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 June 30, 2026 are currently pending.
Status of Claims
As recited in the Office Action of 04/02/2026, claims 1-14, 19-21, 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Response to Amendment
Applicant’s amendments, filed 06/30/2026 are acknowledged. Claim 28 is amended to a method for preventing or treating a disease or a disorder associated with vaginal, rectal and/or intestinal inflammation in a subject in need thereof, comprising administering to the subject the a pharmaceutical composition comprising (i) a cannabinoid, (ii) a short chain fatty acid (SCF), a salt thereof or both and (iii) a pharmaceutically acceptable carrier; wherein: wherein a w/w ratio of said SCF to said cannabinoid within said composition is from 1000:1 to 1:1; wherein said SCF is propionic acid. Claim 29 is also amended wherein the cannabinoid is cannabidiol and is administered rectally. Claim 30 is also amended, wherein the pharmaceutical composition is administered in the form of an enema.
Applicant's arguments, filed 06/30/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103-Rejection Maintained
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) 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Breuer (AU6681790 published 05/23/1991) and Schicho (Pharmacology Vol. 89 pages 149-155 published 2012).
Claim interpretation is as follows: Claim 28 is directed to a method for preventing or treating a disease or a disorder associated with vaginal, rectal and/or intestinal inflammation in a subject in need thereof, comprising administering to the subject the a pharmaceutical composition comprising (i) a cannabinoid, (ii) a short chain fatty acid (SCF), a salt thereof or both and (iii) a pharmaceutically acceptable carrier; wherein: wherein a w/w ratio of said SCF to said cannabinoid within said composition is from 1000:1 to 1:1;wherein said SCF is propionic acid. Applicant is reminded that the claims embrace the transitional phrase “comprising” which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) and MPEP 2111.03. In the present case, the claimed methodology does not exclude the administration of additional short chain fatty acids with propionate, including butyrate.
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). As shown in Examples 1-2 and claims 1-5 of Breuer, administration of compositions comprising the short chain fatty acids propionate and butyrate are efficacious at treating inflammatory bowel disorders, wherein said short-chain fatty acid composition inhibited rectal bleeding and improved quality of life (pages 7-10, Figures 1-2, Tables 2-3, claims 1-5). Regarding claim 30, rectal administration of said propionate and butyrate short chain fatty acid therapy via an enema formulation is embraced within the teachings of Breuer (page 3 lines 1-15; claims 1, 4).
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. Nor does Breuer teach 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 propionate and butyrate 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 propionate and butyrate regimen of Breuer logically flows from the fact that both a composition comprising short-chain fatty acids propionate and butyrate 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 propionate, butyrate 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, 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 prior art 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.").
Applicant traverses. Applicant asserts that Breuer does not teach the presently claimed methodology and the combination of Schicho fails to cure the deficiencies of Breuer. Applicant argues that Breuer mentions a long list of short-chain fatty acids to treat inflammatory bowel disorders but only exemplifies administering butyrate. Additionally, Applicant argues that Breuer is silent on administering the claimed combination of propionate and a cannabinoid to treat the inflammatory bowel disorder. Applicant further contends that the claimed propionate and cannabinoid composition yields an unexpected results over the prior art teachings of Breuer and Schicho as administration of the claimed propionate and cannabinoid composition delivers a synergistic effect at treating ulcerative colitis in a subject in need while propionate alone is ineffective at treating said inflammatory bowel disorder.
Response to Arguments
Applicant’s arguments, filed 06/30/2026 are acknowledged and have been carefully considered. Applicant is reminded that the claims embrace the transitional phrase “comprising” which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) and MPEP 2111.03. In the present, case the claimed methodology does not exclude the administration of additional short chain fatty acids with propionate, including butyrate.
Regarding Applicant’s contention that Breuer mentions a long list of short-chain fatty acids to treat inflammatory bowel disorders but only exemplifies administering butyrate, this argument is unavailing. As shown in Examples 1-2 and claims 1-5 of Breuer, administration of compositions comprising the short chain fatty acids propionate and butyrate are efficacious at treating inflammatory bowel disorders, wherein said short-chain fatty acid composition inhibited rectal bleeding and improved quality of life (pages 7-10, Figures 1-2, Tables 2-3, claims 1-5).
