DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-7, 10-11, and 13-23 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 02/18/2026 has been entered.
Claims 1 and 4 were amended. Claims 18-23 were added. No new material was added.
Applicant’s amendments overcame the previous rejections of claims 1-7, 10-11, and 13-17 under 35 U.S.C 103.
Claims 1-7, 10-11, 13-23 are newly rejected under 35 U.S.C. 103.
Response to Arguments
Applicant’s arguments, see Remarks (pages 8-9), filed 02/18/2026, with respect to the rejection(s) of claim(s) 1-4, 7, 10-11, 13-15, and 17 under 35 U.S.C. 103 over Lovgren, Lalezari, and Klein have been fully considered and are persuasive due to the amendment. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lovgren, Lalezari, Amighi, and Klein.
Applicant's arguments with respect to the rejection of claims 5-6 under 35 U.S.C. 103 over Lovgren, Lalezari, and Amighi have been fully considered but they are not persuasive. Applicant argues that there is no reason for one skilled in the art to switch out the required omeprazole active of Lovgren (Remarks, page 9). This argument is not persuasive, because as previously stated, Lovgren teaches the use of omeprazole for the treatment of gastrointestinal disease (Lovgren, claim 10) and specifically for gastric ulcers (Lovgren, column 1, line 20), while Amighi teaches both omeprazole and pantoprazole as proton pump inhibitors (i.e., a suitable biologically active ingredient as listed in claim 3), and therefore as art recognized equivalents (Amighi, page 14 second paragraph). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to substitute the omeprazole taught by Lovgren for the equivalent drug taught by Amighi for the same purpose.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-7, 10-11, 13-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Lovgren (US 4786505 A; IDS reference, 06/08/2022), further in view of Lalezari (Annals of Gastroenterology, 2012) and Amighi (WO 2017012935 A1), and as evidenced by GSRS (Triethyl Citrate). Lovgren, Lalezari, and Amighi were previously cited by the Examiner.
Regarding claim 1, Lovgren teaches an oral pharmaceutical preparation (i.e., a dosage form) comprising omeprazole (i.e., a biologically active ingredient) in the core, an inert subcoating (i.e., ICL), and an outer layer comprising an enteric coating (i.e., ECL; Lovgren, claim 1). Lovgren further teaches the subcoating layer comprises magnesium oxide or magnesium carbonate (i.e., alkaline agents from the claimed list; Lovgren, claim 2), the enteric coating comprises an enteric coating polymer (Lovgren, column 4, line 65) which can be hydroxypropyl methylcellulose phthalate (i.e., an anionic cellulose as defined by the instant claim 14; Lovgren, column 4, line 66; claim 6), and exemplifies the ratio of the alkaline agent to enteric polymer according to the claimed formula to be about 7% (Lovgren, example 6, (4 g magnesium carbonate x 100) / (4 g magnesium carbonate + 57 g hydroxypropyl methylcellulose phthalate)), which lies within the claimed range of 5-95%. Lovgren teaches the subcoating layer is preferably not less than 10 micrometers (Lovgren, column 4, line 45), which overlaps the claimed range of about 22 micrometers or more. Further, Lovgren teaches the use of the pharmaceutical preparation for the treatment of a gastrointestinal disease comprising administering a therapeutically effective amount to a host (i.e. for treating a disease in a human body wherein the disease requires the release of a certain amount of the biologically active ingredient; Lovgren, claim 10), with dissolution in the small intestine and a bioavailability of about 85% (col. 16, lines 25-30), which overlaps the claimed range of 50% or more.
Lovgren does not specifically state a pH range from 3-5.5 for the small intestine. Lalezari, however, teaches the pH range of the proximal region of the small intestine ranges from 5.5-7 (Lalezari, page 335, “discussion”), which overlaps the claimed range of 3-5.5. Lovgren and Lalezari are both considered to be analogous to the claimed invention because all are in the same field of drug delivery to the small intestine. It would therefore be prima facie obvious to one of ordinary skill in the art that the pharmaceutical composition targeting the small intestine taught by Lovgren would be released at a pH of 5.5-7, the pH of the small intestine, as taught by Lalezari. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Therefore, the composition would be released in the claimed pH range with a reasonable expectation of success.
