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 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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (Step 2A/1)(i.e., a law of nature, a natural phenomenon, or an abstract idea) without practical application (Step 2A/2) or significantly more (Step 2B) (See MPEP 2106). Although the instant claims encompass a composition of matter (Claim 1) and a process (Claim 2)(Step 1), they are directed to the following judicial exceptions (Step 2, Prong 1):
Regarding claim 1, MCP1 is a naturally occurring chemokine found in mammals and is therefore a product of nature. The claim is directed to a judicial exception.
Regarding claim 2, the claim recites “detecting Alzheimer’s disease” which is based upon a natural correlation between the detected “MCP1 of a sample” and Alzheimer’s disease. The claim is therefore, directed to a judicial exception by law of nature.
Step 2A/2: These judicial exceptions are not integrated into a practical application.
Claim 1 merely identifies MCP1 as a marker of Alzheimer’s disease. The phrase “marker of Alzheimer’s disease” describes a property or informational significance of the naturally occurring MCP1 molecule and does not impose any meaningful limitation on the claimed composition and therefore remains directed to the naturally occurring chemokine itself. The only positively step of claim 2 is “detecting MCP1 of a sample” which is simply data gathering (pre-solution activity, see MPEP 2106.05 (g)) only for the purpose of executing the judicial exception of detecting Alzheimer’s disease by natural correlation. The claims fail to provide a specific improvement to a computer, technology, or a technical field resulting in a practical application of the judicial exception. Once the detection of MCP1 and hence Alzheimer’s has been made (or not made), there is no further action. The results of the natural correlation are not used in practical application, for example, treating a patient with a specific drug when the MCP1 levels are above a threshold (See MPEP 2106.04(d)(2)). The recitation, “for the purpose of non-disease diagnosis and/or treatment,” merely states an intended use or purpose of the method and does not positively recite any additional process step that meaningfully limits the claim (See MPEP 2111.02(II)). Accordingly, these additional elements do not integrate the judicial exceptions into a practical application.
Step 2B: The claims do not include additional elements that are sufficient to amount to
significantly more than the judicial exception.
Claim 1 does not recite any structural modification, purification, recombinant production, non-natural formulation, or other feature that would render the claimed MCP1 markedly different from naturally occurring MCP1, and therefore does not provide an inventive concept sufficient to transform the judicial exception into patent-eligible subject matter. Regarding claim 2, the additional element of “detecting MCP1 of a sample,” is well-understood, routine and conventional in the art. A reference Feuerhelm-Heidl (US 20160334422 A1), states that “Monocyte chemotactic protein-1 (MCP-1) is highly induced in a variety of diseases,” ([0019]) and teaches the steps of “determining or diagnosing the presence or the risk of developing of AD based on the level or amount of said biomarker” ([0023]). Accordingly, “detecting MCP1 of a sample” does not amount to significantly more than the judicial exception, and the rejection of claims 1 and 2 under 35 U.S.C. 101 is maintained. Claims 3-11, 13-16 are rejected upon dependency of all the limitations of claims 1 and 2.
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 2-7, and 13 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.
Regarding claims 2-7, l. 2 recites “non-disease diagnosis” which is not a standard term. The meaning of “non-disease diagnosis” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear whether it is the diagnosis of a condition that is not a disease, a non-clinical evaluation, or for research use only. The Examiner, therefore, interprets “non-disease diagnosis” to be defined as any of the listed definitions.
Regarding claim 13, the preamble recites “screening a drug for treating Alzheimer's disease,” yet the body merely recites “using the marker of Alzheimer's disease” and does not recite any step that determines the suitability of a drug candidate. Thus, it is unclear how the recited step accomplishes the claimed screening. The term “using” fails to provide reasonable certainty as to the scope of the claimed method because the claim does not specific how the marker is used. As a result, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention. Accordingly, claim 13 is indefinite because the recited “using” step does not positively recite a sufficiently definite action for performing the claimed drug-screening method.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was 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.
Claims 1-5, 7, 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wyss-Coray et. al (US 20130040844 A1).
