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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-19 and 21 have been considered but are moot because the new ground of rejection over Gertner US 2006/0142790 in view of Samuels et al. US 3976079 as discussed below.
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.
Claims 3, 7, 10, 14 and 21 are 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.
Claim 3 recites the limitation " the first anastomosis device " in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation " the second anastomosis device " in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claims 7 and 14 recites the limitation “the distal end of the button member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner further notes amended claim 1 discloses similar language comprising “to position the opposing distal end of the button member against the second opposing side of the distal tissue” in lines 13-14.
Claim 10 recites the limitation " the first anastomosis device " in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation " the second anastomosis device " in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claims 21 recites the limitation “the distal end of the button member" in line 10. There is insufficient antecedent basis for this limitation in the claim.
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) 1- 4, 7, 9-11, 14-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gertner US 2006/0142790 in view of Samuels et al. US 3976079.
Regarding claims 1, 2, 7, 11, 14, 16 and 17, Gertner discloses a compression securement apparatus for assisting in placing and securing an anastomosis device at a desired target site within a patient (paragraph 0025, 0026, 0084, 0124, approximating body lumens, positioning material between first and second portions and creating pressure or compression), the securement apparatus comprising:
a first compression anastomosis device (posterior anchor, for example, device 49, 92, 330 or 520) for placement on a first side of a distal tissue at a target site having an enterotomy within the patient (for example, paragraph 0025, first expandable element; expandable elements 49, figure 1L; 92, figure 3C-3I; figure 8A, 330; or figure 13A, 510);
one or more guide elements (for example, figure 1, connector 47; figure 3C, connector or guide element 12; figure 8A, connector 332; figure 12B, connector or guide element 333) attached to the first compression anastomosis device (for example, shown in figures 3A-3I showing multiple expandable anchors, figure 8A, or figure 13A), a button member (for example, 51, 72, 94, 336, 550, figures 1L, 3A-3I, 8B13A) comprising a body having a proximal end, an opposing distal end, and a central aperture extending entirely therethrough (for example, see annotated figure 3C below, similar anchors shown in figures 1L, 3A-3I, 13A; connector extends therethrough central aperture receiving connector or guide), wherein the aperture is shaped and/or sized to receive the one or more guide elements therethrough (figures 1L, 3A-3I, 13A; for example, see annotated figure 3C below), wherein the button member configured to translate along the one or more guide elements toward a second opposing side of the distal tissue at the target site within the patient to position the opposing distal end of the button member against the second opposing side of the distal tissue at the target site within the patient with the button member centered relative to the enterotomy (button member slidable along connector and configured to be placed against the opposing side of the distal tissue site, may be centered relative to the enterotomy as the button is centered on the guide placed through the enterotomy; Examiner notes this is functional language and the apparatus comprises the structure configured to be placed as claimed) and the first anastomosis device on the second opposing side of the distal tissue at the target site when the first compression anastomosis device is placed on the first side of the distal tissue at the target site within the patient (for example, paragraph 0025, 0027, compression devices or expandable elements are slidable along connector, expandable elements configured to be expanded on a first and second side of an enterotomy) with the one or more guide elements passing back through the enterotomy in the distal tissue at the target site and received through the central aperture of the button member with the distal end of the button member oriented toward the target site (for example, fig. 1:, 47 extends between anastomosis members; fig. 3I, anchors along connector placed within tissue organs; fig. 14B, 333 extends between anchors 510, 550; Examiner notes the anchors or compression devices may be used in alternate embodiments, such as with an enterotomy as shown in figure 3A-3I, paragraph 0121), wherein the opposing distal end of the button member is configured to be wider than the enterotomy (for example, compression device is the size of the enterotomy, therefore, would be configured to be wider when expanded, shown in figures 3A-3I, 14A, button member is larger than opening so can compress tissue); and a plug member 74 comprising a distal end and an opposing proximal end (for example, figure 3C, distal end adjacent compression device 72, opposite end being the proximal end). Examiner notes various embodiments are disclosed which may read on the claim language, and the various embodiments may be used interchangeably for various locations, as they include an anterior and posterior anchor with a connection there between as desired (paragraph 0084).
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Gertner teaches a plug member 74 to secure the compression device with the guide member and also prevents the button from moving along the guides away from the anastomosis when the plug member is crimped along the button member (paragraph 0116, plug engages connector and can no longer move along the length and prevents the compression device from moving at least in one direction), but fails to explicitly disclose wherein the distal end of the plug member is shaped and/or sized to be received within at least the proximal portion of the central aperture of the button member to be retained therein via a friction fit to secure the one or more guide elements and the first anastomosis device in place, wherein the plug member is tapered in width such that the proximal end is wider than the distal end.
