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 Species A5 (figs. 10-11) and the withdrawal of claims 12 and 13 in the reply filed on 7/14/26 is acknowledged.
However claims 6, 8-10 are also withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim 6 refers to the band being releasable which is only described in the specification for species A1 in figures 1-3, and 8 (specification paragraph [0050]). Claims 8-10 refer to a band with a plurality of apertures and a flap element which is only present in species A1, in figure 8 (specification paragraph [0064]). Since the elected species do not have the limitations described above, claims 6, and 8-10 have been withdrawn.
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 2 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 2, the limitation “elongate body has the shape of a band” renders the claim indefinite because it’s not clear the bounds of what shape constitutes a band.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7 15, 17 19, 21, 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenblatt (US 2017/0360543).
Regarding claim 1, Rosenblatt discloses a surgical device for performing hysteropexy in a subject, said device comprising
a flexible (paragraph [0102] “As noted above, reference to “mesh” is to be taken as a reference to other flat, flexible materials in the alternative or in combination.”) elongate body (paragraph [0096] “FIG. 16 depicts another exemplary embodiment in which an elongated mesh (1)”)
defining first and second free ends (paragraph [0096] “an elongated mesh (1) is provided with a curved needle (2) at a distal end.“ and “On the other (proximal) end of the mesh is a grommet or eyelet (3). The eyelet (3) can be formed with a non-uniform geometry with a distal portion of the eyelet having a larger and generally circular opening, while a more distal portion of the eyelet is formed with a more narrow, and linear slot.“ The examiner notes in fig 16, end 2 is the second end and 3 is the first end.)
and having a first end section that is configured to be formed into a closed loop for extending at least partly around an outer surface of the cervix of the subject (paragraph [0074] “The device can be employed to treat uterine prolapse, by supporting the apex of the vagina (i.e. cervix) by encircling the cervix” ),
and a second end section extending from the closed loop that is configured to be secured to the anterior longitudinal ligament of the subject (paragraph [0058] “In use the surgeon may perform the cerclage using a needle driver…. the sacral extension can be attached in traditional methods to the sacral promontory (anterior longitudinal ligament) or other apical supporting structure, such as the sacrospinous ligament.”) ),
wherein the first end section comprises a fastening arrangement having cooperating connecting elements at or towards respective proximal and distal end portions thereof to facilitate formation of the closed loop. (paragraph [0096] “The eyelet, which can include reinforced material as described above, receives the needle after the cerclage has been performed.” The examiner notes a cerclage is when a band is formed in a loop around the cervical area.)
Regarding claim 2, Rosenblatt discloses the device of claim 1, wherein the elongate body has the shape of a band. (paragraph [0079] “the arm has a length that is sufficient to be configured into an annular band”)
Regarding claim 5, Rosenblatt teaches the device of claim 1, and further teaches wherein the fastening arrangement comprises one or more openings at or towards one of the proximal or distal end portions of the first end section and adapted to receive the respective first or second free end of the elongate body therethrough and facilitate formation of the closed loop. (paragraph [0096] “On the other (proximal) end of the mesh is a grommet or eyelet (3). The eyelet, which can include reinforced material as described above, receives the needle after the cerclage has been performed.”)
Regarding claim 7, Rosenblatt teaches the device of claim 1, and further teaches wherein the fastening arrangement is configured to facilitate adjustment of a size of the closed loop. (paragraph [0097] “The amount of the mesh strip that is inserted through the eyelet may be variable, as it is a function of the circumference of the cervix.”)
Regarding claim 15, Rosenblatt discloses the device of claim 1, and wherein the second end section comprises one or a plurality of further openings disposed at or towards the second free end of the elongate band that facilitate securing the device to the anterior longitudinal ligament. (column 10, line 59 “An eyelet in the body of the mesh may assist with stabilization of the cerclage. The cerclage material can be attached to the sacral mesh extension, which could then be attached to the sacrum (e.g. anterior longitudinal ligament of the sacrum) in one of several methods, such as suturing or tacking.”)
