Prosecution Insights
Last updated: April 19, 2026
Application No. 18/531,355

EXPANDABLE SHEATH FOR INTRODUCING AN ENDOVASCULAR DELIVERY DEVICE INTO A BODY

Non-Final OA §103§112§DP
Filed
Dec 06, 2023
Examiner
BARIA, DINAH N
Art Unit
3774
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
2y 9m
To Grant
99%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
456 granted / 622 resolved
+3.3% vs TC avg
Strong +29% interview lift
Without
With
+29.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
50 currently pending
Career history
672
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
34.9%
-5.1% vs TC avg
§102
21.3%
-18.7% vs TC avg
§112
30.8%
-9.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 622 resolved cases

Office Action

§103 §112 §DP
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. Information Disclosure Statement Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action. Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the longitudinal slit, between the proximal and distal ends of the tubular inner liner, is formed in a pattern that is different from a straight line (claim 7), and the inner surface of the tubular inner liner being at least partially ribbed (claim 10) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 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 appl icant regards as his invention. Claims 1-20 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, which recites the limitations “the inner liner”, on lines 9, 10, 11, 12-13, 17 and 19, “the first edge”, on line 17, and “the second edge”, on line 18; there is insufficient antecedent basis for these limitations in the claim. In order to overcome the rejection, and keep claim terminology consistent, it is suggested the word “tubular” be added before the word “inner”, every time the limitation “the inner liner” is mentioned in the claim, and the word “longitudinal” be added between the words “first” and “edge”, on line 17, and between the words “ second ” and “edge”, on line 1 8. Regarding claim 3 , it is unclear what, if any, additional structural limitation(s) this parameter imparts on the final structure of the claimed invention/tubular inner liner, instead the parameter merely seems to be reciting an intended use/function, however does not include any additional structure which would be needed in order to meet said intended use/function ; and the originally filed disclosure does not aid in clarifying/identify what structure would be needed to meet the claimed intended use/function . Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. Regarding claim 7 , which recites the limitation “the tubular inner”, on line 2; th ere is insufficient antecedent basis for th is limitation in the claim. In order to overcome the rejection, and keep claim terminology consistent, it is suggested the word “liner” be added after the word “inner”. Regarding claim 8 , which recites the limitation “the helical configuration ”, on line 1 ; there is insufficient antecedent basis for this limitation in the claim. In order to overcome the rejection, and keep claim terminology consistent, it is suggested the word “ scroll ” be added between the word s “ helical ” and “configuration” . Regarding claim 1 5 , which sets forth the parameter(s) of “ the sheath exhibits at least a 10% reduction in an insertion force when compared with a substantially identical reference sheath that does not comprise the first polymer layer; and wherein the outer layer is substantially kink resistant ” on the last 4 lines of the claim; however, this parameter(s) is found to be confusing since is unclear what, if any, additional structural limitation(s) th e parameter (s) impart ( s ) on the final structure of the claimed invention . Specifically, the last 4 lines of the claim seem to be reciting function al limitations of the sheath/outer layer , however , it is not clear what exact structure would be needed in order to meet the functional limitations ; would meeting the structural/chemical limitations set forth in the rest of this claim, and/or in the claims this claim depends from, be enough to meet the above mentioned functional limitations , or would additional structure/chemical limitation(s) be needed. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. Examiner’s Notes It is to be noted that in device/apparatus claim s only the claimed structure of the final device bears patentable weight, and intended use /functional language is considered to the extent that it furth er defines the claimed structure of the final device (see MPEP 2114). Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed in vention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. 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. Claim s 1, 2, 9, 11-15 and 17-20 a re rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US PG Pub. 2010/0094392), as disclosed in the IDS dated 12/06/2023, hereinafter Nguyen , in view of Grayzel (US Patent No. 4,921,479), as disclosed in the IDS dated 12/06/2023 . Regarding claims 1, 12 and 20, Nguyen discloses a sheath (8/22) for delivering a medical device (12), illustrated in Figure 1 ([0070], Lines 1-3), wherein the sheath (22) has a proximal end (38) and a distal end (40), illustrated in Figure 3, and comprises a tubular inner liner (24) having a longitudinal slit (36) extending along a length of the tubular inner liner, an outer layer (26), and a braided layer (28) disposed between the tubular inner layer (24) and the outer layer (26), wherein an inner surface (32) of the tubular inner liner (24) defines a lumen of the sheath (30), and wherein the tubular inner liner (24) is configured to