Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This is a continuation-in-part of U.S. Patent Application No. 16/048,856 filed July 30, 2018, which is a continuation of U.S. Patent Application No. 15/877,665, filed on January 23, 2018, now U.S. Patent No. 10,058,515, which is a continuation of U.S. Patent Application No. 15/143,694, filed on May 2, 2016, now U.S. Patent No. 9,889,100, which is a continuation-in-part of U.S. Patent Application No. 14/787,515, filed on October 28, 2015, now U.S. Patent No. 9,956,182, which is a national phase of PCT Patent Application No. PCT/IL2014/050385, filed on April 29, 2014, which claims the benefit of priority of U.S. Provisional Patent Application No. 61/818,525, filed on May 2, 2013.
Claim Status
Claims 1-11, 13-15, 17-18 and 20-23 are pending.
In response to a Restriction/ Election requirement dated April 1, 2025, the Applicant elected Group I, drawn to a method for enhancing the therapeutic effect of a steroid, and the species, inflammatory bowel disease, without traverse, in the reply dated May 29, 2025.
Claims 1-6 and 20-23 read on the elected invention and are currently active and subject to examination. Claims 7-11, 13-15 and 17-18 are withdrawn.
Claim Rejections - 35 USC § 102- Withdrawn- Overcome by Amendment
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Kindler & Shmulewitz (US 20110195096 A1) is withdrawn.
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Yeshurun & Sagiv (WO 2017191630 A1) is withdrawn.
The above rejections were overcome by the amendment of the patient population to steroid sparing CBD.
Claim Rejections - 35 USC § 102- New Grounds of Rejection Necessitated by Amendment
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.
(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 1-6 and 20-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients” (NCT04056442, dated June 29, 2020, p. 1-10) (herein “The Phase 2a Study”).
The effective filing date of the claimed invention is May 16, 2022. The earlier filed applications do not disclose the treatment of steroid-dependent IBD or urticaria.
Claim 1 is directed towards a method of enhancing the therapeutic effect of a steroid in a subject afflicted with steroid dependent inflammatory bowel disease or steroid dependent urticaria, comprising administering to said subject CBD, thereby enhancing the therapeutic effect of a steroid in a subject afflicted with steroid dependent IBD or steroid dependent urticaria.
The Phase 2a study discloses that patients with steroid-dependent Crohn’s disease (IBD) are administered CBD in combination with steroids and that efficacy will be measured by percentage of reduction in dose of steroids without flares 50% reduction in dose of steroids without flares:
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The Phase 2a Study, p. 4;
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The Phase 2a Study, p. 5;
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The Phase 2a Study, p. 6-7;
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The Phase 2a Study, p. 7.
As the phase 2a study discloses a method of treating steroid dependent IBD with a combination of steroids and that the intended outcome is to reduce the effective dose in steroids without flares, the phase 2a study inherently discloses that the method enhances the therapeutic effect of a steroid.
Therefore, claim 1 is anticipated.
Claim 2 is directed towards the method of claim 1, wherein said enhancing the therapeutic effect of the steroid comprises reducing a side effect associated with said steroid or rendering a refractory steroid dose a therapeutically effective dose.
While the phase 2a study does not explicitly mention that the enhancing the therapeutic effect of the steroid comprises reducing a side effect associated with said steroid or rendering a refractory steroid dose a therapeutically effective dose, reduction of side effects would necessarily occur because the patient is receiving a therapeutically effective dose of the CBD in combination with the steroid, and rendering a refractory steroid dose a therapeutically effective dose would necessarily be seen when tapering the steroid dose while not observing flares as shown in the rejection of claim 1.
Therefore, claim 2 is anticipated.
Claim 3 is directed towards the method of claim 1, wherein said enhancing the therapeutic effect of said steroid is reducing the effective dose of said steroid.
As shown in the rejection of claim 1, the phase 2a study teaches that efficacy will be measured by percentage of reduction in dose of steroids without flares. As such the phase 2a study discloses enhancing the therapeutic effect of said steroid is reducing the effective dose of said steroid.
Therefore, claim 3 is anticipated.
Claim 4 is directed towards the method of claim 1, wherein said steroid, said CBD, or any combination thereof is administered systemically. Claim 5 is directed towards the method of claim 1, wherein said steroid, said CBD, or any combination thereof is adminsitered orally or topically.
The phase 2a study teaches that the CBD is administered orally (systemically) with food as shown in the rejection of claim 1 (the phase 2a study, detailed description).
Therefore, claims 4-5 are anticipated.
Claim 6 is directed towards the method of claim 1, wherein the CBD is administered in daily doses of between 5 mg to 600 mg.
The phase 2a study teaches that the CBD is administered in daily doses of 50 mg, 100 mg, 200 mg, or 300 mg as shown in the rejection of claim 1 (the phase 2a study, detailed description).
Therefore, claim 6 is anticipated.
Claim 20 is directed toards the method of claim 1, wherein said steroid dependent IBD is controlled, inhibited, treated or ameliorated by said steroid.
The phase 2a study teaches that the patients have steroid dependent IBD and that reductions in dose of the steroid cause flares of the condition (e.g. the steroid is inhibiting flares and controlling the IBD), as shown in the rejection of claim 1 (the phase 2a study, inclusion criteria).
Therefore, claim 20 is anticipated.
Claim 21 is directed towards the method of claim 6, wherein said CBD dose is about 300 mg.
As shown in the rejection of claim 1, the phase 2a study teaches a dose of 300 mg daily (the phase 2a study, detailed description).
Therefore, claim 21 is anticipated.
Claim 22 is directed towards a method of enhancing the therapeutic effect of a steroid in a subject afflicted inflammatory bowel disease or urticaria, comprising administering to said subject CBD at a dose of 300 mg, thereby enhancing the therapeutic effect of a steroid in a subject afflicted with IBD or urticaria. Claim 23 is directed towards the method of claim 22, wherein the CBD is administered at a daily dose of about 300 mg.
As shown in the rejection of claims 1 and 21 above, the phase 2a study teaches that CBD is administered at a daily dose of 300 mg in combination with steroids for the treatment of steroid dependent CBD. As such, for the reasons given in the rejection of claim 1, claim 21 is anticipated.
Conclusion
No claim is found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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