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 .
The amended claims dated 7/12/2026 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 18 and 19, in the reply filed on 7/12/226 is acknowledged.
Claims 12, 14, 15, 16 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/12/2026.
Applicant’s election of the nine bacteria species recited in claim 1 and the primers in claim 6 in the reply filed on 7/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
The present application is a 371 national stage entry of PCT/KR2022/015881 (filed 10/18/2022), and claims benefit of REPUBLIC OF KOREA 10-2021-0138898 (filed 10/19/2021).
Priority is recognized.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Drawings
High resolution copies of the drawings may be accessed via PAIR/Patent Center Retrieval using the Supplemental Content tab.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The hyperlink appears in para. 146 on p. 23.
Claim Objections
Claim 8 is objected to because of the following informalities: the claim recites “comparing comprises determining the periodontal disease, if, based on a cut-off value of the bacterial % obtained through the quantitative analysis by real-time PCR”. The use of the word “if” appears to be misplaced. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the claim recites “comparing comprises determining the periodontal disease, if, based on a cut-off value of the bacterial count obtained through the quantitative analysis by real-time PCR”. The use of the word “if” appears to be misplaced. Appropriate correction is required.
Claim Interpretation
Claim 1 is drawn to a “method of providing information necessary for diagnosis of a periodontal disease”; however, the active method steps do not explicitly require an active method step of “providing” any information. MPEP 2111.02 states:
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.
Accordingly, the claim language of a "method of providing information necessary for diagnosis of a periodontal disease" merely sets forth the intended use or purpose of the claimed methods, but does not limit the scope of the claims. The claims are given the broadest reasonable interpretation as requiring:
performing quantitative analysis by real-time polymerase chain reaction (real-time PCR) with one or more bacteria selected from the group consisting of comprising Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Porphyromonas endodontalis, Filifactor alocis, and Treponema denticola, Fusobacterium nucleatum, Neisseria subflava, and Rothia dentocariosa in a sample isolated from an individual; and
comparing a bacterial % or a bacterial count obtained through the quantitative analysis by real-time PCR with a set cut-off value indicating the presence of a probing pocket greater than or equal to 5 mm that shows severity of periodontitis.
The step of “performing quantitative analysis by real-time polymerase chain reaction (real-time PCR)” does not set forth any primers or probes that are required as part of the step. The claim is interpreted as specifying the sample comprises the recited bacteria, but does not require amplifying any particular target that is part of the recited bacteria.
Claim 4 further limits the “periodontal disease” set forth in the preamble of claim 1. Claim 4 is given the broadest reasonable interpretation as requiring:
performing quantitative analysis by real-time polymerase chain reaction (real-time PCR) with one or more bacteria selected from the group consisting of comprising Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Porphyromonas endodontalis, Filifactor alocis, and Treponema denticola, Fusobacterium nucleatum, Neisseria subflava, and Rothia dentocariosa in a sample isolated from an individual; and
comparing a bacterial % or a bacterial count obtained through the quantitative analysis by real-time PCR with a set cut-off value indicating the presence of a probing pocket greater than or equal to 5 mm that shows severity of periodontitis.
Claim 5 further limits the “periodontal disease” set forth in the preamble of claim 1 and of claim 4. Claim 5 is given the broadest reasonable interpretation as requiring:
performing quantitative analysis by real-time polymerase chain reaction (real-time PCR) with one or more bacteria selected from the group consisting of comprising Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Porphyromonas endodontalis, Filifactor alocis, and Treponema denticola, Fusobacterium nucleatum, Neisseria subflava, and Rothia dentocariosa in a sample isolated from an individual; and
comparing a bacterial % or a bacterial count obtained through the quantitative analysis by real-time PCR with a set cut-off value indicating the presence of a probing pocket greater than or equal to 5 mm that shows severity of periodontitis.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 4, 5, 6, 7, 8, 10, 11, 18 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
The present claims are drawn to methods, one of the four statutory categories.
The claim(s) recite(s):
“comparing a bacterial % or a bacterial count obtained through the quantitative analysis by real-time PCR with a set cut-off value indicating the presence of a probing pocket greater than or equal to 5 mm that shows severity of periodontitis” (claim 1).
The “comparing” step broadly encompasses an abstract idea. The step may be performed in a purely mental manner as it involves comparing a minimum of two data points. This limited amount of information may be considered by the human mind alone or with the aid of a pen and paper. See MPEP 2106.04(a)(2)(III).
The step also sets forth the relationship between a cut-off value for a bacterial % or a bacterial count and the presence of a probing pocket greater than or equal to 5 mm that shows severity of periodontitis. This relationship is a natural phenomenon.
