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
Applicant’s Request for Reconsideration dated June 24, 2026 is acknowledged.
Claims 1-6, 8-14, 16, 18, 22, 28, 29, 36 and 42 are pending.
Claims 7, 15, 17, 19-21, 23-27*, 30-35, 37 and 43-50 are cancelled.
Claim 1 is currently amended.
Claims 28, 29, 36 and 42 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1-6, 8-14, 16, 18 and 22 as filed on June 24, 2026 are under consideration.
This action is made FINAL.
Withdrawn Objections / Rejections
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8-14, 16, 18 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 as currently amended recites wherein the pH dependent shell composition does not include a synthetic acid insoluble polymer. Applicant’s Remarks do not identify support for the amendment. With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4, 83 USPQ2d 1373, 1376, n.4 (Fed. Cir. 2007). See MPEP 2163. There is no disclosure of a synthetic acid insoluble polymer as newly excluded from the shell. Claims 2-6, 8-14, 16, 18 and 22 are included in this rejection because they depend from claim 1 and thus they also recite new matter.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites amidated pectin, however, claim 1 as currently amended excludes synthetic acid insoluble polymers. Because amidated pectin is synthetic, the embodiment of amidated pectin of claim 4 omits / contradicts the exclusion of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained Grounds of Rejection / New Grounds of Rejection Necessitated by Amendment
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 4-6, 8-14, 16, 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 2015/0366814, published December 24, 2015, of record) in view of Hassan et al. (US 2012/0301546, published November 29, 2012, IDS reference filed February 21, 2024) and Wu (CN 101461792 A, published June 24, 2009, as evidenced by the Google translation, of record).
Hu teaches enteric soft capsules comprising active ingredients (fill material) and a shell formed from a gel mass comprising (a) gelatin, (b) at least one anionic polymer inclusive of pectin (non-amidated, non-synthetic), (c) at least one plasticizer inclusive of dextrose or/and glycerol or/and sorbitol, and (d) water (title; abstract; claims, in particular claim 1; paragraphs [0001]-[0264], in particular [0074]-[0076]; Tables 1, 9, 10, 17-19), as required by instant claims 2, 4, 11-13. Pectin is an enteric (pH dependent) polymer (paragraph [0075]). The capsules may be controlled or delayed release (paragraphs [0052]-[0053]). Enteric dosage forms do not dissolve or disintegrate in gastric acidity for a specified amount of time, usually two hours in 0.1 N hydrochloric acid (HCl), and must release their contents in the intestine in order to fulfill definition requirements for enteric preparations (paragraph [0006]). The enteric soft capsules readily dissolve in the intestinal environment (pH ca. 6.8) (paragraph [0072]) and Hu exemplifies an embodiment of 100% dissolution at 30 minutes (Figure 3), as required by instant claim 22.
The gelatin comprises type A gelatin (claim 3), as required by instant claim 9. The type A gelatin comprises bone, pig skin (hide) or fish (claim 4), as required by instant claim 10.
Hu further teaches (paragraph [0078], Table 1):
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Regarding the ranges based on the dry weight recited in instant claims 5, 6, 8, 14, 16, 18, because the shell of Hu comprises 40 to 70 wt% water / solvent, Hu renders obvious aqueous compositions comprising for example 30 wt% gelatin, 5 wt% pectin and 10 wt% plasticizer or about 67 (~= 30/45) wt% gelatin, about 11 (5/45) wt% pectin and 22 (10/45) wt% plasticizer on a dry basis.
Regarding the exclusion of synthetic acid insoluble polymers recited in instant claim 1 as currently amended, while Hu exemplifies anionic polymers other than pectin (e.g., paragraph [0075]), optional inclusion of a particular component teaches compositions that both do and do not contain that component. See MPEP 2123. Furthermore, Hu exemplifies embodiments of composition wherein the at least one anionic polymer consists (only) of pectin (e.g., Table 1).
Hu does not specifically teach about 0.05 to about 0.15 wt% dextrose as required by claim 1.
This deficiency is made up for in the teachings of Hassan and Wu.
