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 .
Status of the Claims
Claims 1-9 and 12-19 are pending, Claims 1, 3, 5-6, 8, and 16 are amended. Claims 2, 4, 7, 9, and 14-15 are either original or previously presented. Claims 12-13 are withdrawn. Claims 10-11 are cancelled.
Response to Amendment
The amendment to claim 16 overcomes the objection to the Specification, thus the objection to the Specification is withdrawn, however a minor informality in the Specification was found, see the objection to the Specification below. The amendment to claim 5 changing the dependency of this claim to claim 1, overcomes the 35 USC 112(b) rejection of this claim based on the prior dependency from claim 4, and thus this rejection is withdrawn. The amendment to claim 8, changing the word comprising to consisting overcomes the indefiniteness rejection based on the recitation of an improper Markush group, and thus this rejection is withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 and 14-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the rejection of record relied upon Bitar and/or Casey, which Applicant argued did not teach limitations required by the claims, and the new rejection does not rely on these references. The changes to the rejection of record were required by the amendment to the claims.
Applicant’s arguments filed 12/18/2025 have been considered with regard to the remaining 35 USC 112(b) rejections, but are not persuasive.
Applicant argues that functional limitations are permitted within claims. Examiner agrees. The MPEP 2173.05(g) recites that “[f]unctional language does not, in and of itself, render a claim improper.” The MPEP requires, “[a] functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context for which it is used.” Id. However, “[n]otwithstanding the permissible instances, the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite.” Id. Thus, while functional claiming may be permitted, in some situations the use of functional language may render a claim indefinite.
“When a claim limitation employs functional language, the Examiner’s determination of whether the limitation is sufficiently definite will be highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the art).” Id. The MPEP suggests that “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” Id.
Applicant asserts that measuring the amount of aerosolization is a standard practice that would be known to a person of ordinary skill in the art. This statement is unsupported. Applicant has not disclosed a test method for heating the aerosol generating material to 370 °C under a 1.95 L/min airflow, and the prior rejection identified several variables that would need to be established for the aerosolization testing which one of ordinary skill in the art would not know based on the disclosure. This renders the functional limitation indefinite because these variables are expected to affect whether the limitation is met or not for any particular test. The thickness of the composition, the composition component weight percentages, the thickness of the carrier, the geometry of the carrier and substrate, and the rate of heating, are expected to all materially affect whether the functional limitation is met under the conditions that are defined. Thus, even accepting that measuring aerosolization of a substrate is a standard practice, the test conditions do not appear to be, and thus factor 1 weights towards a finding of indefiniteness.
Regarding factor 2, the language appears to only state a result to be obtained rather than the scope of the subject matter covered by the claim. Examiner could find no discussion in the Application of how to vary the aerosol generating substrate to raise or lower the percentage of the aerosol generating agent aerosolized at the test conditions, nor were there any test results upon which such disclosure could be derived. The limitation appears to be a result, that one of ordinary skill in the art would evaluate based on their experimental results for each composition, with no guidance provided how to achieve that result, and thus appears to be a result to be obtained, weighing towards a finding of indefiniteness.
Regarding factor 3, one of ordinary skill in the art would not know the steps or structure (composition) encompassed by the claim, because even if a composition is formed based on the claimed compositional limitations, it is unclear how to perform the functional limitation based on the Application.
Thus, the identified functional limitations, and the claims that incorporate them are regrettably considered indefinite. For the purpose of examination, because Examiner has no basis for finding the functional limitations are not met by any composition meeting the other claimed limitations, the functional limitation will be considered inherent to the composition if the other composition limitations of the claims are met.
The 35 USC 112(b) rejections of claim 6, and now including claim 1 (as a result of the amendment) were not addressed by Applicant in the Response. Examiner identified an issue, considered to render the claims indefinite, because fillers and gelling agents are subject to different ranges, yet at least one material identified by the Specification falls into both categories. It is unclear how to apply the range limitations to a material that falls into both categories, thus these rejections are maintained.
Obvious -Type Double Patenting Rejection
Applicants amended the claims upon which the double patenting rejections were made. The double patenting rejections were reconsidered in light of those amendments. The double patenting rejections were updated based on the amendments, and presented below.
Specification
The disclosure is objected to because of the following informalities: On pg 17-18 lines 31-1 the Specification recites “the filter segment 103” but should recite “the filter segment 109”.
Appropriate correction is required.
