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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 1 recites “a sample to be detected”. The scope of “a sample” is interpreted as a volume of a substance, typically a liquid such as blood, saliva, or a reagent solution. Though not explicitly stated within the specifications in the instant claim, “a sample” will be interpreted by the examiner as a liquid either with or without solid particles contained therein.
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 5 and 6 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.
Claim 5 recites the limitation “wherein a detection concentration of the sample is 1 ng to 0.1 fg.” Nanogram (ng) and Femtogram (fg) units of mass are not indicators of concentration. It is unclear as to what measurements of concentration of the sample of claim 1 are detectable, and fails to further limit the scope of the independent claim.
Furthermore, claim 6 recites wherein the sample is placed on the sample pad in an amount ranging from 1 ng to 0.1 fg. The sample of claim 1, upon which claim 6 depends, is not defined, rendering it unclear what volume of sample is being applied to the sample pad.
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.
Claim(s) 1-9 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 claim(s) 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.
In making a determination of whether the application complies with the written description requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is claiming and what Applicant has possession of. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). See MPEP § 2163.
Claim 1 recites a detection method of ammonia oxidation functional gene (singular) in water treatment, comprising: amplifying ammonia oxidation functional genes (plural). The specification fails to define any ammonia oxidation functional gene aimed for detection by the method, and any of the specific ammonia oxidation functional genes being amplified by PCR for sample preparation. Claim 1 further states “a sample” with no supporting information within the specification regarding the type of sample to be used for testing.
Regarding Claim 1, the specification does not clearly describe or define any ammonia oxidation functional genes aimed for detection or the intended sample used for testing. When turning to the specification, paragraph [0009] recites “In an embodiment of the invention, the ammonia oxidation functional gene includes a 16s rRNA of ammonia oxidizing microorganism, nitrite oxidizing bacteria, denitrifying bacteria, or anammox bacteria.” The specifications routinely mention a sample, without clarification on sample type. For example, paragraph [0011] states “In an embodiment of the invention, the sample is placed on the sample pad in an amount of 1 ng to 0.1 fg.” Paragraph [0006] recites the steps for a sample to be detected in water treatment. A variety of biological samples can be tested using LFAs, including urine, saliva, sweat, serum, plasma, whole blood, and other fluids (Koczula et. al, Portland Press, 2016/pg.111). One of skill in the art wouldn’t know which sample form to use to perform testing, or which ammonia oxidation functional gene of which ammonia-oxidizing microorganism is targeted for detection.
Based on the specification, the applicant does not have possession of the method as claimed. Claims 2-9 are rejected in virtue of dependency on the method of detecting ammonia oxidation functional gene in water treatment and reference to the sample of claim 1.
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.
Claim(s) 1-3 ,5,6, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jui-Chuang (Jui-Chuang et. al., International Journal of Bioscience, Biochemistry and Bioinformatics, 2018, Vol.8, IDS ref.) in view of Short (Short MD, et al., PLoS ONE 8(10), 2013)
Regarding Claim 1, Jui-Chuang teaches modifying primers used for PCR by attaching biotin and digoxigenin to forward and reverse 5' ends respectively for a sample to be detected; providing a lateral flow immunoassay test strip (pg.218/Abstract; pg.219/sec. 2.1), comprising: a sample pad; a binding pad (pg.219/par. 3) configured with a chromogenic substance, and the chromogenic substance is a complex of nano colloidal gold particles and a primary antibody (pg.219/sec.2.2); a nitrocellulose membrane, wherein according to a flow direction of the sample, a test line and a control line are sequentially drawn on the nitrocellulose membrane (pg.219/par. 3; pg.220/ sec. 2.6) , a reagent used in the test line is streptavidin (pg.22/sec. 2.4), and the control line is configured with a secondary antibody (pg.220/par.1); an absorbent pad used to provide a capillary attraction and collect the remaining sample (pg.220/ sec.2.3); and a bottom card, wherein the sample pad, the binding pad, the nitrocellulose membrane, and the absorbent pad are sequentially disposed on the bottom card according to the flow direction of the sample (pg.220/sec.2.6) ; and placing the sample on the sample pad of the lateral flow immunoassay test strip, wherein the sample flows from the sample pad to the absorbent pad, and color development on both the test and control lines when the sample flows through the nitrocellulose membrane indicates a positive result (pg.219/par.3); color development solely on the control line indicates a negative result and no color development indicates an invalid test (pg.219/par.3; pg. 220/par.1).
Regarding Claims 2-3, Jiu-Chuang teaches a primary antibody comprises a mouse anti-digoxigenin antibody (pg.219/sec.2.2) and a secondary antibody comprises a goat anti-mouse antibody (pg.220/par.1).
Jui-Chang fails to teach a detection method of ammonia oxidation functional gene in water treatment by amplifying ammonia oxidation functional genes.
However, Short teaches a detection method of ammonia oxidation functional gene in water treatment through characterization of bacterial and archaeal ammonia oxidizers with functional gene microarray. Functional Gene Microarray (FGA) was employed to assess the relative abundance and diversity of both ammonia-oxidising bacteria (AOB) and archaea (AOA) in the nitrifying IFAS samples. The functional gene of interest (amoA) is amplified from DNA extracted from the wastewater samples, fluorescently labelled and is then applied to the FGA under specific conditions to produce fluorescent probe–target duplexes which can be detected and analyzed (pg.2/C2).
