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 .
Election/Restrictions
Applicant's election with traverse of Group II (claims 27-30) in the reply filed on February 18th, 2026 is acknowledged. The traversal is on the ground(s) that claims 16-30 relate to a product and a process of use of said product. This is not found persuasive because the.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 27-30 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on March 5th, 2026. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed November 27th, 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the applicant has not provided at least an English language abstract of Foreign Patent Document Cite No 4 (DE 102014104335 A1). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
A copy of an English language machine translation of DE 102014104335 A1 has been provided and cited on the PTO-892 form.
Drawings
The drawings were received on November 27th, 2023. These drawings are acceptable.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The use of the terms Profeed, Meiji, Siemens, Multistix, Fendigo, Abaxis, GmbH, CytoFlex, Beckman Coulter, Beckman-Coulter, CytExpert, Thermofisher [Thermo Fisher], East Coast, Bethyl, Tween, Merck, Cellular Technology, Raybiotech, Abbott, AML, Promega, QIIME, Permanova, RANDOX, R&D Systems, Miltenyi Biotec, Biolegend, Becton Dickinson, Illumina, HiSeq, and PlaGe, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 30 is objected to because of the following informalities: "at least 0.1-%" should be amended to "at least 0.1%" . Appropriate correction is required.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The term “parietal” is understood by the examiner as referring to the origin of certain components of the instantly claimed composition in the cell wall(s) of an organism. The instantly claimed composition is recited using the term “comprising” (instant claim 27); therefore, in certain embodiments, the instantly claimed composition encompasses additional components not explicitly recited, such as galacto-oligosaccharides. In the context of the instant claims, weight ratios and weight percentages are understood as equivalent to mass ratios and mass percentages, respectively, because the recited materials of the claimed composition are reasonably present in the same gravitational environment. The claims (27-30) are not interpreted by the examiner as reciting any limitations regarding the utility of the instantly claimed composition expected from administration to the subject.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 27-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more.
The claimed invention is directed to a composition comprising naturally without significantly more. The claim(s) recite(s) a composition comprising a fructo-oligosaccharide composition, and an extract of parietal saccharides from at least one Cyberlindnera species and at least one Saccharomyces species; wherein the extract of parietal saccharides comprises mannans, mannan- oligosaccharides, beta 1,3 glucans, chitin, beta 1,6 glucans, or mixtures thereof; and wherein the weight ratio of the fructo-oligosaccharide composition to the extract of parietal saccharides is at least 2 (instant claim 27). A feed preparation, a food preparation, or a nutraceutical composition comprising the composition of claim 27 (claim 29). This judicial exception is not integrated into a practical application because the applicant merely recites a composition comprising naturally occurring carbohydrates (instant claims 27-30). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because A feed preparation, a food preparation, or a nutraceutical composition comprising the composition of claim 27 (instant claims 29 and 30) are merely routine methods of administering a nutritional composition. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 27-30 are directed to a composition comprising a fructo-oligosaccharide composition, and an extract of parietal saccharides from at least one Cyberlindnera species and at least one Saccharomyces species, the claims are directed to a composition.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow
the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter
Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at:
https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked
to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines,
manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject
matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The
Office released guidance on December 16, 2014 for the examination of claims reciting natural products
under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and
Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d
1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view
that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and
technological work", and are thus excluded from patentability because "monopolization of those
tools through the grant of a patent might tend to impede innovation more than it would tend to
promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at
2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S.
66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this
"exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980.
The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural
phenomena; i.e., one may not patent every "substantial practical application" of an abstract
idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone
test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119
USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and
resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to
by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo
test, because while a preemptive claim may be ineligible, the absence of complete preemption
does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a
physical product, the courts have often referred to the exception as a "product of nature".
Products of nature are considered to be an exception because they tie up the use of naturally
occurring things, but they have been labeled as both laws of nature and natural phenomena.
See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature
exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281
(1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and
"phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of
nature" and "natural phenomenon" as inclusive of "products of nature".
It is important to keep in mind that product of nature exceptions include both naturally
occurring products and non-naturally occurring products that lack markedly different
characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all
non-naturally occurring products is whether they possess markedly different characteristics from
its closest naturally occurring counterpart.
