DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendments
2. The amendment filed Oct 30, 2025 have been entered. Claims 1, 11-13 and 32 have been amended. Claims 15 and 18-31 are withdrawn from consideration. Claims 2-9 and 16-17 is cancelled. Claims 1, 10-14 and 32 are under consideration in this Office Action.
Withdrawal of Claim Objections and Rejections
3. The following objections and rejections have been withdrawn in view of applicants amendments:
a) The scope of enablement rejection of claims 1 and 10-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph;
b) The rejection of claims 1 and 3-14 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception; and
c) The objection of claims 1 and 5.
Maintained Grounds of Rejection
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)(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.
4. Claim 32 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jefferies et al., (JPH01107155 published April 25, 1989; priority to August 1988). The document is available on Google Patents.
The claims are drawn towards a liquid sample in combination with a test agent that includes a liquid samples, a test agents, a reagent and a pH buffer solution.
It is noted that determining the genotype for the liquid sample, if a value of fluorescence intensity or an amount of change over time of fluorescence intensity of the liquid sample is the same as or similar to a value of fluorescence intensity or an amount of change over time of fluorescence intensity of the test agent, then a genotype of the fimA gene of Porphromonas gingivalis within the liquid sample is determined to be the same as that in the test agent, whose genotype is already known and wherein the determination of the genotype of the fimA gene of the liquid sample determines a current periodontal-pathological condition of the subject.
Jefferies et al., disclose a dental diagnosis apparatus and method. Jefferies et al., measures the presence or property and degree of oral disease by absorbing enzyme, antigen, or antibody reactive substrate suited for reaction with organic biological substance that can be related to the disease on an absorbing substance with a dimension that can be inserted into a small recess within a mouth [abstract]. The devices and methods provide an easy and time-effective method for determining the presence or nature and extent of disease in the mouth. Since the concentration of biological material collected by the device is measured by direct reaction between the biological material collected by the device and the substrate on the device, it is necessary to transfer this biological material before measuring the concentration of this biological material. The reaction of the substrate with the biological material is immediate and can often be completed within 40 minutes and can be easily incorporated into normal clinic operations [Detailed Description]. Bacteroides gingivalis is a proteolytic bacterium that produces trypsin-like enzymes and is involved in periodontal diseases caused by Bacteroides gingivalis. These pathogenic bacteria are able to hydrolyze various synthetic substrates of trypsin, and this fact can be used to establish the presence of these bacteria [Detailed Description]. It is noted that Porphyromonas gingivalis was previously known as Bacteroides gingivalis and inherently comprises the FimA gene.
Substrates which may be used to detect neutral proteolytic enzymes are Z-gly-gly-arg-x; where Z represents an inert carrier for the protein moiety of the substrate such as 7-amino-4-methyl coumarin. In particular, a number of amino acid esters such as a number of similar napthylamide and coumarin derivatives have been found to be useful as such substrates [Detailed Description]. Jefferies et al., describe protective group Benzoyl-arginine-4-methylcoumarin-7-amide which exhibits a change in fluorescence upon reaction with antigen or antibody [Detailed Description]. 4-Methylcoumarin-7-acid is a preferred leaving groups for the substrates mentioned above, whether they are enzyme-, antigen- or antibody-reactive [Detailed Description].
