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 .
Status of the Claims
Claims 1, 6-15, and 18-19 are pending in the application.
Claims 9-11, and 13-15 are withdrawn.
Claims 1, 6-8, 12, and 18-19 are the subject of this office action.
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, 6-8, 12, and 18-19 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.
Claim 1 is rejected as indefinite because the preamble of the claim recites a method of attributing an adjusted chronological age to an individual and/or to a biological system of the individual, however, the recited method steps support only the attribution of an adjusted chronological age to an individual, and do not support attribution of an adjusted chronological age to a biological system.
Claim 1 is rejected as indefinite because the exact method of attribution of a biological age is unclear. That is, the claim recites that a measured value of ASO higher than the reference value indicates an increased chronological age such that an increased adjusted chronological age is attributed to the individual, and also recites that a measured value of HbA1c high than the reference value indicates an increased chronological age, such that an increased adjusted chronological age is attributed to the individual. However, it is not clear what happens in several possible embodiments of the claim. For example, what adjusted chronological age is attributed to an individual when both analytes measured are below or equal to their respective reference values? What adjusted chronological age is attributed to an individual when one analyte is less than or equal to the reference value while the other analyte is higher than the reference value? Clarification is required.
Dependent claims 6-8, 12, and 18-19 are rejected as indefinite because they depend on an indefinite claim and fail to remedy its insufficiencies.
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, 6-8, 12, and 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The claim(s) recite(s) a method of attributing an adjusted chronological age to an individual and/or to a biological system of the individual, wherein the method comprises measuring values of particular biomarkers in a biological sample, and attributing an adjusted chronological age to an individual based on whether the measured value of the biomarkers are higher or lower than healthy reference values of the markers. Thus, the claims recite abstract ideas/mental processes, wherein comparing data to a reference value to draw a conclusion is a process that can be performed in the human mind, and thus is an abstract idea/mental process. Though the steps of comparison and conclusion are not explicitly recited, they are both implied and required by the claimed method. That is, in order to determine whether a measured value is higher or lower than a reference value, a practitioner must make a comparison of the measured value to the reference value, and in order to attribute an adjusted chronological age, a practitioner must draw a conclusion based on that comparison.
This judicial exception is not integrated into a practical application because the claims as a whole are directed to the judicial exception itself. That is, the claims are directed to the process of attributing an adjusted chronological age, which is itself the judicial exception. The claims additionally recite further limitations on the comparison and attribution step, or further specify which analytes are detected, but these limitations do not serve to integrate the judicial exception into a practical application as they are either directed to the judicial exception itself or are directed to data gathering steps that support the judicial exception, but which do not themselves comprise a practical application.
Regarding detection of analytes by an array, MPEP 2106.04(d) provides relevant considerations for evaluating whether additional elements integrate a judicial exception into a practical application. The most applicable in the instant case is “implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim”. The recited microarray used for detection of analytes does not integrate the judicial exception into a practical application according to this standard. Considerations relevant to a “Particular Machine” are discussed in MPEP 2106.05(b) which provides the following: in order for a machine to add significantly more, it must play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved; consider whether the involvement of the machine is extra-solution activity or field of use: use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g. in a data gathering step) would not integrate a judicial exception or provide significantly more. As it applies to the instant case, the limitations recite only a generic microarray comprising binding ligands for ASO and HbA1c, wherein microarrays comprising immobilized binding ligands for multiplex detection of analytes in a biological sample are is well known and commonly used in the art, as discussed in further detail below. As such, this machine is recited at a high level of generality and additionally is used only in a data-gathering step, (i.e. one must gather data regarding analyte levels in a sample in order to enable attribution of an adjusted chronological age) and therefore is insufficient to integrate the recited judicial exception into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The additional elements of the claim which are not themselves elements of the judicial exception are related to the particular analytes detected and the method used to detect them. That is, the claims require detection of HbA1c and ASO (plus albumin and/or CRP in claim 19) in a biological sample by contacting a microarray comprising two or more binding ligands that bind to the one or more analytes with the biological sample (additional limitations in the dependent claims require a certain number or particular species of analyte(s)).
These limitations fail to provide significantly more than the recited judicial exception for a number of reasons.
Firstly, steps of detecting particular analytes (HbA1c and ASO, plus albumin and/or CRP in claim 19) amount to mere data gathering in support of the judicial exception (i.e. in order to compare measured analyte data to reference values and attribute an adjusted chronological age based on that comparison, one must first measure the analyte). Such mere data gathering in support of a judicial exception has been identified by the courts as insignificant extra solution activity which cannot constitute significantly more than the judicial exception. See MPEP 2106.05(g).
Furthermore, detection of a biomarker in a biological sample such as blood, serum, or plasma has been specifically identified by the courts to be routine and conventional activity in the life sciences arts (see MPEP 2106.05(d)(II)).
