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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Status of the Claims
Claim 1 is amended. Claims 2-9 and 14-16 are either original or previously presented. Claims 12-13 are withdrawn. Claims 10-11 are cancelled.
Response to Arguments
Applicant’s arguments filed 12/18/2025 have been considered but are not persuasive. Examiner has reconsidered the reference Bitar, realized that the reference was considered too narrowly, and found that it anticipates Amended claim 1, claim 2, 4-5, and 16, see the rejections below. Further rejections of the remaining claims were based on combinations with other references, including Casey, John, and Hajaligo. Additional pertinent prior art was cited as including Greim and Billons.
Applicant asserts that Casey teaches away from substrates that lack tobacco material. Since some of the arguments regarding when a reference teaches away are relevant to the rejection below, the standard for “teaching away” and whether Casey teaches away from an amorphous solid without tobacco material are discussed below.
Reviewing Casey, under the broadest disclosure of the invention, the material is referred to without reference to the inclusion of tobacco in the substrate, ([col 2 lines 48-52]), with the reference discussing that the relative amounts of binder and aerosol former depend upon the situation in which the substrate composition is used, ([col2-3 lines 66-1]). There is no discussion in the reference suggesting that the substrate composition must have tobacco. The assertion that the substrate may or may not have tobacco as desired is properly inferred given the broad disclosure and the subsequent discussion of preferred compositions with the aerosol forming material and the binder applied to materials comprising tobacco, ([col 3 lines 20-24]), because the inventors chose to broadly disclose their invention and then specifically identify a narrower preferred embodiment. This is further suggested by the claims, with claim 1 requiring a stabilized aerosol forming composition comprising an admixture of aerosol forming substance and a binder which stabilizes the aerosol forming substance, with no limitation requiring tobacco, and dependent claims such as claim 6 and 7, which require tobacco.
While one might fairly suggest that Casey teaches substrates comprising tobacco is preferred, this is insufficient to support a legal argument that Casey teaches away from a substrate without tobacco. Applicant’s reliance upon preferred embodiments as teaching away from modifications to the disclosure of Casey is misplaced. “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). MPEP 2123 Rejection Over Prior Art’s Broad Disclosure Instead of Preferred Embodiments, I. Patents Are Relevant As Prior Art For All They Contain.
Reviewing Casey thoroughly, no evidence was found to suggest that a non-tobacco alternative would not work. There was no active discouragement regarding the use of a non-tobacco substrate. One of ordinary skill in the art would expect that a different plant material or extract would work in place of tobacco, and one of ordinary skill in the art would be motivated to replace tobacco with another plant material to change the flavor of the smokeable material away from tobacco to another flavor.
This appears to be simple substitution of a non-tobacco plant material or extract for a tobacco plant material or tobacco extract. “The Federal Circuit’s discussion in ICON also makes clear that if the reference does not teach that a combination is undesirable, then it cannot be said to teach away. An assessment of whether a combination would render the device inoperable must not ignore the modifications that one skilled in the art would make to a device borrowed from the prior art. Id. at 1382, 83 USPQ2d at 1752.” MPEP 2143 B. Simple Substitution of One Known Element for Another to Obtain Predictable Results, Example 5.
Thus, even if changes might be required based on the substitution in the composition to make a substrate workable, if the reference teaches those changes or one of ordinary skill in the art would reasonably be capable of making those changes, then the modified substrate may still be considered obvious.
It is noted that Dow Chem. Co. v. American Cyanamid Co., 816 F.2d 617, 2 USPQ2d 1350 (Fed. Cir. 1987), cited by Applicant in support of their argument is cited instead in the MPEP 716.06 for the proposition that “[e]vidence of copying was persuasive of nonobviousness when an alleged infringer tried for a substantial length of time to design a product or process similar to the claimed invention, but failed and then copied the claimed invention instead.” Here there is no evidence of copying to support a finding of nonobviousness. The analysis from Dow is reproduced below:
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Reviewing Dow, it appears that the limitation was simply not taught by the references, with the exception of Watanabe. Watanabe “taught away” because although it taught that copper metal catalysts could be used, it also taught that copper metal catalysts give poor yields and unexpected side reactions, where the claimed invention did not have these issues and where the claimed invention had excellent results (suggesting that the claimed combination had results that were unexpected compared to what was disclosed in the prior art, although this point was not particularly emphasized).
There is no corollary disclosure in Casey. Dow does not support a finding that Casey teaches away from modifying the amorphous solid.
Understanding what is required for a reference to “teach away” from a modification is important, because the revised rejection below is still grounded in obviousness and relies on the substitution of a plant material or extract for a tobacco material or extract. This rejection below is based on the obvious substitution of plant material or plant extract for tobacco material or extract. This is considered obvious but would not be if a finding could reasonably be made that the references “taught away” from the modification. Because such a finding is unreasonable, Applicant arguments are not persuasive and Casey is considered open to modifications of the amorphous solid including modifications where the tobacco plant material or tobacco extract is substituted for another plant material or plant extract.