Regarding claim 1, Wyss-Coray teaches a marker of Alzheimer's disease, comprising a chemokine MCP1 (the biomarkers used for diagnosis the age-associated disease or disorder may comprise… MCP-1,” wherein “the age-associated disease is…Alzheimer's disease,” and MCP-1 is a natural chemokine; [0143]).
Regarding claim 2, Wyss-Coray teaches a method for detecting Alzheimer's disease for a purpose of non-disease diagnosis and/or treatment (Methods of Diagnosing, Treating and Monitoring Age-Associated Disorders,” such as “Alzheimer's disease”; [0142]-[0143]), comprising: detecting MCP1 of a sample (“the biomarkers used for diagnosis the age-associated disease or disorder may comprise… MCP-1,” wherein “the level of the biomarker may be determined,” and “The biomarkers are obtained from biological fluid samples of the subject”; [0143]; [0183])(The recitation “for a purpose of non-disease diagnosis and/or treatment” is merely an intended purpose because the claim does not positively recite any additional method step beyond detecting MCP1 of a sample. See MPEP 2111.02(II)).
Regarding claim 3, Wyss-Coray teaches the method for detecting Alzheimer's disease for the purpose of non-disease diagnosis and/or treatment according to claim 2, wherein the sample comprises cerebrospinal fluid and/or serum (The biomarkers are obtained from biological fluid samples of the subject, which may be a peripheral biological fluid or a cerebrospinal fluid. Exemplary peripheral biological fluids include…serum; [0143])(The recitation “for a purpose of non-disease diagnosis and/or treatment” is merely an intended purpose because the claim does not positively recite any additional method step beyond detecting MCP1 of a sample. See MPEP 2111.02(II)).
Regarding claim 4, Wyss-Coray teaches the method for detecting Alzheimer's disease for the purpose of non-disease diagnosis and/or treatment according to claim 2, wherein the detecting MCP1 of a sample comprises: detecting an expression level of MCP1 (When the biomarker protein itself is the target, prospective agents are tested for activity in modulating expression levels or activity of the protein itself; [0155]) and/or determining a location of MCP1 (The recitation “for a purpose of non-disease diagnosis and/or treatment” is merely an intended purpose because the claim does not positively recite any additional method step beyond detecting MCP1 of a sample. See MPEP 2111.02(II)).
Regarding claim 5, Wyss-Coray teaches the method for detecting Alzheimer's disease for the purpose of non-disease diagnosis and/or treatment according to claim 4, wherein a method for detecting the expression level of MCP1 comprises real-time fluorescence quantitative PCR detection and/or ELISA detection (immunoassay technology which can quantitatively or qualitatively measure the level of a biomarker in a biological sample. Suitable immunoassay technology includes…ELISA; [0118])(The recitation “for a purpose of non-disease diagnosis and/or treatment” is merely an intended purpose because the claim does not positively recite any additional method step beyond detecting MCP1 of a sample. See MPEP 2111.02(II)).
Regarding claim 7, Wyss-Coray teaches the method for detecting Alzheimer's disease for the purpose of non-disease diagnosis and/or treatment according to claim 2, further comprising a step of detecting any one or a combination of at least two of an activity of regulatory T cells, an activity of T helper cells, an aggregation level of amyloid beta (Aß) plaques, an expression level of inflammatory factors or an expression level of cytokines of the sample (“When the biomarker protein itself is the target, prospective agents are tested for activity in modulating expression levels or activity of the protein itself,” wherein Eotaxin/CCL11 and MCP-1 biomarkers are also cytokines; [0155],[0154])(The recitation “for a purpose of non-disease diagnosis and/or treatment” is merely an intended purpose because the claim does not positively recite any additional method step beyond detecting MCP1 of a sample. See MPEP 2111.02(II)).
