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 1-14 are currently pending and a preliminary amendment to the claims filed on 09/01/2023 are acknowledged.
Election/Restriction
Applicant's election with traverse of Group I (claims 1-8, 13 and 14) and election of species (hydrogenated palm oil for fatty acid) in the Reply filed on 11/14/2025 are acknowledged. By way of applicant’s elections, claims 9-12 have been withdrawn from further consideration. Accordingly, claims 1-8, 13 and 14 are examined on the merits to which the following grounds of rejections are applicable.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that since the product and preparing method (several steps) have common features, it should be examined together without serious burden on examiner; and Applicant argues that search examination of the entire species could be conducted without undue burden on the Examiner.
The Examiner responds that shared technical features were known before the effective filing date of the invention in the prior art (WO2010/060914A1, IDS of 11/13/2023) as noted in the restriction requirement action, and thus, they cannot be considered contribution over the prior art that would otherwise unify the Groups. Therefore, Group I directed to a granule and Group II directed to a method of preparing the granule lack unity under PCT rule 13; and further, the instant application is a national stage entry of a PCT, which follows Unity of Invention rules. See MPEP § 823. There is no requirement for a showing of undue serious burden in searching the groups together under the Unity of Invention rules. See MPEP §1893.03(d); and lastly, species for each fatty materials have mutually exclusive characteristics in chemical structure and properties.
For those reasons, the restriction requirement is deemed proper and Final.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2023 was filed before the mailing date of the instant first 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.
Claim Objections
Claims 7-8 are objected to minor informalities under 37 CFR 1.75.
Claim 7 recites abbreviation “SPAN” in line 6, which should be spelled out.
Claim 8 recites “A population of granules comprising granules according to claim 1…”, but which would be better to write “A population of granules comprising the granules according to claim 1…”
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “the population of granules forming a powder has a flow index of 4 to 7 [FlodexTM index]”. This claim recites “bracket [ ]” which is used to comment on the flow index. However, it is not clear whether the limitation in the bracket is meant to be limitation in this claim. Further, claim 7 recites trademark, “FlodexTM index”. Here, the trademark “Flodex” identifies a commercial product, which is a powder flowability testing instrument. Use of a trademark in claim 7 to define a property or measurement renders the scope of the claim unclear because such terminology may refer to different materials, devices, or methodologies produced by a particular manufacturer and may be subject to change over time. Appropriate correction is requested.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lorenzon (WO2010/060914A1, IDS of 11/13/2023, citation is obtained from its corresponding US Publication no. US2011/0287104A1).
Applicant claims the below claim 1 filed on 09/01/2023:
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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”.
Prior Art
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 50% 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); and the granule product is used for animal feed product (e.g., [0012], [0018] and [0019]).
In light of the foregoing, instant claims 1 and 13 are anticipated by Lorenzo.
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) as applied to instant claims 1 and 13.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Lorenzo was discussed above with respect to instant claims 1 and 13.
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.
In light of the foregoing, instant claims 1-3, 5-7, 13 and 14 are obvious over the applied of Lorenzo.
Claims 4 and 8 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) as applied to instant claims 1-3, 5-7, 13 and 14, in view of Bighelarr (EP2727472A1) and Shanmugam et al. “Granulation techniques and technologies: recent progresses”, Biolmpacts, 2015, 5(1), 55-63.
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)
The difference between the instant application and Lorenzo is that Lorenzo does not expressly teach spherical shape of instant claims 4 and 8. Those deficiencies in Lorenzo are cured by the teachings of Bighelarr and Shanmugam.
Bighelarr discloses animal feed additive with butyrate salt (e.g., sodium butyrate) and the additive is in the form of granules ([0027]); and spherical ([0011]).
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 shape of granule of Bighelarr/Shanmugam, in order to 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 forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
All the examined claims are rejected.
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.
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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