DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The response and amendment filed 11/05/2025 is acknowledged.
Claims 1, 3, 5-11, and 13 are pending.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Response to Arguments
Applicant's arguments filed 11/05/2025 have been fully considered but they are not persuasive.
Applicant argues Singh does not describe Applicants' invention because Singh only provides for formulations comprising lactoferrin and guanosine nucleotides.
This argument is unpersuasive because, as acknowledged by Applicant, Singh teaches iron salts may be optionally present. Singh clearly teaches compositions may include iron, e.g., iron in the form of a salt (Singh, e.g., pg. 14:14-34). Singh exemplifies granules containing divalent iron salts (Singh, e.g., formulations 6, 7, example 20, example 21, example 22, example 23, example 24, example 25). Based on the exemplified formulations containing iron (II) salts, the skilled artisan clearly understood that Singh does not teach away from granules containing iron (II) salts.
Applicant argues Singh does not specifically disclose coated granules/microgranules as administration form. Applicant argues the granulation process described by Singh represents only an intermediate step of the process for the preparation of the compositions, regardless of the type of granulate (wet or dry), formulation, etc. Applicant argues inter alia, a granulate is not present in all the disclosed formulations. Applicant argues granulate is, on the contrary, an essential feature of the claimed invention, together with soluble fibers coated with shellac and alginic acid. Applicant argues all the examples of the present application refer invariably to granulates. The last example refers to chewable tablets always obtained starting from the granulates of the invention, merely as an application example of the granulates.
These arguments are unpersuasive. As noted above, Singh exemplifies a granulate containing divalent iron salts (Singh, e.g., formulations 6, 7, example 20, example 21, example 22, example 23, example 24, example 25). The granulate exemplified in Singh are in administration form, e.g., a tablet as named in claim 11. The granulate are coated with an enteric coating, e.g., shellac and alginate (Singh, e.g., pg. 23: step 22). A combination of shellac and alginate is demonstrated in examples 21 and 23. Singh’s granulate containing a binder and an iron salt, e.g., examples 21 and 23, include the feature of being coated with a combination of shellac and alginate in as much detail as claimed. In the presently claimed formulation, the granulation process is only an intermediate step as well, therefore it is unclear what distinction Applicant is arguing.
Applicant argues Singh generically cites inulin as a binder within a list of about 50 other compounds, implying that the choice of a binder rather than another is irrelevant. Applicant argues Vetter does not correct Singh's deficiencies nor can it provide for the missing link. Singh describes that inulin, shellac and sodium alginate are additives used for the production of the various pharmaceutical forms (tablets, bags, etc.), differently from the present application where inulin, shellac and sodium alginate are essential components of the granulate / granules. Applicant argues the fact that the different elements of the claimed invention (granulate, soluble fibers/inulin, shellac and alginate) are mentioned in Singh as usual components of pharmaceutical compositions is not sufficient to support a prima facie case of obviousness rejection. Applicant argues that it is a bedrock of patent law that a statement that modifications of the prior art to meet the claimed invention would have been "'well within the ordinary skill of the art at the time the claimed invention was made"' because the references relied upon teach that all aspects of the claimed invention were individually known in the art is not sufficient to establish a prima facie case of obviousness without some objective reason to combine the teachings of the references. Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993).
These arguments are unpersuasive.
Singh teaches the granulate is compressed into a tablet core which is subsequently coated with a combination of sodium alginate and shellac. The granulate in the compressed tablet cores of Singh are still a granulate and present in the enteric coated formulations exemplified in Singh. The granulate of claim 1 may be in the form of a tablet as evident from claim 11. Claim 1 only requires the granulate is coated with shellac and sodium alginate. Thus, the claimed invention reads on a granulate compressed into a tablet core and coated with a combination of shellac and sodium alginate as taught by Singh.
The rejection is not a statement that modifications of the prior art to meet the claimed invention would have been “well within the ordinary skill of the art at the time the claimed invention was made” because the references relied upon teach that all aspects of the claimed invention were individually known in the art.
The subject matter of claim 1 differs from compositions exemplified in Singh, e.g., examples 21 and 23, only by the selection of inulin binder having a degree of polymerization ranging between 3 and 5. Singh clearly suggests inulin may be used as a binder (Singh, e.g., pg. 17). The binder is a part of the granulate (Singh, e.g., pg. 22: Wet Granulation). Vetter teaches inulin having a degree of polymerization ranging from 4-60 or 5-25 was known and used in similar nutrient delivery granulates (Vetter, e.g., Abstract, claim 11, pg. 41:14-25). Vetter teaches inulin having a degree of polymerization in this range is effective for more effective delivery to the mucosa of the gastrointestinal tract (Vetter, e.g., pg. 15:24-pg. 16:2). The claimed degree of polymerization overlaps with the range suggested by Vetter and there is no evidence of criticality. In response to Applicant’s argument that inulin was selected as a dietary fiber in the present invention, it is noted that inulin was a known prebiotic fiber as evident from Vetter, e.g., pg. 40:1-5.
