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 .
Detailed Action
Claims 1-18 are currently pending.
Claim Objections
Claims 1-3, and 13-14 are objected to because of the following informalities:
Applicant is advised that should Claims 1-2 be found allowable, Claims 13-14 will be objected to under 37 CFR 1.75 as being a substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). (The phrases “the dose of brivaracetam is lowered” and “with caution” are unclear and do not serve to further limit their respective claims. See 35 USC § 112(b) section below.)
Claim 3 should spell “generalisation" generalization.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-15 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 regards as the invention.
Claims 1-2 and 14-15 recite “the dose of CBD [or BRV] is lowered”. First, the claims lack antecedent basis as no “dose” is described or mentioned in the independent claims. Second, it is unclear with respect to what amount the dose is lowered. Is the amount administered lowered compared to a monotherapy? Compared to an initial dose? The claims to not set forth clear metes and bounds of what “lowered” means in the context of the dosing claims. Claims 3-12 are rejected by virtue of dependency.
Claim 12 recites “brain abnormalities”. It is unclear what brain abnormalities means in the context of epilepsy. Does applicant mean to refer to physical structural abnormalities of the brain? Or does the phrase also include mutations and other biochemical and genetic abnormalities of the brain? Does the term capture all possible forms of epilepsy which would then not further limit Claim 1 at all? The metes and bounds of the limitation are not clear in view of applicant’s disclosure.
Claim 13 recites “with caution”. The term is not defined in applicant’s specification. It is unclear what caution entails aside from those examples detailed in Claims 16-18. Is caution describing some physical step or merely a general approach to administration?
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5 and 8-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 5 requires CBD be synthetic. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Synthetic CBD is the same compound as naturally occurring CBD. The structure of CBD does not change depending on its source. However, CBD in the form of a natural extract as described in Claims 4 and 6-7 also comprises other trace phytocannabinoids and natural products from the sourcing plant.
Claim 8 reads “the CBD is used in combination with one or more…AED”. However, Claim 1 which depends on Claim 8 already requires that the CBD is administered with BRV, an AED, concomitantly. Claim 9 recites compounds which expand the scope of the single AED recited in Claim 1. It is suggested applicant use more precise claim language like “further comprising administering/using” and “additional” or “secondary” to clarify that the “one or more…AED” is in addition to the BRV and CBD of Claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim Rejections - 35 USC § 102
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 1-2, 5, 10-11, and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klotz (Front Neurol. 2019 Dec 10;10:1313. 1-8, cited in 1/22/2024 IDS).
Klotz teaches combination therapies comprising 5-50mg/kg/day of CBD and antiepileptic drugs (AED) (Abstract). AEDs tested include brivaracetam (BRV) (Page 5, Right Col.). Patients are monitored for side effects, resulting in at least two discontinuations (Page 6, Right Col.). Synthetic CBD was used and well-tolerated (Page 6, Right Col.).
Claims 1-3, 5, 8-11, 13-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacobs (Epilepsia. 2019;60.e74-e77, cited in 1/22/2024 IDS, first author Klotz).
Jacobs teaches CBD as a treatment for Lennox-Gastaut and Dravet syndromes with BRV (Abstract; Page e74, Introduction). Patients being treated with 5-50mg/kg/day CBD were concomitantly treated with additional AEDs including clobazam (Page e75, Methods). BRV dosage amounts were reduced from initial amounts due to increased plasma BRV and side effects associated therewith (Page e75, Results).
Claims 1-2, 5, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mukunda (WO2016160542, published 2016, cited in 1/22/2024).
Mukunda teaches “methods for treating seizure disorders such as epilepsy in humans and animals using, the combination of a non-barbiturate anti-epileptic drug (NAED), phytocannabinoid cannabidiol (CBD); and a lipophilic fatty acid such as alpha linolenic acid (ALA)” (Abstract). NAEDs include BRV among two others named (Para 33).
Claim Rejections - 35 USC § 103
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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Klotz (Front Neurol. 2019 Dec 10;10:1313. 1-8, cited in 1/22/2024 IDS).
Klotz teaches combination therapies comprising 5-50mg/kg/day of CBD and antiepileptic drugs (AED) (Abstract). AEDs tested include brivaracetam (BRV) (Page 5, Right Col.). Epilepsy types include Dravet syndrome and Lennox-Gastaut syndrome, and Seizure types include tonic seizures (Page 4, Table 1; Page 6, Table 3). Most patients are treated with two or more AED, among those other AEDs named is clobazam (Page 5, Discussion).
Patients are monitored for side effects, resulting in at least two discontinuations (Page 6, Right Col.). Regarding Claim 18, a practitioner in the art would advise patient of said side effects before administration to achieve informed consent of the patient in need thereof, reducing danger to the patient and the liability of the practitioner.
