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 .
Applicant’s response filed on 6/25/2026 is acknowledged and fully considered.
Status of Application, Amendments, And/Or Claims
The amendments of claims 1, 4 and 12 have been made of record.
Claims 1-16 are pending.
Claims 15-16 remain withdrawn for the reasons of record at pg. 2 of the office action of 1/14/2026.
Claims 1-14 are under consideration.
Response to Arguments
Claim Rejections - 35 USC § 101-maintained
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 1-14 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter for the reasons of record at pg. 3-7 of the office action of 1/14/2026 and as discussed below.
Applicants argue that the office asserts that the thermostable polymerase of SEQ ID NO:1 exists in nature on the basis of search result but the sequence alignment does not include SEQ ID NO: 1 in the sequence alignment.
Applicants’ arguments have been fully considered and they are not persuasive because sequence results are presented in PE2E database. They suggest that thermostable polymerase is present in nature. The sequence search results include sequences wherein amino acid 435 of SEQ ID NO: 1 is leucine. Some of the examples are shown below (it is noted that the alignment of the sequence can be seen in the PE2E search results of 7/31/2026, the sequence alignment is with the instantly claimed SEQ ID NO: 1 with leucine at position 453):
RESULT 1
AAR13143
(NOTE: this sequence has 50 duplicates in the database searched.
See complete list at the end of this report)
ID AAR13143 standard; protein; 834 AA.
XX
AC AAR13143;
XX
DT 15-JUN-2007 (revised)
DT 03-OCT-1991 (first entry)
XX
DE T. thermophilus DNA polymerase I.
XX
KW Thermus thermophilus; thermostable; Tth; amplification; PCR; polymerase;
KW BOND_PC; DNA polymerase I; DNA polymerase I [Thermus thermophilus HB8];
KW DNA polymerase I, thermostable (Tth polymerase 1).;
KW DNA polymerase I, thermostable.
XX
OS Thermus thermophilus.
XX
CC PN WO9109950-A.
XX
CC PD 11-JUL-1991.
XX
CC PF 21-DEC-1990; 90WO-US007639.
XX
PR 22-DEC-1989; 89US-00455967.
PR 21-DEC-1990; 90WO-US007639.
XX
CC PA (CETU ) CETUS CORP.
XX
CC PI Gelfand DH, Lawyer FC, Stoffel S;
XX
DR WPI; 1991-222902/30.
DR N-PSDB; AAQ12748.
DR PC:NCBI; gi55772436.
DR PC:SWISSPROT; P52028.
XX
CC PT Thermus thermophilus DNA polymerase I - used for nucleic acid
CC PT amplification DNA sequencing, nick-translation and reverse transcription.
XX
CC PS Disclosure; Page 7-13; 64pp; English.
XX
CC The Tth enzyme does not become irreversibly denatured to relatively short
CC exposures of temps. of 90-100 degrees C and has optimum activity at 50-90
CC degrees C. The enzyme can be used to design peptides for use as
CC immunogens to prepare antibodies that can be used to identify and purify
CC a thermostable polymerase. See also AAQ12748-51
CC
CC Revised record issued on 15-JUN-2007 : Enhanced with precomputed
CC information from BOND.
XX
SQ Sequence 834 AA;
Query Match 100.0%; Score 4266; Length 834;
Best Local Similarity 100.0%;
Matches 834; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
PNG
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831
688
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Greyscale
PNG
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463
697
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Greyscale
Claim Rejections - 35 USC § 103-maintained
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.
Claim(s) 1-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Gelfand et al. (AU 7244491 A) in view of Zou et al. (US 20050064426) and Asakura et al. (J. Ferment. Bioeng. 76:265-269(1993)) for the reasons of record at pg. 7-11 of the office action of 1/14/2026 and as discussed below.
Applicants argue that applicant amends claim 1 to emphasize aspects of composition which includes a recombinant thermostable DNA polymerase comprising SEQ ID NO:1 or a variant thereof having at least 99% sequence identity to SEQ ID NO: 1, with the proviso that amino acid 453 of SEQ ID NO:1 is leucine.
Applicants’ arguments have been fully considered but they are not persuasive because the prior art (Gelfand et al.) is 100% identical to the instantly claimed amino acid sequence of SEQ ID NO: 1 and it comprises amino acid 453 as leucine (see as discussed above and sequence alignment set forth above). Therefore, the rejection is maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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