Obvious -Type Double Patenting Rejection
“The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent the public policy behind this doctrine is that: The public should…be able to act on the assumption that upon the expiration of the patent it will be free to use not only the invention claimed in the patent but also modifications or variants that would have been obvious to those of ordinary skill in the art at the time the invention was made, taking into account the skill in the art and prior art other than the invention claimed in the issued patent. In re Zickendraht, 319 F.2d 225, 232, 138 USPQ 22, 27 (CCPA 1963) (Rich, J., concurring). Double patenting results when the right to exclude granted in one patent is unjustly extended by the grant of another patent or patents. In re Van Ornum, 686 F.2d 937, 943-44, 214 USPQ 761, 766-67 (CCPA 1982).” MPEP 804 Definition of Double Patenting.
Here Applicants have an issued patent Ghanouni et al. (US 12,178,236 B2) and a pending application 18/816,743 published as Ghanouni et al. (US 2024/0415169 A1) (Ghanouni 2) with claims that render obvious the claims of this application, despite not including the negative limitation excluding tobacco material. This is because one of ordinary skill in the art would reasonably interpret the limitation of an amorphous solid as including embodiments where the amorphous solid that comprises no tobacco material. Granting a patent with a full term would allow the Applicant to unjustly extend their patent term, for at least amorphous solids without tobacco material.
One of ordinary skill in the art would interpret “amorphous solid” as including those that comprise no tobacco material because in Ghanouni the amorphous solid is disclosed including:
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(Ghanouni [col 3 lines 27-33]). Although the amorphous solid may comprise tobacco, tobacco is not required, ([col 20-22 lines 3-4] the definitions section making clear that many, many active substances are listed as suitable, and which comprise no tobacco). Additionally, Ghanouni discloses several embodiments where the amorphous solid does not comprise tobacco, ([col 18 lines 1-17] although the disclosure continues and suggests that the amorphous solid of these embodiments may be included in an aerosol generating article/assembly as a shredded sheet, and the shredded sheet may be blended with cut tobacco, there is no evidence that the amorphous solid of these embodiments have any tobacco). In Ghanouni 2, the specification discloses, in some embodiments “the amorphous solid comprises no tobacco material, but does comprise nicotine.” ([pg 8 lines 24-25]).
Thus, the amorphous solid in both Ghanouni and Ghanouni 2 would be interpreted as including embodiments where the amorphous solid comprises no tobacco material, and failing to make a double patenting rejection would impermissibly extend the patent term of Ghanouni, which has issued as a patent and has claims that already cover this embodiment.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 16 requires that the amorphous solid be bonded to the carrier. The word “bonded” does not appear in the Specification, nor do the words adhere, adhesive, or glue.
The following is a selection, which seems to best support the limitation:
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(Specification [pg 11 lines 11-19]). Appropriate correction is required.
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 1-9 and 14-16 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.
Claim 1 contains the limitation that at least 65wt% of the aerosol generating agent is aerosolized on heating of the aerosol generating material to about 370 °C for a ten second period under a 1.95 L/min airflow. Claim 2 recites at least about 70wt% of the aerosol generating agent is aerosolized, under identical conditions.
The test conditions under which this limitation have been evaluated are not established in the Specification. There are no test results upon which a person of ordinary skill in the art could ascertain which aerosol generating agents incorporated into the amorphous solid would meet this limitation. The limitation requires that the aerosol generating agent is “aerosolized” on heating, yet some of the aerosol generating agents contemplated by the later claims may decompose rather than aerosolize, and potentially combust depending on how the heating to about 370 °C is to be accomplished. It is noted that glycerol has an autoignition temperature of 370 °C, ([Engineering toolbox pg 2]).
The particulars regarding how this limitation should be evaluated are not disclosed. Is it a gentle heating, where the maximum threshold of 370 °C is held for 10 seconds? Is the aerosol generating substrate dropped into a crucible already at 370 °C, bringing the substrate to this temperature as rapidly as possible, and held for 10 seconds with the requisite airflow? It is expected that the outcome of each would be different. One of ordinary skill in the art would be at a loss as to how to evaluate this limitation, because there is no disclosure as to how the limitation should be tested. The USPTO has not provided resources to Examiners for testing functional limitations, and thus the substrates disclosed by the prior art cannot be evaluated to see if the aerosol generating agents might not aerosolize under any permutation of the broadly specified the test conditions for whatever reason, be it decomposition or autoignition, demonstrating that the required functional limitation might not be met.
Because the USPTO does not provide resources to test whether or not a particular amorphous solid meets or does not meet this limitation, for the purposes of examination it will be presumed that if the prior art composition meets the other limitations of the claim, this limitation is also met. This presumption may be rebutted by a showing that such a composition does not meet this limitation, such as through experimental results – however such a showing may raise enablement or at least scope of enablement issues.
It is noted that the boiling point of glycerol is well known to be 290 °C, and it is reasonably expected that an amorphous solid where the aerosol generating agent comprises glycerol were heated over time, to a temperature of 370 °C for ten seconds, there would be no expectation that any appreciable amount of glycerol would be left in the amorphous solid. Whether it aerosolizes, decomposes, or combusts is unclear, but for the purposes of examination it will be presumed that essentially all of the glycerol will aerosolize if the aerosol generating substrate is heated at a reasonable rate from a temperature of about 20°C to a temperature of about 370 °C, where the aerosol generating substrate is held at 370 °C for a period of 10 seconds, under a 1.95 L/min airflow.
