Prosecution Insights
Last updated: April 19, 2026
Application No. 18/270,017

A COMPOSITION FOR USE IN THE TREATMENT OF RECTAL AND/OR INTESTINAL INFLAMMATION

Non-Final OA §103
Filed
Jun 28, 2023
Examiner
KOSTURKO, GEORGE W
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Cannamore Biotechs Ltd.
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
2y 8m
To Grant
99%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allow Rate
379 granted / 699 resolved
-5.8% vs TC avg
Strong +49% interview lift
Without
With
+49.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
52 currently pending
Career history
751
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
40.3%
+0.3% vs TC avg
§102
17.6%
-22.4% vs TC avg
§112
21.7%
-18.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 699 resolved cases

Office Action

§103
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. Claims 1-14, 19-21, 25 and 28-30 filed January 07, 2026 are currently pending. Claims 1, 19 and 28 are independent. Election/Restrictions Applicant’s election without specifying traverse of Group (II), claims 28-30 in the reply filed on 01/07/2026 is acknowledged. 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) ). Claim s 1-14, 19-21, 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/07/2026 . Secondly, Applicant’s election of cannabidiol and ulcerative colitis as the species of cannabinoid and disease associated with intestinal inflammation in the reply filed 01/07/2026 is also acknowledged. Priority Acknowledgement is made of the national stage entry of PCT/IL2021/051560 filed 12/30/2021, which claims priority to U.S. Provisional Application 63132527 filed 12/31/2020. Information Disclosure Statement The information disclosure statement (IDS) submitted on 11/04/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. 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. Claim(s) 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Breuer (AU6681790 published 05/23/1991), Schicho (Pharmacology Vol. 89 pages 149-155 published 2012) and Manolo (US2019/0022229 published 01/24/2019). Breuer (AU6681790 published 05/23/1991) teaches that short-chain fatty acids are normal components of colonic fluid and patients with ulcerative colitis comprise significantly lower concentrations of short chain fatty acids compared to normal patients (page 1 lines 10-33). Breuer teaches the method of treating ulcerative colitis in a subject in need comprising administering a therapeutically effective amount of short-chain fatty acids to the subject in need (claims 1-7). Rectal administration of said short chain fatty acid therapy is embraced within the teachings of Breuer (claims 1, 4). As shown in Figures 1-2, colitis patients receiving said short-chain fatty acid therapy improved on said short chain fatty acid therapy compared to control, wherein both cryptitis abscesses in the mucosa and rectal bleeding were reduced. The difference between the presently claimed and that of Breuer is that Breuer does not specifically teach administering a cannabinoid with the short-chain fatty acid regimen, wherein the short chain fatty acid: cannabinoid weight ratio is from 1:1 to 1000:1 Schicho (Pharmacology Vol. 89 pages 149-155 published 2012) teaches the treatment of colitis in a subject in need comprising intrarectal administration of cannabidiol (CBD) formulated in canola oil (abstract, page 152 left col). As shown in Figure 2B, intrarectal administration of cannabidiol resulted in a significant improvement in colonic inflammation and improved the colitis score of the afflicted patient. No amelioration of colitis was observed when cannabidiol was administered either orally or intragastrically (abstract, page 150 right col., page 152-page 153 right col. , Figure 2). Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to incorporate the cannabinoid cannabidiol into the ulcerative colitis treating short-chain fatty acid regimen of Breuer in view of Schicho arriving at the presently claimed methodology. MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results; In the present case, motivation to combine the cannabinoid cannabidiol into the ulcerative colitis treating short-chain fatty acid regimen of Breuer logically flows from the fact that both a composition comprising short-chain fatty acids and a composition comprising cannabidiol are each recognized in the prior art as being efficacious at treating ulcerative colitis in a subject when rectally administered , which in turn, raises the reasonable expectation of success, that when combined, a composition comprising short chain fatty acids and cannabidiol would be efficacious at treating ulcerative colitis . The instant situation is amenable to the type of analysis set forth in In re Kerkhoven , 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (MPEP 2144.06). Regarding the limitation wherein the short chain fatty acid: cannabinoid weight ratio is from 1:1 to 1000:1 , Manolo (US2019/0022229 published 01/24/2019) teaches solubilizing cannabidiol composition comprising 3000 milligrams of cannabidiol per 1 fluid OZ of C8 caprylic acid ([0066]-[0068]). As evidenced by Aldrich, the density of C8 caprylic acid is 0.91 g/mL or 26.91 g per fluid OZ (29.573 mL per fluid oz). Accordingly, the composition of Manolo containing 3g of cannabinoids in 26.91 g of C8 caprylic acid reads on a composition that comprises a weight ratio of 8.97:1 C8 caprylic acid short chain fatty acid : cannabinoid. Said ratio reads on the presently claimed composition. As evidenced by paragraph [0051], the term short-chain fatty acid reads on compounds that comprise a chain of 1-10 carbons. As such, C8-caprylic acid lies within the genus of short-chain fatty acid. Accordingly, said skilled artisan would have applied the cannabidiol: short-chain fatty acid ratio from Manolo above to the ulcerative colitis cannabidiol and short chain fatty acid regimen of Breuer and Schicho above, arriving at the claimed methodology yielding no more than one would expect from such an arrangement . Applicant is further reminded that , it is considered well within the capabilities of one of ordinary skill in the art to optimize the weight ratio of cannabidiol: short chain fatty acid to provide optimal solubility conditions for the cannabinoid in the short chain fatty acid solution . The weight ratio of cannabidiol: short chain fatty acid in the administered cannabidiol formulation is a result effective parameter that will affect the physical properties of the final composition. The weight ratio of cannabidiol: short chain fatty acid amount of a water soluble surfactant is clearly a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the ratio of cannabidiol and short-chain fatty acid disclosed by Manolo provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal the weight ratio of cannabidiol: short chain fatty acid to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."). Conclusion In view of the rejection(s) set forth above, no claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT GEORGE W KOSTURKO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5903 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9:00-5:30 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT CLINTON A BROOKS can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-7682 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /GEORGE W KOSTURKO/ Primary Examiner, Art Unit 1621
Read full office action

Prosecution Timeline

Jun 28, 2023
Application Filed
Mar 31, 2026
Non-Final Rejection — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
54%
Grant Probability
99%
With Interview (+49.1%)
2y 8m
Median Time to Grant
Low
PTA Risk
Based on 699 resolved cases by this examiner. Grant probability derived from career allow rate.

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