Immediately after completion of incubation, each paper point was examined under ultraviolet light, preferably examined under long wavelength ultraviolet light at about 365 nm. At low concentrations of trypsin, the paper point shows a light blue color under ultraviolet light, at moderate concentrations of trypsin it shows a clearly visible green-blue color, at high concentrations of trypsin it shows a green color, and at higher concentrations of trypsin it becomes bright green. When the trypsin concentration was 0 (zero), the color was deep blue. This finding is used to indicate whether a person is positive or negative for the enzyme in question. This knowledge can be used to develop a fluorescent color difference table that can differentiate trypsin concentrations, theoretically providing a quantitative indication of infection [Example 1]. Example 1 describes how the substrate is incorporated into a paper point and used to measure trypsin wherein the substrate solution is made by dissolving Tris, HCQ, CaCu, deionized water in a buffer with a pH of 8 thereby creating the Trade Solution. [Example 1]. Thus teaching claim 32. Examples 3-7, and the colors developed for a particular concentration of enzyme were similar to those developed with the paper discs of Examples 2-7 below. It has been found that they are the same. The collected gingival crevicular fluid was then eluted with an elution buffer (comprising TRIS, NaCl, CaCl2 and 1% TRITON x-100 in 1 liter of deionized water, said buffer having a pH of 7.5 at room temperature for 30-60 minutes at room temperature by placing the collection strip into of the buffer [Examples 8]. Thus teaching claim 32.
Reactions between enzymes and substrates are confirmed with visible light or fluorescent color indicators, or other indicators such as radioactive indicators, and the reaction and extent of the reaction are stoichiometrically related. Each paper point was then placed with water-impregnated absorbent material in a transparent plastic container. The plastic container and paper points were then incubated in an incubator at 37°C for 30 minutes. Immediately after completion of incubation, each paper point was examined under ultraviolet light (preferably examined under long wavelength ultraviolet light at about 365 nm). At low concentrations of trypsin, the paper point shows a light blue color under ultraviolet light, at moderate concentrations of trypsin it shows a clearly visible green-blue color, at high concentrations of trypsin it shows a green color, and at higher concentrations of trypsin it becomes bright green. A preferred method is the detection of enzymes produced as a result of oral diseases or in diseases diagnosed by oral fluids. Therefore, Jefferies et al., anticipate the instantly rejected claim.
Response to Arguments
5. Applicant's arguments filed Oct 30, 2025 have been fully considered but they are not persuasive. The rejection of claims 32 under 35 U.S.C. 102(a)(1) as being anticipated by Jefferies et al., is maintained for reasons of record. The amended claim is drawn to the liquid sample and its components. The intended use of the liquid sample being used to determine the genotype is not relevant to the specific components. In this, the prior art teach the recited components, therefore the rejection is maintained.
Applicants amended the claims to recite specifically identify the genotypes I, II and IV of P. gingivalis and argue that Jefferies do not teach the identification.
Contrary to Applicants arguments; Jefferies et al., a liquid sample in combination with a test agent that includes a liquid samples, a test agents, a reagent and a pH buffer solution. Jefferies et al., disclose the liquid sample in combination with a test agent. Jefferies et al., describe irradiating a liquid sample with excitation light, the liquid sample including a bacterial body of the microorganism responsible for periodontal disease or a bacterial body-based extractive matter thereof and a reagent in which a substrate for an enzyme reaction by the microorganism responsible for periodontal disease is fluorescently labeled, the liquid sample having a pH value thereof having been adjusted to not lower than pH 7.0 and not higher than pH 8.5 and then having been subjected to the enzyme reaction; and determining the genotype based on an intensity of fluorescence emitted from the liquid sample, wherein the microorganism responsible for periodontal disease is Porphyromonas gingivalis, (Bacteroides gingivalis) wherein the genotype is a polymorphic type of a fimA gene that inherently encodes a fimbrial protein, and wherein the reagent is a protective-group-glycyl-glycyl-L-arginyl-4-methylcoumaryl-7- amide, which is a polypeptide whose N-terminal is protected by a protective group. It is noted that glycyl-glycyl-L-arginyl-4-methylcoumaryl-7-amide (Gly-Gly-Arg-MCA) is also known as Glutaryl-glycyl-L-arginine 7-amido-4-methylcoumarin or G-3950. See https://www.biosynth.com/p/G-3950/103213-40-7-glutaryl-glycyl-l-arginine-7-amido-4. Therefore the amendment does not overcome the disclosure of Jefferies et al., thus the rejection is maintained.
