Office Action Predictor
Last updated: April 17, 2026
Application No. 18/043,241

HAEMOPHILUS INFLUENZAE VACCINE AND METHODS OF USE

Non-Final OA §103
Filed
Feb 27, 2023
Examiner
SHAHNAN SHAH, KHATOL S
Art Unit
1645
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
the rochester general hospital
OA Round
1 (Non-Final)
63%
Grant Probability
Moderate
1-2
OA Rounds
3y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
290 granted / 463 resolved
+2.6% vs TC avg
Strong +54% interview lift
Without
With
+53.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
29 currently pending
Career history
492
Total Applications
across all art units

Statute-Specific Performance

§101
4.8%
-35.2% vs TC avg
§103
39.5%
-0.5% vs TC avg
§102
21.3%
-18.7% vs TC avg
§112
21.8%
-18.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 463 resolved cases

Office Action

§103
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. 2. Applicant’s amendment of 2/27/2023 is acknowledged. Claims 1-2,4-5,8,10-11,13-14,16-20,22-23,25-27,29-32,36,38-39 and 55 are pending. Claims 3, 6-7, 9, 12, 15, 21, 24, 28, 33-35, 37 and 40-54 have been canceled . Status of the Claims 3 . Claims 1-2,4-5,8,10-11,13-14,16-20,22-23,25-27,29-32,36,38-39 and 55 are pending in this application Drawings 4 . The drawings in this application filed 2 / 23 /202 3 are accepted by the examiner. Information Disclosure Statement 5 . The information disclosure statement filed 5/28/2025 ha s been considered. I nitialed cop ies are enclosed. However, t he listing of references in the specification (pages 33-34 ) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Election /Restrictions 6. Applicants ’ election with traverse of 11 / 3 /2025 is acknowledged. Applicants elected invention I I (claims 18-20,22-23,25-27 and 29 ) drawn to a vaccine . The traversal is on the ground of that applicants argue that Green reference do not teach every element of claim 1, suc h as Omp26, PD or PF. However, the Vandepapliere (US 20170068715 A1) reference teaches each and every element of claim 1. Vandepapliere teaches limitations of claim 1, a fusion proteins of antigens derived from Haemophilus spp., including H. influenzae type B including p6 and Omp26 which are lipidated (para (0228] - "Preferred bacterial compositions comprise antigens derived from Haemophilus spp., including H. influenzae type B (for example PRP and conjugates thereof), non-typeable H. influenzae, for example OMP26, high molecular weight adhesins, P 5 , P6, protein D and lipoprotein D derived peptides para (0132) - "Suitably soluble antigens are outside and hydrophobic or lipidated antigens are either contained inside or ou tside "} see para 0132, 0231,0241 . Vandepapliere teaches limitations of claim 18 vaccines derived from Haemophilus spp., including H. influenzae type B including p6 and Omp26 which are lipidated ( see para 0003, 0028,0029, 0228 and claim 6 ) . In this case, the first appearing technical feature does not define a contribution over the prior art. Therefore the requirement is still deemed proper and is therefore made FINAL. C laims 2, 4-5,8,10-11, 13-14, 16-17 and 55 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. Claim 1 is going to be examined because claim 18 depends from claim 1. Claims 1 , 18-20,22-23,25-27 and 29 are under consideration. Claim Rejections - 35 USC § 103 7. 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. 8. Claims 1, 18-20,22-23,25-27 and 29 is/are rejected under 35 U.S.C. 103 as being obvious over Vandepapliere (US 20170068715 A1) and further in view of Pichchero et al. (WO2012170356). The claims are drawn to: Claim 1. A fusion protein comprising all or part of two or more Haemophilus influenzae (Hi) proteins selected from the group consisting of Omp26, P6, PD and PF, wherein at least one of the Hi proteins is lipidated . Claim 18. A vaccine comprising the fusion protein of claim 1. Claim 19. The vaccine of claim 18, wherein the fusion protein in the vaccine elicits an antibody response against the lipidated Hi protein and at least one non- lipidated Hi proteins. Claim 20. The vaccine of claim 18, wherein at least 10% of the fusion proteins in the vaccine comprises a diacyl fatty acid and/or wherein at least 10% of the fusion proteins in the vaccine comprises a triacyl fatty acid. Vandepapliere teaches limitations of claim 1, a fusion proteins of antigens derived from Haemophilus spp., including H. influenzae type B including p6 and Omp26 which are lipidated (para (0228]. Vandepapliere teaches that "Preferred bacterial compositions comprise antigens derived from Haemophilus spp., including H. influenzae type B (for example PRP and conjugates