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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/29/2025 has been entered.
Status of the Claims
Claims 1, 2 and 13-28 are pending.
Claim 1 has been amended.
Response to Arguments
Applicant's arguments filed 8/29/2025 have been fully considered but they are not persuasive.
Regarding the Applicant’s argument that Gomez does not teach combinations of aerosol formers. Gomez merely lists suitable aerosol generating agents for use in the device but does not teach combinations of three such agents. Accordingly, one of skill would not have been motivated to modify Gomez to include three distinct aerosol formers as Gomez solves the problem of consistent and continuous aerosol production by another method. Further, even if one were motivated to include three aerosol formers in the substrate of Gomez, there is nothing in Gomez to lead one to the specific combination as recited in claim 1 as amended.
The Examiner respectfully disagrees. First, Gomez teaches that “In general, any suitable aerosol generating agent or agents may be included in the aerosol-generating substrate of the invention. Suitable aerosol generating agents include, but are not limited to: a polyol such as sorbitol, glycerol, and glycols like propylene glycol or triethylene glycol; a non-polyol such as monohydric alcohols, high boiling point hydrocarbons, acids such as lactic acid, glycerol derivatives, esters such as diacetin, triacetin, triethylene glycol diacetate, triethyl citrate or myristates including ethyl myristate and isopropyl myristate and aliphatic carboxylic acid esters such as methyl stearate, dimethyl dodecanedioate and dimethyl tetradecanedioate,” ([0054]). Thus, it would have been obvious to include a combination of aerosol generating agents. Second, 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 rejection is in view of Gomez, Rabinowitz and Chong, and all the of references are relied upon to teach the independent claim. Lastly, absent unexpected results that occur only with the three claimed aerosol forming materials, it would have been obvious for one of ordinary skill in the art at the time of filing to have chosen any of the aerosol forming materials listed in the combined teachings of Gomez, Rabinowitz and Chong.
Regarding the Applicant’s argument that Rabinowitz discloses the presence of ion pairing agents (including acids such as lactic acid or palmitic acid) in combination with nicotine and thus one of skill in the art would have no reason to modify the article of Gomez to include palmitic acid, as there is nothing to suggest the equivalence of lactic and palmitic acids outside of the role of ion pairing agents, and nothing to suggest palmitic acid would be a suitable aerosol forming agent, the Examiner respectfully disagrees. Rabinowitz teaches adding lactic acid or palmitic acid for the benefit of enhanced vaporization ([0048]).
Regarding the Applicant’s argument that as described in Rabinowitz, the amount of acid present as an ion pairing agent is determined based on the amount of nicotine present, and may be present in a molar ratio in a "range from about 1:3 to about 3:1...." Rabinowitz at paragraph [0050]. Accordingly, the Applicant argues, one of skill would not contemplate the presence of palmitic acid in an amount suitable to act as an aerosol forming component, which is reflected in the aerosol former ratio recited in Applicant's claim 1. The Examiner respectfully disagrees. First, 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 rejection is in view of Gomez, Rabinowitz and Chong, and all of the references are relied upon to teach the independent claim. Second, modified Gomez does not expressly teach the ratio of the first aerosol forming material to the second aerosol forming material to the third aerosol forming material. However, modified Gomez does teach that compositions according to the present disclosure may comprise one solvent or a mixture of two or more solvents such as a mixture of, e.g., two, three, four, or more solvents (Rabinowitz, [0038]). Modified Gomez also teaches that the relative fractions of solvents in a solvent mixture may vary. In some embodiments, the solvent mixture may comprise equal amounts of two or more different solvents, e.g., a 1:1 ratio or mixture. Modified Gomez states that other mixtures and/or ratios of solvents may be suitable, such as, e.g., about 3:2, about 2:1, about 3:1, about 4:1, about 5:1, about 6:1, about 7:1, about 8:1, about 9:1, or about 10:1. Modified Gomez states that the choice of solvent or solvent mixture suitable for a particular composition may be made based on the disclosure herein in combination with general knowledge in the art (Rabinowitz, [0040]). Modified Gomez does not expressly state the ratios for a mixture of three solvents, but the ratios of the three components fall within disclosed amounts (2/3:1, or alternatively 3:2, for between the second and first aerosol forming material and for between the third and first aerosol forming material, and 1:1 for between the second and third aerosol forming material). Thus, one of ordinary skill in the art, when faced with a mixture, would be motivated by common sense to start with a 1:1:1 ratio and modify the ratio based on teachings in the art in combination with general knowledge in the art (Rabinowitz, [0040]) absent evidence of unexpected or surprising results. Given that the art explicitly states that the ratio may be 3:2, it would have been obvious for one of ordinary skill in the art to modify the ratio based on that teachings with a reasonable expectation of success and predictable results. Case law holds that "[h]aving established that this knowledge was in the art, the examiner could then properly rely... on a conclusion of obviousness, 'from common knowledge and common sense of the person of ordinary skill in the art within any specific hint or suggestion in a particular reference.'" In re Bozek, 416 F.2d 1385, 1390, 163 USPQ 545, 549 (CCPA 1969).
