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 .
Election/Restrictions
Claims 66-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected system, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/22/2026.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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.
Claim 27 is 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.
Claim 27 recites the limitation "the conversion(s)" in fourth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 5-7, 9, 11, 13, 18-20, 27, 36 and 38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea that relies on a natural process without significantly more. The claim(s) recite(s) a method of detecting gastrointestinal permeability. This judicial exception is not integrated into a practical application because the claims never provide limitations drawn to using the acquired data; as there is no step of using the acquired data, there is no practical application providing in the claims. See MPEP 2106.04(d).
In order to analyze the claims under 35 USC 101, the Applicant is directed to MPEP 2106, particularly the flow chart provided in section III. The invention is drawn to a method of detecting gastrointestinal permeability by providing a subject with a solution of lactulose and galactose, then after time, acquiring a blood sample, and measuring the ratio of lactulose-to-galactose. Some of the narrower claims specifically describe methods of measuring, like HPLC, sample treatment, like isolating serum from the blood, and descriptions of how much galactose and lactulose to administer. When considering the independent claim, and all of the aforementioned claims that depend on it, the claims are drawn to a method, and as such, the claims comprise a statutory category; therefore, the answer to step 1 is “yes.” The next step asks if the claims are drawn to a natural phenomenon and/or abstract idea. When considering the claims, the method provides for an abstract idea that relies on a natural phenomenon.
The instant invention can be broken into two separate pieces. The first piece is the explicitly claimed method – administering galactose/lactulose, acquire blood, measure levels of galactose/lactulose; the second piece is the metabolic process by which the subject absorbs the claimed sugars into the bloodstream. Since the 35 USC 101 eligibly of the claimed method relies on the eligibility of the metabolic process, this will be discussed first. The claimed metabolic process can be considered a natural relationship when considering the Office guidance regarding Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117, 1135-36, 126 USPQ2d 1266, 1281 (Fed. Cir. 2018) [herein referred to as “Vanda”]. See MPEP 2106.04(b)(I). That is to say, once sugars are administered into the body, all transformations and ratios can be considered natural phenomenon. Since there are no steps that follow the claimed natural phenomenon, the method as a whole must be considered.
When looking at the methods steps, overall, the Applicant is directed to MPEP 2106.04(a), wherein “abstract ideas” are generally defined in the MPEP. Specifically, the claim has three active steps: the first is a step of administering a sugar solution, the second is acquiring a blood sample, and the third is analyzing the blood sample for the presence of the sugars provided in the first step. If it can be shown that all of these steps are well-understood, routine, and conventional steps already performed by the relevant audience, these steps would not elevate the claims beyond abstract idea, since these steps are already routinely performed by the relevant audience. See MPEP 2106.05(d). When considering general medical procedures, it should be noted that the administration of sugar solutions, and the acquiring of blood samples are routine. Furthermore, when it comes to specifically administering sugar solutions to subjects, acquiring blood samples, isolating the serum from the blood, then testing sugar levels this method is already performed and routine in the art. See Haase, et al (The Journal of Pediatrics, 136, 232-237, 2000), page 232, Abstract section; page 235, Figure 2. Similarly, Budillon, et al (Journal of Hepatology, 1, 513-524, 1985) provides for similar sugar solution administration, and blood testing. See page 514, “Summary” section; page 514, 2nd paragraph; page 515, “Materials and Methods” section. As such, based upon the cited prior art, it would be reasonable to suggest that the claimed active steps are considered well-understood, routine, conventional activities already engaged upon by the relevant audience. This assessment would suggest that the answer to question 2a of the flow chart is “yes.”
