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 .
The following action is in response to papers filed 9/08/2025.
Applicant’s election without traverse of live cell, ciprofloxacin, substance that penetrates through a membrane, lysozyme, and FMT specimen in the reply filed on 3/13/2025 is acknowledged.
Claims 1-2, 4-6, 9, 12-13, 16, 18, 20-21, 23-25, 27, 29-30, 34, 36, 45-47 are pending. Claims 3, 7-8, 10-11, 14-15, 17, 19, 22, 26, 28, 31-33, 35, 37-44 have been cancelled. Claim 34 is withdrawn as being drawn to a nonelected species.
The following rejections are maintained with response to arguments following or newly applied (Claims 45-47).
This action is final.
Withdrawn rejections
The 35 USC 112b rejection made in the previous office action is withdrawn based upon amendments to the claims.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,2,4-6,9,13,16,18,20-21,23-25,27,29,36, 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (Korea Australia Rheology Journal 2007 Vol 19 p. 157-164) in view of Hindson et al (US Patent Application 2012/0252015 October 4, 2012).
With regard to claim 1, Hong et al. teaches a step of proving gel capsules, encapsulating invention cells from a population of cells wherein the live cells are labeled green and the dead cells labeled red (p 161-162 1st column 2nd paragraph). However, Hong et al. does not teach a step of amplifying nucleic acid and analyzing the nucleic acid.
With regard to claim 2, Hong et al. teaches a step of individually encapsulating each cell and labeling (p 161-162 1st column 2nd paragraph).
With regard to claim 5, Hong teaches specifically labeling wherein live cells are labeled green and the dead cells labeled red (p 161-162 1st column 2nd paragraph).
With regard to claim 9 and 13 , Hong teaches a florescent label, and therefore it penetrated through a dead cell.
With regard to claim 16, Hong et al. teaches a step of proving gel capsules, encapsulating invention cells from a population of cells wherein the live cells are labeled green and the dead cells labeled red (p 161-162 1st column 2nd paragraph). Hong et al. teaches that there is a step of encapsulating each of the cells, a step of gelatin the liquid droplet and the suspension of the cells is allowed to flow in a microchannel wherein the suspension is sheared with oil (p. 161 and figure 6).
With regard to claim 18, Hong et al. teaches the use of sodium alginate (figure 6).
With regard to claim 21, Hong et al. teaches removing containments (p. 161 1st column).
With regard to claim 27, Hong et al. suggests that the number of cells could be determined by changing the concentration of cells (p. 162 1st paragraph).
However, Hong et al. does not teach a step of amplifying nucleic acid and analyzing the nucleic acid.
With regard to claim 1, Hindson et al teaches a method of detecting amplification of nucleic acids from monodispersed cells (para 490-512).
With regard to claim 4, Hong et al. teaches detection of live cells (p 162), Hindson et al teaches a method of detecting amplification of nucleic acids from monodispersed cells (para 490-512).
With regard to claims 6 and 45, Hindson et al. teaches a method of using ciprofloxacin (para 203-205).
With regard to claim 20, Hindson et al teaches a method of immersing the cells in a step of lysing with phenol (para 371).
With regard to claims 23-25, Hindson et al. teaches measuring amplification of nucleic acids in cells (para 512-515) from different cells (para 508).
With regard to claim 29, Hindson et al. teaches obtaining genomic sequence data (para 512-515).
With regard to claim 36, Hindson et al. taches determining presence of microbes (para 23).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to use the cell analysis of Hong et al. to analyze nucleic acids to determine nucleic acid information from cell populations. The ordinary artisan would have a reasonable expectation to analyze the nucleic acid in the cells of Hong et al. as Hindson et al. teaches analysis of nucleic acids from monodispersed cells.
Response to arguments
The reply traverses the rejection. A summary of the arguetmsn is made below with response to arguments following. The reply asserts that modifying Hong in view of Hindson renders Hong unsatisfactory for its intended purpose because the Hindson method requires methods and compositions for detecting and quantifying polynucleotides in an emulsified droplet based sample (p. 9). The reply asserts that the analysis of Hong would destroy the analyzed cells whereas Hong purpose is identifying live encapsulated cells (p. 9). The reply asserts that there is unexpectedly superior results by seamless integration of viability discrimination with nucleic acid sequences analysis (p. 9). The reply asserts that the methyl yields analytical advantages (p. 9). The reply asserts that it would have higher confidence in live/dead cell ratios, reduce false positive from dead cell DNA contamination and improve accuracy in FMT quality control and pathogen screening.
These arguments have been reviewed but have not been found persuasive.
It is noted that the claims do not require that the individual cells are alive. The reply asserts that the method of Hong would destroy the analyzed cells, however, this appears to be a typographical error and the reply is referring to Hindson et al. The claims are drawn to amplifying the nucleic acids derived from the cells, as Hong et al. teaches that the cells can clow in a microchannel the cells of Hong can be isolated such that nucleic acids can be isolated. Hindson teaches a type of PCR that amplifies nucleic acids from monodispersed cells and as such teaches one a method of amplification. As the claims are drawn to amplifying nucleic acids from the cells, it is regardless of rather the cell is alive or dead. Furthermore, nucleic acid can be obtained from these cells for further PCR analysis. The reply points to unexpected results however, the unexpected results are not specific to the steps of the claims. The claims are drawn to analysis of “viability information” and not “viability discrimination”. . The reply asserts the higher confidence in live/dead cells, reduce false positivity, and improve accuracy, however, the response appears to be arguing these unexpected results and do not provide any evidence that the claim steps have these results.
Claim(s) 12 and 30, 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (Korea Australia Rheology Journal 2007 Vol 19 p. 157-164) and Hindson et al (US Patent Application 2012/0252015 October 4, 2012) as applied to claims 1,2,4-6,9,13,16,18,20-21,23-25,27,29,36, 45 and in view of Honda et al. (US Patent Application Publication 2022/0133813 effective filing 2/9/2018).
Hong et al. teaches a step of proving gel capsules, encapsulating invention cells from a population of cells wherein the live cells are labeled green and the dead cells labeled red (p 161-162 1st column 2nd paragraph). Hindson et al teaches a method of detecting amplification of nucleic acids from monodispersed cells (para 490-512).
However, Hong et al. teaches not teach PMA labeling or evaluating FMT specimen.
With regard to claim 12 and 46, Honda et al. taches methods of analyzing cells (para 3-6). Honda et al. teaches labeling cells with PMA (para 549).
With regard to claim 30 and 47 Honda et al. teaches that the population of cells can be analyzed for fecal transplant (para 5).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Hong et al. and Hindson et al. to use known methods of labeling to evaluate known phenotypes that can be measured in a cell population, such as those taught by Honda et al. The ordinary artisan would have a reasonable expectation of success to label cells with known labels and detect and analyzing nucleic acids associated with fecal transplants.
Response to arguments
The reply traverses the rejection. A summary of the arguetmsn is made below with response to arguments following. The arguments assert that Honda fails to cure the deficiencies of Hong and Hindson (p. 10). However these arguments have been addressed above and therefore the rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682