Claim Objections
Claims 2-9, and 14-19 are objected to because of the following informalities: These claims all start with “An” but should start with “the”.
It is also noted that claims 12-13 also refer to “an aerosol generating substrate” and should instead recite “the aerosol generating substrate” and claim 13 also starts with “An” and should start with “The”, if these claims are eventually to be rejoined. 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 compositions of 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 would depend on the rate of heating, 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 14-19 are rejected based on their dependency to indefinite claim 1.
Claim 1 and Claim 6, which depends on claim 1, recites that the amorphous solid comprises about 15-60 wt% of a gelling agent. Claim 8, which depends on claims 6 and 1, 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 a contemplated amorphous substrate comprising 25wt% cellulose and cellulose derivatives is covered by the claims, because those materials are considered as filler which cannot exceed 20 wt% but are also considered gelling agents which may range up to 60 wt%. 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 2-9, 14-19 are further rejected as indefinite based on their dependency on claim 1.
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) 1-9 and 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malgat et al. (US 2016/0331031 A1) in view of Counts et al. (US 5,369,723), Sutton (WO 2016156495 A2), and John et al. (US 2016/0295922 A1).
Regarding claim 1-2, Malgat discloses an aerosol generating article for use with an aerosol generating device, ([0001]). Malgat discloses that aerosol generating articles comprising an aerosol forming substrate are well known in the art, ([0002]). Malgat discloses an aerosol generating substrate of homogenized tobacco material as an aerosol forming substrate where the aerosol generating substrate may contain tobacco, ([0048], as well as other additives such as non-tobacco fibers, aerosol formers, humectants, flavorants, fillers, and aqueous solvents, ([0049]). Malgat discloses that the aerosol generating substrate may contain between about 1-5% non-tobacco fibers by weight on a dry weight basis, ([0051]), and the fibers may be cellulose fibers, ([0055]), reasonably disclosing filler in the form of cellulose fibers as a part of the aerosol generating substrate. Malgat discloses the aerosol generating material comprises an amorphous solid, ([0054]-[0055] disclosing that the aerosol forming substrate may be formed by a casting process reasonably disclosing an amorphous solid). The amorphous solid comprising an aerosol generating agent, ([0053] having preferably 5%-30% by weight, and preferably the aerosol generating agent is glycerine considered equivalent to glycerol), and a gelling agent, ([0050] explicitly disclosing guar gum, xanthan gum, arabic gum and locust bean gum; cellulosic binders such as, for example, hydroxypropyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, methyl cellulose and ethyl cellulose; polysaccharides such as, for example, starches, organic acids, such as alginic acid, conjugate base salts of organic acids, such as sodium alginate, agar and pectins which include many of the binding agents disclosed in the Specification as gelling agents, rendering those selections obvious choices). Malgat discloses an embodiment where the aerosol generating article comprises the aerosol generating substrate and additionally comprises a carrier that surrounds the amorphous solid, and wherein the carrier comprises a metal foil layer and a support layer, with the support layer abutting the amorphous solid, ([0018], [0080] Fig 3). Malgat does not disclose that the aerosol generating substrate is cast onto the carrier, instead disclosing that the slurry is generally cast onto a conveyor or other support surface, dried, and then removed from the support surface, ([0054]). Although Malgat discloses the inclusion of gelling agents in the form of binders, but Malgot does not disclose the relative amounts to use.
Counts teaches an invention related to electrically heated smoking articles, ([Col 1 lines 7-11), and thus is within the inventor’s field of endeavor. Counts teaches tobacco flavor materials may include continuous sheets, foams, gels, or cast slurries, which may or may not contain tobacco derived materials, ([Col 4 lines 2-5]). Counts teaches that the tobacco flavor material may include humectants, flavorants, gum additives or other binders, ([Col 4 lines 6-8]). Counts teaches a technique of casting the tobacco flavor material onto a carrier or barrier layer, ([Col 8 lines 16-20]), and that altering the binder and other content of the composition the rate of aerosol generation can be selectively controlled, ([Col 8 lines 32-36]). Counts also teaches that for any material that liberates flavors, aerosol and flavor generation can be controlled by changing the basis weight, sheet density, or casting thickness of the sheet, ([Col 7 lines 61-67]). Counts does not teach the relative amount of binder to use in a composition with an aerosol generating agent of about 5-40 wt%.