Applicant argues shellac and sodium alginate are not, used according to the claimed invention to provide an enteric coating, i.e., a coating able to protect the active ingredient (lactoferrin in Singh) from the acidic gastric environment (see discussion on page 10, lines 13-25 of Singh). Applicant argues the claimed compositions release the mineral salt in the stomach, securing its bioavailability. Applicant argues the data reported in Table V on page 14 confirm that the salt is mostly released at the gastric level and only for a minor proportion in the intestine. Applicant argues a skilled person expert would have had to literally overturn the teaching of Singh in order to arrive at the unexpected and surprising results obtainable with the invention presently claimed.
These arguments are unpersuasive. Singh teaches sodium alginate/shellac is an enteric coating which means the coating is insoluble at the low pH of the stomach but soluble at pH of the intestine (Singh, e.g., pg. 10:26-32). Singh teaches enteric coatings are coated by an acid-resistant material which “dissolves easily in a neutral pH condition” (Singh, e.g., pg. 10:26-32). This fact is reiterated in Van Ness specifically with respect to enteric coatings containing sodium alginate and shellac, e.g., enteric coatings dissolve or disintegrate in neutral or mildly alkaline conditions (van Ness, e.g., 0003).
The pH dependent release properties of a sodium alginate/shellac coating are expected to be the same if tested in the same way.
The data in Table V is not in vivo data showing release in the stomach. The data in Table V shows the release after digestion of the granulate at pH 6.9 for 5 minutes at 37°C in a dialysis bag, and then placing in a gastric digestion bath at 37° for 2 hours. See specification, e.g., pg. 13-14: in vitro bioavailability study.
The Gastric Digestion release observed by Applicant is an expected result because of how the composition was tested. Incubating the composition with neutral pH conditions (at pH 6.9 for five minutes, see Buccal digestion, pH 6.9, Specification, ¶ spanning pp. 13-14) is the same pH as the intestine (Intestinal digestion, pH 7.0), and which is a pH at which Singh and van Ness says the enteric coatings such as sodium alginate/shellac should start to release/dissolve/disintegrate. Thus, the buccal digestion step of the Specification’s testing method preceding the gastric digestion step is the same pH as the intestine, and also the same pH at which the enteric coating was expected to start dissolving and allow release. Because the buccal digestion step incubates the composition for five minutes at a neutral pH which allows the enteric coating to start release, e.g., a neutral pH at which sodium alginate/shellac coating dissolves or disintegrates, the skilled artisan would have expected release in the gastric digestion step of the specification since the enteric coating had been compromised by the neutral pH of the buccal digestion step. There is no comparative data using Singh’s granulate showing a difference in properties when tested in the same way.
Applicant has argued claim 7 depends from the claim 1 which is not rejected over the combination of the cited references. Applicant has argued that as claim 1 is patentable, it is respectfully submitted that claim 7 is patentable.
This argument is unpersuasive.
The statement of rejection indicated that claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Singh, WO 2019171236 (cited on Applicant’s IDS dated 03/16/2023) and Vetter, WO 2017140902 A1 (cited on Applicant’s IDS date 03/16/2023) as applied to claims 1-3, 5-6, and 8-13 above.
Claim 1 is not patentable because claim 1 is rejected as non-obvious over the combined teachings of Singh and Vetter, which teachings are also applied to claim 7 further in view of van Ness. Claim 7 is properly rejected under 35 USC 103 because claim 1 is non-obvious based on the combined teachings of Singh and Vetter which are included in the rejection of claim 7.
Applicant argues Van Ness describes enteric compositions wherein the gastroresistant property are provided by shellac and alginate. Applicant argues the formulations described therein are not gastro-resistant notwithstanding the presence of alginate and shellac, disclosed in Van Nesse [sic] as gastro- resistant coating agents.
This argument is unpersuasive.
It is not clear where van Ness teaches the composition are not gastro-resistant. As discussed above, the evidence of record is insufficient to show the claimed formulation lacks gastro-resistant properties.
Applicant argues it is the specific claimed combination of fructans, alginate, shellac in microgranulate form which provides satisfactory organoleptic characteristics combined with a release comparable to ferrous sulfate in free form.
