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 .
Claims 13-20, 23-36 and 38 are pending in this application, Claims 20, 23 and 31 are acknowledged as withdrawn, Claims 13-19, 22, 24-30, 32-36 and 38 were examined on their merits.
Claim Interpretation
The “wherein” clause of Claim 38 has been interpreted as not requiring a step of measuring a predetermined threshold of occult blood. As such, it merely refers to a property of the measured occult blood with regard to any amount of occult blood which has been measured prior to the claimed measurement of occult blood and does not serve to limit the claim.
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 13-19, 22, 24-30 and 32-36 are newly 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, as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
Claim 13 recites the limitations "the first predetermined threshold" and “the second predetermined threshold”. There is insufficient antecedent basis for these limitations in the claim. Claims 13-19, 22, 24-30 and 32-36 are rejected as being dependent upon rejected Claim 13 and for failing to remedy the lack of antecedence basis thereof.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 38 is newly rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Nishinaga et al. (US 2015/0038350 A1), cited in the IDS, as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
Nishinaga et al. teaches a method of measuring the amount of occult blood, total protein concentration and white blood cells/leukocytes in a saliva sample (Pg. 8, [0112], Pg. 15, Table 1 and Pg. 17, Example 1).
Nishinaga et al. further teaches "determining" the risk (including presence of) of periodontal disease, dental caries and the status of oral hygiene (Pg. 3, Paragraphs [0049]-[0050]), wherein the risk is determined to be low/light when the amount of occult blood/leukocytes is below a predetermined threshold, middle/intermediate when the amount of occult blood/leukocytes is at a predetermined threshold or greater or high/serious when the amount of occult blood/leukocytes is at a predetermined threshold or greater based on the measured occult blood and white blood cells as compared to predetermined thresholds (Pg. 15, Table 1).
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 13-19, 22, 24-30 and 32-37, as amended by Applicant on 07/06/2026, are newly rejected under 35 U.S.C. § 101 because the claimed invention is directed to Judicial Exception(s) without significantly more. The claim(s) recite(s) measuring, in a sample from a subject, at least two of an amount of occult blood, a total protein concentration, and a number of white blood cells in a specific order of measurements including operations (i), (ii), (iii) and (iv), the method(s) comprising:
(i)-(a) measuring the amount of occult blood in the sample, (ii)-(a) if the amount of occult blood is less than the first predetermined threshold of the amount of occult blood, measuring the total protein concentration in the sample, and (iii)-(a) if the amount of occult blood is not less than a first predetermined threshold or greater, measuring the number of white blood cells in the sample, wherein the first predetermined threshold is determined in advance of the measuring the amount of occult blood;
or (i)-(b) measuring the total protein concentration in the sample, (ii)-(b) if the total protein concentration is less than a second predetermined threshold of the total protein concentration, measuring of occult blood in the sample, and (iii)-(b) if the total protein concentration is not less than the second predetermined threshold or greater, measuring the number of white blood cells in the sample,
wherein the second predetermined threshold is determined in advance of the measuring the total protein concentration;
and measuring the amount of occult blood in the sample, and measuring the total protein concentration in the sample, wherein the amount of occult blood is less than a first predetermined threshold of the amount of occult blood, and the first predetermined threshold is determined in advance of the measuring the amount of occult blood.
Thus, the claims are drawn to a Judicial Exception of Abstract Ideas/Mental Processes, i.e., "if the occult blood is less than a first predetermined threshold", “if the total protein concentration is less than a second predetermined threshold” and “wherein the amount of occult blood is less than a first predetermined threshold”, the limitations containing an implied mental step/abstract idea of comparing a measured parameter to a predetermined threshold parameter without significantly more.
This judicial exception is not integrated into a practical application because the Judicial Exception(s) do not effect a particular treatment of prophylaxis for a disease or medical condition and at best, merely add append an Abstract Idea (Identifying/determining) to another Natural Phenomenon Judicial Exception(s), i.e., the correlation of the presence, absence or degree of periodontal infection and gingivitis with the amount of naturally occurring parameters.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Step 1) Is the claim to a process, machine, manufacture of composition of matter?
Yes, the claims are drawn to a process.
Step 2A, prong 1) Does the claim recite an Abstract Idea, Law of Nature or Natural Phenomenon?
