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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 26 Dec 2025 has been entered.
Claims 1, 2, 4-9, 12-16, 22, 26, 27, 30, 37, and 43 remain pending in the application.
Claims 1, 15, 30, and 37 are amended.
Claims 3, 10, 11, 17-21, 23-25, 28, 29, 31-36, 38-42 and 44-46 are cancelled.
Claims 16, 22, 26, 27 and 43 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 2, 4-9, 12-15, 30 and 37 are under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 30 Oct 2025 and 06 Feb 2026 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 26 Sep 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Maintained – in modified form
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.
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.
The art in the rejection below was previously applied and is applied again in modified form to address the claim amendments.
Claims 1, 2, 5-7, 9, 12-15, 30 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 2018/0271817, published 27 Sep 2018) in view of Baes (US 2015/0004226, published 01 Jan 2015) as evidenced by PubChem (glycerol).
Hu teaches enteric soft capsules comprising gelatin and matrix fills ([0002]). Hu teaches different gelatin types such as Type A and Type B ([0077], Table 1) rendering obvious instant claim 9. Hu teaches that the soft capsule shell may comprise an anionic polysaccharide such as pectin ([0016]). As Hu does not specify that the pectin should be amidated, it would be obvious to select pectin without the additional step of amidation, thereby rendering the non-amidated pectin of claim 5 obvious. Hu teaches the enteric soft capsule shell can comprise one or more plasticizers such as glycerol, sorbitol and dextrose ([0073],[0076]), rendering it obvious to include these components in the composition. As evidenced by PubChem, glycerol is also known as glycerin (page 1), the term used in the instant claims. Hu teaches the inclusion of one or more film forming polymers in the shell ([0074]), rendering obvious the film former of claim 30. Hu teaches that the matrix fill comprises an active ingredient ([0018], [0021]). Thus, Hu teaches the same components of gelatin, pectin, dextrose, glycerin, sorbitol, a film former and an active in the fill material as in the instant claims.
Hu teaches that the enteric soft capsule shell composition may comprise gelatin from 25-50% and pectin from 2-7% ([0078] Table 1 and [0113] Table 4), rendering obvious the percentage of gelatin and pectin in instant claims 6 and 7. The percentage of gelatin to pectin taught by Hu indicates a ratio of gelatin to pectin of 3.6:1 to 25:1 (i.e. 25:7 to 50:2), rendering obvious claim 14. Hu teaches that the plasticizer (e.g. glycerol or sorbitol) may be from 8-30% ([0078] Table 1) rendering obvious the amount of glycerin (glycerol) and sorbitol in instant claims 1-3 and 30. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Hu teaches the inclusion of gelling agents ([0071], [0077]) at about 0.05% ([0088]). Hu teaches that the enteric soft capsule shell is stable at pH 1.2 for at least 2 hours and dissolves at pH 6.8 within 30 minutes ([0018]), and thus functional parameters of the dissolution and disintegration USP testing of the capsule shell as in claims 12 and 13 are obvious.
