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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a pharmaceutical composition, and the following species:
delta-9-tetrahydrocannabinol (THC) as the elected cannabinoid species; and
silicon dioxide as the elected silica species
are maintained.
Claims 10-12 remain withdrawn and claims 34-36 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on February 19, 2026, wherein claims 1, 7-12 are amended; claims 2-5, 19-28 are cancelled; claims 6, 14-18 are unchanged; and claims 29-39 are newly added.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6-12, 14-18, and 29-39 are pending.
Claims 10-12 remain withdrawn, and claims 34-36 are withdrawn.
Claims 1, 6-9, 14-18, 29-33, and 37-39 are under examination in accordance to the elected species.
Priority
The instant application 17/363,056 filed on June 30, 2021 is a continuation of U.S. Application No. 14/804,384 filed on July 21, 2015, which claims priority to, and the benefits of U.S. Provisional Application No. 61/999,300 filed on July 22, 2014 and U.S. Provisional Application No. 61/999,239 filed on July 21, 2014.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, U.S. Provisional Application No. 61/999,300 and U.S. Provisional Application No. 61/999,239 filed on July 21, 2014., fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application shown as follows: These prior-filed applications fail to disclose the cannabinoid solution in the solid dosage form comprises from 5 wt% to 70% of ethanol by weight of the cannabinoid solution. These prior-filed applications also fail to disclose the pharmaceutical composition species comprising low-substituted hydroxypropyl cellulose. Therefore, the claims are not entitled to the benefit of these prior-filed application and will receive an effective filing date of July 21, 2015, which is the filing date of U.S. Application No. 14/804,384.
Response to Arguments
Applicant does not acquiesce to the Examiner's assertions regarding priority, but did not put forth any specific arguments against this priority section. If applicant asserts the priority document supports the limitation of “the cannabinoid solution in the solid dosage form comprises from 5 wt% to 70% of ethanol by weight of the cannabinoid solution” recites in the instant claim(s), the examiner respectfully requested Applicant to indicate the page and paragraph in each of these prior-filed applications that provide adequate support for this particular limitation.
Action Summary
Applicant’s amendment to the claims filed on February 19, 2026 overcome each and every objection previously sets forth in the Non-Final Office Action mailed on September 19, 2025.
Claims 1, 6-9 and 13-18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn in light of the claim amendment that deletes the recitation of “about”.
Claims 1, 6-9, 13-15, and 17-18 rejected under 35 U.S.C. 103 as being unpatentable over McCarty (WO 2008/127609 A1), in view of Pellikaan et al. (WO 2008/033024 A2) and Whittle et al. (GB 2380129A) are withdrawn in light of the claim amendment that changes the range of wt% of ethanol by weight of the cannabinoid solution. Specifically, applicant amends claim 1 from the recitation of “the cannabinoid solution in the solid dosage form comprises from about 5 wt% to about 95 wt% of ethanol by weight of the cannabinoid solution” to the recitation of “the cannabinoid solution in the solid dosage form comprises from 5 wt% to 70 wt% of ethanol by weight of the cannabinoid solution”, which has a narrower range. Upon further consideration, the prior arts have been revisited, reapplied and modified in light of the claim amendments for the reasons set forth herein.
Claims 1, 6-9, and 13-18 rejected under 35 U.S.C. 103 as being unpatentable over McCarty (WO 2008/127609 A1), in view of Pellikaan et al. (WO 2008/033024 A2) and Whittle et al. (GB 2380129A), as applied to claims 1, 6-9, 13-15, and 17-18 above, and further in view of Rowe et al. (Handbook of Pharmaceutical Excipients. 6th ed. Pharmaceutical Press, 2009. Print.) are withdrawn in light of the claim amendment; However, upon further consideration, the prior arts have been revisited, reapplied and modified in light of the claim amendments for the reasons set forth herein
Claims 1, 6-9, and 13-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-16 of U.S. Patent No. 11,077,086 B2 (referred to herein as reference patent) are maintained, but revisited and modified in light of the claim amendments.
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, 6-9, 14-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over McCarty (WO 2008/127609 A1), in view of Pellikaan et al. (WO 2008/033024 A2) and Whittle et al. (GB 2380129A)(newly reapplied as necessitated by amendment).
McCarty teaches a sublingual/buccal tablet formulation shown as follows:
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(see e.g., Table 1; p. 12, line 5-15). McCarty further teaches the melatonin has poor bioavailability and it is poorly soluble in water or other aqueous biological fluids (see e.g., p. 8, line 4-6). McCarty further teaches the sublingual/buccal delivery, which has melatonin completely dissolved in solution, enhances transmucosal absorption, because melatonin does not have to dissolve in the saliva before being absorbed (see e.g., p.8, line 22-27). McCarty further teaches the pharmaceutically acceptable solvent used for dissolving the melatonin and forming the melatonin-containing solution for associating the melatonin with the carrier particle is selected from, inter alia, polyethylene glycol and ethanol (see e.g., p. 4, line 29 to p.5, line 2). McCarty further teaches in order to convert the liquid melatonin solution into a flowable powder suitable for use in direct compression tableting requires the use of an adsorbent/absorbent carrier, such as silica, including SIPERNAT® 160PQ (see e.g., p. 10, line 15-25). Please note that silica is another name for silicon dioxide, as evidence by claim 6 and paragraph [0034]-[0035] of the instant specification. McCarty further teaches the concentration of active ingredient, such as melatonin, in the solvent is
preferably in the range of about 5% to about 30% and more preferred 10% to 20%; and the preferred weight: weight ratio of carrier: solution being in the range of about 1:0.5 to about 1:4 and more preferred 1:1 to 1:2 (see e.g., p. 5, line 18-19). Please note the weight: weight range of about 1:0.5 to about 1:4 taught by McCarty lies within the weight/weight ratio (from 1:0.5 to 1:5) in claim 1. McCarty further teaches the pharmaceutical composition may further comprise a diluent, a disintegrant, a lubricant, or other excipient as would be readily understood in the pharmaceutical arts for preparation of a final dosage form as desired (see e.g., p. 5, line 22-28). McCarty further teaches diluent may be the water-soluble, direct compression tableting excipient, mannitol (see e.g., p. 10, line 27-28). McCarty further teaches the exemplary disintegrant is sodium starch glycolate and it is use to formulate a rapid breaking apart of the tablet following administration (see e.g., p. 11, line 5-8). McCarty further teaches an exemplary tablet lubricant is sodium stearyl fumarate (see e.g., p. 11, line 7-8). McCarty further teaches the pharmaceutical composition is provided as a unit dose form, and more preferably as a solid dosage form, such as a compressed tablet, for buccal or sublingual administration (see e.g., p. 5, line 29 to p. 6, line 4). McCarty further teaches this drug delivery system provides for rapid onset of drug action with higher and more consistent bioavailability (see e.g., p. 6, line 13-15). McCarty further teaches the pharmaceutical composition contains from about 0.01 to about 3 mg of melatonin per unit dose and more preferred 0.5 to 2 mg (see e.g., p. 5, line 19-21).
