Prosecution Insights
Last updated: August 06, 2026
Application No. 18/280,930

METHODS AND COMPOSITIONS FOR TREATING OR PREVENTING A DISEASE OR A CONDITION

Non-Final OA §102§103§112
Filed
Sep 07, 2023
Priority
Mar 25, 2021 — provisional 63/165,793 +1 more
Examiner
PAK, JOHN D
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Libi Pharm Ltd.
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
2m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
524 granted / 1004 resolved
-7.8% vs TC avg
Strong +38% interview lift
Without
With
+37.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
37 currently pending
Career history
1041
Total Applications
across all art units

Statute-Specific Performance

§101
3.2%
-36.8% vs TC avg
§103
42.0%
+2.0% vs TC avg
§102
13.4%
-26.6% vs TC avg
§112
29.2%
-10.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1004 resolved cases

Office Action

§102 §103 §112
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 . Claims 1-21 are pending in this application. Applicant’s election of the invention of group I, claims 1-5, in the reply filed on 5/31/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The Office action of 12/3/2025 further required election of a species from claim 1, a species from claim 2, and a species from claim 3; and Applicant elected linalyl acetate (claim 1), carene-2 (claim 2), and selenium (claim 3). Applicant is advised that the examined species from claim 2 is expanded to include carene-2, thymol, and/or α-humulene. Claims 6-21 are withdrawn from further consideration as being directed to non-elected subject matter. Claims 1-5 will presently be examined to the extent that they read on linalyl acetate (claim 1), carene-2, thymol, and/or α-humelene (claim 2), and selenium (claim 3). 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. (1) In claim 1, “Cinnamicaldehyde” is not proper nomenclature for a chemical substance. If cinnamic aldehyde were intended, space between the second c and the second a should be inserted. (2) In claim 2, the following two substances are indefinite. The provided nomenclature is vague and confusing as to what substances are intended. PNG media_image1.png 86 422 media_image1.png Greyscale (3) Also in claim 2, “Carene-2” is not the standard nomenclature for the compound that is 3,7,7-trimethylbicyclo[4.1.0]hept-2-ene. Though “carene-2” is used sometimes in literature, such nomenclature inverts the convention of placing the position prefix directly before the parent name. The correct nomenclature is 2-carene. (4) Claim 2 recites menthol as a “further” ingredient, but menthol is already recited in claim 1. Clarification is required. (5) Claim 4 is confusing in that it is directed to a composition but recites treatment by an acid for an ingredient. The full metes and bounds of the claims are unclear. Dependent claims are included here because they do not cure the deficiency of the base claims. 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)(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. Claims 1, 2, and 5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fishman et al. (WO 2021/206688; hereinafter, Fishman). Fishman claims a composition that contains, inter alia (see claim 6): 9-12% linalyl acetate, 0.3-0.7% neral, 0.05-0.1% citronellal, 1-2% citronellol, 0.3-0.7% methylchavicol (synonym for estragole), 0.3-0.7% teripn-4-ol, 0.2-0.5% thymol, 0.3-0.7% α-humulene, 0.5-1% geranial. It is noted that the instant claim 1 requires “beta-citronellol.” Beta-citronellol and citronellol refer to the same substance. See the SciFinder entry for citronellol (PTO-892, Non-Patent Document U). This is permissible use of another reference to show that the Examiner’s interpretation of the prior art is correct. MPEP 2131.01. The claims are thereby anticipated. 35 U.S.C. 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. 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. Claims 1-2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Coppens (WO 2011/117424). Coppens discloses compositions for use in prophylaxis or treatment of diseases caused by viruses (page 1, see under “Field of the invention”), including viruses such as human coronavirus E (page 10, line 5), human coronavirus OC (page 10, line 6), hepatitis C virus (pages 45, 47), many different types of herpes viruses (pages 6-15; page 45, line 4; pages 50, 53, 83-88), line human papillomavirus (page 10, line 10; page 45, line 5; pages 49, 88; claim 1), and diseases such as severe acute respiratory syndrome (page 18, line 11), papilloma (page 5, line 29). Coppens’ composition comprises (-)-carvone, (+)-carvone, trans-geraniol, and “at least one more component selected from essential oil components, including (claims 1-2): linalyl acetate (page 97), citral (page 96), citronellal (page 95), citronellol (page 95)1, estragole (page 97), and 2-carene (page 95). The essential oils are from natural sources, e.g., plants (page 16, lines 1-6). Even though Coppens does not specify “neral,” citral is disclosed. Citral is actually a mixture of the geometric isomers cis-citral (known as neral) and trans-citral (known as geranial). It is noted that beta-citronellol and citronellol synonyms for the same substance. Additional use as a disinfectant is disclosed (claim 10; page 18, line 23). Formulation as a solid, cream, foam, liquid, or aerosol is disclosed (page 18, lines 24-29). Coppens does not explicitly disclose a working example of a composition that contains linalyl acetate, neral, citronellal, beta-citronellol, estragole, and at least “carene-2.” However, Coppens discloses the use of numerous essential oil compounds, including the claimed essential oil compounds, in combination to treat or reduce viruses and diseases caused by viruses. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited reference. Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Coppens (WO 2011/117424) in view of Burke (US 7,311,928) and AT 412703. Coppens discloses compositions for use in prophylaxis or treatment of diseases caused by viruses (page 1, see under “Field of the invention”), including viruses such as human coronavirus E (page 10, line 5), human coronavirus OC (page 10, line 6), hepatitis C virus (pages 45, 47), many different types of herpes viruses (pages 6-15; page 45, line 4; pages 50, 53, 83-88), line human papillomavirus (page 10, line 10; page 45, line 5; pages 49, 88; claim 1), and diseases such as severe acute respiratory syndrome (page 18, line 11), papilloma (page 5, line 29). Coppens’ composition comprises (-)-carvone, (+)-carvone, trans-geraniol, and “at least one more component selected from essential oil components, including (claims 1-2): linalyl acetate (page 97), citral (page 96), citronellal (page 95), citronellol (page 95)2, estragole (page 97), and 2-carene (page 95). The essential oils are from natural sources, e.g., plants (page 16, lines 1-6) such as tea tree oil (page 16, lines 3-4 from the bottom). Even though Coppens does not specify “neral,” citral is disclosed. Citral is actually a mixture of the geometric isomers cis-citral (known as neral) and trans-citral (known as geranial). It is noted that beta-citronellol and citronellol are synonyms for the same substance. Additional use as a disinfectant is disclosed (claim 10; page 18, line 23). Formulation as a solid, cream, foam, liquid, or aerosol is disclosed (page 18, lines 24-29; page 54, last six lines). Burke (US 7,311,928) teaches the combination of selenium and tea tree oil for treatment of virus-induced skin lesions such as human papillomavirus and herpes virus (column 9, lines 50-64; see also column 3, lines 23-27, 43-50; column 6, lines 23-31). Application to the location of the skin lesions, genital tract, and/or skin warts is disclosed (id.). Example 9 discloses an embodiment wherein HPV (human papilloma virus) is treated in a female subject with a composition comprising selenium, tea tree oil, and iodine (see Example 1). See also claims 1-5 and 7. AT 4127033 discloses selenium compounds and an acid such as citric acid or various other acids for treatment of infections with papilloma viruses (claim 1), wherein the pH can be less than 7 (claim 2). Formulation as an ointment (claim 3), gel or emulsion (claim 4) is disclosed. Selenium is disclosed as possessing a protective function against oxidation (page 3, last two lines)4. Combination of inorganic selenium compounds with acids provides a composition with increased antioxidant potential (machine translation page 5, last line, to page 6, line 17). For example, acidified sodium selenite solution is shown (Example 1 on machine translation page 8). Treatment of herpes simplex infection (Examples 1 and 2 on machine translation pages 8-9) and papillomavirus infection (page 8, lines 12-14; Example 6 on machine translation page 12) Coppens does not explicitly disclose a working example of a composition that contains linalyl acetate, neral, citronellal, beta-citronellol, estragole, 2-carene and selenium. However, Coppens discloses the use of numerous essential oil compounds, including linalyl acetate, neral as a component of citral, citronellal, citronellol, estragole, and 2-carene, in combination to treat or reduce viruses and diseases caused by human papillomavirus and herpes viruses. Both Burke and AT 412703 teach selenium compounds to treat infections causes by herpes viruses and papillomaviruses. AT 412703 further teaches the advantage of acidifying selenium for increased activity. The ordinary skilled artisan would have found it obvious to combine selenium or acidified selenium with the essential oil compounds linalyl acetate, neral, citronellal, beta-citronellol, estragole, and 2-carene, because all of the components have been taught by the prior art for treatment of diseases caused by viruses, including herpes viruses and papilloma viruses, and the combination would have been expected to provide benefit to subjects in need of treatment for infections caused by herpes viruses and papilloma viruses. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited references. For the foregoing reasons, all claims under examination must be rejected. No claim is allowed. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. 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 Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /JOHN PAK/Primary Examiner, Art Unit 1699 1 Both (+)- and (-)-citronellol are disclosed on page 95. 2 Both (+)- and (-)-citronellol are disclosed on page 95. 3 Machine translation is provided herewith. 4 Page numbers used in this Office action for AT 412703 are at the upper right corner of each page. Please ignore the page numbers at the bottom, which were generated by machine translation.
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Prosecution Timeline

Sep 07, 2023
Application Filed
Jul 23, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
52%
Grant Probability
90%
With Interview (+37.6%)
3y 1m (~2m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1004 resolved cases by this examiner. Grant probability derived from career allowance rate.

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