Hu does not explicitly teach the ratio of glycerin:sorbitol as in instant claims 1, 15 and 30 or gellan gum as in claim 37. These deficiencies are made up for in the teachings of Baes
Baes teaches gelatin/alginate delayed release capsules ([0001]) where the capsule is resistant to gastric fluid to a degree that is controllable and capable of delivering the active ingredient in the stomach or in the intestine by regulating the dissolution of the shell according to a set pH ([0025]). Baes teaches that the capsule shell comprises at least one plasticizer such as glycerol and sorbitol ([0060]). Baes teaches embodiments where the glycerol and sorbitol are present at a ratio ranging from 0.5 to 2.5 such as from 1 to 2.5 ([0063]) as well as glycerol and sorbitol in combination with maltitol at a ratio of about 1:3:1 ([0065]). Baes teaches that enteric capsules comprising films are known to have gelling agents such as gellan gum ([0009]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed a delayed release soft capsule comprising a fill with active ingredient and a shell with 25-50% glycerol, gelatin, pectin, dextrose, sorbitol, film forming polymer and about 0.05% gellan gum where the glycerol (glycerin) to sorbitol is at a ratio from about 0.5 to 2.5 such as 1 to 2.5 or the ratio is about 1:3. Delayed released capsules with gelatin, pectin, dextrose, glycerin and sorbitol are known from Hu. Similar delayed release capsules comprising gelatin and a ratio of glycerin to sorbitol from about 0.5 to 2.5 such as 1 to 2.5 and alternatively glycerol and sorbitol in combination with maltitol at a ratio of about 1:3:1 are likewise known from Baes. One would thus have a reasonable expectation of success in having the glycerol and sorbitol of Hu at a ratio such as 1 to 2.5 as this is a known range suitable for including such components in a delayed release capsules. The ratio of 1:2.5 does not overlap with the lower limit of 1:3 as claimed, however, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. In the instant case, 1:2.5 and 1:3 glycerin:sorbitol are close and expected to have the same plasticizer properties. Alternatively, a combination of glycerol:sorbitol:maltitol at 1:3:1 is obvious, based on the teachings of Baes as described above, thereby overlapping the claimed glycerin:sorbitol of 1:3 and rendering the ratio as obvious. The examiner notes that the claims are open to additional components such as maltitol due to the open ended comprising language. Regarding the gellan gum as in claim 37, the inclusion of gelling agents at about 0.05% are known from Hu and gellan gum is a known gelling agent from the teachings of Baes, and thus the inclusion of gellan gum is simply using a known prior art element for its intended purpose. Having the gellan gum at about 0.05% does not overlap with the range of 0.1-2% as in claim 37, however, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. In the instant case, the art allows for amounts greater than 0.05% by teaching “about” 0.05% and the about 0.05% and 0.1 wt% of the claims are expected to have the same gelling properties. Regarding the limitation of claim 37 that the capsule begins to dissolve after about 60 minutes when in a medium having a pH of 4, this limitation is understood to be present in the compositions rendered obvious from the teachings of Hu and Baes and the specific pH dependence of the capsule as taught by Hu. Capsule pH dependence, where the capsule is resistant to dissolution at low pH (e.g. does not dissolve at pH 1.2 for at least 2 hours) and readily dissolves at higher pH (e.g. dissolves within 30 minutes at pH 6.8) is known from Hu. Thus, the resistance to dissolution is expected to decrease as the pH increases. As the same composition of the instant claims is obvious from the art, and the pH dependence of the capsule is known, it is thus understood that the property that the capsule “begins to dissolve after about 60 minutes when in a medium having a pH of 4” is understood as present, rendering the claim overall as obvious.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 26 Dec 2025 have been fully considered but they are not persuasive. Applicant argues that the claimed range of glycerin:sorbitol now amened to 1:3 to 1:7 requires sorbitol in significantly greater amounts than glycerin and this is outside the range of 1:2.5 taught by Baes (page 8 of remarks). The examiner does not find this persuasive and acknowledges that 1:2.5 is outside the claimed range of 1:3 to1:7 but the values are close enough to 1:3 that one would expect the ratios to have the same properties. Adjusting the ratio from 1:2.5 to 1:3 is a small incremental adjustment that would be obvious to one of ordinary skill as expecting to have the same properties. The applicant asserts that ratios outside those described in the specification experience premature release of the softgel capsule and fail the two stage disintegration test (page 8 of remarks), but this is not persuasive as the ratios of the specification extend to a lower limit of 1:1.5 ([0062]), thereby actually providing evidence that the 1:2.5 value would be expected to have the same properties as the claimed 1:3. Additionally, the examiner notes that the ratio of 1:3 glycerin to sorbitol is actually taught by Baes in an embodiment with 1:3:1 glycerol:sorbitol:maltitol. The addition of maltitol is allowed for in the claims and the ratio of 1:3 glycerol:sorbitol renders obvious the claimed range. The applicant asserts that the criticality of the claimed range is demonstrated in example 1 of the specification where a ratio of glycerin to sorbitol ranging between 1:2 to 1:5 had the desired release characteristics compared with comparative examples outside this range (pages 8-9 of remarks). This is not persuasive as the range cited by the applicant (1:2 to 1:5) extends into the range rendered obvious by the prior art. Additionally, the data presented in specification is not sufficient to overcome the prima facie case of obviousness as the data is not commensurate in scope with the claims (e.g. [0192] states the tested ratio is 1:2 to 1:5 whereas the claimed range is 1:3 to 1:7). Additionally, the data presented is not clear as to what is being tested. Table 1 presents ranges for different components but the actual amounts used in a formulations are not identified in the experimental tested lots (tables 2-5) or the comparative formulation (table 6) and it is difficult to draw any real conclusion from the data as presented.