McCarty does not teach the elected cannabinoid, delta-9-tetrahydrocannabinol (THC). McCarty also does not teach THC is present at from 10 mg to 30 mg. McCarty does not specifically teach ethanol as the preferred pharmaceutically acceptable solvent although McCarty teaches PEG400 and ethanol are interchangeable.
Pellikaan et al. teaches water-insoluble pharmaceutically active substances include cannabinoids, which are the active constituents of cannabis (see e.g., p. 2, line 3-5). Pellikaan et al. further teaches psychoactive tetrahydrocannabinol (Δ9-THC) is the most important natural cannabinoid (see e.g., p. 2, line 9-10). Pellikaan et al. further teaches oral administration results
in a slow and variable absorption, with a bioavailability of 10-20%, and usually less than 15% (see e.g., p. 2, line 20-21). Pellikaan et al. further teaches oral mucosal delivery offers several distinct advantages over other administration routes, and it is found that medication absorbed through the buccal mucosa enters the circulation 4 to 8 times more rapidly than when it is ingested in pill or capsule form (see e.g., p. 3, line 19-23). Pellikaan et al. further teaches the amount of one or more water-insoluble pharmaceutically active substances contained in the dosage unit typically exceeds 10 μg, and the said amount is most preferably in the range of 1-50 mg (see e.g., p. 9, line 1-3). Pellikaan et al. further teaches the preparation of a tablet for buccal or sublingual administration by citing Example 6 of the British Patent Application GB 2 380 129A (see e.g., p. 3, line 31 to p. 4, line 12).
Whittle et al. (GB 2 380 129A) is a British patent application cited by Pellikaan et al. to teach the preparation of a tablet for buccal or sublingual administration comprising THC, and the formulation of the said tablet is illustrated as follows:
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(see e.g., p. 43, line 21-33; Example 6). Whittle et al. further teaches preferred solvents for use in the formulation are lower alkyl (C1-C4) alcohols, most preferably ethanol (see e.g., p. 17, line 25-28).
In the present case, McCarty clearly teaches the sublingual/buccal tablet formulation in Example 1 and a list of pharmaceutically acceptable solvent, including polyethylene glycol and ethanol. The difference between the sublingual/buccal tablet formulation of Example 1 of McCarty and the claimed invention is that the prior art uses melatonin rather than the elected cannabinoid (Δ9-THC) as the active ingredient with poor water solubility; uses the polyethylene glycol 400 rather than ethanol as the pharmaceutically acceptable solvent; and uses 87 wt% of the solvent (polyethylene glycol 400) by weight of the active ingredient solution rather than 5 wt% to 70 wt% of the solvent (ethanol).
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Please note the sublingual/buccal tablet formulation of Example 1 of McCarty contains 12.5% of active ingredient (melatonin) in the melatonin solvent (melatonin + polyethylene glycol 400); and the weight percentage of solvent (polyethylene glycol 400) with respect to the total weight of the active ingredient solution can be calculated by dividing the amount of solvent (1 mg melatonin) by the total weight of active ingredient solution (1 mg melatonin + 7 mg polyethylene glycol 400) times 100:
7
m
g
s
o
l
v
e
n
t
8
m
g
a
c
t
i
v
e
i
n
g
r
e
i
d
e
n
t
s
o
l
u
t
i
o
n
×
100
=
87.5
%
), gives 87.5 weight % of solvent (polyethylene glycol 400) by weight of the active ingredient solution. Please also note the weight-to-weight ratio of silica to melatonin solution (melatonin + polyethylene glycol 400) can be calculated as follows:
4.50
m
g
s
i
l
i
c
a
8
m
g
a
c
t
i
v
e
i
n
g
r
e
d
i
e
n
t
s
o
l
u
t
i
o
n
=
1
m
g
s
i
l
i
c
a
x
m
g
a
c
t
i
v
e
i
n
g
r
e
d
i
e
n
t
s
o
l
u
t
i
o
n
,
x
=
1.78
, gives 1:1.78. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive the claimed invention by selecting the sublingual/buccal tablet formulation of Example 1 of McCarty, and then modify said formulation by substituting the melatonin with delta-9-tetrahydrocannabinol of Pellikaan et al., then substituting the polyethylene glycol 400 with ethanol of Whittle et al., and then modifying the concentration of active ingredient in the solvent to the range of about 5 to about 30% as taught by McCarty. One of ordinary skill in the art would have been motivated to do so, because the melatonin of McCarty and the delta-9-tetrahydrocannabinol (Δ9-THC) of Pellikaan et al. are active ingredients that are individually taught by the prior arts to have poor bioavailability and poor water solubility issues that can be formulate into a tablet for buccal/sublingual administration; McCarty teaches a list of pharmaceutically acceptable solvents, including polyethylene glycol 400 and ethanol, that is suitable to dissolve active ingredient with poor solubility, in this case, melatonin and Whittle et al. teaches ethanol is the preferred solvent for the buccal or sublingual tablet formulation comprising THC; and McCarty teaches the concentration of active ingredient in the solvent is preferably in the range of about 5% to about 30%. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the ethanol of Whittle et al. would have successfully dissolve delta-9-tetrahydrocannabinol of Pellikaan et al., thus, by replacing the melatonin with delta-9-tetrahydrocannabinol and then replacing polyethylene glycol 400 with ethanol in the sublingual/buccal tablet formulation of Example 1 of McCarty would have successfully dissolve the active ingredient with poor bioavailability and water solubility; and by modifying the concentration of the active ingredient (delta-9-tetrahydrocannabinol) in the solvent (ethanol) in the range of about 5% to about 30% as taught by McCarty, which is about 70% to about 95% of solvent (ethanol), would have successfully dissolve the active ingredient (delta-9-tetrahydrocannabinol) to arrive at a tablet suitable for sublingual/buccal administration. 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).
Regarding the limitation of “adsorbed thereto” in claim 1, said limitation appears to be a method step. Since the claim is interpreted to be a product (a pharmaceutical composition), said method step in the product claims do not appear to further limit the structural components of the composition. Therefore, the composition is a composition which is met by the prior art. In re Thorpe, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir.1985).