Regarding the Applicant’s argument that such combinations could lead to consistent aerosol volume over a series of puffs, with the higher volatility aerosol forming compounds forming a larger percentage of early puffs and the less volatile compounds forming a larger percentage of later puffs. In contrast, despite differences in molecular weight, boiling point, and other physicochemical properties, combinations of glycerin with 1,3- propanediol were nearly indistinguishable from a glycerin control. This data is evidence of unexpected and unpredictable results and is further supportive of the non-obviousness of the subject matter of claim 1 as amended. The Examiner respectfully disagrees. The results are due to the claimed composition, and the Applicant has not shown that the claimed composition, and thus the results of the claimed composition, are not obvious in view of modified Gomez.
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.
Claim(s) 1, 2, 13-24 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOMEZ (WO 2018019855) in view of RABINOWITZ (US 20140345635) and further in view of CHONG (US 20130213417).
US 20190159517 was applied for citation purposes. All citations to ‘Gomez’ refer to US 20190159517.
Regarding claims 1, 2 and 13 Gomez teaches an aerosol generating component comprising a substrate (abstract) impregnated with two or more aerosol forming materials ([0044] and [0054]), including: glycerol, propylene glycol, triacetin and acids such as lactic acid ([0054]). Gomez teaches the substrate comprises a tobacco component in an amount of from 60 to 90% by weight of the substrate and a filler component in an amount of 0 to 20% by weight of the substrate ([0026]). Gomez further teaches that the aerosol generating agents are in an amount from 10%-20% by weight of the tobacco composition ([0026]). Thus, 10%-20% by weight of the tobacco composition, which is from 60%- 90% by weight of the substrate, is within the claimed total loading of from about 15% to about 30% by weight, based on a total weight of the substrate, or roughly 6% to 18% of the total weight of the substrate.
Gomez does not expressly teach that the acid is palmitic acid.
Rabinowitz teaches composition for aerosol generating devices ([0003]) wherein the composition is impregnated onto a fibrous matrix ([0067]). Rabinowitz teaches the inclusion of monoprotic carboxylic acids, including lactic acid or palmitic acid, which are included for the benefit of enhanced vaporization ([0048]). It would have been obvious for one of ordinary skill in the art at the time of filing to have substituted the lactic acid in Gomez with the palmitic acid as taught by Rabinowitz because it has been held that the substitution of one known element (i.e. palmitic acid) for another (i.e. lactic acid) yielding predictable results, specifically enhanced vaporization (Rabinowitz, [0048]), to one of ordinary skill in the art would have been obvious to one of ordinary skill in the art (See 2143B).
Modified Gomez does not expressly teach that the third aerosol forming material is Polysorbate 80.
Chong teaches tobacco solutions for vaporization for inhalation delivery ([0002]). Chong teaches the tobacco solution comprises water; alcohol; propylene glycol; and tobacco constituents ([0013]) and may further include other components. Chong teaches that in order to achieve a lower temperature of vaporization the propylene glycol in the tobacco solution may be substituted with polysorbate 80 ([0028]). Thus, it would have been obvious for one of ordinary skill in the art at the time of filing to have substituted the propylene glycol in modified Gomez with the polysorbate 80 as taught by Chong because it has been held that the substitution of one known element (i.e. propylene glycol) for another (i.e. polysorbate 80) yielding predictable results, specifically a lower temperature of vaporization (Chong, [0028]), to one of ordinary skill in the art would have been obvious to one of ordinary skill in the art (See 2143B).
Modified Gomez does not expressly teach the ratio of the first aerosol forming material to the second aerosol forming material to the third aerosol forming material.
