Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
1. The Applicant’s response to the office action filed on August 06, 2025 is acknowledged.
Status of the Application
2. Claims 49, 52-53, 55-61, 64-66 and 68-70 are pending under examination. New claims 71-73 were added. Claims 1-48, 50-51, 54, 62-63, 67 were canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive in-part for the following reasons.
Response to the Arguments:
3. The objection to the defective sequence listing and CRF has been withdrawn in view of the submission of updated sequence listing and CRF.
Claim Rejections - 35 USC § 112-maintained
4. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 49, 52-53, 55-61 and 64-66 and 68-73 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112(pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)”.
Here, the new limitation of “SEQ ID NO:17, SEQ ID NO: 18, or SEQ ID No:19” in claim 49, 66 and “SEQ ID NO:20 in claim 61 appears to represent new matter. The amended claims further recite complements of SEQ ID NO: 17-20 which lack support in the specification. A careful review of the specification indicates that these sequences were newly added to the specification. The sequences lack descriptive support in the specification and the specification do not support the use of said new specific nucleotide sequences as set forth in SEQ ID NO: 17-20 or complements thereof. Since no basis has been found to support for the new limitations in the specification, the claims are rejected as incorporating new matter. Further, the claims as amended recite a kit comprising ‘a first, second and third nucleotide sequences’ which lack descriptive support in the specification. The specification only has support of a kit comprising oligonucleotides as forward, reverse primers and probes (para 0066, 0070, 0076), however, the specification lacks support for first, second and a third nucleic acid sequence in the specification as claimed.
Response to Arguments:
4. With reference to the rejection of claims under 35 USC 112(a) (new matter), the Applicant’s response has been fully considered and found unpersuasive. With reference to the Applicant’s arguments drawn to deleting the word probe, the arguments were found unpersuasive because the specification lacks support to the recited third nucleotide or oligonucleotide sequences of SEQ ID NO: 17-20 because the specification lack descriptive support for said nucleotide sequences. As discussed in the previous office action the specification has support for sequence of Seq ID NO:3, but not the specific new sequences of SEQ ID NO: 17-20 or complements thereof. Further, the Applicant cited portion of the specification (page 15, line 17-18) to support the claim amendment, discloses primers that hybridize to complementary sequences in a nucleic acid to be amplified. However, the specification lacks support for complements thereof of SEQ ID Nos:17-20 and first, second and third nucleotide sequences as recited in the amended claims. The rejection has been maintained and restated to address the amendment.
5. The rejection of claim under 35 USC 112(b) has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103-maintained
6. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
A. Claims 49, 52-53, 55-61, 64-66, 68-69 and 71-73 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kageyama et al. (US 7, 202,032) in view of Lowe et al. (Nucleic Acids Research, Vol. 18, No. 7, page 1757-1761, 1990).
Note: the first, second and third nucleotide sequences as recited in the claims read on forward primer, reverse primer and a probe.
Kageyama et al. teach a kit of claims 49, 61, 66, 68-69, for detecting norovirus infection in a subject comprising a first nucleotide sequence (forward primer) or an oligonucleotide of sequence of SEQ ID NO: 1 and a second nucleotide sequence (reverse primer) of sequence of SEQ ID NO: 11 and a third nucleotide sequence (probe) containing the sequence of SEQ ID NO:12 having a label attached thereto (col. 11-13, example 1: indicating SEQ ID NO: 3 representing the claimed SEQ ID NO: 1; sequences of SEQ ID No: 10-11, 14 representing the claimed SEQ ID NO: 11-12; SEQ ID NO: 17, col. 5, line 54-65, Fig. 2B: indicating sequence 17 comprising SEQ ID NO: 10; and col. 10, line 33-67, col. 11, line 1-21: indicating kit comprising first and second nucleotide sequences (forward primer and reverse primer) and third nucleic acid sequence (probe) with a label).
With reference to claims 52-53, 71-73, Kageyama et al. teach that the label comprises a fluorescent label or fluorophore and a quencher comprising FAM, TAMARA, ROX, JOE, BHQ1 (col. 9, line 16-67, col. 10, line 1-40, col. 11-13, example 1).
With reference to claims 55-60, 64-65, Kageyama et al. teach that the oligonucleotide comprises at least one polymerase enzyme (Taq polymerase, reverse transcriptase), wherein the enzyme is heat stable and polymerase binds or attaches to the oligonucleotide (primed single-stranded nucleic acid) (col. 10, line 10-33, col. 13, line 31-65).
However, Kageyama et al. did not teach first, second nucleotide sequences (primers) and third nucleotide sequence (probe) consisting of sequence.
