page 6, lines 23-24, page 7, lines 1-6). Modified Ghanouni does not explicitly teach the prior art ranges overlapping the claimed ranges.
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide both the xanthan gum and methyl cellulose of modified Ghanouni at ranges that overlap the claimed ranges. One would have been motivated to do so since Ghanouni discloses that the total weight of the gelling agent overlaps the claimed ranges and that the gelling agent is a mixture.
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 choosing guar gum is the opposite of the disclosure of Ghanouni since Ghanouni is directed to cross linking materials, (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.
Furthermore, 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 such that cross-linking does not occur. Applicant’s argument that Ghanouni would lead one to follow the primary embodiment of Ghanouni are therefore unpersuasive.
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. Applicant’s argument that Ghanouni would lead one to follow the primary embodiment of Ghanouni are therefore unpersuasive.
Regarding (c), all examined claims, including the examined independent claim, are rejected as set forth 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.
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/RUSSELL E SPARKS/ Primary Examiner, Art Unit 1755