Prosecution Insights
Last updated: April 19, 2026
Application No. 19/071,069

Catheter Assemblies with Interfacial pH Controller

Non-Final OA §112§DP
Filed
Mar 05, 2025
Examiner
GEHMAN, BRYON P
Art Unit
3736
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Hollister Incorporated
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
2y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allow Rate
1435 granted / 1949 resolved
+3.6% vs TC avg
Strong +31% interview lift
Without
With
+30.8%
Interview Lift
resolved cases with interview
Fast prosecutor
2y 1m
Avg Prosecution
46 currently pending
Career history
1995
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
51.0%
+11.0% vs TC avg
§102
5.5%
-34.5% vs TC avg
§112
23.7%
-16.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1949 resolved cases

Office Action

§112 §DP
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 . Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The abstract of the disclosure is objected to because it describes nothing new in the art. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). 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. Claims 5 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. In claims 5 and 19, the word "preferably" renders the claim indefinite because it is unclear whether the limitations following the word are part of the claimed invention. See MPEP § 2173.05(d). The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-3, 16 and 20 are rejected on the ground of nonstatutory double patenting over claim 13 of U.S. Patent No.12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: Each claims a catheter assembly comprising a catheter, within a package, with at least a portion of the catheter having a hydrophilic surface, a sleeve (in claim 13 of the parent) associated with an interfacial pH controller and surrounding at least a section of an outer surface of the catheter (in claim 13 of the parent, the sleeve is defined at least partially by a film, the film incorporating a pH controller from claim 1, and a hydration liquid defined in the package and disclosed to be in contact with the hydrophilic surface. As to claim 2, the interfacial pH controller is defined as embedded within at least one layer of the sleeve (see the patent, column 5, lines 35-44). As to claim 3, the interfacial pH controller is defined as coated onto a surface of the sleeve (see the patent, column 5, lines 35-44). As to claim 16, patented claim 13 recites the sleeve is a film. As to claim 20, the hydration liquid is disclosed as within the sleeve and in contact with the hydrophilic surface.( see the patent, column 3, lines 15-31). Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claim 4 is rejected on the ground of nonstatutory double patenting over claims 3 and 13 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 3 and 13. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claims 5 and 6 are rejected on the ground of nonstatutory double patenting over claims 2, 3 and 13 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 2, 3 and 13. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claim 7 is rejected on the ground of nonstatutory double patenting over claims 3, 4 and 13 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 3, 4 and 13. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claims 8 and 9 are rejected on the ground of nonstatutory double patenting over claims 3, 5 and 13 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 3, 5 and 13. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claim 10 is rejected on the ground of nonstatutory double patenting over claims 3, 6 and 13 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 3, 6 and 13. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claims 11 and 12 are rejected on the ground of nonstatutory double patenting over claims 3, 7 and 13 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 3, 7 and 13. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claim 13 is rejected on the ground of nonstatutory double patenting over claims 3, 8 and 13 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 3, 8 and 13. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claims 14 and 15 are rejected on the ground of nonstatutory double patenting over claims 3, 5, 8 and 13 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 3, 5, 8 and 13. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claim 17 is rejected on the ground of nonstatutory double patenting over claims 13 and 14 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 13 and 14. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claim 18 is rejected on the ground of nonstatutory double patenting over claims 13 and 15 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 13 and 15. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Claim 19 is rejected on the ground of nonstatutory double patenting over claims 13 and 16 of U.S. Patent No. 12,257,369 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows: The combined subject matter clearly set forth in patented claims 13 and 16. Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804. Prior Art not relied upon: Please refer to the additional references listed on the attached PTO-892, which, while not relied upon for the claim rejection, these references are deemed relevant to the claimed invention as a whole. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYON P GEHMAN whose telephone number is (571) 272-4555. The examiner can normally be reached on Tuesday through Thursday from 7:30 am to 5:00 pm. 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, Orlando Aviles-Bosques, can be reached on (571) 270-5531. 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. /BRYON P GEHMAN/Primary Examiner, Art Unit 3736 Bryon P. Gehman Primary Examiner Art Unit 3736 BPG
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Prosecution Timeline

Mar 05, 2025
Application Filed
Mar 12, 2026
Non-Final Rejection — §112, §DP (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
74%
Grant Probability
99%
With Interview (+30.8%)
2y 1m
Median Time to Grant
Low
PTA Risk
Based on 1949 resolved cases by this examiner. Grant probability derived from career allow rate.

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