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 .
Priority
The present application claims priority to the following applications: JP2021-149802 and PCT/JP2022/034212, with the effective filing dates of 14 Sept 2021 and 13 Sept 2022, respectively.
Claim Status
This Office Action is in response to Applicant’s Response to Restriction filed, 20 May 2026.
Applicant’s election without traverse of Group I (claims 1, 3, 5-6, 8-14, and 16) in the reply filed 20 May 2026 is acknowledged.
Claims 2, 4, 7, 17-21, 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group (Group II: claim 2, 4, and 7; Group III: claim 17; Group IV: claim 18; Group V: claim 19-21; Group VI: claim 25; Group VII: claim 26; Group VIII: claim 27), there being no allowable generic or linking claim.
Claims 1, 3, 5-6, 8-14, and 16 are pending.
Information Disclosure Statement
The Information Disclosure Statements filed 13 March 2024, 19 April 2024, 28 July 2025, and 27 January 2026 and the references cited therein have been considered, unless indicated otherwise.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
1. Claims 1, 3, 5-6, 8-14, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more as evidenced by Wikipedia 1 (“Caryophyllene,” Wikipedia¸2026, <en.wikipedia.org/wiki/Caryophyllene>, accessed 5 June 2026), Wikipedia 2 (“Menthol,” Wikipedia, 2026, <en.wikipedia.org/wiki/Menthol>, accessed 5 June 2026), Wikipedia 3 (“Caprylic acid,” Wikipedia¸2026, <en.wikipedia.org/wiki/Caprylic_acid>, accessed 5 June 2026), Becker (U.S. Patent No. 8,157,918, issued 17 Apr 2012), Takemoto (Sci. Reports¸2021, 11(1178), 1-9), Park (J. Food Sci.¸2022, 87, 2616-2625), Wikipedia 4 (“Volatility (Chemistry),” Wikipedia, 2026, <en.wikipedia.org/wiki/Volatility_(chemistry)>, accessed 9 June 2026), and Wikipedia 5 (“Boiling-point elevation,” Wikipedia, 2026, <en.wikipedia.org/wiki/Boiling-point_elevation>, accessed 9 June 2026).
Claim 1 recites a composition of caryophyllene and menthol. Claim 3 further recites a composition of caryophyllene, menthol, and a fat/oil (e.g. a medium chain triglyceride). Thus, the instant claims are drawn to a product, which is a statutory category of matter (Step 1: Yes).
The instant claims are drawn to a judicial exception of a natural product, more specifically, a composition of caryophyllene, menthol, and a fat or oil (Table 1, [0192]), which are natural products as evidenced by Wikipedia 1 (page 1, paragraph 1), Wikipedia 2 page 1, paragraph 1), and Wikipedia 3 (page 1, paragraph 1). Thus, claim 1, 3, and their dependent claims are directed toward a composition of naturally-occurring products (Step 2A, Prong 1: Yes). This judicial exception is not integrated into a practical application because the composition of claims 1 and 3 does not exhibit characteristics that are markedly different from the product’s naturally occurring counterpart in its natural state (all three natural products are volatile as evidenced by Becker (column 1, lines 11-12), Takemoto (abstract) and Park (abstract). Further, the composition is expected to be more volatile. Wikipedia 4 teaches that volatility has no defined numerical value but is described in vapor pressure or boiling point, and the boiling point is the temperature at which the vapor pressure of a liquid is equal to the surrounding pressure, causing the liquid to rapidly evaporate or boil (page 1, paragraph 3; page 2, paragraph 1). Wikipedia 5 teaches that volatile mixtures exist as azeotropes and have a lower boiling point than either of the pure components (page 3, paragraph 2). Accordingly, a composition of caryophyllene and menthol or a composition of caryophyllene, menthol, and a fat/oil would be expected to be volatile. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart. See MPEP § 2106.04(c)(II)(C). Thus, the instant claims do not recite any additional elements that integrate the exception into a practical application (Step 2A, Prong 2: No).