When a claim recites a nature-based product limitation, examiners use the markedly
different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based
product limitation and determine the answer to Step 2A. Nature-based products, as used herein,
include both eligible and ineligible products and merely refer to the types of products subject to
the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this
analysis to identify product of nature exceptions. If the claim includes a nature-based product
that has markedly different characteristics, then the claim does not recite a product of nature
exception and is eligible. If the claim includes a nature-based product that does not exhibit
markedly different characteristics from its closest naturally occurring counterpart in its natural
state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires
further analysis in Step 2B to determine whether any additional elements in the claim add
significantly more to the exception.
Nature-based Product Claim Analysis
Where the claim is to a nature-based product by itself, the markedly different
characteristics analysis should be applied to the entire product. Where the claim is to a nature-
based product produced by combining multiple components, the markedly different
characteristics analysis should be applied to the resultant nature-based combination, rather than
its component parts. Where the claim is to a nature-based product in combination with non-
nature based elements, the markedly different characteristics analysis should be applied only to
the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its
naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to
its naturally occurring counterpart in its natural state. Markedly different characteristics can be
expressed as the product’s structure, function, and/or other properties, and are evaluated based
on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-
based product limitation does not exhibit markedly different characteristics, then that limitation is
a product of nature exception. If the analysis indicates that a nature-based product limitation
does have markedly different characteristics, then that limitation is not a product of nature
exception. Because the markedly different characteristics analysis compares the nature-based
product limitation to its naturally occurring counterpart in its natural state, the first step in the
analysis is to select the appropriate counterpart(s) to the nature-based product. When there are
multiple counterparts to the nature-based product, the comparison should be made to the
closest naturally occurring counterpart. When the nature-based product is a combination
produced from multiple components, the closest counterpart may be the individual nature-based
components of the combination. Because there is no counterpart mixture in nature, the closest
counterparts to the claimed mixture are the individual components of the mixture, i.e., each
naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281
(comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes.
In order to show a marked difference, a characteristic must be changed as compared to nature,
and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an
incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at
2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have
caused the claimed product to possess at least one characteristic that is different from that of
the counterpart. If there is no change in any characteristic, the claimed product lacks markedly
different characteristics, and is a product of nature exception.
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable
subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter.
YES, the claims are directed to a composition of matter and a process, which are statutory categories
within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception (e.g., law of nature, natural phenomenon, or an abstract idea; see MPEP 2106.04). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., a composition comprising carbohydrates that naturally occur in certain plant and fungal materials) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual naturally occurring carbohydrates).
Because the claim states the nature-based products which are plant and fungal extracts the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within certain plants (fructo-oligosaccharides; instant claim 27; instant specification, page 13 of 67, lines 12-14) and listed fungi genera (instant claims 27 and 28). This equates to an extract of plant and fungal materials. The process of creating a plant and fungal extract is by partitioning the starting plant and fungal material into separate compositions based upon some property. The closest naturally occurring counterparts of extracted components are those same components when found existing in the plant and fungus in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found in the plant and fungus they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A: prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a)
identifying whether there are any additional recited elements in the claim beyond the judicial exception
and (b) evaluating those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application.
This judicial exception is not integrated into a practical application because the plant and fungal extract composition is only comprising the nature-based components. The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more
than the judicial exception because these components and their activity are already found naturally
occurring in nature and the addition of an intended use does not impart any added benefit to the
compounds or integrate the composition into a practical application.
Step 2B evaluates whether the claim as a whole, amounts to significantly more than the recited
exception, i.e., whether any additional element, or combination of additional elements, adds an
inventive concept to the claim (see MPEP § 2106.05(b)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t
any other additional elements to consider, which does not add an inventive concept to the claims. Thus,the claims are not eligible subject matter under current 35 U.S.C. 101 standards.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Filho and Abou (EP 3476226 A1), and further in view of Van Den Berg et al. (WO 2019170790 A1).