New Grounds of Rejection Necessitated By Applicants Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1 and 10-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a written description rejection.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The claims are drawn to a method of determining genotypes I, II and IV of P. gingivalis wherein the determination of the genotype of the fimA gene of the experimental area determines a current periodontal-pathological condition of the subject. The specification broadly recites the determination of the genotype of the fimA gene of the experimental area determines a current periodontal-pathological condition of the subject. Thus the written description in this case fails to set forth the determination of the genotype of the fimA gene of the experimental area determines a current periodontal-pathological condition of the subject. There is no description within the specification which determines a subject’s current periodontal-pathological condition based on the determination of genotypes I, II and IV. There is no discussion or teaching for the diagnosis or determination of any disease based on the genotype determination. The specification does not even teach which current periodontal-pathological conditions can even be determined. There is no diagnosis of chronic periodontitis, systemic inflammation, orodigestive cancers, neurogenerative diseases, Alzheimer’s disease, atherosclerosis autoimmune conditions, and/or cardiovascular diseases.
There is no disclosure of any specific periodontal-pathological condition, such as systemic inflammation, orodigestive cancers, neurogenerative diseases, Alzheimer’s disease, atherosclerosis autoimmune conditions, and/or cardiovascular diseases based on the determination of genotypes I, II and IV. There is no teaching of any assay that links the presence of genotype I, II and/or IV with any specific periodontal-pathological condition. Therefore the written description is not commensurate in scope with the claims.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). The possible structural variations are limitless to any class of polymer with any biomolecule. It must not be forgotten that the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient as a characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claim recites some functional characteristics, i.e., the mutant SPE-C protects against at least one biological activity or reduces symptoms associated with toxic shock, however the claims lack written description because there is no disclosure of a correlation between function and structure of the mutant. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide any examples of such mutants. The written description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision (see page 115). The skilled artisan cannot envision the detailed structure of the peptide fragments thereof, thus conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. An adequate description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. Furthermore, In The Reagents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of by only their functional activity does not provide an adequate description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of molecules falling within the scope of the claimed genus.
In view of these considerations, a person skilled in the art would not have viewed the teachings of the specification sufficient to show that applicants were in possession of a method for determining genotypes I, II and IV of P. gingivalis wherein the determination of the genotype of the fimA gene of the experimental area determines a current periodontal-pathological condition of the subject as instantly claimed. Therefore the full breadth of the claims fails to meet the written description provision of 35 USC 112, first paragraph.
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.
7. Claims 1 and 10-14 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.
A) Claims 1 and 10-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps and elements, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: There is no step which obtains or treats a sample from subject.
Claim 1 “…providing a series of liquid samples…” however the claims fail to explicitly state that sample was obtained from the subject in need of genotype determination. At best, claim 1 refers to an experimental area but never recites treating the sample from the subject derived. The claims do not recite any association between the subject obtained sample and testing the subject obtained sample on the experimental area. Therefore, the claims are rejected for missing the essential steps of testing a sample from the subject.
B) Claim 1 refers to “..a single control area..” and “..a series of control areas..” however claim 1 than recites “…wherein the control area and the experimental area..” Claim 1 recites the limitation "the control area". There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the control area is referring to the single control area or the series of control areas. Therefore, the metes and bounds of the claim are unclear. See also “the control area” with regard to the extractive matter.
C) Claim 1 recites the limitation "the experimental area". There is insufficient antecedent basis for this limitation in the claim. The claims did not introduce any experimental area , thus the metes and bounds of the claim are unclear. The claim requires clarification to overcome the rejection.
D) Claim 1 recites “…collecting a fluorescence emitted from each of the irradiated control areas with the fluorescence measurement device…” However the metes and bounds of the claim language are unclear. It is unclear if the irradiated control area refers to the single control area or the series of control areas. Therefore the claims require clarification to overcome the rejection.
