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
Status of the Claims
Claims 1, 9-10, 13, 16-17, 20-23, 25, 33, 41, 50-52, 55-56, 58-60, 62-64 and 66 are pending and the subject of this NON-FINAL Office Action. This is the first action on the merits.
Claim Rejections - 35 USC § 112- Indefiniteness
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.
Claims 1, 9-10, 13, 16-17, 20-23, 25, 33, 41, 50-52, 55-56, 58-60, 62-64 and 66 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The metes and bounds of the claims are so unclear and confusing that the Office cannot determine if the instant claims are patentable because it would require the Office to speculate as to the metes and bounds of the instant claims. See MPEP § 2173.06 (“Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”). Specifically, the metes and bounds of the following potentially critical limitations are unclear: “capped target nucleic acid molecules”; “laboratory-compatible medium”; and “fully-assembled nucleic acid molecules.” As to the “capped” nucleic acids, the specification fails to define this. In the art, capped can mean many different things: for example, mRNA cap of 7-methylguanosine structure added to the 5′ end of eukaryotic mRNA that protects the transcript, facilitates translation, and helps the cell distinguish self from foreign RNA; or any number of possible additions to a nucleic acid end. Here, the specification provides a single example: “In some implementations, full-length identifiers are capped with hairpins on the ends (e.g., terminal components designed to contain hairpin structures), such that they do not contain linear ends” (para. 0147). Yet, even here, no specific hairpin structure or composition is disclosed. For example, is this a hairpin adaptor ligated to a specific end? Or is it a hairpin somehow designed to form within the target nucleic acid? The specification fails to provide any details.
Next, the “laboratory-compatible medium” is simply never defined, much less exemplified. It is impossible to determine what “medium” this encompasses.
Finally, the meaning of “fully-assembled nucleic acid molecules” is unclear because what is assembled is never described. Know this is critical to the claim interpretation because the claim ends with a requirement that “the target nucleic acid molecules comprise fully-assembled nucleic acid molecules, each comprising concatenated nucleic acid fragments,” while “the non-target nucleic acid molecules comprise at least one of partially-assembled nucleic acid molecules, un-assembled nucleic acid fragments, or single-stranded nucleic acid fragments.” In fact, the claims never include an assembled nucleic acid, rather only “nucleic acid molecules encoding digital information.” Thus, it is unclear with what, for what and by what the nucleic acids are assembled, which is critical to determining what is a “fully assembled” versus “partially assembled” nucleic acid.
As a concrete example of the difficulty applying prior art here, the Examiner cannot determine, based on a lack of clear definition of a “caped target nucleic acid molecules” versus uncapped “non-target nucleic acid molecules,” whether this prior art applies. More specifically, this capped versus uncapped difference is used to selectively digest uncapped non-target nucleic acids: “the size selection comprises adding to the third pool an exonuclease that selectively degrades exposed linear ends of nucleic acid molecules and degrading exposed linear ends of non-target nucleic acid molecules.” The prior art (US 20190351673) teaches purifying printer-finisher-generated digital-encoding nucleic acids using size selection and exonuclease digestion (paras. 0083, 0151ff & 0171-73), but it is unclear whether the “cap” claimed here encompasses the mere presence of a nucleic acid end that is not blunt (e.g. paras. 0110-0114). Of note, this prior art reference does not teach a hairpin cap. Thus, it is unclear whether this reference is anticipatory prior art, or could form the basis of an obviousness rationale.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELODY TSUI whose telephone number is (571)272-1846. The examiner can normally be reached Monday - Friday, 9am - 5pm.
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/YUNG-SHENG M TSUI/ Primary Examiner, Art Unit 1684
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