Prosecution Insights
Last updated: April 19, 2026
Application No. 18/276,116

SYSTEMS AND METHODS FOR EVALUATING DRUG COMBINATIONS

Non-Final OA §102§103
Filed
Aug 07, 2023
Examiner
PHAM, KHAI QUYNH TIEN
Art Unit
1684
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hunter Biodiscovery Inc.
OA Round
1 (Non-Final)
0%
Grant Probability
At Risk
1-2
OA Rounds
3y 2m
To Grant
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 1 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
11 currently pending
Career history
12
Total Applications
across all art units

Statute-Specific Performance

§101
8.7%
-31.3% vs TC avg
§103
43.5%
+3.5% vs TC avg
§102
19.6%
-20.4% vs TC avg
§112
26.1%
-13.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1 resolved cases

Office Action

§102 §103
DETAILED ACTION Status of the Application Claims 1, 3-10, 12-15, 17-19, 22 , 24, and 25 are pending. Claims 1, 3-10, 12-15, 17-19, 22 , 24, and 25 are under examination. The following Office Action is in response to Applicant's communication dated 0 2 / 21 /202 4 . 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 § 102 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 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) 1, 3-10, 12 , 13, 18, 19, and 2 2 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2 ) as being anticipated by Blainey et al. ( US10981167B2 ). Regarding claim 1 , Blainey discloses a system comprising: a plurality of drug libraries, at least one comprising multiple droplets of multiple drugs, (e.g. droplets containing one set or combinations of molecular species for combinatorial screening [column 1 , line 64 – colum2, line 7 ]) each drug associated with a corresponding unique drug identifier in the system; ( e.g. each droplet carrying a molecular species will also carry a unique barcode [column 8 , line 4 6-50 ]) a live cell library comprising multiple live cells or live cell lines (e.g. in some embodiments, droplets comprise one or more cells [ column 9, lines 38-62 ] ) , each live cell associated with a corresponding unique cell or cell line identifier in the system; (e.g. barcode tag hybridize to cells [column 12, lines 49-52]) a plurality of junctions combining drug droplets from the drug libraries and a live cell from the live cell library, (e.g. droplets containing combinations of drugs and reporter cells [column 13 , li ne 45] ) wherein at least one of said drug libraries produces a random stream of heterogenous drug droplets ( e.g. droplets are randomly distributed onto the microfluidic device , producing random combinations [column 1 , lines 45-46 ] ) , said drug droplets corresponding to drugs in said drug libraries, wherein a cross-sectional dimension of a junction is smaller than diameters of the droplets, (e.g. microfluidic channels can be optimized to control droplet size (e.g. diameter, volume) and droplet merging [column 5, lines 23-62 ] ) wherein the plurality of junctions combines streams of drug droplets from each of the plurality of drug libraries with a stream of live cells from the live cell library, (e.g. droplets containing combinations of molecular species merged. [column 6 , limes 2 9- 36 ] . For example, droplets containing combinations of drugs and reporter cells [column 13, line 45] ) wherein the plurality of junctions forms a plurality of merged sets, each of said merged sets comprising a particular cell from the live cell library and a drug droplet from each of the plurality of drug libraries. ( e.g. merging droplets containing antibiotics , adjuvants and reporter cells [column 13, limes 44-4 5 ]) Regarding claim 3 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Blainey further discloses at least one of the droplets in a set is larger than the other droplets in the set. [ F ig . 12 ] Regarding claim 4 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Blainey further discloses merge set is uniquely identifiable by: ( i ) the unique cell identifier of the particular cell, and (ii) the unique drug identifiers of the drug droplets comprising the merge set. (e.g. merging droplets containing barcoded antibiotics , barcoded adjuvants and reporter cells [column 13, lines 44-4 5 ]. Blainey also discloses in some embodiments, barcode tag s hybridize to cells [column 12, lines 49-52]) Regarding claim 5 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Blainey further discloses drugs in a merge set are identifiable by the identifiers of the drug droplets comprising the merge set. ( e.g. To track and identify molecular species and their combinations, each species is labeled with a unique identifier . Hence, allowing merged droplets to be identified by their combined barcodes, which reveal exactly which species are present [column 8 , lines 41-50 ]) Regarding claim 6 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Blainey further discloses determine, from the plurality of merged sets, effectiveness of a set or sets of drugs with respect to one or more criteria; and identify the drugs in the set or sets of drugs that were effective with respect to the