Sutton teaches an article for use with an apparatus for heating smokable material to volatilize at least one component of the smokeable material the article comprising, a carrier and smokeable material arranged on the carrier, ([pg 1 lines 18-22]), and thus is within the inventor’s field of endeavor. Sutton teaches that smokeable materials may be in the form of extruded tobacco and gels, (pg 6 lines 9-14]), reasonably suggesting that smokeable material may comprise an amorphous solid. Sutton teaches that the smokable material may be bonded to the carrier, ([pg 3 lines 6-7]), and that the carrier is for conducting heat through the carrier towards the smokable material, ([pg 3 lines 21-22). Sutton teaches that the carrier may comprise a first layer of material for example paper, and a second layer of material for example a metal foils, where the smokable material is more readily bondable to the first layer of the carrier than to the second layer of the carrier, ([pg 7 lines 17-19]). Sutton does not teach the relative amount of binder to use in an aerosol generating agent of about 5-40 wt%.
John teaches a device for generating an inhalable aerosol comprising an aerosol generating material, ([0005]), and is thus within the inventor’s field of endeavor. John teaches the aerosol generating material has an integrated electrical heating element, such that the aerosol generating material and heating element form a single unit or composite structure, where the heating element is coated by the aerosol generating material, ([0051]), considered to be a similar technique to that taught by Counts where the tobacco flavor material may be cast onto a carrier. John teaches the aerosol generating material may comprise 10-30 wt% aerosol generating agent in the form of glycerol, ([0067]), similar to the disclosure of Malgat. John teaches that the aerosol generating material may comprise one or more flavorants, ([0069]-[0070]). John teaches that the aerosol generating material may comprise any suitable substances in place of or in addition to a tobacco extract, including water, a binder, an inorganic filler material, and an aerosol generating agent, ([0085]), and where the aerosol generating material may comprise binders in the form of an alginate, celluloses or modified celluloses, starches or modified starches, and natural gums, ([0090]-[091). John teaches that the binder may be included in the aerosol generating material in any suitable concentration and quantity, but suggests that advantageously the material may comprise 20-25% binder by weight, and the binder maybe selected to be sodium alginate, ([0093]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Malgat by the teachings of Counts, Sutton, and John. Malgat discloses an aerosol generating article where the aerosol generating material is circumscribed by a paper and a foil, where the paper abuts the aerosol generating material, but the aerosol generating material is first cast onto a support surface, dried, and then removed from the surface before gathering and wrapping with the carrier. Counts teaches that the step of removing the dried slurry can be eliminated by directly casting the slurry onto the carrier. Sutton teaches the carrier may be a paper and a metal foil, and that it is advantageous to apply the aerosol generating substrate to the paper side because the aerosol generating substrate will more readily bond to the paper layer of the carrier. While Malgat does not disclose the amount of binder to use, John teaches using a binder, considered to be a gelling agent, for an amorphous solid, where the binder is present in the amount of 20-25% by weight. One of ordinary skill in the art would reasonably expect the binder percentage from John to work in the composition of Malgat, because the compositions are otherwise similar, having a similar amount of aerosol generating agent, where the aerosol generating agent was glycerine/glycerol, and because Counts teaches the amount of binder is a variable to control to affect aerosol and flavor generation.
Although none of the references discloses testing the aerosolization of the aerosol generating agent under the test conditions, and this limitation is considered indefinite, because the modified composition has glycerine/glycerol as the aerosol generating agent, 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. Thus, this limitation is reasonably expected to be met by modified Malgat.
Regarding claim 3, modified Malgat discloses an aerosol generating substrate according to claim 1. Malgat discloses the aerosol generating agent in an amount preferably 5%-30% by weight, ([0053]).
Regarding claim 4-5, modified Malgat discloses an aerosol generating substrate according to claim 1. Malgat discloses the aerosol generating agent may is preferably glycerine, ([0053]) considered equivalent to glycerol.
Regarding claim 6, modified Malgat discloses the aerosol generating substrate according to claim 1. Malgat discloses that the aerosol generating agent is preferably 5%-30% by weight, ([0053]), contains a gelling agent, and tobacco in an amount of at least 40% by weight, ([0048]), where tobacco is considered an active ingredient. Malgat discloses the amount of tobacco used will impact the strength of the tobacco flavor, reasonably suggesting to one of ordinary skill in the art to use an amount close to 40% by weight to provide a flavor profile with a more moderate tobacco flavor.
