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. The Applicant’s response to the office action filed on March 30, 2026 is acknowledged.
Status of the Application
2. Claims 1-3, 5, 10 along with elected SEQ ID NO: 1 are pending under examination. New claims 30-32 are added. Claims 2-3, 5-20 and 22 are canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive for the for the following reasons. While incorporating the limitations of canceled claims, the amendment incorporates new limitations (a probe set comprising all sequences of SEQ ID Nos) as opposed to the previously presented claims reciting at least one nucleic acid sequence of SEQ ID Nos., which changed the scope of the claims accordingly the action is made Final necessitated by the Amendment.
Response to Arguments:
3. The rejection of claims under 35 USC 112(b) has been withdrawn in view of the amendment.
4. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Christians et al. has been withdrawn in view of the amendment.
5. The rejection of claims under 35 USC 103 as being obvious over Kuersten et al. in view of Vogelstein et al.; the rejection of claims under 35 USC 103 as being obvious over Kuersten et al. in view of Vogelstein et al. further in view of Grant and Lowe et al. have been withdrawn in view of the amendment.
New Rejections necessitated by the Amendment
Claim Rejections - 35 USC § 112
6A. 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 1-3, 5, 10 and 30-32 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 “wherein the pool of oligonucleotides or the probe set comprises SEQ ID Nos……” in claim 1 appears to represent new matter. The specification discloses a pool of oligonucleotides or probe set comprising at least one sequence of the SEQ ID Nos. or at least one SEQ ID NO: (para 0300, 00421), however, the specification lacks descriptive support for pool of oligonucleotides or a probe set comprising all the specific sequences of the SEQ ID Nos. as claimed. Since no basis has been found to support for the new limitations in the specification, the claims are rejected as incorporating new matter.
6B. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 10, 30-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 step b) recites hybridizing the library fragments to at least one immobilized oligonucleotide to allow binding of the library fragments to at least one immobilized oligonucleotide and step c) collecting library fragments either bound or unbound to at least one immobilized oligonucleotide. The metes and bounds of the claim are unclear and indefinite because it is not clear if the claim requires at least one oligonucleotide from the pool of probe set comprising the sequences of SEQ ID Nos. as recited in claim 1 or does it require all the sequences of SEQ ID Nos. in step a).
Conclusion
Claims 1-3, 5, 10 and 30-32 are free of prior art.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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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.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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