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 .
Current Status
This action is responsive to the amended claims of 10/14/2025. Claims 1-35 are pending. Claims 13-14, 23, and 29-30 have been withdrawn. Claims 1-12, 15-22, 24-28, and 31-35 have been examined on the merits.
Election/Restrictions
Applicant's election with traverse of cannabidiol, mannitol, focal onset seizure, Dravet Syndrome, and phenobarbital in the reply filed on 10/14/2025 is acknowledged. The traversal is on the ground(s) that there is no serious search burden on the Examiner. This is not found persuasive because search burden is not considered when formulating an election requirement for an application filed under 35 USC 371. Rather, unity of invention is the measure by which restriction/elections are made. In this case, Examiner established lack of unity between the instant species in the Restriction/Election Requirement of 09/19/2025 at Pg. 6-9 ¶ 5.
The requirement is still deemed proper and is therefore made FINAL.
A search for the elected species, above, retrieved prior art (see attached search notes). Thus, the Markush search will not be unnecessarily extended in this action, in line with Markush search practice.
The elected species read on claims 1-12, 15-22, 24-28, and 31-35.
Claims 13-14, 23, and 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/14/2025.
Priority
The effective filing date is 04/27/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3-4 are objected to because of the following informalities: both claims recite “37° C. ±2° C.” The period after the first “C” is unnecessary, please strike the period so the claim reads: “37° C ±2° C.” Appropriate correction is required.
Claim Interpretation
Claim 1 recites “cannabidiol (CBD) or a derivative/analog thereof”. Under the broadest reasonable interpretation, “derivative/analog” is understood to encompass any compound that could theoretically be derived from cannabidiol. This wording opens the scope of claim 1 to be very broad. To limit the possible prior art which may be used against the instant claims, Examiner suggests Applicant amend claim 1 as follows:
Applicant may strike the phrase “or a derivative/analog thereof” and replace it with more descriptive phrasing derived from the disclosure found in the specification at Pg. 35. For example, claim 1 may be amended to recite cannabidiol (CBD), cannabidiolic acids, and cannabidiolic acid esters. Alternatively, Applicant could define the derivative/analog thereof as comprising a shared structural element (e.g., the core structure of cannabidiol) or as being a cannabinoid (supported by Pg. 4 last para of the specification). Applicant is asked to verify support in the original disclosure for any amendments made.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26 and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 recites in the last line “infantile spasm (West syndrome)”. Since West syndrome is recited within a pair of parentheses, it is unclear whether the West syndrome is a required limitation (i.e., the infantile spasm is West syndrome) or an exemplary embodiment of infantile spasm (i.e., the genus of infantile spasm includes West syndrome). Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
To overcome: Applicant could amend the claim to recite: 1) only infantile spasm, or 2) only West syndrome, or 3) “infantile spasm, West syndrome” as separate choices. Please do not use parentheses around any limitation other than acronyms.
Regarding claim 35, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The recitation of “valproic acid or its salts such as sodium valproate” leaves it unclear if sodium valproate is a required limitation or merely an exemplary embodiment. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
To overcome: please strike the phrase “such as” and amend to either: 1) “valproic acid or its salts” or 2) “valproic acid or its salts, sodium valproate,”.
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.
Claims 1, 7-8, 10-11,15-16, 18-19, 25-26, 31, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BRUUN (WO 2020/211915, pub. 22 Oct. 2020), evidenced by BUTLER (Butler, S. (Ed.). (2017). Dravet syndrome. In The Macquarie Dictionary (7th ed.). https://access.infobase.com/article/2152179-dravet-syndrome?aid=279753).
Note: the following rejection is based upon art which was found incidental to the search for the elected species. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied to promote compact prosecution of the case.
Regarding claim 1, BRUUN teaches a fast disintegrating tablet comprising a sugar alcohol and a cannabinoid composition comprising one or more cannabinoids which disintegrates in contact with oral saliva (Pg. 92 claim 1) wherein the cannabinoid comprises cannabidiol (CBD), cannabidiolic acid, cannabidivarin, salts, and/or derivatives thereof (Pg. 19 Lines 15-17 & 24). BRUUN teaches the composition further comprises gelatin (Pg. 96 claim 39). BRUUN teaches the tablet is for oral administration (Pg. 1 Line 6) and is preferably used for treatment of epilepsy (Pg. 50 Lines 23-24).