Regarding the limitation of “wherein the THC present from 10 mg to 30 mg” in claim 9, this limitation is drawn to the amount of THC present in the claimed pharmaceutical composition. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the sublingual/buccal tablet formulation set forth above to incorporate THC in an amount of 1-50 mg, as taught by Pellikaan et al., in the formulation. One would have been motivated by the fact that Pellikaan et al. teaches the amount of one or more water-insoluble pharmaceutically active substances, including cannabinoids such as Δ9-THC, is most preferably in the range of 1-50 mg in the dosage unit. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by incorporating the THC in an amount of 1-50 mg would successfully arrive at a tablet suitable for sublingual/buccal administration.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on February 19, 2026 with respect to the rejection of claims 1, 6-9, 13-15, and 17-18 rejected under 35 U.S.C. 103 as being unpatentable over McCarty (WO 2008/127609 A1), in view of Pellikaan et al. (WO 2008/033024 A2) and Whittle et al. (GB 2380129A) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant amends claim 1 from the recitation of “the cannabinoid solution in the solid dosage form comprises from about 5 wt% to about 95 wt% of ethanol by weight of the cannabinoid solution” to the recitation of “the cannabinoid solution in the solid dosage form comprises from 5 wt% to 70 wt% of ethanol by weight of the cannabinoid solution”. It is noted that the range of the weight percentage of ethanol is narrower than the one previously introduced. Applicant further amends claim 1 by adding the recitation of “the weight-to-weight ratio of silica to cannabinoid solution is from 1:0.5 to 1:5”, which is previously recited in claim 13. Each of these findings demonstrate the amendment changes the scope of the claims. Since the previously rejection on the record is form on the basis of “87.5 weight % of ethanol”, the rejection on the record, including prior arts, have been revisited and modified in light of the claim amendments.
Applicant asserts the ethanol taught by the prior art would be removed during processing and would not be present in a solid pharmaceutical composition or pharmaceutical tablet such as those of the claimed invention; specifically, applicant argues the claimed invention requires 5-70% w/w of ethanol by weight of the cannabinoid solution in the composition/tablet, and requires that the ethanol be present in an amount well above any possible residual amounts of ethanol that could be left in prior art compositions that use ethanol as processing aid and evaporate by drying.
In response, the technical feature upon which applicant relies (i.e., the ethanol of the claimed invention present in an amount well above any possible residual amounts of ethanol that could be left in prior art compositions”) is not clearly reflected in the current claim language, and this appears to be mere argument without any factual evidence. The Examiner respectfully noted that the instant claims do not recite the weight-by-weight percentage of the ethanol in the pharmaceutical composition, but recite the weight-by-weight of the ethanol in the cannabinoid solution (i.e., “the cannabinoid solution in the solid dosage form comprises from 5 wt% to 70 wt% of ethanol by weight of the cannabinoid solution”). Based on the instant claim language, the cannabinoid solution is “a cannabinoid solution comprising a mixture of ethanol and a cannabinoid” (see line 2-3 of claim 1). In other words, the weight percentage applicant relies upon reflects the weight (grams) of ethanol presents per 100 grams of the cannabinoid solution (ethanol + a cannabinoid) rather than per 100 grams of the total pharmaceutical composition as a whole. Solely to rebut applicant’s argument that the ethanol sets forth in the sublingual/buccal tablet formulation of McCarty, Pellikaan et al. and Whittle et al. is less than the claimed invention, according to Example 1 of the instant specification (see paragraph [0052]) shown below:
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, the weight percentage of the ethanol with respect to the total weight of the cannabinoid solution (THC + Ethanol) can be calculated as follows:
2.50
m
g
2.50
+
5.00
m
g
×
100
%
=
33.3
%
, which gives 33.3 wt% of ethanol with respect to the total weight of the cannabinoid solution. The pharmaceutical composition of McCarty, Pellikaan et al., and Whittle et al. set forth in the rejection above is form on the basis that one would modify of the sublingual/buccal tablet formulation in Table 1 of McCarty by substituting the melatonin with delta-9-tetrahydrocannabinol of Pellikaan et al. as the active ingredient, then substituting the polyethylene glycol 400 with ethanol of Whittle et al. as the pharmaceutically acceptable solvent, and then modifying the concentration of active ingredient in the solvent to the range of about 5 to about 30%. In other words, the weight percentage of solvent (ethanol) before modifying the concentration of active ingredient can be calculated by using the weight of polyethylene glycol 400 (i.e., “7.00 mg”) with respect to the total weight of the melatonin solution (i.e., 7 mg PEG 400 + 1.00 mg melatonin) shown below:
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477
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7.00
m
g
8
m
g
×
100
%
=
87.5
%
, which gives 87.5 wt% of ethanol with respect to the total weight of the cannabinoid solution. Therefore, when modifying the concentration of active ingredient in the solvent to the range of about 5 to about 30% as taught by McCarty, the concentration of the solvent (ethanol) can be back-calculated as follows:
100
%
-
5
%
=
95
%
100
%
-
30
%
=
70
%
, which gives a range of about 70% to about 95% of ethanol with respect to the total weight of the cannabinoid solution. In view of the foregoing, it is respectfully noted that the weight% of ethanol with respect to the total weight of the cannabinoid not only overlap with the claimed ranges, it is actually higher in the prior art(s). Therefore, applicant’s argument that the prior arts contain less ethanol is not found persuasive.
Applicant further argues the fact that McCarty teaches polyethylene glycol and ethanol in the same list of pharmaceutically acceptable solvent does not make them interchangeable; specifically, applicant directs attention to page 5, line 8-15 of McCarty shown below:
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, and argues one of ordinary skill in the art would have recognized the term “preferably removed” means volatile solvents like ethanol, which has high vapor pressure, are unsuitable for processing into a solid pharmaceutical composition, even when combined with silica. Applicant further argues the ethanol is removed by drying/evaporation in the prior arts, specifically citing Pellikaan et al. and Whittle (see page 9 in the reply), and further argues that failure to actively remove ethanol would risk tablet compression.