This argument is unpersuasive. There is no objective evidence of record showing a side-by-side comparison which establishing criticality of the claimed soluble fructans having a degree of polymerization which overlaps with that suggested by Vetter - or an unexpected difference in properties when compared to the closest prior art - when tested in the same way.
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.
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, 3, 5-6, 8-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Singh, WO 2019171236 (cited on Applicant’s IDS dated 03/16/2023) and Vetter, WO 2017140902 A1 (cited on Applicant’s IDS date 03/16/2023).
Singh teaches compositions for anemia comprising iron salts, e.g., ferrous fumarate (Singh, e.g., pg. 21, formulations 6 and 7, which is a divalent iron salt) in the form of granules comprising a binder (Singh, e.g., pg. 22:18-22) and an enteric coating comprising a mixture of shellac and sodium alginate (Singh, e.g., pg. 23:21-23).
The binders exemplified may be PVP or HPMC (Singh, e.g., examples, e.g., pg. 22:19). Therefore, Singh does not expressly teach a single embodiment comprising soluble fibers selected from fructans having a degree of polymerization ranging between 3 and 5.
Singh teaches inulin as a binder and alternative for PVP or HPMC (Singh, e.g., pg. 17:21-32).
Further, Vetter teaches inulin having a degree of polymerization from 4-60 or from 5-25 (Vetter, e.g., pg. 41: 14-19 and claim 11). Vetter teaches inulin having a degree of polymerization in this range is effective for more effective delivery to the mucosa of the gastrointestinal tract (Vetter, e.g., pg. 15:24-pg. 16:2).
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). MPEP 2144.05.
The claimed range is within the range suggested by Vetter for improving delivery of actives to the mucosal surface for absorption.
It would have been obvious before the effective filing date of the presently claimed invention to modify granule examples in Singh by utilizing inulin having a degree of polymerization in the range of 4-60 or 5-25 as suggested by Vetter to improve the granules in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to optimize the degree of polymerization for inulin to improve delivery of the actives, e.g., ferrous fumarate to mucosal surfaces of the intestine in the same way suggested by Vetter. The skilled artisan would have had a reasonable expectation of success because both documents teach granules for improved delivery of active agents.
Applicable to claims 1 and 13: Singh teaches granules containing ferrous pyrophosphate which is a divalent iron salt (Singh, e.g., example 21).
Applicable to claims 1, 3, and 13: Singh teaches ferrous fumarate which is a divalent iron salt.
Applicable to claim 6: Vetter teaches the polymer may be, e.g., at least 30% (Vetter, claim 6). 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). MPEP 2144.05.
Applicable to claim 8: Singh teaches embodiments containing ferrous bisglycinate in an amount of 42.86% (Singh, e.g., pg. 38: example 20).
Applicable to claim 9: Vetter teaches a kit comprising a bottle and a cap, wherein the cap contains a reservoir for the composition, e.g., in the form of a powder (Vetter, e.g., claim 16).
Applicable to claims 10-11: Singh teaches the composition in the form of a tablet, powder, etc. which meet the limitation of food or pharmaceutical.
Accordingly, the subject matter of claims 1, 3, 5-6, 8-11, and 13 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Singh, WO 2019171236 (cited on Applicant’s IDS dated 03/16/2023) and Vetter, WO 2017140902 A1 (cited on Applicant’s IDS date 03/16/2023) as applied to claims 1, 3, 5-6, and 8-11, and 13 above, and further in view of van Ness, US 20130115285.
The combined teachings of Singh and Vetter teach a composition according to claim 1 which includes an enteric coating containing shellac and alginate as enumerated above.
The combined teachings of Singh and Vetter do not expressly teach the wherein the weight percentage of sodium alginate to the total composition ranges from 1% to 10%, the weight percentage of shellac to the total composition ranges from 1% to 10%, and the weight ratio of sodium alginate to shellac ranges between 1:4 and 4:1.
Van ness teaches shellac and alginate enteric compositions having the claimed features were known and used for enteric coatings. See van Ness, e.g., 0044.
It would have been obvious before the effective filing date of the presently claimed invention to modify the enteric coating of granules in compositions known from the combined teachings of Singh and Vetter using a known enteric combination amount of shellac and alginate such as that known from van Ness with a reasonable expectation of success. The skilled artisan would have seen this modification as the substitution of one known enteric shellac/alginate composition for another to achieve predictable results. The skilled artisan would have had a reasonable expectation of success because Singh clearly suggests enteric compositions having shellac and alginate would be effective for enteric effect.
Accordingly, the subject matter of claims 7 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615