Prosecution Insights
Last updated: April 19, 2026
Application No. 18/566,383

THERAPEUTIC AGENTS AND METHODS FOR TREATMENT OF BARTONELLOSIS

Non-Final OA §102§103
Filed
Dec 01, 2023
Examiner
LAU, JONATHAN S
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Administrators Of The Tulane Educational Fund
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
3y 0m
To Grant
45%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
654 granted / 1028 resolved
+3.6% vs TC avg
Minimal -19% lift
Without
With
+-18.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
41 currently pending
Career history
1069
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
40.1%
+0.1% vs TC avg
§102
17.9%
-22.1% vs TC avg
§112
22.4%
-17.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1028 resolved cases

Office Action

§102 §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. This application is the national stage entry of PCT/US22/31899 , filed 02 June 2022 ; and claims benefit of provisional application 63/195,907 , filed 02 June 2021 . Claims 1-6 , 9-12 , 14-20, 22, and 24-25 are pending in the current application and are examined on the merits herein. 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. Claim s 1, 3, 9, 14, 16, and 18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Rolain et al. ( Antimicrobial Agents and Chemotherapy, 2004, 48(6), p1921-1933, provided by Applicant in IDS filed 16 Oct 2024). Rolain et al. discloses antibiotic treatment recommendations for diseases due to Bartonella species . Bartonella are facultative intracellular b acteria, and t hese diseases include Carrion’s disease caused by Bartonella bacilliformis , trench fever caused by Bartonella quintana , and cat scratch disease (CSD ) caused by Bartonella henselae (page 1921, left column, paragraph 1), implying that treatment of the disease would have been understood to result in reducing the intracellular levels of the bacteria, and addressing limitations of claims 1, 9, and 14. Rolain et al. discloses working embodiments of the regimens for treatment of infections caused by Bartonella species include treatment of CSD with azithromycin, treatment of trench fever with a combination of doxycycline and gentamicin, and treatment of endocarditis with a combination of gentamicin and ceftriaxone or a combination of doxycycline and gentamicin (page 1927, table 6), meeting limitations of claims 1, 3, 9, 14, 16, and 18. Claim Rejections - 35 USC § 103 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. Claim s 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rolain et al. (Antimicrobial Agents and Chemotherapy, 2004, 48(6), p1921-1933, provided by Applicant in IDS filed 16 Oct 2024). Rolain et al. teaches as above regarding claims 1, 3, 9, 14, 16, and 18. Rolain et al. further teaches the in vitro MICs for the different groups of antibiotics for different Bartonella sp. s trains (page 1924, table 3; page 1922, right column, paragraph 2). Gentamicin was bactericidal at 4 μ g/ml, as was rifampin. At this concentration, gentamicin was shown to enter erythrocytes slowly and to reach a peak level of 0.26 μ g/ml after 24 h (paragraph spanning pages 1922-1923) . Rolain et al. further teaches MICs correlate poorly with the in vivo efficacies of antibiotics in patients with Bartonella -related infections , and the different niches that Bartonella occupies in the human host , e.g., sequestration in erythrocytes, may explain such discrepancies between in vitro and clinical data (paragraph spanning pages 1923-1924). Rolain et al. does not specifically disclose the method comprising administering to the subject in need thereof one or more therapeutic agents, wherein the one or more therapeutic agents is at a concentration of from about 0.001 μg/ml to about 5 μg/ml (claim 10 and 17) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rolain et al. in order to select the optimal concentration of the antibiotic through routine experimentation. One of ordinary skill in the art would have been motivated to modify the teachings of Rolain et al. with a reasonable expectation of success because Rolain et al. teaches the in vivo MICs of the antibiotics, and teaches the example of g entamicin being bactericidal at 4 μ g/ml and reach ing a peak level of 0.26 μ g/ml in erythrocytes , suggesting it would have been routine experimentation by one of ordinary skill in the art to determine the optimal concentration of the antibiotic to be effective. See also MPEP 2144.05 at II. providing “ Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ” In this case Rolain et al. teaches the general conditions of the claim