Lovgren does not teach a dosage form free of omeprazole. Amighi, however, teaches a pharmaceutically active compound (i.e., dosage form comprising a biologically active ingredient), comprising a core comprising the pharmaceutically active compound, an intermediate coating layer, and an outmost external protection coating layer (Amighi, claim 1). Amighi teaches both omeprazole and pantoprazole as acid-labile proton pump inhibitors (Amighi, page 14, second paragraph). In view of the teachings of Amighi, both omeprazole and pantoprazole are art recognized equivalents as they are used for the same purpose. Lovgren and Amighi are both considered to be analogous to the claimed invention because all are in the same field of dosage forms comprising a core and external layers which for treating gastrointestinal diseases. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to substitute the omeprazole taught by Lovgren for a different proton pump inhibitor such as pantoprazole as taught by Amighi.
Regarding claim 3, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claim 1. As above, Lovgren teaches omezaprole (i.e., a proton pump inhibitor; Lovgren, claim 1) for the treatment of gastrointestinal disease (Lovgren, claim 10) and states it can be specifically used for gastric ulcers (Lovgren, column 1, line 20), while Amighi teaches both omeprazole and pantoprazole as proton pump inhibitors (Amighi, page 14, second paragraph) for the prevention and treatment of gastric acid related diseases such as gastroesophageal reflux disease (Amighi, page 36, first paragraph). As above, it would have been prima facie obvious to one of ordinary skill in the art to substitute the omeprazole taught by Lovgren for a different proton pump inhibitor such as pantoprazole as taught by Amighi.
Regarding claim 4, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claim 1. As above, Lovgren teaches omezaprole (i.e., a proton pump inhibitor; Lovgren, claim 1) for the treatment of gastrointestinal disease (Lovgren, claim 10) and states it can be specifically used for gastric ulcers (Lovgren, column 1, line 20), while Amighi teaches both omeprazole and pantoprazole as proton pump inhibitors (Amighi, page 14, second paragraph) for the prevention and treatment of gastric acid related diseases such as gastroesophageal reflux disease (Amighi, page 36, first paragraph). As above, it would have been prima facie obvious to one of ordinary skill in the art to substitute the omeprazole taught by Lovgren for a different proton pump inhibitor such as pantoprazole as taught by Amighi.
Regarding claim 5, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 1. Lovgren does not teach the disease is atrial fibrillation and the biologically active ingredient is sotalol. Amighi, however, teaches the pharmaceutically active compound can be an antiarrhythmic (i.e., for atrial fibrillation) which is sotalol (Amighi, page 3, first paragraph). Amighi teaches both omeprazole and sotalol as pharmaceutically active compounds targeting the gastrointestinal tract (Amighi, pages 2-3). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to substitute the omeprazole taught by Lovgren for a recognized equivalent taught by Amighi.
Regarding claim 6, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 1. As above, Lovgren teaches omezaprole (Lovgren, claim 1) for the treatment of gastrointestinal disease (Lovgren, claim 10) and states it can be specifically used for gastric ulcers (Lovgren, column 1, line 20). Lovgren does not teach pantoprazole. Amighi, however, teaches both omeprazole and pantoprazole as acid-labile proton pump inhibitors (Amighi, page 14, second paragraph). In view of the teachings of Amighi, both omeprazole and pantoprazole are art recognized equivalents as they are used for the same purpose. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to substitute the omeprazole taught by Lovgren for a different proton pump inhibitor such as pantoprazole as taught by Amighi.