Claim 27 recites “A composition comprising a fructo-oligosaccharide composition, and an extract of parietal saccharides from at least one Cyberlindnera species and at least one Saccharomyces species; wherein the extract of parietal saccharides comprises mannans, mannan- oligosaccharides, beta 1,3 glucans, chitin, beta 1,6 glucans, or mixtures thereof; and wherein the weight ratio of the fructo-oligosaccharide composition to the extract of parietal saccharides is at least 2”. Claim 28 recites “The composition according to claim 27, wherein the at least one Saccharomyces species is at least one Saccharomyces cerevisiae, and/or wherein the at least one Cyberlindnera species is at least one Cyberlindnera jadinii; and/or wherein the fructo- oligosaccharides are short-chain fructo-oligosaccharides having a polymerization degree ranging from 2 to 6. Claim 29 recites “A feed preparation, a food preparation, or a nutraceutical composition comprising the composition of claim 27”. Claim 30 recites “The feed preparation, the food preparation, or the nutraceutical composition according to claim 29, wherein said feed preparation, food preparation or nutraceutical composition comprises at least 0.1-% of the fructo-oligosaccharide composition in weight relative to the total weight of the feed preparation, the food preparation, or the nutraceutical composition; and at least 0.01% of the extract of parietal saccharides from the at least one Saccharomyces species and parietal saccharides from the at least one Cyberlindnera species, in weight relative to the total weight of the feed preparation, the food preparation, or the nutraceutical composition”.
Filho and Abou recite their claims 1 and 2 as follows:
“1. An immunomodulatory and growth promoting and controlling composition of undesirable bacteria population of the intestinal microbiota, characterized in that it comprises the following components:
(a) Fructooligosaccharides (FOS);
(b) Galacto-oligosaccharides (GOS);
(c) Mannan-oligosaccharides (MOS);
(d) 1,3 and 1,6 Beta-glucans.
2. An immunomodulatory and growth promoting and controlling composition of undesirable bacteria population of the intestinal microbiota according to claim 1, characterized in that it comprises the following components:
(a) Fructooligosaccharides (FOS);
(b) Galacto-oligosaccharides (GOS);
(c) Mannan-oligosaccharides (MOS);
(d) 1,3 and 1,6 Beta-glucans;
(e) other prebiotics with bifidogenic action” (Filho claims 1 and 2; instant claims 27, 28, and 30)
Filho and Abou further recite:
“5. An immunomodulatory and growth promoting and controlling composition of undesirable bacteria population of the intestinal microbiota according to claims 1 or 2, characterized in that it comprises the components:
(a) Fructooligosaccharides (FOS) with short chain polymers and/or Galacto-oligosaccharides (GOS);
(b) Mannan-oligosaccharides (MOS) extracted from Saccharomyces cerevisae;
(c) 1,3 and 1,6 Beta-glucans extracted from Saccharomyces cerevisae,
(d) other prebiotics with bifidogenic effect.
6. An immunomodulatory and growth promoting and controlling composition of undesirable bacteria population of the intestinal microbiota according to claims 1 or 2, characterized in that the FOS or Fructooligosaccharides comprise short chain polymers, which have a greater bifidogenic effect, i.e., comprises GF2, GF3, and GF4” (Filho claims 5 and 6; instant claim 28).
Where GF[number] is an abbreviation for notating a specific glucose-fructose structure (Filho specification, paragraph [0020]; instant claim 28).
Filho and Abou recite “This invention relates to a composition for additives which can be employed in animal feeds, or as growth promoters, or as nutraceuticals, or as prebiotics, or as additives for the control and prophylaxis of pathogenic bacteria in the intestinal tract of animals or farmed animals” (instant claims 29 and 30).
Regarding the description of certain saccharides as “parietal” (instant claims 27 and 30), Filho and Abou recite the following:
“Beta-glucans and mannans are part of the cell wall structure of yeast and fungi. For the industrial extraction of these elements and production of prebiotics, the most common and desirable are those extracted from yeasts of the genera Saccharomyces and Candida” (Filho, specification, paragraph [0036]; instant claims 27 and 30).
“MOS or Mannan-oligosaccharides of the composition of this invention are responsible for the agglutination of bacteria with type 1 fimbriae and must come from yeast cell walls of the genera Saccharomyces or Candida” (Filho, specification, paragraph [0066]; instant claims 27 and 30).
“Beta-glucans of the composition of this invention are responsible for the stimulation of the immune system and must be derived from the yeast cell wall extraction of the genera Saccharomyces or Candida, preferably Saccharomyces cerevisiae, from the sugar cane ethanol production” (Filho, specification, paragraph [0067]; instant claims 27 and 30).
Regarding the weight ratio of the fructo-oligosaccharide composition to the extract of parietal saccharides; Filho and Abou recite mass contents of 5-20% 1,3, and 1,6 Beta-glucans; 3-11% MOS (mannan-oligosaccharides); 3-45% GOS (galacto-oligosaccharides); and 3-80% FOS (fructooligosaccharides); where GOS and FOS are interchangeable (Filho, page 9 of 31, Table 1; paragraph [0012] for the meanings of the terms “GOS” and “FOS”). Therefore, Filho and Abou recite compositions ranging from 8-31% parietal saccharides and 3-80% FOS by mass, overlapping with a mass ratio of at least 2 of fructo-oligosaccharides to parietal saccharides (instant claim 27).