Thus, BRUUN teaches a method of treating epilepsy via oral administration of a rapidly infusing composition (i.e., fast disintegrating tablet) comprising gelatin, a sugar alcohol, and a therapeutically effective amount of cannabidiol or a derivative/analog thereof.
Regarding claims 7-8, BRUUN teaches the sugar alcohol is present in an amount of at least 20% weight of the tablet (Pg. 92 claim 1) or 30% weight of the tablet (Pg. 94 claim 17). BRUUN teaches the sugar alcohol is mannitol (Pg. 94 claim 21).
Regarding claims 10-11, BRUUN teaches the cannabinoid is in solid form (Pg. 21 line 1-2) and the cannabinoid may be substantially or highly purified corresponding to 95% and more preferably 96-99% (Pg. 47 Lines 1-9).
Regarding claims 15-16 and 18, BRUUN teaches the tablet comprises at least one excipient selected from sweetener, flavor, or colorant (Pg. 97 claim 44). Sweeteners include sucralose and acesulfame potassium in combination (Pg. 33 Lines 4-7) and flavors include lemon-lime (Pg. 33 Line 14).
Regarding claim 19, BRUUN teaches buccal administration as a targeted route (Pg. 13 Lines 25-30).
Regarding claims 25-26 and 31, BRUUN teaches the tablet may be used to treat seizures, Dravet syndrome, Lennox Gastaut syndrome, myoclonic seizures, juvenile myoclonic epilepsy, refractory epilepsy, juvenile spasms, West syndrome, infantile spasms, refractory infantile spasms, and tuberous sclerosis complex (Pg. 51 Lines 1-7). The species taught by BRUUN are understood as “childhood epilepsy” based on the naming conventions (i.e., infantile and juvenile) and as evidenced by BUTLER. BUTLER discloses Dravet syndrome is a form of epilepsy that begins in infancy (Pg. 1 sect. 1.).
Regarding claim 34, BRUUN teaches the tablet is suitable for co-administration with an anti-convulsive medication (i.e., an antiepileptic drug) (Pg. 50 Lines 29-31).
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7-8, 10-11,15-16, 18-19, 25-26, 31, and 34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by BRUUN (WO 2020/211915, effectively filed 17 April 2020), evidenced by BUTLER (Butler, S. (Ed.). (2017). Dravet syndrome. In The Macquarie Dictionary (7th ed.). https://access.infobase.com/article/2152179-dravet-syndrome?aid=279753). Note, the effectively filed date of BRUUN corresponds to the international filing date, thus, no priority document is cited below.
BRUUN anticipates the rejected claims as explained above, ¶17.
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 1-12, 15-19, 22, 24-28, 31-32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over BRUUN (WO 2020/211915, pub. 22 Oct. 2020, effectively filed 17 April 2020) as applied to claim 1, further in view of GROTHER (WO 2022/074127, effectively filed 08 Oct. 2020, priority document cited as “PD” below), BROOKS (Brooks, K. Contact Pharma, 2019, 1-17), and LATTANZI (Lattanzi, S. et al., Drugs, 2018, 78, 1791-1804).
Determining the Scope and Contents of the Prior Art:
The teachings of BRUUN are above, ¶ 17. BRUUN further teaches reducing dissolution time and improving speed of cannabinoid absorption improves patient compliance (Pg. 6 Lines 3-4) especially for buccal administration (Pg. 13 Lines 24-31). Further, sensory properties including flavor and sweetness are important to ensure effective oral delivery wherein taste masking is critical (Pg. 2 Lines 14-31).
GROTHER teaches an oral solid dosage form comprising epinephrine, 10-40 wt. % matrix former, and 10-40 wt. % structure former (Pg. 63 claim 1; PD claim 1) wherein the matrix former is bovine gelatin (Pg. 63 claim 7-8; PD claim 7-8) and the structure former is mannitol (Pg. 63 claim 10; PD claim 10). GROTHER teaches the dosage form includes about 25-65 wt.% active agent (Pg. 19 ¶ 0137; PD ¶ 136). The dosage form can also include coloring agents, flavoring agents, and sweeteners (Pg. 11 ¶ 0102; PD ¶ 101). GROTHER teaches suitable coloring agents include yellow iron oxides and FD&C dyes and flavoring agents include lemon (Pg. 11 ¶ 0102; PD ¶ 101). Suitable sweeteners include sucralose and acesulfame K (Pg. 11 ¶ 0103; PD ¶ 102). GROTHER further teaches to micronize the active agent to a diameter of about 10-40 microns (Pg. 15 ¶ 0122; PD ¶ 121), and teaches examples with a D50 of 10-38 microns (Pg. 173 Fig. 76; PD Fig. 76).