Hassan teaches acid-resistant soft gel compositions comprising a) about 15 to 55 wt% water soluble film former inclusive of gelatin, b) about 0.5 to 30 wt% acid insoluble polymer inclusive of pectin, c) about 0.5 to 20 wt% reducing sugar inclusive of glucose (dextrose) and optionally d) about 5 to 30 wt% plasticizer inclusive of glycerol or/and sorbitol (title; abstract; claims, in particular 1-7, 10, 12). Hansen exemplifies the effect of the reducing sugar fructose in concentrations ranging from 0 to 15 wt% and demonstrates fructose improves elasticity in a dose-dependent manner (Example 1, paragraphs [0074]-[0075]; Example 2, paragraph [0085]; Figure 1). Efficacy of enteric soft gelatin capsules is primarily dependent upon elasticity; in general, the non-gelatin component(s) of the shell producing the acid resistance also reduce overall elasticity (paragraphs [0010], [0012]). The reducing sugars provide unexpected advantages in terms of elasticity and mechanical strength (paragraphs [0034], [0035]).
Wu teaches gelatin enteric capsule shell materials (title; abstract; claims). The shells materials may optionally further comprise 0 to 80 parts (wt%) plasticizer selected from inter alia glycerol, sorbitol or/and glucose (dextrose) (claims 5, 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one plasticizer of the shell of the enteric soft capsules of Hu to comprise a combination of a reducing sugar inclusive of glucose (dextrose) with additional plasticizer(s) inclusive of glycerol or/and sorbitol as taught by Hassan because reducing sugars such as glucose provide unexpected advantages in terms of elasticity and mechanical strength in gelatin capsules having potentially compromised elasticity due to the presence of acid-resistant (enteric) polymers. There would be a reasonable expectation of success because Hu embraces combinations of plasticizers inclusive of dextrose, glycerol and sorbitol. It would have been obvious to include the reducing sugar / glucose (dextrose) in the shell of the capsules of Hu in amounts ranging from about 0.5 to 20 wt% as taught by Hassan (where about 0.5 is broadly and reasonably construed as overlapping about 0.15 as instantly claimed because the qualifiers about permits some tolerance) or/and in amounts of 0 to 80 parts (wt%) as taught by Wu because these amounts are known in the art as suitable the inclusion of glucose (dextrose) within the shell of acid-resistant (enteric) gelatin capsules. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Additionally, it would have been prima facie obvious to optimize the amount of the reducing sugar / glucose (dextrose) in the shell of the capsules of Hu in order to adjust elasticity as exemplified by Hassan. It is prima facie obvious to optimize such result-effective variables within prior art conditions or through routine experimentation. See MPEP 2144.05. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 2015/0366814, published December 24, 2015, of record) in view of Hassan et al. (US 2012/0301546, published November 29, 2012, IDS reference filed February 21, 2024) and Wu (CN 101461792 A, published June 24, 2009, as evidenced by the Google translation, of record) as applied to claim 1, 2, 4-6, 8-14, 16, 18 and 22 above, and further in view of Scott et al. (US 2003/0175335, published September 18, 2003, of record).
The teachings of Hu, Hassan and Wu have been described supra.
They do not teach low methoxyl pectin as required by claim 3.
This deficiency is made up for in the teachings of Scott.
Scott teaches pectin film compositions for use in predosed formulations like soft capsules (title; abstract; claims). Pectin has excellent enteric properties (paragraph [0012]). Low methoxyl pectins with a degree of esterification below 50% are especially preferred (paragraph [0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute pectins inclusive of low methoxyl pectins as taught by Scott for the pectin anionic polymer in the soft capsule shells of Hu or/and of Hu in view of Hassan and Wu because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary. One of ordinary skill in the art would have been motivated to make the substitution because Scott teaches low methoxyl pectins are suitable for use in predosed formulations like soft capsules further comprising gelatin as the second film-forming polymer (e.g., claims 1-3).
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant states at page 6 of the Remarks that there is no reason for one of skill in the art to combine Hu and Hassan to arrive at a shell that does not include a synthetic acid insoluble polymer and the claimed amount of dextrose. Applicant emphasizes the teachings of Hassan are applicable to acid-resistant (enteric) polymers, specifically cellulose acetate phthalate, citing to film 1B1 of Example 3.
