JNotice 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 amended claim set filed 13 Dec 2025 is acknowledged. Claims 1-5 are currently pending. Of those, claims 1-2 and 4 are currently amended, and no claims are new. No claims are cancelled. Claims 1-5 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 31 Dec 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 1 Oct 2025 will be referred to as “NFOA.”
The amended drawings filed 31 Dec 2025 are acknowledged but are not entered. As stated in the NFOA (par. 9): “Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d).” At least the pages containing Figures 2A-C and 3A have modifications compared to the original drawings but are not labeled. This is not a complete list of all pages that might have this error.
The amended specification filed 31 Dec 2025 is acknowledged and entered.
Objection(s) and Rejection(s) Withdrawn
The objection relating to sequence disclosures (NFOA par. 9) and the objection to the specification (NFOA par. 10) are withdrawn in view of the amended specification.
The objections to claims 1-2 (NFOA par. 11-12) are withdrawn in view of the claim amendments.
The rejection of claim 4 under 35 U.S.C. 112(b) (NFOA par. 13-14) is withdrawn in view of the claim amendment and the argument that docosahexaenoic acid is a well known omega-3 fatty acid with anti-inflammatory properties.
Drawings
The drawings are objected to because it appears that the drawings were originally created using colors, and the drawings are not clear in a black-and-white format. For example:
The figure legends reference colors in the figures that are not shown, such as “red dashed line” in the description of Figure 1C [0016], “red” and “blue text” in the description of Figure 5, and other locations. – This objection would have been maintained if the amended drawings were entered because the specification filed 31 Dec 2025 still references colors.
In Figure 1A-J, and Figure 4A-B only the “high responder” data has test and control colors chosen so that the contrast can be differentiated (see example below). – This objection would have been maintained for Figure 1D only if the amended drawings were entered (note that the legend of Figure 1D has not been updated to match the other line drawings, for example Figure 1F).
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In Figures 1B, D, F, H, and J, and Figure 3A, the conditions are represented by lines composed from different patterns of dots and dashes, but the figure legend is the same as shown above for Figure 1A and does not reflect the data displayed. – This objection would have been withdrawn if the amended drawings were entered.
In Figure 2A-C, the difference between the “high” “low” and “slow” colors does not lead to enough contrast for the data in each group to be differentiated (legend is the same as Figure 1A above). – This objection would have been maintained for Figure 2A only if the amended drawings were entered (note that Figure 2A does not have text labels or sufficient differences in the legend to differentiate high, low, and slow data).
In Figure 3B, Figure 6A-C, the data cannot be interpreted because the increase and decrease are both represented with darker colors (see example below). – This objection would have been withdrawn if the amended drawings were entered.
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In Figure 5B-C, the legend displays symbols for “detected simultaneously” and “detected on test side prior to control”, but these symbols are not used in the figure (see example below). – This objection would have been withdrawn if the amended drawings were entered.
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In Figures 6D-F, the broken lines used for IL6 and TNF-a look the same and cannot be reliably differentiated. Also, in Figures 6G-I, the broken lines used for Firmicutes SCF and Firmicutes STF look the same and cannot be reliably differentiated. – This objection would have been withdrawn if the amended drawings were entered.
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Also, Figures 6J-L do not appear to be labeled with the inflammatory type they correspond to, either in the figure or the legend, which makes the graphics difficult to interpret. Applicant may wish to label these figure panels, if this addition can be done without introducing new matter. – It is noted that applicant has chosen not to label the panels to differentiate which figure panel corresponds to high, low, and slow data. This objection would have been withdrawn if the amended drawings were entered.
As it appears the drawings were originally created in color, applicant is reminded that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(a)
Claims 1-5 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims recite methods of identifying an individual as being a slow gingivitis responder or a high gingivitis responder. The claim states that this method obtains (a) a pre-gingivitis-derived subgingival plaque sample, (c) an early distant healthy-derived subgingival plaque sample, and (e) a late distant healthy-derived subgingival plaque sample, and (b, e, f) analyzes the bacterial composition of each sample to determine the baseline, early, and late inverted Firmicutes to Bacteroidetes ratio (iFBR), respectively. Then, data analysis is performed to compare the baseline, early, and late iFBRs, wherein:
if the early iFBR is significantly unchanged compared to the baseline iFBR and the late iFBR is significantly changed compared to the baseline iFBR and early iFBR, the individual is a slow gingivitis responder and
if the early iFBR is significantly changed compared to the baseline iFBR and the late iFBR is significantly changed compared to the baseline iFBR, the individual is a high gingivitis responder.
