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
Applicant’s election without traverse of Group II, claims 2-3, in the reply filed on 08/21/2026 is acknowledged.
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.
Claims 2-3 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.
Claims 2-3 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 2 is unclear reciting “wherein an input variable of the early diagnosis model for Alzheimer's disease comprises a peak intensity value of a mass spectrum of the Alzheimer's disease biomarker 11(Z), 14(Z)-eicosadienoic acid according to claim 1” because it is unclear whether the limitations following the phrase “wherein” are part of the claimed invention as elements in the wherein clauses have not been positively claimed. In addition, the claim is unclear because it lacks positive recitation of specific structural elements being claimed. Further, the claim is unclear whether “the Alzheimer's disease biomarker 11(Z), 14(Z)-eicosadienoic acid according to claim 1” is part of the claimed invention. Examiner notes that claim 1 has been withdrawn from consideration, rendering the scope of the claim unascertainable.
Claim 3 is similarly unclear. Furthermore, claim 3 is indefinite reciting “a to-be-detected individual [...] the to-be-detected individual is judged to suffer from or be at risk of suffering from Alzheimer's disease” because the limitation includes an optional element and a functional capability associated with elements that have not been positively claimed, which makes the scope of the claim unascertainable.
Claim 2 recites the limitation "the Alzheimer's disease biomarker 11(Z), 14(Z)-eicosadienoic acid" in L3. There is insufficient antecedent basis for this limitation in the claim.
The term “normal individual” in claim 3 is a relative term which renders the claim indefinite. The term “normal individual” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rezzi et al. (US 2017/0370910 A1) in view of Damian et al. (US 2009/0211346 A1).
Regarding claim 2, Rezzi teaches: 2. An early diagnosis model (Fig. 1, ¶ 0011, 0025+) for Alzheimer's disease (¶ 207), wherein an input variable of the early diagnosis model (e.g., Fatty acid markers can be determined by the quantitative analysis; cis-11,14-Eicosadienoic C20:2 n-6, ¶ 0057-0058) for Alzheimer's disease comprises an intensity value of a mass spectrum (¶ 0043, 0095+) of an Alzheimer's disease biomarker 11(Z), 14(Z)-eicosadienoic acid (see Claim 1 An in vitro method for determining the distinctive disease related nutritional requirements of a subject suffering from a disease characterized by distinctive nutritional requirements in the diseased subject over a healthy subject comprising the steps:
a. determining in a sample of a subject suffering from the disease a profile of statuses of markers indicating the nutritional profile of said subject; b. determining in a sample of a healthy subject a profile of the statuses of the same markers determined in step a; and c. comparing the profiles determined in step a. and b., and thereby determining the distinctive nutritional requirements for nutrients in a patient suffering from the disease.).
Regarding claim 2, Rezzi teaches quantitative determination of the disclosed biomarkers using analytical methods including mass spectrometry. Rezzi also teaches that disease associated nutrient/metabolite profiles can be obtained quantitatively using mass spectrometry by analyzing fatty acid biomarkers, such as cis-11,14-Eicosadienoic C20:2 n-6, see ¶ 0056-0058, 0207. However, Rezzi does not explicitly teach: a peak intensity value of a mass spectrum of the Alzheimer's disease biomarker 11(Z), 14(Z)-eicosadienoic acid.
Damian teaches: An early diagnosis model for Alzheimer's disease (Abstract, 0075+), wherein an input variable of the early diagnosis model for Alzheimer's disease comprises a peak intensity value of a mass spectrum (¶ 0042, 0070-0078) of an Alzheimer's disease marker (see Abstract, ¶ 0035, 0084-0087, Claim 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the use of a peak intensity value of a mass spectrum for a selected marker, as taught by Damian, with an Alzheimer's disease biomarker, such as 11(Z), 14(Z)-eicosadienoic acid as taught by Rezzi, for detecting and quantifying one or more of markers (Damian ¶ 0084-0087+).
Regarding claim 3, modified Rezzi teaches: 3. The early diagnosis model for Alzheimer's disease according to claim 2, wherein an output variable of the early diagnosis model for Alzheimer's disease comprises a comparison of a peak intensity value of a mass spectrum of 11(Z), 14(Z)-eicosadienoic acid in a sample (¶ 0040-0041, 0123-0128) of a to-be-detected individual to a peak intensity value of a mass spectrum of 11(Z), 14(Z)-eicosadienoic acid in a sample of an individual (¶ 0025, 0030-0034, claim 1+). Modified Rezzi further teaches: a quantitative mass spectrometry analysis of fecal calprotectin using mathematical analysis (¶ 0099-0108).
However, modified Rezzi does not explicitly teach: a ratio of a peak intensity value of a mass spectrum of 11(Z), 14(Z)-eicosadienoic acid in a stool sample of a to-be-detected individual to a peak intensity value of a mass spectrum of 11(Z), 14(Z)-eicosadienoic acid in a stool sample of a normal individual, wherein in a case where the ratio is less than 1.
Damian teaches: Prior to statistical analysis, all spectral peaks were aligned and normalized in order to allow for quantitative comparison across all subject samples (¶ 0070).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify Rezzi for the purpose of formulating a mathematical model, such as normalizing all spectral peaks in order to allow for quantitative comparison across all subject samples (Damian ¶ 0070).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LUAN VAN can be reached at (571) 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1795
DEAN KWAK
Primary Examiner
Art Unit 1795
