The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 21 and 23-45 are presented for examination.
Acknowledgement is made of the present application as a divisional of U.S. Patent Application No. 14/815,936, filed July 31, 2015, now U.S. Patent No. 11,331,279 B2, which is a continuation-in-part of U.S. Patent Application No. 14/724,351, filed May 28, 2015, now U.S. Patent No. 11,224,660 B2, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Nos. 62/154,660, filed April 29, 2015, and 62/004,495, filed May 29, 2014.
Requirement for Restriction/Election
Applicant’s election of (i) infantile spasms as the single disclosed species of disease or disorder, (ii) caprylic/capric triglyceride as the single disclosed species of lipid, and (iii) alpha-tocopherol as the single disclosed species of antioxidant, to which examination on the merits will be confined, as stated in the reply filed July 16, 2025, is acknowledged by the Examiner.
Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP §818.01(a)).
Therefore, for the reasons above and those made of record at p.2-6 of the Office Action dated June 6, 2025, the requirement remains proper and is hereby made FINAL.
Claims 43-45 are withdrawn from consideration pursuant to 37 C.F.R. §1.142(b) as being directed to non-elected subject matter.
The claims that are drawn to the elected species are claims 21 and 23-42 and such claims are herein acted on the merits infra.
Information Disclosure Statement
Applicant’s Information Disclosure Statements filed February 18, 2022 (13 pages), April 11, 2022 (three pages), August 4, 2022 (two pages), March 8, 2023 (two pages), May 1, 2023 (two pages), June 23, 2023 (three pages), July 20, 2023 (two pages), September 27, 2023 (two pages), March 27, 2024 (two pages), July 3, 2024 (two pages), January 15, 2025 (three pages), April 1, 2025 (two pages), May 8, 2025 (two pages) and August 20, 2025 (two pages) have each been received and entered into the present application. As reflected by the attached, completed copies of form PTO/SB/08a (42 pages), the Examiner has considered the cited references.
Priority
Acknowledgement is made of the present application as a divisional of U.S. Patent Application No. 14/815,936, filed July 31, 2015, which is a continuation-in-part of U.S. Patent Application No. 14/724,351, filed May 28, 2015, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Nos. 62/154,660, filed April 29, 2015, and 62/004,495, filed May 29, 2014. 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 non-provisional 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 U.S. Provisional Patent Application Nos. 62/004,495, filed May 29, 2014, or 62/154,660, filed April 29, 2015, fails to provide adequate written support in the manner provided by 35 U.S.C. §112(a) (pre-AIA first paragraph) for the instantly claimed formulation containing “from about 0.1 to about 40% of cannabidiol” with “from about 10 to about 95% of lipid” (claim 21), or the more specific, dependent limitations further defining this formulation set forth in claims 24-26 and 30-39. As a result, such claims are not entitled to the benefit of the earlier effective filing date of either one of the ‘495 or ‘660 provisional applications.
The disclosure of U.S. Patent Application No. 14/724,351, filed May 28, 2015, provides adequate written support in the manner provided by 35 U.S.C. §112(a) (pre-AIA first paragraph) for the broadly defined method and formulation of claims 21 and 23, as well as the dependent limitations further defining the lipid as caprylic/capric triglyceride (claim 25), purity of the cannabidiol (claim 26), the formulation being free of alcohol (claim 30), the inclusion of an antioxidant in the recited range (claim 36), or a specific subset of diseases or disorders to be treated (claims 40-42). The ‘351 disclosure, however, does not provide adequate written support in the manner provided by 35 U.S.C. §112(a) (pre-AIA first paragraph) for the narrower limitations of the method that further define (i) the lipid component (claim 24), (ii) the mg/kg per day dose ranges of cannabidiol (claims 27-29), (iii) the full range of “about 1% to about 15%” or “about 1% to about 10%” ethanol (claims 31-32), (iv) the full range of “about 0.001 to about 1%” of antioxidant (claims 33-35), or (v) the narrower concentrations of cannabidiol and caprylic/capric triglyceride (claims 37-39). As a result, claims 24, 27-29, 31-35 and 37-39 are not entitled to the benefit of the earlier effective filing date of the ‘351 application.
Accordingly, the effective filing date of claims 21, 23, 25-26, 30, 36 and 40-42 is May 28, 2015 (the filing date of the ‘351 application) and the effective filing date of claims 24, 27-29, 31-35 and 37-39 is July 31, 2015 (the filing date of the ‘936 application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
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.