Claim 1 has been amended to add a step of administering treatments if the individual is a slow or high gingivitis responder. Claims 2-5 further limit the treatment step, but do not limit the identification step of claim 1.
The specification defines that “[a]n "early distant healthy-derived sample subgingival plaque sample refers to a subgingival plaque sample obtained from a site of healthy tissue that is distant from the site of gingivitis, i.e., the site of localized plaque-induced inflammation, in an individual that has localized plaque-induced inflammation, 7-14 days after the appearance of localized plaque-induced inflammation, or if an induction procedure based on the experimental gingivitis model is employed (which includes a 14-day pre-induction period that begins with a cleaning and examination a day followed by a 21-day induction period during which time there is a cessation of brushing), subgingival plaque sample is obtained 21-28 days after the start of the pre-induction phase, which is 7-14 days after the start of the induction phase” [0022]. A late distant healthy-derived subgingival plaque sample is defined similarly as being from a site of healthy tissue, but taken after 14 days after the appearance of localized plaque-induced inflammation, or after 28 days after the start of the pre-induction phase (after 14 days after the start of the induction phase).
In the examples and specifically Figure 4, the specification performs a study of inducing gingivitis [0059-0060], and collecting subgingival plaque samples for both control (“distant healthy-derived”) and test sites [0062]. Figure 4 shows that the analysis of the samples to determine iFBR occurs for samples collected at day 0 (“baseline”), days 7 and 14 (“early”) and day 21 (“late”). Specifically, Figure 4B shows comparisons of the iFBR data in each sample relative to earlier timepoints, and is reproduced below. The specification teaches that in this figure the significance level is indicated by the asterisks [0016, pg. 7]. (Figure 4A compares the test and control sites at each timepoint, which is not the same as the claimed comparison step).
Figure 4B, version of record filed 10 Feb 2023.
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The data of the specification shows that, contrary to what is claimed, the control/distant healthy-derived site in both the high and slow responders is first significantly changed compared to baseline at 21 days (“late”), and that there is no significant change at either 7 or 14 days (“early”) compared to the day 0 baseline for either the high or slow responder group identified in the examples. Instead of sorting into high and low responders, the claimed comparison determines that both groups are slow gingivitis responders.
One of ordinary skill in the art would not be able to sort individuals into high and slow gingivitis responders with a reasonable expectation of success given the data explicitly showing that high and slow gingivitis responders cannot be differentiated using the claimed comparison step.
In terms of the treatment steps discussed in claims 1-5, the instant specification teaches that “Classic signs and symptoms of gingivitis include red, swollen, tender gums that may bleed when brushing or flossing… Gingivitis is an inflammation of the gums that is the initial stage of gum disease.” [0003-0004]. The instant specification also teaches that low responders, in addition to high and slow responders, also develop gingivitis. See Figure 1C and the description of the figure, which states that the line represents “significant clinical inflammation” [0016], and shows that the low responders reach this level of inflammation by day 21. Also see Figure 1E, which shows the low responders have a visible but not statistically significant increase in bleeding on probing on day 21 that is similar to the visible but not statistically significant increase seen for the slow responders on day 14, which are subjects with gingivitis per claim 2. Therefore, the claimed subject population (individual who has been identified as having gingivitis) includes all three inflammatory types (high, low, and slow responders), but the claim only teaches administering a treatment to two of the inflammatory types (high and slow responders).
From MPEP 2111.04: “The broadest reasonable interpretation of a method 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, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim.” Because claim 1 step (h) and claim 2 step (b) requires that treatment only be administered to two out of the three gingivitis subtypes, this step is not required in the broadest reasonable interpretation of the claim. This interpretation also applies to claims 3-5, which limit the treatment that could be administered but do not require that the treatment be administered to all subjects.
Therefore, claims 1-5 are not enabled because the only required steps in these claims is performing the method of claim 1 steps (a)-(g). Additionally, one of ordinary skill in the art would not be able to diagnose or differentially treat the slow and high gingivitis responders with a reasonable expectation of success because the comparison step of claim 1 cannot differentiate these two groups, as shown above.
Response to Arguments
Applicant argues (Remarks pg. 7) that “The Examiner's rejection is based on a misreading of Figure 4B and the specification's teachings.”
The argument has been carefully considered but is not found persuasive. While it is possible that the Examiner is mis-reading Figure 4B, the arguments do not point out how Figure 4B should be read instead to support the claimed comparison step in claim 1(g) and the Examiner did not identify any errors when reviewing the rejection of record.