Claims 3-9 and 14-16 are rejected based on their dependency to indefinite claim 1.
Claim 5 recites an aerosol generating substrate according to claim 4, wherein the aerosol generating agent comprises glycerol (emphasis added). Claim 4 recites a Markush group where the aerosol generating agent is selected from a list that includes glycerol. It is understood that the list in claim 4 is a closed list, MPEP 2117 Markush Claims, (alternatives of a group can be set for as simply as “the material is A, B, or C”). Thus, open transition of “comprises” following the closed list presented in claim 4 presents confusion regarding the scope of claim 5, rendering the claim indefinite. It is unclear whether if Applicant is claiming that the aerosol generating agent can be glycerol, with or without anything else that might be considered an aerosol generating agent. If Applicant wishes to claim aerosol generating agents that consist of glycerol and one or more aerosol generating agents from the list consisting of erythritol, sorbitol, glycols, monohydric alcohols, high boiling point hydrocarbons, lactic acid, diacetin, triacetin, triethylene glycol diacetate, triethyl citrate, ethyl myristate, isopropyl myristate, methyl stearate, dimethyl dodecanedioate and dimethyl tetradecanedioate, it is recommended that the Applicant restate the claim as dependent on claim 1, with such language. It is noted that an embodiment where the aerosol generating agent consists only of glycerol is already contemplated by claim 4.
Claim 6, which depends on claim 1, recites that the amorphous solid comprises about 1-60wt% of a gelling agent. Claim 8, which depends on claim 6, further recites a list of compounds that the gelling agent may be selected from including: alginates, pectins, starches and starch derivatives, celluloses and cellulose derivatives, gums, silica or silicones compounds, clays, polyvinyl alcohol and combinations thereof. Reviewing claim 1, the amorphous solid comprises less than 20wt% filler. Applicant discloses:
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(Specification [pg 9 lines 13-25]). Because some of the fillers listed above, are also considered gelling agents, it is unclear which percentage limitation should apply to these materials, rendering the claim indefinite. For instance, one of ordinary skill in the art would not reasonably understand whether or not a contemplated amorphous substrate comprising 25wt% cellulose and cellulose derivatives is covered by the claims, because those materials are considered as filler but are also considered gelling agents, and the range for the filler do not coincide with the range for the gelling agent. For the purposes of compact prosecution, the allowable range of less than 20 wt% will be used for materials that are considered both a filler and a gelling agent, as identified in the present Specification, and the gelling agent will be considered the total of all gelling agents including gelling agents that may also be considered fillers.
Claims 7-8 are further rejected as indefinite based on their dependency on claim 6.
Claim 8 is further rejected as indefinite based on the improper recitation of a Markush group, because the group is listed as the group comprising the listed compounds, and the open transition fails to properly apprise one of ordinary skill in the art the scope of the claim. For the purposes of compact prosecution, the listed compounds will be considered to be a closed group.
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.
Claim(s) 1-2, 4-5, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bitar et. al (WO 2016/156495 A2).
Regarding claim 1, Bitar discloses smoking articles comprising carriers and smokeable materials, ([pg 1 lines 18-22]). Bitar discloses a carrier and a smokeable material arranged on the carrier, ([pg 1 lines 21-22]). Bitar discloses that in some embodiments the smokeable material on the carrier, the first layer, comprises an aerosol forming agent, ([pg 2 lines 31-32]), and that in some embodiments the aerosol forming agent comprises glycerol, (pg 3 line 4]). Bitar discloses the term smokeable material may be a non-tobacco containing material or a tobacco containing material, ([pg 6 lines 7-8]), thus contemplating embodiments where the smokeable material does not contain any tobacco material, and further discloses that the smokeable material may be in the form of a gel, ([pg 6 lines 11-12] gel appearing to be the only form listed that doesn’t include tobacco, and anticipating the limitations of an amorphous solid that comprises no tobacco material). Bitar discloses that the carrier is for conducting heat through the carrier towards the smokeable material, and where the carrier may comprise paper and a foil, where the layer of smokeable material may be more readily bond or adhere to the paper layer than the foil layer, ([pg 7 lines 16-29] specifically identifying an embodiment where the carrier is reconstituted tobacco paper and a metal foil, anticipating the limitation requiring a carrier comprising a metal foil layer and a support layer. It is noted that the claim prohibition on tobacco material does not extend to the carrier layer). Bitar discloses that the smokeable material may include other non-tobacco products, which depending on the product may or may not include nicotine, and recites a list of flavorant materials which may be used in the smoking article for the purposes of creating a desired taste or aroma for adult customers, ([pg 6 lines 12-31]).