Yes, Claims 13, 14, 15, 16, 17, 24, 25, 26, 27 and 28, recite Mental Steps/Abstract Ideas and/or a Natural Phenomenon. The Abstract Ideas/Mental Steps of:
"if the occult blood is less than a first predetermined threshold", “if the total protein concentration is less than a second predetermined threshold” and “wherein the amount of occult blood is less than a first predetermined threshold”;
“determining whether the amount of occult blood as measured is less than a first predetermined threshold of the amount of occult blood”, “determining whether the amount of total protein concentration as measured is less than a first predetermined threshold of the amount of the total protein concentration”;
"measuring the number of white blood cells with respect to (implying a comparison to) a third predetermined threshold"; "determining serious periodontal disease", "determining intermediate periodontal disease", "determining light periodontal disease", "determining gingivitis", "determining the periodontal disease improvement period", "determining a healthy condition",
"measuring an ammonia concentration in the sample with respect to (implying a comparison to) a fourth predetermined threshold" and "determining whether the amount of occult blood as measured is less a first predetermined threshold of the amount of occult blood” are a grouping containing Abstract Ideas ("determining", comparing). Claims 15, 17, 26 and 28 additionally recite a Natural Phenomenon. That is, the correlation of the differential presence, absence or degree of periodontal infection and gingivitis with the measured amount of naturally occurring parameters, similar to Mayo, see the MPEP at 2106.04(b), I., iv.
Step 2A, prong 2) Does the claim recite Additional elements that integrate the
Judicial Exception(s) into a practical application?
No, the steps of measuring the amount of occult blood in a sample from a subject
and; measuring the number of white blood cells in the sample or measuring total protein
concentration in an unspecified sample by unspecified/highly generalized chemical analyses are no more than data gathering performed for the mental analysis step of determining the presence, absence or degree of periodontal infection and gingivitis in the subject and are necessary precursors for all uses of the recited exception(s). See the MPEP at 2106.05(g), (3). The steps of Claims 32-35 of performing the measurement steps in a specific order and excluding particular parameters from measurement are also extra-solution activity/data gathering and do not integrate the Judicial Exception(s) into a practical application. The steps of Claims 24 and 36 are drawn to the mere automation of the performance order of the method steps and do not integrate the Judicial Exception(s) into a practical application.
Step 2B) Does the claim recite additional elements that amount to significantly
more than the Judicial Exception(s)?
No, the steps of measuring the amount of occult blood in a sample from a
subject, measuring the number of white blood cells in the sample, measuring
ammonia concentration and the use of the differential concentration of the measured
parameters in a subject sample as compared to some predetermined threshold to
determine the presence, absence or degree of periodontal infection and gingivitis are no
more than what was well-understood, routine and conventional in the art when
appended to the Judicial Exception(s). See Nishinaga et al., cited in the IDS and herein.
Response to Arguments
Applicant's arguments filed 07/06/20206 have been fully considered but they are not persuasive.
The Applicant argues that amended Claim 13 no longer contains abstract ideas/mental steps and is patent eligible consistent with Claim 1 of Example 29 “Julitis” of the Subject Matter Eligibility Examples: Life Sciences. Applicant asserts that the claims do not recite or describe any recognized exception and are focused on detection/measurement of the parameter and not the natural parameter itself (Remarks, Pg. 8, Lines 19-31 and Pg. 9, Lines 1-7).
This is not found to be persuasive for the reasoning provided in the above new rejections, the Examiner notes that at least Claims 13 and 38 still contain implied abstract idea ideas/mental steps and Claims 14, 15, 16, 17, 24, 25, 26, 27 and 28, recite Mental Steps/Abstract Ideas and/or a Natural Phenomenon. The Julitis Example was found to be patent-eligible at step 2a, prong one because it did not recite a Judicial Exception, being limited solely to detecting the presence of JUL-1 in a plasma sample using an anti-JUL-1 antibody. In this instance, the claims at issue still recite either implied or specific abstract ideas/mental steps, as well as a Natural Phenomenon, the correlation of the differential presence, absence or degree of periodontal infection and gingivitis with the measured amount of naturally occurring parameters.
The Applicant argues that Claim 24 has been amended to address a technical problem in conventional measurements in which multiple parameters are measured independently or in an arbitrary order leading to reduced consistency and reliability and requiring complex analysis or skilled artisan interpretation. Applicant asserts the claims now recite an unconventional order of steps not described in the prior art and amounting to significantly more than the Judicial Exceptions (Remarks, Pg. 9, Lines 8-25).
This is not found to be persuasive for the following reasons, as discussed above, the steps of Claims 24 and 36 are drawn to the mere automation of the performance order of the method steps and do not integrate the Judicial Exception(s) into a practical application.
Further, the individual or combined steps of: measuring the amount of occult blood in a sample from a subject, measuring the number of white blood cells in the sample or measuring total protein concentration and the use of the differential concentration of the measured parameters in a subject sample to a predetermined threshold value to determine the presence, absence or degree of periodontal infection and gingivitis are no more than what was well-understood, routine and conventional in the art when appended to the Judicial Exception(s).
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 PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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