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 .
Claim Status
The amendment of 10/24/2025 has been entered. Claims 1, 3-5, 7, and 16-19 are currently pending in this US patent application and were examined on their merits.
Withdrawn Rejections
All rejections of claims 2 and 6 set forth in the previous Office action are withdrawn in light of the amendment of 10/24/2025, which canceled these claims.
All rejections of the claims under 35 U.S.C. 102(a)(1) set forth in the previous Office action are withdrawn in light of the amendment of 10/24/2025, which brought the limitations of previous claims 2 and 6 into claim 1.
Information Disclosure Statement
The information disclosure statements filed in this application on 01/14/2025 and 10/16/2025 have been received and considered.
Claim Interpretation
Claim 1 recites a test method “for mild cognitive impairment.” Claim 3 recites testing the likelihood of the subject having MCI “by comparing the SOD activity value in the biological sample of the subject with a reference value” (emphasis added”, indicating that “testing the likelihood” represents the intended outcome of the recited comparing step. Claim 7 recites further limitations of the preamble of claim 1. A clause in a method claim does not receive weight when it simply expresses the intended result of a process step positively recited. See MPEP § 2111.04. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP § 2111.02 (II). In the instant case, the body of claim 1 fully and intrinsically sets forth all of the limitations of the claimed invention—a step of measuring activity of SOD in a biological sample of a subject—and the preamble merely states the intended purpose of performing the recited method. As such, any prior art that teaches the positively recited step of measuring activity of SOD in a biological sample of a subject will be interpreted to read on claims 1 and 7 in their entirety, regardless of whether the prior art teaches the intended purpose of testing for MCI. Any prior art that teaches the comparing step of claim 3 will be interpreted to read on the entirety of claim 3.
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.
Claim 4 remains rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Please note that this rejection has been slightly augmented to incorporate discussion of the newly-added limitations in claim 4 from the amendment of 10/24/2025. However, because the basis of the rejection is unchanged, the rejection has been maintained.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must (a) not be directed to a judicial exception or must (b) contain additional elements that amount to significantly more than the judicial exception itself.
‘Directed to a judicial exception’ analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of characteristics that can determine the presence of a marked difference include biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic, or physical.
Claim 4 recites a step of assessing the likelihood of the subject having MCI based on a comparison of SOD activity in the subject sample with SOD activity in a sample from a healthy subject and/or an MCI patient. The relationship between the presence of mild cognitive impairment and the activity of superoxide dismutase in the patient with mild cognitive impairment is a natural correlation/law of nature, and determining the relationship requires abstract ideas, all of which are judicial exceptions. As such, claim 4 incorporates a judicial exception.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 4 depends from claim 3, which depends from claim 1. Claim 4 does not recite any required steps other than the measurement of claim 1, the comparison of claim 3, and the assessment of claim 4. The administration step in amended claim 4 occurs only under particular conditions. Because the natural correlation is not used in any way over the full scope of the claim, it cannot be considered to be integrated into a practical application.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of measuring SOD activity in the subject sample (claim 1) and comparing the measured SOD activity with SOD activity in a control sample (claim 3) are well-understood, routine, and conventional in the prior art (see below under Claim Rejections – 35 USC 103). In addition, as these steps are required for the determination of the natural correlation that represents the claimed judicial exception, and as the claims do not require any specific assay for measurement or any particular comparison, the measuring and comparing steps represent insignificant extra-solution activity and mere data gathering in conjunction with a law of nature, which the courts have determined does not amount to significantly more than a judicial exception. See MPEP § 2106.05(I)(A). The Examiner further notes that the administration step in amended claim 4 cannot amount to significantly more than a judicial exception because it does not occur over the full scope of the method of claim 4 (see above). Even if, arguendo, the claim was amended to require the administration step for every embodiment of the method of claim 4, the administration of “a therapeutic agent for MCI” is recited at a high level of generality with no specificity on what therapeutic agent is administered or how the administration occurs. As such, this limitation is, at best, the equivalent of merely adding the words “apply it” to the judicial exception, which neither integrates the judicial exception into a practical application nor amounts to significantly more than a judicial exception. See the discussion on the subject matter eligibility of claim 1 of Example 43 in the October 2019 Subject Matter Eligibility guidance.
Therefore, claim 4 is directed to subject matter that is not patent-eligible and is rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-5, 7, and 16-19 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Sun et al., Experimental Gerontology 118: 72-77 (2019), in view of Ramesh et al., Nigerian Medical Journal 60(3): 133-137 (May-June 2019), and US patent application publication 2015/0119278 filed by Goetzl, published 04/30/2015.