Bitar contemplates a single embodiment where the carrier is for conducting the heat through the carrier towards the smokeable material, (claim 9, depending on claims 1-8, reasonably disclosing the use of a carrier with a metal foil layer), where the layer of smokeable material is bonded to the carrier, (claim 8, depending on claims 1-7, reasonably disclosing the use of paper with the metal foil where the smokeable material, reasonably disclosed as an amorphous solid in the form of a gel without tobacco material, is placed on the paper side of the carrier to facilitate bonding with the paper, anticipating an amorphous solid comprising no tobacco material, the carrier comprising a metal foil layer and a support layer, and further anticipating claim 16, which requires the amorphous solid is bonded to the carrier), where the smokeable material comprises an aerosol forming agent in the smokeable material on the carrier, (claim 7 depending on claim 6, which further depends on claims 1-5), and claim 1 where the smokeable material is arranged on the carrier. This embodiment does not suggest any filler is contemplated in the smokeable material, and thus the limitation requiring less than 20wt% is also anticipated.
Bitar discloses that in an exemplary embodiment, the aerosol forming agent comprises glycerol, ([pg 3 line 4[). One of ordinary skill in the art would at once envisage using glycerol as the aerosol generating agent in the claimed embodiment as identified above, MPEP 2131.02 Genus-Species Situations, III. A Generic Disclosure Will Anticipate A Claimed Species Covered By That Disclosure When The Species Can Be “At Once Envisaged” From the Disclosure. Searching the disclosure of Bitar, glycerol is suggested as the aerosol generating agent multiple times, ([pg 3 line 4], [pg 11 line 26, line 30], [pg 17 lines 16-18]), and it appears the only example of aerosol generating agent disclosed is glycerol. Based on this, one of ordinary skill in the art would at once envisage using glycerol as an aerosol generating agent in any claim where an aerosol generating agent is contemplated, anticipating claims 4-5.
Although Bitar does not disclose the percentage of aerosol generating agent aerosolized on heating the aerosol generating material to about 370°C for a ten-second period under a 1.95L/min airflow, based on the similarity of the prior art composition to the claimed composition, and the well-known boiling point of glycerol (290 °C), it is presumed to be inherent that essentially all of the glycerol will aerosolize if the aerosol generating substrate is heated at a reasonable rate from a temperature of about 20°C to a temperature of about 370 °C, where the aerosol generating substrate is held at 370 °C for a period of 10 seconds, under a 1.95 L/min airflow, anticipating the aerosolization percentage limitation from claim 1 and also the narrower limitation of claim 2.
Claims 1-2, 4-5, and 16 are considered anticipated because each and every element as set forth in the claims are found, either expressly or inherently described, in a single prior art reference, MPEP 2131 Anticipation. As set forth in the rejection above, and the elements are arranged as required by the broad requirements of the claims, rendering them anticipated.
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable Bitar et. al (WO 2016/156495 A2).
Regarding claim 15, Bitar discloses the aerosol generating substrate of claim 1 Bitar discloses that the carrier may comprise layers of materials where one layer is more rigid or robust than the material of the other layer, ([pg 7 lines 24-26]). Bitar does not specifically disclose that the paper used in the carrier is cardboard.
Simple substitution of one known element for another to obtain predictable results is considered prima facie obvious, MPEP 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness, I. Examples of Rationales, (B). Simple substitution of one known element for another to obtain predictable results. It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Bitar and substituted cardboard (a known type of paper product) for the reconstituted tobacco paper used with metal foil as the carrier. Bitar disclosed the claimed invention, except that the support layer of the carrier is disclosed as being made from reconstituted tobacco paper with a metal foil backing instead of cardboard with a metal foil backing.
Bitar discloses paper is an acceptable material, that increased rigidity may be supplied from a layer of the carrier. Cardboard is asserted to be a type of paper that is well known to be thicker and more rigid than regular paper. One of ordinary skill in the art would have recognized that a thicker type of paper such as cardboard would provide the carrier with increased rigidity and made the substitution of cardboard for paper for at least this reason and expected that a carrier comprising a combination of cardboard and foil would have predictably resulted in a more rigid carrier.
Claim(s) 3, and 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bitar et. al (WO 2016/156495 A2), as applied to claim 1 above, and further in view of Casey, III et al. (US 5,415,186) and John et al. (US 2016/0295922 A1).
Regarding claim 3, Bitar discloses an aerosol generating substrate according to claim 1. Bitar does not disclose the percentage of aerosol generating agent contained in the amorphous solid.
Casey teaches improvements to smoking articles, ([col 1 lines 16-17]), and is thus within the inventor’s field of endeavor. Casey teaches a smokeable material comprising a stabilized sheet substrate of the present invention may comprise 30-55 weight percent tobacco or tobacco extract (active substance), ([Col 4 lines 55-60]), optionally 0-25 weight percent of one or more filler materials such as calcium carbonate, ([Col 4 lines 61-63]), 40-50 weight percent of aerosol forming materials such as glycerin, ([Col 4 lines 64-66]), 5-8 weight percent of a binding agent (gelling agent) such as ammonium alginate, ([Col 4-5 lines 67-3]), and optional flavoring agents ([Col 5 lines 12-14]), where the substrate mixture may be cast as a sheet from an aqueous slurry, ([Col 5 lines 21-23]). Casey does not explicitly teach a particular embodiment where the amorphous solid comprises no tobacco material.