one or more criteria. ( the merged droplets contain combinations and evaluate their biological effect using reporter readouts, such as antibiotic/adjuvants combinations. Barcodes allow identification of the components in each droplet [column 8 , lines 1 0 -2 2 ] . Selective marker comprises optical phenotyping [column 14, lines 21-22] ) Regarding claim 7 , Blainey discloses a system of claim 6 as discussed fully above and incorporated here. Blainey further discloses the system identifies the set or sets of drugs that were most effective with respect to the one or more criteria. (e.g. the merged droplets contain combinations and evaluate their biological effect using reporter readouts, such as antibiotic/adjuvants combinations. [ column 8, lines 10-22] ) Regarding claim 8 , Blainey discloses a system of claim 6 as discussed fully above and incorporated here. Blainey further discloses the system identifies one or more drug combinations based on said drug combination's synergistic effect on a cell according to the one or more criteria. (e.g. screening combinations of molecular species ( antibiotic and adjuvants combinations with bacteria) and determining the phenotypic response of the cells, there by identifying effective combinations of molecules [column 8, lines 10-22] ) Regarding claim 9 , Blainey discloses a system of claim 6 as discussed fully above and incorporated here. Blainey further discloses the unique drug identifier for a drug in the plurality of drug libraries comprises a unique DNA sequence for the drug, and wherein the unique cell identifier for a cell in said live cell library comprises a unique DNA sequence for the cell, and wherein the system is constructed and adapted to identify the drugs in the set or sets of drugs by: concatenating the unique DNA sequences in each set; and sequencing concatenated unique DNA sequences. ( e.g. merging droplets containing barcoded antibiotics , barcoded adjuvants and reporter cells [column 13, lines 44-46]. Blainey also discloses in some embodiments, barcode tags hybridize to cells [column 12, lines 49-52]. Wherein barcodes comprise a unique oligonucleotide sequence. [ column 9, lines 11-15] ) Regarding claim 10 , Blainey discloses a system of claim 6 as discussed fully above and incorporated here. Blainey further discloses the one or more criteria are selected from: live versus dead, protein abundance, presence or intensity of cellular proteins, metabolites or metabolite detection, nucleic acid detection, DNA, RNA, and/or other biomarkers. (e.g. alive the reporter cell may express a fluorescent protein. [column 9 , lines 54-61 ]) Regarding claim 12 and 13 , Blainey discloses a system of claim 6 as discussed fully above and incorporated here. Blainey further discloses the plurality of junctions comprise: one or more first junctions for combining a stream of drug droplets from each of the plurality of drug libraries. And t he one or more first junctions form a stream of drug droplet sets. ( e.g. microfluidic device may form a module that is combined with other modules on a single chip, allowing droplet merge module . [column 4 , lines 63 - column5, line 1]) Regarding claim 18 and 22 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Blainey further discloses the corresponding unique drug identifier for a drug in the drug libraries comprises a unique DNA drug identifier, wherein the unique DNA drug identifier for a drug in the plurality of drug libraries comprises a unique DNA sequence for the drug. W herein drugs in a merge set are identifiable by the unique DNA drug identifiers of the drug droplets comprising the merge set. (e.g. merging droplets containing barcoded antibiotics , barcoded adjuvants and reporter cells [column 13, lines 44-46]. Wherein barcodes comprise a unique oligonucleotide sequence. [ column 9, lines 11-15] ) Regarding claim 1 9 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Blainey further discloses the corresponding unique cell identifier for cell types in the live cell library comprises a unique DNA cell identifier, wherein the unique DNA cell identifier for a cell in said live cell library comprises a unique DNA sequence for the cell (e.g. In some embodiments, barcode tags hybridize to cells [column 12, lines 49-52]. Wherein barcodes comprise a unique oligonucleotide sequence. [ column 9, lines 11-15] ) 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. Blainey et al. Claim(s) 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blainey et al. ( US10981167B2 ). Regarding claim 24 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Blainey discloses droplets comprising individual molecular species that are loaded onto a microfluidic device and combined to derive combinations of molecular species for screening assays. Such system utilizes libraries of compounds to enable high throughput screening experiments. Although Blainey does not disclose the specific number of drugs libraries (e.g. up to 1,000 drugs, more preferably up to 2,000 drugs, and even more preferably up to 5,000 drugs ), selecting the number