expand during application of a radial outward force by passage of a medical device through the lumen of the inner liner, illustrated in Figures 2A-2C ([0071]; [0080], 5 th – 3 rd to Last Lines; [0081] & [0092]; [0093], Lines 1-2); but does not specifically teach the tubular inner liner being wound in a helical scroll and expanding by sliding the edges of the slit along an outer/inner surface of the tubular inner liner. However, Grayzel teaches a sheath (110), illustrated in Figure 1, comprising a tubular inner liner (112) having a longitudinal slit extending along a length of the tubular inner liner such that the tubular inner liner is wound in a helical scroll configuration; wherein the longitudinal slit forms a first longitudinal edge (120) and a second longitudinal edge (118) of the tubular inner liner; wherein in the helical scroll configuration at least a portion of an inner surface of the tubular inner liner helically overlays at least a portion of an outer surface of the tubular inner liner and wherein the first longitudinal edge (120) of the tubular inner liner is slidable along at least a portion the inner surface of the tubular inner liner and the second longitudinal edge (118) is slidable along at least a portion of the outer surface of the tubular inner liner; wherein the tubular inner liner is configured to expand from a rest diameter to an expanded diameter by helically sliding the first edge (120) along at least a portion of the inner surface and helically sliding the second edge (118) along the at least a portion of the outer surface of the inner liner during application of a radial outward force by passage of a medical device through the lumen of the inner liner , illustrated in Figure 1; the sheath being safer due to it being self-adjusting and not requiring any external manipulation once implanted/positioned (Column 2, Lines 29-41; Column 3, Lines 25-28 & Column 4, Lines 1-10 and 42-52). In view of the teachings of Grayzel, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the tubular inner liner, of the sheath of Nguyen, to have a longitudinal slit extending along a length of the tubular inner liner, and forming first and second longitudinal edges, such that the tubular inner liner is wound in a helical scroll configuration wherein at least a portion of an inner surface overlays at least a portion of an outer surface, and wherein the tubular inner liner is configured to expand from a rest diameter to an expanded diameter by helically sliding the first longitudinal edge along at least a portion of the inner surface and helically sliding the second longitudinal edge along the at least a portion of the outer surface of the tubular inner liner during application of a radial outward force by passage of a medical device through the lumen of the inner liner ; in order for the tubular inner liner to be self-adjusting and thereby safer, since no external manipulation is required once it has been implanted/positioned, as taught by Grayzel. Regarding claim 2 , Nguyen in view of Grayzel disclose the sheath of claim 1, wherein Grayzel further teaches the tubular inner liner is configured to expand with substantially no gap formed between the first longitudinal edge (420) and the second longitudinal edge (418), illustrated in Figure 6 (Column 3, Lines 54-55 & Colum 5, Lines 45-48). Regarding claim 9 , Nguyen in view of Grayzel disclose the sheath of claim 1, wherein Nguyen further teaches the tubular inner liner (24) comprises a high density polyethylene, polyamide, fluoropolymer, copolymers thereof, or blends thereof ( Nguyen : [0010], Lines 1-4; [0072] & [0122], Lines 7-9). Regarding claim 11, Nguyen in view of Grayzel disclose the sheath of claim 1, wherein Nguyen further teaches the tubular inner liner (24) is lubricious and has a coefficient of friction less than about 0.5 (Nguyen: [0073]). Regarding claim 13 , Nguyen in view of Grayzel disclose the sheath of claim 12, wherein Nguyen further teaches the outer layer (26) comprises a polyether block amide, polyurethane, latex, copolymers thereof, blends thereof, or extrudates of thereof ( Nguyen : [0010], Last 5 Lines; [0072] & [0123], Lines 1-2). Regarding claim 14 , Nguyen in view of Grayzel disclose the sheath of claim 13, wherein Nguyen further teaches at least one layer of the one or more layers, of the outer layer (26), comprises the polyether block amide, and/or wherein at least one layer of the one or more layers comprises polyurethane ( Nguyen : [0010], Last 5 Lines; [0072] & [0123], Lines 1-2). Regarding claim 15 , Nguyen in view of Grayzel disclose the sheath of claim 12, wherein Nguyen further teaches the outer layer (26) comprises a first polymer layer comprising a first compound composition comprising from greater than 0 wt% to less than 100 wt% of a first polymer comprising a polyether block amide, a polyurethane, or a combination thereof based on a total weight of the first compound composition, less than about 65% of an inorganic filler based on a total weight of the first compound composition, and a solid lubricant filler; wherein the sheath exhibits at least a 10% reduction in an insertion force when compared with a substantially identical reference sheath that does not comprise the first polymer layer; and wherein the outer layer is substantially kink resistant ( Nguyen : [0010], Last 5 Lines; [0072] & [0079] – to clarify, it is stated the outer layer can comprise a polyether block amide, a polyurethane, or a combination thereof, and any percentage of this/these materials would be within the range of greater than 0% to less than 100%, it is also stated the outer layer can comprise 5%-45% of