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 .
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.
Response to Amendment
The amendment filed May 29, 2026 has been entered. Claims 1-2, 4-5, 7-9, 14, 16, 18 have been amended, claims 3, 6, 10-13, 15, and 17 are canceled, and claims 20-21 have been added. Applicant’s amendments to the claims have overcome the objections to the specification, 112a, 112b, 112d rejections previously set forth in the Non-Final Office Action mailed December 19, 2025. Applicant’s arguments with respect to the 112b rejections of 8-9 and 14-19 for the phrases food product, pharmaceutical product, and allowing were found to be persuasive. Applicant’s amendments have overcome the 102 rejections of claims 1-2, 4-5, 7-9 over Li (Mar. Drugs, 2019, cited in previous action). Applicants cancellation of claims 3, 12-13, 15, and 17 have rendered the corresponding rejections/objections moot. As such, these rejections and objections are hereby withdrawn.
Applicant’s arguments filed May 29, 2026 with respect to the 102 rejections as they currently apply were fully considered but they were not persuasive. Maintained/New rejections necessitated by Applicant’s amendment are addressed below.
Claims 1-2, 4-5, 7-9, 14, 16, 18-21 are pending in this application.
Priority
This application claims priority under 35 U.S.C. § 371 to International Application No. PCT/JP2021/044875, filed December 7, 2021, and claims priority therethrough under 35 U.S.C. § 119 to Japanese Patent Application No. 2021-089998, filed May 28, 2021, and Japanese Patent Application No. 2020-202884, filed December 7, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies have been received. The Examiner notes that no English language translation was provided.
Maintained/New 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.
Claims 1-2, 4-5, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (Food Func., 2020, IDS filed June 6, 2023) as evidenced by Li (Mar. Drugs, 2019, cited in previous action), hereinafter referred to as Li (Mar. Drugs, 2019) and Miquel (Gut Microbes, 2014, cited in previous action).
Regarding claims 1-2, 4-5, 8-9: Li teaches a composition comprising unsaturated alginate oligosaccharides (UAOS) for the treatment of obesity and related metabolic diseases by modulating gut microbiota (abstract). Li teaches the UAOS (M/G, 1.66) were administered to obese mice (pgs. 4775, bridging para.). The UAOS were administered via intragastric gavage (i.e. food/pharmaceutical product, pg. 4776, fig. 1). Li teaches UAOS treatment increased the abundance of bacteria in HFD-fed mice (pg. 4779, col. 2, para. 1) Li teaches the UAOS were prepared following the previous protocol and cites Li (Mar. Drugs, 2019). According to Li (Mar. Drugs, 2019) the structures of the enzymatic unsaturated alginate oligosaccharides (UAOs) are as follows:
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with an unsaturated double bond between C4 and C5 (pg. 5, para. 1, figure 1A, i.e. instant claim 2). According to the instant specification a double bond at position 4 and 5 of the mannuronic or guluronic acid residues are at the non-reducing end (pg. 17, para. 0025). According to Li (Mar. Drugs, 2019) the main ingredients of the UAOS were disaccharides and trisaccharides (i.e. degree of polymerization of 2-3, pg. 5, last para.). Li demonstrates the UAOS are disaccharides and trisaccharides
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(pg. 4780, figure 7). Thus, following the method of Li (Mar. Drugs, 2019), the UAOS of Li necessarily possess these properties, absent evidence to the contrary.
Although Li does not explicitly disclose that the composition promotes the growth of Faecalibacterium prausnitzii specifically, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112). Miquel discloses that Faecalibacterium prausnitzii is a major commensal bacterium that is widely distributed in the GIT of mammals, including mice (abstract, pg. 147, col. 2, last para.). According to the instant specification the proportion of all enteric bacteria, including Faecalibacterium prausnitzii, were increased because the proportions of oligosaccharides have a polymerization degree of 2 or 3 in the oligosaccharide sample (pgs. 59-60, para. 0086). Wherein mice possess Faecalibacterium prausnitzii as commensal bacterium as disclosed by Miquel, upon administration of the composition Li having polymerization degree of 2 or 3 in the oligosaccharides, the resulting promotion in growth necessarily occurs as a result of practicing the method, absent evidence to the contrary.
Regarding claim 7: Li teaches UAOS treatment significantly decreased the gene expression levels of proinflammatory cytokines associated with oxidative stress (pg. 481, col. 1, para. 2).
Claims 14, 16, 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (Mar. Drugs, 2019, cited in previous action) as evidenced by Haug (Acta Chem. Scand., 1966, cited on PTO-892) and Miquel (Gut Microbes, 2014, cited in previous action).
