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 1-11, 13-17, 21-22, 24, 28, and 30-31 are pending and are subject to this Office Action. Claims 12, 18-20, 23, 25-27, and 29 are cancelled. Claims 15-17, 21-22, 24, 28, and 30-31 are withdrawn.
Response to Arguments
Applicant's arguments filed November 5, 2025 have been fully considered but they are not persuasive.
On pgs 6-8, Applicant argues that since Szekalska and Parreidt fail to disclose a molar ratio of Ca2+ cations to G units, there is not any teaching in John, Szekalska or Parreidt that even could have led a person having ordinary skill in the art to the presently claimed invention, regardless of any technical effect. While Examiner acknowledges that neither Szekalska nor Parreidt discloses a molar ratio of Ca2+ cations to G units is from 0.2:1 to 1:1, Szekalska has been relied upon for its disclosure that alginate gels with an increased amount of repeating G-block units relative to M-blocks are regarded as stiffer, brittle, and more mechanically stable (Szekalska, pg 3, col 2, ln 1-5); and Parreidt has been relied upon for its disclosure that the concentration of Ca2+ ions within the alginate can be modified to control the crosslinking density and tensile strength of the alginate (Parreidt, pg 6, ln 1-5 and ln 18-25; and pg 26, ln 35-36), wherein the Ca2+ ions participate in ionic bonding with the G units of the alginate to cause gelation (Parreidt, pg 5, ln 5-10 and ln 18-21). In view of the above disclosure of Szakalska and Parreidt, the crosslinking density, tensile strength, and stability of the alginate are variables which can be modified by the molar ratio of Ca2+ cations to G units, as stated on the previous non-final rejection. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the result effective variable argument is based on the combined disclosures of Szekalska and Parreidt; and therefore, the applicant’s arguments are unpersuasive.
On pgs. 8-9, Applicant argues that a person having ordinary skill in the art would not have been motivated to specifically include 45-55 wt% menthol in the aerosol-generating material of John. As argued in the previous non-final rejection, the precise menthol content would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because the taste and aroma of the aerosol-generating material is a variable which can be modified by the amount of the menthol, which is added to the material as a flavorant (John, [0069]-[0070]). As such, without showing unexpected results, the claimed menthol content cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the menthol content by routine experimentation to obtain the desired taste and/or aroma, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II).
Furthermore, John states that in embodiments wherein the aerosol generating material comprises one or more flavorants, it may be advantageous for the material to comprise a quantity and concentration of flavorants suitable for delivering desirable quantities of them to the aerosol and/or gas generated from the aerosol generating material, and that desirable quantity may be a quantity that results in a superior sensory experience for the adult consumer of the devices (John, [0071]). As John teaches a solid aerosol generating material comprising about 1-25 wt % tobacco material, about 1-25% nicotine, about 1-90 wt % filler, about 5-50 wt % aerosol generating agent, about 3-50 wt % binder, 3-10% water (John, [0050], [0066]-[0078], [0089]-[0095]), and states that the aerosol generating material may consist of one or more of the following in any possible combination: an aerosol generating agent; a filler; a binder; a flavorant, nicotine, and water (John, [0097], [0260]), John reasonably suggests that there can be embodiments wherein the solid aerosol generating material comprises 45-55% of the flavorant (menthol) by weight.
On pg. 9, Applicant argues that the one of ordinary skill in the art before the effective filing date of the invention would not have optimized the dry weight ratio of cross-linked alginate to pectin by routine experimentation based on the disclosures of John, [0090]-[0092]. Applicant argues that alginate and pectin are merely two of the possible binders, and John teaches away from present Claim 11 because the preferred binder of John is sodium alginate. Examiner respectfully disagrees with the arguments because the disclosure of a preferred embodiment does not necessarily teach away from providing an invention including features of other embodiments. As John explicitly states that one or more binders may be included in the aerosol generating material in any suitable quantity or concentration (John, [0090]-[0091]), it would have been obvious to try employing two of the explicitly listed binders. As stated on the previous non-final rejection, the precise dry weight ratio of the cross-linked alginate to the pectin is from 1:1 to 10:1 would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because John states that the one or more binders may be included in the aerosol generating material in any suitable quantity or concentration, and that the quantity and concentration of the binder may vary depending on the composition of the material, the nature of the heat source, for example the electrical resistance heating element, and the properties desired of the device into which it is incorporated (John, [0090]-[0092]). As such, without showing unexpected results, the claimed dry weight ratio cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the dry weight ratio by routine experimentation to obtain the desired properties, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II).
