Prosecution Insights
Last updated: April 19, 2026
Application No. 18/542,586

Factor VIII Molecules and Their Use

Non-Final OA §102§DP
Filed
Dec 15, 2023
Examiner
MATALKAH, FATIMAH KHALAF
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Expression Therapeutics LLC
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
3y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
17 granted / 24 resolved
+10.8% vs TC avg
Strong +30% interview lift
Without
With
+30.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
45 currently pending
Career history
69
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
44.7%
+4.7% vs TC avg
§102
20.5%
-19.5% vs TC avg
§112
22.3%
-17.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 24 resolved cases

Office Action

§102 §DP
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. Priority Applicant’s claim for the benefit of a prior-filed application provisional application 63029990, filed on 05/26/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged . Specification The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code ( See paragraph [0133] on page 1 9 ) . 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. 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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doering et al ( WO 2016/168728 A2 ) Rega r ding claim s 1 -3 , Doering et al teach an isolated nucleic acid comprising a nucleic acid sequence encoding either SEQ ID NO:11 or SEQ ID NO:125 that share 100% sequence identity with instant SEQ ID NO:3 and SEQ ID NO: 30, respectively . ( See claims 26) Regarding claims 4- 8 , Doering et al also teach a viral vector encoding a recombinant nucleic acid comprising SE Q ID NO:11 or SEQ ID NO: 125, wherein the viral vector is either an AAV vector, a lentiviral vector, a gamma-retro viral vector, or an adenoviral vector. ( See claims 16-19). Doering et al further teach a composition comprising a viral vector encoding nucleic acid comprising with SE Q ID NO:11 or SEQ ID NO: 125 and a pharmaceutically accepted carrier. ( See claim 25). Regarding claim 9, Doering et al also teach a method of inducing blood clotting in a subject in need comprising administering to the subject an effective amount of a viral vector encoding a recombinant nucleic acid comprising SE Q ID NO:11 or SEQ ID NO: 125. ( See claim 32) Regarding claim 10 , Doering et al also teach a method of treating hemophilia comprising administering to a subject in need an effective amount of a viral vector encoding a recombinant nucleic acid comprising SE Q ID NO:11 or SEQ ID NO: 125. ( See claims 33-34). Double Patenting 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 . Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3,5,7-14, and 16 of U.S. Patent No. US 10,898,588 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US 10,898,588 B2 a viral vector encoding a nucleic acid comprising either SEQ ID NO:11 or SEQ ID NO:125 that share 100% sequence identity with instant SEQ ID NO:3 and SEQ ID NO: 30, respectively, and a composition comprising the same. The claims also disclose methods for inducing blood clotting and treating hemophilia, comprising administering the said viral vector to a subject in need. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Enter examiner's name" \* MERGEFORMAT FATIMAH KHALAF MATALKAH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-5652 . The examiner can normally be reached FILLIN "Work schedule?" \* MERGEFORMAT Monday-Friday,7:30 am-4:30 pm EST . 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 Tracy Vivlemore can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-2914 . 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. /FATIMAH KHALAF MATALKAH/ Examiner, Art Unit 1638 /Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
Read full office action

Prosecution Timeline

Dec 15, 2023
Application Filed
Mar 09, 2026
Non-Final Rejection — §102, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12600949
MODIFIED MACROPHAGES, COMPOSITIONS AND USES THEREOF
2y 5m to grant Granted Apr 14, 2026
Patent 12600989
IMPROVED ADENO-ASSOCIATED VIRUS (AAV) VECTOR AND USES THEREFOR
2y 5m to grant Granted Apr 14, 2026
Patent 12590296
METHOD OF CULTURING IMMORTALIZED HUMAN HEPATIC PROGENITORS OR CELLS
2y 5m to grant Granted Mar 31, 2026
Patent 12590294
PROCESS FOR PRODUCING CARDIOMYOCYTES
2y 5m to grant Granted Mar 31, 2026
Patent 12590289
MEDIUM-BASED METHOD REALIZED FOR DIFFERENTIATION OF DENTAL STEM CELLS INTO NEURONS
2y 5m to grant Granted Mar 31, 2026
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
71%
Grant Probability
99%
With Interview (+30.4%)
3y 7m
Median Time to Grant
Low
PTA Risk
Based on 24 resolved cases by this examiner. Grant probability derived from career allow rate.

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