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 .
Claim Objections
Claims 1, 5, and 15 are objected to because of the following informalities:
Claim 1, line 8: the line “wherein the plurality of protrusion portions comprise” should end with a colon to match the grammatical structure established by line 2 and because this line is introducing a list of two additional limitations.
Claim 5, line 1: the first line should include a colon after “wherein” to match previous grammatical patterns and because claim 5 introduces a list of two additional limitations.
Claim 15, line 1: the line “wherein the method comprises bring the tissue…” is grammatically incorrect and should be amended to recite “wherein the method comprises bringing the tissue…” instead.
Claim 15, line 3: there is no antecedent basis for “the state of being raised”, it is recommended that the claim be amended to recite “wherein the method comprises bringing the tissue in the vicinity opening portion to a raised state” instead.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 7 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perkins et al. (US PGPub 2020/0405300 A1).
With respect to claim 1, Perkins et al. discloses a suture for use in flexible endoscopic surgeries for suturing an opening portion of human or animal tissue (see Fig. 1, PP [0149]: “Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings herein may be readily incorporated into a robotic surgical system such as the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif. Similarly, those of ordinary skill in the art will recognize that various teachings herein may be readily combined with various teachings of U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument,” published Aug. 31, 2004, the disclosure of which is incorporated by reference herein”, the Anderson et al. patent ‘524 as incorporated herein states that “the instrument probe assembly may include parts or components generally similar or identical to parts or components (OEM components) of current or future commercially-available endoscopic instruments for surgical or diagnostic uses” in col. 7, lines 7-11), comprising:
a suture body portion (103a-b in Fig. 1);
one stop member (108a-b, see also close-up in Fig. 2, each section 108a and 108b make up a singular unified stop member 108a-b) that is disposed at a center in a lengthwise direction of the suture body portion (103a-b) and prevents the suture body portion from passing through (PP [0004]: “one or more of the suture segments can include anchors, tabs, and/or the like on an end thereof. The anchors, tabs, and/or the like can provide a “stop” (e.g., a stop element) at the end that can increase the holding strength of the suture and further eliminates the need to tie knots to secure the suture”. 108a-b anchors the suture to prevent it from passing through); and
a plurality of protrusion portions (104a-b) that obliquely protrude (PP [0028]: “the first suture segment 102a can include a plurality of barbs or protrusions 104a extending outwardly from the filamentary element 103a. Further, as shown in an example, the second suture segment 102b can include a plurality of barbs or protrusions 104b extending outwardly from the filamentary element 103b”) toward an opposite side to an insertion direction of the suture body portion (see Fig. 3, the barbs 104a-b are oriented obliquely away from their respective stop member portions 108a-b),
wherein the plurality of protrusion portions (104a-b) comprise[:]
a plurality of first protrusion portions (104a) that are disposed on one side (left side in Fig. 3), with the stop member (108a-b) as a reference, in the lengthwise direction of the suture body portion (103a-b), and protrude obliquely toward another side (104a protrudes obliquely in a right-hand direction) and outside of the suture body portion (108a), and
a plurality of second protrusion portions (104b) that are disposed on the other side (right side of 108a-b), with the stop member (108a-b) as the reference, in the lengthwise direction of the suture body portion (103a-b), and protrude obliquely toward the one side (104b protrudes obliquely in a left-hand direction) and outside of the suture body portion (103a-b).
Regarding claim 2, Perkins et al. further discloses wherein both ends of the suture body portion (103a-b in Fig. 1) are inserted from an outer wall side to an inner wall side of tissue in a vicinity of the opening portion (PP [0030]: “The first and second needles or insertion devices 101a, 101b can be any suitable needle or insertion devices configured to pass through tissue”, this is functional language which only requires the suture body to be configured to be inserted from an outer wall side to an inner wall side of tissue, PP [0002]: “a bi-directional wound closure device for multi-purpose or multi-layer tissue closure”, a wound in need of closure comprises an outer wall side and an inner wall side, the suture body as seen in Fig. 1 is configured to be inserted in this manner since MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”).
Regarding claim 3, Perkins et al. further discloses wherein one end of the suture body portion (103a in Fig. 1) is inserted from an outer wall side to an inner wall side of tissue in a vicinity of the opening portion where an opening diameter of the opening portion is maximum (PP [0030]: “The first and second needles or insertion devices 101a, 101b can be any suitable needle or insertion devices configured to pass through tissue”), and another end of the suture body portion (103b) is inserted from an outer wall side to an inner wall side of tissue located on an opposite side to the tissue of the opening portion where the one end of the suture body portion (103a) is inserted (PP [0030]: “The first and second needles or insertion devices 101a, 101b can be any suitable needle or insertion devices configured to pass through tissue”, this is functional language which only requires the suture body to be configured to be inserted from an outer wall side to an inner wall side of tissue, PP [0002]: “a bi-directional wound closure device for multi-purpose or multi-layer tissue closure”, a wound in need of closure comprises an outer wall side and an inner wall side, the suture body as seen in Fig. 1 is configured to be inserted in this manner since MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”).
Regarding claim 4, Perkins et al. further discloses wherein the stop member (108a-b in Fig. 2) holds the opening portion in a closed state on an outer wall side in cooperation with the plurality of protrusion portions (104a-b, 108a-b forms the transition section 107 which holds the suture bodies in place, PP [0031]: “the transition zone or connecting section 107 can be a transition point between one suture segment and another suture segment (e.g., a transition point between two sutures connected together as described herein)”, PP [0028]: “the barbs or protrusions can function to increase the holding strength of the suture”, PP [0006]: “A wound closure or suture device, as described herein, with multiple suture segments can enable a surgeon to close multiple tissue layers”).
Regarding claim 5, Perkins et al. further discloses wherein[:]
the suture body portion (103a-b in Fig. 2) comprises a first suture piece (103a) having the plurality of protrusion portions (104a), and a second suture piece (103b) having the plurality of the protrusion portions (104b), and
the stop member (108a-b) is disposed at a joining portion (107) of the first suture piece (103a) and the second suture piece (103b).
Regarding claim 7, Perkins et al. further discloses wherein the stop member (108a-b in Fig. 3) is plate-shaped (see Figs. 3-4, 108a-b are thin rectangles and are plate-shaped).
Regarding claim 11, Perkins et al. further discloses a bioabsorbable material (PP [0005]: “two or more sutures or suture segments or legs (e.g., barbed and/or non-barbed suture segments or legs) of varying materials (e.g., absorbable or nonabsorbable polymers)”).
Regarding claim 12, Perkins et al. further discloses needles (101a-b in Fig. 1) at both ends of the suture body portion (103a-b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (US PGPub 2020/0405300 A1), as applied to claim 1 above, and further in view of D’Agostino et al. (US PGPub 2013/0226233 A1).
Regarding claim 6, Perkins et al. fails to disclose wherein the stop member has a spherical shape.
In the same field of bidirectional sutures (abstract), D’Agostino et al. teaches a suture system (see Fig. 6) comprising a suture body portions (602a-b) with protrusions (603a-b) and a stop member (610a-b) disposed in the middle of the suture body portions (602a-b). D’Agostino et al. further teaches wherein the stop member (610a-b) has a spherical shape (610a-b are small spherical bead-like elements).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Perkins et al. device according to the teachings of D’Agostino et al. to include a spherical stop member. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of stop members which would have yielded predictable results, particularly since Perkins et al. contemplates a variety of different forms for the stop element (PP [0032]: “the stop elements 108a, 108b can be the same shapes, sizes, and/or the like (e.g., the same t, w, and l). Further, the stop elements 108a, 108b can be different shapes, sizes, and/or the like”). The Perkins et al. device would not operate differently with the stop member as taught by D’Agostino et al. because the stop member of the D’Agostino et al. device is also meant to firmly maintain and fix a suture in place (PP [0112]: “They include tissue stops at each end, to inhibit passage of the grasp engage element into the tissue”, PP [0129]: “Grasp engagement element 606 is provided with tissue stops 610a and 610b, adjacent to the proximal ends 608a and 608b of first and second self-retaining suture segments 602a and 602b”), and the combination as proposed would simply hold the sutures of Perkins et al. in place with the spherical stop member as taught by D’Agostino et al. in lieu of the tabs as described.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (US PGPub 2020/0405300 A1), as applied to claim 1 above, and further in view of Wilson et al. (US PGPub 2018/0214269 A1).