Regarding claim 7, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claim 1. Lovgren teaches the uncoated pellets (i.e., core) as a mixture (i.e., distributed in a matrix) which includes the active ingredient (Lovgren, column 10, example 6).
Regarding claim 10, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claim 1. As above, Lovgren teaches the subcoating layer comprises magnesium oxide or magnesium carbonate (Lovgren, claim 2).
Regarding claim 11, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claim 1. Lovgren further teaches the separating layer may contain a plasticizer (Lovgren, column 4, line 54).
Regarding claim 13, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claim 1. Lovgren teaches the enteric coating polymer can be co-polymerized methacrylic acid/methacrylic acid methyl esters (i.e., a copolymer comprising polymerized units of methacrylic acid and methyl methacrylate; Lovgren, column 4, line 68).
Regarding claim 14, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claim 1. As above, Lovgren teaches the enteric coating polymer can be hydroxypropyl methylcellulose phthalate (i.e., an anionic cellulose; Lovgren, column 4, line 66; claim 6).
Regarding claim 15, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claim 1. As above, Lovgren exemplifies the ratio of the alkaline agent to enteric polymer according to the claimed formula to be about 7% (Lovgren, example 6, (4 g magnesium carbonate x 100) / (4 g magnesium carbonate + 57 g hydroxypropyl methylcellulose phthalate)), which lies within the claimed range of 7-80%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 16, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 1. As above, Lovgren teaches an oral pharmaceutical preparation (i.e., a dosage form) comprising an active ingredient in the core, an inert subcoating (i.e., ICL), and an outer layer comprising an enteric coating (i.e., ECL; Lovgren, claim 1), but Lovgren does not teach the ratio of alkaline agent to enteric polymer as claimed. Amighi teaches a pharmaceutical composition (i.e., a dosage form; Amighi, abstract) containing a pharmaceutically active compound, an intermediate protective layer (i.e., ICL), and an enteric coating layer (i.e., ECL; Amighi, page 66, table 9.1). Amighi teaches a weight ratio of the alkaline additive to the active compound in the range of 30-90% (i.e., 0.3:1 to 0.9:1; Amighi, page 18, 4th paragraph) and teaches a formulation wherein the ratio of omeprazole (i.e., active ingredient) to Eudragit in the enteric coating layer (i.e., the enteric polymer) is 450:420 g (i.e., 1:0.9; Amighi, page 66, table 9.1), suggesting a ratio of alkaline compound to active compound to enteric polymer of 0.9:1:0.9 as a possible embodiment, which would result in a relation of the alkaline agent to the enteric polymer of 50% as claimed. 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 modified the composition of Lovgren to utilize a higher alkaline agent content as taught by Amighi, because Amighi teaches active ingredients such as omeprazole and pantoprazole are acid labile and should be protected (Amighi, page 13, third paragraph). As above, it would have been prima facie obvious to one of ordinary skill in the art to substitute the omeprazole taught by Lovgren for a different proton pump inhibitor such as pantoprazole as taught by Amighi.
Regarding claim 17, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 1. As above, Lovgren does not specifically state a pH range from 3-4.5 for the small intestine. Lalezari teaches the pH range of the proximal region of the small intestine ranges from 5.5-7 (Lalezari, page 335, “discussion”). The property of release of the biologically active ingredient within the claimed pH range is considered to be an inherent property. A chemical composition and its properties are inseparable. Therefore, the composition taught by Lovgren and Amighi would be expected to be capable of releasing the active ingredient at the claimed pH. See MPEP § 2112.01(II). This is further evidenced in the Declarations provided by the Applicant on 05/05/2025 and 11/04/2025, which show the drug release profiles of the provided examples at a pH of 3.0 to 5.5 are essentially equivalent and unchanged with the change in pH over this range (Declaration, examples I6-I8 and I10). Therefore, based on the teachings of Lalezari and the examples provided by the Applicant, it would be reasonable to expect that the composition taught by Lovgren and Amighi would show release of the active ingredient in the pH range as claimed.