(1) Claims 21 and 23-42 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.
Applicant defines the formulation of claim 21 as comprising “from about 0.1 to about 40% of cannabidiol” (CBD) and “from about 10 to about 95% of lipid”.
Applicant fails to set forth the basis for the percent ranges recited in claim 21. It is unclear whether the recited percentage is, e.g., weight/weight, weight/volume, etc. It has been held that, where a claimed value varies with its method of measurement and several alternative methods of measurement are available, the claimed value is indefinite unless the method of measurement is specified. See Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003).
Clarification is required.
Similar ambiguity exists also in claims 31-33 and 36-39, which each recite percentage ranges without identifying the basis of the percentage.
Clarification is required.
Applicant’s claim 21 defines the disease or disorder to be treated as, e.g., West syndrome, infantile spasms, refractory infantile spasms, etc.
It is unclear if West syndrome is synonymous with infantile spasms (in which case the terms are duplicative), or if they indeed circumscribe two different diseases. See, e.g., Wheless et al. (“Infantile Spasms (West syndrome): Update and Resources for Pediatricians and Providers to Share with Parents”, BMC Pediatrics, 2012; 12:108), which appears to suggest that infantile spasms are also known as West syndrome (“[i]nfantile spasms (IS; West syndrome) is a severe form of encephalopathy that typically affects infants younger than 2 years old”; abstract).
Similar ambiguity exists also in claims 40-41, which each recite the identical terms as used in claim 21.
Clarification is required.
Applicant’s claims 27-29 each depend from claim 21 and define “the dose of cannabidiol”.
There is insufficient antecedent basis for the term “the dose of cannabidiol”, as claim 21 from which each of claims 27-29 depends fails to recite a limitation directed to “a dose of cannabidiol”.
Clarification is required.
As claims 23-26, 30, 34-35 and 42 do not remedy these points of ambiguity, they must also be rejected on the same grounds.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and are, thus, properly rejected.
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.
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.
(2) Claims 21, 23-25 and 27-42 are rejected under 35 U.S.C. 103 as being unpatentable over Murty et al. (U.S. Patent Application Publication No. 2011/0092583 A1; 2011, cited by Applicant on the 02/18/22 IDS) in view of Whalley et al. (U.S. Patent Application Publication No. 2013/0296398 A1; 2013, cited by Applicant on the 01/15/25 IDS) and Zupanc (“Infantile Spasms”, Expert Opinion on Pharmacotherapy, 2003; 4(11):2039-2048).
Murty et al. teaches an oral delivery system of dronabinol or other cannabinoids dissolved in an oily medium with at least one surfactant to promote self-emulsification (abstract; p.2, para.[0026]; p.5, para.[0080]).
Murty et al. teaches that the oily medium comprises triglycerides, mixed glycerides, etc., and further teaches preferred forms of triglycerides and/or mixed glycerides for use in the disclosed formulation, including medium chain glycerides, such as caprylic/capric glycerides derived from coconut oil or palm seed oil (e.g., LABRAFAC, MIGLYOL 810, 8121, etc.) (p.5, para.[0082-0085]).
Murty et al. teaches that the cannabinoid may be dronabinol or another cannabinoid used alone or in combination, including, e.g., CBD (p.7, para.[0113]).
Murty et al. teaches that the formulation may further contain, e.g., an antioxidant, co-solvent, etc. (abstract; p.2, para.[0032]; p.5, para.[0080-0081]). Murty et al. teaches that preferred co-solvents for use in the formulation include, e.g., ethanol (p.6, para.[0096]). Murty et al. teaches that preferred antioxidants for use in the formulation include, e.g., alpha-tocopherol (p.6, para.[0097]).
Murty et al. discloses the proportions of the various components of the formulation, teaching that the cannabinoid constitutes most preferably about 1-60% by weight of the formulation; the oily medium constitutes from about 5-90% by weight, preferably about 10-80% by weight or most preferably about 20-80% by weight of the formulation; and the surfactant constitutes from about 5-90% by weight or 20-60% by weight of the formulation (p.7, para.[0103]). Murty et al. teaches that the optional co-solvent is preferably incorporated into the formulation in an amount of about 1-80% by weight, preferably from about 5-50% by weight, and more preferably about 10-50% by weight (p.7, para.[0104]). Murty et al. teaches that the optional antioxidant (e.g., alpha-tocopherol) is preferably incorporated into the formulation in an amount of about 0.01-15% by weight, preferably about 0.5-12.5% by weight (p.7, para.[0105]).
Murty et al. teaches that the particular advantages of the disclosed composition include improved dissolution, stability and bioavailability of the cannabinoid (abstract; p.2, para.[0026]).
Murty et al. differs from the instant claims only insofar as it does not explicitly (i) exemplify a formulation comprising CBD with caprylic/capric triglycerides in the recited amounts (claim 21) or (ii) teach the administration of such formulation to a subject in need of treatment for infantile spasms, or the refractory form thereof (claims 21, 40-42), particularly in which CBD is administered in the recited dosage amounts (claims 27-29).
Whalley et al. teaches CBD at a dose of greater than 300 mg/day in combination with a standard anti-epileptic drug that acts via sodium or calcium channels, for use in the treatment of epilepsy (p.2, para.[0038]; p.3, para.[0043]). Whalley et al. experimentally studies the effects of CBD with the anti-epileptic drug valproate in the art-accepted pentylenetetrazole (PTZ) model or pilocarpine model of epilepsy (p.3, para.[0070]-p.5, para.[0087]; p.5, para.[0088]-para.[0095]). Whalley et al. teaches the addition of CBD with standard anti-epileptic therapy, such as valproate, was effective to treat different types of epilepsy, particularly that which may be refractory to existing medication (p.5, para.[0087], [0090]-[0091], [0096]).
Zupanc teaches infantile spasms as a form of epilepsy found in infants and young toddlers, with peak incidence between 4-7 months of age (abstract; p.2039, para.1). Zupanc teaches that infantile spasms are resistant to most standard anti-epileptic drugs, but that valproate has been used in the treatment of infantile spasms with an efficacy rate of 25-40% (abstract; Table 1, p.2041; col.2, p.2043, para.4-col.1, p.2044, para.1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in employing CBD as the cannabinoid of Murty’s oral formulation because Murty et al. clearly suggests CBD as a suitable cannabinoid for use in the disclosed formulation. The ordinarily skilled artisan also would have had a reasonable expectation of success in employing caprylic/capric triglycerides as the oily medium of Murty’s oral formulation because Murty et al. clearly suggests caprylic/capric triglycerides as a suitable oily medium in which to dissolve the cannabinoid of the disclosed composition. The use, therefore, of CBD as the cannabinoid and caprylic/capric triglycerides as the oily medium of the stabilized oral formulation of Murty et al. would have been prima facie obvious to the ordinarily skilled artisan before the effective filing date of the claimed invention because Murty et al. teaches that the disclosed cannabinoids (of which CBD was explicitly named) and oily mediums (of which caprylic/capric triglycerides were explicitly named), were functionally equivalent as, respectively, the cannabinoid or the oily medium of the oral formulation. The selection, then, of any one of these cannabinoids and/or oily mediums from those provided for in Murty et al. would have been well within the purview of the skilled artisan, said artisan recognizing that any one of the disclosed cannabinoids and/or oily mediums would have been appropriately selected for use in the oral formulation of Murty et al. based upon this functional equivalency. "When a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-96, quoting Sakraida v. AG Pro., Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have found it prima facie obvious to administer the CBD formulation of Murty et al. as described above to a subject in need of treatment for infantile spasms because Zupanc documents infantile spasms as a form of epilepsy treated with the standard anti-epileptic therapy valproate and Whalley et al. demonstrates the anti-epileptic activity of CBD when combined with the standard anti-epileptic drug valproate in varied animal models of epilepsy. The ordinarily skilled artisan would have had a reasonable expectation of success in administering Murty’s CBD formulation for this therapeutic use because Whalley et al. experimentally observed the anticonvulsant efficacy of CBD when used with standard anti-epileptic therapy valproate in various animal models of epilepsy – thus, suggesting its applicability and reasonable expectation of anticonvulsant efficacy in other, different forms of epilepsy, such as the epileptic disorder infantile spasms taught by Zupanc.
The ordinarily skilled artisan would have also found it prima facie obvious to apply such therapy to refractory infantile spasms, given that Zupanc teaches infantile spasms as commonly becoming resistant to standard anti-epileptic therapy and further in view of Whalley’s teaching that CBD may be effectively used for treating refractory epilepsy that is no longer responsive to standard anti-epileptic therapy alone.
Claim 21 defines the formulation as comprising “about 0.1 to about 40%” CBD and “about 10 to about 95%” of lipid.
