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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 15, 2023 has been
considered by the examiner. The Foreign patent document by MedCaptain Medical Technology Co. is not filed in English and therefore has not been considered by the examiner.
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 15 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.
The term “substantially ” in claim 15 line 19 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As recited by the instant claim: "substantially identical to the target sequence". How much of the synthetic nucleotide sequence is considered identical to the target sequence? .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 and 15-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (including a product of nature) without significantly more.
Subject Matter Eligibility Test (see MPEP § 2106):
Step 1: Are the claims to a process, machine, manufacture, or composition of matter?
Yes. The claims are directed towards a composition of matter (kit) comprising nucleic acids Step 2A: Are the claims directed to a judicial exception?
Prong 1: Do the claims recite an abstract idea, law of nature, or natural phenomenon?
As discussed in MPEP 2106.04(II)(A)(1), the meaning of “recites” is “set
forth” or “describes”. That is, a claim recites a judicial exception when the judicial
exception is “set forth” or “described” in the claim. In the instant case, the claims
describe a natural phenomenon (Naturally occurring primer set sequences).
Claims 1 and 2 recite a nucleic acid screening kit comprising inner and outer, forward and backward primer sets selected from 56 different sequences. The kits of claims 3, 4, 9, and 10 are comprised solely of the aforementioned primer sets, with claims 3 and 4 comprising 13 different additional sequences of a Loop F primer. When searched, the primers showed 100% concordance with naturally occurring sequences derived from the homo sapiens genome. A selection of some of the sequence search results is shown below.
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93
380
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SEQ ID 5 compared to Accession # BI047327
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68
360
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SEQ ID 2 compared to Accession # BF197186
SEQ ID 35 compared to Pub # US20080050393A1, SEQ ID 67085
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77
422
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SEQ ID 69 compared to Pub # US20260048130A1, SEQ ID 112
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83
424
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Prong 2: Do the claims recite additional elements that integrate the judicial exception into a
practical application?
As discussed in MPEP 2106.04(II)(A)(2), “Because a judicial exception is
not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06
(quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no
additional claim elements besides the judicial exception, or if the additional claim
elements merely recite another judicial exception, that is insufficient to integrate the
judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract
idea (math) to another abstract idea (encoding and decoding) does not render the claim
non-abstract"); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541,
1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature
(or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial
exception to be eligible, the additional elements (if any) in the claim must "transform the
nature of the claim" into a patent-eligible application of the judicial exception, Alice
Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B.” The
considerations to be used are set forth at MPEP 2106.05(a) through (c) and (e) through
(h).
Simply placing primer sets into a kit does not meaningfully change the primer set itself and is considered insignificant extra-solution activity because there is no structural change to the primers. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). See MPEP § 2106.05(g).
There are no additional elements in claims 1-4,9, and 10; therefore, the judicial exception is not integrated into a practical application.
Step 2B: Do the claims recite additional elements that amount to significantly more than the
judicial exception?
Claims 5-8 and 15-20 provide additional elements (e.g. enzymes, reagents, test tubes) that do not amount to significantly more than the judicial exception; therefore, the judicial exception is not integrated into a practical application, meaning these claims do not contain eligible subject matter.
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) 1-8, 11-13 ,15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dipanjan et. al. (US20210388454A1, published 12/16/21) as evidenced by New England Biolabs (New England Biolab, WarmStart Colorimetric LAMP 2X Master Mix (DNA & RNA), Date Accessed: 3/18/26)
Dipanjan teaches a nanotechnology-based sensing system to detect biological pathogens and the use of RT-LAMP method to target N gene sequence of COVID-19 causative virus, SARS-CoV-2. For the RT-LAMP method, Dipanjan teaches a primer set consisting of six primers in which the forward and backward inner and outer primers are the same as the forward and backward inner and outer primers of the instant application (Table 2). SEQ ID NOs: 60,61, 62, and 63 of the instant application exhibit a 100% identical match with SEQ ID NOs: 10, 11, 12, and 13 of the reference respectively can be shown in Table 2 and the chart below for exemplarily comparison purposes ([0096], instant Claims 1, 2, 11, 12 ,15, 17, 19, 20).
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366
762
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SEQ ID NO: 60 Compared to Pub # US20210388454A1 SEQ ID 10
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128
475
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SEQ ID 62 Compared to Pub # US20210388454A1 SEQ ID 12
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84
605
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SEQ ID 61 Compared to Pub # US20210388454A1 SEQ ID 11
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160
321
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[AltContent: rect]
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278
413
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SEQ ID NO: 63 Compared to Pub # US20210388454A1 SEQ ID 13
Dipanjan teaches usage of WarmStart technology to inhibit activity of Nucleic acid amplification (NAA) reagents at room temperature with a kit that includes WarmStart LAMP 2× Master Mix, which contains a blend of Bst 2.0 WarmStart DNA Polymerase and WarmStart RTx Reverse Transcriptase in an optimized LAMP buffer solution. An example of NAA protocol, Dipanjan teaches that 8 μL aliquots of the NAA reaction mixture from Table 3 were prepared and added to 2 μL of collected sample (sample can be either extracted RNA or direct sample treated with lysis buffer or artificial saliva sample spiked with clinical samples' RNA) in PCR strip tubes or PCR plates. Samples were mixed well by pipetting up and down for few times. Water was used as a negative control ([0099], instant claims 5,7, 11, 15). The examiner is interpreting the usage of PCR strip tubes and the NAA primer mixture of the reference as capable of carrying out the limitations of instant claims 15, 16, 18, and 19 in which singular or multiple tubes contain the negative control, positive control, first and/or second reaction. As evidenced by New England Biolabs, the WarmStart LAMP 2X Master Mix of the reference is offered with dUTP and contains a visible pH indicator for rapid and easy detection of Loop-Mediated Isothermal Amplification (LAMP) and RT-LAMP reactions, teaching the limitations of instant claims 8, 15,17,19, and 20 (New England Biolabs, pg.1).
Dipanjan teaches that kits may include a sample collection apparatus such as a swab or collection vial, a sample collection and/or storage and/or preservation buffer or solution, lysis buffer or detergent, components and reagents for nucleic acid extraction, components and reagents for nucleic acid amplification, and/or a detection apparatus ([0067], instant claim 6).
Dipanjan teaches usage of a forward loop primer sequence SEQ ID NO 14, that is equivalent to SEQ ID NO 64 of the instant application (instant claims 3, 4, 13, 16 and 18). However, the sequence of the instant application contains one additional “g” residue at the end in comparison to the reference sequence, as can be observed below in Table 2 and the sequence alignments for comparative purposes. It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have altered the sequence of the forward loop primer by adding an additional nucleotide in order to optimize the primer to produce characteristics such as increased binding annealing, specificity, and acceleration of amplification of the primer to the target sequence.
[AltContent: textbox (SEQ ID NO. 64)]
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473
487
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188
369
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Rejected Claims Free of the Prior Art
Claims 9, 10, and 14 are free of prior art because they require nucleic acid sequence SEQ ID NO. 4 and the prior art does not teach a sequence identical to SEQ ID NO. 4.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVANDA E. HARVEY-BUTLER/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights