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 invention I, species A in the reply filed on 7/22/26 is acknowledged. Claims 14-17 are withdrawn from consideration by the examiner as being directed to a non-elected species B. Claims 21-25 have been cancelled.
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 11, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whelehan (US2022/0265968 cited in the IDS dated 6/26/24)
Regarding claim 11, Whelehan according to the embodiment of Fig. 1A-1B discloses a device for treating tissue, comprising:
a hollow sheath (120) having sufficient flexibility to be inserted to a target site within a living body within a flexible endoscope (120 is delivered through the tortuous anatomy of the body and would have some degree of flexibility, the sheath can be used with a endoscope, [0020]), the sheath having a length selected to extend from a distal end which, when the device is in an operative configuration, is adjacent to the target site (distal end of the sheath 120 is retracted to release device, [0029]), to a proximal end which remains outside the living body accessible to a user (the sheath 120 includes a handle 113 that is for pulling back the sheath 120 and is operated by an operator, [0021]);
a flexible hollow member (inner catheter 110) extending through the sheath from a proximal end that remains outside the living body (catheter 110 is fixed to handle 113, [0021]) to a distal end which may be extended distally out of the sheath to contact a target portion of tissue adjacent to the target site (distal end of 110 is extended out of sheath 120, see Fig. 1B, the distal end is capable of contact tissue and is intended to be at the target site for delivery of the surgical device, [0022]);
an expansion device (152) coupled to and extending distally from a distal end of the hollow member (where balloon 152 is coupled to a distal portion of 110, this distal portion of 110 is interpreted as a distal end of 210 and therefore the balloon 152 extends distally from this portion, see Fig. 1B), the expansion device being movable from a radially compressed insertion configuration to a radially expanded deployed configuration ([0023]); and
a first therapeutic patch (160) wrapped around the expansion device, the first patch being configured to be forced radially outward into contact with and adhere to a first target portion of tissue when the expansion device is moved to the deployed configuration ([0023]), the expansion device being configured to be moved, after the first patch has been adhered to the first target portion of tissue as desired, from the deployed configuration to the insertion configuration to separate the first patch from the expansion device leaving the first patch in a desired position adhered to the first target portion of tissue ([0027]).
Regarding claim 19, Whelehan discloses the device of claim 11, wherein the first therapeutic patch has a width extending along a longitudinal axis of the expansion device and a length transverse to the width (dimensions of the patch as shown in Fig. 1B), the first therapeutic patch being wrapped around the expansion device so that the length of the first therapeutic patch extends circumferentially around the expansion device ([0027]), the length of the first therapeutic patch being configured to be at least as great as a diameter of the expansion device in the deployed configuration (the length of the patch is capable of being as great as the diameter of the expansion device in the deployed configuration, where the deployed configuration of the expansion device could be inflated to a specific diameter that would correspond to the length of the therapeutic patch, [0027]).
Regarding claim 20, Whelehan discloses the device of claim 11, wherein the first therapeutic patch includes an adhesive having a predetermined cure time (adhesive is used to hold the patch to contacted tissue, the adhesive would have some cure time, [0018]) and wherein the first therapeutic patch is configured to be removable from tissue against which it has been pressed before the predetermined cure time has elapsed since the first therapeutic patch was pressed against the tissue (the patch is capable of performing the claimed function since the patch is configurated to deliver a therapeutic agent over time and then be biodegradable, [0019]).
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.
Claim(s) 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Whelehan (US2022/0265968) in view of Ferrera (US2015/0182361).
Regarding claim 12, Whelehan discloses the device of claim 11, Whelehan does not disclose wherein the expansion device comprises a plurality of members extending from a proximal end of the expansion device to a distal end of the expansion device, the device further comprising: a control wire coupled to a distal end of the expansion device, movement of the control wire proximally relative to the expansion device compressing the expansion device along a longitudinal axis thereof and expanding the expansion device radially away from the longitudinal axis. Ferrera teaches a system for removing obstructions from a body passage, with a catheter 102 (interpreted as the hollow sheath) that is inserted to a target site with a elongate device 104 (interpreted as the flexible hollow member) that slides within the catheter and having an expandable member 106 at its distal end (interpreted as the expansion device). A pull wire 114 (interpreted as the claimed control wire) causes the expandable member 106 to compress axially and thus expand ([0087]). Where pull wire 114 is fixed to the distal end of the elongate device 104 ([0087]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the expansion device with control wire of Ferrera for the expansion device of Whelehan, since the substitution would have yielded the same predictable result of providing an expansion device for medical intervention. Where the modified invention of Whelehan/Ferrera would have the expansion device (106) comprise a plurality of members (wires 110) extending from a proximal end of the expansion device to a distal end of the expansion device (see Fig. 1C of Ferrera).
Regarding claim 13, Whelehan/Ferrera makes obvious the device of claim 12, Ferrera further teaches wherein the members of the expansion device are formed as an expandable tubular stent (the modified invention has an expandable stent structure as shown in Fig. 1C).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Whelehan (US2022/0265968) in view of Palmisano (US2014/0257027).
Regarding claim 18, Whelehan discloses the device of claim 11; yet, is silent regarding further comprising: a second therapeutic patch wrapped around the expansion device and radially outside the first therapeutic patch, the second patch being configured to be forced radially outward into contact with and adhere to a second target portion of tissue when the expansion device is moved to the deployed configuration, the expansion device being configured to be moved, after the second patch has been adhered to the second target portion of tissue as desired, from the deployed configuration to the insertion configuration to separate the second patch from the expansion device leaving the second patch in a desired position adhered to the second target portion of tissue. Palmisano teaches a surgical mesh for tissue repair such as genital prolapse or pelvic organ prolapse ([0024]). The mesh (interpreted as first therapeutic path) having multiple fixation mechanisms (interpreted as a second therapeutic patch). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first and second therapeutic patches of Palmisano for the therapeutic patch of Whelehan, since the substitution would have yielded the predictable result of providing a tissue patch to be adhered to tissue for healing of tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
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