Claim 37 defines the formulation as comprising “about 28% to about 32%” CBD and “about 66% to about 74%” caprylic/capric triglyceride.
Claim 38 defines the formulation as comprising “about 31.09%” CBD and “about 68.385%” caprylic/capric triglyceride.
As summarized above, Murty et al. teaches the incorporation of about 1-60% cannabinoid (including CBD) by weight of the formulation, and about 5-90% (preferably about 10-80%) oily medium (including caprylic/capric triglycerides) by weight of the formulation.
The teachings in Murty et al. suggest the inclusion of the cannabinoid (CBD) and oily medium (caprylic/capric triglycerides) in amounts that clearly circumscribe and/or overlap the ranges and amounts recited in instant claims 21 and 37-38, thereby rendering such ranges and amounts prima facie obvious. As stated in MPEP §2144.05, “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)…” [A] prior art reference that discloses a range encompassing a somewhat narrower range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).”
Claim 27 recites that the dose of CBD is “about 20 to about 100 mg” CBD per kg weight of the subject per day.
Claim 28 recites that the dose of CBD is “about 20 to about 30 mg” CBD per kg weight of the subject per day.
Claim 29 recites that the dose of CBD is “about 30 mg” CBD per kg weight of the subject per day.
Here, Whalley et al. suggests the use of CBD for therapeutic use in epilepsy in an amount that is “greater than 300 mg/day”.
For a human subject of average weight of 60 kg, a dose of 300 mg CBD constitutes a per kg amount of 5 mg/kg per day.
Thus, Whalley et al. suggests that the amount of CBD for this anti-epileptic use is greater than 5 mg/kg per day.
Such range suggested by Whalley et al. circumscribes and/or overlaps the ranges and amounts recited in claims 27-29, thereby rendering such ranges and amounts prima facie obvious. MPEP §2144.05.
Claim 30 recites that the formulation is “free of alcohol”.
Murty et al. teaches ethanol as an optional component of the disclosed stable, oral dosage formulation and, therefore, provides for embodiments of the formulation in which ethanol is absent.
Claim 31 requires that the formulation contain ethanol in an amount "from about 1% to about 15% ethanol".
Claim 32 further limits the amount of ethanol to about 1% to about 10%.
Murty et al. teaches that the optional co-solvent – such as ethanol - is preferably incorporated into the formulation in an amount of 1-80% by weight (preferably 5-50% by weight, more preferably 10-50% by weight of the formulation; p.7, para.[0104]).
The teachings in Murty et al. suggest the inclusion of the co-solvent ethanol into the cannabinoid formulation in amounts that clearly circumscribe and/or overlap the ranges recited in instant claims 31-32, thereby rendering such ranges prima facie obvious. MPEP §2144.05.
Claim 33 recites that the formulation comprises “about 0.001 to about 1% of an antioxidant”.
Claims 34-35 define the antioxidant as, e.g., alpha-tocopherol.
Claim 36 recites that the formulation comprises “about 0.1% to about 1.0%” of alpha-tocopherol, ascorbyl palmitate or a combination thereof.
Murty et al. teaches that the optional antioxidant – defined as including alpha-tocopherol - is preferably incorporated into the formulation in an amount of about 0.01-15% by weight (preferably about 0.5-12.5% by weight; p.7, para.[0105]).
The teachings in Murty et al. suggest the inclusion of the antioxidant (alpha-tocopherol) into the cannabinoid formulation in amounts that clearly circumscribe and/or overlap the ranges recited in instant claims 33 and 36, thereby rendering such ranges prima facie obvious. MPEP §2144.05.
Claim 39 depends from claim 38 (addressed above), and recites that the formulation further comprises “about 0.20%” alpha-tocopherol.
Here, Murty et al. provides for the CBD composition as defined in instant claim 38 for the reasons set forth above.
As further established in the preceding paragraphs, Murty et al. additionally suggests the inclusion of the optional antioxidant – including alpha-tocopherol – within the range of 0.01-15% by weight, which circumscribes Applicant’s instantly claimed amount of “about 0.20%” alpha-tocopherol recited in claim 39 and, thus, renders such range prima facie obvious. MPEP §2144.05.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
(3) Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Murty et al. (U.S. Patent Application Publication No. 2011/0092583 A1; 2011, cited by Applicant on the 02/18/22 IDS) in view of Whalley et al. (U.S. Patent Application Publication No. 2013/0296398 A1; 2013, cited by Applicant on the 01/15/25 IDS) and Zupanc (“Infantile Spasms”, Expert Opinion on Pharmacotherapy, 2003; 4(11):2039-2048),
as applied above to claims 21, 23-25 and 27-42,
further in view of Flockhart et al. (U.S. Patent Application Publication No. 2006/0167283 A1; 2006, cited by Applicant on the 02/18/22 IDS).
