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 .
CONTINUING DATA
This application is a 371 of PCT/CN2021/108344 07/26/2021
FOREIGN APPLICATIONS
CHINA 202010987084.8 09/18/2020
This office action is in response to Applicant’s amendment submitted January 14, 2026. Claims 1-7, 9-10, and 12-16 are pending.
Claims 10, 12-14, 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 October 2, 2025.
The rejection of claim 7 under 35 U.S.C. 112(b) is withdrawn.
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 1-7, 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. Claims 1-7, 9 recite a sugar chain containing the recited building blocks and a composition comprising the sugar chain. The scope of the sugar chains recited in the claims includes products of nature. For example, claim 6 recites blood group antigens, which are naturally occurring in blood. Claim 9 recites 3’-sialyllactose and 6’-sialyllactose, which are human milk oligosaccharides. These are only a few examples of natural products found within the scope of the claims. The published application recites a group of HMOs in paragraph [0191].
Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should 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.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “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…”.
In this case, for example, 3’-SL and 6’-SL naturally occur in human milk. Thus, the closest naturally occurring counterpart for the claimed sugar chain is human milk itself. The claimed sugar chain is not structurally or functionally different from the sugar chain found in nature. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring 3’-SL or 6’-SL. Thus, the claimed sugar chain does not display markedly different characteristics in comparison with the naturally occurring sugar chain. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a sugar chain itself, so there are no additional elements. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, applicant’s claims are directed to a sugar chain itself, so there are no additional elements.
Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicant argues that human milk or blood are not the closest natural counterpart because the markedly different characteristics analysis requires comparison to a counterpart, not a broad mixture containing innumerable different oligosaccharides. Applicant further argues that the defined molecular constructs are not naturally occurring ensembles. This argument is not persuasive because compounds falling within the scope of the claims occur in nature, regardless of whether additional compounds also occur alongside them in nature. There is no change in the characteristics of a compound such as 6’-SL in human milk versus 6’-SL which has been removed from human milk or chemically synthesized.
Applicant argues that the claims do not recite the naturally occurring substance “as is,” but instead define specific terminal configuration at the non-reducing end. This argument is not persuasive because compounds having the recited structures are found in nature. Dependent claim 9 specifically states that the sugar chain is a compound such as 6’-SL, which is found in nature.
Applicant argues that the claims add significantly more because the inventive concept resides in the human-directed molecular architecture of the claimed sugar chains, that the claims recite intentional selection and arrangement of building blocks, defined linkage positions, branching limitations, and terminal placement. This argument is not persuasive because the claims include compounds having arrangement of building blocks, linkage positions, branching limitations, etc. which are found in nature.
Applicant argues that the office suggests that the claims are conventional because the specification does not detail synthesis methods. The examiner reviewed the office action and did not find a statement to that effect in the rejection. For step 2B, the rejection simply states that there are no additional elements.
Applicant has not explained how natural compounds such as (but not limited to) 6’-SL are not within the scope of the claims. To the contrary, 6’-SL is specifically required by dependent claim 9.
Claim Rejections - 35 USC § 112
Claims 1-7, 9 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of Neu5Acα2-N1Gal building block and the xFuc-N1Gal-N1(xFuc-N1)GlcNAc building block is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: members of a Markush group share a “single structural similarity” when they belong to the same recognized class. A recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave the same way in the context of the claimed invention. In this instance, the two building blocks do not belong to the same recognized class because one is drawn to sugar acids and the other is drawn to non-acid aminosugars.
Where the alternatives do not belong to a recognized class, the Markush grouping may still be considered to be proper where the alternatives share a substantial structural feature that is essential to a common use. In this instance, the only shared structural feature of the two groups of building blocks is a galactose moiety. This is not a substantial structural feature because it is only a small part of the claimed sugar chains and the galactose is not bonded to the same additional sugar(s) or in the same place in the chain (at the non-reducing end or not).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Response to Arguments
Applicant argues that each compound shares a common Gal-N1 linkage and functions as a terminal non-reducing glycan motif. This argument is not persuasive because a Gal-N1 linkage is not a substantial structure feature. Galactose is a small part of the claimed sugar chains and is not bonded to the same additional sugar(s) or the same place in the chain. A function of a “terminal non-reducing glycan motif” is not a common use. It is not a use at all; it is a description of a small part of a structure which can contain any number of additional saccharides (due to the “comprising” language in claim 1).
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.
Claim(s) 1-7, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishimura (US 2013/0196881 A1, August 1, 2013).
Nishimura teaches a chip comprising one or more sugar chains. See paragraph [0074]. Nishimura discloses the following sugar chain in Table 2. This is the elected species.
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The sugar chain array comprises a base material and at least one immobilized sugar chain described in Tables 1-6. See paragraphs [0012]- [0014].
Response to Arguments
Applicant argues that Nishimura’s sugar chain is part of a broad analytical library and is not structurally defined by non-reducing end placement as a distinguishing feature. This argument is not persuasive because Applicant has not explained how Nishimura’s compound does not meet the claim limitations. Nishimura’s compound is the elected species and is specifically recited in claim 9.
Applicant argues that disclosure of individual sugar motifs within an array does not anticipate a claim that requires a specific terminal arrangement and structural definition of the sugar chain itself. This argument is not persuasive because the array contains the specific structurally defined compound which is the elected species.
Claim(s) 1-7, 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tao (J. Dairy Sci. 92:2991-3001, 2009).
Tao teaches a chip comprising the following compounds (see page 2995 for the compounds and page 2992 (HPLC-chip/TOF MS) for the HPLC-chip):
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These two compounds contain the building block recited in claim 1. It is noted that claims 1-5 do not require that Fuc is present, as x can be 0. 3’-SL is specifically recited in current claim 9.
Response to Arguments
Applicant argues that Tao teaches that fucosylated oligosaccharides are absent in bovine milk, whereas claim 1 encompass xFuc-containing building blocks. This argument is not persuasive because x can be 0.
Applicant argues that even with respect to 3’SL and 6’-SL, Ta “does not disclose sugar chains structurally defined by non-reducing end placement or constrained by the claimed x and N1 parameters.” This argument is not persuasive because Applicant has not explained how 3’-SL and 6’-SL do not meet the structural requirements of the claims. It is also noted that 3’-SL and 6’-SL are specifically recited in dependent claim 9.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/LAYLA D BERRY/Primary Examiner, Art Unit 1693