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 .
Response to Amendment
The amendment filed 03/12/2026 has been entered. Claims 23-42 remain pending in the application and claims 1-22 are cancelled. Applicant’s amendments to the claims have overcome each claim objection and 112(b) rejection, however has not overcome the interpretation of the prior art rejection previously set forth in the Non-Final Office Action mailed 12/12/2025.
Response to Arguments
Applicant's arguments filed 03/12/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 7-9 that Casey’s tip body 2 and reinforcement columns 3 are not “disposed between the inner and outer surfaces of the sheath body” and in contrast, tip 1 or 20 of the retrieval catheter, in which the Office equates to as the expandable sheath, comprises the tip body 2 and/or the reinforcement columns 3 and therefore, there is no disclosure of additional inner and outer surfaces for the tip 1 or 20, let alone the tip body 2 and the reinforcement columns 3 being disposed between any such further inner and outer surfaces. The Office respectfully disagrees. Firstly, there seems to be no drawing or support in the specification for such an embodiment comprising of four distinct elements: the sheath body, at least one first member, a plurality of second members, and a plurality of third members. The closest drawing that equates to such embodiment is figure 14B, where the first member 1570 is the sheath body 1540. Therefore, the Office has similarly made the rejection as it relates to figure 14B of Applicant’s Drawings. Secondly, the claims as written do not require four distinct elements, thus the possible 112(a) new matter rejection and drawing objection not being made. Claim 23 recites “the sheath body being comprised of” and therefore the at least one first member, the plurality of second members, and the plurality of third members all make up the sheath body, as there is no need for a fourth distinct sheath body element having inner and outer surfaces in which the at least one first member and the plurality of second members are disposed between. Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 23-28, 33-38, and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. (US PGPub 2006/0287669), hereinafter known as “Casey,” in view of Corbett (US PGPub 2013/0053622).
With regards to claim 23, Casey discloses (Figures 2a-2e and 6-7) an expandable sheath 20 comprising:
a sheath body 20 having an inner surface and an outer surface (figures 2a-2e), the inner surface defining a lumen of the sheath body 20 that extends along a longitudinal axis between a proximal end and a distal end of the sheath body 20, the sheath body 20 (paragraph 90 – “It will be appreciated that a mixture/blend/compound of any of the above materials could alternatively be used for the tip body and/or the columns”) being comprised of:
at least one first member 2 disposed between the inner and outer surfaces of the sheath body 20 (the sheath body 20 is comprised of the first member 2, and thus the first member 2 is disposed between the inner and outer surfaces of the sheath body being that it is the sheath body) and extending between the proximal end and the distal end of the sheath body 20, each of the at least one first member 2 comprising a first material having a first elastic modulus (paragraph 33 – polyurethane group of materials);
a plurality of second members 3, each of the plurality of second members 3 disposed between the inner and outer surfaces of the sheath body 20 (paragraph 117; figure 7 – plurality of second members 3 is partially between inner and outer surfaces of the first member 2) and extending between the proximal end and the distal end of the sheath body 20, and each of the plurality of second members 3 comprising a second material having a second elastic modulus that is higher than the first elastic modulus (paragraph 33 – “peba group of materials”);
a plurality of third members 21, each of the plurality of third members 21 extending between the proximal end and the distal end of the sheath body 20, and each of the plurality of third members 21 being at least partially encapsulated within one of the plurality of second members 3 and comprising a third material having a third elastic modulus that is higher than the second elastic modulus (paragraphs 119-120 and 161 – wire reinforcements… stainless steel); and
wherein the sheath body 20 is configured to be radially expandable from an unexpanded state (figure 2a) to an expanded state (figures 2b-2c) to allow a passage of a portion of a medical device 6 through the lumen of the sheath body 20, the portion of the medical device 6 having a transverse cross-sectional area larger than a transverse cross-sectional area of the lumen of the sheath body 20 when the sheath body is in the unexpanded state (figures 2a-2e; paragraphs 97-99).