inorganic filler materials such as barium sulfite, bismuth trioxide, titanium dioxide, bismuth subcarbonate, or combinations thereof, and further stated that the outer layer can comprise a combination of materials including PTFE, which is known in the art to be a lubricating material; additionally, the sheath would exhibit the 10% reduction in insertion force and the outer layer would be substantially kink resistant based on the claimed material/composition of the first polymer layer); and though it is not specifically disclosed that the solid lubricant filler/PTFE is up to about 20 % of the total weight of the first compound composition, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive, concept; and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate percentage for the solid lubricant filler/PTFE, including up to about 20 % of the total weight of the first compound composition, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges /value involves only routine skill in the art (see MPEP 2144.05). Regarding claims 1 7 and 18 , Nguyen in view of Grayzel disclose the sheath of claim 15, wherein Nguyen further teaches the outer layer comprises at least a second polymer layer comprising a second compound composition comprising from greater than 0 wt% to 100 wt% of a second polymer comprising polyurethane, wherein one or more additional polymer layers/at least one intermediate reinforcement layer are/is disposed between the first polymer layer and the second polymer layer extending axially at least a portion of a length of the outer layer ( Nguyen : [0125], Lines 3-6 – to clarify, it is stated that the outer layer can be “ provided with additional layers ”, which could include a second polymer layer and one or more additional polymer layers/at least one intermediate reinforcement layer); and though it is not specifically disclosed the second polymer has a Shore A Durometer from about 20A to about 65A, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive, concept; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate hardness for the polyurethane of the second polymer, including has a Shore A Durometer from about 20A to about 65A, based on the intended use/application of the sheath, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges/value involves only routine skill in the art (see MPEP 2144.05). Regarding claim 1 9 , Nguyen in view of Grayzel disclose the sheath of claim 18, wherein Nguyen further teaches the at least one intermediate reinforcement layer is configured to thermally bond with the first polymer layer, the second polymer layer, or a combination thereof ( Nguyen : [0126]). Claim s 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Grayzel as applied to claim 1 above, and further in view of Khosravi et al. (US Patent No. 5,824,054) Khosravi . Regarding claim s 3-7 , Nguyen in view of Grayzel disclose the sheath of claim 1, wherein Grayzel further teaches the longitudinal slit extends from a proximal end to a distal end of the tubular inner liner (112), illustrated in Figure 1 (Grayzel: Column 2, Lines 30-35 & Column 4, Lines 44-49); but does not specifically disclose the longitudinal slit extends in a direction offset from a longitudinal axis of the tubular inner liner, specifically a diagonal direction, and/or in a pattern that is different from a straight line, and/or at an angle greater than or less than about 90 degrees across a length of the tubular inner liner, and that the tubular inner liner is configured to bend while passing through a patient's natural anatomy without forming a gap between the first and second longitudinal edges. However, Khosravi teaches a sheath (60) having a helically coiled tubular liner (66), in the same field of endeavor, comprising a longitudinal slit (65) extending from a proximal end to distal end in a direction offset from a longitudinal axis of the tubular liner (66), specifically a diagonal direction, and/or in a pattern that is different from a straight line, and/or at an angle greater than or less than about 90 degrees across a length of the tubular liner, thereby allowing the tubular liner (66) to be configured to bend while passing through a patient's natural anatomy without forming a gap/buckling between the first and second longitudinal edges, due to radially distribution of expansive forces by the diagonal longitudinal slit, illustrated in Figures 8A and 8B (Column 9, Lines 51-63). In view of the teachings of Khosravi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the longitudinal slit, of the tubular inner liner of the sheath of Nguyen in view of Grayzel , to extend in a direction offset from a longitudinal axis of the tubular inner liner, specifically a diagonal direction, and/or in a pattern that is different from a straight line, and/or at an angle greater than or less than about 90 degrees across a length of the tubular inner liner, thereby allowing the tubular inner liner to be configured to bend while passing through a patient's natural anatomy without forming a gap/buckling between the first and second longitudinal edges, due to radially distribution of expansive forces by the diagonal longitudinal slit, as taught by Khosravi. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Grayzel as applied to claim 1 above, and further in view of Worthley et al. (WO 2020/056465), as disclosed in the IDS dated 12/06/2023 , hereinafter Worthley . Regarding claim 8 , Nguyen in view of Grayzel disclose the sheath of claim 1, but do not specifically disclose that the helical configuration has a pitch of at least 4 revolutions over every 10 cm of the sheath . However, Worthley teaches a sheath, in the same field of endeavor, wherein it is known that the number of revolutions/overlap can be adjusted to control performance properties, such as stiffness/flexibility ([0031]). In view of the teachings of Worthley, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate pitch/number of revolutions, of the helical configuration of the tubular inner liner of the sheath of Nguyen in view of Grayzel , including at least 4 revolutions over every 10 cm of the sheath , based on the intended performance properties of the sheath. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Grayzel as applied to claim 1 above, and further in view of Wong (US PG Pub. 2018/0043133), as disclosed in the IDS dated 02/11/2026 . Regarding claim 1 0 , Nguyen in view of Grayzel disclose the sheath of claim 1, but do not specifically disclose the inner surface of the tubular inner liner is at least partially ribbed. However, Wong teaches a helically coiled tubular liner (1100), in the same field of endeavor, comprising an inner surface which is at least partially ribbed (1105), illustrated in Figure 28, the ribs/ridges reduce the contact surface between overlapping portions/layers of the tubular liner, thereby reducing friction between the portions/layers of the tubular liner ([0090]). In view of the teachings of Wong, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the inner surface, of the tubular inner liner of the sheath of Nguyen in view of Grayzel , to at least partially be ribbed, in order to reduce the contact surface between overlapping portions/layers of the tubular inner liner, thereby reducing friction between the portions/layers of the tubular inner liner, as taught by Wong. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Grayzel as applied to claim 15 above, and further in view of Shia et al. (US PG Pub. 2022/0126060), hereinafter Shia . Regarding claim 1 6 , Nguyen in view of Grayzel disclose the sheath of claim 15, but do not specifically teach the first compound composition, of the outer layer, further comprises at least one tackiness reducing compound present in an amount from about 1 % to about 20 % based on a total weight of the first compound composition. However, Shia teaches a sheath, in the same filed of endeavor, which includes additives, such as Propell, in the polymer composition of the sheath; Propell is known in the art for its lubricating/tackiness reducing ability ([0135], Last 4 Lines). In view of the teachings of Shia, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first compound composition, of the outer layer of the sheath of Nguyen in view of Grayzel , to further comprise an additive, such as Propell, due to its lubricating/tackiness reducing ability, as taught by Shia; and though it is not specifically disclosed that the Propell is in the amount from about 1 % to about 20 % based on a total weight of the first compound composition, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive, concept; and it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate percentage for the Propell, including from about 1 % to about 20 % of the total weight of the first compound composition, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges /value involves only routine skill in the art (see MPEP 2144.05). 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 . Claim s 1, 12, 15 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 16 and 17 of copending Application No. 18/103,361 (reference application) , and claims 1 and 12-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 11, 13, 16 and 21 of copending Application No. 1 7 / 822 ,6 89 (reference application ) . Although the claims at issue are not identical, they are not patentably distinct from each other because all sets of claims disclose a sheath having proximal and distal end s and compris ing : a tubular inner liner wound in a helical scroll configuration , wherein at least a portion of an inner surface of the tubular inner liner helically overlays at least a portion of an outer surface of the tubular inner liner , such that a first longitudinal edge is slidable along at least a portion the inner surface of the tubular inner liner and a second longitudinal edge is slidable along at least a portion of the outer surface of the tubular inner liner , wherein the inner surface of the tubular inner liner defines a lumen of the sheath; and wherein the tubular inner liner is configured to expand from a rest diameter to an expanded diameter by helically sliding the first edge along at least a portion of the inner surface and helically sliding the second edge along the at least a portion of the outer surface during application of a radial outward force by passage of a medical device through the lumen of the inner liner ; and further comprising an outer layer having one or more layers . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT DINAH BARIA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1973 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 10am - 5pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Jerrah Edwards can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 408-918-7557 . 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. /DINAH BARIA/ Primary Examiner, Art Unit 3774 03/17/2026
Read full office action

Prosecution Timeline

Dec 06, 2023
Application Filed
Mar 17, 2026
Non-Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
73%
Grant Probability
99%
With Interview (+29.1%)
2y 9m
Median Time to Grant
Low
PTA Risk
Based on 622 resolved cases by this examiner. Grant probability derived from career allow rate.

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