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 .
Election/Restrictions
Applicant's election with traverse of Group 1, claims 28-38 in the reply filed on June 8, 2026 is acknowledged. The traversal is on the ground(s) that the “…Action has not shown that a serious burden would be required to examine all of the claims”. This is not found persuasive because the restriction requirement shows plainly that there is both a search and examination burden that would come with examination of each of the inventions together. As made clear in the restriction requirement, Group I is drawn to a eukaryotic cell while Group II is drawn to a platform. While the inventions include similar features, they are distinct. The eukaryotic cell does not include either a library of primers or the aspect of amplification, as encompassed by the platform of Group II. To search and examine each of these inventions either separately or together requires distinct searches that are not co-extensive or overlapping in scope. Therefore, the search and examination burden remains and the arguments to the contrary are wholly unpersuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 39-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 8, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 2, 2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because Figures 1, Figure 33B, 54A-D, 56B are blurry, the characters are unclear or the figures are otherwise incomplete for examination. Figure 1 is blurry, Figure 33B is almost entirely illegible. Figures 54A-D and 56B specifically need clarity in the text included in the figures. That includes the labeling of the x and y axis and for the legend. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 28-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holliger et al. (US Patent 7,514,210; April 2009).
With regarding to claim 28, Holliger teaches a eukaryotic cell (col. 19, lines 31-40, where yeast and other types of cells are included), wherein the cell comprises:
a. an orthogonal signal transduction pathway or orthogonal receptor;
b. a polymerase coupled to said orthogonal signal transduction pathway or orthogonal receptor, wherein said polymerase is only produced when said orthogonal signal transduction pathway or orthogonal receptor is produced (Figure 1A, where the process of the method is depicted; see also col. 2-3, where the various embodiments of the method are described in more detail; look particularly at the third embodiment at col 3, where a recombinant molecule is exposed to an interacting agent);
c. an effector molecule, wherein said effector molecule induces transcription of the orthogonal signal transduction pathway or orthogonal receptor, thereby also inducing expression of the polymerase (Figure 1A, where the process of the method is depicted; see also col. 2-3, where the various embodiments of the method are described in more detail; look particularly at the third embodiment at col 3, where a recombinant molecule is exposed to an interacting agent).
With regard to claim 29, Holliger teaches a eukaryotic cell of claim 28, wherein the cell is in an oil-in-emulsion bubble (col. 5, lines 13-24, where water in oil emulsions are included).
With regard to claim 30, Holliger teaches a eukaryotic cell of claim 28, wherein the orthogonal signal transduction pathway or receptor has undergone multiple rounds of selection (Figure 1A, where the process of the method is depicted; see also col. 2-3, where the various embodiments of the method are described in more detail; look particularly at the third embodiment at col 3, where a recombinant molecule is exposed to an interacting agent).
With regard to claim 31, Holliger teaches a eukaryotic cell of claim 28, wherein said eukaryotic cell is a yeast cell (col. 19, lines 31-40, where yeast and other types of cells are included).
With regard to claim 32, Holliger teaches a eukaryotic cell of claim 28, wherein said polymerase is thermostable polymerase (col. 3-4; col. 3, lines 58-63, where NAP is an enzyme “capable of amplifying nucleic acid from a template”; col. 4, lines 47-54, where the NAP is a thermostable polymerase).
With regard to claim 33, Holliger teaches a eukaryotic cell of claim 28, wherein said orthogonal signal transduction pathway or orthogonal receptor is non-naturally occurring in the eukaryotic cell (Figure 1A, where the process of the method is depicted; see also col. 2-3, where the various embodiments of the method are described in more detail; look particularly at the third embodiment at col 3, where a recombinant molecule is exposed to an interacting agent and where the recombinant molecule itself is not naturally ocurring).
With regard to claim 34, Holliger teaches a eukaryotic cell of claim 33, wherein said orthogonal signal transduction pathway or orthogonal receptor is a variant of a naturally occurring receptor or signal transduction pathway of the eukaryotic cell (Figure 1A, where the process of the method is depicted; see also col. 2-3, where the various embodiments of the method are described in more detail; look particularly at the third embodiment at col 3, where a recombinant molecule is exposed to an interacting agent; where the recombinant molecule is a variant of a naturally occurring enzyme).
With regard to claim 35, Holliger teaches a eukaryotic cell of claim 28, wherein the effector activates the orthogonal signal transduction pathway or orthogonal receptor (see col. 3 where the interaction is detected through “detecting processing of at least one of the first and second nucleic acids by the NAP enzyme”, where the method detects a functional interaction that restores polymerase activity).
With regard to claim 36, Holliger teaches a eukaryotic cell of claim 28, wherein the polymerase is a DNA or RNA polymerase (col. 3-4; col. 3, lines 58-63, where NAP is an enzyme “capable of amplifying nucleic acid from a template”; col. 4, lines 47-54, where the NAP is a thermostable polymerase).
With regard to claim 37, Holliger teaches a eukaryotic cell of claim 28, wherein the effector molecule is an agonist or antagonist of the orthogonal signal transduction pathway or orthogonal receptor (col. 36, lines 5-32).
With regard to claim 38, Holliger teaches a eukaryotic cell of claim 28, wherein the orthogonal signal transduction pathway or orthogonal receptor and polymerase are encoded by a plasmid (col. 13, lines 45-56, where plasmids may be included in the method).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Packer et al. (Nature Rev Genet, 2015, 16:370-394).
Conclusion
No claims are allowed. All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681
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