DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/16/2025 has been entered.
Status of Claims
Currently, claims 1-22 are pending in the instant application. Claims 15-20 are withdrawn from consideration as being drawn to a non-elected invention. Claims 1-14 and 21-22 are currently under examination. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant Application. Response to Applicant's arguments follow. This action is NON-FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 21 and 22 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 21 and 22 have been amended to recite generic terminology for deleted trademarks, however the specification does not appear to support the claims amendments, nor does the response provide any explanation as to where the amendments are expressly supported or why the terminology may be implicitly supported. Applicant may amend the claims or provide an explanation as to how the specification provides an implicit disclosure.
Claims 1-14 and 22-24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 has been extensively amended, however it is grammatically confusing because the structural requirements of the composition are unclear. The claim lists for different combinations of a promoter primer and a non-promoter primer listed a, b, c, and d. However, there is not conjunction between elements c and d, such that it is not clear if the composition comprises all of the elements of a, b, c, and d, or if they are intended to be a list of alternatively useable elements. Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claims 1-14 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Getman (Getman et al; US Patent 8,790,879) in view of Genbank Accession number JF513196 (Genbank, NCBI, NLM, 2011).
With regard to the instant rejection, reference will be made to compositions and kits comprising a promoter primer amplification oligonucleotide comprising SEQ ID NO: 47 and a T7 promoter sequence comprising SEQ ID NO: 65, a non-promoter primer comprising SEQ ID NO: 15, a TCO comprising SEQ ID NO 41, and detection oligonucleotide comprising SEQ ID NO: 58 or 22.
Getman teaches oligonucleotides, and compositions for detecting Trichomonas vaginalis by targeting 18S sequences. Getman teaches a non-promoter amplification primer comprising SEQ ID NO: 15 (SEQ ID NO: 45 of Getman; table 1) as well as a target capture oligonucleotide comprising a target capture region comprising SEQ ID NO: 41 (SEQ ID NO: 90 of Getman; col 6) and an immobilized probe binding region identical to the immobilized binding probe region of instantly recited SEQ ID NO: 3 (SEQ ID NO: 50 of Getman is identical to immobilized; col 7). Getman also teaches compositions which comprise a T7 promoter primer, where the T7 sequence is identical to SEQ ID NO: 65 (SEQ ID NO: 54 of Getman; col 23), a non-promoter primer, a target capture oligonucleotide, and a detection oligonucleotide, as well as any combination therein (col 8). Getman teaches that detection oligonucleotides can comprise a fluorophore and a quencher such as DABCYL and EDANS (col 31), as well as comprise uracil (cols 3-4; whole document). Getman teaches how to design oligonucleotides that detect Trichomonas vaginalis and distinguish from other bacteria (see whole document), including teaching the art accepted methods of achieving optimal specificity by varying hybridization conditions, oligonucleotide length, base composition, melting temperature, etc. Getman differs from the instantly claimed invention in that Getman does not teach a T7 promoter primer comprising SEQ ID NO: 47 or a detection oligonucleotide comprising SEQ ID NO: 58. However, Genbank accession number JF513196 teaches the sequence of an 18S sequence from Trichomonas vaginalis which comprises instantly claimed SEQ ID NOS 15, 22, 41, 47, and 58. With regard to the sequence of the accession number, SEQ ID NO: 15 is identical to positions 256-277, SEQ IDN O: 41 is identical to the reverse complement of positions 230-253, SEQ DINO: 47 is identical to the reverse complement of positions 431-452, SEQ ID NO: 58 is directed to the RNA sequence that matches the positions at nucleotides 241-262, while SEQ ID NO: 22 matches nucleotides 241-267. It is additionally noted that Getman exemplifies the use of kits in the assays taught. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, to have modified the methods of Getman to construct additional oligonucleotides for detection of Trichomonas vaginalis in view of the teachings of Accession number JF513196, and to include those with the oligonucleotides already taught by Getman for the purpose of constructing oligonucleotide compositions and kits that would be able to specifically detect different isolates of Trichomonas vaginalis. Given the routine and predictable experimentation that is required to construct such oligonucleotides and the ready availability of free primer design software, such as Primer3, PrimerQuest, etc which were available and widely used for years prior to the effective filing date, the claimed sequences, sets, and compositions are considered obvious over the teachings of Getman and JF513196, absent secondary considerations. Although Getman does not teach to include sequences to detect species other than T vaginalis, Getman does teach to the existence of other infection causing bacteria, such as Candida, and including to distinguish T. vaginalis from them (whole document). Accordingly, it would have been further prima facie obvious to include oligonucleotides of other species, such as Candida, for the obvious benefit of arriving at oligonucleotides that can detect different infection causing bacteria.
Response to Arguments
The response traverses the rejection and asserts that the claims have been amended to recite the sequences in the examples. This argument has been thoroughly reviewed but was not found persuasive because should the primers and probes taught in the specification have unexpected improved ability to detect T. vaginalis, the claims are not commensurate in scope with such alleged teaching because they allow for additional nucleotides on either side and are not limited to sequences “consisting” of the oligonucleotides taught in the specification. See MPEP 716 for discussion of unexpected results and the requirement that the claimed scope must be commensurate with the unexpected results.
The response further asserts that accession number JF513196 is 476 base pairs long, and that the possible primer combinations is over 1.6 million. The response asserts that obviousness requires a finding that there are a finite number of predictable solutions, whereas the office action has failed to show how to arrive at the claimed primers without under experimentation and impermissible hindsight. This argument has been thoroughly reviewed but was not found persuasive. First, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Additionally, the design of primers for detection of known targets represents routine optimization. The art directed to primer design is over two decades old. Given the ready availability of free primer design software, such as Primer3, PrimerQuest, etc which were available and widely used for years prior to the effective filing date, the claimed sequences, sets, and compositions are considered obvious. For these reasons and the reasons already made of record, the rejection is maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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