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 .
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.
Claims 1, 2, 4, 5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hussman (US 5,782,771).
Regarding claim 1, Hussman discloses a device (Figure 10) capable of functioning as a uterine manipulator comprising: an elongate shaft (146) having a proximal end and a distal end, the elongate shaft being disposed along a longitudinal direction; an expandable anchor (128) coupled to a distal region of the elongate shaft, the expandable anchor configured to be introduced into a uterus of a patient and expanded along a lateral direction transverse to the longitudinal direction after being introduced into the uterus (the anchor would expand laterally from a contracted state within the needle 140 as shown in Figure 11; col. 5, lines 1-4), and a red-light source (144; col. 9, lines 8-10; col. 12, lines 2-3) operably coupled to the distal region of the elongate shaft (via 122), the red-light source being configured to internally illuminate the uterus with red light having a wavelength between about 630 nm and about 700 nm (col. 9, lines 8-10), wherein the red-light source is of sufficient intensity to illuminate the uterus internally and project light through a wall of the uterus and outside of the uterus to permit external observation of the uterus from within an insufflated peritoneal cavity of a patient (the light would be of sufficient intensity to be viewable as claimed - col. 9, lines 13-15).
Regarding claim 2, the red-light source is disposed proximate the expandable anchor (evident from Figure 10).
Regarding claim 4, the red-light source comprises a plurality of LEDs (col. 6, line 19; col. 11, lines 55-67).
Regarding claim 5, the manipulator further comprises a cutting head (needle 140 or 228) coupled to the distal region of the elongate shaft (Figure 11), the cutting head having a cutter (sharp end of needle; col. 9, lines 1-2) configured to separate a uterus from a vagina of a patient (the sharp end could at least be used to create a hole at a border between these tissues thereby separating them).
Regarding claim 7, a handle (240; Figure 22) is operably coupled to the proximal end of the elongate shaft.
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.
Claims 1, 3, 4, 5, 7, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Fontenot (US 6,685,666) in view of Hussman (US 5,782,771).
Regarding claim 1, Fontenot discloses a device (Figure 15(a)) in Applicant’s field of anchoring devices to facilitate dissection (Abstract of Fontenot) and capable of functioning as a uterine manipulator comprising: an elongate shaft (see shaft in Figure 15(a) housing the lumens of Figure 15(b)) having a proximal end and a distal end, the elongate shaft being disposed along a longitudinal direction; an expandable anchor (see “inflated balloon” in Figure 15(a) - col. 8, line 27) coupled to a distal region of the elongate shaft, the expandable anchor configured to be introduced into a uterus of a patient and expanded along a lateral direction transverse to the longitudinal direction after being introduced into the uterus (col. 8, lines 41-42), and a red-light source (“emitting fiber” - col. 8, line 49; col. 7, lines 16-18; col. 7, lines 50-54) operably coupled to the distal region of the elongate shaft (see “emitting fiber lumen” extending to within the balloon in Figure 15(a)), the red-light source being configured to internally illuminate the uterus with red light having a wavelength between about 630 nm and about 700 nm (col. 7, lines 16-18; col. 7, lines 50-54).
Fontenot fails to disclose whether or not the red-light source is of sufficient intensity to project light through a wall of the uterus and outside of the uterus to permit external observation of the uterus from within an insufflated peritoneal cavity of a patient. Fontenot discloses that the red-light source is of sufficient intensity to allow observation after passing through some amount of breast tissue (col. 7, lines 50-60).
Hussman, also in Applicant’s field of anchoring devices to facilitate dissection, disclose the device as described above and further teach providing a similar light source of sufficient intensity to be visible after passing though “several centimeters of tissue” (col. 9, lines 13-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the red-light source of Fontenot with the intensity of the red-light source of Hussman in order to allow viewing of the light through at least several centimeters of tissue to enable easier detection of the anchor. With this modification, the red-light source would be of sufficient intensity to project light through a wall of the uterus and outside of the uterus to permit external observation of the uterus from within an insufflated peritoneal cavity of a patient.
Regarding claim 3, the red-light source is disposed within the expandable member (see “emitting fiber lumen” extending to within the balloon in Figure 15(a))
Regarding claim 4, the red-light source comprises a plurality of LEDs (col. 7, lines 14-18 of Fontenot).
Regarding claim 5, the manipulator further comprises a cutting head (“needle” - Figure 7) coupled to the distal region of the elongate shaft (the distal region would be within the needle as shown for the Figure 7 embodiment), the cutting head having a cutter (sharp beveled end of needle) configured to separate a uterus from a vagina of a patient (the sharp end could at least be used to create a hole at a border between these tissues thereby separating them).
Regarding claim 7, a handle (see multi-lumen port connecting the shaft to the syringe in Figure 15(a) of Fontenot) is operably coupled to the proximal end of the elongate shaft.
Regarding claim 10, the expandable anchor includes an inflatable body configured to be inflated by an inflation fluid (see “inflated balloon” in Figure 15(a) - col. 8, line 27 of Fontenot).
Regarding claim 11, the red-light source is disposed inside of the inflatable body.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sporri et al. (US 2005/0240211) in view of Gruber et al. (US 2008/0097467) and Steger et al. (US 2020/0078109).
Regarding claims 19 and 20, Sporri et al. disclose a device capable of manipulating a uterus (Figure 5B) comprising: a shaft (15) having a proximal end and a distal end, the elongate shaft being disposed along a longitudinal direction; an expandable anchor (22) configured to be introduced into a uterus of a patient and expanded along a lateral direction transverse to the longitudinal direction after being introduced into the uterus (¶[0074]) a reservoir (25; ¶[0075]) of dye (¶[0048]); a fluid conduit (41 or 49) configured to direct the fluorescent dye through the uterine manipulator into the uterus.
Sporri et al. fail to disclose a light source as claimed. Sporri et al. intend to use various visualization means to aid insertion of their device (¶[0092], [0103]).
Gruber et al. disclose a device like Sporri et al. for fallopian tube opening or closing (¶[0086], [0087]) and further disclose a LED light source within a balloon that is inserted into a uterus to aid in visualization during a medical procedure (Figure 11; ¶[0187]). Gruber et al. further disclose that volume occupying or uterus distending embodiments of their balloon (e.g. 800 - Figure 12) can comprise an internal visualization device (¶[0066], [0205]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the balloon of Sporri et al. with the internal LED light source of Gruber et al. in order to aid in visualization during insertion of their device.
Sporri et al. in view of Gruber et al. fail to disclose a fluorescent dye or the light source being configured to induce fluorescence in the fluorescent dye when the fluorescent dye is injected into the uterus.
Steger et al. teach that indocyanine green is a suitable dye for illuminating reproductive organs and is capable of being induced to fluoresce by a light source (¶[0104]-[0106]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the fluorescent dye of Steger et al. as the dye of Sporri et al. as a suidable dye for the intended location of Sporri et al. which can be induced to fluoresce on demand by the light source.
Allowable Subject Matter
Claims 6, 8, 9 and 12-18 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
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771