Regarding claims 14, 16, 18-21: Li teaches the preparation of a composition comprising unsaturated mannuronate oligosaccharides (UAOS) and unsaturated guluronate oligosaccharides (UGOS) from reacting the enzyme alginate lyase Aly08 with Polyguluronate block (Poly G) and polymannuronate (Poly M) (DP = 20–24) prepared from sodium alginate (i.e. allowing an alginate lyase to act on a hydrolysate of sodium alginate, pg. 3, para. 2). The Poly G and Poly M were prepared according to the method of Haug (pg. 3, para. 2). According to Haug the mannuronic acid residues and guluronic acid residues were prepared from the hydrolysis of alginate using acid hydrolysis (abstract). Li teaches the administration of the UAOS to mice via feeding (i.e. formulated as food) exhibited anti-obesity effects (i.e. a pharmaceutical product, abstract). Li teaches the structures of the enzymatic unsaturated alginate oligosaccharides (UAOs) are as follows:
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with an unsaturated double bond between C4 and C5 (pg. 5, para. 1, figure 1A, i.e. instant claim 2). According to the instant specification a double bond at position 4 and 5 of the mannuronic or guluronic acid residues are at the non-reducing end (pg. 17, para. 0025). Li teaches the main ingredients of the UAOS were disaccharides and trisaccharides (i.e. degree of polymerization of 2-3, pg. 5, last para.). Li teaches the UMOS and UGOS were separated (i.e. collected, pg. 5, para. 1).
Although Li does not explicitly disclose that the composition promotes the growth of bacteria, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112). Miquel discloses that Faecalibacterium prausnitzii is a major commensal bacterium that is widely distributed in the GIT of mammals, including mice (abstract, pg. 147, col. 2, last para.). According to the instant specification the proportion of all enteric bacteria, including Faecalibacterium prausnitzii, were increased because the proportions of oligosaccharides have a polymerization degree of 2 or 3 in the oligosaccharide sample (pgs. 59-60, para. 0086). Wherein mice possess Faecalibacterium prausnitzii as commensal bacterium as disclosed by Miquel, upon administration of the composition Li having polymerization degree of 2 or 3 in the oligosaccharides, the resulting promotion in growth necessarily occurs as a result of practicing the method, absent evidence to the contrary.
Response to Arguments
Applicant’s arguments filed May 29, 2026 with respect to the 102 rejections have been fully considered but they are not persuasive.
On page 10 of Applicant’s response, Applicant argues the newly amended claims are directed to a specific and targeted use of narrowly defined alginate oligosaccharides to selectively enhance growth of butyrate-producing bacteria, including F. prausnitzii, which is a well-recognized as an important commensal bacterium associated with intestinal health and butyrate production (para. 6). On page 10 of Applicant’s response, Applicant argues Li neither teaches nor suggests these claimed methods, nor does Li provide any disclosure that would have motivated a person of ordinary skill in the art to employ the presently claimed oligosaccharides for selectively promoting growth of a butyrate-producing bacterium (last para.).
However, as discussed above, Li (Food Func., 2020) teaches a composition comprising unsaturated alginate oligosaccharides (UAOS) for the treatment of obesity and related metabolic diseases by modulating gut microbiota (abstract). According to the instant specification the proportion of all enteric bacteria, including Faecalibacterium prausnitzii, were increased because the proportions of oligosaccharides have a polymerization degree of 2 or 3 in the oligosaccharide sample (pgs. 59-60, para. 0086). The intended purpose of Li (Food Func., 2020) is to thus affect gut microbiota and although Li (Food Func., 2020) does not disclose the effect on promoting growth of a butyrate-producing bacteria, wherein mice possess Faecalibacterium prausnitzii as commensal bacterium as disclosed by Miquel, upon administration of the composition Li having polymerization degree of 2 or 3 in the oligosaccharides, the resulting promotion in growth necessarily occurs as a result of practicing the method, absent evidence to the contrary. Additionally, Li (Mar. Drugs, 2019) is directed to producing a composition, which is used in Li (Food Func., 2020), which necessarily possesses to ability to promote bacterial growth. A composition's properties cannot be separated from the composition itself. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112). The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated (See MPEP 2112. 02 (II)).
On page 11 of Applicant’s response, Applicant argues Li fails to disclose or suggest oligosaccharides having a polymerization degree of 2 or 3, or comprising an unsaturated mannuronic acid residue or a guluronic acid residue at the non-reducing end (para. 1).
However, both Li (Food Func., 2020) and Li (Mar. Drugs, 2019) are directed to compositions made by the same method having disaccharides/trisaccharides which have an unsaturation at the non-reducing end.
On page 11 of Applicant’s response, Applicant argues the presently claimed selection yields results that are both specific and unexpected, wherein oligosaccharides significantly increase the proportion of F. prausnitzii (para. 2). Applicant argues such selective enhancement of F prausnitzii would not have been predictable from the teachings of Li (para. 2).
However, unexpected results cannot overcome a 35 USC § 102. As discussed above, The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112).
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 102 rejection is maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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