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 with traverse of Group I and Species A (claims 1-6 and 12-15) in the reply filed on 12/1/25 is acknowledged. The traversal is on the ground(s) of lack of search burden. This is not found persuasive because of the factors provided in the prior restriction/election requirement, including the need for separate types of search queries and identification of art that would apply to one group/specie but not the other. Claims 7-11 and 16-20 are withdrawn from consideration.
The requirement is still deemed proper and is therefore made FINAL.
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) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wada (US 20190192826).
Regarding claim 1, Wada discloses a medical elongated body (device of fig. 1-4) comprising: a catheter main 110 body possessing an outer surface 117 and a proximal portion (proximal portion of 110, see fig. 2); a hub 120 fixed to the proximal portion of the catheter main body (see fig. 2); a drug 160 disposed on the outer surface of the catheter main body (see fig. 4); a support member 130 connected to the hub and covering the drug disposed on the outer surface of the catheter main body (see fig. 4); the support member including a base portion 135 rotatable in a circumferential direction of the catheter main body (135 designed to be gripped and manipulated relative to the catheter body, see par. 0068-0069, fully capable of being rotated circumferentially) and a covering member that protrudes distally beyond a distal end of the base portion (portions of the strain relief defined between slits 134; see fig. 3B and par. 0069), the covering member covering the drug disposed on the outer surface of the catheter main body (see fig. 4) and overlapping at least a part of the base portion in a radial direction of the catheter main body (base portion and covering member, as defined above, overlap one another); and the covering member being movable relative to the catheter main body and exposes the drug portion as the base portion rotates (par. 0068-0069, fully capable of doing so upon rotation of the base member).
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) 1-3, 12, and 14 (claim 1 in the alternative) is/are rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Makower et al. (US 5290310).
Regarding claim 1, in the alternative, Wada discloses a medical elongated body (device of fig. 1-4) comprising: a catheter main body 110 possessing an outer surface 117 and a proximal portion (proximal portion of 110, see fig. 2); a hub 120 fixed to the proximal portion of the catheter main body (see fig. 2); a drug 160 disposed on the outer surface of the catheter main body (see fig. 4); a support member 130 connected to the hub and covering the drug disposed on the outer surface of the catheter main body (see fig. 4); the support member including a base portion 133 and a covering member that protrudes distally beyond a distal end of the base portion (portion of 130 that is distal of 133), the covering member covering the drug disposed on the outer surface of the catheter main body (see fig. 4); and the covering member being movable relative to the catheter main body and exposes the drug portion (par. 0068-0069). Wada discloses moving the covering portion by pulling it away from the catheter main body (par. 0068-0069) and further envisions modifying the mechanism for movement relative to the catheter body (par. 0142), but, in this interpretation, does not disclose the base portion rotatable in a circumferential direction of the catheter main body; the covering member overlapping at least a part of the base portion in a radial direction of the catheter main body; and the covering member exposes the drug portion as the base portion rotates. However, Makower et al. teaches a mechanism (fig. 10) for retracting a covering member 200 which covers a drug 224 (collagen), utilizing a rotatable base portion 210 which rotates relative to the catheter body and covering member 200 to relatively move the covering member 200 away from the covered drug 224 (col. 9, ln. 64 – col. 10, ln. 47). 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 base and covering portion disclosed by Wada to utilize a rotational retraction mechanism, as taught by Makower et al., for the purpose of providing sufficient structure to reveal the drug, as required by Wada, without the need for continuous grip of the covering member or any concern for the covering member unexpectedly falling back into place.
Regarding claim 2, Makower et al. further teaches the support member includes a connecting member connecting the base portion and the covering member so that the rotation of the base member results in the movement of the covering member relative to the catheter main body (portion of 200 that is drawn over pins 218/220; col. 10, ln. 25-39), and the connecting member is deformable (via splitting apart; col. 10, ln. 25-39) such that a distance between the base portion and the covering member in an axial direction of the catheter main body decreases as the base portion rotates (covering 200 is drawn rearward relative to the base 210; col. 10, ln. 25-39).
Regarding claim 3, Makower et al. further teaches the catheter main body has a first engaging portion (218, 220) in the outer surface, and the covering member has a second engaging portion (portion of 200 that is drawn over pins 218/220; col. 10, ln. 25-39) that is in engagement with the first engaging portion to block rotation of the covering member in the circumferential direction of the catheter main body (col. 10, ln. 25-39).
Regarding claim 12, Wada discloses a medical elongated body (device of fig. 1-4) comprising: a catheter main body 110 possessing a distal end 111 and proximal portion (portion proximal to 111) terminating at a proximal end 113, the catheter main body including a lumen 116 that is open at opposite ends (see fig. 2) and that extends in an axial direction of the catheter main body from the distal end of the catheter main body to the proximal end of the catheter main body (see fig. 2), the catheter main body possessing an outer surface 117; a hub 120 fixed to the proximal portion of the catheter main body (see fig. 2); a drug 160 that contains a hemostatic agent to treat a wound site in a living body (par. 0039), the drug being located on an axially extending drug covered region on the outer surface of the catheter main body (see fig. 4); a base 133 that is tubular and includes a proximal end and a distal end (proximal and distal ends of 133); a cover (portion of 130 that is distal to 133) that includes a distal portion extending distally beyond the distal end of the base (see fig. 2 and 4), the cover extending axially over a longitudinal extent that axially overlaps with at least a distal portion of the drug covered region on the outer surface of the catheter main body at which the drug is located (see fig. 4) so that the distal portion of the drug covered region on the outer surface of the catheter main body at which the drug is located is covered by the distal portion of the cover (see fig. 4); and the cover connected to the base so that movement of the cover exposes the drug in the distal portion of the drug covered region (par. 0068-0069). Wada discloses moving the covering portion by pulling it away from the catheter main body (par. 0068-0069) and further envisions modifying the mechanism for movement relative to the catheter body (par. 0142), but does not disclose the base being rotatably connected to the hub and being rotatable relative to the catheter main body; and the cover including a proximal portion operatively connected to the base so that the rotation of the base results in movement of the distal portion of the cover that uncovers and exposes the drug in the distal portion of the drug covered region. However, Makower et al. teaches a mechanism (fig. 10) for retracting a covering member 200 which covers a drug 224 (collagen), utilizing a rotatable base portion 210 which rotates relative to the catheter body and covering member 200 to relatively move the covering member 200 away from the covered drug 224 (col. 9, ln. 64 – col. 10, ln. 47). 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 base and covering portion disclosed by Wada to utilize a rotational retraction mechanism, as taught by Makower et al., for the purpose of providing sufficient structure to reveal the drug, as required by Wada, without the need for continuous grip of the covering member or any concern for the covering member unexpectedly falling back into place.
Regarding claim 14, Makower et al. further teaches an axially extending groove (slits in 200) and a protrusion (218/220) positioned in the groove (col. 10, ln. 25-39), one of the groove and the protrusion being provided on the catheter main body (protrusion 218/220), and the other of the protrusion and the groove being provided on the cover (slits in 200), the positioning of the protrusion in the groove preventing the cover from rotating when the base is rotated (col. 10, ln. 25-39).
Allowable Subject Matter
Claims 4-6, 13, and 15 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached notice of references cited.
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.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783