The applicant argues that there is no motivation in the art to achieve the specific ratios of the claims as Hu does not provide guidance on combining the glycerol and sorbitol and Baes teaches ratios where glycerol dominates or at most has glycerol to sorbitol at 1:2.5 (page 9 of remarks). The is not persuasive as similar delayed release capsules with the same components of glycerol and sorbitol are known from Hu and Baes, providing one of ordinary skill a reasonable expectation that the ratios taught by Baes would be successful in the compositions of Hu. Even though Baes teaches ratio ranges that include glycerol in a greater amount than sorbitol, which is different from the claimed range, this does not take away from the ratios taught by Baes that render obvious the instant ratios, as described above.
Regarding the amount of gellan gum in claim 37, the applicant argues that the claimed amount of 0.1% is double the about 0.05% amount taught by Hu and thus there is not an expectation that the shell would have the same dissolution properties (page 9 of remarks) The examiner does not find this persuasive. Even though the claimed amount is about double the amount taught by Hu (0.1% vs 0.05%) this is only a change of 0.05% which is a small percentage relative to the composition as a whole and would be expected to have the same properties in this range. Nothing has been pointed to in the specification to indicate the criticality of this range and paragraph [0057] of the specification actually indicates that suitable amounts of gellan gum extend down to 0.05 wt%, providing support that percentages less than 1% would have the same properties.
For these reasons the examiner is not persuaded by the applicant’s arguments and finds the claims obvious over the cited references.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 2018/0271817, published 27 Sep 2018) in view of Baes (US 2015/0004226, published 01 Jan 2015) as evidenced by PubChem (glycerol) as applied to claims 1, 2, 5-7, 9, 12-15, 30 and 37 above and further in view of Okayama et al. (WO 2019/178444, published 19 Sep 2019, listed on IDS filed 01 Nov 2024).
The teachings of Hu and Baes are described supra.
Hu and Baes do not teach low methoxyl pectin. This deficiency is made up for in the teachings of Okayama.
Okayama teaches enteric softgel capsules comprising a fill material and enteric gelatin based shell composition (abstract, [0001]). Okayama teaches the inclusion of low methoxy pectin in the shell composition ([0008]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used low methoxy pectin in the shell of the capsule composition rendered obvious over Hu and Baes. Gelatin based enteric softgel capsules comprising low methoxy pectin are known from Okayama. Thus one of ordinary skill would have a reasonable expectation of success in using low methoxy pectin in the shell composition as it is known as suitable for similar enteric softgel capsules. The use of low methoxy pectin thus represents the use of a known prior art element for its known purpose in forming shells for enteric softgel capsules.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 2018/0271817, published 27 Sep 2018) in view of Baes (US 2015/0004226, published 01 Jan 2015) as evidenced by PubChem (glycerol) as applied to claims 1, 2, 5-7, 9, 12-15, 30 and 37 above and further in view of Tanner et al. (US 6,340,473, 22 Jan 2002, listed on IDS filed 10 May 2023).
