Detailed Action
► Claim(s) 1-12 as presented in the paper(s) filed 01 MAY 2013 is/are pending.
► The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
► The priority date accorded the instant Claims is the filing dated of US provisional application 61766841 filed 20 FEB 2013 by Emerick & Agnew.
35 USC § 112- 2nd Paragraph
► The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
Claim Rejections under 35 USC § 112- 2nd Paragraph
► Claim(s) 1-12 is/are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is indefinite because it is not clear to what the phrase “or both” on line 7 refers.. Furthermore, it is not clear how the “single invariant bases”, on line 4 relate to the first and/or second invariant sequences recited.on lines 5-6. Are the first a second invariant sequences recited on lines 5-6 separate and distinct from the “single invariant bases” ? This appears to be the applicant’s intent. Please Clarify.
Claim 3 is indefinite in that it recites the phrase “rare consensus binding and cleavage site fragments.” This is a relative term and therefore the metes and bounds of what is intended cannot be determined.
35 USC § 103
► The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
► This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. § 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligations under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of potential 35 U.S.C. § 102(f) or (g) prior art under 35 U.S.C. § 103.
Claim Rejection(s) under 35 U.S.C. 103
► Claim(s) 1-12 is/are rejected under under 35 U.S.C. 103(a) as obvious over Fodor et al. [US 2001/0053519 – hereinafter “Fodor”].
Claim 1 is drawn to a plurality (i.e. a set ) of nucleic acid markers, wherein each marker of said plurality comprises a sequence identifiable region, wherein the sequence identifiable region comprises a series of random bases interspersed between single invariant bases, and a first invariant sequence comprising invariant bases flanking the 5’ end of the sequence identifiable region, a second invariant sequence comprising invariant bases flanking the 3’ end of the sequence identifiable region, or both, wherein each nucleic acid marker further comprises a polymerase chain reaction (PCR) primer sequence or its complement adjacent that first invariant sequence or the second invariant sequence, and wherein the single invariant bases, the first invariant sequence, and the second invariant sequence, do not vary within the plurality of nucleic acid markers.
Fodor teach the composition of Claim 1 wherein these inventors teach a generic N-mer array / microarray comprising all possible 25 -mers, See the entire document, noting especially para 101 wherein Fodor teaches generic arrays/microarrays (i.e. N-mer arrays) comprising all possible 25 -mers which set of N-mers meets all of the structural limitations recited. Fodor does not teach using the oligos of their N-mer arrays (i.e. nucleic acid markers) as disclosed by the applicant however a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. In re Casey , 152 USPQ 235 (CCPA 1967); In re Otto , 136 USPQ 458, 459 (CCPA 1963).
Three other notable prior art references found during the search These references have not been used to reject the any Claims and are provided for information only
1Diamond et al.[WO 2011/156795 – hereinafter “Diamond”] who teach N-mer arrays as recited by Fodor (cited above) wherein each N-mer of Diamond’s N-mer array expressly comprise a barcode sequence of from 3-500 bps., See especially para 73.
2Van Dam & Quake [Genome Research 12:145-152(2002) – hereinafter Quake”] teach “short” N-mer arrays (i.e. 9-mer arrays).
3Stockton teach a set of nucleic acid markers useful for genotyping nucleic acid samples. Each oligonucleotide in the set of Stockton comprises a first boundary sequence, a second boundary sequence, a nucleic acid marker, and a label. The first boundary sequence is at the proximal end of the oligonucleotide, relative to the solid support to which the oligonucleotide is attached; the second boundary sequence and the label are at the distal end of the oligonucleotide, relative to the solid support to which the oligonucleotide is attached; and the nucleic acid marker is between the first and the second boundary sequence. The boundary sequences are invariant, and the nucleic acid marker includes the polymorphic region to be assayed.
Where a claimed product and prior art product are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). The patentability of a product depends on its structure and not its intended use.
A long-standing principle in US patent law requires that new use(s) of an “old” product do not make the “old” product patentable. The patentability of a product is determined by its structure and not by its intended use
Intended use limitations are typically not given any patentable weight unless some structural difference is/are imposed by the use or result on the structure of material recited in the claim. In general, intended use limitations are used to give context and focus the examiner's attention on the field of the invention.
Intended use refers to claim language describing what an invention is for, rather than its structure, and it generally carries less weight during examination.
Functional limitations (e.g., “configured to”) differ from intended use; they may be given patentable weight if they impose structural or operational distinctions.
In the instant application Fodor teach a set of nucleic acid marker comprising all of the structural limitations recited by Claims 1-12.
Conclusion
C. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov
EXAMINER SEARCH NOTES
22 NOV 2025 - ECW
Databases searched: All available via PE2E SEARCH
CAplus, Medline and BIOSIS via STNext; and Google Scholar (note the search terms used below)
Reviewed the parent(s), if any, and any search(es) performed therein : see the BIB data sheet
Reviewed, the search(es), if any, performed by prior examiners including any international examiners.
Planned Search
Search terms:
All Inventor(s) e.g. Agnew W/au
Nucleic
Marker$
Primer$
adapt$
(random or invariant) (base$ or nucleotide$ or sequence$)
consensus
PCR
Barcode$
Sequence Identifiable region
Restriction or cleavage
Unpaired loop
► See the Examiner’s PE2E SEARCH notes/strategy in IFW