Regarding claim 13, Wyss-Coray teaches a method for screening a drug for treating Alzheimer's disease, comprising using the marker of Alzheimer's disease according to claim 1 (“methods of screening for candidate agents for the treatment of age-associated disorders or diseases by identifying candidate agents for activity in modulating age-associated disorders/diseases biomarkers,” which includes the biomarker MCP-1; Wyss-Coray, [0027]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wyss-Coray et. al (US 20130040844 A1), in view of Raha et al. (“Neuroprotective Effect of TREM-2 in Aging and Alzheimer’s Disease Model”).
Regarding claim 6, Wyss-Coray teaches the method for detecting Alzheimer's disease for the purpose of non-disease diagnosis and/or treatment according to claim 4.
Wyss-Coray fails to teach a method for determining the location of MCP1 comprises immunofluorescence staining.
Raha teaches a method for determining the location of an AD biomarker comprising immunofluorescence staining (We further confirmed the presence of TREM2 protein in the WT mouse brain using immunofluorescent staining; p. 204, col. 2, para. 3, ll. 5-7).
Raha is considered to be analogous to the claimed invention because it is in the same field of endeavor for Alzheimer’s disease biomarker detection and characterization. Raha uses double immunofluorescence staining to assess co-localization of the Alzheimer’s disease biomarker, TREM-2, with other AD biomarkers and cell types, providing information regarding the extent to which the disease has progressed (p. 200, col. 2, para. 1; Figs. 2-3). Wyss-Coray already employs the immunofluorescence assay to measure the expression level of multiple Alzheimer’s biomarkers in the sample including MCP-1, Eotaxin/CCL11, B2M, and Haptoglobin ([0118][0143]). 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 AD detection method of Wyss-Coray by incorporating the teachings of Raha and using the immunofluorescence staining to also determine the expression location of MCP1 because the results would provide additional diagnostic information regarding the progression of the disease, and this involves the use of a known technique to improve a similar method in the same way (See MPEP 2143(I)(C))(The recitation “for a purpose of non-disease diagnosis and/or treatment” is merely an intended purpose because the claim does not positively recite any additional method step beyond detecting MCP1 of a sample. See MPEP 2111.02(II)).
Claims 8, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wyss-Coray et. al (US 20130040844 A1), in view of Feuerhelm-Heidl (US 20160334422 A1).
Regarding claim 8, Wyss-Coray teaches a kit for detecting Alzheimer's disease, which detects the marker of Alzheimer's disease according to claim 1 (“kits and devices for carrying out any of the methods described herein,” which include biomarkers, associated reagents and a device for measuring the biomarker signal that is associated with Alzheimer's disease within the sample; [0162]-[0176]).
Wyss-Coray is silent to teaching the kit comprises any one of an immunofluorescence staining kit, a real-time fluorescence quantitative PCR kit or an ELISA kit.
Feuerhelm-Heidl teaches an ELISA kit (the kit is an ELISA; [0116]).
Feuerhelm-Heidl is considered to be analogous to the claimed invention because it is in the same field of endeavor for detecting and diagnosing Alzheimer’s disease using a MCP1 biomarker. Wyss-Coray already identifies ELISA as a suitable technique for detecting the disclosed age-associated biomarkers including MCP-1 ([0118]) and further teaches kits comprising reagents specific to such biomarkers [0162]-[0176]). 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 AD detection kit of Wyss-Coray by incorporating the ELISA kit taught by Feuerhelm-Heidl because this would have merely provided a known and routine format for performing the biomarker detection methods taught by Wyss-Coray, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Regarding claim 11, Modified Wyss-Coray teaches the kit for detecting Alzheimer's disease according claim 8, wherein the ELISA kit comprises any one or a combination of at least two of an MCP1 conjugate, a luminescent reagent (“the labels may be, for example…chemiluminescent,” listing ELISA as an assay that amplifies this label; Wyss-Coray, [0120]), a positive control, a standard substance, a diluent, a scrubbing solution or a stop solution.