Claims 18 and 19 set forth several equations, which are mathematical concepts representative of abstract ideas. See MPEP 2106.04(a)(2)(I).
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claimed limitations add insignificant extra-solution activity to the judicial exceptions. As noted in the preamble, the steps are providing information via a data gathering process. See MPEP 2106.05(g).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass the use of PCR, a well-known and conventional assay.
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 6, 7, 8, 10, 11, 18 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
It is noted that the claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Regarding claim 6, the claim recites “a primer set represented by SEQ ID NOS:…”. The use of the term “represented” renders the claim indefinite. It is unclear if the primer set “comprises” the sequence of the recited SEQ ID NOs, “consists of” the sequence of the recited SEQ ID NOs or encompasses portions of the sequence of the recited SEQ ID NOs.
Regarding claim 7, the claim recites “the primer set represented by SEQ ID NOS:…”. It is unclear if the primer set “comprises” the sequence of the recited SEQ ID NOs, “consists of” the sequence of the recited SEQ ID NOs or encompasses portions of the sequence of the recited SEQ ID NOs.
Regarding claim 8, the claim recites “comparing comprises determining the periodontal disease, if, based on a cut-off value of the bacterial % obtained through the quantitative analysis by real-time PCR”. The claim is incomplete as it does not specify how the “determining” is done “based on a cut-off value”.
Regarding claim 8, the recitation of “based on a cut-off value of the bacterial %” in lines 1-2 of the claim is unclear what the relationship is between bacterial % and a cut-off value or how the bacterial % is used to obtain a cut-off value. In addition, the recitations of “represented by” of the claim is unclear. The use of the term “represented” renders the claim indefinite. It is unclear if the primer set “comprises” the sequence of the recited SEQ ID NOs, “consists of” the sequence of the recited SEQ ID NOs or encompasses portions of the sequence of the recited SEQ ID NOs. In addition, the recitation of “the cut-off value of the target gene of the primer set represented by SEQ ID NOS:” is unclear how the cut-off value of the target gene of the primer set represented by the respective SEQ ID NOS: are related.
Regarding claim 8, the claim is incomplete in so far as it encompasses comparing bacterial % to those established for the recited SEQ ID NOs. However, claim 1 does not require the use of any particular primers and thus, lacks the information used to make comparisons detailed in claim 8.
Regarding claim 10, the claim recites “comparing comprises determining the periodontal disease, if, based on a cut-off value of the bacterial % obtained through the quantitative analysis by real-time PCR”. The claim is incomplete as it does not specify how the “determining” is done “based on a cut-off value”.
Regarding claim 10, the recitation of “based on a cut-off value of the bacterial count” in lines 1-2 of the claim is unclear what the relationship is between bacterial count and a cut-off value or how the bacterial count is used to obtain a cut-off value. In addition, the recitations of “represented by” is unclear. The use of the term “represented” renders the claim indefinite. It is unclear if the primer set “comprises” the sequence of the recited SEQ ID NOs, “consists of” the sequence of the recited SEQ ID NOs or encompasses portions of the sequence of the recited SEQ ID NOs. In addition, the recitation of “the cut-off value of the target gene of the primer set represented by SEQ ID NOS:” is unclear how the cut-off value of the target gene of the primer set represented by the respective SEQ ID NOS: are related.
Regarding claim 10, the claim is incomplete in so far as it encompasses comparing bacterial count to those established for the recited SEQ ID NOs. However, claim 1 does not require the use of any particular primers and thus, lacks the information used to make comparisons detailed in claim 10.
Regarding claim 11, the claim is generally narrative and indefinite, failing to conform with current U.S. practice. It appears to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. In addition, the recitation of “wherein the cut-off value is derived from …” in lines 1-5 of the claim is unclear how these variables of derive a cut-off value.
Regarding claim 11, the claim recites “the AUC value for diagnosing a tooth with a probing pocket greater than or equal to 5 mm based on the count of bacteria collected from the tooth for the probing pocket of the tooth from a gingival crevicular fluid sample”. It is unclear what the language is attempting to convey.
Regarding claims 18 and 19, the claims involve equations that rely on bacterial % or bacterial counts for each of the bacteria recited in claim 1. However, claim 1 does not require amplifying targets and determining the bacterial % or count for each of the recited bacteria. Thus, claims 18 and 19 and are incomplete as the information used is not specifically obtained or provided for in the method of claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 7, the claim identifies the target gene recognized by the recited primer sets. The claim does not limit the scope of the primer set and merely provides information regarding the target gene. The claim does not change the scope of how the methods of claim 6 are carried out.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4 and 5 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Masunaga (Journal of Oral Science. 2010. 52(4):615-621).
