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 .
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 83, 84, 93 and 94 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 83 recites “wherein identifying the discrete cells comprises performing cell segmentation”. The meaning of, and therefore the scope of, the term “cell segmentation” is unclear. Paragraph [0020] of the specification contains a discussion of some of the actions that are considered to fall within the scope of “performing cell segmentation”. However, it provides no definition of “cell segmentation”, nor does it limit the particular acts that can be considered “performing cell segmentation”. Therefore, the scope of claim 83, and by dependency claims 84, 93 and 94 is unclear.
Allowable Subject Matter
Claims 74, 76-82, and 85-92 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: A “cell pellet” would be understood by one of skill in the art as being formerly disassociated cells compacted into a clump (“pellet”), typically by a centrifugation or sedimentation process. The closest prior art appears to be Babic (US 2023/0313309), which disclosed methods in which probes to target sequences were incubated with samples containing the target, hybridized to the target, ligated, and the ligated probes subjected to amplification (e.g., Figure 1). In one particular example (Example 11, page 21, paragraph 0199), a pellet comprising a mixture of MCF7 and Jurkat cells was fixed, embedded and sectioned. The “in situ assay” was conducted (referring to the contacting of the section with the ligation probes, e.g., as shown in Figures 8 and 10 and discussed at paragraphs 0143-0147). The slides were then stained with anti-CD3 antibody and hematoxylin, which staining was used to direct the selection of cells for gene expression profiling, for example a cluster of CD3 negative cells. Nucleic acid (including the ligated probes) was eluted from the selected areas (Figure 10) and subjected to PCR and sequencing. See e.g. paragraph 0132: “In some embodiments, the hybridization, ligation, or extension steps can be performed while the target sequence is in situ, as with FFPE samples. This can be particularly useful, for example, when the sample is on a histological slide, so that the ligation is known to occur at a recordable location and can be compared to similar reactions at other locations on the slide.”
As discussed in Babic Example 11, and shown in Table 2 therein, a set of probes for MCF7 expressed cells, and a set of probes for Jurkat expressed cells, were contacted to the pellet section. Certain of the MCF7 targets were not detectably expressed in the Jurkat cells and vice versa.
However, Babic did not “detect[] the hybridized probes or probe sets or products of the hybridized probes or probe sets at locations in the biological sample”. Babic also did not “us[e] the detected RNA transcripts of the first and second sets of genes in the cells to determine one or more success metrics”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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