Prosecution Insights
Last updated: August 15, 2026
Application No. 18/940,147

FAST DISSOLVING SOFTGEL CAPSULES

Non-Final OA §103§112
Filed
Nov 07, 2024
Priority
Aug 12, 2022 — provisional 63/397,554 +2 more
Examiner
BROWE, DAVID
Art Unit
1617
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
R.P. Scherer Technologies LLC
OA Round
5 (Non-Final)
26%
Grant Probability
At Risk
5-6
OA Rounds
2y 1m
Est. Remaining
54%
With Interview

Examiner Intelligence

Grants only 26% of cases
26%
Career Allowance Rate
191 granted / 729 resolved
-33.8% vs TC avg
Strong +28% interview lift
Without
With
+27.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
46 currently pending
Career history
796
Total Applications
across all art units

Statute-Specific Performance

§101
2.6%
-37.4% vs TC avg
§103
46.7%
+6.7% vs TC avg
§102
6.9%
-33.1% vs TC avg
§112
32.2%
-7.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 729 resolved cases

Office Action

§103 §112
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 Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 3, 2026, that includes a response to the Final Office Action mailed March 3, 2026, has been entered. Claims 1, 2, and 38 have been amended; and claims 15-30, 35-37, and 40 have been canceled. Claims 2-9, 11, 13, 14, and 31-34 have been withdrawn. Claims 1, 10, 12, 38, and 39 are currently under examination. Withdrawal of Prior Claim Rejections - 35 USC § 112(b) Claims 1 and 38 have been satisfactorily amended. Therefore, the 35 USC 112(b) rejection presented in the Final Office Action mailed March 3, 2026 is hereby withdrawn. Claim Objections Claims 1, 10, and 38 are objected to because of the following: i). In claim 1, there is an extraneous colon between “comprises” and “maltodextrin”; there should be an “and” between “maltodextrin” and “a plasticizer”; and there is an extraneous “and” between “sorbitan” and “wherein the film”. ii). In claim 1, the expression “comprises…a plasticizer consists of” is in improper English grammatical form. iii). In claim 10, the expression “triacetin, polysorbate, or combinations thereof” is awkward and in improper English grammatical form. Applicant is advised to amend the expression to “triacetin, polysorbate, or a combination thereof”. iv). In claim 38, there is an extraneous colon between “comprises” and “maltodextrin”; there should be an “and” between “maltodextrin” and “a plasticizer”; there is an extraneous “and” between “sorbitan” and “wherein the film”, there should be a semicolon rather than a comma between “sorbitan” and “wherein the film”, and there should be an “and” between “free of gelatin” and “wherein the softgel capsule”. v). In claim 38, the expression “comprises…a plasticizer consists of” is in improper English grammatical form. Appropriate correction is required. Claim Rejections - 35 USC § 103 (I-IV) 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. 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. I. Claims 1, 12, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chinese Patent Application Pub. No. 113332257 A), in view of Sukuru et al. (U.S. Patent Application Pub. No. 2006/0088590). I. Applicant Claims Applicant’s elected subject matter is directed to a softgel capsule comprising i) a film comprising e.g. 1.5-25 wt% maltodextrin, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”. I. Determination of the Scope and Content of the Prior Art (MPEP §2141.01) Chen et al. disclose a softgel capsule comprising i) a film comprising e.g. 18-35 wt% gelatinized starch, and a plasticizer including e.g. sorbitol; and ii) a filler material; wherein the gelatinized starch can be e.g. maltodextrin; and wherein the softgel capsule can be employed as a medicine. Sukuru et al. disclose a softgel capsule comprising i) a film comprising e.g. non-gelatin materials, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”; wherein the softgel capsule is intended to provide immediate-release (abstract; paragraphs 0002-0009, 0015, 0020, 0030, 0042, 0043). I. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02) Chen et al. do not explicitly disclose that the plasticizer further includes sorbitan. This deficiency is cured by the teachings of Sukuru et al. I. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Chen et al. and Sukuru et al., outlined supra, to devise Applicant’s presently claimed softgel capsule. Chen et al. disclose a softgel capsule comprising i) a film comprising e.g. 18-35 wt% gelatinized starch, and a plasticizer comprising sorbitol; and ii) a filler material; wherein the gelatinized starch can be e.g. maltodextrin. Since Chen et al. disclose that their softgel capsule can be employed as a medicine; one of ordinary skill in the art would understand that the filler material can thus contain an “active agent”, or would at the very least be motivated to include an “active agent” in the filler material, with the reasonable expectation that the resulting softgel capsule can be successfully employed as a medicine. Moreover, since Sukuru et al. disclose that softgel capsule films containing sorbitol as a plasticizer do not become brittle over time, but that sorbitol is susceptible to blooming as sorbitol forms white precipitates, and that the combination of sorbitol and sorbitan removes this susceptibility to blooming, one of ordinary skill in the art would thus be motivated to employ the combination of sorbitol and sorbitan as the plasticizer, with the reasonable expectation that the resulting softgel capsule film will not become brittle over time and will not be susceptible to blooming. Since one of ordinary skill in the art, in view of the cited prior art, would thus arrive at an immediate release softgel capsule with the same constituents in the same amounts as the claimed softgel capsule, this softgel capsule would reasonably be expected to have the same properties as the claimed softgel capsule as well, including the film dissolving in less than 20 minutes if the film were to be subjected to the USP Apparatus II test with paddles at 75 RPM in 900 ml of 0.1N HCl and deionized water at “37 degrees” . See also Fang et al., WO 2021/072092, published 4/15/2021. In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary. II. Claims 1, 12, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Kamaguchi et al. (U.S. Patent Application Pub. No. 2005/0069579), in view of Sukuru et al. (U.S. Patent Application Pub. No. 2006/0088590). II. Applicant Claims Applicant’s elected subject matter is directed to a softgel capsule comprising i) a film comprising e.g. 1.5-25 wt% maltodextrin, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”. II. Determination of the Scope and Content of the Prior Art (MPEP §2141.01) Kamaguchi et al. disclose a non-gelatinous capsule comprising i) a film comprising e.g. less than 25 wt%, or about 15%, maltodextrin, and a plasticizer; and ii) a content (i.e. fill material) containing e.g. MCT (i.e. an “active agent”); wherein the capsule can be in the form of a softgel capsule; and wherein the softgel capsule can be employed as a pharmaceutical and can achieve excellent disintegration properties in vivo (abstract; paragraphs 0001, 0010-0016, 0023, 0029, 0038, 0042-0044, 0048, 0052; Table 1). Sukuru et al. disclose a softgel capsule comprising i) a film comprising e.g. non-gelatin materials, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”; wherein the plasticizer can further include e.g. glycerol, and wherein the softgel capsule is intended to provide immediate-release II. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02) Kamaguchi et al. do not explicitly disclose that the plasticizer includes sorbitol and sorbitan. This deficiency is cured by the teachings of Sukuru et al. II. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Kamaguchi et al. and Sukuru et al., outlined supra, to devise Applicant’s presently claimed softgel capsule. Kamaguchi et al. disclose a non-gelatinous capsule comprising i) a film comprising e.g. less than 25 wt%, or about 15%, maltodextrin, and a plasticizer; and ii) a content (i.e. fill material) containing e.g. MCT (i.e. an “active agent”); wherein the softgel capsule can be employed as a pharmaceutical and can achieve excellent disintegration properties in vivo. Since Kamaguchi et al. disclose that their non-gelatinous capsule can be in the form of a softgel capsule, one of ordinary skill in the art would thus be motivated to employ a softgel capsule, with the reasonable expectation that the resulting softgel capsule can be successfully employed as a pharmaceutical and can achieve excellent disintegration properties in vivo. Moreover, since Sukuru et al. disclose that softgel capsule films containing sorbitol as a plasticizer do not become brittle over time, unlike softgel capsule films containing e.g. glycerol as a plasticizer, but that sorbitol is susceptible to blooming as sorbitol forms white precipitates, and that the combination of sorbitol and sorbitan removes this susceptibility to blooming, one of ordinary skill in the art would thus be motivated to include the combination of sorbitol and sorbitan as the plasticizer, with the reasonable expectation that the resulting softgel capsule film will not become brittle over time and will not be susceptible to blooming. Since one of ordinary skill in the art, in view of the cited prior art, would thus arrive at a rapidly disintegrating softgel capsule with the same constituents in the same amounts as the claimed softgel capsule, this softgel capsule would reasonably be expected to have the same properties as the claimed softgel capsule as well, including the film dissolving in less than 20 minutes if the film were to be subjected to the USP Apparatus II test with paddles at 75 RPM in 900 ml of 0.1N HCl and deionized water at “37 degrees” . See also Fang et al., WO 2021/072092, published 4/15/2021. In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary. III. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chinese Patent Application Pub. No. 113332257 A), in view of Fujii et al. (U.S. Patent Application Pub. No. 2013/0189522), and Sukuru et al. (U.S. Patent Application Pub. No. 2006/0088590). I. Applicant Claims Applicant’s elected subject matter is directed to a softgel capsule comprising i) a film comprising e.g. 1.5-25 wt% maltodextrin, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material; wherein the plasticizer can further include triacetin and/or polysorbate. III. Determination of the Scope and Content of the Prior Art (MPEP §2141.01) Chen et al. disclose a softgel capsule comprising i) a film comprising e.g. 18-35 wt% gelatinized starch, and a plasticizer including e.g. sorbitol; and ii) a filler material; wherein the gelatinized starch can be e.g. maltodextrin; and wherein the softgel capsule can be employed as a medicine. Fujii et al. disclose e.g. a softgel capsule comprising i) a film comprising a non-gelatin polymer, and a plasticizer including e.g. sorbitol and glycerol triacetate (i.e. triacetin); and ii) a filler material comprising an oil (abstract; paragraphs 0007, 0010, 0011, 0017, 0024). Sukuru et al. disclose a softgel capsule comprising i) a film comprising e.g. non-gelatin materials, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”; wherein the plasticizer can further include e.g. glycerol, and wherein the softgel capsule is intended to provide immediate-release (abstract; paragraphs 0002-0009, 0015, 0020, 0030, 0042, 0043). III. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02) Chen et al. do not explicitly disclose that the plasticizer further includes sorbitan and triacetin. These deficiencies are cured by the teachings of Fujii et al. and Sukuru et al. III. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Chen et al., Fujii et al., and Sukuru et al., outlined supra, to devise Applicant’s presently claimed softgel capsule. Chen et al. disclose a softgel capsule comprising i) a film comprising e.g. 18-35 wt% gelatinized starch, and a plasticizer comprising sorbitol and glycerol; and ii) a filler material; wherein the gelatinized starch can be e.g. maltodextrin. Since Chen et al. disclose that their softgel capsule can be employed as a medicine; one of ordinary skill in the art would understand that the filler material can thus contain an “active agent”, or would at the very least be motivated to include an “active agent” in the filler material, with the reasonable expectation that the resulting softgel capsule can be successfully employed as a medicine. Moreover, since Fujii et al. disclose that a film for a softgel capsule comprising a non-gelatin polymer, and a plasticizer including e.g. sorbitol and glycerol triacetate (i.e. triacetin) has excellent stability and disintegration ability; and since Sukuru et al. disclose that softgel capsule films containing sorbitol as a plasticizer do not become brittle over time, but that sorbitol is susceptible to blooming as sorbitol forms white precipitates, and that the combination of sorbitol and sorbitan removes this susceptibility to blooming, one of ordinary skill in the art would thus be motivated to employ the combination of sorbitol with triacetin and sorbitan as the plasticizer, with the reasonable expectation that the resulting softgel capsule film will exhibit excellent stability, will not become brittle over time, will not be susceptible to blooming, and will exhibit excellent disintegration ability. Since one of ordinary skill in the art, in view of the cited prior art, would thus arrive at an immediate release softgel capsule with the same constituents in the same amounts as the claimed softgel capsule, this softgel capsule would reasonably be expected to have the same properties as the claimed softgel capsule as well, including the film dissolving in less than 20 minutes if the film were to be subjected to the USP Apparatus II test with paddles at 75 RPM in 900 ml of 0.1N HCl and deionized water at “37 degrees” . See also Fang et al., WO 2021/072092, published 4/15/2021. In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary. IV. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kamaguchi et al. (U.S. Patent Application Pub. No. 2005/0069579), in view of Fujii et al. (U.S. Patent Application Pub. No. 2013/0189522), and Sukuru et al. (U.S. Patent Application Pub. No. 2006/0088590). IV. Applicant Claims Applicant’s elected subject matter is directed to a softgel capsule comprising i) a film comprising e.g. 1.5-25 wt% maltodextrin, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material; wherein the plasticizer can further include triacetin and/or polysorbate. IV. Determination of the Scope and Content of the Prior Art (MPEP §2141.01) Kamaguchi et al. disclose a non-gelatinous capsule comprising i) a film comprising e.g. less than 25 wt%, or about 15%, maltodextrin, and a plasticizer, such as e.g. glycerol; and ii) a content (i.e. fill material) containing e.g. MCT (i.e. an “active agent”); wherein the capsule can be in the form of a softgel capsule; and wherein the softgel capsule can be employed as a pharmaceutical and can achieve excellent disintegration properties in vivo (abstract; paragraphs 0001, 0010-0016, 0023, 0029, 0038, 0042-0044, 0048, 0052; Table 1). Fujii et al. disclose e.g. a softgel capsule comprising i) a film comprising a non-gelatin polymer, and a plasticizer including e.g. sorbitol and glycerol triacetate (i.e. triacetin); and ii) a filler material comprising an oil (abstract; paragraphs 0007, 0010, 0011, 0017, 0024). Sukuru et al. disclose a softgel capsule comprising i) a film comprising e.g. non-gelatin materials, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”; wherein the plasticizer can further include e.g. glycerol, and wherein the softgel capsule is intended to provide immediate-release IV. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02) Kamaguchi et al. do not explicitly disclose that the plasticizer further includes sorbitan and triacetin. These deficiencies are cured by the teachings of Fujii et al. and Sukuru et al. IV. Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Kamaguchi et al., Fujii et al., and Sukuru et al., outlined supra, to devise Applicant’s presently claimed softgel capsule. Kamaguchi et al. disclose a non-gelatinous capsule comprising i) a film comprising e.g. less than 25 wt%, or about 15%, maltodextrin, and a plasticizer, such as e.g. glycerol; and ii) a content (i.e. fill material) containing e.g. MCT (i.e. an “active agent”); wherein the softgel capsule can be employed as a pharmaceutical and can achieve excellent disintegration properties in vivo. Since Kamaguchi et al. disclose that their non-gelatinous capsule can be in the form of a softgel capsule, one of ordinary skill in the art would thus be motivated to employ a softgel capsule, with the reasonable expectation that the resulting softgel capsule can be successfully employed as a pharmaceutical and can achieve excellent disintegration properties in vivo. Moreover, since Fujii et al. disclose that a film for a softgel capsule comprising a non-gelatin polymer, and a plasticizer including e.g. sorbitol and glycerol triacetate (i.e. triacetin) has excellent stability and disintegration ability; and since Sukuru et al. disclose that softgel capsule films containing sorbitol as a plasticizer do not become brittle over time, but that sorbitol is susceptible to blooming as sorbitol forms white precipitates, and that the combination of sorbitol and sorbitan removes this susceptibility to blooming, one of ordinary skill in the art would thus be motivated to employ the combination of sorbitol with triacetin and sorbitan as the plasticizer, with the reasonable expectation that the resulting softgel capsule film will exhibit excellent stability, will not become brittle over time, will not be susceptible to blooming, and will exhibit excellent disintegration ability. Since one of ordinary skill in the art, in view of the cited prior art, would thus arrive at a rapidly disintegrating softgel capsule with the same constituents in the same amounts as the claimed softgel capsule, this softgel capsule would reasonably be expected to have the same properties as the claimed softgel capsule as well, including the film dissolving in less than 20 minutes if the film were to be subjected to the USP Apparatus II test with paddles at 75 RPM in 900 ml of 0.1N HCl and deionized water at “37 degrees” . See also Fang et al., WO 2021/072092, published 4/15/2021. In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary. Response to Arguments Applicant’s arguments filed June 3, 2026 have been fully considered but they are not found persuasive: i) Applicant contends that the Office “misapplies the teachings of Sukuru”; that “Sukuru is directed to improving glycerin based shells that include sorbitol” as “can be seen in [0005] and [0006]”; that “the problem addressed in Sukuru relates to sorbitol blooming in shells that include glycerin” and thus “one of skill in the art looking to Sukuru would have no reason to remove glycerin”; that “even if one of skill in the art would be