Regarding claims 1 and 3, Masunaga teaches performing quantitative PCR (real-time PCR) using a gingival crevicular fluid sample from a subject (p. 616, GCF sampling; and p. 617, Quantitative PCR; and p. 619, right column).
It is noted the claim states the recited bacteria are “in a sample from an individual”. The claim does not specify that the PCR amplified targets within each of the bacteria. The claim is broadly interpreted as performing a quantitative analysis using a sample comprising the recited bacteria as performing PCR on bacteria does not necessarily result in amplifying any bacterial target nucleic acid. Claim 3 provides a particular species of a sample, i.e., gingival crevicular fluid, encompassed by the generic sample of claim 1 comprising the recited bacteria. Thus, the gingival crevicular fluid sample of Masunaga satisfies that the PCR is done with each of the bacteria present.
Masunaga teaches comparing T. forsythia counts (Fig. 3) and P. gingivalis counts (Fig. 2) between groups including comparing healthy samples (Group A) to a threshold set by adult patients with untreated periodontitis, radiographic evidence of alveolar bone loss in each quadrant of dentition, and more than 4 sites with PPD greater than 6 mm (Group C) (p. 616, Subjects).
Regarding claim 4, the claim does not limit the positively active method steps of claim 1 as it further describes the “periodontal disease” of the preamble. Claim 4 is anticipated for the same reason claim 1.
Regarding claim 5, the claim does not limit the positively active method steps of claim 4 as it further describes the “periodontal disease” of the preamble. Claim 5 is anticipated for the same reason claims 1 and 4.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masunaga (Journal of Oral Science. 2010. 52(4):615-621) in view of Kook (WO 2012/134063 A2), Spooner (Scientific Reports. 2016. 6:33638; cited on the 4/11/2024 IDS) and Park (J Korean Soc Dent Hyg. 2017. 17(2):319-330).
Regarding claims 6 and 7, Masunaga teaches performing quantitative PCR (real-time PCR) using a gingival crevicular fluid sample from a subject (p. 616, GCF sampling; and p. 617, Quantitative PCR; and p. 619, right column).
It is noted the claim states the recited bacteria are “in a sample from an individual”. The claim does not specify that the PCR amplified targets within each of the bacteria. The claim is broadly interpreted as performing a quantitative analysis using a sample comprising the recited bacteria as performing PCR on bacteria does not necessarily result in amplifying any bacterial target nucleic acid. Claim 3 provides a particular species of a sample, i.e., gingival crevicular fluid, encompassed by the generic sample of claim 1 comprising the recited bacteria. Thus, the gingival crevicular fluid sample of Masunaga satisfies that the PCR is done with each of the bacteria present.
Masunaga teaches comparing T. forsythia counts (Fig. 3) and P. gingivalis counts (Fig. 2) between groups including comparing healthy samples (Group A) to a threshold set by adult patients with untreated periodontitis, radiographic evidence of alveolar bone loss in each quadrant of dentition, and more than 4 sites with PPD greater than 6 mm (Group C) (p. 616, Subjects).
Masunaga does not specifically teach each of the primer sets set forth in claims 6 and 7.
However, Kook teaches primers represented by:
SEQ ID NOs: 27 and 28 (as encompassed by present SEQ ID NOs: 1 and 2);
SEQ ID NOs: 85 and 86 (as encompassed by present SEQ ID NOs: 3 and 4);
SEQ ID NOs: 25 and 26 (as encompassed by present SEQ ID NOs: 7 and 8);
SEQ ID NOs: 87 and 88 (as encompassed by present SEQ ID NOs: 11 and 12);
SEQ ID NOs: 13 and 14 (as encompassed by present SEQ ID NOs: 13 and 14);
SEQ ID NOs: 23 and 24 (as encompassed by present SEQ ID NOs: 15 and 16); and
SEQ ID NOs: 81 and 82 (as encompassed by present SEQ ID NOs: 17 and 18);
Kook further demonstrates an interest in Filifactor alocis, but does not provide any primer sequences.
Spooner provides primers for Filifactor alocis (p. 6, Nucleic acid extraction and RT-qPCR) that are encompassed by present SEQ ID NOs: 9 and 10.
Kook further demonstrates primers for P. intermedia were known but does not provide any encompassed by claims 6 and 7.