Murty in view of Whalley and Zupanc as applied above to claims 21, 23-25 and 27-42.
Murty in view of Whalley and Zupanc differ from the instant claim only insofar as they do not explicitly teach the use of CBD that is > 98% pure and “synthetically synthesized” (claim 26).
Flockhart et al. teaches that pure preparations of CBD are effective for pharmaceutical use by eliminating psychoactive contaminants, such as THC (p.1, para.[0016]). Flockhart et al. teaches substantially pure CBD synthesized from a CBD-containing extract of plant material, dissolving the extract in solvent to form a solution, removing insoluble material from the solution and evaporating the solvent from the solution to obtain substantially pure CBD (p.1, para.[0018]). Flockhart et al. teaches that the substantially pure CBD yielded from this process is at least 98%, more preferably 99%, or most preferably 99.5% pure (p.1, para.[0019]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in employing the > 98% pure CBD as prepared via Flockhart et al. in the CBD formulation described by Murty et al. because Flockhart et al. teaches the use of pure synthesized CBD for pharmaceutical formulations. The skilled artisan would have found it prima facie obvious to use this > 98% pure synthesized CBD of Flockhart et al. as the CBD component of Murty’s stabilized cannabinoid formulation because the substantially pure synthesized CBD would have been reasonably expected to provide the beneficial pharmacological effects of CBD without psychoactive contaminants (e.g., THC) typically found in traditional CBD preparations.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
(4) Claims 21, 23-25, 30 and 33-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 45 and 48-49 of U.S. Patent Application No. 15/166,476.
Claim 45 of the ‘476 application recites a stable liquid pharmaceutical composition for oral administration consisting of 28-32% w/w CBD, 66-74% w/w caprylic/capric triglyceride, 0.01-1% w/w alpha-tocopherol (an antioxidant), 0.01-2% w/w sweetener, and 0-1% w/w flavoring agent, in which w/w denotes weight by total weight of the formulation, and wherein the formulation contains less than 0.3% w/w delta-9-tetrahydrocannabinol after storage under conditions selected from the group consisting of four weeks at 55°C + 2°C, four weeks at 40°C + 2°C and 75% + 5% relative humidity, and four weeks at 25°C + 2°C and 60% + 5% relative humidity. Claim 48 of the ‘476 application further requires the presence of the flavoring agent as part of the formulation (i.e., the concentration of flavoring agent is > 0% w/w). Claim 49 of the ‘476 application recites that the formulation contains less than 0.5% w/w total impurities after storage under said conditions.
In the ‘476 disclosure, the applicant states that the disclosed formulations are suitable for the treatment of a disease or disorder, or a symptom of a disease or disorder, in which the disease or disorder is, e.g., infantile spasms or refractory infantile spasms (p.4, para.[0020]; p.16-17, para.[000106]; p.24, para.[000163]; p.24, para.[000165]).
MPEP §804(II)(B)(1) clearly instructs that, “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceutical Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
The ranges of CBD, caprylic/capric triglyceride, and alpha-tocopherol recited in the ‘476 copending claims clearly circumscribe and/or overlap Applicant’s instantly claimed ranges of claims 21, 33 and 36-39, thereby rendering such claimed ranges prima facie obvious. MPEP §2144.05 states that, “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) … “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).”
Applicant’s claim 30 requires the formulation to be “free of alcohol”.
As the formulation of the ‘476 copending claims does not recite alcohol as a component of the recited formulation, such formulation necessarily meets Applicant’s limitation of claim 30.
This is a provisional nonstatutory double patenting rejection.
(5) Claim 26 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 45 and 48-49 of U.S. Patent Application No. 15/166,476,
as applied above to claims 21, 23-25, 30 and 33-42,
further in view of Flockhart et al. (U.S. Patent Application Publication No. 2006/0167283 A1; 2006, cited by Applicant on the 02/18/22 IDS).
‘476 as applied above to claims 21, 23-25, 30 and 33-42.
