DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to the amendment received from the applicant on June 24th, 2026. Claims 1-15 have been cancelled. Claims 16-26 have been withdrawn.
Claims 27-30 are pending and were examined on the merits.
Any objections or rejections not reiterated below are hereby withdrawn.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed June 24th, 2026, with respect to the objection to claim 30 have been fully considered and are persuasive. Instant claim 30 does not recite the expression “1.0-%”, but rather “1.0%”. The objection to claim 30 has been withdrawn.
Applicant’s arguments, filed June 24th, 2026, with respect to the rejection of claims 27-30 under 35 U.S.C. 103 have been fully considered and are persuasive. A composition comprising chitin and a mannan-protein complex, as claimed in amended claim 27, from which claims 28-30 depend, is not obvious over the prior art references Filho and Van Den Berg. Therefore, the previous rejection of claims 27-30 under 35 U.S.C. 103 has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the applicant's amendment.
Pending Objections and Rejections
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.
Applicant's arguments filed June 24th, 2026 have been fully considered but they are not persuasive. There are still trademarks and/or tradenames .
The use of the terms Profeed, Abaxis, CytoFlex, Beckman Coulter, Beckman-Coulter, CytExpert, Thermofisher (registered as Thermo Fisher), Thermo (registered as Thermo Fisher), Thermo Fisher Scientific, Bethyl, Tween, Merck, Raybiotech, Abbott, AML, Promega, RANDOX, R&D Systems, Miltenyi biotech (registered as Miltenyi Biotec), Miltenyi Biotec, Legendplex, Biolegend, Becton Dickinson, Illumina, and HiSeq, each of which is a trade name or a mark used in commerce, has been noted in this application. The 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 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.
Applicant's arguments filed June 24th, 2026 have been fully considered but they are not persuasive. The the instantly claimed composition is a human made formulation with deliberate selection and combinations of multiple components from different sources. However, it is not clear from the language of the claims that the composition has functional characteristics or physical or chemical properties that differentiate it from its naturally occurring source materials.
The applicant alleges that the specification further confirms that the claimed combination exhibits properties associated with the claimed formulation as a whole, rather than any single naturally occurring constituent in isolation. The applicant has not specifically pointed out what properties are associated with the claimed formulation as a whole, rather than any single naturally occurring constituent in isolation, and has not pointed out where these properties are supported in the instant specification. Therefore, the applicant’s remarks regarding the rejection of claims 27-30 under 35 U.S.C. 101 do not contain persuasive support for the allegation of properties associated with the claimed formulation as a whole, rather than any single naturally occurring constituent in isolation.
The rejection of claims 27-30 under 35 U.S.C. 101 is maintained.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Filho
(EP 3476226 A1); and further in view of Van Den Berg et al. (WO 2019170790 A1), abbreviated “Van Den Berg”; Kurzinger (US 6306453 B1); Mancebo Molina et al. (WO 2014001589 A1; citations below refer to the English language DERWENT document), abbreviated “Mancebo Molina”; and Courie et al. (US 20090092641 A1), abbreviated “Courie”.
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, glycoproteins, beta 1,3 glucans, chitin, and beta 1,6 glucans; wherein the mannans are complexed at least partially to proteins forming glycoproteins, and at least 20% of said glycoproteins in the extract of parietal saccharides are at least 100 nm long; 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 recites 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 further recites:
“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 recites “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 recites 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).
Although Filho does 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, 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 recites the species Cyberlindnera jadinii. From the teachings of Filho, 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 substituted the 1,3 and 1,6 Beta-glucans extracted from Saccharomyces cerevisiae (Filho, claim 5) with the 1,3 and 1,6 Beta-glucans extracted from the cell wall of Cyberlindnera, with the predictable result of a composition for immunomodulation, promoting growth, and controlling composition of undesirable bacteria population of the intestinal microbiota.
Although Filho does not recite an extract of parietal saccharides comprising chitin, one would have been motivated to incorporate chitin into the immunomodulatory composition recited by Filho (Filho, claim 1), because chitin is known in the art as an immune stimulator (Kurzinger, Description, paragraph (2); instant claim 27). One of skill in the art would have had a reasonable expectation of success at obtaining chitin by extracting it from the cell wall of Saccharomyces cerevisiae according to the protocol recited by Mancebo Molina (Abstract, Description; instant claims 27 and 28). In this case one of skill in the art would have been motivated to combine the teachings of Kurzinger and Mancebo Molina for the practical purpose of obtaining chitin (Mancebo Molina) to use as an immune stimulator (Kurzinger).