Samuels et al. discloses a securement apparatus (for example, figures 2, 3) comprising a button
member 34 having a body (figures 4, 10 and 11), an aperture (with channel 52, figures 4, 10 and 11) for receiving one or more guide elements 24 (figures 2, 9) and a plug member 67 comprising a distal end and an opposing proximal end (for example, distal end 68 and proximal end 66, figure 11), wherein the distal end of the plug member is shaped and/or sized to be received within at least the proximal portion of the central aperture of the button member by a friction fit (for example, figure 11, plug member compresses the suture against the retainer body, thereby resulting in a frictional fit) to be retained therein to secure the one or more guide elements and the first anastomosis device in place against a tissue and/or organ wall (figure 2, column 4, lines 42-51; suture is held against the body to hold in place), the plug secures the one or more guides and also prevents the button from moving along the guides away from the anastomosis when the plug member is retained in the button member (column 4, lines 42-51; suture is held against the button body to hold in place), and wherein the plug member is tapered in width such that the proximal end is wider than the distal end (for example, figure 11, portion 68 tapers to an end portion within channel 52, portion 66 wider than the end portion 68).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Gertner with a suture retaining member comprising a button and a plug member comprising a distal end and an opposing proximal end, wherein the distal end of the plug member is shaped and/or sized to be received within at least the proximal portion of the central aperture of the button member to be retained therein to secure the one or more guide elements and the first anastomosis device, wherein the plug member is tapered in width such that the proximal end is wider than the distal end to insert the plug into the aperture, as taught by Samuels et al. as a known simple substitution of one known element for another to obtain predictable results for securing and releasably retaining a suture or guide members for an anastomosis against tissue and/or organ wall.
Regarding claims 3 and 10, Gertner further comprising a second compression anastomosis device configured for magnetically coupling with the first compression anastomosis device within the patient (paragraph 0025, at least two compression or expandable elements slidable along the connector, paragraph 0030, expandable element or compression anastomosis devices may be are produced from magnetic material), wherein the button member is shaped and/or sized to be positioned between the first anastomosis device and the second anastomosis device when the second anastomosis device is magnetically coupled with the first anastomosis device within the patient (paragraphs 0030, 0136, expandable element or compression anastomosis devices may be are produced from magnetic material, for example, figure 3I shows a third anastomosis device, 94, 92 and 104 therebetween which may be magnetic or have adhesive therebetween).
Regarding claim 4, Gertner discloses wherein the opposing distal end of the button member has a substantially flat surface. (for example, figure 1L, 3C).
Regarding claim 9, Gertner discloses wherein the one or more guide elements are coupled to the first anastomosis device using an adhesive or fastener (for example, paragraph 0093, 0094, 0100; connected at attachment point 16, welded or molded connection or other suitable means of fastening, connection of suture or guide element to the posterior anchor may be by any mechanical means in the art).
Regarding claim 15, Gertner discloses wherein each of the button member and plug member comprises a medical grade material (paragraph 1117, button or anterior anchor is made from biocompatible material or other suitable materials), but fails to explicitly disclose the material of the plug member. It would have been obvious to one having ordinary skill in the art at the time
the invention was made to medical grade material, since it has been held to be within the general skill of
a worker in the art to select a known material on the basis of its suitability for the intended use as a
matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 18 and 19, Gertner discloses wherein the guide elements are sutures or guidewires (for example, figure 0068, figure 12B, paragraph 0091, connector or guide element 12 is a surgical suture, paragraph 0100, connector is a suture; Examiner notes the suture or connector may be considered a guidewire, as it guides a first and/or second compression member over the guide into the target location).