‘476 differs from the instant claim only insofar as it does not explicitly teach the use of CBD that is > 98% pure and “synthetically synthesized” (claim 26).
Flockhart et al. teaches that pure preparations of CBD are effective for pharmaceutical use by eliminating psychoactive contaminants, such as THC (p.1, para.[0016]). Flockhart et al. teaches substantially pure CBD synthesized from a CBD-containing extract of plant material, dissolving the extract in solvent to form a solution, removing insoluble material from the solution and evaporating the solvent from the solution to obtain substantially pure CBD (p.1, para.[0018]). Flockhart et al. teaches that the substantially pure CBD yielded from this process is at least 98%, more preferably 99%, or most preferably 99.5% pure (p.1, para.[0019]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in employing the > 98% pure CBD as prepared via Flockhart et al. in the pharmaceutical formulation of the ‘476 claims because the ‘476 formulation utilizes CBD as the active cannabinoid of the stable oral formulation and Flockhart et al. teaches the use of pure synthesized CBD for pharmaceutical formulations. The skilled artisan would have found it prima facie obvious to use this > 98% pure synthesized CBD of Flockhart et al. as the CBD component of the ‘476 formulation because the substantially pure synthesized CBD would have been reasonably expected to provide the beneficial pharmacological effects of CBD without psychoactive contaminants (e.g., THC) typically found in traditional CBD preparations.
This is a provisional nonstatutory double patenting rejection.
(6) Claims 21, 23-26, 30, 33-36 and 40-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 27, 40, 49 and 53 of U.S. Patent Application No. 15/499,178.
Claim 17 of the ‘478 application recites a method for treating a disease or disorder, or a symptom of a disease or disorder, comprising administering to a patient in need thereof a stable oral liquid formulation comprising about 10.53% w/w CBD, about 88.945% w/w caprylic/capric triglyceride, and about 0.2% w/w alpha-tocopherol, in which “w/w” denotes weight by weight of the formulation and wherein the CBD is > 98% pure, and further wherein the formulation is storage stable for at least four weeks at 25°C + 2°C/60% + 5% relative humidity such that the formulation contains less than 0.3% w/w delta-9-tetrahydrocannabinol after said storage, wherein the disease or disorder is, e.g., infantile spasms or refractory infantile spasms.
Claims 27 and 40 of the ‘478 application recite a method for treating infantile spasms comprising administering to a patient in need thereof a stable oral liquid formulation comprising about 10.53% w/w CBD, about 88.945% w/w caprylic/capric triglyceride, about 0.2% w/w alpha-tocopherol, about 0.3% w/w flavoring agent, and about 0.025% w/w sweetener, in which “w/w” denotes weight by weight of the formulation and wherein the CBD is > 98% pure, and further wherein the formulation is storage stable for at least four weeks at 25°C + 2°C/60% + 5% relative humidity such that the formulation contains less than 0.3% w/w delta-9-tetrahydrocannabinol after said storage.
Claims 49 and 53 of the ‘478 application recite a method for treating infantile spasms comprising administering to a patient in need thereof a stable oral liquid formulation consisting of about 10.53% w/w CBD, about 88.945% w/w caprylic/capric triglyceride, about 0.2% w/w alpha-tocopherol, about 0.3% w/w flavoring agent, and about 0.025% w/w sweetener, in which “w/w” denotes weight by weight of the formulation and wherein the CBD is > 98% pure, and further wherein the formulation is storage stable for at least four weeks at 25°C + 2°C/60% + 5% relative humidity such that the formulation contains less than 0.3% w/w delta-9-tetrahydrocannabinol after said storage.
Applicant’s claim 26 requires the CBD to be “substantially pure, synthetically synthesized, cannabidiol which has a purity greater than 98%”.
The ‘478 claims specify the CBD is > 98% pure, thereby meeting the purity requirement of Applicant’s claim 26.
Though the ‘478 claims do not explicitly teach that the > 98% pure CBD is “synthetically synthesized” as instantly claimed, the > 98% pure CBD of the ‘478 claims is physically identical to the > 98% pure CBD of Applicant’s claim 26, regardless of the manner in which it was sourced. MPEP §2113(I) (“[t]he patentability of a product does not depend on its method of production”; “[i]f the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”).
Applicant’s claim 30 requires the formulation to be “free of alcohol”.
As the formulation of the ‘478 copending claims does not recite alcohol as a component of the recited formulation, such formulation necessarily meets Applicant’s limitation of claim 30.