regarding the effective concentration of the antibiotic to treat Bartonella infection, suggesting it would have been routine experimentation to discover the optimum or workable concentration range. Claims 2 , 4-6, 11-12, 19-20, 22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rolain et al. (Antimicrobial Agents and Chemotherapy, 2004, 48(6), p1921-1933, provided by Applicant in IDS filed 16 Oct 2024) as applied to claim s 1, 3, 9-10, 14, and 16-18 above, and further in view of Sanders ( Journal of Antimicrobial Chemotherapy , 1983 , 11 , Suppl. B, p 21 -31, cited in PTO-892) . Rolain et al. teaches as above. Rolain et al. further teaches Penicillin G has been used to treat Oroya fever (acute Carrion’s disease) . In a large series of acute cases of Oroya fever reported, all 23 patients who received chloramphenicol with another antibiotic were cured, whereas 6 of 42 patients treated with chloramphenicol alone failed therapy and needed penicillin (page 1929, right column, paragraph 4). Rolain et al. further teaches various antibiotics, including doxycycline and amoxicillin, appeared to be effective in reducing the bacterial count in blood in feline animal models (page 1923, right column, paragraph 2). A moxicillin has also been used to treat chronic bacteremia clinically (page 1925, table 4). Rolain et al. does not specifically teach the method wherein the therapeutic agent comprises azlocillin (claim 2, 4, 11, 19, and 24). Sanders teaches a zlocillin is a new semisynthetic penicillin with a broad spectrum of antibacterial activity (page 21, abstract) . Historically, as the penicillin molecule was chemically modified to extend its antibacterial spectrum, the resultant antibiotic lost potency against organisms susceptible to narrower spectrum drugs of this class . In contrast to antipseudomonas penicillins, azlocillin and mezlocillin exemplify the new broad spectrum penicillins that retain activity against many fastidious organisms (page 21, paragraph 1) . Azlocillin is bactericidal for susceptible strains. Like many other inhibitors of cell wall biosynthesis, azlocillin binds to numerous penicillin-binding proteins . The bactericidal effects of azlocillin, in comparison with other penicillins, can be readily demonstrated in quantitative tests with both Gram-positive and Gram-negative bacteria (page 25, paragraphs 3-4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Rolain et al. in view of Sanders in order to substitute the penicillin such as Penicillin G or amoxicillin to be a zlocillin , or to further combine treatment with azithromycin and azlocillin. One of ordinary skill in the art would have been motivated to combine Rolain et al. in view of Sanders with a reasonable expectation of success because Rolain et al. teaches selecting the antibiotic used for the treatment of Bartonella infection such as different penicillins or azithromycin, and teaches the use of combinations of antibiotic s in this treatment, and Sanders teaches a zlocillin is a semisynthetic penicillin with a broad spectrum of antibacterial activity , suggesting it would have been obvious to combine Rolain et al. in view of Sanders in order to select the antibiotic used for the treatment of Bartonella infection to be the penicillin a zlocillin or the combination of azithromycin and the penicillin a zlocillin . Regarding the concentrations of the antibiotic s, Rolain et al. teaches the in vivo MICs of the antibiotics, and teaches the example of g entamicin being bactericidal at 4 μ g/ml and reach ing a peak level of 0.26 μ g/ml in erythrocytes , suggesting it would have been routine experimentation by one of ordinary skill in the art to determine the optimal concentration of the antibiotic to be effective. Conclusion No claim is found to be allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Jonathan S Lau whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3531 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 9a-5p Eastern . 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 Scarlett Goon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)270-5241 . 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. /JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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Prosecution Timeline

Dec 01, 2023
Application Filed
Mar 05, 2026
Non-Final Rejection — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
45%
With Interview (-18.8%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 1028 resolved cases by this examiner. Grant probability derived from career allow rate.

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