John teaches an aerosol generating material for use with aerosol generating devices, ([0050]), and is thus within the inventor’s field of endeavor. John teaches the heating of the aerosol generating material does not result in any significant combustion of the material, ([0052]). John discloses similar ranges for the aerosol generating agent, and that the aerosol generating agent maybe glycerol, ([0067]). John discloses the aerosol generating material may comprise one or more compounds included for the purpose of lowering the boiling point of the one or more substances in the aerosol generating material, ([0068]). John discloses that the aerosol generating material may comprise one or more flavorants, ([0069]), that the flavorants may include extracts of plants and other materials, and that they may be used in any suitable form, for example oil, liquid, or powder, ([0070]), which may be mixed and provided in an aerosol generating material to provide a superior sensory experience for the adult consumer, ([0071]). John teaches that the aerosol generating material may comprise tobacco material, but also that the aerosol generating material may comprise a tobacco substitute, ([0075]). John further teaches that the aerosol generating material may comprise any suitable substance in place of a tobacco extract, including water, a binder, inorganic filler material, and an aerosol generating agent, ([0085]). John teaches similar aerosol generating agents as Casey, ([0064]-[0067]), a similar binder in the form of sodium alginate in amounts that overlap the ranges of Casey, ([0093]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, by substituting the amorphous solid comprising no tobacco material of Bitar, with an amorphous substrate according to Casey, where the amorphous substrate of Casey is modified to comprise no tobacco material as taught by John.
Simple substitution of one known element for another to obtain predictable results is considered prima facie obvious, MPEP 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness, I. Examples of Rationales, (B). Bitar discloses the aerosol generating substrate according to claim 3, except that the amorphous solid of Bitar was not disclosed with a percentage weight of the aerosol generating agent. Casey teaches an amorphous solid that meets the limitations of the aerosol generating agent but comprises tobacco extract which is not permitted in the amorphous solid. John teaches that any suitable material may be substituted for the tobacco extract.
One of ordinary skill in the art would recognize that the flavorant extracts would be suitable substitutes for the tobacco extract in Casey, and that thus substitution would result in a change in the flavor profile of the taste and/or aroma. Based on the teachings of John, one of ordinary skill in the art would have been able to substitute the known flavor extracts for the tobacco extract in the amorphous solid of Casey, and the results of that substitution would have predictably resulted in a change in the flavor profile, according to the flavoring extract substitute.
One of ordinary skill in the art would have then been able to substitute the modified amorphous solid of Casey (which contains no tobacco material), for the generally disclosed amorphous solid of Bitar, with the results of the substitution predictably providing a clearly defined amorphous solid with the specific flavor profile of the flavoring extracts present in the amorphous solid.
Modified Bitar discloses an amorphous solid as taught by Casey and further modified by John where the amorphous substrate comprises with 40-50 weight percent of aerosol forming materials such as glycerin, ([Col 4 lines 64-66]), rendering claim 3 obvious.
Regarding claim 6, modified Bitar discloses the aerosol generating substrate according to claim 1.
Modified Bitar discloses an amorphous solid as taught by Casey and further modified by John where the amorphous substrate comprises with 40-50 weight percent of aerosol forming materials such as glycerin, ([Col 4 lines 64-66]), 30-55 weight percent of a flavor extract (John teaching the substitution of tobacco extract by a non-tobacco flavor extract), optionally 0-25 weight percent of one or more filler materials such as calcium carbonate, 5-8 weight percent of a binding agent (gelling agent) such as ammonium alginate, and optional flavoring agents, where the substrate mixture may be cast as a sheet from an aqueous slurry, rendering claim 6 obvious.
Regarding claim 7, modified Bitar discloses the aerosol generating substrate according to claim 6. The further limitation of this claim requires the amorphous solid is a hydrogel and comprises less than about 20 wt% of water calculated on a wet weight basis.
The term hydrogel is not defined in the claim. It appears once in the present specification, which states the amorphous solid may, in some cases be a hydrogel, followed by limitations directed towards how much water may be present and how little water must be present, ([pg 6 line 24-30]), and the amount of gelling agent in the amorphous solid ([pg 7 lines 1-6]). One of ordinary skill in the art would understand this limitation, in light of the specification, as requiring an amorphous solid that comprises a gelling agent and less than about 20 wt% of water calculated on a wet weight basis. Bitar does not disclose the amorphous solid is a hydrogel.
Casey teaches an example meeting the amorphous solid limitations of claim 6, where the aerosol generating material is dried, ([Col 24 lines 16-17]), but the water percentage of the substrate is not provided for Example 10 after drying. None of the examples of Casey provide a water content for amorphous solids that do not comprise tobacco.
John teaches any suitable quantity of water may be included in the aerosol generating material and gives an example where in some inorganic aerosol generating materials, the water content is between 3-10% water, but where the tobacco-based aerosol generating materials are used, the water content is somewhat higher, between 10-15%.
Because the amorphous solid of modified Bitar is an amorphous solid based on the teachings of Casey modified by John (substituting a flavoring extract for a tobacco extract), and John discloses that the amount of water should be between 3-10% or at most 10-15% for a flavoring extract that is similar to tobacco, it is reasonably concluded that the amorphous solid of modified Bitar is a hydrogel comprising less than about 20% water, rendering this claim obvious.