In response, applicant’s assertion that ethanol is unsuitable for processing into a solid pharmaceutical composition, this appears to be applicant’s mere argument without factual evidence. It is noted that the rejection on the record utilized Pellikaan et al. to teach tetrahydrocannabinol (Δ9-THC)
has poor bioavailability and poor water solubility issues just like melatonin of McCarty, and Whittle et al. to teaches ethanol is the preferred solvent to dissolve THC. In other words, the rejection on the record does not utilize Pellikaan et al. and Whittle et al., respectfully, to teach evaporation of alcohol nor the evaporation of ethanol. It may well be true polyethylene glycol and ethanol are not interchangeable; However, McCarty clearly teaches a list of pharmaceutically acceptable solvent that includes polyethylene glycol and ethanol (see e.g., p. 4, line 29 to p. 5, line2); and teaches that a volatile solvent can be employed to form the solution (see e.g., p. 5, line 8-15). One would have a reasonable expectation of success to select ethanol (volatile solvent) from the list of pharmaceutically acceptable solvent taught by McCarty to dissolve the active ingredient, because Whittle et al. clearly teaches ethanol is a solvent that can dissolve tetrahydrocannabinol (see e.g., Example 6). Applicant did not present any factual evidence supporting ethanol cannot be select to dissolve the tetrahydrocannabinol in the pharmaceutical composition. If applicant asserts ethanol cannot be used as a pharmaceutically acceptable solvent to dissolve cannabinoid, including the elected delta-9-tetrahydrocannabinol, to arrive at the tablet, the Examiner respectfully requested applicant to provide such evidence.
According to MPEP 2123, “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989); and “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971)”. In other words, just because McCarty did not exemplify ethanol as the pharmaceutically acceptable solvent, it does not mean the volatile solvent ethanol is excluded from the pharmaceutically acceptable solvent to be use alone to dissolve the active ingredient in the sublingual/buccal composition. It may well be true ethanol can be evaporated; However, the Examiner respectfully noted that “drying” or evaporation is not the only method for removing volatile solvent in the teachings of McCarty. Specifically, according to page 5, line 8-15 of McCarty shown below:
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, the prior art clearly teaches the volatile solvent can also be removed via absorption; and teaches silica (e.g., SIPERNAT® 160PQ) is an adsorbent/absorbent carrier to convert the liquid melatonin solution into a flowable powder suitable for use in direct compression tableting (see e.g., p. 10, line 15-25). In the present case, the claim recites a limitation that the cannabinoid solution comprising ethanol and cannabinoid is adsorbed onto silica (“a pharmaceutically-acceptable adsorbent, and adsorbed thereto a cannabinoid solution comprising a mixture of ethanol and a cannabinoid” and “the pharmaceutically-acceptable adsorbent is a silica”). In other words, the instant claims clearly uses the same pharmaceutically-acceptable adsorbent (silica) to absorbs the cannabinoid solution comprising ethanol and the cannabinoid. The current claim language does not reflect the volatile solvent ethanol in the cannabinoid solution is not removed via absorption. If applicant asserts ethanol in the cannabinoid solution is not removed by adsorption using silica as the pharmaceutically acceptable adsorbent to arrive at the pharmaceutical composition instantly claimed, said limitation should positively recite in the claim(s).
Lastly, Applicant further argues the claimed invention demonstrates unexpected results (“ethanol in the compositions/tablets of the claimed invention provided rapid release and rapid sublingual delivery of the cannabinoid and did so without irritating the oral mucosa”). Applicant argues the combination of highly viscous liquid (cannabinoid solution) with ethanol surprisingly lower the vapor pressure of ethanol, and cannabinoids dissolved in ethanol allows adsorption onto a silica powder and can be mixed with further pharmaceutical excipients as desired.
In response, Applicant’s assertion of unexpected results is not commensurate in scope with the claimed invention. The specification only disclose two species of sublingual/buccal tablet in Example 1-2 of the specification shown below:
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(see e.g., Example 1, Table 1).
; and
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441
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Greyscale
(see e.g., Example 1, Table 2). It is noted that the disclosure does not specify which species of silica is being used to formulate these sublingual/buccal tablets in the working examples.
In contrast, claim 1 recites “[a] pharmaceutical composition comprising: a pharmaceutically-acceptable adsorbent, and adsorbed thereto a cannabinoid solution comprising a mixture of ethanol and a cannabinoid; wherein: the pharmaceutical composition is a solid dosage form; the solid dosage form is a tablet, powder, or film; the pharmaceutically-acceptable adsorbent is a silica; the cannabinoid solution in the solid dosage form comprises from 5 wt% to 70 wt% of ethanol by weight of the cannabinoid solution; and the weight-to-weight ratio of silica to cannabinoid solution is from 1:0.5 to 1:5”. The claim promise a broad genus of pharmaceutical composition in solid dosage form that contains a broad genus of cannabinoid solution and silica. It is noted that Applicant only exemplified unexpected results using two species of pharmaceutical composition that are both in the form of sublingual/buccal tablet, and that does not provide adequate basis for concluding that similar results would be obtained for other solid dosage form species, such as rectal tablet and topical powder. Additionally, each of these pharmaceutical composition (Example 1-2) uses a specific species of cannabinoid, which are THC and cannabidiol, respectively; and that does not provide adequate basis for concluding that similar results would be obtained using other species of cannabinoid with ethanol to form other species of cannabinoid solution. The sublingual/buccal tablet of Example 1 contains 2.5 mg of ethanol in 7.5 mg of THC solution (THC + ethanol), which when calculated by
2.5
m
g
e
t
h
a
n
o
l
7.5
m
g
T
H
C
s
o
l
u
t
i
o
n
×
100
=
33.3
%
, gives 33.3 wt% of ethanol by weight of the THC solution; and the sublingual/buccal tablet of Example 2 contains 2.6 mg of ethanol in 12.6 mg of cannabidiol solution (cannabidiol + ethanol), which when calculated by
2.6
m
g
e
t
h
a
n
o
l
12.6
m
g
T
H
C
s
o
l
u
t
i
o
n
×
100
=
20.6
%
, gives 20.6 wt% of ethanol by weight of the cannabidiol solution; and that does not adequate basis for concluding that similar results would be obtained in the entire range of 5 wt% to 70 wt% of ethanol by weight of any cannabinoid solution comprising ethanol and any amount of cannabinoid. The weight-to-weight ratio of silica to THC solution in the sublingual/buccal tablet of Example 1, which when calculated by
5.00
m
g
o
f
s
i
l
i
c
a
5.00
m
g
o
f
T
H
C
+
2.50
m
g
o
f
e
h
t
a
n
o
l
=
1
x
,
x
=
1.5
, is 1:1.5; and the weight-to-weight ratio of silica to cannabidiol solution in the sublingual/buccal tablet of Example 2, which when calculated by
8.40
m
g
o
f
s
i
l
i
c
a
10
m
g
o
f
c
a
n
n
a
b
i
d
i
o
l
+
2.60
m
g
o
f
e
h
t
a
n
o
l
=
1
x
,
x
=
1.5
, is 1:1.5; and that does not provide adequate basis for concluding that similar results would be obtained in other weight-to-weight ratio in the range of 1:0.5 to 1:5.