The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The discovery of a composition of naturally-occurring products does not amount to significantly more (Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671-72). See MPEP § 2106.04(c)(II)(A) and 2106.04(c)(II)(C)(2). (Step 2B: No).
Dependent claims 5-6, 8-14, and 16 are included for depending on a rejected claim and not reciting limitations that resolve the rejection.
Accordingly, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
2. Claim(s) 1, 3, 5, 10, 12-13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao (CN 110,437,935, published 9 July 2019; of record, see PTO-892 mailed 13 April 2026) as evidenced by Cobb (“What to know about caprylic triglyceride,” Medical New Today, 23 Mar 2021, <medicalnewstoday.com/articles/caprylic-capric-triglyceride>, accessed 5 June 2026) and NIST (“Butanoic acid, 2-methyl-, 2-phenylethyl ester,” NIST Chemistry WebBook, SRD 69, 2026, <webbook.nist.gov/cgi/cbook.cgi?InChI=1/C13H18O2/c1-3-11(2)13(14)15-10-9-12-7-5-4-6-8-12/h4-8,11H,3,9-10H2,1-2H3>, accessed 5 June 2026).
Zhao teaches compositions containing caryophyllene and menthol for cigarettes (Examples 1-4, pages 13-14; Example 2: page 13, paragraphs 11-12).
Regarding claim 1, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12).
Regarding claim 3, Zhao teaches a composition containing caryophyllene and menthol that contains caprylic capric acid glyceride (Example 2: page 13, paragraphs 11-12), which contains caprylic acid, a natural fatty acid as evidenced by Cobb (page 2, paragraph 1).
Regarding claim 5, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12). The total parts by weight of the composition is 28.09 and the total parts by weight of caryophyllene in the composition is 0.37 parts (0.15 beta-caryophyllene and 0.22 caryophyllene oxide; Example 2, page 13, paragraph 11), which the specification notes that caryophyllene includes beta-caryophyllene and caryophyllene oxide ([0014]). Accordingly,
0.37
28.09
×
100
%
=
1.3
%
.
Thus, Zhao teaches the amount of caryophyllene is 1% mass or more.
Regarding claim 10, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12) with a monocarboxylic acid ester, which is 2-methylbutyric acid-2-phenylether ester as evidenced by NIST (page 1).
Regarding claim 12, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12) with a monocarboxylic acid ester, which is 2-methylbutyric acid-2-phenylether ester as evidenced by NIST (page 1). Zhao teaches the total parts by weight of 2-methylbutyric acid-2-phenylether ester is 2.8 parts by weight and the total parts by weight is 28.09 (Example 2, page 13, paragraph 11). Accordingly,
2.8
28.09
×
100
%
=
10
%
.
Thus, Zhao teaches the amount of ingredient (X) is 1% mass or more.
Regarding claim 13, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12) with a monocarboxylic acid ester, which is 2-methylbutyric acid-2-phenylether ester as evidenced by NIST (page 1). Zhao teaches the total parts by weight of 2-methylbutyric acid-2-phenylether ester is 2.8 parts by weight and the total parts by weight is 28.09. Accordingly,
2.8
28.09
×
100
%
=
10
%
E
x
a
m
p
l
e
2
,
p
a
g
e
13
,
p
a
r
a
g
r
a
p
h
11
.
The amount of caryophyllene in the composition is 1.3% (
0.37
28.09
×
100
%
=
1.3
%
;
E
x
a
m
p
l
e
2
,
p
a
g
e
13
,
p
a
r
a
g
r
a
p
h
11
)
.
Thus, the total of ingredient (X) and caryophyllene is 11.3%. Thus, Zhao teaches the amount of ingredient (X) is 3% mass or more and the combined amount of caryophyllene and ingredient (X) is 5-95% mass.