Regarding claim 17, Rosenblatt discloses a method of performing hysteropexy in a subject, said method (paragraph [0003] “if the primary problem is uterine prolapse, the surgeon may choose to perform a sacrohysteropexy”) including the steps of:
providing a surgical device comprising a flexible elongate body defining first and second free ends and having a first end section that is configured to be formed into a closed loop for extending at least partly around an outer surface of the cervix of the subject, (paragraph [0102] “As noted above, reference to “mesh” is to be taken as a reference to other flat, flexible materials in the alternative or in combination.” paragraph [0096] “FIG. 16 depicts another exemplary embodiment in which an elongated mesh (1)” paragraph [0007] “Cervical cerclage refers to one of several surgical procedures in which a material, such as mesh, tape or suture is used to reinforce the cervix.” The examiner notes a cervical cerclage provides a loop around the cervix.)
and a second end section extending from the closed loop that is configured to be secured to the anterior longitudinal ligament of the subject, (paragraph [0058] “In use the surgeon may perform the cerclage using a needle driver…. the sacral extension can be attached in traditional methods to the sacral promontory (anterior longitudinal ligament) or other apical supporting structure, such as the sacrospinous ligament.”)
wherein the first end section comprises a fastening arrangement having cooperating connecting elements at or towards respective proximal and distal end portions thereof to facilitate formation of the closed loop; (paragraph [0096] “The eyelet, which can include reinforced material as described above, receives the needle after the cerclage has been performed.”)
positioning the first end section adjacent the cervix and/or uterus of the subject so as to extend at least partly therearound; forming the closed loop of the first end section around the cervix and/or uterus of the subject (paragraph [0096] “The eyelet, which can include reinforced material as described above, receives the needle after the cerclage has been performed.”);
and securing the second end section to the anterior longitudinal ligament of the subject (paragraph [0075] The cerclage material can be attached to the sacral mesh extension, which could then be attached to the sacrum (e.g. anterior longitudinal ligament of the sacrum) in one of several methods, such as suturing or tacking.”
Regarding claim 18, Rosenblatt discloses the method of claim 17, further comprising the step of securing the first end section to the cervix and/or uterus of the subject. (paragraph [0057] “the device may consist of two components: a material that is used to create a cervical cerclage (or other type of attachment to the cervix)” The examiner notes this as figure 16, end 1. paragraph [0058] “begin the cerclage posteriorly and would take successive tissue purchases to encircle the cervix…The cerclage would be completed posteriorly on the other side of the cervix and the surgeon may pass the cerclage material (still attached to the needle) through some mechanism on the mesh (e.g. an aperture, such as an eyelet) so that it completes the cerclage and can be cinched down without the need for tying a knot in the cerclage material.”)
Regarding claim 19, Rosenblatt discloses the method of claim 18, further comprising the step of making one or more incisions in a broad ligament of the subject to facilitate positioning of the first end section. (paragraph [0058] “Once this is complete, the sacral extension can be attached in traditional methods to the sacral promontory (anterior longitudinal ligament) or other apical supporting structure, such as the sacrospinous ligament….For example, the surgeon may use sutures or a tacking device”)
Regarding claim 21, Rosenblatt discloses a kit comprising surgical device for performing hysteropexy in a subject,
said device comprising a flexible (paragraph [0102] “As noted above, reference to “mesh” is to be taken as a reference to other flat, flexible materials in the alternative or in combination.”) elongate body (paragraph [0096] “FIG. 16 depicts another exemplary embodiment in which an elongated mesh (1)”)
defining first and second free ends (paragraph [0096] “an elongated mesh (1) is provided with a curved needle (2) at a distal end.“ and “On the other (proximal) end of the mesh is a grommet or eyelet (3). The eyelet (3) can be formed with a non-uniform geometry with a distal portion of the eyelet having a larger and generally circular opening, while a more distal portion of the eyelet is formed with a more narrow, and linear slot.“ The examiner notes in fig 16, end 2 is the second end and 3 is the first end.)
