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 .
Status of the Application
Claims 1-16 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 01/06/2026 are acknowledged. Claims 6 and 12 are amended and new claim 16 is added. Claims under consideration in the instant office action are claims 1-16.
Applicants' arguments, filed 01/06/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Changoer et al. (US 2018/110753, as disclosed in IDS) in view of Glick et al. (US 2017/0056347), and Takatori et al. (Evaluation of sustained release suppositories prepared with fatty base including solid fats with high melting points, International Journal of Pharmaceutics, 2004, 278, pp. 275-282).
Changoer et al. teaches suppository compositions comprising cannabinoids including cannabidiol, and methods of treating pain and inflammatory bowel diseases comprising administering such compositions (see abstract; paragraph 0048). Changoer et al. teaches administering the suppository 1-6 times a day (paragraphs 0033-0036). Changoer et al. teaches such compositions further comprising hyaluronic acid derivatives (paragraph 0056; claims 7-9). Changoer et al. teaches cannabinoids present in an amount of 0.1% to 50% (paragraph 0059).
Changoer et al. does not teach a suppository composition further comprising sodium hyaluronate, fat, water, and glycerol monostearate present in the recited amounts.
Glick et al. is drawn towards compositions useful for treating an abnormal inflammatory response such as inflammatory bowel diseases (see abstract). Glick et al. teaches such compositions in the form of suppositories (paragraphs 0147-0148), which can comprise sodium hyaluronate (paragraph 0119), water (paragraph 0141), and glycerol monostearate (paragraphs 0155, 0217). Glick et al. teaches that formulations can comprise water up to 100% (paragraphs 0211-0212; see Table 9).
Takatori et al. is drawn towards the use of fatty bases including solid fats in suppositories (see abstract). Takatori teaches that incorporation of solid fats provides for control of the rate of drug release from the suppository for maintaining the plasma concentration of drugs for longer time periods (see abstract).
It would have been obvious to one of ordinary skill in the art to formulate a suppository further comprising sodium hyaluronate, fat, water, and glycerol monostearate present in the recited amounts, as suggested by Glick et al. and Takatori et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since such components are commonly formulated for suppository compositions used for the treatment of inflammatory bowel diseases, and the incorporation of solid fat provides for controlled release of the active agent as taught by Takatori et al. (see abstract), with a reasonable expectation of success absent evidence of criticality of the particular formulation.
With regards to the limitation claimed in instant claims 2-4, 6, and 9-11, which claims the concentrations of cannabidiol, sodium hyaluronate, fat, water, and glycerol monostearate, Changoer et al., Glick et al., and Takatori et al. do not specifically teach the exact amounts claimed in instant claims 2-4, 6, 9-11, and 16. However, it would be within the skill of an ordinary artisan to be able to modify the concentrations in order to obtain the desired bioavailability of cannabidiol. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant argues that “Changoer does not disclose, teach, or suggest a suppository composition in which hyaluronic acid or a salt thereof is present as a free hydrophilic therapeutic agent in combination with cannabidiol and water in a suppository base. Nor does Changoer address the technical problem solved by the present invention, namely the formulation of a water-containing suppository that enables effective release and local therapeutic action of hyaluronic acid in mucosal tissues. Changoer therefore operates in a different technical context and addresses a different problem than the present claims, and cannot reasonably serve as a primary reference for the claimed invention.” The Examiner respectfully disagrees since Changoer does teach formulating suppositories that provide easy absorption through mucosal membrane (see abstract).
Applicant also argues that “The Examiner's reliance on Glick therefore depends on extracting isolated terms from unrelated embodiments while disregarding the specific formulations actually disclosed for suppository dosage forms. Such an approach is inconsistent with the requirement that references be considered as a whole, and it does not provide a proper basis for an obviousness rejection.” The Examiner respectfully disagrees since Glick is not limited to specific embodiments and is relied on for teachings regarding components suitable for suppository formulations, such as the ones disclosed by Changoer. Although glycerol monostearate is disclosed as an exemplary wetting agent for oral formulations (paragraphs 0215-0217), Glick does teach that wetting agents can be formulated in enema compositions (paragraphs 0150-0155), and one of ordinary skill in the art would thus be motivated to formulate such components for suppository dosage forms.
Applicant also argues that “A person of ordinary skill in the art, seeking to achieve effective release of a hydrophilic polymer such as sodium hyaluronate, would be dissuaded from adopting the high-viscosity, solid-fat systems emphasized in Takatori. Takatori therefore teaches away from the claimed invention, a factor that weighs strongly against a conclusion of obviousness.” The Examiner respectfully disagrees since Takatori teaches suppository compositions that can comprise fat, which reads on the structural limitations of the claimed invention, and does not teach away from the claimed formulation, which is not drawn towards a specific release profile of the claimed formulation.
Applicant also argues that “the Office Action does not explain why a skilled person would have combined Changoer's lipophilic cannabinoid suppositories with Glick' s unrelated disclosures of hyaluronate cocrystals and Takatori's sustained-release fatty systems to arrive at a water-containing suppository specifically configured for the release of hyaluronic acid. The references address different technical problems and, when considered together, provide no coherent path to the claimed invention other than through hindsight reconstruction.” The Examiner respectfully disagrees since the prior art are drawn towards suppository compositions and there is thus a sufficient nexus between the prior art despite technical problems that may be addressed across the prior art.
Applicant also argues that “The present application demonstrates, through experimental data, that inclusion of water within the claimed ranges produces a markedly improved dissolution and release profile for sodium hyaluronate. These results would not have been predictable from the cited art.” The Examiner respectfully disagrees since it would be expected that suppositories comprising hyaluronic acid derivatives can provide higher absorption through mucosal membrane (see abstract; paragraph 0056; claims 7-9), and the comparative does not account for the difference in the presence of glycerol monostearate or the amount of solid fat between Examples 1 and 2. Additionally, the results of Example 1 are not commensurate in scope with the claims.
Applicant also argues that “A person of ordinary skill in the art, guided by Takatori and the other cited references, would not have reasonably expected that incorporating water into a fatty suppository base would enhance, rather than impede, release of a hydrophilic polymer such as sodium hyaluronate. The comparative dissolution data disclosed in the specification therefore constitute evidence of unexpected results that is commensurate in scope with the claims and directly attributable to the distinguishing feature of the claimed invention, namely the presence of water in the suppository base. Such evidence weighs strongly against a conclusion of obviousness under MPEP §716.02 and controlling
precedent recognizing unexpected results as probative of nonobviousness.” The Examiner respectfully disagrees since the comparative does not account for the difference in the presence of glycerol monostearate or the amount of solid fat between Examples 1 and 2. Additionally, the results of Example 1 are not commensurate in scope with the claims.
Conclusion
Claims 1-16 are rejected.
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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Renee Claytor can be reached at (571)272-8394. 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.
/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights