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 .
Claim Status
Currently, claims 1-6, 13-14, 29-35, 42-45 are pending in the instant application. Claim 7-12, 15-28, and 36-41 have been canceled and claims 1-5, 13-14, 29-35, 42-45 have been withdrawn. This action is written in response to applicant' s correspondence submitted 02/11/2026. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Final.
Election/Restrictions
Newly amended claim 1is directed to an invention that is independent or distinct from the invention originally claimed. Claim 1 is drawn to a first and second CoV2 detection probe oligomer that was non-elected. Applicant elected without traverse the combination of primers and probes for examination SEQ ID NO 28, 87, 30, 90 and 12-17 (see pg. 11-12 response mailed 09/30/2025). Applicant was required to elect primers and one or a combination of probes (see pg. 3-4 of the restriction mailed 7/30/2025).
Claim 12 was withdrawn as non-invention as applicant did not elect the probes recited in original claim 12. Claim 13-14 depended from claim 12 and was withdrawn for these reasons. It is noted that if elected probes SEQ ID NO 14 and 17 were to depend from a pending claim these probes would be examined however none of the claims recite the elected probes and newly amended claim 1 recites non-elected probes without any embodiment drawn to an elected invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 1-5, 13-14, 29-35, 42-45 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 6 is are under examination. Claim 6 is are under examination with respect to SEQ ID NO 28, 30, 87 and 90.
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.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a law of nature. This rejection was previously presented and has been rewritten to address the amendment to the claims.
The claims are drawn to a composition of matter and encompass a natural phenomenon. Specifically the claims are drawn to a composition that comprises oligomers of SARS-CoV-2. Because the claims are drawn to oligomers that comprise nucleic acid sequences to known naturally occurring nucleic acids of SARS-CoV2, the claims encompass a law of nature. Such isolated nucleic acid molecules that are identical to fragments of naturally occurring nucleic acid are naturally occurring sequences.
The specification does not define amplification oligomers. Claim 6 recites a composition or kit comprising amplification oligomers of SEQ ID NO 28, 87, 30, 90. There is no recitation within the claims that indicate that the nucleic acid claimed have any structural or functional characteristics that differ from the naturally occurring nucleic acids. There is no indication in the specification that the nucleic acids claimed here have any structural or functional characteristics that differ from the naturally occurring nucleic acids. The claimed kit comprising reagents include nucleic acids that do not display markedly different characteristic compared to the naturally occurring counterpart.
There is no indication that the composition or kit comprising amplification oligomers results in changing the structure, function or other properties of the naturally occurring nucleic acid. According the nucleic acids are a product of nature exception and the claim is directed to at least one exception. This judicial exception is not integrated into a practical application because the claims recite amplification oligomers that are naturally occurring and the probes and oligomers detect naturally occurring sequences. The recitation of amplification oligomers or probe is nothing more than an attempt to generally link the product of nature to a technological environment and is a nominal extra solution component of the claim and does not structurally change the nucleic acid sequence. Many cited prior art references in this record demonstrate the oligomers are naturally occurring sequences.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims as a whole are not considered to recite any additional elements that amount to significantly more than the naturally occurring nucleotide sequences. Besides the nucleic acids, the claims recite a composition or kit in the preamble with an intended use. Additional claims recite a kit or composition with reconstitution reagents and dried composition of the oligomer combination. As addressed above, this is not considered to be significantly more than the judicial exception. At the time the invention was made, a kit or combination of reagents, including lyophilized reagents was well-established, routine and conventional. Additionally where a composition such as a kit is recited at such a high level of generality it does not meaningfully limit the claim. The recitation of reagents do not structurally change the nucleic acid sequence and is not significantly more than the naturally occurring sequence. Thus the claims as a whole does not amount to significantly more than each “product of nature” by itself and the claims do not qualify as eligible subject matter.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject.
Response to Arguments
The response traverses the rejection on page 11 of the remarks mailed 02/11/2026. The response asserts that amended claim 1 incorporate elements of claim 12. It is noted that claim 12 was withdrawn and newly amended claim 1 is withdrawn as directed to a non-elected embodiment. Claim 6 is an independent claim and does not depend from claim 1. Claim 6 was not amended to recite probes that comprise the recited label. Claim 6 is directed to naturally occurring sequences for the reasons addressed above. The rejection is maintained for the reasons set forth above.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US 11214843 B2, cited on IDS) in view of WHO (2020, cited on IDS), Corman (2020, cited on IDS), Jung (bioRxiv, Feb 27, 2020, pp. 1-13), and Untergasser (NAR, 2007, Vol 35, W71-W74). This rejection was previously presented and has been rewritten to address the amendment to the claims.
Li teaches compositions and kits for specific and differential detection of SARS-CoV-2. Li teaches combinations of primers and probes selected from SEQ ID NO 4-SEQ ID NO 2533. SEQ ID NO 1062 is 20 nucleotides in length and contains instant SEQ ID NO 28. SEQ ID NO 1119 is 19 nucleotides in length and contains SEQ ID NO 87. Li teaches the genetic sequence of SARS-CoV-2 as MN908947.3 (See column 13, lines 62-64). Li teaches primers and probes were designed that targeted the coding region for ORF1ab and include primers and probes specific for SARS-CoV-2 genetic sequence (see column 16, lines 25-30). Li teaches using an in silico standard mapping algorithm zper3p to identify primers and probes with higher specific for SARS-CoV-2 (see column 16, lines 42-50). Li teaches kit components are dried down or lyophilized assays (sese column 32, lines 5-7, claim 47) Li teaches PCR reagents including buffers (reconstituted reagent) (column 9, lines 43-45) (claim 29). Li does not teach amplification oligomers that contain or comprise SEQ ID NO 30, 90.
SEQ ID NO 30, 90 are amplification oligomers that are part of ORF1ab of SARS-CoV-2. Detecting the ORF1ab region of SARS-CoV-2 was known. WHO teaches protocols developed to detect SARS-CoV2. WHO teaches China CDC teaches primers specific for ORF1ab (see pg. 2, published 24 Jan 2020). WHO teaches many different primers and probes including methods of designing primers in the ORF1ab region for detecting SARS CoV-2 (see pg. 3, 7, 63, 74). It is noted the WHO document is not being relied upon for the data provided by the CDC on pg. 8-55.
Corman teaches primers and probes for detection of RdRp, which part of the ORF1ab (See figure 1 and table 1).
Jung teaches comparative analysis of 10 different primer-probe sets for detection of SARS-CoV-2. Jung teaches the most sensitive primer-probe sets are for Orf1 genes. Jung teaches that every primer of Orf assay detected SARS-CoV-2 but ORF1ab primer set was more sensitive (see RdRp/Orf1 assays, pg. 6)
Untergasser teaches a web interface for primer design. Untergasser teaches a program
that allows primer design of a known target. Untergasser teaches the detection task that designs standard PCR primers to detect a given sequence and Primer List which generates all possible primers that can be designed ton a target sequence and meet current requirements (see pg. W73).
It would have been prima facie obvious to one having ordinary skill in the art before the
effective filing to apply familiar primer design parameters to yield amplification oligomers comprising SEQ ID NO 30, 90 with a reasonable expectation of success. Many primers were known at the time of filing to amplify ORF1ab and detect SARS-CoV-2 as taught by Li, WHO, Corman and Jung. Li teaches the same first and second amplification oligomer of the first combination as claimed. Because Li, WHO, Corman and Jung teaches primers to amplify the same region of SARS-CoV-2, ORF1ab, a skilled artisan would have applied familiar primer design parameters to yield the claimed amplification oligomers, primers to amplify the ORF1ab region, including SEQ ID NO 30, 90. To this end, a skilled artisan at the time of filing would have designed primers and probes to known sequences (such as the sequences disclosed in the above references) with a high expectation of success. To design such primers constituted routine and conventional optimization at the time of filing. See In re Aller, 220 F.2d 454, at 456 (CCAP 1955) (“where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”). Numerous references describe how to design and optimize primers and probes for PCR applications. For example, Untergasser teach how to design primers and probes from known sequences using known online primer/probe design programs for use in PCR assays. Untergasser teaches how to use Primer3Plus online program to design primers and probes to known sequences (Untergasser at pgs. W71-74). In other words, Untergasser provides specific guidance and parameters to optimize primer, probe and PCR assay design to yield optimal results; thus, designing amplification oligomers and probes for particular applications constitutes well-known routine optimization. As noted in In re Aller, 105 USPQ 233 at 235, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that the primer selection performed was other than routine, that the products resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. In sum, the claimed amplification oligomers and probes are prima facie obvious because there was clear motivation to design PCR primers to detect the same region, ORF1ab to detect SARS-CoV2; and designing and optimizing such primers and probes constitutes a well-known, routine and conventional technique which would yield the claimed primers with a reasonable expectation of success.