Tanner teaches soft capsules and various film formulations (col 5 lines 20-40). Tanner teaches various percentages of dextrose in the film formulations such as 2.71% in the dry film (col 14 line 51).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included the dextrose at around 2.71% in the soft capsule formulation rendered obvious over Hu and Baes. The inclusion of dextrose in the capsule is known from the teachings of Hu and including dextrose at around 2.71% in soft capsules is known from Tanner. Thus, it would have been obvious to include dextrose at around 2.71%, with a reasonable expectation of success, as this is a known suitable concentration for dextrose in soft capsules.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 37 is rejected above as obvious over the teachings of Hu in view of Baes. The claim is alternatively rejected below.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Fang. (US 2013/0280323, published 24 Oct 2013).
Fang teaches a soft capsule that is acid resistant and comprises a fill comprising a first active ingredient ([0003]). Fang teaches that the acid resistant feature refers to the enteric property of the capsule ([0020]). Fang teaches that the capsule is resistant to dissolution in stomach acid for at least 30 minutes, at least 40 minutes, at least 45 minutes, at least 50 minutes, at least 55 minutes, at least 1 hour, or at least 2 hours ([0020]). The resistance to stomach acid and the variability in time of resistance as described above is understood to render obvious the “begins to dissolve after about 60 minutes when in a medium having a pH of 4.” Fang teaches that the capsule shell may include viscosity modifiers such as gellan gum in an amount greater than 0% and less than 10% by weight ([0028]), rendering obvious the amount of gellan gum in the instant claim.
Fang does not expressly teach the soft capsule with the active ingredient, gellan gum and specific dissolution parameter with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed a soft capsule with 0-10% gellan gum where the capsule is resistant to dissolution in stomach acid for at least 30 minutes, at least 40 minutes, at least 45 minutes, at least 50 minutes, at least 55 minutes, at least 1 hour, or at least 2 hours. One of ordinary skill in the art would have been motivated to do so as each of these components and features are taught by Fang as suitable in soft capsules. One of ordinary skill in the art would have a reasonable expectation of successfully forming a capsule as described above since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Fang.
Response to Arguments
Applicant's arguments filed 26 Dec 2025 have been fully considered but they are not persuasive. Applicant argues that Fang does not teach glycerol and sorbitol in a combination of 1:3 to 1:7 as recited in claim 37 (pages 9-10 of remarks). The examiner does not find this persuasive as claim 37 does not require glycerol or sorbitol to be present in any amount or ratio.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9, 12-15, 30 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-14, 16, 18 and 22 of copending Application No. 17/596,059, over claims 1-9, 12-16 and 22 of copending Application No. 17/772,698, over claims 1-7, 12, 22-27 and 48 of copending Application No. 17/928,955, over claims 1, 2, 4-8, 12, 14-16, 68, 70 and 75 of copending Application No. 18/036,209, over claims 1-3, 5-7, 9-14, 24, 25, 32-35 and 66 of copending Application No. 18/208,635, over claims 1-3, 6-9, 12, 13, 15, 18, 19, 24, 30 and 39-42 of copending Application No. 18/575,474, over claims 1-11, 13-16, 19, 20, 22 of copending Application No. 18/819,147, over claims 1-18 and 20-26 of copending Application No. 18/819,242, over claims 1-5, 8, 10-13, 15, 18, 24-26, 29, 30, 32-35, 44, 50, 56, 65 and 66 of copending Application No. 18/819,296, over claims 1-7, 14, 17, 18, 20, 23, 29, 35 and 46 of copending Application No. 18/838,825, over claims 22-26, 30, 31, 34-42 and 44-47 of copending Application No. 19/300,899, in view of Hu et al. (US 2018/0271817, published 27 Sep 2018) in view of Baes (US 2015/0004226, published 01 Jan 2015) as evidenced by PubChem (glycerol) as applied to claims 1-3, 5-7, 9, 12-15, 30 and 37 above and further in view of Okayama et al. (WO 2019/178444, published 19 Sep 2019).
