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 .
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 9-12 and 14-21 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent 12076046.
Although the conflicting claims are not identical, they are not patentably distinct because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown in the table below (note that the underlined elements are comparable limitations):
Invention 18/757186
US Pat 12076046
1. A sheath comprising: a hub forming a chamber, the hub comprising: a side port in fluid communication with the chamber, and an introducer bore with a seal to maintain hemostasis of the introducer sheath while allowing a medical instrument to be introduced through the introducer bore into the chamber, and a shaft coupled to the hub, the shaft forming a lumen that is in
fluid communication with the chamber of the hub, the shaft comprising: a wire frame with an annealed distal portion, and an additional annealed portion proximal to the annealed distal portion, a second portion of the wire frame being unannealed, the second portion maintaining physical properties of spring temper wire, a jacket encompassing the wire frame, and a liner forming an inner wall, the liner encompassed by the wire frame.
Claims 1-8:
PNG
media_image1.png
360
358
media_image1.png
Greyscale
*note that the middle portion is comparable to the second portion of the invention
2. The sheath of claim 1, wherein the hub is overmolded around a proximal portion of the shaft.
PNG
media_image2.png
34
360
media_image2.png
Greyscale
3. The sheath of claim 1, wherein the hub prevents a proximal end of the wire frame from unraveling.
PNG
media_image3.png
34
368
media_image3.png
Greyscale
4. The sheath of claim 1, wherein the additional annealed portion comprises a proximal portion of the wire is annealed.
Claims 1-8, see claim 1 lines 14-15
5. The sheath of claim 1, wherein the jacket and the liner are reflowed to the wire frame.
PNG
media_image4.png
34
362
media_image4.png
Greyscale
6. The sheath of claim 1, wherein the wire frame comprises flat wires and round wires.
PNG
media_image5.png
32
364
media_image5.png
Greyscale
9. A method of manufacturing a sheath, comprising: forming a frame of a sheath shaft; annealing a plurality of discontinuous portions of the frame, including a distal portion of the frame; reflowing a liner to an interior surface of the frame; reflowing a jacket to an exterior surface of the frame; and overmolding a hub around a proximal portion of the frame to prevent the frame from unraveling at a proximal end, the hub having a chamber in fluid communication with a hollow conduit formed from reflowing the liner and jacket to the frame, a side port in fluid communication with the chamber, and an introducer bore with a seal to maintain hemostasis of the introducer sheath while allowing a medical instrument to be introduced through the introducer bore into the chamber.
Claims 8-18
PNG
media_image6.png
293
353
media_image6.png
Greyscale
PNG
media_image7.png
48
328
media_image7.png
Greyscale
10. The method of claim 9, further comprising: extruding a nylon core, wherein forming the metal wires is performed over the nylon core causing the frame to have an interior diameter equivalent to a diameter of the nylon core; heating and stretching the nylon core to reduce the diameter of the nylon core; and sliding the frame off of the nylon core.
PNG
media_image8.png
132
349
media_image8.png
Greyscale
11. The method of claim 9, wherein annealing the distal portion of the frame comprises annealing with electromagnetic waves.
PNG
media_image9.png
84
362
media_image9.png
Greyscale
*note that RF energy is the equivalent of the electromagnetic waves
12. The method of claim 9, wherein reflowing the liner and the jacket comprises: loading the liner onto a mandrel; sliding the frame over the liner; sliding the jacket over the top of the frame; and applying heat and pressure to the jacket.
PNG
media_image10.png
100
366
media_image10.png
Greyscale
14.The method of claim 12, further comprising twisting the proximal end of the frame and trimming excess metal wires.
PNG
media_image11.png
52
362
media_image11.png
Greyscale
15. The method of claim 12, further comprising stretching the frame for uniformity.
PNG
media_image12.png
44
364
media_image12.png
Greyscale
16. The method of claim 12, wherein applying heat and pressure to the jacket is done using fluorinated ethylene propylene tubing.
PNG
media_image13.png
56
364
media_image13.png
Greyscale
17.The method of claim 9, further comprising adjoining a tip to the distal end of the sheath shaft.
PNG
media_image14.png
36
376
media_image14.png
Greyscale
18. The method of claim 9, further comprising overmolding a radiopaque tip on the distal end of the sheath shaft.
PNG
media_image15.png
36
370
media_image15.png
Greyscale
19. The method of claim 9, wherein only a distal portion of the frame is annealed.
PNG
media_image16.png
40
360
media_image16.png
Greyscale
20. A method of manufacturing a sheath, comprising: extruding a nylon core; braiding metal wires over the nylon core to form a frame; heating and stretching the nylon core to reduce the diameter of the nylon core for removal of the frame, wherein the second portion is spaced apart from the first portion; annealing a first portion and a second portion of the frame; reflowing a liner to an interior surface of the frame and a jacket to an exterior surface of the frame to form a composite conduit; cutting the composite conduit to form a plurality of sheath shafts, wherein the annealed portions extend along a length less than a length of each of the sheath shafts; and overmolding a hub around a proximal portion of the sheath shafts.
PNG
media_image17.png
324
381
media_image17.png
Greyscale
21. The sheath of claim 1, wherein the wire frame comprises a braided wire structure.
Claims 1-8- see claim 1 lines 11-12
22. The method of claim 11, wherein the electromagnetic waves comprise RF radiation.
23. (New) The claim 9, wherein annealing the distal portion of the frame comprises annealing with a heated element.
Thus, the invention of US Patent 12076046, claims 1-19, respectively, are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and its dependent claim 11. In particular, none of the cited references teach or suggest the sheath containing an additional annealed portion proximal to the annealed distal portion; and wherein the electromagnetic waves comprise RF radiation, as required by claim 22.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 9. In particular, none of the cited references teach or suggest annealing a plurality of discontinuous portions of the frame, including a distal portion of the frame; and wherein annealing the distal portion of the frame comprises annealing with a heated element, as required by claim 23.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowable Subject Matter
Claims 22 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
The USC 112b rejection to claims 1-6 and 21 is withdrawn in view of the amendment entered on 2/5/2026.
The Double Patenting rejection made to claims 1-6, 9-12 and 14-21 has been modifying in view of the amendment entered on 2/5/2026. Applicant has not presented any arguments regarding this rejection.
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 Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. 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.
/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773