Synthetic CBD was used and well-tolerated and similar to plant derived CBD (Page 6, Right Col.). With respect to Claims 4 and 6-7, one of skill in the art using the plant-derived extract would therefore minimize non-CBD cannabinoids like THC and CBDV and increase purity to above 95% CBD to more closely approximate the safe, tolerated synthetic CBD because both CBDs are “chemically identical” (Page 7, Right Col.).
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.
PROVISIONAL:
Claims 1-18 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over
Claims
Of Patent App. No. (Checketts)
1-14
18005838
1-14
18005841
1-14 and 16-24
18005843
1-14
18005845
1-13
18005847
1-14
18005848
1-14
18005851
1-14
18005852
1-14
18005853
1-14
18005868
1-14
18005959
1-14
18005960
1-14
18005961
1-13
18006121
1-14
18006125
1-13
18006127
1-13
18006129
15-27
18006131
1-14
18006133
1-14
18311221
1-11
18912442
in view of Klotz (Front Neurol. 2019 Dec 10;10:1313. 1-8, cited in 1/22/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating epileptic seizures of various types comprising administering 5-50mg/kg/day of 95% or 95% pure CBD and an AED.
Checketts does not teach the use of BRV as the AED.
However, Klotz teaches combination therapies comprising 5-50mg/kg/day of CBD and antiepileptic drugs (AED) (Abstract). AEDs tested include brivaracetam (BRV) (Page 5, Right Col.). Epilepsy types include Dravet syndrome and Lennox-Gastaut syndrome, and Seizure types include tonic seizures (Page 4, Table 1; Page 6, Table 3). Most patients are treated with two or more AED, among those other AEDs named is clobazam (Page 5, Discussion).
Patients are monitored for side effects, resulting in at least two discontinuations (Page 6, Right Col.). Regarding Claim 18, a practitioner in the art would advise patient of said side effects before administration to achieve informed consent of the patient in need thereof, reducing danger to the patient and the liability of the practitioner.
Synthetic CBD was used and well-tolerated and similar to plant derived CBD (Page 6, Right Col.). With respect to Claims 4 and 6-7, one of skill in the art using the plant-derived extract would therefore minimize non-CBD cannabinoids like THC and CBDV and increase purity to above 95% CBD to more closely approximate the safe, tolerated synthetic CBD because both CBDs are “chemically identical” (Page 7, Right Col.).
One of skill in the art would therefore find it obvious to select BRV as the concomitant AED for its known and tested combination use with CBD as well as other AEDs.
The copending apps teach more narrow varieties of epilepsy related to mutations or different disorders; however, these subspecies of disease are not precluded by the instant claims.
Since both applications teach the treatment of epileptic seizures comprising administering both CBD and an AED, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of the copending applications.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
Claims 1-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over
Claims
of Patent No. (Checketts)
1-19
10583096
1-24
10709671
1-32
10849860
1-25
10918608
1-22
11065209
1-21
11311498
1-28
11357741
1-19
11679087
1-28
12064399
in view of Klotz (Front Neurol. 2019 Dec 10;10:1313. 1-8, cited in 1/22/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a are directed to a method of treating epileptic seizures of various types comprising administering at least 95% pure CBD and an AED.
Checketts does not teach the use of BRV as the AED.
However, Klotz teaches combination therapies comprising 5-50mg/kg/day of CBD and antiepileptic drugs (AED) (Abstract). AEDs tested include brivaracetam (BRV) (Page 5, Right Col.). Epilepsy types include Dravet syndrome and Lennox-Gastaut syndrome, and Seizure types include tonic seizures (Page 4, Table 1; Page 6, Table 3). Most patients are treated with two or more AED, among those other AEDs named is clobazam (Page 5, Discussion).
Patients are monitored for side effects, resulting in at least two discontinuations (Page 6, Right Col.). Regarding Claim 18, a practitioner in the art would advise patient of said side effects before administration to achieve informed consent of the patient in need thereof, reducing danger to the patient and the liability of the practitioner.
Synthetic CBD was used and well-tolerated and similar to plant derived CBD (Page 6, Right Col.). With respect to Claims 4 and 6-7, one of skill in the art using the plant-derived extract would therefore minimize non-CBD cannabinoids like THC and CBDV and increase purity to above 95% CBD to more closely approximate the safe, tolerated synthetic CBD because both CBDs are “chemically identical” (Page 7, Right Col.).
One of skill in the art would therefore find it obvious to select BRV as the concomitant AED for its known and tested combination use with CBD as well as other AEDs.
The copending apps teach more narrow varieties of epilepsy related to mutations or different disorders; however, these subspecies of disease are not precluded by the instant claims.
Since both applications teach the treatment of epileptic seizures comprising administering both CBD and an AED, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of the above patents.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627