E) Claim 1 recites “…creating a series of thresholds…of the irradiated control areas” However the metes and bounds of the claim language are unclear. It is unclear if the irradiated control area refers to the single control area or the series of control areas. Therefore the claims require clarification to overcome the rejection.
F) Claim 1 recites “irradiating an experimental area, wherein the experimental area is collected from a subject, in a liquid sample…” It is unclear how to collect an experimental area from a subject. Generally a sample is collected from a subject and not an “experimental area”. Additionally, the subjects are not irradiated. The specification teaches the measurement values are obtained from the experimental area. The experimental area is not irradiated and is not obtained from the subject. Therefore, clarification is required to overcome the rejection.
G) Claim 1 is rejected as being incomplete for omitting essential steps and elements, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are with respect to the “irradiating an experimental area, wherein the experimental area is collected from a subject, in a liquid sample with the light source…” It is unclear if the experimental area obtained from the subject is irradiated and then added to the liquid sample with a light source. The sample from the subject never received an fluorescent reagent necessary to produce fluorescence. This sample does not contain any reagents or substrates, is not a any specific pH and does not contain the necessary components for a enzyme reaction. Therefore, it is suggested that this claim recite the necessary steps and reagents necessary to achieve the production of fluorescence.
H) Claim 1 recites “collecting a fluorescence” It is unclear how one collects fluorescence. At best the sample will radiate fluorescence emitted from the fluorescent chromophore whereby the signal of the fluorescence: is then converted into a digital signal by a converter, and is inputted into the controller to produce fluorescence measurement; but fluorescence is not collected.
I) Claim 1 recites the limitation "the start of the enzymatic reaction". There is insufficient antecedent basis for this limitation in the claim. Therefore, the metes and bounds of the claim are unclear and clarification is required to overcome the rejection.
J) Claim 1 recites the limitation "the similarity of the fluorescence". There is insufficient antecedent basis for this limitation in the claim. Therefore, the metes and bounds of the claim are unclear and clarification is required to overcome the rejection.
K) Claim 1 refers to “…fluorescence emitted from the experimental area to a single threshold..” However it is unclear which single threshold is being referred too. For instance, the claims previously recited a first, second and third threshold. Therefore it is unclear which of the first, second or third threshold is the single threshold. Thus, clarification is required to overcome the rejection.
L) Claim 1 recites determining or determination of genotype of the experimental area; however the claims are supposed to determine the genotype obtained from the subject from which the sample is from. At best, the method could determine the genotype contained within the experimental area based upon the first, second and third threshold comparisons. Thus, clarification is required to overcome the rejection.
Pertinent Art
8. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Porphyromonas gingivalis (P. gingivalis), formerly known as Bacteroides gingivalis, is a Gram-negative, asaccharolytic, obligate, capnophile.ic, anaerobic, rod-shaped oral bacteria, primarily associated with the pathogenesis and progression of periodontal disease (How et al., 2016). Chopra et al., (Front Cell Infect Microbiol. 2023 Sep 29;13:1289103).
Glycyl-glycyl-L-arginyl-4-methylcoumaryl-7-amide (Gly-Gly-Arg-MCA) is also known as Glutaryl-glycyl-L-arginine 7-amido-4-methylcoumarin or G-3950. See https://www.biosynth.com/p/G-3950/103213-40-7-glutaryl-glycyl-l-arginine-7-amido-4
Ploeg et al., (FEMS Microbiology Letters, Volume 232, Issue 1, March 2004, Pages 31–37) describe generate quantitative assays for the enumeration of the various P. gingivalis fimbrial subtypes and to monitor these cells in a pilot population of Swiss and Norwegian subjects with or without chronic periodontitis. To be able to quantitate even minor populations of fimA genotypes, a quantitative real-time polymerase chain reaction (PCR) assay was developed and employed.
See WO 2012042870.
Conclusion
9. No claims allowed.
10. THIS ACTION IS MADE FINAL. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Dan Kolker, can be reached on 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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/JANA A HINES/Primary Examiner, Art Unit 1645