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Claims 13-20 and 22-37 are pending in this application, Claims 20, 23 and 31 are acknowledged as withdrawn, Claims 13-19, 22, 24-30 and 32-37 were examined on their merits.
The rejection of Claims 14, 15, 16, 17, 25, 26, 27 and 28 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as the invention, has been withdrawn.
Claim Objections
Claims 20, 23 and 31 are objected to because of the following informalities: The claims are incorrectly identified as “previously presented” when they were withdrawn in the last action. Appropriate correction is required.
Applicant is advised that should claims 13, 14, 15, 16, 17, 18 and 19 be found allowable, claims 24, 25, 26, 27, 28, 29 and 30 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Interpretation
Claims 13, 14, 24 and 25 contain contingent limitations. That is, Claims 13 and
24 require: measuring the amount of occult blood in a sample, and determining if the
amount of occult blood is less than or greater than a first predetermined threshold of the
amount of occult blood, only 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 only if the amount of occult blood is the first predetermined threshold or greater, measuring the number of white blood cells in the sample, or
measuring the total protein concentration in the sample, determining whether
the amount of total protein concentration as measured is less than or greater than a
second predetermined threshold of the total protein concentration, only if the total
protein concentration is less than the second predetermined threshold of the total
protein concentration, measuring the amount of occult blood in the sample, and only if
the total protein concentration is 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. Claims 14 and 25 are also contingent limitations based on the measured
amount of occult blood, wherein measuring the number of white blood cells in the sample includes measuring the number of white blood cells with respect to a
third predetermined threshold. Consistent with the MPEP at 2111/04, II, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, if the measured occult blood concentration in Claim 13, (i)(a) is “determined” to be neither less than or greater than a first predetermined threshold of the amount of occult blood no further measurements are required to take place. Thus, the broadest, reasonable interpretation of the current claims is of two separate measuring steps, that of the measurement of occult blood in a sample (Claims 13 and 24, step (ia) or measuring the total protein concentration in a sample (withdrawn embodiment of Claims 13 and 24, step (ib).
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 and 24-35 (and extended to New Claims 36-37 as amended by Applicant) 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
comprising:
(i)-(a) measuring the amount of occult blood in the sample, (ii)-(a) determining
whether the amount of occult blood as measured is less than or greater than a first
predetermined threshold of the amount of occult blood, (iii)-(a) only 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 (iv)-(a) only if the amount
of occult blood is the 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. Thus, the claims are drawn to
a Judicial Exception of Abstract Ideas/Mental Processes, i.e., "determining whether the
amount of occult blood as measured is less than or greater than a first predetermined
threshold of the amount of occult blood" 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, as discussed above, 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: "determining whether the amount of occult blood as measured is less than or
greater than a first predetermined threshold of the amount of occult blood", "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",
"measuring an ammonia concentration in the sample with respect to
(implying a comparison to) a fourth predetermined threshold", "determining the periodontal disease improvement period", "determining a healthy condition" are a grouping containing an Abstract Idea ("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, measuring the number of white blood cells in the sample and measuring
ammonia concentration in the sample by an unspecified/highly generalized chemical
analysis are no more than data gathering performed to gather data 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 36-37 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 and measuring
ammonia concentration and the use of the differential concentration of the measured
parameters in a subject sample 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. below.
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.
Claims 13-16, 18, 19, 22, 24-27, 29 and 30 are 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 evidenced by Shaddox et al. (2010), of record.
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), and reading on Claims 13, step (ai), 14, 22, 24,
step (ai) and 25, given the claim interpretation discussed above.
Nishinaga et al. further teaches the measurement of one or two or more
parameters selected from the group consisting of: calcium concentration, total protein
concentration, occult blood amount, leukocyte count, alkaline phosphatase activity, and
lactate dehydrogenase activity be measured (Pg. 3, Paragraph [0054]) and wherein at
least one parameter selected from the group consisting of ammonia concentration and
total protein concentration be measured (Pg. 4, Paragraph [0058]).
With regard to Claims 13, 15, 24 and 26, Nishinaga et al. teaches “determining” the risk (including presence of) of periodontal disease (gingivitis being the first stage of
periodontal disease see Shaddox, Pg. 79, Lines 1-7), 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).
With regard to Claims 16 and 27, Nishinaga et al. teaches measuring ammonia
concentration in the sample with respect to a predetermined threshold (Pg. 15, Table 1).
With regard to Claims 18 and 29, Nishinaga et al. teaches the measuring of the
amount of occult blood is based on a measurement of hemoglobin in the sample (Pg. 8,
Paragraphs [0112]-[0113]).
With regard to Claims 19 and 30, Nishinaga et al. teaches the measuring of the
number of white blood cells/leukocytes is based on a measurement of esterase activity
in the sample (Pg. 9, Paragraph [0117]).
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.
