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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 14, 2025 has been entered.
Status of the Application
2. Claims 1-2, 4 and 21-22 are pending under examination. Claims 3 and 5-20 are canceled. The Applicant’s arguments have been fully considered and found persuasive for the following reasons.
Claim Rejections - 35 USC § 102-withdrawn
3. The rejection of claims 1-2, 4 and 21-22 under 35 USC 102(a)(1) as being anticipated by Koster et al. has been withdrawn in view of the persuasive arguments drawn to primer.
Claim Rejections - 35 USC § 103-withdrawn
4. The rejection of claims 1-2, 4 and 21-22 under 35 USC 103 as being unpatentable over Whitfeld et al. in view of Radtkey et al. has been withdrawn in view of the persuasive arguments drawn to primer.
Nucleotide and/or Amino Acid Sequence Disclosures
5. This application contains disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821. Nucleotide and/or amino acid sequences appearing in the drawings (Fig. 2, Fig. 5) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Objection to Duplicate claims
6. Claim 22 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 21. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
7. 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 1, 4 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Latham et al. (US 2010/0243451) in view of Southern et al. (US 6,770,751).
Latham et al. teach a thermocycling method of claim 1 for increasing the number of tandem repeats of a unit sequence that is 1 to 60 nucleotides long in a linear polynucleotide, the method comprising:
i) providing single stranded primer polynucleotide comprising at least two tandem
repeats of a unit sequence that is 1 to 60 nucleotides long (para 0018, 0040-0044, 0214-0220: indicating a primer comprising at least two tandem repeat units);
ii) contacting the primer polynucleotide with a single stranded template polynucleotide comprising at least two tandem repeats that are complementary to the unit sequence of the primer polynucleotide under conditions that permit mismatched duplex formation between a unit sequence and its complement (para 0017-0018, 0040-0044, 0050-0055, 0214-0220, 0234-0236: indicating a primer comprising at least two repeat units partially hybridizes to the target nucleic acid and extends into the entire repeat region of the target); and
iii) contacting the mismatched duplexes with a thermostable 5’ to 3’ polymerase and nucleotides under extension conditions that permit polynucleotide extension in a 5’ to 3’ direction (para 0214-0220, 0234-0236, 0060);
iv) denaturing the duplexes of ii) under denaturing conditions to generate single stranded polynucleotide; and v) repeating the steps ii) to iii) at least once to increase the number of tandem repeats in the polynucleotide (para 0214-0220).
With reference to claim 4, Latham et al. teach that the primer polynucleotide comprises at least tandem repeats of the unit sequence (para 0040-0044).
With reference to claims 21-22, Latham et al. teach that the thermostable polymerase lacks or substantially lack 3’ to 5’ proof-reading activity (para 0060).
However, Latham et al. did not specifically teach immobilizing the primer on a solid substrate and formation of template comprising 5’ overhang comprising at least one tandem repeat unit complementary to primer.
Southern et al. teach a method for analyzing tandem repeat units in a target polynucleotide, wherein the method comprises immobilizing oligonucleotides (primers or probe) on a solid support, wherein the immobilized oligonucleotide comprises a repeat unit section complementary to the repeat unit of a target polynucleotide, hybridizing said immobilized oligonucleotide to the target polynucleotide and forming a 5’ overhang comprising said repeat unit, extending said oligonucleotide with labeled nucleotides and detecting the variable number of repeat units in the target polynucleotide (col. 2, line 52-67, col.3, line 1-8, col. 5, line 19-67, col. 7, line 1-23, Fig. 1-6: indicating solid support attached oligonucleotides and extension of template overhang to detect length of repeat unit sequence).
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 of Latham et al. with the immobilization of the primer on a solid support as taught by Southern et al. to improve the method for analyzing tandem repeats. 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 Southern et al. explicitly taught immobilizing oligonucleotides on a solid support and extending oligonucleotide to determine the length of the variable repeat sequence which provides great sensitivity of the method (col. 6, line 55-64) and such a modification of the method to derive at the claimed method is considered obvious over the cited prior art.
Allowable Subject Matter
8. Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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