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 .
The 112b rejection over “a target deoxyribonucleic acid” is moot because this language was cancelled out of claim 1.
The 112b rejection over the “probe” length is withdrawn because this is an issue of claim breadth and not indefiniteness. A probe comprising a single-stranded DNA is a well known structure in the prior art. There is no question as to metes and bounds.
The rejection for lack of enablement is withdrawn because there are a multitude of known sequences to choose the “probe” of the claimed invention from, and one skilled in the art would know how to make and use the claimed invention in view of the state of the prior art and the instant disclosure together. Likewise, the rejection for lack of written description is withdrawn because possession is adequately demonstrated when considering the instant disclosure in view of the state of the prior art.
New objections and rejections necessitated by amendment are set forth.
Claim Objections
Claim 1 is objected to because of the following informalities: the drawings of the structures appear lighter than the surrounding text and will make them difficult to reproduce.
37 C.F.R. 1.84 states “Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 2, 9, and 22-26 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.
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The claims are indefinite over the illustration of the bond pointed to by an arrow. It is not clear if this is intended to illustrate that the attachment is at any position on the ring? This sort of attachment is typically illustrated by this:
The instant drawing is indefinite
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because it is unclear if the intent is to indicate variable attachment or if the attachment is meant to be at the carbon to the right of the vertical line. This should be clarified on the record either by adjusting the drawing or explaining the intent with clarity.
In claims 22 and 26 the phrase “molecular weight” is indefinite. The recitation “molecular weight” is indefinite because a person of ordinary skill in the art would not understand with reasonable certainty to which type of molecular weight the claim language is referring. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed. Cir. 2015), held that the term “molecular weight” in several polymer claims was indefinite, because the term could mean either peak average molecular weight, number average molecular weight, or weight average molecular weight. Therefore, without a clear indication of how the molecular weight is measured the claimed term is indefinite. MPEP 2173.02 II.
In claims 22-26 the phrase “the crowding agent” lacks antecedent basis because the claim does not recite or require a crowding agent.
Claim 1 is free of the prior art.
MacLean (IDS 11/16/21) teaches preparation of a biotinyl-tetrafluorobenzoyl-lysne group as a label for nucleotide based compounds. The compounds in part (a) of present claim 1 are different from these at least by the nature of the fluorescent moiety, which in the claims is FAM or DNP. Even if it were obvious to attach one of these to a biotin, the prior art does not suggest attaching this structure to a probe comprising a single stranded DNA, nor does the prior art suggest combining such a probe in a composition with formamidopyrimidine DNA glycosylase as currently required.
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 Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682