As in the rejection of claim 1 above, it is obvious to modify Malgat according to the teachings of Counts, Sutton, and John to have a gelling agent of 20-25% binder by weight, ([0093]). Malgat discloss adding flavourants to the aerosol generating material, ([0049]), as does John ([0069]-[0070]), for the obvious motivation of altering the flavor profile of the aerosol generating material with the added flavorant.
Regarding claim 7, modified Malgat 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.
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 Malgat is an amorphous solid based on the teachings of John, which 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 Malgat is a hydrogel comprising less than about 20% water, rendering this claim obvious.
Regarding claim 8, modified Malgat discloses the aerosol generating substrate according to claim 6. Malgat explicitly disclosing guar gum, xanthan gum, arabic gum and locust bean gum, (gums); cellulosic binders such as, for example, hydroxypropyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, methyl cellulose and ethyl cellulose, (cellulose and cellulose derivatives); polysaccharides such as, for example, starches, sodium alginate, and pectins rendering those selections obvious choices, ([0050]).
Regarding claim 9, modified Malgat discloses the aerosol generating substrate according to claim 6. Both Malgat and John disclose/teach adding flavorants to the aerosol generating substrate, for the obvious reason of modifying the flavor of the aerosol generated by the aerosol generating substrate by the added flavorant. Just as Malgat discloses the amount of tobacco used will impact the strength of the tobacco flavor, one of ordinary skill in the art would know that the amount of flavorant added is a result effective variable that can be increased or decreased to optimize the amount of flavor the flavorant adds to the aerosol generated by the aerosol generating substrate. Based on the broadly claimed range of 0.1-80wt% of flavorant, and the nature of the flavorants taught by John, ([0070]), one of ordinary skill in the art would be expected to optimize these flavorants within the claimed range to achieve a desireable flavor profile.
Regarding claim 14, modified Malgat discloses the aerosol generating substrate according to claim 1. While Malgat and Sutton disclose or teach using a paper backed foil with the aerosol generating substrate, these references do not disclose or teach the thickness of the foil. However, Counts does disclose a thickness of aluminum foil in a carrier 0.013 mm thick, and where in another embodiment aluminum foil was 0.006 mm thick, reasonably disclosing aluminum foil suitable for use in a carrier as below 20 micrometers thick, ([col 10 lines 3-20]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected the thickness of the aluminum foil for the aerosol generating substrate based on the teachings of Counts, which reasonably suggest that aluminum foil used as part of a carrier with paper will have a thickness below 20 microns.
Regarding claim 15, modified Malgat discloses the aerosol generating substrate according to claim 1.
Sutton teaches using a combination of foil and paper or the like as the carrier, ([pg 7 lines 17-19]). None of the references explicitly disclose using cardboard as part of the carrier.
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 Malgat further and substituted cardboard (a known type of paper product) for the paper used with metal foil of Sutton. Modified Malgat disclosed the claimed invention, except that the support layer of the carrier is disclosed as being made from paper with a metal foil backing instead of cardboard with a metal foil backing. One of ordinary skill in the art would have expected the substitution to work and provide the obvious advantage of a more robust carrier for the slurry to be cast upon.
Regarding claim 16, modified Malgat discloses the aerosol generating substrate according to claim 1. Casey teaches that the amorphous solid is cast upon the carrier, above, and Sutton teaches that the smokeable material is bonded to the carrier, ([pg 3 lines 6-7]).
Regarding claim 17, modified Malgat discloses the aerosol generating substrate according to claim 1. Malgat discloses the grammage of the aerosol generating material is between 100-300 g/m2, ([0059]). Counts teaches controlling the aerosol and flavor generation by changing the basis weight of the aerosol generating material, ([col 7 lines 63-66]).
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 Malgat according to the teachings of Counts, and altered the basis weight of the composition of modified Malgat within the disclosed range of 100-120 g/m2, to modify the aerosol and flavor generation accordingly.
Regarding claim 18-19, modified Malgat discloses the aerosol generating substrate according to claim 1. Malgat discloses the aerosol generating material may comprise 1-5% non-tobacco fibers, ([0051]), and the aerosol generating material may comprise cellulose fibers, ([0055]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 7-9, 11, 14, and 17, of U.S. Patent No. Ghanouni et al. (US 12,178,236 B2), reference application 17,264,212.