Regarding claim 16, Modified Wyss-Coray teaches the kit for detecting Alzheimer's disease according to claim 8, wherein the ELISA kit comprises an MCP1 conjugate (“the biomarkers described above and below may themselves be conjugated to a label,” wherein the biomarker is MCP1; Feuerhelm-Heidl, [0107]; [0023]), a luminescent reagent (a luminant; Feuerhelm-Heidl, [0090]), a positive control (positive control…is provided; Feuerhelm-Heidl, [0120]), a standard substance (standard solutions; Feuerhelm-Heidl, [0107]), a diluent (supplied OPD diluent; Feuerhelm-Heidl, [0134]), a scrubbing solution (a washing solution; Feuerhelm-Heidl, [0107]), and a stop solution (stop solution; Feuerhelm-Heidl, [0107]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wyss-Coray et. al (US 20130040844 A1), in view of Feuerhelm-Heidl (US 20160334422 A1), as applied to claim 8 above, and in further view of Leng et al. (CN 111474358 A, see attached English translation).
Regarding claim 9, Modified Wyss-Coray teaches the kit for detecting Alzheimer's disease according to claim 8, wherein the kit comprises any one or a combination of at least two of a fixing agent, a dehydrating agent, an embedding agent, a cleaning liquid, a sealing agent, a primary antibody, a second antibody (biomarker-specific reagent (e.g., secondary antibodies); Wyss-Coray, [0169]) or a mounting medium.
Modified Wyss-Coray is silent to teaching the kit comprises an immunofluorescence staining kit.
Leng teaches an immunofluorescence staining kit (a 3 D three-dimensional immune fluorescent dyeing kit; Abstract).
Leng is considered to be analogous to the claimed invention because it is in the same field of endeavor for biomarker localization using immunofluorescence. Wyss-Coray already identifies immunofluorescent assay as a suitable technique for detecting the disclosed age-associated biomarkers including MCP-1 ([0118]) and further teaches kits comprising reagents specific to such biomarkers such as a secondary antibody [0162]-[0176]). 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 AD detection kit of Wyss-Coray in view of Feuerhelm-Heidl by incorporating the immunofluorescent assay kit taught by Leng because this would have merely provided a known and routine format for performing the biomarker detection methods taught by Wyss-Coray, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Claims 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wyss-Coray et. al (US 20130040844 A1), in view of Feuerhelm-Heidl (US 20160334422 A1), as applied to claim 8 above, and in further view of Kim et al. (US 20220252618 A1, EFD 2020-06-10).
Regarding claim 10, Modified Wyss-Coray teaches the kit for detecting Alzheimer's disease according to claim 8, wherein the kit comprises any one or a combination of at least two of an RNA extraction reagent, a reverse transcriptase, an amplification enzyme, a buffer, a primer, an RNA enzyme inhibitor, dNTPs or a fluorescent dye (the biomarker-specific reagent(s) may be labeled with a detectable marker (such as a fluorescent dye or a detectable enzyme; Wyss-Coray, [0168].
Modified Wyss-Coray is silent to teaching the kit comprises a real-time fluorescence quantitative PCR kit.
Kim teaches a real-time fluorescence quantitative PCR kit (“the kit may be an RT-PCR kit,” wherein “real-time RT-PCR” is listed as an analysis method; [0086],[0098]).
Kim is considered to be analogous to the claimed invention because it is in the same field of endeavor for endeavor for detecting and diagnosing Alzheimer’s disease using a MCP1 biomarker (See CCL2 in Table 1). Wyss-Coray already states that “using any one of the well known quantitative PCR methods” is a suitable technique for detecting the disclosed age-associated biomarkers including MCP-1 ([0018]) and further teaches kits comprising reagents specific to such biomarkers [0162]-[0176]). 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 AD detection kit of Wyss-Coray in view of Feuerhelm-Heidl by incorporating the real-time fluorescence quantitative PCR kit taught by Kim because this would have merely provided a known and routine format for performing the biomarker detection methods taught by Wyss-Coray, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Regarding claim 15, Modified Wyss-Coray teaches the kit for detecting Alzheimer's disease according to claim 8.