GROTHER teaches the oral dosage form is a freeze dried (i.e., lyophilized) oral dispersible or disintegrating dosage form suitable for sublingual delivery (Pg. 9 ¶ 95; PD ¶ 94). GROTHER further teaches a method of treating a patient by placing the dosage form in the oral cavity’s buccal region (Pg. 64 claims 19-20; PD claims 19-20).
GROTHER teaches a specific example wherein the dosage form consists of 4% w/w bovine gelatin, 3% w/w mannitol and 4% epinephrine prior to lyophilization (Pg. 21 Table 1; PD ¶ 143), which is about, but slightly less than, 36% gelatin, 27% mannitol, and 36% epinephrine after freeze drying to remove the water. Note, there is also an undisclosed but small amount of citric acid which was used for pH adjustment; the pH modifier is present in an amount of 1-10 wt.% (Pg. 15 ¶ 119; PD ¶ 118). GROTHER teaches the exemplary dosage forms disperse in less than 2 seconds in 20°C water (Pg. 21 Table 1 & Pg. 22 ¶ 148-149; PD ¶ 143). Finally, GROTHER teaches the dosage form as the Zydis unit (Pg. 89 Fig. 21A; PD Fig. 21A).
BROOKS teaches a composition to deliver pharmaceutical grade CBD based on the Zydis orally disintegrating tablet of Catalent (Pg. 2), i.e., the dosage form taught by GROTHER.
LATTANZI teaches adjunctive CBD treatment in patients with Dravet syndrome uncontrolled by concomitant anti-epileptic drugs is effective to reduce seizure frequency (Pg. 1791-1792 Abstract & Key points). LATTANZI teaches ≥50% reduction in monthly frequency of all types of seizure including focal onset (Pg. 1792 sect. 2.3 & Pg. 1798 Table 3). LATTANZI teaches CBD dosages of 5 mg/kg twice a day were given to children aged 4-10 years with a history of Dravet Syndrome uncontrolled by other antiepileptics; further generalized seizures (i.e., generalized onset) are treated with CBD (Pg. 1795 Table 1).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
BRUUN does not teach the limitations of the claims that were not rejected under 35 USC 102, above.
GROTHER does not teach treatment of epilepsy with a CBD dosage form.
BROOKS does not teach a method of treating epilepsy.
LATTANZI does not teach the instant composition.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of method useful for treatment of epilepsy and possesses the technical knowledge necessary to make adjustments to the administered composition to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding cannabinoid dosage forms and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references BRUUN, GROTHER, BROOKS, and LATTANZI.
Regarding claims 1-4, 6, and 8, the artisan would be motivated to treat epilepsy by administering the dosage form of GROTHER comprising cannabidiol (CBD) as the active agent. The artisan would be motivated to substitute the oral dosage form of BRUUN with the lyophilized oral dosage form of GROTHER since reducing dissolution time improves patient compliance, as recognized by BRUUN (Pg. 6 Lines 3-4) and GROTHER’s dosage form dissolves in ~2 seconds (Pg. 21 Table 1 & Pg. 22 ¶ 148-149; PD ¶ 143); i.e., within the instant 1-30 and 1-5 sec. ranges. The artisan would be motivated to have the composition comprise bovine gelatin and mannitol since GROTHER teaches this is the composition that dissolves quickest (Pg. 21 Table 1 & Pg. 22 ¶ 148-149; PD ¶ 143). Further, the artisan would be motivated to choose CBD as the active cannabinoid in order to reduce epileptic seizure frequency as recognized by LATTANZI (Pg. 1791-1792 Abstract & Key points). Moreover, the artisan would have a reasonable expectation of success since the Zydis dosage form of GROTHER may be formulated with CBD, as recognized by BROOKS (Pg. 2).
Further regarding claims 3-4, GROTHER teaches 20°C water vs. the instant 37°C water; however, MPEP 2144.05(II)(A) states: “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).” Thus, the instantly claimed dissolution time at the instant temperature would be well within the practice of the artisan.
