DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 11/14/25 is acknowledged.
Note: Claim 20 was inadvertently left out of Group III in the Restriction Requirement mailed on 11/4/25. It is part of Group III.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-2nd paragraph
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 1 and dependent claims 2-14 thereof 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 1 is vague and confusing because it is unclear what the kit is “testing” and there are no reagents recited in the kit, e.g., just a generic “lateral flow assay test strip”. Accordingly, the claim is incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: elements which would properly allow for detecting/testing an “infectious agent”. It is noted that the term “infectious agent” is also unclear and the metes and bounds of the invention cannot be understood. An infectious agent can be a virus, bacterium, fungus, protozoan, or prion, with transmission occurring through various means like air, water, or vectors. These agents range vastly in size and complexity, from tiny viruses to large parasitic worms. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
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) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ting et al (WO 2010/033740; provided by Applicant) and Yamamoto et al (EP 259837 A2. 12/5/12; provided by Applicant) in view of Hall et al (WO 2022/104083; provided by Applicant) and Cary et al (US 7,910,309).
Ting et al discloses a system for testing an insect (tick) for an infectious agent (Borrelia), the system comprising: an insect macerator (such as Shredder with PCT or BIOMASHER™M device); and a SDS-PAGE Gel. (See the entire document; see references in the search report; especially, figures, 1-6, 8A-8D and 13 and example 13). They disclose an insect processing tool for use in preparing a liquid sample, the insect processing tool comprising: a first component comprising a well having a floor, wherein the floor is configured for supporting a live insect on the floor, and wherein the walls of the well are configured to inhibit the live insect from climbing out of the well; and a second component comprising a post configured for placement within the well; wherein the first component and the second component are threadably engageable to crush an insect between the post and the floor of the well. Ting et al teach at page 12 that simple mechanical grinding processes, such as a mortar in a pestle, may be undesirable because of the likelihood of sample cross-contamination, potential exposure of lab workers to dangerous samples, and uncontrolled grinding force and duration. Example 3 teaches tick DAN extraction and samples and teach that quantification of Borrelia was performed. Figure 8B shows a real time PCR assay of Borrelia burgdorferi 23S rRNA gene which has been strongly amplified from tick DNA preps extracted by the shredder techniques and devices of the present invention coupled with lysing by pressure cycling techniques and devices, the graph showing identification in three of five as Ixodes scapilaris, and in two out of seven unidentified ticks having B. burgdorferi, the tick samples were effectively shredded in one minute (followed by pressure cycling processes) in the same tube or container. FIG. 13 shows the identification of Borrelia burgdorferi DNA from tick DNA Ixodes scapularis.
The instant application differs in that the sample is analyzed using lateral flow assay strip and further the means are packaged into a kit (for claim 1).
Yamamoto et al also discloses a macerator of the instant application (see the entire document, see especially 1A-8C). Further, the reference teaches that the macerator (grinding device) can be used to obtain insect samples. Thus, Yamamoto recites in paragraph [0031]: "The samples that can be ground using the unit for grinding a sample or the unit for grinding and collecting a sample according to the invention can include relatively flexible tissues such as (...) insects; fishes; seashells; bacteria; yeasts; and the like.". Further, Yamamoto recites in paragraph [0035]: "Conventional pestles for grinding a sample comprise a generally sphere-shaped end and such pestles are pressed and rubbed to crush and grind a sample."
Although Ting and Yamamoto do not particularly exemplify the use of a lateral flow strip assay, it is one of the most used means for analyzing a test sample.
For example, Hall et al discloses the lateral flow device of present application (see the entire document, especially figures 1-24). Furthermore, said device can be used to detect sample from insects. Hall recites in paragraph [0101]: "In embodiments according to FIG. 12, cassette 707 may also comprise a code, such as a second QR code 1502 configured to identify, for example, a type of test cassette 707 is configured for (e.g., a test identifier regarding any one or more of bedbugs, ticks, lice, etc.), a duration of the test of cassette 707, a positive and/or negative threshold for the test of cassette 707, a serial number, a lot number, an expiration date, and/or a hash code to ensure cassette 707 is genuine and not counterfeit."
Cary et al recites (see references in the search report and the following citation): "Insect samples may include insect tissue, such as abdomen tissue samples, and samples from interior cavities, including various fluid samples. (...)"; "In some embodiments of the assays of the invention, sample preparation is achieved using lateral flow methodologies, such as those described under the subsection titled LATERAL FLOW-BASED NUCLEIC ACID SAMPLE PREPARATION, infra. This technology adds an up-front, nucleic acid extraction module that can be used in combination with a detection test strip or device, or engineered to be in lateral flow contact with the detection module of a lateral flow test strip or device."; "Disease-Transmitting Vector Infection Assays: In yet another aspect, the invention's citrus assays may be used to monitor various insects for the presence of CVC-causing Xylella and/or CC-causing Xanthomonas bacteria. CVC is known to be transmitted by certain insect vectors, including sharpshooter leafhoppers and spittlebugs (see BACKGROUND, supra). Accordingly, the invention's Xylella assay may be used to detect and monitor the presence of citrus variegated chlorosis-causing Xylella fastidiosa strains in known insect vector populations, as well as to identify potentially new insect vectors capable of transmitting CVC. In this regard, a typical sample matrix would comprise tissue or fluids taken from an appropriate insect vector."
Therefore, starting at Ting and Yamomoto it would have been prima facie obvious for one of ordinary skill in the art looking for alternative means for analyzing insect sample, to use the well-known in the art lateral flow device, such as disclosed as well in Hall or Cary. Because both Hall and Cary teach that the additional technical feature solves the problem posed combining it with the system and method of document Ting and Yamamoto.
Furthermore, claim 1 refers to a kit for testing an insect (tick) for an infectious agent (Borrelia) comprising a macerator and an assay means. This claim is interpreted as meaning a kit containing the said macerator and lateral assay flow device. The intended use of a product, e.g., for testing an insect for an infectious disease, is not a technical feature of the product per se. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Moreover, including containers to package components used for performing a method would have been prima facie obvious to one or ordinary skill in the art. Dependent claims 2-14 do not contain any features which, in combination with the features of any claim to which they refer, fall within the knowledge and the ability of a person skilled in the art and would have been obvious to one of ordinary skill in the art at the time the invention was made.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel E. Kolker, can be reached on (571) 272-3181.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 2/24/26