Office Action Predictor
Application No. 17/328,953

VACCINES AGAINST ANTIGENS INVOLVED IN THERAPY RESISTANCE AND METHODS OF USING SAME

Final Rejection §103§DP
Filed
May 24, 2021
Examiner
REDDIG, PETER J
Art Unit
1646
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Duke University
OA Round
4 (Final)
58%
Grant Probability
Moderate
5-6
OA Rounds
3y 6m
To Grant
83%
With Interview

Examiner Intelligence

58%
Career Allow Rate
582 granted / 1007 resolved
Without
With
+25.6%
Interview Lift
avg trend
3y 6m
Avg Prosecution
59 pending
1066
Total Applications
career history

Statute-Specific Performance

§101
6.4%
-33.6% vs TC avg
§103
25.8%
-14.2% vs TC avg
§102
21.7%
-18.3% vs TC avg
§112
27.2%
-12.8% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§103 §DP
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 . DETAILED ACTION 1. The Amendment filed October 10, 2025 in response to the Office Action of June 10, 2025 is acknowledged and has been entered. Claims 9, 11, 12, 19, and 22 have been amended. New claim 29 has been added. 2. Claims 9-12, 15, 16, 18-25, and 27-29 are currently being examined. Rejections Maintained Priority 3. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed applications fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. Examiner has established a priority date of April 02, 2018 for claims 9-12, 15, 16, 18-25, and 27-29 because the claims as currently constituted recite a method of treating a HER2+ or EGFR+ cancer or precancer comprising administering a vaccine consisting of a vaccine vector encoding a HER3 polypeptide consisting of at least one of SEQ ID NOs: 2, 6-22 and 27-34 thereof to a subject having the cancer or precancer, and subsequently administering a therapeutically effective amount of a checkpoint inhibitor or a polynucleotide encoding a checkpoint inhibitor, wherein the checkpoint inhibitor is selected from the group consisting of an anti-PD-1 agent, an anti- PDL1 agent, and an anti-CTLA-4 agent and a review of the parent applications, other than 15/942,812, does not reveal the claimed limitation. In particular, application 15/962,824 and its parental applications do not teach treating EGFR+ cancers, using a checkpoint inhibitor, a fowl pox vector, a vaccinia vector, a VEE vector, a herpes viral vector, or a minicircle vector. Applicant is invited to submit evidence pointing to the serial number, page and line where support can be found establishing an earlier priority date. Applicant did not specifically traverse the priority date in the response filed March 27, 2025. Thus, the priority date of April 02, 2018 for claims 9-12, 15, 16, 18-25, and 27-29 is maintained for the reasons of record. Rejections Maintained 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 4. Claim(s) 9-12, 15, 16, 18-25, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0377261 A1 (Lyerly et al. Dec. 25, 2014), “Lyerly-3” in view of WO 2016/007499 A1 (Lyerly et al. Jan. 14, 2016, IDS), “Lyerly-2” for the reasons of record. Lyerly-3 teaches a method of treating a cancer or precancer or of reducing the likelihood of the cancer developing resistance to a cancer therapeutic or prevention agent comprising administering a vaccine comprising a polynucleotide encoding a HER3 polypeptide comprising SEQ ID NOs: 2 or 6-22 in a vaccine vector to a subject having the cancer or precancer, wherein administration of the vaccine to the subject treats the cancer or precancer, reduces the likelihood of the cancer or precancer developing resistance to the cancer therapeutic or prevention agent or reverses resistance of the cancer or precancer to the cancer therapeutic or prevention agent. See claims 1, 3, 4, and 6-9. SEQ ID NOs: 2 or 6-22 consist of the claimed SEQ ID NOs: 2 or 6-22. See Sequence Listing of Lyerly-3 and Appendix of the Office Action of Nov. 27, 2024. SEQ ID NO: 2 comprises SEQ ID NOs: 27-34. See Appendix. Lyerly-3 teaches the cancer is a HER2 positive cancer. See claim 13. Lyerly-3 teaches that the vaccine vector is selected from adenovirus or adeno-associated virus (AAV). See claim 8. Lyerly-3 teaches the vaccine is administered concurrently