and having a first end section that is configured to be formed into a closed loop for extending at least partly around an outer surface of the cervix of the subject (paragraph [0074] “The device can be employed to treat uterine prolapse, by supporting the apex of the vagina (i.e. cervix) by encircling the cervix” ),
and a second end section extending from the closed loop that is configured to be secured to the anterior longitudinal ligament of the subject (paragraph [0058] “In use the surgeon may perform the cerclage using a needle driver…. the sacral extension can be attached in traditional methods to the sacral promontory (anterior longitudinal ligament) or other apical supporting structure, such as the sacrospinous ligament.”) ),
wherein the first end section comprises a fastening arrangement having cooperating connecting elements at or towards respective proximal and distal end portions thereof to facilitate formation of the closed loop and optionally instructions for use.. (paragraph [0096] “The eyelet, which can include reinforced material as described above, receives the needle after the cerclage has been performed.”)
Regarding claim 23, Rosenblatt in view of Brown teaches the device of claim 5, and Brown further teaches wherein the one or more openings are disposed at or towards the proximal end portion of the first end section, wherein the one or more openings are adapted to receive the second free end of the elongate body therethrough and facilitate formation of the closed loop. (paragraph [0096] “The eyelet, which can include reinforced material as described above, receives the needle after the cerclage has been performed.” The examiner notes a cerclage is when a band is formed in a loop around the cervical area.)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt in view of Weiser (US 8944989).
Regarding claim 3, Rosenblatt teaches the device of claim 1, but fails to teach wherein the elongate body is substantially formed of a silicone or a derivative thereof.
Weiser teaches an implantable band for pelvic disorders made of silicone. (column 16, line 12 “The mesh may be fabricated from any of a number of biocompatible materials, such as nylon, silicone,”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify Ronsenblatt to use silicone in view of Weiser. One of ordinary skill in the art would have been able to recognize that silicone is a biocompatible material.
Regarding claim 14, Rosenblatt teaches the device of claim 1, but fails to teach wherein the elongate body comprises, consists of or consists essentially of a nonporous material.
Weiser teaches an implantable band for pelvic disorders made of silicone. (column 16, line 12 “The mesh may be fabricated from any of a number of biocompatible materials, such as nylon, silicone,” The examiner notes that silicone is a nonporous material.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify Ronsenblatt to use silicone in view of Weiser. One of ordinary skill in the art would have been able to recognize that a non-porous material would prevent trapping bacteria in the implant.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt in view of Patel (US 2010/0234862).
Regarding claim 11, Rosenblatt teaches the device of claim 1, but fails to teach wherein the first end section further comprises a textured portion disposed on an inner surface of the closed loop.
Patel teaches a surgical clamp for an organ with a textured inner surface. (Fig. 2, element 22. paragraph [0026] “Raised projections 22 are formed on a surface of the band 12 and are utilized as ratchet teeth to bias against reverse movement of the band 12 through the tie 30.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the band taught by Rosenblatt to have a textured inner surface as taught by Patel. One of ordinary skill in the art would have been able to recognize that the textured portion help prevent reverse movement of the band. See paragraph [0026] of Patel.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt in view of Therin (US 2003/0004395).
Regarding claim 16, Rosenblatt teaches the device of claim 1, but fails to teach wherein the second end section comprises one or a plurality of removable segments disposed at or towards the second free end of the elongate band.
Therin teaches a cervical band with a removable segment towards the second free end of the elongate band. (Figure 2, elements 8, 81, 82. paragraph [0046] “Composite band 4 has, at each of its two ends 4a and 4b, a single part, namely a single female part 81, of a connecting means 8 that can be locked and unlocked as desired, while the blunt proximal end of percutaneous needle 3 has another part, for example a male part 82, of the same connecting means 8.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify Rosenblatt figure 16, elements 18, 19 in view of Therin Figure 2, elements 8, 81, 82. One of ordinary skill in the art would have been able to recognize that this is a simple substitution of one connecting element for another for the predictable result of removing the needle after implantation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dudai (US 6676674) and Brown (US 2013/ 0103044) teach a band with multiple openings and textured inner surface to be implanted in a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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