Regarding claim 16, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12), wherein the composition is then formulated into a capsule (Example 2, page 13, paragraph 12).
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.
3. Claim(s) 1, 3, 5-6, 8, 10-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (CN 110,437,935, published 9 July 2019; of record, see PTO-892 mailed 13 April 2026) as evidenced by Cobb (“What to know about caprylic triglyceride,” Medical New Today, 23 Mar 2021, <medicalnewstoday.com/articles/caprylic-capric-triglyceride>, accessed 5 June 2026) and NIST (“Butanoic acid, 2-methyl-, 2-phenylethyl ester,” NIST Chemistry WebBook, SRD 69, 2026, <webbook.nist.gov/cgi/cbook.cgi?InChI=1/C13H18O2/c1-3-11(2)13(14)15-10-9-12-7-5-4-6-8-12/h4-8,11H,3,9-10H2,1-2H3>, accessed 5 June 2026) in view of Gertsch (PNAS, 2008, 105(26), 9099-9104) as evidenced by Fu (Biomedicine & Pharmacotherapy¸2023, 157(114043), 1-13) and Wikipedia 6 (“Dibutyl phthalate,” Wikipedia, 2026, <en.wikipedia.org/wiki/Dibutyl_phthalate>, accessed 5 June 2026).
Zhao (CN 110,437,935, published 9 July 2019; of record, see PTO-892 mailed 13 April 2026) as evidenced by Cobb (“What to know about caprylic triglyceride,” Medical New Today, 23 Mar 2021, <medicalnewstoday.com/articles/caprylic-capric-triglyceride>, accessed 5 June 2026) and NIST (“Butanoic acid, 2-methyl-, 2-phenylethyl ester,” NIST Chemistry WebBook, SRD 69, 2026, <webbook.nist.gov/cgi/cbook.cgi?InChI=1/C13H18O2/c1-3-11(2)13(14)15-10-9-12-7-5-4-6-8-12/h4-8,11H,3,9-10H2,1-2H3>, accessed 5 June 2026) are applied as discussed in the 35 U.S.C. 102 rejection above.
The Examiner notes the relevant teachings with respect to claims 1, 3, 5, 10, 12-13, and 16 are set forth above and are incorporated herein by reference.
Additional relevant teachings are set forth below.
Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12; Examples 1-4; pages 13-14). Zhao additionally teaches the total parts by weight of the composition is 28.09 and the total parts by weight of caryophyllene in the composition is 0.37 parts (0.15 beta-caryophyllene and 0.22 caryophyllene oxide; Example 2, page 13, paragraph 11). Accordingly,
0.37
28.09
×
100
%
=
1.3
%
.
Thus, Zhao teaches the amount of caryophyllene is 1% mass or more. Further, Zhao teaches the amount of menthol in the composition of Example 2 is 1.5 parts, which is 5.3 % (
1.5
28.09
×
100
%
=
5.3
%
;
E
x
a
m
p
l
e
2
,
p
a
g
e
13
,
p
a
r
a
g
r
a
p
h
11
)
.
Additionally, Zhao teaches the caryophyllene loading in Examples 1, 3, and 4 is 1.1%, 1.7% and 1.9%, respectively (Examples 1-4; pages 13-14).
Regarding claim 6, Zhao fails to teach the amount of caryophyllene is 3% mass or more.