Lowe et al. teach a method for designing primers and evaluating their performance wherein Lowe et al. disclose a computer program for rapid selection of nucleotide sequences (primers) or oligonucleotide for polymerase chain reaction (see page 1757, col. 1, abstract). Lowe et al. teach that all nucleotide sequences or oligonucleotides (primers or probes) designed for over 10 gene products were experimentally tested and the results showed that all the amplification products specified by the primers are of the predicted size and also hybridize with the appropriate cDNA or internal
oligonucleotide probe (see page 1780, col. 2, paragraph 1).
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to modify the known nucleotide sequence of the first/second nucleotides or oligonucleotides (primers) and third nucleotide sequence or oligonucleotide (probe) as taught by Kageyama et al. with generating nucleotide sequences (primers/ probes) from a known sequence as taught by Lowe et al. to improve the specificity of detecting target nucleic acid in a sample. The ordinary person skilled in the art would have motivated to generate primers and probe (first, second and third nucleotide sequences) from a known sequence as taught by Lowe et al. and have a reasonable expectation of success that such nucleotide sequences of primers/ probe generated using known sequence as taught by Kageyama et al. would detect target nucleic acid. The claimed nucleotide sequences are functional equivalents of the nucleotide sequences or oligonucleotide sequences (primers and probe) taught by Kageyama et al. in view of Lowe et al. because Lowe et al. explicitly taught that the nucleotide sequences (primers/probe) generated from a known sequence using the computer program would specifically amplify the target sequence and all nucleotide sequences (primers) designed for over 10 gene products from known sequences were experimentally tested and the results showed that all the amplification products specified by the first and second nucleotide sequences (primers) are of the predicted size also hybridize with the appropriate cDNA or internal oligonucleotide or nucleotide sequence (probe) (see page 1760, col. 2, paragraph 1) and such a modification of the known sequences to derive at a sequence consisting of is considered obvious over the prior art, especially the primer and probe sequences are short sequences and it would be obvious to derive a primer or probe consisting of a sequence from the short sequences taught by the prior art.
B. Claim 70 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kageyama et al. (US 7, 202,032) in view of Lowe et al. (Nucleic Acids Research, Vol. 18, No. 7, page 1757-1761, 1990) as applied to claims above, and further in view of Rolfe et al. (J. Clin. Virol., Vol. 39, p. 318-321, (2007)).
Kageyama et al. and Lowe et al. teach a kit comprising a first, second and third nucleotide sequences as discussed above. However, Kageyama et al. did not specifically teach a fourth nucleotide sequence consisting of SEQ ID NO: 7 and a fifth nucleotide sequence consisting of SEQ ID NO:8.
Rolfe et al. teach primers for detecting norovirus infection in a subject comprising a fourth nucleotide sequence (a forward primer) consisting of sequence of SEQ ID NO: 7 and a fifth nucleotide sequence (a reverse primer) consisting of sequence of SEQ ID NO: 8 (page 318, table 1: indicating forward primer MS2F consisting of the sequence of SEQ ID NO:7, and reverse primer MS2R consisting of sequence of SEQ ID NO: 8).
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to modify the kit comprising first, second and third nucleotide sequences (primers and probe) as taught by Kageyama et al. and Lowe et al. with the fourth and fifth nucleotide sequences (forward and reverse primers) as taught by Rolfe et al. to improve the specificity of detecting target nucleic acid in a sample. The ordinary person skilled in the art would have motivated to combine the kit as taught by Kageyama et al. Lowe et al. with a fourth nucleotide sequence (forward primer) consisting of SEQ ID NO: 7 and a fifth nucleotide sequence (reverse primer) consisting of SEQ ID NO: 8 and have a reasonable expectation of success that the combination would improve the sensitivity of the kit composition because Rolfe et al. explicitly taught use of said nucleotide sequences as internal control primers to improve the sensitivity/specificity of the real-time PCR diagnosis of norovirus infection (abstract on page 318) and such a modification is considered obvious over the cited primer art.
Response to Arguments:
6. With the rejection of claims under 35 USC 103 as being unpatentable over Kageyama et al. in view of Lowe et al. and the rejection of claims over Kageyama et al. in view of Lowe et al. further in view of Rolfe et al., the Applicant’s arguments and the amendment have been fully considered and found unpersuasive. The amended claims recite a ‘first, second and a third nucleotide sequence’ replacing a forward primer, reverse primer and a probe. The broader scope of the limitation nucleotide sequences or oligonucleotide sequences read on primers (forward and reverse primers) or probe or sequences. As discussed in the rejection, it would be obvious to generated such sequences as claimed. For all the above the rejection has been maintained and restated to address the amendment.
Conclusion
No claims are allowable.
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.
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/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681