with, before or after administration of the cancer therapeutic or prevention agent. See claim 11 Lyerly-3 teaches the cancer therapeutic or prevention agent is an agent targeting HER2, specifically trastuzumab. See claim 12. Lyerly-3 teaches the cancer or precancer is selected from the group consisting of a breast, prostate, lung, ovarian, colon, rectal, pancreas, bladder, head and neck, and liver. See claim 13. Lyerly-3 teaches the subject develops an immune response to HER3. See claim 14. Lyerly-3 teaches the administration results in decreased tumor growth rate or decreased tumor size after administration as compared to prior to administration. See claim 19. Lyerly-3 teaches the cancer or precancer in individuals administered both the vaccine and the therapeutic or prevention agent does not develop resistance to the cancer therapeutic or prevention agent and is treated. See ¶ [0023] and claims 21-24. Lyerly-3 does not teach administering a checkpoint inhibitor. Lyerly-2 teaches a method of treating a cancer or precancer or of reducing the likelihood of the cancer developing resistance to a cancer therapeutic or prevention agent comprising administering a vaccine comprising a polynucleotide encoding a mutant HER2 and HER3 to a subject having the cancer or precancer, wherein administration of the vaccine to the subject treats the cancer or precancer, reduces the likelihood of the cancer or precancer developing resistance to the cancer therapeutic or prevention agent or reverses resistance of the cancer or precancer to the cancer therapeutic or prevention agent, wherein the cancer is HER2 positive. See claims 1, 5-7, 12 and 13 and p. 7-lines 15-20. Lyerly-2 teaches that the vaccine comprises a polynucleotide encoding a mutant HER2 polypeptide and a HER3 polypeptide in a vaccine vector. See claims 1, 5, 6, and 7 and p. 7-lines 15-20. Lyerly-2 teaches that the HER-3 polypeptide comprises SEQ ID NO: 7. See p. 7-lines 15-18. SEQ ID NO: 7 of Lyerly-2 comprise the claimed SEQ ID NO: 1 and 5. See Appendix of the Office Action of June 07, 2024. Lyerly-2 teaches that a HER3 vaccine can treat a HER2 positive cancer when used in combination with a therapeutic agent targeting HER2. See p. 10-lines 20-22. Lyerly-2 teaches that vaccination with a HER2 vaccine resulted in blocking resistance to HER2 targeting therapeutic agents, inhibited cancer cell growth and resulted in treatment of the cancer. See p. 10-lines 24-27. Lyerly-2 teaches that the vaccine is administered concurrently with, before or after administration of a checkpoint inhibitor immunomodulatory agent. See claim 16. Lyerly-2 teaches wherein the vaccine is administered concurrently with, before or after administration of the cancer therapeutic or prevention agent, wherein the therapeutic agent targets HER2, particularly trastuzumab. See claims 14, 15, and 26. Lyerly-2 teaches the cancer or precancer is selected from a breast, prostate, lung, ovarian, colon, rectal, pancreas, bladder, head and neck or liver cancer or precancer. See claim 18. Lyerly-2 teaches the administration results in decreased tumor growth rate or decreased tumor size after administration as compared to prior to administration. See claim 25. Lyerly-2 teaches that suitable vaccine vectors include, but are not limited to viral vectors such as adenoviral, fowl pox, vaccinia, VEE, etc. See p. 7-lines 6-9. Lyerly-2 teaches a combination of antibodies targeting CTLA4 and PD1 administered in combination with the Her2 vaccine had the most significant anti-tumor effect against HER2 expressing tumors. See paragraph bridging pp. 19-20 and Fig. 13. It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Lyerly-3 and Lyerly-2 and administer an anti-PD-1 agent and an anti-CTLA-4 agent with a vaccine vector encoding a HER3 polypeptide in the methods of Lyerly-3 because Lyerly-2 teaches a combination of antibodies targeting CTLA4 and PD1 administered in combination with a Her2 vaccine had the most significant anti-tumor effect against HER2 expressing tumors. Given the effectiveness of the of antibodies targeting CTLA4 and PD1 administered in combination with