Gertsch teaches that beta-caryophyllene and its derivatives are a common constituent in essential oils of numerous spice and food plants and a major component in Cannabis (abstract). Further, Gertsch teaches that caryophyllene reduces carrageenan-induced inflammatory response in wild-type mice but not in mice lacking CB2 receptors, indicating that caryophyllene exerts cannabimimetic effects in vivo and functions as a nonpsychoactive CB2 receptor ligand in foodstuffs and a macrocyclic anti-inflammatory cannabinoid (abstract).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the composition of Zhao and increase the caryophyllene loading as taught by Gertsch to arrive at instant claim 6. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Zhao teaches a composition containing caryophyllene and menthol,
-Zhao teaches the total parts by weight of the composition is 28.09 and the total parts by weight of caryophyllene in the composition is 0.37 parts (0.15 beta-caryophyllene and 0.22 caryophyllene oxide),
-Zhao teaches
0.37
28.09
×
100
%
=
1.3
%
,
-Zhao teaches the amount of caryophyllene is 1% mass or more,
-Zhao teaches the amount of menthol in the composition of Example 2 is 1.5 parts, which is 5.3 % (
1.5
28.09
×
100
%
=
5.3
%
;
E
x
a
m
p
l
e
2
,
p
a
g
e
13
,
p
a
r
a
g
r
a
p
h
11
)
,
-Zhao teaches the caryophyllene loading in Examples 1, 3, and 4 is 1.1%, 1.7% and 1.9%, respectively,
-Zhao teaches that dendrobium honey essence for popping beads has the characteristics of taste and fragrance, nourishing the spleen and stomach, strengthening muscles and bones, moisturizing skin, and greatly increases the smoker’s sense of pleasure and interest (page 11, paragraph 9),
-Zhao teaches that essential oils are affected by factors such as plant growth environment, temperature, moisture, soil, and light and that honey is affected by the environment, weather, and honey-producing plants (page 11, paragraph 10),
-Zhao teaches that the quality of dendrobium honey flavor fluctuates greatly and has poor stability (page 11, paragraph 10),
-Gertsch teaches that beta-caryophyllene and its derivatives are a common constituent in essential oils of numerous spice and food plants and a major component in Cannabis,
-Gertsch teaches that caryophyllene reduces carrageenan-induced inflammatory response in wild-type mice but not in mice lacking CB2 receptors, indicating that caryophyllene exerts cannabimimetic effects in vivo and functions as a nonpsychoactive CB2 receptor ligand in foodstuffs and a macrocyclic anti-inflammatory cannabinoid, and
-Gertsch teaches that caryophyllene is commonly ingested with vegetable food, and an estimated daily intake of 10-200 mg of this lipophilic sesquiterpene has the potential to modulate inflammatory and other pathophysiological processes via the endocannabinoid system (page 9103, column 2, paragraph 2).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Zhao teaches the caryophyllene loading in Examples 1-4 is 1.1%, 1.3%, 1.7% and 1.9%, respectively (Examples 1-4; pages 13-14). Zhao further teaches compositions that reduce irritation as well as nourish the spleen and stomach, strengthen muscles and bones, moisturize skin, and greatly increase the smoker’s sense of pleasure and interest (page 12, paragraph 6; page 11, paragraph 9), and Gertsch teaches the anti-inflammatory capabilities of caryophyllene. Thus, an artisan having ordinary skill in the art would recognize that optimizing the composition in the amount of caryophyllene via routine experimentation would provide a composition with more anti-inflammatory capabilities. Accordingly, the combination of Zhao and Gertsch teaches a composition wherein the amount of caryophyllene is 3 mass % and the amount of menthol is 5-95% mass.
Regarding claim 8, Zhao teaches the caryophyllene loading in Examples 1-4 is 1.1%, 1.3%, 1.7% and 1.9%, respectively (Examples 1-4; pages 13-14) to generated dendrobium honey essence S1. Additionally, Zhao teaches that the dendrobium honey essence S1 obtained is then mixed with caprylic acid and capric glyceride at a mass ratio of 2683:7362 to create the dendrobium honey fragrance. The caprylic acid (a fat as evidenced by Cobb; page 2, paragraph 1) is present at 26% (
2683
10045
×
100
%
=
27
%
.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Zhao teaches the caryophyllene loading in Examples 1-4 is 1.1%, 1.3%, 1.7% and 1.9%, respectively (Examples 1-4; pages 13-14). Zhao further teaches compositions that reduce irritation as well as nourish the spleen and stomach, strengthen muscles and bones, moisturize skin, and greatly increase the smoker’s sense of pleasure and interest (page 12, paragraph 6; page 11, paragraph 9), and Gertsch teaches the anti-inflammatory capabilities of caryophyllene. Thus, an artisan having ordinary skill in the art would recognize that optimizing the composition in the amount of caryophyllene via routing experimentation would provide a composition with more anti-inflammatory capabilities. Accordingly, the combination of Zhao and Gertsch teaches a composition wherein the amount of caryophyllene is 3% mass in the dendrobium honey essence S1 and the amount of fat is 5-95% mass in the dendrobium honey fragrance.