Modified Wyss-Coray is silent to teaching the real-time fluorescence quantitative PCR kit comprises an RNA extraction reagent, a reverse transcriptase, an amplification enzyme, a buffer, a primer, an RNA enzyme inhibitor, dNTPs, and a fluorescent dye.
Kim teaches a real-time fluorescence quantitative PCR kit comprising an RNA extraction reagent (a primer; [0088], a reverse transcriptase (reverse transcriptase; [0088], an amplification enzyme (enzymes such as Taq-polymerase; [0088], a buffer (buffers; [0088], a primer (a primer; [0088]), an RNA enzyme inhibitor (RNase inhibitors; [0088], dNTPs ((dNTPs); [0088], and a fluorescent dye (a fluorescent-labeled probe; [0089].
Kim is considered to be analogous to the claimed invention because it is in the same field of endeavor for endeavor for detecting and diagnosing Alzheimer’s disease using a MCP1 biomarker (See CCL2 in Table 1). Wyss-Coray already states that “using any one of the well known quantitative PCR methods” is a suitable technique for detecting the disclosed age-associated biomarkers including MCP-1 ([0018]) and further teaches kits comprising reagents specific to such biomarkers [0162]-[0176]). 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 AD detection kit of Wyss-Coray in view of Feuerhelm-Heidl by incorporating the real-time fluorescence quantitative PCR kit taught by Kim because this would have merely provided a known and routine format for performing the biomarker detection methods taught by Wyss-Coray, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wyss-Coray et. al (US 20130040844 A1), in view of Feuerhelm-Heidl (US 20160334422 A1), as applied to claim 8 above, and in further view of Leng et al. (CN 111474358 A, see attached English translation) and Nithiyanandam (US 20180238908 A1).
Regarding claim 14, Modified Wyss-Coray teaches the kit for detecting Alzheimer's disease according to claim 8.
Modified Wyss-Coray fails to teach a immunofluorescence staining kit comprising a fixing agent, a dehydrating agent, an embedding agent, a cleaning liquid, a sealing agent, a primary antibody, a second antibody, and a mounting medium.
Leng teaches an immunofluorescence staining kit (a 3 D three-dimensional immune fluorescent dyeing kit; Abstract) comprising a fixing agent (fixing liquid; Abstract), a dehydrating agent (dehydrating agent; Abstract), an embedding agent (S8, embedding the sample by ion exchange resin; p. 3, l. 21), a cleaning liquid (PBS buffer solution for cleaning; p. 5, ll. 23-24; Abstract), a sealing agent (confining liquid…for sealing; p.3, l. 8; Abstract), a primary antibody (an antibody; Abstract), a second antibody (secondary antibody; Abstract).
Leng is considered to be analogous to the claimed invention because it is in the same field of endeavor for biomarker localization using immunofluorescence. Wyss-Coray already identifies immunofluorescent assay as a suitable technique for detecting the disclosed age-associated biomarkers including MCP-1 ([0118]) and further teaches kits comprising reagents specific to such biomarkers such as a secondary antibody [0162]-[0176]). 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 AD detection kit of Wyss-Coray in view of Feuerhelm-Heidl by incorporating the immunofluorescent assay kit taught by Leng because this would have merely provided a known and routine format for performing the biomarker detection methods taught by Wyss-Coray, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Modified Wyss-Coray fails to teach a mounting medium.
Nithiyanandam teaches a mounting medium (Cells were also incubated…Mounting medium was dropped onto the coverslip and the coverslip was sealed by applying nail polish to avoid drying. ; [0158]).
Nithiyanandam is considered to be analogous to the claimed invention because it is in the same field of endeavor for Alzheimer’s disease diagnosis using biomarkers. 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 AD detection kit of Wyss-Coray in view of Feuerhelm-Heidl and Leng by incorporating the mounting medium taught by Nithiyanandam because mounting medium were conventionally used in immunofluorescent staining procedures to preserve fluorescent signals and prevent specimen drying, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chondrex., 2020 (instant PTO-892) teaches an ELISA Kit to quantify Mouse CCL2.
No claims are allowed.
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/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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