Applicant argues (Remarks pg. 7) “As stated at paragraph [0090] of the originally-filed specification, "[t]he shift was delayed in the control sites until Day 7 for the High-IRTs and Day 14 for the Low- and Slow-IRTs." This temporal difference is precisely what enables differentiation between high and slow responders using the claimed method.
Paragraph [0042] further confirms the claimed method: "If the early iFBR has changed significantly from the baseline iFBR, the individual is identified as a High-IRT and can be treated accordingly. If the early iFBR has not changed significantly from the baseline iFBR, but the late iFBR has changed significantly from the baseline iFBR, the individual is identified as a Slow-IRT and can be treated accordingly."
Applicant further argues (Remarks pg. 8) that “The specification also teaches that "the iFBR changes seen in the control sites over the Induction phase were only statistically significant for the High- and Slow-IRTs." (As-Filed Specification, paragraph [0090]) This confirms that these two groups-the only groups addressed by the claims-can be identified using the claimed method based on the temporal differences in their iFBR shifts at control sites.”
The argument has been carefully considered but is not found persuasive. The examiner recognizes that the specification includes the first quote within paragraph [0090], and that paragraph [0090] references Figure 4A-B, but the data of Figure 4B does not appear to support the statement. The reference to paragraph [0042] is only a statement of how a method could potentially be performed and does not address the data showing that the proposed method is ineffective at classifying with the claimed step. The second quote from [0090] is not relevant to the rejection of record because the rejection does not dispute that high and slow IRT groups both have significant changes relative to baseline at day 21 and that the low IRT group does not have significant changes relative to baseline at day 21 according to Figure 4B, but that that is not the claimed identification step. The Examiner remains of the opinion that one of ordinary skill in the art would not be able to analyze data in the manner claimed with a reasonable expectation of success because the demonstrated data analysis does not match the claimed method.
Applicant argues (Remarks pg. 7) “The specification specifies "early" samples as obtained 7-14 days after induction begins and "late" samples as obtained after 14 days. (See As-Filed Specification, paragraphs [0022]-[0023]).”
The examiner agrees with this statement, note that these paragraphs of the specification were quoted in the rejection of record (NFOA par. 17 and par. 16 above).
Applicant argues (Remarks pg. 7-8) that " Since High-IRTs show iFBR shifts by Day 7 (within the "early" window) while Slow-IRTs show delayed shifts until Day 14 (at the boundary of the "late" window), the claimed comparison step can differentiate between these two groups.”
The argument has been carefully considered but is not found persuasive. Even if one were to accept that the Slow-IRT group showed a shift at day 14, this would still be a shift within the “early” window because a timepoint taken at 14 days was obtained 7-14 days after induction begins, as required by the “early” definition, and is not taken after 14 days, as required by the “late” definition in the specification.
Claim Rejections - 35 USC § 101
Claims 1-5 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1, the claim recites a method of identifying an individual as being a slow gingivitis responder or a high gingivitis responder. The claim states that this method obtains (a) a pre-gingivitis-derived subgingival plaque sample, (c) an early distant healthy-derived subgingival plaque sample, and (e) a late distant healthy-derived subgingival plaque sample, and (b, e, f) analyzes the bacterial composition of each sample to determine the baseline, early, and late inverted Firmicutes to Bacteroidetes ratio (iFBR), respectively. Then, data analysis is performed to compare the baseline, early, and late iFBRs, wherein
if the early iFBR is significantly unchanged compared to the baseline iFBR and the late iFBR is significantly changed compared to the baseline iFBR and early iFBR, the individual is a slow gingivitis responder and
if the early iFBR is significantly changed compared to the baseline iFBR and the late iFBR is significantly changed compared to the baseline iFBR, the individual is a high gingivitis responder.
The calculation of the iFBR is a mathematical principle, and the comparison of the different iFBR values is both a mathematical concept and also a mental step because it can be performed mentally. In the interest of compact prosecution, it is noted that a correlation between certain iFBRs and certain gingivitis responses would also be a natural phenomenon, if the correlation were shown to accurately represent natural variation. (Step 2A Prong 1: yes, recites an abstract idea)
This judicial exception is not integrated into a practical application because although there are additional steps of applying a treatment that occurs if the individual is a slow or high gingivitis responder (claim 1(h) and 2(b)) this is only two out of three gingivitis subtypes. Therefore, the optional treatment steps are not required in the broadest reasonable interpretation of the claim, per MPEP 2111.04 and do not limit the claim to being integrated into a practical application.