Although Filho does not recite an extract of parietal saccharides comprising mannans complexed with proteins, Courie recites mannans and mannan proteins beneficial for the health of the intestinal microbiome, and the value of mannans and manno-proteins as immunobiotics:
“Mannans and manno-protein molecules are beneficial in preventing the attachment of bacteria such as Escherichia coli to the intestinal wall, thus reducing the overall infection challenge in the animal. The mannans and manno-protein complexes add additional protection and reduce overall infection challenge by preventing pathogenic organisms from attaching to the gut, thus the animal is less likely to develop an infection. Mannan has also been shown to mediate phagocytosis of material, including β-glucan, by cells of the immune system (Giaimis et al (1993) Journal of Leukocyte Biology, 54, 564-571). Thus, mannans and manno-protein complexes are also of value as immunobiotics, and may be particularly useful when combined with immuno-enhancing agents” (Courie, paragraph [0009]; instant claim 27).
The term “manno-protein” refers to mannans in covalent association with proteins (Courie, paragraph [0131]; claim 27). Courie recites “These types of polysaccharide complexes are found in the cell wall of various types of cells, including, but not limited to plant, yeast, fungi and bacteria” (paragraph [0131]; claim 27). Courie recites isolation of the complexes from Saccharomyces spp., including Saccharomyces cerevisiae, as a non-limiting example (paragraph [0131]; claims 27 and 28). Courie also recites that mannans may be extracted from various yeast species, and that “Mannans are mannose polymers and represent a significant portion of the total cell wall polysaccharide component; mannans are found in covalent association with proteins, and may also comprise a phosphate component” (Courie, paragraph [0008]; instant claim 27).
One of skill in the art would have been motivated to combine the teachings of the cited references above for the purpose of making a composition for an immunomodulation, promoting growth, and controlling composition of undesirable bacteria population of the intestinal microbiota (Filho, claim 1). One of skill in the art would have had a reasonable expectation of making a composition for an immunomodulation, promoting growth, and controlling composition of undesirable bacteria population of the intestinal microbiota by combining the polysaccharide compounds and complexes taught by references above, resulting in a composition comprising fructooligosaccharides, mannans, mannan-oligosaccharides, glycoproteins, beta 1,3 glucans, chitin, and beta 1,6 glucans (instant claim 27).
The prior art references do not explicitly recite the limitation “at least 20% of said glycoproteins in the extract of parietal saccharides are at least 100 nm long” (instant claim 27). However, these parameters are obvious over routine optimization. One of skill in the art could have separated glycoproteins by mass using column chromatography (including size exclusion chromatography). One of skill in the art could use tandem mass spectrometry analysis of the glycoproteins to propose reasonable structures of the glycoproteins, including their molecular lengths. Alternatively, one of skill in the art could use dynamic light scattering to measure the particle size distribution of glycoproteins. One of skill in the art could test compositions, varying by glycoprotein length distribution, on different subjects and observe the biological effects of administration, including effects on the microbiome using genomic analysis of feces (instant claim 27).
The prior art references do not explicitly recite “the weight ratio of the fructo-oligosaccharide composition to the extract of parietal saccharides is at least 2” (instant claim 27). However, this weight ratio would be obvious to one of skill in the art over routine optimization. One of skill in the art could weigh a plant-derived fructooligosaccharide composition (Filho, specification, paragraph [0020]) and an extract of parietal saccharides from Cyberlindnera and Saccharomyces separately before combining them. One of skill in the art could test compositions, varying by the fructo-oligosaccharide composition : extract of parietal saccharide weight ratio, on different subjects and observe the biological effects of administration, including effects on the microbiome using genomic analysis of feces (instant claim 27).
Filho does not explicitly recite a 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 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, Van Den Berg, Kurzinger, Mancebo Molina, and Courie 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 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 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 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 in view of Van Den Berg, Kurzinger, Mancebo Molina, and Courie, 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 Claims 27-30, 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).
Relevant and Prior Art Made of Record
The relevant and/or prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including the following:
Shin (US 20120129803 A1) recites chitin promoting the proliferation of intestinal beneficial bacteria (paragraph [0008]).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground 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 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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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/
Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights