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 .
Response to Arguments
The Applicant has provided a response, dated 6/4/2026, that includes amendments to the claims and arguments drawn to the previous rejections. Based upon the claim amendments, the previous 35 USC 112(b) rejections is withdrawn.
On page 4 of the Applicant’s Arguments, the Applicant takes issue with differing definitions between the prior art and the instantly claimed exopolysaccharide (EPS). When considering the claim in the context of 35 USC 101 analysis, this distinction is not entirely relevant, since the analysis was based upon lectin-binding for the detection of [exo]polysaccharides is known and well characterized, and widely understood. While there is certain distinction between what the Applicant invented and what is discussed in the prior art, the analysis is drawn to what is claimed. In the instant scenario, the claims require a sample containing an EPS, a lectin that can bind the EPS and is labeled, a second lectin that is specific to EPS and immobilized, and a step of detecting. All of these elements are well-understood, routine, and conventional; while the Applicant might find nuance between their invention and the cited prior art, the claims are broad enough for there to be reasonable overlap between what is claimed and what is presented in the cited prior art.
On pages 5 and 6 of the Applicant’s Arguments, the Applicant continues to contend that Robitaille does not teach a lectin that specifically binds to an EPS. First, it must be explicitly noted that Robitaille cites Ricinus communis agglutinin I (RCA 120) and concanavalin A as a binding lectin. See page 4157, “Lectin-Binding Assay” section. Based upon the fact that these lectins are claimed as “a lectin capable of binding specifically to the EPS,” it is unclear how Robitaille does not teach this limitation. Additionally, the Applicant is also ignoring the fact that the rejections also cited Zhang, et al (International Dairy Journal, 46, 88-95, 2015), page 89, “Fluorescent probes” section, who explicitly describes a lectin that specifically binds to EPS. The broadness of the claim reads upon the method disclosed in Robitaille, wherein Robitaille does discuss EPS binding; however, if the artisan requires a specific EPS binding assay, the claimed specific lectin that binds to EPS is already known, and widely available, as it is sold commercially. The commercial availability of this compound highlights the contention that its use in a method, like that of Robitaille, would continue to be routine and conventional.
On page 6 of the Applicant’s Arguments, the Applicant states that Robitaille does not teach the claimed “combined” assay. To the contrary, Robitaille states “Streptococcus thermophilus cells resuspended in PBS-MCT,” which suggests that the method provided in the “Lectin-Binding Assay” section continues on from the step of resuspending the cells in PBS-MCT to the next step of providing immobilized lectin. Robitaille then provides a step of detecting with a microscope. See pages 4157 and 4158, “Lectin-Binding Assay” and “Lectin-Mediated Adsorption on Agarose Beads” sections. Since it appears clear in the prior art that the method steps continue, as they are claimed, Robitaille appears to read on this limitation, wherein the only main difference is how the cells are detected.
Based upon the Applicant’s Arguments, it appears as though Robitaille does not anticipate the claimed invention. As such, the 35 USC 102 rejections are withdrawn. Currently, it appears as though the claims might be obvious over Robitaille and Uchida (JP 04130274 [IDS Reference]); however, that assessment cannot reasonably be made in the time provided for a response to the instant arguments. Furthermore, providing a claim in compliance with 35 USC 101 would potentially provide for an invention that is not obvious over the prior art.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a method of detecting exopolysaccharides (EPS) in a sample. This judicial exception is not integrated into a practical application because the claims provide for an abstract idea without providing any additional step that inform the artisan how to use to acquired data. For the analysis of the claims under 35 USC 101, the Applicant is directed to MPEP 2106, especially the flow chart provided in section III.
The claims are drawn to a method, and as such, comprise one of the statutory categories, therefore, the answer to step 1 is “yes.” The next step of the analysis asks if the claims are directed to an abstract idea; when considering how an abstract idea is interpreted, the Applicant is directed to MPEP 2106.04(a). Based upon the claim language, the only “transformation” is when the EPS is combined with the labeled and unlabel lectin, the following step, “detecting” can be viewed as a mental step under the above-mentioned section of the MPEP. Therefore, in order to identify if the claim, as whole, can be interpreted as an abstract idea, the claimed transformation must be considered well-understood, routine, and conventional activity. See MPEP 2106.05(d). When viewing the method in light of the prior art, the claimed labeled lectin can include commercially available labeled lectin. See Zhang, et al (International Dairy Journal, 46, 88-95, 2015), page 89, “Fluorescent probes” section. Furthermore, the combined lectin-binding assay, using labeled lectin, followed by lectin-mediated adsorption, using immobilized lectin (claim 10), has been previously described in the prior art. See Uchida (JP 04130274 [IDS Reference]), claim 1; Robitaille, et al (Journal of Dairy Science, 89, 4156-4162, 2006), page 4157, “Lectin-Binding Assay” and “Lectin-Mediated Adsorption on Agarose Beads” section (continues to page 4158). Uchida shows the claimed steps, whereas Robitaille and Zhang show that it would be predictably modifiable for EPS detection. Based upon the fact that the claimed probed and immobilized lectin are already used in the prior art for methods of detecting saccharides that could include EPS would suggest that the claimed method can be considered routine, conventional, and well-understood. Therefore, in step 2A of the 35 USC 101 analysis flow chart, the steps can be considered an abstract idea, as defined by the cited sections of the MPEP. The final step of the flow chart asks if the claims recite significantly more than the judicial exception. However, since there are no steps following the abstract idea that provide for an application of the abstract idea, the claims do not provide for significantly more.
When considering the dependent claims, there does not appear to be any methods steps that would suggest that the claimed method includes a step that amounts to significantly more than the judicial exception. As such, all of the pending claims are ineligible under 35 USC 101.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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