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 .
Application Status
This action is written in response to applicant’s correspondence received 8/7/2025.
Claims 1, 3-5,9,17,22,24-26,41,43,47,52 are currently pending and under examination, claims 27, 29,34-36 and 40 are withdrawn and claims 2,6-8,10-16,18-21,23,28,30-33,37-39,42,44-46,48-51,53-57 are cancelled.
Response to Remarks: The 35 USC § 112(b) and §103 rejections are withdrawn in view of amendments.
Specification Objection
The disclosure is objected to because of the following informalities:
The use of the terms MiSeq and SoLiD, are trade name or marks used in commerce, and have been noted in this application, at least at [0099], [0032] [0034] and at [0088], [0092] respectively. The terms 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.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 9, 17, 22, 24-26, 41,43,47, and 52 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 is indefinite over the recitation of the following phrase: the resulting amplicons are “suitable for qNGS to enable detection of CNV and allele ratio quantitation”. It is unclear what is intended exactly by suitable for qNGS and whether this is meant to reference overall quality of sample, or amplicon length, or quantity, or number of variants for a given site going to be sequenced, or something different, particularly since the phrase continues: to enable detection of CNV and allele ratio quantitation. Further, allele ratio quantitation is something that is performed. There is no definitions section for interpretation of this terminology in this context. ‘Suitable’ appears once in the specification [0096] unrelated to this statement, and ‘suitably’ appears once [0097], unrelated and no other similar recitations exist. The meaning is ambiguous at present.
Claims 3-5, 9, 17, 22, 24-26, 41,43,47,52 depend from claim 1 and are indefinite for the same reason.
Claim 1 also recites the limitation "the resulting amplicons". There is insufficient antecedent basis for this limitation in the claim. Claims 3-5, 9, 17, 22, 24-26, 41,43,47,52 depend from claim 1 and are indefinite for the same reason.
Conclusion
All claims are rejected. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Horth whose telephone number is (703)756-4557. The examiner can normally be reached Monday-Friday 8-4 EST.
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/LISA HORTH/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681