Prosecution Insights
Last updated: April 19, 2026
Application No. 18/085,606

STERILIZATION METHOD FOR MEDICAL RUBBER PART

Non-Final OA §112
Filed
Dec 21, 2022
Examiner
YOO, REGINA M
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Sumitomo Rubber Industries, Ltd.
OA Round
3 (Non-Final)
64%
Grant Probability
Moderate
3-4
OA Rounds
3y 4m
To Grant
69%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
562 granted / 884 resolved
-1.4% vs TC avg
Moderate +6% lift
Without
With
+5.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
61 currently pending
Career history
945
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
35.6%
-4.4% vs TC avg
§102
21.1%
-18.9% vs TC avg
§112
34.6%
-5.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 884 resolved cases

Office Action

§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 . DETAILED ACTION Response to Amendment The amendment filed on 2/09/2026 has been received and claims 1-5 and 8-17 are pending. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/06/2026 has been entered. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-5 and 8-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, in claim 1 there is no written description support for the newly added limitation that the “rubber composition consist[s] essentially of: (a) a base polymer; (b) the polyethylene in a form of fine powder; (c) a triazine derivative as a crosslinking agent; and optionally (d) a filler” within the Specification, particularly as the disclosure (such as Table 1 as well as pp. 11-12 [0057] and p. 13 [0063] of Specification) appears to show that other components such as acid acceptor (hydrotalcite and MgO) and a colorant such as titanium oxide or carbon black and/or plasticizer/oil appear to be present in significant quantity (i.e. at least in the same magnitude as a triazine derivative which is not an optional component). 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 and 8-17 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. In Claim 1, it is not clear whether the claimed elastomer being “a cured produce of a rubber composition consist[s] essentially of” only the components along with “optionally (d) a filler” without including any other additives comprising a significant proportion. In addition, in claim 1 it is not clear whether the limitation that “the packaging article accommodates a plurality of medical rubber parts comprising the medical rubber part made from the elastomer” is attempting to set forth that that the packaging article is capable of containing/accommodating multiple medical rubber parts but only comprises the one medical rubber part made from the elastomer or the packaging article contains a plurality of medical rubber parts all made from the elastomer or that the plurality of medical rubber parts accommodated within the packaging article comprises one medical rubber part made from the elastomer with the other medical rubber parts made from another material. In Claim 10, it is not clear which one of the “plurality of medical rubber part” the limitation “the medical rubber part” in line 3 is attempting to point to. Claims 2-5, 8-9, and 11-17 are rejected due to their dependence on a rejected claim, Response to Arguments Applicant’s arguments with respect to claim(s) 1-5 and 8-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: JP5024694 and JP2003147138 (a radiation sterilizable medical material), JP2007054621 (a medical rubber product made from a composition comprised of polyethylene fine powder and halogenated butyl rubber using a triazine thiol derivative as a vulcanizing agent), JP2002301133 (a medical rubber product made from a composition comprised of polyethylene powder, rubber, magnesium oxide, and triazine). Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST. 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, Maris Kessel can be reached at (571)270-7698. 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. /REGINA M YOO/ Primary Examiner, Art Unit 1758
Read full office action

Prosecution Timeline

Dec 21, 2022
Application Filed
May 31, 2025
Non-Final Rejection — §112
Sep 16, 2025
Applicant Interview (Telephonic)
Sep 16, 2025
Examiner Interview Summary
Sep 25, 2025
Response Filed
Dec 29, 2025
Final Rejection — §112
Feb 09, 2026
Response after Non-Final Action
Mar 06, 2026
Request for Continued Examination
Mar 10, 2026
Response after Non-Final Action
Mar 13, 2026
Non-Final Rejection — §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

3-4
Expected OA Rounds
64%
Grant Probability
69%
With Interview (+5.7%)
3y 4m
Median Time to Grant
High
PTA Risk
Based on 884 resolved cases by this examiner. Grant probability derived from career allow rate.

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