This is a provisional nonstatutory double patenting rejection.
(7) Claims 21, 23-25, 27-30, 37-38 and 40-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 28, 30-32, 34-35, 38 and 40-41 of U.S. Patent Application No. 17/559,155.
Claim 26 of the ‘155 application recites a method for treating infantile spasms in a subject comprising orally administering to the subject a stable liquid composition comprising about 10-32% w/w CBD, about 60-85% w/w caprylic/capric triglycerides, and an antioxidant, wherein the composition contains less than 0.3% w/w delta-9-tetrahydrocannabinol. Claim 28 of the ‘155 application further limits the infantile spasms to refractory infantile spasms. Claims 30-32 of the ‘155 application recite that the dose of CBD administered is 10 mg/kg per day (claim 30), about 30 mg/kg per day (claim 31) or about 100 mg/kg per day (claim 32). Claim 34 of the ‘155 application recites that the composition does not contain alcohol. Claim 35 of the ‘155 application specifies that the CBD is synthetically prepared. Claim 38 of the ‘155 application specifies that the caprylic/capric triglycerides are derived from coconut oil. Claim 40 of the ‘155 application specifies that the antioxidant is alpha-tocopherol. Claim 41 of the ‘155 application defines the subject as one with West syndrome.
The ranges of CBD and caprylic/capric triglyceride recited in the ‘155 copending claims clearly circumscribe and/or overlap Applicant’s instantly claimed ranges of claims 21 and 37-38, thereby rendering such claimed ranges prima facie obvious. MPEP §2144.05 states that, “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) … “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).”
This is a provisional nonstatutory double patenting rejection.
(8) Claim 26 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 28, 30-32, 34-35, 38 and 40-41 of U.S. Patent Application No. 17/559,155,
as applied above to claims 21, 23-25, 27-30, 37-38 and 40-42,
further in view of Flockhart et al. (U.S. Patent Application Publication No. 2006/0167283 A1; 2006, cited by Applicant on the 02/18/22 IDS).
‘155 as applied above to claims 21, 23-25, 27-30, 37-38 and 40-42.
‘155 differs from the instant claim only insofar as it does not explicitly teach the use of CBD that is > 98% pure (claim 26).
Flockhart et al. teaches that pure preparations of CBD are effective for pharmaceutical use by eliminating psychoactive contaminants, such as THC (p.1, para.[0016]). Flockhart et al. teaches substantially pure CBD synthesized from a CBD-containing extract of plant material, dissolving the extract in solvent to form a solution, removing insoluble material from the solution and evaporating the solvent from the solution to obtain substantially pure CBD (p.1, para.[0018]). Flockhart et al. teaches that the substantially pure CBD yielded from this process is at least 98%, more preferably 99%, or most preferably 99.5% pure (p.1, para.[0019]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in employing the > 98% pure CBD as prepared via Flockhart et al. in the pharmaceutical formulation of the ‘155 claims because the ‘155 composition utilizes CBD as the active cannabinoid of the stable oral liquid formulation and Flockhart et al. teaches the use of pure synthesized CBD for pharmaceutical formulations. The skilled artisan would have found it prima facie obvious to use this > 98% pure synthesized CBD of Flockhart et al. as the CBD component of the ‘155 composition because the substantially pure synthesized CBD would have been reasonably expected to provide the beneficial pharmacological effects of CBD without psychoactive contaminants (e.g., THC) typically found in traditional CBD preparations.
This is a provisional nonstatutory double patenting rejection.
(9) Claims 33-36 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 28, 30-32, 34-35, 38 and 40-41 of U.S. Patent Application No. 17/559,155,
as applied above to claims 21, 23-25, 27-30, 37-38 and 40-42,
further in view of Goskonda et al. (U.S. Patent No. 8,222,292 B2, cited by Applicant on the 02/18/22 IDS).
‘155 as applied above to claims 21, 23-25, 27-30, 37-38 and 40-42.
‘155 differs from the instant claims only insofar as it does not explicitly teach the concentration of antioxidant of “about 0.001 to about 1%” (claim 33) or “from about 0.1% to about 1.0%” (claim 36), or “about 0.20%” alpha-tocopherol (claim 39).