Next, regarding Applicant’s contention that Breuer is silent on administering the claimed combination of propionate and a cannabinoid to treat the inflammatory bowel disorder, this argument is unpersuasive. In response to Applicant’s arguments, the Examiner acknowledges and does not dispute Applicants contention that none of the prior art references explicitly teach the combination of a cannabinoid and propionate to treat an inflammatory bowel disorder as claimed. However, the Examiner recognizes that it must be remembered that the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references, which make up the state of the art with regard to the claimed invention. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference and it is not that the claimed invention must be expressly suggested in any one or all of the references; but rather the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208, USPQ 871 (CCPA 1981). As set forth above, Breuer teaches administration of compositions comprising the short chain fatty acids propionate and butyrate are efficacious at treating inflammatory bowel disorders, wherein said short-chain fatty acid composition inhibited rectal bleeding and improved quality of life (pages 7-10, Figures 1-2, Tables 2-3, claims 1-5). Considering that Schicho teaches treatment of colitis in a subject in need comprising intrarectal administration of cannabidiol (CBD) formulated in canola oil wherein said intrarectally administered cannabidiol resulted in a significant improvement in colonic inflammation and improved the colitis score of the afflicted patient, said skilled artisan would have readily predicted that a composition comprising cannabidiol and the short chain fatty acids propionate and butyrate would have treated the inflammatory bowel disorder in the administered patient. Reasonable expectation of success logically flows from the fact that both a composition comprising short-chain fatty acids propionate and butyrate 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, 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 Breuer and Schicho 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.").
Thirdly, regarding Applicant’s unexpected results of propionate alone is ineffective at treating said inflammatory bowel disorder and that the combination of propionate and cannabidiol is synergistic at treating colitis in the afflicted patient (see Groups 6 +7 [0206]-[0212] of the instant specification, the examiner has reviewed the unexpected results in the specification, however said unexpected results are insufficient to overcome a prima facie case for the following reasons.
As shown in MPEP 716.02 (E); An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960).
In the instant case, the closest prior art is Breuer, wherein administration of compositions comprising the short chain fatty acids propionate and butyrate are efficacious at treating inflammatory bowel disorders, inhibiting rectal bleeding and improving quality of life (pages 7-10, Figures 1-2, Tables 2-3, claims 1-5).
Applicants have provided no comparative data to the closest prior art of record to show that 1) the claimed composition comprising any cannabinoid and propionic acid wherein the w/w ratio of propionic acid: cannabinoid is from 1000:1 to 1:1 results in improved efficacy than the prior art butyrate and propionate regimen of Breuer above. In essence, there is no positive control experiment between the instantly claimed therapeutic regimen and that of Breuer. As shown in pages 36-42 of the specification patients treated with 20 mg/kg butyrate had a reduced number of inflammatory lesions in induced colitis animal model compared to control. As such, a skilled artisan would have readily predicted that a combination of propionate and butyrate as taught by Breuer, would also have yielded a reduced number of inflammatory lesions in induced colitis animal model compared to control.
Data must be provided that demonstrates that the instantly claimed combination of any cannabinoid and propionic acid wherein the w/w ratio of propionic acid: cannabinoid is from 1000:1 to 1:1 performs better than the prior art butyrate and propionate regimen of Breuer in order to demonstrate that the claimed combination possesses a property not shared with the closest prior art. Applicant must also show that the different results of the between the instantly claimed and those of the prior art are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(B) and Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Because Applicant has not shown said comparison to the regimen of Breuer, the results lack both statistical and practical significance.
MPEP 716.02(d) addresses the subject of unexpected results commensurate in scope with the claimed invention: "[W]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See In re Peterson, 315 F. 3d 1325, 1329-31 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003). In the present case, the claims embrace the ranges of any “cannabinoid”, which includes tetrahydrocannabidiol (THC), cannabidiol (CBD) or a combination thereof as found in [0040] of the present specification; wherein said any cannabinoid and propionic acid wherein the w/w ratio of propionic acid: cannabinoid is the range from 1000:1 to 1:1.