The claims of application ‘059 are directed to a delayed release softgel capsule comprising a fill material comprising at least one pharmaceutically active ingredient and a pH dependent shell composition where the shell comprises gelatin (Type A or Type B), pectin (low methoxyl pectin, amidated or non-amidated) and 0.01-0.4 wt% dextrose and dissolves in the duodenal area or the intestines. The application recites that the capsule dissolves/disintegrates in less than 60 minutes at pH 6.8. The delayed release and the dissolving in the duodenal area or intestines and at pH 6.8 is understood to render obvious the dissolution parameters of the instant claims requiring delayed release in acidic environments. The application recites 40-80% gelatin, and 2-20% pectin. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 2:1 to 40:1. The application recites about 20-35% plasticizer such as a combination of glycerin and sorbitol. The application does not recite the specific glycerin to sorbitol ratio of the instant claims or a film former or gellan gum.
The claims of application ‘698 are directed to a delayed release softgel capsule comprising a fill material comprising at least one pharmaceutically active ingredient and a shell composition where the shell comprises gelatin, pectin and gellan gum where the shell does not rupture at pH of 4 at 15, 30, 45, or 60 minutes. The delayed release and the dissolution parameter at pH 4 is understood to render obvious the dissolution parameters of the instant claims requiring delayed release in acidic environments. The application recites 40-80% gelatin, 0.1-10 wt% gellan gum, 0.1 to 10 wt% pectin, 0.01 to 2 wt% dextrose and 15-40% plasticizer. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 1:100 to 100:1. The application does not recite the specific glycerin to sorbitol ratio of the instant claims or a film former or the specific types of glycerin and pectin.
The claims of application ‘955 are directed to a delayed release softgel capsule comprising a fill material comprising at least one pharmaceutically active ingredient and a shell composition where the shell comprises 40-80% gelatin, 2-20pectin (low methoxyl pectin) and 0.01-4% dextrose and dissolves in the colon environment and has a gelatin to pectin ratio of 2:1 to 20:1. The application recites dissolving in at least 10 mintes at pH 6.8. The application recites plasticizer such as combinations of glycerin and sorbitol. The application does not recite the specific glycerin to sorbitol ratio of the instant claims or a film former or gellan gum or the specific type of glycerin or non-amidated pectin.
The claims of application ‘209 are directed to a delayed release softgel capsule comprising a fill material comprising at least one pharmaceutically active ingredient and a shell composition where the shell comprises 40-80% gelatin, 2-20% pectin (low methoxyl pectin) and 0.1-4% dextrose where the shell does not dissolve for at least about 15 minutes at acid stage and dissolve with about 60 minutes at pH 6.5 . The application recites plasticizer such as a combination of glycerin and sorbitol and a film former. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 2:1 to 40:1. The application does not recite the specific glycerin or non-amidated pectin to sorbitol ratio of the instant claims or gellan gum.
The claims of application ‘635 are directed to a delayed release softgel capsule comprising a fill material comprising bisadoyl and a shell composition where the shell comprises a film forming material such as gellan gum, 0.01-4% dextrose, 30-80% gelatin, 2-20% pectin, 2-40% plasticizer. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 1.5:1 to 40:1. The application does not recite the specific glycerin to sorbitol ratio of the instant claims, the amount of gellan gum, the dissolution parameters or the specific type of glycerin and pectin.
The claims of application ‘474 are directed to a softgel capsule comprising a fill material and a shell composition where the shell comprising a film forming polymer and a plasticizer such as a combination of glycerin and sorbitol 35-70% gelatin. The application does not recite the specific glycerin to sorbitol ratio of the instant claims, dextrose, gellan gum or the specific type of glycerin or non-amidated pectin or the dissolution parameters.
The claims of application ‘147 are directed to a delayed release softgel capsule comprising a fill material comprising at least one active ingredient and a shell composition where the shell comprises 40-80% gelatin (Type A or Type B), 0.1-10% pectin (low methoxyl pectin, amidated or non-amidated), 0.1-10% gellan gum and 0.01-2% dextrose, 15-40% plasticizer such as a combination of glycerol and sorbitol and does not rupture at 15 minutes in acidic media. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 1:4 to 800:1. The application does not recite the specific glycerin to sorbitol ratio of the instant claims or a film former or the specific dissolution requirements.
