DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection over Cheng et al. US 2011/0060349 in view of Cappiello et al. US 2014/0326249 as discussed below.
Cappiello et al. discloses a multi-actuated trigger 6208 for advancing a needle assembly or delivery tube 6804, a first actuation of the trigger advances the tube a fixed distance with respect to the elongate portion and a second actuation of the trigger deploys the needle or delivery tube further beyond the leading end (paragraph 0217, figures 69-71; first second and third actuation of the trigger moves the tube 6804 forward with respect to the elongate body 6801), the distances may be controlled by changing the appropriate dimensions of the device components (paragraph 0217).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-4, 6-12, and 17-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cheng et al. US 2011/0060349 in view of Cappiello et al. US 2014/0326249.
Regarding claim 1, Cheng et al. discloses a system for treatment of body tissue (paragraph 0002), comprising: an anchor assembly (paragraph 0024) , the anchor assembly including a first component 350 attached to a connector 352 and a second component 555 attachable to the connector 78 (figure 68); a delivery device 100, the delivery device including a handle 102 (figure 1, paragraph 0090), an elongate portion 104 extending from the handle (figure 1), a trigger 108 on the handle (paragraph 0092), the elongate portion including a leading end (distal end of elongate portion 104, leading end 400, figure 21), a needle tube (tube of elongate member 104 receives needle 230 in needle housing, paragraph 0106, figure 21), and a scope assembly (paragraphs 0088, 0140, scope inserted into device, such as endoscope), a first guide disposed at the leading end (needle 230 is guided through the lateral side opening of the elongate member at leading end 400, through openings in member 104 to exit through the side for insertion into tissue, figure 21), a needle assembly 230 extending through the needle tube (within elongate member 104) and configured to be ejected from the leading end generally perpendicularly to the elongate portion by the first guide (for example, figure 21, paragraph 0114, may further include orientation guides to facilitate placement), and the connector extending through the needle assembly (shown once needle is retracted, figure 26, paragraph 0092, paragraph 0108); wherein the elongate portion includes a connector manipulating element configured to facilitate attaching the connector to the second component after inserting the connector into the body tissue (paragraph 0125), the needle assembly advances to a start position with respect to the elongate portion (figures 21, 22, needle assembly 230 advanced out through the device) and advanced through tissue and beyond (figure 23, through and beyond prostate gland).
Cheng et al. fails to explicitly disclose wherein a first actuation of the trigger advances the needle assembly a fixed distance to a start position with respect to the elongate portion, stopping before it contacts the body tissue, such that a tip of the needle extends beyond the leading end of the elongate portion and is visible via the scope assembly, and wherein a second actuation of the trigger deploys the needle further beyond the leading end and through the body tissue.
Cappiello et al. discloses a multi-actuated trigger 6208 for advancing a needle or delivery tube 6804, a first actuation of the trigger advances the tube a fixed distance with respect to the elongate portion (paragraph 0217, figures 69-70, first actuation of the trigger moves the tube 6804 forward with respect to the elongate body 6801 by three centimeters, Examiner notes that stopping before it contacts the body tissue is functional language and the device may be configured to perform this function depending upon the placement or distance from the tissue) and a second actuation of the trigger deploys the needle or delivery tube further beyond the leading end (paragraph 0217, figures 70-71; second actuation of the trigger moves the tube 6804 forward with respect to the elongate body 6801, Examiner notes that moving through tissue is functional language and the device may be configured to perform this function depending upon the placement or distance from the tissue), the distances may be controlled by changing the appropriate dimensions of the device components (paragraph 0217), any suitable mechanism for the motions may be realized, including changing the number of actuations or distances of travel for each actuation (paragraph 0218).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Cheng et al. with a multi-actuating trigger wherein a first actuation of the trigger advances the needle assembly a fixed distance, configured to stop before it contacts the body tissue, and a second actuation of the trigger is configured to deploy the needle through the body tissue, as taught by Cappiello et al. to further move the needle or deployment tube through tissue to place anchors through tissue as required by a particular procedure or anatomy controlled with a single trigger.
Regarding claims 2 and 3, Cheng et al. further comprises a cutter assembly 514, the cutter assembly including a slot (figure 44, 47, 48, 49, 50; suture capture area 559, slot to receive a connector 550, 555) and includes one or more reflection surfaces (paragraph 0114; reflective surface 518, figure 33, 34), wherein the slot is sized and shaped to receive the connector of the anchor assembly, wherein the connector is placed into engagement with the second component (paragraph 0120), the cutter blade is intended to be offset from a bottom side of the proximal anchor by about .004 inches (paragraph 0119, 0125), the anchor assembly having a customizable length (paragraph 0140), but fails to explicitly disclose the slot having a length of greater than .045 inches.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Cheng et al. to have a slot of greater than .045 inches since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Cheng et al. would not operate differently with a slot of greater than .045 inches and the device would function successfully with the claimed range.
Regarding claim 4, Cheng et al. further discloses a needle (paragraph 0092), wherein the connector and a bore extending through the needle are sized so that the connector is supported about a circumference thereof when within the bore extending through the needle (paragraph 0092, needle assembly loaded with the first and second component, needle moves through and exits the needle housing).