However, Modified Gomez does teach that compositions according to the present disclosure may comprise one solvent or a mixture of two or more solvents such as a mixture of, e.g., two, three, four, or more solvents (Rabinowitz, [0038]). Modified Gomez also teaches that the relative fractions of solvents in a solvent mixture may vary. In some embodiments, the solvent mixture may comprise equal amounts of two or more different solvents, e.g., a 1:1 ratio or mixture. Modified Gomez states that other mixtures and/or ratios of solvents may be suitable, such as, e.g., about 3:2, about 2:1, about 3:1, about 4:1, about 5:1, about 6:1, about 7:1, about 8:1, about 9:1, or about 10:1. Modified Gomez states that the choice of solvent or solvent mixture suitable for a particular composition may be made based on the disclosure herein in combination with general knowledge in the art (Rabinowitz, [0040]). Modified Gomez does not expressly state the ratios for a mixture of three solvents, but the ratios of the three components fall within disclosed amounts (2/3:1, or alternatively 3:2, for between the second and first aerosol forming material and for between the third and first aerosol forming material, and 1:1 for between the second and third aerosol forming material). Thus, one of ordinary skill in the art, when faced with a mixture, would be motivated by common sense to start with a 1:1:1 ratio and modify the ratio based on teachings in the art in combination with general knowledge in the art (Rabinowitz, [0040]) absent evidence of unexpected or surprising results. Given that the art explicitly states that the ratio may be 3:2, it would have been obvious for one of ordinary skill in the art to modify the ratio based on that teachings with a reasonable expectation of success and predictable results. Case law holds that "[h]aving established that this knowledge was in the art, the examiner could then properly rely... on a conclusion of obviousness, 'from common knowledge and common sense of the person of ordinary skill in the art within any specific hint or suggestion in a particular reference.'" In re Bozek, 416 F.2d 1385, 1390, 163 USPQ 545, 549 (CCPA 1969).
Regarding claim 14, Gomez does not teach the inclusion of water, which falls within the claimed range of up to about 10% water by weight based on the total dry weight of the impregnated substrate which includes 0% water by weight.
Regarding claim 15, Gomez teaches that the substrate comprises tobacco-derived fibers ([0038]).
Regarding claim 16, Gomez teaches binders such as alginate ([0050]).
Regarding claim 17, Gomez teaches the substrate comprises a tobacco component in an amount of from 60 to 90% by weight of the substrate and a filler component in an amount of 0 to 20% by weight of the substrate ([0026]), wherein the filler comprises wood pulp and cellulose derivatives ([0049]). While Gomez does not expressly teach the explicit amount of each filler component in the substrate, when faced with a mixture, one of ordinary skill in the art would be motivated by common sense to select a 1:1 ratio, a ratio that falls within the presently claimed amount, absent evidence of unexpected or surprising results. Case law holds that "[h]aving established that this knowledge was in the art, the examiner could then properly rely... on a conclusion of obviousness, 'from common knowledge and common sense of the person of ordinary skill in the art within any specific hint or suggestion in a particular reference.'" In re Bozek, 416 F.2d 1385, 1390, 163 USPQ 545, 549 (CCPA 1969).
Regarding claims 18-20, Gomez teaches that the substrate comprises a tobacco component ([0038]) which can comprise nicotine ([0004]).
Regarding claims 21 and 22, Gomez teaches that the substrate is in rod form, which is a substantially cylindrical shape ([0042]).
Regarding claim 23, Gomez teaches an aerosol delivery device (abstract), comprising: the aerosol generating component of claim 1 (see claim 1); and, a heat source configured to heat the impregnated substrate to form an aerosol ([0056]).
Gomez teaches that the device comprises a mouth- end and the user inhales the aerosol formed from the substrate from the mouth end of the aerosol-generating device ([0041]). While Gomez does not expressly state that there is an aerosol pathway extending from the aerosol generating component to the mouth-end of the device, in order for a user to be able to inhale the aerosol at the mouth-end where the users mouth would be located, there must be an aerosol pathway extending from the aerosol generating component to the mouth-end of the device.
Regarding claims 24 and 26-28, Gomez teaches that the heat source is an electrically- powered heating element ([0071]) wherein a power source is electronically connected to the heating element ([0076]) and further comprising a controller configured to control the power transmitted by the power source to the heating element ([0078]).
Claim(s) 24 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GOMEZ in view of RABINOWITZ in view of CHONG as applied to claim 23, above, as evidenced by NORDSKOG (US 20170000188).
Regarding claims 24 and 25, modified Gomez teaches that the device can be a “heat-not-burn” device (Gomez, [0039]), which is a term in the art to describe aerosol generating devices wherein the heat source comprises a combustible ignition source comprising a carbon-based material (see [0030] of NORDSKOG).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANA B KRINKER whose telephone number is (571)270-7662. The examiner can normally be reached Monday, Wednesday, Thursday and Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at 571-270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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YANA B. KRINKER
Examiner
Art Unit 1755
/YANA B KRINKER/Examiner, Art Unit 1755
/ERIC YAARY/Examiner, Art Unit 1755