Prosecution Insights
Last updated: April 19, 2026
Application No. 18/042,376

DEVICE FOR BIOLOGICAL CULTURES

Non-Final OA §102§112
Filed
Feb 21, 2023
Examiner
LEPAGE, JONATHAN EVERETT
Art Unit
1796
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Ospedale San Raffaele S R L
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
3y 8m
To Grant
92%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allow Rate
26 granted / 50 resolved
-13.0% vs TC avg
Strong +40% interview lift
Without
With
+40.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
27 currently pending
Career history
77
Total Applications
across all art units

Statute-Specific Performance

§103
43.3%
+3.3% vs TC avg
§102
25.2%
-14.8% vs TC avg
§112
29.4%
-10.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 50 resolved cases

Office Action

§102 §112
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 . Election/Restrictions Applicant's election with traverse of Group I in the reply filed on 02/17/2026 is acknowledged. The traversal is on the ground(s) that Unity of Invention does exist between Groups I-VI because there is a technical relationship that involves the same special technical feature and search of all of the claims would not impose a serious burden on the examiner. This is not found persuasive because the special technical feature of Groups I-VI does not make a contribution over the prior art as stated on Page 4 of the Office Action dated 12/17/2025. Further, the section of the MPEP, 803, in which the applicant cites applies to applications filed under 35 USC 111(a). However the present application was not filed under 35 USC 111(a) and therefore requirement of the restricted groups being independent or patentably distinct and there being a serious search burden placed on the examiner does not apply. See MPEP 1896 regarding the difference in restriction practice for applications under 35 USC 111(a) and 35 USC 371. The requirement is still deemed proper and is therefore made FINAL. Claims 4-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/17/2026. 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 1-3 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. Regarding Claim 1, lines 4-5 state “at least one layer consisting of highly hydrophobic, inert, and biocompatible material, with contact angle > 90 degrees, hydrophobic layer;”. The term “hydrophobic layer” at the end seems misplaced and makes the sentence unintelligible. Further clarification is requested. For examination purposes, it is being interpreted as “at least one layer consisting of highly hydrophobic, inert, and biocompatible material, with contact angle > 90 degrees;”. Claims 2-3 are further rejected as they depend from Claim 1. Claim Rejections - 35 USC § 102 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. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halverson (US20190085282A1). Regarding Claim 1, Halverson teaches the following: A thin film culture device (cartridge adapted to house at least one biological sample) with at least two overlapping layers (Fig. 2, below) which can include a spacer 24 which is made of polyethylene foam or any material that is hydrophobic, inert to microorganisms and can be sterilized (para 60)(one layer consisting of highly hydrophobic, inert, and biocompatible material, with a contact angle >90 degrees). Note: Hydrophobic materials have a contact angle of 90 degrees by definition. The spacer can be coupled via an adhesive to the first substrate 12 (para 60)(one layer of double sided adhesive) The spacer defines a circular hole (one inner hole); since the adhesive only attaches the spacer to the substrate, the hole would necessarily be in the adhesive layer as well and the hole 26 would remain pervious when said layers overlap one another (see Fig. 2, below) PNG media_image1.png 258 260 media_image1.png Greyscale The walls of the hole provide a well of predetermined size and shape over the growth region of the culture device and the space is thick enough depending on the size of the sample to be placed on the medium (at least one inner hole is closed by the biological sample where loaded in said cartridge) Regarding Claim 2, Halverson teaches all of the limitations of Claim 1 (see above). Halverson further teaches a permeable membrane 14 which is fixed to and is coextensive with at least a growth region of the upper surface of the first substrate (para 32)(at least one membrane adapted to support said at least one biological sample). Regarding Claim 3, Halverson teaches all of the limitations of Claim 1 (see above). Halverson further teaches a water resistant first substrate 12, and a water-resistant second substrate 18 (para 32) and adhesive layers 20 and 20’ (para 59)(also see annotated Fig. 2, reproduced below)(at least four overlapping layers, wherein two hydrophobic layers enclose two layers of double sided adhesive material and said biological sample, where present, is housed between said two layers of double-sided adhesive material). PNG media_image2.png 549 712 media_image2.png Greyscale Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET. 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, Michael Marcheschi can be reached at 571-272-1374. 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. /J.E.L./Examiner, Art Unit 1796 /MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
Read full office action

Prosecution Timeline

Feb 21, 2023
Application Filed
Mar 13, 2026
Non-Final Rejection — §102, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12590277
HIGH-THROUGHPUT ACOUSTOFLUIDIC FABRICATION OF CELL SPEROIDS
2y 5m to grant Granted Mar 31, 2026
Patent 12584122
MEDICAL DEVICE FOR CULTURING BIOLOGICAL SAMPLE AND EMBEDDING BIOLOGICAL SAMPLE IN EMBEDDING MATERIAL, KIT, AND CULTURING AND EMBEDDING METHOD
2y 5m to grant Granted Mar 24, 2026
Patent 12575558
PACKAGING SYSTEM FOR A MEDICAL PRODUCT
2y 5m to grant Granted Mar 17, 2026
Patent 12540301
CELL CULTURE DEVICE
2y 5m to grant Granted Feb 03, 2026
Patent 12507692
ORGAN CONTAINER
2y 5m to grant Granted Dec 30, 2025
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
52%
Grant Probability
92%
With Interview (+40.3%)
3y 8m
Median Time to Grant
Low
PTA Risk
Based on 50 resolved cases by this examiner. Grant probability derived from career allow rate.

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