the Her2 vaccine at inhibiting tumor growth, one would have been motivated to administer an anti-PD-1 agent and an anti-CTLA-4 agent with a HER3 polypeptide of Lyerly-3 to enhance the anti-tumor activity of the treatments of Lyerly-3. Response to Arguments 5. Applicant argues that without acquiescing to the rejection, and solely to facilitate prosecution, claim 9 is amended to recite that the method comprises administering at least one vaccine vector encoding a HER3 polypeptide selected from SEQ ID NOs: 27-34. The HER3 intracellular domain peptides of SEQ ID NOs: 27-34 are not disclosed in the Lyerly-3 or Lyerly-2. As shown at FIGS. 14, 16, and 18 of the present application, these peptides provide the benefit of inducing a stronger immune response than the extracellular domain peptides (e.g. SEQ ID NOs: 5-22). Therefore, Applicant submits that claims 9-12, 15, 16, 18-25, 27, and 28 are not unpatentable over the cited references. Applicant’s arguments have been considered, but have not been found persuasive. Regarding the HER3 polypeptides SEQ ID NOs: 27-34, given the deletion of the consisting language from claim 9 and the comprising language of the claim, the HER3 polypeptides of SEQ ID NOs: 27-34 are interpreted to include polypeptides comprising SEQ ID NOs: 27-34. SEQ ID NO: 2 of Lyerly-3, which is the complete HER3 polypeptide, comprises SEQ ID NOs: 27-34. See Appendix. Thus, Lyerly-3 teaches the HER3 polypeptides of SEQ ID NOs: 27-34. Regarding the argument that SEQ ID NOs: 27-34 provide the benefit of inducing a stronger immune response than the extracellular domain peptides (e.g. SEQ ID NOs: 5-22) as shown in FIGS. 14, 16, and 18, the data do not compare the immune response of SEQ ID NOs: 27-34 to that of the complete HER3 polypeptide SEQ ID NO: 2, which comprises SEQ ID NOs: 27-34. The closest comparison is comparing the ICD peptides with the ECD+ICD peptides. In each example, the level of immune stimulation from the ICD peptides and the ECD+ICD peptides is roughly equivalent and thus not unexpected. See, e.g., Fig. 14A and 16A. Additionally, the specification does not clearly teach which ICD peptides of SEQ ID NOs: 27-34 were used in the cited examples. Furthermore, the instantly claimed SEQ ID NO: 31 comprises both the ECD and ICD domains. Thus the cited evidence is not sufficient to show the non-obviousness of the claimed invention. Therefore, when all of the evidence is considered, Applicant’s arguments are not found persuasive and the rejection is maintained for the reasons previously set forth and above. New Grounds of Rejection 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. 6. Claims 9-12, 15, 16, 18-25, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,487,143 (Nov. 26, 2019, IDS) in view of WO 2016/007499 A1 (Lyerly et al. Jan. 14, 2016, IDS), “Lyerly-2”. The ‘143 claims are drawn to: 1. A vector comprising a promoter operably connected to a first polynucleotide encoding a HER3 antigenic polypeptide consisting of the polypeptide of SEQ ID NO:2, SEQ ID NO:3 or a polypeptide having at least 90% sequence identity to SEQ ID NO: 2 or SEQ ID NO: 3. 2. The vector of claim 1, wherein the HER3 antigenic polypeptide consists of a polypeptide having at least 90% sequence identity to SEQ ID NO: 3. 3. The vector of claim 1, wherein the first polynucleotide is fused in frame to a second polynucleotide encoding a lactadherin polypeptide or portions thereof. 4. The vector of claim 3, wherein the lactadherin polypeptide comprises any one of SEQ ID NOS: 4-7 or a homolog thereof. 5. The vector of claim 1, wherein the vector is selected from the group consisting of an adenoviral vector, a fowlpox vector, a vaccinia vector, a VEE vector, a mini-circle DNA (mcDNA) vector, and a DNA-based vaccination vector. 6. A vaccine composition comprising the vector of claim 1 and a pharmaceutically-acceptable carrier. 7. The vaccine composition of claim 6, wherein the vaccine is capable of eliciting an immune response to a HER3 polypeptide when administered to a subject. 8. The vaccine composition of claim 7, wherein the immune response comprises a T cell mediated response. 