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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 Jul 2026 has been entered.
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 09 Jul 2026 has been entered.
Claims 1, 2, 4-9, 12-16, 22, 26, 27, 30, 37, and 43 remain pending in the application.
Claims 1, 8, 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Claims 16, 22, 26, 27 and 43 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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 statement (IDS) submitted on 15 Jul 2026 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 103
The rejections under 35 U.S.C. 103 are withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
Rejections Pursuant to Double Patenting
The rejections under double patenting is withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
New Grounds of Rejections
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.
Claims 1, 2, 5-9, 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), Tanner et al. (US 5,569,466, published 29 Oct 1996) and Hassan (US 2012/0301546, published 29 Nov 2012).
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 1-2 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 the dextrose from about 0.001-1% (claims 1, 30 and 37) or from0.02-0.2% (claim 8), or gellan gum as in claim 37. These deficiencies are made up for in the teachings of Baes, Tanner and Hassan.
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]).
Tanner teaches fill compositions for soft elastic gel capsules (title) and teaches dextrose is a reducing sugar (col 2 line 13).
Hassan teaches a delivery device of nutraceuticals and or pharmaceuticals such as a soft gel capsule comprising a gelatin-based water soluble film forming polymer, an acid insoluble polymer, at least one reducing sugar and water ([0002]) and Hassan teaches that the reducing sugar is at about 0.5 to 20% w/w ([0016]). Hassan includes pectin as possible acid insoluble polymers ([0043]). Hassan teaches that reducing sugars provide unexpected advantages to gelatin films containing acid insoluble polymers both in terms of elasticity and mechanical strength ([0034]). Hassan teaches that reducing sugars have exceptional plasticizing effect but do not render the gel mass un-sealable or rubbery ([0093]).
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, 0.5-20% 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. It is further known from Tanner that dextrose is a reducing sugar and it is known from Hassan that reducing sugars have exceptional plasticizing effect but do not render the gel mass un-sealable or rubbery and are present from about 0.5-20% w/w in soft gel capsules, rendering it obvious to have the dextrose from 0.5-20% as it was known to one of ordinary skill that dextrose is a reducing sugar and 0.5-20% is a suitable range for reducing sugars in soft gel capsules, providing a reasonable expectation of success in incorporating the dextrose at this amount. The gellan gum at about 0.05% does not overlap with the range of 0.1-2% as in claim 37 and the dextrose at 0.5% does not overlap with 0.2 wt% of claim 8, 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% gellan gum 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. Similarly, absent evidence to the contrary, 0.5% dextrose is expected to have the same property of 0.2% dextrose as in claim 8. 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, Baes, Tanner and Hassan 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 09 Jul 2026 have been fully considered but they are not persuasive. Applicant argues that the cited references do not teach the range of 0.001-1 wt% and argues that this range is beneficial in that the dextrose is in an effective amount to improve the gel strength but not so high that it would interfere with the seal or manufacturability. Applicant argues that the art does not recognize the amount of dextrose as a result effective parameter for improving gel strength. The examiner does not find this persuasive and notes that the newly applied art of Tanner and Hassan render it obvious that dextrose is a reducing sugar and that reducing sugars are present from about 0.5-20% in soft gel capsules. It is further known from Hassan that reducing sugars have exceptional plasticizing effect without rendering the gel mass un-sealable or rubbery.
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), Tanner et al. (US 5,569,466, published 29 Oct 1996) and Hassan (US 2012/0301546, published 29 Nov 2012) as applied to claims 1, 2, 5-9, 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, Baes, Tanner and Hassan are described supra.
Hu, Baes, Tanner and Hassan 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, Baes, Tanner and Hassan. 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.
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, 2, 4-9, 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, 2, 5-8, 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 1-7, 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), Baes (US 2015/0004226, published 01 Jan 2015) as evidenced by PubChem (glycerol), and 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 0.05-0.15 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 ‘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 0.01-4% 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 ‘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.
Claims 1, 2, 4-9, 12-15, 30 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-9, 12, 13, 15, 18, 19, 24, 30 and 39-42 of copending Application No. 18/575,474, in view of Hu et al. (US 2018/0271817, published 27 Sep 2018), Baes (US 2015/0004226, published 01 Jan 2015) as evidenced by PubChem (glycerol), Tanner et al. (US 5,569,466, published 29 Oct 1996), Hassan (US 2012/0301546, published 29 Nov 2012) and Okayama et al. (WO 2019/178444, published 19 Sep 2019).
The claims of application ‘474 are directed to a softgel capsule comprising a fill composition and a shell composition where the shell comprises a film forming polymer and a plasticizer such as a combination of glycerin and sorbitol and the capsule has 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 deficiencies between the application outlined above and the instant claims are made up for in the teachings of Hu, Baes, Tanner, Hassan 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 application 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. Dextrose is known as a reducing sugar and it is known that 0.5-20% is a suitable range for reducing sugars in softgel capsules, thus rendering it obvious to include dextrose at 0.5-20%. The 0.5% dextrose is understood to be close enough to the claimed 0.2% dextrose to be expected to have the same properties. 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.
Claims 1, 2, 4-9, 12-15, 30 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,628,854; claims 1-13 of U.S. Patent No.12,697,305; claims 1-16 of U.S. Patent No. 12,635,719; claims 1-21 of U.S. Patent No. 12,661,326; claims 1-22 of U.S. Patent No. 12,702,647 in view of Hu et al. (US 2018/0271817, published 27 Sep 2018), Baes (US 2015/0004226, published 01 Jan 2015) as evidenced by PubChem (glycerol), and Okayama et al. (WO 2019/178444, published 19 Sep 2019).
The claims of patent ‘854 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, 0.1-5 wt% gellan gum, 2 to 10 wt% pectin, 0.01 to 2 wt% dextrose. 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 patent ‘305 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 0.01-4% 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 minutes 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 patent ‘719 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 patent ‘326 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 patent ‘647 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 deficiencies between the patents 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 09 Jul 2026 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 claim is allowed.
Correspondence
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
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