Regarding claim 8, modified Bitar discloses the aerosol generating substrate according to claim 6. Modified Bitar discloses the amorphous solid where the amorphous substrate comprises a gelling agent such as ammonium alginate may be used to make the substrate, rendering claim 8 obvious.
Regarding claim 9, modified Bitar discloses the aerosol generating substrate according to claim 1, and also as modified in the rejections of claims 3, 6, and 8 above. Bitar discloses a flavorant may be added to the smokeable material, (pg 12 lines 9-12]), but not the percentage amount
Casey teaches optional flavoring agents for the smokeable material, ([Col 5 lines 12-14]), and teaches an example of an amorphous substrate comprising flavor in an amount of 5 wt%, (col 24 Example 10, line 14]).
John teaches the aerosol generating material may comprise more than one flavorant, comprising a quantity and concentration of flavorants suitable for delivering desirable quantities of them to the aerosol, to provide a superior sensory experience for the consumer, ([0071]).
Applying a known technique to a known product ready for improvement to yield predictable results is considered prima facie obvious, MPEP 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness, I. Examples of Rationales, (D). Modified Bitar as described above discloses the device upon which the further limitations of the claimed invention can be seen as an improvement (the addition of a broad range of flavorant amounts). The prior art discloses adding several flavorings extracts together, to further flavor a substrate, and discloses using an amount of flavorant in an amount within the claimed range. One of ordinary skill in the art would have recognized that applying the known technique of adding flavorants in the specified amounts would have predictably resulted in an amorphous solid with the additional flavoring profile and resulted in an improved product with a better sensory profile.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bitar et. al (WO 2016/156495 A2), as applied to claim 1 above, and further in view of Hajaligo et al. US 5,665,262.
Regarding claim 14, Bitar discloses the aerosol generating substrate of claim 1. Bitar does not disclose a thickness of the metal foil.
Hajaligo teaches a tube heater for use in an electrical smoking article, ([col 1 lines 30-32]), and is thus within the inventors field of endeavor. Hajaligo teaches that a carrier which supports a smokable material may provide a separation between the heating elements and the smokeable material, ([col 8 lines 41-43]). Hajaligo teaches an acceptable carrier for use with their invention may be a perforated metallic foil, ([col 8 lines 53-54]). Hajaligo teaches a carrier formed from a 0.0064 mm thick aluminum foil (corresponding to 6.4 microns), ([col 8 lines 57-58]). Hajaligo does not teach forming the carrier with paper in addition to foil.
Applying a known technique to a known product ready for improvement to yield predictable results is considered prima facie obvious, MPEP 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness, I. Examples of Rationales, (D). It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the carrier of Bitar with a metal foil layer comprising the thickness taught by Hajaligo. Bitar discloses the base product upon which the claimed invention can be seen as an improvement, where only the technique of specifying the foil thickness was not disclosed. Hajaligo suggests a thickness for metal foil that may be used as a carrier. One of ordinary skill in the art would have recognized that applying this known technique would have yielded predictable results, a more consistent heating experience compared to a carrier where the metal foil thickness was allowed to vary, resulting in an improved system where users could expect and rely on a consistent heating profile for the aerosol generating substrate.
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.
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Claims 1-9 and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 6-11 and 14-17 of U.S. Patent No. Ghanouni et al. (US 12,178,236 B2).
Regarding claim 1-3, and 6, Ghanouni discloses an aerosol generating substrate wherein the amorphous solid comprises 1-60 wt% of a gelling agent, 5-80 wt% of an aerosol generating agent, and 10-60 wt% of an active substance, wherein the amorphous solid comprises less than 20 wt% filler ([claim 6] (by virtue of depending on claim 1). Ghanouni does not require that the amporphous solid comprise a tobacco material and discloses may active substances that do not comprise tobacco material, ([col 20-22 lines 3-4] the definitions section making clear that many, many active substances are listed as suitable, and which comprise no tobacco). Additionally, Ghanouni discloses several embodiments where the amorphous solid does not comprise tobacco, ([col 18 lines 1-17]). The aerosol generating substrate of Ghanouni according to claim 6 does not disclose that the aerosol generating substrate comprises a carrier wherein the carrier comprises a metal foil layer and a support layer. Ghanouni does not explicitly disclose the functional limitations of the claim are met, because claim 1 discloses that at least 70 wt% of the active ingredient is aerosolized under the specified conditions, whereas claim 1 requires that 65 wt% of the aerosol generating agent to be aerosolized under the specified test conditions.
Ghanouni further discloses that the aerosol generating substrate may additionally comprise a carrier on which the amorphous solid is provided, ([claim 11]), and discloses that the carrier may comprise a paper-backed foil, ([claim 17]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have provided the aerosol generating substrate of claim 6, with the amorphous solid provided on a carrier as taught by claim 11, where the carrier is a paper backed foil as taught by claim 17. Because claim 6 of Ghanouni defines the amorphous solid of claim 1, claim 11 discloses providing the amorphous solid on a carrier, and claim 17 discloses a suitable carrier, it is reasonably suggested to one of ordinary skill in the art to make this combination. Regarding the functional limitation, although Ghanouni does not disclose that this condition would be met, when a composition in the prior art is identical or substantially identical in composition, the claimed properties are considered present. Because the interpretation of amorphous solid includes embodiments where the amorphous solid comprises no tobacco material, this limitation is also considered obvious.