9. A method of treating a cancer or precancerous cells or of reducing the likelihood of the cancer developing resistance to a cancer therapeutic or prevention agent in a subject comprising administering a therapeutically effective amount of the vector of claim 1 to the subject having the cancer or precancerous cells. 10. The method of claim 9, wherein the cancer is HER2 positive. 11. The method of claim 9, wherein the cancer or precancerous cells are selected from a breast, prostate, lung, ovarian, colon, rectal, pancreas, bladder, head and neck or liver cancer or precancerous cells. 12. The method of claim 9, wherein the subject develops an immune response to HER3. 13. The method of claim 12, wherein the immune response comprises a T cell mediated response. 14. The method of claim 9, wherein administration of the vector results in a reduction of HER3 expression on the cancer or precancerous cells after administration of the vector as compared to the level of HER3 on the cancer or precancerous cells prior to vaccination. 15. The method of claim 9, wherein administration of the vector results in decreased tumor growth rate or decreased tumor size after administration as compared to prior to administration. 16. The method of claim 9, further comprising administering a therapeutically effective amount of the cancer therapeutic or prevention agent to the subject. 17. The method of claim 16, wherein the vector is administered concurrently with, before or after administration of the cancer therapeutic or prevention agent. 18. The method of claim 16, wherein the cancer therapeutic or prevention agent is an agent targeting HER2, HER1, estrogen receptor, EGFR, or IGF1R. 19. The method of claim 16, wherein the cancer therapeutic or prevention agent is selected from the group consisting of trastuzumab, lapatinib, cetuximab, pertuzumab, and erlotinib. SEQ ID NO: 2 of the ‘143 claims is identical to the instantly claimed SEQ ID NO: 28. SEQ ID NO: 3 of the ‘143 claims is identical to the instantly claimed SEQ ID NO: 29. See Appendix. The ‘143 claims do not teach administering a checkpoint inhibitor or the HER3 polypeptides of claim 29. Lyerly-2 teaches as set forth above. It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘143 claims and Lyerly-2 and administer an anti-PD-1 agent and an anti-CTLA-4 agent with a vaccine vector encoding a HER3 polypeptide in the methods of the ‘143 claims because Lyerly-2 teaches a combination of antibodies targeting CTLA4 and PD1 administered in combination with a Her2 vaccine had the most significant anti-tumor effect against HER2 expressing tumors. Given the effectiveness of the of antibodies targeting CTLA4 and PD1 administered in combination with the Her2 vaccine at inhibiting tumor growth, one would have been motivated to administer an anti-PD-1 agent and an anti-CTLA-4 agent with a HER3 polypeptide of the ‘143 claims to enhance the anti-tumor activity of the treatments of the ‘143 claims. Additionally, it would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘143 claims and Lyerly-2 and the ‘143 claims and treat with an additional HER-3 polypeptide like SEQ ID NO: 7 of Lyerly-2, which comprise the claimed SEQ ID NO: 1 and 5, to further stimulate an anti-tumor immune response. One would have been motivated treat with an additional HER-3 polypeptide like SEQ ID NO: 7 of Lyerly-2 to optimize the treatment of the HER2 positive cancer Conclusion 7. All other objections and rejections recited in the Office Action of June 10, 2025 are withdrawn in view of Applicant’s amendments and arguments 8. No claims allowed. 9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action. 