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 .
Claim Status
The claim set filed 11/20/25 is acknowledged. Claims 1-9 are pending. Claims 1-3 and 7 are amended.
Claims 1-9 are currently under consideration for patentability under 37 CFR 1.104.
Objections Withdrawn
The objection to the disclosure for the use of the term TRITON, TRASYLOL, NP-40, SEPHAROSE, TWEEN, PROTEIN CHIP, and possibly others, which are trade names or marks used in commerce, is withdrawn in light of Applicant’s amendments thereto.
Withdrawn Rejections
The rejection of claim(s) 1-9 under 35 U.S.C. 103 as being unpatentable over Anderberg et al (WO 2011/106746 A1; filed 2/26/11; published 9/1/11) as evidenced by TentaGel by Rapp Polymere (downloaded from https://www.rapp-polymere.com/products/resins/tentagel-m-nh2M301002.1G on 5/15/25) in view of Short et al (WO 2014/190234 A4; filed 5/23/14; published 11/27/14) is withdrawn in light of Applicant’s amendments and arguments thereto.
Maintained Rejections
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.
The rejection of claims 7-9 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 is maintained. The rejection of claims 1-6 is withdrawn in light of Applicant’s amendments thereto.
Claim 7 recites the limitation "the proteins". There is insufficient antecedent basis for this limitation in the claim.
Claims depending from the rejected claims do not remedy the deficiency and therefore are also rejected.
Applicant has not provided arguments or amendments to address the rejection and therefore the rejection is maintained.
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.
(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.
The rejection of claim(s) 1-6 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Anderberg et al (WO 2011/106746 A1; filed 2/26/11; published 9/1/11) as evidenced by TentaGel by Rapp Polymere (downloaded from https://www.rapp-polymere.com/products/resins/tentagel-m-nh2M301002.1G on 5/15/25) is maintained.
Claim 1 is directed to a kit for detecting at least three biomarkers for gingivitis in a sample of saliva of a human patient, said kit comprising one or more detection reagents for detecting proteins consisting of Hepatocyte growth factor (HGF), Interleukin-1b (IL-1b), and C-reactive protein (CRP), optionally, wherein the one more detection reagents comprise three detection reagents, a first detection reagent for detecting Hepatocyte growth factor (HGF), a second detection reagent for detecting Interleukin-1b (IL-1b), and a third detection reagent for detecting C-reactive protein (CRP).
Claim 2 is directed to a kit according to claim 1, wherein the one or more detection reagents are contained on a solid support.
Claim 3 is directed to a kit according to claim 2, wherein the solid support comprises a chip.
Claim 4 is directed to a kit according to claim 2, wherein the solid support comprises a microtiter plate.
Claim 5 is directed to a kit according to claim 2, wherein the solid support comprises a resin comprising said detection reagent.
Claim 6 is directed to a kit according to claim 1, further comprising a mass spectrometry probe.
Claim 7 is directed to a system for diagnosing gingivitis in a human subject, the system comprising: a container adapted to receive an oral fluid sample from a human subject; a detector adapted to detect in the oral fluid sample within the container the proteins consisting of HGF, IL-1b, and CRP; and a processor adapted to determine from the determined concentrations of said proteins an indication of whether the subject has gingivitis.
Claim 8 is directed to a system according to claim 7, further comprising: a user interface for presenting the indication to a user; and a data connection between the processor and the user interface for transferring the indication from the processor to the user interface.
Claim 9 is directed to a system according to claim 8, wherein the user interface is a remote interface.
Regarding the limitations of instant claim 1, Anderberg teaches kits comprising reagents to measure biomarkers (see e.g. [0045]). The reagents can be included in a kit for an assay (see e.g. paragraph [0046]). The invention measures various biomarkers, including the biomarkers listed in Table 2 (see e.g. paragraph [0099]). The biomarkers can include Hepatocyte Growth factor (see e.g. Table 2, page 26, left column of the table), IL-1beta (see e.g. Table 2, page 26, left column of the table), and C-reactive protein (see e.g. Table 2, page 25, right column of the table). The assay can be used to measure biomarkers in saliva (see e.g. paragraph [0042], [0106]). The reagents can comprise one or more solid phase antibodies comprising an antibody that detects a biomarker bound to a solid support (see e.g. paragraph [0046]). The reagents can also include one or more detectably labeled antibodies to detect the intended biomarker target (see e.g. paragraph [0046]). The phrase “one or more” suggests that as many as three detection antibodies for three biomarkers are encompassed. A structurally complete invention is present in the claim body and the claim uses the preamble only to state a purpose or intended use for the invention. Therefore, the preamble is not interpreted as a claim limitation, but merely an intended use.
Regarding the limitations of instant claim 2, the detection reagents, such as antibodies that bind to the biomarker, can be bound to a solid support (see e.g. paragraph [0046], [0113]).
Regarding the limitation of instant claim 3, the solid support can comprise a glass or silicon wafer, which meets the limitation of a “chip” when the term is given the broadest reasonable interpretation (see e.g. paragraph [0113]).
Regarding the limitation of instant claim 4, the biomarker analytes can be measured in a microtiter plates (see e.g. paragraph [0113], [0123], [0163], [0177]).
Regarding the limitations of instant claim 5, the solid support can comprise compounds such as TentaGels (see Anderberg paragraph [0113]), which as shown in the TentaGel information by Rapp Polymere, is a resin (see TentaGel, entire reference).
Regarding the limitation of claim 6, the biomarker can be determined by mass spectrometry (see e.g. paragraph [0101], [0112]), and the kit can contain labeled molecules to generate a signal that is related to the presence or amount of biomarker of interest (see e.g. paragraph [0112]).
Applicant’s Arguments
Applicant argues:
1. Anderberg is directed to renal injury and renal failure, and while it does describe generic assay modalities and solid supports, and lists biomarkers among broad tables and paragraphs, it does not disclose a saliva kit configured for diagnosing gingivitis arranged as three separate detection reagents.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
1. First, Anderberg specifically discusses measurement of biomarkers in saliva. As stated above, Anderberg teaches that the assay can be used to measure biomarkers in saliva (see e.g. paragraph [0042], [0106]). Therefore the kit of Anderberg is configured for use with a saliva sample as required by the instant claims.
Second, the preamble of the instant claims recite what amounts to an intended use (i.e. “configured for diagnosing”). As stated in MPEP 2111.02, 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. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). The preamble of the instant claims does not set forth any structural limitations, but instead provides only a statement of purpose or use. The instant claims sets forth a variety of kit components, including detection reagents for three biomarker proteins, that when combined, are capable of performing the required diagnosis. Anderberg meets the structural limitations of the kit, and therefore would inherently be capable of performing the required diagnosis.
Furthermore, the kit requires specific components which are all described within the Anderberg reference. MPEP 2131.02 states that when the species is clearly named in a reference, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that “the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in 35 U.S.C. § 102(a), in that publication.”). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.). Applicant has acknowledged in the reply filed 11/20/25 that the individual components of the instant kit, including the biomarkers, are described in Anderberg. Therefore, the claims are anticipated, and the rejection is maintained.
Conclusion
No claim is 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.
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/ANDREA K MCCOLLUM/Examiner, Art Unit 1674
/BRIAN GANGLE/Primary Examiner, Art Unit 1645