Casey is silent to a hub coupled to the proximal end of the sheath body, the hub comprising a conduit in fluid communication with the lumen of the sheath body.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to provide a hub at the proximal end of the sheath body, Corbett teaches (Figure 2) a hub 22/30/40/50 coupled to the proximal end of the sheath body (see lumen extending out from hub 22), the hub 22 comprising a conduit in fluid communication with the lumen of the sheath body (paragraphs 36-37, 39, 45, and 50-51).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expandable sheath of Casey to include a hub as taught by Corbett for the purpose of flushing the device and keeping it clear of blood (paragraph 45 of Corbett).
With regards to claim 24, as rejected above, it would be obvious to modify the expandable sheath of Casey to include the hub of Corbett. Corbett further discloses wherein the hub 22/30/40/50 further comprises a flexible portion 30/40/50 and a rigid portion 22, wherein the rigid portion 22 comprises a port 26/27 in fluid communication with the conduit of the hub 22 and the lumen of the sheath body (paragraphs 37, 41, and 44-45). Thus, when incorporating the hub of Corbett, the claimed limitation is considered obvious.
With regards to claim 25, as rejected above, it would be obvious to modify the expandable sheath of Casey to include the hub of Corbett. Corbett further discloses wherein the port 26/27 is configured as a flushing port 26 to enable the conduit of the hub and the lumen of the sheath body to be flushed with a fluid (paragraphs 45 and 50). Thus, when incorporating the hub of Corbett, the claimed limitation is considered obvious.
With regards to claim 26, as rejected above, it would be obvious to modify the expandable sheath of Casey to include the hub of Corbett. Corbett further discloses wherein the port 26/27 is in fluid communication with a pressure bag 24 (figure 2; paragraphs 37 and 39). Thus, when incorporating the hub of Corbett, the claimed limitation is considered obvious.
With regards to claim 27, as rejected above, it would be obvious to modify the expandable sheath of Casey to include the hub of Corbett. Corbett further discloses wherein the pressure bag 24 is configured to flush a space between the medical device and the sheath body with the fluid (paragraphs 37, 39, 45 and 50 – functional limitation – pressure bag 24 is capable of flushing a space as disclosed in paragraphs 45 and 50). Thus, when incorporating the hub of Corbett, the claimed limitation is considered obvious.
With regards to claim 28, as rejected above, it would be obvious to modify the expandable sheath of Casey to include the hub of Corbett. Corbett further discloses wherein the pressure bag 24 is in communication with an infusion pump (paragraphs 37, 39, 45 and 50). Thus, when incorporating the hub of Corbett, the claimed limitation is considered obvious.
With regards to claim 33, Casey further discloses wherein the medical device 6 is an intravascular medical device 6 (paragraphs 82 and 97-99 – medical device is functionally recited in claim 23 and therefore is not required to be positively part of the expandable sheath).
With regards to claim 34, the medical device to be used with Casey’s expandable sheath is capable of being a percutaneous heart pump comprising a pump head with electromechanical components, a pump handle in communication with control circuitry configured to control the pump head, and a catheter connecting the pump head and the pump handle (paragraphs 82 and 97-99 – medical device is functionally recited in claim 23 and therefore is not required to be positively part of the expandable sheath, thus it can be interpreted that a percutaneous heart pump is capable of being the medical device that can be retrieved within the retrieval catheter).
With regards to claim 35, Casey further discloses wherein the first material comprises at least one of: an elastomer (paragraph 33 – polyurethane group of materials).
With regards to claim 36, Casey further discloses wherein the second material comprises at least one of: a polyether block amide (paragraph 33- peba group of materials).
With regards to claim 37, Casey further discloses wherein the third material comprises at least one of, stainless steel (paragraphs 34, 119-120, and 161).
With regards to claim 38, Casey further discloses wherein the sheath body 20 is configured to automatically return to the unexpanded state after the passage of the portion of the medical device 6 (see transition from figure 2b to figure 2c, distal end of the sheath body returns to the unexpanded shape in figure 2c after the medical device 6 passes through the distal end and into the middle of the sheath body).