Regarding claim 11, Zhao teaches that the dendrobium honey pop-ball cigarettes incorporate the essence of dendrobium essential oils, which have the characteristics of taste and fragrance and the effects of clearing away heat, nourishing the spleen and stomach, strengthening muscles and bones, moisturizing the skin, and increasing the smoker’s sense of pleasure and interest (page 11, paragraph 9). Thus, Zhao suggests incorporating the active ingredients of dendrobium essential oil, such as dibutyl phthalate as evidenced by Fu (page 3, Table 1, column 2). Dibutyl phthalate is a dicarboxylic acid as evidenced by Wikipedia 6 (page 1, structure). Accordingly, Zhao suggests the ingredient (X) is a dicarboxylic acid ester.
4. Claim(s) 1, 3, 5-6, 8-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (CN 110,437,935, published 9 July 2019; of record, see PTO-892 mailed 13 April 2026) in view of Gertsch (PNAS, 2008, 105(26), 9099-9104) as evidenced by Cobb (“What to know about caprylic triglyceride,” Medical New Today, 23 Mar 2021, <medicalnewstoday.com/articles/caprylic-capric-triglyceride>, accessed 5 June 2026), NIST (“Butanoic acid, 2-methyl-, 2-phenylethyl ester,” NIST Chemistry WebBook, SRD 69, 2026, <webbook.nist.gov/cgi/cbook.cgi?InChI=1/C13H18O2/c1-3-11(2)13(14)15-10-9-12-7-5-4-6-8-12/h4-8,11H,3,9-10H2,1-2H3>, accessed 5 June 2026), Fu (Biomedicine & Pharmacotherapy¸2023, 157(114043), 1-13), and Wikipedia 6 (“Dibutyl phthalate,” Wikipedia, 2026, <en.wikipedia.org/wiki/Dibutyl_phthalate>, accessed 5 June 2026) as applied to claims 1, 3, 5-6, 8, 10-13, and 16 above and further in view of Becker (U.S. Patent No. 8,157,918, issued 17 Apr 2012).
Zhao (CN 110,437,935, published 9 July 2019; of record, see PTO-892 mailed 13 April 2026) and Gertsch (PNAS, 2008, 105(26), 9099-9104) as evidenced by Cobb (“What to know about caprylic triglyceride,” Medical New Today, 23 Mar 2021, <medicalnewstoday.com/articles/caprylic-capric-triglyceride>, accessed 5 June 2026), NIST (“Butanoic acid, 2-methyl-, 2-phenylethyl ester,” NIST Chemistry WebBook, SRD 69, 2026, <webbook.nist.gov/cgi/cbook.cgi?InChI=1/C13H18O2/c1-3-11(2)13(14)15-10-9-12-7-5-4-6-8-12/h4-8,11H,3,9-10H2,1-2H3>, accessed 5 June 2026), Fu (Biomedicine & Pharmacotherapy¸2023, 157(114043), 1-13), and Wikipedia 6 (“Dibutyl phthalate,” Wikipedia, 2026, <en.wikipedia.org/wiki/Dibutyl_phthalate>, accessed 5 June 2026) are applied as discussed in the 35 U.S.C. 103 rejection above.