According to MPEP 716.02(d), “whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. In the present case, the sublingual/buccal tablet in Example 1-2 does not exemplify other solid dosage form species aside from sublingual/buccal tablet, and that is not commensurate in scope to encompass any tablet, powder and film. The sublingual/buccal tablet in Example 1-2 also does not exemplify other weight-to-weight ratio of silica to cannabinoid solution (THC + ethanol or cannabidiol + ethanol) aside from 1:15, and that is not commensurate in scope to encompass the full range of 1:0.5 to 1:5. The sublingual/buccal tablet in Example 1-2 only exemplify 20.6 wt% and 33.3 wt% of ethanol by weight of the cannabidiol solution consisting of ethanol and a cannabinoid (THC or cannabidiol), and that is not commensurate in scope to encompass the full range of 5 wt% to 70 wt% of ethanol by weight of any cannabinoid solution (ethanol + any amount of cannabinoid). These finding demonstrates that applicant’s assertion of unexpected results is not commensurate in scope with the claimed invention, thus, the argument is not persuasive.
Additionally, the unexpected results that applicant relies upon (“rapid release and rapid sublingual delivery of the cannabinoid”) is not reflect in the current claim language. Said unexpected results would have been expected, because McCarty clearly teaches the disintegrant, such as sodium starch glycolate, is use to formulate a rapid breaking apart of the tablet following administration (see e.g., p. 11, line 5-8); and the drug delivery system, including the sublingual/buccal tablet formulation in table 1, provides for rapid onset of drug action with higher and more consistent bioavailability (see e.g., p. 6, line 13-15). This concept is also taught by Pellikaan et al., “oral mucosal delivery offers several distinct advantages over other administration routes… It is found that medication absorbed through the buccal mucosa enters the circulation 4 to 8 times more rapidly than when it is ingested in pill or capsule form” (see e.g., p. 3, line 19-23). In other words, the sublingual/buccal tablet is known in the art to have the characteristic of rapid release and rapid sublingual delivery, and that is not an unexpected property. According to the declaration under 37 CFR 1.132 filed on April 29, 2025, which is acknowledged and addressed by the Examiner in the previous Non-Final Office Action mailed on September 19, 2025, the declarant notes ”adsorbing the cannabinoid ethanolic solution into a silica adsorbent dilutes the amount of ethanol contacting the mucosal tissue, rendering it much less if not non-irritating” (see page 6, numbered list 17 in the declaration). It is respectively noted that the same silica is being utilized in the sublingual buccal tablet formulation in Table 1 of McCarty, and that is taught to be an adsorbent/absorbent carrier used to covert the liquid solution into a flowable powder suitable for use in direct compression tableting (see e.g., p. 10, line 15-20). In other words, by utilizing the same silica, one would reasonably have expected that said silica will successfully adsorb to a solution containing ethanol as the pharmaceutically acceptable solvent to convert into a powder, in the absence of evidence to the contrary.
Therefore, applicant’s argument is not found persuasive for the reasons set forth herein.
Claims 1, 6-9, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over McCarty (WO 2008/127609 A1), in view of Pellikaan et al. (WO 2008/033024 A2) and Whittle et al. (GB 2380129A), as applied to claims 1, 6-9, 14-15, and 17-18 above, and further in view of Rowe et al. (Handbook of Pharmaceutical Excipients. 6th ed. Pharmaceutical Press, 2009. Print.)(newly reapplied as necessitated by amendment).
The teachings of McCarty, Pellikaan et al. and Whittle et al. are set forth above and applied as before.
McCarty, Pellikaan et al. and Whittle et al. does not teach the disintegrant comprises low-substituted hydroxypropyl cellulose as claimed in claim 16.
Rowe et al. teaches low-substituted hydroxypropyl cellulose is primarily used as a disintegrant, and as a binder for tablets and granules in wet or dry granulation. Rowe et al. further teaches it has been used in the preparation of rapidly disintegrating tablets produced by direct compression methods Rowe et al. further teaches a low particle size and high hydroxypropyl content is recommended to produce round spheres and rapid dissolution (see e.g., p. 322, right column, 1st paragraph under “7. Applications in Pharmaceutical Formulation or Technology”).
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the pharmaceutical composition of McCarty, Pellikaan et al. and Whittle et al. set forth above by substituting one art recognized equivalent disintegrant for another, and substitutes sodium starch glycolate taught by McCarty with low-substituted hydroxypropyl cellulose taught by Rowe et al. One would have been motivated to do so, because Row et al. teaches low-substituted hydroxypropyl cellulose is suitable for preparing rapidly disintegrating tablets produced by direct compression. One would have a reasonable expectation of success to arrive the claimed invention, because one would have reasonably expected that the low-substituted hydroxypropyl cellulose taught by Rowe et al. would rapidly disintegrate in the mouth as the sodium starch glycolate taught by McCarty.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on April 29, 2025 with respect to the rejection of claims 1, 6-9, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over McCarty (WO 2008/127609 A1), in view of Pellikaan et al. (WO 2008/033024 A2) and Whittle et al. (GB 2380129A), as applied to claims 1, 6-9, 13-15, and 17-18 above, and further in view of Rowe et al. (Handbook of Pharmaceutical Excipients. 6th ed. Pharmaceutical Press, 2009. Print.) have been fully considered but they are not persuasive.
Since Applicant did not put forth any arguments against this rejection, and Applicant's arguments with respect to McCarty, Pellikaan et al. and Whittle et al. in the rejection under 35 U.S.C. § 103 set forth above are not persuasive for the reasons set forth above, claims 1, 6-9, and 13-18 are rejected for the reasons set forth herein.
Claims 29-33, 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over McCarty (WO 2008/127609 A1), in view of Pellikaan et al. (WO 2008/033024 A2) and Whittle et al. (GB 2380129A).