On pg. 9-10, Applicant argues that there is no clear reason or rationale for a person having ordinary skill in the art to combine John (which relates to a device for generating an inhalable aerosol) with Szekalska or Parreidt (let alone with both of these references) when preparing an aerosol-generating material product. Applicant argues that combination of John with Szekalska and Parreidt is entirely reliant on hindsight knowledge of the present invention. Examiner respectfully disagrees with the arguments because the Szekalska has been relied upon for its disclosure that alginate gels with an increased amount of repeating G-block units relative to M-blocks are regarded as stiffer, brittle, and more mechanically stable (Szekalska, pg 3, col 2, ln 1-5); and Parreidt has been relied upon for its disclosure that the concentration of Ca2+ ions within the alginate can be modified to control the crosslinking density and tensile strength of the alginate (Parreidt, pg 6, ln 1-5 and ln 18-25; and pg 26, ln 35-36), wherein the Ca2+ ions participate in ionic bonding with the G units of the alginate to cause gelation (Parreidt, pg 5, ln 5-10 and ln 18-21). As John, Szekalska, and Parreidt are directed to alginates, Szekalska and Parreidt provide sufficient motivation to modify the molar ratio of Ca2+ ions to G units in John. The combination of John, Szekalska, and Parreidt does not require replacement of the alginate of John with those of Szekalska or Parreidt.
On pgs. 10, Applicant argues that pages 37-38 and Fig. 8 of the specification provides data to support that the claimed range of calcium cations to G units impacts the menthol sensory performance. Fig. 8 demonstrates that an alginate having a molar ratio of Ca2+ ions to G units within the range disclosed in Claim 2 (0.3:1 to 0.5:1) provides a higher menthol output relative to an alginate having a molar ratio outside of the range (0.2:1). However, since Fig. 8 only includes two representative values for the molar ratio of Ca2+ ions to G units (0.2:1, 0.4:1), it is unclear how the upper values of the ranges for the molar ratio of Ca2+ ions to G units claimed in Claims 1 and 2 have been determined. Therefore, the data provided in the specification does not sufficiently demonstrate the criticality of the claimed molar ratios.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over John (US 2016/0295922 A1) in view of Szekalska (“Alginate: Current Use and Future Perspectives in Pharmaceutical and Biomedical Applications”) and Parreidt (“Alginate-Based Edible Films and Coatings for Food Packaging Applications”).
Regarding Claim 1, John, directed to alginates ([0090]-[0091]), teaches an aerosol-generating material comprising an amorphous solid ([0050], [0066]-[0078], [0089]-[0095]; John teaches a solid aerosol generating material comprising about 1-25 wt % tobacco material, about 1-25% nicotine, about 1-90 wt % filler, about 5-50 wt % aerosol generating agent, about 3-50 wt % binder, 3-10% water. John does not explicitly define a shape of form for the solid aerosol generating material; therefore, the solid aerosol generating material is an amorphous solid), the amorphous solid comprising:
menthol ([0069]-[0070], The aerosol generating material may comprise one or more flavorants such as menthol);
1-60 wt% of a gelling agent, the gelling agent comprising calcium alginate ([0090]-[0093], The solid aerosol generating material comprising about 3-50 wt % binder. The binder may be calcium alginate. [0226]-[0029], Example 4 shows that an alginate binder behaves as a gelling agent); and
0.1-50 wt% of an aerosol-former material ([0066]-[0067], The solid aerosol generating material comprising about 5-50 wt % aerosol generating agent. The aerosol generating agent may be glycerol. Glycerol is an aerosol-former material; see instant specification, pg 9, ln 17-18).
