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 .
DETAILED ACTION
1.Applicant’s election without traverse of Group I (claims 33-43) in the reply filed on May 19, 2026 is acknowledged.
Status of the Application
2. Claims 33-43 are considered for examination. Claims 44-56 were withdrawn from further consideration as being drawn to nonelected group. Claims 1-32 were canceled.
Priority
3. This application filed on February 24, 2023 is a 371 of PCT/KR2021/011556 filed on August 27, 2021 which claims foreign priority to KR10-2020-109386 filed on August 28, 2020.
Objection to the Specification
4. The disclosure is objected to because of the following informalities:
The use of the term (fluorophores) (para 0303, 308, table 2-3, fig. 8-9), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The fluorophores are not followed by generic names. Appropriate correction is required.
Claim Rejections - 35 USC § 103
5. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 33-43 are rejected under 35 U.S.C. 103 as being unpatentable over Mullinax et al. (US 2003/0175740) in view of Chanda et al. (US 2008/0182296).
Mullinax et al. teach a method of claim 33, 35, for conducting a positive control reaction for a target nucleic acid-detecting composition by using a pre-positive control composition, the method comprising the steps of: (a) mixing the target nucleic acid-detecting composition (target nucleic acid and primers) and the pre-positive control composition, wherein, the target nucleic acid-detecting composition comprises target nucleic acid-detecting oligonucleotides comprising a forward primer oligonucleotide and a reverse primer oligonucleotide for target nucleic acid amplification (para 0095-0105, 0003-0009, 0017-0022, 0225);
the pre-positive control composition comprises a pre-positive control oligonucleotide, the pre-positive control oligonucleotide comprising a partial sequence of a complete-positive control oligonucleotide for the target nucleic acid sequence (para 0089-0093, 0017-0022, 0225-0227);
the pre-positive control oligonucleotide comprises a sequence overlapping with at least one oligonucleotide selected from among the target nucleic acid-detecting oligonucleotides and a different pre-positive control oligonucleotide, wherein the overlapping sequence of the pre- positive control oligonucleotide is identical or complementary to an overlapping sequence of the at least one oligonucleotide (para 0095-0102, 0003-0009, 0017-0022, 0225-0227);
the pre-positive control composition comprises one or more pre-positive control oligonucleotides (para 0099, table 1, 0225-0227); and
(c) amplifying the positive control oligonucleotide using the forward primer oligonucleotide and the reverse primer oligonucleotide (para 0097-0102, 0017-0022, 0225-0227).
With reference to claim 34, Mullinax et al. teach that the one or more pre-positive control oligonucleotides comprise a sequence overlapping with at least one of the target nucleic acid- detecting oligonucleotides (para 0095, 0225-0227).
With reference to claim 36, Mullinax et al. teach that the 3'-end of the pre-positive control oligonucleotide is extendable therefrom (para 0095-0096).
With reference to claim 37, Mullinax et al. teach that the combinations have overlapping sequences being neither identical nor complementary to each other (para 0092-0093).
With reference to claim 38, Mullinax et al. teach that the pre-positive control oligonucleotide is a pre-positive control templating oligonucleotide or a pre-positive control linking oligonucleotide; the pre-positive control templating oligonucleotide comprising a sequence that overlaps with at least one of the forward primer oligonucleotide or reverse primer oligonucleotide and not comprising sequences that overlap totally with the full sequences of the forward primer oligonucleotide and the reverse primer oligonucleotide, and the pre-positive control linking oligonucleotide comprising sequences overlapping with two different pre-positive control oligonucleotides at its 3'-end and 5'-end and not comprising a sequence overlapping with the forward primer oligonucleotide or the reverse primer oligonucleotide (para 0095-01012, table 1).
With reference to claim 39, Mullinax et al. teach that the pre-positive control composition comprises one to five pre-positive control oligonucleotides (para 0099, table 1).
With reference to claim 40, Mullinax et al. teach that the pre-positive control composition comprises one pre-positive control oligonucleotide, wherein the one pre-positive control oligonucleotide comprises one pre-positive control templating oligonucleotide (para 0089-0095).
With reference to claim 41, Mullinax et al. teach that the one pre-positive control templating oligonucleotide comprises sequences overlapping with the forward primer oligonucleotide and reverse primer oligonucleotide at its 3'-end and 5'-end and does not comprise sequences overlapping totally with the full sequences of the forward primer oligonucleotide and the reverse primer oligonucleotide (0097-0098).
With reference to claim 42, Mullinax et al. teach that the pre-positive control composition comprises (i) two pre-positive control oligonucleotides, wherein the two pre-positive control oligonucleotides consist of two pre-positive control templating oligonucleotides, (ii) three pre- positive control oligonucleotides, wherein the three pre-positive control oligonucleotides consist of two pre-positive control templating oligonucleotides and one pre-positive control linking oligonucleotide, or (iii) four pre-positive control oligonucleotides, wherein the four pre-positive control oligonucleotides consist of two pre-positive control templating oligonucleotides and two pre-positive control linking oligonucleotides (para 0099, table 1).
With reference to claim 43, Mullinax et al. teach that the two pre-positive control templating oligonucleotides consist of a first pre-positive control templating oligonucleotide comprising a sequence overlapping with the forward primer oligonucleotide and a second pre-positive control templating oligonucleotide comprising a sequence overlapping with the reverse primer oligonucleotide (para 0003-0009).
However, Mullinax et al. did not teach producing a complete positive-control through assembly process.
Chanda et al. teach an assembly PCR method from large number of overlapping oligonucleotides to assemble in an overlap PCR to produce full-length nucleic acid sequence (gene) (para 0008-0012, 0018-0019, 0048, 0065-0068).
It would have been prima facie obvious to an ordinary person skilled in the art before the effective filling date of the invention to combine the method as taught by Mullinax et al. with the overlapping oligonucleotide assembly process as taught by Chanda et al. to improve the method for producing complete positive control. The ordinary person skilled in the art would have motivated to combine the references and have a reasonable expectation of success that the combination would improve the sensitivity of the method because Chanda et al. explicitly taught assembling overlapping oligonucleotides to produce complete full-length nucleic acid sequence (0008-0012) and such a modification of the method to derive at the claimed method is considered obvious over the cited prior art.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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, Gary Benzion can be reached at 571-272-0782. 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.
Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
Prosecution Insights