Regarding claim 5, the artisan would have been motivated to optimize the wt.% of gelatin. MPEP 2144.05(II)(A) provides guidance about the routine optimization of prior art conditions: "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). "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.").” Furthermore, MPEP 2144.05(I) provides guidance about overlapping ranges: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Here, GROTHER teaches bovine gelatin at less than 36 wt.% (Pg. 21 Table 1; PD ¶ 143) and in the range of 10-40 wt. % (Pg. 63 claim 1; PD claim 1) which overlaps with the instant range of 10-35 wt.%. Since the wt.% is the concentration of gelatin, the instant case is equivalent to the difference in concentration cited in the MPEP. Therefore, the determination of the optimum or workable gelatin wt.% is well within the practice of the artisan. Furthermore, absent any evidence demonstrating a patentable difference between the instant and prior art compositions and the criticality of the claimed wt.%, the determination of the optimum or workable wt.% given the guidance of the prior art would have been generally prima facie obvious to the artisan.
Regarding claim 7, BRUUN teaches the sugar alcohol (i.e., mannitol) is at least 20% weight of the tablet (Pg. 92 claim 1) or 30% weight of the tablet (Pg. 94 claim 17) and GROTHER teaches 27% mannitol (Pg. 21 Table 1; PD ¶ 143). These percentages lie within the instant range of 5-35 wt.%. Further, the instant range would be obvious by the same logic applied to claim 5, above. Thus, the claim is obvious.
Regarding claim 9, the 25-65 wt.% active agent, i.e., CBD, taught by GROTHER (Pg. 19 ¶ 0137; PD ¶ 136) lies within the instantly claimed range of 20-70 wt.%. Further, the instant range would be obvious by the same logic applied to claims 5 & 7, above. Thus, the claim is obvious.
Regarding claims 10-11, since BRUUN teaches the cannabinoid is in solid form (Pg. 21 line 1-2) and is more preferably 96-99% pure (Pg. 47 Lines 1-9) the instant limitations are explicitly taught. Further, it would be obvious for the CBD to be in a solid form since the final dosage form of GROTHER is lyophilized, i.e., a freeze dried solid. Since the final dosage form is solid it would follow that the components are solid.
Regarding claim 12, the D50 of 10-38 microns taught by GROTHER (Pg. 173 Fig. 76; PD Fig. 76) lies within the instantly claimed range of 1-50 microns. Thus, the claim is obvious.
Regarding claims 15-18, both BRUUN (Pg. 97 claim 44) and GROTHER (Pg. 11 ¶ 0102; PD ¶ 101) teach the dosage form includes sweeteners, flavors, or colorants. The artisan would be motivated to include the sweeteners sucralose and acesulfame K in combination (BRUUN Pg. 33 Lines 4-7; GROTHER Pg. 11 ¶ 0103; PD ¶ 102) and the flavor lemon-lime (BRUUN Pg. 33 Line 14) since taste masking via flavorings and sweeteners is critical to ensure effective oral delivery, as recognized by BRUUN (Pg. 2 Lines 14-31). Further the artisan would be motivated to use lemon-lime since GROTHER also teaches lemon flavor (Pg. 11 ¶ 0102; PD ¶ 101) and the two would be understood as obvious variants since both are citrus flavors. GROTHER teaches suitable coloring agents include yellow iron oxides and FD&C dyes (Pg. 11 ¶ 0102; PD ¶ 101); the instant FD&C Yellow #5 is an obvious variant of the dyes. It would be obvious to use this color since the flavor is lemon-lime and lemons are yellow.
Regarding claim 19, the artisan would be motivated, with an expectation of success, to administer the dosage form via the buccal mucosa since GROTHER teaches this as a preferred route (Pg. 64 claims 19-20; PD claims 19-20). Further, as recognized by BRUUN (Pg. 13 Lines 24-31), reduced dissolution time is particularly useful for buccal administration. Thus, the quick dissolution time of GROTHER makes the dosage form obvious for buccal administration.
Regarding claims 22, 24, and 32, since LATTANZI teaches CBD treatment results in ≥50% reduction in frequency of all types of seizure including focal onset (Pg. 1792 sect. 2.3 & Pg. 1798 Table 3) and teaches generalized seizures (i.e., generalized onset) are treated with CBD (Pg. 1795 Table 1), the artisan would be motivated to treat focal onset and/or generalized onset seizures with the CBD composition made obvious by BRUUN, GROTHER, and BROOKS. Further, the artisan would expect the CBD composition to reduce seizure frequency by at least 50%, in view of LATTANZI.
Regarding claims 25-28 and 31, LATTANZI teaches patients’ seizure frequency is reduced by CBD administration (Pg. 1791-1792 Abstract & Key points) and the patients were children aged 4-10 years with a history of Dravet Syndrome uncontrolled by other antiepileptics (i.e., drug-resistant) (Pg. 1795 Table 1). Thus, the artisan would be motivated to treat this patient population (i.e., children with drug-resistant Dravet syndrome) with the CBD composition made obvious, above, in order to reduce seizure frequency.
Regarding claim 34, the artisan would be motivated, with an expectation of success, to administer the CBD composition with another antiepileptic drug since BRUUN (Pg. 50 Lines 29-31) teaches the CBD dosage may be administered with an anticonvulsant and LATTANZI teaches CBD concomitant with antiepileptics is an effective treatment (Pg. 1791-1792 Abstract & Key points).
Thus, claims 1-12, 15-19, 22, 24-28, 31-32, and 34 are obvious.
Claims 1, 20-21, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over BRUUN (WO 2020/211915, pub. 22 Oct. 2020, effectively filed 17 April 2020), GROTHER (WO 2022/074127, effectively filed 08 Oct. 2020, priority document cited as “PD” below), BROOKS (Brooks, K. Contact Pharma, 2019, 1-17), and LATTANZI (Lattanzi, S. et al., Drugs, 2018, 78, 1791-1804) as applied to claim 1 above, and further in view of ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
Determining the Scope and Contents of the Prior Art:
BRUUN, GROTHER, BROOKS, and LATTANZI teach the instant claim 1, see ¶ 24 above for the teachings.
ANSEL teaches the safe and effective dose of a drug depends on a number of
factors including characteristics of the drug, the dosage form, and a variety of patient
factors (Pg. 48 Left Col. para 2) and the effective dose may be different for different
patients (Pg. 48 Left Col. para 4). ANSEL further teaches the schedule of dosage or the
dosage regimen is determined based on a drug’s duration of action, pharmacokinetics, and characteristics of the dosage form (Pg. 40 Right Col. para 2).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
BRUUN, GROTHER, BROOKS, and LATTANZI do not teach the instant dosages and effects thereof.
ANSEL does not teach the instant method.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of epilepsy and possesses the technical knowledge necessary to make adjustments to the dosage regimen to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding dosing of cannabinoids and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references BRUUN, GROTHER, BROOKS, LATTANZI, and ANSEL.
Regarding claims 20-21, the artisan would be motivated to optimize the dosage and dosing regimen of the CBD. See ¶ 24, under claim 5 above, for the citations of MPEP 2144.05(I)-(II)(A) regarding routine optimization of prior art conditions.
In the instant case, LATTANZI teaches dosages of 5 mg/kg twice a day (Pg. 1795 Table 1) which is considered to approach the instantly claimed 0.1 to 5 mg/kg/day wherein doses are given 1-3 times per day. Since ANSEL teaches the safe and effective dose of a drug depends on many factors (Pg. 48 Left Col. para 2), the effective dose may be different for different patients (Pg. 48 Left Col. para 4), and the dosage regimen is determined by the drug’s pharmacokinetics and characteristics of the dosage form (Pg. 40 Right Col. para 2), the artisan would recognize the dosage/dosing regimen as a result-effective variable, i.e., a variable that achieves a recognized result. Thus, the dosage is analogous to the “concentration or temperature” recited in the MPEP and may be optimized by routine experimentation. Therefore, the determination of the optimum or workable dosage/dosing regimen of the CBD and composition thereof would have been well within the practice of the artisan. Furthermore, absent any evidence demonstrating a patentable difference between the instant and prior art compositions and the criticality of the claimed dosage, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the artisan.
Regarding claims 32-33, in view of ANSEL, the artisan would recognize the relationship between a drug’s dosage and the drug’s effect on the target disease. Thus, the artisan would recognize the efficacy of a drug as an outcome of the dosage/dosing regimen and would recognize the dosage/dosing regimen as a results-effective variable, i.e., a variable that achieves a recognized result. In the instant case, since the optimization of the CBD dosage/dosing regimen is obvious, the optimization of the drug’s efficacy at reducing seizure frequency would naturally follow. Furthermore, in view of LATTANZI teaching ≥50% reduction in seizure frequency (Pg. 1792 sect. 2.3 & Pg. 1798 Table 3), the artisan would have a reasonable expectation of success in reducing the total seizure frequency (i.e., convulsive frequency) by at least 50% or at least 70% upon optimization of the dosage/dosing regimen.