Szekalska, directed to alginates (pg 1, col 1, ln 1-13), demonstrates that the term ‘calcium alginate’ refers to an alginate cross-linked by the addition of calcium ions (pg 2, col 2, ln 9-15; and pg 3, col 2, ln 1-15). Szekalska further demonstrates that alginate is composed of a block copolymer comprising covalently linked blocks of (1-4)-linked β-D-mannuronate (M) and α-L-guluronate (G) residues (pg 1, col 1, ln 1-13). Therefore, the calcium alginate taught by John is calcium-crosslinked alginate comprising α-(1-4)-linked L-guluronate (G) units.
John does not teach the aerosol-generating material wherein the amorphous solid comprises 0.1-80 wt% of menthol, wherein a molar ratio of Ca2+ cations to G units is from 0.2:1 to 1:1.
The precise menthol content would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because the taste and aroma of the aerosol-generating material is a variable which can be modified by the amount of the menthol, which is added to the material as a flavorant (John, [0069]-[0070]). As such, without showing unexpected results, the claimed menthol content cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the menthol content by routine experimentation to obtain the desired taste and/or aroma, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II). Further, because the claimed range for the amount of menthol is so broad, a specific range is not needed in John since the claimed range covers about 80% of the possible choices.
Szekalska, directed to alginates (pg 1, col 1, ln 1-13), teaches a calcium cross-linked alginate (pg 2, col 2, ln 9-15; An alginate gelled by the addition of calcium ions is a calcium cross-linked alginate),
wherein alginate gels with an increased amount of repeating G-block units relative to M-blocks are regarded as stiffer, brittle, and more mechanically stable (pg 3, col 2, ln 1-5).
Parreidt, directed to alginates (pg 1, ln 1), teaches a calcium cross-linked alginate (pg 5, ln 5-16),
wherein the concentration of Ca2+ ions within the alginate can be modified to control the crosslinking density and tensile strength of the alginate (pg 6, ln 1-5 and ln 18-25; and pg 26, ln 35-36),
wherein the Ca2+ ions participate in ionic bonding with the G units of the alginate to cause gelation (pg 5, ln 5-10 and ln 18-21).
The precise molar ratio of Ca2+ cations to G units would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because alginate gels with an increased amount of repeating G-block units relative to M-blocks are regarded as stiffer, brittle, and more mechanically stable (Szekalska, pg 3, col 2, ln 1-5), and the concentration of Ca2+ ions within an alginate can be modified to control the crosslinking density and tensile strength of the alginate (Parreidt, pg 6, ln 1-5 and ln 18-25; and pg 26, ln 35-36). As the Ca2+ ions participate in ionic bonding with the G units of the alginate to cause gelation (Parreidt, pg 5, ln 5-10 and ln 18-21), the crosslinking density, tensile strength, and stability of the alginate are variables which can be modified by the molar ratio of Ca2+ cations to G units. As such, without showing unexpected results, the claimed molar ratio cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the molar ratio by routine experimentation to obtain the desired crosslinking density, tensile strength, and stability, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II).
The ranges for the gelling agent and the aerosol-former material disclosed by the prior art overlap the claimed ranges, and therefore the claimed ranges are considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 2, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1, but does not teach the aerosol-generating material wherein the molar ratio of calcium to G units is from 0.3:1 to 0.5:1.