With regards to claim 40, Casey further discloses wherein each of the plurality of second members 3 is at least partially encapsulated within the first member 2 (paragraph 117; figure 7 – plurality of second members 3 is partially, not fully, encapsulated within the first member 2).
With regards to claim 41, the combination discloses the expandable sheath as claimed in claim 40. The combination is silent wherein each of the plurality of second members is fully encapsulated within the first member.
However, in the figures 20-22 embodiment of Casey, Casey teaches wherein each of the plurality of second members 3 is fully encapsulated within the first member 2 (paragraph 133).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expandable sheath of Casey/Corbett to include wherein each of the plurality of second members is fully encapsulated within the first member as taught by the figures 20-22 embodiment of Casey for the purpose of preventing delamination between the first and second members (paragraph 133 of Casey).
With regards to claim 42, Casey further discloses wherein each of the plurality of third members 21 is fully encapsulated within its respective second member 3 of the plurality of second members 3 (paragraphs 119-120).
Claims 23-24 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Casey in view of Ginn et al. (US PGPub 2016/0128723), hereinafter known as “Ginn.”
With regards to claim 23, Casey discloses (Figures 2a-2e and 6-7) an expandable sheath 20 comprising:
a sheath body 20 having an inner surface and an outer surface (figures 2a-2e), the inner surface defining a lumen of the sheath body 20 that extends along a longitudinal axis between a proximal end and a distal end of the sheath body 20, the sheath body 20 (paragraph 90 – “It will be appreciated that a mixture/blend/compound of any of the above materials could alternatively be used for the tip body and/or the columns”) being comprised of:
at least one first member 2 disposed between the inner and outer surfaces of the sheath body 20 (the sheath body 20 is comprised of the first member 2, and thus the first member 2 is disposed between the inner and outer surfaces of the sheath body being that it is the sheath body) and extending between the proximal end and the distal end of the sheath body 20, each of the at least one first member 2 comprising a first material having a first elastic modulus (paragraph 33 – polyurethane group of materials);
a plurality of second members 3, each of the plurality of second members 3 disposed between the inner and outer surfaces of the sheath body 20 (paragraph 117; figure 7 – plurality of second members 3 is partially between inner and outer surfaces of the first member 2) and extending between the proximal end and the distal end of the sheath body 20, and each of the plurality of second members 3 comprising a second material having a second elastic modulus that is higher than the first elastic modulus (paragraph 33 – “peba group of materials”);
a plurality of third members 21, each of the plurality of third members 21 extending between the proximal end and the distal end of the sheath body 20, and each of the plurality of third members 21 being at least partially encapsulated within one of the plurality of second members 3 and comprising a third material having a third elastic modulus that is higher than the second elastic modulus (paragraphs 119-120 and 161 – wire reinforcements… stainless steel); and
wherein the sheath body 20 is configured to be radially expandable from an unexpanded state (figure 2a) to an expanded state (figures 2b-2c) to allow a passage of a portion of a medical device 6 through the lumen of the sheath body 20, the portion of the medical device 6 having a transverse cross-sectional area larger than a transverse cross-sectional area of the lumen of the sheath body 20 when the sheath body is in the unexpanded state (figures 2a-2e; paragraphs 97-99).
Casey is silent to a hub coupled to the proximal end of the sheath body, the hub comprising a conduit in fluid communication with the lumen of the sheath body.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to provide a hub at the proximal end of the sheath body, Ginn teaches (Figures 1, 17 and 31A-31D) a hub 8/310/324 coupled to the proximal end of the sheath body 10/301 (figures 1 and 17), the hub comprising a conduit 8 in fluid communication with the lumen of the sheath body (paragraph 32).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expandable sheath of Casey to include a hub as taught by Ginn for the purpose of inserting fluids into the sheath body (paragraph 32 of Ginn).
With regards to claim 24, as rejected above, it would be obvious to modify the expandable sheath of Casey to include the hub of Ginn. Ginn further discloses wherein the hub 8/310/324 further comprises a flexible portion 8 and a rigid portion 310/324, wherein the rigid portion 310/324 comprises a port (where 368 is inserted into) in fluid communication with the conduit 8 of the hub 310 and the lumen of the sheath body 301 (figures 1 and 17). Thus, when incorporating the hub of Ginn, the claimed limitation is considered obvious.