Regarding claim 4-5, modified Ghanouni meet sthe limitations of claim 1. Ghanouni discloses that the aerosol generating agent may be selected from the group comprising erythritol, sorbitol, glycerol, glycols, monohydric alcohols, high boiling point hydrocarbons, lactic acid, diacetin, triacetin, triethylene glycol diacetate, triethyl citrate, ethyl myristate, isopropyl myristate, methyl stearate, dimethyl dodecanedioate, and dimethyl tetradecanedioate, ([claim 9]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have provided the aerosol generating substrate with the amorphous solid comprising an aerosol generating agent according to claim 9. Modified Ghanouni discloses that the amorphous solid comprises an aerosol generating agent. Claim 9 provides a list of acceptable aerosol generating agents. One of ordinary skill in the art would find it obvious to select an aerosol generating agent from this list, including selecting glycerol, which meets the claimed limitation.
Regarding claim 7, modified Ghanouni meets the limitations of claim 6. Modified Ghanouni does not disclose the amorphous solid is a hydrogel and comprises less than about 20 wt% of water. Ghanouni discloses that the amorphous solid is a hydrogel and comprises less than about 15 wt % of water calculated on a wet weight basis, ([claim 7]).
It would be obvious to one of ordinary skill in the art to further modify Ghanouni with the limitations of claim 7. The limitations of claim 7 are designed to be incorporated with the amorphous substrate of modified Ghanouni.
Regarding claim 8, modified Ghanouni meets the limitations of claim 6. Ghanouni discloses that the gelling agent comprises one or more compounds selected from the group comprising alginates, pectins, starches and starch derivatives, celluloses and cellulose derivatives, gums, silica or silicones compounds, clays, polyvinyl alcohol, and combinations thereof, ([claim 8]).
It would be obvious to incorporate a gelling agent from the list provided by Ghanouni because these are intended for use in the amorphous substrate of modified Ghanouni.
Regarding claim 9, modified Ghanouni comprising the limitations of claims 6, 11, and 17.
Ghanouni discloses that amorphous solid may comprise up to 60wt% of flavorant, ([claim 4]). The limitations of claim 4 are designed to be incorporated with the amorphous substrate of modified Ghanouni.
Regarding claim 15, modified Ghanouni comprising the limitations of claims 6, 11, and 17.
Ghanouni discloses the carrier materials may be selected from a list including cardboard, metal foil, paper, and combinations thereof, ([claim 14]). It would be obvious to substitute one carrier for another from a list that includes both carriers as acceptable.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 11, and 17 of U.S. Patent No. Ghanouni et al. (US 12,178,236 B2) in view of Hajaligo et al. US 5,665,262.
Regarding claim 14, modified Ghanouni discloses the aerosol generating substrate of claim 1, but does not disclose the thickness of the metal foil later.
Hajaligo discloses a metal foil used as a carrier, where the metal foil is less than 20 microns thick, ([col 8 lines 57-58]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the carrier of modified Ghanouni with a metal foil layer comprising the thickness taught by Hajaligo. Because Hajaligo suggests the metal foil may be used as a carrier, which reasonably suggests a workable thickness of the metal foil layer in a carrier laminate, and one of ordinary skill in the art would have a reasonable expectation of success in using a metal foil layer of this thickness in the carrier.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 11, and 17 of U.S. Patent No. Ghanouni et al. (US 12,178,236 B2) in view of Bitar et. al (WO 2016/156495 A2).
Regarding claim 16, modified Ghanouni discloses the aerosol generating substrate according to claim 1. Ghanouni does not disclose that the amorphous solid is bonded to the carrier.
Bitar discloses carriers that are used to support smokable materials, ([pg 1 lines 21-28]). . Bitar discloses the first layer of smokeable material is bonded to the carrier, ([pg 3 lines 6-7]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Ghanouni by bonding the amorphous layer to the carrier as taught by Bitar, for the obvious reason of preventing the amorphous solid from becoming dislodged from the carrier.
Claims 1-9 and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4, 5, 8, 10, and 12of copending Application No. Ghanouni et al. (US 2024/0415169 A1) (Ghanouni 2).
Regarding claims 1-3, 6-7, 9, and 15 Ghanouni 2 discloses an aerosol generating substrate comprising an aerosol generating material comprising an amorphous solid, where in the amorphous solid comprises from about 1-15wt% water, and wherein the amorphous solid comprises 1-60% of a gelling agent, 5-80% of an aerosol generating agent, and optionally 0.1-60% of an active substance and/or flavorant, ([claim 2]). This amorphous solid is considered to meet the limitation of a hydrogel. Amorphous solid as interpreted according to the specification, includes embodiments where the amorphous solid comprises no tobacco material, ([pg 8 lines 24-25]). Ghanouni 2 does not disclose using a filler material, and thus would be considered to include amorphous substrates without a filler material.
