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 of primer set (iii) and the specific set of claim 4 (SEQ ID NO: in the reply filed on 1/28/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
This application is a 371 and being considered under lack of unity practice. Upon finding of an allowable species, any species that shares a special technical feature with the allowed species will be rejoined. Here it is noted that the art of record supports that “LAMP primers” is not a special technical feature in view of the prior art.
Interview
The remarks filed 1/28/26 thank the Examiner for an interview. However, in the conversation held on 1/28/26, the merits of the application were not discussed. Applicant’s representative indicated that a change of election was desired, and the examiner suggested filing a supplemental paper.
Claim Rejections - 35 USC § 112
Claims 1, 4, 8-15, 18, 22-26 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the sets of LAMP primers is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the alternatives do not share a common structural feature as each set of primers has a unique sequence composition and target in the SARS-COV-2 genome.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
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(s) 1, 4, 8-15, 18, 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lamb et al. (medRxiv 2020.02.19.20025155 (2020) doi:10.1101/2020.02.19.20025155; 17 pages) and GenBank MN908947.3 (3/18/2020; Severe acute respiratory syndrome coronavirus 2 isolate Wuhan-Hu- complete genome).
Lamb et al. teach a LAMP primer set and a method for the detection of COVID-19 (SARS-CoV-2) in a variety of sample types, including saliva. The LAMP primer set taught by Lamb is specific for the ORF1ab portion of the genome (p. 4, p. 14; p. 5-7).
The reference teaches aligning 23 different COVID-19 strains to identify areas of sequence conservation as well as comparison to other coronavirus sequences to identify areas of divergence (p. 4). The reference teaches that “an area” of GenBank MN908947 was identified that had high homology with other COVID-19 strains. The reference teaches that a commercially available LAMP primer design tool was used to select RT-LAMP primers. The primers are listed in Table 1 (p. 4, p. 14).
The reference teaches carrying out LAMP using a strand-displacement polymerase, namely a Bst polymerase (p. 6), and detecting covid in saliva (p. 3).
The method taught by Lamb includes steps of contacting a sample with a set of LAMP primers under conditions to amplify a SARS-CoV-2 nucleic acid, and detecting the amplification product (p. 6; Figure 3).
With regard to the requirement that the regents make up a “kit” the instant specification does not teach a limiting definition of a “kit” and the broadest reasonable interpretation of a “kit” includes a set of reagents. The reference teaches the reagents together for the practice of the method. Nothing further appears to be required to meet the claimed “kit” limitation.
The primers taught by Lamb et al. hybridize to portions of GenBank MN908947.3 between nucleotides 3043-3331.
Lamb et al. does not teach primers comprising SEQ ID NO: 13-18.
Nucleotides 2-21 of SEQ ID NO: 14 are the complement of nucleotides 3-21 of the B3 primer taught by Lamb et al. That is, the primer set of Lamb et al. and the instant primer set amplify regions of the prior art sequence that are overlapping. The instantly claimed primer sethybridizes to portions of GenBank MN908947.3 at nucleotides 2765-3065. The GenBank record evidences that the primers of Lamb and the instant primers are within the portion of the covid genome encoding orf1ab.
All of the claimed primers hybridize to portions of the known covid sequence, as taught in MN9018947.3.
Instant SEQ ID NO: 13 is identical to nucleotides 2765-2784 of the prior art sequence.
Instant SEQ ID NO: 14 is identical to the complement of nucleotides 3045-3065 of the prior art sequence.
Instant SEQ ID NO: 15 is identical to the complement of nucleotides 2872-2890 (nucleotides 1-29 of SEQ ID NO: 15) joined to nucleotides 2828-2846 of the prior art sequence (nucleotides 20-28 of SEQ ID NO: 15).
Instant SEQ ID NO: 16 is identical to nucleotides 2930-2952 of the prior art sequence (nucleotides 1-23 of instant SEQ ID NO: 16) joined to the complement of nucleotides 2988-3005 of the prior art sequence (nucleotides 23-42 of SEQ ID NO: 16).
Instant SEQ ID NO: 17 is identical to the complement of nucleotides 2849-2870 of the prior art sequence.
Instant SEQ ID NO: 18 is identical to nucleotides 2961-2981 of the prior art sequence.
It would have been prima facie obvious for one of ordinary skill in the art to conduct the LAMP covid detection method of Lamb using oligonucleotide primers having 90% or more sequence identity to instant SEQ ID NO: 13-28. An ordinary artisan would have been motivated to do so with a reasonable expectation of success, since: (i) Lamb expressly taught designing oligonucleotide primers from the known Covid sequence, and teaches that and “area” within the known MN908947 sequence was identified with high homology to COVID-19 strains and was divergent for Bat SARS-like coronavirus (p. 4) (ii) the complete sequence MN908947 sequence was known in the art at the time of the invention, and (iii) Lamb taught rules for designing amplification primers and disclosed a publicly available program that uses the disclosed rules to design primers from any known target nucleic acid sequence.
The combined teachings of the cited references would have suggested a finite number of possible LAMP primer pairs that could be designed from the known region “near” where the disclosed primers amplified to sequence to the ordinary artisan, and, based on the teachings of Lamb, the ordinary artisan would have expected predictable results in obtaining and using these oligonucleotides in the covid detection method of Lamb to detect the target pathogen. Thus, absent any evidence of unexpected results with respect to particular primers capable of amplifying SARS-CoV-2 the claimed set of primers and method for using them in LAMP amplification was prima facie obvious in view of the combined teachings of the cited references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lalli et al. teach LAMP amplification of SARS-CoV-2 from saliva employing the primers taught by Lamb, throughout.
CN111549176 also teaches a LAMP primer set that amplifies an portion of the covid genome overlapping with the instant primer set, namely teaching primers that hybridize between nucleotides 3041 and 3334 of the reference GenBank MN908947 referred to in this Office action.
Unrau et al. (WO 2020/245808) teach a primer for isothermal amplification which comprises instant SEQ ID NO: 13, see SEQ ID NO: 22 therein.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682