This is unpersuasive because Hu, as a whole, is drawn to all-natural enteric soft capsules comprising acid insoluble enteric polymers inclusive of pectin and plasticizers inclusive of dextrose as set forth in the rejection. That the examples of Hassan employ cellulose acetate phthalate is acknowledged but not found persuasive because Hassan expressly teaches alternate insoluble polymers to include pectin (e.g., claim 10). The citation to film 1B1 of Example 3 of Hassan is inapt because example 1B1 does not comprise an enteric polymer. Example 2B1 comprising an enteric polymer “remained intact and flat after 2 hours” (e.g., paragraph [0088]). Applicant’s apparent position that pectin is not an enteric polymer is unpersuasive.
Applicant’s citation to paragraph [0046] of the specification as evidencing an interaction of dextrose with gelatin is acknowledged but not found persuasive because it is known in the art that dextrose crosslinks gelatin. See at least Digenis et al., made of record December 12, 2025.
Applicant’s rehashed allegation regarding the criticality of the claimed range of dextrose citing to the data within the specification remains unpersuasive for reasons of record. Table 2 does not in any way demonstrate unexpected results at least because the compositions of the dosages are not disclosed. The citation to the failure of the Group 5 example is unpersuasive because the instantly claimed dosages need only remain intact for 60 minutes in acidic medium. Furthermore, the Group 5 example does not “fail” at 6 months, as is expected. See at least Hakata et al., made of record December 12, 2025.
Therefore, the rejections of record over Hu are properly maintained in slightly modified form as necessitated by Applicant’s amendment.
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 1-6, 8-14, 16, 18 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable (1) over claims 1-7, 12, 22-24, 26, 27 and 48* of copending Application No. 17/928,955; (2) over claims 1-12, 15, 19, 29-31, 33, 34 and 49 of copending Application No. 18/031,669; (3) over claims 1, 2, 4-9, 12-15, 30 and 37 of copending Application No. 18/036,207; (4) over claims 1, 2, 5-8, 12, 14-16, 33, 68, 70 and 75 of copending Application No. 18/036,209; (5) over claims 1-3, 5-7, 9-14, 24, 25, 32-35 and 66 of copending Application No. 18/208,635; (6) over claims 1-5, 8, 10-13, 15, 18, 24-26, 33-35, 44, 50, 65 and 66 of copending Application No. 18/819,296; (7) over claims 1-7, 11, 14, 17, 18, 20, 23, 29, 35 and 46 of copending Application No. 18/838,825; and (8) over claims 22, 24, 26, 30, 34-38, 40-42, 44, 45 and 51-53 of copending Application No. 19/300,899 in view of Hu et al. (US 2015/0366814, published December 24, 2015, of record) and Scott et al. (US 2003/0175335, published September 18, 2003, of record).
* Claims were renumbered
Withdrawn composition claims of the copending Applications are included in this rejection because withdrawn claims are still pending
Even though a Notice of Allowance has been mailed and the Issue fee paid, the rejections over the ‘955 claims and the ‘296 claims remain provisional because these applications have not yet issued as patents
The instant claims are drawn to a delayed release softgel capsule comprising (a) a fill material comprising at least one pharmaceutically active ingredient and (b) a pH dependent shell composition comprising gelatin, pectin and about 0.05 to 0.15 wt% dextrose and not comprising synthetic acid insoluble polymers, wherein the capsule dissolves in the intestine in less than about 45 minutes and wherein the capsule remains intact for at least 60 minutes in 0.1 N HCl. The shell may further comprise a plasticizer / glycerol from about 15 to 40 wt%. The pectin may be low methoxyl pectin or be optionally amidated. The shell may comprise about 40 to 80 wt% of the gelatin or about 2 to 20 w% of the pectin. The gelatin may be type A or/and type B or the gelatin may be sourced from fish, hide or/and bone. The shell may dissolve / disintegrate in less than about 30 minutes or less than about 5 minutes at pH 6.8.
The (1) copending ‘955 claims are drawn to various delayed release softgel capsules comprising (a) a fill material comprising at least one pharmaceutically active ingredient and (b) a pH dependent shell composition comprising gelatin, pectin and dextrose, wherein the shell ruptures in the colon (intestine). The shell may further comprise a plasticizer / glycerol. The pectin may be low methoxyl pectin or be optionally amidated. The shell may comprise about 40 to 80 wt% of the gelatin, about 2 to 20 w% of the pectin or about 0.01 to 4 wt% of the dextrose. The shell may dissolve / disintegrate in less than about 60 minutes or less than about 5 minutes at pH 6.8 or may dissolve / disintegrate in at least about 15 minutes or at least about five hours in 0.1 N HCl. The copending ‘955 claims differ from the instant claims with respect to the amount of plasticizer and the species and types of gelatin.