Regarding Claims 5 and 6, wherein the sample is placed on the sample pad and a detection concentration of the sample is 1 ng to 0.1 fg. Jui-Chuang teaches a detection limit for the sample was as low as 0.01μl, and of which corresponding amount was about 0.49 ng ([sec. 3.3]) and the test reproducibility of HLA-A3101 on MBLF strips was conducted by loading 100ng, 10ng, and 1ng of its PCR product in two sets. (pg.223/ FIG.11)
Regarding Claim 9, the method of detecting ammonia oxidation functional gene in water treatment of claim 1, wherein a width of the sample pad, the binding pad, the nitrocellulose membrane, the absorbent pad, and the bottom card in a flow direction perpendicular to the sample is the same, and the width is 2 mm to 6 mm. Jui-Chuang teaches a procedure for making the test strip in which the nitrocellulose membrane, sample pad, conjugate pad, and absorbent pad are adhered to the plastic card. The finished membrane-pad-card assembly is finally cut into 5mm-wide and ready-to-use strips. ([sec 2.6])
Short recites that traditional culture-based assays such as most probable number and selective cultivation methods for detecting nitrifying microbes in environmental samples are both time-consuming (due to the slow growth rates of these organisms) and erroneous (due to sub-optimal culture conditions), resulting in a misleading representation of the target microbial community (pg.1/par.2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the test method of Jui-Chang (Membrane Based Lateral-Flow) to incorporate the teachings of Short (characterizing bacterial and archaeal ammonia oxidizers) to produce a rapid cost-effective platform to manipulate a sample for detection of Ammonia oxidation functional gene in water treatment.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jui-Chuang (Jui-Chuang et. al., International Journal of Bioscience, Biochemistry and Bioinformatics, 2018, Vol.8, IDS ref.) and Short (Short MD, et al., PLoS ONE 8(10), 2013) as applied to claims 1-3,5,6, and 9 above, and further in view of Junier (Junier et. al, Appl Microbiol Biotechnol, 2009).
Regarding Claim 4, Jui-Chuang and Short fail to teach on the method of detecting ammonia oxidation functional gene in water treatment of claim 1, wherein the ammonia oxidation functional gene comprises a 16S rRNA of ammonia oxidizing microorganism, nitrite oxidizing bacteria, denitrifying bacteria, or anammox bacteria.
However, Junier teaches that the most traditionally used phylogenetic marker for studying microbial communities is the 16S rRNA gene. AOB (Ammonia oxidizing bacteria) represent one of the bacterial groups for which the amplification and analysis of the 16S rRNA gene has been successfully used (pg.426; C2/par.2) and further that conventional microbial nitrogen removal is based on the oxidation of ammonia and nitrite by AOB and nitrite-oxidizing bacteria, respectively, followed by the reduction of nitrate by heterotrophic denitrifying bacteria (pg.434; C2/par.4). The study of anammox bacteria in natural assemblages has been usually based on 16S rRNA phylogenetic markers (pg.426; C2/par.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the test method of Jui-Chang and teachings of Short to incorporate the teachings of Junier (detection of the 16s rRNA functional gene) to produce a rapid cost-effective platform to manipulate a sample to detect Ammonia oxidation functional gene in water treatment.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jui-Chuang (Jui-Chuang et. al., International Journal of Bioscience, Biochemistry and Bioinformatics, 2018, Vol.8, IDS ref.) and Short (Short MD, et al., PLoS ONE 8(10), 2013) as applied to claims 1-3,5,6, and 9 above, and further in view of Ruvinsky (US 20110076697 A1) as evidenced by Unsworth (Unsworth, The Biomimicry Institute, 2021) and Beckman (Beckman et. al, PubMed Central, 2022).
Regarding Claim 7, Ruvinsky teaches the material of the pre-filter and conjugate pad, which equate to the instant sample pad and binding pad may be formed of borosilicate glass fibers with a polyvinyl alcohol binder. ([0053], [0055]). As evidenced, Beckman teaches on borosilicate glass as a nonwoven fiber material (pg.37/sec. 2.1). Ruvinsky teaches the material of the absorbent pad may be formed of a cellulosic fibrous material ([0059]). As evidenced by Unsworth, Cotton fibers are composed primarily of cellulose that are arranged in long, parallel chains that give the fibers strength and durability (par. 2). Ruvinsky further teaches a substrate which equates to the instant bottom card, made of high impact polystyrene sheet and an adhesive layer ([0058]).
Regarding Claim 8, Ruvinsky teaches a pre-filter which equates to the instant sample pad with a length of 12.5 mm and about 15.0 mm; or of about 14.0 mm, a conjugate pad which equates to the instant binding pad with a length of 9.0 mm and about 12.0 mm; or of about 10.0 mm, a migration membrane which equates to the instant nitrocellulose membrane with a length of about 22.0 mm and about 30.0 mm; or of about 25.0 mm, an absorbent pad with a length of about 19.0 mm and about 22.0 mm; or of about 20.0 mm, and a substrate which equates to the instant bottom card with a length of 61.0 mm and about 63 mm; or of about 62.5 mm ([0050]). All referenced ranges are encompassed within the ranges of the claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the test method of Jui-Chang and teachings of Short to incorporate the teachings of Ruvinsky to adjust the dimensions and material composition of the test strip for optimal sample flow rate and proper interaction between reagents to achieve desired sensitivity, accuracy, and speed of the test.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Avanda Harvey-Butler whose telephone number is (571)272-6511. The examiner can normally be reached M-F, 9-5 ET.
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/AVANDA E. HARVEY-BUTLER/ Examiner, Art Unit 1683
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683