Also, the data collection steps of claim 1 (a)-(f) do not integrate the judicial exception. As in MPEP 2106.04(d), the claim does not use the judicial exception to improve a computer or some other technology, does not apply the judicial exception for a particular treatment, does not perform the data analysis using a particular machine, and does not use the judicial exception to transform one article to another. Instead, the non-mathematical steps of obtaining subgingival plaque samples and obtaining the microbiome data required to calculate the iFBR is insignificant extra solution activity because it is mere data gathering. MPEP 2106.05(g) states that the courts have found the following to be mere data gathering: performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); and determining the level of a biomarker in blood, Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. at 79, 101 USPQ2d at 1968. In this claim, as in the prior cases, the non-mathematical steps of the method merely perform laboratory manipulation on samples from individuals. (Step 2A Prong 2: no, not integrated into a practical application)
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because, in addition to the considerations in Step 2A Prong 2, the non-mathematical and non-mental data gathering steps are well-understood, routine, conventional activity in the field. The specification teaches that “[m]ethods of collecting subgingival plaque samples are well known to those skilled in the art” [0048] and that “in human gut microbiome research the use of a Firmicutes/Bacteroidetes ratio (FBR) has been accepted as an index for measuring the state of the gut microbiome” [0038], teaching that the sample processing steps required to produce the data on Firmicutes and Bacteroidetes abundance are “accepted”. (Step 2B: no, not significantly more). Therefore, claim 1 is rejected as being directed to a judicial exception.
Regarding claims 2-5, claim 2 adds a second treatment step for the same individuals who have been identified as slow and high gingivitis responders. Claims 3-5 further limit the treatment step(s) only. Because claim 2 step (b) requires that treatment only be administered to two out of the three gingivitis subtypes, the treatment step is not required in the broadest reasonable interpretation of the claim, per MPEP 2111.04. Therefore, the treatment step does not limit the claim, claims 2-5 require only performing the method of claim 1, and these claims are rejected for the same reasons as claim 1 is rejected.
Response to Arguments
Applicant argues (Remarks pg. 9) that “Claim 1 (as incorporated by claim 2) only identifies individuals as either slow OR high gingivitis responders-it does not provide for identifying "low responders." The claim recites that "if the early iFBR is significantly unchanged compared to the baseline iFBR and the late iFBR is significantly changed compared to the baseline iFBR and early iFBR, the individual is a slow gingivitis responder and if the early iFBR is significantly changed compared to the baseline iFBR and the late iFBR is significantly changed compared to the baseline iFBR, the individual is a high gingivitis responder." These are the only two possible identification outcomes under the claimed method. Therefore, every individual processed through the method of claim 1 would necessarily be identified as either a slow or high gingivitis responder, which would trigger one of the two treatment steps in claim 2 step b).”
This argument has been carefully considered but is not found persuasive. The claim is not limited to performing the method in individuals who are either slow OR high gingivitis responders. The preamble of claim 1 reads “identifying and treating an individual as being a slow gingivitis responder or a high gingivitis responder”, so it uses a generic individual. Claim 1 step (a) begins with samples from “the individual”, and there is no step of pre-identifying the gingivitis response before step (a) in order to select method subjects. Therefore, the claimed method begins with samples from any individual (slow, high, OR low responders) but only classifies and applies treatments to some of the individuals (slow OR high gingivitis responders, but not low responders). Therefore, the examiner’s position remains that the treatment step is optional and that it cannot be used to integrate the judicial exception or be significantly more.
Claim Rejections - 35 USC § 102
Claims 1-5 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kerns (2021; made of record in IDS filed 18 Aug 2023) as evidenced by Bamashmous et al. (30 June 2021; made of record in IDS filed 10 Feb 2023) and Supplementary Information (PTO-892), and Colgate website (recordings captured 2021 and 2020; PTO-892).
Kerns teaches that the human induced gingivitis experiment used “the previous study methodology” established by Bamashmous et al. (pg. 28 section 2.2.1), and included a hygiene phase for two weeks prior to baseline (Day -14 – Day 0), and a gingivitis induction phase lasting for three weeks (Day 0 – Day 21). Kerns teaches that “Subgingival plaque samples were collected in the previous study at each study visit from both control and test sides” (pg. 28 section 2.2.3). The “control” side is the claimed “distant healthy-derived subgingival plaque sample”, and Figure 7 (pg. 39) demonstrates that samples were taken and the Bacteroidetes/Firmicutes ratio (iFBR) was calculated at day 0 (“baseline”, steps a-b), days 7 and 14 (“early”, steps c-d), and day 21 (“late”, steps e-f).