The (2) copending ‘669 claims are drawn to various modified release softgel capsules comprising (a) a fill material comprising at least one active and (b) a pH dependent shell composition comprising about 45 to 75 wt% gelatin, pectin (non-amidated) and about 0.005 to 0.15 wt% dextrose. The shell may further comprise a plasticizer. The shell may comprise about 2 to 20 w% of the pectin. The copending ‘669 claims differ from the instant claims with respect to the species and amount of plasticizer, the species of pectin, the species and types of gelatin and with respect to the dissolution / disintegration properties.
The (3) copending ‘207 claims are drawn to various delayed release softgel capsules comprising (a) a fill material comprising at least one active and (b) a pH dependent shell composition comprising gelatin, pectin, about 0.001 to 1 wt% dextrose, about 5 to 40 wt% glycerin, and about 10 to 20 wt% sorbitol. The pectin may be low methoxyl pectin or be optionally amidated. The shell may comprise about 40 to 80 wt% of the gelatin or about 2 to 20 w% of the pectin. The gelatin may be type A or/and type B. The shell may dissolve / disintegrate in less than about 60 minutes or less than about 5 minutes at pH 6.8 and does not dissolve in 0.1 N HCl for at least about 15 minutes or at least about 120 minutes. The copending ‘207 claims differ from the instant claims with respect to the sources of gelatin and with the respect to the intestinal dissolution property.
The (4) copending ‘209 claims are drawn to various delayed release softgel capsules comprising (a) a fill material comprising at least one active and (b) a pH dependent shell composition comprising gelatin, a low methoxyl pectin and dextrose. The shell may further comprise a plasticizer / glycerol from about 15 to 40 wt%. The shell may comprise about 40 to 80 wt% of the gelatin, about 2 to 20 w% of the low methoxyl pectin or about 0.01 to 4 wt% of the dextrose. The shell may dissolve / disintegrate in less than about 60 minutes or less than about 5 minutes at pH 6.8 and does not dissolve / disintegrate in 0.1 N HCl for at least about 15 minutes or at least about 120 minutes. The copending ‘209 claims differ from the instant claims with respect to the species of pectin and the species and types of gelatin and with the respect to the intestinal dissolution property.
The (5) copending ‘635 claims are drawn to a softgel capsule comprising (a) a fill material comprising bisacodyl (active) and (b) a shell composition comprising a film forming material and an enteric polymer (pH dependent, delayed release) comprising methyl acrylic acid copolymer. The film forming material may comprise gelatin. The enteric polymer may further comprise pectin. The shell may further comprise dextrose or a plasticizer. The plasticizer may comprise from about 2 to 40 wt% of the shell. The pectin may be optionally amidated. The shell may comprise about 30 to 80 wt% of the gelatin, about 2 to 20 w% of the pectin or about 0.01 to 4 wt% of the dextrose. The copending ‘635 claims differ from the instant claims with respect to species of plasticizer, the species of pectin, the species and types of gelatin and with respect to the dissolution / disintegration properties.
The (6) copending ‘296 claims are drawn to a softgel capsule comprising (a) a fill material comprising bisacodyl (active) and (b) a shell composition comprising a film former / gelatin, a plasticizer comprising sorbitol and sorbitan, and an enteric polymer comprising pectin (pH dependent, delayed release, non-amidated), wherein the capsule remains intact for at least 15 minutes in pH 1.2 media. The shell may further comprise dextrose. The shell may comprise about 30 to 80 wt% of the gelatin, about 2 to 20 w% of the pectin or about 0.01 to 4 wt% of the dextrose. The gelatin may be type A or/and type B. The shell may disintegrate in less than about 60 minutes at pH 6.8. The copending ‘296 claims differ from the instant claims with respect to the species of pectin, the species of gelatin and the amount / type of plasticizer and with the respect to the intestinal dissolution property.
The (7) copending ‘825 claims are drawn to a softgel capsule comprising (a) a fill material comprising valproic acid (active) and (b) a shell composition comprising gelatin, a plasticizer / glycerol and an enteric polymer / pectin (pH dependent, delayed release). The shell may further comprise dextrose. The pectin may be optionally amidated. The shell may comprise about 25 to 55 wt% of the gelatin, about 3 to 22 w% of the pectin or about 0.01 to 1 wt% of the dextrose. The copending ‘825 claims differ from the instant claims with respect to the plasticizer and types and amounts thereof, the species of pectin, the species and types of gelatin and with respect to the dissolution / disintegration properties.
