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
The specific restriction requirement as set forth in the office action mailed 7/8/26 is hereby withdrawn. Election by original presentation will still be considered, as necessary, regarding any future claim amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 17 recites “a mechanical means that activates upon expansion of the expandable medical device”, which invokes 35 U.S.C. 112(f), but the disclosure as a whole fails to specify the specific underlying subject matter for performing this claimed function of mechanical activation upon expansion of the expandable medical device.
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 applicant regards as his invention.
Claim 20 is 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 20, the claim recited a second drug coating without identification of a relative first drug coating, so that it is unclear how many drug coatings are present and where any additional drug coatings may be located. For the purposes of examination, the limitation of claim 20 will not be interpreted to require any first drug coating.
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, 2, and 8-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McQuilkin et al. (US 4888000).
Regarding claim 1, McQuilkin et al. discloses a method of treatment (fig. 1-3, utilizing structures of fig. 1-8) comprising: advancing an expandable medical device 20 and a radially expandable tubular sheath 42 surrounding at least a portion of the expandable medical device to a treatment area within a patient (fig. 2); applying tension to an activation line 22 to split the sheath to form a first sheath segment and a second sheath segment (segments 25 and 26; fig. 3 and 7); and removing the first sheath segment from a portion of the expandable medical device (col. 2, ln. 15-20).
Regarding claim 2, McQuilkin et al. discloses the expandable medical device is a balloon (see fig. 2; col. 2, ln. 11-12).
Regarding claim 8, McQuilkin et al. discloses removing the second sheath segment from at least a portion of the expandable medical device (col. 2, ln. 15-20).
Regarding claim 9, McQuilkin et al. discloses orienting the expandable medical device subsequent to the step of removing the first sheath segment and prior to the step of removing the second sheath segment from the patient (the device being continually “oriented” into its desired position throughout the procedure, see fig. 2-3).
Regarding claim 10, McQuilkin et al. discloses upon applying tension to the activation line, the first sheath segment is pulled towards a proximal end of the expandable medical device (see fig. 3 vs. fig. 2, where the result of pulling 22 has moved the segment closer toward the proximal end of 42).
Regarding claim 11, McQuilkin et al. discloses the activation line comprises a first portion attached to the first sheath segment (portion 22 attached to 20) and a second portion attached to the second sheath segment (connecting wall between 25 and 26).
Regarding claim 12, McQuilkin et al. discloses the first portion of the activation line has a length that is shorter than a length of the second portion of the activation line (see fig. 2-3 and fig. 7).
Regarding claim 13, McQuilkin et al. discloses the first sheath segment splits along two split lines which are parallel to a longitudinal axis of the expandable medical device (see fig. 7).
Regarding claim 14, McQuilkin et al. discloses tension is applied to the activation line manually (via 22; col. 2, ln. 19-20).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over McQuilkin et al. in view of Sahatjian (US 5304121).
Regarding claim 3, McQuilkin et al. discloses the method as claimed, except for an outer surface of the balloon comprises a drug coating. However, Sahatjian teaches providing an outer surface of a balloon with a drug coating (abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a drug coating as taught by Sahatjian on the outer surface of the balloon of McQuilkin et al. in order to deliver drug to tissue at the balloon location during the procedure.
Claim(s) 4-7 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over McQuilkin et al. in view of Armstrong (US 20060015171).
Regarding claims 4-7, McQuilkin et al. discloses the method as claimed, except for specifically disclosing the sheath is hydrophobic; the sheath comprises an extruded polymeric tube; the sheath comprises a wrapped polymeric material; and/or the sheath comprises ePTFE. However, Armstrong teaches forming a splittable sheath in the form of a tube, structured as an extruded tube, comprises of wrapped polymeric (ePTFE) material (par. 0100) which is hydrophobic (ePTFE is hydrophobic). 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 sheath of McQuilkin et al. to be comprises of ePTFE meeting these claim limitations, as taught by Armstrong, for the purpose of providing benefits such as a smooth, continuous outer surface and thin wall thickness (par. 0018).
Regarding claim 19, McQuilkin et al. discloses the method as claimed, except for the expandable medical device is a stent. However, Armstrong teaches utilizing a splittable sheath device in combination with an expandable stent (abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a stent as taught by Armstrong in the method of McQuilkin et al. for the purpose of adapting the method for stent placement.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McQuilkin et al. in view of Slattery et al. (US 20130226279).
Regarding claims 16 and 17, McQuilkin et al. discloses the method as claimed, except for specifically disclosing a distal end of the first sheath segment and a distal end of the second sheath segment are secured to an elongate member; and/or the first sheath segment and the second sheath segment are secured to the elongate member by a mechanical means that activates upon expansion of the expandable medical device. However, Slattery et al. teaches securing a sheath 150 to an elongate member 110 (fig. 1-5), either proximally or distally (par. 0023-0024) in a way that mechanically activates upon expansion of the expandable medical device (par. 0023-0024). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McQuilkin et al. to utilize the attachment and activation means as taught by Slattery et al. for the purpose of providing sufficient structure to achieve a desired relative position between the elements up until the point of splitting the sheath.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McQuilkin et al. in view of Weber (US 20090204196).
Regarding claim 20, McQuilkin et al. discloses the method as claimed, except for specifically disclosing n outer surface of the sheath comprises a second drug coating, and wherein upon inflation of the expandable medical device to a desired inflation diameter, the second drug coating is delivered to the treatment area. However, Weber teaches providing layered coatings of drugs on a sheath element to be expanded and delivered by the expandable device (see at least par. 0027). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McQuilkin et al. to include a coating to be delivered as claimed, as taught by Weber, for the purpose of providing sufficient structure to delivery an advantageous drug to the position of the sheath during device placement.
Allowable Subject Matter
Claims 15 and 18 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:
Wallace et al. (WO 9811846) – splittable sheath with everting portion
Chung et al. (US 20180055670)
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
