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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's AF submission filed on 10/15/25 has been entered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 120, 130, 132, 134. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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 6 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.
It is not understood how “pressure from a proximal end of the system” can be applied to a proximal end of the functional and/or therapeutic agent which is a liquid but more importantly where or how is pressure existing in some arbitrary space with no boundaries as the claim does not detail there is some enclosed space.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Regarding the rejection of claim 9, Applicant argues the functional agent was alleged to be in contact with a stent and no suggestion in Grandt to not have the agent to not be in communication with the stent. However, this feature is taught in the new reference to Kusleika and presented below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,3,5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kusleika et al. (WO 96/32078). Fig. 11 shows a system for maintaining a flow path in tissue, comprising: a first sheath 122; a stent 124 disposed within the first sheath, the stent configured to be deployed from the first sheath to transition between a first configuration, within the first sheath. Fig. 7 shows a second configuration, outside the first sheath. Fig. 11 shows a second sheath 120 disposed about the first sheath such that the first sheath extends longitudinally within the second sheath. Kusleika et al. also disclose (page 8, lines 4-7) there is a space defined between an exterior of the first sheath and an interior of the second sheath configured to retain a liquid therein; and a functional agent (lubricant) provided in a liquid form or liquid carrier and disposed within the space defined between the exterior of the first sheath and the interior of the second sheath. Kusleika et al. further disclose (claim 11 of doc) the liquid is distally extrudable out of the space between the first sheath and the second sheath via pore 69 (Fig. 5) and onto the stent since it is released to lumen of body. Regarding clam 3, Fig. 10 shows an inner member (guidewire), wherein: the stent is disposed about an inner member; and the first sheath is proximally longitudinally retractable with respect to the inner member, the inner member is distally longitudinally extendable with respect to the first sheath, or both, such that the stent is released from within the first sheath to transition to the second configuration. With respect to claim 5, Kusleika discloses (page 13) the second sheath is proximally longitudinally retractable with respect to the inner member, the inner member is distally longitudinally extendable with respect to the second sheath, or both; and the system is configured to dispose the functional and/or therapeutic agent on the surface of the stent when the second sheath is proximally retracted with respect to the inner member, the inner member is distally extended with respect to the second sheath, or both.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 7,8 are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika et al. (WO 96/32078) in view of Ikeda (EP 2821467). Kusleika et al. is explained supra. However, Kusleika et al. did not disclose the functional agent comprises a first component, and a second component, the first component and the second component configured to react when in contact with each other. Ikeda teaches (paragraph 14) a functional agent (lubricity) the functional agent comprises a first component, and a second component, the first component and the second component configured to react when in contact with each other. It would have been obvious to one of ordinary skill int the art to provide a functional agent such as a lubricant for use by delivering a first component, and a second component which are configured to react when in contact with each other as taught by Ikeda in the system of Kusleika et al. such that it provides lubricity at time of use and when exposed to liquids such as in blood vessel and improves delivery to reduce any unwanted resistance, see Ikeda para. 66.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Grandt (WO 2011/050979) in view of Kusleika et al. (WO 96/32078). Grandt shows (Fig. 3A) a system 300, comprising: a stent comprising a lumen extending longitudinally therethrough, the stent configured to shift between a first configuration and a second configuration, see paragraph 114. Grandt also discloses (paragraph 114) in the second configuration, the stent defines a first retention member, a second retention member, and a saddle region extending therebetween; and when the stent is positioned within a body lumen in the second configuration. Fig. 3A shows the first retention member 310a, the second retention member 310b, the saddle region therebetween. Grandt further discloses (paragraph 124) a functional and/or therapeutic agent is delivered by a delivery system component 370 through a space "surrounding" the stent to be extruded over the stent in area thereabout 330 and the tissue wall of the lumen define a volume configured to retain the functional and/or therapeutic agent therein. However, Grandt did not disclose the functional agent is in liquid form or not in communication with the stent is in the first configuration to be extruded over the stent when the stent is extended into the second configuration. Kusleika et al. teach (page 8, lines 4-7) there is a functional (lubricant) agent used with the system to aid in movement of the sheath on the stent. It can be seen (Fig. 11) the functional agent taught by Kusleika is in space that is not in communication with the stent. It would have been obvious to one of ordinary skill in the art in delivering a functional agent via a fluid as taught by Kusleika et al. in the system of Grandt such that it able to flow along the surface of the sheath and be used as a lubricant to improve slidability of the sheath in the vessel. Regarding claim 10, it can be seen (Fig. 3A of Grandt) the tissue 390 is spaced away from the saddle region defining space 330. With respect to claim 11, Grandt discloses (pages 11-14) there can be numerous types of functional and/or therapeutic agents selected from a healing agent, functional or a therapeutic agent.
Allowable Subject Matter
Claims 2,4 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799