Prosecution Insights
Last updated: April 19, 2026
Application No. 17/290,219

COMPOSITIONS AND METHODS FOR IN VIVO SCREENING OF THERAPEUTICS

Non-Final OA §102§103§DP
Filed
Apr 29, 2021
Examiner
ZHANG, KAIJIANG
Art Unit
1684
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Gordian Biotechnology Inc.
OA Round
1 (Non-Final)
76%
Grant Probability
Favorable
1-2
OA Rounds
2y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allow Rate
518 granted / 678 resolved
+16.4% vs TC avg
Strong +36% interview lift
Without
With
+35.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
28 currently pending
Career history
706
Total Applications
across all art units

Statute-Specific Performance

§101
6.3%
-33.7% vs TC avg
§103
26.5%
-13.5% vs TC avg
§102
24.5%
-15.5% vs TC avg
§112
26.6%
-13.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 678 resolved cases

Office Action

§102 §103 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after Ma rch 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election /Restrictions 2 . Applicant’s election without traverse of Group I (claims 1-18) in the reply filed on 11/14 /2025 is acknowledged. 3 . Claims 1- 22 are pending in the application. Claims 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-18 are cu rrently under examination. Specification 4. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see paragraph [0168] of the specification) . Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. 5. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Double Patenting 6 . The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . 7 . Claims 1-18 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-18 of U.S. Patent No. 11, 739,370 . Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-18 of U.S. Patent No. 11,739,370 teach or render obvious all the steps and elements as recited in instant claims 1-18 . Specifically, claim 1 of U.S. Patent No. 11,739,370 is drawn to a method that has all the steps and elements required by the method of instant claim 1 and is more specific regarding how the step of identifying a candidate therapeutic moiety is done . In addition, the other fea tures or elements as recited in dependent claims 2-18 are also t aught or render ed obvious by claims 1-18 of U.S. Patent No. 11,739,370 . 8 . Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 , 3, 6, 8-9, 11-13, 16, 19-20, 27-30, 33, 35-36, 38, 40 and 42 of copending Application No. 18/ 279,555 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3, 6, 8-9, 11-13, 16, 19-20, 27-30, 33, 35-36, 38, 40 and 42 of copending Application No. 18/279,555 teach or render obvious all the steps and elements as recited in instant claims 1- 18 . Specifically, c laim 1 of copending Application No. 18/279,555 anticipates instant claim 1 by disclosing a method that has all the steps and elements as recited in instant claim 1 and includes an extra element (i.e., one or more sequences encoding a non - coding nuclear retention RNA motif ) in the expression cassettes . In addition, the other fea tures as recited in dependent claims 2- 1 8 are also t aught or render ed obvious by claims 1, 3, 6, 8-9, 11-13, 16, 19-20, 27-30, 33, 35-36, 38, 40 and 42 of copending Application No. 18/279,555 . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim Rejections - 35 USC § 102 9 . 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 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. 10 . 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 effec tive filing date of the claimed invention. 1 1 . Claims 1- 8, 11-14 and 16- 18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lim et al. ( WO 2017/040694 A2 ). Regarding claim 1 Lim et al. teach, throughout the whole document, a method for identifying a candidate therapeutic moiety (see paragraph [0006]: “Methods of screening a synthetic modular polypeptide library to identify a selected phenotype associated with a member of a synthetic modular polypeptide library” ; Figure 24 ) comprising: administering to an animal (e.g., a small animal such as a mouse) or an organoid a library of expression cassettes (see paragraphs [00290], [00293] and [00405]; Figure 24) comprising: a plurality of nucleic acid sequences, each encoding a different therapeutic moiety operably linked to a therapeutic moiety barcode (see paragraph [0007]: “…wherein the barcoded library of nucleic acids comprises a plurality of members, each of which plurality of members comprises a nucleotide sequence encoding a different synthetic modular polypeptide” ; Figures 1 and 5 ) ; and a plurality of nucleic acid sequences encoding one or more reporters that collectively, when expressed in a cell, are indicative of a cell state or a likelihood of a cell state of the cell (see paragraph [0022]: “…wherein each nucleotide sequence encoding a different synthetic modular polypeptide comprises a sequence encoding a detectable reporter in operable linkage with the nucleotide sequence encoding the synthetic modular polypeptide” ; paragraph [0034]: “…a plurality of unique polynucleotides each comprising a nucleotide sequence encoding a unique synthetic modular polypeptide wherein each unique polynucleotide further comprises a promoter sequence operably linked to both the coding region and a reporter sequence encoding a detectable polypeptide, wherein the detectable polypeptide is an optically detectable polypeptide including, e.g., an optically detectable fluorescent polypeptide.” ) ; and identifying a candidate therapeutic moiety that results in a change in a cell state or a likelihood of a cell state of a cell of the animal or the organoid (see paragraph [0019]: “…method of identifying