Regarding claim 9, while the combination of Zhao and Gertsch (as evidenced by Cobb, NIST, Fu, and Wikipedia 4) teaches a composition having caryophyllene, they differ from that of the instantly claimed invention in that they do not explicitly teach a composition having 15% mass caryophyllene.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective
filing date of the instantly claimed invention to exemplify the composition of Zhao and Gertsch with the composition of Becker to arrive at the instantly claimed invention.
One of ordinary skill in the art would have been motivated to make such a selection, with
a reasonable expectation of success, because Becker teaches that menthol is a preferred flavorant of cigarettes (abstract). Becker teaches that flavorants are frequently added to tobacco products to achieve desirable organoleptic sensations (column 1, lines 9-10). Becker additionally teaches that menthol is one of those flavorants and that menthol is a volatile compound that tend to vaporize and gradually escape from the tobacco product during storage (column 1, lines 10-13). Becker teaches methods to keep the flavorant present in the cigarette (encapsulating the menthol) while enabling the flavorant to be gradually released when the tobacco products are smoked (column 1, lines 24-30; column 2, lines 35-45). Further, Becker teaches that menthol is present in the cigarette up to about 20% and more preferably about 10-15% (column 7, lines 32-39). Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). Becker teaches that menthol is present in the cigarette up to about 20% and more preferably about 10-15% (column 7, lines 32-39), which overlaps with the claimed invention. Further, the range of the claimed invention does not provide an unexpected result in view of Becker, who describes cigarettes containing a flavorant and methods to encapsulate menthol (column 1, lines 24-30; column 2, lines 35-45). Thus, the combination of Zhao, Gertsch, and Becker teaches the amount of menthol is 15% mass or more.
Regarding claim 14, Becker teaches that the flavorant is liquid or the encapsulated flavorant is a liquid (column 7, lines 57-62; column 9, lines 8-11).
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.
5. Claims 1, 3, 5-6, 8-14, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 5, 8-9, 11-17, and 19 of copending Application No. 18/691,716 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/691,716 claims a composition comprising caryophyllene and a flavoring agent (menthol) and derivatives therein (claim 1).
Regarding claim 1, ‘716 claims a composition comprising caryophyllene and menthol (claims 1 and 5).
Regarding claim 3, ‘716 claims the composition further comprises a fat or oil (claims 1-2 and 5).
Regarding claim 5, ‘716 claims the amount of caryophyllene is 1 mass% or more (claim 8).
Regarding claim 6, ‘716 claims the amount of caryophyllene is 3 mass% or more and the amount of caryophyllene relative to the combined amount of caryophyllene and the flavoring agent is 5-95 mass% (claim 9).
Regarding claim 8, ‘716 claims the amount of the caryophyllene is 3 mass% or more and the amount of the caryophyllene relative to the combined amount of the caryophyllene, the flavoring agent, and the fat or oil is 5-95 mass% (claim 11).
Regarding claim 9, ‘716 claims the amount of the menthol in the composition is 15 mass% or more (claim 12).
Regarding claim 10, ‘716 claims the composition further comprising at least one ingredient (X) selected from dicarboxylic acid esters, diol esters, monocarboxylic acid esters, esters of polyols having three or more hydroxy groups, esters of polycarboxylic acids having three or more carboxyl groups, polyol ethers, polyamines, and alcohols having six or more carbon atoms (claim 13).
Regarding claim 11, ‘716 claims further comprising a dicarboxylic acid ester as the ingredient (X) (claim 14).
Regarding claim 12, ‘716 claims the amount of the ingredient (X) is 1 mass% or more (claim 15).
Regarding claim 13, ‘716 claims the amount of the ingredient (X) is 3 mass% or more and the amount of the ingredient (X) relative to the combined amount of the caryophyllene and the ingredient (X) is 5-95 mass% or more (claim 16).
Regarding claim 14, ‘716 claims the composition is in a liquid form (claim 17).
Regarding claim 16, ‘716 claims a capsule having a core and a shell wherein the core is formed of the composition (claim 19).
6. Claims 1, 5, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 and 7-9 of copending Application No. 17/910,672 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection.
U.S. Application No. 17/910,672 teaches a composition comprising caryophyllene and a flavoring agent and a capsule comprising caryophyllene (claims 5 and 8). In order to properly construe the scope of claim 5 of ‘672 as to what is a flavoring agent, the Examiner looked to the specification, and ‘672 teaches the flavoring agent is menthol ([0165]).
Regarding claim 1, ‘672 claims a composition comprising caryophyllene and a flavoring agent (menthol) (claim 5; [0165]).
Regarding claim 5, ‘672 claims the amount of caryophyllene is 1 mass% or more (claim 7).
Regarding claim 16, ‘672 claims a capsule having a core and a shell wherein the core is formed of the composition comprising caryophyllene (claims 8-9).
7. Claim 1, 3, 5, 10, 12-13, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/250,599 in view of Zhao (CN 110,437,935, published 9 July 2019; of record, see PTO-892 mailed 13 April 2026) as evidenced by Cobb (“What to know about caprylic triglyceride,” Medical New Today, 23 Mar 2021, <medicalnewstoday.com/articles/caprylic-capric-triglyceride>, accessed 5 June 2026) and NIST (“Butanoic acid, 2-methyl-, 2-phenylethyl ester,” NIST Chemistry WebBook, SRD 69, 2026, <webbook.nist.gov/cgi/cbook.cgi?InChI=1/C13H18O2/c1-3-11(2)13(14)15-10-9-12-7-5-4-6-8-12/h4-8,11H,3,9-10H2,1-2H3>, accessed 5 June 2026).
U.S. Application No. 18/250,599 claims a composition comprising caryophyllene (claim 1). ‘599 further teaches that a tobacco filter, a smoking tool, and a tobacco comprising the caryophyllene composition (claims 15-17).
Regarding claim 1, ‘599 fails to teach the composition has menthol.
Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12; Examples 1-4; pages 13-14). Zhao additionally teaches the total parts by weight of the composition is 28.09 and the total parts by weight of caryophyllene in the composition is 0.37 parts (0.15 beta-caryophyllene and 0.22 caryophyllene oxide; Example 2, page 13, paragraph 11). Accordingly,
0.37
28.09
×
100
%
=
1.3
%
.
Thus, Zhao teaches the amount of caryophyllene is 1% mass or more. Further, Zhao teaches the amount of menthol in the composition of Example 2 is 1.5 parts, which is 5.3 % (
1.5
28.09
×
100
%
=
5.3
%
;
E
x
a
m
p
l
e
2
,
p
a
g
e
13
,
p
a
r
a
g
r
a
p
h
11
)
.
Additionally, Zhao teaches the caryophyllene loading in Examples 1, 3, and 4 is 1.1%, 1.7% and 1.9%, respectively (Examples 1-4; pages 13-14).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to modify the composition of ‘599 to include menthol like the composition of Zhao to arrive at instant claim 1.
One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘599 teaches a composition comprising caryophyllene,
-‘599 teaches that a tobacco filter, a smoking tool, and a tobacco comprising the caryophyllene composition,
-Zhao teaches a composition containing caryophyllene and menthol,
-Zhao teaches the total parts by weight of the composition is 28.09 and the total parts by weight of caryophyllene in the composition is 0.37 parts (0.15 beta-caryophyllene and 0.22 caryophyllene oxide),
-Zhao teaches
0.37
28.09
×
100
%
=
1.3
%
,
-Zhao teaches the amount of caryophyllene is 1% mass or more,
-Zhao teaches the amount of menthol in the composition of Example 2 is 1.5 parts, which is 5.3 % (
1.5
28.09
×
100
%
=
5.3
%
;
E
x
a
m
p
l
e
2
,
p
a
g
e
13
,
p
a
r
a
g
r
a
p
h
11
)
,
-Zhao teaches the caryophyllene loading in Examples 1, 3, and 4 is 1.1%, 1.7% and 1.9%, respectively,
-Zhao teaches that dendrobium honey essence for popping beads has the characteristics of taste and fragrance, nourishing the spleen and stomach, strengthening muscles and bones, moisturizing skin, and greatly increases the smoker’s sense of pleasure and interest (page 11, paragraph 9),
-Zhao teaches that essential oils are affected by factors such as plant growth environment, temperature, moisture, soil, and light and that honey is affected by the environment, weather, and honey-producing plants (page 11, paragraph 10),
-Zhao teaches that the quality of dendrobium honey flavor fluctuates greatly and has poor stability (page 11, paragraph 10), and
-Zhao teaches compositions that reduce irritation as well as nourish the spleen and stomach, strengthen muscles and bones, moisturize skin, and greatly increase the smoker’s sense of pleasure and interest (page 12, paragraph 6; page 11, paragraph 9).
Accordingly, the combination of ‘599 and Zhao teaches a composition of caryophyllene and menthol.
Regarding claim 3, Zhao teaches a composition containing caryophyllene and menthol that contains caprylic capric acid glyceride (Example 2: page 13, paragraphs 11-12), which contains caprylic acid, a natural fatty acid as evidenced by Cobb (page 2, paragraph 1).
Regarding claim 5, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12). The total parts by weight of the composition is 28.09 and the total parts by weight of caryophyllene in the composition is 0.37 parts (0.15 beta-caryophyllene and 0.22 caryophyllene oxide; Example 2, page 13, paragraph 11), which the specification notes that caryophyllene includes beta-caryophyllene and caryophyllene oxide ([0014]). Accordingly,
0.37
28.09
×
100
%
=
1.3
%
.
Thus, Zhao teaches the amount of caryophyllene is 1% mass or more.
Regarding claim 10, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12) with a monocarboxylic acid ester, which is 2-methylbutyric acid-2-phenylether ester as evidenced by NIST (page 1).
Regarding claim 12, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12) with a monocarboxylic acid ester, which is 2-methylbutyric acid-2-phenylether ester as evidenced by NIST (page 1). Zhao teaches the total parts by weight of 2-methylbutyric acid-2-phenylether ester is 2.8 parts by weight and the total parts by weight is 28.09 (Example 2, page 13, paragraph 11). Accordingly,
2.8
28.09
×
100
%
=
10
%
.
Thus, Zhao teaches the amount of ingredient (X) is 1% mass or more.
Regarding claim 13, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12) with a monocarboxylic acid ester, which is 2-methylbutyric acid-2-phenylether ester as evidenced by NIST (page 1). Zhao teaches the total parts by weight of 2-methylbutyric acid-2-phenylether ester is 2.8 parts by weight and the total parts by weight is 28.09. Accordingly,
2.8
28.09
×
100
%
=
10
%
E
x
a
m
p
l
e
2
,
p
a
g
e
13
,
p
a
r
a
g
r
a
p
h
11
.
The amount of caryophyllene in the composition is 1.3% (
0.37
28.09
×
100
%
=
1.3
%
;
E
x
a
m
p
l
e
2
,
p
a
g
e
13
,
p
a
r
a
g
r
a
p
h
11
)
.
Thus, the total of ingredient (X) and caryophyllene is 11.3%. Thus, Zhao teaches the amount of ingredient (X) is 3% mass or more and the combined amount of caryophyllene and ingredient (X) is 5-95% mass.
Regarding claim 16, Zhao teaches a composition containing caryophyllene and menthol (Example 2: page 13, paragraphs 11-12), wherein the composition is then formulated into a capsule (Example 2, page 13, paragraph 12).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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