10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time 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, Janet L Epps-Smith can be reached on 571-272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Peter J Reddig/ Primary Examiner, Art Unit 1642 APPENDIX Alignment of SEQ ID NO: 27 with SEQ ID NO: 2 of Lyerly-3 Title: US-17-328-953-27 Perfect score: 43 Sequence: 1 LAEVPDLLE 9 Scoring table: BLOSUM62 Gapop 10.0 , Gapext 0.5 Searched: 1 seqs, 1342 residues Total number of hits satisfying chosen parameters: 1 Minimum DB seq length: 0 Maximum DB seq length: inf Post-processing: Minimum Match 0% Maximum Match 100% Listing first 1 summaries Database : AASEQ2_12232025_130458.pep:* SUMMARIES % Result Query No. Score Match Length DB ID Description ---------------------------------------------------------------------------- 1 43 100.0 1342 1 AASEQ2_12232025_130458 ALIGNMENTS RESULT 1 AASEQ2_12232025_130458 Query Match 100.0%; Score 43; DB 1; Length 1342; Best Local Similarity 100.0%; Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 LAEVPDLLE 9 ||||||||| Db 917 LAEVPDLLE 925 Alignment of SEQ ID NO: 28 with SEQ ID NO: 2 of Lyerly-3 Title: US-17-328-953-28 Perfect score: 80 Sequence: 1 YMVMVKCWMIDENI 14 Scoring table: BLOSUM62 Gapop 10.0 , Gapext 0.5 Searched: 1 seqs, 1342 residues Total number of hits satisfying chosen parameters: 1 Minimum DB seq length: 0 Maximum DB seq length: inf Post-processing: Minimum Match 0% Maximum Match 100% Listing first 1 summaries Database : AASEQ2_12232025_130711.pep:* SUMMARIES % Result Query No. Score Match Length DB ID Description ---------------------------------------------------------------------------- 1 80 100.0 1342 1 AASEQ2_12232025_130711 ALIGNMENTS RESULT 1 AASEQ2_12232025_130711 Query Match 100.0%; Score 80; DB 1; Length 1342; Best Local Similarity 100.0%; Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 YMVMVKCWMIDENI 14 |||||||||||||| Db 941 YMVMVKCWMIDENI 954 Alignment of SEQ ID NO: 29 with SEQ ID NO: 2 of Lyerly-3 ALIGNMENT: Query Match 100.0%; Score 68; Length 1342; Best Local Similarity 100.0%; Matches 12; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 VMVKCWMIDENI 12 |||||||||||| Db 943 VMVKCWMIDENI 954 Alignment of SEQ ID NO: 28 with SEQ ID NO: 2 of US 10,487,143 US-15-726-177-2 Sequence 2, US/15726177 Patent No. 10487143 GENERAL INFORMATION APPLICANT: DUKE UNIVERSITY APPLICANT: LYERLY, Herbert K. APPLICANT: OSADA, Takuya APPLICANT: HARTMAN, Zachary C. TITLE OF INVENTION: VACCINES AGAINST HER3 ANTIGENS AND METHODS OF USING THE SAME FILE REFERENCE: 5667-00415 CURRENT APPLICATION NUMBER: US/15/726,177 CURRENT FILING DATE: 2017-10-05 PRIOR APPLICATION NUMBER: US 62/404,538 PRIOR FILING DATE: 2016-10-05 NUMBER OF SEQ ID NOS: 11 SEQ ID NO 2 LENGTH: 14 TYPE: PRT ORGANISM: Artificial Sequence FEATURE: OTHER INFORMATION: Synthetic: HER3 Antigen 2 Query Match 100.0%; Score 80; Length 14; Best Local Similarity 100.0%; Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 YMVMVKCWMIDENI 14 |||||||||||||| Db 1 YMVMVKCWMIDENI 14 Alignment of SEQ ID NO: 29 with SEQ ID NO: 3 of US 10,487,143 US-15-726-177-3 Sequence 3, US/15726177 Patent No. 10487143 GENERAL INFORMATION APPLICANT: DUKE UNIVERSITY APPLICANT: LYERLY, Herbert K. APPLICANT: OSADA, Takuya APPLICANT: HARTMAN, Zachary C. TITLE OF INVENTION: VACCINES AGAINST HER3 ANTIGENS AND METHODS OF USING THE SAME FILE REFERENCE: 5667-00415 CURRENT APPLICATION NUMBER: US/15/726,177 CURRENT FILING DATE: 2017-10-05 PRIOR APPLICATION NUMBER: US 62/404,538 PRIOR FILING DATE: 2016-10-05 NUMBER OF SEQ ID NOS: 11 SEQ ID NO 3 LENGTH: 12 TYPE: PRT ORGANISM: Artificial Sequence FEATURE: OTHER INFORMATION: Synthetic: HER3 Antigen 3 Query Match 100.0%; Score 68; Length 12; Best Local Similarity 100.0%; Matches 12; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 VMVKCWMIDENI 12 |||||||||||| Db 1 VMVKCWMIDENI 12
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Prosecution Timeline

May 24, 2021
Application Filed
Sep 03, 2021
Response after Non-Final Action
Jun 04, 2024
Non-Final Rejection — §103, §DP
Oct 07, 2024
Response Filed
Nov 22, 2024
Final Rejection — §103, §DP
Mar 27, 2025
Request for Continued Examination
Mar 28, 2025
Response after Non-Final Action
Jun 06, 2025
Non-Final Rejection — §103, §DP
Oct 10, 2025
Response Filed
Dec 25, 2025
Final Rejection — §103, §DP
Feb 27, 2026
Interview Requested
Mar 06, 2026
Examiner Interview Summary
Mar 06, 2026
Applicant Interview (Telephonic)
Mar 30, 2026
Request for Continued Examination
Apr 01, 2026
Response after Non-Final Action

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