Prosecution Insights
Last updated: April 19, 2026
Application No. 18/249,545

COMPOSITION FOR THE TREATMENT OF BIOLOGICAL, CYTOLOGICAL, HISTOLOGICAL AND AUTOPSICAL SAMPLES

Non-Final OA §102§103§112
Filed
Apr 19, 2023
Examiner
FAN, LYNN Y
Art Unit
1759
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Diapath S P A
OA Round
1 (Non-Final)
47%
Grant Probability
Moderate
1-2
OA Rounds
3y 9m
To Grant
96%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allow Rate
221 granted / 472 resolved
-18.2% vs TC avg
Strong +49% interview lift
Without
With
+48.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
50 currently pending
Career history
522
Total Applications
across all art units

Statute-Specific Performance

§101
4.5%
-35.5% vs TC avg
§103
45.5%
+5.5% vs TC avg
§102
11.2%
-28.8% vs TC avg
§112
25.2%
-14.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 472 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Status of the Claims Claims 11-12 and 14-15 have been canceled. Claims 1-10, 13 and 16 are currently pending. Election/Restrictions Applicant’s election of Group II, Claims 6-10 and 16, and of species paraffin of about 50%, ethyl alcohol and isopropyl alcohol of about 20%, and isoparaffin of about 30%, in the reply filed on 9/11/2025 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 § 818.03(a)). The requirement is still deemed proper and is therefore made FINAL. Claims 1-5, 7-9 and 13 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Claims 6, 10 and 16 are being examined in this application, insofar as they read on the elected species of paraffin of about 50%, ethyl alcohol and isopropyl alcohol of about 20%, and isoparaffin of about 30%. Claim Objections Claim 16 is objected to because of the following informalities: the recitation of “andr” on line 3 is suggested to read “and”. Appropriate correction is required. Claim Rejections - 35 USC § 112 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 6, 10 and 16 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 pre-AIA the applicant regards as the invention. Claim 6, line 4, the recitation of “optionally” is indefinite as it is unclear if the limitation that follows is required to meet the scope of the invention. Claim 16, line 2-3 & 5, the percentage has no unit. 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 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. (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 6 and 10 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Buchta et al (US 2019/0358160 A1; 11/28/2019.). The instant claims recite a composition comprising paraffin, at least one alcohol selected from ethyl alcohol and isopropyl alcohol, at least one hydrocarbon selected from naphtha, octane, isoparaffin and limonene, and optionally 2,2-dimethoxypropane. Buchta teaches a composition (para 0202, 0205, 0210) comprising isoparaffin, paraffin, and mixtures thereof (para 0215), in an amount from about 1% to about 10% by weight (para 0213). Buchta teaches the composition comprises an organic solvent, wherein suitable organic solvent includes ethyl alcohol and isopropyl alcohol (para 0251), and the organic solvent is present in an amount from about 1% to about 20% by weight (para 0250). The composition does not comprise ketones. Therefore the reference anticipates the claimed subject matter. 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 of this title, 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. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Buchta et al (US 2019/0358160 A1; 11/28/2019.) as applied to claims 6 and 10 above. Buchta does not teach the composition comprises both ethyl alcohol and isopropyl alcohol as well as the claimed concentrations (claim 16). However, Buchta does teach the composition comprises an organic solvent, when necessary or desirable, facilitate solubilization of an active pharmaceutical ingredient (para 0249), and suitable organic solvents include ethyl alcohol and isopropyl alcohol (para 0251). In addition, Buchta does teach the composition comprises isoparaffin, paraffin, and mixtures thereof (para 0215), in an amount from about 1% to about 10% by weight (para 0213), and the organic solvent is present in an amount from about 1% to about 20% by weight (para 0250). Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate ethyl alcohol and isopropyl alcohol, when necessary or desirable, facilitate solubilization of an active pharmaceutical ingredient, as evidenced by Buchta. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration of the claimed components as a matter of routine experimentation. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate an optimized amount of paraffin, ethyl alcohol, isopropyl alcohol, and isoparaffin, with a reasonable expectation for successfully obtaining a composition. Conclusion No claims are allowed. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm. 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, Curtis Mayes can be reached on (571)272-1234. 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. /Lynn Y Fan/ Primary Examiner, Art Unit 1759
Read full office action

Prosecution Timeline

Apr 19, 2023
Application Filed
Oct 20, 2025
Non-Final Rejection — §102, §103, §112 (current)

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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
47%
Grant Probability
96%
With Interview (+48.7%)
3y 9m
Median Time to Grant
Low
PTA Risk
Based on 472 resolved cases by this examiner. Grant probability derived from career allow rate.

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