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
Claims 1-3, 5-7 and 9-14 are currently pending and amendments to the claims filed on 05/26/2026 are acknowledged. By way of applicant’s election of 11/14/21025, claims 9-12 have been withdrawn, and thus, claims 1-3, 5-7 and 13-14 are being examined at this time.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/20/2026 was filed before the mailing date of the instant action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Withdrawn rejections:
Applicant's amendments and arguments filed 05/25/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Rejection --- as necessitated by amendment
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.
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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-3, 5-7, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzon (WO2010/060914A1, IDS of 11/13/2023, citation is obtained from its corresponding US publication no. US2011/0287104A1) in view of CN102,579,369A(IDS of 03/20/2026, hereinafter CN ‘369) and Shanmugam et al. “Granulation techniques and technologies: recent progresses”, Biolmpacts, 2015, 5(1), 55-63 (of record).
Applicant claims the below claim 1 filed on 0/26/2026:
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For examination purpose
Claim 13 recites “A population of granules which can be obtained according to the method according to claim 9”, but which recites a product-by-process features. It is noted that product-by-process limitations are not seen as structurally limiting the instant granule composition because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP 2113 reads “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” Further, as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Accordingly, in the instant case, it is interpreted that claim 13 recites “A population of granules comprising sodium butyrate particles, fatty material matrix comprising fatty acids, encapsulating the sodium butyrate particles, the granule preserving its morphology following gastric and enteric digestion simulation in vitro tests, and the granule featuring a gastric resistance conferring protection on the sodium butyrate particles in the stomach and featuring a sustained release of sodium butyrate particles in the intestinal tract”.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Lorenzo teaches process for the production of an n-butyric acid compound in micro-encapsulated form, for animal or human consumption (title); the product produced by the process is in the form of granules (e.g., [0058]) and the product comprises sodium butyrate particles, a matrix of fatty materials comprising fatty acids encapsulating said sodium butyrate particles (e.g., [0030]-[0033], claim 1 of prior art) wherein the fatty acids are lipid matrix that includes C14, 16, 18, 20, and 22 fatty acids (e.g., [0040]); the product has optimal characteristics of resistance to acid environment (e.g., [0044]), and Example 1 discloses granules containing sodium butyrate powder, fatty acid lipid matrix of C14, 16, 18 triglyceride encapsulating the sodium butyrate powder and calcium sulphate dihydrate, and here, the said granules read on the claimed granule and population containing granules, and an in vitro digestion evaluation was performed and it consists of a series of tests which reproduces a three-stage chemical enzymatic incubation according to the test protocol established by Boisen’s method: stage 1 (stomach), stage 2 (small intestine) and stage 3 (large intestine) (e.g., [0068]-[0070] and Table 1), and in particular, Table 1 shows that the sodium butyrate of Example 1 is remained in stomach at an amount of 61.17% which reads on the claimed gastric protection rate of TRC1 65% or more, the sodium butyrate of Example 1 is remained in small intestine at an amount of 26.68%, and thus its release rate in the small intestine is 34.49% (=61.76%-26.68%) which is within the claimed TRC2 release rate range of higher than or equal to 25%, and the sodium butyrate of Example 1 is remained in large intestine at an amount of 19.73% and thus its release rate in large intestine is 6.95% (26.68%-19.73). Therefore, from the teachings of Example 1, the morphology of granule composition is maintained after gastric and enteric digestion and said granule exhibited a gastric resistance that confers protection on the sodium butyrate particles in the stomach and sustained release of the sodium butyrate particles in the intestinal tract (e.g., [0068]-[0070] and Table 1). Here, Example 1 of Lorenzo reads on the first-wherein clause (TRC1) because instant claim 1 recites the first wherein clause, and/or the second and third wherein clauses. Thus, under the broadest reasonable interpretation, claim 1 recites alternative limitation using “and/or”, thereby encompassing embodiments satisfying the first wherein clause alone. See MPEP2131 Anticipation: “When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.” Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) (instant claims 1 and 13, in part); and the granule product is used for animal feed product (e.g., [0012], [0018] and [0019]).