Figure 7 shows that the slow responders control samples show no significant difference between iFBR at baseline and “early” days 7 or 14 (note the lack of asterisks denoting significance and also the relatively minor change in the data), but that there was a significant change between the iFBR at baseline and “late” date 21 (P ≤ 0.001 as described in the figure legend) (Figure 7 pg. 39). Kerns also shows that the group labeled “high” responders also show no significant difference between iFBR at baseline and “early” days 7 or 14 and show a significant change between the iFBR at baseline and “late” date 21 (P ≤ 0.001 as described in the figure legend) (Figure 7 pg. 39), and would be considered “slow” responders by the claim. Also, Kerns also shows that the group labeled “high” responders do not show significant differences relative to baseline at either early or late days (Figure 7 pg. 39), and are not addressed by the claims.
MPEP 2111.02 states: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” The claim 1 preamble’s intended use “of identifying an individual as being a slow gingivitis responder or a high gingivitis responder” does not lead to any manipulative difference between the steps of Kerns and the claims, so it does not distinguish the claims from the prior art.
During the resolution phase, Kerns teaches that “the previous study methodology” was established by Bamashmous et al. (pg. 28 section 2.2.1). The Supplementary Information of Bamashmous teaches that in the resolution phase, “Participants were given again detailed instructions in oral hygiene methods using the provided electric toothbrush (Philips Sonicare Electric Toothbrush), toothpaste (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste), and dental floss (Oral B Glide) beginning the same day and continued twice daily during the resolution phase.” (pg. 14 section 1.1.1.3). The repeated administration of toothpaste meets the requirement for a second application step (see claim 2). The Colgate website teaches that this toothpaste comprises fluoride (an ingredient with antimicrobial activity, see claim 3), and free from ingredients with anti-inflammatory activity (no other active ingredients per Colgate website, none of the ingredients in claim 4). Therefore, those identified as slow gingivitis responders (the Kerns “high” and “slow” groups) were administered the oral care composition required by claims 1-5.
Response to Arguments
Applicant argues (Remarks pg. 10) that Kerns does not teach identifying high gingivitis responders because all subjects are classified as slow responders, and that Kerns does not teach differential treatment based on responder type as recited by amended claim 1 step h). “the Colgate website shows this toothpaste contains only fluoride (antimicrobial) with no anti-inflammatory ingredients. (See Colgate website reference). … The prior art toothpaste lacks any anti- inflammatory ingredients. Furthermore, in Kerns/Bamashmous, the same toothpaste was administered to all participants regardless of their responder classification-there was no differential treatment based on identification as a slow or high responder.”
This argument has been carefully considered but is not found persuasive. As an initial matter, the Examiner appreciates the agreement that the Colgate toothpaste contains antimicrobial but no anti-inflammatory ingredients. The arguments have not disputed that slow responders were identified by the method of claim 1 (g) and that those slow responders were treated as required by claim 1 (h), claim 2(b) and claims 3-5. The claim does not require that high gingivitis responders be identified and treated; instead the claim states that the method is performed on “an individual” (i.e. a single person) who must be either a slow responder (as is the case for all participants from Kerns) or a high responder (as is the case for no participants from Kerns), but cannot be both by the claimed definition. The courts have established that "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960). See also MPEP 2131.02.I. In this situation, the claim recites a genus of possibilities (the individual is identified as either a slow or high responder) and Kerns anticipates the method by showing a specific species within the claimed genus (all individuals are identified as a slow responder and treated accordingly). Therefore, the claim remains rejected for the reasons of record and the reasons herein.
New Rejection(s)
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 2-5 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.
Claim 2 recites the limitation "one or more oral care compositions comprising one or more ingredients having antimicrobial activity and one or more ingredients having anti- inflammatory activity." There is unclear antecedent basis for this limitation in the claim because it is unclear if this is claiming antecedent basis back to the “one or more oral care compositions” that is administered in the administration step of claim 1 (i.e. the same composition is administered in both steps) or whether the two administration steps can be met by different sets of "one or more oral care compositions."
Claim 3 recites the limitation "the one or more ingredients having antimicrobial activity". There is insufficient antecedent basis for this limitation in the claim because it is unclear whether this claims antecedent basis to the administration step of claim 1 or 2.
Claim 4 recites the limitation "the one or more ingredients having anti-inflammatory activity". There is insufficient antecedent basis for this limitation in the claim because it is unclear whether this claims antecedent basis to the administration step of claim 1 or 2.
Claim 5 recites the limitation "the one or more oral care composition". There is insufficient antecedent basis for this limitation in the claim because it is unclear whether this claims antecedent basis to the administration step of claim 1 or 2.
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 AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 28, 2026
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