of compounds including in a screening library would have been a matter routine optimization for one of ordinary skill in the art depending on the desired scale of the screening experiment and the throughput of the microfluidic system. The prior art system already contemplates screening combinations of molecular species and therefor requires selecting the size of the compound library used in the assay. See MPEP § 2144.05 (II), 2144.05 (III)(C) In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) . Regarding claim 25 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Similar to claim 24, Blainey discloses high throughput screening system, but does not disclose the specific number of cells (e.g. 100 cell lines ). The prior art already teaches performing cell-based assays using droplets, and therefore the specific number of cells is a matter routine optimization. See MPEP § 2144.05 (II), 2144.05 (III)(C) In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) . Blainey et al. and Dressler et al. Claim(s) 14, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blainey et al. ( US10981167B2 ) in view of Dressler et al. ( J Biomol Screen 19.4 (2014): 483-496 ) Regarding claim 14 , Blainey discloses a system of claim 1 as discussed fully above and incorporated here. Blainey discloses microfluidic systems for screening combination of molecular species using droplets that contain barcoded reagents and biological materials, where the droplets comprising different molecular species are combined and analyzed to evaluate interactions between compounds and cells. However, Blainey does not explicitly describe the droplet combinations through multiple sequential droplet merging. Dressler discloses d roplet- b ased m icrofluidics systems commonly incorporate multiple microfluidic operation s, including droplet generation , mixing, splitting, and merging, which can be integrated along a m icrofluidic channel to manipulate droplets sequentially during high-throughput experimentation, enabling stepwise processing and combination of reagents within droplets during screening experiments. Such systems allow reagents or biological components to be added to droplets in successive operation along the microfluidic device to carry out complex assays or screening workflow. [ page 485 ] As of the application’ s effective filing date, one of ordinary skill in the art would have had a reasonable expectation of success and motivated to combine these teachings to implement Blainey ’s droplet-combination system using multiple droplet-merging junctions arranged sequentially within the m icrofluidic device, as taught by Dressler , in order to allow droplets containing different reagents or biological components to be controlled in a stepwise manner. Incorporating sequential droplet manipulation operation such as merging at different positions within a m icrofluidic channel would have represented a routine design choice in droplet- m icrofluidic systems and would have yielded predictable results, namely enabling staged combination of reagents and biological samples for high-throughput screening assays , consistent with KSR International Co. v. Teleflex Inc. , 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (see MPEP § 2143, A ). Regarding claim 1 5 , Blainey discloses a system of claim 1 4 as discussed fully above and incorporated here. Blainey further discloses each of said merged sets comprising one or more of a particular cell type from the live cell library and a drug droplet from each of the plurality of drug libraries. (e.g. merging droplets containing barcoded antibiotics , barcoded adjuvants and reporter cells [column 13, lines 44-46]) Regarding claim 17 , Blainey discloses a system of claim 1 5 as discussed fully above and incorporated here. Blainey further discloses each merged set is uniquely identifiable by the unique cell identifier of the particular cell type and the identifiers of the drug droplets. (e.g. To track and identify molecular species and their combinations, each species is labeled with a unique identifier . Hence, allowing merged droplets to be identified by their combined barcodes, which reveal exactly which species are present [column 8, lines 41-50]) Conclusion No claims are allowed Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Khai Quynh Tien Pham whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6998 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-T, 9-4 ET . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Heather Calamita can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-2876 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KHAI QUYNH TIEN PHAM/ Examiner, Art Unit 1684 /JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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Prosecution Timeline

Aug 07, 2023
Application Filed
Mar 16, 2026
Non-Final Rejection — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 1 resolved cases by this examiner. Grant probability derived from career allow rate.

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