DETAILED ACTION
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claims 1-6 and 8 are pending and examined in the instant Office action.
Withdrawn Rejections
The rejections of the claims under 35 U.S.C. 112 are withdrawn in view of either amendments filed to the instant set of claims on 6 November 2025 or arguments on pages 5-6 of the Remarks.
The rejections of the claims under 35 U.S.C. 101 are withdrawn in view of amendments filed to the instant set of claims on 6 November 2025. Specifically, the claims recite treating the CTC-derived organoid cultures with a plurality of candidate drugs.
Claim Rejections - 35 USC § 103
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.
The following rejection is reiterated:
Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. [WO 2021/188578 A1].
Claim 1 is drawn to a method for proving drug recommendation. The method comprises obtaining a liquid biopsy of the patient. The method comprises isolating CTCs of the patient from the liquid biopsy. The method comprises expanding the CTCs in vitro to obtain CTC-derived organoid cultures of the patient. The method comprises treating the CTC-derived organoid cultures with a plurality of candidate drugs. The method comprises calculating a plurality of relative cell viabilities respectively corresponding to a plurality of candidate drugs based on viable cell counts of the CTC-derived organoid cultures and viable cell counts of the CTC-derived organoid cultures respectively reacted with the candidate drugs. The method comprises providing a personalized drug recommendation of the candidate drugs based on the relative cell viabilities.
The document of Yu et al. studies screening methods to identify small molecule compounds that promote or inhibit the growth of CTCs [title]. Paragraphs 3 and 63 of Yu et al. teach that CTCs are found in organs. Claim 18 of Yu et al. teaches obtaining blood of a subject, isolating the CTCs from the blood, and then expanding the CTCs in cultures. Paragraphs 3 and 63 of Yu et al. teach a liquid biopsy. Figures 4A and 4C illustrates cultures of CTCs either as a control or in the presence of (i.e. after treatment with) drug(s) Figure 4B and 4D of Yu et al. plot the viable cell counts of the control culture of CTCs or the CTCs in the presence of drug(s). While Yu et al. does not recommend drug(s), it would be obvious to recommend the drug or drug combination that most reduces the population of CTCs as a personalized drug recommendation for each CTC.
With regard to claim 2, the interval plots within the data of Figures 4B and 4D of Yu et al. are interpreted to be scores. While Yu et al. does not recommend drug(s), it would be obvious to recommend the drug or drug combination that most reduces the score reflecting the population of CTCs.
With regard to claims 3-4, each of Figure 4B and 4D contains four interval plots reflecting the cell viability and cell viability score under four different conditions. It is interpreted that each plot in each of Figure 4B and 4D is weighted identically.
With regard to claims 5-6, while Yu et al. does not recommend drug(s), it would be obvious to predict then recommend that the drug or drug combination that most reduces the score range reflecting the population of CTCs, is most effective at reducing circulating tumor cells.
With regard to claim 8, paragraph 26 of Yu et al. lists the cancers to which the study is applicable.
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify the analysis of CTC viability as a result of being cultured in the presence of drug(s) by use of predicting and recommending the drug(s) that result in the lowest number of CTCs because lowering CTCs reduces tumor (and potentially cancer) cells in the culture.
Response to Arguments
Applicant's arguments filed 6 November 2025 have been fully considered but they are not persuasive.
Applicant cites portions of Yu et al. (e.g. claim 1 and paragraphs 19 and 30 of Yu et al.) that are not relied upon in the instant rejection.
Applicant’s central argument is that not preserving heterogeneity of the CTCs teaches away from CTCs representing actual tumors, which are more heterogeneous. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. preservation of the heterogeneity of the CTCs) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Related Prior Art
The document of Chen et al. [WO 2021/088902 A1] has an overlapping inventive entity and teaches ex vivo expansion of CTCs, preparation from composite membrane, and a medication test method.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is 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 Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/Primary Examiner, Art Unit 1686 26 December 2025