Thus, claims 1, 20-21, and 32-33 are obvious.
Claims 1 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over BRUUN (WO 2020/211915, pub. 22 Oct. 2020, effectively filed 17 April 2020), GROTHER (WO 2022/074127, effectively filed 08 Oct. 2020, priority document cited as “PD” below), BROOKS (Brooks, K. Contact Pharma, 2019, 1-17), and LATTANZI (Lattanzi, S. et al., Drugs, 2018, 78, 1791-1804) as applied to claim 1 above, and further in view of ZHANG (Zhang, L.L. et al., Epileptic Disord., 2011, 13(4), 349-365).
Determining the Scope and Contents of the Prior Art:
BRUUN, GROTHER, BROOKS, and LATTANZI teach the instant claim 1, see ¶ 24 above for the teachings.
ZHANG teaches phenobarbital, an antiepileptic drug, is widely used because of its low cost (Pg. 349 Abstract).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
BRUUN, GROTHER, BROOKS, and LATTANZI do not teach wherein the antiepileptic drug is phenobarbital.
ZHANG does not teach administration of the instant composition
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of epilepsy and possesses the technical knowledge necessary to make adjustments to the composition/drugs administered to optimize/enhance the treatment. Said artisan has also reviewed the problems in the art regarding antiepileptic drugs and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references BRUUN, GROTHER, BROOKS, LATTANZI, and ZHANG.
The artisan would be motivated to administer the instant CBD dosage form by the method made obvious by BRUUN, GROTHER, BROOKS, and LATTANZI to a patient receiving phenobarbital in order to further reduce seizure frequency. The artisan would have an expectation of success in administering the concomitant therapies since 1) phenobarbital is widely used, as recognized by ZHANG (Pg. 349 Abstract) and 2) adjunctive CBD treatment is effective at reducing seizure frequency in treatment with concomitant antiepileptics, as recognized by LATTANZI (Pg. 1791-1792 Abstract & Key points).
Moreover, the artisan would have a reasonable expectation of success that by combining the instant CBD dosage form with phenobarbital, one would have achieved a composition useful for treating epilepsy since both are taught by the prior art as suitable for the treatment of epilepsy. As set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art.
Thus, claims 1 and 34-35 are obvious.
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 1-12, 15-22, 24-28, and 31-35 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 16-25 of U.S. Patent No. 11,672,761 in view of BRUUN (WO 2020/211915, pub. 22 Oct. 2020, effectively filed 17 April 2020), GROTHER (WO 2022/074127, effectively filed 08 Oct. 2020, priority document cited as “PD” below), BROOKS (Brooks, K. Contact Pharma, 2019, 1-17), and LATTANZI (Lattanzi, S. et al., Drugs, 2018, 78, 1791-1804), ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53), and ZHANG (Zhang, L.L. et al., Epileptic Disord., 2011, 13(4), 349-365).
Determining the Scope and Contents of the Prior Art:
Patent ‘761 is drawn to a lyophilized rapidly infusing buccal composition comprising bovine gelatin at 10-35 wt%, a sugar alcohol at 5-35 wt%, and a solid form of 95-99.9% pure CBD at 20-70 wt%; the composition disintegrates in 1-5 sec. in DI water at 37°C (claim 16, 21-25). The composition further comprises a sweetener, a flavorant that is lemon-lime, and a colorant that is FD&C yellow #5 (claims 17-19); the CBD is micronized with a D50 diameter of 1-50 microns (claim 20). These teachings are species of the instant claims.
The teachings of BRUUN, GROTHER, BROOKS, LATTANZI, ANSEL, and ZHANG are in ¶ 24-26, above.
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
Patent ‘761 does not teach a method of treating epilepsy and the associated seizures, syndromes, and dosages of the CBD.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a CBD composition useful for treatment of epilepsy and possesses the technical knowledge necessary to make adjustments to the composition and method to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatment options for epilepsy and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Patent ‘761, BRUUN, GROTHER, BROOKS, and LATTANZI, ANSEL, and ZHANG.