The claims of application ‘242 are directed to a delayed release softgel capsule comprising a fill material comprising an active ingredient and a shell composition where the shell comprises 15-60% gelatin (Type A or Type B), 2.5-20% pectin (low methoxy pectin), 2-10% plasticizer such as a combination of glycerin and sorbitol, gellan gum, and 0.001-5% dextrose where the shell does not rupture at pH 1.2 at 15 minutes. A delayed release capsule that does not rupture at pH 1.2 is understood to render obvious the instant dissolution parameters. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 1:1.3 to 24:1. The application does not recite the specific glycerin to sorbitol ratio of the instant claims or a film former or the amount of gellan gum.
The claims of application ‘296 are directed to a softgel capsule comprising a fill material comprising bisacodyl and a shell composition where the shell comprises a film forming material, a plasticizer of sorbitol and sorbitan, 30-80% gelatin (Type A or Type B), 2-20% pectin and 0.01-4% dextrose. The application recites staying intact for at least 15 minutes at pH 1.2 and disintegrating in 60 minutes or less at pH 6.8. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 1:1.5 to 40:1. The application does not recite the specific glycerin to sorbitol ratio of the instant claims or a film former or gellan gum or the specific type of pectin.
The claims of application ‘825 are directed to a softgel capsule comprising a fill material comprising valproic acid and a shell composition where the shell comprises 25-55% gelatin, plasticizer such as a combination of glycerin and sorbitol, 3-22% pectin (amidated/non-amidated) and 0.01-10% dextrose. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 1:0.88 to 18.3:1. The application does not recite the specific glycerin to sorbitol ratio of the instant claims or a film former or gellan gum or the specific type of glycerin or low methoxyl pectin or the dissolution parameters.
The claims of application ‘899 are directed to a softgel capsule comprising a fill material comprising an active agent and a shell composition where the shell comprises 15-60% gelatin, 1-25% pectin (low methoxy pectin), 5-60% plasticizer, 0.001-5% gellan gum and 0.001-5% dextrose. The amount of gelatin and pectin results in a gelatin to pectin ratio ranging from 1:1.6 to 60:1. The application does not recite the specific glycerin to sorbitol ratio of the instant claims or a film former or the specific type of glycerin or non-amidated pectin or the dissolution parameters.
The deficiencies between the applications outlined above and the instant claims are made up for in the teachings of Hu, Baes and Okayama.
Soft capsules that comprise an active ingredient and have delayed release under acidic conditions and release contents under more basic conditions and that comprise components such as gelatin, pectin, dextrose, glycerol (glycerin) and sorbitol are known from Hu. The applications detailed above recite capsules with similar ingredients such as gelatin and pectin. The inclusion of gellan gum at 0.5% and a ratio of glycerin to sorbitol from about 0.5 to 2.5 such as 1 to 2.5 in delayed release capsules are also known from Baes. Gellan gum at about 0.5% is understood as close to about 1% and providing the same properties as 1% gellan gum. The use of the specific Type A and Type B gelatin is known from Hu and the low methoxy pectin is known from Okayama, who also teaches enteric gelatin based shell compositions. The specific parameters of the dissolution regarding the resistance to dissolution at low pH and quicker dissolution at high pH are known form Hu, rendering these parameters as obvious to one of ordinary skill. Thus, each of the limitations absent from the reference applications are known in the prior art and are taught as suitable for delayed release capsules and thus one would have a reasonable expectation of success in incorporating the components listed above into the capsules of the reference applications as they are known prior art elements and parameters that are used according to their taught function.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 26 Dec 2025 have been fully considered but they are not persuasive. Applicant requests that the double patenting rejections be held in abeyance. The examiner notes that a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02).
Conclusion
No claims are allowed.
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.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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