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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 30, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 42 is objected to because of the following informalities: “LPS” should first be spelled out followed by the abbreviation in parenthesis. Appropriate correction is required.
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.
Claims 28 – 32, 34 – 41 and 47 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.
Claims 28 and the above identified dependents are drawn to a reaction medium comprising “at least one binding partner” of “a component” of a “target microorganism” or “component derived from said microorganism” coupled to “at least one nanoparticle.” These claims are considered genus claims that encompass a wide array of binding partners that might bind to any component of any microorganism, or any component derived from any microorganism and also “at least one nanoparticle.” The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of coupled agents (e.g. a binding agent plus nanoparticle).
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all agents that might bind to any microorganism or any part of any microorganism let alone any component derived from any microorganism. The possible variations of binding component plus nanoparticle are limitless with potentially millions of types of coupled compounds (conjugates). The instant disclosure identifies only four (4) binding agents, one (1) microorganism and one (1) component derived from a microorganism; and only three (3) nanoparticles (examples 1 – 7). The binding agents include Anti STX1 antibodies, Anti STX2 antibodies, IgG anti E. coli antibodies and Phage protein Eco 026 BP1, each of which bind to E. coli or the lipopolysaccharide (LPS) thereof, which are conjugated to silver or gold. The specification fails to identify any aptamer or primer, nor does it describe any other antibodies or phage proteins. The specification also fails to identify any other component of any other target microorganism or any component derived from any microorganism at all.
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 them. 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. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of the various binding agents, components or microorganisms to reflect this variance in the genus since the specification does not provide any examples of such a genus of “binding agents,” “target microorganisms,” “components of target microorganisms,” “components derived from any microorganism” and “nanoparticles.” Accordingly, the specification fails to provide adequate written description for these named genera and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of the various binding agents, target microorganisms, components of target microorganisms, components derived from any microorganism and nanoparticles, the specification does not describe the claimed binding agents, target microorganisms, components of target microorganisms, components derived from any microorganism and nanoparticles in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these genera at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
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 28 – 47 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 28 and its dependents are drawn to a reaction medium, however are rendered indefinite for reciting “liable” as the phrase is subjective and not clearly defined by the claim language or specification.
Claims 29 and 30 are indefinite for reciting “gelled reaction” as the phrase lacks proper antecedent basis.
Claims 32 – 40 are indefinite for reciting “gelled medium” as the phrase lacks proper antecedent basis.
Claims 36 – 38 are indefinite because the claim appears to change the composition of the gelled reaction medium rather than further defining the medium.
Claims 40 – 41 and 46 and 47 are indefinite for depending on canceled claims. Clarification is required.
Claim 43 is rendered indefinite for reciting “makes it possible to cover” because it is unclear what is required by the claim. Further, “LPS-specific phage protein” lacks proper antecedent basis.
In claim 44, line 2, it is unclear whether the nanoparticle concentration is 1010 – 1012 or 1010 – 1012 nanoparticles/ml of reaction medium.
In claim 46, “said at least one antibody” lacks proper antecedent basis since there are two recitations of “at least one antibody,” rendering the scope of the claim unclear.
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.
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.
Claims 28 – 41 and 44 – 47 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (2016) as supported by Zhang et al. (2000).
Regarding claims 28 – 33, 35, 41, 45 – 46, Wang teaches strips for detecting E. coli (target microorganism) in a sample, wherein the strips comprise monoclonal antibodies against Stx1 or Stx2 (specific binding agent to target microorganism) coupled to colloidal gold nanoparticles (abstract, p.7).
Although Wang does not teach the strips in a gelled reaction medium, the strips are disclosed to be placed on environmental sources, water samples, meat samples or any other sample to be tested (p.2, 6). In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to place the strip in any environment suspected of having E. coli, to include gelled media, culture media, visualization media or agar, and with a reasonable expectation for successfully obtaining a medium comprising the strip.
Regarding claim 34, Wang teaches the nanoparticles have a diameter of about 40 nm, which is within the claimed range.
Regarding claims 36 – 39 and 47, Wang teaches the E. coli are induced with 100 ng/ml ciprofloxacin to produce Shiga toxin (abstract, p.2, 6). Regarding claims 40 – 41, Wang does not expressly teach the inducing antibiotic is mitomycin C. However, Wang teaches the stx genes are encoded by prophages and induced by antibiotics such as ciprofloxacin and references Zhang et al. (p.2) who teaches both ciprofloxacin and mitomycin C are both Stx prophages which induce Stx in vitro (see Zhang, p. 664) in the amount of 500 ng/ml (0.5 mg/L) (p.665). Thus, at the time the claims were filed, when considering the full teachings and references of Wang, one of ordinary skill in the art would have been motivated to induce the E. coli of Wang with either ciprofloxacin or mitomycin C, and optimize the amount thereof, with a reasonable expectation for successfully inducing the bacteria to produce Shiga toxin.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
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