Claims 13-19, 22, 24-30 and 32-35 (and including New Claims 36-37) are newly rejected under 35 U.S.C. 103 as being unpatentable over Nishinaga et al. (US 2015/0038350 A1), cited in the IDS, as evidenced by Shaddox et al. (2010), of record, as necessitated by Applicant’s amendment to the claims filed 01/06/2026.
The teachings of Nishinaga et al. were discussed above.
Nishinaga et al. did not teach determining serious periodontal infection if the
amount of occult blood is the first predetermined threshold or greater, the number of
white blood cells is the third predetermined threshold or greater, and the ammonia
concentration is the fourth predetermined threshold or greater;
determining a periodontal disease improvement period if the amount of occult
blood is the first predetermined threshold or greater, the number of white blood cells is
the third predetermined threshold or greater, and the ammonia concentration is less
than the fourth predetermined threshold;
determining intermediate periodontal infection if the amount of occult blood is the
first predetermined threshold or greater, the number of white blood cells is less than the
third predetermined threshold, and the ammonia concentration is the fourth
predetermined threshold or greater;
determining the periodontal disease improvement period if the amount of occult
blood is the first predetermined threshold or greater, the number of white blood cells is
less than the third predetermined threshold, and the ammonia concentration is less than
the fourth predetermined threshold;
determining light periodontal infection if the amount of occult blood is less than
the first predetermined threshold, the total protein concentration is the second
predetermined threshold or greater, and the ammonia concentration is the fourth
predetermined threshold or greater;
determining the periodontal disease improvement period if the amount of occult
blood is less than the first predetermined threshold, the total protein concentration is the
second predetermined threshold or greater, and the ammonia concentration is less than
the fourth predetermined threshold;
determining gingivitis if the amount of occult blood is less than the first
predetermined threshold, the total protein concentration is less than the second
predetermined threshold, and the ammonia concentration is the fourth predetermined
threshold or greater; and
determining a healthy condition if the amount of occult blood is less than the first
predetermined threshold, the total protein concentration is less than the second
predetermined threshold, and the ammonia concentration is less than the fourth
predetermined threshold, as required by Claims 17 and 28;
measurement of the amount of occult blood and number of white blood cells in a
specific order of measurements, as required by Claim 32;
wherein white blood cells are not measured (excluded) in the sample, as required
by Claim 33;
wherein total protein concentration is not measured (excluded) in the sample, as
required by Claim 34;
wherein ammonia concentration is not measured (excluded) in the sample, a
required by Claim 35;
or, controlling, by a controller, the specific order of measurements by configuring a sequence of operations steps (i)-(a)-(iv)-(a) or (i)-(b)-(i)-(iv), as now required by Claims 36 and 37.
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Nishinaga et al. of
measuring the amount of occult blood and white blood cells/leukocytes in a saliva
sample, to perform the measurements in a specific order because the selection of any
order of performing process steps is prima facie obvious in the absence of new or
unexpected results. See the MPEP at 2144.04, IV. C. Those of ordinary skill in the art would have been motivated to make this modification in order to sequentially measure multiple particular parameters indicative of the risk or presence of periodontal disease or dental caries. There would have been a reasonable expectation of success in making this modification because measurements may only be performed sequentially or simultaneously.
It would have been further obvious to those of ordinary skill in the art before the
effective filing date of the claimed invention to modify the method of Nishinaga et al. of
determining the risk (including presence of) of periodontal disease (gingivitis being the
first stage of periodontal disease see Shaddox, Pg. 79, Lines 1-7), dental caries and the
status of oral hygiene in a subject by measuring the amount of occult blood, white blood
cells/leukocytes, total protein concentration and ammonia in a saliva sample, 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 to use the determination as a baseline for assessing whether a treatment improves (periodontal disease improvement period) the serious, intermediate, or light periodontal disease (encompassing gingivitis) because the use of controls or standards in the sciences for determining the effect of a variable is a foundational aspect. Those of ordinary skill in the art would have been motivated to make this modification in order to assess the effectiveness of a therapy/treatment on the periodontal disease. There would have been a reasonable expectation of success in making this modification because the reference teaches determination of the stage of periodontal disease using the same measured parameters as claimed and those of ordinary skill in the art would have been familiar with the use of controls to determine the effect of a treatment on the disease.
It would have been further obvious to those of ordinary skill in the art before the
effective filing date of the claimed invention to modify the method of Nishinaga et al. of
measuring the amount of occult blood and white blood cells/leukocytes in a saliva
sample, to exclude white blood cell measurement, total protein concentration
measurement or ammonia concentration measurement because the reference teaches
the measurement of one or two or more parameters selected from the group consisting
of: calcium concentration, total protein concentration, occult blood amount, leukocyte
count, alkaline phosphatase activity,
and lactate dehydrogenase activity be measured (Pg. 3, Paragraph [0054]) and wherein at least one parameter selected from the group consisting of ammonia concentration and total protein concentration be measured (Pg. 4, Paragraph [0058]). Those of ordinary skill in the art would have been motivated to make this modification in order to exclude extraneous parameter measurements if not needed for the method. There would have been a reasonable expectation of success in making this modification because the reference teaches the exclusion of multiple parameters from measurement.