Additionally, the measurement of HbA1c and ASO in a biological sample is well known in the art, wherein the art indicates that these are well known and commonly detected analytes. For example, the following references indicate measurement of both HbA1c and ASO in a biological sample, and some show additional measurement of albumin and/or CRP. These references support the conclusion that measurement of these biomarkers is routine and conventional in the art and has been performed by a number of different practitioners using different well-known methods for a variety of different applications:
IBL-America (Immuno-Biological Laboratories Inc. (IBL-America). User’s Manual: Human HbA1c ELISA. 27 September 2019. Pg. 1-9; previously cited): detection of HbA1c by ELISA
Aa et al (Aa, Khaled and Hassan Aa. “Anti Streptolysin O; Normal Values for Healthy Children Aged from 5 to 15 Years Old in Sana'a City-Yemen.” Annals of Clinical and Laboratory Research 3 (2015): n. pag.; previously cited): detection of ASO by ELISA
Takami et al ((2003), Blood Test Values and Community Periodontal Index Scores in Medical Checkup Recipients. Journal of Periodontology, 74: 1778-1784.): measurement of bHbA1c, ASO, CRP in biological samples
Dogan et al (Serum IL-1β, IL-2, and IL-6 in Insulin-Dependent Diabetic Children, Mediators of Inflammation, 2006, 059206, 6 pages, 2006.): measurement of HbA1c, ASO, CRP in biological samples
Almehmadi et al ((2015). Erectile dysfunction is a prognostic indicator of comorbidities in men with late onset hypogonadism. The Aging Male, 18(3), 186–194.): measurement of HbA1c and ASO in biological samples.
Additionally, measurement of analytes in a sample via contacting the sample with a microarray comprising binding ligands to the analytes is a method which was known in the art before the effective filing date of the claimed invention and which was known to be particularly advantageous for multiplex measurement of multiple analytes, and which was known to be adaptable to a wide variety of analytes:
Ling et al (Multiplexing molecular diagnostics and immunoassays using emerging microarray technologies. Expert Rev Mol Diagn. 2007 Jan;7(1):87-98.; previously cited): Ling is a review of prior art which discloses that microarray immunoassay comprise detection of an analyte by contacting a microarray comprising binding ligands to one or more analytes with a biological sample; microarray immunoassays are useful for multiplex detection of protein analytes with high throughput and high sensitivity. Ling specifically teaches that the same reagents used in an ELISA can be used in a microspot assay to yield increased assay sensitivity. (Abstract; Box 1; Box 2; Pg. 91, Col. 2-Pg. 92, Col. 1).
As such, measurement of HbA1c and ASO (plus albumin and/or CRP as in claim 19) using a microarray as recited in the instant application does not contribute significantly more than the judicial exception because it amounts to detection of well known analytes by well known methods and is recited at a high level of generality, such that it is considered routine and conventional in the art.
Subject Matter Free of Prior Art
Claims 1, 6-8, 12, and 18-19 are rejected as described above, but appear to be free of the prior art.
The closest prior art is Park et al (Developing a biological age assessment equation using principal component analysis and clinical biomarkers of aging in Korean men. Arch Gerontol Geriatr. 2009 Jul-Aug;49(1):7-12.; previously cited), as discussed at length in the previous rejection.
Park teaches measurement of analytes including HbA1c, CRP, and albumin in biological samples, wherein measurement of analytes is used to attribute an adjusted biological age to an individual.
Park differs from the instant claims in that it does not disclose measurement of ASO.
Though measurement of ASO is known in the art, as discussed above, the prior art does not specifically teach or motivate measurement of ASO in a method of attributing and adjusted chronological age to an individual.
Response to Arguments
Applicant’s arguments filed 12 August 2026 have been fully considered.
Previous 112(b) rejections are withdrawn in view of the amendments to the claims. New grounds of 112(b) rejections which address the amended claims are presented above.
Regarding the 101 rejection:
Applicant argues that the claims as a whole are not directed to an abstract idea because they do not merely recite a mental process, but include a sequence of physical steps which cannot be performed in the human mind. This argument is not persuasive because these physical steps are performed only as data gathering steps in support of the recited judicial exception and therefore do not integrate the judicial exception into a practical application. That is, one cannot attribute an adjusted chronological age without performing the data gathering steps of measuring HbA1c and ASO.
Applicant argues that the claims recite significantly more than the recited judicial exception. Applicant argues that the inventive concept resides in the non-conventional and non-generic combination of elements, i.e. that the specific combination of binding ligands to the specific combination of aging related biomarkers to attribute an adjusted chronological age is novel and non-conventional. Applicant argues that the specifically recited microarray resolves a technical problem in the art and enables simultaneous multiplex detection of distinct aging biomarkers in a single sample.
These arguments are not persuasive both because these steps constitute mere data gathering in support of the judicial exception, and because these steps are insufficient to constitute significantly more than the judicial exception, as discussed at length in the rejection above.
Previous 102 and 103 rejections are withdrawn in view of the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