McCarty teaches a sublingual/buccal tablet formulation shown as follows:
PNG
media_image1.png
274
579
media_image1.png
Greyscale
(see e.g., Table 1; p. 12, line 5-15). Please note the sublingual/buccal tablet formulation in Table 1 contains 84 wt% of mannitol (diluent) by weight of the tablet; 3% of sodium starch glycolate (disintegrant) by weight of the tablet; 0.5 wt% of sodium stearyl fumarate (lubricant) by weight of the tablet. Please also note sublingual/buccal tablet formulation in Table 1 contains 12.5% of melatonin (active ingredient) in the melatonin solvent (melatonin + polyethylene glycol 400); and the weight percentage of solvent (polyethylene glycol 400) with respect to the total weight of the active ingredient solution can be calculated by dividing the amount of solvent (1 mg melatonin) by the total weight of active ingredient solution (1 mg melatonin + 7 mg polyethylene glycol 400) times 100:
7
m
g
s
o
l
v
e
n
t
8
m
g
a
c
t
i
v
e
i
n
g
r
e
i
d
e
n
t
s
o
l
u
t
i
o
n
×
100
=
87.5
%
), gives 87.5 weight % of solvent (polyethylene glycol 400) by weight of the active ingredient solution. Please also note the weight-to-weight ratio of silica to melatonin solution (melatonin + polyethylene glycol 400) can be calculated as follows:
4.50
m
g
s
i
l
i
c
a
8
m
g
a
c
t
i
v
e
i
n
g
r
e
d
i
e
n
t
s
o
l
u
t
i
o
n
=
1
m
g
s
i
l
i
c
a
x
m
g
a
c
t
i
v
e
i
n
g
r
e
d
i
e
n
t
s
o
l
u
t
i
o
n
,
x
=
1.78
, gives 1:1.78. McCarty further teaches the melatonin has poor bioavailability and it is poorly soluble in water or other aqueous biological fluids (see e.g., p. 8, line 4-6). McCarty further teaches the sublingual/buccal delivery, which has melatonin completely dissolved in solution, enhances transmucosal absorption, because melatonin does not have to dissolve in the saliva before being absorbed (see e.g., p.8, line 22-27). McCarty further teaches the pharmaceutically acceptable solvent used for dissolving the melatonin and forming the melatonin-containing solution for associating the melatonin with the carrier particle is selected from, inter alia, polyethylene glycol and ethanol (see e.g., p. 4, line 29 to p.5, line 2). McCarty further teaches in order to convert the liquid melatonin solution into a flowable powder suitable for use in direct compression tableting requires the use of an adsorbent/absorbent carrier, such as silica, including SIPERNAT® 160PQ (see e.g., p. 10, line 15-25). Please note that silica is another name for silicon dioxide, as evidence by claim 6 and paragraph [0034]-[0035] of the instant specification. McCarty further teaches the concentration of active ingredient, such as melatonin, in the solvent is
preferably in the range of about 5% to about 30% and more preferred 10% to 20%; and the preferred weight: weight ratio of carrier: solution being in the range of about 1:0.5 to about 1:4 and more preferred 1:1 to 1:2 (see e.g., p. 5, line 18-19). Please note the weight: weight range of about 1:0.5 to about 1:4 taught by McCarty lies within the weight/weight ratio (from 1:0.5 to 1:5) in claim 1. McCarty further teaches the pharmaceutical composition may further comprise a diluent, a disintegrant, a lubricant, or other excipient as would be readily understood in the pharmaceutical arts for preparation of a final dosage form as desired (see e.g., p. 5, line 22-28). McCarty further teaches diluent may be the water-soluble, direct compression tableting excipient, mannitol (see e.g., p. 10, line 27-28). McCarty further teaches the exemplary disintegrant is sodium starch glycolate and it is use to formulate a rapid breaking apart of the tablet following administration (see e.g., p. 11, line 5-8). McCarty further teaches an exemplary tablet lubricant is sodium stearyl fumarate (see e.g., p. 11, line 7-8). McCarty further teaches the pharmaceutical composition is provided as a unit dose form, and more preferably as a solid dosage form, such as a compressed tablet, for buccal or sublingual administration (see e.g., p. 5, line 29 to p. 6, line 4). McCarty further teaches this drug delivery system provides for rapid onset of drug action with higher and more consistent bioavailability (see e.g., p. 6, line 13-15). McCarty further teaches the pharmaceutical composition contains from about 0.01 to about 3 mg of melatonin per unit dose and more preferred 0.5 to 2 mg (see e.g., p. 5, line 19-21).
McCarty does not teach the elected cannabinoid, delta-9-tetrahydrocannabinol (THC). McCarty also does not teach THC is present at from 10 mg to 30 mg.
Pellikaan et al. teaches water-insoluble pharmaceutically active substances include cannabinoids, which are the active constituents of cannabis (see e.g., p. 2, line 3-5). Pellikaan et al. further teaches psychoactive tetrahydrocannabinol (Δ9-THC) is the most important natural cannabinoid (see e.g., p. 2, line 9-10). Pellikaan et al. further teaches oral administration results
in a slow and variable absorption, with a bioavailability of 10-20%, and usually less than 15% (see e.g., p. 2, line 20-21). Pellikaan et al. further teaches oral mucosal delivery offers several distinct advantages over other administration routes, and it is found that medication absorbed through the buccal mucosa enters the circulation 4 to 8 times more rapidly than when it is ingested in pill or capsule form (see e.g., p. 3, line 19-23). Pellikaan et al. further teaches the amount of one or more water-insoluble pharmaceutically active substances contained in the dosage unit typically exceeds 10 μg, and the said amount is most preferably in the range of 1-50 mg (see e.g., p. 9, line 1-3). Pellikaan et al. further teaches the preparation of a tablet for buccal or sublingual administration by citing Example 6 of the British Patent Application GB 2 380 129A (see e.g., p. 3, line 31 to p. 4, line 12).
Whittle et al. (GB 2 380 129A) is a British patent application cited by Pellikaan et al. to teach the preparation of a tablet for buccal or sublingual administration comprising THC, and the formulation of the said tablet is illustrated as follows:
PNG
media_image2.png
296
483
media_image2.png
Greyscale
(see e.g., p. 43, line 21-33; Example 6). Whittle et al. further teaches preferred solvents for use in the formulation are lower alkyl (C1-C4) alcohols, most preferably ethanol (see e.g., p. 17, line 25-28).