The precise molar ratio of Ca2+ cations to G units would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because alginate gels with an increased amount of repeating G-block units relative to M-blocks are regarded as stiffer, brittle, and more mechanically stable (Szekalska, pg 3, col 2, ln 1-5), and the concentration of Ca2+ ions within an alginate can be modified to control the crosslinking density and tensile strength of the alginate (Parreidt, pg 6, ln 1-5 and ln 18-25; and pg 26, ln 35-36). As the Ca2+ ions participate in ionic bonding with the G units of the alginate to cause gelation (Parreidt, pg 5, ln 5-10 and ln 18-21), the crosslinking density, tensile strength, and stability of the alginate are variables which can be modified by the molar ratio of Ca2+ cations to G units. As such, without showing unexpected results, the claimed molar ratio cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the molar ratio by routine experimentation to obtain the desired crosslinking density, tensile strength, and stability, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II).
Regarding Claim 3, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1. John further teaches the aerosol-generating material wherein the calcium-crosslinked alginate also comprises β-(1-4)-linked D-mannuronate acid (M) units ([0090]-[0093], The solid aerosol generating material comprising about 3-50 wt % binder. The binder may be calcium alginate. Alginate is composed of a block copolymer comprising covalently linked blocks of (1-4)-linked β-D-mannuronate (M) and α-L-guluronate (G) residues; see Szekalska, pg 2, col 2, ln 9-15; and pg 3, col 2, ln 1-15).
Regarding Claim 4, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 3, but does not teach the aerosol-generating material wherein a molar ratio of G units to M units is from 1:2 to 10:1
Szekalska, directed to alginates (pg 1, col 1, ln 1-13), teaches a calcium cross-linked alginate (pg 2, col 2, ln 9-15; An alginate gelled by the addition of calcium ions is a calcium cross-linked alginate),
wherein alginate gels with an increased amount of repeating G-block units relative to M-blocks are regarded as stiffer, brittle, and more mechanically stable (pg 3, col 2, ln 1-5),
wherein alginate gels with an increased amount of repeating M-block units relative to G-blocks are regarded as softer and more elastic (pg 3, col 2, ln 1-5).
The precise molar ratio of G units to M units would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because alginate gels with an increased amount of repeating G-block units relative to M-blocks are regarded as stiffer, brittle, and more mechanically stable (Szekalska, pg 3, col 2, ln 1-5), and alginate gels with an increased amount of repeating M-block units relative to G-blocks are regarded as softer and more elastic (pg 3, col 2, ln 1-5). Therefore, the stability, elasticity, softness, and ductility of the alginate within the aerosol-generating material is a variable which can be modified by molar ratio of G units to M units. As such, without showing unexpected results, the claimed menthol content cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the molar ratio by routine experimentation to obtain the desired stability, elasticity, softness, and ductility, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II). Further, because the claimed range for the amount of menthol is so broad, a specific range is not needed in John since the claimed range covers about 80% of the possible choices.
Regarding Claim 5, Because John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1 as applied above, one of ordinary skill would reasonably expect the aerosol-generating material of the prior art to contain at least 60% of the menthol by dry weight of the menthol present in the aerosol-generating material before storage when stored for 30 days in a sealed container under ambient conditions (22 °C; 60% relative humidity; 1013 mbar) as claimed, absent evidence to the contrary, since the aerosol-generating material of the prior art is equivalent to the claimed aerosol-generating material.
Regarding Claim 6, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1. John further teaches the aerosol-generating material wherein the amorphous solid comprises the aerosol-former material in an amount of 10-30wt% ([0066]-[0067], The solid aerosol generating material comprising about 5-50 wt % aerosol generating agent. The aerosol generating agent may be glycerol).
The range for the aerosol-former material amount disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 7, John in view of Szekalska and Parreidt does not teach the material wherein the amorphous solid comprises the menthol in an amount of 40-60wt%.
The precise menthol content would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because the taste and aroma of the aerosol-generating material is a variable which can be modified by the amount of the menthol, which is added to the material as a flavorant (John, [0069]-[0070]). As such, without showing unexpected results, the claimed menthol content cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the menthol content by routine experimentation to obtain the desired taste and/or aroma, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II).