Park provides primers for P. intermedia (Table 2) that are encompassed by present SEQ ID NOs: 5 and 6.
It would have been prima facie obvious to have applied the combined primers of Masunaga, Kook, Spooner and Park to the GCF sample of Masunaga in order to identify which bacteria are present in the sample and at what level they are present. One would be motivated to do so because the primers are highly sensitive with excellent species-specificity for the purpose of quantitatively detecting the causative agent causing oral bacterial infections. The modification has a reasonable expectation of success as it simply involves running additional PCRs with known samples using known primers.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masunaga (Journal of Oral Science. 2010. 52(4):615-621) in view of Tomas (Frontiers in Microbiology. 2017. 8: pages 1-16).
It is noted, as discussed above, claims 8 and 10 are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Regarding claims 8 and 10, Masunaga teaches performing quantitative PCR (real-time PCR) using a gingival crevicular fluid sample from a subject (p. 616, GCF sampling; and p. 617, Quantitative PCR; and p. 619, right column).
It is noted the claim states the recited bacteria are “in a sample from an individual”. The claim does not specify that the PCR amplified targets within each of the bacteria. The claim is broadly interpreted as performing a quantitative analysis using a sample comprising the recited bacteria as performing PCR on bacteria does not necessarily result in amplifying any bacterial target nucleic acid. Claim 3 provides a particular species of a sample, i.e., gingival crevicular fluid, encompassed by the generic sample of claim 1 comprising the recited bacteria. Thus, the gingival crevicular fluid sample of Masunaga satisfies that the PCR is done with each of the bacteria present.
Masunaga teaches comparing T. forsythia counts (Fig. 3) and P. gingivalis counts (Fig. 2) between groups including comparing healthy samples (Group A) to a threshold set by adult patients with untreated periodontitis, radiographic evidence of alveolar bone loss in each quadrant of dentition, and more than 4 sites with PPD greater than 6 mm (Group C) (p. 616, Subjects).
Masunaga does not specifically teach the cut-offs described in claims 8 and 10.
However, Tomas teaches a method for diagnosis of periodontitis based on quantitative real-time PCR analysis of a group of bacterial species comprising comparing the detection frequences and levels of the group of bacterial species detected in subgingival sites with different periodontal conditions of a healthy control site and moderate to severe chronic periodontal site (abstract lines 1-32; pg. 2-3 paragraph bridging pg. 2 & 3 lines 1-18; pg. 4 column 2 1st full paragraph lines 1-15). Tomas also teaches that this method provides good predictive accuracy enabling improved patient monitoring and control of disease at the site-specific level (pg. 13-14 paragraph bridging pg. 13 & 14 lines 5-20).
Tomas teaches determining the best cut-off value to provide a percentage of correct predictions that was maximum from detection frequencies and levels of a group of bacterial species through ROC curve analysis where an AUC of 0.76 or above were selected to distinguish healthy versus periodontitis sites and further teaches assessing other clinical parameters comprising bleeding on probing, probing pocket depth, and clinical attachment loss (pg. 5 column 1 5th full paragraph lines 1-3; pg. 5 column 2 1st full paragraph lines 1-12; pg. 5 column 2 2nd full paragraph lines 1-11).
Masunaga and Tomas are considered to be analogous to the claimed invention because they are all in the same field of detection and quantification of bacterial species through real-time PCR in patients with periodontitis. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of calculating an abundance of the bacterial group (bacterial % or bacterial count) using real-time PCR, wherein the sample comprises the bacteria recited in claim 1 and comparing the obtained calculated value with a cut-off value of the abundance ratio of bacterial groups as done in Masunaga to incorporate comparing the detection frequences and levels of the group of bacterial species (bacterial % or bacterial count) with different periodontal conditions of a healthy control site and periodontitis as taught in Tomas because Tomas teaches that doing so would provide a method with good predictive accuracy enabling improved patient monitoring and control of disease at the site-specific level.
Tomas does not teach the specific cut-off values listed in claims 8 and 10; however, the cut-off value is prima facie obvious in view of the routine nature of reaction condition optimization as taught in Tomas. As set forth in the MPEP 2144.05IIA:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)
Tomas teaches determining the best cut-off value to provide a percentage of correct predictions that was maximum from detection frequencies and levels of a group of bacterial species (bacterial % or bacterial count) through ROC curve analysis where an AUC of 0.76 or above were selected. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining the best cut-off values from detection frequencies and levels of a group of bacterial species in healthy and periodontal samples as taught in Tomas to obtain the claimed specific cut-off values due to the routine nature of reaction condition optimization.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
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