The (8) copending ‘899 claims are drawn to a softgel capsule comprising (a) a fill material comprising an active agent and (b) a shell comprising gelatin and 7.5 to 15 wt% pectin (pH dependent, delayed release, non-amidated). The pectin may be low methoxy pectin, or the shell may comprise a plasticizer in an amount of about 5 to 60 wt%, or the shell may comprise gelatin in an amount of about 15 to 60 wt%, or the shell may comprise dextrose in an amount of about 0.001 to 5 wt%. The copending ‘899 claims differ from the instant claims with respect to the species of plasticizer / glycerol, the species and types of gelatin and with respect to the dissolution properties.
However, the differences between the gelatin / pectin / dextrose shells of the capsules of the conflicting, copending claims and the instant claims are obvious in view of the teachings of Hu and of Scott as elaborated supra. In view of Hu it would have been prima facie obvious to substitute plasticizers inclusive of glycerol or/and sorbitol for the generic plasticizer of the copending claims because it is prima facie obvious to substitute equivalents for the same purpose (MPEP 2144.06 II) or/and it would have been prima facie obvious to modify the capsule shell composition of the copending claims to comprise such plasticizers inclusive of glycerol in amounts from 8 to 30 wt% and to optimize the amounts in order to plasticize the capsule shell composition. In view of Hu it would have been prima facie obvious to substitute gelatins inclusive of type A gelatin sourced from bone, pig or fish for the gelatin of the copending claims because it is prima facie obvious to substitute equivalents for the same purpose (MPEP 2144.06 II). In view of Scott it would have been prima facie obvious to substitute low methoxyl pectins with a degree of esterification below 50% for the pectin of the copending claims because it is prima facie obvious to substitute equivalents for the same purpose (MPEP 2144.06 II). Regarding the dissolution / disintegration properties and dissolution in the intestine, such is considered to be latent to the compositions of the copending claims in view of Hu and Scott. In further support of this presumption, Hu teaches enteric soft capsules by definition do not dissolve or disintegrate in gastric acidity such as for 2 hours in 0.1 N HCl and readily dissolve in the intestinal environment (pH ca. 6.8) (paragraph [0072]) and exemplifies an embodiment of 100% dissolution at 30 minutes (Figure 3) and Scott evidences pectin confers enteric properties to capsules, meaning the capsules have pH dependent solubility and are readily soluble under intestinal conditions (simulated by a pH of 6.8) (e.g., paragraphs [0002], [0004], [0012]). Regarding the exclusion of synthetic acid insoluble polymers, although the capsules of the conflicting, copending claims generally do not require such, in view of Hu it would have been prima facie obvious to include or/and to exclude additional polymers, although Hu teaches pectin to be sufficient to provide an enteric gelatin capsule.
This is a provisional nonstatutory double patenting rejection.
Claims 1-6, 8-14, 16, 18 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable (A) over claims 1-11 of U.S. Patent No. 12,628,854 (Application No. 17/772,698); (B) over claims 1-16 of U.S. Patent No. 12,635,719 (Application No. 18/819,147); and (C) over claims 1-21 of U.S. Patent No. 12,661,326 (Application No. 18/819,242); in view of Hu et al. (US 2015/0366814, published December 24, 2015, of record) and Scott et al. (US 2003/0175335, published September 18, 2003, of record).
The instant claims have been described supra.
The (A) ’854 Patent claims are drawn to a delayed release softgel capsule comprising (a) a fill material comprising at least one active and (b) a shell composition comprising gelatin, a pH dependent polymer comprising pectin (non-amidated) and gellan gum, and about 0.01 to 2 wt% dextrose. The shell may comprise about 40 to 80 wt% of the gelatin or about 2 to 20 w% of the pectin. The ’854 Patent claims differ from the instant claims with respect to the plasticizer and species thereof, the species of pectin, the species and types of gelatin and with respect to the dissolution / disintegration properties.