With regard to Claims 36 and 37, the Examiner notes that the Claims respectively depend from Claims 12 and 24 which contain contingent limitations as discussed in the Claim Interpretation above. The broadest, reasonable interpretation of the claims is of two separate measuring steps, that of the measurement of occult blood in a sample (Claims 13 and 24, step (ia) or measuring the total protein concentration in a sample (withdrawn embodiment of Claims 13 and 24, step (ib). It would have been further obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Nishinaga et al. of determining the risk (including presence of) of periodontal disease, dental caries and the status of oral hygiene in a subject by measuring the amount of occult blood, white blood
cells/leukocytes, total protein concentration and ammonia in a saliva sample, to utilize a controller configured with a sequence of operations to control the specific order of performance of the measurement because this is no more than the automation of a manual activity. See the MPEP at 2144.04, III.
Those of ordinary skill in the art would have been motivated to make this modification in order to eliminate the need to manually perform the process steps of the method of Nishinaga. There would have been a reasonable expectation of success in making this modification because Nishinaga already teaches the ordered sequence of manually performing the measuring step.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/06/2026, with respect to the above withdrawn rejection have been fully considered and are persuasive.
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive.
The Applicant argues that the Examiner’s construal of the claims as only requiring a measurement of occult blood and comparing the obtained measurement to a predetermined threshold amount of occult blood is incorrect as steps (ii-a) or (ii-b) and one of (iii-a) and (iv-a) or (iii-b) and (iv-b) must be performed (Remarks, Pg. 8, Lines 6-16).
This is not found to be persuasive for the reasoning provided in the above Claim Interpretation. That is, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, if the measured occult blood concentration in Claim 13, (i)(a) is “determined” to be neither less than or greater than a first predetermined threshold of the amount of occult blood no further measurements are required to take place. Thus, the broadest, reasonable interpretation of the current claims is of two separate measuring steps, that of the measurement of occult blood in a sample (Claims 13 and 24, step (ia) or measuring the total protein concentration in a sample (withdrawn embodiment of Claims 13 and 24, step (ib).
The Applicant argues that the objection to Claims 24-30 is provisional and therefore chooses not to address the objection until a finding of allowable material (Remarks, Pg. 8, Lines 19-21).
This is not found to be persuasive and the Examiner notes the objection remains in effect.
The Applicant argues that the claims are directed to specific, physical measurements on a sample and determining a stage of periodontal disease without human interaction. Applicant asserts that the claimed method cannot be practically performed in the human mind (Remarks, Pg. 9, Lines 8-18).
This is not found to be persuasive for the reasoning provided in the above rejection. The claims only require performance of a physical method step of measuring the amount of occult blood in a sample and a mental step abstract idea of determining/comparing the amount of measured occult blood to a predetermined threshold value and contingently performing another measurement of another parameter based on the comparison. This measurement can be performed in the human mind as one could envision comparing an obtained measurement value to a lookup table of occult blood values. The claims 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.
The Applicant argues that the claims provide a technical solution to a technical problem (technology improvement) and are not directed to an Abstract Idea and are patent eligible (Remarks, Pg. 9, Lines 20-29).
This is not found to be persuasive for the following reasons, as discussed above 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 and measuring ammonia concentration in the sample by an unspecified/highly generalized chemical analysis are no more than data gathering performed to gather data 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 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 method is highly generalized and measures well known biomarkers of gingivitis (periodontal disease) to gather and analyze data such that any improvement to the existing technology is demonstrated.
The Applicant argues that the claims recite significantly more than the Judicial Exception by reciting an unconventional sequence of steps (Remarks, Pg. 9, Lines 31-32 and Pg. 10, Lines 1-12).
This is not found to be persuasive for the following reasons, as discussed above, 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 and measuring ammonia concentration and the use of the differential concentration of the measured parameters in a subject sample 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).
The Applicant argues that Nishinaga does not disclose each and every feature of the claimed invention, e.g. the claimed sequence of measurement steps. Applicant notes that the required measurement step occurs first since the determining step requires a measurement and the subsequent steps are performed based on the result of the determining step (Remarks, Pg. 10, Lines 18-32 and Pg. 11, Lines 1-5).
This is not found to be persuasive for the reasoning provided above, that is, consistent with the MPEP at 2111.04, II, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, if the measured occult blood concentration in Claim 13, (i)(a) is “determined” to be neither less than or greater than a first predetermined threshold of the amount of occult blood no further measurements are required to take place. Thus, the broadest, reasonable interpretation of the current claims is of two separate measuring steps, that of the measurement of occult blood in a sample (Claims 13 and 24, step (ia) or measuring the total protein concentration in a sample (withdrawn embodiment of Claims 13 and 24, step (ib). As discussed in the prior action and above, Nishinaga anticipates the claimed measurement step.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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