a selected phenotype associated with a synthetic modular polypeptide in a cell comprising sequencing the barcode of the identified genetically modified host cell to identify the synthetic modular polypeptide associated with the phenotype” ; Figure 24 ). Regarding claim 2 The method according to Lim et al. , wherein the cell state is a healthy cell state, a non-diseased cell state, or a normal cell state and a change in the cell state associated with the identified candidate therapeutic moiety is a change from a normal or non-diseased cell state to a disease state (see paragraph [00286]). Regarding claim 3 The method according to Lim et al. , wherein the change in the cell state (e.g., phenotype) or a likelihood of the cell state correlates to a therapeutic effect resulting from the candidate therapeutic moiety (see paragraphs [0006], [0019] and [00289]-[00290]; Figure 24). Regarding claim 4 The method according to Lim et al. , further comprising enriching or sorting a population of cells having the change in the cell state or the likelihood of the cell state (see paragraphs [00249], [00281], [00404] and [00413]; Figure 24). Regarding claim 5 The method according to Lim et al. , wherein the enriching or sorting comprises enriching or sorting the population of cells based on a level of the one or more reporters (see paragraphs [00249] and [00413]). Regarding claim 6 The method according to Lim et al. , wherein the enriching or sorting comprises performing FACS, an affinity purification method, flow cytometry, or microfluidic sorting (see paragraphs [00194], [00281], [00404] and [00413]). Regarding claim 7 The method according to Lim et al. , wherein the identifying comprises identifying the candidate therapeutic moiety based on a presence of the therapeutic moiety barcode in the cell (see paragraph [0019]). Regarding claim 8 The method according to Lim et al. , wherein the identifying comprises performing single cell analysis, RNA sequencing, single cell RNA sequencing, droplet-based single cell RNA sequencing, bulk analysis, or sequencing a population of cells to determine an amount of the candidate therapeutic moiety present in the population of cells (see paragraphs [0019], [0021] and [00404]; Figure 24). Regarding claim 11 The method according to Lim et al. , wherein the likelihood of the cell state correlates with a level of protein or oligonucleotide expression in the cell (see paragraphs [0022]-[0024], [00139] and [00194]-[00195]). Regarding claim 1 2 The method according to Lim et al. , wherein the level of protein or oligonucleotide expression is measured using a histological or fluorescent staining method (see paragraph [00195]). Regarding claim s 13- 14 The method according to Lim et al. , wherein the different therapeutic moieties (e.g., synthetic polypeptide/protein-based therapeutic moieties . See paragraphs [0006]-[0017] and [0026]) are product of transgenes ( Note that paragraph [0052] of applicant’s disclosure defines the term “transgene” to includ e “any exogenous nucleic acid sequence that is artificially introduced into a cell or the genome of a cell”). Regarding claim 16 The method according to Lim et al. , wherein each expression cassette in the library of expression cassettes is packaged in an expression vector (see paragraphs [00146], [00408]-[00410]). Regarding claim s 17 -18 The method according to Lim et al. , wherein the expression vector is a virus , wherein the virus is a lentivirus (see paragraphs [00410] and [00412]). 12. Claims 1- 8, 11-13 and 15- 18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chenchik et al. ( WO 2013/169917 A 1 ). Regarding claim 1 Chenchik et al. teach, throughout the whole document, a method for identifying a candidate therapeutic moiety (e.g., candidate effector or shRNA) comprising: administering to an animal (e.g., a mouse) or an organoid a library of expression cassettes (see page 18, lines 13-25; page 31, lines 15-30; page 42, line 25 – page 43, line 10; page 46, lines 11-29) comprising: a plurality of nucleic acid sequences, each encoding a different therapeutic moiety (e.g., effector or shRNA ) operably linked to a therapeutic moiety barcode (see Abstract; page 3, line 14 – page 5 , line 27 ) ; and a plurality of nucleic acid sequences encoding one or more reporters that collectively, when expressed in a cell, are indicative of a cell state or a likelihood of a cell state of the cell (see page 6, lines 4-6; page 7, lines 28-30; page 24, line 30 – page 25, line 4; page 38, paragraph 1; Figures 1-2) ; and identifying a candidate therapeutic moiety that results in a change in a cell state or a likelihood of a cell state of a cell of the animal or the organoid (see page 3, lines 14-26; Figure 2). Regarding claim 2 The method according to Chenchik et al., wherein the cell state is a healthy cell state, a non-diseased cell state, or a normal cell state (see page 3, line 5 – page 6, line 18; page 11, line 14 – page 18, line 27). Regarding claim 3 The method according to Chenchik et al., w herein the change in the cell state or a likelihood of the cell state correlates to a therapeutic effect resulting from the candidate therapeutic moiety (see page 3, line 5 – page 6, line 18; page 11, line 14 – page 18, line 27). Regarding claim 4 The method according to Chenchik et al., further comprising enriching or sorting a population of cells having the change in the cell state or the likelihood of the cell state (see Abstract; page 3, line 14 – page 5, line 27 ; Figure 2 ) . Regarding claim 5 The method according to Chenchik et al., wherein the enriching or sorting comprises enriching or sorting the population of cells based on