In the present case, McCarty clearly teaches the sublingual/buccal tablet formulation in Example 1 (the formulation comprising 84 wt% of mannitol [diluent] by weight of the tablet; 3% of sodium starch glycolate [disintegrant] by weight of the tablet; 0.5 wt% of sodium stearyl fumarate [lubricant] by weight of the tablet; 87.5 wt % of solvent [polyethylene glycol 400] by weight of the active ingredient solution [melatonin + polyethylene glycol 400]; and the weight-to-weight ratio of silica to the active ingredient solution [melatonin + polyethylene glycol 400] is 1:1.78) and a list of pharmaceutically acceptable solvent, including polyethylene glycol and ethanol. The difference between the sublingual/buccal tablet formulation of Example 1 of McCarty and the claimed invention is that the prior art uses melatonin rather than the elected cannabinoid (Δ9-THC) as the active ingredient with poor water solubility; uses the polyethylene glycol 400 rather than ethanol as the pharmaceutically acceptable solvent; and uses 87 wt% of the solvent (polyethylene glycol 400) by weight of the active ingredient solution rather than 5 wt% to 70 wt% of the solvent (ethanol). It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive the claimed invention by selecting the sublingual/buccal tablet formulation of Example 1 of McCarty, and then modify said formulation by substituting the melatonin with delta-9-tetrahydrocannabinol of Pellikaan et al., then substituting the polyethylene glycol 400 with ethanol of Whittle et al., and then modifying the concentration of active ingredient in the solvent to the range of about 5 to about 30% as taught by McCarty. One of ordinary skill in the art would have been motivated to do so, because the melatonin of McCarty and the delta-9-tetrahydrocannabinol (Δ9-THC) of Pellikaan et al. are active ingredients that are individually taught by the prior arts to have poor bioavailability and poor water solubility issues that can be formulate into a tablet for buccal/sublingual administration ; McCarty teaches a list of pharmaceutically acceptable solvents, including polyethylene glycol 400 and ethanol, that is suitable to dissolve active ingredient with poor solubility, in this case, melatonin and Whittle et al. teaches ethanol is the preferred solvent for the buccal or sublingual tablet formulation comprising THC; and McCarty teaches the concentration of active ingredient in the solvent is preferably in the range of about 5% to about 30%. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the ethanol of Whittle et al. would have successfully dissolve delta-9-tetrahydrocannabinol of Pellikaan et al., thus, by replacing the melatonin with delta-9-tetrahydrocannabinol and then replacing polyethylene glycol 400 with ethanol in the sublingual/buccal tablet formulation of Example 1 of McCarty would have successfully dissolve the active ingredient with poor bioavailability and water solubility; and by modifying the concentration of the active ingredient (delta-9-tetrahydrocannabinol) in the solvent (ethanol) in the range of about 5% to about 30% as taught by McCarty, which is about 70% to about 95% of solvent (ethanol), would have successfully dissolve the active ingredient (delta-9-tetrahydrocannabinol) to arrive at a tablet suitable for sublingual/buccal administration. 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).
Regarding the limitation of “adsorbed thereto” in claim 29, said limitation appears to be a method step. Since the claim is interpreted to be a product (a pharmaceutical composition), said method step in the product claims do not appear to further limit the structural components of the composition. Therefore, the composition is a composition which is met by the prior art. In re Thorpe, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir.1985).
Regarding the limitation of “wherein the THC present from 10 mg to 30 mg” in claim 33, this limitation is drawn to the amount of THC present in the claimed pharmaceutical composition. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive the claimed invention by further modifying the sublingual/buccal tablet formulation set forth above to incorporate THC in an amount of 1-50 mg, as taught by Pellikaan et al. One would have been motivated by the fact that Pellikaan et al. teaches the amount of one or more water-insoluble pharmaceutically active substances, including cannabinoids such as Δ9-THC, is most preferably in the range of 1-50 mg in the dosage unit. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by incorporating the THC in an amount of 1-50 mg would successfully arrive at a tablet suitable for sublingual/buccal administration.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 29-33 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over McCarty (WO 2008/127609 A1), in view of Pellikaan et al. (WO 2008/033024 A2) and Whittle et al. (GB 2380129A), as applied to claims 29-33, 37 and 39 above, and further in view of Rowe et al. (Handbook of Pharmaceutical Excipients. 6th ed. Pharmaceutical Press, 2009. Print.).
The teachings of McCarty, Pellikaan et al. and Whittle et al. are set forth above and applied as before.
McCarty, Pellikaan et al. and Whittle et al. does not teach the disintegrant comprises low-substituted hydroxypropyl cellulose as claimed in claim 38.
Rowe et al. teaches low-substituted hydroxypropyl cellulose is primarily used as a disintegrant, and as a binder for tablets and granules in wet or dry granulation. Rowe et al. further teaches it has been used in the preparation of rapidly disintegrating tablets produced by direct compression methods Rowe et al. further teaches a low particle size and high hydroxypropyl content is recommended to produce round spheres and rapid dissolution (see e.g., p. 322, right column, 1st paragraph under “7. Applications in Pharmaceutical Formulation or Technology”).
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the pharmaceutical composition of McCarty, Pellikaan et al. and Whittle et al. set forth above by substituting one art recognized equivalent disintegrant for another, and substitutes sodium starch glycolate taught by McCarty with low-substituted hydroxypropyl cellulose taught by Rowe et al. One would have been motivated to do so, because Row et al. teaches low-substituted hydroxypropyl cellulose is suitable for preparing rapidly disintegrating tablets produced by direct compression. One would have a reasonable expectation of success to arrive the claimed invention, because one would have reasonably expected that the low-substituted hydroxypropyl cellulose taught by Rowe et al. would rapidly disintegrate in the mouth as the sodium starch glycolate taught by McCarty.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6-9, and 15-18 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-16 of U.S. Patent No. 11,077,086 B2 (referred to herein as reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of reference patent is drawn to the same pharmaceutical composition comprising a pharmaceutically-acceptable adsorbent silica, and adsorbed thereto a cannabinoid solution comprising a mixture of ethanol and delta-9-tetrahydrocannabinol as the cannabinoid; wherein the pharmaceutical composition is a solid dosage form, and the solid dosage form is a tablet, powder, or film; cannabinoid solution in the solid dosage comprises from about 5 wt % to about 95 wt% of ethanol by weight of the cannabinoid solution (see claims 1 and 3); wherein the silica is silicon dioxide (see claim 2); wherein the THC is present at from about 0.5 mg to about 50 mg (see claim 4), or from about 10 mg to about 30 mg (see claim 5); wherein the weight/weight ratio of silica: cannabinoid solution is from about 1.0:2.0 to about 1.0:3.0, or from about 1.0:1.0 to about 1.0:1.5 (see claims 9-10); further comprising a water-soluble diluent, a disintegrant, a lubricant, or mixtures thereof (see claim 13); wherein the water-soluble diluent comprises mannitol (see claim 14); wherein the disintegrant comprises low-substituted hydroxypropyl cellulose (see claim 15); wherein the lubricant comprises sodium stearyl fumarate (see claim 16).