The CBD composition of Patent ‘761 is analogous to the lyophilized CBD composition of GROTHER/BROOKS and the oral CBD composition taught for treatment of epilepsy by BRUUN. The artisan would recognize these references as relevant to the disclosure of Patent ‘761 and would further recognize the composition of the Patent as analogous. Thus, in view of the teachings of BRUUN and LATANZI above, the artisan would be motivated to treat epilepsy and the instant species of epilepsy in order to reduce seizure frequency, as recognized by LATANZI (Pg. 1791-1792 Abstract & Key points). Since the Patent is analogous to the references GROTHER, BROOKS, and BRUUN, the logic applied in ¶ 24-26 above, would apply here as well regarding the obviousness of the composition, treatment of epilepsy and species thereof, and the dosages/dosing regimen of the CBD composition and the effects thereof on seizure frequency (further in view of ANSEL and MPEP 2144.05(I)-(II)(A)). Further, in view of ZHANG, as explained above, the artisan would have a motivation, at least upheld by In re Kerkhoven, to combine the CBD composition with another antiepileptic drug such as phenobarbital.
Claims 1-12, 15-22, 24-28, and 31-35 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 21-24, 31-32, and 37 of copending Application No. 18/307,228 (reference claims of 08/01/2025) in view of BRUUN (WO 2020/211915, pub. 22 Oct. 2020, effectively filed 17 April 2020), GROTHER (WO 2022/074127, effectively filed 08 Oct. 2020, priority document cited as “PD” below), BROOKS (Brooks, K. Contact Pharma, 2019, 1-17), and LATTANZI (Lattanzi, S. et al., Drugs, 2018, 78, 1791-1804), ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53), and ZHANG (Zhang, L.L. et al., Epileptic Disord., 2011, 13(4), 349-365).
Determining the Scope and Contents of the Prior Art:
The reference claims are drawn to a lyophilized rapidly infusing buccal composition comprising gelatin at 10-35 wt%, a sugar alcohol at 5-35 wt%, and a solid form of 95-99.9% pure CBD at 20-70 wt%; the composition disintegrates in 1-5 sec. in DI water at 37°C (claim 21, 31-32, & 37). The composition further comprises a sweetener, a citrus flavorant, and a colorant that is FD&C yellow #5 (claims 22-24). These teachings are species of the instant claims.
The teachings of BRUUN, GROTHER, BROOKS, LATTANZI, ANSEL, and ZHANG are in ¶ 24-26, above.
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
The reference claims do not teach a method of treating epilepsy and the associated seizures, syndromes, the dosages of the CBD, and the species of the composition components.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a CBD composition useful for treatment of epilepsy and possesses the technical knowledge necessary to make adjustments to the composition and method to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatment options for epilepsy and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references App. No. ‘228, BRUUN, GROTHER, BROOKS, LATTANZI, ANSEL, and ZHANG.
The CBD composition of App. No. ‘228 is analogous to the lyophilized CBD composition of GROTHER/BROOKS and the oral CBD composition taught for treatment of epilepsy by BRUUN. The artisan would recognize these references as relevant to the disclosure of App. No. ‘228 and would further recognize the composition of ‘228 as analogous. Thus, in view of the teachings of BRUUN and LATANZI above, the artisan would be motivated to treat epilepsy and the instant species of epilepsy in order to reduce seizure frequency, as recognized by LATANZI (Pg. 1791-1792 Abstract & Key points). Since ‘228 is analogous to the references GROTHER, BROOKS, and BRUUN, the logic applied in ¶ 24-26 above, would apply here as well regarding the obviousness of the composition, treatment of epilepsy and species thereof, and the dosages/dosing regimen of the CBD composition and the effects thereof on seizure frequency (further in view of ANSEL and MPEP 2144.05(I)-(II)(A)). Further, in view of ZHANG, as explained above, the artisan would have a motivation, at least upheld by In re Kerkhoven, to combine the CBD composition with another antiepileptic drug such as phenobarbital.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-12, 15-22, 24-28, and 31-35 are rejected.
Note: SEARCH 1-4 of the attached search notes retrieved more related Patents/co-pending Applications. These were briefly considered for double patenting, but ultimately were not applied because they were: 1) directed to methods of treating different diseases not recognized as obvious variants of epilepsy, 2) packaging for therapeutics, or 3) compositions comprising active ingredients other than CBD and derivatives thereof.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625