Goskonda et al. teaches antioxidants suitable for incorporation into stable liquid oral cannabinoid formulations, including alpha-tocopherol, which function to stabilize the cannabinoid by inhibiting degradation and enhance stability of the formulation during storage (abstract; col.8, l.54-col.9, l.8). Goskonda et al. teaches that the amount of antioxidant to be used is optimized for each formulation to obtain a stable product, but is generally within the range of 0.001% to about 20% w/w of the formulation (col.9, l.13-27).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in incorporating the antioxidant – defined further as alpha-tocopherol – of the ‘155 stable liquid CBD formulation in an amount of about 0.001-1% w/w (claim 33), about 0.1-1% w/w (claim 26) or about 0.20% w/w of the formulation because Goskonda et al. teaches that stabilizing antioxidants, including alpha-tocopherol, were used in stable liquid cannabinoid formulations generally within the range of 0.001-20% w/w to achieve this stabilizing effect. The skilled artisan would have found it prima facie obvious to employ amounts within this broader range for the stable liquid CBD formulation of the copending ‘155 claims to enhance stability of the formulation and mitigate degradation of CBD in the formulation.
The range of antioxidant suggested for use by Goskonda et al. in stable liquid cannabinoid formulations clearly circumscribes Applicant’s instantly claimed ranges of “about 0.001 to about 1%” w/w (claim 33), “about 0.1% to about 1.0%” w/w (claim 36) or “about 0.20%” w/w (claim 39), thereby rendering such claimed ranges or amounts prima facie obvious. MPEP §2144.05 states that, “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) … “[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).”
This is a provisional nonstatutory double patenting rejection.
(10) Claims 21, 23-25, 30 and 33-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7-8 of U.S. Patent No. 11,331,279 B2.
Claim 1 of the ‘379 patent recites a stable liquid pharmaceutical formulation for oral administration comprising a substantially pure CBD at a concentration of 31.09% by weight, caprylic/capric triglyceride at a concentration of 68.385% by weight, and an antioxidant consisting of about 0.20% by weight alpha-tocopherol, wherein the % by weight is of the formulation.
Claim 2 of the ‘379 patent recites a method of treating epilepsy comprising administering to a subject in need of epilepsy treatment an effective amount of this stable liquid pharmaceutical formulation defined in claim 1. Claims 3 and 7-8 of the ‘379 patent further define the epilepsy as infantile spasms (claim 7) or West syndrome (claim 8).
Applicant’s claim 30 requires the formulation to be “free of alcohol”.
As the formulation of the ‘379 patent claims does not recite alcohol as a component of the recited formulation, such formulation necessarily meets Applicant’s limitation of claim 30.
This is a nonprovisional nonstatutory double patenting rejection.
(11) Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7-8 of U.S. Patent No. 11,331,279 B2,
as applied above to claims 21, 23-25, 30 and 33-42,
further in view of Flockhart et al. (U.S. Patent Application Publication No. 2006/0167283 A1; 2006, cited by Applicant on the 02/18/22 IDS).
‘379 as applied above to claims 21, 23-25, 30 and 33-42.
‘379 differs from the instant claim only insofar as it does not explicitly teach the use of CBD that is > 98% pure and “synthetically synthesized” (claim 26).
Flockhart et al. teaches that pure preparations of CBD are effective for pharmaceutical use by eliminating psychoactive contaminants, such as THC (p.1, para.[0016]). Flockhart et al. teaches substantially pure CBD synthesized from a CBD-containing extract of plant material, dissolving the extract in solvent to form a solution, removing insoluble material from the solution and evaporating the solvent from the solution to obtain substantially pure CBD (p.1, para.[0018]). Flockhart et al. teaches that the substantially pure CBD yielded from this process is at least 98%, more preferably 99%, or most preferably 99.5% pure (p.1, para.[0019]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in employing the > 98% pure CBD as prepared via Flockhart et al. in the pharmaceutical formulation of the ‘379 patent claims because the ‘379 formulation utilizes substantially pure CBD as the active cannabinoid of his stable oral formulation and Flockhart et al. teaches the use of > 98% pure synthesized CBD for pharmaceutical formulations. The skilled artisan would have found it prima facie obvious to use this > 98% pure synthesized CBD of Flockhart et al. as the CBD component of the ‘379 formulation because the > 98% pure synthesized CBD would have been reasonably expected to provide the beneficial pharmacological effects of CBD without psychoactive contaminants (e.g., THC) typically found in traditional CBD preparations.
This is a nonprovisional nonstatutory double patenting rejection.
Conclusion
Rejection of claims 21 and 23-42 is proper.
Claims 43-45 are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 76