Regarding claims 1-2, Ghanouni claims:
An aerosol generating substrate, claim 1, comprising,
an aerosol generating material, claim 1,
the aerosol generating material comprises an amorphous solid, claim 1,
the amorphous solid comprising an aerosol generating agent,
the amorphous solid comprises:
less than 20 wt% filler, claim 1,
about 5-40 wt% aerosol-generating agent, claim 6 claiming a broader range, rendering the claimed range obvious, and
about 15-60 wt% gelling agent, claim 6 claiming a broader range, rendering the claimed range obvious),
wherein the aerosol generating substrate additionally comprises a carrier on which the amorphous solid is provided, claim 11, and
wherein the carrier comprises a metal foil layer and a support layer, claim 17.
The limitation wherein at least about 65wt% of the aerosol generating agent is aerosolized, and further at least about 70wt% 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 1.95L/min airflow, is considered inherent based on the reasoning in the prior art rejections above because one of ordinary skill in the art would interpret the limitation of an aerosol generating agent consistent with the Specification which discloses glycerol is an acceptable choice for the aerosol generating agent, Specification pg 7 lines 7-12, and because glycerol is claimed as an acceptable choice for the aerosol generating agent, claim 9.
Regarding claim 3, Ghanouni discloses an aerosol generating substrate according to claim 1.
Ghanouni discloses about 1-60 wt% aerosol-generating agent, claim 6 claiming a broader range, rendering the claimed range obvious.
Regarding claim 4-5, Ghanouni discloses an aerosol generating substrate according to claim 1.
Ghanouni discloses the aerosol generating agent is selected from 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, where the selection of any of these is an obvious choice rendering the selection of glycerol obvious.
Regarding claim 6, Ghanouni discloses an aerosol generating substrate according to claim 1.
Ghanouni discloses an aerosol generating substrate wherein the amorphous solid comprises:
about 1-60 wt% of a gelling agent, claim 6 claiming a broader range rendering the claimed range obvious;
about 5-80 wt% of an aerosol generating agent, claim 6 claiming a broader range rendering the claimed range obvious; and
about 10-60 wt% of an active substance, claim 6 claiming a broader range rendering the claimed range obvious;
and optionally a flavorant, claim 4,
wherein these weights are calculated on a dry weight basis.
Regarding claim 7, Ghanouni discloses an aerosol generating substrate according to claim 6.
Ghanouni discloses the amorphous solid is a hydrogel and comprises less than about 20 wt% of water calculated on a wet weight basis, claim 7 claiming a narrower range.
Regarding claim 8, Ghanouni discloses an aerosol generating substrate according to claim 6.
Ghanouni discloses the gelling agent comprises one or more compounds selected from the group consisting of alginates, pectins, starches and starch derivatives, celluloses and cellulose derivatives, gums, silica or silicones compounds, clays, polyvinyl alcohol and combinations thereof, claim 8.
Regarding claim 9, Ghanouni discloses an aerosol generating substrate according to claim 1.
Ghanouni discloses the aerosol generating substrate comprises from about 0.1-80wt% of flavorant, calculated on a dry weight basis, claim 4 claiming a narrower range.
Regarding claim 15, Ghanouni discloses an aerosol generating substrate according to claim 1.
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.
Regarding claim 16, Ghanouni discloses an aerosol generating substrate according to claim 1.
Ghanouni discloses that the carrier comprises a porous layer that abuts the amorphous solid, claim 16, where the carrier comprises a paper backed foil, claim 17. The Specification, pg 11 lines 5-7, discloses that such an arrangement may cause the amorphous layer to form a strong bond with the porous layer, rendering the claimed limitation an obvious embodiment of these claims.
Regarding claim 18-19, Ghanouni discloses an aerosol generating substrate according to claim 1.
Ghanouni discloses the aerosol generating substrate comprises less than 20% filler, claim 1. Ghanouni discloses that the gelling agent may comprise cellulose and cellulose deriviatives, claim 8, which are understood to also be considered fillers according to the reference specification, pg 9 lines 9-11. The Specification suggests that the cellulose and cellulose may be fibrous organic filler material, pg 13-15. Because the Specification suggests that the cellulose and cellulose derivatives may be fibrous organic filler material, these limitations are considered to be obvious embodiments where the gelling agent comprises cellulose and cellulose derivatives.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 11, and 17 of U.S. Patent No. Ghanouni et al. (US 12,178,236 B2) reference application 17,264,212, 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 carrier.
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.
Claims 1-9 and 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 8 -10, and 12 of copending Application No. Ghanouni et al. (US 2024/0415169 A1) (Ghanouni 2), reference application 18/816,743.