As cited in MPEP 716.02(D) “[T]o establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). However, as shown in the present specification, Applicant has demonstrated 1 specific composition comprising one specific cannabinoid (cannabidiol; CBD) and propionate (P); wherein the weight ratio is 2:1 CBD: propionate (20 mg/kg CBD, 10 mg/kg propionate) is efficacious at treating ulcerative colitis in a murine DSS induced ulcerative colitis animal model (pages 36-42). Applicant has not demonstrated criticality of the claimed range of any “cannabinoid”, which includes tetrahydrocannabidiol (THC), cannabidiol (CBD) or a combination thereof as found in [0040] of the present specification. Nor has Applicant demonstrated criticality of the claimed range of wherein the w/w ratio of propionic acid: cannabinoid is the range from 1000:1 to 1:1.
In the instant case, just as a single point in space fails to define a line, one of ordinary skill in the art cannot ascertain a trend in the single exemplified datapoint of 2:1 CBD: propionate in the specification that would allow him/her to reasonably extend the probative value to any alternative concentrations of CBD: propionate within the boundary of 1:1000 as recited in the instant claims, or a basis to conclude that substitution of 2:1 CBD: propionate for alternative ratios of CBD: propionate encompassed with the ranges of claim 28 would comprise the unexpected and striking decrease in ulcerative colitis over the prior art of record, absent any concrete evidence or scientifically sound reasoning as to why these other embodiments would have been reasonably expected to demonstrate the same unexpected reduction in inflammatory bowel disorder with using different concentrations CBD and propionate in comparison to that disclosed in Breuer and Schicho above. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
NEW REJECTION NECESSITATED BY AMENDMENT
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Breuer (AU6681790 published 05/23/1991) and Schicho (Pharmacology Vol. 89 pages 149-155 published 2012) as applied to claims 28-29 in view of Whittle (GB2377633 published 01/22/2002).
As disclosed above, the combination of Breuer and Schicho render obvious the rectal administration of a therapeutic regimen comprising the short chain fatty acids propionate and butyrate in addition to the cannabinoid cannabidiol to treat inflammatory bowel disorders in a subject in need, as Breuer teaches that rectal administration a composition comprising the short chain fatty acids propionate and butyrate in the form of an enema is efficacious at treating inflammatory bowel disorders, wherein said short-chain fatty acid composition inhibited rectal bleeding and improved quality of life. In addition, Schicho teaches intrarectal administration of cannabidiol (CBD) formulated in canola oil resulted in a significant improvement in colonic inflammation and improved the colitis score of the afflicted patient compared to no amelioration of colitis was observed when cannabidiol was administered either orally or intragastrically (Breuer: page 3 lines 1-15, pages 7-10, Figures 1-2, Tables 2-3, claims 1-5; Schicho: abstract, page 150 right col., page 152-page 153 right col., Figure 2).
The difference between the presently claimed methodology and that embraced within the combined teachings of Breuer and Schicho is that neither Breuer nor Schicho teach intrarectal administration of cannabidiol, wherein cannabidiol is formulated as an enema.
Whittle (GB2377633 published 01/22/2002) teaches formulation of cannabidiol for rectal administration in the form of a foaming enema to treat inflammatory bowel disorders (page 23-24, Example 9).
Therefore, said skilled artisan would have found it prima facie obvious to rectally administer the short chain fatty acid propionate, butyrate and cannabidiol composition in the form of an enema in view of the combined teachings of Breuer, Schicho and Whittle, arriving at the presently claimed methodology. Motivation to administer said therapeutic regimen comprising the short chain fatty acids propionate, butyrate and cannabidiol rectally via an enema logically flows from the fact enema formulations comprising the short chain fatty acids propionate butyrate are taught by Breuer coupled with the knowledge of Schicho and Whittle teach administration of cannabidiol rectally, in the form of an enema to treat inflammatory bowel disorders. Accordingly, said artisan would have readily predicted that rectal administration of therapeutic regimen comprising the short chain fatty acids propionate, butyrate and cannabidiol rectally via an enema would have treated the disorder in the afflicted patient.
Conclusion
In view of the rejections set forth above, no claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/ Primary Examiner, Art Unit 1621
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