DETAILED ACTION
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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/30/2026 has been entered.
Status of Application
Claims 180-183 and 198-199 are pending and under consideration.
This Official Action is Non-Final.
Claim Rejections - 35 USC § 112
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 180-183 and 198-199 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 180 has been amended to recite that the synthetic oligosaccharide preparations are prepared with resins with sulfonic acid functionality. While the present specification provides for the use of specific catalysts such as 2-pyridinesulfonic acid, (+)-camphor-10-sulfonic acid Dowex Marathon C® (see Examples 6-8), there is no support the general concept of using any resin with sulfonic acid functionality
Specification
The amendment filed is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the present specification has been amended to recite that the synthetic oligosaccharide preparations are prepared with resins with sulfonic acid functionality. While the present specification provides for the use of specific catalysts such as 2-pyridinesulfonic acid, (+)-camphor-10-sulfonic acid Dowex Marathon C® (see Examples 6-8), there is no support the general concept of using any resin with sulfonic acid functionality
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
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 180-183, 198-199 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication No. 2016/0366909 (GEREMIA).
GEREMIA discloses administering a base composition [0013] and a synthetic oligosaccharide preparation comprising one or more oligosaccharides. This includes compositions with more than 3 different oligosaccharides See [0097]-[0098], [0101], [0103].
[0058] teaches that the oligosaccharide are added to animal feed and can be produced so to provide different properties. The oligosaccharide compositions may be characterized based on the type of oligosaccharides present, degree of polymerization, glass transition temperature, hygroscopicity, and glycosidic bond type distribution.
The oligosaccharides can be determined as the number average of species containing one, two, three, four, five, six, seven, eight, nine, ten to fifteen, and greater than fifteen, anhydrosugar monomer units [0097]. In [0097], it is taught that spectrophotometric methods are used to determine oligosaccharide content. It is taught that lower levels of degradation products results in higher selectively. The amount of sugar degradation products after combining the one or more sugars with the catalyst is less than about 10% (or less than about 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.75%, 0.5%, 0.25%, or 0.1%), such as less than about 10% of any one or combination of 1,6-anhydroglucose (levoglucosan, an anhydrous sugar) [0101].
Claim 180 recites that the synthetic oligosaccharide preparation is catalytically synthesized using a catalyst selected from the group consisting of 2-pyridinesulfonic acid, (+)- camphor-10-sulfonic acid and resin with sulfonic acid functionality. However, this recitation is interpreted in a manner similar to that of a product by process recitation in that no active steps of synthesizing the synthetic oligosaccharide with any type of saccharide. Moreover, there is no evidence that the catalyst is critical.
Thus, the number of different fractions and amount of anhydro-subunits can be varied based on the desired properties. In this regard, these are result effective variables and it would have been obvious to provide fractions that independently comprise 0.5 to 15% anhydro-subunits based on the desired properties of the final composition.
The administration of the composition would naturally result in the increase and decrease of the metabolites as claimed, as the same type of oligosaccharides are administered. Given the prior art teaches the administration of compounds comprising base nutritional compositions and a synthetic oligosaccharide composition, any effects on the level of a plurality of metabolites are considered to be present in the animals administered the prior art composition in the absence of convincing arguments or evidence to the contrary.
Response to Arguments
Applicant's arguments filed 1/30/2026 have been fully considered but they are not persuasive.
The applicant argues that GEREMIA has been misinterpreted. In particular, the applicant argues that [0097] of GEREMIA merely discloses that the average DP can be analyzed by determining an average of species containing one or more anhydrosugar monomer units. The applicant also argues that [0101] of GEREMIA merely discloses that in some embodiments the oligosaccharide compositions have particularly low sugar degradation products. Among others, levoglucosan is listed, which is a monomeric anhydro-sugar, i.e. DP1. There is, however, no disclosure of any DP2 anhydro-sugar.
However, GEREMIA does teach providing oligosaccharide compositions suitable for use in animal feed compositions, and methods for producing oligosaccharide compositions suitable for use in animal feed compositions. In one aspect, provided is a method of producing an animal feed composition, by: combining feed sugar with a catalyst to form a reaction mixture; producing an oligosaccharide composition from at least a portion of the reaction mixture; and combining the oligosaccharide composition with a base feed to produce an animal feed composition [0008]. Additionally, the oligosaccharide composition can be a “short oligosaccharide composition” referring to oligosaccharide composition with an average DP of about 2, about 3, about 4, about 5, about 6, or about 7 [0067]. Paragraphs [0097] and [0101] must be taken into consideration with the overall teachings of GEREMIA.
It is alleged that it is not clear, how and why the number of different fractions could be varied based on "the desired properties" in GEREMIA.
However, GEREMIA does teach that the properties of such compositions may vary, depending on the type of sugars as well as the reaction conditions used [0058]. In this regard, one skilled in the art would have been motivated to optimize the reaction conditions and types of sugars used. It is also noted that while the current claims recite catalysts there no specific recitation of the sugars or additional reaction conditions.
Applicant also argues that without the benefit of the disclosure of the present application one would not have gleaned the present invention from GEREMIA.
However, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The applicant argues that different that different synthetic oligosaccharides achieve different effects. This is allegedly shown in the present application, e.g. Table 26, or in paragraph [1219] of Example 40. It is argued that "It was confirmed that different treatment groups from the broiler study of Example 35 exhibited different and statistically distinguishable functional metabolic signatures."
However, there is no evidence to suggest the differences result from the catalyst. Example 35 [001154] indicates that the T5 exhibited the most significant difference. T5 coincides with Example 9.2 which relies on Example 2 [001058]. Example 2 [1045] shows that glucose monohydrate (1,150 g) was added to a three-liter, three-neck round bottom flask with one center 29/42 ground glass joint and two side 24/40 ground glass joints. A 133 mm Teflon stirring blade was affixed to glass stir shaft using PTFE tape. The stir rod was secured through the center port of the flask using a Teflon bearing adapter and attached to an overhead high-torque mechanical mixer via flex coupling. The flask was secured inside a hemispherical electric heating mantle operated by a temperature control unit via a J-type wand thermocouple inserted through a rubber septum in one of the side ports. The tip of the thermocouple was adjusted to reside within the reaction mixture with several mm clearance above the mixing element. A secondary temperature probe connected to an auxiliary temperature monitor was also inserted and secured by the same means. The second side port of the flask was equipped with a reflux condenser cooled by a water-glycol mixture maintained below 4 C by a recirculating bath chiller. The reaction mixture was gradually heated to 130° C. with continuous mixing with a stir rate of 80-100 rpm. When the reaction temperature increased to between 120° C. and 130° C., (+)-Camphor-10-sulfonic acid (1.16 g, Sigma-Aldrich, St. Louis) was added to the three-neck flask and the apparatus was switched from a reflux condenser to a distillation configuration with a round bottom collection flask placed in an ice bath. This setup was maintained for 1 and a half hours, after which the thermocouple box was powered off, the distillation apparatus was removed, and 390 g of 23 degrees C. distilled water was gradually added into the three-neck flask. The resulting mixture was left to stir at 40 rpm for 10 hours until the moment of collection. Approximately 1300 g of a viscous, dark-amber material was collected and measured to have a concentration of 72.6 brix. None of this Is reflected in the claims. In this regard, applicant’s arguments are not commensurate in scope with the claims (i.e., in particular the saccharide used and conditions to obtains such saccharide) . Thus, while the applicant argues that specific synthetic oligosaccharide preparations can produced significant results, the breadth of the claims are such that they are not commensurate in scope with applicant’s arguments.
Conclusion
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/PHILIP A DUBOIS/Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791