Prosecution Insights
Last updated: October 01, 2026
Application No. 18/389,636

EXPANDABLE SHEATH AND METHODS OF USING THE SAME

Non-Final OA §102§103§DOUBLEPATENT
Filed
Dec 19, 2023
Priority
Jul 08, 2016 — provisional 62/360,162 +3 more
Examiner
PRICE, NATHAN R
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
1 (Non-Final)
53%
Grant Probability
Moderate
1-2
OA Rounds
1y 3m
Est. Remaining
92%
With Interview

Examiner Intelligence

Grants 53% of resolved cases
53%
Career Allowance Rate
276 granted / 517 resolved
-16.6% vs TC avg
Strong +39% interview lift
Without
With
+38.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
42 currently pending
Career history
561
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
42.4%
+2.4% vs TC avg
§102
27.0%
-13.0% vs TC avg
§112
21.9%
-18.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 517 resolved cases

Office Action

§102 §103 §DOUBLEPATENT
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 without traverse of Group II (claims 9-18) in the reply filed on 5/27/26 is acknowledged. Claims 1-8, 19, and 20 are withdrawn from consideration. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 62360162, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The subject matter of at least the elected claims 9-18 is not described in the disclosure of the prior-filed provisional application. Claim Objections Claim 9 is objected to because of the following informalities: “is slidingly engages” is grammatically incorrect. Appropriate correction is required. Double Patenting 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 9-11, 14, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 10856981. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 9-11, 14, and 15 are anticipated by claim 17 of the patent. Claims 12, 13, and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 10856981 in view of Benjamin et al. as cited under 35 U.S.C. 102(a)(1) below and/or Wall et al. as cited under 35 U.S.C. 103(a) below. 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. Claim(s) 9-14 and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Benjamin et al. (US 20090105806). Regarding claim 9, Benjamin et al. discloses an expandable sheath (embodiment of fig. 15, utilizing members as illustrated in fig. 21 and 21A and described in par. 0088) comprising: a plurality of curved arms 72 (specifically two of arms 72 that are located opposite each other at a point along 74) coupled at their proximal end along a spine (the illustrated at the relative top of the sheath in fig. 15 labeled 74), the spine extending parallel to a central longitudinal axis of the sheath (see fig. 15), each of the plurality of curved arms including a groove provided in an end surface of the curved arm (groove formed between 106a/b and its respective arm, see fig. 21-21A), such that an opposite end surface of a first curved arm of the plurality of curved arms is slidingly engages the groove of the end surface of an adjacent curved arm (par. 0088, specifically in the embodiment described where the groove is so arranged that expansion of the annular members is not restricted); wherein the plurality of curved arms move between an unexpanded configuration and an expanded configuration where the plurality of curved arms are moved away from the central longitudinal axis of the sheath (abstract; see structure of fig. 15 which is fully capable of performing the claimed function; see par. 0088, specifically in the embodiment described where the groove is so arranged that expansion of the annular members is not restricted). Regarding claim 10, Benjamin et al. discloses the plurality of curved arms slidingly engage during movement between the unexpanded configuration and the expanded configuration (see structure of fig. 15 which is fully capable of performing the claimed function; see par. 0088, specifically in the embodiment described where the groove is so arranged that expansion of the annular members is not restricted). Regarding claim 11, Benjamin et al. discloses the plurality of curved arms further include a ridge 106a/b projecting from the opposite end surface, the ridge slidingly engaging the groove during movement between the unexpanded configuration and the expanded configuration (each of 106a/b engages an opposing groove defined by the other of 106a/b and its respective arm; see fig. 21 and 21A). Regarding claim 12, Benjamin et al. discloses the groove includes an end surface at a terminating end of the groove proximate the spine, the end surface providing a contact surface for the ridge such that engagement between the end surface and a corresponding end surface of the ridge limits rotational movement of the plurality of arms toward the unexpanded configuration (surface at the junction of each of 106a/b and its respective arm, against which the opposite member of 106a/b is stopped; specifically in the embodiment as described in par. 0088 where the arrangement does not restrict expansion). Regarding claim 13, Benjamin et al. discloses the plurality of curved arms are rotationally coupled at their proximal end along the spine (see fig. 15). Regarding claim 14, Benjamin et al. discloses the first curved arm rotates away from the central longitudinal axis in a first direction towards the expanded configuration, and the adjacent curved arm rotates away from the central longitudinal axis in a second direction towards the expanded configuration (the arms, as identified in claim 1 above, rotate away from the axis opposite of each other; see fig. 15). Regarding claim 16, Benjamin et al. discloses longitudinal motion is restricted between the plurality of curved arms (restricted at least by spine 74 at the top of the sheath in fig. 15, but also by element 74 at the bottom of the sheath). Regarding claim 17, Benjamin et al. discloses the expandable sheath further comprises a fixation mechanism restricting longitudinal motion therebetween the plurality of curved arms (bottom element 74 in fig. 15). Regarding claim 18, Benjamin et al. discloses the fixation mechanism includes at least one of a suture, a rivet, or a bonding agent (bottom element 74 in fig. 15). 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, 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. Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benjamin et al. in view of Wall (US 5192307). Regarding claim 15, Benjamin et al. discloses the expandable sheath as claimed, except for specifically disclosing each of the plurality of curved arms includes a projection extending from end surface, the projection received within an opening provided on the opposite end surface of an adjacent curved arm such that the plurality of curved arms are rotationally coupled at the projection, wherein the projection and the opening extend in a direction along the spine. However, Wall teaches an alternative method of forming a spine where each arm 51 includes a projection extending from an end surface (portion of 54 extending from each arm towards the next arm) an opening 58 on an opposite end to couple to one another (see fig. 9-12). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the spine 74 of Benjamin et al. to utilize the projection and opening arrangement as taught by Wall for the purpose of providing sufficient structure to selectively couple the arms to one another. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time. 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 Tsai can be reached at 571-270-5246. 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. /NATHAN R PRICE/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Dec 19, 2023
Application Filed
Aug 31, 2026
Non-Final Rejection mailed — §102, §103, §DOUBLEPATENT (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
53%
Grant Probability
92%
With Interview (+38.9%)
4y 0m (~1y 3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 517 resolved cases by this examiner. Grant probability derived from career allowance rate.

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