The (B) ’719 Patent claims are drawn to a delayed release softgel capsule comprising (a) a fill material comprising at least one active and (b) a shell composition comprising about 60 to 80 wt% type A or/and type B gelatin, comprising a pH dependent polymer comprising pectin and gellan gum, and comprising about 0.01 to 2 wt% dextrose. The shell may further comprise a plasticizer / glycerol from about 15 to 40 wt%. The pectin may be low methoxyl pectin or be optionally amidated. The shell may comprise about 0.1 to 10 w% of the pectin. The ’719 Patent claims differ from the instant claims with respect the sources of gelatin and with respect to the dissolution / disintegration properties.
The (C) ’326 Patent claims are drawn to a delayed release softgel capsule comprising (a) a fill material comprising an active, (b) a shell composition comprising about 2.5 to 20 wt% pectin (pH dependent, non-amidated), and a coating comprising an enteric polymer (pH dependent), wherein the shell does not rupture in 0.1 N HCl at 15 minutes. The shell may further comprise a plasticizer / glycerol from about 5 to 60 wt% or may further comprise gelatin or may further comprise dextrose. The pectin may be low methoxy pectin. The shell may comprise about 15 to 60 wt% of the gelatin or about 0.001 to 5 wt% of the dextrose. The gelatin may be type A or/and type B or the gelatin may be sourced from fish, hide or/and bone. The ’326 Patent claims differ from the instant claims with respect to the dissolution / disintegration properties.
However, the differences between the gelatin / pectin / dextrose shells of the capsules of the conflicting Patent claims and the instant claims are obvious in view of the teachings of Hu and of Scott as elaborated supra. In view of Hu it would have been prima facie obvious to substitute plasticizers inclusive of glycerol or/and sorbitol for the generic plasticizer of the copending claims because it is prima facie obvious to substitute equivalents for the same purpose (MPEP 2144.06 II) or/and it would have been prima facie obvious to modify the capsule shell composition of the Patent claims to comprise such plasticizers inclusive of glycerol in amounts from 8 to 30 wt% and to optimize the amounts in order to plasticize the capsule shell composition. In view of Hu it would have been prima facie obvious to substitute gelatins inclusive of type A gelatin sourced from bone, pig or fish for the gelatin of the Patent claims because it is prima facie obvious to substitute equivalents for the same purpose (MPEP 2144.06 II). In view of Scott it would have been prima facie obvious to substitute low methoxyl pectins with a degree of esterification below 50% for the pectin of the Patent claims because it is prima facie obvious to substitute equivalents for the same purpose (MPEP 2144.06 II). Regarding the dissolution / disintegration properties and dissolution in the intestine, such is considered to be latent to the compositions of the copending claims in view of Hu and Scott. In further support of this presumption, Hu teaches enteric soft capsules by definition do not dissolve or disintegrate in gastric acidity such as for 2 hours in 0.1 N HCl and readily dissolve in the intestinal environment (pH ca. 6.8) (paragraph [0072]) and exemplifies an embodiment of 100% dissolution at 30 minutes (Figure 3) and Scott evidences pectin confers enteric properties to capsules, meaning the capsules have pH dependent solubility and are readily soluble under intestinal conditions (simulated by a pH of 6.8) (e.g., paragraphs [0002], [0004], [0012]). Regarding the exclusion of synthetic acid insoluble polymers, although the capsules of the conflicting, Patent claims generally do not require such, in view of Hu it would have been prima facie obvious to include or/and to exclude additional polymers, although Hu teaches pectin to be sufficient to provide an enteric gelatin capsule.
Response to Arguments: Double Patenting
Applicant’s repeated statement that the instant application has an earlier filing date than 17/772,698 and repeated reference to MPEP 804 at page 9 of the Remarks is acknowledged. However, because this application has issued as a patent, there is no basis for withdrawing the rejection based on the earlier filing date.
Applicant’s repeated statement that the remaining applications differ with respect to amount of dextrose and with respect to dissolution in the intestines and in acid at page is acknowledged. However, all of the remaining applications embrace dextrose in amounts which overlap and fully encompass the claimed range, and all of the remaining applications are drawn to capsules comprising gelatin and pectin which are enteric capsules which would have the definitional properties of enteric capsules of non-dissolution in the stomach (acidic pH) and dissolution in the intestines (pH 6.8). Applicant’s repeated statement that there is no motivation to arrive at the claimed invention based on Hu and Scott is unpersuasive as re-iterated infra because all of the copending Applications are drawn to gelatin-pectin capsules as already possessed by Hu.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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