Regarding claim 8, Perkins et al. fails to disclose wherein the stop member has a coil shape.
In the same field of sutures (abstract), Wilson et al. teaches a suture (see Fig. 12) comprising a suture body portion (242) and a stop member (240), wherein the stop member (240) has a coil shape (PP [0030]: “a coiled knot configuration”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Perkins et al. device according to the teachings of Wilson et al. to include a coiled stop member. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of stop members which would have yielded predictable results, particularly since Perkins et al. contemplates a variety of different forms for the stop element (PP [0032]: “the stop elements 108a, 108b can be the same shapes, sizes, and/or the like (e.g., the same t, w, and l). Further, the stop elements 108a, 108b can be different shapes, sizes, and/or the like”). The Perkins et al. device would not operate differently with the stop member as taught by Wilson et al. because the coil of the Wilson et al. device is also meant to firmly maintain and fix a suture in place (PP [0131]: “the distal anchor 240 transitioning from an elongated configuration to a knot configuration”), and the combination as proposed would simply hold the sutures of Perkins et al. in place with the coiled knot as taught by Wilson et al. in lieu of the tabs as described.
Regarding claim 9, Perkins et al. further discloses wherein the stop member is a knot formed by tying the suture body portion.
In the same field of sutures (abstract), Wilson et al. teaches a suture (see Fig. 12) comprising a suture body portion (242) and a stop member (240), wherein the stop member (240) is a knot (PP [0030]: “a coiled knot configuration”) formed by tying the suture body portion (242, PP [0138]: “a large or bulky knot made of ePTFE suture or other appropriate material that is formed by the delivery device 130 and that attains a significant size in the left atrium LA, above the leaflet L2. The knot can be in the form of one or more multi-turn coils of the suture or other material used to form the tether (described in more detail below), which coils can be changed from an elongated configuration to a knot configuration by approximating opposite ends of the coil(s) towards each other to form one or more loops”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Perkins et al. device according to the teachings of Wilson et al. to include a stop member which is a knot. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of stop members which would have yielded predictable results, particularly since Perkins et al. contemplates a variety of different forms for the stop element (PP [0032]: “the stop elements 108a, 108b can be the same shapes, sizes, and/or the like (e.g., the same t, w, and l). Further, the stop elements 108a, 108b can be different shapes, sizes, and/or the like”). The Perkins et al. device would not operate differently with the stop member as taught by Wilson et al. because the knot of the Wilson et al. device is also meant to firmly maintain and fix a suture in place (PP [0131]: “the distal anchor 240 transitioning from an elongated configuration to a knot configuration”), and the combination as proposed would simply hold the sutures of Perkins et al. in place with the coiled knot as taught by Wilson et al. in lieu of the tabs as described.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (US PGPub 2020/0405300 A1), as applied to claim 1 above, and further in view of Miraki et al. (US PGPub 2016/0270776 A1).
Regarding claim 10, Perkins et al. fails to disclose wherein the stop member is a clip that can hold the suture body portion.