Although Filho and Abou do not recite an extract of parietal saccharides from at least one Cyberlindnera species, specifically Cyberlindnera jadinii, Van Den Berg recites:
“The present invention relates to yeast beta glucans for increasing the acetate concentration in the colon of a patient. According to another aspect, the present invention relates to yeast beta glucans for use in a method of treating or preventing a condition selected from overweight and obesity in a human or animal patient in need thereof”. (Field of the Invention), where:
“’Yeast beta-glucans’ (YBG), or yeast β-glucans, is defined herein as β-D-glucose polysaccharides containing a β-1,3-D-glucose backbone with β-1,6-D-glucose branches which are derived from yeast cell walls” (Definitions, paragraph 1; instant claims 27, 28, and 30), and
“In a preferred embodiment, the present yeast beta glucans are derived from a yeast of the genera Cyberlindnera, Candida, Yarowia, Pichia, Saccharomyces. More preferably the yeast is of the species Cyberlindnera jadinii, Yarowia lipolytica, Pichia pastoris, Candida utilis, Saccharomyces cerevisiae or Saccharomyces boulardii” (page 7 of 19, lines 18-21; instant claims 27, 28, and 30).
Although not reciting the same therapeutic effect as Filho and Abou, the disclosure of Van Den Berg makes of record the derivation of β-D-glucose polysaccharides containing a β-1,3-D-glucose backbone with β-1,6-D-glucose branches from the cell wall of Cyberlindnera, and explicitly the species Cyberlindnera jadinii. One of skill in the art would recognize that these beta glucans, through derived from Cyberlindnera jadinii, would be useful in preparing a composition for immunomodulation, promoting growth, and controlling composition of undesirable bacteria population of the intestinal microbiota (Filho, claim 1). Therefore, one of skill in the art could have combined the inventions of Van Den Berg and Filho with the predictable result of a composition for immunomodulation, promoting growth, and controlling composition of undesirable bacteria population of the intestinal microbiota, within the limitations of the instantly claimed composition (Filho, claim 1; instant claims 27, 28, and 30).
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). The compositions of Van Den Berg (in the embodiments derived from Cyberlindnera, including Cyberlindnera jadinii) and Filho are both thought to be useful for preparing a third composition for immunomodulation, promoting growth and controlling composition of undesirable bacteria population of the intestinal microbiota, as of record above.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, because Filho and Abou disclose the use of a composition comprising fructooligosaccharides; mannan-oligosaccharides; and 1,3 and 1,6 Beta-glucans for immunomodulation; promoting growth; and controlling composition of undesirable bacteria population of the intestinal microbiota; especially in the absence of evidence to the contrary (Filho, claim 1; instant claims 27, 28, and 30).
Filho and Abou do not explicitly recite a feed preparation, food preparation, or nutraceutical composition comprising at least 0.1% weight of the fructo-oligosaccharide composition and at least 0.01% weight of the extract of parietal saccharides from Saccharomyces sp. and Cyberlindnera sp. (instant claim 30). However, these weight percentages are achievable to one of skill in the art through routine optimization. One of skill in the art could use a scale instrument to control the weights of the materials combined to make the feed preparation, food preparation, or nutraceutical composition. One of skill in the art could then administer (to subject animals) different compositions comprising different weight percentages of the fructo-oligosaccharide composition and the extract of parietal saccharides from Saccharomyces sp. and Cyberlindnera sp. These different compositions could then be compared in terms of their utility, for instance at promoting body weight gain in pigs (Filho, Examples 17, 18, and 19).
Filho and Abou, and Van Den Berg are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the weight percentages of the fructo-oligosaccharide composition and the extract of parietal saccharides from Saccharomyces sp. and Cyberlindnera sp.in a feed preparation, food preparation, or nutraceutical composition; the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the feed preparation, food preparation, or nutraceutical composition), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Filho and Abou, and in view of Van Den Berg, the invention as a whole, drawn to a composition comprising a fructo-oligosaccharide composition, and an extract of parietal saccharides from at least one Cyberlindnera species and at least one Saccharomyces species as described in Claim 27, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67,
205 USPQ 594 (CCPA 1980), and “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).
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655