thereof), non -typeable H. influenzae, for example OMP26, high molecular weight adhesins, P5, P6, protein D and lipoprotein D, or multiple copy variants or fusion proteins thereof."; para (0132). Vandepapliere teaches further that "Suitably soluble antigens are outside and hydrophobic or lipidated antigens see para 0132,0231,0241. Vandepapliere teaches limitations of claim 18 vaccines derived from Haemophilus spp., including H. influenzae type B including p6 and Omp26 which are lipidated ( see para 0003, 0028,0029, 0228 and claim 6). Vandepapliere teaches limitations of claim 19 to generate lipidated fusion proteins of Omp26 and P6 H. influenzae , in order to increase the immunogenicity of these antigens. Vandepapliere teaches non- lipidated proteins (par 0241). Vandepapliere teaches limitations of claim 20 highly acylated fatty acids ( see para 0014). Vandepapliere teaches limitations of claim 25, administration of vaccine to a subject ( para 0151, 0246). Vandepapliere teaches limitations of claim 26 infection, otitis, pneumonia (see para 0025, 0163, 0252-269). Vandepapliere teaches limitations of claim 27, orally, intramuscularly. Intranasally and subcutaneously (see para 0281, 0295, 0299). Additionally, Pichchero et al. teach Vaccines and immunogenic fusion proteins from H.influenzae P6, PD and Omp26 proteins ( see claims 1, 18, 16, 18, 20, 21, 23, 31 and pages 1, 7,8, 9, 15, 21, 22, 23, 45, 53, 54, 68, 69, 70, 71, 72, 73, 74, 75, 83, 89 and example 1.). Pichchero et al. teach lapidated proteins see page 91. Pichchero et al. teach COPD , Otitis, sinusitis, bronchitis, pneumonia see claim 35, page 71 and 76. Pichchero et al. teach oral, intranasal, intramuscular, subcutaneous injection see claim 28 and pages 31 and 53. As to claim 29, Pichchero et al. teach mixture of two proteins ( see page 3 claims 23, 33). As to clams 20 and 23 Pichchero et al. teach triacyl fatty acids ( see page 11). The advantage of including Pichchero et al. is that it teaches mixture of two proteins for treatment of multiple diseases including COPD and pneumonia( see claim 35). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of the cited references to obtain the instant invention. Since Vandepapliere teaches specifically vaccines and fusion proteins comprising lipidated forms of P6 and Omp26, it would have been obvious to one of ordinary skill in the art to have applied teachings of Pichchero et al., who also teach Vaccines and immunogenic fusion proteins from Influenzas P6, PD and Omp26 proteins. The advantage of including Pichchero et al. is that it teaches mixture of two proteins P6 and Omp26for treatment of multiple diseases including COPD and pneumonia( see claims). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the teaching of references to include the mixed composition of claim 29, because Pichchero et al. teach mixture of two proteins. The advantage of combing Pichchero et al. and Vandepepliere is that Pichchero et al teach mixture of two proteins P6 and Omp26for treatment of multiple diseases including COPD and pneumonia ( see claims) and Vandepapliere teaches limitations of claim 18 vaccines derived from Haemophilus spp., including H. influenzae type B including p6 and Omp26 which are lapidated and highly aclylated lipids ( see para 0003, 0014, 0028,0029, 0228 and claim 6). Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to include or exclude a protein in an immunogenic composition or a vaccine thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known compositions that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary. Conclusion 9 . No claims are allowed. 10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KHATOL S SHAHNAN SHAH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0863 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Tue, Thurs-Fri 12pm-8pm . 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 Daniel E. Kolker can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272 -3181 . 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. KHATOL SHAHNAN -SHAH/ Examiner, Art Unit 1645 December 6, 2025 /JANA A HINES/ Primary Examiner, Art Unit 1645
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Prosecution Timeline

Feb 27, 2023
Application Filed
Dec 06, 2025
Non-Final Rejection — §103
Mar 23, 2026
Response Filed

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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
63%
Grant Probability
99%
With Interview (+53.8%)
3y 7m
Median Time to Grant
Low
PTA Risk
Based on 463 resolved cases by this examiner. Grant probability derived from career allow rate.

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