In the same field of securing sutures to a tissue within the body (abstract), Miraki et al. teaches a stop member (see various embodiments in Figs. 1-16) that is a clip configured for holding a suture body portion (PP [0024]: “The disclosed suture clips can secure a single suture or two or more sutures at the same time. Furthermore, some of the disclosed suture clips include two or more slots or other suture engagement regions, each of which is configured to receive and engage at least one suture independently”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Perkins et al. device according to the teachings of Miraki et al. to include a clip. One of ordinary skill in the art would have been motivated to perform this modification as it is a simple substitution of stop members which would have yielded predictable results, particularly since Perkins et al. contemplates a variety of different forms for the stop element (PP [0032]: “the stop elements 108a, 108b can be the same shapes, sizes, and/or the like (e.g., the same t, w, and l). Further, the stop elements 108a, 108b can be different shapes, sizes, and/or the like”). The Perkins et al. device would not operate differently with the stop member as taught by Miraki et al. because the clip of the Miraki et al. device is also meant to firmly maintain and fix a suture in place (PP [0024]: “The disclosed suture clips can secure a single suture or two or more sutures at the same time. Furthermore, some of the disclosed suture clips include two or more slots or other suture engagement regions, each of which is configured to receive and engage at least one suture independently”), and the combination as proposed would simply hold the sutures of Perkins et al. in place with the clip as taught by Miraki et al. in lieu of the tabs as described.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al. (US PGPub 2020/0405300 A1) in view of Avelar et al. (US PGPub 2011/0264138 A1).
With respect to claim 13, Perkins et al. discloses a method for suturing an opening portion of human or animal tissue in flexible endoscopic surgeries by a suture (PP [0149]: “Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings herein may be readily incorporated into a robotic surgical system such as the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif. Similarly, those of ordinary skill in the art will recognize that various teachings herein may be readily combined with various teachings of U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument,” published Aug. 31, 2004, the disclosure of which is incorporated by reference herein”, the Anderson et al. patent ‘524 as incorporated herein states that “the instrument probe assembly may include parts or components generally similar or identical to parts or components (OEM components) of current or future commercially-available endoscopic instruments for surgical or diagnostic uses” in col. 7, lines 7-11), a suture (see Fig. 1) comprising:
a suture body portion (103a-b in Fig. 1);
one stop member (108a-b, see also close-up in Fig. 2) that is disposed at a center in a lengthwise direction of the suture body portion (103a-b) and prevents the suture body portion from passing through (PP [0004]: “one or more of the suture segments can include anchors, tabs, and/or the like on an end thereof. The anchors, tabs, and/or the like can provide a “stop” (e.g., a stop element) at the end that can increase the holding strength of the suture and further eliminates the need to tie knots to secure the suture”. 108a-b anchors the suture to prevent it from passing through); and
a plurality of protrusion portions (104a-b) that obliquely protrude (PP [0028]: “the first suture segment 102a can include a plurality of barbs or protrusions 104a extending outwardly from the filamentary element 103a. Further, as shown in an example, the second suture segment 102b can include a plurality of barbs or protrusions 104b extending outwardly from the filamentary element 103b”) toward an opposite side to an insertion direction of the suture body portion (see Fig. 3, the barbs 104a-b are oriented obliquely away from their respective stop member portions 108a-b),
wherein the plurality of protrusion portions (104a-b) comprise[:]
a plurality of first protrusion portions (104a) that are disposed on one side (left side in Fig. 3), with the stop member (108a-b) as a reference, in the lengthwise direction of the suture body portion (103a-b), and protrude obliquely toward another side (104a protrudes obliquely in a right-hand direction) and outside of the suture body portion (108a), and
a plurality of second protrusion portions (104b) that are disposed on the other side (right side of 108a-b), with the stop member (108a-b) as the reference, in the lengthwise direction of the suture body portion (103a-b), and protrude obliquely toward the one side (104b protrudes obliquely in a left-hand direction) and outside of the suture body portion (103a-b).
However, Perkins et al. is silent on wherein both ends of the suture body portion are inserted from an outer wall side to an inner wall side of tissue in a vicinity of the opening portion.