Regarding claim 18, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 13. As above, Lovgren further teaches the subcoating layer comprises magnesium oxide or magnesium carbonate (i.e., alkaline agents from the claimed list; Lovgren, claim 2).
Regarding claim 19, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 14. As above, Lovgren further teaches the subcoating layer comprises magnesium oxide or magnesium carbonate (i.e., alkaline agents from the claimed list; Lovgren, claim 2).
Regarding claim 20, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 10. Lovgren further teaches the subcoating can be hydroxypropyl methylcellulose (Lovgren, column 8, lines 36-38).
Regarding claim 22, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 10. Lovgren teaches citric acid esters such as Citroflex (i.e., triethyl citrate as evidenced by GSRS) and talc can be included in the enteric coating layer (Lovgren, column 5, lines 10-18).
Regarding claim 23, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 22. Lovgren teaches the enteric coating polymer can be Eudragit L100-55 (Lovgren, column 5, line 7), which is defined in the instant specification as a suitable copolymer comprising methacrylic acid and ethyl acrylate (specification, page 10, lines 21-23).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lovgren (US 4786505 A; IDS reference, 06/08/2022), Lalezari (Annals of Gastroenterology, 2012), and Amighi (WO 2017012935 A1) as applied to claims 1, 3-7, 10-11, 13-20, and 22-23, and further in view of Klein (American Association of Pharmaceutical Scientists, 2010). References were previously cited by the Examiner.
Regarding claim 2, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 1. Lovgren further teaches an active ingredient is released in an amount of 5% after 2 hours (i.e., 10% or less for 120 min) in gastric fluid USP (Lovgren, column 14, example 2), but does not state the specific pH of gastric fluid USP. Klein, however, teaches the pH of gastric fluid USP traditionally utilized to be 1.2 (Klein, page 398, “simulated gastric fluid”). It would have been prima facie obvious to one of ordinary skill in the art to use the traditional gastric fluid USP with a pH of 1.2 taught by Klein in the experiments taught by Lovgren. Lovgren further teaches the same composition to be 91% dissolved after 10 minutes at a pH of 6 (Lovgren, column 14, example 2), which is substantially close to the range of 3-5.5 in the instant claim, and within the pH range of the small intestine as taught by Lalezari to be 5.5-7. While the exact pH used is not taught by Lovgren, it would be obvious to one of ordinary skill in the art that a similar pH value within the range of the small intestine, as taught by Lalezari, could result in a similar outcome. Lovgren, Lalezari, Amighi, and Klein are all considered to be analogous to the claimed invention because all are in the same field of drug delivery to the small intestine.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lovgren (US 4786505 A; IDS reference, 06/08/2022), Lalezari (Annals of Gastroenterology, 2012), and Amighi (WO 2017012935 A1) as applied to claims 1, 3-7, 10-11, 13-20, and 22-23, and further in view of Lad (US 20110189271 A1). Lovgren, Lalezari, and Amighi were previously cited by the Examiner.
Regarding claim 21, Lovgren, Lalezari, and Amighi teach all the elements of the current invention as applied to claims 20. Lovgren and Amighi both teach the separating (i.e., intermediate coating) layer can contain plasticizers (Lovgren, column 4, lines 54-56; Amighi, page 23, third paragraph), but do not specifically teach glycerin. Lad, however, teaches pharmaceutical formulations comprising cores with an intermediate layer and an enteric coating layer (Lad, abstract), and teaches glycerin as a useful plasticizer (Lad, page 8, paragraph 0112). Lovgren, Amighi, and Lad are all considered to be analogous to the claimed invention because all are in the same field of pharmaceutical compositions comprised of the claimed structure. It would have been prima facie obvious to modify the separating layer of Lovgren and Amighi to use a specific plasticizer as taught by Lad, because both teach the use of plasticizers, while Lad teaches glycerin to be a known, useful plasticizer in the field.
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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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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