Regarding claim 6, Cheng et al. further comprising a keyhole (figure 48) defined by the cutter assembly 514 wherein a connector indicating feature is added to the keyhole to identify the position of the connector (paragraph 0121, contoured to guide connector into the suture capture area 559 on proximal portion of needle window 557, paragraph 0114 additionally discloses reflective surfaces to improve visualization of the connector when the area is dark).
Regarding claim 7, Cheng et al. discloses wherein the cutter assembly including a window (paragraph 0121).
Regarding claim 8, Cheng et al. discloses wherein the cutter assembly including a window (paragraph 0121, figure 48, 49), wherein reflection surfaces are provided on the window (edge or distal aperture of the window about 559 is configured to provide the reflective tip as claimed, additionally, it is made of a metallic material such as stainless steel, paragraph 0119, which may provide a reflective surface).
Regrading claim 9, Cheng et al. discloses a cutter assembly, the cutter assembly configured to move and stop prior to engaging the connector (paragraph 0034; cutter assembly configured to move with the device prior to severing the connector).
Regarding claim 10, Cheng et al. discloses the cutter assembly further comprises a second guide to center the connector (paragraph 0034).
Regarding claim 11, Cheng et al. discloses a second guide configured to displace the connector perpendicularly with respect to the elongate portion (figures 50, 56, 57, connector 352 is aligned perpendicularly once needle is deployed perpendicularly through the elongate portion).
Regarding claim 12, Cheng et al. discloses the second guide is sliding and spring biased (paragraph 0033, spring driven deployment of needle, needle perpendicular).
Regarding claim 17, Cheng et al. discloses the second component 555 is advanced against the backstop when the second component is being engaged with the connector (paragraph 0125, backstop 583, figure 60).
Regarding claim 18, Cheng et al. discloses the connector manipulating element comprises a temporary restraint positioned to engage the second component (figure 60) and launch the second component from the delivery device (paragraph 0126, anchor actuator assembly is locked or unlocked by the drive 126 including a pusher block and spring).
Regarding claim 19, Cheng et al. discloses a cutter including a cutter tail (figure 48, end of cutter body).
Regarding claim 20, Cheng et al. discloses a cutter assembly configured to be advanced toward a leading end of a spring biased proximal anchor (cutter may be configured to be advanced toward a spring biased proximal anchor, by moving the cutter in the appropriate direction, Examiner notes the spring biased proximal anchor is not claimed, and only must be configured).
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cheng et al. US 2011/0060349 in view of Cappiello et al. US 2014/0326249, as discussed above, and further in view of Whisenant et al. US 2005/0125032.
Regarding claim 5, Cheng et al. discloses a connector 352, but fails to explicitly disclose a portion of the connector includes an over jacket.
Whisenant et al. discloses an anchor component having a connector having an over jacket (paragraph 0156, connector may be coated with coating or over jacket 158) to help promote growth while minimizing thrombosis and embolization or assisting in facilitating closure (paragraph 0156).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Cheng et al. with a connector over jacket, as taught by Whisenant et al. to help promote growth and assist in facilitating closure.
Claim 13-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Cheng et al. US 2011/0060349 in view of Cappiello et al. US 2014/0326249, as discussed above in view of Utsugi US 4452236 and in view of Shiono et al. US 2008/0208220.
Regarding claim 13-16, Cheng et al. discloses a second guide member, but fails to disclose the second guide embodies a looped wire, wherein the second guide embodies an elongate pusher including a recess for the connector (paragraph 0035), the pusher including a spring configured to engage the second component and a recess to receive the second component.
Utsugi teaches a system for treatment of body tissue, comprising an assembly for deployment being perpendicular to the elongate member (figure 3, assembly 31, a treatment tool which may vary according to the specific therapy, thereby comparable to the needle assembly of Tong et al.), a second guide member 32 which is configured to center the connector (for manipulation of the assembly 31, in combination the connector would be deployed through the assembly 31 or the needle assembly), the second guide configured to displace the connector perpendicularly with respect to the elongate portion (pulled by control wire 38 to move the member 32 from the dashed lines, to the solid line in as indicated in figure 3, moving the assembly 31 perpendicular to the elongate portion through channel 27 and perpendicularly through the exit of the device). Utsugi teaches an elastic or spring guide member 32 having a variety of configurations for displacing the assembly 31 (for example, figures 6-9), but fails to disclose guide being sliding and spring biased, embodies a looped wire, or embodies an elongate pusher including a recess for the connector, the pusher including a spring configured to engage the second component.
Shiono et al. teaches a system for treatment of body tissue having a first component 2A, a
second component 2B and a connector 3 (figure 2), a delivery device (figure 1) having a guide 10, the
guide is sliding and spring biased (paragraph 0064, guide 10 advances and retreats within needle with
spring 15), the guide embodies a looped wire (loop around guide 10, figure 7), a pusher including a
spring configured to engage the second component (figures 1, 7, pusher 10 with spring 15) in order to
slide a pusher member for placing first and second anchor components and connecting member.
Therefore, it would have been obvious to one having ordinary skill in the art before the
invention was made to modify Cheng et al. with a second guide configured to displace the connector perpendicularly with respect to the elongate portion, as taught by Utsugi, and with the guide being sliding and spring biased, the guide embodies a looped wire, or a pusher including a spring configured to engage the second component, as taught by Shiono et al. as known guide or pusher configurations for operating and delivering an anchor having a first component, second component and connector.
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.
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/C.C.L/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771