Regarding Claim 8, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1. John further teaches the aerosol-generating material wherein the amorphous solid comprises: 20-35 wt% of the gelling agent ([0090]-[0093], The solid aerosol generating material comprising about 3-50 wt % binder. The binder may be calcium alginate);
15-25 wt% of the aerosol-former ([0066]-[0067], The solid aerosol generating material comprising about 5-50 wt % aerosol generating agent. The aerosol generating agent may be glycerol);
menthol;
wherein these weights are calculated on a dry weight basis ([0094]-[0095]; The aerosol generating material comprises from about 3wt% to 15 wt% of water. As water may be included in the formulation at as low as 3wt%, it is reasonably understood that the range of 3-50wt% (WWB) provided for the binder (gelling agent) would still overlap the claimed range of 20-35 wt% (DWB), and the range of 5-50 wt% (WWB) provided for the aerosol-former would still overlap the claimed range of 15-25 wt% (DWB)),
but does not teach the aerosol-generating material comprising 45-55 wt% of the menthol.
The precise menthol content would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because the taste and aroma of the aerosol-generating material is a variable which can be modified by the amount of the menthol, which is added to the material as a flavorant (John, [0069]-[0070]). As such, without showing unexpected results, the claimed menthol content cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the menthol content by routine experimentation to obtain the desired taste and/or aroma, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II).
The ranges for the gelling agent and the aerosol-former disclosed by the prior art overlap the claimed ranges, and therefore the claimed ranges are considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 9, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1. John further teaches the aerosol-generating material wherein the cross-linked alginate comprised in the gelling agent is present in the amorphous solid in an amount of from about 15-40wt% of the amorphous solid on a dry weight basis ([0090]-[0093], The solid aerosol generating material comprising about 3-50 wt % binder (gelling agent). The binder may consist solely oof calcium alginate; and [0094]-[0095]; The aerosol generating material comprises from about 3wt% to 15 wt% of water. As water may be included in the formulation at as low as 3wt%, it is reasonably understood that the range provided for the binder (gelling agent) would still overlap the claimed range of 15-40wt% (DWB)).
The range for the aerosol-former material amount disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 10, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1. John further teaches the aerosol-generating material wherein the gelling agent further comprises pectin ([0091]).
Regarding Claim 11, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 10. John further teaches the aerosol-generating material wherein the gelling agent may comprise both pectin and calcium-crosslinked alginate ([0090]-[0091]),
but does not teach the aerosol-generating material wherein a dry weight ratio of the cross-linked alginate to the pectin is from 1:1 to 10:1.
The precise dry weight ratio of the cross-linked alginate to the pectin is from 1:1 to 10:1 would have been considered a result effective variable by one of ordinary skill in the art before the effective filing date of the invention because John states that the one or more binders may be included in the aerosol generating material in any suitable quantity or concentration, and that the quantity and concentration of the binder may vary depending on the composition of the material, the nature of the heat source, for example the electrical resistance heating element, and the properties desired of the device into which it is incorporated (John, [0090]-[0092]). As such, without showing unexpected results, the claimed dry weight ratio cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized the dry weight ratio by routine experimentation to obtain the desired properties, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art (see MPEP § 2144.05, II).
Regarding Claim 13, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1. John further teaches the aerosol-generating material comprising from about l wt% to about 15wt% of water (WWB) ([0094]-[0095]; The aerosol generating material comprises from about 3wt% to 15 wt% of water. It is reasonably understood that this value is measured on a wet weight basis).
Regarding Claim 14, John in view of Szekalska and Parreidt teaches the aerosol-generating material according to claim 1. John further teaches the aerosol-generating material wherein the aerosol-former material is selected from erythritol, propylene glycol, glycerol and mixtures thereof ([0066]-[0067], The solid aerosol generating material comprising about 5-50 wt % aerosol generating agent. The aerosol generating agent may be glycerol).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN M. MARTIN whose telephone number is (703)756-1270. The examiner can normally be reached M-F 8:00-5:00.
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/J.M.M./
Examiner, Art Unit 1755
/PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755