motivated to make the claimed combination, there would be no reasonable expectation of success that such formulation would achieve the claimed dissolution performance”; that “Sukuru does not teach maltodextrin at all” and “the interaction between a plasticizer consisting of sorbitol and sorbitan and maltodextrin is unpredictable from Sukuru’s teachings with a carrageenan and modified starch”; and that “similar reasons as discussed…can be applied in relation to the rejection of Kamaguchi in view of Sukuru”. The Examiner, however, would like to point out the following: 1. In stark contrast to Applicant’s assertion, the Office is not misapplying the teachings of Sukuru at all. Indeed, none of the cited references; i.e. not Chen, not Kamaguchi, and not Sukuru; requires glycerin at all. While Applicant refers to paragraphs [0005] and [0006], it is noted that these paragraphs are found in the background section of Sukuru and discuss the problems with employing glycerin as a plasticizer, either alone or in combination with sorbitol. In contrast to Applicant’s assertion, Sukuru’s solution to this is not to keep employing the combination of glycerin and sorbitol, but rather to employ the combination of sorbitol and sorbitan as the plasticizer. No glycerin is required. 2. As early as the abstract, Sukuru makes it clear that their invention relates to a non-blooming plasticizer composition, and that this composition is a mixture of sorbitol and sorbitan. Sukuru never mentions glycerin at all anywhere in the abstract. The abstract goes on to further teach that this non-blooming plasticizer, i.e. the combination of sorbitol and sorbitan, can be mixed, alone or in combination with other shell additives, with gelatin or non-gelatin materials to prepare soft capsules. Again, no mention at all of glycerin. Only Applicant is attempting to insert glycerin here as some sort of required ingredient. But this is contrary to the express teachings of Sukuru. 3. As just mentioned, the abstract specifically discloses the production of soft capsules by simply combining e.g. non-gelatin materials with the combination of sorbitol and sorbitan. No other elements are required. Clearly, glycerin is not required at all. Multiple examples in Sukuru disclose a capsule shell comprising gelatin or non-gelatin polymers with the combination of sorbitol and sorbitan, and no glycerin at all. Example 15 discloses a capsule shell comprising e.g. modified starch, sorbitol, and sorbitan, with no glycerin at all. 4. Maltodextrin is a type of modified starch. Without question, if Sukuru discloses that the combination of sorbitol and sorbitan works with modified starch, one of ordinary skill in the art would certainly expect it would successfully work with maltodextrin. More broadly, Sukuru expressly teaches that their plasticizer, i.e. the mixture of sorbitol and sorbitan, works with non-gelatin materials just fine. 5. One of ordinary skill in the art, in view of the cited prior art, would arrive at the claimed composition. Since the composition is the same, the properties must be the same as well. Applicant has not provided any evidence to the contrary. Again, Sukuru alone discloses, e.g. in the abstract, that their plasticizer, i.e. the mixture of sorbitol and sorbitan, can be employed alone (i.e. no requirement for glycerin) in a capsule shell with e.g. non-gelatin materials, and further with e.g. an oil-based fill. Moreover, Sukuru discloses that the softgel capsule is intended to provide immediate-release. Even if Sukuru also discloses that the capsule could be modified further to include elements that make the capsule exhibit e.g. delayed release or enteric release, such a disclosure does not detract from the fact that one could arrive at an immediate release dosage form. For the foregoing reasons, the 35 USC 103 rejection is hereby maintained. Conclusion No claims are allowed. Inquiries Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST. 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, Sue Liu can be reached at 571-272-5539. 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. /DAVID BROWE/Primary Examiner, Art Unit 1617
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Prosecution Timeline

Show 5 earlier events
Sep 30, 2025
Request for Continued Examination
Oct 07, 2025
Response after Non-Final Action
Nov 05, 2025
Non-Final Rejection mailed — §103, §112
Feb 05, 2026
Response Filed
Mar 03, 2026
Final Rejection mailed — §103, §112
Jun 03, 2026
Request for Continued Examination
Jun 08, 2026
Response after Non-Final Action
Jul 15, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
26%
Grant Probability
54%
With Interview (+27.7%)
3y 11m (~2y 1m remaining)
Median Time to Grant
High
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