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 .
Election/Restrictions
Applicant's election with traverse of group I, species Shigella and ipaH gene in the reply filed on 9/3/2026 is acknowledged. The traversal is on the ground(s) that there is no burden to examine all groups and species together. This is not found persuasive because the requirement was set forth under Lack of Unity standards and applicant did not traverse the rational given to support the requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7, 18-20, 22, 28-29, 32, 34-35, 60, 62 and 63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/3/2026.
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.
Claim 31 is 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 31 is incomplete because it depends from a cancelled claim. Therefore, the metes and bounds of the claim cannot be determined.
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 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.
Claim(s) 1, 2, and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN111575167A.
A machine translation of CN111575167A is attached to the patent publication. Paragraph numbering in this rejection is from the machine translation.
The reference teaches obtaining a sample from a subject that is suspected of comprising a target microorganism. See ¶0028, 0035. The reference further teaches contacting the sample with a lysis solution to form a mixture. See ¶0028, 0035. The reference teaches filtering the mixture through a filter to form a filtered mixture that comprises DNA or RNA of the target microorganism. See ¶0055. The reference teaches contacting the filtered mixture with loop mediated isothermal amplification (LAMP) reagents and a primer set specific to the target microorganism, wherein the reagents and primer set is lyophilized. See ¶0013, 0053, 0066, 0071-0078 . The reference teaches amplifying the DNA or RNA of the target microorganism and detecting the presence or absence of the amplicon See ¶0034, 83.
Regarding claim 2, the primers taught by the reference inherently target the Zika virus POLY gene.
Regarding claim 34, the reference teaches blood sample. See ¶0035.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN111575167A in view of Nixon et al. (Anal. Chem. 2014, 86, 4387−4394).
The teachings of CN111575167A are given previously in this Office action and are applied here. The reference does not teach a method wherein the filter comprises a LAMP inhibitor control DNA and wherein the filtered mixture comprises DNA or RNA of the target microorganism and the lamp inhibitor control DNA.
Nixon teaches adding a control nucleic acid into a lysis buffer. This is considered an “inhibitor control DNA” because it would be an indicator of inhibitors present in the process of amplification. See p. 4388, Col. 1.
It would have been obvious to have modified the method taught by CN111575167A by including an inhibitor control in the lysis buffer. One would have been motivated to do so in order to provide a way to test for inhibitors in a process and confirm that negative results are not due to inhibition. When the lysed sample is applied to the filter, the filter would “comprise” the control DNA, and the control DNA would flow through the filter with the sample nucleic acids.
Claim(s) 3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN111575167A in view of Song et al. (FEMS Microbiology Letters 243 (2005) 259–263).
The teachings of CN111575167A are given previously in this Office action and are applied here. The reference does not teach amplification of a target that is ipaH gene or a target microorganism that is Shigella spp.
Song et al. teach LAMP amplification of Shigella ipaH gene. Throughout.
It would have been obvious to have modified the method taught in CN111575167A by applying the primers for the detection of Shigella ipaH gene to and to have carried out the method disclosed by CN111575167A for the detection of Shigella. CN111575167A teach that their method and device are to enable detection of apthogens on a larger scale in order to more effectively prevent and control infectious diseases (¶0005), and Song et al. teach a target infectious disease agent as well as LAMP primers for detecting it.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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