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 Species A (claims 10-16 & 21-23) in the reply filed on 2/10/2026 is acknowledged.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/10/2026.
Response to Amendment
In the amendment filed on 2/10/2026, the claim numbering was corrected via cancelling of claims 17-20 and addition of claims 21-23.
Claim Rejections - 35 USC § 102
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 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.
Claims 10, 12, 13, & 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lenker et al. (US Pub. No. 2006/0052750 A1).
Regarding claim 10, Lenker et al. disclose an expandable sheath (paragraph [0015]) for deploying a medical device (intended use), comprising: a first polymeric layer 832 (Fig. 8A; ‘inner layer of polymeric material’ discussed in paragraph [0015]); a braided layer 804 (Fig. 8A) positioned radially outward of the first polymeric layer 832 (Fig. 8A - ‘braided reinforcement 804’; it is clear that the braided layer is intended to be positioned between the first polymer layer 832 and the second polymeric layer 806 as it is discussed in paragraph [0015] that the inner and outer layers are bonded at a plurality of points to lock the braided structure in place), the braided layer 804 comprising a plurality of filaments braided together; a radiopaque feature 838 (Fig. 8B - ‘expandable radiopaque marker’; other radiopaque feature options are discussed in paragraph [0016]) positioned radially outward of the first polymeric layer 832 (Fig. 8B); and a second polymeric layer 806 (Fig. 8A; ‘outer layer of polymeric material’- paragraph [0015]) positioned radially outward of the braided layer 804 and the radiopaque feature 838 (outermost layer - Figs. 8A-8B), the second polymeric layer 806 coupled to the first polymeric layer such that the braided layer 804 and the radiopaque feature 838 are encapsulated between the first and second polymeric layers 832, 806 (discussed in paragraph [0015] that the inner and outer layers are bonded at a plurality of points to lock the braided structure in place, and radiopaque feature is between both polymeric layers - Fig. 8B); wherein when a medical device is passed through the sheath, a diameter of the sheath expands from a first diameter to a second diameter around the medical device (sheath 800 of Figs. 8A-B is an expandable sheath; therefore, the sheath is capable of expanding when something is inserted therein).
Regarding claim 12, Lenker et al. further disclose wherein the radiopaque feature 838 is adjacent to and does not directly contact the braided layer 832 (Fig. 8B; radiopaque feature 838 is located in the adjacent distal portion of the sheath which is adjacent to the proximal portion of the sheath that contains the braided layer).
Regarding claim 13, Lenker et al. further disclose wherein the radiopaque feature 838 is positioned distal to a distal end of the braided layer 832 (Fig. 8B; radiopaque feature 838 is located in the adjacent distal portion of the sheath which is distal to the proximal portion of the sheath that contains the braided layer).
Regarding claim 16, Lenker et al. further disclose wherein the radiopaque feature 838 is indirectly coupled to a filament of the braided layer 832 (radiopaque feature 838 is indirectly attached to the braided layer 832 via distal reinforcement 812; Figs. 8A-8B).
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 11 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lenker et al. (US Pub. No. 2006/0052750 A1).
Regarding claim 11, Lenker et al. fail to explicitly disclose wherein the embodiment of Figs. 8A-B includes at least one of a radiopaque polymer layer or a longitudinally extending cord. However, Lenker et al. disclose a further modification/ embodiment wherein radiopaque filler materials can be added to the polymer inner layer during extrusion to enhance visibility under fluoroscopy. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the suggested radiopaque filler materials in the polymeric inner layer in the embodiment of Figs. 8A-B to further enhance visibility of the sheath. This modification would read on the ‘radiopaque polymer layer’.
Regarding claim 14, Lenker et al. fail to explicitly disclose wherein the radiopaque feature comprises a circumferentially extending series of chevrons connected to form a zig-zagged ring. However, Lenker et al. discuss radiopaque marker options in paragraph [0016], one of which includes an expandable marker fabricated as undulated or wavy rings. Since the radiopaque marker 838 of Figures 8A-B is an expandable radiopaque marker, it is considered that is would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the expandable coil member 838 with the alternatively suggested expandable wavy ring, as suggested in Lenker et al.’s disclosure.
Claims 15, 21, & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Lenker et al. (US Pub. No. 2006/0052750 A1) in view of Ravichandran et al. (US Pub. No. 2013/0018318 A1).
Regarding claims 15, 21, and 22, Lenker et al. fail to explicitly disclose wherein the radiopaque feature is positioned within a cell of the braided layer [claim 15]; wherein the radiopaque feature directly contacts a filament of the braided layer [claim 21]; and the filament mating with a groove on the radiopaque feature, or radiopaque feature comprising a radiopaque coating on the filament [claim 22].
However, Ravichandran et al. teach an introducer sheath having a similar construction, including a braided layer 16 (comprising filaments 22; Fig. 5) wherein the a securement mechanism 45 (radiopaque solder - abstract) is utilized to address fraying of the braided layer (paragraph [0042]). The securement mechanism spans and fills the open cells of the braided layer 16 (paragraph [0042]; this would apply to the claim limitation ‘directly contacts a filament of the braided layer’ from claim 21 and would also act as a ‘radiopaque coating’ on the filaments that are secured to the radiopaque solder from claim 22 as seen in Fig. 5) and can include a radiopaque material to enhance its visibility under fluoroscopy (paragraph [0044]).
Lenker et al. discloses the use of soldering along the sheath to prevent movement of the braided layer (discussed in paragraph [0015] that the inner and outer layers are bonded at a plurality of points to lock the braided structure in place).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the securement mechanism/radiopaque solder, as suggested and taught by Ravichandran et al., for the purpose of minimizing/eliminating fraying of the braided layer while enhancing visibility under fluoroscopy. Further, the securement mechanism/radiopaque solder could be used in place of the intended solders of Lenker et al.’s sheath (broadly defined in Lenker et al.) to fix the braided layer in place.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et al. (US Pub. No. 2006/0052750 A1) in view of Uesugi, et al. (EP 3 677 227 A1).
Regarding claim 23, Lenker et al. fail to explicitly disclose wherein the radiopaque feature comprises at least one of a coil or a tube, wherein a filament of the braided layer extends through a lumen of the radiopaque feature. However, Lenker et al. discuss radiopaque marker options in paragraph [0016] to include ‘other structures such as are found commonly on stents, grafts or catheters used for endovascular access in the body’.
Uesugi, et al. teach visualization of a stent/medical device utilizing passing the filament threads constituting a braid structure through a radiopaque metal tube or coil (paragraph [0027]). Since Lenker et al. discloses the use of radiopaque markers found commonly on stents, grafts, or catheters used for endovascular access, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the radiopaque coil or tube threaded over a filament of the braided layer, as suggested and taught by Uesugi et al., for visualization of the sheath.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 March 6, 2026