Lorenzo discloses the granular material based on sodium butyrate in powder form with a degree of purity greater than 90-95% (e.g., [0032]) and thus impurities including butyric acid may be present in the level of less than 5% (instant claim 2); as the lipid matrix, the fatty acids include C14, 16, 18, 20, and 22 in an amount of between 40 and 90% (e.g., [0040]) which overlaps the instant range of 40-80%, and C18 can be present in an amount of 20-50% and C16 can be present in an amount of 50-75% relative of the total fatty acids (e.g., [0048]) and thus the amount of C16+C18 can be 70% or more and thus, the ratio of C16 (50-75%) to C18 (20-50%) may be e.g., a range of 1 to 3.75 (=50/50% to 75/20%) that overlaps the instant range of 0.7 to 1.7. MPEP 2144.05:“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).”(instant claim 3); the lipid matrix further comprises a mineral agent in an amount of 1-20% (e.g., claim 1 of prior art) that overlaps the instant range of 2 to 10% and the mineral agent includes calcium sulphate dihydrate (e.g., [0042] and claim 2 of prior art). See MPEP 2144.05 above (instant claim 5); the lipid matrix comprises fatty acids such as C14, 16, 18, 20, and 22 in an amount of between 40 and 95% (e.g., abstract and [0040]) that overlaps the instant range of 40-80% and the sodium butyrate is present at an amount of 50% (e.g., [0034]) that is within the claimed range of 20-60% and the fatty acid includes preferably hydrogenated palm oil (elected species) (e.g., [0049])(instant claim 6); and the particle size of the granule may be below 500 microns (e.g., [0060]) which overlaps the instant range of 200microns to 1.5mm and the granule size depends on the supply pressure and the nozzle shape (e.g., [0061]), and sodium butyrate in powder has between 10-200 microns ([0032]) that overlaps the instant range of 50-1200 microns. See MPEP2144.05 noted above (instant claim 7). It is noted that instant claim 7 recites a list of alternatives “particle size”, “SPAN value”, “flow index”, or “moisture pick-up”, and thus, when the prior art teaches one of them, i.e., particle size, it reads on instant claim 7. In this context, please see MPEP 2143: Obviousness can be established by showing that the prior art would have suggested any one of the claimed alternative to one of ordinary skill in the art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009); and Lorenzo further discloses the granule product is used for animal feeds (e.g., [0012], [0018] and [0019]), and the particle size of the granules may be below 500 microns which overlaps the instant range of 200microns to 1.5mm and the granule size depends on the supply pressure and the nozzle shape (e.g., [0061]), and sodium butyrate in powder has between 10-200 microns ([0032]) that overlaps the instant range of 50-1200 microns (instant claim 14). It is noted that instant claim 14 recites a list of alternatives “particle size”, “SPAN value”, “flow index”, or “moisture pick-up”, and thus, when the prior art teaches one of them, i.e., particle size, it reads on instant claim 14. See MPEP 2143 noted above.
However, Lorenzo does not expressly teach spherical morphology of instant claims 1 and 13. The deficiency is cured by CN ‘369 and Shanmugam.
CN ‘369 discloses sodium butyrate enteric sustained release preparation and preparation method thereof (title); the preparation contains sodium butyrate that is white spherical particles (abstract and claim 8 of prior art) wherein the particles 200-500 microns which reads on the claimed granules as supported by instant publication at [0197] (granule size: 200microns – 1.5mm); sodium butyrate is the organic acid sodium salt of SCFA, has the breeding performance of animals of improvement, regulates the intestinal microbial population structure of community, keeps multiple effects such as intestinal normal morphology and enhancing human body immunity function (page 3, first para. of the translation); such sphericity morphology provides good fluidity and intestinal dissolving, good stability, humidity resistance can in gastrointestinal, slowly discharge, and improve the bioavailability of the product (page 4, fourth para. of translation). That is, CN ‘369 teaches/suggests white spherical particles of sodium butyrate, typically sized 200 to 500 micrometers, act as an enteric sustained-release preparation that preserves particle morphology, reduces hygroscopicity, and minimizes volatile odors while protecting the active core through simulated gastric and intestinal environments.
Shanmugam discloses granules are produced to enhance the uniformity of the API in the final product, to increase the density of the blend so that it occupies less volume per unit weight for better storage and shipment, to facilitate metering or volumetric dispensing, to reduce dust during granulation process to reduce toxic exposure and process-related hazards, and to improve the appearance of the product, and consequently, the ideal characteristics of granules include spherical shape for improved flow, narrow particle size distribution for content uniformity and volumetric dispensing, sufficient fines to fill void spaces between granules for better compaction and compression characteristics, and adequate moisture and hardness to prevent breaking and dust formation during process (see introduction – right column on page 55).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the teachings of Lorenzo with spherical morphology of granules of CN’369/Shanmugam, in order to keep particle morphology, reduce hygroscopicity, and minimize volatile odors while protecting the active core through simulated gastric and intestinal environments, as taught by CN ‘369, and provide improved flow, narrow particle size distribution for content uniformity and volumetric dispensing, sufficient fines to fill void spaces between granules for better compaction and compression characteristics, and adequate moisture and hardness to prevent breaking and dust formation during process, as taught by Shanmugam.
In light of the foregoing, instant claims 1-3, 5-7, 13 and 14 are obvious over the applied of Lorenzo in view of CN ‘369/Shanmugam.
Response to Arguments
Applicant’s arguments have been fully considered, but are moot in view of new reference of CN ‘369. However, the Examiner would like to address the followings.
Applicant argues that Lorenzon teaches TRCl 1 value of 61.17% and TRC3 value of 19.73% (see Table 1 of Lorenzon); and Shanmugam remains silent about relationship between granule morphology and gastric protection rate or sustained release.
The Examiner responds that Lorenzon teaches 61.17% of TRC1 which is close enough to the claimed range of 65%. In this regard, please see MPEP 2144.04. A prima facie case of obviousness applies when claimed ranges overlap with prior art or are so close that a skilled person would expect identical properties (Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)). TRC2 of Lorenzon overlaps the claimed TRC2 range while TRC3 of Lorenzon does not overlaps the claimed TRC3 range. However, Applicant can rebut this by proving criticality, unexpected results, or that the prior art teaches away. Further, instant Table 1 requires specific amounts of sodium butyrate and fatty materials, and however, the claimed invention does not require such amounts. Thus the tested data is not commensurate with the scope of instant claim 1. And, Shanmugam does not disclose relationship between granule morphology and gastric protection rate or sustained release, and but CN ‘369 discloses this features.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
All the examined claims are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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