In the same field of bidirectional sutures (abstract), Avelar et al. teaches a method of deploying a suture (Fig. 1A) including protrusions on the suture body (see barbs in Figs. 1B-D), two needles on opposite ends of the suture body (see 110 and 112), and a stop member (130), and further teaches a transition section (224 in Figs. 2A-C) between the plurality of protrusions. Avelar et al. further teaches wherein both ends of the suture body portion are inserted from an outer wall side to an inner wall side of tissue in a vicinity of the opening portion (see Fig. 1E, the ends 110 and 112 are inserted from an outer wall of the opening 160 to an inner wall side).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have applied the Avelar et al. method to the suture apparatus disclosed by Perkins et al. such that both ends of the suture body portion are inserted from an outer wall side to an inner wall side of tissue in a vicinity of the opening portion. One of ordinary skill in the art would have been motivated to perform this modification as doing so constitutes the use of a known technique to a similar device ready for improvement to yield predictable results, as the bidirectional suture disclosed by Perkins et al. is structurally similar to that taught by the Avelar et al. reference. Performing the method of Avelar et al. with the device of Perkins et al. therefore would not alter the main operating principle of the Perkins et al. device, which is also intended for approximating tissue through the use of a bidirectional suture (PP [0002]).
Regarding claim 14, Perkins et al. as modified by Avelar et al. further discloses wherein one end of the suture body portion (103a-b in Fig. 1 of Perkins et al.) is inserted from an outer wall side to an inner wall side of tissue in a vicinity of the opening portion (see Fig. 1E of Avelar et al., the ends 110 and 112 are inserted from an outer wall of the opening 160 to an inner wall side) where an opening diameter of the opening portion is maximum (the opening 160 has a maximum diameter), and another end of the suture body portion (103a-b in Fig. 1 of Perkins et al.) is inserted from an outer wall side to an inner wall side of tissue (see Fig. 1E of Avelar et al., the ends 110 and 112 are inserted from an outer wall of the opening 160 to an inner wall side) located on an opposite side to the tissue opening portion where the one end of the suture body portion is inserted (see 160, each section of the suture body portion is on opposite sides of the opening 160).
Regarding claim 15, Perkins et al. as modified by Avelar et al. further discloses wherein the method comprises bring[ing] the tissue in the vicinity of the opening portion (160 in Fig. 1E of Avelar et al.) in the state of being raised by inserting both ends of the suture body portion from an outer wall side to an inner wall side of tissue in a vicinity of the opening portion (160, the suture body 142 and 146 is inserted from an outer wall side to an inner side wall, PP [0068]: “The physician has taken a bite through the tissue 162 on both sides of opening 160”, see Fig. 1E where the tissue is raised by the suture body portion), and closing the opening portion by inserting continuously both ends of the suture body portion to the tissue in the vicinity of the opening portion that is raised (PP [0069]: “The physician wishes to move the transition section 144 so that it is approximately centered upon opening 160 and then pick up needle 112 and take another bite through the tissue on each side of opening 160 moving from right to left”, emphasis added).
Regarding claim 16, Perkins et al. as modified by Avelar et al. further discloses wherein the one stop member (108a-b in Fig. 2 of Perkins et al.) is arranged inserting between outer walls of the opening portion in the tissue (160 in Fig. 1E of Avelar et al.) in the vicinity of the opening portion that is raised (see Fig. 7A, PP [0070]: “The first task for the physician is how to identify section 144, differentiate it from sections 142 and 146 and then center section 144 upon opening 160. If section 144 is provided with markers 154, as shown in FIGS. 1A, 1C the physician can identify section 144, differentiate it from sections 142 and 146 and then pull the suture through until section 144 is centered upon opening 160”, the combination as proposed would place the center stop member 108a-b of Perkins et al. between the raised edges of the opening 160 during tensioning of the suture, see central transition section 144 in Fig. 1A of Avelar et al. which is unmarked but centered over the incision in Fig. 1E).
Conclusion
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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