DETAILED ACTION
The present application is a domestic application filed 03 March 2023, which is a continuation of US Application No. 16/743,806 (now US Patent No. 11,622,974), filed 15 January 2020, which claims priority to US Provisional Application No. 62/869,248, filed 01 July 2019, and US Provisional Application No. 62/794,452, filed 18 January 2019.
The preliminary amendment filed 19 November 2025 is acknowledged. Claims 1-7 and 25-28 are pending in the current application.
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 .
Information Disclosure Statement
The information disclosure statement filed 03 March 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 and 25-28 in the reply filed on 19 November 2025 is acknowledged.
Applicant’s election without traverse of high acyl gellan in the reply filed on 19 November 2025 is acknowledged. To expedite prosecution of the present application, the species has been expanded to include low acyl gellan.
Canceled claims 8-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 November 2025.
Claim Objections
Claim 1 is objected to because of the following informalities: The recitation “DP” is defined in the present Specification as “Degree of Polymerization” (see paragraph [0104] of the present PGPub). It is respectfully requested that the first instance of an abbreviation be accompanied by the actual full term.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-7 and 25-28 are 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.
The recitation “a sphingan oligosaccharide with DP from 2 to 30” in claim 1 renders the claim herein indefinite. According to the Specification, “native sphingan” comprises a substituted or unsubstituted tetrameric saccharide (“tetramer”) depicted generally as [([Wingdings font/0xE0]3)Glc, (β1[Wingdings font/0xE0]4)GlcA, (β1[Wingdings font/0xE0]4)Glc, and (1[Wingdings font/0xE0]4)Rha)], (Spec: para [0101]).
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The value ‘n’ refers to a whole or fractional number, and refers to the number of tetrameric units that may be substituted or unsubstituted (Spec: para [0103]). Thus, a DP of 16 is equivalent to where n is four.
The expression “sphingan oligosaccharide” (or “SOS”), as used herein, refers to high/low acyl sphingan having a DP greater than or equal to two and less than or equal to thirty (i.e., 2 ≥ DP ≤ 30). It is understood that a SOS obtained from a high/intermediate/low acyl sphingan (or HA/IA/LA sphingan) may comprise a plurality of oligosaccharides.”. (Spec: para [0106]).
The term “oligosaccharide” and “sphingan oligosaccharide” are not clearly defined. It is not clear what is meant by a “plurality of oligosaccharides”. The term “plurality of oligosaccharides” is not recited in the claims. Furthermore, the claims do not recite the SOS are obtained from a high/intermediate/low acyl sphingan. And finally, since it appears the oligosaccharide does not require the tetramer that is the defining structure and definition and meaning of a sphingan, and in light of the varying structures recited in claim 7 (i) as examples of a sphingan oligosaccharide, the term “shingan oligosaccharide” is broadly and reasonably interpreted to include any oligosaccharide comprising glucose, glucuronic acid and rhamnose.
The recitation “high/intermediate/low sphingan” in claim 7 renders the claim herein indefinite. It’s not clear if this refers to the molecular weight, percent acylation, or percent glycerate.
Claim 7 is directed towards alternative compositions. It’s not clear if all the components in (i) are required since the end of the limitation for (i) recites “, or a combination thereof”. On the other hand, the group of oligosaccharides listed in section (ii) does not recite an “and”, or an “or” before the last alternative. See MPEP 2173.05(h) for guidance on how to recite alternative limitations.
It’s also not clear if the abbreviated monosaccharides listed within the parenthetical markers are required. This is particularly confusing with the recitation “an octamer (Glc,GlcA,Glc,Rha,Glc,GlcA,Glc,Rha) with acetate and/or glycerate, Glc,GlcA,Glc, Rha,Glc,GlcA, Glc,Rha”. The alternatives listed in claim 7 (ii) include components within parenthesis, and components without parenthesis. Finally, the last eight saccharide abbreviations include spaces between “Glc,GlcA,Glc” and “Rha,Glc,GlcA” and “Glc,Rha”. It was assumed spaces between lists of abbreviations indicated a break, or separation, or distinction in oligosaccharide composition. However, the use of spaces in what appears to be reference to an octamer enters ambiguity into the claim. These issues are repeated throughout claim 7.
Tables such as the one recited on p.30 of the Specification; or listing each discrete oligosaccharide on separate lines might be beneficial in clarifying the oligosaccharides present and defined within the composition.
The recitation “The ingestible composition of claim 1, for use (A) promoting beneficial bacterial growth in the colon of a mammal by a method comprising ingesting…” in claim 4, renders the claim and dependent claims 5, 6 and 25-28 herein indefinite. The present claims are product claims, yet claim 4 appears to recite a method of use, which is another statutory category of invention. Applicant elected Group I, drawn to an ingestible composition for examination. The claims should be amended so that claim 4 is clearly not drawn to a method having an active step.
Similarly, the recitation of “mammal is a human and the amount of the sphingan is 10 mg/kg to 150 mg/kg of the human ingesting the composition” in claim 5 appears to be an active step, which is improper in a product claim.
Claim Interpretation
Claim 1 is directed towards a “sphingan oligosaccharide” having a DP from 2 to 30. As discussed above, since sphingan is understood to represent a tetramer, and a molecule having a DP2 would not exist as a tetramer, the term “sphingan oligosaccharide with DP from 2 to 30” has no understood meaning or definition.
According to claim 7, the prebiotic comprises “a composition comprising Glc,GlcA”. Thus, any composition comprising an oligosaccharide comprising glucose and glucuronic acid, wherein the oligosaccharide has a DP from 2 to 30, will read on the claims.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 25-28 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hotchkiss et al. (US Patent No. 8,313,789, cited in PTO-892).
Hotchkiss et al. disclose a prebiotic comprising a pectic oligosaccharide (POS) having a DP of 4 to 8 (col.3:5-12). According to Table 1, lemon POS comprises glucose, and glucuronic acid, i.e. Glc,GlcA (col.7 and 8).
As discussed above, a “sphingan oligosaccharide” is interpreted to include any composition comprising an oligosaccharide comprising glucose and glucuronic acid, wherein the oligosaccharide has a DP from 2 to 30, will read on the claims.
The limitations recited in claim 4 are interpreted as an intended use of the composition, and do not have patentable weight. The same applies to newly added claims 25-28.
Thus, the disclosure of Hotchkiss et al. anticipates claims 1-7 and 25-28 of the present application.
Claim(s) 1-7 and 25-28 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Nobuyuki et al. (JPH09-234065, cited in IDS submitted 19 November 2025).
Nobuyuki et al. disclose obtaining a gellan oligosaccharide that can be used as food material (title). Nobuyuki et al. disclose the use of a gellan lyase that cleaves a tetrasaccharide unit from the end of gellan, to give: ∆-4,5-GlcA-(1[Wingdings font/0xE0]4)-β-D-Glc-(1[Wingdings font/0xE0]4)-α-L-Rha-(1[Wingdings font/0xE0]3)-β-D-Glc (claims). The D-glucosyl residue is O-acetylated or glycerinated (para [0002]).
The gellan oligosaccharide therefore has a DP of 4. And since Noboyuki et al. disclose it can be used as food material, it is an ingestible composition.
The recitation “for a prebiotic” in claim 1 is an intended use of the composition. The limitations recited in claim 4 are similarly interpreted as an intended use of the composition, and do not have patentable weight. The same applies to newly added claims 25-28.
Thus, the disclosure of Nobuyuki et al. anticipates claims 1-7 and 25-28 of the present application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 and 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,297,299. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed towards obtaining a sphingan oligosaccharide having a molecular weight of not more than 10 kDa (claim 1). Claim 20 is drawn towards an ingestible composition comprising a prebiotic effective amount of the composition of claim 1. Claim 24 further defines the sphingan oligosaccharide as having a DP of 2 to 16.
The limitations recited in claim 4 are interpreted as an intended use of the composition, and do not have patentable weight. The same applies to newly added claims 25-28.
Thus, the disclosure of the ‘299 Patent anticipates claims 1-7 and 25-28 of the present application.
Claims 1-7 and 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,622,974. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 is directed towards a gellan oligosaccharide comprising the same oligosaccharides recited in present claim 7. Claim 1 is directed towards a method of administering a composition comprising said oligosaccharides as a prebiotic.
The limitations recited in claim 4 are interpreted as an intended use of the composition, and do not have patentable weight. The same applies to newly added claims 25-28.
Thus, the disclosure of the ‘974 Patent anticipates claims 1-7 and 25-28 of the present application.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699