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).
Therefore, claims 1, 6-9, and 13-18 are rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant's arguments filed on February 19, 2026 with respect to the rejection of claims 1, 6-9, and 13-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-16 of U.S. Patent No. 11,077,086 B2 (referred to herein as reference patent) have been fully considered but they are not persuasive.
In Summary, Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection, but make a note that a terminal disclaimer will be filed upon identification of allowable subject matter.
In response, since Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection, the rejection is maintained, but revisited and modified in light of the claim amendments for the same reasons of record and the reasons set forth herein.
Claims 29-33 and 37-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-16 of U.S. Patent No. 11,077,086 B2 (referred to herein as reference patent), in view of McCarty (WO 2008/127609 A1) and Pellikaan et al. (WO 2008/033024 A2).
The claims of reference patent is drawn to the same pharmaceutical composition comprising a pharmaceutically-acceptable adsorbent silica, and adsorbed thereto a cannabinoid solution comprising a mixture of ethanol and delta-9-tetrahydrocannabinol as the cannabinoid; wherein the pharmaceutical composition is a solid dosage form, and the solid dosage form is a tablet, powder, or film; cannabinoid solution in the solid dosage comprises from about 5 wt % to about 95 wt% of ethanol by weight of the cannabinoid solution (see claims 1 and 3); wherein the silica is silicon dioxide (see claim 2); wherein the THC is present at from about 0.5 mg to about 50 mg (see claim 4), or from about 10 mg to about 30 mg (see claim 5); wherein the weight/weight ratio of silica: cannabinoid solution is from about 1.0:2.0 to about 1.0:3.0, or from about 1.0:1.0 to about 1.0:1.5 (see claims 9-10); further comprising a water-soluble diluent, a disintegrant, a lubricant, or mixtures thereof (see claim 13); wherein the water-soluble diluent comprises mannitol (see claim 14); wherein the disintegrant comprises low-substituted hydroxypropyl cellulose (see claim 15); wherein the lubricant comprises sodium stearyl fumarate (see claim 16).
The claims of reference patent does not teach the amount of diluent in the tablet is from 5 wt% to 95 wt% by weight of the tablet; the amount of disintegrant in the tablet is from 0.5 wt% to 25 wt% by weight of the tablet; and the amount of lubricant in the tablet is from 0.1 wt% to 5 wt% by weight of the tablet.
McCarty teaches a sublingual/buccal tablet formulation shown as follows:
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(see e.g., Table 1; p. 12, line 5-15), enhances transmucosal absorption of melatonin, which has poor bioavailability and is poorly soluble in water or other aqueous biological fluids (see e.g., p. 8, line 4-6; p.8, line 22-27). McCarty further teaches silica, including SIPERNAT® 160PQ, is an adsorbent/absorbent carrier used to convert the liquid melatonin solution into a flowable powder suitable for use in direct compression tableting (see e.g., p. 10, line 15-25). Please note that silica is another name for silicon dioxide, as evidence by claim 6 and paragraph [0034]-[0035] of the instant specification. McCarty further teaches sodium starch glycolate is an exemplary disintegrant use to formulate a rapid breaking apart of the tablet following administration (see e.g., p. 11, line 5-8); mannitol is a water-soluble diluent (see e.g., p. 10, line 27-28); sodium stearyl fumarate is an exemplary tablet lubricant (see e.g., p. 11, line 7-8); and polyethylene glycol is pharmaceutically acceptable solvent used for dissolving the melatonin and forming the melatonin-containing solution, and examples of pharmaceutically acceptable solvent includes ethanol (see e.g., p. 4, line 29 to p.5, line 2). McCarty further teaches the concentration of active ingredient, such as melatonin, in the solvent is preferably in the range of about 5% to about 30% and more preferred 10% to 20%; and the preferred weight: weight ratio of carrier: solution being in the range of about 1:0.5 to about 1:4 and more preferred 1:1 to 1:2 (see e.g., p. 5, line 18-19). Please note the sublingual/buccal tablet formulation in Table 1 contains 84 wt% of mannitol (diluent) by weight of the tablet; 3% of sodium starch glycolate (disintegrant) by weight of the tablet; 0.5 wt% of sodium stearyl fumarate (lubricant) by weight of the tablet.
Pellikaan et al. teaches water-insoluble pharmaceutically active substances include cannabinoids, which are the active constituents of cannabis (see e.g., p. 2, line 3-5); and psychoactive tetrahydrocannabinol (Δ9-THC) is the most important natural cannabinoid (see e.g., p. 2, line 9-10). Pellikaan et al. further teaches oral administration results in a slow and variable absorption (see e.g., p. 2, line 20-21); and medication absorbed through the buccal mucosa enters the circulation 4 to 8 times more rapidly than when it is ingested in pill or capsule form (see e.g., p. 3, line 19-23).
In the present case, the difference between the pharmaceutical composition of the reference patent and the claimed pharmaceutical tablet is that the prior art does not expressly teach the weight percentage of water-soluble diluent, disintegrant, and lubricant with respect to the total weight of the pharmaceutical composition. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the pharmaceutical composition of the reference patent to incorporate the water-soluble diluent, the disintegrant, and the lubricant in the same amounts (weight-by-weight percentage) as those taught in Table 1 of McCarty to arrive at the tablet suitable for sublingual/buccal administration. Please note the sublingual/buccal tablet formulation in Table 1 of McCarty contains 84 wt% of water-soluble diluent by weight of the tablet; 3% of disintegrant by weight of the tablet; 0.5 wt% of lubricant by weight of the tablet. One would have been motivated to do so, because the active ingredient of the pharmaceutical composition taught by McCarty (melatonin) and the reference patent (delta-9-tetrahydrocannabinol) are each individually taught by the prior arts (McCarty and Pellikaan et al.) to having have poor water solubility issue and can be formulated into pill/tablet form suitable for buccal administration to facilitate absorption; and McCarty provides the amount of water-soluble diluent, the disintegrant, and the lubricant with respect to the total amount of the pharmaceutical composition that can be incorporate along with water-insoluble active ingredient and pharmaceutically acceptable solvent (e.g., polyethylene glycol 400 or ethanol) to arrive at a tablet suitable for sublingual/buccal administration. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by incorporating the water-soluble diluent, the disintegrant, and the lubricant of reference patent in the same amounts (weight-by-weight percentage) as those taught in Table 1 of McCarty would have successfully arrive at a pharmaceutical composition that is a tablet suitable for sublingual/buccal administration.
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).
Therefore, claims 29-33 and 37-39 are rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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