a level of the one or more reporters (see page 7, lines 28-30; page 24, line 30 – page 25, line 4; page 38, paragraph 1; Figures 1-2) . Regarding claim 6 The method according to Chenchik et al., wherein the enriching or sorting comprises performing FACS, an affinity purification method, flow cytometry, or microfluidic sorting (see page 33, lines 25-31; page 46, lines 5-29 ). Regarding claim 7 The method according to Chenchik et al., wherein the identifying comprises identifying the candidate therapeutic moiety based on a presence of the therapeutic moiety barcode in the cell (see Abstract; page 3, line 5 – page 4, line 6). Regarding claim 8 The method according to Chenchik et al., wherein the identifying comprises performing single cell analysis, RNA sequencing, single cell RNA sequencing, droplet-based single cell RNA sequencing, bulk analysis, or sequencing a population of cells to determine an amount of the candidate therapeutic moiety present in the population of cells (see page 33, lines 3-31). Regarding claim 11 The method according to Chenchik et al., wherein the likelihood of the cell state correlates with a level of protein or oligonucleotide expression in the cell (see paragraph bridging pages 4-5; page 11, lines 14-26). Regarding claim 12 The method according to Chenchik et al., wherein the level of protein or oligonucleotide expression is measured using a histological or fluorescent staining method (see page 45, lines 18-22; page 46, lines 5-26). Regarding claim 13 The method according to Chenchik et al., wherein the different therapeutic moieties are selected from the group consisting of: DNA, RNA, shRNA, siRNA, miRNA, an antisense oligonucleotide, a morpholino, a protein degradation tag, a product of a transgene, a gene editing complex, a Cas fusion protein, CRISPRi , CRISPRa , an RNA editing element, a regulatory element of RNA splicing, an RNA degradation element, an epigenetic modification element, and any combination thereo f (see page 4, lines 7-13; page 5, lines 22-27). Regarding claim 15 The method according to Chenchik et al., wherein the different therapeutic moieties are shRNA (see page 4, lines 7-13; page 5, lines 22-27 ; Figures 1-2). Regarding claim 16 The method according to Chenchik et al., wherein each expression cassette in the library of expression cassettes is packaged in an expression vector (see page 4, lines 12 -13; page 5, lines 2 5 -27; page 6, lines 15-16; Figures 1-2). Regarding claim s 17 -18 The method according to Chenchik et al., wherein the expression vector is a virus , wherein the virus is an adeno-associated virus (AAV), an adenovirus, or a lentivirus (see page 4, lines 12-13; page 5, lines 25-27; page 6, lines 15-16; page 36, lines 4-11; Figures 1-2) . Claim Rejections - 35 USC § 103 1 3 . 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 of this title, 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. 14. 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. 1 5 . Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chenchik et al. (WO 2013/169917 A1) as applied to claim s 1 and 7-8 above, and further in view of Macosko et al. ( Cell 2015, 161 : 1202 - 1214 ). Chenchik et al. teach the method of claims 1 and 7-8 as discussed above. Although Chenchik et al. teach that the identifying step comprises performing sequencing, Chenchik et al. do not specifically disclose the use of droplet-based single cell RNA sequencing in the identifying step. However, Macosko et al. teach that such sequencing may be performed using droplet-based single cell RNA sequencing (see Abstract; Figure 2). Macosko et al. further teach that droplet-based single cell RNA sequencing enables highly parallel sequencing analysis of thousands of individual cells, representing “a 100-fold improvement in both time and cost” relative to other existing methods (see Abstract; page 1211, column 1, last paragraph). It would have been prima facie obvious to one of o rdinary skill in the art before the effective fi ling date of the claimed invention to use droplet-based single cell RNA sequencing , as taught by Macosko et al. , in the identifying step of the method of Chenchik et al. thus arriving at the instantly claimed invention, because droplet-based single cell RNA sequencing would enable highly parallel sequencing analysis of thousands of individual cells, representing “a 100-fold improvement in both time and cost” relative to other existing methods (see Macosko et al. , Abstract; page 1211, column 1, last paragraph). In addition, combining prior art elements according to known methods to yield predictable results is considered prima facie obvious (see MPEP 2143.I.A). Given the teachings of the prior art and the level of the ordinary skilled artisan at the effective fi ling date of the claimed invention , it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention . Conclusion 1 6 . No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KAIJIANG ZHANG whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-5207 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday, 8:30 am - 5 pm . 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 on 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. /KAIJIANG ZHANG/ Primary Examiner, Art Unit 1684
Read full office action

Prosecution Timeline

Apr 29, 2021
Application Filed
Dec 09, 2025
Non-Final Rejection — §102, §103, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
76%
Grant Probability
99%
With Interview (+35.5%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 678 resolved cases by this examiner. Grant probability derived from career allow rate.

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