Response to Arguments
The response traverses the rejection on pages 11-13 of the remarks mailed 02/11/2026. The response asserts that SEQ ID NO 1062 is the reverse complement of SEQ ID NO 28 and SEQ ID NO 1119 is the reverse complement of SEQ ID NO 87. The response asserts that orientation of the sequence is critical and SEQ ID NO 1062 cannot form a primer pair with SEQ ID NO 1119 because the primers are orientated in directions away from each other. The response asserts that the primers of Li will initiate DNA synthesis away from each other and not toward each other for amplification. This response has been reviewed but not found persuasive. SEQ ID NO 28 and SEQ ID NO 87 are not primer pairs that amplify a specific target sequence. SEQ ID NO 28 and 87 are an amplification oligomer that comprises a target hybridizing sequence. The claims are directed to products as such the oligomer sequences are the only requirement of the claim. Applicant appears to be arguing that SEQ ID NO 28 and 87 are primer pairs. SEQ ID NO 28 and 87 are not amplification primer pairs, the specification discloses primer pairs comprising SEQ ID NO 12-13 which comprise the sequence of SEQ ID NO 28 and 87. SEQ ID NO 28 and 87 are not defined or claimed to be primer pairs. As such the teaching of SEQ I DNO1062 and SEQ ID NO 1119 which comprise the amplification oligomers of SEQ ID NO 28 and 87 teach the sequence. Additionally, Li teaches SEQ ID NO 28 is nucleotides 150-162 and SEQ ID NO 87 is 213-224 of SEQ ID NO 1. Li further teaches SEQ ID NO 152 which comprises SEQ ID NO 28 ad is not a complement of SEQ ID NO 28. However because the claims do not require forward and reeve primers and only require amplification oligomers which does not impart any structural requirements on the claimed sequences, the teaching of Li comprise SEQ ID NO 28 and 87.
The response further asserts that entering SEQ ID NO 1 from Li does not produce any primers with applicants claimed primers. The response asserts that none of the 5 pairs of amplification primers identified by Untegasser matched or overlapped with Applicants claimed primers. The response asserts one primer overlapped with Applicants claimed primer but was not contained within SEQ ID NO 29 as required by the claims. This response has been thoroughly reviewed but not found persuasive. SEQ ID NO 29 is not under examination. SEQ ID NO 1 taught by Li was cited to teach the sequence comprises SEQ ID NO 13 and SEQ ID NO14 of the sequence, however the pending claim does not require any specific primers and this response is moot. Furthermore it is noted that SEQ ID NO 1 of Li does not comprise the entire Orf1ab region but only a small portion and the rejection was based on designing primers for the Orf1ab not SEQ ID NO 1 disclosed by Li. While applicant demonstrates using Primerplus3 yields different primers, this does not provide evidence of unexpected results and merely demonstrated that multiple primers can be used to amplify a specific target region. However it is noted that the claims are not directed to methods of detecting a target sequence using specific primer pairs, the claims are directed a composition comprising an amplification oligomer that comprise a specific sequence. This limitation does not require specific primer pair and the intended use of the claim, amplification oligomer does not structurally change the nucleic acid sequence. As such the teaching of Li in combination with WHO, Corman, and Jung would yield the composition claim because Li teaches oligomers for SARS-CoV2 that comprise SEQ ID NO 28 and 87 and WHO, Corman and Jung render obvious oligomers that comprise SEQ ID NO 30 and 90. It is noted that the claims are not limited to primers that consist of SEQ ID NO 12 and 23 or SEQ ID NO 15 or SEQ ID NO 16, consistent with the elected invention nor does the specification or response provide unexpected results of these specific primers. This is not to be construed with providing evidence. Applicant is reminded of the timely submission of evidence as stated in MPEP 716.01. While the response demonstrates many different primer pairs can be generated with Primer3, this demonstrates that it would be routine experimentation to design primers to known sequences and provide amplification oligomers including SEQ ID NO 30 and 90, designing amplification oligomers is well-known and routine optimization is not considered invention and there is no evidence that the oligomers were not routine. For these reasons and reasons of record this rejection is maintained.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
Prosecution Insights