Regarding claims 1-2, Ghanouni 2 claims:
An aerosol generating substrate, claim 1, comprising,
an aerosol generating material, claim 1,
the aerosol generating material comprises an amorphous solid, claim 1,
the amorphous solid comprising an aerosol generating agent,
the amorphous solid comprises:
less than 20 wt% filler, claim 2 disclosing percentages of components of the composition totalling over 100% and thus reasonably disclosing an embodiment where filler is less than 20% in the amorphous solid,
about 5-40 wt% aerosol-generating agent, claim 2 claiming a broader range, rendering the claimed range obvious, and
about 15-60 wt% gelling agent, claim 2 claiming a broader range, rendering the claimed range obvious),
wherein the aerosol generating substrate additionally comprises a carrier on which the amorphous solid is provided, claim 4, and
wherein the carrier comprises a metal foil layer and a support layer, claim 8 disclosing the carrier maybe a paper-backed foil.
The limitation wherein at least about 65wt% of the aerosol generating agent is aerosolized, and further at least about 70wt% 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 1.95L/min airflow, is considered inherent based on the reasoning in the prior art rejections above because one of ordinary skill in the art would interpret the limitation of an aerosol generating agent consistent with claim 12, which lists glycerol is claimed as an acceptable choice for the aerosol generating agent..
Regarding claim 3, Ghanouni 2 discloses an aerosol generating substrate according to claim 1.
Ghanouni 2 discloses about 1-60 wt% aerosol-generating agent, claim 2 claiming a broader range, rendering the claimed range obvious.
Regarding claim 4-5, Ghanouni 2 discloses an aerosol generating substrate according to claim 1.
Ghanouni 2 discloses the aerosol generating agent is selected from erythritol, glycerol, and propylene glycol, (a type of glycol), and mixtures thereof, claim 12, where the selection of any of these is an obvious choice rendering the selection of glycerol obvious.
Regarding claim 6, Ghanouni 2 discloses an aerosol generating substrate according to claim 1.
Ghanouni 2 discloses an aerosol generating substrate wherein the amorphous solid comprises:
about 1-60 wt% of a gelling agent, claim 2 claiming a broader range rendering the claimed range obvious;
about 5-80 wt% of an aerosol generating agent, claim 2 claiming a broader range rendering the claimed range obvious; and
about 10-60 wt% of an active substance, claim 2 claiming a narrower range rendering the claimed range obvious;
and optionally a flavorant, claim 2,
wherein these weights are calculated on a dry weight basis.
Regarding claim 7, Ghanouni 2 discloses an aerosol generating substrate according to claim 6.
Ghanouni 2 discloses the amorphous solid is a hydrogel and comprises less than about 20 wt% of water calculated on a wet weight basis, claim 1 claiming a narrower range of the water and the Specification disclosing that the form of the amorphous solid having less than about 15% is a hydrogel, pg 9 line 7-9.
Regarding claim 8, Ghanouni 2discloses an aerosol generating substrate according to claim 6.
Ghanouni 2 discloses the gelling agent comprises one or more compounds selected from the group consisting of alginates, pectins, and combinations thereof, claim 12.
Regarding claim 9, Ghanouni 2discloses an aerosol generating substrate according to claim 1.
Ghanouni 2 discloses the aerosol generating substrate comprises from about 0.1-80wt% of flavorant, calculated on a dry weight basis, claim 2 claiming a narrower range.
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, especially because one of ordinary skill in the art would consult the reference Specification to determine what thickness of foil to use to meet the limitation of reference claim 10, and the reference Specification discloses the metal foil may be less than 20 micrometers, pg 6 lines 17-19.
Regarding claim 15, Ghanouni 2 discloses an aerosol generating substrate according to claim 1.
Ghanouni 2 discloses the carrier materials may be selected from a list including cardboard, metal foil, paper, and combinations thereof, claim 5, claim 8 (paper-backed foil). It would be obvious to substitute one carrier for another from a list that includes both carriers as acceptable.
Regarding claim 16, Ghanouni 2 discloses an aerosol generating substrate according to claim 1.
Ghanouni 2 discloses that the carrier comprises a surface abutting the amorphous solid, and a surface facing away from the amorphous solid that is suitable for contacting a heater, claim 9. The Specification informs one of ordinary skill in the art that this may be interpreted as an arrangement where the amorphous solid is provided on the paper side of the paper backed foil, where the amorphous solid will form a strong bond with the paper porous layer that abuts the amorphous solid, pg 5 lines 20-27.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.E.V./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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