Sun teaches the assessment of plasma SOD activity levels in samples obtained from Chinese older adults (see entire document, including page 73, left column, paragraph 3, to right column, paragraph 2; cf. claims 1, 5, 7, and 19; see above under Claim Interpretation for the Examiner’s interpretation of the intended results recited in instant claims 1, 3, and 7; given that SOD is inherently capable of scavenging superoxide, any activity of SOD can be interpreted as “superoxide scavenging activity” as recited in instant claims 5 and 19, which does not recite the performance of any particular assay or the measurement of any particular reagent, such as superoxide, in the biological sample). The cognitive function of the subjects was also determined (page 73, left column, paragraph 5). Participants with cognitive decline were identified and their SOD activity levels were compared with one another, leading to the identification of a link between higher levels of plasma SOD activity and a higher risk of cognitive decline (page 74, right column, paragraph 4; page 75, Tables 1 and 2; page 76, Figure 2; cf. claims 3-4; the Examiner notes that comparing all SOD levels with each other and with subjects’ level of cognitive decline, which is required to construct the data analyses in the cited tables/figures, intrinsically requires the comparing step of claim 3 and the assessment step of claim 4, as well as the comparisons with healthy patients and patients with cognitive decline as recited in claims 16-17).
However, Sun does not teach that the SOD levels tested were from saliva as recited in instant claims 1 and 19 or that the patients had the amount of SOD suppression recited in instant claims 18-19.
Ramesh teaches the collection of saliva samples from healthy nonsmokers, light smokers, and heavy smokers (see entire document, including page 134, left column, paragraphs 3-5). The activity of SOD was measured in the samples and compared between the subject groups (page 134, right column, paragraphs 1-5; page 135, Table 1; cf. claims 1, 5, 7, and 19; see above under Claim Interpretation for the Examiner’s interpretation of the intended results recited in instant claims 1, 3, and 7; given that SOD is inherently capable of scavenging superoxide, any activity of SOD can be interpreted as “superoxide scavenging activity” as recited in instant claim 5, which does not recite the performance of any particular assay or the measurement of any particular reagent, such as superoxide, in the biological sample).
Goetzl teaches that neurodegenerative disorders in subjects may be diagnosed by measuring the levels of biomarkers, which may be SOD, in samples from patients, which may be saliva (see entire document, including pages 2-3, paragraph 0007; cf. claims 1 and 19). Once diagnosed, the neurodegenerative condition may be treated through a therapeutic regimen (page 2, paragraph 0007; cf. claim 4).
While Sun does not teach that the SOD levels tested were from saliva as recited in instant claims 1 and 19, it would have been obvious to one of ordinary skill in the art to do so because Ramesh teaches that salivary SOD levels can be determined from patient samples and compared between subject groups as required by the methods of instant claims 1 and 19 and because Goetzl suggests that salivary SOD levels can be used to diagnose neurodegenerative disorders in subjects. While Sun, Ramesh, and Goetzl do not teach that patients with the particular SOD suppression levels recited in instant claims 18-19 are included in the study, it would have been obvious to one of ordinary skill in the art to include any MCI patient in the study of Sun, including those with the particular SOD activity levels indicated in instant claims 18-19. One of ordinary skill in the art would have a reasonable expectation that performing the SOD activity analysis method of Sun with saliva instead of plasma as taught by Ramesh would successfully result in the determination of the relationship between salivary SOD levels and cognitive decline, as suggested by Goetzl.
Therefore, claims 1, 3-5, 7, and 16-19 are rendered obvious by Sun in view of Ramesh and Goetzl and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant has traversed the above rejection of claim 4 under 35 U.S.C. 101. Applicant states the addition of a limitation requiring administering “a therapeutic agent for MCI” to a patient if said patient is assessed as likely to have MCI into claim 4 renders the rejection moot (remarks, page 4). This argument has been fully considered but has not been found persuasive.
As discussed above, the Examiner notes that the administration step of amended claim 4 does not occur in all embodiments of the method of claim 4, such as embodiments in which the subject is not assessed as likely to have MCI. As such, the administration does not occur over the full scope of the claimed method, so it cannot cause the claim to become eligible under 35 U.S.C. 101 because embodiments exist in which the added step is not performed. A claim must be eligible over its entire scope to satisfy the requirements of 35 U.S.C. 101. In addition, the administration of “a therapeutic agent for MCI” is recited at too high a level of generality to represent a practical application of the judicial exception or significantly more than the judicial exception, as discussed more extensively above.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 01/28/2026