The aerosol generating substrate of Ghanouni 2 according to claim 2 does not disclose that the aerosol generating substrate comprises a carrier wherein the carrier comprises a metal foil layer and a support layer. Ghanouni 2 does not disclose the functional limitations of the claim are met.
Ghanouni 2 discloses the aerosol generating substrate further comprises a carrier on which the amorphous solid is provided, ([claim 4]). Ghanouni 2 discloses that the carrier is formed from materials selected from metal foil, paper, cardboard, and combinations thereof, ([claim 5]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Ghanouni 2 according to limitations from the dependent claims because one of ordinary skill in the art would reasonably believe that these limitations are compatible with each other and result in a workable aerosol generating substrate on a carrier. Thus, one of ordinary skill in the art would have expected that the composition ranges of claim 2, were compatible with the limitations of supporting the amorphous substrate on a carrier in claim 4, where the carrier is selected from a combination of a metal foil and either paper or cardboard, ([claim 5]). Regarding the functional limitation, although Ghanouni 2 does not disclose that this condition would be met, when a composition in the prior art is identical or substantially identical in composition, the claimed properties are considered present.
Regarding claim 4-5, modified Ghanouni 2 meets the limitations of claim 1. Ghanouni discloses that the aerosol generating agent may be selected from the group comprising erythritol, propylene glycol, glycerol, and mixtures thereof, ([claim 12).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have provided the aerosol generating substrate with the amorphous solid comprising an aerosol generating agent according to claim 12. Modified Ghanouni 2 discloses that the amorphous solid comprises an aerosol generating agent. Claim 12 provides a list of acceptable aerosol generating agents. One of ordinary skill in the art would find it obvious to select an aerosol generating agent from this list, including selecting glycerol, which meets the claimed limitations.
Regarding claim 8, modified Ghanouni 2 meets the limitations of claim 6. Ghanouni discloses that the gelling agent comprises one or more compounds selected from the group comprising alginates, pectins, starches and starch derivatives, celluloses and cellulose derivatives, gums, silica or silicones compounds, clays, polyvinyl alcohol, and combinations thereof, ([claim 8]).
It would be obvious to incorporate a gelling agent from the list provided by Ghanouni 2 because these are intended for use in the amorphous substrate of modified Ghanouni 2.
Regarding claim 14, modified Ghanouni 2 discloses the aerosol generating substrate of claim 1. Ghanouni 2 discloses that the carrier has a thickness in a range of about 10 micrometers to about 2.5 mm, ([claim 10]). Ghanouni 2 further discloses that the carrier may be a metal foil layer and a support layer, ([claim 8]).
It would be obvious to one of ordinary skill in the art to provide a carrier that meets is within the range of 10-20 micrometers, which further comprises a metal foil layer, and such a carrier would have a metal foil layer that is less than 20 micrometers.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4, and 5 of Ghanouni et al. (US 2024/0415169 A1) (Ghanouni 2) in view of Bitar et. al (WO 2016/156495 A2).
Regarding claim 16, modified Ghanouni 2 discloses the aerosol generating substrate according to claim 1. Ghanouni 2 does not disclose that the amorphous solid is bonded to the carrier.
Bitar discloses carriers that are used to support smokable materials, ([pg 1 lines 21-28]). . Bitar discloses the first layer of smokeable material is bonded to the carrier, ([pg 3 lines 6-7]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Ghanouni 2 by bonding the amorphous layer to the carrier as taught by Bitar, for the obvious reason of preventing the amorphous solid from becoming dislodged from the carrier.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Greim et al. (WO 2009/118085). Greim discloses an aerosol generating substrate, where the aerosol forming substrate releases a plurality of volatile compounds upon heating, ([pg 1 lines 31-32]). Griem discloses that the aerosol generating substrate comprises an aerosol former, and that examples of suitable aerosol formers are glycerine and propylene glycol, ([pg 3 lines 1-2]). The aerosol generating substrate of Greim may be either a tobacco containing substrate or alternatively may comprise a non-tobacco material, ([pg 2 lines 34-36]), and reasonably suggests herb leaf as an alternative material to tobacco leaf, ([pg 3 lines 4-6] disclosing herb leaf in contrast to tobacco leaf and other tobacco containing options), suggesting that the aerosol generating substrate may be made without any tobacco material. The solid substrate may be provided on or embedded in a thermally stable carrier, where the carrier may take many forms including sheet form, and a tubular carrier having a thin layer of the solid substrate deposited on its inner surface, where the tubular carrier is formed of a paper or paper like material, and the solid substrate may be deposited on the surface of the carrier in the form of a sheet, foam, gel or slurry, ([pg 3 lines 11-20]).
Billons et al. (US 2020/0297023 A1). Billons discloses a reconstituted plant sheet obtained by a papermaking process and comprising solid additives, ([0001]), disclosing the solid additive can be plant dust, a diluent, a texturing agent, a powdered flavouring, a dye, a gel, or a mixture thereof, ([0016]).
The Engineering Toolbox, Fuels and Chemicals – Autoignition Temperatures, (2003), available online at https://www.engineeringtoolbox.com/fuels-ignition-temperatures-d_171.html.
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/D.E.V./Examiner, Art Unit 1747
/DIONNE W. MAYES/Primary Examiner, Art Unit 1747