With regards to claim 30, as rejected above, it would be obvious to modify the expandable sheath of Casey to include the hub of Ginn. Ginn further discloses wherein the port (where 368 is inserted into) is configured as a balloon port to inflate a balloon 367 (paragraph 71; figure 31C). Thus, when incorporating the hub of Ginn, the claimed limitation is considered obvious.
With regards to claim 31, as rejected above, it would be obvious to modify the expandable sheath of Casey to include the hub of Ginn. Ginn further discloses wherein the hub 310/324 further comprises at least one hemostatic valve 324 in communication with the lumen of the sheath body (figure 17; paragraphs 60 and 71). Thus, when incorporating the hub of Ginn, the claimed limitation is considered obvious.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Casey in view of Corbett, and further in view of Butterfield (US Patent 5,827,223).
With regards to claims 28-29, Casey/Corbett disclose the expandable sheath as claimed in claim 26. The combination is silent wherein the pressure bag is in communication with an infusion pump (claim 28); and wherein the pressure bag and the infusion pump regulate a flow rate of the fluid into a patient (claim 29).
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to regulate the flow rate, Butterfield teaches (Figure 1) wherein the pressure bag 14 is in communication with an infusion pump 24 (figure 1; Col 4 lines 32-64); and wherein the pressure bag 14 and the infusion pump 24 regulate a flow rate of the fluid into a patient (Col 1 lines 19-22).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expandable sheath of Casey/Corbett to include the infusion pump as taught by Butterfield for the purpose of providing a positive means for controlling the amount of fluid administered (Col 1 lines 19-22 of Butterfield).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Casey/Ginn in view of Smith et al. (US PGPub 2014/0121448), hereinafter known as “Smith.”
With regards to claim 32, Casey/Ginn disclose the expandable sheath as claimed in claim 23. The combination is silent wherein the hub further comprises a plurality of wings with a plurality of securing holes.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to provide a plurality of securing holes, Smith teaches (Figures 2-5) wherein the hub further comprises a plurality of wings 30 with a plurality of securing holes (see suture wing 30 with one wing on each side, each wing has at least two holes as seen in figures 2A and 5; paragraph 23).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expandable sheath of Casey/Ginn to include wherein the hub further comprises a plurality of wings with a plurality of securing holes as taught by Smith for the purpose of securing the elongated body to the patient (paragraph 23 of Smith).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Casey in view of Corbett, and further in view of Little et al. (US PGPub 2014/0275795), hereinafter known as “Little.”
With regards to claim 39, Casey/Corbett disclose the expandable sheath as claimed in claim 23. The combination is silent wherein a diameter of the outer surface at the proximal end of the sheath body is larger than a diameter of the outer surface at the distal end of the sheath body, when the sheath body is in the unexpanded state.
However, in a similar field of endeavor of expandable sheaths, Little teaches (Figure 24) wherein a diameter of the outer surface at the proximal end 2440 of the sheath body 2410 is larger than a diameter of the outer surface at the distal end 2420 of the sheath body 2410, when the sheath body 2410 is in the unexpanded state (paragraphs 104-105).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expandable sheath of Casey/Corbett to include wherein a diameter of the outer surface at the proximal end of the sheath body is larger than a diameter of the outer surface at the distal end of the sheath body, when the sheath body is in the unexpanded state as taught by Little for the purpose of allowing the practitioner to gently part and move tissue out of the way allowing insertion of the sheath into the vesicle (paragraph 105 of Little).
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 23 and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 10,967,152 (Korkuch 152). Claims 23 and 31 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,697,002 (Korkuch 002). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
18/616,368 Claims
Korkuch 152 Claims
Korkuch 002
23 and 31
1 and 11
1 and 7
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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, Jackie Ho can be reached at 571-272-4696. 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.
/MOHAMMED S ADAM/Examiner, Art Unit 3771 04/28/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
Prosecution Insights