Regarding claim 21, Gertner discloses a method of securing a compression anastomosis, the compression securement apparatus for assisting in placing and securing an anastomosis device at a desired target site within a patient (paragraph 0025, 0026, 0084, 0124, approximating body lumens, positioning material between first and second portions and creating pressure or compression), the securement apparatus according to claim 1 (as discussed above),
delivering the first compression anastomosis device of the securement apparatus through an enterotomy to a target within the patient at the first side of the distal tissue (for example, paragraph 0025, 0121; through a penetration or otomy of the gastrointestinal organ; first expandable element; expandable elements 49, figure 1L; 92, figure 3C-3I; figure 8A, 330; or figure 13A, 510),
the first compression anastomosis device is coupled to the one or more guide elements of the securement apparatus (for example, figure 1, connector 47; figure 3C, connector or guide element 12; figure 8A, connector 332; figure 12B, connector or guide element 333), that pass back through the enterotomy and through the central aperture of the button member of the securement apparatus with the distal end of the button member oriented toward the target site (for example, fig. 1:, 47 extends between anastomosis members; fig. 3I, anchors along connector placed within tissue organs; fig. 14B, 333 extends between anchors 510, 550; Examiner notes the anchors or compression devices may be used in alternate embodiments, such as with an enterotomy as shown in figure 3A-3I, paragraph 0121), translating the button member along the one or more guide elements toward the target site within the patient to position the button member relative to the target site and the first compression device such that the distal end of the button engages with the second opposite side of the distal tissue (for example, paragraph 0025, 0027, compression devices or expandable elements are slidable along connector, expandable elements to be expanded on a first and second side of an enterotomy, may be placed on both sides of a tissue, the sides may be each side or opposite sides of the organ lumen having an otomy)
inserting the plug member of the securement apparatus 74 along the central aperture of the button member to secure the one or more guide members with the button member and the first compression anastomosis device respectively secured against the first side and the second opposing side of the distal tissue at the target site (paragraph 0116, plug engages connector and can no longer move along the length and prevents the compression device from moving at least in one direction), but fails to explicitly disclose wherein the distal end of the plug member is received within at least the central aperture of the button member. Examiner notes various embodiments are disclosed which may read on the claim language, and the various embodiments may be used interchangeably for various locations, as they include an anterior and posterior anchor with a connection there between as desired (paragraph 0084).
Samuels et al. discloses a securement apparatus (for example, figures 2, 3) comprising a button member 34 having a body (figures 4, 10 and 11), an aperture (with channel 52, figures 4, 10 and 11) for receiving one or more guide elements 24 (figures 2, 9) and a plug member 67 comprising a distal end and an opposing proximal end (for example, distal end 68 and proximal end 66, figure 11), wherein the distal end of the plug member is shaped and/or sized to be received within at least the proximal portion of the central aperture of the button member by a friction fit (for example, figure 11, plug member compresses the suture against the retainer body, thereby resulting in a frictional fit) to be retained therein to secure the one or more guide elements and the first anastomosis device in place against a tissue and/or organ wall (figure 2, column 4, lines 42-51; suture is held against the body to hold in place), the plug secures the one or more guides and also prevents the button from moving along the guides away from the anastomosis when the plug member is retained in the button member (column 4, lines 42-51; suture is held against the button body to hold in place), and wherein the plug member is tapered in width such that the proximal end is wider than the distal end (for example, figure 11, portion 68 tapers to an end portion within channel 52, portion 66 wider than the end portion 68).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Gertner with a suture retaining member comprising a button and a plug member comprising a distal end and an opposing proximal end, wherein the distal end of the plug member is received within at least the proximal portion of the central aperture of the button member to be retained therein to secure the one or more guide elements and the first anastomosis device, as taught by Samuels et al. as a known simple substitution of one known element for another to obtain predictable results for securing and releasably retaining a suture or guide members for an anastomosis against tissue and/or organ wall.
Claim(s) 5, 6, 8, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gertner US 2006/0142790 in view of Samuels et al. US 3976079 and further in view of Li et al. US 5258015.
Regarding claims 5, 6, 12 and 13, Gertner discloses the button member may have various shapes as other embodiments are possible (paragraph 108), but fails to explicitly disclose wherein the proximal end of the button member has a sloped shape or a dome shape, wherein at least the proximal portion of the central aperture tapers in width from a proximal-most opening of the central aperture adjacent to the proximal end of the button member towards a distal-most opening of the central aperture adjacent to the distal end of the button member.
Li et al. teaches a securement apparatus, comprising a first compression device 4 (figures 1), one or more guides (for example, figure 1, guide or filament 6; figure 5, guide or filament 90, figure 7, guide or filament 110) and a second compression device 10 comprising a cap or button (figure 1, 10, or figure 5, 92), the button comprising a sloped shape or dome shape (figures 1, 5, 7), wherein at least the proximal portion of the central aperture tapers in width from a proximal-most opening of the central aperture adjacent to the proximal end of the button member towards a distal-most opening of the central aperture adjacent to the distal end of the button member (for example, figure 7, column 6, lines 34-40; line 59-column 7, line 2; tapered hole 118 to receive wedging sleeve 114).
Therefore, it would have been an obvious matter of design choice to provide a sloped shape or dome shape since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Additionally, it would have been obvious to modify the central aperture to have a taper in width from a proximal-most opening of the central aperture adjacent to the proximal end of the button member towards a distal-most opening of the central aperture adjacent to the distal end of the button member, as taught by Li et al., to receive a locking plug to increase contact more firmly with the guide or filament to move into the locking configuration.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C.L/ Examiner, Art Unit 3771
/DARWIN P EREZO/ Supervisory Patent Examiner, Art Unit 3771
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