The final question asks if the claimed judicial exception provides for significantly more than solely an abstract idea. As discussed above, the claims provide for elements that parallel the Vanda example, wherein the method claims the diagnostic, without providing for steps of using said diagnostic. For example, if the instant claims provide for a ratio that shows a pathology, a specifically claimed limitation drawn to treating would potentially provide for an eligible claim. See MPEP 2106.04(d)(2). Since there is no step of applying the claimed data, the claim as a whole cannot be considered eligible under 35 USC 101. Additionally, the dependent claims that are cited in the rejection are also ineligible because the do not provide for the practical application, as required by the most recent guidance regarding 35 USC 101 eligibility.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6, 7, 9, 11, 13, 18-20, 27, 36 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haase, et al (The Journal of Pediatrics, 136, 232-237, 2000) and Budillon, et al (Journal of Hepatology, 1, 513-524, 1985). Haase teaches methods of determining gastrointestinal permeability. See page 232, “Abstract” section. Haase provides a sugar solution, then after time, acquires a blood sample, and analyzes the sample for the presence of various sugars. See page 233, entire; page 235, Figure 2. Although Haase’s sugar solution is slightly difference, Haase explicitly shows (in figure 2) that the ratio of various sugars, compared to the administered lactulose, is different in the subjects, compared to the healthy controls. This would suggest to the ordinary artisan that any ratio of sugars, compared to an administered amount of lactulose, can be used to determine a healthy gastrointestinal permeability.
Budillon also provides for a method of determining gastrointestinal permeability by providing an intravenous solution of galactose. See page 513, “Summary” section; page 515, “Materials and Methods” section. Budillon explicitly notes the importance of various sugar ratios, and how they could affect intestinal function, like permeability. See page 522, “Conclusion” section.
When taking Haase and Budillon together, it would be clear to the ordinary artisan that gastrointestinal permeability can be performed by provide a subject lactulose and another sugar, followed by providing a blood test to determine the ratio of the administered sugars. Furthermore, it can be reasoned that once the blood/serum sample is acquired, any known methods of detecting the sugars in a blood sample would be considered obvious variants.
With respect to claim 1, Haase and Budillon teach steps that would overlap with the claimed method. Both provide a reasonable rationale as to why the ordinary artisan would find the ratio of lactulose-to-galactose to be an obvious indicator for gastrointestinal permeability.
With respect to claim 2, there is nothing non-obvious about repeating a diagnostic test, since the ordinary artisan would be compelled to continue blood tests to determine any changes to permeability.
With respect to claim 3, Haase utilizes blood tests 90 minutes after administration. See page 233, left column.
With respect to claim 6, based upon the data provided in Figure 2 of Haase, the ordinary artisan would be capable of determining a ratio of lactulose and another sugar, for the purposes of diagnosing gastrointestinal permeability.
With respect to claims 7, 9, 11, and 13, Haase and Budillon provide for overlapping methods with overlapping concentrations of sugars. The ordinary artisan would be capable in optimizing the ratio of sugars provided in the initial solution.
With respect to claims 18 and 19, both Haase and Budillon measure the claimed sugars. As such, this limitation must have been fulfilled.
With respect to claims 20, 27, 36, and 38, both Haase and Budillon provide for several different methods of determining the amount of galactose and lactulose in a blood sample. When considering methods of determining the presence of a sugar in a blood sample, it can be reasoned that any known method of acquiring a sugar concentration would be obvious to the ordinary artisan. All of the cited methods provide for generally routine methods of determining the presence of sugar in a blood sample. Regardless of whether it is a direct measure, or an indirect measure, it would inform the artisan of the exact same data. Since this is the case, all methods can be considered obvious variants that would not impact the methods of determining gastrointestinal permeability, since the ratio would be consistent regardless of detection means.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Haase, et al (The Journal of Pediatrics, 136, 232-237, 2000) and Budillon, et al (Journal of Hepatology, 1, 513-524, 1985) and evidenced by Fleming, et al (Clinical Chemistry, 42, 445-448, 1996). Fleming indicates that the sugars discussed in Haase/Budillon can be routinely tested by acquiring a subject’s serum, including for testing gastrointestinal permeability; Fleming notes that this method provides for a high degree of accuracy. See page 445, “Abstract” and “Introduction” sections.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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